JP5334850B2 - Method, system and apparatus for reducing internal tissue pore size - Google Patents

Abstract

A medical system for treating an internal tissue opening can include a closure device and associated delivery device. The closure device can include a body portion operatively associated with a first anchor and a second anchor. The body portion can include a plurality of segments defining a multi-cellular structure. A segment can define a variable width along a length of the segment to have a substantially equal stress level along the length when deflected. The closure device can be configured to apply lateral force to tissue of the internal tissue opening to bring tissue together for closure. The closure device can have a substantially flat aspect, and have a depth thickness that is substantially greater than the thickness or width of a majority of the members forming the closure device. The closure device can also include a member adapted to induce tissue growth.

Description

  The present invention relates to medical devices and methods for treating internal tissue structures. More particularly, the present invention relates to medical devices, systems and methods that reduce the size of internal tissue holes.

  Physical malformations or defects present at birth can be harmful and even cause death if left uncorrected. PFO (Patent Foramen Oval) is an example of a congenital heart defect that can be problematic and is associated with other factors such as blood clots or other congenital heart defects This can even cause death. PFO occurs when the opening between the two upper chambers of the heart cannot be closed after childbirth.

  Some of the problems with PFO can occur when a blood clot moves from the right atrium of the heart to the left atrium through the PFO and collects in an artery that supplies blood to the brain. Clots in the left atrium can pass through the aorta and migrate to the brain or other organs, causing embolism, stroke, or heart attack. The PFO is treated by being closed by a surgical procedure. In addition, other similar defects (eg, septum or others) that require some tissue to be closed in order to function properly are: atrial septal defects (ASD), ventricular septum General categories such as defects (ventricular-septal defects, VSD) and patent ductus arteriosus can be included.

  1A-1C show various views of a heart with PFO. The heart 10 is shown in cross section in FIG. 1A. In a normal heart 10, the right atrium 30 receives systemic venous blood from the superior vena cava 15 and the inferior vena cava 25 and then delivers blood to the right ventricle 60 via the tricuspid valve 35. However, in the heart 10 shown, a septal defect, shown as PFO 50, exists between the right atrium 30 and the left atrium 40.

  The PFO 50 is shown as an open flap over the septum between the right atrium 30 and the left atrium 40 of the heart. In a normal heart 10, the left atrium 40 receives oxygenated blood from the lungs via the pulmonary artery 75 and then delivers blood to the left ventricle 80 via the mitral valve 45. In the heart 10 having a PFO 50, some systemic venous blood also flows from the right atrium 30 through the PFO 50, mixes with oxygenated blood in the left atrium 40, and then passes through the left aorta 85 to the ventricle 80. Sent to the body.

  During fetal development of the heart 10, the interventricular septum 70 divides the right ventricle 60 and the left ventricle 80. In contrast, the atrium is only partially divided into the right and left chambers during normal fetal development, creating a foramen ovale that fluidly connects the right and left atrial chambers. As shown in FIG. 1B, the incomplete fusion of the primary septum 52 with the secondary septum 54 of the atrial wall can result in a passageway 58, shown as PFO 50.

  FIG. 1C provides an illustration of a crescent-shaped overhanging configuration of the secondary septum 54 from within the right atrium 30 in the heart 10 with the PFO 50. The secondary septum 54 is defined by a lower surface 55 corresponding to the solid line in FIG. The secondary septum 54 and the primary septum 52 merge at the end of the secondary septum 54. The front end 56a and the rear end 56p are referred to herein as “merger points” for the secondary septum 54 and the primary septum 52. The length of the overhang of the secondary septum 54 (which is the distance between the upper surface 53 and the lower surface 55) increases toward the central portion of the secondary septum as shown.

  The passage 58 between the right atrium 30 and the left atrium 40 is defined by the portion of the primary septum 52 and the secondary septum 54 between the fusion points 56a and 56p that could not be fused. The passage 58 is often at the apex of the secondary septum 54 as shown. When viewed in the right atrium 30, the portion of the secondary septum 54 to the left of the passage 58 (referred to herein as the posterior portion 57p of the secondary septum) is the secondary to the right of the passage 58. It is longer than the portion of the septum 54 (referred to herein as the anterior portion 57a of the secondary septum 54). In addition to being usually long, the rear portion 57p also typically has a more tapered taper than the front portion 57a, as shown. The front pocket 59a is the area defined by the overhang of the front portion 57a of the secondary septum 54 and the primary septum 52, and the front pocket 59a extends from the front fusion point 56a toward the passageway 58. Similarly, the rear pocket 59p is an area defined by the overhang of the rear portion 57p of the secondary septum 54 and the primary septum 52, and the rear pocket 59p extends from the front fusion point 56p toward the passage 58. .

  Conventional treatments for PFO and other related conditions generally involve invasive surgery, which also presents risks to the patient. Although there are some less invasive treatments for PFO, such treatments have been less effective at closing PFO openings compared to techniques involving invasive surgery.

US Provisional Application No. 60 / 821,947 US Provisional Application No. 60 / 821,949 US Provisional Application No. 60 / 829,507 US Provisional Application No. 60 / 866,047 US Provisional Application No. 60 / 942,625 US Patent Application No. 11 / 8836,000 US patent application Ser. No. 11 / 836,016 US patent application Ser. No. 11 / 836,037 US patent application Ser. No. 11 / 836,051 US patent application Ser. No. 11 / 836,013 US patent application Ser. No. 11 / 836,026 US patent application Ser. No. 11 / 836,123

  The present invention relates to medical systems, devices and methods for reducing the size of internal tissue pores, such as Patent Foramen Oval (PFO).

  In one embodiment of the invention, the medical system can include an occlusive device and an associated delivery device. The medical system is configured to allow medical personnel to selectively position an occlusive device within the internal tissue hole and deploy it near the tissue in the hole.

  In accordance with one embodiment of the present invention, the closure device can include a multi-cell body portion that is operably coupled to the first anchor and the second anchor. The multi-cell body portion is configured to allow the closure device to contract into and expand into a relatively narrow undeployed configuration without plastic deformation or failure. The first and second anchors may be configured to engage at least a portion of tissue, such as a wall of an internal tissue hole and / or a passage tissue of the hole.

  In one embodiment of the present invention, the occlusion device can include a growth material to facilitate tissue growth. The occlusion device can also include one or more indicators to facilitate assessment of the position and / or orientation of the occlusion device relative to the internal tissue hole.

  In accordance with the present invention, the transport device can include a transport assembly, an actuation assembly, and a release assembly operably coupled to the handle body. In one embodiment of the invention, the transport assembly facilitates selective delivery of the closure device from the transport device and is operatively coupled to the actuation assembly and release assembly. The actuation assembly interacts with the handle body to selectively deploy the closure device from the delivery assembly. In one embodiment of the invention, the actuating assembly is configurable to deploy at least a portion of the occlusion device with a first movement and to deploy a second portion of the occlusion device with a second movement. The release assembly can be coupled to the handle body to facilitate detachment of the closure device from the delivery device.

  In one embodiment, the closure device is coupled to the delivery device by one or more tethers and one or more wires, the tethers are coupled to the handle body, and the wires are coupled to the biasing member of the release assembly. The tether can be configured to receive a portion of the closure device within the tether to facilitate securing the closure device to the delivery device. The wire is removably coupled to the closure device to allow selective disconnection of the closure device from the delivery device by movement of the biasing member.

  These and other objects and features of the invention will become more apparent from the following description and appended claims, and may be understood by the embodiments of the invention described hereinafter.

  In order to further clarify the above and other advantages and features of the present invention, a more detailed description of the invention is provided by reference to specific embodiments illustrated in the accompanying drawings. It is understood that these drawings depict only typical embodiments of the invention and therefore should not be considered as limiting the scope of the invention. The invention will be described and explained with additional specificity and detail through the accompanying drawings.

1 is an exemplary view of a heart having a patent foramen ovale. 1 is an exemplary view of a heart having a patent foramen ovale. 1 is an exemplary view of a heart having a patent foramen ovale. 6 is a flowchart illustrating a method for reducing the size of an internal tissue hole in one embodiment. FIG. 3 is a schematic diagram illustrating a process of placing an obturator against an internal tissue hole using the obturator in one embodiment. Schematic which shows the process of arrange | positioning the 1st part of the obstruction | occlusion instrument in one Example. FIG. 3 is a schematic diagram illustrating the process of placing a second portion of an occlusion device and an internal tissue hole having a reduced size in one embodiment. FIG. 3 is a schematic diagram showing a step of releasing the closure device from the transport device in one embodiment. The figure which shows the medical system by this invention. 1 shows a closure device according to the present invention. 1 shows a closure device according to the present invention. 1 shows a closure device according to the present invention. The figure which shows the conveying apparatus in one Example. Sectional drawing which shows the conveying apparatus in one Example. Sectional drawing which shows the conveying apparatus in one Example. Sectional drawing which shows the conveying apparatus in one Example. Sectional drawing which shows the conveying apparatus in one Example. The exploded view of the conveyance apparatus in one Example. The figure which shows the Example of the obstruction | occlusion instrument partially expanded within the internal tissue hole. FIG. 9B illustrates the transport device in a direction corresponding to the partially deployed closure device of FIG. 9A in one embodiment. The exploded view of the closure device in one Example. The exploded view of the closure device in one Example. The figure which shows the state of the conveying apparatus when the obstruction | occlusion instrument in one Example is released. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. 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Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. Schematic of the closure device in this invention. The figure which shows conveyance of the obstruction | occlusion instrument using the front-end | tip and / or proximal end locator apparatus in this invention. The figure which shows conveyance of the obstruction | occlusion instrument using the front-end | tip and / or proximal end locator apparatus in this invention. The figure which shows conveyance of the obstruction | occlusion instrument using the front-end | tip and / or proximal end locator apparatus in this invention. The figure which shows conveyance of the obstruction | occlusion instrument using the front-end | tip and / or proximal end locator apparatus in this invention. The figure which shows conveyance of the obstruction | occlusion instrument using the front-end | tip and / or proximal end locator apparatus in this invention. The figure which shows conveyance of the obstruction | occlusion instrument using the front-end | tip and / or proximal end locator apparatus in this invention. The figure which shows conveyance of the obstruction | occlusion instrument using the front-end | tip and / or proximal end locator apparatus in this invention. The figure which shows conveyance of the obstruction | occlusion instrument using the front-end | tip and / or proximal end locator apparatus in this invention. The figure which shows conveyance of the obstruction | occlusion instrument using the front-end | tip and / or proximal end locator apparatus in this invention. The figure which shows conveyance of the obstruction | occlusion instrument using the front-end | tip and / or proximal end locator apparatus in this invention. The figure which shows the expandable obstruction | occlusion device in this invention. The figure which shows the expandable obstruction | occlusion device in this invention. The figure which shows the expandable obstruction | occlusion device in this invention. The figure which shows the expandable obstruction | occlusion device in this invention. The figure which shows the expandable obstruction | occlusion device in this invention. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the releasing mechanism in some Examples. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the conveying apparatus in this invention. The figure which shows the structure which accelerates | stimulates the growth of the structure | tissue in some Examples. The figure which shows the structure which accelerates | stimulates the growth of the structure | tissue in some Examples. The figure which shows the structure which accelerates | stimulates the growth of the structure | tissue in some Examples. The figure which shows the structure which accelerates | stimulates the growth of the structure | tissue in some Examples. The figure which shows the structure which accelerates | stimulates the growth of the structure | tissue in some Examples. The figure which shows the structure which accelerates | stimulates the growth of the structure | tissue in some Examples. 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  The present invention relates to medical systems, methods and devices for reducing the size of internal tissue holes. According to the description, the devices disclosed herein can be used to treat various internal tissue holes such as, for example, left atrial appendages, paravalvular leaks, PDAs, and VSDs. However, for the sake of brevity, references are often made to reduce the size of the opening in the heart tissue known as patent ductus arteriosus (PFO) or to close the opening. Accordingly, it will be understood that references to PFO openings do not limit the present invention.

  In the following description, numerous specific details are set forth to assist in enabling an understanding of the present invention. In other instances, aspects of the delivery device and / or the closure device or medical device as a whole have not been described in particular detail to avoid unnecessarily obscuring the present invention. Moreover, the drawings are diagrammatic and schematic representations of some embodiments of the invention and are not intended to limit the invention, and the drawings are not necessarily drawn to scale.

  In at least one embodiment, the disclosed occluding device provides a force to occlude the pores associated with the PFO and allows the occlusion of the pores over time during the natural healing process. When placed, the closure device has a flat surface with a thin wall that is wide and long. The length of the instrument corresponds to the length of the internal tissue hole, i.e. the length of the passage of the internal tissue hole. The instrument width corresponds to a dimension that substantially intersects the instrument length.

  The occlusion device comprises an expandable multi-cell structure configured to apply a lateral force to the wall of the internal tissue hole. In one embodiment, the lateral force increases the width of the passage to sufficiently reduce the passage height of the internal tissue hole to reduce its size and close the internal tissue hole. Depending on the structural characteristics of the device, the flat surface will not bend, i.e. the flat surface will not roll up, preventing or substantially preventing the device from trying to push the PFO open rather than closing it. Limit to. This property is shown in FIG. 1E in that the struts are in a preferred bending direction oriented parallel to the plane of the instrument and in a preferred non-bending direction oriented perpendicular to the plane of the instrument. The details are described later.

  In the following description, numerous specific details are set forth to assist in enabling an understanding of the present invention. In other instances, aspects of the delivery device and / or the closure device or medical device as a whole have not been described in particular detail to avoid unnecessarily obscuring the present invention. Further, the drawings are diagrammatic and schematic representations of some embodiments of the invention, are not intended to limit the invention, and are not necessarily drawn to scale. Is done.

  FIG. 2 is a flowchart illustrating a method for reducing the size of an internal tissue hole according to one embodiment. Each process is introduced after each process is described with respect to the schematic shown in FIGS. 3A-3D. The method begins at step S80, where an occlusive device is first placed against the internal tissue hole. In at least one embodiment, the step of initially placing the closure device relative to the internal tissue hole uses a delivery device configured to hold the closure device at the distal end and the user at the proximal end. Allowing the deployment of the closure device to be controlled.

  The occlusion devices described herein include retractable multi-cell occlusion devices that are housed in a deflated state within a delivery device and are positioned relative to an internal tissue hole. Furthermore, such a configuration of the closure device allows the closure device to transition between a non-expanded state, that is, a compressed state, and a deployed state, that is, an uncompressed state, without causing malfunction, ie, plastic deformation.

  The method continues with placing a first portion of the closure device using a transport device in step S81. Arrangement of the first portion of the closure device includes expanding at least one of the cell portions from a contracted position to an expanded position within the transport device. Furthermore, in step S82, the arrangement of the second portion of the closure device may optionally include a step of expanding another cell portion from the contracted state to the expanded state in the transport device. It is also possible to arrange a plurality of cell portions in a plurality of steps as required.

  With reference to FIG. 3A, regardless of the number of steps for placing the closure device, once placed, the closure device exerts a force on the internal tissue hole to close the hole. When the closure device is positioned to close the internal tissue hole, the closure device is released from the transport device in step S83, and the transport device is recovered in step S84. The various steps of the method shown in FIG. 2 are described in a schematic diagram.

  FIG. 3A is a schematic diagram illustrating a process of placing the closure device 90 with respect to the internal tissue hole 91 using the transport device 92 (process S80). The internal tissue hole 91 is shown as a hole having a passage extending from the proximal surface to the distal surface. For ease of reference, the distance between the proximal surface and the distal surface can also be expressed as the length of the internal tissue hole 91.

  As described above, the dimension of the closure device 90 corresponding to the length of the internal tissue hole 91 is expressed as the length of the closure device 90. When placed, the closure device 90 expands, applying a lateral force against the wall of the internal tissue hole 91 to reduce the size of the hole. The direction in which the closure device 90 expands may be expressed as the width of the closure device 90. In at least one embodiment, the closure device 90 may be substantially flat across its width when in the contracted and expanded states described below.

  In the present embodiment, the transport device 92 includes a distal end portion 92a and a proximal end portion 92b. The transport device 92 further includes a transport assembly 93 near the distal end 92a and an actuating assembly 94 and a release assembly 95 near the proximal end 92b. The closure device 90 includes a plurality of foldable cells that expand to the expanded state described above. The closure device 90 is shown in a contracted state within the transport assembly 93. Therefore, the step of disposing the closure device 90 with respect to the internal tissue hole 91 includes a step of disposing the distal end portion 93 a of the transport assembly 93 in the vicinity of the internal tissue hole 91.

  When placed in the transport assembly 93, the closure device 90 is connected to a pressing member 96 that is coupled to the control anchor 97. The transport assembly 93 is coupled to a control assembly 98a and a control assembly 98b that are part of the closure device 90. In one embodiment, when the control anchor 97 is advanced, the control assemblies 98a, 98b and the transport assembly 93 are held fixed together. When the control anchor 97 moves forward with respect to the control assemblies 98a and 98b and the transport assembly 93, the control anchor 97 drives the pressing member 96, and the pressing member 96 presses the closing device 90 against the transport assembly 93 in the distal direction. .

  As shown in FIG. 3B, the control anchor 97 is advanced until it contacts the first control assembly 98a and the first portion 90a of the closure device 90 is withdrawn from the distal end 93a of the transport assembly 93. . When the first portion 90a of the closure device 90 is withdrawn from the transport assembly 93, the first portion 90a is deployed by being expanded from the compressed state shown in FIG. 3A to the expanded state shown in FIG. 3B. . In the example of FIG. 3B, the transport assembly 93 at least partially penetrates the internal tissue hole 91 and transports the first portion 90a of the closing device 90 to the distal end side of the internal tissue hole 91 (step S81). Next, the first portion 90 a is pulled out so as to contact the tip opening of the internal tissue hole 91.

  Thereafter, when the control anchor 97 comes into contact with the first control assembly 98a, the control anchor 97 and the first control assembly 98a move together relative to the second control assembly 98b and the transport assembly 93, thereby causing the occlusion device to move away from the transport assembly 93. Draw 90 more. In particular, as shown in FIG. 3C, the control anchor 97 and the first control assembly 98a are driven until the first control assembly 98a contacts the second control assembly 98b. In at least one embodiment, this distance allows the closure device 90 to be fully pressed from the distal end 93a of the transport assembly 93 so that it can be fully deployed (step S82).

  When the closure device 90 is fully deployed, at least the second portion 90b of the closure device 90 expands outward within the internal tissue hole 91. When the second portion 90b expands outward, the width of the second portion 90b expands and a lateral force is applied to the internal tissue hole 91. This lateral force is applied so as to substantially follow the width of the internal tissue hole 91. When the second portion 90b further spreads, a part of the side surface of the illustrated internal tissue hole is pulled away, and a part of the upper portion and the lower portion of the internal tissue hole 91 approach each other. As a result, the internal tissue hole 91 contracts and closes.

  When the closure device 90 is fully deployed, the third portion 90 c of the closure device 90 is disposed on the proximal side of the internal tissue hole 91. As described above, the first portion of the closure device 90 can be disposed on the distal end side of the internal tissue hole 91. When fully deployed, the third portion 90 c is disposed on the proximal side of the internal tissue hole 91. With such a configuration, the possibility of the closure device 90 moving in the internal tissue hole 91 is reduced.

  When the internal tissue hole 91 is closed, the closing device 90 is released from the transport device 92 as shown in FIG. 3D (step S83). As shown in FIGS. 3A-3D, the released portion 95 of the transport device 92 moves with the pressing member 96 during deployment of the closure device 90. Release coupler 99 couples release assembly 95 to closure device 90. In one embodiment, the release assembly 95 moves proximally relative to the actuation assembly 94 to release the closure device 90. As the release assembly 95 moves proximally, the release coupler 99 releases the closure device 90 from the transport device 92, in particular the transport assembly 93. Details of the plurality of release configurations will be described later.

  Thus, the system is configured to deploy the closure device to close the internal tissue hole. The following is a detailed description of the medical system, including details on exemplary delivery devices and closure devices. A description of other occlusive devices follows the description of in-grow material configurations that can be used in the occlusive device. Next, other delivery devices are described along with a plurality of release assemblies that can be used with the closure device.

  One configuration of relative movement between multiple control assemblies and control anchors has been described with respect to multi-stage deployment of an occlusion device 90 that includes multiple cells. In addition to the movements described above, the closure device 90 can be deployed by moving any number of control assemblies and / or control anchors in any order. The plurality of delivery devices shown herein are configured to fully deploy the closure device 90. Each of the components can be combined as needed. It is not limited to use with the devices and assemblies described herein.

  FIG. 4 is a perspective view of a medical system 100 configured to facilitate closure of an internal tissue hole, according to one embodiment of the present invention. In the illustrated example, the medical system 100 is adapted to facilitate the installation and deployment of the closure device 200 with respect to the internal tissue hole and the closure device 200 adapted to reduce the size of the internal tissue hole. A transport apparatus 300. The medical system 100 of the present invention can provide a number of advantages. For example, the medical system 100 can be configured to be used with different sizes, shapes, and types of internal tissue holes. In addition, the medical system 100 can provide various safety measures to increase the safety and efficiency of positioning the closure device 200. Further, the medical system 100 can be configured to provide a distributed lateral force against the tissue of the internal tissue hole.

  In the illustrated example, the transport device 300 includes a handle body 302, an actuation assembly 320 operatively coupled to the handle body 302, a release assembly 340 operatively coupled to the handle body 302, an actuation assembly 320, and a release assembly 340. And a transport assembly 360 operatively coupled to the handle body 302. The handle body 302 can be configured to provide a gripping surface for the user. The handle body 302 can be used to position the closure device 200 and facilitate deployment of the closure device 200 from the transport assembly 360. As described in more detail herein below, the actuation assembly 320 can move relative to the handle body 302 to selectively deploy a predetermined portion of the closure device 200 from the transport assembly 360. For example, as described below, the actuation assembly 320 is configured to receive actuation input from a user to deploy the closure device 200 in one or more stages.

  The transport assembly 360 houses the closure device 200 in a non-deployed orientation to facilitate deployment of the closure device 200. The delivery assembly 360 includes one or more tethers 364 connected to the closure device 200 to allow the closure device 200 to be deployed and to further separate the closure device 200 from the delivery assembly 360. First, the configuration of the closure device 200 will be described in detail, and then the deployment of the closure device 200 by the transfer device 300 will be described.

  Referring to FIG. 5A, the closure device 200 is shown in a fully deployed, expanded, relaxed or uninhibited configuration. According to one embodiment of the present invention, the closure device 200 can be configured to close the internal tissue hole, or can be configured to reduce the size of the internal tissue hole and close the internal tissue hole. In one example, the occlusion device 200 can reduce the size of the internal tissue hole by bringing the tissue of the internal tissue hole, such as a passage tissue in the PFO, close together. As described more fully later herein, the closure device 200 can approximate the tissue by applying a lateral force to the tissue of the internal tissue hole. Similarly, the closure device 200 may be configured to allow a user to evaluate the position and / or orientation of the closure device 200 during and after positioning of the closure device 200 within the internal tissue hole.

  According to one embodiment of the present invention, the closure device 200 can be a non-tubular stent. The closure device 200 is configured to assume a substantially flat configuration, i.e., can be configured to be substantially planar, as shown, for example, in FIGS. 5A and 39M. Further, the closure device 200 may be configured to resist movement out of a plane (such as the plane 260 in FIG. 39B). However, the closure device 200 may be bent out of plane when positioned within the tissue hole.

  The closure device 200 according to one embodiment of the present invention has many advantages. For example, the closure device 200 can be configured to be reliable and compliant. The configuration of the closure device 200 can be transitioned between an undeployed configuration and a deployed configuration without causing the closure device 200 to break or plastically deform. The closure device 200 can be used to close various types, shapes, and dimensions of internal tissue holes. Furthermore, the closure device 200 can accommodate a range of PFO path lengths, for example. Similarly, the closure device 200 can be partially or fully deployed from the transport device 300 or received within the original transport device 300. The closure device 200 may be configured to substantially match the size and shape of the tissue hole. For example, undulations on the distal and proximal anchors allow the anchor to substantially or to some extent match the tissue pore anatomy.

  In general, the closure device 200 can have a substantially flat surface having a length and height greater than its depth or depth thickness. For example, in one embodiment, the closure device 200 has a total length of 22 mm, a height of 7.5 mm, and a depth thickness of 0.4 mm. According to one embodiment of the present invention, when the closure device 200 is in a relaxed or fully expanded configuration, as shown in FIG. 5A, the distance between the opposing ends of the proximal anchor 218 is about 22 mm. The distance between the most proximal attachment member 240 of the body portion 202 and the most distal indicator 220 of the body portion 202 may be about 7.5 mm, and the closure device 200 of FIG. The depth thickness designated as DT may be about 0.4 mm.

  Further, the majority of segments comprising the closure device 200 can have a thickness or width that is substantially less than the depth thickness of the segments. The closure device 200 can resist out-of-plane movement due to the size and configuration of the sections. For example, the closure device 200 may be configured to be substantially flat within the first plane. A section configuration, for example a section having a certain depth thickness, allows the closure device 200 to move out of the first plane in the same way that a beam (I beam) resists bending in the direction of the web of the beam. Can easily withstand. The first plane can be the plane 260 shown in FIG. 39M.

  In one embodiment, the closure device 200 may comprise a single structure or may be formed from multiple parts. If the closure device 200 comprises a single structure, the closure device 200 can be cut from a single piece of material, such as with a laser, thereby eliminating the need to assemble and bond together with different sections. The closure device can also be formed from multiple pieces of material. A single configuration can provide advantages such as ease of manufacture and reliability. For example, for an occlusive device having a single configuration, assembly is not required. Similarly, an occlusion device having a single configuration may not include different elements or sections that need to be joined by a joint, thereby reducing the likelihood of breakage. The closure device 200 can be made of a superelastic material such as a superelastic metal or a superelastic polymer. Further, the closure device 200 can be formed from polymers including nitinol, stainless steel, magnesium alloys, and biodegradable polymers.

  In some embodiments according to the present invention, the closure device 200 can be formed by utilizing a pressurized stream of water, such as a water jet, to remove material from the piece of material. Further, it is contemplated that the closure device 200 may be formed by utilizing one or more of die casting, chemical etching, photolithography, electrical discharge machining, or other manufacturing techniques. The closure device 200 may be formed by use of a rolling mill or other type of device that is adapted to remove material to form a desired shape.

  The closure device 200 comprises a plurality of sections joined together by known joining processes, such as by adhesive, by interference fit, by crimping, by fasteners, by welding, or by some combination thereof. It will be appreciated by those skilled in the art in view of the disclosure provided herein. For example, in one embodiment, an occlusive device can include multiple sections joined together by various welds to form an occlusive device according to the present invention. In other examples, the sections can be coupled together by a plurality of means, such as by welding, fasteners, and / or a combination of adhesives. The section can be a wire or a plurality of joined or wound wires that are crimped together or joined together by a joining process to form the closure device 200.

  In the illustrated example, the closure device 200 includes a body portion 202, a first anchor 204 operably coupled to the body portion 202, and a second anchor 206 operably coupled to the body portion 202. The body portion 202 can be configured to facilitate application of a lateral force to the tissue of the internal tissue hole. Similarly, the body portion 202 may be configured to allow the closure device 200 to transition between an undeployed configuration and a deployed configuration. For example, the closure device 200 may be configured to self-expand from an unrestrained or undeployed configuration, for example, as shown in FIG. 5B, to a relaxed configuration, as shown in FIG. 5A. In other words, since the closure device 200 can have a preferential arrangement, movement of the closure device 200 from the first configuration to the second configuration can generate internal stress in the closure device 200. . These internal stresses can help bias the closure device 200 to the first configuration. For example, in one embodiment, the closure device 200 can have a preferential arrangement in a relaxed or fully deployed arrangement, as shown in FIG. 5A. In this example, movement of the closure device 200 to a detained position, for example as shown in FIG. 5B, can generate internal stress in the closure device 200, thereby causing the closure device 200 to There is a bias to return to the relaxed position.

  In the illustrated example, the body portion 202 includes one or more cells 208 defined by a plurality of sections 210. The body portion 202 can include one or more openings. In one embodiment, the aperture is defined by cell 208, in other words, by a plurality of sections 210. In one example, section 210 can be a strut or a body support section. The cells 208 may be different or may be at least partially defined by a common section. For example, cell 208A as the most distal cell of body portion 202 and cell 208C as the most proximal cell of body portion 202 are different and are defined by different sections 210 relative to each other. However, cell 208B is partially defined by section 210C that similarly defines a portion of cell 208A. Similarly, cell 208B is partially defined by section 210G that partially defines cell 208C. Similarly, cell 208D shares section 210D with cell 208A and shares section 210H with cell 208C.

  Section 210 may be shaped and configured to have a substantially uniform stress at any given point along a length as section 210 is displaced. For example, the section 210A can include a first portion 230 having a greater width or thickness than the second portion 232, where the width or thickness decreases from the first portion 230 to the second portion 232, ie, is Tapered to provide a substantially uniform stress level along the length. In other embodiments, the section can have a substantially constant width along its length.

  FIG. 5C is a cut-away view of a portion of the closure device 200 including the first portion 230 and the second portion 232 of the section 210A. In the illustrated example, the width or thickness of the section 210A varies along the portion of the section 210A from the location where the section 210A extends from the portion 254 that joins the section 210A to the section 210C to the intermediate portion 234. As the closure device 200 transitions between an expanded or otherwise related configuration and a restrained or otherwise contracted configuration, the highest level of stress in the section 210 is present. The section 210 is displaced while concentrating on the coupling portion 254 and decreasing towards the intermediate portion 234. Section 210 can be configured to have substantially the same stress level along the length of section 210 between coupling portion 254 and intermediate portion 234. A uniform stress level can be achieved by causing the width of the section 210 to vary from the first portion 230 to the second portion 232 in an appropriate manner. In one embodiment, the width of the first section 230 of the section is about 0.1 mm and can taper to about 0.05 mm of the second section 232 of the section.

  In other embodiments, uniform stress levels can be achieved by utilizing gradients of materials having different characteristics. In other embodiments, section 210 has various widths along its length to achieve a substantially uniform stress level between first and second portions 230 and 232 of the section. A sufficient material gradient may be included. In the illustrated example, the first portion is adjacent to the coupling portion 254 and the second portion is adjacent to the intermediate portion 234. In a further embodiment, the joint of the interconnecting segments can include a biasing member, such as a spring, so that the segments move relative to each other to contract or expand the closure device 200. It becomes possible. Furthermore, the biasing members of the coupling portion may have a preferential arrangement of the sections with respect to each other.

  With continued reference to FIG. 5A, section 210 may also be configured to have a rectangular cross-section. In other examples, section 210 can have an elliptical cross section. In further embodiments, section 210 can have a circular or rounded cross section. Further, in one embodiment, the thickness or width to depth thickness or aspect ratio of the first and second portions 230, 232 can be in the range of at least about 1: 2 to about 1:20. . In one embodiment, the aspect ratio of width to depth thickness of the first portion 230 can be at least about 1: 2, and the aspect ratio of width to depth thickness of the second portion 232 is at least about 1: 2. 4 may be sufficient. In an alternative embodiment, the aspect ratio of the first portion 230 may be approximately 1: 4 and the aspect ratio of the second portion 232 may be approximately 1: 8. Thus, the closure device 200 can substantially resist out-of-plane movement while allowing in-plane movement during repositioning of various portions of the closure device 200.

  Partition 210 can be configured to be compliant. The compliance of section 210 allows cell 208 and thus body portion 202 to be arranged in various orientations. For example, the body portion 202 can be placed or transitioned between a non-deployed configuration as shown in FIG. 5B and a fully deployed configuration as shown in FIG. 5A. The compliance of section 210 can facilitate handling by the closure device 200 for various types, shapes, and dimensions of internal tissue holes. For example, the dimensions and configuration of the first and second anchors 204, 206 and the body portion 202 allow the closure device 200 to accommodate various sizes, shapes, and types of internal tissue holes. In one embodiment, the first anchor 204 can engage the wall tissue of the internal tissue hole and the second anchor 206 can engage only the passage tissue of the internal tissue hole to approximate the tissue. it can. In an alternative embodiment where the internal tissue hole has a short passage length, the second anchor 206 can engage the internal tissue hole passage tissue and opposing walls to approximate the tissue.

  The section 210 can include an intermediate portion 234 configured to facilitate fixation of the growth material relative to the occlusion device 200, or an indicator that facilitates determination of the position of the occlusion device 200 relative to the internal tissue hole. 220 can be used. Further, the intermediate portion 234 can be configured to facilitate measurement of the characteristics of the internal tissue pores. In one example, the intermediate portion 234 can include one or more openings. The opening may be configured to receive a securing element such as a thread through the opening to facilitate securing the growth material to the closure device 200. The intermediate portion 234 may be configured to be rigid or rigid compared to the first portion 230, the second portion 232, or both. The rigid intermediate portion 234 can increase the reliability of the section 210.

  In another example, the intermediate portion 234 can include an indicator 220, such as a dense metal rivet or a dense collection of materials, for use in determining the orientation and / or position of the closure device 200. . Understanding the orientation and / or position of the closure device 200 can facilitate determining the physical characteristics of the internal tissue hole and / or the relative position of the closure device 200 relative to the internal tissue hole. For example, if the distance between the indicators 220 is known, by determining the new distance between the indicators 220 when the closure device 200 is positioned within the tissue hole, the healthcare professional can determine the opening or passage width, etc. The physical properties of can be evaluated. Similarly, the indicator 220 can be positioned on the first and second anchors 204, 206. Indicator 220 may be configured and disposed on closure device 200 such that indicator 220 is substantially aligned when first anchor 204 is deployed. In this way, the health care professional can determine whether the first anchor 204 has been fully deployed.

  In some cases, it may be difficult to observe the closure device 200 when the angle is inclined with respect to an observation surface such as an X-ray fluoroscope. When the closure device 200 is thus tilted, it may be difficult to accurately determine the distance of interest. However, if the various distances between the indicators are known, the user can use the known distances to calculate the distance of interest by using the geometric shape.

  In one example, sections 210 along the same or common side plane can have substantially the same length. Thus, substantially the same length of section 210 allows body portion 202 to transition between an undeployed configuration and an expanded configuration without section 210 being damaged. For example, in one embodiment, sections 210A and 210B have substantially the same length, sections 210E, 210C, 210D, and 210K have substantially the same length, sections 210F, 210G, 210H, and 210L. Have substantially the same length, and sections 210I and 210J have substantially the same length. In this configuration, the body portion 202 can be retracted or placed into a non-deployed configuration, as shown in FIG. 5B, without causing damage to the body portion 202 of the closure device.

  The closure device 200 allows for a preferential deployment of a fully deployed configuration, as shown in FIG. 5A. Because the closure device 200 is deployed from the delivery device 300, the configuration of the closure device 200 can be preferentially transitioned toward a fully deployed configuration. Thus, since the closure device 200 is deployed within the internal tissue hole, the preferential placement of the closure device 200 allows the closure device 200 to apply a lateral force to the tissue of the internal tissue hole. In other words, the body portion 202, the first anchor 204, and the second anchor 206 are displaced by the applied force to reposition the closure device 200, for example, from a fully deployed configuration to a non-deployed configuration. Thus, the closure device 200 will tend to return to a fully deployed configuration as the body portion 202, the first anchor 204, and the second anchor 206 are displaced. When the closure device 200 is positioned within the internal tissue hole, the displaced body portion 202, the first anchor 204, and the second anchor 206 attempt to return to the fully deployed configuration of the closure device 200, so Can have a tendency to apply lateral forces to the tissue.

  The body portion 202 can be operatively coupled to the first anchor 204 and the second anchor 206. The first and second anchors 204, 206 can be configured to transition between deployed and undeployed configurations. The first and second anchors 204, 206 can be configured to apply a lateral force to the tissue of the internal tissue hole to engage and / or contact a portion of the wall tissue and / or passage tissue of the internal tissue hole. It is. In one example, the first anchor 204 may be a left atrial anchor and the second anchor 206 may be a right atrial anchor.

  In the illustrated example, the first anchor 204 can include a first anchor section 212 and an opposing second anchor section 214. Similarly, the second anchor 206 can include a first anchor member 216 and an opposing second anchor member 218. The first anchor section 212 can be configured to move relative to the second anchor section 214. Similarly, the first anchor member 216 may be configured to move relative to the second anchor member 218. Thus, the closure device 200 can accommodate various types, shapes, and dimensions of internal tissue holes. The first anchor section 212 and the second anchor section 214 can be configured to be substantially the same in size, shape, and configuration. Thus, references to one configuration and / or function of the first or second anchor section apply to the other anchor section. In one embodiment of the present invention, the first anchor 204 and / or the second anchor 206 can include one or more undulations. The undulation can facilitate placement or movement of the anchor relative to the body portion 202, for example, from a deployed configuration to a non-deployed configuration. Furthermore, undulations can facilitate the anchor to substantially conform to the anatomy of the tissue pore.

  The first anchor section 212 can include a distal end 224 and a proximal end 226. The first anchor section 212 can be defined by various sections and can include a reinforcing section 228 and one or more engagement members 222. For example, in the illustrated example, the first anchor section 212 is at least partially defined by the section 210K of the cell 208D. Engagement member 222 may be a micropost or tines configured to contact and / or engage tissue. The engagement member 222 can include a sharp tip or can be blunted. The engagement member 222 can be configured to provide a degree of surface texture to increase the engagement of the first anchor 204 into the tissue.

  The first anchor section 212 can be configured to transition between an undeployed configuration as shown in FIG. 5B and a fully deployed configuration as shown in FIG. 5A. In the first anchor section 212, the distance from the proximal end 226 of the section including the engaging member 222 to the distal end 224 is the distance from the proximal end 226 of the section including the reinforcing section 228 and the section 210K to the distal end 224. It may be configured to be substantially equal. The second anchor section 214 can be configured similarly to the first anchor section 212.

  The first anchor section 212 may be configured to define a closed perimeter. For example, the first anchor section 212 can include a reinforcing section 228 that extends from the body portion 202 to a section having an engagement member 222, which is connected to the sections 210K, 210L to provide the section 210K. Defines a closed perimeter. Further, the two reinforcing sections 228 can extend from the coupling portion 254 of the body portion 202 and can be coupled near the tip 224 of the first anchor 204. Thus, there are a plurality of anchor portions extending from the body portion 202. Thus, the anchor of the present invention is reinforced to provide high rigidity and strength to facilitate stabilization and maintenance of the closure device 200 within the tissue structure.

  The first anchor member 216 can include a distal end 236 and a proximal end 238. The first anchor member 216 can be defined by various sections and can include one or more engagement members 222. For example, in the illustrated example, the first anchor member 216 is at least partially defined by the section 210L of the cell 208D. The engagement member 222 can include a sharp tip or can be blunted. The engagement member 222 can be configured to provide some surface texture to increase the engagement of the second anchor 206 into the tissue.

  It will be appreciated by those skilled in the art in view of the disclosure provided herein that the engagement member 222 can vary in size and shape and can be positioned at various locations on the closure device 200. It will be. In an alternative embodiment, the one or more engagement members may extend out of the plane of the closure device, relative to a substantially flat plane of the closure device 200, such as the plane 260 of FIG. Can contact vertical tissue.

  The first anchor member 216 can be configured to transition between an undeployed configuration as shown in FIG. 5B and a fully deployed configuration as shown in FIG. 5A. In the first anchor member 216, the distance from the proximal end 238 of the section including the engaging member 222 to the distal end 236 is substantially equal to the distance from the proximal end 238 of the section including the section 210L to the distal end 236. It may be configured as follows. Thus, as shown in FIG. 5B, the first anchor member 216 can be detachably coupled to the transport device 300 when in the non-deployed arrangement inside the transport device 300. The second anchor member 218 can be configured similarly to the first anchor member 216.

  The first anchor section 212 can also include a first portion 256 and a second portion 258 configured to facilitate engagement of the internal tissue hole. For example, the first anchor section 212 can be configured to include one or more undulations that cause the first portion 256 to be positioned very close to the second portion 258. Thus, because the tissue is positioned between the first portion 256 and the second portion 258, the configuration of the first anchor section 212 engages the tissue between the first portion 256 and the second portion 258, and Alternatively, the position of the closure device 200 with respect to the tissue hole can be easily maintained with the tissue sandwiched to some extent.

  The closure device 200 may also include an attachment member 240 for use in removably connecting the closure device 200 to the delivery device 300, as disclosed more fully hereinbelow. The attachment member 240 can include an opening 242 for use in facilitating the connection of the closure device 200 to the delivery device 300.

  FIG. 5B shows the closure device 200 in an undeployed or restrained configuration. The configuration of the body portion 202 and the first and second anchors 204, 206 is such that the closure device 200 is fully deployed as shown in FIG. 5A and deployed from the preferential arrangement as shown in FIG. 3B. Or allow repositioning to a contracted configuration. In a contracted or undeployed configuration, the first anchor 204 extends to the distal end, the second anchor 206 extends to the proximal end, and the attachment member 240 is the most proximal end of the second anchor 206 and the body portion 202. It is a part of.

  In the illustrated example, the closure device 200 is positioned inside the transport portion 366 of the transport device 300. The configuration of the closure device 200 allows the preferential placement of the closure device 200 to cause a predetermined portion of the closure device 200 to exert a force on the wall of the transport portion 366. The closure device 200 is configured to be received in and deployed from the transport portion 336.

  FIG. 6 shows an embodiment of the transfer device 300. In the illustrated example, the delivery assembly 360 includes a catheter 362 having a delivery portion 366 and a plurality of tethers 364 that are at least partially received by the catheter 362. The tether 364 can be configured to facilitate selective disconnection of the closure device 200 from the transport device 300. The transport portion 366 may be configured to receive the closure device 200 within the transport portion 366. Since the catheter 362 can be coupled to the actuation assembly 320, movement of the actuation assembly 320 can cause movement of the catheter 362.

  In the illustrated example, the actuation assembly 320 includes a first member 322 operably coupled to the handle body 302, a second member 324 operably coupled to the first member 322 and the handle body 302, and the first member 322. It includes a knob 338 that connects. Actuation assembly 320 can be utilized by a user to selectively deploy occlusion device 200 from catheter 362. As will be described later, the medical staff can deploy the first anchor 204 by moving the knob 338 connected to the first member 322 in the proximal direction (FIG. 4). Thereafter, the second member 324 rotates to allow the remaining portion of the closure device 200 to be deployed from the transport portion 366 of the transport device 300.

  In addition to providing a two-stage deployment process, the exemplary delivery device 300 shown in FIG. 6 can also be configured to allow medical personnel to evaluate the progress of the deployment process. In particular, the handle body 302 includes an indicia 304 so that a user can evaluate the deployment of the closure device 200 from the transport device 300 and predict the separation of the closure device 200 from the transport device 300. Can do. For example, the mark 304 can include a deployment mark 306 and a release mark 308. Using the deployment mark 306, the user can evaluate the degree of deployment of the closure device 200 from the catheter 362, and using the release mark 308, the closure device 200 from the delivery device 300 can be evaluated. Can be predicted. The handle body 302 can also include a release pin groove 310. Release pin groove 310 can be operatively coupled to release assembly 340 to facilitate selective disconnection of closure device 200 from tether 364.

  In accordance with one embodiment of the present invention, the release assembly 340 can include a biasing member 342 that is operatively coupled to the handle body 302 to facilitate disconnection of the closure device 200. A release knob 346 can be provided to manipulate the position of the biasing member 342 to release or disconnect the closure device 200. In one embodiment, the release knob 346 is coupled to the biasing member 342 and moving the biasing member 342 relative to the handle body 302 by movement of the release knob 346 separates the handle body 302 and the release knob 346. It becomes possible. In this embodiment, the release knob 346 cooperates with the tether 364A-C, so that the release knob moves in the proximal direction with respect to the handle body 302, and the tether 364A-C is pulled in the proximal direction. Release the closure device 200. Details of the operation of release assembly 340 and other release assemblies are described in detail below.

  FIG. 7A is a cross-sectional view of the distal end portion of the catheter 362. In the illustrated example, the catheter 362 includes a delivery portion 366 for use in positioning the catheter 362. Catheter 362 can be formed from an elastic material that provides sufficient axial rigidity to allow medical personnel to position catheter 362 relative to the internal tissue hole, and medical personnel. Have sufficient rotational rigidity to allow the catheter 362 to be rotated by rotating the handle body 302.

  In one example, the catheter 362 includes knitted polyimide. In other examples, the catheter 362 is made from a material having sufficient axial stiffness, such as a braided reinforcement polymer, an axial reinforcement polymer, a metal reinforcement polymer, a carbon reinforcement polymer, or some other type of axial stiffness polymer. be able to. The transport portion 366 can be formed from a thermoplastic elastomer such as PEBAX®. In other examples, the transport or tip portion 366 can be made from a material that has sufficiently flexible properties, such as a polymeric material. In other examples, the transport portion 366 can include a combination of materials, such as a metal material and a polymer material.

  The delivery portion 366 can define a lumen 368 to facilitate placement of the catheter 362. For example, a guide wire can be received within lumen 368 to guide catheter 362 to a desired location. Thus, the closure device 200 may be quickly and efficiently placed in close proximity to the internal tissue hole. Further, the transport portion 366 can be formed to include a bend, for example, to facilitate installation of the transport portion 366 through the PFO. In one embodiment of the present invention, the catheter 362 can be considered a rapid exchange catheter, and the delivery or tip portion 366 allows the guidewire to quickly and efficiently attach to the catheter 362 for placement of the catheter 362. Allows to be concatenated.

  Catheter 362 and delivery portion 366 are different from lumen 368 and may be configured to at least partially accommodate tether 364 in a remote lumen. For example, the lumen 368 may be in a non-coaxial arrangement spaced from the lumen that houses the tether 364 so that the guidewire is not introduced into the lumen or space in which the tether 364 is received, Can be received through lumen 368. In this way, the user at least partially houses the tether 364 and is inserted at the distal end of the catheter 362, rather than the lumen that requires the guidewire to be introduced into the lumen at the proximal end of the catheter 362. A guide wire can be introduced into the cavity 368. In an alternative embodiment, the lumen 368 configured to receive the guide wire therein may be positioned within the lumen that houses the tether 364. In this example, lumen 368 includes an opening and outlet at the distal end of catheter 362 to facilitate rapid placement of the guidewire through lumen 368.

  In one example, the catheter 362 can include a rounded cross section and the delivery portion 266 can include a rectangular cross section. The rectangular cross-section of the transport portion 266 can facilitate proper deployment of the closure device 200 from the transport device 300 and can facilitate the closure device 200 being reintroduced into the original transport portion 366. The rectangular cross-section of the transport portion 266 can be sized so that the tether 364 is linearly adjacent. Thus, the reintroduction of the closure device 200 into the transport portion 366 may reduce the likelihood that the tethers 364 will cross each other.

  In one embodiment of the invention, the tether 364 includes three tethers 364A-364C, each tether 364 being sized to attach to and / or house the attachment member 240 therein. Made and configured like that. An example of a tether is a line or hollow tube that is coupled to the handle body 302. The tether 364 includes a flexible hollow shaft that is sufficiently rigid so that the closure device 200 is pushed out of the delivery portion 366 when the actuation assembly 320 moves the catheter 362 proximally relative to the handle body 302. Can be provided. Similarly, the closure device 200 can be configured to be pulled back into the transport portion 366 as the actuation assembly 320 moves distally relative to the handle body 302.

  In one embodiment, the tether 364 can be a stainless steel coil covered by a heat shrink tube, thereby imparting some tensile strength and stiffness to the coil. In an alternative embodiment, the tether 364 can be a polymer tube. In yet a further embodiment, the tether 364 can be a combination of a polymer material and a metal material. In some embodiments, additional heat shrink tubing covers the proximal sections of the three tethers 364A-364C. Heat shrink covering can increase the column strength of the tether 364, which can assist in the deployment / reintroduction of the closure device 200 from / into the transport portion 366. Because the tether 364 can have a tip configured to accommodate the shape and dimensions of the closure device attachment member 240, the attachment member 240 is received within the tip of the tether 364, as shown in FIG. 7B. Can be done.

  The tether 364 is flexible enough to substantially prevent the placement of the closure device 200 from being distorted or otherwise affected when the closure device is deployed from the catheter 362. It can be made from a material and has sufficient axial strength to facilitate deployment of the closure device 200 when the catheter 362 moves proximally relative to the closure device 200. The tether 364 has a lumen extending through the tether 364 that is sized and configured to allow a plurality of wires 378 to be housed within the tether 364 and movable within the tether 364. Can have.

  FIG. 7B shows a cross section of the attachment member 240 of the closure device 200 received by the tether 364 and connected by the first wire 378a and the second wire 378b. In the described embodiment, the second wire 378b extends through the tether 364 and extends from the tether 364 to form a loop. The loop extends through the opening 242 in the attachment member 240 of the closure device 200. The first wire 378a extending through and from the tether 364 extends through the loop of the second wire 378b by the loop of the second wire 378b disposed through the opening 242 of the mounting member 240. Forming a locking element; When the first wire 378a fully penetrates the loop of the second wire 378b, the first wire 378a is pulled through the loop of the second wire 378b, and the second wire 378b is pulled from the opening 242 of the mounting member 240. Until it is withdrawn, the closure device 200 remains connected to the transport device 300.

  The first wire 378a and the second wire 378b are attached to the biasing member 342 at the base end portion (FIG. 6). Thus, the first and second wires 378a, 378b extend from the distal end of the closure device 200 and reach the biasing member 342 via the tethers 364a-c. Thus, when the biasing member 342 moves in the proximal direction, the wires 378a and 378b also move in the proximal direction.

  7C-7D are cross-sectional views illustrating the transport assembly 360 that couples to the actuation assembly 320. However, for simplicity, FIG. 7C does not include biasing member 342, release wires 378a, 378b and cooperating release knob 346, and FIG. 7D shows first member 322 and handle body 302 and second member 324. Details regarding the interaction between the transport assembly 360 and the actuating assembly 320 are shown without showing details regarding. In the illustrated example, the proximal end portion of the catheter 362 is coupled to the distal end portion of the second member 324. Thus, movement of the second member 324 can cause a corresponding movement of the catheter 362. For example, when the second member 324 moves proximally relative to the handle body 302, the catheter 362 also moves proximally relative to the handle body 302.

  According to one embodiment of the invention, the tether 364 extends from the delivery portion 366 through the catheter 362 and the second member 324, and the tether 364 is coupled to the handle body 302. In at least one embodiment, the tether 364 is coupled to the handle body 302 and the first and second members 322 and 324 are coupled to the catheter 362 to move the first and second members 322 and 324. Thus, the catheter 362 and the handle body 302 move relative to each other, and as a result, the catheter 362 and the tethers 364a-c move. As will be described in detail below, the closure device 200 is deployed as the tethers 364a-c move.

  The tether 364 can be fixed to the handle body 302 by an intermediate member 376, for example. The tether 364 can be covered by the first and second housings 370, 372 to provide a degree of rigidity to the portion of the tether disposed inside the handle body 302 and the second member 324. For example, in one embodiment, the first housing 370 includes a rigid hollow metal rod configured to house three tethers 364a-364c therein. The first housing 370 can extend from the intermediate member 376 that facilitates securing the tether 364 to the handle body 302 and terminates at a point beyond the handle body 302.

  In the illustrated example, the second housing 372 extends from the distal end of the first housing 370 and extends into the catheter 362. The second housing 372 can include an elastic material configured to resist axial stretching while allowing some degree of bending. In one embodiment, the second housing 372 comprises a coil of metal, such as stainless steel, configured to resist axial stretching and still allow some degree of bending. The second housing 372 allows a medical professional to bend a portion of the catheter 362 when necessary to operate the delivery device 300 for placement of the closure device 200. A seal 374 is provided between the first housing 372 and the second member 324 so that bodily fluid that may have entered the catheter 362 enters the handle body 302 or otherwise is improperly drained from the delivery device 300. Can be reduced or substantially prevented.

  In the illustrated example, the second member 324 can comprise an elongate shaft that defines an axial lumen 348 and a lumen 350 in fluid communication with the axial lumen 348. The lumen 350 can be configured to couple to a medical device to remove fluid from the delivery device 300. The axial lumen 348 can be sized to accommodate and allow movement of the tether 362, the first housing 370, and the second housing 372 within the axial lumen 348. . The second member 324 can include a guide 326. As described more fully herein below, guide 326 can be configured to cooperate with first pin 352 and second pin 354 to affect movement of second member 324 relative to handle body 302. is there.

  In the illustrated example, the first member 322 is sized and configured so as to allow the second member 324 to be received and moved within the first member 322. Provide a tube. The first member 322 can be operably coupled to the handle body 302 and the second member 324 to facilitate deployment of the closure device 200. For example, the first member 322 is connected to the handle body 302 by the third pin 356. The third pin 356 is received within the guide 358 of the first member 322. Guide 358 interacts with third pin 356 to affect the movement of first member 322 relative to handle body 302.

  The first pin 352 can connect the first member 322 to the second member 324. When the first pin 352 connects the first member 322 to the second member 324, the second pin 354 connects the handle body 302 to the second member 324, and the third pin 356 connects the handle body 302 to the first member 322. However, the movement of the first member 322 can selectively deploy the closure device 200 from the transport portion 366.

  FIG. 8 is an exploded view of the actuation assembly 320 and release assembly 340. The second member 324 is received in the first member 322, and the first member 322 is received in the knob 338 and the handle body 302. The second member 324 includes a guide 326 having a first portion 326a and a second portion 326b, the guide 326 being formed by a slot formed in the outer surface of the second portion 326b. In the illustrated example, the first portion 326 a is straight, extends along at least a portion of the length of the first member 322, and couples to the second portion 326 b of the guide 326. The second portion 326b can include a helical groove or slot that begins with and is adjacent to the first member 322 and extends distally therefrom.

  The guide 326 of the second member 324 is configured to interact with the handle body 302 and the first member 322 to selectively retract the catheter 362, thereby deploying the closure device 200. For example, the first portion 326a of the guide 326 is configured to interact with and extend into the first portion 326a of the guide 326 by interacting with a second pin 354 that is secured within the handle body 302 by a thread. Thus, the second member 324 can move in the lateral direction with respect to the handle main body 302. Thus, the rotation of the handle body 302 can be shifted to the rotation of the second member 324, and thus the catheter 362 and the delivery portion 366.

  The second portion 326b of the guide 326 is configured to interact with the first pin 352 secured within the first member 322 by a thread and extend into the second portion 326b of the guide 326. Thus, when the first member 322 rotates, the first pin 352 interacts with the second portion 326b to move the second member 324 in the proximal direction. As the second member 324 moves proximally relative to the handle body 302, the catheter 362 moves proximally relative to the handle body 302, thereby exposing the closure device 200 from the delivery portion 366. Or expanded.

  In the illustrated example, the first member 322 can include a guide 358 defined by a slot or groove formed on the outer surface of the first member 322. In the illustrated example, the guide 358 can include a first portion 358a connected to the second portion 358b. The first portion 358a of the guide 358 is straight and extends along at least a portion of the length of the first member 322 and can be coupled and adjacent to the second portion 358b. The second portion 358 b of the guide 358 is a spiral groove that wraps around at least a portion of the outer surface of the first member 322 and can extend along at least a portion of the length of the first member 322.

  As previously described, a third pin 356 that is secured to the handle body 302 by a sled can extend into the guide 358 and affect the movement of the first member 322 relative to the handle body 302. For example, because the third pin 356 is positioned at the most proximal portion of the first portion 358a, the closure device 200 is completely received within the transport portion 366 and is enclosed by the transport portion 366. As indicated by the arrow in FIG. 4, the first member 322 moves in the proximal direction, so that the third pin 356 moves in the first portion 358 a of the guide 358 and moves from the transport portion 366 to the first of the closure device 200. One anchor 204 is deployed.

  The length of the first portion 358a corresponds to the distance that the first member 322, and thus the catheter 362, must travel to deploy the first anchor 204 of the closure device 200 from the delivery portion 366. For example, a medical professional can move the knob 338 coupled to the first member 322 in the proximal direction. The movement of the knob 338 in the proximal direction allows the third pin 356 to move linearly within the first portion 358a of the guide 358. Thus, the second member 324 can move correspondingly with the first member 322 for the first pin 352 connecting the first member 322 to the second member 324. Since the third pin 356 is positioned at the location of the guide 358 where the first portion 358a contacts the second portion 358b, the first member 322 rotates to leave the rest of the closure device 200 from the transport portion 366 of the transport device 300. Can be selectively expanded.

  As the first member 322 rotates, the third pin 356 is positioned in the second portion 358b, affecting the movement of the first member 322 relative to the handle body 302, and the first member 322 coupled to the first member 322. The pin 352 interacts with the second portion 326 b of the guide 326 to move the second member 324 in the proximal direction with respect to the handle body 302. Proximal movement of the second member 324 can thus cause further deployment of the closure device 200 from the transport portion 366. As will be appreciated, the knob 338 is coupled to the first member 322 to facilitate and allow movement of the first member 322 relative to the handle body 302.

  The double movement required to deploy the closure device 200 can provide several efficiency and safety benefits. For example, the healthcare professional can move the knob 338 in a first direction (ie, linearly proximal) to deploy the first anchor 204 from the delivery portion 366. Thus, a medical professional can move the handle body 302 to position the first anchor 204 to strike the wall tissue of the internal tissue hole, for example, against the left atrial wall of the heart. When the first anchor 204 is positioned against the wall, the healthcare worker can move the knob 338 in the second direction (ie, rotate the knob) to further deploy the closure device 200 from the delivery portion 366. it can. The double movement allows the user to predict the deployment of the closure device 200 to reduce the risk of early deployment of the closure device.

  It is provided herein that other means of controlling the movement of one member relative to another member, such as the movement of the first member relative to the second member, can be utilized without departing from the scope and spirit of the present invention. It will be understood by those skilled in the art in view of the disclosure. For example, structures configured to substantially limit or control movement of the first element relative to the second element and / or handle body can be utilized. In one example, the structure can include a cam and a follower. In an alternative embodiment, the structure can include a slider.

  Release assembly 340 can be configured to be received within the proximal end of handle body 302. Release assembly 340 is configured to provide additional safety mechanisms for medical personnel and patients by reducing the risk of premature disconnection of closure device 200 while closure device 200 is properly positioned within the internal tissue hole. May be. For example, a healthcare professional using the medical system 100 of the present invention can manipulate the actuation assembly 320 to deploy the closure device 200 for positioning within the internal tissue hole. To deploy the first portion of the closure device 200, the first movement, which is a linear movement, causes the user to move the knob 338 and the first member 322 in the proximal direction and then the occlusion by a rotational movement. The remaining portion of the instrument 200 can be deployed. Once the closure device 200 is deployed, the health care provider may need to move his hand to utilize the release assembly 340 to release the closure device 200 from the delivery device 300.

  In the illustrated example, the release assembly 340 can include a release knob 346 coupled to the biasing member 342 that is received within the proximal end of the handle body 302. The biasing member 342 is configured to act similar to a spring and can be configured to include a plurality of slots 318 disposed therein. The slot 318 may be configured and disposed within the biasing member 342 to allow at least a portion of the biasing member 342 to be compressed. By pressing the biasing member 342, the release pin 344 can move the release pin 344 toward the tip of the biasing member 342.

  When the biasing member 342 is positioned in the handle body 302, the biasing member 342 is configured to naturally maintain its position in a state where the release pin 344 enters the release pin groove 310 as shown in FIG. 8. As a force is applied to the release knob 346 in the distal direction (ie, compresses the biasing member 342), the release pin 344 exits the end portion of the release pin groove 310 and the proximal end portion of the release pin groove 310 And the closure device 200 can be released from the transport device 300.

  The closure device 200 is housed by the tether 364 and is released from the transport device 300 by moving a plurality of wires 378 coupled to the biasing member 342. FIG. 7 shows a cross-sectional view of the attachment member 240 of the closure device 200 received in the tether 364 and joined by the first and second wires 378s, 378b. In the illustrated example, the second wire 378b can extend through the tether 364 and out of the tether 364 to form a loop. The loop can extend through the opening 242 in the attachment member 240 of the closure device 200. With the loop of the second wire 378b positioned through the opening 242 of the mounting member 240, the first wire 378a that extends through and out of the tether 364 passes through the loop of the second wire 378b. It can extend through to form a locking mechanism. When the first wire 378a extends sufficiently through the loop of the second wire 378b, the first wire 378a is withdrawn through the loop of the second wire 378b and the second wire 378b is opened in the opening 242 of the mounting member 240. The closure device 200 may remain coupled to the transport device 300 until it is withdrawn out of the device.

  The first wire 378 a and the second wire 378 b can be attached to the proximal end portion with respect to the biasing member 342. Thus, movement of the biasing member 342 in the proximal direction can similarly cause movement of the wire 378 in the proximal direction. In one embodiment, the movement of the biasing member 342 moves a distance sufficient for the first wire 378a to be removed from the loop of the second wire 378b before the second wire 378b is moved by the biasing member 342. The wire 378 is coupled to the biasing member 342 so as to do so. The wire 378 can comprise a metal wire such as a nitinol wire. The wire 378 can also include a stainless steel wire or some other type of metal or rigid polymer. The wire 378 can be made of a material that has sufficient tensile strength to secure the closure device 200 to the tether 364 without breaking or being substantially deformed. In one embodiment of the present invention, wire 378B can include a stainless steel wire and wire 378A can include a nitinol wire.

  Other types and configurations of biasing members can be utilized without departing from the scope and spirit of the present invention. For example, in one embodiment, the release assembly can include a rotating member coupled to the stationary element. In this embodiment, rotation of the rotating member can cause the fixing element to wrap around the rotating member, thereby moving the distal end of the fixing element proximal to the handle body. The closure device 200 is released from the transport device 300 by moving a plurality of wires 378 housed in the tether 364 and coupled to the biasing member 342.

  The method of use of the medical system 100 will now be described with reference to a particular internal tissue hole, or PFO. FIG. 9A shows the positioning of the catheter 362 through the PFO passageway 58 with the first anchor 204 of the closure device 200 deployed. By positioning the catheter 362 through the internal tissue hole and moving the first member 322 with a first (ie, linear) first movement to deploy the first anchor 204 of the closure device 200 A medical system 100 is utilized to close the internal tissue hole. After the first anchor 204 of the closure device 200 is deployed, the delivery device 300 moves proximally and sits against the wall of the tissue hole or otherwise internal tissue as shown in FIG. 9A. Engage with the wall of the hole. This may be done by moving the handle body 302 in the proximal direction.

  After the first anchor 204 is positioned against the wall of the internal tissue hole, the knob 338, and hence the first member 322, can be moved by a second movement, ie, as shown in FIG. 9B. It can be rotated to deploy further portions of the closure device 200. After the closure device 200 is fully deployed and conforms to the anatomy of the internal tissue hole, the release assembly 340 is activated to selectively transfer the delivery device 300 from the closure device 200 as shown in FIGS. Can be separated.

  Release assembly 340 moves biasing member 342 distally relative to handle body 302 and then rotates the biasing member relative to handle body 302 and then proximally relative to handle body 302. Operated by moving. Thus, the closure device 200 substantially conforms to the internal tissue pore anatomy. As previously noted, the configuration of the occlusion device 200 is such that when the occlusion device 200 is positioned within the internal tissue hole, as shown, the members of the occlusion device 200 are lateral to the tissue of the internal tissue hole, such as the PFO passageway 58. Apply directional force to bring the PFO tissue closer for closure.

  The transport device 300 may be formed to transport the closure device by other configurations. In particular, FIGS. 12A-12N illustrate other configurations of occlusion devices 200a-n that use cells of different patterns and dimensions, such patterns being selected for a typical PFO anatomy. Possible normal dimension cell structures are shown in FIGS. 12A-12N. By using a multi-cell structure, the occlusion elements 12A-12N have features that match the typical PFO anatomy and enhance the function of the occlusion devices 200a-n that are retractable within the catheter delivery system. Can do.

  FIG. 12A shows an occlusion device 200a having a 5-cell design that is narrower in the middle portion 1205 than the distal and proximal ends 1210a, 1210b. This basic design represents the function of expanding the cell of the tip 1210a and the cell of the base 1210b outside the PFO passage having a relatively narrow constriction.

  FIG. 12B shows an occlusion device 200b having a 5-cell design that is restrained to the extent that it can extend into the atrium and provide wider anchoring points in the top and bottom cells. The 12C-E show other closure devices 200c-e having other cell configurations that include cells of different dimensions. Different sized cells impart rigidity to selected regions of the occlusion device structure, resulting in different amounts of force applied to the internal tissue holes. For example, the closure device 200c shown in FIG. 12C provides engagement by providing a relatively small cell that is positioned at or near the distal and proximal ends 1210a, 1210b. It is also possible to give further rigidity at the landing point. The closure device 20Od illustrated in FIG. 12D is formed to be disposed in a passage such as the intermediate portion 1205, and a part thereof can be given additional rigidity. Thus, it is possible to use smaller cells in the intermediate portion 1205 as shown in FIG. 12D.

  FIG. 12E shows an occlusion device 20Oe that combines the structures shown in FIGS. 12B and 12D. Other combinations of cell dimensions and placement are possible. Each combination may be tailored to specific desired characteristics of the device. For example, FIGS. 12F-N show occlusion devices 200f-n having other cell structures that can be adapted to various needs of PFOs having different widths and lengths and having a typical shape.

  FIGS. 12O-T illustrate an occlusion device 200o-t that is further adapted to allow proximal and distal anchoring and has a cellular structure that can accommodate different lengths of PFO passages. FIG. 120 shows an occlusion device 200o having a single central cell structure with elongated arms 1220a-d, based on the central cell structure within an internal tissue hole, such as a PFO passage, at each corner. Designed to be attached to the end side and the tip side. The elongated arms 1220a-d may be considered as other cells that can contract when the closure device 200o contracts within the transport device.

  If the central cell of a single central cell structure does not extend sufficiently along the passage, the structure can be secured to the central cell which is almost completely inside the passage by an arm with an additional length. FIGS. 12P and 12Q show occlusion devices 200p, 200q, respectively, in which other central cells are added to provide additional width and length. In FIGS. 12O-Q, the elongated arms 1220a-d of the closure device 200o-q may include serrated ends. When the closure devices 200p, 200q are deployed, the serrated ends of the elongated arms 1220a-1220d are secured to the tissue.

  12R-12T show a single cell design with smoother arms. In these designs, the elongated arms 1220a-1220d are still used to provide adaptability to changes in the length of the internal tissue hole, but are non-invasive to the internal tissue hole and surrounding tissue. Do the fixing.

  12U-12X illustrate occlusion devices 200u-200x having a cell structure similar to the cell structure described in FIGS. 12U-12X. These are examples of designs that are adaptable to a particular PFO anatomy.

  As shown in FIGS. 12Y-12Z, it is possible to form a cell structure that maintains the anchoring element and the desired lateral force, and that accommodates different lengths of PFO. As shown to FIG. 12Y, the obstruction | occlusion instrument 1200y has added the surface wider than a surface with a height to a cell. Such a configuration forms a structure that exhibits a shortening function and maintains substantially the same width. FIG. 12Z shows another cell structure, which has the function of shortening and couples more force from the top and bottom to the end of the constriction by moving the mounting point from its middle part. Let me. This changes the length of the passage, limits the force applied in the internal tissue hole, and more independently on one side without interference of the right and left anchoring elements from the opposite side To be able to act.

  Also, depending on the structure of the internal tissue hole such as the PFO anatomy, the right-hand side of the closure device structure may have different dimensions as shown in FIGS. 13A-13C. In particular, FIG. 13A shows an occlusion device 200a 'in which the right (lower) anchor 1300a includes a cellular structure that is smaller than the left anchor 1300b. FIGS. 13B-13C show occlusion devices 200b 'and 200c', respectively, which have anchors 1300 only on the left or right side, respectively. By providing an anchor on only one side of the internal tissue hole, it is possible to accommodate an internal tissue hole with a tapered passage where it is desirable to close only the wider side of the passage.

  Securing the PFO obturator structure within the PFO can also be done within the PFO passage as shown in FIGS. 14A-14B. FIG. 14A shows an occlusion device 200d ', which has small barbs 1400 included in the cell structure along both sides. When deployed, the spatula 1400 actively engages the tissue to prevent the closure device 200d 'from moving within the internal tissue hole. FIG. 14B shows another deployable structure 1410 that can be added to the structure of the closure device 200e ′ and expanded to the width of the internal tissue hole once the device is deployed. is there. In FIGS. 14A-14B, the anchor may be the end of a single wire as shown, or more prominently to engage tissue near the passage of the internal tissue hole, or It may be a bowl-shaped element.

  Various methods can be used to manufacture the closure device, and various materials can be used. In one configuration, as shown in FIGS. 15A-15B, the closure device can be formed from a wire having a rectangular cross-section, such wire being bent and shaped and connected. A particular aspect ratio and curvature of a single closure device element 1500 is shown in FIG. 15A, and two of these elements are connected and shown in FIG. In addition to such a starting structure, it is also possible to provide the desired complete cell structure. The starting wire may be formed by a metal extrusion such as a metal such as stainless steel (SS) or stainless steel alloy, tantalum, biocompatible metal, nickel titanium (NiTi), or a different polymer or bioabsorbable polymer. . Shape memory materials and shape memory polymers such as NiTi can be heat-treated to form a curved shape as shown in FIG. 15A.

  In many cell structures, it is desirable to keep the angle of curvature within the elastic limits of the starting material so that the structure can contract within a catheter or other restraining member and further develop into the desired shape within the internal tissue hole. As shown in FIG. 15B, when the component is made of metal, as shown in FIG. 15B, the coil is made of a wire that is bent and moored at the joint portion of the component, biocompatible solder, adhesive, It may be carried out by resistance welding or laser welding, or by melting the polymer material at a desired joint location by direct heating or ultrasonic heating. By combining such connection methods, it is possible to further support the joint and impart characteristics. For example, the coil is formed of a radiopaque material such as platinum or a platinum alloy to allow visualization with fluoroscopes and x-rays in addition to securing the components.

  The closure device may also be cut from a flat sheet of starting material. By way of example, the cutting of the structure is performed mechanically for larger cells and / or by laser or photolithography for smaller structures. Such material cutting may be performed using an instrument in an arrangement shape or an expanded shape for a material having no shape memory property. For shape memory metals such as NiTi, the restrained shape is cut out after heat treatment of the instrument into an expanded shape, so that components can be more efficiently stored when contracted for transport .

  Another way to form the desired structure of the closure device is to use a mesh woven from wires or polymer filaments, thereby forming a flat sheet. The cell structure exists as a space between the braided wires, and this structure can be folded when delivered by a catheter. Wire ends extending from this structure can be pushed back into the knitted mesh, or the wire ends can be exposed and engaged and secured to the surrounding tissue when placed in the internal tissue hole May be. Such wire ends may be terminated by forming interconnecting loops at the end intersections.

  FIGS. 16A-16C show an occlusion device configured to self-adjust to the length of the internal tissue hole passage. In particular, FIG. 16A shows an occlusion device 200f that includes an anchor element 1600 at a tip 1210a. The distal end 1210a and the proximal end 1210b are shown wider than the central portion 1205, and the central portion 1205 may be a relatively narrow constricted portion. As described above, when the closure device 200f 'is disposed, the closure device 200f' expands from the compressed state in the transfer device to the expanded state, and in this state, the closure device 200f 'becomes wider. In this embodiment, in addition to expanding from the compressed state, the length of the closure device 200f decreases until it approximates the length of the internal tissue hole passage. In FIG. 16A, the width of the closure device 200f 'is in an expanded state, and the entire length of the closure device 200f' is also expanded. The proximal end portion 1210b can also be formed to have a reduced length by, for example, winding.

  FIG. 16A shows the closure device 200f 'in an initial non-inhibited state. In the uninhibited state, the proximal end portion 1210b is wound toward the central portion 1205. As a result, the proximal portion 1210b shown in FIG. 16B wraps around to reach the entry point of the PFO passage in the right atrium, which in turn can reduce the possibility of movement of the closure device 200f ′ within the passage. provide. FIG. 16C shows an occlusion device 200g ' whose proximal end 1210b is not wrapped around the entire device but is made of a coiled wire. The closure devices 200f ', 200g' may be formed from a metallic material including NiTi, and its shape memory is set to the shape of FIGS. 16B and / or 16C.

  Yet another closure device 200h 'is shown in FIG. 17A. The central portion 1205 of the closure device 200h ′ includes a mechanical relaxation point 1700 that provides additional flexibility to the distal end 1210a and proximal end 1210b to accommodate different anatomy of the internal tissue hole. Can do. Due to this flexibility, the distal end portion 1210a rotates relative to the proximal end portion 1210b as shown in FIG. 17B, and further enables out-of-plane rotation.

  18A-18B show an occlusion device 200i ', and a portion of this device placed in the right atrium of the heart includes a proximal anchor 1800 that is a rigid structural member. The proximal anchor 1800 may be attached to the rest of the closure device 200i 'by a spring member 1810 that allows the location of the proximal anchor 1800 to change depending on the length of the PFO passage. The illustrated proximal anchor 1800 may be solid in this embodiment and may be folded lengthwise for transport as shown in FIG. 18B. The solid proximal anchor 1800 may further include a structure not specifically shown but specifically designed to fit the anatomy on the right side of the atrial septum, such as a secondary It includes the ability to fold and position under the typical arch shape of the septum.

  Up to now, several examples of closure devices have been described. Such an occlusion device has been described in connection with an occlusion device that expands from a compressed state to an initial state, i.e., an uncompressed state, to form the occlusion device in an uncompressed state and / or to mold the occlusion device. Expansion occurs due to the elasticity of the material used. Other configurations may be used, in which a force separate from and / or applied to the spring force that cooperates with compression of the closure device Thereby mechanically driving the closure device from the compressed state to the uncompressed state.

  19A and 19B are schematic views of the occlusion element 200j '. The closure element 200j 'includes an outwardly biased end 1921, a connecting member 1922, and a pinned contact 1923. Connection member 1922 is coupled to opposing expansion member 1920 by pinned contact 1923. With such a configuration, the closing element 200j 'expands from the contracted state as shown in FIG. 19A to the expanded state as shown in FIG. 19B, and further contracts. Also, the closure element 200j 'can be further contracted to fit within the transport device.

  When the occlusion element 200j expands, the expansion member 1920 applies a lateral force to the internal tissue hole passage wall in a manner similar to that described above. As described above, the expansion member 1920 includes an end 1921 that is biased outward. The outwardly biased end 1921 allows the expansion member 1920 to be easily secured to the internal tissue hole and / or easily adapted to the desired anatomy.

  The occlusion element 200j 'can be expanded by moving the central portion of the connecting member 1922 in the opposite direction indicated by the arrow 1924. The expansion member 1922 moves in the opposite direction from the expansion member 1920 that is driven outward 1925. When the connecting members 1922 are spaced apart from each other in the direction 1924, they are placed in place by over-center latching of the connecting members 1922.

  FIG. 19C is a diagram partially showing the connection member 1922 in a separated state. The connecting member 1922 may have an engagement element 1927 at the junction of the pinned contacts 1923 that are coupled at different angles, which can change the separation of the expansion members 1920. In particular, element 1927 may include a diagonal tab. FIG. 19D illustrates the interaction of the connection member 1922. Element 1927 allows adjacent connecting members to rotate relative to each other in one direction and prevents rotation in the opposite direction. In one embodiment, elements 1927 may interact in a ratchet manner.

  FIG. 20 shows an occlusion device 200k '. The closure device 200 k ′ includes an expansion member 1920 that is coupled to a strut 2000 that is located at least partially within the tube 2010. The biasing element 2020 biased outward at the end of the strut 2000 is restrained by the tube 2010. When the closure device 200k 'is arranged, such as when released from the conveying device, the urging element 2020 allows sliding fit, but it has compression resistance due to outward urging. Due to the outward biasing of the biasing element 2020, the closure device 200k 'is secured in an expanded state and secured to the wall of the internal tissue hole.

21A and 21B show a mechanically positionable closure device 2001 '. The closure device 2001 ′ with the pinned contacts 1923 and the rigid connection member 1923 is first expanded along the axial direction 2198 of the structure. Expansion member 1920 is secured to distal connection member 1922a at point 2191 and is directed outward by manipulating tether 2196 that passes through opening 2192 at proximal connection member 1922b. Tension is maintained by the tether 2196 and the stop 2193 is slid along the tether 2196 in the distal direction until the proximal connection member 1922b is coupled and the proximal connection member 1922b is directed in the proximal direction. When the proximal end connection member 1922b moves in the proximal direction, the proximal end connection member 1922b moves the expansion member 1920 outward.

  FIG. 21B shows a cross section of the stop 2193 relative to the opening 2192 of the proximal end connection member 1922b, with a bowl-shaped surface 2195 formed to secure the stop 2193 from movement in the proximal direction relative to the tether 2196. ing. After the stop 2193 is tightened against the proximal connection member 1922b, the tether 2196 is cut proximally relative to the stop 2193, thereby releasing the closure device 2001 'in the expanded position.

  Figures 22A and 22B show an occlusion device 200m 'that can be transformed from an inline shape (Figure 22A) to a "T" shape (Figure 22b). The occlusion device 200m 'includes an anchor arm 2200 that is expandable to close an internal tissue hole as described above and / or position the system relative to the internal tissue hole. The closure device 200m 'forms alternating hinge portions by including thick portions 2204 and thin portions 2208. The closure device 200m 'further includes an actuation member 2210 secured to the distal end 1210a and extending from the distal end 1210a through a hole 2220 formed in the proximal end 1210b.

  In order to move the closure device 200m ′ from the series position shown in FIG. 22B to the extended position shown in FIG. 22A, the distal end 1210a is moved to the proximal end 1210b by pulling the actuating member 2210 toward the proximal end 1210b. Move closer to. When the actuating member 2210 is pulled toward the proximal end 1210b, the anchor arm 200m 'expands as shown in FIG. 22B, particularly due to the configuration of the closure device 200m' and the anchor arm 200m '.

  The closure device 200m 'may be formed from NiTiNoI, stainless steel, or other materials that can be elastically recovered from a large deformation. The actuating member may be formed from a metal or polymer material having one or more strands. The curved structure can also be manufactured from a tube or a flat sheet.

  Figures 23A-23D show an occlusion device 200n 'using a combination of a bending hinge and a pivot point. The closure device 200 n ′ includes an arm 2200, an actuating member 2210, and a body 2300. Anchor arm 2200 is connected to actuating member 2210 by pivot 2310. With such a configuration, the actuating member 2210 pulls the anchor arm 2200 toward the proximal end 1210b and arranges the anchor arm 2200 as shown in FIG. 23A, or the actuating member 2210 pushes the anchor arm 2200 to the base An anchor arm 2200 can be positioned away from the end 1210b as shown in FIG. 23B. Thus, the anchor arm 2200 can be placed by pushing or pulling the actuation member 2210.

  The body 2300 includes a bent portion 2320 whereby the pivot 2310 connects the anchor arm 2200 to the body 2300. As shown in FIG. 23C, when the anchor arm 2200 is positioned, the bent portion 2320 bends outward to accommodate the expansion of the anchor arm 2200 relative to the body 2300. In one embodiment, the body 2300 is tubular and may be formed from Nitinol, stainless steel, or other material that can be elastically recovered from large strains. The anchor arm 2200 and the pivot 2310 may be made of stainless steel or other material having sufficient strength and rigidity to resist delivery and stent opening forces. The actuating member 2210 may be formed from a metal or polymer material having one or more strands. The curved structure can also be manufactured from a tube or a flat sheet. FIG. 23C shows an occlusion device 200o 'that includes a pivot 2310, rather than a combination of pivot and bend 2320.

  Accordingly, the closure device 200 can be mechanically opened using a combination of actuating members, pivots, and / or bends. The occlusion device can also be used as part of a system having other occlusion devices, in which one or more occlusion devices place the system relative to the internal tissue hole. And as an additional locator device, an additional closure device is used to close the internal tissue hole. Such a configuration will be described in detail below.

  FIGS. 24A and 24B illustrate a medical system 100 ′ configured to close one or more occlusion devices with respect to the internal tissue hole to close the internal tissue hole. In the illustrated example, the leading edge 1210a of the system 100 'includes a tip locator device 2400a that is operable similar to the closure device 200m' described in FIGS. 22A-22B. System 100 'further includes closure device 200 and proximal locator device 2400b. The closure device 200 is similar to the closure device shown in FIG. 5A, and the proximal locator device 2400b operates in a manner similar to the distal locator device 2400b. Tip locator device 2400a includes an anchor arm 2200a. The anchor arm 2200a may be connected to the first anchor 204. In one example, anchor arm 2200a is connected to first anchor 204 by a distal stent compression tab 2410a. The closure device 200 is further coupled to a proximal locator device 2400b. In one example, anchor arm 2200b on proximal locator device 2400b is coupled to second anchor 206 by, for example, proximal stent compression tab 2410b.

  In order to place the tip locator device 2400a, the tip locator device 2400a is first placed beyond the tip surface of the internal tissue hole. Next, when the tip locator device 2400a is arranged, the anchor arm 2200a and the first anchor 204 expand. Once the distal locator device 2400a is in place, the system 100 is pulled proximally to move the closure device 200 and in particular bring the first anchor 204 into contact with the tissue at the distal surface of the internal tissue hole. In the case of PFO, the first anchor 204 can be pulled against the primary septum.

  In one embodiment, proximal locator device 2400b and second anchor 206 of closure device 200 are withdrawn from delivery catheter 2410 and maintain tension on distal locator device 2400a. In the illustrated example, the second anchor 206 expands when pulled out. While maintaining the tension on the distal locator device 2400a, the proximal locator device 2400b is pressed toward the distal portion 1210a. After the occlusion device 200 is deployed, a proximal locator device 2400b is deployed to position the anchor arm 2200b against tissue at the proximal surface of the internal tissue hole, such as a second septum of the left atrium. Extend to

  As the proximal locator device 2400b is pulled in the proximal direction to release the second anchor 206, the proximal locator device 2400b can contract into a linear shape. The tip locator device 2400a is then pressed toward the tip to release the first anchor 204. The tip locator device 2400a is further deflated and the entire system is retrieved with the exception of the deployed closure device 200.

  FIGS. 25A and 25B are partial views showing a medical system 100 ″ for delivering an occlusion device 200p ′ when the occlusion device 200p ′ itself does not include a proximal fixation arm or a distal fixation arm. The occlusion device 200p ′. Retained by a laterally extending barbed profile 2500 that is incorporated into the tissue of the patent foramen ovale passage by lateral pressure exerted by the closure device 200p ', in which case the proximal anchor expander is removed and the foramen ovale is removed. Replaced by a tab 2502 used to compress the closure device 200p ′ to place the closure device 200p ′ in the passage of an internal tissue hole, such as a patent passage. 100 ″ is provided against the primary septum at the entrance to the patent foramen ovale passage by tip locator device 2400a. The system 100 "can be configured to reduce or remove the anchor arm in the atrium of the heart after the occlusion device 200o 'and the remainder of the transmission system 100" have been removed.

  Figures 25C-25F show balloon-type occlusion devices for occluding internal tissue holes. In particular, FIG. 25C shows a balloon-type occlusion device 200q 'that includes a plurality of chambers 2505 interconnected. FIG. 25D is a diagram showing a balloon-type obturator 200q 'taken along line AA. As shown in FIGS. 25C and 25D, some of the interconnected chambers 2505 are relatively long and thin cavities arranged side by side. The interconnected chambers 2505 communicate with the manifold portion 2510. Manifold portion 2510 receives fluid from fill port 2515. Fluid entering the manifold portion 2510 from the fill port is distributed to the interconnected chambers 2505 and fills the interconnected chambers 2505 with the fluid.

  The interconnected chambers 2505 are configured to expand when filled with fluid to occlude internal tissue holes. In particular, due to the configuration of the interconnected chambers 2505, when the interconnected chambers 2505 are inflated, the balloon-type closure device 200q 'expands to the side relatively large with respect to the increase in thickness. By expanding the balloon-type occlusion device 200q 'to a relatively large side surface, as described above, side pressure is generated against the passage of the internal tissue hole to close the internal tissue hole. Accordingly, the configuration of the interconnected chambers 2505 allows the closure device 200q 'to occlude internal tissue holes such as patent foramen ovale.

  FIG. 25E shows a balloon-type occlusion device 200r 'that includes flared interconnected chambers 2520. FIG. At least one of the flared interconnected chambers 2520 includes a passage section 2525 and a flared tip portion 2530. The flared tip portion 2530 is configured to expand distally of the internal tissue hole, thereby providing a tip anchor to the closure device 200r '. A portion similar to the flared tip portion 2530 is also provided at the proximal end of the interconnected chamber 2520 to provide a proximal anchor for the closure device 200r '.

  FIG. 25F shows an occlusion device 200s' that includes an isolated chamber 2535. FIG. Isolated chamber 2535 forms a first anchor 2540 and a second anchor 2545. The isolated chamber 2535 is inflated in a predetermined order to install and place the closure device 200s' as desired. For example, the chamber corresponding to the isolated chamber 2535 or the first anchor 2540 is expanded to position the closure device 200s' at the entrance of the internal tissue hole. In the case of a patent foramen ovale, the first anchor 2540 is inflated in the left atrium. The central cavity is subsequently inflated, expanding the central portion 2550 of the closure device 200s' and occluding the passage of the internal tissue hole. The proximal cavity is inflated to expand the second anchor 2545. The balloon-type occlusion devices and other devices described above are formed from absorbable or non-absorbable biomaterials. Such a configuration allows the physician to leave a balloon inflated to open the foramen ovale as an occlusive implant. Although specific configurations have been described above, balloon-type occlusion devices can be used that include multiple chambers including a combination of isolated chambers and interconnected chambers that are inflated at various stages.

  In an embodiment, after the closure device is deployed, the closure device is released from the rest of the system by a release mechanism. Accordingly, a plurality of release mechanisms are provided to release the closure device from the locator device and / or delivery device when the closure device is placed to close an internal tissue hole, such as a patent foramen ovale. For example, the systems 100 ′, 100 ″ shown in FIGS. 24A, 24B and 25A, 25B have a post-in-hole configuration that connects the closure devices 200 and 200o ′ to the medical systems 100 ′, 100 ″, respectively. use. Other configurations may be used to selectively release the closure device from the delivery system. In addition to the normal attachment points for the closure device, the normal transfer points for the transfer device are described below. The various configurations described below may be adjusted for use with any number of transport devices in combination with any number of closure devices.

  26A-26E illustrate a plurality of release mechanisms 2600a-2600e for releasing the closure device 90 from the transport device 92. FIG. In particular, the closure device 90 includes attachment members 240a-240e that couple the closure device 90 to a portion of the transport device 92. For ease of reference, the pressing members 96a-96e are described as the portion of the transport device to which the mounting member 240 is selectively fixed. For example, FIG. 26A shows a release mechanism 2600a that includes a post 2602 formed on the closure device 90 where the attachment member 240a fits into a hole 2605 formed in a corresponding portion of the pressing member 96a. The attachment member 240a, ie, the cooperating closure device 90, is held by the pressing member 96a as long as the attachment member 240a is pressed by the pressing member 96a. When released from the press, the post 2602 slides out of the hole 2605 in the corresponding portion of the mounting member 240a.

  FIG. 26B shows a release mechanism 2600b that includes an attachment member 240b and a pressing member 96b for holding the closure device 90 and selectively releasing the closure device 90 from the delivery device. The illustrated release mechanism 2600 b includes a flexible loop 2610 attached to the pressing member 96. The loop 2610 extends through a hole 2615 formed in the mounting member 364b. Loop 2610 is held in place by release wire 2620. To release the closure device 90, the release wire 2620 is withdrawn from the tether loop 2610. By releasing the loop 2610, that is, by sliding the loop 2610 away from the transport device 300, the closure device 90 is released.

  FIG. 26C shows a release mechanism 2600 c that utilizes a mounting member 240 c that includes a tab 2622. Tab 2622 is configured to engage with pressing member 96c. In particular, the tab 2622 is configured to have a dog-leg shape so as to extend into a slot 2624 formed in the pressing member 96c. Release wire 2625 extends into pressing member 96c and retains tab 2622 that engages slot 2624 as shown. When the release wire 2625 is pulled proximally, the release wire 2625 is released from engagement with the tab 2622. When the tab 2622 is released from the tab 2615, the tab 2622 is released from the slot 2620 and the pressing member 96c is released from the mounting member 240c, thereby releasing the closure device 90.

  FIG. 26D shows a release mechanism 2600d including a structure of a mounting member 240d and a pressing member 96d including a flexible filament 2630. The flexible filament 2630 extends through a transverse hole 2635 formed in the pressing member 96d as shown in the drawing, passes through the hole 2640 of the mounting member 240d to the distal end side, and returns into the pressing member 96d. The cutting blade 2645 also preferably cooperates with the pressing member 96d. The cutting blade 2645 is configured to move to the tip side through the transverse hole 2635, thereby cutting the flexible filament 2630. When the flexible filament 2630 is cut, the attachment member 240d is released from the pressing member 96d.

  FIG. 26E shows a release mechanism 2600e having a mounting member 240e held by nesting tabs 2650, 2655 that overlap within the pressing member 96e. The overlapping tab 2650 is part of the mounting member 240e, and the overlapping tab 2655 cooperates with the pressing member 96e. The attaching member 240e is connected to and held by the pressing member 96e by the overlapping tabs 2650 and 2655. In order to release the mounting member 240e, the overlapping tabs 2650 and 2655 are moved to the front end side with respect to the pressing member 96e. When the overlapping tabs 2650 and 2655 are removed from the pressing member 96e, the overlapping tabs 2650 and 2655 become separable, thereby releasing the mounting member 240e from the pressing member 96e.

  In the example shown in FIG. 27A, the release mechanism 2600f includes a pressing member 96f formed from a meltable material. The meltable material is, but is not limited to, a polymer filament formed from one polymer fiber or a bundle of many fibers. The pressing member 96f is fixed to the attachment member 240f. In the illustrated embodiment, the pressing member 96f passes through a coil 2600 made of a conductive wire. Coil 2700 is attached to the power source through lead 2705 with low resistance.

  When the current passes through the coil 2700, the pressing member 96f is heated until the pressing member 96f melts due to the resistance of the coil, thereby cutting the pressing member 96f from the mounting member 240f in the proximal direction. When the pressing member 96f is cut, the attachment member 240f, that is, the closing device cooperating with the pressing member 96f is released. The power supply 2705 is configured to supply a direct current to heat the coil 2700 with resistance. It is also preferable for the power supply 2705 to supply an alternating current in a range up to a high frequency. The coil 2700 may also be covered by an optional insulating layer 2710. By providing the insulating layer 2710, heat from the coil 2700 due to heating is transferred to the surrounding tissue or fluid.

  In another example, release mechanism 2600f and resistance coil 2700 form a resistance temperature device (RTD) that provides feedback regarding the temperature of pressing member 96f while current flows through coil 2700. The coil 2700 in this example is formed of a metal that exhibits a relatively large change when heated, such as nickel, copper, or platinum, but is not limited thereto. The actual temperature of the pressing member 96f is monitored at predetermined intervals during heating by removing the heating current and applying a known voltage to the delivery mechanism 2600f including the coil 2700. The resistance measurement thus obtained is proportional to the temperature of the known RTD coil.

  FIG. 27B is a schematic view of a release mechanism 2600g including a bimetal actuator 2720. FIG. The bimetal actuator 2720 can be configured to mechanically remove a closure device (not shown) from the transport device at a predetermined temperature or temperature range. The bimetal actuator 2720 includes a bimetal strip 2725 wound in a coil shape that can be connected to a fixing member 2730 that connects the mounting member 240g to the pressing member 96g. Therefore, when the fixing member 2730 is in a predetermined position, the pressing member 96g can drive the attachment member 240g by the fixing member 2730. More specifically, the fixing member 2730 is engaged with both the mounting member 240g and the pressing member 96g, whereby the movement of the pressing member 96g is transmitted from the pressing member 96g to the fixing member 2730 and further transmitted to the mounting member 240g.

  The bimetal strip 2725 is configured to be unwound at a high temperature. When the bimetal strip 2725 is unwound, the fixing member 2730 is pulled out of the connection with the pressing member 96g. After the fixing member 2730 is pulled out of engagement with the attachment member 240g, the attachment member 240g is free to move, thereby being released from the release mechanism 2600g. Further movement of the bimetal strip 2725 releases the pressing member 96g and removes it in the proximal direction as desired.

  FIG. 27C is a schematic view of a release mechanism 2600h including a bimetal coil 2725. FIG. The bimetal coil 2725 is connected to the lever arm 2735, and the lever arm 2735 is connected to the fixing member 2730. Lever arm 2735 rotates about pivot point 2740. When the winding of the bimetal coil 2725 is released according to, for example, a rise in temperature, the bimetal coil 2725 drives the lever arm 2735. The lever arm 2725 includes a relatively short portion 2745 a on the proximal end side of the bimetal coil 2725 and a relatively long portion 2745 b on the proximal end side of the fixing member 2730. With these configurations, it is possible to increase the amount of movement that occurs when the bimetal coil 2725 is unwound. Therefore, the fixing member 2730 can be moved from the engagement with the attachment member 240g and further from the engagement with the pressing member 96g by utilizing a relatively small increase in temperature. Additional configurations of the bimetal release mechanism can be adjusted to match various closure device shapes.

  The release mechanism and assembly may also utilize a shape memory actuator to release the closure device. A predetermined shape memory alloy, such as Nitinol, can be displaced from a first shape to a preset shape when a predetermined temperature defined by the alloy configuration is exceeded. Figures 27D-27H show release mechanisms 2600i-2600l that utilize shape memory materials. In FIG. 27D, release mechanism 2600 i includes shape memory actuator 2750. Shape memory actuator 2750 is secured to closure device 90. In particular, the first portion 2750 a of the shape memory actuator 2750 is fixed to the attachment member 240 i of the closure device 90. The closure device 90 further has a recess 2755 defined on the side facing the mounting member 240i. The shape memory actuator 2750 extends from the attachment member 240 i through the pressing member 96 i and fits into the recess 2755.

  In particular, the shape memory actuator 2750 extends through the loop 2757 of the pressing member 96i, but in the second position shown in FIG. It extends into the recess 2755. The recess 2755 may be formed with a wire loop for the shape memory actuator 2750 and other fixing points. The shape memory actuator 2750 may have a shape that is adjusted to be secured within the recess 2755. While a pin and loop configuration has been described above, another pin and receiving device configuration may be used to hold the closure device until the closure device is selectively released.

  FIG. 27E shows releasing the pressing member 96 i by heating the shape memory actuator 2750. More specifically, when shape memory actuator 2750 is heated to a temperature above the transition temperature of the shape memory material, shape memory actuator 2750 returns to the preset shape shown in FIG. 27E. The preset shape of the shape memory actuator 2750 is a coiled shape, whereby the shape memory actuator 2750 is pulled toward the mounting member 240i to release the pressing member 96i. When the pressing member 96i is released, the closure device 90 is freely moved with respect to the pressing member 96i and thereby released as well.

  27F and 27G are schematic diagrams illustrating a release mechanism 2600j including a plurality of shape memory actuators 2750a, 2750b. As shown in FIG. 27F, shape memory actuators 2750a, 2750b extend in opposite directions from opposing portions of closure device 90, but shape memory actuators 2750a, 2750b transition shape memory material from which shape memory actuators 2750a, 2750b are formed. Keep below temperature. In such a structure, each of the shape memory actuators 2750a and 2750b extends through a loop 2757 formed at least partially on the pressing member 96j.

  FIG. 27G shows shape memory actuators 2750a, 2750b heated to a temperature above the transition temperature of the shape memory material. When the shape memory actuators 2750a and 2750b are heated to exceed the transition temperature of the shape memory material, the shape memory actuators 2750a and 2750b return to a preset state such as the coiled structure shown in FIG. 27G. When the shape memory actuators 2750a and 2750b return to the preset state, the pressing member 96j is removed from the fixed position of the loop 2757 as shown in FIG. 27G, and the pressing member 96j is released. The heat input to heat the shape memory actuators 2750, 2750a, 2750b is provided by external exposure to high temperatures, heating by high frequency, and supply of current to the actuator members.

  In another example (not shown), a number of shape memory fixing members are formed to release the pressing member. In another example (not shown), these multiple shape memory anchors are configured such that a portion of the device is released at a first temperature and another portion of the device is released at a second temperature. It has an actuator that transitions at different temperatures. In another example (not shown), the pressing member or the pressing members may be made of a conductive material, and the electrical connection to the implant may be broken when the pressing member is released. In combination with the above-described embodiments, mechanical removal may be suitably performed from the transplanted portion, and at the same time, driving may be generated at a preset temperature or temperature range.

  In an embodiment, the pressing member comprises a central portion including one or more filaments such as polymer filaments or bundles of filaments. The polymer material includes, but is not limited to, nylon, Dacron (registered trademark), polyester, polyethylene, Teflon (registered trademark), PTFE, Kevlar (registered trademark), Spectra (registered trademark), and the like. These materials also extend to the proximal operating side of the device and are a component of a large pressing member system consisting of a polymeric catheter, stainless steel or other biocompatible alloy metal hypotube.

  FIGS. 27I and 27J show a release mechanism 2600k that includes a cutting portion 2760. FIG. Cutting unit 2760 is coupled to shape memory actuator 2750c. Shape memory actuator 2750 c is secured to first portion 2765 of closure device 90. The pressing member 96j is fixed to the second portion 2770b of the closing device 90. The pressing member 96j extends away from the second portion 2770b and extends through the opening 2772 formed in the cutting portion 2760, but the shape memory actuator 2750c maintains the transition temperature or lower and remains in the first position.

  When shape memory actuator 2750c is heated above the transition temperature, shape memory actuator 2750c transitions to the preset shape shown in FIG. 27J. Accordingly, the shape memory actuator 2750 c is pulled toward the first portion 2765 of the closure device 90. By pulling the shape memory actuator 2750c toward the first part 2765 of the closure device, the cutting portion 2760 is also pulled in the same direction, whereby the cutting portion 2760 cuts the pressing member 96j. As a result, the closing device 90 is released from the pressing member 96j.

  The characteristics of the shape memory alloy can also be used to release the securing member 2730 as shown in the release mechanism 2600k 'of FIGS. 27K and 27L. In particular, shape memory actuator 2750d is secured to closure device 90 shown as a ground. The connecting portion 2775 is connected to the shape memory actuator 2750d at the first end portion 2775a, and is connected to the fixing member 2730 at the second end portion 2775b. The pivot point 2735 configured to rotate about the pivot point 2735 is fixed to the closure device 90. In particular, the connecting portion 2775 rotates in accordance with the movement of the shape memory actuator 2750d, whereby the movement of the shape memory actuator 2750d is transmitted to the fixing member 2730 by the connecting portion.

  The fixing member 2730 is engaged with both the mounting member 240k ′ and the pressing member 96k ′, whereby the movement of the pressing member 96k ′ is transmitted from the pressing member 96k ′ to the fixing member 2730 and further transmitted to the mounting member 240k ′. The Therefore, when the shape memory actuator 2750d is held at a temperature equal to or lower than the transition temperature of the shape memory material, the shape memory actuator 2750d keeps the extended state, and the fixing member 2730 is engaged with the attachment member 240k ′ and the pressing member 96k ′. Hold the match.

  FIG. 27L shows that the shape memory material of shape memory actuator 2750d is heated to a temperature above the transition temperature and shape memory actuator 2750d returns to a preset state corresponding thereto. When the shape memory actuator 2750d returns to the preset state as shown in FIG. 27L, the first end 2775a is pulled out toward the closing device 90, whereby the fixing member 2730 is first engaged with the pressing member 96k ′. The engagement is released and then the engagement with the mounting member 240k ′ is released. Accordingly, the closure device 90 is released from the pressing member 96k 'by heating the shape memory actuator 2750d.

  Release mechanism 2650l may be actuated by a phase change of material in a closed space as shown in FIGS. 27M and 27N. FIG. 27M shows a cylinder 2780 and a piston 2785 attached to the closure device 90. The cylinder 2780 and the piston 2785 cooperate with a connecting portion 2775 connected to the fixing member 2730. The fixing member 2730 fixes the pressing member 96l to the mounting member 240l. The attachment member 240l is a part of the closure device 90.

  Heating the material in cylinder 2780 creates pressure that acts to move piston 2785 away from cylinder 2780. When the piston 2785 is operated so as to be separated from the cylinder 2780, the piston 2780 acts on the connecting portion 2775 and acts on the fixing member 2730. When the fixing member 2730 is acted in this way, the pressing member 96l is released from the closure device 90.

  FIGS. 27M and 27N show another example (not shown) of a release mechanism that utilizes phase change including removal of the connecting portion 2775 and direct connection of the securing member 2730 and the piston 2785. In another example, the system (not shown) replaces the piston and cylinders 2780, 2785 with a bellows assembly that also becomes a sealed container for the phase change material extending axially when the phase change occurs. Phase change materials used in the present system that expand upon heating include, but are not limited to, various hydrocarbon fluids such as heptane, isopropyl alcohol and the like. Wax formulations such as those used in thermostats such as conventional automobile engine thermostats are also available.

  In an embodiment, a portion of the release mechanism, such as a shape memory actuator, is attached to the closure device. Such attachment can be switched and / or changed as desired. In another example (not shown), the shape memory actuator may be attached to the pressing member. In yet another example (not shown), the shape memory actuator may be attached to a combination occlusion device and push member. In yet another alternative (not shown), shape memory actuators may be attached to other portions of the medical system.

  A transport device 2800 that can be used to position the closure device 90 will be described with reference to FIGS. 28-38B. Further, a method of using the transfer device 2800 will be described. In the illustrated configuration, the transfer device 2800 includes a main handle 2802, a guide catheter 2818 that is connected to the main handle 2802 and extends from the main handle 2802 to the distal end, a press handle 2820 that is connected to the main handle 2802, and a release that is connected to the press handle 2820. A knob 2826 and an end cap 2832 are provided. The main handle 2802 has a long cylindrical shape and is substantially hollow. The main handle 2802 is configured to assist the user in placing the closure device 100.

  The flow passage 2816 communicates with a part of the main handle. The first stopper 2812 and the second stopper 2814 are selectively movable with respect to the main handle 2802. The flow passage 2816 can be configured to communicate with the guide catheter 2818. The first stopper 2812 is configured to be received in the first groove 2804 shown in FIG. 29, and the second stopper 2814 is received in the second groove 2806 shown in FIG. 29, and is configured to be at least partially movable. The The first groove 2804 extends in the radial direction along the periphery of the main handle 2802. First groove 2804 receives first stopper 2812 and is configured such that first stopper 2812 is at least partially rotatable there. The first groove 2804 includes a first opening 2808. The first opening 2808 extends through the wall of the main handle 2802. The first opening 2808 can be configured to receive a set screw (not shown) located in a hole provided through the first stopper 2812. This hole allows the set screw to be received in the first opening 2808, thereby restricting the rotation of the first stopper 2812 relative to the main handle 2802. A portion of the first stopper 2812 may extend into the first opening 2808 instead of or in addition to the set screw.

  Similarly, the second groove 2806 extends radially along the periphery of the main handle 2802. The second groove 2806 is configured to receive a second stopper 2814 and the second stopper 2814 is at least partially pivoted therein. The second groove 2806 includes a second opening 2810. The second opening 2810 extends through the wall of the main handle 2802. The second opening 2810 can be configured to receive a set screw (not shown) located in a hole provided through the second stopper 2814. This hole allows the set screw to be received in the second opening 2810, thereby restricting the rotation of the second stopper 2814 relative to the main handle 2802. A portion of the second stopper 2814 may extend into the second opening 2810 instead of or in addition to the set screw.

  The first stopper 2812 is received by the first groove 2804 and is at least partially rotatable in the circumferential direction within the first groove 2804. At least a portion of the first stopper 2812 and a set screw passing through the first stopper 2812 extend into the first opening 2808 or through the first opening 2808. As will be described more fully below, the first stopper 2812 can be configured to allow selective placement of the patent foramen ovale closure device 3000. Similarly, the second stopper 2814 is received in the second groove 2806 and is at least partially rotatable in the circumferential direction within the second groove 2806. At least a part of the second stopper 2814 and a set screw passing through the second stopper 2814 extend to the second opening 2810 or through the second opening 2810. As will be described more fully below, the second stopper 2814 can be configured to allow selective placement of the patent foramen ovale closure device 3000. The distance between the first stopper 2812 and the second stopper 2814 is such that when the pressing handle 2820 moves in the distal direction with respect to the main handle 2802 while holding the proximal anchor 3008 in the guide catheter 2818, the distal anchor 3006 is sufficiently removed from the guide catheter 2818. It corresponds to the interval that can be exposed and placed.

  The patent foramen ovale occlusion device 3000 is inserted into the distal end of the guide catheter 2818 such that the proximal anchor 3008 extends proximally and the distal anchor 3006 extends distally into the guide catheter 2818. The foramen ovale closure device 3000 can be attached to the transport device 2800 through the use of tabs 3012.

  The transport apparatus 2800 further includes a pressing tube 2834 (FIG. 31). The pressure tube 2834 is received in the guide catheter 2818 (FIG. 28), is movable within the guide catheter 2818, and extends from the distal end of the guide catheter 2818 to the pressure handle 2820. The pressure tube 2834 can be coupled to the pressure handle 2820 such that movement of the pressure handle 2820 relative to the main handle 2802 causes movement of the obturator occlusion device 3000 from the distal end of the catheter shaft.

  In the illustrated embodiment, the transport apparatus 2800 includes one or more flexible tubes 2836 (FIGS. 30A-31). The number of flexible tubes 2836 can optionally correspond to the number of tabs 3012 of the patent foramen ovale closure device 100. In one structure, the flexible tube 2836 can be coupled to the pressure tube 2834 such that movement of the pressure tube 2834 results in movement of the flexible tube 2836.

  Typically, the push tube 2834 can accept various wires, tubes, etc. of the transport device 2800 and can assist the placement device 3000. For example, the push tube 2834 can receive thermocouples, tubular members that receive thermocouples and associated electrically communicating wires, RF energy transfer and return wires, conductors, and the like.

  As shown in FIG. 31, one flexible tube 2836 is provided spaced from two adjacently positioned flexible tubes 2836. The resulting gap is capable of receiving portions of wires, tubes, etc. that are received by the push tube 2834. For example, thermocouples, tubular members that receive thermocouples and related electrically communicating wires, RF energy transfer and return wires, conductors, etc. can be withdrawn from the push tube 2834 and moved to the closure device 3000.

  To assist in the above movement, each flexible tube 2836 includes a tubular cap 2840 as shown in FIGS. 30A-30C. Tubular cap 2840 can be sized and configured to receive tab 3012. Tubular cap 2840 includes a slot 2842 sized and configured to receive a foot 3014 of tab 3012. The tubular cap 2840 may be sized and configured such that the foot 3014 of the tab 3012 is in the slot 2842 and the removal wire 2838 extends through the distal end of the tubular cap 2840 and out of the distal end. Thus, the removal wire 2838 biases the tab 3012 and retains it within the tubular cap 2840, thereby closing the patent foramen ovale until the removal wire 2838 is moved away from the foot 3014 as described below. It functions to prevent removal of instrument 3000 from transport device 2800. FIGS. 30A-30C show one flexible tube 2836 when the removal wire 2838 is continuously moved proximally such that the foot 3014 is removed from the tubular cap 2840.

  Guide catheter 2818 can be coupled to main handle 2802. Guide catheter 2818 can be configured to house at least a portion of pressure tube 2834 and other portions of device 2800. The guide catheter 2818 may be further configured so that the pressure tube 2834 can rotate and translate there. The distal end of the guide catheter 2818 can be configured to receive a patent foramen ovale closure device 3000.

  FIGS. 28 and 32 show that the pressing handle 2820 is substantially hollow and is a rigid cylindrical member. The pressure tube 2834 can be connected to the pressure handle 2820. In this manner, the occlusion device 3000 for opening the foramen ovale can be disposed from the guide catheter 2818 by the movement of the pressing handle 2820 in the distal direction relative to the main handle 2802. In the illustrated embodiment, the push handle 2820 includes a first portion 2820a and a second portion 2820b. The first portion 2820a may be configured and dimensioned to be received within at least a portion of the main housing 2802 and to be movable. The first portion 2820 a includes a track 2822. The track 2822 can be configured to receive set screws for the stopper 2812 and the stopper 2814 such that the set screw can be translated along the track 2822.

  Track 2822 is point no. 1, point no. 2, point no. 3 and point no. Including various points indicated by 4 and symbols. Point No. 3 and point no. The spacing between 1 may correspond to a spacing sufficient to expose and position the distal anchor 3006 from the guide catheter 2818 when the push handle 2820 moves distally relative to the main handle 2802. Further, this spacing is sufficient to hold proximal anchor 3008 within guide catheter 2818. Point No. 2 and the most proximal point of the track 2822 can correspond to a sufficient distance to place the entire foramen ovale closure device 3000 from the guide catheter 2818.

  The first stopper 2812 and the second stopper 2814 are movable between a closed position and an open position. For example, in the first stopper 2812, the set screw of the first stopper 2812 is point No. 1 in the closed position, the set screw is point no. 2 and no. 4 is in the open position. In the second stopper 2814, the set screw of the second stopper 2814 is point no. 3 and point no. 1 is in the closed position, the point no. 2 and point no. 4 is in the open position. When the first stopper 2812 and the second stopper 2814 are in the closed position as shown in FIG. 28, the first stopper 2812 is in the open position and the second stopper 2814 is closed as shown in FIGS. 34A and 35A. 36 and 37A, both the first stopper 2812 and the second stopper 2814 are in the open position.

  The second portion 2820 b of the push handle 2820 can be configured to receive at least a portion of the release knob 2826. Second portion 2820b includes a pinhole 2824 that can receive pin 2824a. Pin 2824a can be received and moved along track 2828 of release knob 2826. The specification disclosed herein will enable those skilled in the art to understand that various pin and groove configurations can serve as guides and other configurations can function as well without departing from the scope and spirit of the invention. Will be done. For example, the pin and groove configurations may be replaced with various connections that allow sufficient movement for the various elements of the present invention to function properly.

  As shown in FIG. 33, the release knob 2826 can be configured so that the closure device 3000 can be easily removed from the transport device 2800. At least a portion of the release knob 2826 is received within the proximal end of the push handle 2820 and can be sized and configured to be movable. The removal wire 2838 can be coupled to the release knob 2826. In this manner, the obturator puncture device 3000 with the patent foramen ovale can be removed from the conveying device 2800 by the movement of the release knob 2826 in the proximal direction relative to the pressing handle 2820.

  Release knob 2826 includes a track 2828. The track 2828 can be configured to receive a portion of the pin 2824a (FIG. 32) from the second portion 2820b of the push handle 2820 and function as a guide to guide the movement of the pin 2824a. The track 2828 can be configured such that the release knob 2826 can rotate and / or translate in either a clockwise or counterclockwise direction with respect to the push handle 2820. The configuration of the track 2828 can restrict the movement of the release knob 2826 relative to the press handle 2820 such that the locus of movement of the release knob 2826 relative to the press handle 2820 is defined by the contour of the track 2828. Track 2828 includes a clasp 2830. The release knob 2826 inadvertently moves the removal wire 2836 relative to the tubular cap 2840 so that the foot 3014 of the patent foramen ovale closure device 3000 does not come out of the slot 2842 of the tubular cap 2840. 2830 can be configured to reduce movement of release knob 2826 relative to push handle 2820.

  As shown in FIG. 34A, the transfer device 2800 further includes an end cap 2832. End cap 2832 can be coupled to the proximal end of release knob 2826. The end cap 2832 can be configured such that, but is not limited to, various wires and / or tubes extending through a thermocouple, electrode wire, RF wire, or conductor. Guide catheter 2818, main handle 2802, main handle 2802, push handle 2820, and release knob 2826 may be configured such that various wires extend through thermocouples, electrode wires, and / or RF wires and conductors. . Further, the guide catheter 2818 and the main handle 2802 may be further configured such that the push shaft 2836 extends therethrough and is movable therein.

  Guide catheter 2818 is adjusted to be placed through the patent foramen ovale so that the distal end of guide catheter 2818 is located within the left atrium. The patent foramen ovale closure device 3000 can be placed from the guide catheter 2818 by moving the push handle 2820 relative to the main handle 2802. This movement may include any of movement of the push handle 2820 to the main handle 2802, movement of the main handle 2802 to the push handle 2820, and combinations thereof. These can be performed by the steps described later. First, the first stopper 2812 is moved from the closed position to the open position, and as a result, the set screw of the first stopper 2812 is moved to the point no. 1 to No. Move to 2. Subsequently, as shown in FIG. 2 to No. 4 and the set screw of the second stopper 2814 is point No. 3 to No. The main handle 2802 is moved in the proximal direction with respect to the pressing handle 2820 so as to move to 1. This movement of the main handle 2802 relative to the push handle 2820 is sufficient for the distal anchor 3006 of the closure device 3000 to extend from the distal end of the guide catheter 2818 and be placed in the left atrium.

  The user can manipulate the main handle 2802 until the distal anchor 3006 is positioned against tissue adjacent to the patent foramen ovale in the left atrium. In order to arrange the proximal anchor 3004, the user moves the second stopper 2814 to the open position (the set screw of the second stopper 2814 moves from point No. 1 to point No. 2) as shown in FIG. Subsequently, as shown in FIG. 37A, the main handle 2802 is moved in the proximal direction with respect to the pressing handle 2820. Point No. The distance of the track 2822 from 2 to the proximal proximal point is such that the main handle 2802 causes the proximal anchor 3008 to extend sufficiently from the distal end of the guide catheter 2818, thereby opening the foramen ovale in the right atrium. Sufficient to move it into engagement with tissue adjacent to the.

  The patent foramen ovale closure device 3000 is removed from the transport device 2800 by use of the release knob 2826. The removal wire 2838 can be pulled proximally through the tubular cap 2840 by moving the release knob 2826 proximally relative to the push handle 2820 as shown in FIG. 38A. Due to the configuration of the track 2828 of the release knob 2826 and the pin of the push handle 2820, the release knob 2826 is sufficiently against the push handle 2820 to move the removal wire 2838 past the foot 3014 of the tab 3012 in the proximal direction. It is movable. When the removal wire 2838 is moved past the foot 3014, the foot 3014 is moved out of the slot 2842 by the ramp 3014a of the foot 3014. Thus, the tab 3012 is removed from the flexible tube 2836 and thereby removed from the transport apparatus 2800. At this point, the patent foramen ovale closure device 3000 is in place and the delivery device 2800 is removed from the patient's body.

  Although described with respect to the delivery device 3000 and the placement of the delivery device 3000, the present invention is typically applied to the delivery and placement of structures that can be placed within a body lumen, which structures optionally receive RF and other electromagnetic energy. However, it can be said that the transplantation of the structure is assisted regardless of whether or not the structure is a structure composed of a flat surface. Additional information regarding the closure device 3000, the structure, function, use and operation of the delivery device 2800, and the invention disclosed herein, is disclosed in Appendices A, B and C, which is hereby disclosed in its entirety. Shall.

  FIG. 39A shows an occlusion device 90 that includes an attached growth media structure 3900. The closure device 90 includes a plurality of cells 3902. The growth structure 3900a includes a filament 3905 that is secured to the central portion of the closure device 90. By securing the filament 3905 to the central portion of the occlusion device 90, tissue growth is promoted into the occlusion device 90 in the center of the occlusion device 90 as compared to the surrounding portion of the occlusion device 90 that is exposed to blood flow. The As shown in FIG. 39A, filament 3905 is coiled around one or more cell 3902 portions. The growth material in the present embodiment includes a biocompatible polymer material fiber having a relatively large surface area on which a tissue can grow. Examples thereof include registered trademark Dacron (polyester), PTFE, and other filaments. It is done.

  In FIG. 39A, the filament 3905 is shown as one fiber. Although one fiber is used, filament 3905 also refers to a bundle of fibers having a bundle structure or a twisted structure. The surface of the fiber bundle has many protruding ends of individual fibers due to looser bundles and twists. The end of the additional fiber becomes the surface on which the tissue grows. A fiber or a bundle of fibers is fixed to the structure of the cell 3910 by thermal bonding or an adhesive.

  FIG. 39B shows a growth structure 3900b that includes a filament 3905. FIG. As shown in FIG. 39B, the closure device 90 includes an outer shape 3910 such as a hole formed in the closure device 90. The outer shape 3915 provides an additional fixing point for the additional fixing point of the filament 3905. The filament 3905 is loosely sewn through these points, or is fixed in the vicinity of each outer shape 3910 through which the filament 3905 passes by an adhesive or a knot of the filament.

  Although not shown, the filament 3905 extends across only one cell or across all cells of the structure. Further, the passage of the illustrated filament 3905 is knitted alternately on the side of the structure. In such a structure, 3905 has a function of occupying space from the plane of the structure. Further, when the closure device 90 is in a compressed state for delivery, all of the fiber material is expelled from between the struts of the closure device 90, thereby creating a compression structure for delivery through and through the catheter. It can be compressed more efficiently.

  In at least one embodiment, a growth medium, such as a growth filament, is attached to the closure device by a loop of growth material wire, suture material or thread. In this example, the growth medium is attached to one side of the closure device structure. In another example, the growth medium is sandwiched between two connected foramen ovale closure devices. By using multiple occlusion devices, the function of the structure can be separated (eg, fixation and tissue expansion) and the media can be fixed in place. In yet another example, the growth medium may be knitted through the cells of the closure device and secured by knitting, or additional securing techniques or components may be provided.

  In another example shown in FIG. 39C, the growth structure 3900c includes filaments 3905 that are secured to the closure device 90 in a predetermined pattern. The amount of growth medium secured to the closure device 90 by the growth structure pattern is relatively increased. Further shown in the pattern is the point at which the filament 3905 is attached and held at a fixed distance from each other when the closure device 90 is placed. With such a configuration, the degree of tension of the filament 3905 is kept relatively constant over a wide range of arrangement.

  FIG. 39D shows a growth structure 3900d where the points at which the filament 3905 is secured to the closure device 90 are not held at regular intervals from each other when the closure device 90 is deployed. With such a configuration, when the closure device 90 is arranged, the filament 3905 is loosened.

  FIG. 39E shows a growth structure 3900e in which the growth medium of the strip 3915 is secured to the closure device 90. FIG. In particular, the growth media strip 3915 is secured to opposing sides of the cell portion of the closure device 90. The strip 3915 is a loosely knitted gauze-like material that is knitted into the connecting structure. The strip 3915 may be secured to the closure device 90 by any suitable method. In one structure 3900f, strip 3915 is wrapped around the cell portion of closure device 90 and returned onto strip 3915 as shown in FIG. 39F. The overlapping portions of strip 3915 may be secured together.

  FIG. 39G shows a growth structure in which one or more membranes 3920 are secured to the closure device 90. The membrane 3920 includes a number of materials including, but not limited to, registered trademark Dacron (polyester) formed into the membrane by weaving, weaving and other methods, PTFE and bio-absorbable polymer fibers. It is not something. The membrane pattern may be pre-cut as desired and secured to the closure device 90 by any suitable method.

  In addition to fixing the growth medium to one occlusion device, the growth medium is also fixed to a number of occlusion devices that are placed together. In particular, FIG. 39H shows a growth structure in which the membrane 3920 is held between two occlusion devices 90a, 90b. By using multiple occlusion devices 90a, 90b, the stiffness of the two devices can be increased while firmly securing the membrane 3920 when used simultaneously.

  Figures 39I and 39J show additional structures in which multiple occlusion devices are used simultaneously. In FIG. 39I, the closure devices 90c, 90d are configured differently. FIG. 39K shows a similar structure with different closure devices 90e, 90f. The second closing device 90f is biased out of the plane with respect to the first closing device 90e. Such a configuration is an out-of-plane structure that contacts the surrounding tissue, thereby securing the closure device 90e to the internal tissue hole.

  FIG. 39K illustrates one example of an occlusion device 200 that may include a member 250, such as a growth material. Member 250 can be configured to cause tissue growth. Member 250 is secured to closure device 200 by a securing element such as thread 252. For example, the thread 252 can extend through the member 250 and through an opening in the intermediate portion 234 to secure the member 250 to the closure device 200. In other embodiments, the member 250 can be secured to the closure device 200 by well-known securing means such as adhesive, thermal welding, or other known or later-developed securing means.

  Member 250 and thread 252 can include a biodegradable material such as polylactic acid, polyglycolic acid, or collagen. The member 250 may be sized and configured to allow the closure device 200 to be deployed from and received within the transport portion 366 of the transport device 300. Further, the member 250 can be configured to interact with the tissue of the internal tissue hole to promote tissue growth for closure of the internal tissue hole. For example, the member 250 can interact with the PFO passageway tissue 58 to promote tissue growth within the PFO passageway 58.

  Member 250 can be any suitable material that can or tends to promote tissue growth. Examples of such materials can include polymeric materials or woven materials such as woven metal or biological materials. In one example, member 250 can be a piece of foam. In alternative embodiments, member 250 can be a piece of yarn, cloth, or string, or some combination thereof. Other tissue growth promoting members can include a coating deposited on the closure device 200. In other embodiments, member 250 may be a piece of foam, a piece of knitted material, such as a piece of yarn or string, or a cloth having a film deposited thereon.

  Member 250 can comprise a material such as a piece of polyurethane or some other biocompatible polymer including a biodegradable polymer. The member 250 can also include Dacron or polymer threaded material that is woven, knitted, or formed into a compressed nonwoven. Member 250 can also include a metallic material such as nitinol, stainless steel, or some other biocompatible alloy, or a biodegradable metal such as a magnesium alloy, or some combination thereof. In one embodiment, member 250 comprises a metal wire.

  FIG. 39M shows a side view of the closure device 200 and shows an example of a closure device having a substantially flat configuration. In the illustrated example, the closure device 200 can include a depth or depth thickness designated as DT, and a plane 260 that extends vertically to enter and exit the plane of the page. In this embodiment, member 250 can extend beyond both first edge 262 and second edge 264 of closure device 200. Thus, the member 250 can contact tissue adjacent to the closure device 200 to promote tissue growth within the tissue hole.

  Member 250 is sized and configured to exceed at least the first edge 262 of the closure device 200 by a distance sufficient to contact tissue in the tissue hole. In one example, the member 250 can extend at least beyond the first edge 262 by a distance sufficient to contact tissue adjacent the first edge 262, thereby contacting the tissue. The end of the member 250 is displaced or bent. In this way, more surface area of member 250 can contact the tissue, thereby facilitating increased tissue growth. In other embodiments, the member 250 can extend beyond both the first edge 262 and the second edge 264 by a distance sufficient to bend the ends of the member 250, rather than contacting tissue. Many surface areas can be provided. In one example, the member 250 can extend at least 0.5 mm to 5 mm beyond the first edge 262. In another example, it may extend at least 0.5 mm to 5 mm beyond the first edge 262 and may extend at least 0.5 mm to 5 mm beyond the second edge 264. it can. Furthermore, the member 250 can have a thickness of at least between 0.25 mm and 2 mm.

  Further, in some embodiments, the member 250 may be configured to reduce the size of the remaining voids in the tissue hole after the closure device 200 is positioned in the tissue hole. The member 250 that extends beyond the first edge 262 of the closure device 200 is an example of a member 250 that extends substantially out of the plane of the substantially flat configuration.

  As mentioned above, the cell structure is variable and / or irregular. A completely arbitrary structure of very small cells also has the property of providing the correct pressure on the internal tissue pores. These structures are preferably made of fine wires formed in a flat shape, but have sufficient space to provide compressibility within the transport system. Other arbitrary cell structures are made of polymer foams such as ePTFE and polyurethane, but are not limited thereto.

  Since the implant is a metal-based structure, the surface finish is by electropolishing. In the present invention, all or part of the apparatus is polished by electropolishing to obtain a smooth and scratch-free surface. The end of the device is specifically designed to contact the inner sidewall of the passage and is polished by electropolishing so that the sharp end of the structure punctures the tissue except in the desired location for anchoring. To prevent that. The smooth surface of the edge is susceptible to coatings that add lubricity for easy transport. The surface of the device other than the outer end is preferably a rough surface, which assists in a fixed position and / or a position for more aggressive tissue ingrowth after implantation. In parts of the structure where roughness is more demanding, the roughness is added by grit blasting, chemical etching or other mechanical means using suitable polishing tools. The polymer structure may be smoothed as well or surface-treated as desired for fixation and growth.

  The occlusion device is also adjustable to function as a delivery platform for drugs and / or other materials that can facilitate closure of internal tissue holes. In at least one embodiment, the drug is delivered by elution from a polymer-based coating or the like. These agents include vascular endothelial cell growth factor that promotes blockage of internal tissue pores, synthetically or naturally occurring proteins, and / or purified proteins such as collagen or bovine serum albumin.

  A structure that performs the same function as a multi-cell structure may be composed of one member. The single member has the locking characteristics shown in the example in which an anchor is formed to secure the device from the distal side in the arrangement. Behind the constricted portion of the structure, the portion of the member is configured to generate lateral pressure and locking force in the opening. In addition to the lateral pressure exerted by the lowermost part of the device through the constricted part of the device, the support force for supporting the tip anchor is also obtained. The most proximal portion of the member may be provided with a relief that compresses the closure device within the catheter for delivery. Other means of providing this shape may be used, such as local material property variations of coil springs or member portions. The single member structure may also be integrated and have a more complex anchor (3) as shown in FIG. 14B.

  In addition to the above, it is desirable to add additional features that promote growth to occlude internal tissue holes, such as patent foramen ovale. The registered trademark Dacron felt, fabrics, yarns and fabrics of polymer materials such as filaments such as PTFE, ePTFE, etc. are wound around the foramen ovale occlusion device or knitted through a cell, so that the desired A surface where the tissue grows more aggressively at the site is obtained. Metal fine wires, nets or blades may be used. Alternatively, fabric or thin membranes may be sewn, welded or attached to the struts to cover the desired portion of the foramen ovale closure device.

  In addition to the embodiments described above, the present invention relates to other different medical devices, systems and methods. For example, in another configuration, a medical device is disclosed having a multi-cell structure that transitions from a contracted state to an expanded state, the multi-cell structure including a constricted portion and at least one anchor portion, wherein the anchor portion is When the device is in the expanded state, it is wider than the constricted portion, and the constricted portion is configured to engage the passage of the internal tissue hole in the expanded state to occlude the internal tissue hole. The device can also include one or more distal and / or proximal anchors. These anchors may have approximately the same width, or one may be wider than the other. These anchors can also include a plurality of elongate arms. One or more of such elongate arms may have a serrated end, for example, the serrated end faces the center of the internal tissue hole passage when the medical device is deployed. Configured as follows. The elongate arm may also have a smooth edge. A multi-cell structure may comprise a plurality of cell portions having substantially the same dimensions, and the cell portions may be of different dimensions. The medical device may also be configured to reduce overall dimensions when deployed. Where the medical device includes a distal anchor and a proximal anchor, the proximal anchor may be configured to be at least partially rounded to reduce its overall dimensions when the medical device is deployed. The medical device can also include a spring member and a solid anchor portion secured to the constricted portion. The solid anchor portion may be a solid proximal anchor portion. In one embodiment where the medical device includes both a proximal anchor arm and a distal anchor arm, the constricted portion of the medical device can include a hinge portion. By forming the medical device from an elastic material, the medical device can be expanded from a compressed state to an expanded state by a spring force generated at least partially from the elastic material. The medical device may also be mechanically expanded from a compressed state to an expanded state.

  The medical device in one embodiment includes opposing expansion members and at least one connection member that couples the expansion members. The connecting member may be formed to shift the opposing expansion member from a compressed state to an expanded state in order to seal the internal tissue hole. The medical device can also have a plurality of connecting members and contacts pinned between adjacent connecting members and between an extension arm facing the connecting member. Pinned contacts are configured to allow the connecting members to move relative to each other during deployment of the medical device and to allow the expansion member to expand but prevent the expansion member from contracting after deployment of the medical device. It is also possible to include a modified ratchet mechanism. The medical device may further include an actuating member, such as a cable or tether, coupled to the at least one connecting member. The extension arm may be configured to expand from a compressed state to an expanded state by pulling the actuation member proximally. The medical device may also include a locking member configured to secure the expansion member in the expanded state. The locking member may include a fastener that cooperates with the actuating member. Furthermore, the connecting member may have a strut or piston configuration.

  In yet another configuration, the medical device includes a plurality of elongate arms and an actuating member coupled to the arms, such that the actuating member mechanically expands from the retracted position to the expanded position. Is formed. The actuating member may include alternating thin and thick portions. Furthermore, the actuating member may be configured to be retracted proximally and / or moved distally to mechanically expand the arm. The medical device may also include a body portion operable in association with the arm. The body portion may include a bent portion and / or a pivot that couples the arm to the body portion. The medical device may be a distal locator device, a proximal locator device and / or an occlusion device.

  In yet another configuration, the medical system includes a first medical device having an expandable elongated arm and the arm expands from a contracted state to an expanded state and is positioned at the opening of the internal tissue hole. A second medical device cooperating with the first medical device, wherein the second medical device has a multi-cell structure that transitions from a contracted state to an expanded state, and the multi-cell structure is A constricted portion configured to engage an engagement with the passage of the internal tissue hole in the expanded state to close the internal tissue hole. The first medical device may be a distal locator device or a proximal locator device. For example, the first medical device may be configured to be located at the distal end opening of the internal tissue hole. The medical system includes a third medical device that cooperates with a second medical device, the third medical device including an elongate elongate arm that expands from a contracted state to an expanded state. , Disposed at the proximal opening of the internal tissue hole. The second medical device can also include outward teeth, a first anchor portion, and / or a second anchor portion.

  An apparatus for releasing an implant within a body lumen includes an attachment member coupled to the implant and a pressing member that cooperates with the attachment member. The device may be configured to secure the implant relative to the delivery device prior to releasing the implant so that the attachment member is releasable. The mounting member may have a post configuration, and the pressing member has a hole formed to receive the post. The mounting member includes a loop and a pin made of a material coupled to the pressing member. The loop extends through a hole formed in the mounting member and is fixed to the mounting member by the pin, and the mounting member is removed by removing the pin. release. The mounting member further includes a tab, and the pressing member includes a pin formed to contact the pressing member and hold the tab. The tab may be bent. The pressing member includes a slot configured to receive a portion of the tab, and the device is further configured to retain the tab within the slot and be withdrawn to release the tab from the slot. Including release wires. The pin and tab may be held in an engaged state and may be an interlock member held in the pressing member, which are released when moved from the pressing member. The pressing member may be formed from a meltable material. In such an example, the device may further include a coil of conductive wire, and a portion of the pressing member extends at least partially through the coil. The device releases the mounting member by heating the coil and melting a portion of the pressing member. An insulating material may surround at least a portion of the coil. The apparatus may also include a current source configured to provide direct current and / or alternating current to the coil. The current source can also be configured to provide alternating current to the coil up to radio frequency frequencies. The coil may also be a resistance temperature device and may be formed from nickel, copper and / or platinum, or other suitable material.

  In another example, the device includes a bimetallic actuator configured to release the mounting member from the pressing member at a particular temperature range. The bimetal actuator may include a bimetal strip and a fixing member that cooperate with both the mounting member and the pressing member. The fixing member may be configured to connect the pressing member to the mounting member when engaged and to be released in a specific temperature region to separate the mounting member from the pressing member. Each of the pressing member and the attachment member may include a receiving portion, and may be a loop formed so that the fixing member can at least partially pass through each receiving portion. The bimetal actuator may be directly fixed to the fixing member, and / or the connecting part may couple the bimetal strip and the fixing member. The pivot may be coupled to the coupling member. The apparatus in the different example further includes a pivot coupled to the coupling member. The connecting member may include a first part located on the proximal side of the bimetal strip with respect to the pivot and a second part located on the proximal side of the bimetal strip with respect to the pivot, wherein the first part is Shorter than the second part.

  In yet another example, the medical device is configured to transition between an initial shape below the transition temperature and a preset shape above the transition temperature, fixing the mounting member in the initial shape, Release the member. The pressing member may include a receiving portion. The shape memory actuator is pulled out of engagement with the receiving portion when it transitions to a preset shape to penetrate the receiving portion in the initial shape, fix the pressing member to the mounting member, and release the pressing member from the mounting member. For example, the attachment member has a recess, and the shape memory actuator is engaged with the recess in the initial state, and is released from the engagement with the recess when the shape memory actuator is shifted to the preset shape. The plurality of shape memory actuators may engage the receiving portion from opposite sides of the mounting member in a preset shape. Further, the device may include a cutting element secured to the shape memory actuator, the cutting element being configured to excise a portion of the pressing member when the shape memory actuator transitions to a preset shape. For example, the cutting element may have an opening defined therein and at least a portion of the pressing member may extend through the opening. In addition, the apparatus may include a connecting portion and a fixing member, the connecting portion connecting the shape memory actuator to the fixing member. The fixing member connects the pressing member to the mounting member when the shape memory actuator is in the initial shape, and releases the pressing member from the mounting member when the shape memory actuator is in the preset shape. The pivot may be formed to cooperate with the connecting portion. In other examples, the device includes an implant, a coupling member and a cylinder and a piston secured to the securing member. The fixing member may be configured to release the pressing member in response to an operation such as expansion of the cylinder and the piston. The phase change material may be expanded within the enclosed space of the cylinder to drive the piston. Phase change materials may include hydrocarbon fluids and wax formulations, such as those used in typical automotive engine thermostats. As an example, a transverse hole is formed in the pressing member, and a hole is formed in the mounting member. The device may include a flexible filament that extends through the transverse hole through the hole to the tip of the pressing member. The device may include a cutting element. The cutting element engages the filament in the transverse hole and cuts the filament.

  A transport device for transporting an obturator includes a handle body and a pressing handle that cooperates with the handle body, the pressing handle having a guide slot. The guide slot is configured such that the push handle moves a first linear distance linearly relative to the handle body to deploy the first portion of the closure device. The guide slot further moves the linear distance further to deploy the second part of the closure device such that the push handle moves linearly relative to the handle body and moves the second linear distance. Configured to expand. The guide slot may be configured such that the push handle rotates a rotational distance between the first linear distance and the second linear distance. The first groove and the second groove are formed in the handle body, and the first stopper and the second stopper cooperate with these grooves. The first stopper and the second stopper may cooperate with the guide slot. The first stopper and the second stopper are formed to move between the first position and the rotation position in order to suppress the movement of the pressing handle. For example, by rotating the first stopper to the rotation position, the pressing handle moves from the first position to the second position, and after rotating the first stopper to the rotation position, the second stopper is rotated to the rotation position. Thus, the pressing handle can be moved from the second position to the third position. The linear distance from the first position to the second position corresponds to the first linear distance, and the distance between the second position and the third position corresponds to the second linear distance. Thus, in one example, the guide slot includes a first linear portion, a transverse portion that intersects and communicates with the first linear portion, and a second that is substantially parallel to the first linear portion. A linear portion is included, and the second linear portion is in communication with the transverse portion. The delivery device may also include a release assembly configured to release the closure device from the delivery device. The release assembly includes a release cap having a slot, the slot having a linear portion and a transverse portion orthogonal to the linear portion, the linear portion extending proximally of the transverse portion. The slot also includes a detent configured to communicate with the transverse portion. In one example, the pin is coupled to the handle portion and the handle portion cooperates with the pin. The transport device may also include an outflow lumen that communicates with the handle body.

  The medical device has a multi-cell structure configured to transition from a contracted state to an expanded state, and the multi-cell structure engages the passage of the internal tissue hole in the expanded state to close the internal tissue hole A constricted portion and a growth medium having a growth structure secured to the medical device. The growth structure has at least one filament fixed to the central portion of the medical device, a filament wound around the central portion of the medical device, and / or an anchor point formed to have a fixed growth medium including. The anchor point allows the filament to be secured to the medical device by stitching, adhesive fixation, and / or knots. In another example, the point at which the growth medium is attached to the closure device is maintained at a constant distance from each other when the closure device is deployed. The growth medium also includes a strip of growth medium. The strip may be formed by loosely knitting gauze-like material woven in a grid. The strip may also be wrapped around the cell portion of the closure device. The growth medium may also include a film. The growth medium may be at least partially disposed between the closure device and the adjacent closure device. The occlusion device and adjacent occlusion devices may be different or may be substantially similar.

  In yet another configuration, the medical device may have multiple chambers that expand from a contracted state to an expanded state, and these chambers are in an expanded state to close internal tissue holes. It has a constricted portion formed to engage the passage of the internal tissue hole. The chamber has a distal anchor portion and / or a proximal anchor portion. The distal anchor portion is initially formed to expand and the proximal anchor portion is formed to expand following expansion of the distal anchor portion. These chambers may be connected to each other, separated from each other, or may be configured by mixing them. These chambers may also be formed from a bioabsorbable material.

  In another example, a method for separating a tether from an implant within a body lumen includes positioning the implant within the body lumen and attaching the tether to the implant to assist in positioning the implant within the body lumen. And applying at least one of an electrical input or a heat input to the tether to separate the tether from the implant. Applying at least one of electrical input or heat input includes applying the electrical input to the tether to melt the tether away from the implant, and releasing the securing member from engagement with the tether. Applying a heat input to the bimetallic actuator to separate the implant from the implant and releasably disengaging the implant from the implant to move a portion of the shape memory actuator relative to the implant to free the tether from the implant. Applying heat input to the coupled shape memory actuator; applying heat input to the shape memory actuator; the shape memory actuator being attached to a cutting structure that at least partially surrounds the tether; and / Or separate the tether from the implant The phase change assembly in order and a step of applying a heat input.

The present invention can also include the following methods, systems and apparatus.
A medical device comprising a body portion comprising two or more cells, the body portion being transitionable between a deployed configuration and a non-deployed configuration, comprising at least one anchor coupled to the body portion The at least one anchor is configured to reduce movement of the proximal end of the medical device when the medical device is positioned within the internal tissue hole.

  A medical device comprising: a multi-cell structure configured to selectively expand and contract between a deployed configuration and a non-deployed configuration; and a first anchor operably coupled to the multi-cell structure, The first anchor is adapted to selectively engage at least a portion of the wall of the internal tissue hole and includes a second anchor operably coupled to the multi-cell structure, the second anchor having an internal opening A medical device adapted to selectively engage at least another portion of the wall of the medical device.

  A method for closing a patent foramen ovale comprising positioning at least a portion of a medical device within the left atrium of the heart, the medical device comprising a first anchor, a multi-cell structure coupled to the first anchor, And a second anchor coupled to the multi-cell structure, wherein the first anchor, the multi-cell structure, and the second anchor are configured to selectively move between a non-deployment arrangement and a deployment arrangement, Positioning at least a portion of the first anchor to hit at least a portion of the left atrial wall of the heart, and positioning at least a portion of the second anchor to hit at least one of a patent foramen ovale or the right atrial wall of the heart Including the step of:

  A medical device that approximates the tissue of an internal tissue hole, comprising a body portion comprising two or more cells, wherein the body portion is adapted to apply a lateral force to the tissue of the internal tissue hole, A medical device comprising at least one anchor operably coupled to a body portion.

  A medical device for bringing the tissue of an internal tissue hole closer, comprising a multi-cell structure adapted to selectively expand and contract between a deployed configuration and a non-deployed configuration, wherein the multi-cell structure is preferentially expanded At least one anchor operably coupled to the multi-cell structure, the at least one anchor being adapted to transition between a deployed configuration and a non-deployed configuration, the at least one anchor At least a portion of the anchor is a medical device adapted to apply a lateral force to at least a portion of the tissue in the internal tissue hole when the first anchor is deployed.

  A method for reducing the size of an internal tissue hole comprising positioning at least a portion of a medical device through an internal tissue hole, the medical device comprising a multi-cell structure and at least one anchor coupled to the multi-cell structure; The at least one anchor and the multi-cell structure are adapted to selectively transition between a non-deployed configuration and a deployed configuration, and by at least partially deploying the at least one anchor, an internal tissue hole Applying a lateral force to the tissue.

  A medical device comprising two or more cells forming a body portion, wherein the body portion transitions between a contracted configuration and an expanded configuration to apply a lateral force against the tissue of the internal tissue hole. Said at least one anchor connected to said body portion, said at least one anchor extending in a distal direction when said at least one anchor contracts, said at least one anchor being contracted A medical device that extends in the lateral direction when moving from an expanded position to an expanded position.

  A method of deploying an occluding device comprising deploying a left anchor of an occluding device from a delivery device, the delivery device comprising an actuating assembly operably coupled to a handle body, wherein the left anchor Deployment is achieved by linearly moving at least a portion of the actuation assembly relative to the body and rotating the at least a portion of the actuation assembly relative to the handle body to remove the closure from the transport device. Deploying the second anchor of the instrument.

  A delivery device for an internal tissue hole closure device, comprising a handle body including first and second guide members, a first member operably coupled to the handle body, and at least one of the first members defining a guide The first guide member cooperates with the guide to affect the movement of the first member relative to the handle body, and the first member includes a guide structure and operates on the first member. A second member operatively coupled and at least a portion of the second member defining a second guide, wherein the guide structure is associated with the second guide and the second member relative to the first member. A transport device that affects movement and the second guide member cooperates with the second guide to affect the movement of the second member relative to the handle body.

  A delivery device for an internal tissue hole closure device, at least partially received within at least a portion of a handle body, a first pin coupled to the handle body, a second pin coupled to the handle body, and the handle body. And a first cam adapted to be movable relative to at least a portion, the first cam including a slot formed on an outer surface of the first cam, the slot being A first portion and a second portion, wherein the first portion of the slot extends along at least a portion of the length of the first cam, and the second portion of the slot includes the first cam A first pin received in the slot, coupled to the first cam, and at least in at least a portion of the first cam. A second cam that is received in part and is movable relative to at least a portion, wherein the second cam is formed on an outer surface of the second cam and Including a second slot, wherein the first slot of the second cam extends at least partially around the second cam, and the second slot of the second cam is the length of the second cam. The third pin is received in the first slot of the second cam, and the second pin is received in the second slot of the second cam. Conveyor configured to.

  A medical device for closing an internal tissue hole, comprising a multi-cell structure configured to assume a substantially flat configuration, and at least one anchor operably coupled to the multi-cell structure, wherein the at least one anchor A medical device comprising a plurality of sections that at least partially define a closed perimeter.

  A medical device for closing an internal tissue hole, wherein the multi-cell structure is adapted to be transitionable between a first configuration and a second configuration, and at least one anchor operably coupled to the multi-cell structure; A medical device comprising a tissue growth member coupled to the multi-cell structure, wherein the tissue growth member enhances tissue growth in an internal tissue hole.

  An expandable medical device that is at least partially deployable within a tissue structure, the non-tubular multi-cell body configured to deploy from a non-deployed orientation, the body defining at least two openings A medical device comprising a plurality of interconnected body support sections and comprising at least one anchor coupled to the body portion.

  An expandable medical device that is at least partially deployable within a tissue structure, the frame configured to assume a substantially flat shape, the frame transitioning between a first orientation and a second orientation A medical device comprising a central portion adapted to, the central portion comprising a plurality of struts forming a multi-cell structure.

  A medical device for reducing the size of a patent foramen ovale (PFO) comprising a self-expanding frame configured to be compressed within a catheter and configured to assume a generally flat shape The frame has a central portion, the central portion having proximal and distal anchors extending therefrom, such that the central portion self-expands outwardly with respect to the wall of the patent foramen ovale Medical device composed.

  A medical device for reducing the size of an internal tissue hole, the frame including a central portion having a plurality of struts forming a multi-cell structure, the central portion having at least one anchor extending therefrom; and The medical device includes: a central portion configured to have a substantially flat shape, and a member that cooperates with the frame and promotes tissue growth in the internal tissue hole.

  A medical device for occluding an internal tissue hole, comprising a frame including a central portion, the central portion having at least one anchor extending therefrom, and configured to have a substantially flat shape, A tissue growth promoting member attached to the frame, wherein the member is configured to extend substantially out of the plane from the substantially planar arrangement so as to promote tissue growth in the internal tissue hole. Medical device composed.

  A medical implant delivery system for delivering a medical device into a body, comprising a handle, a catheter connected to the handle by a line connected to the medical device, and a tip portion connected to the distal end of the catheter The tip portion defines at least a first passage and a second passage extending at least partially along a length of the tip portion, the first passage configured to move along a guide wire, wherein the second passage is A system configured to communicate with the catheter and configured to facilitate delivery of the medical device, wherein the first and second passages are spaced apart.

  A delivery device configured to be coupled to a catheter for delivering a medical device into the body, comprising a tip portion connected to the distal end of the catheter, wherein the tip member is at least partially along its length At least a first passage and a second passage extending in a general manner, wherein the first passage is configured to move along a guide wire, the second passage is configured to communicate with the catheter, and the medical device A transport device configured to facilitate transport of the device, wherein the first and second passages are spaced apart.

  A medical implant delivery system for delivering a medical device into the body, comprising a handle, a catheter connected to the handle by a line connected to the medical device, and a tip connected to the tip of the catheter The tip portion defines at least a first passage and a second passage extending at least partially along its length, the first passage configured to move along a guide wire, A system in which two passages are configured to communicate with the catheter and are configured to facilitate delivery of the medical device, wherein the first and second passages are non-coaxially disposed.

  A transport device for transporting a medical device, comprising a handle body and an actuating assembly cooperating with the handle body, wherein the actuating assembly is disposed on the handle body for positioning at least a portion of the medical device. A transport device adapted to move linearly relative to the actuator and wherein the actuation assembly is adapted to rotate relative to the handle body for positioning additional portions of the medical device.

  A transport device for transporting a patent foramen ovale occlusion device comprising: a handle body; a first body adapted to cooperate with the handle body and move linearly relative to the handle body; A member coupled to the handle body and the first member and adapted to move linearly relative to the handle body and adapted to rotate relative to the handle body and the first member; A conveying device comprising two members.

  A method for positioning an occlusion device for an internal tissue hole, the method comprising positioning a left anchor of an occlusion device from a delivery device, the delivery device comprising an actuation assembly coupled to a handle body, the left anchor comprising Adapted to be arranged by a first movement of at least a part of the actuating assembly relative to the handle body, and from the conveying device by a second movement of at least a part of the actuating assembly relative to the handle body. Positioning the right anchor of the closure device.

  A method for occluding an internal tissue hole, the internal tissue hole comprising first and second opposing tissue walls and a passage forming the internal tissue hole with respect to the first and second opposing tissue walls. Providing the first anchor of the closure device from the transport device by moving at least a portion of the actuation assembly of the transport device in a linear direction relative to a handle body of the transport device; Positioning the first anchor toward the first tissue wall of the internal tissue and rotating at least a portion of the actuation assembly to at least one of the passage of the internal tissue hole or at least one of the second tissue walls Positioning a second anchor of the closure device from the delivery device to engage a portion.

  A method for occluding a patent foramen ovale, wherein at least a portion of an actuation assembly of the transport device is positioned relative to a handle body of the transport device for positioning at least a portion of the closure device from the transport device Translating, wherein the closure device comprises a multi-cell structure coupled to the first portion and a second portion coupled to the multi-cell structure; and a first internal tissue Placing the first anchor toward a tissue wall and rotating at least a portion of the actuation assembly to place the second portion of the closure device from the delivery device.

  A medical system for treating an internal tissue hole, comprising a multi-cell structure and at least one anchor cooperating with the multi-cell structure, a handle body, and an actuating assembly cooperating with the handle body The actuating assembly is adapted to selectively position at least a first portion of the occlusion device by a first movement and selectively position at least a second portion of the occlusion device by a second movement. System adapted to.

  A medical system for treating a tissue structure, comprising a medical device comprising a frame configured to assume a substantially flat shape, the frame including a central portion and at least one anchor extending therefrom, wherein the central portion Comprises a plurality of struts forming a multi-cell structure, comprising a multi-cell structure and at least one anchor cooperating with the multi-cell structure, and a transport device, the transport device comprising a handle body and an actuating assembly A system adapted to allow the actuation assembly to position the at least one anchor by movement of at least a portion thereof.

  The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are illustrative and should be considered in all respects without limitation. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. Changes in meaning and scope equivalent to the claims are intended to be embraced within the scope of the claims.

Claims (14)

A medical device positionable at least partially within a hole formed in a tissue structure,
A skeleton configured to assume a flat shape, the skeleton including a central portion and at least one anchor extending from the central portion, the central portion including a plurality of central frame struts having a length and a width; The width of at least one strut of the plurality of central frame struts varies to taper along at least a portion of the length of the strut and is directly interconnected to other portions of the skeleton A medical device that forms a tapered end. The medical device according to claim 1, wherein the central portion is configured to selectively expand from a contracted orientation to a desired deployment in a tissue structure. The medical device according to claim 1, wherein the framework has a multi-cell structure. The medical device according to claim 1, wherein the plurality of central frame struts have equal lengths. The medical device of claim 1, wherein at least one strut of the plurality of central frame struts is configured to have a uniform stress along at least a portion of its length when deflected. The medical device of claim 1, wherein at least one strut of the plurality of central frame struts at least partially forms the at least one anchor. The medical device according to claim 1, wherein at least one strut of the plurality of central frame struts has an aspect ratio of a depth dimension to a width dimension of at least 2: 1. The medical device according to claim 7, wherein the aspect ratio is between 2: 1 and 10: 1. The medical device according to claim 7, wherein the aspect ratio is 4: 1. 8. The medical device of claim 7, wherein the plurality of central frame struts are configured to resist movement out of a flat shaped surface. The medical device according to claim 7, wherein the central portion includes a plurality of struts forming a multi-cell structure. The medical device according to claim 7, wherein the depth dimension is defined to extend perpendicular to a flat-shaped surface of the skeleton. The medical device according to claim 1, further comprising a tissue growth promoting member associated with the skeleton. Said tissue growth promoting member, medical device according to claim 1 3 attached to the framework so as to extend from the surface of the flat shape.

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