MXPA06004947A - Sheath for enabling insertion and extraction of anastomotic ring applier - Google Patents

Abstract

A surgical tool or applier for deploying an anastomotic ring that comprises a handle connected to an elongate shaft that terminates in an anastomotic ring deployment mechanism, which is moveable from an unactuated position to an actuated position. In order to prevent tissue from becoming trapped in the ring deployment mechanism during insertion or extraction of the tool, a sheath is adapted to cover ring deployment mechanism during insertion and extraction. The sheath is moveable with the ring deployment mechanism from the unactuated position to the actuated position. The sheath may comprise an elastomeric material, a braided thread, or another material.

Description

COVER FOR ALLOWING THE INSERTION AND EXTRACTION OF AN ANASTOMOTIC RING APUCHOR FIELD OF THE INVENTION In general, the present invention relates to surgery and, more particularly, to a device for performing a surgical procedure in the digestive system.

BACKGROUND OF THE INVENTION The percentage of the world population that suffers from morbid obesity is constantly growing. Severely obese people may be at increased risk of heart disease, stroke, diabetes, lung disease, and accidents. Due to the effects of morbid obesity on the patient's life, methods of treating morbid obesity have been the subject of intense research. A known method for treating morbid obesity includes the use of anastomotic rings. The devices for applying the anastomotic rings are known. Devices of this nature are commonly adapted to insert an anastomotic ring compressed into an anastomotic opening, formed between proximal walls of gastrointestinal tissue. These applicator devices may utilize a ring deployment mechanism comprising an expansion element that is actuated once the compressed ring is placed in the anastomotic opening, causing the anastomotic ring to expand from its cylindrically compressed position to a hollow rivet driven position. With some conventional anastomotic ring applicator devices that use fingers or similar members to expand anastomotic rings, it may be possible for the tissue to be trapped between the fingers of the applicator device when it is inserted adjacent to the proximal gastrointestinal tissue walls. Similarly, it may be possible for the tissue. get caught in the deployment mechanism during removal of the device from the site of the anastomosis. Entrapment of tissue between the fingers can result in undesirable consequences, such as perforation or tearing of the tissue, or even compromising the integrity of the anastomosis. Some known anastomotic ring applicator devices incorporate a tubular sheath which is slidably located on the elongated shaft. The tubular sheath is normally in position on the ring deployment mechanism, while the device is inserted adjacent to the site of the anastomosis during removal of the device, and can be retracted to allow deployment of the ring. In this way, it may be desirable to have an anastomotic ring applicator device that provides a lesser likelihood that the tissue will be caught in the ring deployment mechanism of the device, but does not necessarily require time and a mechanism to retract a sleeve from the devices. fingers of the device.

BRIEF DESCRIPTION OF THE INVENTION In one embodiment, the anastomotic ring applicator device comprises a handle attached to an elongated shaft. The elongated arrow includes an anastomotic ring deployment mechanism. A sheath covers the ring deployment mechanism as it is inserted adjacent to the site of the anastomosis and as it is removed from the site, thus preventing tissue from being caught in the deployment mechanism. This embodiment does not require the surgeon to separately actuate the sheath and the ring deployment mechanism. In another embodiment, an anastomotic ring applicator device comprises a handle attached to an elongated shaft comprising a proximal portion and a distal portion. The distant portion of the elongated arrow includes a ring deployment mechanism. The ring deployment mechanism comprises a plurality of fingers that are movable from a non-driven position in longitudinal alignment with the elongated shaft, to a second position in which the fingers act outwardly of a longitudinal axis of the elongated shaft to actuate a portion. of the anastomotic ring. further, the device comprises a sheath which is adapted to cover the fingers of the ring deployment mechanism, and which is adapted to move with the fingers of the first position in longitudinal alignment with the elongated arrow, to the second position in which the fingers they move out of the longitudinal alignment with the arrow. Therefore, the device can prevent tissue from being caught in the fingers of the ring deployment mechanism. In another embodiment, an anastomotic ring applicator device comprises a handle attached to a ring deployment mechanism by an elongated shaft. The ring deployment mechanism comprises a longitudinal end and a center portion. The device comprises a drive mechanism that is adapted to move the longitudinal end of the deployment mechanism to the center position, thereby actuating a portion of the anastomotic ring. The applicator device also comprises a sheath which is adapted to cover the longitudinal end of the ring deployment mechanism, and which is adapted to move with the longitudinal end toward the center of the device. This can allow safe insertion and removal of the device, without adding retraction steps of the sheath to the process of deploying the anastomotic ring.BRIEF DESCRIPTION OF THE FIGURES The appended drawings that are incorporated and constitute a part of this specification illustrate versions of the invention and, together with the general description of the invention given above and the detailed description of the versions given below, serve to explain the principles of the present invention. Figure 1 is a perspective view of an anastomotic ring applicator device. Figure 2 is a partial perspective view of the distal portion of an anastomotic ring applicator device, retaining an anastomotic ring in an unactuated position. Figure 3 is a partial perspective view of the distal portion of the device of Figure 2, shown without a sheath retaining an anastomotic ring in the actuated position. Figure 4 is a front view of an operated anastomotic ring. Figure 5 is a perspective view of the anastomotic ring applicator device of Figure 1, with the distal portion of its driven ring deployment mechanism. Figure 6 is a perspective view of the device of Figure 1, with the distal portion and the proximal portion of its ring deployment mechanism actuated.

Fig. 7 is a perspective view of separate parts of the anastomotic ring deployment mechanism of Fig. 1. Fig. 8 is a cross-sectional perspective view of separate portions of a proximal portion of the device of Fig. 1, with a left half of accommodation omitted. Figure 9 is a partial cross-sectional view of the distal portion of the device of Figure 1 inserted through an anastomotic opening. Figure 10 is a partial cross-sectional view of the distal portion of the device of Figure 1, forming an anastomotic junction between proximal gastrointestinal tissue walls. Figure 11 is a partial cross-sectional view of a proximal portion of the device of Figure 1. Figure 12 is a cross-sectional view taken along the plane 12 of Figure 11. Figure 13 is a sectional view. cross section taken along plane 13 of figure 11.

DETAILED DESCRIPTION OF THE INVENTION Turning to the drawings, in which similar numbers denote similar components in all the various views, Figure 1 depicts an applicator, 10, which is operable to deploy and actuate an anastomotic ring device (not shown in Figure 1), a generally cylindrical shape to a shape having properties of a hollow rivet, or ring, capable of forming an anastomotic junction at a target anastomosis site, for example in a gastric bariatric bypass of a morbidly obese patient. Figure 2 depicts another applicator, 12. It will be appreciated that the applicators, 10, 12, can be used in a variety of ways including, without limitation, laparoscopically or endoscopically. The applicator 12 is shown in Figure 2 with an anastomotic ring, 14, in a deployment mechanism, 16. In Figure 2, the anastomotic ring 14 is shown in the cylindrical, compressed position. In Figure 3, the deployment mechanism 16 of the applicator 12 has moved the anastomotic ring 14 to the hollow rivet-shaped position, actuated. Figure 4 is a close-up view of the anastomotic ring 14 in the actuated position. The anastomotic ring 14 may comprise a shape memory effect material (SME), such as nitinol by way of example only, which further aids the actuation to a hollow rivet coupling shape. Other suitable anastomotic ring materials 14 will be apparent to those of ordinary skill in the art. An exemplary anastomotic ring 14 is described in detail in the publication of the U.S. patent application. 2003/0032967, by Park and others. It will be appreciated that the terms "near" and "distant" are used herein to refer to a clinician holding a handle of the applicator 10. It will also be appreciated that for convenience and clarity, spatial terms such as "right" and "left", "vertical" and "horizontal", are used here with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting or absolute. In addition, aspects of the invention have application to surgical procedures performed endoscopically and laparoscopically, as well as an open procedure or other procedures. The use of these similar terms or terms should not be considered to limit the present invention to only one category of surgical procedure. Referring again to Figure 1, the applicator 10 of the present example comprises a handle, 17, attached to an elongated arrow, 18, having a proximal end, 20, and a distal end, 22. As shown in Figure 1 , the elongated arrow 18 is flexible either in its entire length or in one or more joints. Of course, alternatively the arrow 18 may be rigid, elastic, malleable, or may have other properties. The distal end 22 of the arrow 18 comprises a ring deployment mechanism, 24. The deployment mechanism 24 can be operated by a button or lever located on the handle 17. As shown in Figure 1, in one embodiment, the handle 17 comprises a pair of actuator members, 26, 28. In the present example, the actuator members 26, 28, comprise slides. The operation of exemplary actuator slides 26, 28 will be described below. However, it will be appreciated that the actuating members 26, 28 can take a variety of other forms and have a variety of other functions. In the present example, the ring deployment mechanism 24 is located proximal to a tip 30. The applicator 10 includes a functionality to prevent tissue from being caught in the deployment mechanism 24 when the applicator 10 is inserted or removed from the site. of the anastomosis. In Figure 1 there is shown a proximal sheath, 32, and a distant sheath, 34. Referring to Figure 7, the ring deployment mechanism 24 of the present example is shown in a perspective view of separate parts, showing how the sheath next 32 is fitted over a plurality of proximal fingers 36, and the distal sleeve 34 fits over a plurality of distal fingers 38. The ring deployment mechanism 24 comprises a stationary molded drive member, 40. Of course, the limb Molded drive 40 can be formed using any suitable method other than molding. In the present example, the molded drive member 40 comprises proximal fingers, 36, and distal fingers, 38. The molded drive member 40 also has a central portion, 46, which is fixedly attached to the middle tube 45. The middle tube 45 it is fixed at the distal end 22 of the arrow 18. Nearby fingers 36 are connected to a first actuator slide, 26, by means of push-pull cables, 42, of the arrow 18 (figure 12). The push-pull wires 42 are in communication with an outer tube, 43, which is fixedly connected with the proximal fingers 36. The distal fingers 38 are connected to a second actuating slide, 28, by means of internal tubes, 44A and 44B, of arrow 1 (figure 13). The inner tube 44A is fixedly connected to the inner tube 44B. The proximal fingers 36 and the distal fingers 38 are in a double hinged relationship with a central portion 46 of the molded actuator member 40. Other configurations suitable for the ring deployment mechanism 24 will be apparent to those of ordinary skill in the art. Figs. 8 and 11 show exemplary components of the handle 17. In the present example, the distal movement of the first actuator slide 26 communicates distant movement to the proximal fingers 36 by means of the push-pull wires 42, thereby causing the proximal fingers 36 are externally operated in the form of an umbrella, due to its hinged relation to the central portion 46. Similarly, the proximal movement of the second actuating slide 28 communicates movement close to the distal fingers 38 by means of the inner tubes 44A and 44B, causing the distal fingers 38 to be actuated externally. due to its hinged relationship with the central portion 46. Thus, in this example, the remote movement of the first actuator slide 26 drives a proximal potion of the anastomotic ring 14, from the compressed position to the driven position, while the movement The next one of the second actuator slide 28 drives a distal portion of the anastomotic ring 14 from the compressed position to the actuated position. In another embodiment, the handle 17 is configured in such a way that the first actuator slide 26 is in communication with distal fingers 38, while the second actuator slide 28 is in communication with proximal fingers 36. Suitable configurations for performing these relations will be obvious for those who have average knowledge in the subject. Alternatively, any other means, method, or mechanism suitable for actuating an anastomotic ring from a compressed position to an actuated position can be used. The fingers 36, 38 are configured to retain an anastomotic ring by engaging the petals, 51, before and during deployment of the anastomotic ring, and to release the petals 51 after deployment of the anastomotic ring 51. The proximal fingers 36 and the distant fingers 38 of the present example comprise gripping slots 48, each of which includes an interiorly directed retention tip, 50. The gripping slots 48 can assist in retaining the anastomotic ring 14 when in the compressed position, while the tip retention 50 may allow uncoupling of the anastomotic ring 14 from the petals 51 of the anastomotic ring 14, after it has been deployed in the actuated position. Other suitable configurations for the fingers 36, 38 will be evident to those of ordinary skill in the art. As shown in Figure 7 the ring deployment mechanism 24 includes spaces, 54, between the proximal fingers 36 and between the distal fingers 38. The proximal sheath 32 is adapted to cover the proximal fingers 36, and the distal sleeve 34 is adapted to cover the distal fingers 38, to prevent tissue from being lodged in the spaces 54 during insertion and removal of the applicator 10. As shown in Figure 5, the distal sleeve 34 is adapted to move to a driven position together with the distal fingers 38, in response to the proximal movement of the second actuator slider 28. This allows the distal sleeve 34 to prevent tissue from being trapped in the spaces 54 during insertion or removal of the applicator 10, without affecting the deployment of the anastomotic ring 14, or require the surgeon to take extra time and effort to retract the sheath. Figure 6 shows the proximal fingers 36 and the distal fingers 36 moved to the expanded position as a result of the movement of the actuating slides 26, 28. The proximal and distal sleeves 32, 34 can be fixed to the proximal and distant fingers 36, 38 respectively, by means of an adhesive, such as an adhesive, by means of mechanical fasteners, or by any other suitable means or method. In one embodiment, the proximal and distal sheaths 32, 34, comprise an elastomeric material that expands with proximal and distal fingers 36, 38, respectively. In another embodiment, the proximal and distant sheaths 32, 34 are made of braided yarn. Even if the yarn material does not have elasticity it can be easily dilated, ensuring coverage of the spaces 54 and while allowing the fingers 36, 38 to move to the expanded position. Other suitable materials and configurations for covers 32, 34 will be apparent to those with average knowledge in the art. In an example of operation, the anastomotic ring 14 is retained in the ring deployment mechanism 24 by fastening grooves 48 of the proximal and distant fingers 36, 38. The applicator 10 is inserted adjacent to the anastomotic site, where an opening 56 is formed in two gastrointestinal passages. next 58, 60, as shown in Figure 9. As the applicator 10 is inserted, the proximal and distant covers 32, 34, act to prevent tissue from being trapped in the spaces 54. Of course, the covers 32, 34 They can serve a variety of other purposes. Referring now to Figure 10, once the ring deployment mechanism 24 is inserted into the anastomotic opening, the first and second actuator slides 26, 28 can be moved to their respective activated positions, causing fingers 36, 38 are operated externally. This can expand the anastomotic ring 14 from its cylindrically compressed position to its hollow rivet operated position, forming an anastomotic junction between the walls of the gastrointestinal tissue. Other applications and methods of operating the applicator 10 will be evident to those with average knowledge in the field.

Claims (20)

NOVELTY OF THE INVENTION CLAIMS

1. - A surgical instrument for implanting an anastomotic ring device, comprising: (i) a handle; (ii) a ring deployment mechanism configured to receive an anastomotic ring, wherein the ring deployment mechanism is adapted to move between a generally cylindrical non-driven position and a hollow rivet-forming driven position; (iii) a drive mechanism for communicating a driving force to the ring deployment mechanism; (V) an elongated arrow joining the handle to the ring deployment mechanism, and operatively configured to transfer the driving force of the handle to the ring deployment mechanism; and (v) a cover adapted to cover the ring deployment mechanism during insertion and removal of the instrument, wherein the cover is adapted to move from the non-actuated position to the actuated position together with the ring deployment mechanism.

2. The surgical instrument according to claim 1, further characterized in that the sheath comprises an elastomeric polymer.

3. The surgical instrument according to claim 1, further characterized in that the sheath comprises a braided material.

4. - The surgical instrument according to claim 3, further characterized in that the braided material is expandable.

5. The surgical instrument according to claim 1, further characterized in that said ring deployment mechanism comprises: a movable proximal portion from the non-actuated position to the actuated position to deploy the proximal portion of the anastomotic ring, and a distal portion movable from the non-actuated position to the actuated position to deploy the distal portion of the anastomotic ring.

6. The surgical instrument according to claim 5, further characterized in that the sheath comprises a proximal portion adapted to cover the proximal portion of the ring deployment mechanism, and a distal portion adapted to cover the distal portion of the deployment mechanism of ring.

7. The surgical instrument according to claim 6, further characterized in that it comprises a first actuator for communicating movement to the proximal portion of the ring deployment mechanism, and a second actuator for communicating movement to the distal portion of the deployment mechanism of ring.

8. The surgical instrument according to claim 7, further characterized in that the actuation of the first actuator moves both the proximal portion of the ring deployment mechanism and the proximal portion of the sheath, from the non-actuated position to the actuated position.

9. - The surgical instrument in accordance with the claim 7, further characterized in that the actuation of the second actuator moves both the distal portion of the ring deployment mechanism and the distal portion of the sheath, from the non-driven position to the driven position.

10. The surgical instrument according to claim 1, further characterized in that the sleeve is secured to the ring deployment mechanism by means of an adhesive.

11. The surgical instrument according to claim 1, further characterized in that the sheath is snapped onto the ring deployment mechanism.

12. The surgical instrument according to claim 1, further characterized in that the cover snaps over the ring deployment mechanism.

13. A surgical instrument for implanting an anastomotic ring, comprising: (i) a handle; (ii) an elongated arrow comprising a proximal portion and a distal portion, wherein said elongate arrow is attached to said handle adjacent to the proximal portion of the elongated shaft; (iii) a ring deployment mechanism comprising a longitudinal end and a central portion located on the distal portion of the elongated shaft, wherein the ring deployment mechanism is configured to receive a compressed anastomotic ring; (iv) a drive mechanism for moving the longitudinal end of the ring deployment mechanism toward the central portion of the ring deployment mechanism to drive a portion of the anastomotic ring; and (v) a sheath adapted to cover at least a portion of the longitudinal end of the ring deployment mechanism during insertion and removal of the instrument, wherein the sheath is adapted to move along with the longitudinal end of the ring deployment mechanism. .

14. The surgical instrument according to claim 13, further characterized in that it comprises a second longitudinal end adapted to move from an initial position toward the central portion of the ring deployment mechanism, to operate a second portion of the anastomotic ring.

15. The surgical instrument according to claim 14, further characterized in that it comprises a second cover adapted to cover the second longitudinal end of the ring deployment mechanism, the cover being further adapted to move together with the second longitudinal end of the ring mechanism. deployment of ring.

16. An instrument for implanting an anastomotic ring, the instrument comprising: (i) an arrow having a distal end and a proximal end, the distal end having an axis defining longitudinal and radial directions; (I) a ring deployment mechanism positioned at the distal end of the arrow on the shaft, the ring deployment mechanism having a plurality of members operable to be moved in a radial direction from a first position to a second position, in wherein the first position corresponds to a non-driven position of an anastomotic ring, wherein the second position corresponds to an actuated position of an anastomotic ring; (iii) a driving mechanism in communication with the ring deployment mechanism, the driving mechanism being operable to move the plurality of members from the first position to the second position; and (iv) one or more covers that cover at least a portion of the plurality of members, wherein the covers (one or more) are configured to move in the radial direction, from the first position to the second position, with the members corresponding.

17. The instrument according to claim 16, further characterized in that the movement of the covers (one or more) is substantially restricted to the longitudinal direction.

18. The instrument according to claim 16, further characterized in that the covers (one or more) comprise at least one of an elastic material or a yarn material.

19. The instrument according to claim 16, further characterized in that the plurality of members are also operable to be moved in the longitudinal direction.

20. The instrument according to claim 16, further characterized in that the covers (one or more) are configured to cover spaces defined by the members of the plurality of members.