CN117481873B - Artificial implant and interventional system - Google Patents
Artificial implant and interventional system Download PDFInfo
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- CN117481873B CN117481873B CN202410002484.7A CN202410002484A CN117481873B CN 117481873 B CN117481873 B CN 117481873B CN 202410002484 A CN202410002484 A CN 202410002484A CN 117481873 B CN117481873 B CN 117481873B
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- 239000007943 implant Substances 0.000 title claims abstract description 59
- 230000000903 blocking effect Effects 0.000 claims abstract description 33
- 238000000034 method Methods 0.000 claims abstract description 12
- 230000006835 compression Effects 0.000 claims abstract description 11
- 238000007906 compression Methods 0.000 claims abstract description 11
- 230000008569 process Effects 0.000 claims abstract description 7
- 230000017531 blood circulation Effects 0.000 claims description 10
- 230000004323 axial length Effects 0.000 claims description 8
- 230000008859 change Effects 0.000 claims description 8
- 229920000642 polymer Polymers 0.000 claims description 8
- 239000002184 metal Substances 0.000 claims description 7
- 230000002093 peripheral effect Effects 0.000 claims description 6
- 238000004804 winding Methods 0.000 claims description 6
- 230000007704 transition Effects 0.000 claims description 5
- 239000011248 coating agent Substances 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- 230000004044 response Effects 0.000 claims description 4
- 238000003466 welding Methods 0.000 claims description 4
- 230000007547 defect Effects 0.000 abstract description 2
- 230000000694 effects Effects 0.000 description 5
- 230000000670 limiting effect Effects 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 238000013461 design Methods 0.000 description 3
- 230000033001 locomotion Effects 0.000 description 3
- 230000013011 mating Effects 0.000 description 3
- 230000001681 protective effect Effects 0.000 description 3
- 229920005830 Polyurethane Foam Polymers 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 238000011084 recovery Methods 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000006978 adaptation Effects 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 210000003709 heart valve Anatomy 0.000 description 1
- 208000018578 heart valve disease Diseases 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The application discloses an artificial implant and an interventional system, wherein the artificial implant comprises: the support is of a tubular structure, and the tubular structure can radially deform and has a corresponding compression state and an expansion state along with deformation; the plugging part is connected with the bracket and is circumferentially arranged along the bracket, and at least one part of the plugging part protrudes out of the periphery of the bracket in the expanded state of the bracket; and the actuating piece is connected with the bracket, acts on at least one part of the plugging part along the radial inward direction of the bracket under the driving of the bracket in the process of converting the bracket from the expansion state to the compression state, and acts in a mode of line contact to press the plugging part radially inward. According to the application, the occurrence rate of paravalvular leakage is effectively reduced through the arrangement of the blocking part, the actuating part can effectively drive the blocking part to adapt to the deformation of the bracket, the defects of access limitation and easy falling and breakage are effectively overcome, and a sufficient structural basis is provided for the optimal arrangement of the artificial implant.
Description
Technical Field
The present application relates to the field of medical devices, and in particular to artificial implants and interventional systems.
Background
Heart valve replacement has been widely used clinically as an effective means of treating heart valve disease, and there has been no adequate solution to the paravalvular leakage (PVL) problem within the industry. Paravalvular leakage is an unstructured valve dysfunction, often occurring early and late after prosthetic valve replacement surgery. The main treatment means after paravalvular leakage can be divided into surgical treatment and interventional treatment. In any way, there are problems such as complications, increased mortality, and high occurrence rate of paravalvular leakage.
From the aspect of valve design, the occurrence rate of paravalvular leakage is reduced, and a common mode is to increase a skirt design at the inflow end of the valve to seal the paravalvular leakage part, wherein a skirt material mainly comprises a biological skirt and a polymer skirt. It is expected that the introduction of the skirt increases the access size of the delivery device and limits the design of the prosthetic valve, which can easily cause problems such as damage and detachment of the skirt during loading, delivery and recovery of the prosthetic valve. Has serious influence on the development of the technical route.
Disclosure of Invention
In order to solve the above technical problems, the present application discloses an artificial implant comprising:
the stent is of a tubular structure, a blood flow channel is arranged in the stent, and the tubular structure can radially deform and has a corresponding compression state and an expansion state along with the deformation;
A leaflet coupled to the stent and adapted to control a blood flow passageway;
A blocking member connected to the stent and arranged circumferentially along the stent, at least a portion of the blocking member protruding beyond an outer periphery of the stent in an expanded state of the stent;
And the actuating piece is connected with the bracket, and is driven by the bracket to act on at least one part of the plugging part along the radial inward direction of the bracket in the process of the transition of the bracket from the expansion state to the compression state.
The following provides several alternatives, but not as additional limitations to the above-described overall scheme, and only further additions or preferences, each of which may be individually combined for the above-described overall scheme, or may be combined among multiple alternatives, without technical or logical contradictions.
Optionally, the actuation member acts on the occluding component in a line contact to press the occluding component radially inward.
Optionally, the actuating member is a polymer wire, a metal wire, or a hybrid wire of a polymer and a metal.
Optionally, the plugging member is a plurality of deformable plugging blocks, each plugging block is arranged at intervals, and the actuating member presses the individual plugging block or presses the plurality of plugging blocks synchronously.
Optionally, the support is provided with a first connection point and a second connection point which are axially arranged at intervals, the actuating piece is a flexible piece or a deformable structure, at least one end of the actuating piece is connected with the first connection point, and at least the other end of the actuating piece is connected with the second connection point.
Optionally, the stent has a lattice structure, the axial length of at least one lattice in the lattice structure changes in response to a change in the axial length of the lattice or lattices during a transition from a different state of the stent.
Optionally, the actuating member comprises at least one traction wire, two ends of which are respectively constrained by two or more positions axially spaced on the stent, the traction wire being relaxed in the expanded state to allow the blocking member to protrude outwards, and being tightened in the compressed state to press the blocking member radially inwards.
Optionally, the actuating member comprises a plurality of traction wires and is arranged as follows:
A plurality of traction wires extending in an axial direction of the stent; and/or
At least one of the traction wires extends in the circumferential direction of the stent; and/or
At least one of the traction wires extends in both the axial and circumferential directions of the stent; and/or
At least one of the traction wires has a portion extending in an axial direction of the stent and another portion extending in a circumferential direction of the stent.
Optionally, the ends of the traction wires are connected to the stent and/or other traction wires by one or more of tying, threading, winding, bonding, welding.
Optionally, in at least one grid, a traction wire extending in the axial direction of the stent and a traction wire extending in the circumferential direction of the stent are intersected, and the two traction wires are positioned or movably arranged compared with the intersection point.
Optionally, one of the traction wires is provided with a threading ring, and the threading ring is used for threading other traction wires;
the threading ring is formed by winding the traction wire; or (b)
The threading ring degree is independently arranged and connected to the corresponding traction wire.
Alternatively, within a single mesh, the traction wires pass through the geometric center of the mesh;
The traction wires are provided with a plurality of traction wires which are mutually intersected, and the intersection positions are close to the geometric center of the grid.
Optionally, each grid provided with the plugging member corresponds to at least one traction wire, and the number of the traction wires in each grid provided with the plugging member is the same or different.
Optionally, the plugging member is a plurality of deformable plugging blocks, each plugging block is arranged at intervals, and all the plugging blocks are extruded by one traction wire.
Optionally, the local fretwork of support forms the grid structure, the radial dimension of traction wire is less than or is close to the radial dimension of grid structure's rib.
Optionally, the artificial implant further comprises:
The inner covering film is distributed around the inner peripheral wall of the bracket, the blocking part is fixed on the outer side of the inner covering film, and the bracket protrudes outside the bracket through a corresponding grid in a release state;
And the outer covering film is distributed around the outer peripheral wall of the bracket, and part or all of the blocking part and/or the actuating part is/are wrapped by the outer covering film.
The application also discloses an artificial implant comprising:
the stent is of a tubular structure, a blood flow channel is arranged in the stent, and the tubular structure can radially deform and has a corresponding compression state and an expansion state along with the deformation;
A leaflet coupled to the stent and adapted to control a blood flow passageway;
A blocking member connected to the stent and arranged circumferentially along the stent, at least a portion of the blocking member protruding beyond an outer periphery of the stent in an expanded state of the stent;
and the traction wires are respectively constrained by two spacing parts on the axial direction of the bracket, and loose in the expanded state of the bracket to allow the plugging part to be protruded outwards, and relatively tight in the compressed state of the bracket to press the plugging part inwards in the radial direction.
The application also discloses a method for driving the deformation of the plugging component of the artificial implant, the artificial implant at least comprises a bracket, the plugging component is connected with the bracket and is circumferentially arranged along the bracket, and at least one part of the plugging component protrudes out of the periphery of the bracket in the expanded state of the bracket;
And (3) threading a traction wire on the support, allowing the plugging part to be outwards protruded when the traction wire is loosened, and tightening the traction wire when the plugging part is driven to deform so that the traction wire acts on at least one part of the plugging part along the radial inward direction of the support.
Alternatively, tightening the traction wire fully utilizes stent deformation, or
One end of the traction wire is connected to the bracket, and the other end of the traction wire extends out of the self-use end of the bracket and tows the free end; or (b)
Both ends of the traction wire are free ends extending out of the bracket, and the two free ends are drawn.
The method for driving the deformation of the artificial implant plugging component can be implemented in vivo or in vitro when the stent is radially compressed and loaded, so that the artificial implant is transferred to the catheter component.
The application also discloses an interventional system comprising:
the artificial implant is the artificial implant in the technical scheme and is in a compressed state;
The catheter assembly penetrates through the artificial implant and is connected with the artificial implant; at least one tube is wrapped around the outer periphery of the artificial implant;
A control handle connected to and driving the catheter assembly.
In interventional systems, a prosthetic implant may be loaded into a catheter assembly using the methods of the present application.
According to the technical scheme disclosed by the application, the occurrence rate of paravalvular leakage is effectively reduced through the arrangement of the plugging part, the actuating part can effectively drive the plugging part to adapt to the deformation of the bracket, the defects of access limitation and easiness in falling and breakage are effectively overcome, and a sufficient structural basis is provided for the optimal arrangement of the artificial implant.
Specific advantageous technical effects will be further explained in the detailed description in connection with specific structures or steps.
Drawings
FIG. 1 is a schematic illustration of an artificial implant according to an embodiment;
FIG. 2 is an enlarged schematic view of the occlusion member portion of the prosthetic implant of FIG. 1;
fig. 3 to 8 are schematic views of different views of the engagement of the blocking member and the actuator in different states;
FIGS. 9-15 are schematic views of actuator arrangements in various embodiments;
FIG. 16 is a schematic view of an artificial implant according to another embodiment;
FIG. 17 is a schematic cross-sectional view of the prosthetic implant of FIG. 16;
fig. 18 to 19 are schematic views showing the engagement of the blocking member and the actuator in different states according to still another embodiment;
FIG. 20 is a schematic view of a manual implant loading or retrieval process without an actuator;
Fig. 21 is a schematic view of a manual implant loading or retrieval process provided with an actuator.
Reference numerals in the drawings are described as follows:
400. an artificial implant;
401. An inflow side; 402. an outflow side; 403. a blood flow channel;
410. A bracket; 4111. a wide area; 4131. a first connection point; 4132. a second connection point; 4133. a third connection point; 4134. a limit structure; 4135. a connection hole;
420. A blocking member; 422. a block;
430. Valve leaves;
440. an inner coating film;
450. An outer coating film;
460. An actuator; 4601. traction wire; 4602. traction wire; 4603. traction wire; 461. a protective sleeve; 462. threading the ring.
470. An outer catheter.
Detailed Description
The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.
Referring to fig. 1 to 8, the present application discloses an artificial implant comprising:
the stent 410 is a tubular structure, and the tubular structure can radially deform and has a corresponding compression state and an expansion state along with deformation;
A blocking member 420 connected to the stent 410 and circumferentially arranged along the stent 410, at least a portion of the blocking member 420 protruding beyond the outer circumference of the stent 410 in the expanded state of the stent 410;
An actuator 460 coupled to the stent 410, the actuator 460 being configured to act radially inward along the stent 410 upon at least a portion of the occluding component 420 upon actuation of the stent 410 during transition of the stent 410 from the expanded state to the compressed state. For example, by wire contact to squeeze the occluding component 420 into the interior space of the stent 410.
The stent 410 has axially opposite inflow and outflow sides 401, 402 in a blood flow environment, the interior of the stent 410 being a blood flow channel 403, and the prosthetic implant further comprises leaflets 430 attached to the stent 410 for controlling the blood flow channel 403. The leaflet 430 is 2, 3 or 4 pieces that mate with each other. The leaflet 430 is a biomaterial or a polymeric material. In the drawings, the occluding component 420 is on the inflow side 401 of the leaflet 430. The blocking member 420 achieves a leakage-proof effect by protruding outwardly relative to the stent 410 when the stent 410 is in an expanded state (see fig. 5 and 7), the blocking member 420 is compressed to conform to the shape of the stent 410 when the stent 410 is in a compressed state (see fig. 6 and 8), the blocking member 420 is driven in an assisted manner by the actuator 460 during the compression, and the actuator 460 is also responsive to a change in the state of the stent (see fig. 3 and 4).
The actuator 460 presses the occluding component 420 in a manner that acts radially inward of the stent 410 on at least a portion of the occluding component 420, and in some embodiments the site of action preferably passes through the geometric center of the radially projected shape of the occluding component 420. Referring to fig. 3, when the stent 410 is a lattice structure, the action site passes through a wide region 4111 having the largest circumferential dimension of the lattice structure.
When the actuator 460 is in a line contact mode, the line contact mode is a straight line (or curve) as shown in fig. 3 or 9, the line contact mode is a cross mode as shown in fig. 10 and 11, the line contact mode is a radial mode as shown in fig. 12, and the line contact mode is a grid mode as shown in fig. 13.
The stent 410 has a lattice structure, and during transition of different states of the stent 410, the axial length of at least one lattice in the lattice structure changes accordingly, and the actuator 460 is responsive to the change in axial length of the lattice. Referring to fig. 15, the actuator 460 may also be responsive to axial length changes of the plurality of meshes.
There are various forms in the implementation of the effect of the actuator 460. For example, the actuator 460 is a deformable member or assembly that adjusts its configuration in response to the state of the bracket 410. For another example, the actuator 460 is a transmission member or assembly that transfers the state switch of the stent 410 to the occluding member 420.
The actuator 460 includes at least one traction wire, the ends of which are constrained by two or more axially spaced apart portions of the stent 410, respectively, and which in the expanded state are relaxed to allow the occluding component to be convex (see figures 3, 5 and 7) and in the compressed state are tensioned to press the occluding component radially inward (see figures 4, 6 and 8). Wherein the details of the arrangement of the actuator 460 are not shown in figures 3 and 4 for the sake of brevity, the occluding component is embodied in the form of an occluding block 422 in figures 5 to 8. Preferably, the actuator 460 is a polymer wire, a metal wire, or a hybrid polymer and metal wire. Referring to fig. 2, the radial dimension of the actuator 460 approximates the radial dimension of the ribs of the bracket to withstand greater torque. Referring to fig. 3, the radial dimension of the actuating member 460 is smaller than the radial dimension of the ribs of the bracket to concentrate the stress and optimize the compression effect.
The occluding component 420 is a plurality of deformable occluding blocks 422, with the occluding blocks 422 being spaced apart. In cooperation with the blocking member 420, and as shown in fig. 2, the actuator 460 drives the individual blocking pieces 422 in motion, which allows for precise control of the state changes of the blocking pieces 422.
Also, referring to fig. 14, the actuator 460 simultaneously drives the plurality of blocks 422. This arrangement allows for a reduced number of moving parts and optimizes the overall state control of the artificial implant. For better control of the block 422, the block 422 fills the grid where it is located and within a single grid, the wires are pulled through the geometric center of the grid. The above-described arrangements may also be coordinated with one another, and with reference to fig. 13, one portion of the actuator 460 drives movement of an individual block (the block or blocks are not shown in fig. 13 for simplicity of presentation of details of the arrangement of the actuator 460), and another portion synchronizes movement of multiple blocks.
In the manner of engagement with the bracket 410, referring to fig. 4, the bracket 410 is provided with first and second connection points 4131 and 4132 spaced apart in the axial direction, each of which is a location that is susceptible to binding the brake.
The actuator 460 is a flexible member or deformable structure, with at least one end of the actuator 460 being connected to the first connection point 4131 and at least the other end being connected to the second connection point 4132. For example, referring to the embodiment shown in fig. 3 and 4, the first connection point 4131 and the second connection point 4132 are located at the mesh vertices of the stent 410, respectively. For another example, in fig. 9, the bracket 410 is provided with first connection points 4131, second connection points 4132 and third connection points 4133 which are spaced apart in the axial direction, wherein the first connection points 4131 are located at grid vertices of the bracket 410, the second connection points 4132 and the third connection points 4133 are located on ribs of the bracket 410, and the second connection points 4132 and the third connection points 4133 are aligned or offset in the circumferential direction of the bracket 410.
It can be appreciated that the connection point needs to meet a certain limiting effect in terms of arrangement. For example, as shown in fig. 3, the connection points are mesh vertices of the stent 410; as further shown in fig. 13, the connection point is a connection hole 4135 formed on the bracket 410; as another example, as shown in FIG. 13, the attachment points may be in the form of notches or wavy stop structures 4134 on the bracket 410, or the like. As can be seen from the above description, the connection point serves to limit the positional relationship between the actuator 460 and the bracket 410, but does not necessarily limit the spatial position of the actuator 460. For example, in fig. 13, the connection point is in the form of a connection hole 4135 and the actuator 460 is a pull wire that is movably threaded into the connection hole 4135 to adjust its axial position. As another example, in fig. 9-12, the attachment points of the actuator 460 and the bracket 410 are tied to each other, thereby limiting the spatial position of the actuator and effecting a secure attachment. In a connected manner, the ends of the actuator 460 are thus connected to the bracket 410 and/or other actuator 460 by one or more of tying (see fig. 9), threading (see fig. 13), wrapping (see fig. 12), bonding, and welding.
Referring to fig. 3, the actuator 460 is coupled to the bracket 410 by a protective sheath 461 to reduce wear and distribute stresses. The protective sheath 461 and/or the actuation member 460 can be selected from a high molecular material that is resistant to wear and/or self-wetting. In the embodiment shown with reference to the figures, the actuator 460 includes a plurality of traction wires and has a variety of arrangements.
For example, as shown in fig. 9, a plurality of traction wires extend in the axial direction of the stent 410. The axially extending traction wires are capable of responding to changes in the axial length of the stent 410, thereby achieving a driving effect. The stability of driving can be improved to many traction wires that set up side by side.
As further shown in fig. 10-12, for example, at least one traction wire extends in the circumferential direction of the stent 410. The traction wires can be matched with each other to realize the function on the plugging part. For example, in fig. 10, the circumferentially extending traction wire can restrict the lower end positions of the traction wires extending in both axial directions, and the positions of the traction wires can be stably set even if they are connected to the smoothly excessive ribs. For example, in FIG. 11, in addition to being able to position the lower end of the axially extending pulling wire, the circumferentially extending pulling wire, in cooperation with the axially extending pulling wire, is also able to participate in squeezing the occluding component together in response to a change in condition of the stent 410; it will be appreciated that the circumferentially extending traction wires can be varied in position to engage the axially extending traction wires by adjustment in length (shown in fig. 12).
As also shown in fig. 13, for example, a portion of at least one traction wire extends in the axial direction of the stent 410 and another portion extends in the circumferential direction of the stent 410. In this embodiment, the circumferentially extending traction wires can provide a structural basis for synchronizing multiple blocks in addition to being able to cooperate with the axially extending traction wires to participate in responding to changes in the state of the stent 410.
It will also be appreciated that the traction wires may also be configured such that at least one traction wire extends in both the axial and circumferential directions of the stent 410; for example, the traction wires extend obliquely with respect to the axis of the stent.
The above arrangement modes can be implemented independently or can be mutually cooperated.
When a plurality of traction wires exist, the traction wires can be independently arranged or matched with each other. Referring to the embodiment shown in fig. 13, within at least one grid, a traction wire extending in the axial direction of the stent 410 is interdigitated with a traction wire extending in the circumferential direction of the stent 410. The intersection location is near the geometric center of the grid where it is located. The two traction wires can be positioned and arranged compared with the crossing point so as to improve the load strength. Reference is also made to the figure, in which two traction wires are movably arranged compared to the crossing point. One traction wire is provided with a threading ring 462 and is used for threading other traction wires through the threading ring 462. In the forming mode of the threading ring 462, the threading ring 462 is formed by winding the traction wire; or the threading rings 462 are independently arranged and connected to the corresponding traction wires. For example, the threading ring 462 is a separate polymer ring or a metal ring. The connection between the threading ring 462 and the traction wire can be made by various methods such as penetration, welding, adhesion, winding, etc.
In the embodiment shown in the drawings, each grid provided with the plugging members 420 corresponds to at least one traction wire, and the number of traction wires in each grid provided with the plugging members 420 is the same or different. The number of traction wires in each mesh provided with the plugging members 420 should be considered when calculating the number of traction wires in a mating relationship with the plugging members 420 in the mesh, except that the number of traction wires passing through the mesh on the extending path without being in a mating relationship with the plugging members 420 in the mesh is not counted.
The extension path of the traction wire has various arrangements. Referring to fig. 13, after the traction wires 4601 axially extend from the grid vertices of the stent through the connecting holes 4135 on the left side of the drawing, the circumferentially extending through the threading ring 462 may be as follows:
Near the connection with the bracket, the constraint path is completed, for example, in a mode shown by a broken line in the figure, one end of the traction wire is connected to a limit structure 4134 on the bracket;
the connecting holes 4135 extending to the right in the figure extend along the path of the traction wires 4602 and are connected with the grid vertexes or the connecting holes of the bracket;
The connecting hole 4135 extending to the right in the drawing then follows the path of the traction wire 4603 to the next grid, cooperating with another traction wire.
In connection with the above, it will be appreciated that there are a variety of flexible manners of engagement between the actuator 460, the bracket 410 and the occluding component 420. Referring to the embodiment of fig. 14, the occluding component is a plurality of deformable occluding blocks 422, each occluding block 422 being spaced apart, and all occluding blocks 422 being extruded by a single traction wire. In this embodiment, a traction wire refers to a continuous constraint path, and does not limit the number of actual components of the traction wire, for example, a traction wire may be formed by connecting multiple traction components. The solution in this embodiment can be understood that the traction wires 4603 in fig. 13 are turned into axial extension through the connection holes 4135 or the vertices of the grids of the stent after encircling the stent, and on the basis of this embodiment, the axial traction wires may be independently or not arranged in each grid or multiple grids, and the matching relationship between the traction wires may be realized by a traction ring or may be realized by other manners.
One end or two ends of the traction wire can also extend out of the bracket to serve as a free end, the rest part of the traction wire penetrates to the grid structure of the bracket in a roundabout way, and after the plugging part is driven to deform, the traction wire can be removed and is not strictly limited to enter the body along with the bracket when in use.
Wherein the occluding component and the actuating component may be disposed on a variety of stents, such as stent 410 shown in figures 14-15, stent 410 shown in figure 16, and deformable stents of other forms.
In the embodiment shown with reference to fig. 16 to 19, the artificial implant further comprises:
the inner covering film 440 is distributed around the inner peripheral wall of the bracket 410, the blocking member 420 is fixed on the outer side of the inner covering film 440, and the bracket 410 protrudes outside the bracket 410 through the corresponding grid in the release state;
The outer cover 450 is distributed around the outer peripheral wall of the stent 410, and part or all of the occluding component 420 and/or the actuating member 460 is surrounded by the outer cover 450.
The inner covering film 440 and the outer covering film 450 can be PU films, the blocking part 420 can be PU foam, and the PU films and the PU foam have the advantages of good elasticity, easy deformation and recovery. The inner and outer covers can be adapted to the state change of the stent in a compliant manner, and the blocking member 420 can change its own spatial volume to adapt to the state change of the stent. Corresponding structures, such as grooves or slits or partial stiffening, can also be provided on the blocking element 420. The above-described structure may be implemented independently to improve compliance of the occluding component 420 or to optimize the mating relationship between the occluding component and the actuating member, such as to maintain the actuating member in a particular position to improve driving. Similarly, corresponding guiding structures may be provided on the inner and outer covers, such as those shown in fig. 18 and 19, and guiding structures may be provided on the inner cover 440 to enhance its adaptation to stent state changes. The guiding structure is a crease (i.e. the black line position shown in the figures). The occluding component 420 is aligned with the guiding structure.
Wherein the inflow side ends of the outer cover 450 and the inner cover 440 may be independently provided, as shown in fig. 16, for example. Referring to fig. 17, when the two are connected and made of the same material, the outer covering film 450 is formed by everting the inner covering film 440 to the outside of the stent. Further, the outer covering film 450 and the inner covering film 440 may be implemented separately, for example, fig. 18 and 19 only show the cross section of the artificial implant in different states in the case of separately disposing the inner covering film 440.
It is to be appreciated that the present application also discloses an interventional system comprising:
the artificial implant is the artificial implant in the technical scheme and is in a compressed state;
The catheter assembly penetrates through the interior of the artificial implant and is connected with the artificial implant; at least one tube (e.g., outer catheter 470 shown in fig. 20 and 21) is wrapped around the outer periphery of the artificial implant;
a control handle connected to and driving the catheter assembly.
Referring to fig. 20, in the embodiment without the actuator, during the process of loading or retrieving the artificial implant 400 into the outer catheter 470 of the delivery system, the outer catheter 470 needs to be pushed relative to the artificial implant 400, so that the outer catheter 470 gradually wraps the artificial implant 400, during this process, the blocking member 420 further protrudes outside the periphery of the bracket 410 due to radial compression of the bracket 410, and at this time, the outer catheter 470 and the protruding blocking member 420 rub against each other, which easily causes the blocking member 420 to damage or even fall off from the bracket 410. Referring to fig. 21, when the stent 410 is radially compressed, the actuator 460 applies a radially inward force to the occluding component 420, and the occluding component 420 is compressed into the interior space of the stent 410, thereby reducing the risk of damaging and dislodging the occluding component during loading or retrieval (the occluding component 420 and the actuator 460 are shown in fig. 21 in multiple numbers, two at different locations are indicated for simplicity of illustration, not all). Other specific implementation procedures are described above, and are not described herein.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description. When technical features of different embodiments are embodied in the same drawing, the drawing can be regarded as a combination of the embodiments concerned also being disclosed at the same time.
The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application.
Claims (15)
1. An artificial implant, comprising:
the stent is of a tubular structure, a blood flow channel is arranged in the stent, and the tubular structure can radially deform and has a corresponding compression state and an expansion state along with the deformation;
A leaflet coupled to the stent and adapted to control a blood flow passageway;
the plugging component is a plurality of deformable plugging blocks, each plugging block is connected to the bracket and is arranged at intervals along the circumferential direction of the bracket, and at least one part of the plugging blocks protrudes out of the periphery of the bracket in the expanded state of the bracket;
an inner coating film distributed around the inner peripheral wall of the bracket, wherein each blocking block is fixed on the outer side of the inner coating film;
An actuating member coupled to the frame, the actuating member including at least one traction wire as a flexible member, the traction wire being relaxed in the expanded state and being taut in the compressed state;
In the process of converting the stent from the expansion state to the compression state, the traction wire is driven by the stent to act on at least one part of the plugging block along the radial inward direction of the stent, and the plugging block enters the inner space of the stent after being extruded.
2. The prosthetic implant of claim 1, wherein the actuation member acts on the occluding member in a line contact to press the occluding member radially inward;
The actuating piece is a polymer wire, a metal wire or a mixed braided wire of a polymer and a metal;
The actuator presses a single block or simultaneously presses multiple blocks.
3. The artificial implant according to claim 1, wherein the support is provided with a first connection point and a second connection point which are arranged at intervals in the axial direction, the actuating member is a flexible member, and at least one end of the actuating member is connected to the first connection point, and at least the other end is connected to the second connection point.
4. The prosthetic implant of claim 1, wherein the scaffold has a lattice structure, the axial length of at least one lattice in the lattice structure changing in response to a transition from the different states of the scaffold, the actuator being responsive to the axial length change of the lattice or lattices.
5. The artificial implant of claim 1, wherein the traction wire is constrained at both ends by two or more axially spaced locations on the stent, the traction wire being relaxed to allow the occluding member to protrude outward, the traction wire being tightened to press the occluding member radially inward.
6. The prosthetic implant of claim 1, wherein the actuating member comprises a plurality of pull wires and is configured as follows:
A plurality of traction wires extending in an axial direction of the stent; and/or
At least one of the traction wires extends in both the axial and circumferential directions of the stent; and/or
At least one of the traction wires has a portion extending in an axial direction of the stent and another portion extending in a circumferential direction of the stent.
7. The artificial implant of any one of claims 5 or 6, wherein the ends of the traction wires are connected to the stent and/or other traction wires by one or more of tying, threading, winding, bonding, welding.
8. The prosthetic implant of claim 7, wherein within at least one lattice, a traction wire extending in an axial direction of the stent and a traction wire extending in a circumferential direction of the stent intersect, the traction wires being positioned or movably disposed as compared to the intersection point.
9. The artificial implant according to claim 7, wherein one traction wire is provided with a threading ring and the threading ring is used for threading other traction wires;
the threading ring is formed by winding the traction wire; or (b)
The threading ring degree is independently arranged and connected to the corresponding traction wire.
10. The prosthetic implant of claim 7, wherein the pull wires pass through the geometric center of a single mesh within the mesh;
The traction wires are provided with a plurality of traction wires which are mutually intersected, and the intersection positions are close to the geometric center of the grid.
11. The artificial implant according to claim 7, wherein each mesh provided with said blocking means corresponds to at least one traction wire, and the number of said traction wires in each mesh provided with said blocking means is the same or different.
12. The prosthetic implant of claim 7, wherein the occluding component is a plurality of deformable occluding blocks, each of the occluding blocks being spaced apart, all of the occluding blocks being extruded by a single traction wire.
13. The artificial implant of claim 7, wherein the stent is partially hollowed out to form a lattice structure, and the radial dimension of the traction wires is smaller than or close to the radial dimension of the ribs of the lattice structure.
14. The artificial implant of claim 1, wherein the artificial implant further comprises:
an outer covering film distributed around the outer peripheral wall of the stent, wherein part or all of the blocking member and/or the actuating member is/are wrapped by the outer covering film;
in the release state of the bracket, the blocking part protrudes out of the bracket through the corresponding grid.
15. An interventional system, comprising:
an artificial implant according to any one of claims 1 to 14 in a compressed state;
The catheter assembly penetrates through the artificial implant and is connected with the artificial implant; at least one tube is wrapped around the outer periphery of the artificial implant;
A control handle connected to and driving the catheter assembly.
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