Prosthetic valve and transcatheter prosthetic valve replacement system

Abstract

The embodiment of the present application provides a valve stent and a transcatheter artificial valve replacement system. The artificial valve comprises a valve stent; a positioning stent connected with the valve stent, a plurality of bending sections are formed at the distal end of the positioning stent; the valve stent and the positioning stent both comprise a radially compressed delivery state and a radially expanded implanted state, when the valve stent is in the delivery state, the bending sections are bent to the proximal side; when the valve stent is in the implanted state, the bending sections are bent to the distal side so that the bending sections are wrapped outside part of the valve stent.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an artificial valve and a transcatheter artificial valve replacement system. BACKGROUND

[0002] An artificial heart valve is a heart interventional medical device for treating heart valve diseases or defects. In the interventional surgery process, the artificial valve is delivered to the designated position for positioning, and then the valve is axially moved to the appropriate position.

[0003] The artificial heart valve in the related art has the problems of inconvenient implantation and inaccurate valve positioning. SUMMARY

[0004] The purpose of the embodiments of the present application is to provide an artificial valve and a transcatheter artificial valve replacement system to solve the technical problems of inconvenient implantation and inaccurate valve positioning of the artificial heart valve in the related art.

[0005] The artificial valve provided by the embodiments of the present application includes a valve support and a positioning support connected with the valve support, a plurality of bending segments are formed at the distal end of the positioning support, the valve support and the positioning support both include a radially compressed delivery state and a radially expanded implanted state, when the valve support is in the delivery state, the bending segments bend towards the proximal side, and when the valve support is in the implanted state, the bending segments bend towards the distal side to wrap around part of the valve support outside.

[0006] The plurality of bending segments are formed at the distal end of the positioning support, due to the structure of the bending segments, the valve support part and the positioning support can be integrally cut from a memory alloy material, and during the change of the positioning support from the delivery state to the implanted state, the bending segments change from bending towards the proximal side in the delivery state to bending towards the distal side (folding) in the implanted state, so that the bending segments can wrap part of the valve support and provide clamping force to the native valve leaflet between the proximal end of the positioning support and the valve support. In addition, after the release of the positioning support is completed, the valve support does not need to be axially displaced and then released, the entire release process is simple and fast, which can improve the positioning reliability of the valve support and facilitate the placement of the artificial heart valve to a more appropriate position in the body.

[0007] In some embodiments, the proximal end side of the valve stent is formed with a plurality of first avoiding spaces; the distal end of the positioning stent is formed with a plurality of second avoiding spaces; wherein, when the valve stent and the positioning stent are in the delivery state, a part of the positioning stent is located in the first avoiding space, and a part of the valve stent is located in the second avoiding space; when the valve stent and the positioning stent are in the implanted state, the positioning stent is wrapped outside the valve stent.

[0008] In the delivery state of the positioning stent, the bending segment is bent towards the proximal end to form an inward folding segment, and the positioning stent and the valve stent do not overlap in the radial direction, thereby ensuring that the artificial valve has a smaller delivery diameter during delivery. In the implanted state of the positioning stent, the positioning stent itself deforms and expands, and each positioning arm wraps the proximal stent segment of the valve stent to provide radial support force. At the same time, the bending segment is bent towards the distal end to form an outward folding segment, and the outwardly folded bending segment wraps the distal stent segment to provide clamping force to the native valve leaflet located between the proximal end of the positioning stent and the valve stent. In addition, after the positioning stent is released, the valve stent does not need to be axially displaced before being released, and the entire release process is simple and fast, which can improve the positioning reliability of the valve stent and facilitate the placement of the artificial heart valve in a more suitable position in the body.

[0009] In some embodiments, the valve stent comprises a distal stent segment and a proximal stent segment connected to each other, the proximal stent segment is closer to the proximal end than the distal stent segment, and the proximal stent segment is formed with a plurality of first avoiding spaces; the positioning stent comprises a plurality of positioning arms, each of the positioning arms comprises a first positioning arm and a second positioning arm, the distal end of the first positioning arm and the distal end of the second positioning arm are connected by a corresponding bending segment, the proximal end of the first positioning arm of each positioning arm is connected to the proximal end of the second positioning arm of the adjacent positioning arm, and the second avoiding space is formed between the adjacent two positioning arms; wherein, when the valve stent is in the implanted state, the positioning arm is wrapped outside the proximal stent segment, and the bending segment is wrapped outside part of the distal stent segment.

[0010] The native valve leaflet between the proximal end of the positioning stent and part of the distal end (close to the proximal end) of the valve stent forms a certain clamping force, which facilitates the placement of the artificial heart valve in a more suitable position in the body.

[0011] In some embodiments, the bending segment is arc-shaped. The arc-shaped bending segment is easy to bend when it is bent from the inward folding (proximal end bending) to the outward folding (distal end bending), and can reduce the damage to the human body tissue.

[0012] In some embodiments, the arc of the bending segment protrudes towards the proximal side when the valve stent is in the delivery state; the arc of the bending segment protrudes towards the distal side when the valve stent is in the implanted state.

[0013] In some embodiments, the proximal stent segment comprises a plurality of elastic units distributed in a circumferential direction, and the first avoidance space is formed between two adjacent elastic units.

[0014] In some embodiments, the valve stent and the positioning stent are connected by a connecting rod.

[0015] In some embodiments, one end of the connecting rod is connected to the proximal end of the positioning stent, and the other end of the connecting rod is connected to the elastic unit.

[0016] In some embodiments, the bending segment is provided with a barb. By piercing the native valve leaflet with the barb, the artificial valve is prevented from being mispositioned again, forming reliable positioning.

[0017] In some embodiments, the valve stent is in a cylindrical mesh shape in the implanted state.

[0018] In some embodiments, the valve stent and the positioning stent form an integrated structure.

[0019] In some embodiments, the valve stent is provided with a connecting head for connecting a delivery mechanism.

[0020] In some embodiments, further comprising: a valve component connected in the valve stent.

[0021] The embodiments of the present application also provide a transcatheter artificial valve replacement system, comprising: the artificial valve according to any one of the above embodiments; and a delivery mechanism, wherein the artificial valve can be contracted in the delivery mechanism or released from the delivery mechanism. BRIEF DESCRIPTION OF DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments of the present application. It should be understood that the following drawings only show some embodiments of the present application, and therefore should not be regarded as a limitation on the scope, and for those skilled in the art, other related drawings can also be obtained without creative labor on the basis of these drawings.

[0023] Figure 1 A structural schematic diagram of an artificial valve in a delivery state is provided for the embodiments of the present application.

[0024] Figure 2 Another perspective structural schematic diagram of an artificial valve in a delivery state is provided for the embodiments of the present application.

[0025] Figure 3 Another structural schematic diagram from the perspective of the artificial valve delivery state provided in the embodiments of this application;

[0026] Figure 4 This is a schematic diagram of the valve stent in its delivery state provided in the embodiments of this application;

[0027] Figure 5 This is a structural schematic diagram of the positioning bracket in the conveying state provided in the embodiments of this application;

[0028] Figure 6 This is a schematic diagram illustrating the change of the bending section of the positioning bracket provided in this application embodiment during the transition from the conveying state to the release state. Detailed Implementation

[0029] The technical solutions in the embodiments of this application will now be described with reference to the accompanying drawings.

[0030] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, terms such as "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0031] Please refer to Figures 1-4 , Figure 1 This is a schematic diagram of the structure of an artificial valve in delivery state, provided in an embodiment of this application. Figure 2 Another perspective structural schematic diagram of the artificial valve delivery state provided in the embodiments of this application; Figure 3 Another structural schematic diagram from the perspective of the artificial valve delivery state provided in the embodiments of this application; Figure 4 This is a schematic diagram of the valve stent in its delivery state as provided in an embodiment of this application.

[0032] This application provides an artificial valve, including: a valve stent 10 and a positioning stent 20.

[0033] The positioning stent 20 is connected to the valve stent 10. The distal end of the positioning stent 20 has multiple bent segments 22. Both the valve stent 10 and the positioning stent 20 include a radially compressed delivery state and a radially expanded implantation state. When the valve stent 10 is in the delivery state, the bent segments 22 bend towards the proximal side; when the valve stent 10 is in the implantation state, the bent segments 22 bend towards the distal side so that the bent segments wrap around part of the valve stent 10.

[0034] In the embodiments of the present application, during the implantation of the artificial valve into the human body, the side close to the operator is the proximal end, and the side away from the operator is the distal end. The radially compressed delivery state refers to that, during the delivery of the artificial valve into the human body, the valve stent 10 and the positioning stent 20 are compressed and accommodated in the tube bundle of the delivery device by the radial force. The radially expanded implantation state refers to that, during the implantation of the artificial valve into the designated position of the human body, the valve stent 10 and the positioning stent 20 are released from the tube bundle, so that the valve stent 10 and the positioning stent 20 change from the radial compression to the radial expansion by the elasticity thereof to keep the artificial valve at the aortic valve annulus lesion site. The axial direction refers to the extension direction of the artificial valve from the distal end to the proximal end in the compressed state, the radial direction refers to the deformation direction of the artificial valve from the compression to the expansion, and the circumferential direction refers to the direction around the axial direction of the artificial valve.

[0035] In the embodiments of the present application, the plurality of bending segments 22 are formed at the distal end of the positioning stent 20. Due to the structure of the bending segments 22, the valve stent 10 and the positioning stent 20 can be integrally cut from the memory alloy material, and during the change of the positioning stent 20 from the delivery state to the implantation state, the bending segments 22 change from the proximal end bending in the delivery state to the distal end bending (folding) in the implantation state, so that the bending segments 22 can wrap part of the valve stent 10 and provide clamping force to the native valve leaflets between the proximal end of the positioning stent and the valve stent. In addition, after the release of the positioning stent is completed, the valve stent does not need to be axially displaced before being released, the whole release process is simple and fast, and the positioning reliability of the valve stent can be improved, which facilitates the placement of the artificial heart valve to a more suitable position in the body.

[0036] In some embodiments, a plurality of first avoiding spaces 10a are formed at the proximal end side of the valve stent 10, and a plurality of second avoiding spaces 20a are formed at the distal end side of the positioning stent 20. When the valve stent 10 and the positioning stent 20 are in the delivery state, part of the positioning stent 20 is located in the first avoiding space 10a, and part of the valve stent 10 is located in the second avoiding space 20a. When the valve stent 10 and the positioning stent 20 are in the implantation state, the positioning stent 20 wraps outside the valve stent 10 to position the valve stent 10.

[0037] The valve stent 10 is connected with a valve component (not shown in the figure). The valve component, for example, contains a plurality of prosthetic valve leaflets, which can be sewn to the valve stent 10. In the delivery state, the valve stent 10 has a proximal end side close to the positioning stent 20 and a distal end side away from the positioning stent 20, and a plurality of first avoiding spaces 10a are circumferentially distributed at the proximal end side of the valve stent 10.

[0038] In the delivery state, the positioning support 20 has a distal end side close to the valve support 10 and a proximal end side away from the valve support 10, and a plurality of second avoiding spaces 20a are distributed on the distal end side of the positioning support 20. In the delivery state, the part on the distal end side of the positioning support 20 is embedded into the first avoiding space 10a, and the part on the proximal end side of the valve support 10 is embedded into the second avoiding space 20a. The positioning support 20 and the valve support 10 are partially nested with each other in the axial direction, that is, the positioning support 20 and the valve support 10 have alternating parts in the circumferential direction, that is, the positioning support 20 and the valve support 10 do not overlap in the circumferential direction. When the artificial valve reaches the predetermined position in the human body, the positioning support 20 is released first to be positioned, and then the valve support 10 is released. Due to the alternating parts of the positioning support 20 and the valve support 10 in the circumferential direction and due to the existence of the bending segments 22, after the valve support 10 is released, the proximal end side part of the valve support 10 is automatically wrapped in the inner cavity of the positioning support 20, without the need to move the valve support 10 in the axial direction, the positioning of the valve support 10 is automatically completed, the operation is convenient, and the accuracy of the positioning of the artificial valve is improved.

[0039] Figure 5 A schematic view of the positioning support structure in the contracted state is provided for the embodiments of the present application. Figure 6 A schematic view of the positioning support in the expanded state is provided for the embodiments of the present application.

[0040] Referring to Figures 4-6 In some embodiments, the valve support 10 includes a distal support segment 11 and a proximal support segment 12 connected with each other, the proximal support segment 12 is closer to the proximal end than the distal support segment 11, and the proximal support segment 12 is formed with a plurality of first avoiding spaces 10a; the positioning support 20 includes a plurality of positioning arms 21, each of the positioning arms 21 includes a first positioning arm 211 and a second positioning arm 212, the distal end of the first positioning arm 211 and the distal end of the second positioning arm 212 are connected through a corresponding bending segment 22, the proximal end of the first positioning arm 211 of each of the positioning arms 21 is connected with the proximal end of the second positioning arm 212 of the adjacent positioning arm 21, and the gap between the first positioning arm 211 and the second positioning arm 212 of the adjacent two positioning arms 21 forms a second avoiding space 20a; wherein, in the implanted state of the valve support 10, the positioning arms 21 wrap outside the proximal support segment 12, and the bending segments 22 wrap outside part of the distal support segment 11.

[0041] The plurality of positioning arms 21 can be distributed in the circumferential direction of the positioning support 20. The distal end of the first positioning arm 211 and the distal end of the second positioning arm 212 are connected through a corresponding bending segment 22, that is, the number of the bending segments 22 corresponds to the number of the positioning arms 21, and the distal end of the first positioning arm 211 and the distal end of the second positioning arm 212 of each of the positioning arms 21 are connected through a corresponding bending segment 22.Figure 6 , the proximal ends or the distal ends of the plurality of first positioning arms 211 and the plurality of second positioning arms 212 are sequentially connected in a multi-bent shape. A second avoiding space 20a is formed between two adjacent positioning arms 21, and an opening of the second avoiding space 20a faces the valve stent 10, so that in the delivery state, the proximal stent segment 12 of the valve stent 10 is located in the second avoiding space 20a, thereby avoiding the overlap between the positioning stent 20 and the valve stent 10 in the circumferential direction.

[0042] Preferably, in the delivery state of the valve stent 10, the axial length of the distal stent segment 11 can be greater than or equal to the axial length of the proximal stent segment 12. The distal stent segment 11 and the proximal stent segment 12 can be integrally cut and formed. The proximal stent segment 12 can be formed by extending the distal stent segment 11 towards the proximal direction. For example, referring to Figure 4 The proximal stent segment 12 can include a plurality of elastic units 121 distributed in the circumferential direction, each of which can be formed by extending the distal stent segment 11 towards the proximal direction, and a receiving portion of the positioning stent 20 is formed between two adjacent elastic units 121.

[0043] The bent segment 22 is integrally cut and formed with the positioning arm 21, that is, the first positioning arm 211, the second positioning arm 212 and the corresponding bent segment 22 of each positioning arm 21 are integrally cut and formed. Due to the integrally formed structure of the bent segment 22 and the positioning arm 21, in the delivery state of the positioning stent 20, the bent segment 22 is bent towards the proximal direction to form an inner folding segment, in the implanted state of the positioning stent 20, the positioning stent 20 is deformed and expanded, each positioning arm 21 wraps the proximal stent segment 12 of the valve stent 10 to provide clamping force to the native leaflet between the proximal end of the positioning stent 20 and the valve stent 10, at the same time, the bent segment 22 is bent towards the distal direction to form an outer folding segment, the outer folding bent segment 22 wraps the part of the distal stent segment 11, further providing clamping force to the native leaflet between the positioning stent 20 and the part of the distal stent segment 11 of the valve stent 10, that is, the native leaflet between the proximal end and the part of the distal stent segment 11 of the valve stent 10 is clamped to facilitate the placement of the artificial heart valve in a more suitable position in the body.

[0044] In some embodiments, the above-mentioned bent segment 22 can be arc-shaped, for example, circular arc-shaped. The arc-shaped bent segment 22 is better wrapped around the distal stent segment 11 of the valve stent 10 when it is folded from the inner folding (proximal bending) to the outer folding (distal bending), thereby improving the positioning support capability of the valve stent 10.

[0045] In some embodiments, the arc of the bending segment 22 protrudes towards the proximal side when the valve stent 10 is in the delivery state; the arc of the bending segment 22 protrudes towards the distal side when the valve stent 10 is in the implanted state. When the valve stent 10 changes from the delivery state to the deployed state, the arc of the bending segment 22 changes from the proximal side protrusion to the distal side protrusion.

[0046] In some embodiments, the valve stent 10 and the positioning stent 20 are connected by a connecting rod 30. Preferably, the connecting rod 30 is integrally cut with the valve stent 10 and the positioning stent 20.

[0047] Further, one end of the connecting rod 30 is connected with the proximal end of the positioning arm 21, and the other end of the connecting rod 30 is connected with the elastic unit 121 of the proximal stent segment 12.

[0048] In some embodiments, referring to Figure 5 The bending segment 22 is provided with a barb 23 to prevent the artificial valve from being mispositioned again by piercing the native valve leaflet with the barb 23 when the positioning stent 20 reaches the designated position, thereby forming reliable positioning. The barb 23 is integrally cut with the bending segment 22, and the tip of the barb 23 can be directed towards the proximal side.

[0049] In some embodiments, the valve stent 10 is in a cylindrical mesh shape in the implanted state. The proximal stent segment 12 and the distal stent segment 11 of the valve stent 10 are in a cylindrical mesh shape in the implanted state, and form a radial support force with the aortic valve annulus.

[0050] In some embodiments, the valve stent 10 is provided with a connecting head 24 for connecting a delivery mechanism.

[0051] The application also provides a transcatheter artificial valve replacement system, which comprises the artificial valve according to any one of the above embodiments and a delivery mechanism, and the artificial valve can be contracted in or released from the delivery mechanism. Specifically, the delivery mechanism comprises a catheter seat and a delivery tube bundle connected with the catheter seat, and the artificial valve can be contracted in or released from the delivery mechanism. In use, the artificial valve is delivered to a designated position by the delivery mechanism, the positioning stent 20 is first released and positioned at the aortic annulus lesion site, and then the valve stent 10 is released, the valve stent 10 is automatically deformed and expanded to be wrapped in the inner cavity of the positioning stent 20, without the need to axially move the valve stent 10, thereby achieving accurate and convenient positioning.

[0052] The above merely provides an example of the present application and is not intended to limit the protection scope of the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application. It should be noted that similar reference numerals and letters represent similar items in the following drawings, and thus, once an item is defined in one drawing, it need not be further defined and explained in subsequent drawings.

[0053] The above merely provides an example of the present application and is not intended to limit the protection scope of the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application. It should be noted that similar reference numerals and letters represent similar items in the following drawings, and thus, once an item is defined in one drawing, it need not be further defined and explained in subsequent drawings.

[0054] It should be noted that the relational terms herein such as first and second and the like are used solely to distinguish one from another entity or action without necessarily requiring or implying any actual relationship or order between such entities or actions. Moreover, the terms "comprises", "comprising", or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by "comprises... a" does not, without more constraints, exclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.

Claims

1. A prosthetic valve, comprising: The artificial valve comprises: a valve support; a positioning support connected with the valve support, a distal end of the positioning support being formed with a plurality of bending segments; the valve support and the positioning support each comprise a radially compressed delivery state and a radially expanded implanted state, when the valve support is in the delivery state, the bending segments bend towards the proximal side; when the valve support is in the implanted state, the bending segments bend towards the distal side to wrap around part of the outer side of the valve support; the valve support and the positioning support are connected by a connecting rod; the valve support, the positioning support and the connecting rod are integrally cut and formed.

2. The artificial valve according to claim 1, wherein: a plurality of first avoiding spaces are formed on the proximal side of the valve support; a plurality of second avoiding spaces are formed on the distal end of the positioning support; wherein, when the valve support and the positioning support are in the delivery state, part of the positioning support is located in the first avoiding space, and part of the valve support is located in the second avoiding space; when the valve support and the positioning support are in the implanted state, the positioning support wraps around the outer side of the valve support.

3. The artificial valve according to claim 2, wherein: the valve support comprises a distal support segment and a proximal support segment connected with each other, the proximal support segment is closer to the proximal side than the distal support segment, and the proximal support segment is formed with a plurality of the first avoiding spaces; the positioning support comprises a plurality of positioning arms, each of the positioning arms comprises a first positioning arm and a second positioning arm, the distal end of the first positioning arm and the distal end of the second positioning arm are connected by a corresponding bending segment, the proximal end of the first positioning arm of each of the positioning arms is connected with the proximal end of the second positioning arm of the adjacent positioning arm, and the gap between the first positioning arm and the second positioning arm of the adjacent two positioning arms forms the second avoiding space; wherein, when the valve support is in the implanted state, the positioning arms wrap around the outer side of the proximal support segment, and the bending segments wrap around part of the outer side of the distal support segment.

4. The artificial valve according to any one of claims 1-3, wherein: the bending segments are arc-shaped.

5. The artificial valve according to claim 3, wherein: the first positioning arm, the second positioning arm and the corresponding bending segment are integrally cut and formed.

6. The artificial valve according to claim 3, wherein: the proximal support segment comprises a plurality of elastic units distributed in the circumferential direction, and the first avoiding space is formed between adjacent two elastic units.

7. The artificial valve according to claim 1, wherein: one end of the connecting rod is connected with the proximal part of the positioning support, and the other end of the connecting rod is connected with the valve support.

8. The artificial valve according to claim 1, wherein: the bending segments are provided with barbs.

9. The artificial valve according to claim 1, wherein: the valve support is in a cylindrical mesh shape in the implanted state.

10. The prosthetic valve of claim 1, wherein, the positioning stent is provided with a connection head for connecting a delivery mechanism.

11. The prosthetic valve of claim 1, wherein, Further comprising: a valve component connected within the valve stent.

12. A transcatheter prosthetic valve replacement system, characterized in that, including: the prosthetic valve of any one of claims 1-11; a delivery mechanism, the prosthetic valve being collapsible in or releasable from the delivery mechanism.

Images