Clip assembly fixation mechanism and valve repair device

Abstract

This invention discloses a clamping mechanism for a clip assembly and a valve repair device. The clamping mechanism includes: a clamp plate having a first side and a second side opposite to each other along its thickness direction, and the clamp plate having an opening; and a clip including a first spring and a first tongue connected to the first spring, the first spring being located on a first side of the clamp plate, and the first tongue being configured to extend from the first side through the opening to the second side, or the first tongue being located on the first side of the clamp plate; wherein at least one of the first spring and the first tongue includes a first arched portion. By providing a first arched portion on at least one of the first spring and the first tongue, the space for accommodating the valve leaflet can be increased while ensuring clamping stability, especially for hypertrophic valve leaflets, achieving better clamping force.

Description

Technical Field

[0001] This disclosure relates to a clamping mechanism for a clip assembly and a valve repair device. Background Technology

[0002] The heart is divided into left and right ventricular septa, each containing a ventricle and an atrium. The ventricles and atria are separated by the interventricular septum and interatrial septum, respectively. Between the atria and ventricles are valves that prevent backflow of blood. Normal valves (mitral or tricuspid valves) allow blood to flow in only one direction within the heart. However, when mitral or tricuspid regurgitation occurs, it causes an increase in atrial pressure. This increased pressure leads to atrial enlargement, which in turn enlarges the valve annulus, further increasing the degree of regurgitation.

[0003] In the treatment of mitral or tricuspid regurgitation, transcatheter aspiration (TCA) is currently the most common method for edge-to-edge repair of heart valves to minimize trauma. Edge-to-edge repair uses a clamp to connect two leaflets that cannot close properly together, allowing them to close together during systole, thus eliminating or reducing mitral or tricuspid regurgitation. During diastole, the original valve changes from one large opening to two small openings without affecting the leaflet's opening.

[0004] With the aging population, more and more patients are experiencing moderate to severe mitral and tricuspid regurgitation, and some even exhibit calcification and fibrosis of the valve leaflets, leading to increased leaflet thickness. For patients with severe regurgitation, the valve clamp needs to grasp more leaflets to achieve better regurgitation control. However, existing valve repair devices have limited space for leaflet accommodating patients with leaflet hypertrophy or severe regurgitation, significantly limiting their applicability. Summary of the Invention

[0005] According to embodiments of this disclosure, a fixing mechanism for a clip assembly and a valve repair device are provided.

[0006] According to a first aspect of this disclosure, a fixing mechanism for a clip assembly is provided, comprising: a clamping plate having a first side and a second side opposite to each other along its thickness direction, the clamping plate having an opening; a clip including a first spring and a first tongue connected to the first spring, the first spring being located on a first side of the clamping plate, the first tongue being configured to extend from the first side through the opening to the second side or the first tongue being configured to be located on a first side of the clamping plate; wherein at least one of the first spring and the first tongue includes a first arched portion.

[0007] In at least some embodiments, the first spring includes the first arched portion, the first spring including a proximal end and a distal end opposite to each other along its extension direction, the proximal end being configured to connect with the first tongue; the first arched portion is configured to be close to the proximal end of the first spring and arch towards the side away from the first tongue in the thickness direction of the first spring.

[0008] In at least some embodiments, the first spring includes a first side and a second side opposite to each other in its thickness direction, the first side being close to the first tongue and the second side being away from the first tongue; the first spring also includes a barbed area located on the first side of the first spring, and the clip also includes barbs disposed in the barbed area and configured to abut against the clip plate; wherein the first arched portion arches toward the second side of the first spring and is located on the side of the barbed area near the proximal end of the first spring.

[0009] In at least some embodiments, the first tongue includes the first arched portion, the first tongue having a proximal end and a distal end opposite to each other along its extension direction, the proximal end of the first tongue being configured to connect with the first spring; the first arched portion is disposed at the proximal end of the first tongue and arches toward the side away from the first spring in the thickness direction of the first tongue.

[0010] In at least some embodiments, the clip further includes: a second spring clip located on a first side of the clamping plate, and the first spring clip located between the clamping plate and the second spring clip in the thickness direction of the clamping plate; a second tongue clip stacked with the first tongue clip and connected to the second spring clip, the second tongue clip being configured to extend from the first side of the clamping plate through the opening to a second side of the clamping plate or the second tongue clip being located on the first side of the clamping plate; wherein at least one of the second spring clip and the second tongue clip includes a second arched portion.

[0011] In at least some embodiments, the first spring includes the first arched portion; the second spring includes the second arched portion; the second arched portion arches away from the second tongue in the thickness direction of the second tongue, and the outer contours of the second arched portion and the first arched portion are conformal or non-conformal.

[0012] In at least some embodiments, the outer contours of the second arch and the first arch are conformal, and the number of the first arch is equal to the number of the second arch, such that the second arch contacts and covers the first arch in a one-to-one correspondence.

[0013] In at least some embodiments, the number of the first arched portions is at least two, the at least two first arched portions are arranged along the extension direction of the first spring piece, and adjacent two first arched portions have a first spacing in the extension direction of the first spring piece, and the first arched portion has a first length in the extension direction of the first spring piece; the number of the second arched portions is at least two, the at least two second arched portions are arranged along the extension direction of the second spring piece, and adjacent two second arched portions have a second spacing in the extension direction of the second spring piece, and the second arched portion has a second length in the extension direction of the second spring piece; wherein, the first length is greater than or equal to the first spacing, and the second length is greater than or equal to the second spacing.

[0014] In at least some embodiments, the outer contours of the second arch and the first arch are not coconformal, and the number of the first arch is greater than the number of the second arch, such that a gap is provided between the second arch and the plurality of the first arches.

[0015] In at least some embodiments, the second tongue includes a second arched portion, the second tongue having a proximal end and a distal end opposite to each other along its extension direction, the proximal end of the second tongue being configured to connect with the second spring; the second arched portion is disposed at the proximal end of the second tongue and arches toward the side away from the second spring in the thickness direction of the second tongue.

[0016] In at least some embodiments, the first tongue includes the first arched portion, and the second arched portion of the second tongue is conformal to the first arched portion of the first tongue.

[0017] In at least some embodiments, the clamp includes a peripheral region surrounding the opening, the peripheral region including a third arch that arches toward a second side of the clamp in the thickness direction of the clamp.

[0018] According to a second aspect of this disclosure, a valve repair device is provided, including a fixing mechanism for the aforementioned clip assembly. Attached Figure Description

[0019] To more clearly illustrate the technical solutions of the embodiments of this disclosure, the accompanying drawings of the embodiments will be briefly described below. Obviously, the drawings described below only relate to some embodiments of this disclosure and are not intended to limit this disclosure.

[0020] Figure 1 This is a schematic diagram of the valve repair device provided in the embodiments of this disclosure in its extended state;

[0021] Figure 2 This is a schematic diagram of the valve repair device provided in the embodiments of this disclosure in the open state;

[0022] Figure 3 This is a schematic diagram of the valve repair device provided in the embodiments of this disclosure in the closed state;

[0023] Figure 4 A schematic diagram of the fixing mechanism of the clip assembly provided in the embodiments of this disclosure;

[0024] Figure 5 This is a schematic diagram of the structure of the first spring and the first tongue according to an embodiment of the present disclosure;

[0025] Figure 6 A side view of the fixing mechanism clamping the leaflet according to an embodiment of this disclosure;

[0026] Figure 7 Another side view of the clamping mechanism for the leaflets provided in an embodiment of this disclosure;

[0027] Figure 8 This is a schematic diagram of the structure of the second spring and the second tongue provided in the embodiments of this disclosure;

[0028] Figure 9 A schematic diagram of the fixing mechanism provided in another embodiment of this disclosure;

[0029] Figure 10 for Figure 9 A partial structural diagram of the fixing mechanism;

[0030] Figure 11 This is a schematic diagram of the fixing mechanism provided in another embodiment of the present disclosure;

[0031] Figure 12 This is a structural schematic diagram of a fixing mechanism provided in yet another embodiment of the present disclosure;

[0032] Figure 13 This is a structural schematic diagram of a fixing mechanism provided in another embodiment of the present disclosure. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of the embodiments of this disclosure clearer, the technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this disclosure. All other embodiments obtained by those skilled in the art based on the described embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

[0034] Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning understood by one of ordinary skill in the art to which this disclosure pertains. The terms “first,” “second,” and similar terms used in this patent application specification and claims do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as “comprising” or “including” indicate that the element or object preceding “comprising” or “including” encompasses the element or object listed following “comprising” or “including” and its equivalents, and do not exclude other elements or objects. Terms such as “connected” or “linked” are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. Terms such as “upper,” “lower,” “left,” and “right” are used only to indicate relative positional relationships, and these relative positional relationships may change accordingly when the absolute position of the described object changes.

[0035] According to an embodiment of this disclosure, a fixing mechanism for a clip assembly is provided, comprising: a clamping plate and clips. The clamping plate includes a first side and a second side opposite to each other along its thickness direction, and the clamping plate has an opening. The clips include a first spring and a first tongue connected to the first spring, the first spring being located on a first side of the clamping plate, and the first tongue being configured to extend from the first side through the opening to the second side, or the first tongue being configured to be located on the first side of the clamping plate. At least one of the first spring and the first tongue includes a first arched portion.

[0036] In the fixing mechanism of the clamping assembly provided in the above-described embodiments of the present disclosure, by providing a first arched portion on at least one of the first spring and the first tongue, the space for accommodating the leaflets can be increased while ensuring clamping stability. In particular, it can achieve better clamping force for thick leaflets.

[0037] According to another embodiment of this disclosure, a valve repair device including the above-described clip assembly of fixing mechanism is also provided.

[0038] The present disclosure will now be described through specific embodiments. To keep the following description of the embodiments of the present disclosure clear and concise, detailed descriptions of known functions and components may be omitted. When any component of an embodiment of the present disclosure appears in more than one drawing, the component may be represented by the same reference numerals in each drawing.

[0039] Figure 1 This is a schematic diagram of the valve repair device provided in the embodiments of this disclosure in its extended state; Figure 2 This is a schematic diagram of the valve repair device provided in the embodiments of this disclosure in the open state; Figure 3 This is a schematic diagram of the valve repair device provided in the embodiment of this disclosure in the closed state.

[0040] like Figures 1 to 3 As shown, the valve repair device 1 has multiple states, such as an extended state, an open state, and a closed state. The valve repair device 1 can switch between these states to adapt to the structural requirements of the valve repair device during delivery, when the diameter of the delivery device is limited, when grasping the valve leaflets, and when clamping the valve leaflets.

[0041] For example, the valve repair device 1 provided according to the embodiments of this application includes: a spacer element 11, an inner clamping assembly 12, a clip assembly 13, and an outer clamping element 14.

[0042] For example, the valve repair device 1 includes a proximal end 1A and a distal end 1B that are opposite each other in the longitudinal direction (e.g., the Z direction shown in the figure). The delivery device includes a drive shaft 20, which is detachably connected to the valve repair device 1. Figure 1 As shown, for example, the drive shaft 20 passes through a through-hole in the spacer element 11 and is connected to the distal end 1B. The drive shaft 20 is configured to move in the +Z direction (e.g., be pulled back in the +Z direction). During delivery to the target location on the heart via the delivery device, the valve repair device 1 is in Figure 1 The extended state shown is... Figure 1 This is a structural diagram of the valve repair device 1 in the delivery state.

[0043] For example, the inner clamp assembly 12 includes two clamps 201, which are movably connected to the spacer element 11, for example, by hinges. When the drive shaft 20 is pulled back in the +Z direction, the distal end 1B gradually approaches the spacer element 11 in the Z direction. Since the spacer element 11 is relatively fixed, the two clamps 201 are forced to open in the lateral direction. At this time, the valve repair device 1 is in the position... Figure 2 The open state is shown.

[0044] For example, the clip assembly 13 includes two clips 202, each corresponding to one of two clamping plates 201. One end of each clip 202 is connected to the clamping plate 201, and the other end is open relative to the clamping plate 201. For example, each clip 202 is provided with a traction hole 32, and a traction line 30 is connected to the traction hole. By pulling the traction line 30, the opening and closing angle of the clip 202 can be adjusted, thereby capturing the natural petiole and fixing the captured natural petiole using the gap between the clip 202 and the clamping plate 201.

[0045] For example, the external clamping element 14 includes two external clamping arms 141, each corresponding to one of the two clamping plates 201. One end of each external clamping arm 141 is connected to the clamping plate 201, and the other ends of each external clamping arm 141 are connected together (i.e., forming the distal end 1B), forming a clamping space between the two external clamping arms 141. When the captured natural leaflet is fixed by the clips 202 and the clamping plate 201, under the elastic restoring force of the two external clamping arms 141, the two clamping plates 201, the two clips 202, and the spacer element 11 are folded into the clamping space. At this time, the valve repair device 1 is in position... Figure 3 The closed state is shown. Finally, by operating the drive shaft 20, it is disengaged from the valve repair device 1, and the traction wire 30 is pulled out from the traction hole 32, thus holding the valve repair device 1 on the natural valve, thereby completing the clamping of the natural valve.

[0046] For example, the valve repair device 1 also includes two fixing mechanisms 200 for the clip assembly 13. Since the two fixing mechanisms 200 have the same structure, the following description will take one fixing mechanism 200 as an example.

[0047] Figure 4 This is a structural schematic diagram of the fixing mechanism of the clip assembly provided in an embodiment of this disclosure. (In conjunction with...) Figures 2 to 4 The fixing mechanism 200 includes a clamping plate 201 and a clamping piece 202.

[0048] For example, such as Figure 4 As shown, the clamping plate 201 includes a first side S1 (e.g., the upper side shown in the figure) and a second side S2 (e.g., the lower side shown in the figure) that are opposite each other along its thickness direction (e.g., the Z direction shown in the figure). The clamping plate 201 has an opening 2011, which is a through hole penetrating the clamping plate 201.

[0049] For example, clamping piece 202 includes a first spring piece 211 and a first tongue piece 221 connected to the first spring piece 211. The first spring piece 211 is located on a first side S1 of clamping plate 201, and the first tongue piece 221 is configured to extend from the first side S1 through an opening 2011 to a second side S2. By extending the first tongue piece 221 through the opening 2011 to the second side S2 of clamping plate 201, the clamping force between the first spring piece 211 and clamping plate 201 can be increased.

[0050] In some embodiments, at least one of the first spring piece 211 and the first tongue piece 221 includes a first arched portion P1. That is, the first spring piece 211 includes the first arched portion P1, or the first tongue piece 221 includes the first arched portion P1, or both the first spring piece 211 and the first tongue piece 221 include the first arched portion P1. Hereinafter, the term "arched portion" includes an arcuate structure, which may be part of a parabola, a circle, or an ellipse.

[0051] Figure 5 This is a schematic diagram of the structure of the first spring and the first tongue according to an embodiment of this disclosure. For example, as shown... Figure 4 and Figure 5 As shown, the first spring plate 211 includes a proximal end 211A and a distal end 211B opposite to each other along its extension direction. For example, when the valve repair device 1 is in the open state, the proximal end 211A is close to the spacer element 11, and the distal end 211B is away from the spacer element 11 (e.g., Figure 2 (As shown). The proximal end 211A is connected to the first tongue 221, while the distal end 211B is not connected to the first tongue 221, i.e., it is in a suspended state. In this way, a connecting end and an opening and closing end are provided between the first tongue 221 and the first spring 211.

[0052] For example, the first spring piece 211 includes a first arched portion P11, which is positioned near the proximal end 211A of the first spring piece 211 and arches away from the first tongue piece 221 in the thickness direction of the first spring piece 211. That is, the first arched portion P11 is located near the connection end between the first spring piece 211 and the first tongue piece 221 and arches towards... Figure 4 The upper protrusion shown.

[0053] In the fixing mechanism 200 of this application, the natural leaflet extends through the distal end 211B of the first spring 211 into the gap between the first spring 211 and the first tongue 221. Once the gap between the first spring 211 and the first tongue 221 is fixed, the clamping force is relatively constant. Moreover, the closer to the connecting end, the smaller the gap; the closer to the opening and closing end, the smaller the clamping force.

[0054] The inventors discovered that, due to the inconsistent thickness of the natural leaflets in each individual, the clamping force between the first spring 211 and the first tongue 221, while suitable for clamping leaflets with smaller thicknesses, may be insufficient for thicker leaflets. To improve the clamping force, a common approach is to reduce the gap between the first spring 211 and the first tongue 221, thereby increasing the clamping force at the opening end when holding the leaflet. However, this method makes the gap or space at the connecting end even narrower, making it difficult for the heart leaflet to extend to the connecting end, resulting in incomplete clamping. Furthermore, when facing thicker native leaflets, it becomes even more difficult for the leaflet to extend into the elastic clamp, making leaflet clamping more challenging.

[0055] Figure 6 A side view of the fixing mechanism clamping the leaflet according to an embodiment of this disclosure; Figure 7 Another side view of the clamping mechanism for the leaflets provided in an embodiment of this disclosure.

[0056] like Figure 6 and Figure 7As shown in this embodiment, by providing a first arched portion P11 on the first spring piece 211, the space for accommodating the leaflets is increased because the first arched portion P11 has an outwardly convex arc-shaped structure. Figure 6 In the process, for the thinner original leaflet A1, some of the original leaflets A1 can be stacked in the first arched part P11, so that the first spring piece 211 is closer to the thicker area of ​​the original leaflet A1, that is, the distance between the first spring piece 211 and the first tongue piece 221 is not expanded, thereby ensuring clamping stability. Figure 7 In the case of the thicker original leaflet A2, the edge of the original leaflet A2 will be accommodated in the first arched part P11, and will not expand the connection between the first spring piece 211 and the first tongue piece 211, thereby avoiding insufficient clamping force at the opening and closing end and ensuring clamping stability.

[0057] In addition, by setting the first arched part P11, the distal end 211B of the first spring piece 211 can be made more biased toward the first tongue piece 221 without changing the positional relationship between the connection between the first spring piece 211 and the first tongue piece 221, thereby obtaining a larger clamping force at the opening and closing end, ensuring that the entire first spring piece 211 has a large clamping force from the proximal end to the distal end.

[0058] For example, such as Figure 4 As shown, the first spring piece 211 includes a first side S11 and a second side S12 that are opposite to each other in its thickness direction (e.g., the Z direction shown in the figure). The first side S11 is close to the first tongue piece 221, and the second side S12 is away from the first tongue piece 221. Figure 5 As shown, the first spring 211 also includes a barb region 2115 located on the first side S11 of the first spring 211, and the clamping plate 202 also includes barbs 2116 disposed in the barb region 2115 and configured to abut against the clamping plate 201. By providing barbs, it is more convenient to capture the petals and fix the captured petals between the first spring 211 and the clamping plate 201.

[0059] For example, such as Figure 4 and Figure 5 As shown, the first arched portion P11 arches towards the second side S12 of the first spring piece 211 and is located on the side of the barb region 2115 near the proximal end 211A of the first spring piece 211. In this embodiment of the present disclosure, by setting the first arched portion P11 on the side of the barb region 2115 near the proximal end 211A of the first spring piece 211, the space for accommodating the leaflet can be increased without changing the existing design of the barb region, thereby reducing the manufacturing difficulty.

[0060] For example, such as Figure 5As shown, the first spring 211 includes a first hollow area 2111 and a first peripheral area 2112 surrounding the first hollow area 2111. The first peripheral area 2112 includes a first portion 2113 and a second portion 2114 extending along the extending direction of the first spring 2111. The first hollow area 2111 is located between the first portion 2113 and the second portion 2114. By providing the first hollow area 2111, on the one hand, the elasticity of the first spring can be enhanced, which is beneficial for capturing and fixing the leaflet; on the other hand, compared with the case where the first spring 211 is a solid structure, the overall weight of the fixation mechanism or valve repair device can be reduced.

[0061] In some embodiments, the first arched portion P11 is disposed on at least one of the first portion 2113 and the second portion 2114. That is, the first arched portion P11 may be disposed on the first portion 2113, or the first arched portion P11 may be disposed on the second portion 2114, or the first arched portion P11 may be disposed on both the first portion 2113 and the second portion 2114.

[0062] For example, such as Figure 5 As shown, the first arched portion P11 is provided on both the first portion 2113 and the second portion 2114. By providing the first arched portion P11 on both the first portion 2113 and the second portion 2114, more valves can be accommodated without affecting the overall weight of the fixation mechanism or the valve repair device.

[0063] In this embodiment of the disclosure, the clip 202 can be a single layer or multiple layers, such as a double-layer structure. For example, as... Figures 1 to 4 As shown, the clip 202 has a double-layer structure. When the clip 202 is designed as a superposition of the first elastic piece 211 and the second elastic piece 212, the thickness of the elastic piece can be reduced, and the elasticity of the elastic piece can be improved while ensuring the strength of the elastic piece. When gripping the leaflet, the elastic piece and the clip can open to a larger angle relative to each other, so as to facilitate the capture of the leaflet.

[0064] Figure 8 This is a schematic diagram of the structure of the second spring and the second tongue provided in the embodiments of this disclosure.

[0065] For example, such as Figure 4 and Figure 8As shown, the clamping plate 202 further includes a second spring 212 and a second tongue 222. The second spring 212 is located on the first side S1 of the clamping plate 201, and in the thickness direction of the clamping plate 201, the first spring 211 is located between the clamping plate 201 and the second spring 212, and the second tongue 222 is stacked on top of the first tongue 221. That is, in the Z direction, the second spring 212 is stacked on top of the first spring 211, and the second tongue 222 is stacked on top of the first tongue 221. For example, the second tongue 222 is connected to the second spring 212, and the second tongue 222 extends from the first side S1 of the clamping plate 201 through the opening 2011 to the second side S2 of the clamping plate 201.

[0066] In this embodiment of the present disclosure, by providing a second spring 212 on the first spring 211 and a second tongue 222 on the first tongue 221, the elasticity of the first spring and the first tongue can be enhanced.

[0067] In some embodiments, at least one of the second spring 212 and the second tongue 222 includes a second arched portion P2. That is, the second spring 212 includes the second arched portion P2, or the second tongue 222 includes the second arched portion P2, or both the second spring 212 and the second tongue 222 include the second arched portion P2.

[0068] For example, such as Figure 4 and Figure 8 As shown, the second spring piece 212 includes a second arched portion P21. By providing the second arched portion P21 in the second spring piece 212, the elastic restoring force of the first arched portion P11 can be enhanced without affecting the existing design of the first arched portion P11.

[0069] In some embodiments, the second arched portion P2 arches outward toward the side away from the second tongue 222 in the thickness direction of the second tongue 222, and the outer contours of the second arched portion P2 and the first arched portion P1 may or may not be co-conformal.

[0070] For example, such as Figure 4 and Figure 8 As shown, the outer contours of the second arched portion P21 and the first arched portion P11 are conformal, that is, the arc structure of the second arched portion P21 and the arc structure of the first arched portion P11 are the same in curvature, so that the second arched portion P21 covers and fits tightly against the first arched portion P11, thereby further enhancing the elastic recovery force of the first arched portion P11.

[0071] above Figures 1 to 8In the illustrated embodiment, the first spring 211 and the second spring 212 are respectively provided with a first arched portion P11 and a second arched portion P21, but the first tongue 221 and the second tongue 222 are not provided with any arched portions. However, it is understood that in other embodiments of this disclosure, the first tongue 221 may also be provided with a first arched portion P11, and the second tongue 222 may also be provided with a second arched portion P21.

[0072] Figure 9 This is a schematic diagram of the fixing mechanism provided in another embodiment of the present disclosure.

[0073] For example, such as Figure 9 As shown, the fixing mechanism 200 includes a clamping plate 201 and a clamping piece 202, wherein the clamping piece 202 includes a first spring piece 211, a first tongue piece 221, a second spring piece 212, and a second tongue piece 222.

[0074] For example, the first tongue 221 includes a first arched portion P12. The first tongue 221 includes a proximal end 221A and a distal end 221B opposite to each other along its extension direction. The proximal end 221A of the first tongue 221 is connected to the first spring piece 211. The first arched portion P12 is disposed at the proximal end 221A of the first tongue 221 and arches towards the side away from the first spring piece 211 in the thickness direction of the first tongue 221. That is, the first arched portion P12 is close to the connection end of the first tongue 221 and the first spring piece 211, and arches downward as shown in the figure. By providing the first arched portion P12 on the first tongue 221, the space for accommodating the leaflet can be further increased.

[0075] For example, the first tongue 221 is located on the first side S1 of the clamping plate 201. That is, at least part of the first tongue 221 is fixed to the first side S1 of the clamping plate 201, for example, by two rivets 223.

[0076] Compared to Figure 4 When the first tongue 221 passes through the clamping plate 201, by placing the first tongue 221 on the first side S1 of the clamping plate 201, the height of the first tongue 221 in the thickness direction of the clamping plate 201 can be reduced while having approximately the same accommodating space. In this way, when the first spring 211 opens, the force generated by the first tongue 221 in resisting deformation is smaller.

[0077] For example, the second tongue 222 includes a second arched portion P22, which has a proximal end 222A and a distal end 222B opposite to each other along its extension direction. The proximal end 222A of the second tongue 222 is connected to the second spring 212. The second arched portion P22 is disposed at the proximal end 222A of the second tongue 222 and arches away from the second spring 212 in the thickness direction of the second tongue 222. That is, the second arched portion P22 is close to the connection end of the second tongue 222 and the second spring 212, and arches downward as shown in the figure. By providing the second arched portion P22 on the second tongue 222, the elastic restoring force of the first arched portion P12 can be enhanced without affecting the existing design of the first arched portion P12.

[0078] For example, the second tongue 222 is located on the first side S1 of the clamping plate 201, and the first tongue 221 is located between the clamping plate 201 and the second tongue 222 in the thickness direction of the clamping plate 201. That is, at least part of the second tongue 222 is fixed to the first side S1 of the clamping plate 201, for example, by using two rivets 223 to fix the first tongue 221 and the second tongue 222 together to the clamping plate 201.

[0079] Compared to Figure 4 When the second tongue 222 passes through the clamping plate 201, by placing the second tongue 222 on the first side S1 of the clamping plate 201, the length of the second tongue 222 in its extension direction can be increased and the height of the second tongue 222 in the thickness direction of the clamping plate 201 can be reduced while having approximately the same accommodating space. Thus, when the first spring tab 211 opens, the force generated by the second tongue 222 in resisting deformation is smaller. Furthermore, by placing the second tongue 222 on the first tongue 221, the elastic restoring force of the first tongue 221 can be improved.

[0080] For example, such as Figure 9 As shown, at least a portion of the first arch P12 is located in the opening 2011, and at least a portion of the second arch P22 is located in the opening 2011. With the above arrangement, the overall structure of the fixing mechanism 200 can be made smaller and more compact while providing a larger space for the leaflets.

[0081] For example, the outer contours of the second arched portion P22 and the first arched portion P12 are conformal. That is, the arc structure of the second arched portion P22 and the arc structure of the first arched portion P12 are the same in curvature, so that the second arched portion P22 covers and fits tightly against the first arched portion P12, thereby further enhancing the elastic restoring force of the first arched portion P12.

[0082] In some embodiments, there may be multiple first arched portions P11 on the first spring piece 211 and multiple second arched portions P21 on the second spring piece 212. For example, multiple first arched portions P11 may form a wave-shaped structure, and multiple second arched portions P21 may also form a wave-shaped structure.

[0083] For example, such as Figure 9 As shown, the first spring 211 includes at least two first arched portions P11, which are arranged along the extending direction of the first spring 211 (e.g., the transverse direction shown in the figure). For example, the second spring 212 includes at least two second arched portions P21, which are arranged along the extending direction of the second spring 212 (e.g., the transverse direction shown in the figure).

[0084] For example, the first spring 211 and the second spring 212 can be connected relative to each other but not completely fixed by a film covering them. During the opening or closing of the springs, the first spring 211 and the second spring 212 can move relative to each other.

[0085] For example, the second spring 212 does not have barbs. This avoids misalignment of the barbs caused by the relative movement of the first spring 211 and the second spring 212 during the opening process. Furthermore, when piercing the leaflet, only the barbs on the first spring 211 are present, which reduces the thickness of the barbs and increases the piercing force on the leaflet. Compared to... Figure 4 The illustration shows only one first arched portion P11 and one second arched portion P12. In this embodiment, by providing at least two first arched portions P11 and at least two second arched portions P21, the accommodating space for the leaflets can be further increased. Furthermore, suitable accommodating spaces can be provided for leaflets of different lengths. For example, when the leaflet is long, the excess leaflet can be accommodated in the accommodating space on the right side of the figure; when the leaflet is short, the excess leaflet can be accommodated in the accommodating space on the left side of the figure.

[0086] For example, the outer contours of at least two first arched portions P11 and at least two second arched portions P21 are conformal, thus the elastic restoring force of at least two first arched portions P11 can be enhanced by at least two second arched portions P2. The number of first arched portions P11 is equal to the number of second arched portions P21, such that the second arched portions P21 contact and cover the first arched portions P21 in a one-to-one correspondence, thereby further enhancing the elastic restoring force of at least two first arched portions P11.

[0087] Figure 10 for Figure 9 A partial structural diagram of the fixing mechanism. (See attached diagram.) Figure 10As shown, two adjacent first arched portions P11 have a first spacing Pd in ​​the extending direction of the first spring piece 211, and each first arched portion P11 has a first length L1 in the extending direction of the first spring piece 211. The first length L1 is greater than or equal to the first spacing Pd, which further ensures that more leaflets can be accommodated. Preferably, the first length L1 is greater than the first spacing Pd.

[0088] It is understood that the two adjacent second arched portions P21 also have a second spacing (not shown) in the extension direction of the second spring 212, and the second arched portion P21 has a second length (not shown) in the extension direction of the second spring 212. The second length is greater than or equal to the second spacing, so as to enhance the elastic restoring force of at least two first arched portions P11 while ensuring that more leaflets can be accommodated.

[0089] For example, such as Figure 10 As shown, the sum of the lengths L2 of the two first arched portions P11 in the extension direction of the first spring 211 does not exceed 30% of the total length of the first spring 211. This ensures that the position of the first spring 211 for accommodating the leaflet can be fully opened when capturing the leaflet.

[0090] Figure 11 This is a structural schematic diagram of a fixing mechanism provided in another embodiment of the present disclosure. Figure 11 and Figure 9 The difference is that the clamp 201 includes a third arched part P3.

[0091] For example, such as Figure 11 As shown, the clamping plate 201 includes a peripheral region 2012 surrounding the opening 2011. The peripheral region 2012 includes a third arched portion P3. In the thickness direction of the clamping plate 201, the third arched portion P3 arches towards the second side S2 of the clamping plate 201, that is, the third arched portion P3 protrudes downward as shown in the figure. Since the third arched portion P3 of the clamping plate 201 is close to the connection end of the first spring and the first clamping piece, compared to... Figure 9 By setting a third arched part P3, the space for accommodating the leaflets is further increased, and the leaflets can be extended to the connecting end to ensure proper clamping.

[0092] Figure 12 This is a schematic diagram of the fixing mechanism provided in yet another embodiment of the present disclosure. Figure 12 and Figure 11 The difference is that the first spring 211 includes at least two first arched portions P11, and the second spring 212 includes a second arched portion P21.

[0093] In some embodiments, the outer contours of the second arched portion P21 and the first arched portion P11 are not conformal, and the number of first arched portions P21 is greater than the number of second arched portions P11, such that a gap is provided between the second arched portion P21 and the plurality of first arched portions P11. For example, as Figure 12 As shown, at least two first arched portions P11 form a wave-shaped structure, and the second arched portion P21 forms a single arc-shaped structure, thus creating a gap between them. Through the above arrangement, the second spring piece 212 can also enhance the elastic restoring force of the first spring piece 211, so as to jointly clamp the leaflet.

[0094] Figure 13 This is a structural schematic diagram of a fixing mechanism provided in another embodiment of the present disclosure. Figure 13 and Figure 12 The difference lies in the position of the limiting block 2013 on the clamping plate 201.

[0095] Figure 12 In the middle, the clamping plate 201 also includes a limiting block 2013, which is configured to abut against the clamping piece, such as the first spring piece 211, to maintain a gap between the clamping piece 202 (e.g., the first spring piece 211) and the clamping plate 201 to accommodate the leaflet.

[0096] Figure 12 In this design, the first spring piece 211 has multiple rows of barbs (e.g., four rows 2116a to 2116d as shown in the figure), with each row including multiple barbs 2116. Each pair of adjacent rows of barbs has a gap, such as a first gap GP1, a second gap GP2, and a third gap GP3. In the extending direction of the first spring piece 211, the first gap GP1 is furthest from the first arched portion P11 of the first spring piece 211, and the third gap GP3 is closest to the first arched portion P11 of the first spring piece 211. Figure 12 In the middle, the limiting block 2013 is located in the first gap GP1.

[0097] In some embodiments, the limiting block 2013 may be located in a gap other than the first gap GP1. For example, as Figure 13 As shown, the limiting block 2013 can be located in the second gap GP2 or the third gap GP3.

[0098] Compared to being located in the first gap GP1, setting the limiting block 2013 in the second gap GP2 or the third gap GP3 can further improve the clamping force between the clamping piece and the clamping plate, thereby improving the clamping stability, while ensuring that there is a gap between the clamping piece and the clamping plate to accommodate the leaflets.

[0099] In some embodiments, such as Figure 1The diagram shows the structure of the valve repair device in its extended state, i.e., its delivery state. The spacer element 11 includes a spacer body 110 with a first stiffness, meaning the stiffness of the main body of the spacer element 11 is defined as the first stiffness. The spacer element 11 moves along the -Z direction under the force output from the drive shaft 20 of the delivery device. During this movement, due to the first stiffness, the spacer element 11 itself will not deform.

[0100] In some embodiments, the two clamping plates 201 of the inner clamping assembly 12 each have a second stiffness. For example, as Figure 2 As shown, each clamp 201 includes a proximal end 201A and a distal end 201B opposite to each other in its extending direction. The proximal end 201A is close to the spacer element 11, and the distal end 201B is away from the spacer element 11. The proximal end 201A is movably linked to the spacer body 110, for example, via a first hinge 131; the distal end 201B is movably linked to the outer clamp arm 141, for example, via a second hinge 123. Due to the second stiffness of the clamp 201, after the valve repair device is delivered to the target position, the valve repair device changes from an extended state to an open state. By pulling back the drive shaft 20 through the external handle end, and because the proximal end of the spacer element 11 is fixed on the external delivery device and its position remains unchanged, the clamp 201 itself will not deform when the proximal ends 201A and 201B of the clamp 201 are subjected to forces from the spacer element 11 and the outer clamp element 14.

[0101] like Figure 1 and Figure 2 As shown, during the movement of the drive shaft 20 along the +Z direction, since the spacer element 11 itself does not deform and the spacer body 110 is movably connected to the two clamping plates 201 respectively, the two clamping plates 201 are... Figure 1 Its initial basically vertical state gradually unfolded into Figure 2 The device is in a basic horizontal state. Simultaneously, because the two outer clamping arms 141 of the outer clamping element 14 are movably connected to the two clamping plates 201 respectively, and because the spacer element 11 is relatively fixed in position, the Z-axis space of the valve repair device is compressed during the movement of the drive shaft 20 along the +Z direction. The two clamping plates 201 and the two outer clamping arms 141 are forced to gradually increase the distance in the lateral direction, that is, they simultaneously open to both sides (outwards), resembling an inverted umbrella shape. On the side where the outer clamping element 14 is connected to the clamping plate 201, the strength of the outer clamping element 14 is less than the strength of the clamping plate 201.

[0102] In this embodiment of the disclosure, when the two clamping plates 201 are substantially in the same plane (e.g.) Figure 2When the valve repair clamp is in the open position (as shown in the diagram), it is ready to capture the leaflet. Pull the clamp 202 upwards. Due to the high elasticity of the clamp 202, it can open to nearly 90° relative to the clamp 201. This not only facilitates leaflet capture but also allows the leaflet to extend as deeply as possible to the proximal end 201A of the clamp 201, ensuring clamping stability, depending on the patient's condition. After the leaflet reaches the appropriate position, release the clamp 202, which, together with the clamp 201, clamps the leaflet.

[0103] In some embodiments, such as Figure 1 , Figure 2 As shown, the two outer clamping arms 141 of the outer clamping element 14 are integrally formed with the distal end 143, and the two outer clamping arms 141 each have a third stiffness. Because the outer clamping arms 141 have a third stiffness, when the outer clamping arms 141 are subjected to the force from the two clamping plates 201, the side of the outer clamping arms 141 closer to the clamping plates 201 is stretched open.

[0104] For example, the two outer clamping arms 141 have a U-shaped structure. When the two clamping plates 201 are in the same plane, the two outer clamping arms 141 are gradually opened until they reach the maximum opening range. At this time, the valve repair device 1 presents a state similar to an inverted umbrella.

[0105] For example, the stiffness distribution of each outer clamping arm 141 near the second hinge portion 123 is smaller than the stiffness distribution near the distal end 143. This ensures that when the two outer clamping arms 141 are in the open state, the outer clamping arm 141 located on the distal end 143 side can provide the valve repair clamp with a restoring force that moves inward.

[0106] like Figure 2 and Figure 3 As shown, when the drive shaft 20 continues to move along the +Z direction, due to the elastic restoring force of the two outer clamping arms 141 and the pulling force of the drive shaft 20 on the outer clamping arms 141, the distal ends 143 of the outer clamping arms 141 continue to move towards the spacer element 110, and the two distal ends 201B of the two clamping plates 201 move inward, thereby causing the spacer element 11, the inner clamping assembly 12, and the clamping plate assembly 13 to retract entirely into the clamping space of the two outer clamping arms 141, achieving... Figure 3 The closed state is shown. At this time, both clamped leaflets are in contact with the spacer element 110, forming the connection point of the leaflets. There is no gap at the connection point, which can better avoid backflow after the leaflets are clamped (the leaflets are not shown in the figure).

[0107] In some embodiments, the two clips 202 each have a fourth stiffness. Because the two clips 202 have a fourth stiffness, when the clips 202 are subjected to the force of the traction wire 30, the two clips 202 will bend slightly in the middle due to their own elasticity. However, when the valve repair device 1 switches between different states, the two clips 202 will not deform because they are not subjected to force.

[0108] In some embodiments, the second stiffness of the clamp 201 and the first stiffness of the spacer 110 may be the same or different. When the second stiffness and the first stiffness are different, for example, when the second stiffness is greater than the first stiffness, the clamp 201 can withstand a greater force than the spacer 110, that is, the strength of the clamp 201 and the overall stability of the leaflet repair device are improved, which is therefore preferred.

[0109] In some embodiments, the second stiffness of the clamping plate 201 is greater than the third stiffness of the outer clamping arm 141. With the above arrangement, it is beneficial to provide a certain force to the outer clamping arm 141 during the process of the clamping plate 201 unfolding outward to the same horizontal plane, so that the two outer clamping arms 141 unfold outward.

[0110] In some embodiments, the fourth stiffness is less than the third stiffness. This makes the two clamping pieces 202 more flexible and elastic relative to the two outer clamping arms 141. When the clamped leaflets are thicker, the better flexibility and elasticity of the clamping pieces 202 allow for better cooperation with the clamping plate 201 when holding the leaflets, further improving clamping stability.

[0111] In this article, the term "stiffness" refers to the ability of a structure to resist elastic deformation under stress. "Stiffness" characterizes the ease with which a structure deforms or the external force required for deformation. For example, the stiffness of a spacer refers to the external force required for its deformation, the stiffness of a clamping plate refers to the external force required for its deformation, and the stiffness of an outer clamping arm refers to the external force required for its deformation. It should be understood that the stiffness of the outer clamping arm being less than that of the inner clamping arm means that the force applied to the outer clamping arm when it deforms cannot cause deformation. The stiffness of the main body of the spacer element refers to its ability to resist elastic deformation under stress.

[0112] In the clamping mechanism and leaflet repair device provided in the above-described embodiments of this disclosure, by providing a first arched portion on at least one of the first spring and the first tongue, the space for accommodating the leaflet can be increased while ensuring clamping stability. This is particularly beneficial for patients with thickened (large) leaflets or severe regurgitation, achieving better clamping force to improve regurgitation repair performance. Furthermore, by including a second arched portion P2 in at least one of the second spring 212 and the second tongue 222, the elastic recovery force of the first spring 211 can be further enhanced. Moreover, by providing a third arched portion P3 on the clamp, the space for accommodating the leaflet can be further increased.

[0113] The following points should be noted in this article:

[0114] (1) The accompanying drawings of the embodiments of this disclosure only involve the structures involved in the embodiments of this disclosure. Other structures can be referred to the general design.

[0115] (2) Where there is no conflict, the embodiments of this disclosure and the features in the embodiments can be combined with each other to obtain new embodiments.

[0116] (3) The above description is merely an exemplary embodiment of this disclosure and is not intended to limit the scope of protection of this disclosure. The scope of protection of this disclosure is determined by the appended claims.

Claims

1. A fixing mechanism for a clip assembly, comprising: A clamping plate, the clamping plate including a first side and a second side opposite to each other along its thickness direction, the clamping plate having an opening; The clip includes a first spring and a first tongue connected to the first spring, the first spring being located on a first side of the clamping plate, and the first tongue being configured to extend from the first side through the opening to a second side or the first tongue being located on the first side of the clamping plate. The first spring includes at least two first arched portions, and the clamping piece further includes a second spring and a second tongue. The second spring is located on a first side of the clamping plate, and the first spring is located between the clamping plate and the second spring in the thickness direction of the clamping plate. The second tongue is stacked with the first tongue and connected to the second spring. The second tongue is configured to extend from the first side of the clamping plate through the opening to the second side of the clamping plate, or the second tongue is located on the first side of the clamping plate. The second spring includes a second arched portion, which arches outward toward a side away from the second tongue in the thickness direction of the second tongue, and the outer contours of the second arched portion and the first arched portion are not coconformal; The number of first arched portions is greater than the number of second arched portions, such that a gap is provided between the second arched portions and the plurality of first arched portions; the at least two first arched portions form a wave-shaped structure, and the second arched portions form a single arc-shaped structure, thus forming the gap between the at least two first arched portions and the second arched portions; The clamp includes a peripheral region surrounding the opening, the peripheral region including a third arched portion that arches toward a second side of the clamp in the thickness direction of the clamp to further increase the space for accommodating the leaflets.

2. The fixing mechanism according to claim 1, wherein: The first spring sheet includes a proximal end and a distal end opposite to each other along its extension direction, the proximal end being configured to connect with the first tongue sheet; The first arched portion is configured to be close to the proximal end of the first spring piece and arch towards the side away from the first tongue piece in the thickness direction of the first spring piece.

3. The fixing mechanism according to claim 2, wherein, The first spring includes a first side and a second side opposite to each other in its thickness direction, the first side of the first spring being close to the first tongue, and the second side of the first spring being away from the first tongue; The first spring also includes a barbed area located on a first side of the first spring, and the clip also includes barbs disposed in the barbed area and configured to abut against the clip plate; The first arched portion arches towards the second side of the first spring piece and is located on the side of the barbed area near the proximal end of the first spring piece.

4. A valve repair device, comprising a fixing mechanism for the clip assembly as described in any one of claims 1-3.

Images