A prosthetic valve

Abstract

The utility model relates to a kind of artificial valve, including leaf, valve frame and suture ring, the leaf is placed in the valve frame, the valve frame is set on the suture ring;The valve frame has multiple convex segments, multiple suture marks are set on the suture ring, each suture mark is set between two adjacent convex segments.By the above setting, the suture mark is set between two adjacent convex segments, and the operator can know the approximate position of the convex segment by observing the suture mark, so in the process of replacement surgery, the part provided with the suture mark is sutured and fixed with the part close to left coronary sinus, right coronary sinus and non-coronary sinus in aortic valve ring, which can avoid the convex segment from blocking or even occluding left coronary sinus, right coronary sinus or non-coronary sinus.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to an artificial valve. Background Technology

[0002] In the prior art, the artificial aortic valve used for aortic valve replacement includes a valve frame and valve leaflets. Since there are usually three valve leaflets, the edges of two adjacent valve leaflets are fixed together by the valve frame. In order to fix the edges of two adjacent valve leaflets, the valve frame is provided with corresponding protrusions. However, the aortic valve annulus is relatively close to the left coronary sinus, right coronary sinus and non-coronary sinus, and the artificial valve will block the surgeon's view during replacement, making it impossible for the surgeon to observe the position of the protrusions.

[0003] Therefore, during the replacement process, the protruding part poses a risk of obstructing or even blocking the left coronary sinus, right coronary sinus, or non-coronary sinus, which is not conducive to the operation. Utility Model Content

[0004] To solve the above-mentioned technical problems, this utility model provides an artificial valve, including a leaflet, a valve frame, and a suture ring. The leaflet is placed in the valve frame, and the valve frame is disposed on the suture ring. The valve frame has multiple raised segments, and the suture ring is provided with multiple suture marks. Each suture mark is disposed between two adjacent raised segments. At least one suture mark and the other suture marks are not on the same plane. The distance from one suture mark to the raised segment is h1, and the distance from the other suture mark to the raised segment is h2, where 1 < h1 / h2 ≤ 1.8.

[0005] In some possible embodiments, the leaflet includes a plurality of leaflets forming a leaflet structure, with the edges of two adjacent leaflets fixed in the protruding segment.

[0006] In some possible embodiments, the valve frame further includes concave segments, each of which is located between two adjacent convex segments, and each of which is located between two adjacent concave segments, with the convex segments and concave segments alternating.

[0007] In some possible embodiments, the suture ring includes multiple crest segments and multiple trough segments, and the suture mark disposed on the trough segments. The crest segments are disposed corresponding to the raised segments, and the trough segments are disposed corresponding to the concave segments. The crest segments and the trough segments are disposed alternately.

[0008] In some possible embodiments, the width of the suture mark 21 is 0.5mm-3mm.

[0009] In some possible embodiments, the suture ring includes an outer wall, an inner wall, and a plurality of first beams located between the two, the plurality of first beams being spaced apart along the circumferential direction of the outer wall and the inner wall, such that a plurality of hollow grids are formed inside the suture ring a.

[0010] In some possible embodiments, the suture loop has an alternating first grid and a second grid, the width of the first grid being greater than the width of the second grid, and the central angle α corresponding to the first grid being greater than the central angle β corresponding to the second grid.

[0011] In some possible embodiments, the grid comprises two sub-grids, adjacent to each other, separated by a second beam arranged along the circumferential direction of the suture ring.

[0012] By setting the suture marks between two adjacent protruding segments, the surgeon can determine the approximate location of the protruding segments by observing the suture marks. Therefore, during the replacement surgery, suturing and fixing the portion with the suture marks to the parts of the aortic valve annulus near the left coronary sinus, right coronary sinus, and non-coronary sinus can prevent the protruding segments from obstructing or even blocking the left, right, or non-coronary sinus. Furthermore, the height difference between the suture marks allows the suture ring to precisely adapt to the shape of the native valve annulus, resulting in a tighter fit between the artificial valve and the native valve annulus, reducing gaps, lowering the risk of intraoperative bleeding, and reducing postoperative complications such as paravalvular leakage due to poor fit. Moreover, the suture ring matching the shape of the native valve annulus makes it easier for the surgeon to position and operate during suturing, resulting in a more even suture distribution, reducing abnormal local tension caused by improper suturing, and minimizing damage to the artificial valve and native tissue. Attached Figure Description

[0013] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the present invention and, together with the description, serve to explain the principles of the present invention.

[0014] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0015] Figure 1 This is a schematic diagram of the artificial valve of this utility model;

[0016] Figure 2 for Figure 1 A bottom view of an artificial valve;

[0017] Figure 3 for Figure 1 Exploded view of an artificial valve;

[0018] Figure 4 for Figure 1 A schematic diagram of an artificial valve from another perspective;

[0019] Figure 5 for Figure 1 A schematic diagram of an artificial valve implanted in the body;

[0020] Figure 6 A schematic diagram of a suture loop according to another embodiment;

[0021] Figure 7 A schematic diagram of a suture ring according to yet another embodiment;

[0022] Figure 8 for Figure 7 A schematic diagram of the suture ring from another perspective;

[0023] Figure 9 A schematic diagram of a grid according to another embodiment;

[0024] Figure 10 This is a schematic diagram of a suture ring according to another embodiment. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model 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 utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0026] In the field of medical devices, "proximal" refers to the end closer to the operator, while "distal" refers to the end farther from the operator. Those skilled in the art can understand the specific meaning of these terms in this invention based on the actual situation.

[0027] like Figure 1-3 As shown, this utility model provides an artificial valve 1, which includes a leaflet 4, a valve frame 3, and a suture ring 2. The leaflet 4 is placed in the valve frame 3, and the valve frame 3 is disposed on the suture ring 2. The valve frame 3 has a plurality of protruding segments 31 that protrude along the axial direction. The suture ring 2 is provided with a plurality of suture marks 21, and each suture mark 21 is disposed between two adjacent protruding segments 31.

[0028] With the above setup, the suture mark 21 is placed between two adjacent protruding segments 31. The surgeon can observe the suture mark 21 to know the approximate location of the protruding segment 31. Therefore, during the replacement surgery, the part with the suture mark 21 is sutured and fixed to the part of the aortic valve annulus near the left coronary sinus, right coronary sinus, and non-coronary sinus. This can prevent the protruding segment 31 from blocking or even sealing the left coronary sinus, right coronary sinus, or non-coronary sinus.

[0029] Specifically, the suture ring 2 can be made of various suitable materials (such as the polymer polyetheretherketone, or elastic materials such as elastic silicone), and the outer surface of the suture ring 2 is covered with a biocompatible film (such as PET). The suture ring 2 and the film can be connected to each other by sutures.

[0030] The leaflet 4 serves as a one-way flow valve, allowing blood to flow in only one direction. The leaflet 4 can be made of animal-derived materials, such as bovine or porcine pericardium. The leaflet 4 includes three leaflets 42, which form the leaflet structure. The edges 41 of two adjacent leaflets 42 are fixed in the raised section 31 by sutures or other components. The valve frame 31 is a slender component made of a single wire drawn from a flexible metal such as nickel-cobalt alloy or stainless steel. Its ends are connected by pressing and welding, and then pre-shaped to form three raised sections 31 with inverted U-shaped structures and three lower concave sections 32 in the axial direction. Each concave section 32 is located between two adjacent raised sections 31, and each raised section 31 is located between two adjacent concave sections 32. The concave segment 32 is alternately arranged with the suture ring 2, which is circular or nearly circular in shape. The suture ring 2 includes three peak segments 22 and three trough segments 23 in the axial direction, and the suture mark 21 is provided on the trough segment 23. The peak segments 22 are arranged corresponding to the protruding segments 31, and the trough segments 23 are arranged corresponding to the concave segments 32. That is, each trough segment 23 is arranged between two adjacent peak segments 22, and each peak segment 22 is arranged between two adjacent trough segments 23. The peak segments 22 and trough segments 23 are alternately arranged. The concave segment 32 of the flap 3 is connected to the suture ring 2 by suturing.

[0031] With the above configuration, the valve leaflet 4 and the suture ring 2 are combined together using the valve frame 3. The suture ring 2 is used to suture with the aortic valve annulus to fix the artificial valve 1 onto the aortic valve annulus. After the aortic valve annulus is implanted, during the cardiac cycle, based on the principle of hemodynamics, the valve leaflet 4 will open and close. The suture ring 2 can expand and contract along with the aortic valve annulus. The valve frame 3 will also expand and contract under the action of the suture ring 2. Thus, the valve frame 3 can cooperate with the movement of the valve leaflet 4, so that the artificial valve 1 can open and close normally.

[0032] Furthermore, since the valve frame 3 has the protruding section 31 and the concave section 32 in the axial direction, and the suture ring is correspondingly provided with the crest section 22 and the trough section 23, the shapes of the valve frame 3 and the suture ring 2 are matched, so that the suture ring 2 can better transmit the force to the valve frame 3 and provide transmission efficiency.

[0033] Furthermore, since the suture mark 21 is located in the trough segment 23, which corresponds to the concave segment 32 of the valve frame 3, the position of the concave segment 32 of the valve frame 3 can be determined based on the position of the suture mark 21, thereby inferring the position of the convex segment 31 of the valve frame 3. Therefore, during the replacement process, the surgeon can adjust the position of the artificial valve 1 based on the positions of the left coronary sinus, right coronary sinus, and non-coronary sinus, as well as the position of the suture mark 21, thereby avoiding the convex segment 31 of the valve frame 3 from blocking or occluding the left coronary sinus, right coronary sinus, or non-coronary sinus, and improving the safety and reliability of the procedure.

[0034] It should be noted that the three leaflets 42 of the leaflet 4 are merely examples. In some possible embodiments, the leaflets 42 may also be four, five, or even more. Correspondingly, the protruding segment 31 and the concave segment 32 of the petiole frame 3 may also be four, five, or even more.

[0035] like Figure 5 As shown, the artificial valve 1 can be implanted onto the aortic valve annulus 7 in the aorta 6, and a portion of the artificial valve 1 is located in the aorta 6.

[0036] like Figure 4As shown, in some possible embodiments, at least one of the suture marks 21a and the other suture marks 21b (another suture mark 21b is not shown in the figure) are not on the same plane. The distance from the suture mark 21a to the protrusion 31 is h1, and the distance from the suture mark 21b to the protrusion 31 is h2, where h1 is slightly larger than h2. Generally, 1 < h1 / h2 ≤ 1.8; preferably, 1.05 < h1 / h2 ≤ 1.5; more preferably, 1.08 < h1 / h2 ≤ 1.3.

[0037] Through the above configuration, at least one of the suture marks 21a differs in height from the other suture marks 21b. This height difference distinguishes different regions of the artificial valve, matching the physiological structures of the aortic valve annulus and the left, right, and non-coronary sinuses. In conventional native valves, the sinus floor of the non-coronary sinus is lower than that of the left and right coronary sinuses. Therefore, the portion of the artificial valve with suture mark 21b is sutured to the non-coronary sinus, and the two portions of the artificial valve with suture mark 21a are sutured to the left and right coronary sinuses, respectively. Observing the suture mark 21b can serve as a guide for the surgeon, thereby avoiding the risk of partially obstructing or blocking the non-coronary sinus by suturing the portion of the artificial valve with suture mark 21a to the non-coronary sinus.

[0038] Furthermore, the aforementioned height difference setting allows for precise adaptation to the native valve annulus morphology, resulting in a tighter fit between the artificial valve and the native annulus, reducing gaps, lowering the risk of intraoperative bleeding, and minimizing postoperative complications such as paravalvular leakage due to poor fit. Additionally, the suture ring matching the native valve annulus morphology makes it easier for surgeons to position and manipulate the sutures during surgery, resulting in more even suture distribution, reducing abnormal local tension caused by improper suturing, and minimizing damage to both the artificial valve and the native tissue.

[0039] Furthermore, the suture mark 21 can simultaneously puncture both the inner structure and the outer membrane of the suture ring 2. As it passes through different layers, the suture mark 21 tightly binds each layer together, forming a stable and robust overall structure. This multi-layered reinforcement enhances the overall mechanical properties of the suture ring 2, enabling it to maintain structural integrity and stability even under tissue movement and external traction, thus reducing the risk of surgical failure or instrument displacement due to structural loosening.

[0040] Secondly, from the perspective of appearance and safety, the suture mark 21 can ensure close contact between the covering membrane on the suture ring 2 and the outer surface of the suture ring 2, significantly reducing the gap between the covering membrane and the suture ring 2, and effectively reducing the outer contour of the artificial valve. This reduction in outer contour reduces friction and irritation to surrounding tissues in vivo, lowering the risk of tissue damage. Furthermore, it reduces the gap between the suture ring 2 and the covering membrane, as a larger gap can lead to uneven stress distribution, affecting the lifespan of the covering membrane and consequently the lifespan and function of the artificial valve. Therefore, a smaller gap can extend the lifespan of the covering membrane, and thus extend the lifespan of the artificial valve.

[0041] like Figure 2 As shown, the width of the suture mark 21 is W. When reinforcing sutures multi-layered structures (such as the inner and outer fabric layers of a suture ring) with a suture mark 21 (e.g., approximately 3 mm), a width W provides a larger contact area and friction, resulting in a tighter bond between the layers of the suture ring, enhancing overall mechanical stability, effectively resisting external forces from physiological activities, and reducing the risk of structural loosening or displacement. An excessively wide suture mark 21 may increase tissue reaction, while an excessively narrow one may impair its function. An appropriate width range helps balance the interaction between the suture mark 21 and human tissue.

[0042] Generally, the width W is 0.5mm-3mm. This range can reduce irritation to surrounding tissues, decrease the probability of inflammatory reactions and adverse reactions, and improve the biocompatibility of artificial valves and other devices in vivo while satisfying the function of suture reinforcement. Preferably, the width W is 0.8mm-2.5mm; more preferably, the width W is 1mm-1.5mm.

[0043] like Figure 6 As shown, in some possible embodiments, the suture ring 2 is further provided with a pad 5, the pad having a structure that matches the valve frame 3, including multiple protruding sections 51 and concave sections, and multiple through holes 52 are provided on the edge of the pad 5, the through holes 52 being used for suturing connection with the valve frame 3; the portion of the pad 5 near the suture ring 2 is suturing connection with the suture ring 2.

[0044] The above-mentioned configuration can strengthen the connection between the valve frame 3 and the suture ring 2, prevent the valve frame 3 and the suture ring 2 from separating, and further enhance the safety and reliability of the artificial valve.

[0045] like Figure 7-8As shown, in some possible embodiments, the suture ring 2a includes an outer wall 241, an inner wall 242, a plurality of beams 243 located between the two, and a bottom wall at the bottom and a top wall at the top (not shown in the figure). The plurality of beams 243 are spaced apart along the circumferential direction of the outer wall 241 and the inner wall 242, so that a plurality of hollow grids 24 are formed inside the suture ring 2a.

[0046] With the above configuration, since the suture ring 2a has multiple hollow grids 24, the weight of the suture ring 2a can be reduced, thereby reducing the pressure on the aortic valve annulus after the artificial valve is implanted onto it.

[0047] Furthermore, during the process of the suture needle piercing the suture ring 2a from the bottom wall, there are two scenarios: 1) the suture needle pierces the suture ring 2a from the first part 244 corresponding to the beam 243 in the bottom wall; 2) the suture needle pierces the suture ring 2a from the second part 245 in the bottom wall. When piercing the suture ring 2a from the first part 244, due to the presence of the beam 243, there is significant resistance, which provides the surgeon with real-time tactile feedback, indicating that the suture needle is piercing the first part. When piercing the suture ring 2a from the second part 245, due to the hollow structure of the mesh 24, the resistance is smaller when the suture needle pierces the second part 245, and the resistance disappears after the suture needle passes through the second part 245. This change in resistance also provides the surgeon with another type of tactile feedback.

[0048] Two different tactile feedbacks allow the surgeon to pinpoint the location of the second part 245 on the bottom wall, facilitating subsequent threading.

[0049] Furthermore, if the suture needle slips during the puncture process, it will deviate from the ideal suture point, making it difficult for the surgeon to implant the valve at the predetermined implantation site. Because the suture ring 2a has a certain degree of flexibility, when the suture needle punctures the second part 245, the second part 245 will be concave inward (i.e., concave towards the center of the bottom wall or mesh 24). This concavity guides the suture needle to continue puncturing in the current direction without slipping, improving the reliability of the puncture process.

[0050] Furthermore, after the suture follows the suture needle out of the mesh, the beams 243 and the outer wall 241 and inner wall 242 distributed on both sides can restrict the movement of the suture, which helps to stabilize the suture; and the reduced range of motion of the suture can also reduce the wear of the suture and suture ring, and improve the safety and reliability of the artificial valve.

[0051] like Figure 9As shown, in some possible embodiments, the suture ring has an alternately arranged first grid 24a and second grid 24b, the width S1 of the first grid 24a is greater than the width S2 of the second grid 24b, and the central angle α corresponding to the first grid 24a is greater than the central angle β corresponding to the second grid 24b.

[0052] With the above configuration, since the thickness t of beam 243 is fixed, the more first grids 24a there are, the fewer beams 243 there are. However, if the number of first grids 24a is too large (i.e., the number of beams 243 is too small), the overall strength of the suture ring will decrease. Therefore, in this embodiment, the first grids 24a and the second grids 24b are alternately arranged, which can reduce the number of beams 243 while maintaining the strength of the suture ring.

[0053] Generally, 1 < S1 / S2 ≤ 2; preferably, 1.1 < S1 / S2 ≤ 1.8; more preferably, 1.2 < S1 / S2 ≤ 1.5.

[0054] like Figure 10 As shown, in some possible embodiments, the interior of the suture ring 2b is provided with a double mesh 24c in the radial direction, and two adjacent meshes 24c are separated by a beam 246, which is arranged along the circumferential direction of the suture ring 2b.

[0055] With the above configuration, one grid 24 is radially divided into two parallel grids 24c. During the puncture process, the suture needle needs to pass through the bottom wall and enter the grid 24c. The distance between the outer wall 241 and the beam 246 is smaller than the distance between the outer wall and the inner wall 242, thereby reducing the range of motion of the suture.

[0056] Furthermore, the beam 246 connects two adjacent beams 243 together, strengthening the suture ring 2b. When the outer wall 241 is subjected to external force, the structure of the beams 246 and 243 can reduce the force transmitted to the inner wall 242, so that the inner wall 242 can still maintain its original shape when the outer wall 241 is subjected to a large force, thus avoiding large deformation of the inner wall 242.

[0057] It should be noted that the terms "one embodiment," "embodiment," "exemplary embodiment," "some embodiments," etc., mentioned in the specification indicate that the described embodiment may include a specific feature, structure, or characteristic, but not every embodiment necessarily includes that specific feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, implementing such a feature, structure, or characteristic in conjunction with other embodiments, whether explicitly described or not, is within the knowledge scope of those skilled in the art.

[0058] It should be readily understood that the terms “on,” “above,” and “on top of” in this disclosure should be interpreted in the broadest possible sense, such that “on” means not only “directly on something” but also “on something” with an intermediate feature or layer therebetween, and that “above” or “on top of” means not only “on top of something” but also “on top of something” without an intermediate feature or layer therebetween (i.e., directly on something).

[0059] Furthermore, for ease of explanation, spatially relative terms such as "below," "below," "under," "above," and "above" may be used to describe the relationship of one element or feature relative to other elements or features as shown in the figures. Spatially relative terms are intended to encompass different orientations of the device in use or operation other than those shown in the figures. The device may have other orientations (rotated 90 degrees or in other orientations), and the spatially relative descriptive terms used herein may be interpreted accordingly.

[0060] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0061] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model.

Claims

1. An artificial valve, characterized in that, The device includes leaflets, a valve frame, and a suture ring. The leaflets are placed in the valve frame, and the valve frame is disposed on the suture ring. The valve frame has multiple axially protruding segments. The suture ring is provided with multiple suture marks, each of which is disposed between two adjacent protruding segments. At least one suture mark is not on the same plane as the other suture marks. The distance from one suture mark to the protruding segment is h1, and the distance from the other suture mark to the protruding segment is h2, where 1 < h1 / h2 ≤ 1.

8.

2. The artificial valve according to claim 1, characterized in that, The leaflet includes multiple leaflets, which form a leaflet structure, and the edges of two adjacent leaflets are fixed in the protruding segment.

3. The artificial valve according to claim 2, characterized in that, The flap also includes a plurality of concave segments along the axial direction, each concave segment being located between two adjacent convex segments, and each convex segment being located between two adjacent concave segments, with the convex segments and the concave segments being alternately arranged.

4. The artificial valve according to claim 3, characterized in that, The suture ring includes multiple peak segments and multiple trough segments, and the suture mark is disposed on the trough segment. The peak segments are disposed corresponding to the protruding segments, and the trough segments are disposed corresponding to the concave segments. The peak segments and the trough segments are disposed alternately.

5. The artificial valve according to claim 4, characterized in that, The outer surface of the suture ring is covered with a biocompatible membrane, and the suture ring and the membrane are connected to each other by sutures.

6. The artificial valve according to claim 5, characterized in that, The suture mark simultaneously punctures the suture ring and the covering membrane.

7. The artificial valve according to any one of claims 1-6, characterized in that, The width of the suture mark is 0.5mm-3mm.

8. The artificial valve according to any one of claims 1-6, characterized in that, The suture ring includes an outer wall, an inner wall, and a plurality of first beams located between the two. The plurality of first beams are spaced apart along the circumferential direction of the outer wall and the inner wall, so that a plurality of hollow grids are formed inside the suture ring.

9. The artificial valve according to claim 8, characterized in that, The suture ring has an alternating first grid and a second grid, the width of the first grid being greater than the width of the second grid, and the central angle α corresponding to the first grid being greater than the central angle β corresponding to the second grid.

10. The artificial valve according to claim 8, characterized in that, The grid includes two sub-grids, which are separated by a second beam that is arranged along the circumferential direction of the suture ring.

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