medical devices

Abstract

The present disclosure relates to a medical device for repairing a patient's heart valve. The medical device includes a pad, which is configured to be located between a first leaflet and a second leaflet of a heart valve and to follow the movement of the second leaflet. The pad has a first apposition surface, which is configured to face the first leaflet and to periodically apposition and separation with the first leaflet as the pad follows the movement of the second leaflet. By locating the pad between a pair of leaflets, the medical device provided by the present disclosure can improve the closure of the valve, so that the pair of leaflets of the valve can be properly appositioned, thereby effectively preventing or reducing the backflow of blood. In addition, the medical device provided by the present disclosure has less interference with blood flow, and thus can reduce the possibility of stenosis. In addition, the medical device provided by the present disclosure will not affect or less affect the movement of the leaflets, thereby not or less causing problems to the structure and function of the leaflets.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical devices, and in particular to a medical device. Background Art

[0002] Heart valves are the valves between the atria and ventricles, or between the ventricles and arteries. They play a key role in the heart's constant blood circulation. After blood has flowed through them, the valves close, preventing backflow.

[0003] Several structural factors can affect the proper closure of heart valves, leading to blood regurgitation. For example, if the mitral valve fails to close properly, such as incompletely, blood can flow from the left ventricle through the mitral valve into the left atrium during systole, potentially harming the patient's health. Related technologies offer repair devices with a clip-like structure that improve valve closure by clamping onto a pair of leaflets.

[0004] However, this prosthetic device has several drawbacks. For example, it reduces the effective area for blood flow through the valve, which can lead to another problem: stenosis. Furthermore, it clamps the leaflets together, preventing them from naturally coapting and deactivating during the cardiac cycle. Over time, this can cause problems with the leaflets' structure and function. Summary of the Invention

[0005] In view of the above, the present disclosure provides a medical device for repairing a heart valve of a patient.

[0006] The medical device provided by the present disclosure includes a pad, which is configured to be located between a first leaflet and a second leaflet of a heart valve and to follow the movement of the second leaflet. The pad has a first apposition surface, which is configured to face the first leaflet and periodically apposition to and separation from the first leaflet as the pad follows the movement of the second leaflet.

[0007] By using a pad positioned between a pair of leaflets, the medical device provided by the present disclosure can improve valve closure, enabling the valve to close properly, thereby effectively preventing or reducing blood backflow. Furthermore, the medical device provided by the present disclosure minimally interferes with blood flow, thereby reducing the likelihood of stenosis. Furthermore, the medical device provided by the present disclosure does not affect, or minimally affects, the movement of the leaflets, thereby causing no or minimal problems with the structure and function of the leaflets.

[0008] In a possible implementation, the first apposition surface is configured to be concave in a direction away from the first leaflet.

[0009] Configuring the first apposition surface to be concave in a direction away from the first leaflet can enable the first apposition surface to better match the first leaflet, thereby enabling the first apposition surface to better apposition with the first leaflet.

[0010] In one possible implementation, the valve is used to allow blood to flow from the first chamber into the second chamber and prevent blood from flowing in the opposite direction, and the first accommodating surface is configured to be oriented toward the first chamber and gradually extend toward the side where the first leaflet is located.

[0011] In some cases, a small amount of blood may still flow back from the second chamber into the first chamber. The first apposition surface is concave in a direction away from the first leaflet and gradually extends toward the first chamber and toward the first leaflet. This structure can change the direction of blood flowing from the second chamber to the first chamber, guiding the blood flow to one side and avoiding blood flow directly facing the first chamber, thereby reducing the impact of reflux on the patient's heart function.

[0012] In one possible implementation, the first mating surface has a first edge portion and a second edge portion located at opposite ends thereof, respectively, the first edge portion is configured to be close to the first chamber relative to the second edge portion, and the angle formed by the cross-section of the first edge portion and the cross-section of the second edge portion is in the range of greater than or equal to 10 degrees and less than or equal to 45 degrees.

[0013] The larger the angle formed by the tangent plane of the first edge portion and the tangent plane of the second edge portion, the greater the change in the flow direction of blood flowing from the second chamber to the first chamber by the first accommodating surface. Setting the angle formed by the two within this range can effectively guide blood flow from the second chamber to the first chamber to one side while ensuring good alignment of the first leaflet with the first accommodating surface.

[0014] In one possible implementation, the valve is configured to allow blood to flow from the first chamber into the second chamber and prevent blood from flowing in the opposite direction. The cushion further comprises a top surface configured to face the first chamber and bulge toward the first chamber.

[0015] To better match the first and second leaflets, the pad's thickness gradually increases toward the first chamber, which can easily lead to blood pooling at the top of the pad. Configuring the pad's top surface to bulge toward the first chamber effectively prevents or reduces blood pooling at the top of the pad.

[0016] In a possible implementation, the top surface is configured to gradually extend toward the second chamber and toward the side where the first leaflet is located.

[0017] This configuration of the top surface can effectively avoid or reduce the accumulation of blood on the top of the pad. In addition, this configuration of the top surface can also reduce the pad's resistance to blood flow from the first chamber to the second chamber, better guiding the blood flow from the first chamber to the second chamber.

[0018] In one possible implementation, the top surface has a third edge portion and a fourth edge portion located at opposite ends thereof, respectively, the fourth edge portion is configured to be close to the second chamber relative to the third edge portion, and the angle formed by the cross-section of the third edge portion and the cross-section of the fourth edge portion is in the range of greater than or equal to 10 degrees and less than or equal to 45 degrees.

[0019] In this way, the top surface can better guide the blood flow from the first chamber to the second chamber, thereby reducing the obstruction of blood flow from the first chamber to the second chamber.

[0020] In one possible implementation, the pad further has a second apposition surface, which is configured to face the second leaflet and be concave in a direction away from the second leaflet, and to maintain apposition with the second leaflet as the pad follows the movement of the second leaflet.

[0021] The second apposition surface faces the second leaflet and is recessed in the direction away from the second leaflet. This structure enables the second apposition surface to better match the second leaflet and fit the second leaflet better, thereby effectively avoiding or reducing blood accumulation between the second apposition surface and the second leaflet.

[0022] In one possible implementation, the pad is configured to be attached to the second leaflet.

[0023] The pad is attached to the second leaflet so as to follow the movement of the second leaflet.

[0024] In one possible implementation, the valve is used to allow blood to flow from a first chamber into a second chamber and prevent flow in the opposite direction, and the medical device also includes a support member configured to be located within the first chamber and to position a pad between the first leaflet and the second leaflet, wherein the pad is connected to the support member in a manner capable of following the movement of the second leaflet.

[0025] The support member disposed in the first chamber enables the pad to be securely positioned between the first leaflet and the second leaflet. The pad is connected to the support member in a manner that allows it to follow the movement of the second leaflet, ensuring that the pad follows the movement of the second leaflet, thereby causing the first apposition surface to periodically engage and disengage with the first leaflet. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following briefly introduces the drawings required for use in the embodiments.

[0027] It should be understood that the following drawings only illustrate certain embodiments of the present disclosure and therefore should not be regarded as limiting the scope. A person of ordinary skill in the art can derive other relevant drawings based on these drawings without inventive effort.

[0028] It should be understood that the same or similar reference numerals are used in the drawings to represent the same or similar elements (components or components).

[0029] It should be understood that the drawings are merely schematic and that the sizes and proportions of elements (components or components) in the drawings are not necessarily accurate.

[0030] Figure 1 Schematic diagram of the structure of a medical device according to an embodiment of the present disclosure.

[0031] Figure 2 is a structural schematic diagram of a medical device according to another embodiment of the present disclosure.

[0032] Figure 3A and Figure 3B yes Figure 2 Schematic diagram of the structure of the pad of the medical device.

[0033] Figure 4 is a structural schematic diagram of a medical device according to another embodiment of the present disclosure.

[0034] Figure 5 is a structural schematic diagram of a medical device according to another embodiment of the present disclosure. DETAILED DESCRIPTION

[0035] In order to enable those skilled in the art to better understand the technical solutions of the present disclosure, the technical solutions in the embodiments of the present disclosure will be clearly and completely described below in conjunction with the drawings in the embodiments of the present disclosure. Obviously, the described embodiments are only part of the embodiments of the present disclosure, not all of the embodiments. Based on the embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field should fall within the scope of protection of the present disclosure.

[0036] Figure 1 1 is a schematic structural diagram of a medical device 10 according to an embodiment of the present disclosure. Figure 1 The medical device 10 is shown in a state where it is placed at a heart valve of a patient.

[0037] exist Figure 1 In the figures (and other figures of the present disclosure), the heart valve is located between the first chamber and the second chamber, and is used to allow blood to flow from the first chamber into the second chamber and prevent reverse flow. The heart valve includes a pair of first leaflets FL and second leaflets SL that match each other.

[0038] Under normal circumstances, the first leaflet FL and the second leaflet SL naturally coapt to close the valve and separate to open it during the cardiac cycle, allowing blood to flow from the first chamber into the second chamber and preventing reverse flow. However, in patients with valvular regurgitation, when valve closure is required, the first leaflet FL and the second leaflet SL fail to achieve proper coaptation, with reduced coaptation and / or a gap between them. This allows blood to flow from the second chamber into the first chamber through the valve during systole, resulting in regurgitation.

[0039] Figure 1 The valve in (and other figures of the present disclosure) can be a mitral valve. Correspondingly, the first chamber is the left atrium, the second chamber is the left ventricle, one of the first leaflet FL and the second leaflet SL is the anterior leaflet, and the other is the posterior leaflet.

[0040] It should be understood that the medical device provided by the present disclosure is not limited to application on the mitral valve, but can also be applied to other heart valves.

[0041] See also Figure 1 The medical device 10 includes a pad 11 having a first coaptation surface 111. When the medical device 10 is placed in the patient's heart, the pad 11 is located between the first leaflet FL and the second leaflet SL of the heart valve and moves with the second leaflet SL. The first coaptation surface 111 faces the first leaflet FL and can periodically coapt and separate with the first leaflet FL as the pad 11 moves with the second leaflet SL. In one example, when the first coaptation surface 111 is coapted with the first leaflet FL, the coaptation length between the two can range from 6 to 12 mm.

[0042] By means of the pad 11 located between a pair of leaflets, the medical device 10 can improve the closure of the valve, allowing the first leaflet FL and the second leaflet SL to properly appose, thereby effectively preventing or reducing blood backflow. In addition, the medical device 10 has little interference with blood flow, thereby reducing the possibility of stenosis. In addition, the medical device 10 will not affect or will have little effect on the movement of the leaflets, thereby causing no or little problems to the structure and function of the leaflets. In other words, the cardiac implant 100 provided by the present disclosure does not restrict or hinder the spontaneous movement (closing, opening) of the valve, and at the same time, it has no effect on the supporting structure of the valve, and will not produce corresponding adverse effects.

[0043] The pad 11 may be attached to the second leaflet SL so as to follow the movement of the second leaflet SL. In other words, the pad 11 may be attached to the second leaflet SL so as to become a part thereof so as to follow the movement of the second leaflet SL, thereby enabling the first apposition surface 111 to periodically apposition and separation with the first leaflet FL as the second leaflet SL moves.

[0044] As an exemplary implementation, see again Figure 1 The medical device 10 may further include a fixing member 12. In one example, the fixing member 12 may be a pin 12. When the medical device 10 is placed in the patient's heart, the pin 12 may penetrate the second leaflet SL and attach the pad 11 to the second leaflet SL, so that the pad 11 can follow the movement of the second leaflet SL.

[0045] The medical device 10 may include only one spike 12 or multiple spikes 12, which is not specifically limited in this disclosure. The spike 12 may be integrally formed with the pad 11, or the two may be two independent components, which is not specifically limited in this embodiment of the disclosure.

[0046] Figure 2 2 is a schematic structural diagram of a medical device 20 according to another embodiment of the present disclosure. Figure 2 The medical device 20 is shown in a state where it is placed at a heart valve of a patient.

[0047] See also Figure 2 The medical device 20 includes a cushion 21 having a first accommodating surface 211. In some embodiments, the cushion 21 can be configured to gradually increase in thickness toward the first chamber, thereby better matching the shapes of the first leaflet FL and the second leaflet SL and better achieving valve closure.

[0048] When the medical device 20 is placed in the patient's heart, the pad 21 is located between the first leaflet FL and the second leaflet SL and can follow the movement of the second leaflet SL. The first mate surface 211 faces the first leaflet FL and can periodically mate with and separate from the first leaflet FL as the pad 21 follows the movement of the second leaflet SL.

[0049] The first accommodating surface 211 may be a concave surface. More specifically, when the medical device 20 is placed in the patient's heart, the first accommodating surface 211 may be concave in a direction away from the first leaflet FL. In this manner, the first accommodating surface 211 can better match the first leaflet FL, thereby enabling the first accommodating surface 211 to better align with the first leaflet FL.

[0050] See again Figure 2 In a non-limiting example, when the medical device 20 is placed in the patient's heart, the first mate surface 211 tends toward the first chamber and gradually toward the side where the first leaflet FL is located (ie Figure 2 to the left in the image.

[0051] In some cases, a small amount of blood may still flow back from the second chamber into the first chamber. The first accommodating surface 211 is concave (in the direction away from the first leaflet FL) and gradually extends toward the first chamber and toward the side where the first leaflet FL is located. This structure can increase blood flow resistance and reduce blood flow, and change the direction of blood flow from the second chamber to the first chamber, guiding the blood flow to one side and preventing the blood flow from directly facing the first chamber and the blood vessels above, thereby reducing the impact of blood flow from the second chamber to the first chamber on the patient's heart function.

[0052] Figure 3A It is a schematic structural diagram of the pad 21. Figure 3A As shown, the direction indicated by the thick arrow may represent the flow direction of the blood flowing from the second chamber to the first chamber under the guidance of the first mating surface 211 .

[0053] As an exemplary implementation, see Figure 2 and Figure 3A The first mating surface 211 has a first edge portion 211a and a second edge portion 211b located at opposite ends thereof. When the medical device 20 is placed in the patient's heart, the first edge portion 211a is closer to the first chamber than the second edge portion 211b.

[0054] The angle between the tangent plane of the first mating surface 211 and the tangent plane of the second edge 211b gradually increases as it approaches the first edge 211a. The angle (acute angle) α formed between the tangent planes of the first edge 211a and the second edge 211b can be within a range of 10 degrees or greater and 45 degrees or less. Preferably, α can be within a range of 15 degrees or greater and 30 degrees or less.

[0055] The larger the angle α formed between the cross-section of the first edge portion 211a and the cross-section of the second edge portion 211b, the greater the change in the direction of blood flow from the second chamber to the first chamber caused by the first mate surface 211. Setting the angle α within this range effectively guides blood flow from the second chamber to the first chamber to one side while ensuring good alignment of the first leaflet FL with the first mate surface 211.

[0056] In one example, see again Figure 2 The cushion 21 may further have a top surface 212, which may be a convex surface. When the medical device 20 is placed in the patient's heart, the top surface 212 of the cushion 21 is located at one end of the cushion close to the first chamber, and the top surface 212 faces the first chamber and convex (towards the first chamber).

[0057] To better match the first leaflet FL and the second leaflet SL, the thickness of the pad 21 gradually increases toward the first chamber, which may cause blood to easily accumulate on the top of the pad 21. Because the pad 21 has a convex top surface 212 (toward the first chamber), the accumulation of blood on the top of the pad 21 can be effectively avoided or reduced.

[0058] In a non-limiting example, see again Figure 2 When the medical device 20 is placed in the patient's heart, the top surface 212 of the cushion 21 tends to the second chamber and gradually moves toward the side where the first leaflet FL is located (ie Figure 2 to the left in the image.

[0059] This configuration of the top surface 212 of the pad 21 can effectively prevent or reduce the accumulation of blood on the top of the pad 21. In addition, this configuration of the top surface 212 of the pad 21 can also reduce the obstruction and impact of the pad 21 on the blood flow from the first chamber to the second chamber, thereby better guiding the blood flow from the first chamber to the second chamber.

[0060] Figure 3B It is a schematic structural diagram of the pad 21. Figure 3B As shown, the direction indicated by the thick arrow may represent the flow direction of blood flowing from the first chamber to the second chamber under the guidance of the top surface 212 of the pad 21 .

[0061] In one example, see Figure 2 and Figure 3B The top surface 212 of the pad 21 has a third edge portion 212a and a fourth edge portion 212b located at opposite ends thereof. When the medical device 20 is placed in the patient's heart, the fourth edge portion 212b is closer to the second chamber than the third edge portion 212a.

[0062] The angle between the cross-section of the top surface 212 and the cross-section of the third edge portion 212a gradually increases as it approaches the fourth edge portion 212b. The angle β formed between the cross-section of the third edge portion 212a and the cross-section of the fourth edge portion 212b can be within a range of 10 degrees or greater and 45 degrees or less. In particular, the range of β can be 15 degrees or greater and 30 degrees or less.

[0063] In this way, the top surface 212 of the pad 21 can better guide the blood flow from the first chamber to the second chamber, reducing the obstruction of the pad 21 to the blood flow from the first chamber to the second chamber.

[0064] In a specific example, see again Figure 2The cushion 21 may further include a second accommodating surface 213. The second accommodating surface 213 may be a concave surface. More specifically, when the medical device 20 is positioned in the patient's heart, the second accommodating surface 213 faces the second leaflet SL and is concave away from the second leaflet SL. Furthermore, when the medical device 20 is positioned in the patient's heart, the cushion 21 follows the movement of the second leaflet SL, maintaining the second accommodating surface 213 in accommodating relationship with the second leaflet SL.

[0065] This structure can make the second mating surface 213 of the pad 21 better match the second leaflet SL and fit the second leaflet SL better, thereby effectively avoiding or reducing the accumulation of blood between the second mating surface 213 of the pad 21 and the second leaflet SL.

[0066] In a non-limiting example, see again Figure 2 The medical device 20 may further include a pin 22. When the medical device 20 is placed in the patient's heart, the pin 22 may penetrate the second leaflet SL and attach the pad 21 to the second leaflet SL, so that the pad 21 can follow the movement of the second leaflet SL.

[0067] The medical device 20 may include only one nail 22 or multiple nails 22, which is not specifically limited in this disclosure. The nail 22 may be formed integrally with the pad 21, or the two may be two independent components, which is not specifically limited in this embodiment of the disclosure.

[0068] There are many ways to attach the pad to the second leaflet SL, which are not specifically limited in this disclosure. A possible implementation method is exemplified below with reference to the accompanying drawings.

[0069] Figure 4 is a structural diagram of a medical device 30 according to another embodiment of the present disclosure. Figure 4 The medical device 30 is shown to be placed at a patient's heart valve. The medical device 30 is substantially the same as the medical device 20, and for the sake of brevity, the similarities are not described again.

[0070] See also Figure 4 Medical device 30 includes a cushion 31 having a first accommodating surface 311. When medical device 30 is installed in a patient's heart, cushion 31 is positioned between the first leaflet FL and the second leaflet SL and follows the movement of the second leaflet SL. As the second leaflet SL moves, the first accommodating surface 311 periodically engages and disengages with the first leaflet FL, thereby periodically closing and opening the valve.

[0071] The medical device 30 further includes a clamp 32, which may be integrally formed with the cushion 31. Of course, in other embodiments, the clamp 32 may be a separate component from the cushion 31. When the medical device 30 is installed in the patient's heart, the clamp 32 clamps the second leaflet SL and attaches the cushion 31 to the second leaflet SL, thereby enabling the cushion 31 to follow the movement of the second leaflet SL.

[0072] The present disclosure is not limited to attaching the pad to the second leaflet SL. Positioning the pad between the first leaflet FL and the second leaflet SL and enabling the pad to follow the movement of the second leaflet SL may also be achieved through other implementations.

[0073] Figure 5 is a structural schematic diagram of a medical device 40 according to another embodiment of the present disclosure. Figure 5 The figure shows a state where the medical device 40 is placed at the heart valve of a patient. The medical device 40 is substantially the same as the medical device 20. For the purpose of brevity, the similarities are not repeated.

[0074] See also Figure 5 The medical device 40 includes a cushion 41 and a support member 42. When the medical device 40 is placed in the patient's heart, the support member 42 is located in the first chamber, and the cushion 41 is connected to the support member 42 in a manner that can follow the movement of the second leaflet SL, so that the cushion 41 is positioned between the first leaflet FL and the second leaflet SL and can follow the movement of the second leaflet SL.

[0075] As a specific implementation, the pad 41 can be hinged to the support 42 so that the pad 41 can follow the movement of the second leaflet SL. As another specific implementation, the pad 41 can be connected to the support via a flexible member (or portion) so that the pad 41 can follow the movement of the second leaflet SL.

[0076] The support member 42 placed in the first chamber securely positions the pad 41 between the first leaflet FL and the second leaflet SL. The pad 41 is connected to the support member 42 so that it can follow the movement of the second leaflet SL. This ensures that the pad 41 follows the movement of the second leaflet SL, thereby periodically engaging and disengaging the first apposition surface with the first leaflet FL.

[0077] In one example, the support member 42 can be annular to reduce the impact on blood flow. Of course, in other examples, the support member 42 can also be semi-annular or partially annular. In one example, the support member 42 can be constructed to be relatively soft, or flexible, so that it can adaptively deform as the first cardiac chamber contracts and relaxes, thereby reducing the negative impact on cardiac function.

[0078] There are many ways to implement the support member 42, and this disclosure does not specifically limit this. In a non-limiting example, see again Figure 5 The support member 42 may be in the form of a foldable and unfoldable mesh. During implantation, the support member 42 may be folded first and then unfolded in the first chamber. In some embodiments, the support member 42 may be placed at the annulus so that the support member 42 can be securely fixed.

[0079] It should be understood that the term “including” and its variations used in the present disclosure are open inclusions, that is, “including but not limited to.” The term “one embodiment” means “at least one embodiment,” and the term “another embodiment” means “at least one additional embodiment.”

[0080] It should be understood that although the terms "first" or "second" may be used in the present disclosure to describe various elements (such as the first mating surface and the second mating surface), these elements are not limited by these terms. These terms are only used to distinguish one element from another.

[0081] It should be noted that the various specific technical features (elements) described in the above specific embodiments can be combined in any appropriate manner without contradiction. In order to avoid unnecessary repetition, the present disclosure will not further describe various possible combinations.

[0082] It should be understood that in the embodiments of the present disclosure, "at least one" refers to one or more, and "more than one" refers to two or more. "And / or" describes the association relationship between associated objects, indicating that three relationships can exist. For example, "A and / or B" can mean: A exists alone, A and B exist simultaneously, and B exists alone.

[0083] It should be understood that multiple components and / or parts can be provided by a single integrated component or part. Alternatively, a single integrated component or part can be divided into separate multiple components and / or parts. The disclosure "a" or "an" used to describe a component or part does not mean to exclude other components or parts.

[0084] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure pertains. The terms used herein in the specification of this disclosure are for the purpose of describing specific embodiments only and are not intended to limit this disclosure. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0085] The above description is merely a specific embodiment of the present disclosure, but the scope of protection of the present disclosure is not limited thereto. Any changes or substitutions that can be conceived by a person skilled in the art within the technical scope disclosed in this disclosure should be included in the scope of protection of the present disclosure. Therefore, the scope of protection of the present disclosure should be based on the scope of protection of the claims.

Claims

1. A medical device for repairing a heart valve of a patient, wherein the valve is configured to allow blood to flow from a first chamber into a second chamber and prevent blood from flowing in the opposite direction, wherein: The medical device includes a pad, which is configured to be located between a first leaflet and a second leaflet of the heart valve and to follow the movement of the second leaflet. The pad has a first apposition surface and a top surface. The first apposition surface is configured to face the first leaflet and to periodically apposition with and separation from the first leaflet as the pad follows the movement of the second leaflet, wherein the first apposition surface is configured to be concave in a direction away from the first leaflet, the top surface is configured to face the first chamber and to convex in the direction of the first chamber, and the top surface is configured to gradually extend toward the side where the first leaflet is located toward the second chamber.

2. The medical device according to claim 1, wherein The first accommodating surface is configured to gradually extend toward the first chamber and toward the side where the first leaflet is located.

3. The medical device according to claim 2, wherein The first mating surface has a first edge portion and a second edge portion located at opposite ends thereof, respectively. The first edge portion is configured to be close to the first chamber relative to the second edge portion, and the angle formed by the cross-section of the first edge portion and the cross-section of the second edge portion is in the range of greater than or equal to 10 degrees and less than or equal to 45 degrees.

4. The medical device according to claim 3, characterized in that The angle formed by the tangent plane of the first edge portion and the tangent plane of the second edge portion is in a range of greater than or equal to 15 degrees and less than or equal to 30 degrees, and the pad is configured to gradually increase in thickness toward the first cavity.

5. The medical device according to claim 1, wherein The top surface has a third edge portion and a fourth edge portion located at opposite ends thereof, respectively. The fourth edge portion is configured to be close to the second chamber relative to the third edge portion. The angle formed by the cross-section of the third edge portion and the cross-section of the fourth edge portion is in the range of greater than or equal to 10 degrees and less than or equal to 45 degrees.

6. The medical device according to claim 1, wherein The pad also has a second mate surface, which is configured to face the second leaflet and be concave in a direction away from the second leaflet, and the second mate surface is configured to gradually extend toward the side where the second leaflet is located toward the first chamber, so that the pad remains mate with the second leaflet as it moves along with the second leaflet.

7. The medical device according to claim 1, wherein The pad is configured to be attached to the second leaflet.

8. The medical device according to claim 1, wherein The valve is used to allow blood to flow from the first chamber into the second chamber and prevent flow in the opposite direction. The medical device also includes a support member configured to be located in the first chamber and to position the pad between the first leaflet and the second leaflet, wherein the pad is connected to the support member in a manner that can follow the movement of the second leaflet.

9. The medical device according to claim 8, characterized in that The pad is connected to the support member via a flexible member.

Images