Valve leaflet enhancing device and system

Abstract

The utility model relates to a valve leaflet enhancing device and system, the valve leaflet enhancing device can enter the heart through a conveying device, release at the valve and capture a lesion unilateral valve leaflet, and the valve leaflet enhancing device can be used for enhancing the valve leaflet by changing the shape of the valve leaflet, shortening the distance between the valve leaflet and increasing the closing area and cooperative movement of the mitral valve. Therefore, the valve leaflet is repaired and enhanced, normal closing of the mitral valve is promoted, and related symptoms caused by incomplete closing of the mitral valve are relieved. In addition, the valve leaflet reinforcing device does not damage the original state of the valve leaflet, and the opportunity of a secondary operation is reserved.

Description

Technical Field

[0001] The utility model relates to the field of medical devices for interventional surgery, and in particular to a valve leaflet enhancement device and system. Background Art

[0002] The mitral valve is located between the left atrium and the left ventricle. It is responsible for controlling the flow of blood from the left atrium to the left ventricle and closes to prevent blood from flowing backward when the ventricle contracts.

[0003] Mitral regurgitation (MR) refers to the inability of the mitral valve of the heart to close completely, resulting in some blood flowing back into the atrium when the heart contracts. This will cause the heart's pumping efficiency to decrease because some blood will be wasted by reflux, which will lead to excessive workload on the heart and may cause a series of heart problems.

[0004] Currently, treatment options for MR vary depending on the severity of the condition, including medication, surgical repair, or mitral valve replacement. Epidemiological studies in Europe and the United States show that the prevalence of MR in people over 75 years old can be as high as 10%, significantly higher than that of aortic valve disease. Given the direct link between mitral valve disease and an aging population, as well as my country's vast population base, the potential number of patients with mitral regurgitation could reach tens of millions. However, the total number of patients undergoing mitral valve surgery in my country each year is less than 40,000, creating a significant treatment gap and placing a significant medical burden on society.

[0005] Based on the above reasons, how to design a leaflet enhancement device to reduce regurgitation without destroying the original state of the leaflet has become a technical problem that urgently needs to be solved. Utility Model Content

[0006] The utility model discloses a leaflet reinforcement device, which aims to solve the technical problems existing in the prior art.

[0007] The utility model adopts the following technical solutions:

[0008] In one aspect, the present invention provides a leaflet reinforcement device, comprising a clamping assembly, a reinforcement assembly, and a connecting assembly;

[0009] The clamping assembly includes a first clamping arm and a second clamping arm;

[0010] The first clamping arm includes a first connecting end and a first clamping end, the first connecting end and the first clamping end are capable of bending relative to each other, and the first connecting end is fixed to one side of the circumference of the connecting assembly;

[0011] The second clamping arm includes a second connecting end and a second clamping end, the second connecting end and the second clamping end are capable of being bent relative to each other, the second connecting end and the first clamping end are arranged parallel to or coplanar with each other, and the second clamping end is provided with a leaflet anchoring element in a direction facing the first clamping end, and the leaflet anchoring element can cooperate with the first clamping end to clamp the leaflet;

[0012] The connecting assembly can be detachably connected to the conveying device;

[0013] The reinforcing component includes a fixing portion and a functional portion. The fixing portion is fixedly arranged on one side of the circumference of the connecting component, and the functional portion bulges outward in a direction away from the fixing portion. The functional portion can be compressed during delivery and radially elastically expanded when released at the valve to fill the regurgitation area between the leaflets.

[0014] As a preferred technical solution, the fixing part is configured into a shape that matches the outer contour of the connecting component; the functional part is configured into a three-dimensional configuration, including a cylindrical, truncated cone, hemispherical, ellipsoidal, semi-ellipsoidal, irregular three-dimensional shape or a shape that matches the valve regurgitation orifice area.

[0015] As a preferred technical solution, the functional part includes a support frame and a coating. The support frame has a compressed configuration and an expanded configuration formed by self-deformation from the compressed configuration. The coating tightly covers the outer contour of the support frame to form a closed three-dimensional structure.

[0016] As a preferred technical solution, the support frame includes multiple arc units, the plane where the arc units are located is perpendicular to the central axis of the connecting component when released, and the multiple arc units are arranged in parallel along the length direction of the fixed part, and the arc units can be bent toward the distal end during transportation.

[0017] As a preferred technical solution, the arc unit includes an arc rod and a connecting rod. The connecting rod is arranged along the axial direction of the connecting component. Multiple arc units are fixed to the fixed part through the connecting rod. The arc rod is a regular arc, an elliptical arc, an irregular curve or a shape that is adapted to the valve regurgitation area.

[0018] As a preferred technical solution, the sizes of the multiple arc-shaped rods are the same;

[0019] Alternatively, the sizes of the plurality of arc-shaped rods increase sequentially from the proximal end to the distal end;

[0020] Alternatively, the sizes of the plurality of arc-shaped rods decrease sequentially from the proximal end to the distal end;

[0021] Alternatively, the sizes of the plurality of arc-shaped rods first increase and then decrease from the proximal end to the distal end.

[0022] As a preferred technical solution, the sizes of the multiple arc-shaped rods gradually increase from the proximal end to the distal end, and the multiple connecting rods gradually approach the clamping assembly from the proximal end to the distal end.

[0023] As a preferred technical solution, the support frame includes a self-expanding stent, which includes a plurality of axially arranged arc-shaped connecting rods. The arc-shaped connecting rods can expand radially outward when released and fold toward the distal end when compressed.

[0024] As a preferred technical solution, the support frame includes an elastic matrix, and the elastic matrix includes a flexible polymer material with biocompatibility.

[0025] As a preferred technical solution, the coating includes a polymer sealing film.

[0026] As a preferred technical solution, a first bending section is provided between the first connecting end and the first clamping end, and a second bending section is provided between the second connecting end and the second clamping end, and both the first bending section and the second bending section have a bending resilience;

[0027] The arc length of the first bending segment is greater than the arc length of the second bending segment, and / or the curvature of the first bending segment is not greater than the curvature of the second bending segment.

[0028] As a preferred technical solution, the first clamping end and the second connecting end are both configured as rectangular frames, the second connecting end is fixedly arranged inside the first clamping end, and at least the inner side surface of the second connecting end is coplanar with the inner side surface of the first clamping end.

[0029] As a preferred technical solution, the leaflet anchoring element includes several spike structures, which extend toward the first clamping end, and multiple spike structures are distributed on the outside of the first clamping end for cooperating with the first clamping end and anchoring the leaflet.

[0030] As a preferred technical solution, the middle part of the connecting component is axially through, for passing the actuating rod, the first clamping end is connected to the actuating rod through a first traction line, and the first traction line is used to control the opening and closing of the first clamping end relative to the connecting component; the second clamping end is connected to the second traction line, the second traction line extends axially to the proximal end of the conveying device, and the second traction line is used to control the opening and closing of the second clamping end relative to the second connecting end.

[0031] On the other hand, the present invention also provides a leaflet enhancement system, comprising a delivery device and a leaflet enhancement device as described in any one of the above items, wherein the delivery device and the leaflet enhancement device are detachably connected.

[0032] As a preferred technical solution, a first release connector is provided at the proximal end of the leaflet reinforcement device, and a second release connector is provided at the distal end of the delivery device, and the first release connector can be snap-connected with the second release connector.

[0033] The technical solution adopted by the utility model can achieve the following beneficial effects:

[0034] The present utility model mainly provides a leaflet enhancement device and system, wherein the leaflet enhancement device can enter the heart through a delivery device and be released at the valve to capture the diseased unilateral leaflet. By changing the shape of the leaflet and shortening the distance between the leaflets, the closing area and coordinated movement of the mitral valve are increased, thereby repairing and enhancing the leaflet to promote the normal closure of the mitral valve and alleviate the related symptoms caused by mitral regurgitation. In addition, the leaflet enhancement device does not destroy the original state of the leaflet, retaining the opportunity for secondary surgery.

[0035] Compared to existing technologies, the present invention further incorporates a reinforcement component that is compressed during delivery and automatically expands to a three-dimensional configuration upon release. The expanded reinforcement component blocks the mitral valve regurgitation orifice, reducing regurgitation and allowing blood to flow normally to the main ventricle, improving the heart's pumping efficiency. Furthermore, a sealing membrane is applied to the surface of the reinforcement component to accelerate endothelialization with cardiac tissue.

[0036] In addition, the proximal end of the leaflet augmentation device and the distal end of the delivery device can be engaged and connected, which not only makes the leaflet augmentation device more stable during delivery, but also makes the release of the leaflet augmentation device more convenient. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The schematic embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0038] Figure 1 This is a structural diagram of a leaflet reinforcement device in a preferred embodiment of Example 1 of the present invention;

[0039] Figure 2 This is a three-dimensional diagram of a partial structure of a leaflet reinforcement device in a preferred embodiment of Example 1 of the present invention;

[0040] Figure 3 This is a three-dimensional diagram of a partial structure of the leaflet reinforcement device in another preferred embodiment of Example 1 of the present invention;

[0041] Figure 4 This is a three-dimensional diagram of a partial structure of a leaflet reinforcement device in a preferred embodiment of Example 1 of the present invention;

[0042] Figure 5 This is a three-dimensional diagram of a portion of the structure of the leaflet reinforcement device in a preferred embodiment of Example 1 of the present invention from another angle;

[0043] Figure 6This is a structural diagram of a clamping assembly in a preferred embodiment of Example 1 of the present utility model;

[0044] Figure 7 This is a structural diagram of a clamping assembly in a preferred embodiment of Example 1 of the present utility model when the first clamping arm is in a fully open state;

[0045] Figure 8 This is a structural schematic diagram of the clamping assembly in a preferred embodiment of Example 1 of the present invention at another angle when the first clamping arm is in a fully open state;

[0046] Figure 9 This is a structural diagram of the second clamping arm in a preferred embodiment of Example 1 of the present utility model;

[0047] Figure 10 This is a structural diagram of the second clamping arm when it is opened in a preferred embodiment of Example 1 of the present utility model;

[0048] Figure 11 This is a structural diagram of the second clamping arm during prefabrication and bending in a preferred embodiment of Example 1 of the present utility model;

[0049] Figure 12 This is a structural diagram of a leaflet anchoring element in a preferred embodiment of Example 1 of the present utility model;

[0050] Figure 13 This is a structural diagram of a first clamping arm when it is opened in a preferred embodiment of Example 1 of the present utility model;

[0051] Figure 14 This is a structural diagram of the first clamping arm during prefabrication and bending in a preferred embodiment of Example 1 of the present invention;

[0052] Figure 15 This is a schematic diagram of the positions of the clamping assembly, the connecting assembly, and the reinforcing assembly in a preferred embodiment of Example 1 of the present invention;

[0053] Figure 16 This is a schematic diagram of the positions of the clamping assembly, the connecting assembly, and the reinforcing assembly in another preferred embodiment of Example 1 of the present invention;

[0054] Figure 17 This is a schematic diagram of a leaflet enhancement device in a preferred embodiment of Example 1 of the present invention when it begins to capture the leaflet;

[0055] Figure 18 This is a schematic diagram of the leaflet reinforcement device after capturing the leaflet in a preferred embodiment of Example 1 of the present invention;

[0056] Figure 19This is a diagram of the working state of the leaflet enhancement device in the heart in a preferred embodiment of Example 1 of the present invention;

[0057] Figure 20 This is a schematic diagram of the structure of the leaflet enhancement device in the outer delivery sheath in a preferred embodiment of Examples 1 and 2 of the present invention;

[0058] Figure 21 This is a structural diagram of the leaflet enhancement device in a preferred embodiment of Examples 1 and 2 of the present invention when the delivery sheath is withdrawn;

[0059] Figure 22 This is a schematic diagram of the leaflet enhancement device when released from the delivery device in a preferred implementation manner of Examples 1 and 2 of the present invention.

[0060] Description of reference numerals:

[0061] Clamping assembly 100, first clamping arm 110, first clamping end 111, first connecting end 112, first bending section 113, first traction line 114, second clamping arm 120, second clamping end 121, second connecting end 122, second bending section 123, leaflet anchoring element 124, second traction line 125; connecting assembly 200, first release joint 210; reinforcing assembly 300, support frame 310, connecting rod 311, elastic base 312, arc rod 313, connecting rod 314, coating 320, fixing part 330; delivery device 400, second release joint 410, outer delivery sheath 420; actuator rod 500; leaflet 600. DETAILED DESCRIPTION

[0062] In order to make the purpose, technical solution and advantages of the present invention more clear, the technical solution of the present invention will be clearly and completely described below in conjunction with the specific embodiments of the present invention and the corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and / or" unless the content clearly indicates otherwise.

[0063] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be internal communication between two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. In addition, in the description of this application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0064] In the field of interventional medical device technology, the direction closest to the operator is generally defined as the proximal end, and the direction away from the operator is defined as the distal end. The direction of the central axis of objects such as cylinders and tubes is defined as the axial direction. The radial direction refers to the direction passing through the central axis in a radial plane, for example, along a straight line of diameter or radius, or perpendicular to the central axis.

[0065] Obviously, the embodiments described are only a part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0066] In order to solve the problems existing in the prior art, the embodiment of the present application provides a leaflet reinforcement device, including a clamping assembly 100, a reinforcement assembly 300 and a connecting assembly 200; the clamping assembly 100 includes a first clamping arm 110 and a second clamping arm 120; the first clamping arm 110 includes a first connecting end 112 and a first clamping end 111, the first connecting end 112 and the first clamping end 111 can be bent relative to each other, and the first connecting end 112 is fixed to one side of the circumference of the connecting assembly 200; the second clamping arm 120 includes a second connecting end 122 and a second clamping end 121, the second connecting end 122 and the second clamping end 121 can be bent relative to each other, and the second connecting end 122 is arranged parallel to or coplanar with the first clamping end 111, and the second clamping end 121 is provided with a leaflet anchoring element 124 in the direction of the first clamping end 111, and the leaflet anchoring element 124 can cooperate with the first clamping end 111 and clamp the leaflet; the axial end of the connecting component 200 can be detachably connected to the conveying device 400; the reinforcing component 300 includes a fixing portion 330 and a functional portion, the fixing portion 330 is fixedly arranged on one side of the circumference of the connecting component 200, and the functional portion bulges outward in a direction away from the fixing portion 330, and the functional portion can be compressed during transportation, and radially elastically expand when released at the valve, and fill the regurgitation area between the leaflets.

[0067] Example 1

[0068] Taking mitral valve implantation as an example, this embodiment 1 provides a leaflet enhancement device to solve the technical problems existing in the prior art.

[0069] according to Figures 1-19The leaflet reinforcement device includes a clamping component 100, an enhancement component 300 and a connecting component 200, wherein the connecting component 200 can be clamped with the conveying device 400 so that the leaflet reinforcement device can be released in time after being clamped with the leaflet 600. The clamping component 100 and the enhancement component 300 are circumferentially arranged on both sides of the connecting component 200. The clamping component 100 can open and close and clamp the leaflet 600 to reduce mitral valve regurgitation. The enhancement component 300 can self-expand after release and fill the regurgitation orifice area to further alleviate the regurgitation phenomenon; since the positions between the enhancement component 300, the connecting component 200 and the valve remain relatively stable, when operating the clamping component 100, the enhancement component 300 will not be displaced. Instead, the enhancement component 300 will play a positioning role after release, so as to facilitate the operation of the clamping component 100 and avoid the clamping component 100 from being dislocated or falling off due to lack of stability when opening and closing.

[0070] like Figure 5 In a preferred embodiment, the connecting component 200 is roughly tubular, and a first release connector 210 is provided at its proximal end. When the leaflet augmentation device is transported in the body, the first release connector 210 can be engaged with the transport device 400; the middle part of the connecting component 200 is axially penetrated for passing the actuating rod 500, and the actuating rod 500 can perform coaxial reciprocating motion relative to the leaflet augmentation device. The actuating rod 500 can be regarded as one of the components of the leaflet augmentation device. The proximal end of the actuating rod 500 extends outside the body. While keeping the position of the connecting component 200 stationary, the clamping component 100 can be controlled to open and close through the axial movement of the actuating rod 500.

[0071] In a preferred embodiment, the clamping assembly 100 and the reinforcing assembly 300 can be respectively arranged on opposite sides of the connecting assembly 200 in the circumferential direction, and the two are symmetrically distributed relative to the connecting assembly 200, that is, the geometric center A of the clamping assembly 100, the geometric center C of the reinforcing assembly 300 and the central axis B of the connecting assembly 200 are located on the same straight line, such as Figure 15 .

[0072] In another preferred embodiment, the line connecting the geometric center A of the clamping assembly 100 and the central axis B of the connecting assembly 200 and the line connecting the geometric center C of the reinforcing assembly 300 and the central axis B of the connecting assembly 200 form an angle, such as Figure 16 This angle can be set based on the actual morphology of the leaflets 600. Because different patients have different physiological / pathological conditions, this angle is not specifically limited. In this embodiment, after the clamping assembly 100 clamps and secures the leaflets 600, a certain angle may exist between the regurgitant area and the position of the leaflets 600. In this case, the reinforcement assembly 300 can more accurately block the regurgitant area to minimize regurgitation.

[0073] like Figure 6-9 In a preferred embodiment, the clamping assembly 100 includes a first clamping arm 110 and a second clamping arm 120. The first clamping arm 110 includes a first clamping end 111 and a first connecting end 112, with a first bending section 113 between the two. The first clamping end 111 and the first connecting end 112 can be bent relative to each other through the first bending section 113; the second clamping arm 120 includes a second clamping end 121 and a second connecting end 122, with a second bending section 123 between the two. The second clamping end 121 and the second connecting end 122 can be bent relative to each other through the second bending section 123.

[0074] Preferably, the first connection end 112 is arranged on one side of the circumference of the connection component 200, for realizing a fixed connection between the clamping component 100 and the connection component 200; specifically, the first connection end 112 can be configured with a shape that is compatible with the outer contour of the connection component 200, and is connected by a mechanical structure such as screws, and then fixed by welding.

[0075] Preferably, the second connecting end 122 is arranged parallel to or coplanar with the first clamping end 111, and a leaflet anchoring element 124 is also provided at the end of the second clamping end 121. The leaflet anchoring element 124 extends toward the first clamping end 111 and can cooperate with the first clamping end 111 to capture the leaflet 600 and ensure that the clamping assembly 100 is stable and does not fall off after capturing the leaflet 600.

[0076] In a preferred embodiment, the first bending section 113 and the second bending section 123 are prefabricated with resilience, and in the initial state, the first clamping end 111 and the first connecting end 112 are in a bent state, and the second clamping end 121 and the second connecting end 122 are in a bent state, respectively. Figure 11 、 Figure 14 The setting of the bent state can enable the first clamping arm 110 and the second clamping arm 120 to have a greater clamping force and a greater clamping amplitude, so as to ensure stable clamping of the leaflet 600.

[0077] In a preferred embodiment, the arc length of the first bending section 113 is greater than the arc length of the second bending section 123, or the bending curvature of the first bending section 113 is configured to be no greater than the bending curvature of the second bending section 123, so as to ensure that the first clamping arm 110 is sufficient to accommodate the second clamping arm 120 in the bent state, and to ensure that the first clamping arm 110 and the second clamping arm 120 do not cause obstruction to each other during the process of relative clamping or relative opening.

[0078] Preferably, the first clamping end 111 is connected to the actuating rod 500 through a first traction line 114, and the first traction line 114 extends to the proximal end outside the body through the actuating rod 500; the second clamping end 121 is connected to a second traction line 125, and the second traction line 125 extends to the proximal end outside the body through the sheath.

[0079] When the clamping assembly 100 is opened, the actuating rod 500 is pushed distally, causing the distal end of the actuating rod 500 to move axially relative to the connecting assembly 200. The actuating rod 500 can drive the first clamping end 111 to open relative to the connecting assembly 200 via the first traction line 114. At this time, the first bent section 113 gradually transitions from a bent state to a substantially straightened state. The specific opening and closing angle of the first clamping end 111 is positively correlated with the distance the actuating rod 500 is pushed distally. The longer the actuating rod 500 is pushed distally, the greater the opening angle of the first clamping end 111 relative to the first connecting end 112. Preferably, the opening and closing angle of the first clamping end 111 relative to the first connecting end 112 is 0-180°. Furthermore, the opening of the second clamping end 121 can be controlled by pulling back the second traction line 125, and the closing of the second clamping end 121 can be controlled by releasing the second traction line 125. Preferably, the opening and closing angle of the second clamping end 121 relative to the second connecting end 122 is between 0-180°. When the leaflet augmentation device is ready to release and capture the leaflet 600 in the heart, the first traction line 114 and the second traction line 125 are cut and pulled out, and then the actuator rod 500 is withdrawn, so that the connecting device and the conveying device 400 are separated from each other to complete the release operation of the leaflet augmentation device.

[0080] like Figure 10 、 Figure 13 In a preferred embodiment, the first clamping end 111 and the second connecting end 122 are both configured as a rectangular frame, and the first connecting end 112 and the second clamping end 121 are both configured as a roughly sheet shape.

[0081] like Figure 6 In a preferred embodiment, the second connecting end 122 is fixedly arranged on the inner side of the first clamping end 111, and the inner side surface of the second connecting end 122 is coplanar with the inner side surface of the first clamping end 111, so as to increase the contact area between the first clamping end 111 and the leaflet 600 and improve the stability when capturing the leaflet 600.

[0082] Preferably, the frame-shaped second connecting end 122 is sleeved on the inner side of the frame-shaped first clamping end 111, and the two are fixedly connected by welding, bonding, etc. More preferably, the sizes of the two match each other in order to achieve better welding performance.

[0083] In a preferred embodiment, the first clamping arm 110 and the second clamping arm 120 are both cut from metal tubes of the same outer diameter. Therefore, by designing the cutting dimensions, the first clamping end 111 and the second connecting end 122 are completely fitted together, and are easy to weld and assemble.

[0084] During the opening and closing process of the first clamping arm 110 and the second clamping arm 120, the first connecting end 112 is fixed to the connecting assembly 200 and is relatively stationary. When the first clamping end 111 is pulled to move, the second connecting end 122 is welded and fixed to the first clamping end 111, so the second connecting end 122 can move together with the first clamping end 111.

[0085] In a preferred embodiment, the first bending section 113 and the second bending section 123 are both configured as folded structures formed by bending back and forth in a direction intersecting the axial direction in an elongated structure.

[0086] In a preferred embodiment, the folded structure includes a plurality of axially connected S-shaped structures. In another preferred embodiment, the folded structure includes a plurality of chain ring structures. Alternatively, the folded structure may be provided with only S-shaped structures, only chain ring structures, or an alternating arrangement of S-shaped structures and chain ring structures.

[0087] like Figure 9 、 Figure 12 Preferably, the leaflet anchoring element 124 can be integrally formed or fixed with the second clamping end 121, and the leaflet anchoring element 124 includes several spike structures, which all extend toward the first clamping end 111 and are distributed on the outside of the first clamping end 111, and can cooperate with the first clamping end 111 and anchor the leaflet; preferably, the spike structure is in the shape of a small and inwardly curved barb, which is conducive to being more stable and not easy to fall off after capturing the leaflet 600.

[0088] In a preferred embodiment, the leaflet anchoring element 124 is cut and formed by a thin-walled metal tube. By directly cutting the thin-walled metal tube, the barbs can be made sharper, and through the cutting pattern design, the cut barbs tend to be inward, similar to a rake structure, which can capture the leaflet 600 more stably and firmly, reducing the risk of the device falling off; preferably, the leaflet anchoring element 124 is connected to the second clamping end 121 by welding, so that the barbs can move with the opening and closing of the second clamping end 121.

[0089] Preferably, the first clamp arm 110 and the second clamp arm 120 are both cut from shape memory metal, wherein the first bending section 113 and the second bending section 123 are prefabricated with an inward-bending resilience through heat treatment. It should be noted that although the first bending section 113 and the second bending section 123 can be configured to bend inward during production, when the leaflet enhancement device is transported, the first clamp arm 110 and the second clamp arm 120 are both straight in the axial direction, so as to reduce the diameter of the entire leaflet enhancement device, which is beneficial for the delivery of the device in the body.

[0090] Preferably, the bending angle of the first bending section 113 and the second bending section 123 during heat treatment is between 180° and 215°. The prefabricated bending angle can increase the resilience of the shape memory metal. After the device captures the leaflet 600 and closes, the first clamp arm 110 and the second clamp arm 120 can provide greater clamping force, making the device more stable after release and reducing the risk of falling off.

[0091] Preferably, the shape-memory metal is nickel-titanium alloy, which not only recovers its original shape after a certain deformation but also exhibits excellent biocompatibility, corrosion resistance, and durability, and does not induce immune or rejection reactions in the human body, effectively reducing the risk of postoperative complications. Furthermore, nickel-titanium alloy has a density approximately half that of iron, effectively reducing the weight of the entire device and improving ease of use and comfort.

[0092] Preferably, the material of the leaflet anchoring element 124 is the same as or different from the material of the first clamping arm 110 and the second clamping arm 120 . Since the leaflet anchoring element 124 does not involve bending, it can also be made of metal without shape memory properties.

[0093] In a preferred embodiment, the reinforcement component 300 includes a fixing portion 330 and a functional portion. The fixing portion 330 is fixedly arranged on one circumferential side of the connecting component 200, and the functional portion bulges outward in a direction away from the fixing portion 330. The functional portion can be compressed during transportation and radially elastically self-expanded during release, and fill the regurgitation area between the leaflets 600, thereby reducing regurgitation.

[0094] As mentioned above, in a preferred embodiment, the line connecting the geometric center A of the clamping assembly 100 and the central axis B of the connecting assembly 200 and the line connecting the geometric center C of the reinforcing assembly 300 and the central axis B of the connecting assembly 200 form an angle, such as Figure 16 In order to achieve more precise sealing of the regurgitation area, in an optional embodiment, the expansion direction of the functional part and the fixing direction of the fixing part 330 may also form an angle. At this time, the leaflet 600, the clamping assembly 100, and the functional part are not on the same straight line, and the functional part can be adaptively set according to the specific position of the regurgitation area.

[0095] Preferably, the fixing portion 330 is configured to be in a shape that matches the outer contour of the connecting component 200 so as to fit tightly, such as an arc or other curved shape, and the two are fixed by welding, bonding, clamping or riveting to ensure the stability of the relative position between the two; alternatively, the connecting component 200 can also be designed to have a shape structure that matches the fixing portion 330 at a position relative to the fixing portion 330 to facilitate assembly and connection between the two.

[0096] Preferably, the functional part can be roughly attached to the periphery of the fixed part 330 in the compressed state, and has a three-dimensional configuration in the expanded state. Specifically, different shapes can be designed according to the anatomical structure of the mitral valve. Since there may be a height difference between the anterior and posterior lobes of the mitral valve or a leaflet defect, the functional part can be designed to be cylindrical, truncated cone, hemispherical, ellipsoidal, semi-ellipsoidal, an irregular three-dimensional configuration or a shape that matches the regurgitant orifice area, which is conducive to filling the regurgitant orifice area.

[0097] like Figure 1-5 In a preferred embodiment, the functional portion includes a support frame 310 and a coating 320, wherein the support frame 310 has a compressed configuration and an expanded configuration formed by self-deformation of the compressed configuration, and the coating 320 is tightly attached to and completely covers the outer contour of the support frame 310 to form a closed three-dimensional structure; when the support frame 310 is deformed from the compressed configuration to the expanded configuration, the coating 320 is subjected to force and expands accordingly to form the above-mentioned three-dimensional configuration.

[0098] Preferably, the coating 320 may be made of a polymer sealing film to accelerate the endothelialization process between the functional part and the internal tissue. On the one hand, it can improve the tolerance and compatibility of the functional part and prevent thrombosis. On the other hand, it can also enhance the anchoring effect of the functional part and extend the life of the device.

[0099] like Figure 3 In a preferred embodiment, the support frame 310 is an elastic matrix 312, which can be made of a flexible polymer material with biocompatibility and directly manufactured into a corresponding three-dimensional configuration through 3D printing, laser cutting or mold injection molding.

[0100] Preferably, in order to make the elastic base 312 have a smaller volume when compressed, hollowing or grooves can be set in some areas thereof to ensure that it is sufficient to support the coating 320 when expanded and is easier to compress and transport.

[0101] Specifically, the elastic matrix 312 can be made of one or more materials selected from polylactic acid, polycaprolactone, polyurethane or polyacrylate, etc., which are not specifically limited here.

[0102] In a preferred embodiment, the support frame 310 is a self-expanding stent, which can be specifically a metal support with a shape memory effect, such as using the same material as the clamping assembly 100; the self-expanding stent can be compressed during transportation and return to the specific shape at the time of manufacture due to its shape memory effect when released.

[0103] In a preferred embodiment, the support frame 310 is configured as a plurality of axially arranged connecting rods 311, such as Figure 2 Specifically, the connecting rods 311 are arc-shaped or bent, and the two ends of several connecting rods 311 are fixed, so that the support frame 310 is roughly in the shape of a vertical lantern. When the support frame 310 is released, the several connecting rods 311 can expand radially. When compressed, the several connecting rods 311 can bend toward the distal end to achieve radial collapse.

[0104] Optionally, the support frame 310 may also be configured as a plurality of grid-like structures.

[0105] like Figure 4 、 Figure 5 In another preferred embodiment, the support frame 310 includes a plurality of arc-shaped units, which can bend toward the distal end during transportation. When released, the plane of the arc-shaped units is roughly perpendicular to the central axis of the connecting component 200 to support the coating 320.

[0106] Compared with the above-mentioned cylindrical grid structure 311 or elastic matrix 312, the arc-shaped unit has a smaller weight and can have a smaller volume when compressed and transported. Due to its simpler structure, it can also have a faster self-expansion speed when released.

[0107] Preferably, the arc unit includes an arc rod 313 and a connecting rod 314, the connecting rod 314 is arranged along the axial direction of the connecting component 200, and multiple arc rods 313 are arranged in parallel along the length direction of the fixing part 330, and multiple arc units are fixed to the fixing part 330 through the connecting rod 314; in order to enable the arc unit to form a corresponding three-dimensional configuration after self-expansion and supporting the sealing membrane, it is preferred that the arc rod 313 is a regular arc, an elliptical arc, an irregular curve or a shape that is adapted to the valve regurgitation area.

[0108] Optionally, the plurality of axially arranged arc-shaped rods 313 may be coaxially or non-coaxially arranged.

[0109] Optionally, the sizes of the multiple arc rods 313 are the same; or, the sizes of the multiple arc rods 313 increase successively from the proximal end to the distal end; or, the sizes of the multiple arc rods 313 decrease successively from the proximal end to the distal end; or, the sizes of the multiple arc rods 313 first increase and then decrease from the proximal end to the distal end.

[0110] In a more preferred embodiment, the sizes of the multiple arc rods 313 gradually increase from the proximal end to the distal end, and the multiple connecting rods 314 gradually approach the clamping assembly 100 from the proximal end to the distal end; on the one hand, this design can make the arc unit easier to compress into the delivery sheath when bending toward the distal end, and on the other hand, it can make the arc unit more compatible with the shape of the reflux port area after expansion.

[0111] In this embodiment, the leaflet enhancement device is operated as follows:

[0112] like Figure 17-20 When the leaflet augmentation device enters the delivery device 400, the relative position relationship between the actuating rod 500 and the connecting assembly 200 is controlled, and the first clamping arm 110 is fully extended by tightening the first traction line 114, and the second traction line 125 is loosened at the same time, so that the second clamping arm 120 is attached to the first clamping arm 110. At this time, the entire clamping assembly 100 is in a fully open state. Figure 20 Since the enhancement component 300 can be compressed, it can be deformed by external force. When the leaflet enhancement device enters the outer delivery sheath 420, the wall of the outer delivery sheath 420 produces radial inward and axial downward pressure on the enhancement component 300. The functional part of the enhancement component 300 is deformed downward by the external force to reduce the volume, so that the device can enter the outer delivery sheath 420.

[0113] When the device reaches the desired position in the heart, the outer delivery sheath 420 is withdrawn, and the functional part is no longer subjected to external forces and expands to the expanded configuration. Figure 21 When the device needs to be retracted during surgery, reverse the above steps.

[0114] When the leaflet reinforcement device captures the leaflet 600, the actuator rod 500 is withdrawn proximally, driving the first traction line 114 to move, thereby further driving the first clamping end 111 to move upward. At this time, the second clamping end 121 is pulled open by the second traction line 125 and is close to the first connecting end 112. The leaflet anchoring element 124 and the first clamping end 111 are at a corresponding opening and closing angle, as shown in FIG. Figure 17 , adjust the device to a suitable position, place the leaflet 600 between the first clamping end 111 and the leaflet anchoring element 124, then release the second traction line 125. Due to the prefabricated inward rebound force of the second clamping arm 120, the leaflet anchoring element 124 is driven to fit toward the first clamping end 111, clamping the leaflet 600. Figure 18 , completing the capture operation of the leaflet 600; during the capture process, the reinforcement component 300 remains stationary relative to the actuator rod 500.

[0115] After the leaflet augmentation device has clamped the leaflet 600 at the appropriate position, the device is ready to be withdrawn and released. First, the second traction line 125 is cut and withdrawn, then the first traction line 114 is cut and withdrawn, and finally the actuator rod 500 is withdrawn to complete the release of the device. After the actuator rod 500 is withdrawn, the first release joint 210 and the second release joint 410 at the distal end of the delivery device 400 can move freely in the horizontal direction, thereby realizing the release operation of the entire device. Figure 22 , the working status of the device in the heart after release is as follows Figure 19 .

[0116] Example 2

[0117] Still taking mitral valve implantation as an example, this embodiment 2 provides a leaflet enhancement system, including the above-mentioned leaflet enhancement device and its delivery device 400. The technical features already included in the above-mentioned embodiment 1 are naturally inherited in this embodiment and will not be repeated.

[0118] refer to Figure 20-22 Preferably, the delivery device 400 is provided with an operating handle and a tubular member at the proximal end, and a second release connector 410 at the distal end. The second release connector 410 engages with the first release connector 210 at the proximal end of the leaflet augmentation device. In a more preferred embodiment, the delivery device 400 also includes necessary equipment such as an outer delivery sheath 420, a guide catheter, and a guidewire, which are not further described here.

[0119] refer to Figure 22 Preferably, the longitudinal cross-section of the first release joint 210 is an S-shaped surface, and a through hole is provided along the axial direction of the first release joint 210; preferably, the longitudinal cross-section of the second release joint 410 is also an S-shaped surface, and matches the curved surface of the first release joint 210, and is used to circumferentially limit the first release joint 210, and a through hole is also provided along the axial direction of the second release joint 410. The two through holes are coaxially arranged for passing the actuating rod 500.

[0120] Preferably, in order to determine the exact position of the leaflet augmentation device during surgery, the first release connector 210 and the second release connector 410 can be made of any biocompatible metal or developable polymer material, preferably nickel titanium, stainless steel or an injection molded part with barium sulfate added, and more preferably nickel titanium alloy.

[0121] In this embodiment, the specific method of using the leaflet enhancement system is described in the above-mentioned embodiment 1 and will not be repeated here.

[0122] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the purpose of the present invention and the claims, all of which are within the protection of the present invention.

Claims

1. A leaflet enhancement device, characterized in that: It includes a clamping component, a reinforcing component and a connecting component; The clamping assembly includes a first clamping arm and a second clamping arm; The first clamping arm includes a first connecting end and a first clamping end, the first connecting end and the first clamping end are capable of bending relative to each other, and the first connecting end is fixed to one side of the circumference of the connecting assembly; The second clamping arm includes a second connecting end and a second clamping end, the second connecting end and the second clamping end are capable of being bent relative to each other, the second connecting end and the first clamping end are arranged parallel to or coplanar with each other, and the second clamping end is provided with a leaflet anchoring element in a direction facing the first clamping end, and the leaflet anchoring element can cooperate with the first clamping end to clamp the leaflet; The connecting assembly can be detachably connected to the conveying device; The reinforcing component includes a fixing portion and a functional portion. The fixing portion is fixedly arranged on one side of the circumference of the connecting component, and the functional portion bulges outward in a direction away from the fixing portion. The functional portion can be compressed during transportation, and radially elastically expand when released at the valve to fill the regurgitation area between the leaflets.

2. The leaflet enhancement device according to claim 1, characterized in that: The fixing portion is configured into a shape that matches the outer contour of the connecting component; the functional portion is configured into a three-dimensional configuration, including a cylindrical, truncated cone, hemispherical, ellipsoidal, semi-ellipsoidal, irregular three-dimensional shape or a shape that matches the valve regurgitation orifice area.

3. The leaflet enhancement device according to claim 2, characterized in that: The functional part includes a support frame and a covering film. The support frame has a compressed configuration and an expanded configuration formed by self-deformation from the compressed configuration. The covering film tightly covers along the outer contour of the support frame to form a closed three-dimensional structure.

4. The leaflet enhancement device according to claim 3, characterized in that: The support frame includes a plurality of arc-shaped units, the plane where the arc-shaped units are located is perpendicular to the central axis of the connecting component when released, and the plurality of arc-shaped units are arranged in parallel along the length direction of the fixing part, and the arc-shaped units can be bent toward the distal end during transportation.

5. The leaflet enhancement device according to claim 4, characterized in that: The arc-shaped unit includes an arc-shaped rod and a connecting rod. The connecting rod is arranged along the axial direction of the connecting component. Multiple arc-shaped units are fixed to the fixed part through the connecting rod. The arc-shaped rod is a regular arc, an elliptical arc, an irregular curve or a shape that is adapted to the valve regurgitation orifice area.

6. The leaflet enhancement device according to claim 5, characterized in that: The sizes of the plurality of arc-shaped rods are all the same; Alternatively, the sizes of the plurality of arc-shaped rods increase sequentially from the proximal end to the distal end; Alternatively, the sizes of the plurality of arc-shaped rods decrease sequentially from the proximal end to the distal end; Alternatively, the sizes of the plurality of arc-shaped rods first increase and then decrease from the proximal end to the distal end.

7. The leaflet enhancement device according to claim 5, characterized in that: The sizes of the plurality of arc-shaped rods gradually increase from the proximal end to the distal end, and the plurality of connecting rods gradually approach the clamping assembly from the proximal end to the distal end.

8. The leaflet enhancement device according to claim 3, characterized in that: The support frame includes a self-expanding stent, which includes a plurality of axially arranged arc-shaped connecting rods. The arc-shaped connecting rods can expand radially outward when released and fold toward the distal end when compressed.

9. The leaflet enhancement device according to claim 3, characterized in that: The support frame includes an elastic matrix comprising a flexible polymer material having biocompatibility.

10. The leaflet enhancement device according to claim 3, characterized in that: The coating film includes a polymer sealing film.

11. The leaflet enhancement device according to claim 1, characterized in that: A first bending section is provided between the first connecting end and the first clamping end, and a second bending section is provided between the second connecting end and the second clamping end, and both the first bending section and the second bending section have a bending resilience; The arc length of the first bending segment is greater than the arc length of the second bending segment, and / or the curvature of the first bending segment is not greater than the curvature of the second bending segment.

12. The leaflet enhancement device according to claim 1, characterized in that: The first clamping end and the second connecting end are both configured as rectangular frames. The second connecting end is fixedly disposed inside the first clamping end, and at least the inner side surface of the second connecting end is coplanar with the inner side surface of the first clamping end.

13. The leaflet enhancement device according to claim 1, characterized in that: The leaflet anchoring element includes a plurality of spike structures, which extend toward the first clamping end. The plurality of spike structures are distributed on the outside of the first clamping end and are used to cooperate with the first clamping end and anchor the leaflet.

14. The leaflet enhancement device according to claim 1, characterized in that: The middle part of the connecting component is axially through and is used to pass through the actuating rod. The first clamping end is connected to the actuating rod through a first traction line, and the first traction line is used to control the opening and closing of the first clamping end relative to the connecting component; the second clamping end is connected to a second traction line, and the second traction line extends axially to the proximal end of the conveying device. The second traction line is used to control the opening and closing of the second clamping end relative to the second connecting end.

15. A leaflet enhancement system, characterized in that: It comprises a delivery device and the leaflet enhancement device according to any one of claims 1 to 14, wherein the delivery device is detachably connected to the leaflet enhancement device.

16. The leaflet enhancement system according to claim 15, wherein: The proximal end of the leaflet reinforcement device is provided with a first release connector, and the distal end of the delivery device is provided with a second release connector, and the first release connector can be snap-connected with the second release connector.

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