A single-fixation valve repair device and a heart valve repair system

Abstract

The single-fixing valve repairer comprises a clamping part and a flow blocking block, wherein the clamping part comprises a first clamping arm and a second clamping arm with elasticity for clamping a heart valve; the flow blocking block comprises a support and a flow blocking film, the flow blocking film is fixed by the support and connected to the clamping part, and bulges to one side to form a flow blocking part, so that the flow blocking film hides an implant interface arranged on the clamping part. The repairer can effectively reduce the stimulation of the exposed implant interface to the heart tissue and improve the treatment effect of the heart regurgitation surgery. The application further provides a heart valve repair system.

Description

Technical Field

[0001] This invention belongs to the field of surgical instruments, specifically relating to a heart valve repair device and a heart valve repair system. Background Technology

[0002] With the development of cardiac surgery techniques, implantable interventional devices have become an effective treatment for mitral or tricuspid regurgitation. Among them, edge-to-edge repair is a relatively mature and widely used technique. For example, patent application CN115399920A discloses a single-fixed leaflet choke repair clip, which can fix the choke device on the heart valve leaflet to improve blood regurgitation. However, existing technologies still have certain shortcomings. Due to the complex shape of the choke device, the effective working area size of the choke device is not well controlled. The implanted choke device is prone to insufficient adhesion to the valve during closure, affecting the regurgitation elimination effect; or the choke device may abnormally interfere with the heart tissue, causing abnormal stimulation to the heart tissue. Therefore, providing a valve repair device to improve the implantation effect of interventional devices has high practical value. Summary of the Invention

[0003] The purpose of this invention is to provide a single-fixation valve repair device to reduce implant irritation to cardiac tissue and improve the surgical treatment effect of cardiac regurgitation. This invention also provides a heart valve repair system.

[0004] According to one aspect of the present invention, a single-fixation valve repair device is provided, the repair device comprising a clamping portion and a flow-blocking block, wherein: the clamping portion includes a first clamping arm and a second clamping arm with elasticity, one end of the first clamping arm and the second clamping arm being a fixed end connected together, and the other end of the first clamping arm and the second clamping arm being a free end, wherein in a free state the first clamping arm and the second clamping arm are clamped together to allow the heart valve to be clamped between the first clamping arm and the second clamping arm; the flow-blocking block includes a support member and a flow-blocking membrane, the flow-blocking membrane being fixed to the support member and supported by the support member, the flow-blocking block being fixedly connected to the clamping portion through the support member, the surface of the flow-blocking membrane bulging toward the opposite valve forming a flow-blocking portion, the flow-blocking portion including a first end closest to the free end of the first clamping arm and a second end farthest from it, the thickness of the flow-blocking portion gradually decreasing from the middle toward the first end and the second end; the clamping portion includes an implantation interface for connecting a cardiac surgery implantation device to the single-fixation valve repair device; the implantation interface is at least partially shielded by the flow-blocking membrane.

[0005] The clamping section connects the prosthesis to the heart valve, while the flow-blocking section fills the area not covered by the heart valve during diastole, thus treating cardiac regurgitation. During systole and diastole, the prosthesis moves with the heart valve. Existing prosthesis implantation interfaces are exposed, which can irritate heart tissue or interfere with heart valve movement, affecting the repair outcome. By concealing the implantation interface with a flow-blocking membrane, direct contact between the rigid parts of the prosthesis and heart tissue is avoided, reducing irritation and improving surgical treatment results.

[0006] Preferably, the edge of the flow-blocking portion is provided with a flexible skirt extending outward. The flexible skirt can further improve the sealing ability of the valve edge, reduce the rigidity of the flow-blocking block edge area, and reduce stimulation to the heart tissue; at the same time, when there are progressive cardiac symptoms, the flexible skirt can adaptively increase the repair area of ​​the heart valve.

[0007] Optionally, the flexible skirt is formed by attaching it to the edge of the flow-blocking portion using the same material as the flow-blocking membrane. Attachment can be achieved through methods such as sewing or bonding, which are simple and easy to process.

[0008] Optionally, the flexible skirt is formed by stretching the flow-blocking membrane relative to the support member to an excess length and then fixing it in place. A skirt formed by stretching the flow-blocking membrane has better overall integrity.

[0009] Furthermore, the flexible skirt extends outward from the flow-blocking portion by 2-5 mm.

[0010] Preferably, the first clamping arm can open as the traction cable of the cardiac surgical implantation device is stretched. When the cardiac surgical implantation device is connected to the implantation interface, the implantation interface is axially oriented with respect to the connection direction with the cardiac surgical implantation device, and the angle between the axial direction and the first clamping arm in its free state is 45°-135°. After the prosthesis is implanted, the clamping arm needs to be moved by the traction cable of the surgical instrument. Within the range of 45°-135°, the traction cable can effectively apply force to the clamping arm, preventing the clamping arm from failing to open or from being damaged.

[0011] Furthermore, the clamping part includes a fixing member, wherein the first clamping arm and the second clamping arm partially overlap at the fixing part and are connected together by the fixing member, and the implantation interface is disposed on the fixing member. The first clamping arm and the second clamping arm are each configured as independent metal sheets for easy processing and assembly. The method of fixing the overlapping part of the first clamping arm and the second clamping arm with the fixing member can further improve the elasticity of the clamping part and make the structure of the clamping part more robust.

[0012] Optionally, the fixing member protrudes from the clamping portion and provides thickness-direction support to the flow-blocking portion. The support provided by the clamping portion helps improve the stability of the flow-blocking portion's profile.

[0013] Furthermore, the support member is configured as an annular support wire, which passes through and is fixed to the clamping portion. The support member includes a main support wire to provide circumferential support for the flow-blocking membrane. The support wire structure is lightweight, easy to deform and reset, and can provide effective support for the flow-blocking membrane.

[0014] Preferably, the support further includes one or more auxiliary support wires, which protrude towards the flow-blocking portion to provide support for the flow-blocking membrane. The auxiliary support wires can provide better support for the flow-blocking portion, improving the fit between the repair device and the heart tissue during valve closure.

[0015] Preferably, at least one of the auxiliary support wires is provided with a bent portion, the bent portion having a bend along the contour surface of the flow-blocking block towards the inner side of the annulus, to provide additional support for the flow-blocking membrane. The bent portion can provide better support for the area between the two support wires to maintain the surface stability of the flow-blocking portion.

[0016] Preferably, a reinforcing portion extending along the surface of the clamping portion is provided at the connection between the support wire and the clamping portion. The reinforcing portion abuts against the surface of the clamping portion to prevent the support wire from rotating around the clamping portion. The reinforcing portion fitting against the surface of the clamping portion can improve the stability of the support wire and prevent the support wire from rotating around a fixed position.

[0017] Furthermore, a support wire fixing member is provided on the clamping part, the support wire fixing member having a through hole to allow the support wire to pass through, and a locking ring is also provided between the support wire fixing member and the clamping part, the locking ring being used to tighten the support wire fixing member onto the clamping part. The fixing member and the locking ring can further improve the stability of the support wire.

[0018] Alternatively, the support member can be configured as a metal mesh. A metal mesh woven into a three-dimensional structure can also provide support for the flow-blocking membrane.

[0019] Optionally, the support member is configured as a support frame machined from a sheet metal. Sheet metal is easier to machine and allows for better control over its shape.

[0020] Optionally, the flow-blocking block further includes a buffer portion extending toward the back of the flow-blocking portion and at least partially covering the clamping portion. The buffer portion can prevent the clamping portion from directly contacting the tissue inside the heart during cardiac pulsation, reducing the stimulation of the implanted prosthesis on the heart.

[0021] Furthermore, the flow-blocking membrane forms a closed structure around the support. The closed structure of the flow-blocking block can reduce disturbance to blood flow within the heart, while facilitating endothelial growth, encapsulating the entire flow-blocking block, and improving the integrity and sealing of the flow-blocking block.

[0022] Optionally, the flow-blocking block is filled with supporting fibers. The supporting fibers can maintain the shape stability of the flow-blocking block and reduce the amount of blood flowing into the flow-blocking block.

[0023] Optionally, the back of the flow-blocking part is open, giving the flow-blocking block a bowl-shaped structure. An open back structure of the flow-blocking part prevents blood from accumulating inside the flow-blocking block.

[0024] Furthermore, the clamping part and the support are made of shape memory alloy. The prosthesis can be folded outside the body into a shape that is easy to transport, and unfolds to function under the influence of body temperature after implantation.

[0025] Furthermore, the contact surfaces of the first and / or second clamping arms with the heart valve are provided with protruding retaining spikes. These retaining spikes enhance the adhesion between the clamping portion and the valve, improving the fixation of the prosthesis within the heart.

[0026] Preferably, the surface of the clamping portion is covered with a biocompatible membrane. The biocompatible membrane can reduce the stimulation of the clamping portion on cardiac tissue.

[0027] Furthermore, the length of the flow-blocking portion along the distance between the first end and the second end is 2mm-10mm; taking the line connecting the first end and the second end as a reference line, the maximum thickness of the flow-blocking portion to the reference line is 2mm-8mm; the projection of the maximum height point of the flow-blocking portion onto the reference line at a distance of 2mm-8mm from the second end is 2mm-8mm; the maximum width of the flow-blocking portion body perpendicular to the extending direction of the clamping portion is 5mm-20mm. Reasonably setting the key dimensions of the flow-blocking portion can achieve a better flow-blocking effect.

[0028] Furthermore, the flow-blocking part is provided with flexible skirts on both sides or one side perpendicular to the reference line. The length of the flexible skirt extending outward from the flow-blocking part on one side is 2mm-5mm, and the maximum width of the flow-blocking part including the flexible skirt in the direction perpendicular to the reference line is 5mm-23mm.

[0029] Preferably, in the flow-blocking section, d ≥ (ld).

[0030] Furthermore, the flow-blocking membrane is sutured and fixed to the support by a biocompatible membrane, with the suture connector located inside the flow-blocking membrane. Positioning the suture connector inside the flow-blocking membrane further reduces irritation to the cardiac tissue.

[0031] According to another aspect of the present invention, a heart valve repair system is provided, comprising a cardiac surgical implantation instrument and a valve repair device connected to the cardiac surgical implantation instrument, wherein the valve repair device is any of the aforementioned single-fixation valve repair devices. This heart valve repair system can effectively reduce the stimulation of cardiac tissue after the valve repair device is implanted in the heart, thereby improving surgical outcomes.

[0032] Furthermore, the cardiac implantation device includes a disengager, a cannula, and a fixing pin. The fixing pin, disengager, and cannula are nested sequentially from the inside out and are capable of relative movement along the axial direction. The disengager includes a traction wire that can be connected to the valve repair device and pull the valve repair device to actuate. The end of the disengager includes a connecting bayonet, and the fixing pin passes through the connecting bayonet to allow the implantation interface and the choke membrane portion covering the implantation interface to enter the connecting bayonet and be fixed by the fixing pin, thereby connecting the valve repair device to the cardiac implantation device. The cannula is capable of axial movement and nesting outside the disengager, thereby compressing the valve repair device from a free state and holding it in a retracted state. Attached Figure Description

[0033] Figure 1a This is a schematic diagram of the heart valve repair device in the first embodiment;

[0034] Figure 1b This is a schematic diagram of the clamping part and support structure of the heart valve repair device in the first embodiment;

[0035] Figure 2 This is a schematic diagram of the flow-blocking block structure in the second embodiment;

[0036] Figure 3a This is a schematic diagram of the first clamping arm structure in the first embodiment;

[0037] Figure 3b This is a schematic diagram of the second clamping arm structure in the first embodiment;

[0038] Figure 4a This is a schematic diagram of the connection structure between the heart valve repair device and the cardiac surgical implantation instrument in the first embodiment;

[0039] Figure 4b for Figure 4a Enlarged structural diagram of region A in the middle;

[0040] Figure 5a This is a schematic diagram of the clamping part and support structure of the heart valve repair device in the third embodiment;

[0041] Figure 5b This is a schematic diagram of the support wire fixing structure in the third embodiment;

[0042] Figure 6 This is a schematic diagram of the clamping part and support structure of the heart valve repair device in the fourth embodiment;

[0043] Figure 7a This is a schematic diagram of the heart valve repair device structure in the fifth embodiment;

[0044] Figure 7b This is a schematic diagram of the cross-sectional structure of the heart valve repair device in the fifth embodiment;

[0045] Figure 8a This is a schematic diagram of the heart valve repair device structure in the sixth embodiment;

[0046] Figure 8b This is a schematic diagram of the support wire structure in the sixth embodiment;

[0047] Figure 9 This is a schematic diagram of the clamping part and support structure of the heart valve repair device in the seventh embodiment;

[0048] Figure 10 This is a schematic diagram of the clamping part and support structure of the heart valve repair device in the eighth embodiment;

[0049] Figure 11a This is a schematic diagram of the valve opening during the implantation of the heart valve repair device in the first embodiment;

[0050] Figure 11b This is a schematic diagram of valve closure during the implantation of the heart valve repair device in the first embodiment;

[0051] Figure 11c This is a schematic diagram of a pair of heart valve repair devices implanted.

[0052] The purpose of the above-described drawings is to provide a detailed description of the invention so that those skilled in the art can understand the technical concept of the invention, and not to limit the invention. For the sake of brevity, the above-described drawings only schematically depict the structures related to the technical features of the invention, and do not depict the complete structure and all details strictly according to actual scale. Detailed Implementation

[0053] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings.

[0054] The term "embodiment" as used herein means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment herein. The phrase appearing in various places in the specification does not necessarily refer to the same embodiment, nor is it limited to mutually exclusive, independent, or alternative embodiments. Those skilled in the art will understand that the embodiments herein can be combined with other embodiments without causing structural conflicts.

[0055] In this description, unless otherwise expressly specified and limited, the technical terms "installation," "connection," "joining," etc., should be interpreted broadly, referring to movable connections, fixed connections, or integration. Those skilled in the art can understand the specific meaning of these terms in the embodiments of this application based on the specific circumstances.

[0056] In this description, terms such as "upper," "lower," "left," "right," "lateral," "longitudinal," "height," "length," and "width," which indicate orientation or positional relationships, are intended to accurately describe the embodiments and simplify the description, rather than limiting the parts or structures involved to have a specific orientation, or to be installed or operated in a specific orientation, and should not be construed as limiting the embodiments in this document.

[0057] In this description, terms such as "first" and "second" are used only to distinguish different objects and should not be construed as indicating relative importance or limiting the number, specific order, or primary / secondary relationship of the described technical features. In this description, "multiple" means at least two.

[0058] Compared to conventional edge-to-edge heart valve repair devices, the single-fixation heart valve repair device only requires a single clamping device to connect and fix to the heart valve. Its simple structure, quick implantation, and minimal damage to the heart valve are advantages. However, the inventors recognized that... Figure 11c As shown, the single-fixation heart valve repair device used for minimally invasive surgery needs to retain the interface 5 for docking with the cardiac implantation surgical instruments. During the contraction and relaxation of the heart, this interface 5 may irritate the heart tissue, or even interfere with the normal closure of the valve during the relaxation of the heart, which may have an adverse effect on the patient's health.

[0059] To address the aforementioned problems, the first embodiment of the present invention provides a method such as... Figure 1a The heart valve repair device shown includes a clamping part 1 and a flow blocking block 2.

[0060] Combination Figure 1b , Figure 3a and Figure 3bThe clamping part 1 includes a first clamping arm 11 and a second clamping arm 12. The first clamping arm 11 and the second clamping arm 12 each have fixed ends 111 and 121 and free ends 112 and 122, respectively. The fixed ends 111 and 121 are connected together by a fixing member 13. The fixing member 13 has an elongated through hole. The fixed ends 111 and 121 of the first clamping arm 11 and the second clamping arm 12 overlap and are inserted into and engaged in the elongated through hole for fixation. The fixing member 13 has a through-hole-shaped implantation interface 131. Through holes 114 and 123 are also provided on the fixed ends 111 and 121, respectively. After the fixed ends 111 and 121 are inserted into the fixing member 13, the through holes 114 and 123 are coaxially connected to the implantation interface 131 for connection with a cardiac surgery implantation device. During implantation, a heart valve, such as a mitral valve, can be clamped between the first clamping arm 11 and the second clamping arm 12, thereby... Figure 11a As shown, the repair device is fixed to the heart valve 41.

[0061] The flow-blocking block 2 includes a support wire 22 and a flow-blocking membrane 20 made of biocompatible material (such as PET, PTFE, or biomembrane) sewn onto the support wire 22. The flow-blocking membrane 20 forms a closed bag-like structure around the support wire 22. The flow-blocking membrane 20 bulges outward toward the opposite heart valve 42 to form a tortoise-shell-shaped flow-blocking portion 21. The flow-blocking portion 21 has a first end 211 closest to the free end 112 of the first clamping arm and a second end 212 furthest from it. The thickness of the flow-blocking portion gradually decreases from the middle toward the first end 211 and the second end 212. The support wire 22 provides circumferential support to the flow-blocking portion 21 from the inside. When the prosthesis is fixed to the heart valve 41, the flow-blocking portion 21 can expand the coverage area of ​​the valve 41 during diastole, such as... Figure 11b As shown, it fits together with the contralateral heart valve 42, thereby eliminating cardiac regurgitation.

[0062] The fixation element 13 and the implantation interface 131 are covered and shielded within the flow-blocking portion 21 by the flow-blocking membrane 20. This prevents the fixation element 13 and the implantation interface 131 from directly contacting the heart tissue when the prosthesis moves with the valve 41, thereby reducing the stimulation to the heart after implantation. Simultaneously, the upper surface of the fixation element 13 provides some thickness-direction support to the flow-blocking portion 21 from the inside of the flow-blocking block 2, thus helping to maintain the shape and structure of the flow-blocking portion 21.

[0063] The process of implanting the prosthesis into the heart is as follows: Figure 4a and Figure 4bAs shown. First, the prosthesis is installed on the cardiac implantation surgical instrument 3. The dissociator 31 of the surgical instrument 3 has a connecting slot at its end. The implantation interface 131, partially covered by the flow-blocking membrane 21, enters this connecting slot. The fixing pin 33 penetrates the flow-blocking part 21 and passes through the implantation interface 131 covered by the flow-blocking membrane 20, fixing the prosthesis onto the dissociator 31, so that the axis of the cardiac implantation surgical instrument 3 coincides with the z-axis of the implantation interface 131. The traction wire 32 is fixed to... Figure 3a The traction wire of the first clamping arm 11 is passed through the hole 113. Then, the first clamping arm 11 and the second clamping arm 12 are bent towards the z-axis until they are pressed against the disengager 31. The repair device is then housed in a cannula (not shown), maintaining its housed state under the pressure of the cannula. The cardiac implantation surgical instrument 3 is inserted into the patient's heart through the aorta. The cannula is retracted along the z-axis, releasing the pressure on the first clamping arm 11 and the second clamping arm 12, restoring them to a free state. In a preferred embodiment, the angle α between the z-axis and the extension direction y of the first clamping arm 11 in the free state is between 45° and 135°, so that the traction wire 32 can better apply force to the first clamping arm 11, allowing the first clamping arm 11 to rotate clockwise towards the z-axis under the action of the traction wire 32, preventing the first clamping arm from failing to open or from being damaged. Figure 11a The first clamping arm 11 opens relative to the second clamping arm 12 under the action of the traction line 32, so that the clamping part 1 clamps the heart valve 41. The first clamping arm 11 is provided with protruding fixing needles 113 on the clamping surface to make the clamping part 1 clamp more firmly. After the first clamping arm 11 clamps in place, the traction line 32 is released and retracted, and then the fixing needle 33 also retracts along the z-axis, the dissociator 31 separates from the repair device, and the implantation is completed.

[0064] In the preferred second embodiment, such as Figure 2 As shown, the edge of the flow-blocking portion 21 is provided with an outwardly extending flexible skirt 213, which is made of the same material as the flow-blocking membrane 20. The flexible skirt 213 can be sewn or glued separately as an accessory to be attached to the edge of the flow-blocking portion 21, or it can be formed by leaving a redundant section in the edge area when the flow-blocking membrane 20, which is sewn into a bag shape, is fitted onto the support wire 22 for sewing and fixation. The flexible skirt 213 can further improve the adhesion between the flow-blocking portion 21 and the contralateral heart valve 42, reducing rigid collisions with the contralateral heart valve 42. Furthermore, when there is a risk of progression of cardiac disease, the flexible skirt 213 can provide a safety margin for the flow-blocking portion 21, reducing the probability of recurrence of cardiac regurgitation. In a preferred embodiment, the length of the flexible skirt 213 extending outward from the edge of the flow-blocking portion 21 is 2mm-5mm.

[0065] A third embodiment of the present invention provides a single-fixation heart valve repair device, such as... Figure 5aAs shown (the flow-blocking membrane 20 and flow-blocking portion 21 are not shown in the figure), the support wire in this repair device includes a main support wire 22a and an auxiliary support wire 22b. The main support wire 22a provides circumferential support for the flow-blocking portion 21 to form the circumferential contour of the flow-blocking portion 21. The auxiliary support wire 22b protrudes towards the flow-blocking portion 21, thereby providing support for the flow-blocking portion 21 along the thickness direction to improve the flow-blocking effect of the flow-blocking portion 21. In this embodiment, it is not necessary to provide support for the flow-blocking portion 21 through the fixing member 13. A support wire fixing member 23 is fixedly provided on the first clamping arm 11 of the clamping portion 1. The structure of the support wire fixing member 23 is as follows: Figure 5b As shown, the support wire fixing member 23 is provided with a through hole 232, through which the main support wire 22a and the auxiliary support wire 22b pass and are connected to the support wire fixing member 23. The support wire fixing member 23 and the clamping part 1 can be connected by welding or riveting. A locking ring 231 can also be provided on the outside of the support wire fixing member 23, either simultaneously or separately, as a connection structure between the support wire fixing member 23 and the clamping part 1. The locking ring 231 surrounds the support wire fixing member 23 and passes through the clamping part 1, thereby clamping the support wire fixing member 23 onto the first clamping arm 11. A groove-shaped structure 233 is provided in the middle of the support wire fixing member 23, and the bottom of the groove-shaped structure 233 is connected to the through hole 232. After the main support wire 22a and the auxiliary support wire 22b pass through the through hole 232 of the support wire fixing member 23, they emerge through the groove structure 233, extend along the surface of the first clamping arm 11 for a certain distance, and then fold back through the groove structure 233 to pass back into the support wire fixing member 23, thereby forming a reinforcing part 221. The reinforcing part 221 abuts against the surface of the first clamping arm 11 to provide additional support for the main support wire 22a and the auxiliary support wire 22b, preventing them from rotating around the support wire fixing member 23, and making the flow blocking part 21 more secure.

[0066] The fourth embodiment of the present invention provides a single-fixation heart valve repair device, such as... Figure 6As shown (the flow-blocking membrane 20 and flow-blocking portion 21 are not shown in the figure), the support wires in this repair device include a main support wire 22a, an auxiliary support wire 22b, and a second auxiliary support wire 22c. The main support wire 22a provides circumferential support to the flow-blocking portion 21, forming its circumferential profile. The auxiliary support wire 22b protrudes towards one side of the flow-blocking portion 21, providing thickness-direction support. The second auxiliary support wire 22c protrudes towards the flow-blocking portion 21 from the inner side of the auxiliary support wire 22b, providing support to the center of the protruding surface of the flow-blocking portion 21. Furthermore, the top of the protruding portion of the second auxiliary support wire 22b is provided with a bent portion 222 extending laterally towards the inner side of the annular structure along the profile of the flow-blocking portion 21. The bent portion 222 further enhances the support for the flow-blocking portion 21, maintaining the stability of its outer profile shape during operation and preventing deformation of the flow-blocking portion 21 under thickness-direction pressure, thereby achieving a better effect in suppressing cardiac reflux. The main support wire 22a, auxiliary support wire 22b, and second auxiliary support wire 22c pass through and are fixed to the support wire fixing member 23 welded to the surface of the first clamping arm 11. The locking ring 231 further tightens the support wire fixing member 23 onto the surface of the first clamping arm 11. Reinforcing portions 221 are provided at the positions where the main support wire 22a, auxiliary support wire 22b, and second auxiliary support wire 22c connect to the support wire fixing member 23. The reinforcing portions 221 extend along the surface of the clamping portion 1, and each reinforcing portion 221 is gathered together by a fixing ring 232 fixed to the surface of the first clamping arm 11 to provide more robust support for each support wire and prevent rotation or wobbling of the support wire fixing member 23. The fixing ring 232 can be welded to the surface of the first clamping arm 11 or pass through the first clamping arm 11 and tightened together with the reinforcing portion 221.

[0067] The fifth embodiment of the present invention provides a single-fixation heart valve repair device, such as... Figure 7a and Figure 7b As shown in the diagram, in this repair device, the support component for the flow-blocking membrane 20 is made of metal, such as nickel-titanium alloy, and a woven support mesh 22d. This support mesh 22d is fixed to the clamping part 1 by binding or welding. The shape of the flow-blocking block 2 is determined by the shape of the support mesh 22d. During assembly, the size of the mesh opening of the support mesh 22d can be adjusted to enlarge or tighten, allowing for more flexible assembly.

[0068] In a preferred embodiment, the length l between the first end 211 and the second end 212 of the flow-blocking portion 21 along the extending direction of the clamping portion 1 is in the range of 2mm-10mm; taking the line 24 connecting the first end 211 and the second end 212 as a virtual reference line, the distance from the highest point H of the flow-blocking portion 21 to the connecting line 24, i.e., the effective thickness h of the flow-blocking block 2, is in the range of 2mm-8mm; the distance d from the projection H' of point H on the connecting line 24 to the endpoint d of the connecting line 24 at the end of the flow-blocking block 2 is 2mm-8mm; the maximum width w of the flow-blocking block 2 perpendicular to the extending direction of the clamping portion 1 is 5mm-20mm. Figure 11a and Figure 11b The length *l*, thickness *h*, and width *w* together determine the maximum coverage area of ​​the flow-blocking block 2, while the distance *d* and thickness *h* together determine the fit between the flow-blocking block 2 and the contralateral heart valve 42. Based on the specific circumstances of the patient's heart and the misalignment gap between valve 41 and the contralateral heart valve 42, appropriately selecting the size of the flow-blocking block 2 within the aforementioned numerical range can effectively repair the heart valve 41, thereby achieving the technical effect of eliminating cardiac regurgitation.

[0069] In a further preferred embodiment, the two sides of the flow-blocking portion 21 can be as follows: Figure 2 The device is provided with a flexible skirt 213, which extends 2mm-5mm from the flow-blocking portion 21 to the edge. The maximum width of the flow-blocking portion 21, including the flexible skirt 213, is 5mm-23mm. This improves the sealing ability of the prosthesis while reducing its footprint within the heart. In some preferred embodiments, the dimensional relationship of the flow-blocking portion 21 satisfies d≥(ld), combined with... Figure 11b The maximum thickness of the flow-blocking part 21 is located near the clamping end of the repair device, which can make full use of the volume of the flow-blocking part and make the position of the flow-blocking part 21 and the opposite valve 42 closer to the inner side of the opposite valve 42, thus avoiding poor sealing at the edge.

[0070] The sixth embodiment of the present invention provides a single-fixation heart valve repair device, such as... Figure 8a As shown. In this repair device, the flow-blocking block 2 has a bulging flow-blocking portion 21 on one side of the clamping portion 1, and a buffer portion 25 is provided on the other side of the clamping portion 1, that is, the back side of the flow-blocking portion, and the buffer portion 25 covers the end of the clamping portion 1. Figure 8b As shown, the support wire 22 of the repair device has a folded-back portion 223 that bends toward the back of the flow-blocking portion 21 to provide support for the buffer portion 25. Since the buffer portion 25 covers the end of the clamping portion 1, it can effectively prevent adverse stimulation caused by the clamping portion 1 coming into contact with the tissues inside the heart during the contraction and relaxation of the heart.

[0071] In a preferred embodiment, the choke block 2 is filled with biocompatible fibers to better support the choke membrane 20, thereby maintaining the stability of the shape of the choke block 2 during cardiac contraction and relaxation, ensuring the elimination of cardiac reflux. The biocompatible fibers also reduce the amount of blood flowing into the choke block.

[0072] The seventh embodiment of the present invention provides a single-fixation heart valve repair device, such as... Figure 9 As shown (the flow-blocking membrane 20 and flow-blocking portion 21 are not shown). In this prosthesis, the first clamping arm 11 and the second clamping arm 12 are configured as an integrated structure, integrally formed, with their respective fixing ends 111 and 121 connected as one piece. A protruding connector 13b is provided at the connection position between the first clamping arm 11 and the second clamping arm 12, and a through hole (not shown) is provided on the connector 13b for connection with cardiac implantation surgical equipment. The integrated clamping portion 1 has a simple structure and lower production cost. The flow-blocking membrane 20 is fixed and supported by a mesh-like support frame 22e, which is made by cutting a perforated mesh from a stamped metal plate and is fixedly connected to the clamping portion 1 by multiple connecting rings 224. The support frame obtained by stamping and cutting the metal plate has higher dimensional accuracy. The flow-blocking membrane 20 is sutured and fixed to the support frame 22e to form the flow-blocking portion 21.

[0073] In an optional embodiment, the flow-blocking membrane 20 covers the support frame 22e only from one side of the outside, and the back side of the flow-blocking portion 21 is open, making the flow-blocking block 2 have an overall bowl-shaped structure. Blood will not accumulate inside the bowl-shaped flow-blocking portion 21, and the overall weight is lighter.

[0074] The eighth embodiment of the present invention provides a single-fixation heart valve repair device, wherein the first clamping arm 11 of the repair device is structured as follows: Figure 10 As shown (the flow-blocking membrane 20 and the flow-blocking section 21 are not shown). The first clamping arm 11 is connected to the support ring 225, which is fixed to the first clamping arm 11 by welding or as a whole, and is used to provide support for the flow-blocking section. Six support ribs 22f are evenly connected circumferentially on the support ring 225, and the support ribs 22f are welded to the support ring 225 or as a whole. Each support rib 22f protrudes and bends towards one side of the first clamping arm 11, with its end extending towards the center of the support ring 225 to form support for the flow-blocking section 21 in the thickness direction. The support ribs 22f have a larger cross-sectional area than the support wires or support mesh, so the overall structure has higher strength, can provide more stable support for the flow-blocking membrane, and is not easily deformed during the process of fixing the flow-blocking membrane, thus making the shape of the flow-blocking section 21 more stable.

[0075] In a preferred embodiment of the invention, the clamping part 1 of various structures and the support members of the flow-blocking membrane (including support wires, support meshes, or support ribs, and other forms of support frames) are all made of shape memory alloy. Shape memory alloy has good elasticity, allowing the clamping part 1 to open and close within a confined space after insertion into the heart, effectively fixing it to the heart valve. The support member can be formed into the target structure at body temperature, then compressed and folded at low temperature, and stored within the cannula of the cardiac implantation surgical device, so that it can be inserted into the heart through the narrowed aorta. After entering the heart, the cannula retracts, the shape memory alloy pressure is released, and it automatically unfolds into the target structure, enabling it to continue to function normally.

[0076] In a preferred embodiment of the present invention, the outer side of the clamping portion 1 is covered with a biocompatible membrane. This biocompatible membrane can be made of the same material as the flow-blocking membrane, or it can be a mesh woven from biocompatible fibers. Covering the outer side of the clamping portion 1 with a biocompatible membrane can reduce the stimulation of the heart by the metal structure, which is conducive to the occurrence of endothelial growth and the long-term firm bonding between the clamping portion 1 and the heart valve.

[0077] In a preferred embodiment of the present invention, the flow-blocking membrane is made of a biocompatible membrane sewn into a bag-like structure and sewn onto the support. During the sewing and fixing process, the suture joint is housed inside the flow-blocking block 2 by flipping inside and out, reducing the exposure of the irregular structure on the outside of the flow-blocking block 2, thereby improving the fluid performance of the flow-blocking block 2 and reducing interference and stimulation to the heart tissue and blood.

[0078] The purpose of the above embodiments is to provide a further detailed description of the present invention in conjunction with the accompanying drawings, so that those skilled in the art can understand the technical concept of the present invention. Within the scope of the claims of the present invention, optimization or equivalent substitution of the involved part structure and materials, as well as combination of implementation methods in different embodiments without causing structural and principle conflicts, all fall within the protection scope of the present invention.

Claims

1. A single-fixation valve repair device, comprising a clamping part and a flow-blocking block, wherein the clamping part includes a first clamping arm and a second clamping arm with elasticity, the first clamping arm and the second clamping arm being respectively configured as independent metal plates, one end of the first clamping arm and the second clamping arm being a fixed end connected together, and the other end of the first clamping arm and the second clamping arm being a free end, wherein in the free state the first clamping arm and the second clamping arm are clamped together to allow the heart valve to be clamped between the first clamping arm and the second clamping arm; characterized in that: The flow-blocking block includes a support member and a flow-blocking membrane. The flow-blocking membrane is fixed to the support member and supported by the support member. The flow-blocking block is fixedly connected to the clamping part through the support member. The surface of the flow-blocking membrane that bulges toward the opposite valve forms a flow-blocking part. The flow-blocking part includes a first end that is closest to the free end of the first clamping arm and a second end that is farthest away. The thickness of the flow-blocking part gradually decreases from the middle to the first end and the second end. The clamping portion includes an implantation interface for connecting a cardiac surgery implantation device to the single fixed valve repair device; the implantation interface is at least partially shielded by the flow-blocking membrane; the clamping portion includes a fixing member, wherein the first clamping arm and the second clamping arm partially overlap at the fixing end and are connected together by the fixing member, and the implantation interface is disposed on the fixing member; the fixing member and the implantation interface are covered by the flow-blocking membrane within the flow-blocking portion, and the fixing member protrudes from the clamping portion and provides thickness-direction support for the flow-blocking portion.

2. The single fixed valve repair device according to claim 1, characterized in that, The flow-blocking part is provided with a flexible skirt extending outward at its edge.

3. The single fixed valve repair device according to claim 2, characterized in that, The flexible skirt is formed by attaching the same material as the flow-blocking membrane to the edge of the flow-blocking portion.

4. The single-fixation valve repair device according to claim 2, characterized in that, The flexible skirt is formed by stretching the flow-blocking membrane relative to the support member to an extra length and fixing it in place.

5. The single-fixation valve repair device according to any one of claims 2 to 4, characterized in that, The flexible skirt extends outward from the flow-blocking part by 2-5 mm.

6. The single-fixation valve repair device according to claim 1 or 2, characterized in that, The first clamping arm can open as the traction line of the cardiac surgery implantation device is stretched. The implantation interface is axial with the connection direction with the cardiac surgery implantation device as the axis. The angle between the axis and the first clamping arm in the free state is 45°-135°.

7. The single fixed valve repair device according to claim 1, characterized in that, The support member is configured as an annular support wire, which passes through and is fixed to the clamping part. The support member includes a main support wire for providing circumferential support for the flow-blocking membrane.

8. The single fixed valve repair device according to claim 7, characterized in that, The support member also includes one or more auxiliary support wires, which protrude toward the flow-blocking part to provide support for the flow-blocking membrane.

9. The single fixed valve repair device according to claim 8, characterized in that, At least one of the auxiliary support wires is provided with a bend, the bend being provided along the contour surface of the flow-blocking block toward the inner side of the annulus, to provide additional support for the flow-blocking membrane.

10. The single-fixation valve repair device according to any one of claims 7 to 9, characterized in that, A reinforcing portion extending along the surface of the clamping portion is provided at the connection between the support wire and the clamping portion. The reinforcing portion abuts against the surface of the clamping portion to prevent the support wire from rotating around the clamping portion.

11. The single-fixation valve repair device according to any one of claims 7 to 9, characterized in that, The clamping part is provided with a support wire fixing member, which has a through hole to allow the support wire to pass through. A locking ring is also provided on the outside of the support wire fixing member, which is used to clamp the support wire fixing member on the clamping part.

12. The single-fixation valve repair device according to claim 1 or 2, characterized in that, The support component is configured as a metal wire mesh.

13. The single-fixation valve repair device according to claim 1 or 2, characterized in that, The support is configured as a support frame cut from a metal plate.

14. The single-fixation valve repair device according to claim 1 or 2, characterized in that, The flow-blocking block also includes a buffer portion that extends toward the back of the flow-blocking portion and at least partially covers the clamping portion.

15. The single-fixation valve repair device according to claim 1 or 2, characterized in that, The flow-blocking membrane forms a closed structure around the support.

16. The single-fixation valve repair device according to claim 15, characterized in that, The flow-blocking block is filled with supporting fibers.

17. The single-fixation valve repair device according to claim 1 or 2, characterized in that, The back of the flow-blocking part is open, making the flow-blocking block have a bowl-shaped structure.

18. The single-fixation valve repair device according to claim 1 or 2, characterized in that, The clamping part and the support are made of shape memory alloy.

19. The single-fixation valve repair device according to claim 1 or 2, characterized in that, The first clamping arm and / or the second clamping arm are provided with protruding fixing spikes on the contact surface with the heart valve.

20. The single-fixation valve repair device according to claim 1 or 2, characterized in that, The surface of the clamping part is covered with a biocompatible membrane.

21. The single-fixation valve repair device according to claim 1 or 2, characterized in that, The length l between the first end and the second end of the flow-blocking part is 2mm-10mm; taking the line connecting the first end and the second end as the baseline, the maximum thickness h of the flow-blocking part to the baseline is 2mm-8mm; the distance d from the projection of the maximum height point of the flow-blocking part on the baseline to the second end is 2mm-8mm; the maximum width w of the flow-blocking part body perpendicular to the baseline direction is 5mm-20mm.

22. The single-fixation valve repair device according to claim 21, characterized in that, The flow-blocking part is provided with flexible skirts on both sides or one side perpendicular to the reference line. The length of the flexible skirt extending outward from the flow-blocking part on one side is 2mm-5mm, and the maximum width of the flow-blocking part including the flexible skirt in the direction perpendicular to the reference line is 5mm-23mm.

23. The single-fixation valve repair device according to claim 21, characterized in that, d≥(ld).

24. The single-fixation valve repair device according to claim 1 or 2, characterized in that, The flow-blocking membrane is stitched together with a biocompatible membrane and fixed to the support, with the suture joint located inside the flow-blocking block.

25. A heart valve repair system, comprising a cardiac surgical implantable device and a valve repair device connected to the cardiac surgical implantable device, characterized in that, The valve repair device is a single fixed valve repair device as described in any one of claims 1 to 24.

26. The heart valve repair system according to claim 25, characterized in that, The cardiac surgical implantable device includes a disengager, a cannula, and a fixing pin. The fixing pin, disengager, and cannula are nested sequentially from the inside out and are capable of relative movement along the axial direction. The disengager includes a traction wire that can be connected to the valve repair device and pull the valve repair device to actuate. The end of the disengager includes a connecting bayonet, and the fixing pin passes through the connecting bayonet to allow the implantation interface and the choke membrane portion covering the implantation interface to enter the connecting bayonet and be fixed by the fixing pin, thereby connecting the valve repair device to the cardiac surgical implantable device. The cannula can move axially and nest outside the disengager, thereby compressing the valve repair device from a free state and holding it in a retracted state.

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