Valve repair system with foldable valve leaflets

Abstract

The invention relates to the field of medical instruments, in particular to a valve repair system with a foldable valve leaflet, comprising an implant configured to fold and anchor a part of valve leaflet tissue; the conveying device is detachably connected with the implant and is configured to be capable of conveying the implant to a target heart valve and manipulating the implant and / or valve leaflet tissue so that the target valve leaflet tissue part can be contained in the anchoring area of the implant; the conveying device actuates the implant, so that the implant completes folding and anchoring of a target valve leaflet tissue part, and after the implant completes anchoring, the conveying device is disconnected from the implant and releases the implant; according to the valve repairing device, after the valve leaflets are folded and clamped, the valve repairing device cannot be exposed out of the involution faces of the valve leaflets, damage caused by collision between the adjacent valve leaflets and an instrument when the valve is closed is avoided, the number of implants is reduced, and the load on valve leaflet movement is relieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a valve repair system with foldable leaflets. BACKGROUND

[0002] Traditional surgical treatment of posterior leaflet prolapse of the mitral valve can be divided into leaflet level surgical methods, commonly used folding (McGoon technique) and resection (triangular resection, quadrilateral resection, sliding plasty or wedge resection). Among surgical methods, typical open chest and open heart surgery has too much invasiveness, needs to establish extracorporeal circulation, has a high incidence of complications and infection risk, and many patients cannot tolerate the huge surgical risk and can only wait for death helplessly.

[0003] The existing mature valve repair technology of intervention type is mainly the leaflet clamping technology. This technology changes the original physiological structure of the valve, and has a large reduction in the effective opening area of the valve and a serious impact on secondary intervention surgery.

[0004] For example, patent application CN 107438409 B discloses a minimally invasive transcatheter leaflet folding repair device, which comprises a grabbing forceps (1) and a folding forceps (2). The grabbing forceps (1) is suitable for grabbing the leaflet edge (3). The folding forceps (2) comprises two rotatable wings (4, 5) and a central shaft (6). The wings (4, 5) can rotate around the central shaft in a "butterfly way" so that the folding forceps (2) can adopt a closed or open configuration. The present application also relates to a method for using the medical device. The device can complete the function of leaflet folding to reduce the opening area of the valve and achieve the purpose of repairing the valve. However, the patent solution can only be used for surgical operation, which has a large surgical trauma to the patient. Secondly, the area of the leaflet resection depends on the size of the wings, and the corresponding adjustment cannot be made according to the patient's anatomical structure during the operation, which leads to the fact that the device is not universally applicable to different patients.

[0005] Patent application CN202310002600.0 discloses a minimally invasive transcatheter valve leaflet folding repair device, belonging to the field of medical device technology. It includes a capture clip, a folding clip, a traction mechanism, and a stop mechanism. One end of the capture clip has a movable, openable and closable clamping arm, and the other end has a traction mechanism for pulling the clamping arm. The folding clip includes two foldable wings, each located on one side of the clamping arm, and a detachable stop mechanism on each wing to restrict the folding movement of the wings. In this design, the repair device uses a traction mechanism to push and pull the clamping arm downwards. This results in a relatively large size for the traction and stop mechanisms at the front end, causing the front end to be exposed at the valve leaflet mating surface. When the autologous valve leaflet mates, the front end of the repair device may collide with the leaflet, causing damage. Furthermore, the repair device leaves a large amount of implanted material in the heart, which is heavy and will inevitably have an adverse effect on the movement of the valve leaflet.

[0006] In summary, although existing technologies exist to reduce the leaflet area to reduce the valve opening area and thus repair the valve, they still have disadvantages such as limitations on the surgical path, damage to the leaflet due to the exposed repair device on the occlusal surface, and the large number and weight of implants affecting leaflet movement. Therefore, it is necessary to improve the repair device to meet the requirements of minimally invasive surgery, and to achieve valve repair without damaging or affecting the movement of other leaflets, so as to meet clinical needs. Summary of the Invention

[0007] This application is made in view of the above and other ideas.

[0008] One of the purposes of this application is to overcome the shortcomings of the prior art and provide a valve repair system with foldable leaflets, addressing issues such as the limitations of existing repair devices on surgical pathways or the impact damage to the leaflet tissue after implantation and the influence on the leaflet's movement morphology.

[0009] The technical solution adopted to solve the technical problem of the present invention is to provide a foldable leaflet valve repair system, including an implant configured to fold and anchor a portion of the leaflet tissue; a delivery device detachably connected to the implant and configured to: deliver the implant to a target heart valve and manipulate the implant and / or leaflet tissue to include a portion of the target leaflet tissue within the anchoring area of ​​the implant; the delivery device actuates the implant to complete the folding and anchoring of the target leaflet tissue portion, and after the implant has completed anchoring, the delivery device is deconnected from the implant and released.

[0010] As a further improvement of the present invention, the delivery device includes an auxiliary clamping device configured to be detachably connected to the implant, and the auxiliary clamping device can actuate and control the opening and closing of the implant to assist the implant in folding and clamping the target leaflet tissue.

[0011] As a further improvement of the present invention, the auxiliary clamping device includes a leaflet clamping assembly and an actuation control mechanism, wherein the leaflet clamping assembly is detachably connected to the implant, and the actuation control mechanism is configured to manipulate the leaflet clamping assembly to perform opening and closing actions, thereby driving the implant to open and close synchronously.

[0012] As a further improvement of the invention, the delivery device further includes a leaflet manipulation mechanism configured to operate independently of the auxiliary clamping device to bring a portion of the target leaflet tissue into the anchoring area by pushing or lifting the leaflet tissue toward the anchoring area of ​​the implant.

[0013] As a further improvement of the present invention, the leaflet manipulation mechanism includes a pre-fixation component and a pushing component; wherein, the pre-fixation component is configured to cooperate with the auxiliary clamping device to pre-fix the target leaflet tissue; the pushing component is configured to push the pre-fixed target leaflet tissue toward the anchoring area of ​​the implant after the pre-fixation component has completed the pre-fixation of the leaflet.

[0014] As a further improvement of the present invention, the actuation control mechanism includes a drive screw, a drive nut sleeved on the drive screw, a linkage rod connecting the drive nut and the leaflet clamp assembly, and an engagement sleeve sleeved on the drive screw. The engagement sleeve is configured to selectively engage or disengage with the drive nut. When the engagement sleeve engages with the drive nut, rotating the drive screw can drive the drive nut to generate axial displacement, thereby driving the leaflet clamp assembly and the implant to perform opening and closing actions through the linkage rod.

[0015] As a further improvement of the present invention, the engagement sleeve and the drive nut are engaged by a snap-fit ​​structure, and the linkage rod is connected to the drive nut and the leaflet support assembly respectively in a hinged manner.

[0016] As a further improvement of the present invention, after the implant is folded and clamps the leaflet tissue, the surgeon can remove the engagement cannula and leaflet manipulation mechanism from the heart and observe the leaflet alignment and blood backflow through imaging equipment. If further adjustment is needed, the surgeon can push the engagement cannula directly along the drive screw and re-engage it with the drive nut. By manipulating the drive screw, the leaflet clamping assembly and the implant are opened, and the leaflet manipulation mechanism is operated to push a portion of the leaflet tissue again until an ideal leaflet alignment is achieved. At this point, the control wire can be removed, and the delivery device and the implant are separated, leaving only the implant in the heart. This greatly reduces the amount of implant and the weight burden on the leaflets. Furthermore, the reversible adjustment method significantly increases the error tolerance of the device. The surgeon can perform multiple operations and observe through imaging to adjust it to the ideal state.

[0017] As a further improvement of the present invention, the distal end of the drive screw is provided with a threaded structure, the drive nut is sleeved and connected to the threaded structure, and is fixed to the drive nut by a meshing sleeve. Rotating the drive screw realizes the axial movement of the drive nut, so that it can drive the leaflet clamp assembly and implant to open and close through the linkage rod.

[0018] As a further improvement of the present invention, the leaflet clamping assembly includes at least two clamping arms, and the leaflet clamping assembly has an unfolded configuration and a retracted configuration, wherein the leaflet clamping assembly can hold a portion of the target leaflet tissue and cooperate with the leaflet manipulation mechanism to capture and pre-fix the target leaflet tissue.

[0019] As a further improvement of the present invention, the clamping arm is a foldable multi-segment arm structure, and the clamping arm is an L-shaped structure to form a leaflet support platform.

[0020] As a further improvement of the present invention, the clamping arm is a straight arm structure design, or the clamping arm is an arc-shaped arm structure design.

[0021] As a further improvement of the present invention, the clamp arm can be loaded in a straight line inside the delivery sheath during delivery. When it enters the ventricle, the clamp arm can return to an L-shaped structure and unfold to form a leaflet support platform to support the leaflet tissue.

[0022] As a further improvement of the present invention, the implant has an unfolded configuration and a clamped configuration; wherein, when the implant is in the unfolded configuration, it forms an anchoring region that can accommodate a portion of the leaflet tissue; when the target leaflet tissue is partially included in the anchoring region of the implant, the implant can be converted from the unfolded configuration to the clamped configuration, and the implant folds a portion of the leaflet tissue and anchors it to the leaflet tissue.

[0023] As a further improvement of the present invention, after implantation, all structures of the implant are located on the non-compartmental surface of the target leaflet tissue (leaflets can be divided into compartmental and non-compartmental surfaces, wherein the compartmental surface refers to the side of the leaflet that contacts and adheres to the valve when it is closed, while the non-compartmental surface is the side of the leaflet that does not contact the valve. For example, for the atrioventricular valve, the non-compartmental surface refers to the side of the leaflet facing the ventricular wall, while for the aortic valve, the non-compartmental surface refers to the side facing the aortic vessel wall). The advantage of this design is that after the valve repair device is implanted, when the autologous valve changes from open to closed, the valve repair device will not collide with the adjacent leaflets, thereby avoiding damage to the adjacent leaflets.

[0024] As a further improvement of the present invention, the delivery device further includes a control wire for manipulating the connection and disassembly of the implant and the leaflet clip assembly, wherein the implant and the leaflet clip assembly are both provided with connection holes, the drive screw is hollow inside, and the control wire passes through the inside of the drive screw and the connection hole to connect the implant and the leaflet clip assembly. When the control wire is withdrawn from the connection hole, the implant and the leaflet clip assembly are separated.

[0025] As a further improvement of the present invention, the support arm is also provided with an extension component, which has a three-dimensional structure to increase the support area of ​​the leaflet support platform. Furthermore, the extension component is made of a material with developing function or carries developing marks.

[0026] As a further improvement of the present invention, the extended component is made of a material with developing function or carries developing marks.

[0027] As a further improvement of the present invention, the implant is designed with an L-shaped structure, wherein the initial state of the implant is a closed state, and the implant is provided with a fixation structure for anchoring the leaflet tissue.

[0028] As a further improvement of the present invention, the shape of the implant is generally similar to that of the leaflet clip assembly.

[0029] As a further improvement of the present invention, the pre-fixing component includes at least one pressure flap, and the pushing component includes a pushing rod and a set of deformable thrust members disposed at the distal end of the pushing rod, the set of thrust members being configured to diverge and expand in a circumferential direction.

[0030] As a further improvement of the present invention, the valve spring is provided with a guide hole. After the target leaflet tissue is pre-fixed, the push rod passes through the guide hole along a preset path. At this time, the thrust stop is folded in the opposite direction by the guide hole until the push rod completes the push and retracts. The thrust stop provides the push rod with a counter-thrust force toward the proximal end. The function of the thrust stop is to increase the contact area with the leaflet tissue and to provide a counter-thrust force when the push rod retracts, assisting the push rod to disengage from the anchoring area.

[0031] As a further improvement of the present invention, the implant is made of shape memory metal material and integrally molded, such as nickel-titanium alloy; of course, polymer materials can also be used, which can further reduce the weight of the implant and reduce the impact on leaflet movement.

[0032] As a further improvement of the present invention, taking mitral valve repair as an example, the specific operating steps of the heart valve repair device of the present invention are as follows: 1. The valve repair device is loaded into the delivery sheath. At this time, the leaflet clip assembly and the implant are both in a closed configuration and loaded into the delivery sheath. The delivery sheath passes through the fossa ovalis and enters the left atrium; 2. The delivery sheath advances, the leaflet clip assembly is in a closed configuration, and after the delivery sheath is adjusted, the valve repair device enters the left ventricle; 3. The leaflet clip assembly holds the leaflet, the pre-fixation assembly is operated to cooperate with the clip arm to press the leaflet, and the auxiliary clamping is operated. 1. The device opens the leaflet clip assembly and implant. 2. The pusher assembly is operated to push the leaflet tissue into the anchoring area of ​​the implant using the pusher rod and its anti-push element. 3. The pusher rod and its anti-push element are removed, and the pre-fixation assembly is pulled up. The drive screw is rotated to close the leaflet clip assembly and implant. 4. The engagement cannula and pusher assembly are removed, and the device's effectiveness is evaluated via imaging to determine if further adjustments are needed. 5. If the device is effective, the control wire is disconnected from the connection hole to detach the implant from the delivery device. The delivery device is then removed from the body, leaving only the implant anchored to the leaflet tissue, thus completing the surgery.

[0033] Compared with the prior art, the advantages of the technical solution of this application include at least the following: In existing technologies, after the repair device clamps and folds the leaflets, some instruments are exposed on the occlusal surface of the leaflets, leading to tissue damage due to collisions between the leaflets and adjacent leaflets during occlusion. Furthermore, the large size and weight of the implant significantly affect the movement and morphology of the leaflet tissue, resulting in excessive burden on the leaflets and subsequent lesions over time. According to a concept of this application, an auxiliary clamping device is used to manipulate the opening and closing of the implant, and a second control pushes the leaflet tissue into the anchoring area of ​​the implant. After the implant completes the folding and anchoring of the leaflet tissue, the delivery device is withdrawn from the body, leaving only the implant in the heart. This solution can repair the valve by adjusting its occlusion state by folding the leaflets to reduce their surface area. All structures of the implant are located on the non-occlusal surface of the leaflets, avoiding collisions between the leaflets and adjacent leaflets during occlusion and thus preventing leaflet damage. It also greatly reduces the size of the implant and alleviates the burden on the leaflet tissue.

[0034] According to a concept of this application, the implant is detachably connected to the delivery device via a control wire, and the engagement cannula and the drive nut are reversibly connected or separated. This allows the engagement cannula and the push assembly to be withdrawn from the heart after the implant has initially folded and anchored the target leaflet tissue, leaving only the drive screw and the implant inside the heart. The occlusion status of the valve can be observed through imaging. If it is necessary to adjust the folding area of ​​the leaflet, the engagement cannula can be re-engaged with the drive nut along the drive screw, and the auxiliary clamping device can be manipulated to open the implant, thereby capturing and folding the leaflet again. This greatly improves the error tolerance of the device and ensures the repair effect of the device.

[0035] According to a concept of this application, the clamping arm is provided with an extension component, which not only expands the leaflet support platform to support a larger area of ​​leaflet tissue, but also has a imaging function, which makes it easier for the surgeon to determine the specific position of the instrument during the operation, thus providing convenience for the surgical procedure.

[0036] According to a concept of this application, a valve repair device utilizes a scheme to repair the valve by reducing the surface area of ​​the valve leaflets to adjust the occlusion state of the leaflets. This scheme can achieve the repair effect of valve regurgitation without interfering with long-term treatment plans such as valve replacement surgery or annuloplasty.

[0037] The embodiments of this application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0038] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figure 1 , Figure 2 , Figure 3 This is a schematic diagram of the repair clip of the present invention.

[0039] Figure 4 , Figure 5 , Figure 6 This is a schematic diagram of the delivery device entering the heart in this invention.

[0040] Figures 7 to 11 This is a schematic diagram of the operation process of the repair clip of the present invention.

[0041] Figure 12 This is a schematic diagram of the final implantation of the repair clip in this invention.

[0042] The features represented by the numbers in the attached diagram are as follows: 1-Implant, 11-Anchoring area, 2-Delivery device, 21-Auxiliary clamping device, 211-Leaflet support clamp assembly, 2111-Clip arm, 212-Actuation control mechanism, 2121-Drive screw, 2122-Drive nut, 2212-Linkage rod, 2124-Engaging sleeve, 22-Leaflet manipulation mechanism, 221-Pre-fixation assembly, 2211-Valve pressure spring, 2212-Guide hole, 222-Push assembly, 2221-Thrust member, 23-Connecting hole. Detailed Implementation

[0043] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0044] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0045] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0046] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0047] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0048] Example 1: This example uses mitral valve repair as an example. Figure 1 , Figure 2 and Figure 3 As shown, a foldable leaflet valve repair system includes an implant 1 configured to fold and anchor a portion of the leaflet tissue; a delivery device 2 detachably connected to the implant 1 and configured to: deliver the implant 1 to a target heart valve and manipulate the implant 1 and / or the leaflet tissue such that a portion of the target leaflet tissue is incorporated into an anchoring region 11 of the implant 1; the delivery device 2 actuates the implant 1 to complete the folding and anchoring of the target leaflet tissue portion, and after the implant 1 has completed anchoring, the delivery device 2 is deconnected from the implant 1 and released.

[0049] In this embodiment, the delivery device 2 includes an auxiliary clamping device 21, which is configured to be detachably connected to the implant 1. The auxiliary clamping device 21 can actuate and control the opening and closing of the implant 1 to assist the implant 1 in folding and clamping the target leaflet tissue.

[0050] In this embodiment, the auxiliary clamping device 21 includes a leaflet clamping assembly 211 and an actuation control mechanism 212. The leaflet clamping assembly 211 is detachably connected to the implant 1, and the actuation control mechanism 212 is configured to manipulate the leaflet clamping assembly 211 to perform opening and closing actions, thereby driving the implant 1 to open and close synchronously.

[0051] In this embodiment, the delivery device 2 further includes a leaflet manipulation mechanism 22, which is configured to operate independently of the auxiliary clamping device 21, so as to partially incorporate the target leaflet tissue into the anchoring region 11 by pushing or lifting the leaflet tissue toward the anchoring region 11 of the implant 1.

[0052] In this embodiment, the leaflet manipulation mechanism 22 includes a pre-fixation component 221 and a pushing component 222; wherein, the pre-fixation component 221 is configured to cooperate with the auxiliary clamping device 21 to pre-fix the target leaflet tissue; the pushing component 222 is configured to push the pre-fixed target leaflet tissue into the anchoring area 11 of the implant 1 after the pre-fixation component 221 has completed the pre-fixation of the leaflet.

[0053] In this embodiment, the actuation control mechanism 212 includes a drive screw 2121, a drive nut 2122 sleeved on the drive screw 2121, a linkage rod 2213 connecting the drive nut 2122 and the leaflet clamp assembly 211, and an engagement sleeve 2124 sleeved on the drive screw 2121. The engagement sleeve 2124 is configured to selectively engage or disengage with the drive nut 2122. When the engagement sleeve 2124 engages with the drive nut 2122, rotating the drive screw 2121 can drive the drive nut 2122 to generate axial displacement, thereby driving the leaflet clamp assembly 211 and the implant 1 to perform opening and closing actions through the linkage rod 2213.

[0054] In this embodiment, the engagement sleeve 2124 and the drive nut 2122 are engaged by a snap-fit ​​structure, and the linkage rod 2213 is hinged to the drive nut 2122 and the leaflet support assembly 211 respectively.

[0055] In this embodiment, after the implant 1 is folded and clamps the leaflet tissue, the surgeon can remove the engagement cannula 2124 and the leaflet manipulation mechanism 22 from the heart. The surgeon can then observe the leaflet alignment and blood backflow through imaging equipment. If further adjustment is needed, the surgeon can push the engagement cannula 2124 directly along the drive screw 2121 and re-engage it with the drive nut 2122. By manipulating the drive screw 2121, the surgeon can control the leaflet clamping assembly 211 and the implant 1 to open, and operate the leaflet manipulation mechanism 22 to push a portion of the leaflet tissue again until an ideal leaflet alignment is achieved. At this point, the control wire (not shown) can be removed, and the delivery device 2 is separated from the implant 1, leaving only the implant 1 in the heart. This greatly reduces the amount of implant 1 and the weight burden on the leaflets. Furthermore, the reversible adjustment method significantly increases the device's error tolerance. The surgeon can perform multiple operations and observe the images to adjust it to the ideal state.

[0056] In this embodiment, the distal end of the drive screw 2121 is provided with a threaded structure, and the drive nut 2122 is sleeved and connected to the threaded structure. Furthermore, the drive nut 2122 is fixed to the drive screw 2124 by the engagement sleeve. Rotating the drive screw 2121 realizes the axial movement of the drive nut 2122, so that it can drive the leaflet clamp assembly 211 and the implant 1 to open and close through the linkage rod 2213.

[0057] In this embodiment, the leaflet clamping assembly 211 includes at least two clamping arms 2111. The leaflet clamping assembly 211 has an unfolded configuration and a retracted configuration. The leaflet clamping assembly 211 can hold a portion of the target leaflet tissue and cooperate with the leaflet manipulation mechanism 22 to capture and pre-fix the target leaflet tissue.

[0058] In this embodiment, the clamp arm 2111 is a foldable multi-segment arm structure, and the clamp arm 2111 has an L-shaped structure to form a leaflet support platform. The shape of the implant 1 is generally similar to that of the leaflet clamp assembly 211. The implant 1 has an L-shaped structure design. The initial state of the implant 1 is a closed state. The implant 1 is provided with a fixation structure for anchoring the leaflet tissue.

[0059] In this embodiment, the implant 1 has an unfolded configuration and a clamped configuration; wherein, when the implant 1 is in the unfolded configuration, it forms an anchoring region 11 that can accommodate a portion of the leaflet tissue; when the target leaflet tissue is partially incorporated into the anchoring region 11 of the implant 1, the implant 1 can be converted from the unfolded configuration to the clamped configuration, and the implant 1 folds a portion of the leaflet tissue and anchors it to the leaflet tissue.

[0060] In this embodiment, after implantation, all structures of the implant 1 are located on the non-compartmental surface of the target leaflet tissue (leaflets can be divided into compartmental and non-compartmental surfaces. The compartmental surface refers to the side where adjacent leaflets contact and adhere when the valve is closed, while the non-compartmental surface is the side where adjacent leaflets cannot contact each other. For example, for the atrioventricular valve, the non-compartmental surface refers to the side of the leaflet facing the ventricular wall, while for the aortic valve, the non-compartmental surface refers to the side facing the aortic vessel wall). The advantage of this design is that after the valve repair device is implanted, when the autologous valve changes from open to closed, the valve repair device will not collide with adjacent leaflets, thereby avoiding damage to adjacent leaflets.

[0061] In this embodiment, the delivery device 2 further includes a control wire (not shown) for manipulating the connection and disconnection of the implant 1 and the leaflet clip assembly 211. Both the implant 1 and the leaflet clip assembly 211 are provided with connection holes 23. The drive screw 2121 is hollow inside. The control wire (not shown) passes through the interior of the drive screw 2121 and the connection hole 23 to connect the implant 1 and the leaflet clip assembly 211. When the control wire (not shown) is withdrawn from the connection hole 23, the implant 1 and the leaflet clip assembly 211 are separated.

[0062] In this embodiment, after the implant 1 is folded and clamps the leaflet tissue, the surgeon can remove the engagement cannula 2124 and the leaflet manipulation mechanism 22 from the heart. The surgeon can then observe the leaflet alignment and blood backflow through imaging equipment. If further adjustment is needed, the surgeon can push the engagement cannula 2124 directly along the drive screw 2121 and re-engage it with the drive nut 2122. By manipulating the drive screw 2121, the surgeon can control the leaflet clamping assembly 211 and the implant 1 to open, and operate the leaflet manipulation mechanism 22 to push a portion of the leaflet tissue again until an ideal leaflet alignment is achieved. At this point, the control wire (not shown) can be removed, and the delivery device 2 is separated from the implant 1, leaving only the implant 1 in the heart. This greatly reduces the amount of implant 1 and the weight burden on the leaflets. Furthermore, the reversible adjustment method significantly increases the device's error tolerance. The surgeon can perform multiple operations and observe the images to adjust it to the ideal state.

[0063] In this embodiment, the support arm 2111 is also provided with an extension component. The extension component has a three-dimensional structure to increase the support area of ​​the leaflet support platform. Furthermore, the extension component is made of a material with developing function or carries developing marks.

[0064] In this embodiment, the pre-fixing component 221 includes at least one pressure flap 2211, and the pushing component 222 includes a pushing rod and a set of deformable thrust members 2221 disposed at the distal end of the pushing rod. The set of thrust members 2221 is configured to expand outward in a circumferential direction.

[0065] In this embodiment, the implant 1 is a one-piece molded metal rod, which is lightweight and has little impact on the movement of the leaflets.

[0066] In this embodiment, the valve spring 2211 is provided with a guide hole 2212. After the target leaflet tissue is pre-fixed, the push rod passes through the guide hole 2212 along a preset path. At this time, the thrust stop 2221 is folded in the opposite direction by the guide hole 2212 until the push rod completes the push and retracts. The thrust stop 2221 provides the push rod with a counter-thrust force towards the proximal end. The function of the thrust stop 2221 is to increase the contact area with the leaflet tissue and to provide a counter-thrust force when the push rod retracts, assisting the push rod to detach from the anchoring area 11.

[0067] The implantation process of the foldable leaflet valve repair system of the present invention into the left heart is as follows: The valve repair device is loaded into the delivery sheath. At this time, both the leaflet clip assembly 211 and the implant 1 are in a closed configuration, loaded into the delivery sheath, which passes through the fossa ovalis and enters the left atrium. Figure 4 and Figure 5 As shown; 2. The delivery sheath advances, the leaflet clamp assembly 211 is in a retracted configuration, and after the delivery sheath is adjusted, the valve repair device enters the left ventricle, as... Figure 6 As shown; 3. The leaflet support assembly 211 supports the leaflet, as shown. Figure 7 As shown, the pre-fixing component 221 is operated to cooperate with the clamping arm 2111 to press the leaflet (as shown). Figure 8 (As shown), and operate the auxiliary clamping device 21 to open the leaflet clamping assembly 211 and the implant 1, and operate the pushing assembly 222 to push the pushing rod and its anti-thrust member 2221 to push the leaflet tissue into the anchoring area 11 of the implant 1 (as shown). Figure 9 (as shown); 4. Remove the push rod and its thrust stop 2221, and pull up the pre-fixation assembly 221. Rotate the drive screw 2121 to close the leaflet clip assembly 211 and the implant 1; 5. Remove the engagement cannula 2124 and the push assembly 222, and evaluate the device effect through imaging to determine if further adjustments are needed (e.g., Figure 10 and Figure 11 (as shown); 6. If the device works well, remove the control wire (not shown) from the connection hole 23 to detach the implant from the delivery device 2, remove the delivery device 2 from the body, leaving only the implant 1 anchored to the leaflet tissue, as shown. Figure 12 As shown, the surgery was completed.

[0068] This invention can be used not only for mitral valve repair treatment, but also for tricuspid valve treatment. The only difference is that the access path of the delivery device 2 is different from that in the above embodiment. The different access paths are common knowledge to those skilled in the art, and therefore will not be described in detail in this invention specification.

[0069] The foregoing description of the embodiments described above is provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed. Clearly, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A valve repair system with foldable leaflets, characterized in that: Includes an implant configured to fold and anchor a portion of the leaflet tissue; A delivery device detachably connected to the implant and configured to: deliver the implant to a target heart valve and manipulate the implant and / or leaflet tissue such that a portion of the target leaflet tissue is incorporated into the anchoring region of the implant; The delivery device actuates the implant, causing the implant to fold and anchor the target leaflet tissue portion, and after the implant is anchored, the delivery device is disconnected from the implant and released.

2. The valve repair system with foldable leaflets according to claim 1, characterized in that: The delivery device includes an auxiliary clamping device configured to be detachably connected to the implant, and the auxiliary clamping device can actuate and control the opening and closing of the implant to assist the implant in folding and clamping the target leaflet tissue.

3. The valve repair system with foldable leaflets according to claim 2, characterized in that: The auxiliary clamping device includes a leaflet clamping assembly and an actuation control mechanism. The leaflet clamping assembly is detachably connected to the implant, and the actuation control mechanism is configured to manipulate the leaflet clamping assembly to perform opening and closing actions, thereby driving the implant to open and close synchronously.

4. The valve repair system with foldable leaflets according to claim 3, characterized in that: The delivery device also includes a leaflet manipulation mechanism configured to operate independently of the auxiliary clamping device to bring a portion of the target leaflet tissue into the anchoring area by pushing or lifting the leaflet tissue toward the anchoring area of ​​the implant.

5. The valve repair system with foldable leaflets according to claim 4, characterized in that: The leaflet manipulation mechanism includes a pre-fixation component and a pushing component; wherein, the pre-fixation component is configured to cooperate with the auxiliary clamping device to pre-fix the target leaflet tissue; the pushing component is configured to push the pre-fixed target leaflet tissue toward the anchoring area of ​​the implant after the pre-fixation component has completed the pre-fixation of the leaflet.

6. The valve repair system with foldable leaflets according to claim 3, characterized in that: The actuation control mechanism includes a drive screw, a drive nut sleeved on the drive screw, a linkage rod connecting the drive nut and the leaflet clip assembly, and an engagement sleeve sleeved on the drive screw. The engagement sleeve is configured to selectively engage or disengage with the drive nut. When the engagement sleeve engages with the drive nut, rotating the drive screw can drive the drive nut to generate axial displacement, which in turn drives the leaflet clip assembly and the implant to perform opening and closing actions via the linkage rod.

7. The valve repair system with foldable leaflets according to claim 4, characterized in that: The leaflet clamping assembly includes at least two clamping arms, and has an unfolded configuration and a retracted configuration. The leaflet clamping assembly can hold a portion of the target leaflet tissue and cooperate with the leaflet manipulation mechanism to capture and pre-fix the target leaflet tissue.

8. The valve repair system with foldable leaflets according to claim 1, characterized in that: The implant has an unfolded configuration and a clamped configuration; wherein, when the implant is in the unfolded configuration, it forms an anchoring region that can accommodate a portion of the leaflet tissue; when the target leaflet tissue is partially included in the anchoring region of the implant, the implant can be converted from the unfolded configuration to the clamped configuration, wherein the implant folds a portion of the leaflet tissue and anchors it to the leaflet tissue.

9. The valve repair system with foldable leaflets according to claim 1, characterized in that: After implantation, all structures of the implant are located on the non-occlusive surface of the target leaflet tissue.

10. A valve repair system with foldable leaflets according to claim 6, characterized in that: The delivery device further includes a control wire for manipulating the connection and disconnection of the implant and the leaflet clip assembly. Both the implant and the leaflet clip assembly are provided with connection holes. The drive screw is hollow inside. The control wire passes through the inside of the drive screw and the connection hole to connect the implant and the leaflet clip assembly. When the control wire is withdrawn from the connection hole, the implant and the leaflet clip assembly are separated.

11. A valve repair system with foldable leaflets according to claim 7, characterized in that: The support arm is also provided with an extension component, which has a three-dimensional structure to increase the support area of ​​the leaflet support platform.

12. The valve repair system with foldable leaflets according to claim 4, characterized in that: The pre-fixing component includes at least one pressure plate, and the pushing component includes a pushing rod and a set of deformable thrust members disposed at the distal end of the pushing rod.

13. A valve repair system with foldable leaflets according to claim 12, characterized in that: The valve spring is provided with a guide hole. After the target valve tissue is pre-fixed, the push rod passes through the guide hole along a preset path. When the push rod completes the push and retracts, the thrust stop provides the push rod with a counter-thrust force toward the proximal end.

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