Apparatus and method for repairing native valve leaflets of a human heart - Patents.com

Abstract

A native valve leaflet treatment system and method are provided for treating native heart valve leaflets prior to heart valve repair or replacement surgery. The treatment system includes a delivery device (10) configured to enter the heart and a native valve leaflet treatment device (14) housed in a compressed state within the delivery device (10). The treatment device (14) includes a clamping structure (1) configured to hold at least a portion of the native valve in a deployed state. The treatment device (14) is delivered into the heart using the delivery device (10) and released near the native heart valve where the treatment device (14) expands and the clamping structure (1) captures and holds the native valve leaflets such that the native valve does not obstruct blood flow.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority to U.S. Patent Application No. 18 / 047,515, filed October 18, 2022. This application also claims the benefit of and priority to Chinese Patent Application No. 202211096015.3, filed September 8, 2022. The entire contents of these applications are incorporated herein by reference.

[0002] The present disclosure relates to medical devices and methods, and more particularly to devices and methods for treating native valve leaflets in the heart prior to heart valve repair or replacement surgery. [Background technology]

[0003] The human heart has four chambers and four valves. Heart valves control the direction of blood flow. A fully functioning heart valve ensures that proper blood circulation is maintained during the cardiac cycle. When heart valve regurgitation or leakage occurs due to primary or secondary disease and the valve is unable to maintain normal heart function, surgical intervention may be required to repair the heart valve and restore normal heart function.

[0004] Currently, standard heart valve treatment options include surgical intervention for repair or replacement of the heart valve, such as through open surgery or minimally invasive procedures (such as endovascular or transcatheter procedures). Regardless of the type of procedure, the native leaflets of the heart valve need to be properly treated before the valve is repaired or replaced, either by manipulating the position of the leaflets or by reshaping the leaflets to ensure that they do not obstruct blood flow. This improves blood flow dynamics and facilitates subsequent surgical procedures for repair or replacement of the heart valve.

[0005] Therefore, there is a need for a device for treating the native leaflets of a heart valve prior to valve repair or replacement surgery. Summary of the Invention

[0006] SUMMARY Accordingly, the present application is directed to native leaflet treatment devices and methods that substantially overcome one or more of the problems due to limitations and shortcomings of the related art.

[0007] It is an object of the present application to provide a native valve leaflet manipulation system and associated methods for treating native valve leaflets, such as bending or trimming the native leaflets, prior to heart valve repair or replacement surgery.

[0008] Additional features and advantages of the present application will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the present application. The objectives and other advantages of the present application will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

[0009] In order to achieve the above object, the present invention provides a native leaflet treatment system for treating native leaflets of a native valve of a heart, comprising: a delivery device including a sheath and a tip portion and configured to be inserted into the heart; and a native leaflet treatment device having a compressed state and a deployed state for delivery, wherein in the compressed state, the treatment device is compressed and contained within the delivery device, and in the deployed state, the treatment device is expanded, the treatment device including a clamping structure, and in the deployed state, the clamping structure is configured to capture and hold at least a portion of the native valve.

[0010] In some embodiments, the treatment device includes a fixation device and a plurality of connecting bridges connecting the clamping structure and the fixation structure, the fixation structure being connected to a first end of the connecting bridges, and in a deployed state, the fixation structure being configured to abut against an annulus of the native valve.

[0011] In some embodiments, the treatment device further includes a plurality of puncture elements connected to the fixation structure and having sharp tips toward the clamping structure, the sharp tips being configured to pierce the annulus of the native valve in the deployed state.

[0012] In some embodiments, the clamping structures, the securing structures and the connecting bridges are formed from a shape memory material.

[0013] In some embodiments, the treatment device further includes a plurality of proximal locking members coupled to the anchoring structure and configured to be releasably coupled to a sheath of the delivery device when the treatment device is housed within the delivery device.

[0014] In some embodiments, the treatment device further includes a plurality of distal locking members coupled to the clamping structure and configured to be releasably coupled to the tip of the delivery device when the treatment device is housed within the delivery device.

[0015] In some embodiments, the plurality of proximal locking members are each coupled to an upper point of the fixation structure, and the plurality of distal locking members are each coupled to a lower point of the clamping structure.

[0016] In some embodiments, the multiple proximal locking members are each coupled to an upper point of the fixation structure, the treatment device further includes multiple legs, each leg having an upper end coupled to an upper point of the clamp structure and bending downwardly in the deployed state, and the multiple distal locking members are each coupled to a lower end of the multiple legs.

[0017] In some embodiments, each of the clamping structures and the fixing structures are formed with connected struts, and in the deployed state, each of the clamping structures and the fixing structures form a wave-like structure, with each connecting bridge connected to a lower point of the wave-like structure of the fixing structure and a lower point of the wave-like structure of the clamping structure, and both the clamping structure and the fixing structure extending upwards and outwards from each of the lower points that are joined to the connecting bridges.

[0018] In some embodiments, in the deployed state, the fixation structures form an angle of between 0 degrees and 75 degrees with respect to the horizontal plane of the treatment device.

[0019] In some embodiments, the treatment device is formed from a plurality of interconnected repeating units that are angularly arranged about a longitudinal axis of the treatment device.

[0020] In some embodiments, in a top view in a deployed state, the treatment device has an open shape that forms an incomplete ring about the longitudinal axis.

[0021] In some embodiments, in a top view in a deployed state, the treatment device has a closed shape that forms a complete ring about the longitudinal axis.

[0022] In some embodiments, the delivery device further comprises a wire passing through the sheath and connected at a distal end to the tip of the delivery device.

[0023] In another aspect, the present application provides a native leaflet treatment method for treating a native valve leaflet using a native leaflet treatment system, the treatment system including a delivery device and a native leaflet treatment device housed in a compressed state within the delivery device, the native leaflet treatment device including a clamping structure, the native leaflet treatment device configured to self-expand to a deployed state upon release from the delivery device, the method including inserting the delivery device housing the treatment device into an atrium of the heart and passing the native valve through the native valve, releasing the treatment device from the delivery device, where the treatment device self-expands to the deployed state, the clamping structure capturing and holding at least a portion of the native valve, and withdrawing the delivery device from the heart.

[0024] In some embodiments, the delivery device includes a sheath and a tip portion disposed at a distal end of the sheath, and the releasing step includes releasing a proximal portion of the treatment device from the sheath while holding the distal end of the treatment device at the tip portion, such that the released proximal portion of the treatment device self-expands and abuts against the annulus of the native valve, and then releasing the distal end of the treatment device from the tip portion.

[0025] In some embodiments, the delivery device includes a sheath and a tip disposed at a distal end of the sheath, and the releasing step includes releasing a distal portion of the treatment device including a clamping structure from the tip and the sheath while retaining a proximal end of the treatment device within the sheath, whereby the clamping structure self-expands to capture and hold at least a portion of the native valve, and then releasing the proximal end of the treatment device from the sheath, whereby the treatment device self-expands to further abut against the annulus of the native valve.

[0026] In some embodiments, the therapeutic device in the deployed state is secured to the annulus of the native valve by a number of puncturing elements.

[0027] In another aspect, the present application provides a method for treating native leaflets of a native heart valve, comprising transcatheterically delivering a treatment device into the heart, the treatment device self-expanding to capture and hold the native leaflets prior to repairing or replacing the native valve.

[0028] In some embodiments, the atrium is the left atrium and the native valve is the mitral valve.

[0029] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the claimed application.

[0030] In order to more clearly explain the embodiments of the present application, drawings are provided herein. These drawings show some embodiments of the present application. Those skilled in the art can derive other drawings based on the drawings provided herein without creative work. [Brief description of the drawings]

[0031] [Figure 1] 1 is a perspective view of a native heart valve leaflet treatment device according to an embodiment of the present application. [Figure 1A] FIG. 2 is a top view showing the native valve treatment device in FIG. 1. [Diagram 2]2 is another perspective view of the native valve treatment device in FIG. 1. [Diagram 3] 1 illustrates a delivery device including a native leaflet treatment device delivered into a heart according to an embodiment of the present application. [Figure 4-5] 2 illustrates two steps of deploying the treatment device in FIG. 1 in the heart to treat the native valve leaflets according to an embodiment of the present application. [Figure 6] 1 is a perspective view of a native heart leaflet treatment device according to another embodiment of the present application. [Figure 7-8] FIG. 7 shows two steps of deploying the treatment device in the heart to treat the native valve leaflets. [Figure 9] 1 is a perspective view of a native heart leaflet treatment device according to yet another embodiment of the present application. [Figure 10-11] FIG. 10 shows two steps of deploying the treatment device in the heart to treat the native valve leaflets. [Figure 12] 2 illustrates an alternative deployment method for native leaflet treatment using the treatment device in FIG. 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] Hereinafter, the embodiments of the present invention will be described with reference to the drawings. These embodiments are only a part of the possible embodiments of the present application, but are not all of the embodiments. Based on the description in this specification, a person skilled in the art can derive other embodiments that fall within the scope of the protected application.

[0033] In the following description, terms such as center, top, bottom, left, right, vertical, horizontal, inside, outside, etc. are understood to indicate a location or orientation with respect to what is shown in the drawings. These are used for the convenience of describing the embodiments, and do not imply that all components or elements must have such a specific location or orientation, or must operate relative to such a specific location or orientation. These terms do not limit the scope of this application.

[0034] In the following description, terms such as coupled, connected, and attached should be understood in a broad sense. Unless otherwise specified, a connection may be a fixed connection, a removable connection, or an integral connection, may include a mechanical connection or an electrical connection, may be a direct connection or an indirect connection through an intermediary, or may refer to an internal connection between two components. The meaning of these terms can be appropriately understood by those skilled in the art based on the context.

[0035] In addition, the various embodiments of the present application may be combined where appropriate. (Embodiment 1)

[0036] This embodiment of the present application provides a treatment device and system for treating the native leaflets of a heart valve, which may be suitably used to treat the native leaflets of the mitral or tricuspid valve. Current minimally invasive valve repair or replacement procedures are unable to adequately treat the native anterior leaflet of the mitral valve. The native leaflets of the aortic and pulmonary valves do not typically need to be treated prior to repair or replacement surgery.

[0037] The native heart leaflet treatment system according to this embodiment includes a delivery device 10 and a native leaflet treatment device 14. The delivery device 10 includes a sheath (also represented in the drawings by reference character 10) and a tip 11 disposed at a distal end of the sheath. The delivery device 10 has a structure configured to enter the heart with an entry profile of 50 French (F) or less. The treatment device 14 has a compressed state for delivery in which it is compressed and housed within the sheath 10 of the delivery device, and a deployed state (FIGS. 1, 2, 5) in which it is released from the sheath 10 and self-expands. In the deployed state, the treatment device 14 is formed of multiple interconnected repeating units angularly arranged about a longitudinal axis.

[0038] In a top view (when viewed longitudinally), the expanded treatment device 14 may have a circular or D-shaped (i.e., having relatively straight and curved sides) or elliptical shape that conforms to the anatomical shape of the mitral valve or a portion thereof. In various embodiments, the device may be a closed structure (referred to as an O-shape, see Figures 6 and 9, described in more detail below) that forms a complete ring in top view, or an open structure (referred to as a C-shape, see Figures 1, 1A, 2) that forms an incomplete ring.

[0039] As shown in Figures 1 and 2, in the deployed state, the treatment device 14 includes a clamping structure 1 configured to clamp the native valve 13. The clamping structure 1 is connected to the fixation structure 2 by a connecting bridge 3. The fixation structure 2 is arranged in a more proximal position (upstream in the blood flow direction) with respect to the clamping structure 1 and is configured to abut the annulus of the native heart valve from the atrial side. In the illustrated embodiment, the clamping structure 1 and the fixation structure 2 are both formed of connected struts and have a wavy shape, with the connecting bridge 3 connected to the lower part of the wavy structure. In a side view (perpendicular to the longitudinal direction), the clamping structure 1 and the fixation structure 2 extend upwards and outwards from a lower point joined to the connecting bridge 3.

[0040] It should be noted that in most orientations of the drawings in this disclosure, the terms "distal" and "proximal" refer to positions relative to the delivery device, and the term "inner" refers to the direction from the atrium to the ventricle (direction of blood flow), which in these instances is also the proximal to distal direction.

[0041] 2, in side view, the fixation structure 2 forms an angle α with respect to the horizontal plane, which angle α can be between 0 degrees and 50 degrees. Alternatively, the fixation structure 2 has a saddle-shaped shape that changes in slope from a more vertical orientation at the inner diameter to a more horizontal orientation at the outer diameter, with the angle α varying between 0 degrees and 75 degrees. For purposes of this specification, the horizontal plane can be defined as the plane that passes through the upper or lower end of the treatment device 14.

[0042] When the treatment device 14 is in the deployed state and positioned around the native heart valve, the fixation structure 2 is fixed to the annular tissue and the clamping structure 1 captures the native leaflet 13. The clamping structure 1 and the connecting bridge 3 fold the native leaflet 13 and push it outward and upward towards the fixation structure 2 so that the native leaflet 13 no longer obstructs the blood flow. This positioning achieves the desired treatment of the native leaflet 13, which improves the blood flow dynamics and facilitates subsequent surgical treatment.

[0043] To secure the treatment device, the fixation structure 2 includes multiple puncture elements 4, each sharpened downward (towards the ventricle and the clamping structure 1). In the deployed state, the puncture elements 4 are configured to secure the treatment device against the native heart valve, piercing the annulus tissue. In a preferred embodiment, each puncture element 4 is a pin or a rivet. In the illustrated embodiment, the puncture elements 4 are positioned near the outermost and uppermost points of the wavy structure of the fixation structure 2, but may be positioned at other positions along the fixation structure 2.

[0044] Preferably, the clamping structure 1, the fixing structure 2 and the connecting bridge 3 are made of a shape memory material such as Nitinol.

[0045] The treatment device 14 further includes a plurality of locking structures for releasably attaching the treatment device 14 to the delivery device. The locking structures include a proximal locking member 5 and a distal locking member 6. The proximal locking members 5 are fixedly coupled to the fixation structure 2, each having an upwardly projecting head shaped to be releasably coupled to the sheath 10 of the delivery device when the treatment device 14 is housed within the sheath. In the illustrated embodiment, the proximal locking members 5 are disposed at the top of the wavy structure of the fixation structure 2. The distal locking members 6 are fixedly coupled to the clamping structure 1, each having a downwardly projecting head shaped to be releasably coupled to the tip 11 of the delivery device when the treatment device 14 is housed within the sheath. In the illustrated embodiment, the distal locking members 6 are disposed at the bottom of the wavy structure of the clamping structure 1. The releasable coupling of the proximal and distal locking members 5 and 6 to the sheath 10 and tip 11 may be achieved by snaps, locks, or other suitable structures within the delivery device.

[0046] A connecting wire 12 is attached to the tip 11 of the delivery device and allows the tip to be separated from the sheath in a controlled manner. The wire 12 is made of a relatively stiff material, such as a metal wire. The wire 12 passes through the sheath 10 and is connected to a control mechanism at the other end of the delivery system, outside the patient's body.

[0047] As shown in Figures 3-5, during the treatment procedure, the delivery device 10 is inserted into the heart until the tip 11 is located at the desired position relative to the native valve leaflets. At this time, the proximal locking member 5 is unlocked and removed from the sheath 10 while the distal locking member 6 is held attached to the tip 11. The sheath 10 is then retracted an appropriate distance and separated from the tip 11, while the tip is held in the desired position by the support of the wire 12. As a result, the treatment device 14, which is still attached to the tip 11 of the delivery device, is released from the sheath 10 and begins to change shape from a compressed state to an expanded state, as shown in Figure 4. In the partially expanded state shown in Figure 4, the fixation structure 2 expands to rest on the native valve annulus tissue and the clamping structure 1 begins to push the native valve leaflets 13 upward. The distal locking member 6 is then unlocked and removed from the tip 11, the tip is moved a short distance toward the left ventricle, and the treatment device 14 is completely released from the delivery device 10. As a result, the treatment device 14 is in a fully deployed state, the fixation structure 2 is disposed in the left atrium and abuts against the valve annulus, and the clamp structure 1 is disposed in the left ventricle. In this state, the treatment device adjusts the position of the valve leaflets as described above, thereby achieving treatment of the native valve 13. Then, the delivery device 10 including the tip portion 11 and the sheath 10 is withdrawn from the heart.

[0048] Any suitable attachment and locking / unlocking structures may be used within the delivery device to attach the proximal and distal locking members 5, 6 to the sheath 10 and tip 11, respectively. Any suitable control mechanisms may be used to unlock from the sheath 10 and tip 11. Attachment and locking / unlocking structures and control mechanisms of this type are known and are used in various types of devices for performing minimally invasive surgery.

[0049] The native heart valve leaflet repair system described above can treat the native leaflets of a human heart valve prior to a heart valve repair or replacement surgery (which may be a minimally invasive or open surgery), which improves the success rate of the surgery, reduces the complexity of the surgical procedure and the required surgical instruments, and reduces the overall risk of the surgery.

[0050] By treating the native valve 13 prior to heart valve repair or replacement surgery according to the embodiments of the present application, the native valve 13 can be treated without stopping the heart. The process and results of the treatment can be monitored in real time using an ultrasound imaging device, and corrections or additional treatments can be performed as necessary based on the monitoring. This treatment solves the following problems of the current technology: When performing open-chest surgery under cardiopulmonary bypass with the heart stopped, the treatment results of the native valve leaflets cannot be evaluated, and when performing minimally invasive surgery, the native valve leaflets cannot be treated prior to heart valve repair or replacement surgery. (Embodiment 2)

[0051] This embodiment provides a method of treating native heart valve leaflets 13 using a minimally invasive procedure to bend or cut the native mitral or tricuspid leaflets prior to valve repair or replacement, performed by a surgeon manipulating a delivery device directly or via a robotic system.

[0052] Using the native heart valve leaflet repair system described in embodiment 1, the treatment method includes:

[0053] The treatment device 14 is folded, compressed, and loaded into the delivery device sheath 10. In one example, the clamp structure 1 is folded upward and positioned next to the connecting bridge 3. The treatment device is then in a compressed state for delivery.

[0054] A delivery device 10 including a therapeutic device is inserted along the inferior vena cava and passes through the right atrium 7 and the interatrial septum into the left atrium 8. The sheath 10 of the delivery device is adjustable in bending. After reaching the left atrium 8, the distal portion of the delivery device 10 forms an arc shape. The distal portion of the delivery device including the tip 11 passes through the mitral valve into the left ventricle 9.

[0055] While maintaining the position of the tip 11, the sheath 10 is retracted an appropriate distance to release the treatment device 14 from the sheath. The tip 11 is then moved an appropriate distance towards the left ventricle to completely release the treatment device 14 from the delivery device 10. Without the constraint of the delivery device 10, the fixation structures 2, clamping structures 1 and connecting bridges 3 (made of shape memory material) will self-expand to their deployed state, i.e., the shape they had before being compressed and loaded into the sheath.

[0056] In the deployed state, the piercing element 4 pierces the annular tissue of the native valve, and the treatment device is fixed to the annular tissue, while the clamping structure 1 pushes and bends the native anterior leaflet outward and upward toward the left atrium 8, capturing most of the leaflet in the space between the connecting bridge 3 and the clamping structure 1.

[0057] After the treatment device 14 is fully released and the clamping structure 1 captures and folds the natural anterior leaflet, the entire delivery device 10 is withdrawn from the body, completing the procedure. Additional Embodiments

[0058] As previously mentioned, the treatment device 14 is C-shaped in top view and extends around only a portion of the annulus of the native heart valve. Preferably, the treatment device 14 is positioned around the annulus in an angular position that overlaps at least the native anterior leaflet to treat the anterior leaflet, as shown in Figures 4 and 5. In this embodiment, the shorter posterior leaflet may be left untreated.

[0059] 6-8 show a native leaflet treatment device and system according to another embodiment of the present invention. As shown in FIG. 6, the native leaflet treatment device 15 in this embodiment is similar to the treatment device 14 shown in FIGS. 1, 1A, 2, 4, 5, but has a closed ring structure (O-shape) in top view. Furthermore, the puncture element 4 is omitted because the closed O-shape can be tightly placed around the entire native annulus without the puncture element 4. This treatment device 15 can treat (e.g., fold) both the anterior and posterior native leaflets, as shown in FIGS. 7 and 8. The treatment method using the associated delivery system 10 and treatment device 15 is similar to that using the treatment device 14, as shown in FIGS. 7 and 8.

[0060] 9-11 show a native valve leaflet treatment device and system according to yet another embodiment of the present application. As shown in FIG. 9, the native valve leaflet treatment device 16 in this embodiment is similar to the treatment device 15 shown in FIG. 6-8, but the clamp structure 1 further includes a plurality of legs 17 coupled to the clamp structure 1. In the illustrated embodiment, the legs 17 are bent downwards with their proximal ends coupled to the top of the wavy structure of the clamp structure 1. Furthermore, instead of the distal locking member 6 coupled to the clamp structure 1 as in the embodiment of FIG. 1 and FIG. 6, the treatment device 16 in this embodiment has a plurality of distal locking members 18 disposed at the distal ends of the legs 17.

[0061] As shown in FIG. 10, during deployment, when the fixation structure 2 is released from the sheath and the distal locking member 18 remains retained within the tip 11, the clamping structure 1 is restrained by the legs 17 and does not bend completely upward, but assumes a nearly horizontal angle. On the other hand, in the absence of the distal locking member 6, the connecting bridge 3 can be more fully expanded (compared to the embodiment of FIG. 1 and FIG. 6). In this partially expanded state, the clamping structure 1 and the legs 17 form a nearly horizontal annular disc, which can better capture the native leaflets 13. The distal locking member 18 is then released from the tip 11, and the treatment device 16 reaches a fully deployed state shown in FIG. 11. In the fully deployed state, the clamping structure 1 is bent upward, the legs 17 are bent downward, and all or most of the leaflets are captured in the space between the connecting bridge 3 and the clamping structure 1.

[0062] FIG. 12 shows an alternative deployment sequence of the treatment device 14 of embodiment 1 of FIG. 1. In this alternative sequence, first, the clamping structure 1 and the connecting bridge 3 are released from the sheath, and the distal locking member 6 is released from the tip 11 (or the distal locking member 6 may be omitted entirely), while the proximal end of the treatment device 14, including the proximal locking member 5, remains held within the sheath 10, as shown in FIG. 12. In this partially expanded state, the lower portion of the clamping structure 1 and the connecting bridge 3 expand outwardly, folding the native leaflet 13 and trapping it in the space between the connecting bridge 3 and the clamping structure 1. Subsequently (not shown), the proximal locking member 5 is unlocked, and the treatment device 14 is fully released from the sheath 10. In the fully deployed state, the fixation structure 2 expands and folds outwardly to rest on the annulus tissue.

[0063] Similarly, the treatment devices 15 and 16 in the embodiments of Figures 6 and 9 may also be deployed in this alternative sequence and will not be described in detail herein.

[0064] It should be noted that the native heart valve leaflet treatment device according to various embodiments of the present application is not a replacement heart valve and does not have a prosthetic leaflet. Moreover, since the main function of the clamping structure 1 and the connecting bridge 3 is to capture and hold the native valve 13 (especially the anterior valve), the shape and size of the clamping structure 1 and the connecting bridge 3 are designed to accommodate all or most of the native anterior valve in the space between the clamping structure 1 and the connecting bridge 3, as shown in the side views of Figures 4, 5, 7, 8, 10 and 11. Therefore, the length of the connecting bridge 3, i.e., the distance between the connection point with the fixing structure 2 and the corresponding connection point with the clamping structure 1, is preferably about one-third to one-half of the typical length of the anterior leaflet, and the radial distance between the upper end of the clamping structure 1 and the connecting bridge 3 is preferably more than twice the typical thickness of the anterior leaflet.

[0065] It will be apparent to those skilled in the art that various modifications and variations can be made in the present application's native leaflet treatment method and device without departing from the spirit or scope of the present application. Thus, it is intended that this application cover such modifications and variations as come within the scope of the appended claims and their equivalents.

[0066] Explanation of drawing symbols 1. clamping structure, 2. fixation structure, 3. connecting bridge, 4. puncturing element, 5. proximal locking member, 6. distal locking member, 7. right atrium, 8. left atrium, 9. left ventricle, 10. delivery device, 11. tip of delivery device, 12. connecting wire, 13. native valve leaflet, 14. native valve leaflet treatment device, 15. alternative native valve leaflet treatment device, 16. alternative native valve leaflet treatment device, 17. legs of clamping structure, 18. distal locking member.

Claims

1. 1. A native valve repair system for repairing a native valve leaflet of a native heart valve, comprising: a delivery device configured to be inserted into the heart, the delivery device including a sheath and a tip; a native leaflet treatment device having a compressed state and a deployed state for delivery, wherein in the compressed state, the treatment device is compressed and contained within a delivery device, and in the deployed state, the treatment device is expanded; A native valve leaflet repair system for treating native valve leaflets of a native valve of a heart, wherein the treatment device includes a clamping structure, and in the deployed state, the clamping structure is configured to capture and hold at least a portion of the native valve.

2. The treatment device comprises: A fixed structure; a plurality of connecting bridges connecting the clamping structure and the fixing structure; The native valve leaflet therapy system of claim 1 , wherein the fixation structure is connected to a first end of a connecting bridge, and in the deployed state, the fixation structure is configured to abut an annulus of the native valve.

3. The native valve leaflet treatment system of claim 2, wherein the treatment device further comprises a plurality of puncture elements connected to the fixation structure and having sharp tips toward the clamping structure, the sharp tips being configured to pierce the annulus of the native valve in the deployed state.

4. The native leaflet repair system of claim 2 , wherein the clamping structure, the anchoring structure and the connecting bridge are formed of a shape memory material.

5. 3. The native leaflet treatment system of claim 2, wherein the treatment device further comprises a plurality of proximal locking members coupled to the fixation structure and configured to be releasably coupled to the sheath of the delivery device when the treatment device is contained within the delivery device.

6. 6. The native leaflet treatment system of claim 5, wherein the treatment device further comprises a plurality of distal locking members coupled to the clamping structure and configured to be releasably coupled to a tip of the delivery device when the treatment device is contained within the delivery device.

7. The native leaflet therapy system of claim 6 , wherein the plurality of proximal locking members are each coupled to an upper point of the fixation structure and the plurality of distal locking members are each coupled to a lower point of the clamping structure.

8. the plurality of proximal locking members are each coupled to an upper point of the fixation structure; The native valve leaflet treatment system of claim 6, wherein the treatment device further includes a plurality of legs, each leg having an upper end coupled to an upper point of the clamp structure and bent downward in the deployed state, and the plurality of distal locking members are respectively coupled to lower ends of the plurality of legs.

9. the clamping structure and the fixing structure are each formed of a connected post; 3. The native leaflet therapy system of claim 2, wherein in the deployed state, each of the clamping structure and the fixation structure forms a wavy structure, with each connecting bridge connected to a lower point of the wavy structure of the fixation structure and a lower point of the wavy structure of the clamping structure, and both the clamping structure and the fixation structure extend upwardly and outwardly from each of the lower points coupled to the connecting bridges.

10. The native valve leaflet repair system of claim 2 , wherein in the deployed state, the fixation structure forms an angle of between 0 degrees and 75 degrees with respect to a horizontal plane of the treatment device.

11. The native valve leaflet repair system of claim 1 , wherein the treatment device is formed of a plurality of interconnected repeating units arranged angularly about a longitudinal axis of the treatment device.

12. The native leaflet repair system of claim 11 , wherein in a top view in the deployed state, the treatment device has an open shape that forms an incomplete ring about the longitudinal axis.

13. The native leaflet repair system of claim 11 , wherein in a top view of the deployed state, the treatment device has a closed shape forming a complete ring about the longitudinal axis.

14. The native leaflet therapy system of claim 1 , wherein the delivery device further comprises a wire passing through the sheath and connected at a distal end to the tip of the delivery device.

15. 1. A native leaflet treatment method for treating a native valve leaflet using a native leaflet treatment system, the treatment system including a delivery device and a native leaflet treatment device housed in a compressed state within the delivery device, the native leaflet treatment device including a clamping structure, the native leaflet treatment device configured to self-expand to a deployed state upon release from the delivery device, the method comprising: inserting the delivery device containing the therapeutic device into an atrium of the heart and through the native valve; releasing the treatment device from the delivery device, wherein the treatment device self-expands to the deployed state and the clamping structure captures and holds at least a portion of the native valve; and withdrawing the delivery device from the heart.

16. The delivery device includes a sheath and a tip disposed at a distal end of the sheath, and the releasing step includes: releasing a proximal portion of the treatment device from the sheath while holding the distal end of the treatment device at a tip, wherein the released proximal portion of the treatment device self-expands and abuts against the annulus of the native valve; and thereafter releasing the distal end of the treatment device from the tip.

17. The delivery device includes a sheath and a tip disposed at a distal end of the sheath, and the releasing step includes: releasing a distal portion of the treatment device, including the clamping structure, from the tip and the sheath while retaining a proximal end of the treatment device within the sheath, whereby the clamping structure self-expands to capture and retain at least a portion of the native valve; 16. The method of claim 15, further comprising releasing the proximal end of the treatment device from the sheath, such that the treatment device self-expands and further abuts against the annulus of the native valve.

18. The method for native valve leaflet treatment according to claim 15 , wherein the treatment device in the deployed state is fixed to the annulus of the native valve by a plurality of puncture elements.

19. 1. A method for treating native leaflets of a native valve of a heart, comprising delivering a treatment device into the heart via a catheter, the treatment device self-expanding to capture and hold the native leaflets prior to repairing or replacing the native valve.

20. 20. The method of claim 19, wherein the atrium is the left atrium and the native valve is the mitral valve.

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