CN115517814A

CN115517814A - Heart valve repair device and system

Info

Publication number: CN115517814A
Application number: CN202110708377.2A
Authority: CN
Inventors: 张海波; 李立光; 张庭超; 梁华光
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2021-06-24
Filing date: 2021-06-24
Publication date: 2022-12-27

Abstract

A heart valve repair device and system are disclosed, wherein a heart valve repair device comprises: an occluding portion having opposing first and second ends and an expandable body extending between the first and second ends, the expandable body positioned between at least two leaflets of the heart valve; an anchor portion, one end of the anchor portion being connected to the first end, the other end of the anchor portion being connected to the heart; the supporting part comprises a first supporting element and a second supporting element which are connected, the first supporting element and the second end are movably connected, the first supporting element is simultaneously pressed on at least two valve leaflets of the heart valve, and the second supporting element is positioned on the atrium side of the heart valve after being unfolded. The system comprises the heart valve repair device, a delivery device and a control unit. The heart valve repair device and system have good functions of treating and improving blood reflux of the diseased heart valve in medical application.

Description

Heart valve repair device and system

Technical Field

The disclosure belongs to the field of medical equipment, relates to cardiac intervention type treatment equipment, and particularly relates to a heart valve repair device and system.

Background

The mitral valve is a one-way "valve" between the Left Atrium (LA) and the Left Ventricle (LV), which ensures blood flow from the left atrium to the left ventricle. Referring to fig. 1, a normal, healthy mitral valve has a plurality of chordae tendineae. The valve leaves of the mitral valve are divided into an anterior leaf and a posterior leaf, when the left ventricle is in a diastole state, the two are in an opening state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contracted state, the chordae tendineae are stretched and the anterior and posterior leaflets are closed well, thereby ensuring blood flow from the left ventricle through the Aortic Valve (AV) to the aorta. If the chordae tendineae or papillary muscles are diseased, such as by rupture of the chordae tendineae in the posterior leaflet as shown in fig. 2, the mitral valve will not return to a closed position as it would in a normal state when the left ventricle is in a contracted state, and the momentum of the blood flow will cause the leaflets to prolapse, causing regurgitation into the left atrium.

Currently, the mode of surgically implanting artificial chordae tendineae is usually adopted to treat and improve the blood regurgitation and leaflet prolapse caused by the diseased heart valve, but this process needs to adopt invasive chest-opening technology and cooperate with general anesthesia and moderate low temperature extracorporeal circulation as auxiliary support, so that there are many defects such as complicated surgical process, high surgical cost, high degree of patient trauma, high risk of complications, long hospitalization time and pain in the patient recovery process.

In the prior art, an alternative adjustable minimally invasive access device is provided that passively assists in closing and supporting prolapsed heart valve leaflets by using occluding balls affixed to the ventricular wall to increase the coaptation area and/or decrease the coaptation depth of the leaflets, thereby treating and improving regurgitation of the diseased heart valve.

However, in the operation of this device, the blocking ball itself is apt to drift along with the blood flow, and thus the prolapsed valve leaflet drifts or even enters into the atrium, so that it is difficult to continuously and stably play a good role in treating and improving the blood reflux of the diseased heart valve.

Disclosure of Invention

In view of the deficiencies and drawbacks of the prior art, in one aspect, the present disclosure is directed to a heart valve repair device comprising:

an occluding portion having opposing first and second ends and an expandable body extending between the first and second ends, the expandable body positioned between at least two leaflets of the heart valve;

one end of the anchoring part is connected with the first end of the blocking part, and the other end of the anchoring part is connected with the heart;

the supporting part comprises a first supporting element and a second supporting element which are connected, the first supporting element is movably connected with the second end of the blocking part, the first supporting element is simultaneously crimped on at least two valve leaflets of the heart valve, and the second supporting element is positioned on the atrium side of the heart valve after being unfolded.

In some embodiments, the first support element comprises at least one flexible strip substantially perpendicular to the direction of the coaptation edges of at least two leaflets of the heart valve, and the second support element comprises at least one flexible ring-shaped member having at least one end movably attached to the ring-shaped member.

In certain embodiments, the first support element comprises a plurality of bars disposed substantially parallel or staggered therebetween.

In certain embodiments, the ring has a profile selected from any one of a saw tooth, a wave, and a helix.

In certain embodiments, further comprising a biocompatible coating or coating disposed on the noodle and/or the ring.

In certain embodiments, a heart valve repair device further comprises a first adjustment mechanism for effecting an articulating connection between the second end of the occluding portion and the first support element.

In certain embodiments, the first adjustment mechanism includes a link connected to the second end of the occlusion, a control member for controlling movement of the link, and a self-locking assembly for locking the position of the link.

In some embodiments, a heart valve repair device further comprises a second adjustment mechanism for effecting an articulating connection between at least one end of the strip and the ring-shaped member.

In certain embodiments, the expandable body is a mesh made of a shape memory material.

In certain embodiments, the expandable body is a balloon.

In certain embodiments, the inner and/or outer surfaces of the mesh structure are applied with a biocompatible coating or layer.

In certain embodiments, the outer surface of the balloon is applied with a biocompatible coating.

In some embodiments, the anchor comprises a suture, the proximal end of which is fixed at an apical or ventricular wall location.

In certain embodiments, the anchoring portion further comprises a rivet connected to the proximal end of the suture, the rivet having a sharpened tip.

In another aspect, the present disclosure is directed to a heart valve repair system comprising: the heart valve repair device comprises a heart valve repair device with the structure, a conveying device and a control unit connected with the conveying device.

Compared with the prior art, the heart valve prosthetic devices and system that this disclosure provided mutually supports between through using shutoff portion, supporting part and the anchoring part, has effectively avoided the shutoff portion to follow washing out of blood flow and has wandered at will, not only can continuously stably provide the holding power to the leaflet, avoids the leaflet to float simultaneously to the atrium to fine treatment and the palirrhea condition of blood of improving pathological change heart valve.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present disclosure and, together with the description, serve to explain the principles of the disclosure.

In order to more clearly illustrate the embodiments or technical solutions in the prior art of the present disclosure, the drawings used in the description of the embodiments or prior art will be briefly described below, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without inventive exercise.

Fig. 1 shows a schematic view of a normally healthy mitral valve.

Figure 2 shows a schematic view of a rupture of the chordae tendineae resulting in prolapse of the leaflets.

Fig. 3 illustrates a schematic representation of the operation of a heart valve repair device according to certain embodiments of the present disclosure.

Fig. 4 illustrates a schematic structural view of a heart valve repair device in certain embodiments of the present disclosure.

Fig. 5A-5B illustrate schematic structural views of a first support element in certain embodiments of the present disclosure.

Fig. 6A-6B illustrate schematic structural views of a first support element in certain embodiments of the present disclosure.

Fig. 7A-7C illustrate a structural schematic of a second support element in certain embodiments of the present disclosure.

Fig. 8 shows a schematic structural view of a support portion of a cover film in certain embodiments of the present disclosure.

FIGS. 9A-9B show a schematic view of the overall structure of a support portion in certain embodiments of the present disclosure

Fig. 10 shows a schematic structural view of a first adjustment mechanism in certain embodiments of the present disclosure.

Fig. 11 shows a schematic view of the second adjustment mechanism before and after adjusting the position in certain embodiments of the present disclosure.

Figure 12 shows a schematic view of the structure of the occluding portion in certain embodiments of the present disclosure.

FIG. 13 illustrates a schematic structural view of an expandable body in certain embodiments of the present disclosure.

FIG. 14 illustrates a schematic structural view of an expandable body in certain embodiments of the present disclosure.

Fig. 15A-15B illustrate a schematic structural view of an expandable body in certain embodiments of the present disclosure.

Fig. 16A-16B illustrate schematic structural views of expandable bodies in certain embodiments of the present disclosure.

Detailed Description

In the following description, certain specific details are included to provide a thorough understanding of various disclosed embodiments. One skilled in the relevant art will recognize, however, that the embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, and so forth.

Throughout this specification and the claims which follow, unless the disclosure requires otherwise, the words "comprise", "comprises", and "comprising" are to be construed in an open, inclusive sense, i.e., "including but not limited to".

Reference throughout the specification to "one embodiment," "an embodiment," "in another embodiment," or "in certain embodiments" means that a particular reference element, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" or "in another embodiment" or "in certain embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular elements, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

To make the objects, technical solutions and advantages of the embodiments of the present disclosure more clear, the technical solutions of the embodiments of the present disclosure will be described clearly and completely with reference to the drawings in the embodiments of the present disclosure, and it is obvious that the described embodiments are some embodiments of the present disclosure, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments disclosed herein without making any creative effort, shall fall within the protection scope of the present disclosure.

It should be understood that the directions or positional relationships indicated by the terms "front", "back", "upper", "lower", "left", "right", "longitudinal", "lateral", "vertical", "horizontal", "top", "bottom", "inner", "outer", "leading", "trailing", etc. are constructed and operated in specific directions based on the directions or positional relationships shown in the drawings, and are only for convenience of describing the present technical solution, but do not indicate that the device or element referred to must have a specific direction, and thus, cannot be construed as limiting the present disclosure.

It should also be noted that, unless expressly specified or limited otherwise, the terms "mounted," "connected," "secured," "disposed," and the like are to be construed broadly and encompass, for example, fixed connections as well as removable connections or integral parts; they may be directly connected or indirectly connected through intervening media, or may be connected through the use of two elements or the interaction of two elements. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element or intervening elements may also be present. The specific meaning of the above terms in the present disclosure can be understood by those of ordinary skill in the art as appropriate.

In the description of the present disclosure, it is still noted that the proximal end refers to the end of the instrument or component near the operator, and the distal end refers to the end of the instrument or component away from the operator; axial refers to a direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, radial refers to a direction perpendicular to the axial direction, and circumferential refers to a direction around the axial direction.

In one aspect, the present disclosure relates to a heart valve repair device, comprising: an occluding portion having opposing first and second ends and an expandable body extending between the first and second ends, the expandable body positioned between at least two leaflets of the heart valve; one end of the anchoring part is connected with the first end of the blocking part, and the other end of the anchoring part is connected with the heart; a support portion, the support portion including a first support element and a second support element connected to each other, the first support element being movably connected to the second end of the blocking portion, the first support element being crimped to at least two leaflets of the heart valve at the same time, and the second support element being positioned on an atrial side of the heart valve after being deployed.

Referring to fig. 3 and 4, a heart valve repair device 100 is generally positioned at the mitral valve of heart 10 for treating and ameliorating mitral regurgitation. The heart valve repair device 100 includes a support portion 110, an occluding portion 120, and an anchoring portion 130. The supporting portion 110 includes a first supporting element 112 and a second supporting element 114 connected to each other, the first supporting element 112 is connected to the second supporting element 114, the first supporting element 112 is pressed over the two leaflets 14 of the mitral valve at the same time, so as to fix the occluding portion 120, prevent the occluding portion 120 from floating along with blood, press the two leaflets at the same time, and provide a supporting force for the prolapsed leaflets 14, and prevent the prolapsed leaflets 14 from floating toward or into the atrium. The placement of the second support element 114 over the leaflets 14 of the atrium prevents the entire heart valve repair device 100 from falling into the ventricle while better securing and adjusting the occlusion 120 in cooperation with the first support element 112. The occluding portion 120 is placed between the leaflets 14 of the mitral valve to increase the coaptation edges of the leaflets 14 and prevent the prolapsed leaflets 14 from drifting toward the atrium. The first end 122 of the blocking portion 120 is connected to one end 132 of the anchoring portion 130, and the second end 126 of the blocking portion 120 is movably connected to the first support element 112. One end 132 of the anchor portion 130 is connected to the first end 122 of the occluding portion 120 and the other end 136 of the anchor portion 130 is connected to the heart 10, thereby securely securing the entire heart valve repair device 100 via the anchor portion 130 and preventing the device 100 from drifting into the atrium.

The first support element 112 may comprise at least one strip having a certain elasticity, the strip having a certain width, when the heart contracts and expands, the at least one strip is approximately perpendicular to the direction of the coaptation edges of the two leaflets 14 of the heart valve, so that the strip can press against the leaflets 14, preventing the prolapsed leaflets 14 from drifting toward or into the atrium. In addition, the bar-shaped member is movably connected with the second end of the blocking part 120, so that the blocking part 120 can be fixed, and the blocking part 120 is prevented from floating along with blood. The strip member is selected from any one or combination of strip sheet, rod and belt. The first support element 112 may be made of titanium alloy, nickel titanium alloy, cobalt chromium alloy, stainless steel, or a high elastic polymer material. The first support element 112 may also be at least partially made of a radiopaque material or include a radiopaque marker to facilitate fluoroscopic visualization. As shown in fig. 5A-5B, in some embodiments, first support element 112 includes a strip 1122 in a V-like configuration, which reduces the stress at which the strip bends. In order to provide a certain supporting force for the valve leaflets 14 and ensure that the valve leaflets 14 do not drift to the atrium side, the strip-shaped sheets 1122 have a certain inclination, height and width, the inclination A ranges from 10 degrees to 30 degrees, the overall height is controlled to be 5-20mm from the coaptation edge, the width ranges from 0.5 mm to 3mm, and the overall structural arrangement can enable the strip-shaped sheets 1122 to extend to the position close to the valve edges of the valve leaflets, so that the valve leaflets can be well prevented from drifting to the atrium. The two ends of the strip 1122 may be connected to the second supporting element 114 by any one of clipping, buckling, pressing, clamping, etc., wherein at least one end of the strip 1122 is movably connected to the second supporting element 114. As shown in fig. 6A-6B, in some embodiments, the first support element 112 may include a plurality of V-shaped like strip-shaped sheets 1122, the plurality of V-shaped like strip-shaped sheets 1122 are substantially parallel or staggered, spaced apart from each other by 5-15mm, and the overall height is controlled to be 5-20mm from the coaptation edge, forming a fence or grid to increase the strength of the first support element 112 and better ensure that the prolapsed leaflet 14 does not drift to the atrium side. In some embodiments, as shown in fig. 8, to ensure that the first support element 112 does not damage the leaflets 14, a biocompatible covering 1124 or coating is applied over at least a portion of the periphery of the first support element 112 by sewing, gluing, or heat staking. The coating 1124 also reduces undesirable adhesions or adhesions between the leaflets 14 and the first support element 112 during the cardiac cycle.

The second support element 114 comprises at least one ring with elasticity for placement on the atrial side of the valve leaflets 14. The outline of the annular piece is selected from any one or combination of sawtooth, wave and spiral. In some embodiments, the second support element 114 may comprise only one loop of annular material, may be a mesh of multiple loops interwoven, or may be a dense ribbon or sheet. The second support element 114 may be laser cut from tubing or braided from filaments. The second support element 114 may be made of titanium alloy, nickel titanium alloy, cobalt chromium alloy, stainless steel, or a highly elastic polymer material. The second support element 114 may also be at least partially made of a radiopaque material or include a radiopaque marker to facilitate fluoroscopic visualization. As shown in fig. 7A-7C, in certain embodiments, second support element 114 comprises a skirt-like, serrated annular member 1142. In order to ensure that the annular member 1142 can be always fixed above the valve leaflet 14 during the contraction and extrusion of the heart, so that the annular member 1142 can be well adapted to the shape of the diseased valve while not causing further damage to the diseased valve, the annular member 1142 is provided with a slope, and the slope range is 15-80 degrees. Because the original enlarged heart volume will gradually shrink and the form of the diseased valve tissue (such as valve annulus) will change accordingly as the regurgitation degree is reduced after the prosthetic device is implanted, in order to ensure that the annular member 1142 is firmly supported in the atrium (i.e. on the atrial side of the valve leaflets) all the time, the annular member 1142 is arranged to have a certain height in the range of 10-40mm, so that the annular member 1142 can be well attached to the valve annulus 12 of the diseased valve even if the shape of the diseased valve changes continuously. In order to ensure that the annular member 1142 does not fall into the heart ventricle and does not damage the contact surface with the valve annulus 12 of the diseased valve during diastole, the maximum outer diameter of the lower end of the annular member 1142 is set to be 35-45mm, and the width of the lower end of the annular member 1142 is set to be 0.2-3mm. In certain embodiments, the second support element 114 may also include a hollow expandable mesh stent 1144. In some embodiments, as shown in fig. 8, to ensure that the second support element 114 does not damage the leaflets 14, at least a portion of the outer surface of the second support element 114 is coated with a biocompatible covering 1146 or a coating, such as by sewing, gluing, or heat staking. The covering film 1146 can reduce the occurrence of undesirable sticking or adhesion between the leaflet 14 and the second support element 114 during the cardiac cycle.

In some embodiments, as shown in fig. 9A-9B, the support portion 110 is integrally configured in the shape of an umbrella disk, such that if the occluding portion 120 is positioned too high or too low relative to the mitral valve leaflets after the initial deployment of the heart valve repair device 100 is fully released, the device 100 can be smoothly retrieved for redeployment without requiring a large external force to force the deformed contraction, thereby adjusting the position of the heart valve repair device 100. Specifically, the support portion 110 includes a first support element 112 and a second support element 114 having a slope, wherein the first support element 112 is a plurality of strip-shaped fins 1122 radially distributed from the center, the second support element 114 is a skirt-like indented annular member 1142, one end of each strip-shaped fin 1122 is movably connected to a sawtooth end point of the annular member 1142 at intervals, the strip-shaped fins 1122 have a slope in the range of 15-20 °, the annular member 1142 also has a slope in the range of 40-70 °, and the overall arrangement is such that the regret operation is facilitated when the heart valve repair device 100 needs to be redeployed after being completely released.

In some embodiments, the heart valve repair device 100 further comprises a first adjustment mechanism 140 for providing an articulating connection between the second end 126 of the occluding portion 120 and the first support member 112, thereby adjusting the relative position between the occluding portion 120 and the diseased heart valve and locking the position between the occluding portion 120 and the valve when the area of regurgitation is in a preferred improved state as viewed by medical images. The first adjustment mechanism 140 includes a link member 142 coupled to the second end 126 of the closure portion, a control member 144 for controlling movement of the link member 142, and a self-locking assembly 146 for locking the position of the link member 142. In certain embodiments, as shown in fig. 10, the connecting member 142 includes a connecting portion 1422 and a pulley 1424, and the control member 144 includes an attachment portion 1442 at least partially attached to the first support element 112, a slide rail 1444, and a control portion 1446. Wherein the connecting portion 1422 can be connected to the second end 126 of the blocking portion by means of bonding, crimping, welding, stitching, integral molding, etc. The pulley 1424 is received within a slide rail 1444 in the control member 144, and is free to move along the slide rail 1444. Attachment portion 1442 may be at least partially attached to first support member 112 by adhesive, crimping, welding, stitching, integral molding, etc., slide 1444 may be used to accommodate pulley 1424 and limit the path of movement of pulley 1424, and control portion 1446 may provide good control of movement of pulley 1424 within slide 1444. The self-locking assembly 146 can be any known self-locking device, as long as it can lock the relative position of the pulley 1424 in the sliding rail 1444.

In some embodiments, the heart valve repair device 100 further comprises a second adjustment mechanism 150 for effecting articulation of at least one end of the strip 112 with the loop-shaped member 114. In certain embodiments, as shown in fig. 11, when the position of the broken chordae tendineae or the prolapsed leaflet 14 is severe or special, adjusting the relative position between the first support element 112 and the occlusion 120 by the first adjustment mechanism 140 alone may not have served a good regurgitation-improving effect, the relative position between the entire first support element 112 and the second support element 114 may be adjusted by the second adjustment mechanism 150. The second adjustment mechanism 150 may be any known adjustment device, such as: gear assemblies, ratchets or robotic arms, and the like.

Referring again to fig. 3, the occluding portion 120 is positioned between the leaflets of the heart valve to support the leaflets 14 and to occlude the leaflet 14 gap while preventing the prolapsed leaflets 14 from drifting toward the atrium. The occluding portion 120 has opposing first and second ends 122, 126 and an expandable body 124 extending between the first and second ends 122, 126, the expandable body 124 being positioned between at least two leaflets 14 of the heart valve. The expandable body 124 has some elasticity and flexibility so as to support the valve leaflets 14 and to occlude the valve leaflet 14 spaces.

As shown in FIG. 12, in certain embodiments, the expandable body 124 is a mesh structure made of a shape memory material, such as nickel titanium alloy, stainless steel, titanium alloy, cobalt chromium alloy, and the like. To ensure that the expandable body 124 does not damage the annulus 12 and leaflets 14, a biocompatible coating or coating is applied to at least a portion of the inner and/or outer surfaces of the expandable body 124 by suturing, bonding, or heat staking. Optionally, the outer diameter of the head end of the expandable body 124 is smaller than the inner diameter of the second support element 114, ensuring that the head end of the expandable body 124 can be inserted into the inner bore of the second support element 114 when the expandable body 124 is impacted in the reverse direction at a high reflux rate. The maximum outer diameter of the expandable body 124 ranges from 10-15mm, enabling better blood occlusion without interfering with the closing of the leaflets 14 when the expandable body 124 is impacted by a greater regurgitation velocity. In certain embodiments, the expandable body 124 can also be provided as a balloon, the outer surface of which is coated with a biocompatible coating.

As shown in fig. 13, in some embodiments, the expandable body 124 can be provided as an ellipsoidal structure 1242 having a certain elasticity and flexibility that ensures that the ellipsoidal structure 1242 can deform and cling to the leaflets 14 when the heart contracts and the leaflets 14 are closed, thereby preventing and improving regurgitation.

As shown in fig. 14, in certain embodiments, the expandable body 124 may be provided as an inverted cone-shaped structure 1244, having some elasticity and flexibility. The outer diameter of the head end of the inverted cone-shaped structure 1244 is set to be 10-15mm, so that after the inverted cone-shaped structure 1244 is extruded and deformed by the valve leaflets 14, the head end can form a circular structure, a better blood plugging effect can be achieved, a better supporting force is provided for the valve leaflets 14, and the prolapsed valve leaflets 14 are prevented from drifting to atria; and because the outer diameter of the middle part and the tail part of the inverted cone-shaped structure 1244 contacting with the valve leaflet 14 is smaller, a gap can not occur when the valve leaflet 14 is closed, and a better plugging effect is achieved.

As shown in fig. 15A-15B, in some embodiments, the expandable body 124 can be provided as an oblate spheroid structure 1246, having some elasticity and flexibility. The external diameter of the long axis of the oblate spheroid structure 1246 is set to 20-30mm, and the external diameter of the short axis is set to 5-10mm. When the leaflet 14 squeezes the oblate spheroid structure 1246, the oblate spheroid structure 1246 can provide a larger regurgitation area coverage, achieve a better therapeutic effect, and more conform to the anatomy of the leaflet 14, facilitating the fitting of the leaflet 14 and the expandable main body 124.

As shown in fig. 16A-16B, in some embodiments, the expandable body 124 can be provided as a fusiform structure 1248, having a certain elasticity and flexibility. The outer diameter range of the long axis of the fusiform structure 1248 is 30-40mm, the outer diameter range of the short axis is 5-10mm, when the prolapse of the mitral valve leaflet 14 and the lesion are serious, the fusiform structure 1248 is more in line with the anatomical structure of the leaflet 14, complete regurgitation area coverage is provided, and the fusiform structure 1248 is tightly attached to the whole leaflet 14, so that a good regurgitation control treatment effect is achieved.

The anchoring portion 130 is used to secure the entire heart valve repair device 100, preventing the device 100 from drifting into the atrium. An anchoring portion 130 that includes a connecting portion 132, a suture 134, and a securing portion 136. Specifically, one end 132 of the anchor portion 130 is connected to the first end 122 of the occlusion portion 120, and the other end 136 of the anchor portion 130 is connected to the heart 10. As shown in fig. 3 and 4, in order to avoid damaging the diseased valve or hooking the chordae tendineae when the anchoring portion 130 is anchored, the anchoring portion 130 includes a suture 134, one end of the suture 134 may be connected to the first end 122 of the blocking portion 120 by bonding, crimping, welding, suturing, integral molding, or the like, and the other end (free end) of the suture 134 is fixed at the apex position or ventricular wall position. When the fine adjustment of the reflux state is needed, the suture thread 134 can be pulled back and forth to adjust and observe the reflux image in real time, and when the ideal treatment effect is achieved, the free end of the suture thread 134 is tied with a load bag knot and fixed on the apex of the heart or the ventricular wall, so that the state of the blocking part 120 is fixedly maintained. Optionally, a spacer 136 may be added to the position of the purse-string knot and the apex or the center of the ventricular wall, and the suture 134 may be fixed to the apex or the ventricular wall to reduce damage to the heart.

In some embodiments, the anchor 130 may also include a rivet attached to the proximal end of the suture 134, with the rivet being embedded in the heart tissue for fixation. The body of the rivet may be spiral, umbrella, spiral, or barb shaped and include a pointed tip. In some embodiments, the anchor 130 may further include a fixation device such as a clip (not shown).

In another aspect, the present disclosure is directed to a system for heart valve repair comprising a heart valve repair device 100, a delivery device, and a control unit coupled to the delivery device. The heart valve repair device 100 is constructed the same as the device 100 described above; a detachable connection between the delivery device and the heart valve repair device 100 for receiving and delivering the heart valve repair device 100; the control unit is used to control the advancement and retraction of the delivery device, as well as the connection and release between the delivery device and the heart valve repair device 100, to place the heart valve repair device 100 in a desired location.

The following description of the use of a heart valve repair system provided in certain embodiments is provided by way of example of transapical implantation of a heart valve repair device 100:

through the manner of apical puncture, the control unit is adjusted to control the advancing or withdrawing of the delivery device, and the heart valve repair device 100 is delivered into the left atrium; slow adjustment allows the heart valve repair device 100 to be placed near the mitral valve with a small amplitude of retraction of the delivery device; adjusting the distal end of the delivery device under ultrasound guidance until the prosthetic heart valve device 100 is properly positioned at the desired implantation site, at which time the control unit releases the connection between the delivery device and the prosthetic heart valve device 100, allowing the prosthetic heart valve device 100 to be fully released from the delivery device; further, observing the reflux condition through images, and adjusting the first adjusting mechanism 140 or the second adjusting mechanism 150 in real time, so as to move the position of the occlusion part 120 until the occlusion part 120 is determined to be at a reasonable position, thereby achieving a better blood reflux improvement condition and locking the position of the occlusion part 120; the anchor 130 is then further fine tuned to secure the entire heart valve repair device 100 to the heart via the anchor 130 when the improved regurgitation condition is optimal. At this point, the gap between the two leaflets 14 of the mitral valve is improved from a larger gap to a smaller gap, thereby improving or reducing mitral regurgitation.

Other adaptations and modifications may occur to those skilled in the art in light of the foregoing description of the disclosure. For example, the prosthetic heart valve repair device 100 can also be delivered to the left ventricle via a catheter, through the femoral vein, through a puncture in the interatrial septum, and into the left atrium. For example, in addition to mitral valve repair, it may also be applied to repair of diseased valves such as the tricuspid valve.

In the present disclosure, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions.

From the foregoing it will be appreciated that, although specific embodiments of the disclosure have been described herein for purposes of illustration, various modifications or improvements may be made by those skilled in the art without departing from the spirit and scope of the disclosure, which should be limited only by the claims appended hereto.

Claims

1. A heart valve repair device, comprising:

2. The device of claim 1, wherein the first support element comprises at least one flexible strip substantially perpendicular to the direction of the apposition edges of the at least two leaflets of the heart valve, and wherein the second support element comprises at least one flexible ring, at least one end of the strip being movably attached to the ring.

3. The device according to claim 2, characterized in that said first support element comprises a plurality of bars arranged substantially parallel or staggered one with respect to the other.

4. A device according to claim 2 or 3, wherein the ring has a profile selected from any one of a sawtooth, a wave, and a helix.

5. The device of claim 4, further comprising a biocompatible coating or coating disposed on the strip and/or on the ring.

6. The device according to claim 1 or 2, further comprising a first adjustment mechanism for enabling the moveable connection between the second end of the occlusion part and the first support element.

7. The device of claim 6, wherein the first adjustment mechanism comprises a link coupled to the second end of the occlusion portion, a control member for controlling movement of the link, and a self-locking assembly for locking the position of the link.

8. The device according to claim 2, characterized in that it further comprises a second adjustment mechanism for enabling the movable connection between at least one end of said bar and said annular element.

9. The device of claim 1, wherein the expandable body is a mesh structure made of a shape memory material; or the expandable body is a balloon.

10. The device of claim 9, wherein a biocompatible coating or coating is applied to the inner and/or outer surface of the mesh structure; or the outer surface of the balloon is applied with a biocompatible coating.

11. The device of claim 1, wherein the anchoring portion comprises a suture having a proximal end fixed at an apical location or a ventricular wall location.

12. The device of claim 11, wherein the anchoring portion further comprises a rivet connected to a proximal end of the suture, the rivet having a sharpened tip.

13. A heart valve repair system, comprising:

the heart valve repair device of any one of claims 1-12;

the device comprises a conveying device and a control unit connected with the conveying device.