WO2023169376A1

WO2023169376A1 - Forming device for repairing valve

Info

Publication number: WO2023169376A1
Application number: PCT/CN2023/079916
Authority: WO
Inventors: 吕世文; 陈志�; 陈琼; 鲁侃; 马振宇; 崔泽浩
Original assignee: 宁波健世科技股份有限公司
Priority date: 2022-03-07
Filing date: 2023-03-06
Publication date: 2023-09-14
Also published as: CN116712214A

Abstract

A forming device for repairing a valve, relating to the field of medical instruments, and comprising a contraction framework (11) and at least one covering layer (12). The covering layer (12) is fixedly connected to the contraction framework (11). A ring contraction component (1) has a predetermined form and a contracted form. The contraction framework (11) is provided with at least one first fixing component used for limiting the effective length of a control element (2) acting on the contraction framework (11). The covering layer (12) is provided with a plurality of second fixing components used for fixing the ring contraction component (1) and the cardiac tissue. When the ring contraction component (1) is in the contracted form, the contraction stroke of one side of the ring contraction component (1) is greater than the contraction stroke of the other side of the ring contraction component (1). Due to the difference in the contraction strokes, the cardiac tissue located on one side of the ring contraction component (1) moves towards the center of an autologous valve, so that the originally expanded autologous valve is reduced, and different degrees of contraction of the cardiac tissues on the two sides of the ring contraction component (1) can effectively reduce the generation of wrinkles without affecting other blood vessels.

Description

Valve repair device

Technical field

The present application relates to the field of medical devices, and in particular to valvuloplasty devices for repairing valves.

Background technique

As the population ages, the incidence of heart valve disease has increased significantly. In particular, the incidence of mitral regurgitation (MR) is more than five times that of patients with aortic stenosis. It is estimated that there are more than 10 million patients with severe MR in my country. MR is caused by changes in the mitral valve leaflets and their structure, resulting in poor anastomosis between the anterior and posterior mitral valve leaflets, and blood flowing backward from the left ventricle to the left atrium, causing some symptoms. According to the pathogenesis, MR can be divided into primary (organic) and secondary (functional), accounting for approximately 50% each. Patients with mild MR may not develop clinical symptoms for a long time and have a good prognosis. Patients with severe MR may be accompanied by symptoms such as palpitations, chest tightness, and shortness of breath. Patients with acute severe MR have poor tolerance and are prone to death. Clinical studies have shown that drug treatment can only improve patients' symptoms, but cannot prolong their survival time or the timing of surgery. Surgical valve repair or replacement is recognized as the standard method for treating MR and has been proven to relieve patients' symptoms and prolong their survival time. However, surgical treatment has the disadvantages of large trauma, slow postoperative recovery, significant postoperative pain, and high risks. At the same time, 50% of MR patients do not receive effective treatment because of high-risk factors such as low cardiac function, advanced age, and history of thoracotomy, which are not suitable for surgery. In the past decade, transcatheter mitral valve interventional treatment technology has developed rapidly, especially the launch of MitraClip, which has brought hope to many patients. The latest research shows that MitraClip is more effective in treating functional reflux than medication. Facing the huge market, major companies and capital have stepped into the ranks of MR treatment.

Because of this, MR treatment is ushering in the era of interventional treatment after experiencing traditional surgical thoracotomy and minimally invasive small incision surgery. Interventional heart valve treatment has the advantage of being less invasive than traditional treatment, bringing hope to high-risk patients who are not suitable for surgery. Although interventional heart valve treatment has many advantages over traditional treatment, it faces many technical difficulties, such as difficulty in positioning. Difficulty in positioning brings risks to interventional treatments. In order to obtain clear images, contrast agents need to be used multiple times during surgery, exposing patients to the hazards of contrast agents. Multiple and large doses of X-rays expose patients to excessive amounts of cumulative radiation and expose them to the risk of radiation damage. If the released implant is not in an ideal position or is displaced or even falls off due to positioning issues, the patient may face the risk of having to undergo traditional thoracotomy surgery again, which can seriously endanger life. Therefore, technology that ensures timely and accurate positioning of implants is of great clinical value for interventional surgery.

Patent US11076958B2 discloses a device for repairing a heart valve, the device comprising a catheter sized for delivery through the vasculature of a subject and an elongated and flexible valvuloplasty structure having an elongated The lumen and the valvuloplasty structural axis extending along the lumen. The annuloplasty structure is sized and configured for delivery to the subject's heart through the catheter substantially along a catheter axis of the catheter while the annuloplasty structure axis is substantially parallel to the catheter axis . The device also includes a plurality of anchors configured for delivery to a region of cardiac tissue from a proximal end of the catheter toward a distal end of the catheter and substantially along the valvuloplasty structural axis and the catheter axis while at least a portion of the valve The plastic surgery structure is located in the delivery channel of the catheter; it can be seen from Figure 201 of the patent: this solution can only reduce the distance between the anchor points/needle insertion points during the ring shrinking operation, resulting in the tissue above the ring shrinking device appearing Obvious folds and uneven ring shrinkage can cause the coronary arteries on the outer wall of the heart and other blood vessels attached to the outer wall of the heart to twist, causing complications.

Patent US11103349B2 discloses various embodiments involving devices for minimally invasive medical treatment. The device is a hollow tube having a first end, a second end and one or more anchors configured to extend outwardly from an exterior of the hollow tube, the The hollow tube has a plurality of cutouts on the outside, characterized in that the cutouts allow the hollow tube to be flexible; in addition, the hollow tube may have at least one buckling mechanism configured to secure the first The first end and the second end are connected together; in this solution, the contraction force between the anchor points cannot be evenly distributed during ring shrinkage repair, resulting in local uneven contraction of the autologous annulus. At the same time, due to uneven contraction of the autologous annulus, it causes damage to the tissue. The damage is also greater.

Patent US20210275306A1 discloses an exemplary method of performing a valvuloplasty procedure, including introducing a catheter into the left atrium of the heart, deploying a first member from the catheter, and anchoring the first member to the mitral annulus in the left atrium. the posterior side of the catheter, deploying the second member from the catheter, anchoring the second member to the anterior side of the mitral annulus in the left atrium, deploying the flexible tensile member from the catheter, and connecting the tensile member to the first member and the second member and applying tension to the tensile member to draw the first member and the second member toward each other and bring the posterior and anterior sides of the mitral annulus closer together. The operation process of this plan is very complicated, and it requires very high accuracy of the doctor's operation and clinical surgical angiography. On the one hand, it greatly increases the time of the operation and is very detrimental to the patient's postoperative recovery; on the other hand, this plan requires a lot of effort in shrinking the ring. During the operation, the distance between the anchor points/needle insertion points can only be reduced, which will lead to obvious wrinkles in the tissue above the ring shrinking device, uneven shrinking of the ring, and the coronary arteries and other attachments to the outer wall of the heart. The blood vessels in the outer wall of the heart become twisted, causing complications.

Patent CN113558826A discloses a forming ring assembly, which includes a polymer braided tube, an anchor, a shrinkage wire and a bidirectional shrinkage device; a delivery assembly used to deliver the forming ring assembly to a target location; continuously An anchor assembly, the continuous anchor assembly is used to fix the forming ring assembly at a target location. The shrink ring component used in this solution is flexible, and when shrinking the ring, the distance between the anchor points is simultaneously reduced to achieve repair. Whether the shrink ring is uniform depends on the distance control of each anchor point when the needle is inserted, and it is difficult to ensure that the shrink ring is Ring uniformity.

In summary, although the above technologies have some clinical results, they all have shortcomings, and a new valvuloplasty device for repairing the valve is urgently needed to solve the above problems.

Contents of the invention

In view of the above and other concepts, the present application is proposed. The main purpose of this application is to overcome some problems and deficiencies of the prior art.

In terms of the application of atrioventricular valve surgery, this application aims to provide a valvuloplasty device for repairing the valve for patients with heart valve disease and need interventional treatment, thereby solving the problem of the inability of the heart valve repair system in the existing technology to uniformly shrink the ring, After the shrinkage ring is repaired, it is easy to produce wrinkles and cause problems such as distortion of other blood vessels in the heart.

According to one aspect of the present application, a shrinking ring component for valve repair is provided, including a shrinking skeleton and at least one covering layer; the covering layer is fixedly connected to the shrinking skeleton; the shrinking ring component has a predetermined shape; Contracted form; the shrinking frame is provided with at least one first fixing component for limiting the effective length of the control element acting on the shrinking frame, and the covering layer is provided with a plurality of shrinking ring members for fixing the heart tissue The second fixing component; the shrink ring member drives the heart tissue to shrink evenly during the contraction process.

Further, the first fixing component is a connecting hole and a shrink hole, the second fixing component is an anchoring hole; the shrink frame is made of rigid material, and the covering layer is made of flexible material.

Further, the connecting hole and/or the shrink hole are arranged on one side of the shrink frame in the circumferential direction; the anchor hole is arranged in the middle position of the shrink ring member in the longitudinal direction, or in the longitudinal direction of the shrink ring member. The middle position of the direction is on the other side away from the shrinkage hole.

Further, the shrinkage frame includes several shrinkage units, the length of one side of the shrinkage unit is greater than the length of the other side of the shrinkage unit, and the adjacent shrinkage units are fixedly connected on one side.

Further, the contraction unit is generally in a trapezoidal or "M"-shaped structure.

Further, the covering layer is generally in a sheet-like structure; the plurality of anchor holes are evenly distributed on the covering layer.

Further, the predetermined shape of the ring-shrinking component matches the shape of the autologous valve annulus; the longitudinal section of the ring-shrinking component is arc-shaped.

According to one aspect of the present application, a valvuloplasty device for repairing a valve is provided, including: a shrinking ring member, a control element and an anchoring member; the control element is connected to the shrinking ring member through a locking ring hole; The control element is used to control the shrinking ring member to convert from a predetermined form to a contracted state; the anchoring member fixes the shrinking ring member on the heart tissue through the anchoring hole; when the shrinking ring member is in the contracted state When , the contraction stroke of the heart tissue on the side close to the shrinking ring member is greater than the contraction stroke of the heart tissue on the side far away from the shrinking ring member.

Further, the shrinkage ring component includes a first shrinkage member and a second shrinkage member, and the first shrinkage member and the second shrinkage member are adjacently anchored to the autologous valve annulus or atrial tissue through the anchoring member. Wherein, pulling the control element causes the first shrinking member and the second shrinking member to shrink, and the adjacent ends of the first shrinking member and the second shrinking member are both closer to the center of the native valve.

Further, the first shrinking member and the second shrinking member are adjacently anchored in the shrinking annular area set by the autologous valve annulus or atrial tissue through the anchoring member, and the control element is manipulated to cause the first The shrinking member and the second shrinking member shrink, and the adjacent ends of the first shrinking member and the second shrinking member are both closer to the center of the native valve, and drive the middle part of the set shrinking ring area to move closer to the center of the native valve.

Further, when the shrinking ring member is in a contracted state, the heart tissue located on one side of the shrinking ring member moves toward the center of the native valve.

Furthermore, when the shrinking ring member is in a predetermined shape, the longitudinal section of the shrinking ring member has an arc-shaped structure so that the shrinking ring member can fit the heart tissue.

Further, when the shrinking ring member is converted from a predetermined shape to a shrinking shape, the circumference of the shrinking ring member gradually decreases.

Furthermore, the shrinkage ring component includes a shrinkage frame and an outer fabric covering layer. The shrinkage frame is made of a rigid material with a certain elasticity. The rigidity of the shrinkage frame can be stably maintained when it enters the heart and abuts against the heart tissue. It maintains a predetermined shape, and the contractile skeleton can contract and relax correspondingly with the beating of the heart in the contracted state, which can avoid tearing the heart tissue.

Further, the control element is an elongated member, and one end of the control element is fixed to the shrinking frame. Pulling the other end of the control element can drive the shrinking frame to shrink evenly. It can avoid concentrating the contractile force on a certain anchor point and causing damage to the heart tissue.

Further, the control element includes a connecting part and a locking part; when pre-installed, the connecting part passes through the connecting hole, and the other end of the control element is pulled so that the locking part passes through the locking hole to real-time The contracted state of the shrink ring member is locked.

Further, the middle area of the locking part is hollowed out, and the outer edge of the locking part is provided with spines; when the locking part passes through the locking hole, both sides of the locking part are compressed toward the middle hollow area, When the thorn passes through the locking hole, it rebounds to its natural state to achieve locking, which is very convenient to operate.

Further, the shrinkage frame includes a connecting hole and a locking hole, and the control element includes a connecting part and a locking part; when pre-assembled, the connecting part passes through the connecting hole, and the other end of the control element is pulled so that the The locking part passing through the locking hole can lock the contracted state of the shrink ring member in real time; pulling the control element so that the locking part passes through the locking hole can realize the shrink ring forming and lock the contracted state of the shrink ring member in real time. , which reduces the steps required for fixation after the contraction operation, reduces the difficulty of the operation and also saves the time of the operation.

According to one aspect of the present application, a delivery system for valve repair is provided: including a control handle, a delivery catheter, and an anchoring component. The anchoring component includes a needle hiding tube, a needle pusher, a guide, and a fixed wire ring. ; During pre-assembly, the plastic surgery device and the anchoring component are set in the delivery catheter, and the needle pushing member, guide member and fixed wire loop are all set in the needle hiding tube, which can realize pre-anchoring. The guidance and positioning greatly saves the space of the sheath, especially when there are multiple anchoring components in the delivery catheter, which facilitates transvascular delivery. The anchoring component and the shrink ring component The proximal end of the guide is connected to the control handle through the fixed wire loop, and the distal end of the guide is detachably connected to the anchor; when anchoring, tighten the guide The piece makes the needle-containing tube abut against the constriction ring member along the guide piece, and pushes the needle-pushing piece to make the anchoring piece pass through the outer fabric covering member and pierce into the heart tissue.

Further, a plurality of anchoring assemblies are provided in the delivery catheter. After entering the heart, the plurality of needle-hiding tubes are pressed against the shrink ring member along the guide member, and the control handle is operated so that the The shrink ring member is positioned against the heart tissue.

Further, the anchoring member has a preset shape, pushing the needle pushing member can cause the anchoring member to protrude from the needle hiding tube and return to the preset shape, and pulling the guide member can cause the anchoring member to The anchoring piece is recovered into the needle-hiding tube. When the anchoring piece protrudes from the needle-hiding tube but fails to be anchored successfully, the guide can be pulled so that the anchoring piece is recovered into the needle-hiding tube and can be tried again. Anchor until the anchoring is successful, the operation is simple and the instrument has a high fault tolerance rate, which has good clinical significance.

Further, the fixed wire loops are evenly arranged on the implantation device, and the distal end of the needle-hiding tube is provided with a bending structure. Tightening the guide can make the distal ends of multiple needle-hiding tubes The port abuts the implant device evenly.

Furthermore, the distal ends of multiple needle-hiding tubes are arranged in the delivery catheter in a stepped manner, and the plastic surgery devices are axially arranged in the delivery catheter, so that the sheath space can be effectively utilized and the sheath space can be maximized. Minimize the diameter of the loading tube to facilitate transvascular delivery.

Further, it also includes a bending member, the distal end of the bending member is connected to the distal end of the needle-hiding tube, and the proximal end is connected to the control handle; wherein, the fixed wire loop is connected to the implant instrument The point is called a fixed point, and operating the bending member can cause the distal end of the needle-containing tube to move relative to the fixed point.

Compared with the existing technology, the advantages and beneficial technical effects of this application include at least the following:

1. In the existing technology, when performing ring shrinkage repair, the shaping device can only reduce the distance between anchor points, but cannot reduce the already expanded atrial space. At the same time, severe wrinkles will be produced during ring shrinkage, resulting in The branch vessels affecting the outer wall of the heart are twisted, affecting the blood supply function; in one embodiment of the present application, when the shrinking ring member is in a contracted state, the contraction stroke of one side of the shrinking ring member is greater than the contraction stroke of the other side of the shrinking ring member, Due to the difference in contraction stroke, the heart tissue located on one side of the shrinking ring member will move toward the center of the native valve, thereby shrinking the originally expanded native valve. At the same time, the different degrees of contraction of the heart tissue on both sides of the shrinking ring member can effectively reduce the folds. produced and will not affect other blood vessels.

2. Different from the prior art, in one embodiment of the present application, the shrinkage frame is made of elastic rigid material, and the shrinkage ring member can still follow the heart beat to a certain amount of contraction and relaxation after contraction, avoiding Excessive stiffness will cause tearing of the heart tissue after contraction, and at the same time, uniform contraction can be achieved to avoid concentrating the contraction force on a certain anchor point and causing damage to the heart tissue.

3. Different from the prior art, in one embodiment of the present application, the shrink ring member includes a shrink frame and an outer fabric covering layer, and the shrink frame is made of rigid material; the shrink ring member is fixed on the On the heart tissue; since the shrinkage skeleton is made of rigid materials, the entire shrinkage ring component has a certain degree of rigidity. The heart tissue is restricted by the covering layer of the shrinkage ring component during the shrinkage process, thereby avoiding the occurrence of wrinkles in the heart tissue during the contraction process. Further ensures the uniformity of the shrinkage ring.

4. Different from the prior art, in one embodiment of the present application, pulling the control element so that its locking portion passes through the locking hole can not only realize shrink ring forming, but also lock the shrinking state of the shrink ring member in real time, reducing shrinkage. Fixed steps are required after the operation, which reduces the difficulty of the operation and saves the time of the operation.

5. Different from the prior art, in one embodiment of the present application, the needle pushing member, the guide member and the fixed wire loop are all arranged in the needle hiding tube, which can not only realize the guidance and positioning before anchoring, but also maximize the This greatly saves the space of the sheath and facilitates transvascular delivery.

6. Different from the prior art, in one embodiment of the present application, when the anchoring member protrudes from the needle-containing tube but fails to be anchored successfully, the guide member can be pulled to allow the anchoring member to be recovered into the needle-containing tube. And the anchoring can be tried again until the anchoring is successful. The operation is simple and the instrument has a high fault tolerance rate, which has good clinical significance.

7. Different from the prior art, in one embodiment of the present application, the shrinking ring member includes a first shrinking ring member and a second shrinking ring member, and the first shrinking ring member and the second shrinking ring member are adjacent to each other through a fixing element. It is anchored in the contractile ring area set by the native valve annulus or atrial tissue. Pulling the control element can make the set contractile ring area move toward the center of the valve, so that it can reduce the distance between adjacent valve leaflets in a targeted manner and increase the The apposition area between adjacent valve leaflets can more effectively repair valve regurgitation.

Embodiments of the present application can achieve other beneficial technical effects that are 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. of.

Description of the drawings

The above-described features and advantages and other features and advantages of these embodiments, as well as the manner of achieving them, will be more apparent, and embodiments of the present application may be better understood, by referring to the following description in conjunction with the accompanying drawings, in which:

Figure 1a is a schematic diagram of the overall structure of the shrink ring component of the present application.

Figures 2a to 2c are schematic diagrams of the ring shrinking process of the ring shrinking component of the present application under the action of the control element.

[Amended in accordance with Rule 26 14.04.2023]
Figure 3 is an embodiment of the shrinkable frame of the present application.

Figures 4a-4b are schematic structural diagrams of the control components of the present application.

Figures 5a to 5h are schematic structural diagrams of the delivery system of the present application and a schematic diagram of the anchoring process of the anchoring component.

Figures 6a and 6b are schematic diagrams of the process of the delivery system of the present application entering the left atrium.

Figures 7a to 7g are schematic diagrams of the operation process of repairing the mitral valve in this application.

The names of the parts designated by each number in the drawing are as follows: 1-shrink ring member, 11-shrink skeleton, 111-connection hole, 112-locking hole, 12-outer fabric covering layer, 2-control element, 21-connection part , 22-locking part, 3-anchoring piece, 4-delivery system, 41-control handle, 42-delivery catheter, 43-anchoring component, 431-hiding needle tube, 432-needle pushing piece, 433-guide piece, 434-Fixed wire loop, 435-Fixed point, 44-Shrink ring control part, 5-First shrinking part, 6-Second shrinking part.

Detailed ways

The details of one or more embodiments of the application are set forth in the following description of the drawings and the detailed description. Other features, objects, and advantages of the present application will be apparent from the description, drawings, and claims.

It is to be understood that the illustrated and described embodiments are not limited in application to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The illustrated embodiments are capable of other embodiments and of being practiced or carried out in various ways. Each example is provided by way of explanation of the disclosed embodiments, not limitation. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of the present application without departing from the scope or spirit of the disclosure. For example, features illustrated or described as part of one embodiment can be used with another embodiment to still produce further embodiments. This disclosure is therefore intended to cover such modifications and variations as come within the scope of the appended claims and their equivalents.

Likewise, it is to be understood that the phrases and terminology used herein are for the purpose of description and should not be regarded as limiting. The use of "including," "including," or "having" and variations thereof herein is intended to include the items listed thereafter and their equivalents, as well as possible additional items, in an open-ended manner.

The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

In this application, the proximal end refers to the end close to the surgical operator, and the distal end refers to the end far away from the surgical operator; the direction with the longer length of the shrinking member is the circumferential direction; the circumferential direction or the tangential direction to the shrinking member The direction perpendicular to the direction is the longitudinal direction.

In the existing technology, during the process of atrioventricular valve replacement, the autologous valve usually cannot work normally, and this traditional treatment method will cause the entire valve to be in a state of regurgitation during the replacement process, resulting in long operation time. It is very short-lived and high-risk, and can cause various illnesses.

Example 1:

As shown in Figure 1a, in this embodiment, it includes a shrinking ring member 1, a control element 2 and an anchor 3; the shrinking ring member 1 is generally in a sheet-like structure, and the shrinking ring member 1 has a predetermined shape and makes the body The contracted shape of the valve reshaping; the control element 2 is connected to the shrinking ring member 1; and operating the control element 2 can cause the shrinking ring member 1 to convert from a predetermined shape to a contracted shape; the anchor 3, The shrink ring member 1 is fixed on the heart tissue through the anchor 3; and when the shrink ring member 1 is in a contracted state, the contraction stroke of one side of the shrink ring member 1 is greater than that of the shrink ring. The contraction stroke of the other side of member 1.

According to an example, the shrink ring member 1 includes several shrink units, the length of one side of the shrink unit is greater than the length of the other side of the shrink unit, and the adjacent shrink units are fixedly connected on one side; the two shrink units The structure with a difference in side width can make the shrinkage stroke of one side of the shrink ring member 1 significantly larger than the shrinkage stroke of the other side when shrinking the ring member 1, which can effectively alleviate the occurrence of wrinkles after the plastic surgery device is shrunk and formed, and avoid the occurrence of wrinkles. It interferes with other blood vessels of the heart, and at the same time, it can move the tissue near the native valve annulus toward the center of the native valve relative to the tissue in the atrium, which can effectively reduce the space of the atrium and ventricle that are expanded due to valve disease, thereby effectively preventing Valvular regurgitation.

According to an example, the contraction unit is generally in the form of a trapezoidal or "M"-shaped structure or other configurations that are narrow at the top and wide at the bottom.

According to an example, the control element 2 is close to or located on one side of the shrink ring member 1 , and the anchor 3 is close to or located on the other side of the shrink ring member 1 ; such a design can make the control element 2 During operation, the contraction stroke of one side of the shrink ring member 1 will be significantly greater than the contraction stroke of the other side of the shrink ring member 1 .

According to an example, one side of the ring shrinking member 1 is close to the autologous valve annulus, and the other side of the ring shrinking member 1 is away from the autologous valve annulus. The arthroplasty device is anchored at the autologous valve annulus. When the When the shrinking ring member 1 is in the contracted state, it has a "C" shape, and the heart tissue at the native valve annulus moves toward the center of the native valve, as shown in Figures 2a to 2c and Figures 7c to 7d.

According to an example, when the shrinking ring member 1 is in a predetermined shape, the longitudinal section of the shrinking ring member 1 has an arc-shaped structure so that the shrinking ring member 1 can fit the heart tissue, and when the shrinking ring member 1 During the process of converting from the predetermined form to the contracted form, the circumference of the shrink ring member 1 gradually decreases.

According to an example, the shrink ring member 1 includes a shrink frame 11 and an outer fabric covering layer 12. The shrink frame 11 is made of a rigid material. The rigid shrink frame 11 can be stable when entering the heart and abutting against the heart tissue. The predetermined shape is maintained, and the shrinkable skeleton 11 has an elastic modulus in both the predetermined shape and the contracted shape. The elastic modulus in the contracted state allows the plastic surgery device to have a certain telescopic stroke during the beating of the heart. , to avoid tearing the heart tissue.

According to an example, the shrink ring member 1 includes a first shrinking member 5 and a second shrinking member 6 , and the first shrinking member 5 and the second shrinking member 6 are adjacently anchored by the anchoring member 3 At the native valve annulus or atrial tissue, the control element 2 is pulled to cause the first contraction part 5 and the second contraction part 6 to contract, and the first contraction part 5 and the second contraction part 6 are adjacent to each other. The ends are all close to the center of the native valve.

According to an example, the first shrinking member 5 and the second shrinking member 6 are adjacently anchored in the shrinking ring area set by the autologous valve annulus or atrial tissue through the anchoring member 3 (for mitral valve treatment) When The adjacent ends of the two shrinking members 6 are both moved closer to the center of the native valve, and drive the middle part of the set shrinking ring area closer to the center of the native valve, as shown in Figure 7e and Figure 7f.

According to an example, the control element 2 is an elongated member, and one end of the control element 2 is fixed to one end of the shrinking frame 11. Pulling the other end of the control element 2 can drive the shrinking frame 11 to shrink evenly. , which can avoid concentrating the contraction force on a certain anchor point and causing damage to the heart tissue.

According to an example, the shrinkable frame 11 includes a connecting hole 111 and a locking hole 112. As shown in Figure 3, the control element 2 includes a connecting portion 21 and a locking portion 22; when pre-assembled, the connecting portion 21 passes through all The connecting hole 111, pulling the other end of the control element 2 so that the locking portion 22 passes through the locking hole 112 can lock the contracted state of the shrink ring member 1 in real time; pulling the control element 2, so that the locking portion 22 Passing through the locking hole 112 can not only realize the shrink ring forming, but also lock the shrinking state of the shrink ring component 1 in real time, which reduces the steps that need to be fixed after the shrinking operation, reduces the difficulty of the operation, and saves the time of the operation.

According to an example, the middle area of the locking part 22 is hollowed out, as shown in Figures 4a and 4b, and the outer edges on both sides of the locking part 22 are provided with thorns. When the locking part 22 passes through the locking hole, 112, both sides of the locking portion 22 are compressed toward the hollow area in the middle. When the spines pass through the locking holes 112, they rebound to the natural state to achieve locking. The operation is very convenient.

According to another example, the delivery system 4 includes a control handle 41, a delivery catheter 42, and an anchoring assembly 43. As shown in Figures 5a and 5b, the anchoring assembly 43 includes a needle hiding tube 431, a needle pusher 432, a guide 433 and fixed wire loop 434; during pre-assembly, the plastic surgery device and anchoring assembly 43 are provided in the delivery catheter 42, and the needle pushing member 432, guide member 433 and fixed wire loop 434 are all provided in The needle-hiding tube 431 can not only realize the guidance and positioning before anchoring, but also save the space of the sheath to a great extent. Especially when multiple anchoring components 43 are installed, it is convenient for transvascular delivery. , the anchor 3 and the shrink ring member 1 are connected through the fixed wire ring 434, the proximal end of the guide 433 is connected to the control handle 41, and the distal end of the guide 433 is connected to The anchoring member 3 is detachably connected; when anchoring, tighten the guide member 433 so that the needle hiding tube 431 abuts the shrink ring member 1 along the guide member 433, and pushes the needle pushing member 432 so that the anchoring member 3 passes through the outer fabric covering layer 12 and is inserted into the heart tissue, as shown in Figures 5d to 5h.

According to an example, the delivery catheter 42 is provided with a plurality of anchoring assemblies 43. After entering the heart, the plurality of needle-hiding tubes 431 abut against the shrink ring member 1 along the guide 433, and the operation The control handle 41 causes the shrink ring member 1 to abut against the heart tissue, as shown in Figures 7a and 7b.

According to an example, the anchoring member 3 is an anchoring needle. The structure of the anchoring member 3 can be in various forms (such as a hyperbolic needle). The anchoring member 3 has a preset shape. Pushing the needle pushing member 432 can cause the anchor 3 to protrude from the needle-hiding tube 431 and restore the preset shape, and pulling the guide 433 can cause the anchor 3 to be recovered into the needle-hiding tube 431, When the anchor 3 protrudes from the needle-hiding tube 431 but fails to anchor successfully, the guide 433 can be pulled so that the anchor 3 can be recovered into the needle-hiding tube 431 and anchoring can be attempted again until the anchoring is successful. It is simple and has high fault tolerance rate of the instrument, which has good clinical significance.

According to an example, the fixed wire loops 434 are evenly arranged on the implantation instrument, and the distal end of the needle-hiding tube 431 is provided with a bending structure. Tightening the guide 433 can make multiple The distal end of the needle tube 431 evenly abuts the implantation instrument.

According to an example, the distal ends of a plurality of needle-hiding tubes 431 are arranged in the delivery catheter 42 in a stepped manner, as shown in Figures 5b and 5c, and the plastic surgery devices are axially arranged in the delivery catheter 42, This can effectively utilize the sheath space and greatly reduce the diameter of the loading tube, which is convenient for transvascular delivery.

According to an example, the delivery catheter 42 is also provided with a shrink ring control member 44. The proximal end of the shrink ring control member 44 is connected to the control handle 41, and the distal end of the shrink ring control member 44 is detachably connected to the control element 2. When the shrink ring member is 1. After the anchoring is completed, operating the shrink ring control member 44 can pull the control element 2 to move toward one end relative to the shrink ring member 1. After completing the ring shrinkage, the shrink ring control member 44 and the control element 2 are disassembled and separated and withdrawn from the body.

An exemplary operation process of repairing the mitral valve of the valvuloplasty device of the first embodiment is as follows:

1. Operate the delivery system 4 to enter the right atrium from the superior vena cava, and then pass through the interatrial septum to the left atrium, as shown in Figures 6a and 6b;

2. Operate the control handle 41 to push each needle-hiding tube 431 out of the delivery catheter 42 toward the distal end. At this time, the plastic surgery device also follows the needle-hiding tube 431 and extends out of the delivery catheter 42, as shown in Figures 7a and 7b;

3. Tighten the guide 433 so that the distal end of each needle-hiding tube 431 is against the shrinking ring member 1, observe the impact and operate the control to make the shrinking ring member 1 close to the autologous valve annulus;

4. Push the needle pusher 432 so that the anchor 3 extends out of the needle hiding tube 431 and returns to the preset shape. Observe whether the anchor 3 pierces the outer fabric covering 12 and penetrates into the heart tissue. If the anchor 3 If the anchoring is successful, the guide 433 and the anchor 3 are disassembled and separated, as shown in Figures 5d to 5h. If the anchoring fails, the guide 433 is pulled so that the anchor 3 can be recovered into the needle hiding tube 431. And you can try anchoring again until the anchoring is successful, as shown in Figure 7c;

5. Operate the shrinking ring control part 44 to pull the control element 2 to move toward one end relative to the shrinking ring member 1. After completing the ring shrinking, the shrinking ring control part 44 and the control element 2 are disassembled and separated and withdrawn from the body, as shown in Figure 7d.

Example 2:

The second embodiment is generally the same as the first embodiment, except that this embodiment is also provided with a bending member that can operate the position of the distal port of the needle-hiding tube 431 to move.

When used for the treatment of mitral valve disease, the delivery system 4 includes a control handle 41, a delivery catheter 42, and an anchoring component 43. The anchoring component 43 includes a needle hiding tube 431, a needle pusher 432, and a guide 433. , fixed wire loop 434 and bending component; during pre-assembly, the plastic surgery device and anchoring assembly 43 are arranged in the delivery catheter 42, and the needle pushing member 432, guide member 433 and fixed wire loop 434 are all Disposed in the needle-hiding tube 431, the distal end of the bending member is connected to the distal end of the needle-hiding tube 431, and the proximal end is connected to the control handle 41. The anchoring member 3 is connected to the shrink ring member. 1 is connected through the fixed wire loop 434, and the point where the fixed wire loop 434 is connected to the implant instrument is called a fixed point 435. Operating the bending member can make the distal end of the needle hiding tube 431 relative to the fixed point. Point 435 moves, the proximal end of the guide 433 is connected to the control handle 41, and the distal end of the guide 433 is detachably connected to the anchor 3; when anchoring, tighten the guide The member 433 makes the needle-hiding tube 431 abut the shrink ring member 1 along the guide member 433, and pushes the needle push member 432 to make the anchor member 3 pass through the outer fabric covering layer 12 and pierce into the heart tissue.

In this regard, the relevant structure and concept of Embodiment 2 are similar to Embodiment 1, and therefore will not be described again here.

Claims

A shrink ring component, including a shrink frame and at least one covering layer; the covering layer is fixedly connected to the shrink frame; the shrink ring member has a predetermined shape and a shrink shape; characterized in that: the shrink frame is provided with At least one first fixing component is used to limit the effective length of the control element acting on the contraction frame, and the covering layer is provided with a plurality of second fixing components used to fix the shrinking ring member and the heart tissue.
The shrink ring component according to claim 1, characterized in that: the first fixing component is a connecting hole and a shrinking hole, the second fixing component is an anchoring hole; the shrinking frame is made of rigid material, The covering layer is made of flexible material.
The shrink ring member according to claim 2, characterized in that: the connecting hole and/or the shrink hole are provided on one side of the shrink frame in the circumferential direction; and the anchoring hole is provided on the shrink ring. The middle position in the longitudinal direction of the member, or the middle position in the longitudinal direction of the shrink ring member is on the other side away from the shrink hole.
The shrink ring member according to claim 1, characterized in that: the shrink skeleton includes several shrink units, the length of one side of the shrink unit is greater than the length of the other side of the shrink unit, and the adjacent shrink units Fixed connection on one side.
The shrink ring component according to claim 1, characterized in that: the covering layer is generally in a sheet-like structure; and the plurality of anchor holes are evenly distributed on the covering layer.
The ring-shrinking component according to claim 1, characterized in that: the predetermined shape of the ring-shrinking component matches the shape of the autologous valve annulus; and the longitudinal section of the ring-shrinking component is arc-shaped.
A valvuloplasty device for repairing a valve, including a ring-shrinking component, a control element and an anchoring component, characterized in that: the ring-shrinking component is the ring-shrinking component according to any one of claims 1 to 7.
The device for repairing valves according to claim 7, wherein the shrinking ring member includes a first shrinking member and a second shrinking member, and the first shrinking member and the second shrinking member pass through The anchoring member is adjacently anchored at the native valve annulus or atrial tissue, wherein pulling the control element causes the first constricting member and the second constricting member to contract, and the first constricting member and the second constricting member contract. The adjacent ends of the shrinking member are all close to the center of the native valve.
The device for valve repair according to claim 8, characterized in that: the first shrinking member and the second shrinking member are adjacently anchored to the autogenous valve annulus or atrial tissue through the anchoring member. In the set contraction ring area, the control element is manipulated to cause the first contraction member and the second contraction member to contract, and the adjacent ends of the first contraction member and the second contraction member are both closer to the center of the native valve, And drive the middle part of the set contraction ring area closer to the center of the native valve.
The valvuloplasty device according to claim 8, characterized in that: the control element is connected to the shrinking ring member through a locking ring hole; the control element is used to control the shrinking ring member to a predetermined position. The form is converted into a contracted form; the anchoring member fixes the shrinking ring member to the heart tissue through the anchoring hole; when the shrinking ring member is in the contracted state, the heart tissue on the side close to the shrinking ring member contracts. The stroke is greater than the contraction stroke of the heart tissue on the side away from the shrink ring member.
The valvuloplasty device according to claim 8, wherein when the shrinking ring member is in a predetermined shape, the longitudinal section of the shrinking ring member has an arc-shaped structure to facilitate the adhesion of the shrinking ring member. Combined with heart tissue.
The valvuloplasty device according to claim 8, wherein the circumference of the ring-shrinking member gradually decreases during the process of converting the ring-shrinking member from a predetermined shape to a contracted shape.
The valvuloplasty device according to claim 8, wherein the shrinking ring member includes a shrinking frame and an outer fabric covering layer, the shrinking frame is made of a rigid material with a certain elasticity, and the shrinking ring member In the contracted state, the contractile skeleton can correspondingly contract and relax following the beating of the heart.
The valvuloplasty device according to claim 8, wherein the control element is an elongated member, and one end of the control element is fixed to the shrinking frame, and the control element is pulled by The other end can drive the shrinkage frame to shrink evenly.
The device for valve repair according to claim 8, characterized in that: the control element includes a connecting part and a locking part; when pre-assembled, the connecting part passes through the connecting hole, and the control element is pulled The other end of the element allows the locking portion to pass through the locking hole to lock the contracted state of the shrink ring member in real time.
The valvuloplasty device according to claim 15, wherein the middle area of the locking part is hollowed out, and the outer edge of the locking part is provided with spines.
A delivery system for the plastic surgery device according to any one of claims 8 to 16, characterized in that: the delivery system includes a control handle, a delivery catheter, and an anchoring component, and the anchoring component includes a needle-hiding tube, Push pin piece, guide piece and fixed wire loop.
The plastic surgery device delivery system according to claim 17, characterized in that: during pre-assembly, the plastic surgery device and the anchoring assembly are disposed in the delivery catheter, and the push pin member, the guide member and the fixation wire The rings are arranged in the needle-hiding tube, the anchoring member and the shrinking ring member are connected through the fixed wire loop, the proximal end of the guide member is connected to the control handle, and the guide member The distal end is detachably connected to the anchor;

When anchoring, tighten the guide member so that the needle-hiding tube abuts against the shrink ring member along the guide member, and push the needle pushing member so that the anchor member passes through the outer fabric covering layer pieces and penetrate into the heart tissue.
The plastic surgery device delivery system according to claim 17, wherein the delivery catheter is provided with a plurality of anchoring assemblies. After entering the heart, the plurality of needle-hiding tubes abut against the guiding member along the guide member. By operating the control handle against the ring-shrinking member, the ring-shrinking member is brought into contact with the heart tissue.
The plastic surgery device delivery system according to claim 17, wherein the anchoring member has a preset shape, and pushing the needle pushing member can cause the anchoring member to protrude from the needle-containing tube and recover. The preset shape is set, and pulling the guide member can cause the anchor member to be recovered into the needle-containing tube.