CN113855328A - A transcatheter heart valve replacement system - Google Patents

Abstract

Translated fromChinese

本申请涉及医疗器械领域，具体涉及一种经导管心脏瓣膜置换系统，包括：瓣膜支架，其具有预设形态；修复机构，其构造成位于自体瓣膜的中间区域并用于夹合自体瓣叶；并且，所述修复机构具有捕捉和分离两种形态；其中，当所述修复机构处于捕捉形态并夹合自体瓣叶时，所述瓣膜支架处于所述修复机构的中间区域，并且所述瓣膜支架恢复为预设形态并促使所述修复机构拆卸分离；本申请方案置换的瓣膜支架未植入之前，自体瓣膜依旧能正常工作，为手术争取更多时间并有效降低了并发症；瓣膜支架可沿导引内芯顺利抵达修复机构的中间区域，定位准确且操作更为便捷，瓣膜支架在逐步径向扩张恢复预设形态时，修复机构分离并环抱在瓣膜支架的外周，完成植入。

The present application relates to the field of medical devices, in particular to a transcatheter heart valve replacement system, comprising: a valve stent, which has a preset shape; a repair mechanism, which is configured to be located in the middle region of the native valve and used to clamp the native valve leaflets; and , the repair mechanism has two modes of capture and separation; wherein, when the repair mechanism is in the capture mode and clamps the native valve leaflets, the valve support is in the middle area of the repair mechanism, and the valve support recovers It is a preset shape and promotes the disassembly and separation of the repair mechanism; the native valve can still work normally before the valve stent replaced by the solution of the present application is not implanted, which buys more time for the operation and effectively reduces the complications; the valve stent can be guided along the guide. The inner core reaches the middle area of the repair mechanism smoothly, the positioning is accurate and the operation is more convenient. When the valve stent gradually expands radially to restore the preset shape, the repair mechanism is separated and embraced on the periphery of the valve stent to complete the implantation.

Description

Transcatheter heart valve replacement system

Technical Field

The present application relates to the field of medical devices, and in particular, to a transcatheter heart valve replacement system.

Background

From the viewpoint of heart structure, whether the mitral valve or the tricuspid valve has special physiological structure, so that the accurate positioning and fixing of the product are very difficult. The location of the mitral valve, particularly within the heart, and its complex anatomy present significant challenges to mitral valve replacement.

Prior art anchoring techniques have mostly employed radial support of the atrioventricular annulus by the stent. This technique has the disadvantage of easily causing compression of the tissue surrounding the annulus, which tends to cause the stent and the compressed tissue to affect the outflow tract. In a long term, with reduced regurgitation, ventricular atrial pressure is reduced, the heart structure is reconstructed, and the large-size stent can influence the reduction of the size of the valve annulus, so that the internal structure of the heart is influenced.

In addition to this, the anchoring technique is also used to fix the leaflets by implanting a docking device in advance at the leaflets, with the stent being spread inside the docking device. Patent CN109789019A describes a heart valve pair wire loop and system from Edwards Lifesciences. The leaflets and the stent are tightly hooped together by wrapping the docking device around the outside of the leaflets. The stent is fixed in a prominent way, but the anterior lobe is greatly hooped on the stent and the left outflow blood is blocked and is not solved.

Patent CN106255476B describes a system for implanting a heart valve from the company Highlife, comprising: a radially self-expanding tubular body having an inflow end and an outflow end and a protrusion extending from a side surface of the tubular body toward the inflow end; a valve disposed within and attached to the tubular body; a fabric configured to form a pocket between the tubular body and the protrusion; and an elongate outer member arranged to be moved into the pocket and to guide cardiac tissue into the pocket such that the cardiac tissue is located between the tubular body and the elongate outer member. The technical method is also that a clamping piece is placed outside valve leaflets, and then a self-expanding valve is implanted, the clamping piece fixes the bracket at the valve leaflets, and the clamping piece is an 'annular valve', although the annular valve avoids the oppression to the annular tissue, the obstruction to the left outflow tract is not solved.

Patent US20080033541 discloses a method of securing a mitral valve stent to the mitral valve annulus using a stent secured to the stent to impinge against a substantial portion of the left atrium, thereby achieving an anchoring effect. The problem with this design is that the prosthetic mitral valve is subject to large impact forces of up and down displacement during motion, and if the struts are not sufficiently rigid, they are difficult to anchor; however, if the struts are too rigid, atrial tissue is easily damaged.

Patent CN202110076329.6 discloses a transcatheter atrioventricular valve replacement system, which comprises a valve stent, artificial valve leaflets, anchors, a covering membrane and a fixing ring. The fixing ring is a circular ring-shaped structure, can be in a circle or a plurality of circles, is coiled around the chordae tendineae of the mitral valve or the tricuspid valve by adopting a method of implantation through a catheter, and draws the chordae tendineae under each valve leaflet from the periphery to the center. The valve support comprises a body support, an atrium plate surface and a connecting piece. The anchoring piece is a plurality of structures which are connected with the body support and are blunt at the tail end of the atrium side in a reverse bending way, and the anchoring piece can hook the fixing ring to fix the valve support. The technical scheme has the defects that: the fixing ring is implanted into the heart firstly, but the fixing ring and the autologous valve or the valve support implanted later do not have a fixed stress point, so that the fixing ring is difficult to anchor with the autologous valve leaflet and the valve support, the scheme of the fixing ring is lack of practicability in implementation, and the implementation difficulty in clinical operation is very high.

In view of the foregoing, although the above techniques have some clinical success, they are deficient and a new transcatheter heart valve replacement system is needed to solve the above problems.

Disclosure of Invention

The present application has been made in view of the above and other concepts. The primary object of the present application is to overcome some of the problems and deficiencies of the prior art.

In the aspect of the application of atrioventricular valve surgery, the present application aims to provide a transcatheter heart valve replacement system for patients who have lesions in the atrioventricular valve and need interventional therapy, so that the problems of the prior art that the heart valve replacement system causes compression on the native valve annulus and the leaflets block the outflow tract and the like can be solved.

According to an aspect of the present application, there is provided a transcatheter heart valve replacement system comprising: a valve stent having a preset configuration; a repair mechanism configured to be positioned in a middle region of the native valve and to pinch the native valve leaflets; the repair mechanism has two forms of catching and separating; wherein when the repair mechanism is in the capture configuration and clamps the native valve leaflets, the valve stent is in a middle region of the repair mechanism, and the valve stent returns to the preset configuration and facilitates detachment of the repair mechanism.

According to one embodiment, when the repair mechanism captures and pinches the native valve leaflets, the repair mechanism moves towards the atrium direction; thus, the height of the valve leaf can be lifted, and the obstruction to the left ventricular outflow tract is avoided.

According to one embodiment, the repair mechanism comprises a first clamping device and a second clamping device, wherein the first clamping device and the second clamping device are detachably connected; and the first clamping device and the second clamping device can respectively catch and clamp different autologous valve leaflets.

According to an embodiment, the first clamping device and the second clamping device are made of metal memory alloy materials.

According to one embodiment, the first and second clamping devices are each provided with an engagement structure that defines the relative positions of the first and second clamping devices and the native valve leaflet.

According to one embodiment, the occluding structure may be barbs or other structures that anchor to the leaflets so that the first and second occluding devices can securely bite into the native leaflets.

According to another embodiment, the occluding structure may be disposed at one end of each of the first and second occluding devices, and the occluding structure may "staple" the native valve leaflets to prevent slippage after the first and second occluding devices occlude the native valve leaflets.

According to one embodiment, a leaflet receiving cavity is formed at one end of the first and second clamping devices, and when the first and second clamping devices capture and clamp the native leaflets, a portion of the native leaflets is curled in the leaflet receiving cavity.

According to one embodiment, the device further comprises a guiding inner core; the far end of the guide inner core is provided with a controllable release part, and the controllable release part is detachably connected with the first clamping device and the second clamping device respectively.

According to an embodiment, the first clamping device is provided with a first support member, and the first support member is provided with a first disengaging portion; the second clamping device is provided with a second supporting member, and the second supporting member is provided with a second disengaging part; wherein, first portion of releaseing and second of releaseing pass through the guide inner core realizes dismantling the connection.

According to an embodiment, the controllable release portion is substantially cylindrical in configuration, the first and second release portions can be mutually engaged to form a snap-like connection, and then the controllable release portion is inserted between the first and second release portions to form a detachable connection; when the controllable releasing part withdraws from the middle of the first releasing part and the second releasing part, the valve support provides radial expansion force for the first clamping device and the second clamping device, so that the first clamping device and the second clamping device are completely detached and separated.

According to one embodiment, after the repair mechanism has completed capturing and pinching the leaflets, the valve stent may be advanced along the inner guide core and into the middle region of the repair mechanism.

According to one embodiment, an expandable channel is formed between the first and second support members when the repair mechanism is in the capture state; and after the valve stent enters the expandable channel, the controllable release part is detached and separated from the repair mechanism, and the valve stent radially expands to restore to a preset shape and promotes the first clamping device and the second clamping device to be separated.

According to one embodiment, the valve holder is provided with a leak-proof ring within the atrium, the leak-proof ring being configured to adapt to the morphology of the valve annulus physiology.

According to one embodiment, the anti-leakage ring has a predetermined shape, and is in a grid-like or zigzag-like or wavy structure.

According to another embodiment, the repair mechanism includes an atrial fixation portion configured to conform to the shape of the valve annulus anatomy.

According to an embodiment, the valve stent may be a ball-expanded stent or a self-expanding stent.

According to one embodiment, the repair mechanism includes an anchoring ring that is at the periphery of and encircles the native valve leaflet when the repair mechanism captures the native valve leaflet.

According to an embodiment, the anchoring ring is connected with the first and second clamping means, respectively.

According to an embodiment, the anchoring ring is substantially a ring-shaped structure; and the anchoring ring is a closed-loop structure or the anchoring ring and the repair mechanism are matched to form a closed-loop structure.

According to an embodiment, the circumference of the anchoring ring is smaller than the circumference of the valve stent; and, the anchoring ring has a circumference smaller than a circumference of the native annulus.

According to one embodiment, the anchoring ring cooperates with the valve support to curl native leaflets in an atrial direction during radial expansion back to the preset configuration.

According to one embodiment, said anchoring ring is substantially sheet-like, thread-like or twine-like.

According to one embodiment, the anchoring ring may be a suture, braid, ePTFE or other high molecular polymer, and may be made of a sheet, filament or other possible friction enhancing shape made of the material Niti.

According to one embodiment, the anchoring ring has a peripheral covering membrane that increases friction with the native leaflets.

According to one embodiment, the system further comprises a first delivery device for loading and delivering the repair mechanism, wherein the guiding core is disposed within the first delivery device, and a second delivery device for loading and delivering the valve stent, and wherein the second delivery device is accessible into the body along a path of the guiding core.

Compared with the prior art, the application has the advantages and beneficial technical effects that at least the following are included:

1. the traditional valve prosthesis can cause the autologous valve to be immediately out of work when the replacement is carried out; in one embodiment of the application, the repair mechanism is used for capturing and clamping the autologous valve leaflets to realize edge-to-edge repair, so that the regurgitation of the valve can be effectively reduced, and meanwhile, the autologous valve still can normally work before the replaced valve stent is implanted, so that more time is won for the operation and the complications are effectively reduced; meanwhile, the valve stent can smoothly reach the middle area of the repair mechanism along the guide inner core, the positioning is accurate, the operation is more convenient, and when the valve stent gradually expands in the radial direction and recovers the preset shape, the repair mechanism is separated and encircles the periphery of the valve stent to complete the implantation.

2. Different from the prior art, in one embodiment of the present application, after the controllable release portion is withdrawn from the middle of the first release portion and the second release portion, the valve stent provides radial expansion force to the first clamping device and the second clamping device during the gradual radial expansion to restore the preset shape, so as to complete the detachment and separation; the structure is simple to assemble, the disassembly operation is very convenient, the development of clinical operation is facilitated, and the clinical significance is good.

3. Different from the prior art, in one embodiment of the application, the leaflet containing cavities are formed in one end of the first clamping device and one end of the second clamping device, so that when the repair mechanism captures and clamps the leaflets, part of the autologous leaflets can be curled in the leaflet containing cavities, the length of the leaflets is shortened, the obstruction to the left ventricular outflow tract is effectively avoided, and the influence of native leaflet tissues on blood flow after replacement is reduced; especially when used for mitral valve replacement, the utility model is very applicable to the physiological characteristics of the mitral valve anterior lobe, and has good clinical significance.

4. Different from the prior art, in one embodiment of the application, the anchoring ring is connected with the repair mechanism, when the repair mechanism enters the heart to capture the valve leaflets, the anchoring ring is arranged on the periphery of the autologous valve leaflets, at the moment, the repair mechanism is lifted towards the direction of the atrium, so that part of the autologous valve leaflets can be fished up by the anchoring ring, the valve stent is further radially expanded to support the anchoring ring, and the anchoring ring and the autologous valve leaflets are anchored; and the anchoring ring limits the axial displacement of the valve stent, so that the valve stent is prevented from radially supporting the native valve annulus, and meanwhile, the anchoring ring can curl part of the native valve leaflets, so that the influence of the native valve leaflet tissue on blood flow after replacement is reduced.

Embodiments of the present application may realize other beneficial technical effects not listed individually, which other technical effects may be partially described below and which would be expected and understood by those skilled in the art after reading the present application.

Drawings

The above features and advantages and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description, taken in conjunction with the accompanying drawings, wherein:

FIGS. 1 a-1 b are schematic and schematic views of the overall structure of the valve stent and the repair mechanism of the present invention.

Fig. 2a to 2i are schematic structural diagrams and schematic diagrams of the repair mechanism, the core wire guide and the first conveying device according to the present invention.

Fig. 3 a-3 d are schematic views of the first delivery device of the present invention entering the heart and then the prosthetic device facing the orifice of the mitral valve.

Fig. 4 a-4 j are schematic diagrams illustrating the process of the repair mechanism of the present invention capturing and clamping the anterior and posterior leaflets of a mitral valve together with a second delivery device to release a valve stent.

Fig. 5 a-5 f are schematic views of a prosthetic device provided with an anchoring ring according to another embodiment of the present invention.

Fig. 6 a-6 j are schematic views illustrating a process for repairing a mitral valve according to another embodiment of the present invention.

FIGS. 7 a-7 b are schematic views of a prosthetic device with atrial appendages according to another embodiment of the present invention.

The names of the parts indicated by the numbers in the drawings are as follows: 1-a valve stent, 11-a containment ring, 2-a repair mechanism, 21-a first clamping device, 211-a first support member, 2111-a first release, 22-a second clamping device, 221-a second support member, 2211-a second release, 23-an occlusion structure, 24-a leaflet-receiving lumen, 25-an expandable channel, 26-an atrial fixation, 3-an anchoring ring, 4-a guiding core, 41-a controlled release, 5-a first delivery device, 6-a second delivery device.

Detailed Description

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

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

Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items possible.

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

In this application, proximal refers to the end proximal to the operator and distal refers to the end distal to the operator.

In the prior art, the native valve usually fails to work normally in the process of replacing the atrioventricular valve, and the traditional treatment means can cause the whole valve to be in an orifice regurgitation state in the process of replacing, thus causing short operation time and high risk, and possibly causing various diseases.

According to one embodiment, for example in the treatment of mitral valve disease, there is provided a transcatheter heart valve replacement system, as shown in fig. 1a and 1b, comprising: avalve stent 1 having a preset configuration; arepair mechanism 2 configured to be positioned in the middle region of the native valve and to clamp the native valve leaflets; the repair means 2 has two forms of catching and separating; wherein, when therepair mechanism 2 is in the capture shape and clamps the autologous valve leaflets, thevalve support 1 is in the middle area of therepair mechanism 2, and thevalve support 1 is restored to the preset shape and facilitates the disassembly and separation of therepair mechanism 2.

According to an example, therepair mechanism 2 comprises afirst clamping device 21 and asecond clamping device 22, thefirst clamping device 21 and thesecond clamping device 22 being detachably connected; moreover, the first andsecond clamping devices 21 and 22 can respectively capture and clamp different autologous valve leaflets; thefirst clamping device 21 captures and clamps the front valve leaflet, thesecond clamping device 22 captures and clamps the back valve leaflet, and the repairingmechanism 2 is moved towards the atrium after the repairingmechanism 2 clamps the self valve leaflet, so that the height of the valve leaflet can be lifted, and the left ventricular outflow tract is prevented from being blocked.

According to an example, thefirst clamping device 21 and thesecond clamping device 22 are made of a metal memory alloy material.

According to an example, the first andsecond clamping devices 21 and 22 are each provided with anengagement structure 23, wherein theengagement structure 23 can define the relative positions of the first andsecond clamping devices 21 and 22 and the native valve leaflets, as shown in fig. 2e and 2 f.

According to one embodiment, the occludingstructure 23 may be barbs or other structures capable of anchoring with the leaflets so that the first andsecond occluding devices 21 and 22 can firmly grasp the native leaflets.

According to an example, one end of the first andsecond clamping devices 21 and 22 are each provided with aleaflet receiving cavity 24, and when the first andsecond clamping devices 21 and 22 capture and clamp the native leaflets, a portion of the native leaflets is curled within theleaflet receiving cavity 24; according to the physiological anatomical structure of the heart, the anterior valve leaflet of the mitral valve is long, and in the traditional replacement surgery, the autologous valve leaflet has no special treatment measures, so that the anterior valve leaflet can shield the left ventricular outflow tract and has great influence on blood outflow; thefirst clamping device 21 is provided with the valveleaflet accommodating cavity 24, so that when the first clamping device captures and clamps the front valve leaflet, the part of the front valve leaflet, which is close to the tip of the valve leaflet, can be curled in the valveleaflet accommodating cavity 24, the length of the front valve leaflet can be shortened, the left ventricular outflow tract is prevented from being shielded, and the repairingmechanism 2 is very convenient to capture and clamp the autologous valve leaflet and has good clinical significance.

According to an example, further comprises a guidingcore 4; after therepair mechanism 2 finishes catching and clamping the valve leaflets, thevalve stent 1 can enter and reach the middle area of therepair mechanism 2 along theinner guide core 4; the distal end of the guidinginner core 4 is provided with acontrollable release portion 41, and thecontrollable release portion 41 is detachably connected with thefirst clamping device 21 and thesecond clamping device 22 respectively, as shown in fig. 2a to 2 i.

According to an example, thefirst clamping device 21 is provided with afirst support member 211, and thefirst support member 211 is provided with afirst disengagement portion 2111; thesecond nip device 22 is provided with asecond support member 221, and thesecond support member 221 is provided with a second escapingportion 2211; wherein the first andsecond relief portions 2111 and 2211 are detachably connected by theguide core 4, as shown in fig. 2h and 2 i.

According to an example, thecontrollable release portion 41 has a substantially cylindrical configuration, the first andsecond release portions 2111 and 2211 can be engaged with each other to form a snap-like connection, and then thecontrollable release portion 41 is inserted between the first andsecond release portions 2111 and 2211 to form a detachable connection; after thecontrollable release portion 41 is withdrawn from the middle between the first andsecond release portions 2111 and 2211, thevalve stent 1 provides radial expansion force to the first andsecond clamping devices 21 and 22, so that the first and second clamping devices complete detachment.

According to an example, when therepair mechanism 2 is in the capture state, thefirst support member 211 and thesecond support member 221 form anexpandable channel 25 therebetween; and, after the valve-stent 1 enters theexpandable channel 25, the controllable releasingpart 41 is detached from therepair mechanism 2, and the valve-stent 1 is radially expanded to restore to the preset configuration and to facilitate the separation of thefirst clamping device 21 and thesecond clamping device 22.

According to an example, thevalve holder 1 is provided with aleakage prevention ring 11 in the atrium, theleakage prevention ring 11 being configured to adapt to the shape of the valve annulus physiology.

According to an example, thevalve stent 1 may be a balloon stent or a self-expanding stent.

According to an example, afirst delivery device 5 for loading and delivering therepair mechanism 2 is further included, wherein the guidingcore 4 is disposed within thefirst delivery device 5, and asecond delivery device 6 for loading and delivering thevalve stent 1, and wherein thesecond delivery device 6 is accessible into the body along the path of the guidingcore 4.

An exemplary procedure for repairing a mitral valve in a transcatheter heart valve replacement system according to one embodiment is as follows:

1. operating thefirst delivery device 5 from the inferior vena cava into the heart, and subsequently operating thefirst delivery device 5 such that therepair mechanism 2 passes through the atrial septum, as shown in figures 3 a-3 c; continuing to operate thefirst delivery device 5 to bend so that therepair mechanism 2 is facing the orifice of the mitral valve, as shown in fig. 3 d;

2. operating thefirst delivery device 5 to make the first andsecond clamping devices 21 and 22 respectively capture and clamp the anterior and posterior leaflets of the mitral valve, as shown in fig. 4a and 4b, and when therepair mechanism 2 clamps the leaflets, thefirst delivery device 5 is withdrawn from the body and the guidingcore 4 is retained, as shown in fig. 4 c;

3. operating thesecond delivery device 6 to enter the heart along the path of the guidinginner core 4, as shown in fig. 4d and 4e, operating the guidinginner core 4 to detach from the repairingmechanism 2 when thevalve stent 1 enters the middle area of the repairingmechanism 2, further operating thesecond delivery device 6 to gradually release thevalve stent 1, and radially expanding thevalve stent 1 and restoring the preset shape, as shown in fig. 4 f-4 h;

4. thevalve stent 1 is radially expanded to make the first andsecond clamping devices 21 and 22 thereof abut against the periphery of thevalve stent 1 and return to the preset configuration and be anchored in the heart, as shown in fig. 4i and 4, therepair mechanism 2 is clamped between thevalve stent 1 and the native leaflets, and then thesecond delivery device 6 is withdrawn from the body.

Example two:

the second embodiment is substantially the same as the first embodiment, except that theprosthetic device 2 in this embodiment further comprises ananchoring ring 3, wherein theanchoring ring 3 engages thevalve stent 1 to anchor it to the native leaflets.

As shown in fig. 5a, in the present embodiment, avalve stent 1 is included, which has a preset shape; and arepair mechanism 2 configured to be positioned in a middle region of the native valve and to pinch the native valve leaflets; wherein therepair mechanism 2 comprises afirst clamping device 21 and asecond clamping device 22; theanchoring ring 3 is fixedly connected with the repairingmechanism 2; when therepair mechanism 2 catches and clamps the autologous valve leaflets, theanchoring ring 3 is positioned at the periphery of the autologous valve leaflets and embraces the autologous valve leaflets, and thevalve stent 1 is positioned in the middle area of therepair mechanism 2; when thevalve stent 1 is radially expanded to restore to the preset shape, thefirst clamping device 21 and thesecond clamping device 22 respectively lean against the periphery of thevalve stent 1, thevalve stent 1 radially supports theanchoring ring 3, and theanchoring ring 3 is matched with thevalve stent 1 to realize anchoring with the autologous valve leaflets and limit the axial movement of the autologous valve leaflets.

In this embodiment, thevalve stent 1 can enter and reach the middle region of therepair mechanism 2 along theinner guiding core 4 after therepair mechanism 2 finishes catching and clamping the valve leaflets.

In this embodiment, the first andsecond clamping devices 21 and 22 are two separate members and are axially arranged in thefirst delivery device 5, and when thefirst clamping device 21 is used to capture the anterior leaflet, thesecond clamping device 22 is released to capture and clamp the posterior leaflet.

In this embodiment, theanchoring ring 3 is connected to the first and second clamping means 21 and 22, respectively, as shown in fig. 5 b-5 d.

In the present embodiment, theanchoring ring 3 is substantially a ring-shaped structure; and, theanchoring ring 3 cooperates with theprosthetic mechanism 2 to form a closed loop structure.

In this embodiment, the circumference of theanchoring ring 3 is smaller than the circumference of thevalve stent 1; and, the circumference of theanchoring ring 3 is smaller than the circumference of the native annulus.

In this embodiment, after therepair mechanism 2 captures and clamps the autologous leaflets, the guidinginner core 4 is pulled to make therepair mechanism 2 clamp the autologous leaflets and lift towards the atrium; when thevalve support 1 enters the middle area of therepair mechanism 2 along the guideinner core 4, the guideinner core 4 withdraws towards the near end relative to therepair mechanism 2 to detach and separate thevalve support 1, theanchoring ring 3 and thevalve support 1 cooperate to curl the autologous valve leaflets towards the atrium direction in the process of radially expanding and restoring thevalve support 1 to the preset shape, and thevalve support 1 is fixed on the autologous valve leaflets through theanchoring ring 3.

In this embodiment, theanchoring ring 3 is substantially sheet-like, thread-like or twine-like, as shown in fig. 5c and 5 e.

In this embodiment, anchoringring 3 may be a suture, braid, ePTFE or other high molecular polymer, and may be made of Niti material in sheet, thread or other possible shape that increases friction.

In this embodiment, theanchoring ring 3 has a peripheral membrane that increases the friction with the native leaflets, as shown in fig. 5 f.

An exemplary procedure for repairing a mitral valve of a transcatheter heart valve replacement system of the second embodiment is as follows:

1. operating thefirst delivery device 5 from the inferior vena cava into the heart, and subsequently operating thefirst delivery device 5 such that therepair mechanism 2 passes through the atrial septum, as shown in figures 3 a-3 c; continuing to operate thefirst delivery device 5 to bend so that therepair mechanism 2 is facing the orifice of the mitral valve, as shown in fig. 3 d;

2. operating thefirst delivery device 5 to make the first andsecond clamping devices 21 and 22 respectively capture and clamp the anterior and posterior leaflets of the mitral valve, and when therepair mechanism 2 clamps the leaflets, thefirst delivery device 5 is withdrawn from the body and the guidinginner core 4 is retained, as shown in fig. 6a and 6 b;

3. when thevalve stent 1 enters the middle area of therepair mechanism 2, thesecond delivery device 6 is further operated to gradually release thevalve stent 1, and thevalve stent 1 radially expands and restores the preset shape, as shown in fig. 6 c-6 f;

4. thevalve stent 1 is radially expanded so that the first andsecond clamping devices 21 and 22 thereof are placed against the outer circumference of thevalve stent 1, further radially expanded so that it supports theanchoring ring 3 and returns to the preset configuration to be anchored in the heart, the native leaflets are clamped between the anchoringring 3 and thevalve stent 1, and then thesecond delivery device 6 is withdrawn from the body, as shown in fig. 6g to 6 j.

In this regard, the related configuration and concept of the second embodiment are similar to those of the first embodiment, and thus, the description thereof will not be repeated here.

Example three:

the third embodiment is substantially the same as the second embodiment except that theprosthetic device 2 further includes anatrial fixation portion 26.

As shown in fig. 7a, in the present embodiment, a valve stent 1 is included, which has a preset shape; and a repair mechanism 2 configured to be positioned in a middle region of the native valve and to pinch the native valve leaflets; wherein the repair mechanism 2 comprises a first clamping device 21 and a second clamping device 22; the repair mechanism 2 comprises an atrium fixing part 26, the atrium fixing part 26 is configured to adapt to the shape of the valve annulus physiological structure, the atrium fixing part 26 is fixedly connected with the first clamping device 21 and the second clamping device 22 respectively, and the anchoring ring 3, the anchoring ring 3 is matched and connected with the first clamping device 21 and the second clamping device 22 respectively; when the repair mechanism 2 catches and clamps the autologous valve leaflets, the anchoring ring 3 is positioned at the periphery of the autologous valve leaflets and embraces the autologous valve leaflets, and the valve stent 1 is positioned in the middle area of the repair mechanism 2; when the valve stent 1 is radially expanded to restore to the preset shape, the first clamping device 21 and the second clamping device 22 respectively lean against the periphery of the valve stent 1, the valve stent 1 radially supports the anchoring ring 3, and the anchoring ring 3 is matched with the valve stent 1 to realize anchoring with the autologous valve leaflets and limit the axial movement of the autologous valve leaflets.

In the present embodiment, theatrium fixing portion 26 has a predetermined shape, and theatrium fixing portion 26 has a grid-like or zigzag-like structure or a wave-like structure, as shown in fig. 7 b.

In this regard, the related configuration and concept of the third embodiment are similar to those of the second embodiment, and thus, the description thereof will not be repeated here.

The foregoing description of the example embodiments of the present application has been presented for the purposes of illustration and description. The foregoing description is not intended to be exhaustive or to limit the application to the precise configuration and/or construction disclosed, and obviously many modifications and variations are possible to those skilled in the art in light of the above teaching without departing from the invention. It is intended that the scope and equivalents of the invention be defined by the following claims.

Claims (20)

Translated fromChinese

1.一种经导管心脏瓣膜置换系统，包括：1. A transcatheter heart valve replacement system comprising:瓣膜支架；和修复机构，其构造成位于自体瓣膜的中间区域并用于夹合自体瓣叶；a valve stent; and a repair mechanism configured to be positioned in the middle region of the native valve and for clamping the native valve leaflets;并且，所述修复机构具有捕捉和分离两种形态；Moreover, the repair mechanism has two forms of capturing and separating;其中，当所述修复机构处于捕捉形态并夹合自体瓣叶后，所述瓣膜支架被输送至所述修复机构的中间区域；当所述修复机构处于分离形态时，所述瓣膜支架径向扩张，并且所述修复机构被夹在所述瓣膜支架与心脏内壁之间。Wherein, when the repair mechanism is in the captured state and clamps the native valve leaflets, the valve stent is delivered to the middle area of the repair mechanism; when the repair mechanism is in the separated state, the valve stent radially expands , and the repair mechanism is sandwiched between the valve support and the inner wall of the heart.2.根据权利要求1所述的一种经导管心脏瓣膜置换系统，其中，所述修复机构包括第一夹合装置和第二夹合装置，所述第一夹合装置和第二夹合装置可拆卸连接；2. A transcatheter heart valve replacement system according to claim 1, wherein the repair mechanism comprises a first clamping device and a second clamping device, the first clamping device and the second clamping device Detachable connection;并且，所述第一夹合装置和第二夹合装置可分别捕捉并夹合不同的自体瓣叶。Moreover, the first clamping device and the second clamping device can respectively capture and clamp different native valve leaflets.3.根据权利要求1或2所述的一种经导管心脏瓣膜置换系统，其中，在所述修复机构捕捉并夹合自体瓣叶的过程中，所述修复机构向心房方向移动使得部分自体瓣叶被卷曲在所述第一夹合装置和第二夹合装置内。3. A transcatheter heart valve replacement system according to claim 1 or 2, wherein in the process of capturing and clamping the native valve leaflets by the repair mechanism, the repair mechanism moves toward the atrium to make part of the native valve The leaves are crimped within the first and second clamping means.4.根据以上权利要求中任一项所述的一种经导管心脏瓣膜置换系统，其中，还包括导引内芯；4. A transcatheter heart valve replacement system according to any one of the preceding claims, further comprising a guide core;所述导引内芯的远端设有可控释放部，所述可控释放部分别与所述第一夹合装置和第二夹合装置可拆卸连接。The distal end of the guiding inner core is provided with a controllable release part, and the controllable release part is respectively detachably connected with the first clamping device and the second clamping device.5.根据权利要求4所述的一种经导管心脏瓣膜置换系统，其中，所述瓣膜支架可沿着所述导引内芯进入并抵达所述修复机构的中间区域。5. A transcatheter heart valve replacement system according to claim 4, wherein the valve stent is accessible along the guide core to reach the intermediate region of the repair mechanism.6.根据权利要求5所述的一种经导管心脏瓣膜置换系统，其中，当所述瓣膜支架处于所述修复机构的中间区域时，所述可控释放部与所述修复机构拆卸分离；6. The transcatheter heart valve replacement system according to claim 5, wherein when the valve support is in the middle region of the repair mechanism, the controllable release portion is disassembled and separated from the repair mechanism;其中，所述瓣膜支架径向扩张并将所述第一夹合装置和第二夹合装置夹在所述瓣膜支架与心脏内壁之间。Wherein, the valve stent radially expands and sandwiches the first clamping device and the second clamping device between the valve stent and the inner wall of the heart.7.根据权利要求3-6中任一项所述的一种经导管心脏瓣膜置换系统，其中，所述第一夹合装置设有第一支撑构件，并且所述第一支撑构件设有第一解脱部；所述第二夹合装置设有第二支撑构件，并且所述第二支撑构件设有第二解脱部；7. A transcatheter heart valve replacement system according to any one of claims 3-6, wherein the first clamping device is provided with a first support member, and the first support member is provided with a first support member. a release portion; the second clamping device is provided with a second support member, and the second support member is provided with a second release portion;其中，所述第一解脱部和第二解脱部通过所述导引内芯实现可拆卸连接。Wherein, the first disengagement part and the second disengagement part are detachably connected through the guiding inner core.8.根据权利要求7中所述的一种经导管心脏瓣膜置换系统，其中，当所述修复机构处于捕捉状态时，所述第一支撑构件与第二支撑构件之间形成可扩张通道；8. A transcatheter heart valve replacement system according to claim 7, wherein an expandable channel is formed between the first support member and the second support member when the repair mechanism is in a captured state;并且，所述瓣膜支架进入所述可扩张通道后，所述可控释放部与所述修复机构拆卸分离，所述瓣膜支架径向扩张并将所述第一夹合装置和第二夹合装置夹在所述瓣膜支架与心脏内壁之间。In addition, after the valve stent enters the expandable channel, the controllable release portion is disassembled and separated from the repair mechanism, and the valve stent radially expands the first clamping device and the second clamping device. sandwiched between the valve support and the inner wall of the heart.9.根据权利要求3-8中任一项所述的一种经导管心脏瓣膜置换系统，其中，所述第一夹合装置和第二夹合装置均设有咬合结构，其咬合结构可限定所述第一夹合装置、第二夹合装置与自体瓣叶之间的相对位置；和9. A transcatheter heart valve replacement system according to any one of claims 3-8, wherein the first clamping device and the second clamping device are provided with an occlusal structure, and the occlusal structure can define the relative positions between the first clamping device, the second clamping device, and the native leaflets; and所述第一夹合装置的一端和第二夹合装置的一端均设有瓣叶容置腔，当所述第一夹合装置和第二夹合装置捕捉并夹合自体瓣叶并向心房方向提拉时，部分自体瓣叶被卷曲在所述瓣叶容置腔内。One end of the first clamping device and one end of the second clamping device are provided with leaflet accommodating cavities. When the direction is pulled, part of the native leaflet is crimped in the leaflet accommodating cavity.10.根据权利要求9中所述的一种经导管心脏瓣膜置换系统，其中，所述第一夹合装置和第二夹合装置采用金属记忆合金材料制成。10. A transcatheter heart valve replacement system according to claim 9, wherein the first clamping device and the second clamping device are made of metal memory alloy material.11.根据以上权利要求中任一项所述的一种经导管心脏瓣膜置换系统，其中，所述瓣膜支架在心房内设有防漏环，所述防漏环被构造成适应瓣环生理结构的形态。11. A transcatheter heart valve replacement system according to any one of the preceding claims, wherein the valve support is provided with a leak-proof ring within the atrium, the leak-proof ring being configured to accommodate annulus physiology Shape.12.根据权利要求1-10中任一项所述的一种经导管心脏瓣膜置换系统，其中，所述修复机构包括心房固定部，所述心房固定部被构造成适应瓣环生理结构的形态。12. A transcatheter heart valve replacement system according to any one of claims 1-10, wherein the repair mechanism comprises an atrial fixation portion configured to conform to the shape of the valve annulus physiology .13.根据上述任一项权利要求所述的一种经导管心脏瓣膜置换系统，其中，所述瓣膜支架可以是球扩支架或自膨支架。13. A transcatheter heart valve replacement system according to any preceding claim, wherein the valve stent may be a ball expandable stent or a self-expanding stent.14.根据上述任一项权利要求所述的一种经导管心脏瓣膜置换系统，其中，所述修复机构包括锚定环，在所述修复机构夹合自体瓣叶后，所述锚定环处于自体瓣叶的外周。14. A transcatheter heart valve replacement system according to any one of the preceding claims, wherein the repair mechanism includes an anchoring ring that is in a position after the repair mechanism clamps the native valve leaflets. Periphery of native leaflets.15.根据权利要求14所述的一种经导管心脏瓣膜置换系统，其中，所述锚定环分别与所述第一夹合装置和第二夹合装置连接。15. The transcatheter heart valve replacement system of claim 14, wherein the anchoring rings are connected to the first and second clamping devices, respectively.16.根据权利要求14所述的一种经导管心脏瓣膜置换系统，其中，所述锚定环为闭环结构或者所述锚定环与所述修复机构配合形成闭环结构。16. The transcatheter heart valve replacement system according to claim 14, wherein the anchoring ring is a closed-loop structure or the anchoring ring cooperates with the repair mechanism to form a closed-loop structure.17.根据权利要求14-16中任一项所述的一种经导管心脏瓣膜置换系统，其中，所述锚定环的周长小于所述瓣膜支架的周长；并且，所述锚定环的周长小于自体瓣环的周长。17. A transcatheter heart valve replacement system according to any one of claims 14-16, wherein the perimeter of the anchoring ring is less than the perimeter of the valve support; and, the anchoring ring The circumference is smaller than the circumference of the native annulus.18.根据权利要求14-17中任一项所述的一种经导管心脏瓣膜置换系统，其中，当所述瓣膜支架径向扩张时，所述修复机构抵靠或贴靠在所述瓣膜支架的外周，所述瓣膜支架径向支撑所述锚定环使得部分自体瓣叶被卷曲。18. A transcatheter heart valve replacement system according to any one of claims 14-17, wherein the repair mechanism abuts or abuts against the valve support when the valve support is radially expanded The valve support radially supports the anchoring ring so that part of the native leaflet is crimped.19.根据权利要求14-18中任一项所述的一种经导管心脏瓣膜置换系统，其中，所述锚定环大体呈片状、丝状或麻绳状。19. A transcatheter heart valve replacement system according to any one of claims 14-18, wherein the anchoring ring is generally in the shape of a sheet, wire or twine.20.根据权利要求14-19中任一项所述的一种经导管心脏瓣膜置换系统，其中，所述锚定环的外周覆膜，其覆膜可增加与自体瓣叶之间的摩擦力。20. A transcatheter heart valve replacement system according to any one of claims 14-19, wherein the outer periphery of the anchoring ring is covered with a covering that can increase the frictional force between the native valve leaflets .

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