WO2022166063A1

WO2022166063A1 - Anchoring device and artificial heart valve device

Info

Publication number: WO2022166063A1
Application number: PCT/CN2021/099452
Authority: WO
Inventors: 赵婧; 刘祥; 闻靖
Original assignee: 上海臻亿医疗科技有限公司
Priority date: 2021-02-05
Filing date: 2021-06-10
Publication date: 2022-08-11

Abstract

An anchoring device (200), comprising a first anchoring portion (230), which is constructed to have a plurality of telescopic units (231); and a second anchoring portion (220), which comprises a first anchoring member (221), a second anchoring member (222) and a connecting portion (223). The first anchoring portion (230) is constructed to be at least partially accommodated in a telescopic unit accommodating space (2230) of the connecting portion (223). By means of at least partially accommodating the plurality of telescopic units of the first anchoring portion in the telescopic unit accommodating space, the hooking of chordae tendineae when the first anchoring portion extends and retracts can be reduced, thereby reducing damage to surrounding tissue. Further disclosed is an artificial heart valve device comprising the anchoring device.

Description

Anchoring device and artificial heart valve device

technical field

The present invention relates to the technical field of medical devices, in particular to an anchoring device for anchoring a heart valve, and an artificial heart valve device.

Background technique

The heart contains four chambers, the right atrium (RA), right ventricle (RV), left atrium (LA), and left ventricle (LV). Throughout the cardiac cycle, the pumping action of the left and right sides of the heart generally occurs simultaneously. The valve that separates the atrium from the ventricle is called the atrioventricular valve. The atrioventricular valve acts as a one-way valve to ensure the normal flow of blood in the heart chambers. The atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and from there to the lungs; blood returns to the left atrium through the pulmonary veins. The aortic valve directs blood flow through the aorta and from there to the periphery. There is usually no direct connection between the ventricles or between the atria.

At the onset of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricle. Shortly thereafter, the atrioventricular valve opens to allow unobstructed flow from the atrium into the corresponding ventricle. Shortly after the onset of ventricular systole (ie, ventricular emptying), the tricuspid and mitral valves close normally, forming a seal that prevents backflow from the ventricle into the corresponding atrium.

Despite the rapid development of mitral valve replacement technology, there are still some recognized challenges in valve design, such as valve anchoring. Some of the existing mitral valve designs adopt the methods of clipping the valve leaflets and grasping the valve leaflets or tissue for anchoring. These anchoring methods will stretch the chordae tendineae and cause damage to the native valve leaflets. There is also anchoring through the Oversize design of the stent body. With this anchoring method, the stent compresses the tissue, which affects the contraction of the heart, and there is a risk of conduction block.

Therefore, it is necessary to design effective anchoring devices for mitral and tricuspid valves.

SUMMARY OF THE INVENTION

The present invention provides an anchoring device and an artificial heart valve device, which can solve the above-mentioned defects in the prior art.

The technical scheme of the present invention is as follows:

An anchoring device for anchoring a heart valve at a native valve annulus, the heart valve is provided with a connecting piece extending in an axial direction, the anchoring device comprising: a first anchoring portion configured to have a plurality of telescopic units, In order to make the first anchoring part expand and contract during cardiac activity; the second anchoring part includes a first anchoring part, a second anchoring part and a connecting part, the first anchoring part, the second anchoring part and the The connecting portion is coaxially arranged, wherein the first anchor and the second anchor are arranged oppositely, and one end of the connecting portion is fixed to the first anchor, and the other end is fixed to the second anchor; One end of the first anchoring portion is fixed to the connecting piece, and the other end is fixed to the second anchoring portion, the connecting portion is configured with an accommodating space for a telescopic unit, and the first anchoring portion is configured to be at least partially accommodated in The telescopic unit is accommodated in the accommodating space.

Oppositely disposed first and second anchors can be fixed on both sides of the tissue, such as at the apex of the heart, or at the interventricular septum, such as the first anchor is attached to the apical epicardium, and the second The anchor is located on the inner wall of the heart apex, and has a large contact area with the tissue to provide axial retention force for the heart valve and prevent the heart valve from falling into the atrium; wherein, the first anchor part can be stretched during the heart activity, used to bear The force exerted on the valve prosthesis during the cardiac activity, so that the valve prosthesis can adapt to different tensile forces, and it is not easy to cause damage to the tissue due to stress concentration during the cardiac activity; the first anchoring part is at least partially accommodated in the connection The expansion and contraction unit in the inner part is contained in the accommodating space, so the first anchoring part is not easy to hook the tendon chord when it is expanded and contracted, so as to reduce the damage to the surrounding tissue.

In some embodiments, a plurality of the telescopic units are coaxially arranged and connected in sequence. The first anchoring part composed of a plurality of telescopic units has good axial extensibility and the ability to restore deformation, so that it can expand and contract during cardiac systole and diastole, and bear the force generated by cardiac activity.

In some embodiments, the diameter of the telescopic unit increases in a direction away from the heart valve, so that the telescopic unit with the smallest diameter is deformed first, and the telescopic unit with the largest diameter is deformed during the stretching process of the first anchoring portion. Since it is far from the valve prosthesis, it is generally not deformed or the deformation amount is small, so that the first anchoring part can better share the force generated by the contraction of the heart. In some embodiments, the diameters of the telescopic units decrease in the direction away from the heart valve; or, in some embodiments, the diameters of a plurality of the telescopic units are the same, and the pulling force on the plurality of telescopic units is dispersed, Better anchorage.

In some embodiments, the first anchor portion is configured to be received within the telescopic unit receiving space in an unextended state, and the first anchor portion is configured to be adjacent to at least a portion of the valve prosthesis The telescopic unit can freely expand and contract in the accommodating space of the telescopic unit. The first anchoring part completely accommodated in the accommodating space of the expansion and contraction unit is not easy to hook the tendon chords during expansion and contraction, does not interfere with external tissues and structures, and enables the first anchoring when the artificial heart valve device is delivered. The first anchoring portion is accommodated in the accommodating space of the telescopic unit for delivery; and the first anchoring portion can freely expand and contract during the heart activity, so as to share the force on the artificial heart valve device when the heart contracts or relax, so that the valve prosthesis can be Adapt to different pulling forces.

In some embodiments, the connecting portion includes a first connecting portion and a second connecting portion, wherein the first connecting portion is fixed to the first anchor and the second connecting portion is fixed to the second connecting portion An anchor, wherein the first anchor and the second anchor are connected to the second connection through the first connection part. This configuration reduces the overall manufacturing difficulty of the second anchoring portion, and makes the manufacturing and forming of the first anchor and the second anchor easier.

In some embodiments, during prefabrication, the axial dimension of the connecting portion is smaller than the sum of the axial dimensions of the first anchor and the second anchor. Therefore, when the first anchor and the second anchor are used fixedly, the first anchor and the second anchor are subjected to mutual pressing force in the axial direction, so that a clamping force is generated between the first anchor and the second anchor. The holding force, which enables the second anchoring portion to be firmly attached to the tissue when in use, thereby enhancing the anchoring effect of the second anchoring portion.

In some embodiments, the first anchor member and the second anchor member are respectively configured to have a plurality of circumferentially arranged bending units, one end of the plurality of the bending units is connected, and the other end is bent and extended outwards; The bending unit of one anchor is bent toward the side of the second anchor, and the bending unit of the second anchor is bent toward the side of the first anchor. Wherein, the bending unit is a single rod-shaped or sheet-shaped structure, or the bending unit is a ring-shaped structure composed of a rod-shaped or sheet-shaped structure. The first anchor and the second anchor can be pressed to the conveyor for delivery, and can be restored to the original state after being released; and, when several bending units are in contact with the tissue, there are more contact points to prevent stress concentration on the tissue. damage.

In some embodiments, the second anchoring part is configured such that after the first anchoring part and the second anchoring part are connected by the connecting part, the bending unit of the first anchoring part and the second anchoring part The bending elements of the anchor are interspersed and distributed. This enables the first and second anchors to be squeezed and deformed in the axial direction when the first and second anchors are successively released on both sides of the tissue to form a clamping force, thereby forming a clamping force with the tissue. More secure anchoring.

In some embodiments, the second anchor portion is configured such that the radial dimension of the first anchor is greater than the radial dimension of the second anchor, or the radial dimension of the second anchor is greater than all the radial dimension of the first anchor.

In some embodiments, the connection between the first connection part and the second connection part is at least one of a wire knot connection, a hook connection, a snap connection, a gapless connection or a screw connection. Such a connection mode has the advantages of simple structure, and at the same time, a stable fixed connection can be formed between the first connection part and the second connection part.

In some embodiments, the second anchor portion is integrally manufactured to improve the connection strength of the first anchor and the second anchor; or the first anchor and the second anchor are separately formed, and then The fixed connection reduces the difficulty of forming the first anchor and the second anchor.

In some embodiments, the first anchor has a symmetrical structure with respect to the connecting portion, and the second anchor has a symmetrical structure with respect to the connecting portion. The symmetrical structure makes the forming of the first anchor and the forming of the second anchor easier, and when released to the tissue, the symmetrical structure makes the first anchor and the second anchor respectively contact with the tissue. will be more dispersed and thus more stable in anchoring to the tissue and will not move.

In some embodiments, the first anchoring portion and the second anchoring portion are respectively made of shape memory material. The first anchoring part and the second anchoring part can be pressed into the catheter, and can be restored to a preset state after being released, so as to meet the needs of interventional operations.

The present invention also provides a prosthetic heart valve device comprising the anchoring device as described above.

Compared with the prior art, the beneficial effects of the present invention are as follows:

First, in the anchoring device and the prosthetic heart valve device of the present invention, the first anchor and the second anchor that are oppositely arranged can be fixed on both sides of the tissue, such as at the apex of the heart, or at the interventricular septum, It has a large contact area with the tissue to provide axial retention force for the heart valve to prevent the heart valve from falling into the atrium; and the first anchor and the second anchor can form a clamping effect from both sides of the tissue, so that the second anchor The anchoring part provides stable anchoring force, and the anchoring is more reliable; when the axial dimension of the connecting part is smaller than the sum of the axial dimensions of the first anchor and the second anchor, or further the first anchor When the bending unit and the bending unit of the second anchor are interspersed and distributed, after the first anchor and the second anchor are placed at the target position, the two are pressed against each other, so that the first anchor and the second anchor are pressed against each other. A greater clamping force is generated between the anchors, which can make the second anchoring portion more firmly attached to the tissue, thereby enhancing the anchoring effect of the second anchoring portion.

Second, in the anchoring device and the artificial heart valve device of the present invention, the first anchoring part can expand and contract during the heart activity, and is used to bear part of the heart activity and exert the force on the valve prosthesis, so that the valve prosthesis can adapt to Different pulling forces are not easy to cause damage to the tissue due to stress concentration during the heart activity; the first anchoring part is at least partially accommodated in the accommodating space of the telescopic unit in the connecting part, so the first anchoring part is not easily hooked during expansion and contraction chordae tendineae to reduce damage to surrounding tissues; the first anchoring portion is configured to be accommodated in the accommodating space of the telescopic unit in an unextended state, so that the first anchoring portion is not easily hooked after release and during use The chordae tendineae are attached, which will not interfere with external tissues and structures; at least part of the telescopic units in the first anchoring part close to the valve prosthesis can freely expand and contract in the accommodating space of the telescopic unit, and you can worry about visceral contraction or The force on the artificial heart valve device during relaxation enables the valve prosthesis to adapt to different pulling forces.

Thirdly, the prosthetic heart valve device of the present invention can be crimped and loaded in the delivery device for delivery, such as delivery through the apical route and the atrial septal route. Compared with the apical route, the atrial septal route through the femoral vein is less invasive, and the audience Wider; under the transseptal approach, the anchoring portion can be anchored to the apex or to the ventricular wall.

Of course, it is not necessary for any product embodying the present invention to achieve all of the above-described advantages simultaneously.

Description of drawings

1 is a schematic structural diagram of an artificial heart valve device according to Embodiment 1 of the present invention;

Fig. 2 is the partial structure schematic diagram of the artificial heart valve device of the embodiment 1 of the present invention;

3A is a schematic structural diagram of the first anchoring portion of Embodiment 1 of the present invention;

3B is a schematic structural diagram of another first anchoring portion according to Embodiment 1 of the present invention;

3C is a schematic structural diagram of yet another first anchoring portion according to Embodiment 1 of the present invention;

Fig. 4 is the front view structure schematic diagram of the second anchoring part of the embodiment 1 of the present invention;

5 is a schematic structural diagram of the second anchoring portion in the prefabricated state of Embodiment 1 of the present invention;

6A is a schematic diagram of the overall structure of the first anchor and the second anchor according to Embodiment 1 of the present invention;

6B is another schematic structural diagram of the first anchor and the second anchor according to Embodiment 1 of the present invention;

6C is another structural schematic diagram of the first anchor and the second anchor according to Embodiment 1 of the present invention;

6D is a schematic diagram of the overall structure of another second anchoring portion according to Embodiment 1 of the present invention;

6E is a schematic diagram of the overall structure of yet another second anchoring portion according to Embodiment 1 of the present invention;

7A is a schematic diagram of the delivery structure of the artificial heart valve device according to Embodiment 1 of the present invention;

7B is a schematic diagram of the release structure of the second anchoring portion according to Embodiment 1 of the present invention;

FIG. 7C is a schematic diagram of the delivery completion structure of the artificial heart valve device according to Embodiment 1 of the present invention.

Reference numerals: valve prosthesis 100; first region 101; second region 102; third region 103; stent 110; anchoring device 200; 223; second anchor 222; bending unit 224; first bending unit 2241; second bending unit 2242; first anchoring part 230; telescopic unit 231; Section 2232.

Detailed ways

In the description of the present invention, it should be noted that the valve prosthesis is also referred to as a heart valve, which is a prosthetic structure deployed at the native valve annulus to replace the native valve. Wherein, the artificial heart valve device of the present invention may be a mitral valve valve or a tricuspid valve valve.

In the description of the present invention, it should be noted that the accommodating space for the telescopic unit in the connecting portion is a column-shaped space, or a substantially column-shaped space, so that the first anchoring portion can expand and contract therein, wherein the connecting portion can adopt It is integrally manufactured and formed, at this time, the connecting part is a hollow tubular structure with both ends open; or the connecting part is formed by connecting the first connecting part and the second connecting part.

The radial dimension of the accommodating space of the telescopic unit, that is, the inner diameter of the connecting portion.

The axial dimension of the first anchor is the axial dimension of the first anchor in the prefabricated state, and the axial dimension of the second anchor is the axial dimension of the second anchor in the prefabricated state.

Interspersed distribution refers to interspersed along the axial direction of the heart valve.

The distal end refers to the side away from the operator, and the proximal end refers to the side closer to the operator.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. The indicated orientation or positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, which is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the indicated device or element must have a specific orientation or a specific orientation. construction and operation, and therefore should not be construed as limiting the invention. Furthermore, the terms "first", "second", and "third" are used for descriptive purposes only and should not be construed to indicate or imply relative importance.

In the description of the present invention, it should be noted that the terms "installed", "connected" and "connected" should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood in specific situations.

As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

The present invention will be further described below in conjunction with specific embodiments.

Example 1

This embodiment provides an artificial heart valve device, see FIG. 1 to FIG. 7C , which are schematic structural diagrams of the artificial heart valve device in this embodiment, wherein the heart valve is composed of a valve prosthesis 100 , a connector 210 and an anchoring device 200, the valve prosthesis 100 includes a stent 110, a skirt and artificial valve leaflets.

As shown in FIG. 1 , the artificial heart valve device of this embodiment can be longitudinally divided into a first region 101 , a second region 102 and a third region 103 . After implantation in the human body, the first region 101 is attached to the native mitral valve. On the ring, the valve prosthesis 100 is prevented from falling from the left atrium to the left ventricle. The second area 102 is used to carry the artificial valve leaflets, and at the same time, it is supported on the tissue to play a certain role of fixing and sealing; the third area 103 is the The anchoring mechanism of the heart valve in the left ventricle prevents the prosthesis from being impacted by blood into the left atrium when the prosthesis is closed.

Among others, stent 110 can provide several functions for valve prosthesis 100, including serving as the main structure of the valve, carrying internal prosthetic leaflets, serving as a seal to inhibit paravalvular leakage between valve prosthesis 100 and the native valve, and delivering The connection structure of the system (hanging ears or fixed ears), etc. Optionally, the stent 110 is woven or cut. Optionally, the stent 110 is made of nickel-titanium alloy or other biocompatible materials with shape memory properties, and elastically or plastically deformable materials, such as balloons, can also be selected. Expandable material.

Further, the bracket 110 is a columnar structure with open ends, such as a cylinder, an ellipse column, etc., and its cross-section is configured as a circle, an ellipse, a petal shape, a round shape, a D shape, and the like. The stent 110 is constructed as a grid-like structure, which is composed of a number of closed geometric cells arranged, such as diamond, square, heart, teardrop, etc., so that the stent 110 can be compressed into the sheath when loaded, and can be recovered when released. undisturbed.

The prosthetic leaflets are dynamically switched between open and closed states, in which the prosthetic leaflets are closed or joined in sealing abutment. The prosthetic valve leaflets can be formed from any suitable material or combination of materials, and in some embodiments, biological tissue such as chemically stable tissue from a heart valve from an animal such as a pig, or pericardial tissue from an animal such as bovine (bovine pericardium) or sheep (sheep pericardium) or pig (porcine pericardium) or equine (horse pericardium), preferably bovine pericardium tissue. Prosthetic leaflets can also be made from small intestinal submucosal tissue, in addition, synthetic materials can also be used for the prosthetic leaflets, such as expanded polytetrafluoroethylene or polyester; Ether urethanes, segmented polyether urethanes, silicone polyether urethanes, silicone-polycarbonate urethanes, and ultra-high molecular weight polyethylene. Additionally, biocompatible polymers can be used for prosthetic valve leaflets, optionally including polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride , other fluoropolymers, silicone polyesters, siloxane polymers and/or oligomers, and/or polylactones, and block copolymers using them. Optionally, the prosthetic leaflets have a surface that is treated (or reacted with) an anticoagulant, including but not limited to heparinized polymers.

The skirt can be a single-layer structure, or a double-layer structure inside and outside. Knitted, woven, woven polyester fabrics, PTFE, ePTFE and other materials can be selected, which mainly play the role of sealing and prevent backflow.

The end of the valve prosthesis 100 is provided with a connecting piece 210 , and the connecting piece 210 extends along the axial direction of the valve prosthesis 100 . The ends are joined, such as by stitching. The connector 210 provides traction for the stent 110 to prevent the stent 110 from being impacted by blood and displaced to the left ventricle when the heart contracts. Of course, the valve prosthesis 100 can also be configured with other anchoring structures to prevent the valve prosthesis 100 from falling from the left atrium. into the left ventricle.

The connector 210 may be, for example, a pull cord, wire, or rod-like structure, etc., and may be made of, for example, a biocompatible polymeric material including, but not limited to, ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene, and the like. The connector 210 may be inelastic to provide a more robust stent anchoring force, or elastic to provide a higher degree of stretch compliance during the cardiac cycle. Alternatively, the connector 210 may be made of a bioabsorbable material and thereby provide temporary fixation until endothelialization between the prosthesis and assembly is sufficient to provide an anchoring force for the valve prosthesis. Optionally, the connecting member includes a pulling rope, a connecting wire or a connecting rod, and the like.

1-4, the anchoring device 200 includes a first anchoring part 230 and a second anchoring part 220, the first anchoring part 230 is configured to have a plurality of telescopic units 231, so that the first anchoring part 230 is in the Telescoping during cardiac activity; the second anchoring part 220 includes a first anchoring part 221 , a second anchoring part 222 and a connecting part 223 , the first anchoring part 221 , the second anchoring part 222 , and the connecting part 223 Coaxial arrangement, wherein the second anchor 222 is arranged opposite to the first anchor 221, one end of the connecting portion 223 is fixed to the first anchor 221, and the other end is fixed to the second anchor 222; one end of the first anchoring portion 230 is fixed to the connecting member 210, and the other end is fixed to the second anchoring portion 220, the connecting portion 223 is configured with a telescopic unit accommodating space 2230, and the first anchoring portion 230 is configured to be at least partially accommodated within the telescopic unit accommodating space 2230 .

In the anchoring device of this embodiment, the oppositely arranged first anchor 221 and second anchor 222 can be respectively released on both sides of the tissue. Or attached at the interventricular septum, with a large contact area with the tissue, to provide axial retention for the heart valve and prevent the heart valve from falling into the atrium. Wherein, the first anchoring portion 230 can expand and contract during heart activity, and can be used to analyze the force applied to the valve prosthesis 100 during heart activity, so that the valve prosthesis can adapt to different pulling forces and is not affected during heart activity. It is easy to cause damage to the tissue due to stress concentration; the first anchoring part 230 is at least partially accommodated in the telescopic unit accommodating space 2230 in the connecting part, so the first anchoring part 230 is not easy to hook the tendon chord when it expands and contracts, so as to reduce the impact on the surrounding area. tissue damage.

Specifically, the telescopic unit 231 is configured as a helical coil. In some embodiments, a plurality of the telescopic units 231 are coaxially arranged and connected end to end in sequence, and the first anchoring portion 230 composed of the plurality of telescopic units 231 has good axial extensibility and the ability to restore deformation, thereby It can expand and contract during cardiac systole and diastole, and withstand the force generated by cardiac activity.

In some embodiments, the diameters of the plurality of telescopic units 231 increase in the direction away from the valve prosthesis 100 , as shown in FIG. 3A , that is, the telescopic unit with the largest diameter among the plurality of telescopic units 231 is located away from the connector 210 , and the multi- Among the telescopic units 231 , the telescopic unit with the smallest diameter is located close to the connecting member 210 , and the telescopic unit with the smallest diameter is connected with the connecting member 210 . In this way, during the stretching process of the first anchoring part 230, the telescopic unit with the smallest diameter is deformed first (because the contraction force of the heart is first transmitted to the end of the connector 210 close to the valve prosthesis 100), and the diameter Since the largest telescopic unit is far away from the valve prosthesis 100 , it is generally not deformed or the deformation amount is small, so that the first anchoring portion 230 can better share the force generated by the heart contraction.

In an optional embodiment, the diameter of the telescopic unit 231 decreases in a direction away from the valve prosthesis 100 . As shown in FIG. 3B , the telescopic unit with the largest diameter is arranged close to the connecting piece 210 , and the telescopic unit with the smallest diameter is arranged at a position away from the connecting piece 210 , wherein the telescopic unit with the largest diameter is connected with the connecting piece 210 , and similarly The purpose of making the first anchoring portion 230 cooperate with the connecting member 210 to adapt to the beating of the heart can be achieved.

In some embodiments, the diameters of the plurality of telescopic units 231 are the same. As shown in FIG. 3C , a plurality of telescopic units 231 with the same diameter are connected in sequence in the axial direction, and the telescopic units 231 are preferably distributed at equal intervals. When the two ends of the connecting member 210 have tension, the telescopic unit 231 close to the connecting member 210 among the multiple telescopic units 231 with the same diameter is stretched first, and the remaining multiple telescopic units 231 are in order from near to far away from the connecting member 210 Stretch until the elastic force of the plurality of telescopic units 231 with the same diameter is balanced with the contraction force of the heart. After the tension is released, the telescopic units 231 of the plurality of telescopic units 231 with the same diameter that are far away from the connecting piece 210 first return to their original state, and the remaining multiple telescopic units 231 return to their original state in order from farthest to the closest to the connecting piece 210 . The advantage of this embodiment is that the tensile force received by the plurality of telescopic units 231 is dispersed, and the anchorage is better.

In some embodiments, the first anchoring portion 230 is configured to be accommodated in the telescopic unit accommodating space 2230 in an unextended state, and the first anchoring portion 230 is configured to be close to the valve prosthesis. At least part of the telescopic units 231 can be freely expanded and contracted in the telescopic unit accommodating space 2230 .

In the embodiment shown in FIG. 2 , in a natural state, the first anchoring portion 230 is completely accommodated in the connecting portion, so that the first anchoring portion 230 is not easily hooked to the tendon chord after release and during use, and the external The tissue and structure will not interfere; and, when the prosthetic heart valve device of this embodiment is delivered, the first anchoring portion 230 is accommodated in the accommodating space of the telescopic unit for delivery. Wherein, in the stretched state, the first anchoring portion 230 may be completely accommodated in the telescopic unit accommodating space 2230; or, the first anchoring portion 230 may also be configured such that the stretched portion is accommodated in the telescopic unit Outside the space 2230, for example, the stretched and elongated portion extends to a position close to the valve prosthesis 100, which will not be repeated here.

In an optional embodiment, the first anchoring portion 230 is configured such that in an unextended state, the telescopic unit 231 close to the valve prosthesis 100 is accommodated in the telescopic unit accommodating space 2230 and away from the valve The telescopic unit 231 of the prosthesis 100 is disposed outside the telescopic unit accommodating space 2230 , that is, away from the telescopic unit 231 of the valve prosthesis 100 and extends beyond the first anchor 221 , so that the end of the first anchor portion 230 is It can be fixed on the outer side of the first anchor 221 to facilitate the fixing between the first anchor part 230 and the second anchor part 220 .

Further, in some embodiments, the connecting portion 223 has a uniform inner diameter along the axial direction. In order to enable the first anchoring portion 230 to freely expand and contract in the axial direction within the connecting portion 223 , the telescopic unit 231 of the first anchoring portion 230 has an inner diameter. The radial dimension should be smaller than the radial dimension of the telescopic unit accommodating space 2230 .

In some embodiments, the radial dimension of at least part of the telescopic unit 231 should be smaller than the radial dimension of the telescopic unit accommodating space 2230 , and further, at least part of the telescopic unit 231 close to the valve prosthesis 100 has a diameter The radial dimension should be smaller than the radial dimension of the telescopic unit accommodating space 2230 . Therefore, during the cardiac activity of the first anchoring portion 230, at least part of the telescopic unit 231 can be freely expanded and contracted in the connecting portion 223 to withstand the force generated during the cardiac activity.

Wherein, in the embodiment shown in FIG. 3A , the telescopic unit 231 away from the valve prosthesis 100 may be configured to have the same radial dimension as the telescopic unit accommodating space 2230 or a size larger than that of the telescopic unit accommodating space 2230 . The radial dimension is larger, while the radial dimension of the telescopic unit 231 close to the valve prosthesis 100 should be smaller than the radial dimension of the telescopic unit accommodating space 2230, so that the telescopic unit 231 close to the valve prosthesis 100 can freely expand and contract . In the embodiment shown in FIG. 3B , the radial dimension of the telescopic unit 231 close to the valve prosthesis 100 should be smaller than the radial dimension of the telescopic unit accommodating space 2230 .

In some embodiments, the radial dimensions of the plurality of telescopic units 231 are smaller than the radial dimensions of the telescopic unit accommodating space 2230 , so that the entire first anchoring portion 230 can freely expand and contract in the connecting portion. In the embodiment shown in FIG. 3C , the radial dimension of the telescopic unit 231 should be slightly smaller than the radial dimension of the telescopic unit accommodating space 2230 , so that the first anchoring portion 230 can freely expand and contract in the axial direction.

In some embodiments, when the inner diameter of the connecting portion 223 is different in the axial direction, the first anchoring portion 230 is configured to be at least partially close to the telescopic unit 231 of the valve prosthesis and can be connected to the telescopic unit Free expansion and contraction in the accommodating space 2230, that is, the radial dimension of the telescopic unit 231 close to the valve prosthesis should be smaller than the radial dimension of the telescopic unit accommodating space 2230 on the side close to the valve prosthesis, so that during the heart activity process , the telescopic unit 231 close to the valve prosthesis can be stretched and contracted to bear the force generated during the heart activity.

Wherein, the end of the first anchoring portion 230 is fixed to the second anchoring portion 220, and the fixing method can be wire knot or welding; the end of the first anchoring portion 230 can be fixed in the telescopic unit accommodating space 2230, Or fixed to the outer side of the first anchor 221 , and the fixing method can be selected according to actual needs, which will not be repeated here.

Specifically, the second anchoring portion 220 may be integrally manufactured. That is, the first anchor 221 , the second anchor 222 , and the connecting portion 223 are integrally manufactured. For example, a tubular structure is cut by a cutting process. The integral manufacturing process makes the first anchor 221 , the second anchor The connection strength of the anchor 222 is higher, and the overall structure of the second anchor portion 220 is more stable.

In some embodiments, the connection part includes a first connection part 2231 and a second connection part 2232, see FIG. 4-FIG. 6C, the first connection part 2231 is fixed to the first anchor 221, the first connection part 2231 Two connecting parts 2232 are fixed to the second anchor 222 , and the first anchor 221 and the second anchor 222 are connected to the second connecting part 2232 through the first connecting part 2231 . The first connecting portion 2231 and the first anchor member 221 can be manufactured integrally, the second connecting portion 2232 and the second anchor member 222 can be manufactured integrally, and then the first connecting portion 2231 and the second connecting portion 2232 can be fixedly connected .

In some embodiments, the first anchor 221 , the second anchor 222 , and the connecting portion 223 are formed separately, and two ends of the connecting portion 223 are respectively fixed to the first anchor 221 and the second anchor 222 . In some embodiments, the first anchor 221, the second anchor 222, the first connecting part 2231 and the second connecting part 2232 can also be manufactured separately, and then the first connecting part 2231 and the first anchor 221 are fixed, and the first connecting part 2231 and the first anchor 221 are fixed. The two connecting parts 2232 are fixed to the second anchor 222 , and then the first connecting part 2231 and the second connecting part 2232 are fixedly connected. This configuration reduces the difficulty of manufacturing the second anchor portion 220 as a whole, and makes the manufacturing and molding of the first anchor 221 and the second anchor 222 easier. Wherein, after the second anchoring portion 220 is fixed and formed, the telescopic unit accommodating space 2230 is formed between the first connecting portion 2231 and the second connecting portion 2232 to accommodate the above-mentioned first anchoring portion 230 .

In some embodiments, during prefabrication, the axial dimension of the connecting portion 223 is smaller than the sum of the axial dimensions of the first anchor 221 and the second anchor 222 . Referring to FIG. 5 , the first anchor 221 and the second anchor 222 are in a prefabricated state, the axial dimension of the first connecting portion 2231 is h1, the axial dimension of the first anchor 221 is H1, and the second connecting portion 2232 The axial dimension is h2, the axial dimension of the second anchor 222 is H2, wherein, the axial dimension of the connecting portion 223 is h1+h2, and h1+h2 should be smaller than H1+H2. Therefore, after the first anchor 221 and the second anchor 222 are fixedly connected, as shown in FIG. 4 , the first anchor 221 and the second anchor 222 are subjected to mutual pressing force in the axial direction, so that the first anchor A clamping force F is generated between the member 221 and the second anchor member 222 , and the clamping force F can make the second anchor portion 220 more firmly attached to the tissue, thereby enhancing the anchoring effect of the second anchor portion 220 . Wherein, to generate the clamping force, the first anchor 221 and the second anchor 222 can be made of shape memory materials, preferably shape memory materials with better biocompatibility, such as shape memory metal materials such as nickel-titanium alloy or Shape memory polymer materials.

In some embodiments, the first anchor 221 and the second anchor 222 are respectively configured to have several bending units 224, wherein the bending units 224 are configured to be formed by rod-like or sheet-like structures. The bending units 224 are evenly distributed along the circumferential direction, so that the first anchor 221 and the second anchor 222 can be crimped to the conveyor for delivery, and can return to their original shape after being released. When several bending units 224 are formed into a dense network structure, the first anchor 221 and the second anchor 222 can also provide a certain blocking effect.

Specifically, as shown in FIG. 6A-FIG. 6C, they are schematic structural diagrams of the first anchor 221 and the second anchor 222 in a prefabricated state, wherein the first anchor 221 and the second anchor 222 are respectively configured as umbrellas The bending unit 224 is an annular shape formed by a rod-shaped structure, a plurality of bending units 224 are evenly distributed along the circumferential direction, and adjacent bending units 224 are stacked. The size of the first anchor 221 and the second anchor 222 may be the same or different, and the shapes of the first anchor 221 and the second anchor 222 may be the same or different.

In the embodiment shown in FIG. 6A , the first anchor 221 and the second anchor 222 are respectively configured as umbrella-shaped structures of the same size, and the axial dimension of the first connecting portion 2231 is smaller than that of the first anchor 221 . , the axial dimension of the second connecting portion 2232 is smaller than the axial dimension of the second anchor 222 . In the embodiment shown in FIG. 6B , the first anchor 221 and the second anchor 222 have the same shape, and the size of the first anchor 221 is smaller than that of the second anchor 222 ; in the embodiment shown in FIG. 6C , the first anchor 221 is smaller in size than the second anchor 222 . The anchor 221 and the second anchor 222 are different in size and shape. The first anchor 221 is in the shape of a flat umbrella, the second anchor 222 is in the shape of a concave umbrella, and the size of the first anchor 221 is larger than that of the second anchor 222 ; Wherein, the axial dimension of the first connecting part 2231 is larger than the axial dimension of the first anchor 221, the axial dimension of the second connecting part 2232 is smaller than the axial dimension of the second anchor 222, the first connecting part 2231, the first The sum of the axial dimensions of the two connecting portions 2232 is smaller than the sum of the axial dimensions of the first anchor 221 and the second anchor 222 .

Since the first anchor 221 is released at the apical epicardium and plays a supporting role, the preferred size of the first anchor 221 can be larger than that of the second anchor 222, and has a relatively larger surface area, so that it can interact with the second anchor 222. The tissue is in multi-point contact, so that the force is more dispersed, and the stress concentration is prevented from causing damage to the tissue.

In some embodiments, the first anchor 221 and the second anchor 222 are respectively configured to have a plurality of bending units 224, wherein the second anchor portion 220 is configured to be used when the first anchor 221, After the second anchors 222 are fixedly connected, the bending units 224 of the first anchors 221 and the bending units 224 of the second anchors 222 are interspersed and distributed. With such a structure, when the first anchor 221 and the second anchor 222 are successively released on both sides of the tissue, the first anchor 221 and the second anchor 222 can be squeezed and deformed in the axial direction to form a clamping force, so as to form a more reliable anchoring effect with the tissue.

In the embodiment shown in FIG. 6D , the first anchor 221 and the second anchor 222 are respectively configured as umbrella structures, the second anchor 222 has a second bending unit 2242 , and the first anchor 221 has a first bending unit 2241, the first bending unit 2241 and the second bending unit 2242 are respectively annular shapes constructed from rod-shaped structures, wherein the size of the second bending unit 2242 is larger than that of the first bending unit 2241, and is connected to The axial dimension of the portion 223 is smaller than the sum of the axial dimensions of the first anchor 221 and the second anchor 222 . After the first anchor 221 and the second anchor 222 are fixedly connected, the first bending unit 2241 is inserted into the second bending unit 2242, thereby forming an inserted structure, so that the first anchor 221 and the second anchor 222 are released. Then a clamping force is formed between the two.

In the embodiment shown in FIG. 6E , the first anchor 221 and the second anchor 222 are respectively configured as radial structures, the second anchor 222 has a second bending unit 2242 , and the first anchor 221 has a first bending unit 2241 , the first bending unit 2241 and the second bending unit 2242 are arc structures formed by sheet materials, respectively, and the bending units of the first anchor 221 and the second anchor 222 are radially distributed in the same way, And the axial dimension of the connecting portion 223 is smaller than the sum of the axial dimensions of the first anchor 221 and the second anchor 222 . Wherein, after the first anchor 221 and the second anchor 222 are fixedly connected, the first bending unit 2241 is inserted into the gap formed by the adjacent two second bending units 2242 of the second anchor 222, thereby forming an alternately inserted The structure enables the first anchor 221 and the second anchor 222 to form a clamping force between them after they are released.

Wherein, the first connection part 2231 and the second connection part 2232 can be connected by one of: wire knot connection, hook connection, snap connection, gapless connection, and screw connection, or two or more of them can be used. a combination of connections. Wherein, the first connecting portion 2231 can be configured with a male structure, and the second connecting portion 2232 can be configured with a female structure matching the male structure, so that the first connecting portion 2231 and the second connecting portion 2232 can form a stable connection, such as the first connection The first connecting portion 2231 and the second connecting portion 2232 are configured with a male thread, the second connecting portion 2232 is configured with a female thread, and the first connecting portion 2231 and the second connecting portion 2232 are connected by a thread; female buckle, the first connecting part 2231 and the second connecting part 2232 are connected by snaps; or, the first connecting part 2231 is configured with a hook, the second connecting part 2232 is configured with a concave part matched with the hook, the first connecting part 2231, the second connecting part 2231 The two connecting parts 2232 are connected by hooking; or, the outer surface of the first connecting part 2231 is smooth, the inner surface of the second connecting part 2232 is smooth, the second connecting part 2232 is sleeved outside the first connecting part 2231, and the first connecting part 2232 is A gapless connection is formed between the part 2231 and the second connecting part 2232 to realize the fixing of the two. Such a connection method has the advantages of simple structure, and at the same time, a stable fixed connection can be formed between the first connection portion 2231 and the second connection portion 2232 .

In some embodiments, the first anchor 221 has a symmetrical structure with respect to the connecting portion 223 , and the second anchor 222 has a symmetrical structure with respect to the connecting portion 223 . The forming of the second anchor 222 will be easier, and when it is released to the tissue, the symmetrical structure makes the forces generated when the first anchor 221 and the second anchor 222 contact the tissue are more dispersed, so that the contact force with the tissue will be more dispersed. The anchorage is also more stable and does not move.

The first anchor 221 and the second anchor 222 in this embodiment may be manufactured by a braiding process, or may be cut. In the embodiment shown in FIG. 6E, the first anchor 221 and the second anchor 222 may be manufactured by a cutting process. In the embodiment shown in FIG. 6A-FIG. 6D, the first anchor 221, The second anchor 222 can be manufactured by weaving or cutting. Specifically, it can be cut from a pipe, or woven from a metal wire.

When the anchoring device 200 of this embodiment is loaded, the curved unit of the first anchor 221 can be extended toward the distal end, the curved unit of the second anchor 222 can be extended toward the proximal end, and the first anchor portion 230 is located in the telescopic unit accommodating space 2230 , thereby crimp loading the anchoring device 220 into the conveyor for delivery.

The artificial heart valve device of this embodiment is released on both sides of the tissue through the first anchor 221 and the second anchor 222, and a clamping force is generated between the first anchor 221 and the second anchor 222, so that the second anchor portion Compared with the existing anchoring methods for grasping tissue, the 220 can provide better anchoring effect and cause less damage to the tissue. In addition, the first anchoring part 230 is configured to have axial extensibility, so during the systole and diastole of the heart, the first anchoring part 230 can expand and contract in the axial direction, so as to bear the force generated by the heart activity, and make the valve prosthesis 100 can better adapt to different pulling forces. Meanwhile, the first anchoring portion 210 is at least partially accommodated in the telescopic unit accommodating space 2230 of the second anchoring portion 220 , so the first anchoring portion 210 will not interfere with the outside during expansion and contraction, and will not pull the tendon. The cooperation of the first anchoring portion 230 and the second anchoring portion 220 provides stable, effective and reliable anchoring for the valve prosthesis 100 of this embodiment.

In this embodiment, the anchoring device 200 includes a first anchoring portion 230, and the first anchoring portion 230 provides axial extensibility to withstand the force generated during the heart activity. Of course, in some optional embodiments, The anchoring device 200 only includes the second anchoring part 220 but not the first anchoring part 230 . The end of the connecting piece 210 is directly connected with the second anchoring part 220 , and the anchoring effect is provided by the second anchoring part 220 .

In some optional embodiments, the anchoring device 200 includes a first anchoring part 230 and a second anchoring part 220, wherein the second anchoring part 220 only includes the first anchoring part 221 and the connecting part 223, but does not include the second anchoring part 220 Anchor 222, attached to one side of the tissue through the first anchor 221 serves as an anchor.

The prosthetic heart valve device of this embodiment can be crimped and loaded into the delivery device for delivery, such as delivery via the apical route and the atrial septal route. Compared with the apical route, the transfemoral atrial septal route is less traumatic and has a wider audience. ; Under the transseptal approach, the anchoring part can be anchored to the apex or to the ventricular wall.

Specifically, the delivery process of the artificial heart valve device of the present embodiment is as follows:

7A-7D, embodiments of transseptal delivery of a prosthetic heart valve device are illustrated. Although this example only describes the method in relation to the native mitral valve, it can similarly be used for other native heart valves (eg, the tricuspid valve).

Step 1: As shown in Figure 7A, the delivery 201 enters the right atrium via the inferior vena cava, and then traverses the atrial septum and mitral valve to the vicinity of the apex, where the distal end of the delivery 201 can pass through the apex of the heart as shown opening.

Step 2: As shown in Figure 7B, the anchoring device 200 is released by relative movement between it and a portion of the delivery 201 (eg, catheter or sheath). By relative movement is meant that the anchoring device 200 can be advanced through the catheter or sheath and out of the distal end of the delivery device 201 . The first anchor 221 is released first, and the second anchor 222 is released later. Further movement between the anchoring device 200 and the catheter or sheath can effectively deploy the location of the anchoring device 200, eg, pulling the anchoring device 200 proximally against the tip of the heart, which can be done by pulling on the suture or connector 210 to execute.

Step 3: As shown in Figure 7C, the catheter or sheath can be moved relative to the stent 110, releasing the stent portion of the valve prosthesis, allowing the valve prosthesis to be fully released at the target location. For example, the catheter or sheath can be withdrawn proximally relative to the stent 110 . In some embodiments, the length of the connector 210 can be modified at this stage or at any previous stage to adjust the tension of the connector 210 for optimal clamping force for the first anchor 221 and the second anchor 222; Finally, the connector 210 is fixed and cut, and then the delivery system is withdrawn to complete the release.

This embodiment also provides another delivery process of the artificial heart valve device, as follows:

The present invention may also be used to deliver a prosthetic heart valve device via a transapical approach, although this example only describes the method in relation to the native mitral valve, but is similarly applicable to other native heart valves (eg, the tricuspid valve).

Step 1: The delivery device 201 can be advanced through the tip of the heart to the vicinity of the native mitral valve. The catheter or sheath is moved relative to the stent 110, gradually releasing the stent 110, skirt, and prosthetic valve leaflets, allowing the valve prosthesis to be deployed at the target location. The position of the valve portion can be adjusted by the connector 210 .

Step 2: The sheath can be moved proximally relative to the stent 110 such that the distal end of the catheter or sheath is positioned outside the heart. The connector 210 is released and the anchoring device 200 is released by relative movement between it and the catheter or sheath of the delivery 201 . By relative movement is meant that the anchoring device 200 can be advanced in a direction towards the heart (distal end) through the catheter or sheath. When the anchoring device 200 extends beyond the sheath or catheter, the anchoring device 200 is slowly released.

The second anchor 222 is released first, and the first anchor 221 is released later. Further movement between the anchoring device 200 and the catheter or sheath can effectively deploy the anchoring device 200 in position, fully releasing the anchoring device 200 at or near the apex of the heart. In some embodiments, the length of the connector 210 can be modified at this stage or any previous stage to adjust the tension of the connector 210 for optimal clamping force for the first anchor 221 and the second anchor 222.

Step 3: Finally, fix and cut the connector 210, and then withdraw from the conveying system to complete the release.

The above disclosure is only the preferred embodiments of the present invention, and the preferred embodiments do not describe all the details in detail. It should be understood that these embodiments are only used to illustrate the present invention, but not to limit the protection scope of the present invention, and the present invention is only subject to rights Requirements and Limitations of their Full Scope and Equivalents.

This specification selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present invention, so that those skilled in the art can make good use of the present invention. Improvements and adjustments made by those skilled in the art according to the present invention in practical applications still belong to the protection scope of the present invention. The technical features in the different embodiments above can be combined arbitrarily on the premise that there is no conflict with each other.

Claims

An anchoring device for anchoring a heart valve at a native valve annulus, wherein the heart valve is provided with a connector extending in the axial direction, wherein the anchoring device comprises:

The first anchoring part is configured to have a plurality of telescopic units, so that the first anchoring part can expand and contract during the heart activity;

The second anchoring part includes a first anchoring piece, a second anchoring piece and a connecting part, the first anchoring piece, the second anchoring piece and the connecting part are coaxially arranged, wherein the first anchoring piece, The second anchors are arranged oppositely, and one end of the connecting portion is fixed to the first anchor, and the other end is fixed to the second anchor;

One end of the first anchoring portion is fixed to the connecting piece, and the other end is fixed to the second anchoring portion, the connecting portion is configured with an accommodating space for a telescopic unit, and the first anchoring portion is configured to be at least partially accommodated in The telescopic unit is accommodated in the accommodating space.
The anchoring device according to claim 1, wherein a plurality of the telescopic units are coaxially arranged and connected in sequence.
The anchoring device according to claim 2, wherein the diameter of each telescopic unit increases in a direction away from the heart valve, or the diameter of each telescopic unit decreases in a direction away from the heart valve, or each The telescopic units have the same diameter.
The anchoring device according to claim 1, wherein the first anchoring portion is configured to be accommodated in the telescopic unit accommodating space in an unextended state, and the first anchoring portion is configured to be close to At least part of the expansion and contraction unit of the valve prosthesis can be freely expanded and contracted in the accommodating space.
The anchoring device of claim 1, wherein the connecting portion comprises a first connecting portion and a second connecting portion, wherein the first connecting portion is fixed to the first anchor, the second connecting portion The connecting part is fixed to the second anchor, and the first anchor and the second anchor are connected with the second connecting part through the first connecting part.
The anchoring device according to claim 1 or 5, characterized in that, during prefabrication, the axial dimension of the connecting portion is smaller than the sum of the axial dimensions of the first anchor and the second anchor.
The anchoring device according to claim 1 or 5, wherein the first anchor member and the second anchor member are respectively configured to have a plurality of circumferentially arranged bending units, one end of the plurality of the bending units is connected, and the other One end is bent and extended outward; and the bending unit of the first anchor is bent to the side of the second anchor, and the bending unit of the second anchor is bent to the side of the first anchor.
The anchoring device according to claim 7, wherein the bending unit is a single rod-shaped or sheet-shaped structure, or the bending unit is an annular structure composed of a rod-shaped or sheet-shaped structure.
The anchoring device according to claim 7, wherein the second anchoring portion is configured such that after the first anchoring member and the second anchoring member are connected through the connecting portion, the first anchoring member The bending unit of the second anchor is interspersed with the bending unit of the second anchor.
8. The anchoring device of claim 7, wherein the second anchor portion is configured such that the radial dimension of the first anchor is greater than the radial dimension of the second anchor, or the second anchor The radial dimension of the anchor is greater than the radial dimension of the first anchor.
The anchoring device according to claim 5, wherein the connection between the first connection part and the second connection part adopts: wire knot connection, hook connection, snap connection, gapless connection or At least one of threaded connections.
The anchoring device according to claim 1, wherein the second anchoring part is integrally manufactured; or the first anchor and the second anchor are separately formed and then fixedly connected.
The anchoring device according to claim 1, wherein the first anchor member has a symmetrical structure relative to the connecting portion, and the second anchor member has a symmetrical structure relative to the connecting portion.
The anchoring device according to claim 1, wherein the first anchoring part and the second anchoring part are respectively made of shape memory material.
A prosthetic heart valve device comprising the anchoring device of any one of claims 1-14.