CN218739255U - Implantable valve device - Google Patents

Abstract

The utility model discloses an implantable valve device, which comprises a valve prosthesis and an anchoring structure, wherein the anchoring structure comprises an anchoring part and a connecting part, and two end parts of the connecting part are respectively connected with the valve prosthesis and the anchoring part; wherein the anchor is configured to be axially extensible to accommodate different pulling forces of the valve prosthesis. In the valve device of the utility model, the anchoring part is fixed at the end part of the connecting piece and is anchored at the epicardium of the heart apex or the ventricular wall to provide anchoring force to prevent the valve prosthesis from falling into the atrium; in addition, the anchoring piece has axial extensibility, and can be stretched and restored to the original shape, so that in the process of beating the heart, the anchoring piece can be stretched and deformed along the axial direction to adjust the length of the connecting piece in a micro mode, the valve prosthesis can adapt to different tensile forces, and damage to the heart caused by overlarge tensile force is prevented.

Description

Implantable valve device

Technical Field

The utility model relates to the technical field of medical equipment, concretely relates to a valve device for replacing or replacing native valve.

Background

The heart contains four chambers, the Right Atrium (RA), right Ventricle (RV), left Atrium (LA), and Left Ventricle (LV). The pumping action of the left and right sides of the heart generally occurs simultaneously throughout the cardiac cycle. The valve that separates the atrium from the ventricle is called the atrioventricular valve, which acts as a one-way valve to ensure the normal flow of blood in the heart chamber. 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 arteries, and from there to the lungs; the 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 beginning of ventricular filling (diastole), the aortic and pulmonary valves close to prevent regurgitation from the arteries into the ventricles. Shortly thereafter, the atrioventricular valves open to allow unimpeded flow from the atria into the respective ventricles. Shortly after the ventricular systole (i.e., ventricular emptying) begins, the tricuspid and mitral valves normally close, forming a seal that prevents backflow from the ventricles into the respective atria.

When problems occur with the atrioventricular valve, it fails to function properly, resulting in improper closure. Atrioventricular valves are complex structures, typically comprising an annulus, leaflets, chordae tendineae and a support structure, with each atrium connected to its valve by the atrial vestibulum. The mitral valve has two leaflets, and the attachment or engagement of the respective surfaces of each leaflet to one another helps provide closure or sealing of the valve, thereby preventing blood flow in the wrong direction. Failure of the leaflets to seal during ventricular systole is known as mal-coaptation and can reverse blood flow (regurgitation) through the valve. Cardiac valve insufficiency can have serious consequences for a patient, often leading to heart failure, reduced blood flow, reduced blood pressure, and/or reduced oxygen flow to human tissues. Mitral insufficiency may also cause blood to flow back from the left atrium into the pulmonary veins, causing congestion. Severe valvular insufficiency, if left untreated, can lead to permanent disability or death.

Transcatheter mitral valve replacement surgery (TMVR) is a method that uses a catheter intervention to compress a prosthetic valve extracorporeally to a delivery system, deliver it along a vascular path or through the apex, and release it to the mitral annulus to replace the native valve. Compared with the surgery operation, the TMVR does not need an extracorporeal circulation auxiliary device, has small wound and quick recovery of the patient, and can obviously improve the hemodynamic index of the postoperative patient.

Although mitral valve replacement techniques have been developed at a rapid pace, there are several recognized challenges in valve design, such as valve anchoring. The existing mitral valve designs adopt the valve clamping blades or the valve clamping blades are used for anchoring, and the two anchoring modes can pull the chordae tendineae and damage the native valve blades. There is also anchoring by the Oversize design of the stent body, with which the stent stresses the tissue, affecting the heart contraction, and risking conduction block.

SUMMERY OF THE UTILITY MODEL

The utility model provides an implantable valve device, which can solve the defects in the prior art.

The technical scheme of the utility model as follows:

an implantable valve device comprising a valve prosthesis for replacing or replacing a native valve and an anchoring structure for anchoring the valve prosthesis, the anchoring structure comprising an anchoring element and a connector element, the two ends of the connector element being connected to the valve prosthesis and the anchoring element, respectively; wherein the anchor is configured to be axially extensible to accommodate different pulling forces of the valve prosthesis.

The anchor is fixed at the end of the connector and when the valve device is implanted, the anchor anchors at the epicardium or ventricular wall (e.g., ventricular septum) to provide an anchoring force that prevents the valve prosthesis from falling into the atrium. In addition, the anchoring piece also has axial extensibility, and can be stretched and restored to the original shape, so that the anchoring piece can be stretched and deformed along the axial direction in the beating (contraction and relaxation) process of the heart, the length of the connecting piece is micro-adjusted, the valve prosthesis can adapt to different pulling forces, and the damage to the heart caused by overlarge pulling force is prevented.

In some embodiments, the anchor is configured with a plurality of helical elements, i.e. the anchor is a helical structure which may provide the anchor with axial extensibility.

In some embodiments, the diameter of the spiral unit increases in a direction away from the valve prosthesis, wherein the spiral unit with the smallest diameter is connected with the connecting element, and the spiral unit with the smallest diameter is firstly deformed during the stretching process, while the spiral unit with the largest diameter is generally not deformed or is deformed by a small amount, so that the spiral unit with the largest diameter can continuously provide good anchoring force without being influenced. In some embodiments, the diameter of the spiral unit decreases progressively in the direction away from the valve prosthesis, and the spiral unit with the largest diameter is connected with the connecting element, so that the aim of matching the anchoring element with the connecting element to adapt to the beating of the heart can be achieved. In other embodiments, the diameters of a plurality of spiral units are the same, the tension force applied to the plurality of spiral units is dispersed, and the anchoring property is better.

In some embodiments, the anchors are configured such that in an unstressed state, adjacent helical elements are equally spaced such that tension may be evenly distributed during stretching.

In some embodiments, the anchor is configured to assume a disc-like or spring-like shape in an unstressed state. When the anchoring member is configured like a disk, it may, for example, take on a "mosquito coil" shape, allowing a greater contact area between the anchoring member and the heart tissue at the anchoring location.

In some embodiments, the anchor is made of a shape memory material, and when the valve device is loaded, the anchor can be stretched to a nearly linear state for delivery, so that compared with the pull rope anchor in the prior art, the anchor has a small cross section and is easier to deliver; after release the anchor assumes a disc-like or spring-like shape as described above.

During the systole or diastole, the screw unit of the anchor member will generate axial extension and contraction along with the beating of the heart, and easily generate force to the tissue. To this end, in some embodiments, the valve device further comprises a tissue-engaging spacer movably disposed to the anchoring structure. Wherein, the anchoring piece is separated from the tissue by the arranged isolating piece, so that the damage to the tissue caused by the direct contact of a plurality of spiral units and the tissue in the beating process of the heart is avoided. In addition, after the valve device is anchored, the isolating piece is always attached to the tissue, and the function of blocking the wound can be achieved.

In some embodiments, the spacer is sleeved on the anchor, or the spacer is sleeved on one end of the connecting piece and is close to the position of the anchor. The isolating piece and the connecting piece or the anchoring piece are in non-fixed connection, so that the isolating piece can only do axial movement, and the degrees of freedom in other directions are limited. The mode of establishing makes to produce relative movement between isolator and the spiral unit, and during cardiac contraction or diastole, the axial extension of spiral unit can carry out fine-tuning to the length of connecting piece to adapt to different pulling force demands, prevent that the pulling force is too big to cause the damage to the heart.

In some embodiments, the spacer is configured to conform to the tissue anchoring site, and the spacer can closely conform to the tissue to achieve a better occlusion effect.

In some embodiments, the spacer is made of a shape memory material or an elastic material, so that the spacer can be crimped into a catheter of the delivery device for delivery, and compared with the prior art, the transcatheter delivery does not need to be opened, thereby reducing wounds and injuries.

Compared with the prior art, the beneficial effects of the utility model are as follows:

firstly, the anchoring part of the anchoring device of the utility model is fixed at the end of the connecting piece, after the valve device is implanted, the anchoring part is anchored at the epicardium of the apex of the heart or the ventricular wall to provide anchoring force, so as to prevent the valve prosthesis from falling into the atrium; in addition, the anchoring piece also has axial extensibility, and can be stretched and restored, so that the anchoring piece can be stretched and deformed along the axial direction in the beating process of the heart, the length of the connecting piece can be adjusted in a micro-way, the valve prosthesis can adapt to different tension, and the heart is prevented from being damaged by the overlarge tension.

Second, the utility model discloses an anchor assembly, anchor assembly structure are for having the helical structure of a plurality of spiral units, work as when anchor assembly is made by shape memory material, at valve device loading in-process, anchor assembly can stretch and carry for the less state of diameter again, and the sectional area is little, changes the transport.

Thirdly, when the anchoring device is provided with the isolating piece, the isolating piece can isolate the anchoring piece from the tissue, so that damage to the tissue caused by direct contact of a plurality of spiral units and the tissue in the beating process of the heart is avoided; the cooperation of barrier member and anchor assembly can play better anchor effect, and in addition, the barrier member can be constructed for attaching all the time on organizing, can also play the effect of shutoff wound.

Of course, it is not necessary for any particular product to achieve all of the above-described advantages at the same time.

Drawings

Fig. 1 is a schematic view of the overall structure of a valve device according to example 1 of the present invention;

fig. 2 is a partial schematic view of an anchoring structure according to embodiment 1 of the present invention;

fig. 3A is a schematic view of an embodiment of the anchor according to embodiment 1 of the present invention;

fig. 3B is a schematic view of another embodiment of the anchor member according to embodiment 1 of the present invention;

fig. 3C is a schematic view of another embodiment of the anchor according to embodiment 1 of the present invention;

fig. 4A is an initial schematic view of implantation of the valve device of example 1 of the present invention;

fig. 4B is a schematic view of the release process of the valve device according to example 1 of the present invention when implanted;

fig. 4C is a schematic view of another release process when the valve device of example 1 of the present invention is implanted;

fig. 4D is a schematic view showing the end of release of the valve device according to example 1 of the present invention when implanted.

Reference numerals: a valve prosthesis 100; a first region 101; a second region 102; a third region 103; a support 110; an anchor structure 140; a connector 141, an anchor 142; a spiral unit 1421; a spacer 143; a conveyor 201.

Detailed Description

The utility model provides an implantable valve device for replace or replace the native valve of pathological change, this valve device includes valve prosthesis 100 and anchor structure 140, and this anchor structure 140 includes anchor assembly 142 and connecting piece 141.

Taking the mitral valve device as an example, as shown in fig. 1, the valve device can be longitudinally divided into a first region 101, a second region 102, and a third region 103. After the valve device is implanted into a human body, the first area 101 is attached to the valve ring of a native mitral valve of a heart to prevent the valve prosthesis 100 from falling into the left ventricle from the left atrium, the second area 102 is used for bearing artificial valve leaflets, and meanwhile, the second area 102 is supported on tissues to play a certain role in fixing and sealing; third region 103 serves as an anchoring structure 140 for valve prosthesis 100 within the left ventricle, providing an axial anchoring force to the valve prosthesis, preventing valve prosthesis 100 from being impacted by blood into the left atrium when it is closed.

Specifically, the valve prosthesis 100 is mainly composed of a stent 110, a skirt and an artificial valve leaflet. Stent 110 can provide several functions for valve prosthesis 100, including serving as the main structure of the valve, carrying the prosthetic leaflets inside, serving as a seal to inhibit paravalvular leakage between the mitral valve prosthesis and the native valve, the attachment structure to the delivery system (by providing a tab or retaining ear on the end of stent 110), and so forth. Optionally, the stent 110 is woven or cut, optionally, the stent 110 is made of nitinol or other biocompatible material having shape memory characteristics, and optionally, an elastically or plastically deformable material, such as a balloon expandable material. Valve prosthesis 100 is implanted into the body via a delivery device, such as a delivery sheath, into which valve prosthesis 100 is crimped and released and expanded to the shape shown in fig. 1 after implantation at the target site.

The support 110 is a cylindrical structure with two open ends, such as a cylinder, an elliptic cylinder, etc., and the cross section thereof is configured to be circular, elliptic, petal-shaped, quasi-circular, D-shaped, etc. The stent 110 is constructed in a lattice-like structure consisting of a plurality of closed geometric units arranged in a diamond shape, a square shape, a heart shape, a drop shape, etc., so that the stent 110 can be compressed into a sheath when loaded and can be restored to its original shape when released. Of course, in some embodiments, the stent 110 may also be configured as a circumferentially non-closed structure, such as a sector, and such a valve prosthesis 100 may be used to replace native leaflets of a lesion, rather than a total replacement.

Specifically, the connecting element 141 is connected to one end of the valvular prosthesis 100, and the extending structure extending from the end points of the diamond-shaped geometric units at one end of the stent 110 is connected to the end of the connecting element 141, such as by sewing. The connecting member 141 provides traction to the stent 110 to prevent the stent 110 from being displaced to the left ventricle by blood impact during systole. The connection 141 may be, for example: a drawstring, a wire or rod-like structure, etc., and the connecting member 141 may be made of a material such as a biocompatible polymer, including but not limited to ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene, etc. Connectors 141 may be inelastic to provide a more secure stent anchoring force; it may also be resilient to provide a higher degree of traction compliance during the cardiac cycle. Alternatively, the attachment 141 may be made of a bioabsorbable material and thereby provide temporary fixation until endothelialization between the valve prosthesis and the tissue is sufficient to provide an anchoring force for the valve prosthesis.

The artificial valve leaflet is dynamically switched between an open state and a closed state, and in the closed state, a plurality of artificial valve leaflets are tightly closed or converged in a sealing and abutting mode. The prosthetic leaflet can be formed of any suitable material or combination of materials, and in some embodiments, a biological tissue such as a chemically stable tissue from a heart valve of an animal (e.g., a pig), or a pericardial tissue of an animal such as a bovine (bovine pericardium) or ovine (ovine pericardium) or porcine (porcine pericardium) or equine (equine pericardium), preferably bovine pericardial tissue, can be selected. The artificial leaflet may also be made of small intestine submucosal tissue, and in addition, synthetic materials may also be used for the artificial leaflet, for example, expanded polytetrafluoroethylene or polyester; optionally, thermoplastic polycarbonate polyurethane, polyether polyurethane, segmented polyether polyurethane, silicone-polycarbonate polyurethane, and ultra-high molecular weight polyethylene are also included. Additionally, biocompatible polymers can be used for the artificial valve leaflet, the polymers optionally including polyolefins, elastomers, polyethylene glycols, polyethersulfones, polysulfones, polyvinylpyrrolidones, polyvinyl chlorides, other fluoropolymers, silicone polyesters, silicone polymers and/or oligomers, and/or polylactones, and block copolymers using the same. Optionally, the artificial leaflet has a surface treated with (or reacted with) an anticoagulant, including but not limited to heparinized polymers.

The skirt edge can be in a single-layer structure or an inner-outer double-layer structure, and materials such as knitted, woven and braided polyester fabrics, PTFE, ePTFE and the like can be selected. The skirt 120 covers the support 110 and serves primarily as a seal to prevent reflux.

The utility model discloses an anchor assembly structure is for having the axial extensibility, therefore when anchor assembly attaches with the tissue, not only can provide the anchor effect, moreover at the heart in-process of beating (shrink and diastole), anchor assembly can produce the axial tension in order to undertake the partial pulling force of connecting piece, prevents the connecting piece is at heart activity in-process to the dragging of tissue.

Further, when the anchoring member is constructed of the shape memory alloy, the anchoring member can be stretched to a nearly linear state, so that the valve device can be loaded in the catheter of the conveyor in a whole for conveying, the sectional area is smaller, and the risk is smaller.

In the description of the present invention, it should be noted that the valve prosthesis 100 of the present invention can also be used as a tricuspid valve.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood in specific cases to those skilled in the art.

As used in this specification, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise.

The present invention will be further described with reference to the following specific examples.

Example 1

The present embodiment provides an implantable valve device, referring to fig. 1 to 4D, which are schematic structural views of the valve device of the present embodiment, the valve device includes a valve prosthesis 100 for replacing or replacing a native valve and an anchoring structure 140 for anchoring the valve prosthesis 100, the anchoring structure 140 includes an anchoring element 142 and a connecting element 141, and two ends of the connecting element 141 are connected to the valve prosthesis 100 and the anchoring element 142 respectively; wherein the anchors 142 are configured to have an axial extension to accommodate different pulling forces of the valve prosthesis 100.

The anchors 142 of the present embodiment are attached to tissue to provide an anchoring force, such as anchoring to the epicardium or ventricular wall, providing an axial retention force that prevents the valve prosthesis 100 from falling into the atrium. Because the anchoring member has axial extensibility, the anchoring member 142 can be stretched and deformed in the axial direction during the beating (contraction and relaxation) of the heart, so as to realize the micro adjustment of the length of the connecting member 141, thereby enabling the valve prosthesis 100 to adapt to different pulling forces and preventing the damage to the heart caused by excessive pulling force.

In some embodiments, the anchoring member 142 is configured to have a plurality of spiral units 1421 distributed along the axial direction, and the plurality of spiral units 1421 are coaxially disposed, so as to provide better axial extensibility for the anchoring member 142, and easily recover when tensile deformation occurs. The anchoring part 142 can play a role in anchoring and can adjust the tension of the connecting piece.

Specifically, the anchor 142 is comprised of 2-10 spaced apart helical elements 1421. In some embodiments, the diameter of the plurality of spiral units 1421 increases in a direction away from the valve prosthesis 100 (fig. 3A), i.e., the spiral unit 1421A with the largest diameter of the plurality of spiral units 1421 is located at a position away from the valve prosthesis 100, and the spiral unit 1421B with the smallest diameter of the plurality of spiral units 1421 is located at a position close to the valve prosthesis 100, wherein the spiral unit 1421B with the smallest diameter is connected to the connecting member 141. With such an arrangement, the spiral unit 1421B with the smallest diameter can be deformed first when the connecting element 141 is stretched (because the contraction force of the heart is transmitted to the connecting element 141 first near the end of the valve prosthesis 100), while the spiral unit 1421A with the largest diameter is generally not deformed or deformed by a small amount because it is far from the valve prosthesis 100, so that the spiral unit 1421A with the largest diameter can continuously provide a good anchoring force without being affected during the contraction or relaxation of the heart; the phenomenon that all or more of the coils move integrally when the connecting element 141 is subjected to the force of the heart contraction is avoided.

In an alternative embodiment, the diameter of the spiral unit 1421 decreases in a direction away from the valve prosthesis 100. As shown in fig. 3B, the largest diameter spiral unit 1421A is disposed near the connecting element 141, and the smallest diameter spiral unit 1421B is disposed far from the connecting element 141, wherein the largest diameter spiral unit 1421A is connected to the connecting element 141, and the purpose of adapting the anchoring element 142 to the heart beat by matching with the connecting element 141 can also be achieved.

In some embodiments, a plurality of the spiral units 1421 have the same diameter. As shown in fig. 3C, a plurality of spiral units 1421 having the same diameter are spaced apart in the axial direction, and the spiral units 1421 are preferably equally spaced apart from each other. When the two ends of the connecting member 141 have a tensile force, the spiral unit near the valve prosthesis 100 among the plurality of spiral units 1421 having the same diameter is first stretched, and the remaining plurality of spiral units are sequentially stretched from the proximal to the distal according to the distance from the valve prosthesis 100 until the elastic force of the plurality of spiral units 1421 having the same diameter is balanced with the contraction force of the heart. After the pulling force is released, the spiral units far away from the valve prosthesis 100 in the plurality of spiral units 1421 with the same diameter are firstly restored to the original state, and the rest of the plurality of spiral units are sequentially restored to the original state from far to near from the valve prosthesis 100. The advantage of this embodiment is that the tension on the plurality of spiral units 1421 is distributed and the anchoring is better.

In some embodiments, the spiral elements comprising the anchoring elements 142 are non-constant diameter spiral elements, the anchoring elements 142 are configured in a disk-like shape, as shown in fig. 1, the anchoring elements 142 are in a "mosquito coil" shape in an unstretched natural state, and the "mosquito coil" anchoring elements 142 can have a larger contact area with the anchoring site of the heart tissue.

In some embodiments, the anchoring member 142 is configured to be in a spring shape, such as a compression spring shape in an unstressed natural state, and a plurality of spiral units 1421 are distributed along an axial direction, wherein the spiral units constituting the anchoring member 142 may be equal-diameter spiral units or unequal-diameter spiral units, as shown in fig. 3A to 3C.

In some embodiments, the anchor 142 is made of a shape memory material with good biocompatibility, such as a shape memory metal material such as nitinol or a shape memory polymer material. When the valve device of the embodiment is loaded, the anchoring piece 142 can be stretched to be in a nearly linear shape and then conveyed, so that compared with the pull rope anchoring piece in the prior art, the cross section is small, and the conveying is easier; the anchor 142 assumes a disc-like or spring-like shape as described above upon release. The valve device of this embodiment may be implanted with less trauma by the option of trans-atrial septal implantation.

In a preferred embodiment, the valve device further comprises a tissue-engaging spacer 143, the spacer 143 being movably disposed on the anchoring structure 140. During systole or diastole, the spiral units 1421 of the anchor 142 will stretch and contract axially along with the heart, which is easy to apply force to the tissue, and the anchor 142 is separated from the tissue by the spacer 143, so as to avoid the damage to the tissue caused by the direct contact between the spiral units 1421 and the tissue. In addition, as the anchoring member 142 is axially stretched or contracted, the spacer 143 is always attached to the tissue, and can also serve to close the wound.

In some embodiments, the spacer 143 is sleeved on the anchor 142, and preferably, the spacer 143 is sleeved on an end of the spiral unit 1421 of the anchor and is close to the connecting element 141. In some embodiments, the isolation member 143 is sleeved on an end of the connection member 141 at a position close to the anchoring member 142, so that the isolation member 143 can be closely attached to the tissue, and the axial telescopic movement of the anchoring member 142 is facilitated, so that the screw unit 1421 can adjust the length of the connection member 141 slightly during the systole or diastole to meet different tension requirements. The isolating piece 143 is connected with the connecting piece 141 or the anchoring piece 142 in a non-fixed manner, so that the isolating piece can only move axially, and the degrees of freedom in other directions are limited, thereby achieving a better blocking effect.

Specifically, the spacer 143 may be a circular, circular arc, rectangular, disc-shaped, or other plate-like structure. In order to allow the spacer 143 to closely conform to the tissue for better sealing, the spacer 143 should be configured to conform to the tissue anchoring site. The spacers 143 are configured to conform to the shape of the epicardium (with curvature) when the anchor 142 is anchored in an apical position, and the spacers 143 are configured to conform to the shape of the ventricular wall (with a near-planar surface) when the anchor 142 is anchored in a ventricular wall position, such as a ventricular septum.

Wherein, the spacer 143 may be configured as a spacer structure, and the center of the spacer has a small hole through which the spacer is inserted between the connecting member 141 and the anchoring member 142, so that the spacer can slide axially along the connecting member 141 or along the anchoring member 142.

Further, the outer diameter of the isolation member 143 is adapted to the catheter of the delivery device, and the structure and/or material arrangement makes the outer diameter of the isolation member 143 after release slightly larger than the outer diameter of the catheter of the delivery device, so that the wound can be blocked after release. For example, the spacer 143 is made of a shape memory metal sheet, an elastic rubber sheet, or the like, and is folded or bent to be pressed in the catheter, and when released, the outer diameter of the spacer 143 becomes larger after the pressing force of the catheter is released, so that the effect of blocking the wound is achieved.

In some embodiments, anchor 142 is further provided with a stop means for preventing spacer 143 from sliding off the free end of anchor 142. Wherein the stop means may be provided between the two ends of the anchoring member 142, or the stop means may be provided at the free end of the anchoring member 142, for example, in such a way that the radial dimension of the free end of the anchoring member 142 is larger than the radial dimension of the central aperture of the spacer member 143, so as to prevent the spacer member 143 from slipping out of the free end of the anchoring member 142 during implantation of the valve device in the body and during use.

The present embodiments also provide a method of replacing a heart valve, comprising providing an implantable valve device, the valve device being a valve device as described in any one of the above or a similar valve device.

The interatrial septum approach through the femoral vein is less traumatic and more popular than the apical approach. The anchoring structure may be anchored to the apex of the heart or to the ventricular wall of the heart under the transseptal path. The anchoring apex is illustrated in this example and referring to fig. 4A-4D, an embodiment of a prosthetic valve prosthesis 100 delivered transatrial-the-atrial is illustrated, although this example describes only the method associated with the native mitral valve, but similarly, other native heart valves (e.g., tricuspid valve) are also contemplated.

Step 1: as shown in fig. 4A, the delivery device 201 enters the right atrium via the inferior vena cava and then passes through the interatrial septum and mitral valve to near the apex, and the distal end of the delivery device 201 may pass through the opening of the apex of the heart.

And 2, step: as shown in fig. 4B, the anchor 142 is released by relative movement between it and a portion of the delivery device 201 (e.g., a catheter or sheath), by which is meant that the anchor 142 can be advanced through the catheter or sheath and out the distal end of the delivery device 201, with the anchor 142 being released first and the spacer 143 being released later.

And 3, step 3: as shown in fig. 4C, further movement between the anchor 142 and the catheter or sheath can be effective to deploy the position of the anchor 142, for example, pulling the anchor 142 proximally to abut the apex of the heart, which can be performed by pulling on the suture or connector 141.

And 4, step 4: as shown in fig. 4D, the catheter or sheath can be moved relative to the stent 110, releasing the stent portion of the valve, allowing the valve to be fully released at the target site. For example, the catheter or sheath may be withdrawn proximally relative to the stent 110. In some embodiments, the length of the connection 141 may be modified at this stage or any previous stage to adjust the tension of the connection 141 to achieve the best sealing effect of the gasket 143. Finally, the connector 141 is fixed and cut, and the delivery system is withdrawn, completing the release.

In some embodiments, the valve devices described above can also be used for transapical delivery. Although this example describes only methods relating to the native mitral valve, it is similarly applicable to other native heart valves (e.g., tricuspid valves), and replacement methods delivered via the apical route include:

step 1: transporter 201 may be advanced through the tip of the heart to the vicinity of the native mitral valve. The catheter or sheath is moved relative to stent 110 to gradually release stent 110, the skirt, and the prosthetic valve leaflets to allow the valve to be deployed at the target site, and the position of valve prosthesis 100 can be adjusted by attachment element 141.

Step 2: the sheath can be moved proximally relative to the stent 110 so that the distal end of the catheter or sheath is positioned outside the heart and the anchor 142 is released by relative movement between it and the catheter or sheath of the delivery device 201. By relative movement, it is meant that the anchor 142 may be advanced in a direction toward the heart (distal end) through a catheter or sheath. The anchor 142 is slowly released as the anchor 142 extends beyond the sheath or catheter. Wherein the spacer 143 is released first and the anchor 142 is released later.

And step 3: further movement between the anchor 142 and the catheter or sheath can effectively deploy the position of the anchor 142, fully releasing the anchor 142 against or near the apex of the heart. In some embodiments, the length of the coupling 141 may be modified at this stage or any previous stage to adjust the tension of the coupling 141 to achieve the best sealing effect of the spacer 143.

And 4, step 4: finally, the connector 141 is fixed and cut, and the delivery system is withdrawn, completing the release.

While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, to thereby enable others skilled in the art to best utilize the invention. In practical applications, the improvement and adjustment made by those skilled in the art according to the present invention still belong to the protection scope of the present invention. The technical features in the different embodiments can be combined arbitrarily without mutual conflict.

Claims (10)

1. An implantable valve device, comprising a valve prosthesis for replacing or replacing a native valve and an anchoring structure for anchoring the valve prosthesis, the anchoring structure comprising an anchoring element and a connecting element, the two ends of the connecting element being connected to the valve prosthesis and the anchoring element, respectively; wherein the anchor is configured to be axially extensible to accommodate different pulling forces of the valve prosthesis.

2. The implantable valve device of claim 1, wherein the anchor is configured with a plurality of helical units.

3. The implantable valve device of claim 2, wherein the diameter of the helical unit increases in a direction away from the valve prosthesis, or the diameter of the helical unit decreases in a direction away from the valve prosthesis, or the diameters of a plurality of the helical units are the same.

4. The implantable valve device of claim 2, wherein the anchors are configured such that, in an unstressed state, adjacent helical units are equally spaced.

5. The implantable valve device of claim 1, wherein the anchor is configured to assume a disk-like or spring-like shape in an unstressed state.

6. The implantable valve device of any one of claims 1-5, wherein the anchor is made of a shape memory material.

7. The implantable valve device of claim 1, further comprising a tissue-engaging spacer movably disposed to the anchoring structure.

8. The implantable valve device of claim 7, wherein the spacer is sleeved on the anchor, or the spacer is sleeved on one end of the connector and at a position close to the anchor.

9. The implantable valve device of claim 7, wherein the spacer is configured to conform to a shape at a tissue anchoring location.

10. The implantable valve device of claim 7, 8 or 9, wherein the spacer is made of a shape memory material or an elastic material.

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