CN116616956A - Artificial implantation heart valve - Google Patents

Abstract

The application discloses a prosthetic implanted heart valve having a spatial axial direction and axially opposite inflow and outflow sides, the prosthetic implanted heart valve comprising: the inner frame is of a radially deformable tubular structure, and a blood flow channel is arranged in the inner frame; a leaflet connected to the inner frame to change the opening degree of the blood flow channel; the outer frame is of an integrated annular structure and comprises a plurality of arm parts in the circumferential direction, the outflow side of each arm part is fixedly connected with the inner frame, and a first gap capable of clamping the primary tissue is formed between the inflow side of each arm part and the outer periphery of the inner frame; the outflow sides of the two adjacent arm parts are mutually close to form an intersection part, and the intersection part extends from the outer side of the outer frame to the inner side of the inner frame radially inwards and is fixedly attached to the inner wall of the inner frame. The junction part of the artificial implantation heart valve extends to the inner side of the inner frame and is abutted against the inner frame, so that the artificial implantation heart valve is convenient to load and adjust the posture in the body in the releasing process, and is more convenient to operate.

Description

Artificial implantation heart valve

Technical Field

The application relates to the technical field of medical appliances, in particular to a heart valve implanted artificially.

Background

The artificial heart valve is an artificial organ made of artificial materials and capable of being implanted into the heart of a human body to replace heart valves such as aortic valves, pulmonary valves and tricuspid valves, so that blood flows unidirectionally, and has the function of a natural heart valve. Generally, the existing heart valves of workers are implanted into corresponding parts through a catheter, including an inner frame and an outer frame for clamping the native valve, but in the prior art, a step positioned on the outer peripheral surface of the heart valve prosthesis is formed at the junction of the outer frame and the inner frame, so that inconvenience or potential safety hazard is caused to the loading and the internal posture adjustment of the heart valve prosthesis in the release process.

Disclosure of Invention

The application provides a prosthetic heart valve, which solves the problems that the peripheral surface of the prosthetic heart valve is provided with steps, and the adjustment of the internal posture in the loading and releasing processes of the prosthetic heart valve causes inconvenience or potential safety hazard in the prior art.

A prosthetic implanted heart valve having a spatial axial direction and axially opposite inflow and outflow sides, the prosthetic implanted heart valve comprising:

the inner frame is of a radially deformable tubular structure, and a blood flow channel is arranged in the inner frame;

a leaflet coupled to the inner frame to change an opening degree of the blood flow channel;

the outer frame is of an integrated annular structure and comprises a plurality of arm parts in the circumferential direction, the outflow side of each arm part is fixedly connected with the inner frame, and the inflow side of each arm part is arranged on the periphery of the inner frame and forms a first gap capable of clamping the primary tissue with the inner frame;

the outflow sides of the two adjacent arm parts are mutually close to form an intersection part, and the intersection part extends from the outer side of the outer frame to the inner side of the inner frame radially inwards and is fixedly attached to the inner wall of the inner frame.

The following provides several alternatives, but not as additional limitations to the above-described overall scheme, and only further additions or preferences, each of which may be individually combined for the above-described overall scheme, or may be combined among multiple alternatives, without technical or logical contradictions.

Optionally, the inner frame has a grid structure, each grid is surrounded by a frame strip, and the junction part has a bifurcation structure extending to the outflow side.

Optionally, the bifurcation structure extends along a frame strip of the inner frame.

Optionally, the node part of the bifurcation structure is provided with a suture hole.

Optionally, the arm includes root, middle part and head in proper order from the outflow side to the inflow side, in the release state, the circumference span of arm is narrowed gradually from root to head, have the isolation clearance between middle part and the periphery of inner frame.

Optionally, the head portion is abutted against the outer periphery of the inner frame.

Optionally, the outer frame is a frame strip structure, the frame strip of the head has wavy relief, and the surface has anti-skid grooves.

Optionally, at least one of the two axial ends of the inner frame is provided with a connecting lug matched with the conveying system, and the connecting lug and the inner frame are of an integrated structure.

Optionally, the engaging lug is T shape, and quantity is three, and circumference evenly arranges, and each engaging lug highly varies.

Optionally, the prosthetic implanted heart valve has relative:

the inner frame and the outer frame are radially compressed in a compressed state, and the inflow side of the outer frame is close to the periphery of the inner frame;

a transitional state in which the inflow side of the outer frame expands radially outwardly relative to the outer circumference of the inner frame, at least a portion of the inner frame remaining radially compressed;

and in a released state, the inner frame and the outer frame are both radially expanded.

The junction part of the artificial implantation heart valve extends to the inner side of the inner frame and is abutted against the inner frame, so that the artificial implantation heart valve is convenient to load and adjust the posture in the body in the releasing process, and is more convenient to operate.

Drawings

FIG. 1a is a schematic diagram of an embodiment of a prosthetic heart valve;

FIG. 1b is a schematic top view of the prosthetic implanted heart valve of FIG. 1 a;

FIG. 2a is a schematic illustration of the structure of the aorta;

FIG. 2b is a schematic illustration of the structure of an artificial implanted heart valve interventional aorta;

FIG. 2c is a schematic diagram of a transport system;

FIG. 3a is a schematic view of an artificial implanted heart valve in a compressed state;

FIG. 3b is a schematic view of an artificial implanted heart valve in a transitional state;

FIG. 3c is a schematic view of an embodiment of a prosthetic heart valve with connecting lugs; the method comprises the steps of carrying out a first treatment on the surface of the

FIG. 4a is a schematic diagram of an embodiment of a prosthetic heart valve;

FIG. 4b is a schematic view of the mechanism of the outer frame of FIG. 4 a;

FIG. 4c is a schematic view of the inner frame of FIG. 4 a;

FIG. 4d is a schematic view of a portion of the inner frame and outer frame of FIG. 4 a;

reference numerals in the drawings are described as follows:

600. an aorta; 601. native valve leaflets; 602. the valve sinus;

700. artificial implantation of a heart valve; 701. a bracket; 703. a connecting lug; 710. valve leaves; 720. an inner frame; 750. an outer frame; 751. a first gap; 752. a junction; 753. an arm section; 7531. root part; 7532. a middle part; 7533. a head; 7534. an anti-skid groove; 754. an isolation gap; 755. a suture hole;

800. a catheter assembly; 801. a proximal end; 802. a distal end; 803. a loading section; 808. a control handle.

Detailed Description

The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

In the present disclosure, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or as implicitly indicating the number, order of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present application, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

Referring to fig. 1a to 2c, the prosthetic heart valve 700 of the present application generally comprises a deformable stent 701 and leaflets 710 connected in the stent 701, the stent 701 is generally cylindrical, the side wall is a hollow grid structure, including an inner frame 720 and an outer frame 750, and the outer frame 750 is mainly used as a positioning structure, and a skirt or a peripheral leakage preventing material may be further disposed on the inner side and/or the outer side of the inner frame 720 for preventing peripheral leakage.

According to different release modes, the stent 701 is made of a corresponding material, such as nickel-titanium alloy with shape memory capable of self-expanding in vivo, stainless steel material released by ball expansion, etc., the stent 701 can be formed by cutting a tube or weaving wires, and the valve blades 710 can be connected to the stent 701 by stitching, bonding or molding with an integral mold.

For ease of understanding and showing the structural features of the product of the present application, in the following embodiments, the aortic valve 600 is provided with three native leaflets 601, and the valve sinus 602 is provided between each native leaflet 601 and the peripheral vessel wall, and the prosthetic heart valve 700 has a spatial axial direction and axially opposite inflow and outflow sides according to the normal blood flow direction, wherein X1 is the inflow side, X2 is the outflow side, and the arrow direction is the blood flow direction.

In an embodiment of the present application, the artificial implantation heart valve 700 includes an inner frame 720, valve leaflets 710 and an outer frame 750, the outer frame 750 can be positioned in the body at each valve sinus 602, the inner frame 720 and the outer frame 750 can accommodate the native valve leaflets 601, and the outer frame 750 can be abutted against the bottom of the valve sinus 602 to perform the function of axial and circumferential positioning, so as to prevent the problem of position deviation of the artificial implantation heart valve 700 under the action of blood flow.

The inner frame 720 is of a radially deformable tubular structure, and a blood flow channel is arranged inside the inner frame; the leaflet 710 is connected to the inner frame 720 to change the opening degree of the blood flow channel; the outer frame 750 itself has an integral ring structure, and includes a plurality of arm portions 753 in the circumferential direction, wherein the outflow side of each arm portion 753 is fixedly connected to the inner frame 720, and the inflow side of each arm portion 753 is located at the outer periphery of the inner frame 720 and forms a first gap 751 with the inner frame 720, which can hold native tissue, in this embodiment, native valve leaflet 601.

The leaflet 710 includes a plurality of cooperating pieces, the number and circumferential position of each arm 753 matching the corresponding leaflet 710. In this embodiment, the number of leaflets 710 and arms 753 is 3. Wherein the leaflet 710 is a biomaterial or a polymeric material.

The ring structure of the outer frame 750 itself can be integrally formed during processing, that is, the support strength is ensured, and the assembly with the inner frame 720 is simplified to a certain extent.

The interventional instrument is typically delivered and manipulated intraoperatively using a delivery system, which generally includes a control handle 808 and a catheter assembly 800, the catheter assembly 800 including a plurality of controlled members therein, the catheter assembly 800 or the entire delivery system having a proximal end 801 proximal to the operator and an opposite distal end 802, the distal ends 802 of each controlled member cooperatively manipulating the interventional instrument.

Referring to fig. 3 a-3 b, the prosthetic heart valve 700 is delivered to a designated location or retrieved by a catheter assembly 800, and the prosthetic heart valve 700 has relative:

in the compressed state, both the inner frame 720 and the outer frame 750 are radially compressed, and the inflow side of the outer frame 750 is closed to the outer periphery of the inner frame 720;

in a transitional state, the inflow side of the outer frame 750 expands radially outward relative to the outer circumference of the inner frame 720, at least a portion of the inner frame 720 remaining radially compressed, at which time the outer frame 750 may form a gap with the outer wall of the inner frame 720 for the native valve leaflet 601 to enter;

in the released state, both the inner and outer frames 720, 750 radially expand toward a pre-heat set shape, typically with at least one native leaflet 601 sandwiched and defined between the outer and inner frames 750, 720 if in an in vivo environment.

In this embodiment, the inner frame 720 and the outer frame 750 are both switched from the compressed state to the released state by adopting a self-expanding manner, so as to fully exert the positioning function of the outer frame 750, at least two catheter assemblies 800 in the delivery system can be configured, the distal ends of the two catheter assemblies are provided with loading sections 803, the openings of the two loading sections 803 are opposite, and the insertion devices are loaded and wrapped when the two loading sections 803 are buckled with each other.

Referring to fig. 3c, the prosthetic heart valve 700 may generally have a coupling structure for mating with the catheter assembly 800, for example, at least one of the two axial ends of the inner frame 720 has a coupling lug 703 for mating with a delivery system, the coupling lug 703 being integrally formed with the inner frame 720 and being T-shaped in particular for engaging the catheter assembly 800 in a compressed state (fig. 3c is with the coupling lug 703 and the remaining views are omitted). In this embodiment, the number of the connecting lugs 703 is three, and the connecting lugs 703 are uniformly arranged in the circumferential direction, and of course, considering the potential safety hazard caused by the overlarge short-time deformation of the inner frame 720 when the stent 701 is completely released, the heights of the connecting lugs 703 in the application are different, so that the inner frame 720 is released in stages to avoid stabbing the vessel wall.

Referring to fig. 4 a-4 d, in one embodiment, a prosthetic heart valve 700 is provided, comprising an inner frame 720, leaflets 710, and an outer frame 750, the outer frame 750 itself being of unitary annular construction, comprising a plurality of arms 753 in the circumferential direction, the outflow side of each arm 753 being fixedly connected to the inner frame 720, the inflow side of each arm 753 being at the outer periphery of the inner frame 720 and forming a first gap 751 with the inner frame 720 for holding native tissue.

The outflow sides of the adjacent arm portions 753 are close to each other to form an intersection portion 752, and the intersection portion 752 extends radially inward from the outer side of the outer frame 750 to the inner side of the inner frame 720 and is fixed against the inner wall of the inner frame 720. When loading is needed, the catheter assembly 800 gradually accommodates the bracket 701 from the outflow side to the inflow side of the bracket 701, and the intersection 752 is fixed on the inner wall of the inner frame 720, that is, the outer periphery of the inner frame 720 has no outer convex node fixed with the outer frame 750, so that the interference problem between the intersection 752 and the end of the loading section 803 is avoided. Likewise, the structure can also adjust the posture in the body in time during the process of releasing the artificial implantation heart valve 700, thereby being more convenient for operation.

The diameter of the inner frame 720 of the present application is gradually reduced and gradually increased from the outflow side to the inflow side, wherein the diameter of the inflow side is smaller than the diameter of the outflow side, and the junction 752 is at the middle position of the inner frame 720, and the diameter of the junction is the smallest.

The arm portion 753 includes a root portion 7531, a middle portion 7532, and a head portion 7533 in this order from the outflow side to the inflow side, and in the released state, the circumferential span of the arm portion 753 is gradually narrowed from the root portion 7531 to the head portion 7533 with an isolation gap 754 between the middle portion 7532 and the outer periphery of the inner frame 720.

The arm 753 gradually narrows from the root portion 7531 to the head portion 7533, for example, is of a U-shaped frame structure as a whole, interference with the joint of two adjacent native leaflets 601 can be avoided, the head portion 7533 can extend into and abut against the bottom of the valve sinus 602, the isolation gap 754 is formed by protruding the middle portion 7532 towards the periphery, deformation of the native leaflets 601 is absorbed as much as possible in the radial direction, and blocking of the coronary after excessive deformation of the native leaflets 601 is avoided.

The head 7533 abuts the outer periphery of the inner frame 720, enabling the inner frame 720 and the outer frame 750 to provide a more efficient clamping force in the released state. In order to increase the holding force, the head 7533 may be abutted against the outer periphery of the inner frame 720 and may have a pre-tightening force.

In this embodiment, the outer frame 750 is of a frame strip structure, the frame strip of the head 7533 has wavy relief, the head 7533 is wrapped with a layer of protective film, and the protective film can be made of pericardium material, so that the outer frame 750 can be prevented from stabbing the blood vessel and the native valve leaflet 601, and the wavy relief is also convenient for fixing the protective film to prevent slipping.

The protective film is generally fixed to the head 7533 by a binding wire, in an embodiment, the surface of the frame strip of the head 7533 is provided with anti-slip grooves 7534, so that the binding wire can be positioned conveniently, and the number of the anti-slip grooves 7534 can be set according to requirements, for example, the number of the anti-slip grooves 7534 on two sides of the frame strip of the head 7533 is 2.

The inner frame 720 has a mesh structure, each mesh is surrounded by frame strips, and the junction 752 has a bifurcated structure extending to the outflow side. In this embodiment, the bifurcation structure is specifically a bifurcation, and each branch extends along the frame strip of the inner frame 720, and has an expanding tendency at the end, for example, forming a T-shaped structure. The node portion of the bifurcated structure is provided with a suture hole 755, the suture hole 755 has a positioning function, the inner frame 720 and the outer frame 750 are fixed to each other by a binding wire passing through the suture hole 755, and the binding wire is also wound and bound to make a T-shaped structure of each branch and end portion.

The outer frame 750 is fixed with the inner frame 720 together through a bifurcation structure, so that the problem that the connection part of the end part is broken due to concentrated stress is avoided, and further, the bifurcation structure is easy to fold, so that the problem that the part is difficult to compress and load is avoided. Wherein, the end of the T-shaped structure can form a cross with the frame strip of the inner frame 720, which is convenient for winding the binding wire.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description. When technical features of different embodiments are embodied in the same drawing, the drawing can be regarded as a combination of the embodiments concerned also being disclosed at the same time.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application.

Claims (10)

1. A prosthetic implantable heart valve having a spatial axial direction and axially opposite inflow and outflow sides, the prosthetic implantable heart valve comprising:

the inner frame is of a radially deformable tubular structure, and a blood flow channel is arranged in the inner frame;

a leaflet coupled to the inner frame to change an opening degree of the blood flow channel;

the outer frame is of an integrated annular structure and comprises a plurality of arm parts in the circumferential direction, the outflow side of each arm part is fixedly connected with the inner frame, and the inflow side of each arm part is arranged on the periphery of the inner frame and forms a first gap capable of clamping the primary tissue with the inner frame;

the outflow sides of the two adjacent arm parts are mutually close to form an intersection part, and the intersection part extends from the outer side of the outer frame to the inner side of the inner frame radially inwards and is fixedly attached to the inner wall of the inner frame.

2. The prosthetic implantable heart valve of claim 1, wherein the inner frame has a lattice structure, each lattice being defined by frame strips, the intersections having bifurcated structures extending to the outflow side.

3. The prosthetic implantable heart valve of claim 2, wherein the bifurcated structure extends along a frame strip of the inner frame.

4. The prosthetic implantable heart valve of claim 2, wherein the node portion of the bifurcation has suture openings.

5. The prosthetic implantable heart valve of claim 1, wherein the arm comprises a root portion, a middle portion, and a head portion in order from the outflow side to the inflow side, the circumferential span of the arm being tapered from the root portion to the head portion in the released state, the middle portion being spaced from the outer periphery of the inner frame by an isolation gap.

6. The prosthetic implanted heart valve of claim 5, wherein the head abuts an outer periphery of the inner frame.

7. The prosthetic implantable heart valve of claim 5, wherein the outer frame is a frame strip structure, the frame strip of the head has an undulating shape, and the surface has a cleat.

8. The prosthetic implantable heart valve of claim 5, wherein at least one of the axial ends of the inner frame has a connector lug for mating with a delivery system, the connector lug being of unitary construction with the inner frame.

9. The prosthetic implantable heart valve of claim 8, wherein the connector lugs are T-shaped, three in number, and circumferentially uniformly arranged, with each connector lug being of a different height.

10. The prosthetic implanted heart valve of claim 1, wherein the prosthetic implanted heart valve has, in terms of radial deformation, relative:

the inner frame and the outer frame are radially compressed in a compressed state, and the inflow side of the outer frame is close to the periphery of the inner frame;

a transitional state in which the inflow side of the outer frame expands radially outwardly relative to the outer circumference of the inner frame, at least a portion of the inner frame remaining radially compressed;

and in a released state, the inner frame and the outer frame are both radially expanded.