CN215130906U

CN215130906U - Anchoring device, replacement device and replacement system for heart valve

Info

Publication number: CN215130906U
Application number: CN202121346726.2U
Authority: CN
Inventors: 何东; 张海军; 刘祥; 赵婧
Original assignee: Jiangsu Zhenyi Medical Technology Co ltd; Shanghai Zhenyi Medical Technology Co ltd
Current assignee: Jiangsu Zhenyi Medical Technology Co ltd; Shanghai Zhenyi Medical Technology Co ltd
Priority date: 2021-06-17
Filing date: 2021-06-17
Publication date: 2021-12-14
Anticipated expiration: 2031-06-17

Abstract

The utility model relates to the field of medical equipment, especially, relate to an anchoring device of heart valve, anchoring device includes the ventricle section, the ventricle section includes the anchor section and snatchs the section, the anchor section is the helix circle form, the radius of curvature of spiral coil is unchangeable, each line interval homogeneous phase of spiral coil, anchoring device does not include the atrium section. The anchoring device is made of an elastic material. The utility model discloses an anchor adopts the design of valve and anchor separation, can reduce conveying system's transport sheath pipe radial dimension when keeping the anchor effect. When the anchoring device is released, the grabbing section can grab the native valve leaflets or the chordae tendineae automatically, the anchoring ring structure in the prior art is changed, guide wires are not needed, the anchoring section can surround the native valve leaflets automatically, the conveying device is simplified, the conveying steps are simplified, and meanwhile, the anchoring effect is good and the shape of the valve prosthesis is self-adaptive.

Description

Anchoring device, replacement device and replacement system for heart valve

Technical Field

The utility model relates to the field of medical equipment, especially, relate to an anchor of heart valve.

Background

The heart contains four chambers, the Right Atrium (RA), the Right Ventricle (RV), the Left Atrium (LA), and the Left Ventricle (LV). The pumping action on 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 start of the ventricular systole (i.e. ventricular emptying), the tricuspid and mitral valves normally close, thereby preventing 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 that typically include an annulus, native leaflets, chordae tendinae, and a support structure. Each atrium is connected to its valve by the atrial vestibule. 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 from the left atrium back 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 a surgical operation, the TMVR does not need an extracorporeal circulation auxiliary device, has small wound and quick recovery of a patient, can obviously improve the hemodynamic index of the patient after the operation, and has smaller wound of an interatrial space path through a femoral vein and wider audience compared with a cardiac apex path.

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 traditional anchoring mode is mainly designed by grabbing native valve leaflets through a designed anchor claw or designing a valve main body Oversize (the Oversize refers to the fact that the design size of a prosthetic valve is larger than the size of native tissues, so that the native tissues can be squeezed after the prosthetic valve is released, and the anchoring effect is generated), but the two anchoring modes easily cause damage to the native valve leaflets or press the native valve annulus tissues, and adverse effects are generated on the recovery of patients.

SUMMERY OF THE UTILITY MODEL

In view of the above-mentioned drawbacks of the prior art, it is an object of the present invention to provide an anchoring device for a heart valve, which solves the problems of the prior art.

In order to achieve the above objects and other related objects, the present invention provides an anchoring device for a heart valve, the anchoring device including a ventricular segment, the ventricular segment including an anchoring section, the anchoring section is in a spiral coil shape, a curvature radius of the spiral coil is not changed, each inter-line distance of the spiral coil is the same, the anchoring device does not include an atrial segment.

Preferably, the anchoring means are made of an elastic material.

Preferably, one end of the anchoring section extends to form a grabbing section, and the grabbing section is in a spiral coil shape.

Preferably, the number of turns of the coil of the grasping section is 0.5 to 3 turns.

Preferably, the gripping section has a radius of curvature greater than the radius of curvature of the anchoring section.

The present invention also provides a heart valve replacement device comprising the heart valve anchoring device and a valve prosthesis, the valve prosthesis being arranged to be suitable for being wholly or partially disposed in an interior space formed by the anchoring device.

The present invention also provides a heart valve replacement system including a heart valve replacement device and a delivery system.

Preferably, the delivery system comprises a delivery sheath, a delivery catheter and a connecting piece, wherein the delivery catheter is sleeved in the delivery sheath, and the connecting piece is connected with the delivery catheter.

Preferably, the connecting member is a connecting wire or a butt joint.

As mentioned above, the anchoring device for heart valve of the present invention has the following advantages:

1. when the anchoring device is released, the native valve leaflets or chordae tendineae can be automatically grabbed.

2. By adopting the design of separating the valve from the anchoring device, the radial size of the delivery sheath of the delivery system can be reduced while the anchoring effect is kept.

3. The anchoring ring structure in the prior art is changed, a guide wire is not needed, the anchoring ring structure can automatically surround the native valve leaflet, the conveying device is simplified, and the conveying steps are simplified.

4. The anchoring effect is good and the valve prosthesis shape is self-adaptive.

Drawings

Fig. 1 is a schematic view of an anchoring device for a heart valve according to the present invention.

Fig. 2 is a schematic view of the valve prosthesis and the implantation process thereof according to the present invention.

Fig. 3 is a schematic cross-sectional view of the heart valve replacement device of the present invention after implantation.

Fig. 4 shows a schematic diagram of a connector according to an embodiment of the present invention.

Fig. 5 is a schematic view of a connector according to another embodiment of the present invention.

Fig. 6 is a schematic view showing the implantation process of the anchoring device for heart valves according to the present invention.

Description of the element reference numerals

1 ventricular segment

11 anchoring section

111 free end of anchoring section

111a through hole

12 grabbing segment

121 grabbing section free end

2 valve prosthesis

21 outflow section

22 annulus segment

23 inflow section

31 conveying sheath

32 delivery catheter

33 connecting piece

331 screw end

332 smooth end

41 aorta

42 native valve leaflet

43 cord of chordae tendineae

h height

Detailed Description

The following description is provided for illustrative purposes, and other advantages and features of the present invention will become apparent to those skilled in the art from the following detailed description.

Please refer to fig. 1 to 6. It should be understood that the structure, ratio, size and the like shown in the drawings attached to the present specification are only used for matching with the content disclosed in the specification, so as to be known and read by those skilled in the art, and are not used for limiting the limit conditions that the present invention can be implemented, so that the present invention has no technical essential meaning, and any structure modification, ratio relationship change or size adjustment should still fall within the scope that the technical content disclosed in the present invention can cover without affecting the function that the present invention can produce and the purpose that the present invention can achieve. Meanwhile, the terms such as "upper", "lower", "left", "right", "middle" and "one" used in the present specification are for convenience of description, and are not intended to limit the scope of the present invention, and changes or adjustments of the relative relationship thereof may be made without substantial technical changes, and the present invention is also regarded as the scope of the present invention.

As shown in fig. 1, the utility model provides an anchoring device for heart valve, anchoring device includes ventricular segment 1, ventricular segment 1 includes anchoring section 11, anchoring section 11 is the spiral coil form, spiral coil's radius of curvature is unchangeable, each line interval homogeneous phase of spiral coil, anchoring device does not include the atrium section.

In the present invention, the anchoring device may also be referred to as an anchoring coil.

The anchoring device is made of an elastic material. The elastic material is, for example, an elastic thread. In a preferred embodiment, the anchoring means are made of one or more elastic wires. The elastic wire can generate larger elastic deformation in the axial direction or the radial direction and the circumferential direction. The anchoring means has an elasticity which is determined by the material and the shape.

The material of the elastic wire is selected from a metal material and/or a high polymer material. The metal material is selected from one or more of the following materials: stainless steel, titanium and titanium alloys, nitinol. The polymer material is nylon, for example. The elastic thread may be made of segments of two or more of the above materials.

The cross section of the elastic wire is circular or rectangular. The cross-sectional area of the elastic wire may be constant, i.e., the thickness of the elastic wire is uniform, or may be variable.

In one embodiment, the surface of the elastic wire is provided with a covering layer. In one embodiment, the coating is a coating or a sleeve. The coating is for example sprayed with an organic material. The sleeve pipe is a hollow pipe and can be sleeved outside the elastic wire. The hollow pipe can be made by seamless extrusion or sewing of coiled plates. The covering layer is made of polyethylene, polytetrafluoroethylene, PET and other materials or a combination of the materials.

The number of turns of the coil of the anchor segment 11 is at least 1 turn. In a preferred embodiment, the number of coil turns of the anchor segment 11 is 3.

The shape of each coil in the spiral coil of the anchoring section 11 is selected from circular arc, circle or ellipse. The curvature radius of each coil of the anchoring section 11 is 5-20 mm.

The pitch of the spiral coils is the pitch between adjacent spirals.

The primary function of the anchoring section 11 is to provide an anchoring force for the prosthetic valve.

In one embodiment, the surface of the anchoring section 11 is provided with a covering layer. The covering layer can further increase the anchoring effect, and can increase the high friction coefficient on the surface so as to improve the anchoring friction force.

In one embodiment, a gripping section 12 extends from one end of the anchoring section 11, and the gripping section 12 is in the shape of a spiral coil.

The number of turns of the coil of the gripping section 12 is 0.5-3 turns. The gripping section 12 may be a single circular arc or may be formed of multiple circular arcs. The radius of curvature of each circular arc segment of the grabbing segment 12 is 5-30 mm.

The grasping section 12 mainly functions to grasp native tissues such as native valve leaflets and chordae tendineae, so as to guide the subsequent anchoring section 11 to position and perform anchoring.

In one embodiment, the gripping section 12 is provided with a coating on its surface.

The coating may further increase the gripping effect and may reduce the coefficient of friction at the surface to reduce the resistance to travel of the gripping section 12.

After the grabbing segment 12 is connected with one end of the anchoring segment 11, the grabbing segment 12 and the anchoring segment 11 have a free end, namely a grabbing segment free end 121 and an anchoring segment free end 111 respectively.

The free end 111 of the anchoring section is connected to the delivery system. The anchoring section free end 111 may be provided with different features depending on the delivery system used when the anchoring device is implanted in the body. For example, may be provided with threads or through holes 111 a. The shape of the through-hole 111a is not particularly limited, and for example, the cross section may be circular, rectangular, or kidney-shaped. The axis of the through-hole 111a may be perpendicular or parallel to the anchor plane. This arrangement allows the anchoring device to be securely connected to the delivery system, thereby preventing the anchoring device from slipping off during delivery.

It should be noted that the movement of the native valve may be somewhat affected during and after the anchor is fully released, but the basic function of the native valve is still normal. Thus, the heart can maintain normal function during surgery without the need for an external heart-lung machine or to arrest the heart. This allows the physician more time to perform subsequent preparation of the valve prosthesis for implantation or to perform surgical procedures.

The wire spacing between the grasping section 12 and the anchoring section 11 is the same or different from the wire spacing in the anchoring section 11, as long as the height h of the anchoring device of the heart valve is ensured to be appropriate. The height h of the anchoring device of the heart valve is 3-20 mm.

The gripping section 12 has a radius of curvature greater than the radius of curvature of the anchoring section 11. The larger radius of curvature of the grasping section 12 is more conducive to grasping, and thus grasping, the native leaflets or chordae tendineae. The anchoring section 11 has a small radius of curvature to provide the radial force required for anchoring.

The anchoring device in the prior art comprises an atrium section, the atrium section is arranged in an atrium after the anchoring device is implanted into a body, and the atrium section can press an annulus and easily injure native valve leaflets, so that the recovery of a patient is not facilitated. Because the anchoring device of the application only comprises the ventricle section and does not comprise the atrium section, the annular ring can not be pressed, and the anchoring device can be prevented from falling off.

The utility model also provides a heart valve replacement device, heart valve replacement device includes heart valve's anchor and valve prosthesis 2, valve prosthesis 2 is set up to be suitable for whole or part to arrange in the inner space that the anchor formed.

As shown in fig. 2, the valve prosthesis 2 is in the shape of a cylinder open at both ends and comprises a connected outflow section 21 and an annulus section 22. The outflow end 21 is arranged and adapted to be placed wholly or partly in the inner space formed by the anchoring means and/or the flap ring segment 22 is arranged and adapted to be placed wholly or partly in the inner space formed by the anchoring means.

In a preferred embodiment, the valve prosthesis 2 further comprises an inflow section 23 connected to the annulus section 22. The presence of the inflow section 23 may make the valve prosthesis 2 more stable while preventing paravalvular leakage.

The cylindrical shape is a hollow shape. For example, other cylindrical shapes such as a cylinder, a cone, or a kidney can be used.

The valve prosthesis 2 may replace a native mitral valve or a tricuspid valve. The valve prosthesis 2 enters the atrium via the inferior vena cava or other pathway, passes through the interatrial septum and enters the inner space formed by the anchoring device, and then can be released in the anchoring device by balloon disposable balloon expansion or self-expanding segmented sheath withdrawal.

The cross-sectional structure of the heart valve replacement device after implantation in the body is shown in fig. 3, in which the valve prosthesis 2 is provided with an inflow section 23, the outflow section 21 is approximately cylindrical, and the implantation site is a mitral valve. The ring segment 22 is located at the native annulus and the native tissue (native leaflets or chordae tendineae) is acted upon by the anchoring device and the valve prosthesis 2, conforming to the outer contoured surface of the valve prosthesis 2, with the anchoring device wrapping uniformly around the native leaflets or chordae tendineae to provide the anchoring force. The grasping section free end 121 and the anchoring section free end 111 are attached to the native valve leaflet or valve, and the influence on the flow of the heart blood is reduced.

The utility model also provides the anchoring device of the heart valve and/or the application of the heart valve replacing device in the preparation of heart valve replacing products.

The anchoring device and the valve prosthesis 2 in the heart valve replacement product are accessed via different routes.

The delivery system is a device for implanting a heart valve replacement device within a human body.

As shown in fig. 2 and 6, the delivery system includes a delivery sheath 31, a delivery catheter 32, and a connector 33, the delivery catheter 32 is sleeved in the delivery sheath 31, and the connector 33 is connected to the delivery catheter 32. The delivery system may also include other components, such as a handle.

In the embodiment shown in fig. 4, the connecting member 33 is a connecting wire. The connecting wire is selected from metal elastic wire, operation suture, tether or strap. The connecting wire may be made of one or more materials. The material of the connecting wire is, for example, one or more of nickel titanium, stainless steel, nylon, and other biocompatible materials. The number of connecting wires may be one or more. In this embodiment, the free end 111 of the anchoring section is provided with a through hole 111 a. The connecting wire may be passed through the through-hole 111a and into the delivery catheter 32 for connection to a handle or other component of the delivery system, or may be otherwise secured to the through-hole 111 a. Preferably, the connecting wire may be left with some margin inside or outside the delivery catheter 32 so as not to impede the anchor section free end 111 from backing out to fit the valve outer contour when the anchoring device is unwound. After implantation of the valve prosthesis 2 is completed, the connecting wires are cut off and pulled out of the delivery system.

In the embodiment shown in fig. 5, the connector 33 is a butt joint having a threaded end 331 at one end and a smooth end 332 at the other end. In such an embodiment, one end of the delivery catheter 32 is threaded to mate with the threaded end 331. When implanted, the smooth end 332 of the abutment is fixedly connected to the free end 111 of the anchoring section. The fixed connection is selected from a welded or clamped connection.

The heart valve of the utility model is selected from a mitral valve or a tricuspid valve.

The implantation process of the heart valve replacement system of the utility model is as follows:

anchoring device release procedure as in fig. 2, the delivery sheath 31 may be advanced into the left ventricle via the aorta 41 or other pathway, and the delivery catheter 32 is subsequently released from within the delivery sheath 31, the delivery catheter 32 forming a semicircular or other arcuate trajectory along the ventricular wall that encompasses a portion of the native tissue (the native leaflets and/or chordae tendineae) to form a release pathway for the anchoring device. After completion of the trajectory release, the anchoring device may be advanced into the left ventricle via the delivery catheter 32. The grasping section free end 121 is released first and, due to its large radius of curvature, is also able to grasp the native leaflets 42 and/or chordae tendineae 43 along the ventricular wall travel, forming a circular arc coil approximately parallel to the annulus, along which the remainder of the anchoring device will continue to be released. As the anchoring device advances, the smaller diameter anchoring segment 11 begins to enter the ventricle, and the anchoring segment 11 may further wrap the native leaflets 42 and/or chordae tendineae 43 into the anchoring device. The anchoring device continues to be advanced until the anchoring segment free end 111 exits the delivery catheter 32, completing the release of the anchoring device.

Valve prosthesis implantation procedure as shown in fig. 3, after the release of the anchoring device is completed, the valve prosthesis 2 is implanted. The valve prosthesis 2 enters the atrium via the inferior vena cava or other routes, passes through the interatrial septum, enters the anchoring device, and is released in the anchoring device through the balloon disposable ball expansion or self-expanding segmented sheath withdrawal mode. The anchoring section 11 expands in diameter after being stressed, and the anchoring device generates elastic and/or plastic deformation. When the anchoring section 11 deforms, the external contour of the valve prosthesis 2 is adaptively implanted, and anchoring force is generated on the valve prosthesis 2. When the anchoring section 11 is deformed by expanding, the loop of the grasping section 12 unwinds, i.e. the free end 121 of the grasping section retreats along the loop, and preferably, the grasping section 12 is also tightly attached to the outer contour of the valve prosthesis 2 to provide anchoring effect. When the anchoring section 11 expands and deforms, the free end 111 of the anchoring section also tends to unwind, at the moment, the unwinding degree can be controlled through the connecting piece 33, and the free end 111 of the anchoring section can also unwind so as not to influence the ventricular blood outflow. The free end 111 of the anchoring section, after unwinding, follows the outer contour of the valve prosthesis 2, providing an anchoring effect. After the valve prosthesis 2 is completely released and the valve prosthesis 2 and the anchoring device are confirmed to be firmly implanted and set, the delivery system is withdrawn, the connection between the connecting piece 33 and the free end 111 of the anchoring section of the anchoring device is released, so that the delivery system is withdrawn, the whole implantation operation of the valve prosthesis 2 and the anchoring device is completed, and the cross-sectional structure of the heart valve replacement device after being implanted in the body is shown in fig. 3.

The utility model discloses an anchor passes through the aortic route and implants, and valve prosthesis implants from another route, the utility model discloses an implantation mode can realize that anchor's conveying system does not withdraw from when implanting valve prosthesis, and anchor keeps fixed through conveying system always, takes one's place until valve prosthesis. This implant provides a foundation for the anchoring device of the present invention not to include an atrial section. The anchoring device without the atrial section relieves the compression and blocking phenomena on the cardiac tissues, and the anchoring device can be initially released in the ventricle from the aorta instead of the atrial septal path, and the diameter of the anchoring device is changed when the valve prosthesis is released, so that the anchoring force is provided. Since the anchoring device and the valve prosthesis are implanted through the same path of the apex or the atrial septum in the prior art, the delivery system must be withdrawn when the valve prosthesis is implanted, and after the delivery system is withdrawn, if the anchoring device does not have an atrial segment to fix it, the anchoring device can easily slide off, so that the atrial segment must be included in the anchoring device. The atrial section of the prior art anchoring devices can thus be used to hold the anchoring device during the period of time when the delivery system is withdrawn during implantation of the valve prosthesis, ensuring that the anchoring device does not slip.

To sum up, the utility model discloses various shortcomings in the prior art have effectively been overcome and high industry value has.

The above embodiments are merely illustrative of the principles and effects of the present invention, and are not to be construed as limiting the invention. Modifications and variations can be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which may be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims

1. An anchoring device for a heart valve, characterized in that the anchoring device comprises a ventricular segment (1), the ventricular segment (1) comprises an anchoring segment (11), the anchoring segment (11) is in the shape of a helical coil, the radius of curvature of the helical coil is constant, the respective wire spacings of the helical coil are the same, and the anchoring device does not comprise an atrial segment.

2. The heart valve anchoring device of claim 1, wherein the anchoring device is made of an elastic material.

3. The heart valve anchoring device of claim 2, wherein the surface of the resilient material is provided with a covering layer.

4. The heart valve anchoring device according to claim 1, characterized in that a gripping section (12) extends from one end of the anchoring section (11), said gripping section (12) being in the form of a helical coil.

5. The heart valve anchoring device according to claim 4, characterized in that the grasping section (12) has a number of coil turns of 0.5-3 turns.

6. The heart valve anchoring device of claim 1, wherein the height h of the anchoring device is 3-20 mm.

7. The heart valve anchoring device of claim 4, wherein the gripping section (12) has a radius of curvature greater than the radius of curvature of the anchoring section (11).

8. A heart valve replacement device, characterized in that it comprises a heart valve anchoring device according to any of claims 1-7 and a valve prosthesis (2), said valve prosthesis (2) being arranged to be adapted to be placed wholly or partly in an inner space formed by said anchoring device.

9. The heart valve replacement device according to claim 8, wherein the valve prosthesis (2) is cylindrical with two open ends and comprises an outflow section (21), a valve ring section (22) and an inflow section (23) which are connected in sequence; the outflow section (21) is adapted to be placed wholly or partly in the inner space formed by the anchoring means, and/or the flap ring segment (22) is adapted to be placed wholly or partly in the inner space formed by the anchoring means.

10. A heart valve replacement system comprising the heart valve replacement device of any one of claims 8-9 and a delivery system.

11. The heart valve replacement system of claim 10, wherein the delivery system includes a delivery sheath (31), a delivery catheter (32), and a connector (33), the delivery catheter (32) being nested within the delivery sheath (31), the connector (33) being connected to the delivery catheter (32).

12. Heart valve replacement system according to claim 11, wherein the connecting member (33) is a connecting wire and the free end (111) of the anchoring section is correspondingly provided with a through hole (111 a).

13. A heart valve replacement system according to claim 12, wherein the connector (33) is a butt joint having a threaded end (331) at one end and a smooth end (332) at the other end, and correspondingly the delivery catheter (32) is provided with a thread at one end matching the threaded end (331) and the smooth end (332) is arranged to be adapted to connect with the free end (111) of the anchoring section.