WO2022257702A1

WO2022257702A1 - Fixing structure of heart valve prosthesis

Info

Publication number: WO2022257702A1
Application number: PCT/CN2022/092578
Authority: WO
Inventors: 梁玉晨
Original assignee: 启晨(上海)医疗器械有限公司
Priority date: 2021-06-10
Filing date: 2022-05-13
Publication date: 2022-12-15
Also published as: CN113262079A

Abstract

The present invention relates to the technical field of medical instruments, and in particular to a fixing structure of a heart valve prosthesis. The fixing structure comprises a support member and a tether fixing member. The side of the support member that faces the heart is provided with a flexible coating layer, and the side thereof that is away from the heart is provided with a fixing end, and a valve tether passes through the center of the support member, is wound around the fixing end, and is fixedly connected to the tether fixing member. According to the present invention, the fixing structure is simple, is convenient to operate, has an increased contact area between the tether and the organ, and greatly reduces the risk of bleeding or tearing at the wound site. The device can also be used for anchoring at a puncture or opening formed by other medical instruments during surgery.

Description

A fixing structure of artificial heart valve

technical field

The invention belongs to the technical field of medical devices, and in particular relates to a fixing structure of an artificial heart valve.

Background technique

Normal heart valves are important structures that maintain the direction in which the heart pumps blood. Valvular disease such as stenosis and insufficiency will lead to changes in hemodynamics, causing a series of pathophysiological lesions, which are life-threatening in severe cases. There are many causes of heart valve disease, which are related to genetics, immunity, infection, etc., which also make heart valve disease one of the more common heart diseases. With the continuous advancement of science and technology, artificial heart valve replacement technology has become the main means and one of the most effective ways to treat heart valve diseases. This technology intervenes in the human body through a catheter, and places the artificial heart valve at the lesion position of the human body, so as to realize the treatment of the disease.

In order to ensure high effectiveness, the fixed position of the valve in the human body is extremely important. Therefore, it is necessary to set a certain fixed structure to limit the position of the artificial valve. For example, in the case of mitral valve replacement, it is necessary to ensure that the replaced valve cannot be displaced into the atrium under the impact of blood flow, resulting in device failure. Therefore, it is necessary to install a fixed structure outside the apex of the heart, and connect the valve support to the fixed structure through a tether. In this way, the position of the valve support is fixed. In addition, it can also avoid the tether being directly connected to the heart, and the small contact surface will cause excessive local pressure, which may cause apical tearing and other hidden dangers.

However, the fixed structure of the current technology is relatively complicated, and there are many steps in the use process, which is not conducive to the doctor's operation. Moreover, the fixing method of the needle-like pinning structure is easy to bend or even break the fixing needle under the action of long-term tension, resulting in product failure and endangering the health of patients.

Contents of the invention

Based on the above-mentioned shortcomings and deficiencies in the prior art, one of the purposes of the present invention is to at least solve one or more of the above-mentioned problems in the prior art. An artificial heart valve fixing structure.

In order to achieve the above object of the invention, the present invention adopts the following technical solutions:

The fixing structure of the artificial heart valve provided by the present invention, the fixing structure includes a support member and a tether fixing member with one end connected to the side of the support member facing away from the heart; wherein, the support member is provided on the side facing the heart There is a flexible covering layer, a fixed end is provided on the side facing away from the heart, and a plurality of U-shaped grooves are opened on the edge of the fixed end, and the valve tether passes through the support member and is wound around at least one of the U-shaped grooves. After the groove, connect with the tether holder.

As a preferred solution, the support member is provided with a flexible covering layer on the side facing the heart, and a fixed end is provided on the side facing away from the heart, and a plurality of U-shaped grooves are opened on the edge of the fixed end, and the valve tether passes through the pass through the support piece, wrap around in the U-shaped groove, and be connected and fixed with the tether fixing piece.

Preferably, the support member is provided with a first through hole, and after the valve tether fixing member passes through the first through hole, it wraps around the U-shaped groove, so as to temporarily fix the valve tether in the U-shaped groove .

Preferably, the first through hole is a threaded hole. After the valve tether fixing member passes through the first through hole, the valve tether is wound around the U-shaped groove to pre-fix the valve tether, and is fixedly connected to the valve tether by thread. on the support.

Preferably, the side of the supporting member facing the heart is provided with a plurality of second through holes, and sutures are passed through the second through holes to sew the flexible covering layer on the supporting member.

Preferably, the support member is provided with one or more third through holes on the side facing away from the heart, and the tether fixing member is sewn on the flexible covering layer through the third through holes.

Preferably, the side of the support member facing the heart is a plane circle, and the diameter of the plane circle is 1-50mm, such as 3mm, 8mm, 40mm, 45mm, more preferably 10-35mm, such as 15mm, 20mm, 30mm, etc. Wait.

Preferably, the side of the support member facing the heart is an arc-shaped structure, the maximum cross-sectional diameter of the arc-shaped structure is 1-50mm, and the height difference is 0.1-10mm, such as 0.5mm, 1mm, 8mm, etc., more preferably 1.5-7mm, such as 2mm, 3mm, 5mm, 6mm, etc.

Preferably, the flexible covering layer is an elastic medical material, and the elastic medical material is one or more combinations of medical plastic, medical sponge and biological tissue, wherein the biological tissue can be bovine pericardium, pig pericardium patch, etc. .

Preferably, the flexible covering layer is a non-elastic medical material, the non-elastic medical material is a medical polymer material, and the fabric is one or more combinations of plain fabric, twill fabric, and grid fabric.

Preferably, the outer surface of the flexible covering layer is provided with one or more combinations of recombinant proteins, collagen, growth factors, and antibacterial agents.

The present invention compares with prior art, beneficial effect is:

The present invention can be operated more simply, accurately and safely, reduces the operating requirements for doctors, and has a more stable connection mode, which can avoid subsequent possible loosening, increases the contact area between the tether and the organs, and greatly reduces the position of the wound Risk of bleeding or tearing.

Description of drawings

Fig. 1 is the schematic diagram of preferred position of the present invention in use;

Fig. 2 is an assembly drawing of an embodiment of the present invention;

Fig. 3 is a schematic cross-sectional view of a fixing structure according to an embodiment of the present invention;

Fig. 4 is a schematic diagram of a support member according to an embodiment of the present invention;

Fig. 5 is a top view of the tether winding method according to an embodiment of the present invention;

Fig. 6 is a cross-sectional view of a tether winding method according to an embodiment of the present invention;

Fig. 7 is an assembly diagram of another embodiment of the present invention fixed structure;

Fig. 8 is a top view of another embodiment of the support of the present invention;

Fig. 9 is a cross-sectional view of another embodiment of the present invention;

Fig. 10 is a schematic diagram of a tether winding method and a screw fixing method according to another embodiment of the present invention;

In the figure: 1 fixed structure, 2 valve tether, 3 valve, 4 model of left atrium and left ventricle, 11 flexible covering layer, 12 support piece, 13 tether fixation piece

Detailed ways

In order to illustrate the embodiments of the present invention more clearly, the specific implementation manners of the present invention will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention, and those skilled in the art can obtain other accompanying drawings based on these drawings and obtain other implementations.

As shown in FIG. 1 , it is a fixing structure of an artificial heart valve provided by the present invention. The specific structure is shown in FIGS. 2-3 , a flexible covering layer 11 , a support member 12 , and a tether fixing member 13 . The details of the supporting member are shown in FIG. 4 , the U-shaped wire slot 121 , the first through hole 122 , the winding post 123 , the chassis 124 , the second through hole 125 , and the third through hole 126 . The tether anchor is a suture (hereinafter referred to as the anchor).

The flexible layer 11 is covered on the side of the support 12 close to the heart, and the fixing thread 113 is connected with the flexible layer 11 by sewing or bonding, and is wound through the third through hole on the side of the support away from the heart. A first through hole is left in the center of the support member 12, through which the valve tether (shown as a black filled line in the figure) passes through. Finally, the tether and the fixing thread are tied or stitched after being threaded out to achieve fixation. The flexible layer can be any medical material with better biocompatibility, such as PET, PTFE, TPU, polyamide, etc., and the thickness is any thickness between 0.05-10mm, such as 0.5mm, 1mm, 2.5mm, 3mm, etc. The structure can be single-layer or multi-layer, and the material can be elastic or inelastic, and an elastic body (not shown in the figure) can also be added between the flexible layer and the support to better fit the human body structure. Specially, the parts in contact with the human body can also be coated with drugs to increase biocompatibility, activate cell activity, and reduce healing time, such as proteins, growth factors, antibacterial agents and other drugs that promote tissue growth. The fixing thread can be PTFE suture thread or other materials with good biocompatibility, and can be a single-thread structure or a multi-thread braided structure. The combination of the fixed line and the tether can be knotted as shown in the figure, or stitched, or other structures can be added to allow the two to be combined and fixed. The knotting method can be a double-thread knot or a multi-thread knot.

The valve tether passes through the first through hole, and is wound with the winding post through three U-shaped wire grooves, and the tether is pre-fixed to maintain a certain tension. The chassis is covered with a flexible layer, and the two can be fixed by sutures passing back and forth through the second through hole 1 . One end of the fixing wire is sewn or glued on the flexible layer, and the other end passes through the third through hole. Finally, the fixed line and the tether can be fixed by knotting, sewing and other connection methods.

In other embodiments, the shape of the support member can be a variable I-shape, for example, the upper and lower planes can be umbrella-shaped, funnel-shaped, concave or convex arc-shaped, and the like. The supporting member can be in an integrated shape, or can be a splicing of the upper and lower plates and the central column, or any one of the plates and the column is integrated, and the other plate is spliced and other variable structures. The supporting member can be made of stainless steel, cobalt-chromium alloy, nickel-titanium alloy, PEEK, nylon and other materials with good biocompatibility. The slots can be any number between 1-20, such as 1, 3, 5, 10, etc. The shape of the trunking can be a combined structure of rectangle + circle as shown in the figure, or it can be a rectangle alone, or a variable rectangle and other structures that can pass through the rope. The width of the slot is any value between 0.01-10mm, such as 1mm, 2mm, 5mm, etc. The first through hole is a round hole that passes through the support as a whole. There are guide rounded corners or guide bevels at both ends to facilitate the passage of the tether. Any value between -10mm, such as 1mm, 2mm, 3mm, etc. The winding column is shown as a cylinder. In addition, it can also be a square or other structure. In addition, the surface is convenient for winding and increases the friction of winding. It can also be made into a wolf tooth shape, a honeycomb shape, or a back shape. Or frosted and other surface shapes.

In other embodiments, the upper and lower chassis can be circular, square or irregular, and the contact surface with the flexible layer can be flat as shown in the figure, or a slightly arc-shaped shape that fits the apex of the heart more closely. The second through hole of the chassis can be circular, square or other shapes that can pass through sutures. In addition, there may be no second through hole, and the flexible layer cooperates with the supporting member by bonding or other means.

The preferred winding method is shown in Figures 5-6. After the tether passes upward through the first through hole 121, it first passes through the U-shaped groove 1211 downward, and circles the winding post 123 counterclockwise at 90 degrees, and passes upward through 1212. Then cross the first through hole, go downward from 1213 , encircle the winding column 123 at 90 degrees counterclockwise, and pass upward from 1211 , at this time, the passing position is symmetrical to the fixed line passing position 126 with respect to the first through hole.

In other embodiments, the tether fixing member 13 may be a fixing screw structure (hereinafter referred to as fixing screw). As shown in FIG. 7 , a first through hole is provided in the center of the support member, and the hole is a threaded hole. The valve tether passes through this hole, and then pre-fixes through the U-shaped groove at the fixed end and the central column. Finally, the fixing screw is rotated to the inside of the first through hole, and the tether is compressed by the tightening effect between the threads to achieve fixation. Among them, the flexible layer is preferably a medical material suitable for wound growth and promoting wound healing. The medical material is one or more combinations of medical plastic, medical sponge and biological tissue, such as PET, PTFE and other multi-layer or single-layer materials. , can be an elastic material or a non-elastic material, or a combination of the two, for example, a layer of elastic material is sandwiched between two non-elastic materials, and the elastic material can make the shape fit the wound more closely.

As shown in Figure 8-9, it is the top view and B-B section view of the support. Wherein 121 is the first through hole, the function is to facilitate the passage of the tether on the valve, and the inner thread of the hole cooperates with the outer thread of 13 to realize the compression and fixation of the tether. 122 is a second through hole, which is convenient for subsequent fixing with the flexible layer 11 by sutures. 123 is a U-shaped groove, which is used together with the outer column of 124 for pre-fixing the valve, 125 is the fixed end of the support, and 126 is the chassis of the support. The shape of the chassis can be round or square, and the surface contacting the apex can be flat or curved, so as to better fit the wound. The chassis has a second through hole, preferably, the chassis and the flexible layer can be sewn together through the second through hole. The two can also be bonded directly by bonding or the like. The function of the fixed end is to wrap the tether after passing through to realize pre-fixation. After the tether passes through 121, it passes through the U-shaped groove provided on the side of 121, and then passes through the groove 123 at the fixed end, and is wound on the outer column of 124 to realize the pre-fixation of the tether.

As shown in FIG. 10 , it is a winding and fixing method of a tether in an embodiment. The valve tether passes through the central through hole from the direction of the support chassis. After passing out, it passes through the central groove of the fixed end, and then penetrates through the groove on the disk surface. After going around the middle column for a week, it passes through the groove to achieve pre-clamping , and then screw in the retainer to compress the tether to ensure final fixation. The matching structure of the top layer of the fixing screw can be a straight line, or a cross, and can also be a shape such as a groove. The overall shape of the screw can be the shape shown in the figure, or it can be a self-tapping screw or a counterbore screw or similar shapes.

The above is only a detailed description of the preferred embodiments and principles of the present invention. For those of ordinary skill in the art, according to the ideas provided by the present invention, there will be changes in the specific implementation, and these changes should also be It is regarded as the protection scope of the present invention.

Claims

A fixing structure for an artificial heart valve, characterized in that the fixing structure includes a support and a tether fixing member with one end connected to the side of the support facing away from the heart; wherein, one side of the support facing the heart The side is provided with a flexible covering layer, and the side facing away from the heart is provided with a fixed end, and a plurality of U-shaped grooves are opened on the edge of the fixed end, and the valve tether passes through the support member and is wound around at least one of the After the U-shaped groove, it is connected with the tether fixing part.
The fixing structure according to claim 1, wherein the supporting member is provided with a first through hole, and the valve tether fixing member is wound around the U-shaped groove after passing through the first through hole.
The fixing structure according to claim 2, wherein the first through hole is a threaded hole, and after the valve tether fixing member passes through the first through hole, it is wrapped around the U-shaped groove to pre-fix the The valve is tethered and fixedly connected to the support by threads.
The fixing structure according to claim 1, characterized in that, the side of the supporting member facing the heart is provided with a plurality of second through holes, and sutures pass through the second through holes to cover the flexible covering. Layers are stitched to the support.
The fixing structure according to claim 1, wherein the supporting member is provided with one or more third through holes on the side facing away from the heart, and the tether fixing member is sewn on the side through the third through holes. on the flexible coating.
According to the fixing structure according to claim 1, characterized in that, the side of the supporting member facing the heart is a plane circle, and the diameter of the plane circle is 1-50 mm.
An artificial heart valve fixing structure according to claim 1, characterized in that, the side of the supporting member facing the heart is an arc-shaped structure, the maximum cross-sectional diameter of the arc-shaped structure is 1-50mm, and the height difference 0.1-10mm.
The fixing structure according to claim 1, wherein the flexible covering layer is an elastic medical material, and the elastic medical material is one or a combination of medical plastic, medical sponge and biological tissue.
The fixing structure according to claim 1, wherein the flexible covering layer is a non-elastic medical material, the non-elastic medical material is a medical polymer material, and the fabric is plain fabric, twill fabric, grid fabric, etc. one or more combinations of .
The fixing structure according to claim 1, characterized in that, the outer surface of the flexible covering layer is provided with one or more combinations of recombinant proteins, collagen, growth factors, and antibacterial agents.