A fixing structure for an artificial heart valve

Abstract

The present invention discloses a fixing structure of an artificial heart valve, comprising a flexible coating layer, a support member and a tether fixing member, wherein the flexible coating layer covers the side of the support member facing the heart, and the tether fixing member is fixedly connected to the flexible coating layer; the side of the support member facing away from the heart is provided with a fixing end, and a plurality of wire grooves are provided along the edge of the fixing end, and the support member is also provided with a first through hole for the valve tether to pass through; the valve tether passes through the first through hole, is wound around at least one of the wire grooves, and is connected to the tether fixing member. The fixing structure is simple and ingenious, easy to operate, reduces the operating requirements for operators, and has a stable connection method. By increasing the contact area between the tether and the organ, the risk of bleeding or tearing at the wound position is greatly reduced, and the use effect is guaranteed, which is conducive to the promotion and application of the fixing structure of the artificial heart valve in the field of medical device technology.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a fixing structure of an artificial heart valve and a use method thereof. Background Art

[0002] Normal heart valves are important structures that maintain the direction of blood flow in the heart. Valvular diseases such as stenosis and insufficiency will lead to changes in hemodynamics, causing a series of pathological and physiological changes, which can be life-threatening in severe cases. There are many causes of heart valve disease, which are related to genetics, immunity, infection, etc., which also makes 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 one of the main means and most effective ways to treat heart valve disease. This technology intervenes in the human body through a catheter and places an artificial heart valve at the lesion site of the human body, thereby achieving treatment of the disease.

[0003] In order to ensure high effectiveness, it is extremely important for the valve to be fixed in the human body. Therefore, a certain fixed structure needs to be set to limit the position of the artificial valve. For example, when replacing the mitral valve, it is necessary to ensure that the replaced valve cannot be offset into the atrium under the impact of blood flow, causing device failure. Therefore, it is necessary to set a fixed structure on the outside of the apex and connect the valve stent to the fixed structure through a tether to achieve the fixation of the valve stent position. In addition, it can also avoid the tether being directly connected to the heart, and the small contact surface will cause excessive local pressure, leading to hidden dangers such as apical tearing.

[0004] However, the fixing structure in the prior art is usually complex in structure and has many steps in the use process, which is not conducive to the doctor's operation. In addition, the fixing method of the needle-shaped pinning structure is prone to bending or even breaking under long-term tension, resulting in product failure, endangering the patient's health, and being not conducive to the patient's recovery. Summary of the invention

[0005] In order to overcome the defects in the above-mentioned prior art, the object of the present invention is to provide a fixing structure of an artificial heart valve, which is simple and ingenious, easy to operate, reduces the operating requirements for operators, has a stable connection method, and greatly reduces the risk of bleeding or tearing at the wound site by increasing the contact area between the tether and the organ, thereby ensuring the use effect, and is conducive to the promotion and application of the above-mentioned fixing structure of the artificial heart valve in the field of medical device technology.

[0006] In order to achieve the above-mentioned invention objectives, the present invention adopts the following technical solutions: a fixing structure for an artificial heart valve, comprising a flexible covering layer, a support member and a tether fixing member, wherein the flexible covering layer covers the side of the support member facing the heart, and the tether fixing member is fixedly connected to the flexible covering layer; a fixed end is provided on the side of the support member facing away from the heart, a plurality of wire grooves are provided along the edge of the fixed end, and the support member is also provided with a first through hole for the valve tether to pass through; the valve tether passes through the first through hole, is wrapped around at least one of the wire grooves, and is connected to the tether fixing member.

[0007] As a preferred solution of the present invention, the support member includes a chassis and a winding post, the chassis is arranged toward the heart side, the winding post is arranged away from the flexible covering layer and is fixedly connected to the chassis, and the first through hole passes through the chassis and the winding post.

[0008] As a preferred solution of the present invention, the chassis is provided with a plurality of second through holes, the tether fixing member passes through the second through holes, and the flexible covering layer is sewed to the chassis.

[0009] As a preferred solution of the present invention, the winding pole is provided with at least one third through hole, and the tether fixing member is sewn to the flexible covering layer through the third through hole.

[0010] As a preferred solution of the present invention, the bottom plate is a flat circular shape with a diameter of 1 mm to 50 mm.

[0011] As a preferred solution of the present invention, the wire trough is arranged in a "U" shape.

[0012] As a preferred solution of the present invention, the first through hole is a threaded hole and is located at the center of the support member.

[0013] As a preferred solution of the present invention, the flexible coating layer is made of an elastic medical material, and the elastic medical material is one or a combination of medical plastics, medical sponges and biological tissues.

[0014] As a preferred solution of the present invention, the flexible covering layer is made of non-elastic medical material, the non-elastic medical material is medical polymer fabric, and the fabric is one or more combinations of plain fabric, twill fabric, and mesh fabric.

[0015] As a preferred embodiment of the present invention, the outer surface of the flexible coating layer is provided with one or more combinations of recombinant proteins, collagen, growth factors and antibacterial agents.

[0016] Compared with the prior art, the beneficial effects of the present invention are: a fixing structure of an artificial heart valve in the present invention is simple and ingenious, easy to operate, reduces the operating requirements for operators, and has a stable connection method. By setting a support member and a flexible covering layer, the contact area between the tether and the organ is increased, which greatly reduces the risk of bleeding or tearing at the wound site, ensures the use effect, and is conducive to the promotion and application of the above-mentioned fixing structure of the artificial heart valve in the field of medical device technology. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a schematic diagram of a preferred position of a fixing structure of an artificial heart valve in the present invention during use;

[0018] Figure 2 is a structural schematic diagram of a fixing structure of an artificial heart valve in Example 1;

[0019] Figure 3 is a structural cross-sectional view of a fixing structure of an artificial heart valve in Example 1;

[0020] Figure 4 is a structural schematic diagram of a support member in a fixing structure of an artificial heart valve in Example 1;

[0021] Figure 5 is a top view of a tether winding method of a fixing structure of an artificial heart valve in Example 1;

[0022] Figure 6 yes Figure 5 Structural cross-section view along the AA axis;

[0023] Figure 7 is a structural schematic diagram of a fixing structure of an artificial heart valve in Example 2;

[0024] Figure 8 is a top view of a fixing structure of an artificial heart valve in Example 2;

[0025] Fig. 9 yes Figure 8 Structural cross-section view along the BB direction;

[0026] Fig.10 It is a schematic diagram of a tether winding method of a fixing structure of an artificial heart valve in Example 2.

[0027] Figure numerals: 1. fixing structure; 2. valve tether; 3. valve; 4. left atrium and left ventricle model; 11. flexible covering layer; 12. support member; 120. fixed end; 121. wire groove; 1211. first wire groove; 1212. second wire groove; 1213. third wire groove; 122. first through hole; 123. winding column; 124. chassis; 125. second through hole; 126. third through hole; 127. fixing screw; 13. tether fixing member. DETAILED DESCRIPTION

[0028] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific implementation disclosed below.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0030] In the field of interventional medical devices, the “distal end” is defined as the end away from the operator during surgery, and the “proximal end” is defined as the end close to the operator during surgery. “Axial” refers to the direction parallel to the line connecting the distal and proximal centers of the medical device, and “radial” refers to the direction perpendicular to the above axial direction.

[0031] In the description of the present invention, it is necessary to understand that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0032] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection, an electrical connection, or a communication connection; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0033] like Figure 1 1 is a schematic diagram of the specific installation position of a fixing structure of an artificial heart valve of the present invention, wherein 1 is the fixing structure in the embodiment; 2 is the valve tether; 3 is the valve; and 4 is the left atrium and left ventricle model.

[0034] Example 1: Figures 2 to 6 As shown, a fixing structure of an artificial heart valve comprises a flexible covering layer 11, a support member 12 and a tether fixing member 13. In order to enhance the user experience, the flexible covering layer 11 is covered on the side of the support member 12 facing the heart, and the tether fixing member 13 is fixedly connected to the flexible covering layer 11. The arrangement of the support member 12 can increase the contact area between the tether and the internal organs, greatly reduce the risk of bleeding or tearing at the wound position, ensure the use effect, and facilitate the promotion and application of the fixing structure of the artificial heart valve in the field of medical device technology. The side of the support member 12 facing away from the heart is provided with a fixing end, and a plurality of wire grooves 121 are provided along the edge of the fixing end. The support member 12 is also provided with a first through hole 122 for the valve tether 2 to pass through; the valve tether 2 passes through the first through hole 122, wraps around at least one of the wire grooves 121, and is connected to the tether fixing member 13.

[0035] The support member 12 includes a chassis 124 and a winding post 123. The chassis 124 is disposed toward the heart, the winding post 123 is disposed away from the flexible covering layer 11 and is fixedly connected to the chassis 124, and the first through hole 122 is disposed through the chassis 124 and the winding post 123. The chassis 124 is provided with a plurality of second through holes 125, and the tether fixing member 13 passes through the second through holes 125 to sew the flexible covering layer 11 to the chassis 124. The winding post 123 is provided with at least one third through hole 126, and the tether fixing member 13 is sewed to the flexible covering layer 11 through the third through hole 126.

[0036] The tether fixing member 13 is a suture line (hereinafter referred to as the fixing line), which is connected to the flexible covering layer 11 by sewing or bonding, and passes through the third through hole 126 on the side of the support member 12 away from the heart and is wound around. The first through hole 122 is set at the center of the support member 12, and the valve tether 2 (shown by the black filling line in the figure) passes through the first through hole 122, and finally the valve tether 2 and the fixing line are fixed after passing through. The fixing line and the valve tether 2 can be combined by knotting as shown in the figure, or by suturing, or adding other structures to combine and fix the two. The knotting method can be a double-line knot or a multi-line knot.

[0037] Among them, the flexible covering layer 11 can be any medical material with good biocompatibility, such as PET, PTFE, TPU, polyamide, etc., with any thickness between 0.05-10mm, such as 0.5mm, 1mm, 2.5mm, 3mm, etc. The structure can be designed as a single layer or a multi-layer, the material can be elastic or inelastic, and an elastomer (not shown in the figure) can be added between the flexible covering layer 11 and the support member 12 to better fit the human body structure.

[0038] Furthermore, the part of the flexible coating layer 11 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 line can be a PTFE suture line or other materials with good biocompatibility, and can be a single-line structure or a multi-line braided structure.

[0039] The wire groove 121 in this embodiment is set in a "U" shape, which is convenient for winding the valve tether 2. The wire groove 121 in this embodiment is set to three, namely the first wire groove 1211, the second wire groove 1212 and the third wire groove 1213. The valve tether 2 passes through the first through hole 122, and is wound around the winding column 123 through the three U-shaped wire grooves, namely the first wire groove 1211, the second wire groove 1212 and the third wire groove 1213, so as to pre-fix the valve tether 2 to maintain a certain tension.

[0040] The flexible covering layer 11 is covered on the bottom plate 124, and the bottom plate 124 and the flexible covering layer 11 can be fixed by passing a suture back and forth through the second through hole 125. One end of the fixing line is sutured or bonded to the flexible covering layer 11, and the other end passes through the third through hole 126. Finally, the fixing line and the valve tether 2 can be fixed by knotting, suturing, etc.

[0041] The chassis 124 can be circular with a diameter of 1 mm to 50 mm, and is used to fix the winding post 123 and the flexible covering layer 11, increase the contact area between the tether and the organ, and greatly reduce the risk of bleeding or tearing at the wound site. It can also be square or other irregular shapes, and the contact surface with the flexible covering layer 11 can be a flat surface as shown in the figure, or a slightly arc shape that fits the apex better. The second through hole 125 on the chassis 124 can be circular, square or other shapes that can pass through the suture line. In addition, there can be no second through hole, and the flexible covering layer 11 cooperates with the support member 12 by bonding or other means.

[0042] The shape of the support member 12 can also be a variable I-shaped, for example, the upper and lower side planes can be umbrella-shaped, funnel-shaped, concave or convex arc-shaped, etc. The support member 12 can be an integral shape, or a structure in which the upper and lower plates are spliced ​​with the central column, or any one plate is integral with the column, and the other plate is spliced, etc. The material of the support member 12 can be stainless steel, cobalt-chromium alloy, nickel-titanium alloy, PEEK, nylon and other materials with good biocompatibility. The wire groove 121 can be any value between 1-20, such as 1, 3, 5, 10, etc. The shape of the wire groove 121 can be a combination of a rectangle and a circle as shown in the figure, or it can be a single rectangle, or other structures such as a variable rectangle that can pass through the valve tether 2.

[0043] The width of the wire groove 121 is any value between 0.01-10mm, such as 1mm, 2mm, 5mm, etc. The first through hole 122 is a round hole that passes through the support member 12 as a whole. Both ends of the first through hole 122 are provided with guide fillets or guide bevels to facilitate the passage of the tether. It can also be square, D-shaped, irregularly round or shaped, and the diameter can be any value between 0.01-10mm, such as 1mm, 2mm, 3mm, etc. The winding column 123 is shown as a cylindrical shape. In addition, it can also be a square or other structure. In addition, the surface can be made into wolf tooth shape, honeycomb shape, Chinese character shape, or frosted shape or other surface shapes to facilitate winding and increase the friction of winding.

[0044] Among them, the flexible covering layer 11 is preferably a medical material suitable for wound growth and promoting wound healing. The medical material is one or a combination of medical plastics, medical sponges and biological tissues, such as PET, PTFE and other multi-layer or single-layer materials, and can be an elastic material or a non-elastic material. The non-elastic medical material is a medical polymer fabric, and the fabric is one or more combinations of plain fabric, twill fabric, mesh fabric, or a combination of elastic material and non-elastic material, such as a layer of elastic material sandwiched between two non-elastic materials. The elastic material can make the shape more fit the wound position.

[0045] The outer surface of the flexible coating layer 11 is provided with one or more combinations of recombinant proteins, collagen, growth factors, and antibacterial agents.

[0046] The preferred winding method is as follows Figure 5 and Figure 6 As shown, after the valve tether 2 passes upward through the first through hole 121, it first passes downward through the first wire groove 1211, surrounds the winding post 123 90 degrees counterclockwise, and passes upward from the second wire groove 1212, then crosses the first through hole 122, goes downward from the third wire groove 1213, surrounds the winding post 123 90 degrees counterclockwise, and passes upward from the first wire groove 1211. At this time, the valve tether 2 exit position and the third through hole 126 where the fixed line exits are symmetrically arranged with respect to the first through hole 122.

[0047] Example 2: Figures 7 to 10 As shown, the feature of this embodiment that distinguishes it from Embodiment 1 is that: the support member 12 in this embodiment is provided with a fixing screw 127, as shown in FIG. Figure 8 As shown, a first through hole 122 is provided at the center of the support member 12, and the first through hole 122 is a threaded hole. The valve tether 2 passes through the first through hole 122, and then is pre-fixed by means of a wire groove 121 and a winding post 123 provided on the edge of the fixed end 120. Finally, the fixing screw 127 is rotated into the first through hole 122, and the valve tether 2 is compressed by the tightening action between the threads to achieve fixation.

[0048] like Figure 8 and Fig. 9 As shown, the function of the first through hole 122 is to facilitate the passage of the valve tether 2, and the internal thread of the first through hole 122 is threadedly matched with the external thread on the fixing screw 127 to achieve the compression and fixation of the valve tether 2. The function of the second through hole 125 is to facilitate the subsequent fixation with the flexible covering layer 11 through sutures. The wire groove 121 is a U-shaped groove, which is used together with the winding post 123 for pre-fixation of the valve tether 2. The shape of the chassis 124 can be circular or square, and the surface contacting the apex can be a flat surface or an arc surface, which is convenient for better fitting the wound position. The function of the fixed end 120 is to achieve pre-fixation by winding after the valve tether 2 passes through. After the valve tether 2 passes through the first through hole 122, it passes through the wire groove 121 of the U-shaped groove structure set on the side of the fixed end 120, and then passes through the wire groove 121, and is wound on the winding post 123 to achieve pre-fixation of the valve tether 2.

[0049] like Fig.10As shown, the winding and fixing method of the valve tether 2 of this embodiment. The valve tether 2 passes through the first through hole 122 located in the center from the direction of the bottom plate 124 of the support member 12, and then passes through the wire groove 121 of the fixed end 120, and then passes through the groove of the disk surface. After winding around the winding column 123 for one circle, it passes through the wire groove 121 to achieve pre-clamping, and then the fixing screw 127 is screwed in to compress the valve tether 2 to ensure the final fixation. The top layer matching structure of the fixing screw 127 can be a straight line, or a cross shape, or a groove shape. The overall shape of the fixed screw 127 can be the shape shown in the figure, or it can be a self-tapping screw or a countersunk screw or a similar shape.

[0050] The fixing structure of an artificial heart valve in the above-mentioned embodiment has a simple and ingenious structure, is easy to operate, reduces the operating requirements for operators, and has a stable connection method. By providing a support member 12 and a flexible covering layer 11, the contact area between the valve tether 2 and the organ is increased, which greatly reduces the risk of bleeding or tearing at the wound site, ensures the use effect, and is conducive to the promotion and application of the above-mentioned fixing structure of the artificial heart valve in the field of medical device technology.

[0051] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention; therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

[0052] Although the following terms are used more frequently in this paper: 1, fixing structure; 2, valve tether; 3, valve; 4, left atrium and left ventricle model; 11, flexible covering layer; 12, support member; 120, fixing end; 121, wire groove; 1211, first wire groove; 1212, second wire groove; 1213, third wire groove; 122, first through hole; 123, winding post; 124, chassis; 125, second through hole; 126, third through hole; 127, fixing screw; 13, tether fixing member, etc., the possibility of using other terms is not excluded. These terms are used only to more conveniently describe and explain the essence of the present invention; interpreting them as any additional limitation is contrary to the spirit of the present invention.

Claims

1. A fixing structure for an artificial heart valve, characterized in that: The invention comprises a flexible covering layer (11), a support member (12) and a tether fixing member (13), wherein the flexible covering layer (11) covers the side of the support member (12) facing the heart, and the tether fixing member (13) is fixedly connected to the flexible covering layer (11); a fixed end is provided on the side of the support member (12) facing away from the heart, and a plurality of wire grooves (121) are provided along the edge of the fixed end; the support member (12) is also provided with a winding post (123) and a first through hole (122) for the valve tether (2) to pass through; the winding post (123) is arranged away from the flexible covering layer (11), and the first through hole (122) is a threaded hole and is arranged at the center of the support member (12); the valve tether (2) passes through the first through hole (122), is wound around at least one of the wire grooves (121) and the winding post (123), and is then connected to the tether fixing member (13).

2. The fixing structure of an artificial heart valve according to claim 1, characterized in that: The support member (12) is provided with a chassis (124), the chassis (124) is arranged towards the heart, the chassis (124) is fixedly connected to the winding post (123), and the first through hole (122) is arranged to penetrate the chassis (124) and the winding post (123).

3. The fixing structure of an artificial heart valve according to claim 2, characterized in that: The chassis (124) is provided with a plurality of second through holes (125), and the tether fixing member (13) passes through the second through holes (125) to sew the flexible covering layer (11) to the chassis (124).

4. The fixing structure of an artificial heart valve according to claim 3, characterized in that: The winding post (123) is provided with at least one third through hole (126), and the tether fixing member (13) is sewn onto the flexible covering layer (11) through the third through hole (126).

5. The fixing structure of an artificial heart valve according to claim 4, characterized in that: The bottom plate (124) is a flat circular shape with a diameter of 1 mm to 50 mm.

6. The fixing structure of an artificial heart valve according to claim 1, characterized in that: The wire trough (121) is arranged in a "U" shape.

7. The fixing structure of an artificial heart valve according to claim 1, characterized in that: The flexible coating layer (11) is made of an elastic medical material, and the elastic medical material is one or a combination of medical plastics, medical sponges and biological tissues.

8. The fixing structure of an artificial heart valve according to claim 1, characterized in that: The flexible covering layer (11) is made of a non-elastic medical material, which is a medical polymer fabric, and the fabric is a combination of one or more of plain fabric, twill fabric, and mesh fabric.

9. The fixing structure of an artificial heart valve according to claim 1, characterized in that: The outer surface of the flexible coating layer (11) is provided with one or more combinations of recombinant proteins, collagen, growth factors, and antibacterial agents.

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