A type of artificial heart valve mitral valve repair ring

Abstract

An artificial heart valve angioplasty ring is a ring body comprising a support tube, the outer layer of which is a biocompatible medical implantable polyester fabric, and an inner core inside the support tube. The inner core adopts an inner core cluster structure, which is composed of multiple similar concentric coils. The angioplasty ring has better support and myocardial compliance, and the gap between the silicone tube and the inner core filaments further enhances its support and compliance. The clusters of finer inner core filaments with gaps contribute to the lightweight design of the angioplasty ring.

Description

Technical Field

[0001] This invention relates to a medical device, and more particularly to a prosthetic ring used in artificial heart valve repair surgery. Background Technology

[0002] The use of annuloplasty rings for valvuloplasty was first introduced in the 1970s. In recent years, valvuloplasty has developed rapidly, maturing both theoretically and clinically. Annuloplasty rings, as a mature product, are widely used. The mitral valve annulus is a fibrous band of tissue attached to the edge of the left atrium / ventricular foramen, and has a three-dimensional "saddle-shaped" appearance. Currently, mitral valve annuloplasty rings are classified into three types: rigid rings, soft rings, and semi-elastic rings. Rigid rings have a metallic core, which provides good correction for the valve but has poor myocardial compliance. Soft rings use medical-grade non-metallic polymer materials for the core, offering good three-dimensional flexibility and myocardial compliance, but they lack the sustained, firm support and shaping effect needed for severely deformed annuloplasty rings. Semi-elastic rings offer the best results in both correction and myocardial compliance. Their core materials are broadly divided into two types: metallic and medical-grade non-metallic polymer materials. The cross-section of these materials can be circular, triangular, rectangular, or polygonal. For easier postoperative observation, rings using medical-grade non-metallic polymer materials require the inclusion of X-ray-visible inorganic materials in the silicone tubing or core material, making the process complex. Even semi-elastic rings with a metallic core can still experience overcorrection or poor compliance because their core cross-section, whether rectangular or circular, is a solid, integrated structure. Summary of the Invention

[0003] The technical problem to be solved by this invention is to change the structure and composition, using an inner core composed of N (N≥1) medical metal alloy wires to form an inner core cluster. This achieves a valve that has both sufficient rigidity to ensure the correction of diseased or deformed valve annulus, and sufficient three-dimensional flexibility to meet the requirements of myocardial compliance after correction, so as to maximize its recovery.

[0004] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is: an artificial heart valve angioplasty ring, which is a ring body including a support tube, the outer layer of which is a biocompatible medical implantable polyester fabric, characterized in that: the support tube has an inner core, the inner core adopts an inner core cluster structure, which is composed of multiple similar concentric coils.

[0005] Furthermore, the support tube is made of medical polymer material that can be implanted into the body.

[0006] Furthermore, the support tube is made of silicone material to form a silicone sleeve.

[0007] Furthermore, the support tube has a raindrop-shaped cross-section with a thinner outer side and a thicker inner side. The outer side of the raindrop-shaped structure facilitates suturing with human tissue.

[0008] Furthermore, the outermost layer of the forming ring is covered with polyester fabric.

[0009] Furthermore, the cross-section of a single coil in the inner core is circular, triangular, rectangular, or polygonal.

[0010] Furthermore, the multiple coils in the inner core cluster are arranged in a circular, triangular, rectangular, or polygonal array pattern in cross-section.

[0011] Furthermore, multiple coils within the inner core cluster are made of metal or polymer materials.

[0012] Furthermore, multiple coils in the inner core cluster may use the same material or different materials; if different materials are used, they may be a combination of metal and polymer materials, or a combination of different metals, or a combination of different polymers. The different materials meet the requirements of biocompatibility and do not produce mutual chemical reactions.

[0013] Furthermore, the individual coils within the core are shaped like a three-dimensional saddle.

[0014] The beneficial effects of this invention are as follows: 1. The inner core structure is formed by stacking saddle-shaped inner core wires of the same shape, which creates a semi-elastic effect. This method gives the angioplasty ring better support and myocardial compliance. At the same time, there is a gap between the silicone tube and the inner core wires, which further enhances its support and compliance. 2. Because it is a cluster of relatively thin inner core wires with gaps, it is equivalent to lightweighting the angioplasty ring. The lighter weight can minimize the cardiac load and the "foreign body sensation" caused by the angioplasty for the patient. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the three sides and three-dimensional shape of the forming ring;

[0016] Figure 2 This is a cross-sectional view of the formed ring.

[0017] In the picture: 1. Polyester fabric, 2. Silicone sleeve, 3. Inner core cluster. Detailed Implementation

[0018] The present invention will be further described below with reference to the accompanying drawings. It should be understood that the content described herein is for illustration and explanation only and is not intended to limit the present invention.

[0019] A medical device implanted in the human body, specifically relating to a cardiac surgery mitral valve annuloplasty ring. The artificial mitral valve annuloplasty ring includes a core wire cluster, a silicone sleeve covering the core wire cluster, and a medical polyester fabric covering the silicone sleeve. The polyester fabric of the annuloplasty ring has three circumferential markings to facilitate adjustment of the relative position of the annuloplasty ring and the human valve annulus. The silicone sleeve has a raindrop-shaped cross-section, which facilitates suturing with human tissue and avoids contact between the suture needle and the inner core wire cluster during implantation, preventing a feeling of obstruction.

[0020] Example 1

[0021] See Figure 1 , Figure 2 This is a three-dimensional schematic diagram and a cross-sectional view of the artificial heart valve angioplasty ring of the present invention. The artificial heart valve angioplasty ring of the present invention uses implantable medical materials as the support tube structure. Silicone material can be used to form a silicone sleeve as the support tube. The outer diameter of the silicone sleeve is 1.8–2.5 mm, and the wall thickness is 0.3–1.2 mm. The silicone sleeve has a raindrop-shaped structure, with a thinner outer side and a thicker inner side. The raindrop-shaped structure facilitates suturing of the angioplasty ring to human tissue on the outer side, while the thinner outer part is used for suturing with human tissue, avoiding contact between the suture needle and the inner core cluster during implantation, thus preventing a feeling of suture blockage.

[0022] The inner core is housed within a silicone sleeve inside a raindrop-shaped structure. The inner core is made of metal or a relatively rigid polymer material, such as titanium alloy or polyethylene. The inner core employs an inner core cluster structure, composed of multiple similar concentric coils. Each coil is three-dimensionally saddle-shaped with a circular, triangular, rectangular, or polygonal cross-section, possessing a certain degree of elastic retention. The multiple coils within the inner core cluster are arranged in a circular, triangular, rectangular, or polygonal array pattern in cross-section.

[0023] In addition, the core material is not made of pure polymer material, but of the same metal material or different materials (a combination of metal material and medical polymer material is used as the core cluster).

[0024] If different materials are used, a combination of metal materials and polymer materials, or a combination of different metals, or a combination of different polymer materials can be used. The different materials used must meet the requirements of biocompatibility and must not produce mutual chemical reactions.

[0025] Multiple similar concentric coils can be made of the same material or different materials, such as some coils being metal and some coils being made of polymer materials.

[0026] By varying the number, cross-sectional shape, arrangement, and material composition of the inner core wires, the elasticity and weight required to obtain the inner core cluster can be adjusted.

[0027] The outermost layer of the angioplasty ring is usually covered with a commonly used non-toxic, non-irritating active medical fiber fabric, such as polyester fabric, with a wall thickness of 0.2–0.5 mm. There are three markings a, b, and c on the medical fiber fabric. The distance between markings a and b is the distance between the left and right fibrous triangles of the human heart valve annulus. The size of this angioplasty ring is generally determined by this distance. During the surgery, markings a and b on the angioplasty ring are aligned with the left and right fibrous triangles of the human heart valve annulus to improve surgical accuracy and save surgical time.

[0028] The surgical outcome of this type of ring-forming surgery can be easily observed during the postoperative recovery process by imaging under X-ray or CT-X.

[0029] The core structure of this application uses stacked saddle-shaped core wires of the same shape. The stacking of multiple single wires creates a semi-elastic effect, which gives the forming ring better support and myocardial compliance.

[0030] The gap between the silicone tube and the inner core wire provides better support and conformability.

[0031] Because it is a cluster composed of finer inner core filaments, there are gaps between the individual filaments, which provides better support and compliance.

[0032] Furthermore, the inner core cluster is composed of different materials. Since the different materials used have different densities, it is equivalent to making the entire angioplasty ring lightweight. The lighter weight can minimize the cardiac load on the patient and reduce the "foreign body sensation" caused by the angioplasty.

[0033] By varying the number, cross-sectional shape, arrangement, and material composition of the inner core wires, different elasticity, support, compliance, and weight characteristics can be obtained. This allows for the production of formed rings that meet a variety of performance requirements.

[0034] Finally, it should be noted that the above description is merely an explanation of the present invention and is not intended to limit the invention. Although the present invention has been described in detail, those skilled in the art can still modify the technical solutions described above or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An artificial heart valve annuloplasty ring, being a ring body, comprising a support tube, the outer layer of which is a biocompatible, medical implantable polyester fabric, characterized in that: The support tube has an inner core, which is in the form of a core cluster composed of multiple similar concentric coils, each of which is in the form of a three-dimensional saddle, and the core is formed by stacking the same shape of the saddle-shaped core coils, and there is a gap between the single coils, and the cross section of the single coil is circular or polygonal.

2. The prosthetic heart valve annuloplasty ring of claim 1, wherein: The support tube is made of medical material that can be implanted in the body.

3. The prosthetic heart valve annuloplasty ring of claim 1, wherein: The support tube is formed by a silica gel sleeve made of medical silica gel material.

4. The prosthetic heart valve annuloplasty ring of claim 1, wherein: The cross section of the support tube is in the form of a raindrop structure, and the outer thickness is smaller than the inner thickness, and the inner thickness is larger than the outer thickness, and the outer side of the raindrop structure is convenient for suturing with human tissues.

5. The prosthetic heart valve annuloplasty ring of claim 1, wherein: The outermost layer of the forming ring is covered with polyester fabric.

6. The prosthetic heart valve annuloplasty ring of claim 1, wherein: The multiple coils in the core cluster are arranged in the form of a circular or polygonal array in the cross section.

7. The prosthetic heart valve annuloplasty ring of claim 1, wherein: The multiple coils in the core cluster are made of metal or high polymer material.

8. The prosthetic heart valve annuloplasty ring of claim 1, wherein: The multiple coils in the core cluster are made of the same material or different materials; if different materials are used, metal and high polymer materials are combined, or different metals are combined, or different high polymers are combined, and different materials meet the biological compatibility requirements and do not produce mutual chemical reactions.

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