Heart valve replacement device

Abstract

The utility model provides a heart valve replacement device, which belongs to the technical field of medical instruments and comprises a valve main body, an annular support is arranged on the edge of the valve main body, the annular support is of an annular structure and comprises an inner ring and an outer ring, the inner ring is in direct contact with a heart valve ring, and the outer ring is in an annular structure. The annular support is composed of a series of spring pieces, the valve body is in seamless connection with the annular support, the spring pieces are distributed on the annular support in a radial mode, an anchoring structure is arranged at the implanting end of the valve body and is spiral, and the annular support is composed of a series of elastic memory alloy spring pieces. The two ends of the spring piece are fixedly connected with the inner ring and the outer ring of the annular support respectively to form a closed annular structure, the problem that a valve is not matched after being implanted due to a traditional valve replacement operation is solved, and the success rate of valve implantation is increased.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, and in particular relates to a heart valve replacement device. Background Art

[0002] The heart valve annulus, a ring-shaped structure located at the base of the heart valve, plays a key role in maintaining the normal physiological function of the heart valve. It not only provides the necessary support for the valve, but also works with the valve to regulate the unidirectional flow of blood, prevent blood backflow, and ensure the effective pumping of the heart. The size and shape of the heart valve annulus vary from person to person and change with factors such as age and disease status. For example, the diameter of the mitral valve annulus and tricuspid valve annulus in healthy adults usually ranges from 25mm to 35mm, but this value fluctuates due to individual differences, heart disease or the aging process.

[0003] Although modern medicine has made significant progress, there are still many challenges and limitations in the treatment of valvular heart disease, especially for valve replacement surgery. Traditional valve replacement surgery, whether using mechanical valves or biological valves, faces the following problems: Due to individual differences in the size of the heart valve ring, it is very difficult to find a valve that completely matches the size of the patient's heart valve ring, which may lead to mismatch after valve implantation, thereby affecting valve function and life. Traditional valve replacement surgery usually requires thoracotomy, which is traumatic and has a long recovery period, increasing the risk of complications, especially for elderly patients or patients with more comorbidities. Although biological valves have good biocompatibility, due to the limitations of their own materials, their long-term durability is not as good as mechanical valves, and secondary surgery may be required for replacement, increasing the economic burden and psychological pressure on patients. Traditional valve implantation usually relies on delicate suturing techniques, which require extremely high operating skills of doctors, and improper suturing may cause paravalvular leakage and affect valve function. Utility Model Content

[0004] In view of this, the utility model provides a heart valve replacement device, which solves the problem of valve incompatibility after implantation caused by traditional valve replacement surgery and improves the success rate of valve implantation through the provision of an annular stent composed of a series of elastic memory alloy spring sheets and an anchoring structure.

[0005] The utility model is achieved in this way:

[0006] The utility model provides a heart valve replacement device, comprising a valve body, wherein an annular support is arranged at the edge of the valve body, the annular support is an annular structure, the annular support comprises an inner ring and an outer ring, the inner ring is in direct contact with the heart valve ring, the annular support is composed of a series of spring sheets, the valve body and the annular support are seamlessly connected, the spring sheets are radially distributed on the annular support, and an anchoring structure is arranged at the implantation end of the valve body, the anchoring structure is spiral.

[0007] The ring stent is composed of a series of elastic memory alloy spring sheets, which are evenly distributed to form a ring structure. The inner ring of the ring stent directly contacts the heart valve ring, while the outer ring provides structural support and shape retention.

[0008] On the basis of the above technical solution, the heart valve replacement device of the utility model can also be improved as follows:

[0009] Wherein, the length of each spring leaf is 0.5 to 0.7 times the radius of the valve body, the width of the spring leaf is 1 / 10 to 1 / 8 of the length of the spring leaf, and the thickness of the spring leaf is equal to 1 / 10 to 1 / 5 of the width of the spring leaf.

[0010] Furthermore, two ends of the spring sheet are respectively fixedly connected to the inner ring and the outer ring of the annular bracket to form a closed annular structure.

[0011] Adjacent spring sheets are indirectly connected through the inner and outer rings of the annular support. The two ends of each spring sheet are respectively fixed on the inner and outer rings, and the inner and outer rings themselves are continuous closed loop structures, which constitutes an indirect connection between the spring sheets.

[0012] Furthermore, the pitch of the anchoring structure is 1.5 to 2 times the thickness of the valve body, and the thread depth of the anchoring structure is 0.2 to 0.3 times the thickness of the valve body.

[0013] Furthermore, the surfaces of the valve body and the anchoring structure are coated with an anti-coagulation coating, and the coating has a thickness of 1 μm to 5 μm.

[0014] The anticoagulant coating uses polymer materials with anticoagulant function, such as:

[0015] Polytetrafluoroethylene (PTFE): Due to its good chemical stability, it can effectively reduce platelet activation when blood comes into contact with the material surface, thereby reducing thrombosis.

[0016] Polyurethane (PU): Certain modified polyurethane materials have good biocompatibility and anti-coagulation properties.

[0017] Heparin coating: Directly use heparin or other anticoagulant drugs as a coating to reduce the risk of thrombosis through drug release mechanism.

[0018] Furthermore, the outer diameter of the valve body is 20 mm to 30 mm, the inner diameter is 18 mm to 28 mm, and the radius of the valve body is equal to 1 / 4 of the average value of the inner diameter and outer diameter of the valve body.

[0019] Furthermore, the annular bracket is made of nickel-titanium alloy.

[0020] The material of the annular stent is nickel-titanium alloy, with an elastic modulus of 100 GPa to 110 GPa, a Poisson's ratio of 0.3 to 0.4, and a yield strength of 1000 MPa to 1200 MPa, so as to meet the elasticity and biocompatibility requirements of the stent.

[0021] Furthermore, the outer ring diameter of the annular support is 1.1 to 1.3 times greater than the inner ring diameter.

[0022] Furthermore, the valve body and the annular stent are seamlessly connected via biocompatible material.

[0023] Furthermore, the valve body is composited with multiple layers of biocompatible materials, including one of polyurethane, silicone or bioceramics.

[0024] Compared with the prior art, the beneficial effects of a heart valve replacement device provided by the utility model are:

[0025] Precise fit: Equipped with an annular stent with adjustable tension and a preset elastic memory alloy spring sheet, the valve can automatically adapt to the actual size of the heart valve ring after implantation, without the need for complex size matching, greatly improving the success rate of valve implantation and the patient's quality of life;

[0026] Minimally invasive implantation: The spiral bioresorbable anchoring structure designed at the valve implant end allows the valve to be easily screwed into the inner wall of the heart valve ring, reducing surgical trauma, shortening recovery time, and lowering the risk of complications, which is especially suitable for elderly or frail patients;

[0027] No additional sutures are required: The bioabsorbable anchoring structure is gradually absorbed by the human body after implantation, and no additional sutures are required, thus avoiding suture complications that may occur in traditional valve implantation, such as paravalvular leakage or infection, and improving the safety and success rate of the operation;

[0028] Enhanced biocompatibility and durability: The valve body is made of biocompatible materials, combined with a unique structural design, which not only improves the biocompatibility of the valve and reduces rejection reactions, but also enhances the durability of the valve and extends the service life of the valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the technical solutions of the embodiments of the utility model, the drawings required for use in the description of the embodiments of the utility model will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0030] Figure 1 A side view of a heart valve replacement device;

[0031] Figure 2 A top view of a heart valve replacement device;

[0032] In the accompanying drawings, the components represented by the reference numerals are listed as follows:

[0033] 10. Valve body; 20. Annular stent; 21. Spring leaf; 30. Anchoring structure. DETAILED DESCRIPTION

[0034] In order to make the purpose, technical solution and advantages of the implementation mode of the present invention clearer, the technical solution in the implementation mode of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the implementation mode of the present invention.

[0035] like Figure 1 , Figure 2 As shown, it is a first embodiment of a heart valve replacement device provided by the utility model. In this embodiment, it includes a valve body 10, wherein an annular support 20 is arranged at the edge of the valve body 10, and the annular support 20 is an annular structure. The annular support 20 includes an inner ring and an outer ring, and the inner ring directly contacts the heart valve ring. The annular support 20 is composed of a series of spring leaves 21. The valve body 10 and the annular support 20 are seamlessly connected. The spring leaves 21 are radially distributed on the annular support 20. The implantation end of the valve body 10 is provided with an anchoring structure 30, and the anchoring structure 30 is spiral.

[0036] The anchoring structure is spiral, similar to the shape of a screw, which allows the valve to be screwed into the inner wall of the heart valve ring like a screw, providing immediate and reliable fixation. The pitch and thread depth of the spiral design are carefully calculated to ensure that it will not damage the heart tissue during implantation, while providing sufficient friction to prevent valve displacement.

[0037] In the above technical solution, the length of each spring leaf 21 is 0.5 to 0.7 times the radius of the valve body 10, the width of the spring leaf 21 is 1 / 10 to 1 / 8 of the length of the spring leaf 21, and the thickness of the spring leaf 21 is equal to 1 / 10 to 1 / 5 of the width of the spring leaf 21.

[0038] Furthermore, in the above technical solution, two ends of the spring sheet 21 are respectively fixedly connected to the inner ring and the outer ring of the annular bracket 20 to form a closed annular structure.

[0039] When in use, the fixed connection adopts one or a combination of the following methods:

[0040] Welding: Use laser welding or ultrasonic welding technology to connect the spring leaf to the inner and outer rings of the annular bracket to ensure the strength and durability of the connection parts.

[0041] Bonding: Use a medical-grade adhesive to firmly bond the spring leaf to the inner and outer rings of the ring stent. The adhesive must be biocompatible to ensure that it does not cause an immune response or affect blood flow.

[0042] Mechanical connection: The spring leaf is fixed to the inner and outer rings of the ring bracket by small clips or similar devices. This method requires precise design to ensure the reliability of the connection and the freedom of movement of the spring leaf.

[0043] Furthermore, in the above technical solution, the pitch of the anchoring structure 30 is 1.5 to 2 times the thickness of the valve body 10 , and the thread depth of the anchoring structure 30 is 0.2 to 0.3 times the thickness of the valve body 10 .

[0044] Furthermore, in the above technical solution, the surfaces of the valve body 10 and the anchoring structure 30 are also coated with an anti-coagulation coating, and the coating thickness is 1 μm to 5 μm.

[0045] In addition to the use of bioabsorbable materials, the surface treatment of the anchoring structure is also very important. The surface may be treated with special coatings, such as hydrophilic coatings or anticoagulant coatings, to further improve biocompatibility and reduce the risk of thrombosis, while promoting tissue healing and long-term stability of the valve.

[0046] Furthermore, in the above technical solution, the outer diameter of the valve body 10 is 20 mm to 30 mm, the inner diameter is 18 mm to 28 mm, and the radius of the valve body 10 is equal to 1 / 4 of the average value of the inner diameter and the outer diameter of the valve body 10 .

[0047] Furthermore, in the above technical solution, the annular bracket 20 is made of nickel-titanium alloy.

[0048] Furthermore, in the above technical solution, the outer ring diameter of the annular bracket 20 is 1.1 to 1.3 times greater than the inner ring diameter.

[0049] Furthermore, in the above technical solution, the valve body 10 and the annular stent 20 are seamlessly connected by biocompatible material.

[0050] Furthermore, in the above technical solution, the valve body 10 is composited with multiple layers of biocompatible materials, including one of polyurethane, silicone or bioceramics.

[0051] The anchoring structure is made of bioabsorbable materials, such as polylactic acid (PLA), polycaprolactone (PCL) or other advanced biodegradable polymers. These materials have sufficient strength and stability at the initial stage of implantation, and are gradually absorbed by the body as the body's natural metabolism process, and eventually disappear completely, avoiding inflammation or foreign body reactions that may be caused by long-term retention.

[0052] Specifically, the principle of the utility model is as follows: the core technology of the utility model lies in the adjustable tension ring bracket equipped on the edge of the valve body, which is composed of a series of preset elastic memory alloy spring leaves. These spring leaves have excellent elastic recovery ability and memory characteristics. After being implanted in the heart valve ring, they can automatically adjust their diameter according to the size of the ring to achieve a close fit between the valve and the valve ring. The material selection of the spring leaves, such as nickel-titanium alloy (NiTi), not only has good biocompatibility, but also can withstand the repeated stress when the valve is opened and closed, ensuring the long-term stability and safety of the valve;

[0053] In addition, the spiral bioabsorbable anchoring structure at the implant end of the valve uses biodegradable materials, such as polylactic acid (PLA) or polycaprolactone (PCL). These materials can provide stable anchoring in the early stage of implantation to ensure the positioning and fixation of the valve. Over time, these materials will be safely absorbed by the human body, and there is no need to worry about complications caused by long-term retention. This design not only simplifies the valve implantation process, but also reduces the patient's discomfort after surgery and improves the overall efficiency and safety of the operation.

Claims

1. A heart valve replacement device, comprising a valve body (10), characterized in that: An annular support (20) is arranged at the edge of the valve body (10). The annular support (20) is an annular structure. The annular support (20) comprises an inner ring and an outer ring. The inner ring is in direct contact with the heart valve ring. The annular support (20) is composed of a series of spring sheets (21). The valve body (10) and the annular support (20) are seamlessly connected. The spring sheets (21) are radially distributed on the annular support (20). An anchoring structure (30) is arranged at the implantation end of the valve body (10). The anchoring structure (30) is spiral.

2. A heart valve replacement device according to claim 1, characterized in that: The length of each spring sheet (21) is 0.5 to 0.7 times the radius of the valve body (10), the width of the spring sheet (21) is 1 / 10 to 1 / 8 of the length of the spring sheet (21), and the thickness of the spring sheet (21) is equal to 1 / 10 to 1 / 5 of the width of the spring sheet (21).

3. A heart valve replacement device according to claim 2, characterized in that: The two ends of the spring sheet (21) are respectively fixedly connected to the inner ring and the outer ring of the annular bracket (20) to form a closed annular structure.

4. A heart valve replacement device according to claim 3, characterized in that: The pitch of the anchoring structure (30) is 1.5 to 2 times the thickness of the valve body (10), and the thread depth of the anchoring structure (30) is 0.2 to 0.3 times the thickness of the valve body (10).

5. A heart valve replacement device according to claim 4, characterized in that: The surfaces of the valve body (10) and the anchoring structure (30) are also coated with an anti-coagulation coating, and the thickness of the coating is 1 μm to 5 μm.

6. A heart valve replacement device according to claim 5, characterized in that: The outer diameter of the valve body (10) is 20 mm to 30 mm, the inner diameter is 18 mm to 28 mm, and the radius of the valve body (10) is equal to 1 / 4 of the average value of the inner diameter and the outer diameter of the valve body (10).

7. A heart valve replacement device according to claim 6, characterized in that: The annular support (20) is made of nickel-titanium alloy.

8. A heart valve replacement device according to claim 7, characterized in that: The outer ring diameter of the annular support (20) is 1.1 to 1.3 times greater than the inner ring diameter.

9. A heart valve replacement device according to claim 8, characterized in that: The valve body (10) and the annular stent (20) are seamlessly connected via biocompatible material.

10. A heart valve replacement device according to claim 9, characterized in that: The valve body (10) is made of a composite of multiple layers of biocompatible materials, including one of polyurethane, silica gel or bioceramics.

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