A heart valve replacement prosthesis and its fastening apex pad

Abstract

The present invention discloses a heart valve replacement prosthesis and a fastening apex pad thereof, belonging to the field of medical devices. The apex pad comprises a blocking disc body with a central through hole and a threaded locking nail with a central hole. The central through hole is set as a countersunk structure. The inner wall of the countersunk structure is provided with an internal thread matching the external thread of the threaded locking nail. A compressible ring is provided at the bottom of the countersunk structure. When the threaded locking nail is screwed into the central through hole, the compressible ring is squeezed to shrink the through hole in the center of the compressible ring, thereby completing the clamping and fastening of the tether passing through the central through hole. A fixed pile with a hole for fixing the end of the tether is provided on the blocking disc body. The present invention adopts the principle of thread pressure and deformation of the compression ring, and uses friction and material cross-interlocking to fix the tether, thereby achieving non-destructive extrusion and fastening of the tether, which is simple, convenient and safer. The knotting and fixing of the end of the tether can also be achieved through the fixed pile, thereby ensuring long-term use effect and high safety and stability.

Description

Technical Field

[0001] The invention relates to the field of medical instruments, and in particular to a heart valve replacement prosthesis and a fastening apex pad thereof. Background Art

[0002] Transapical valve repair or replacement surgery combines the advantages of surgery and interventional surgery and is gradually being recognized by the medical community. During the transapical valve repair or replacement surgery, a hole is first made at the apex of the heart, and then the instruments and products are delivered to the lesion through this hole. The repair prosthesis or replacement prosthesis is then accurately and firmly fixed, and then all the instruments are removed, and finally the apex is sutured. In general, the apex of the heart is only sutured but not blocked after surgery. Since the heart is beating all the time and the blood pressure in the ventricle is very high, apical bleeding is a very serious complication after this surgery. Once apical bleeding occurs, it will lead to the patient's death.

[0003] At present, many well-known medical device manufacturers at home and abroad have launched products for interventional valve replacement. Among them, the tendyne product of Abbott Laboratories in the United States uses the apical pad to perform apical occlusion, which greatly reduces the risk of apical bleeding and greatly improves the patient's postoperative survival rate. The important component of the apical pad of the tendyne product is the needle. When the length of the tether is adjusted appropriately, the needle needs to be passed through the tether to firmly fix the stent part to the valve ring, and the apical pad also firmly blocks the apical opening. However, the fastening tether structure of the apical pad of the tendyne product is too complicated, with too many parts and too complex shapes. At the same time, they are all very small, and the sizes of various parts are mutually restricted. This structure is not only difficult to realize in production, but also very troublesome in assembly. If you are not careful, it will cause parts loss, blockage, jamming and other inconveniences in operation. If the assembly is not appropriate, it will cause medical accidents on the operating table. This structure not only brings severe challenges to production and processing, but also has mechanical weaknesses, which can easily lead to failure during long-term use. At the same time, due to the size design of the firing pin inside, the diameter and height of the apex pad will inevitably become larger, which will have a significant impact on the use effect.

[0004] It can be seen that the apex pad of the above-mentioned existing heart valve replacement prosthesis still has inconveniences and defects in structure, method and use, and it is urgent to be further improved. How to create a new heart valve replacement prosthesis and its fastening apex pad, so that it can achieve the fixation of the tether by screwing the material to squeeze and deform, with fewer parts, simple and flexible fixing method, convenient processing, and also through the setting of the fixing pile, realize the double insurance of fixation, firm and reliable, and good long-term use effect, has become a goal that the current industry urgently needs to improve. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide a fastening apex pad for a heart valve replacement prosthesis, so that the tether can be fixed by screwing the material and extruding and deforming it, with fewer parts, simple and flexible fixing method, convenient processing, firmness and reliability, thus overcoming the shortcomings of the existing fastening apex pad for a heart valve replacement prosthesis.

[0006] In order to solve the above technical problems, the present invention provides a fastening apex pad for a heart valve replacement prosthesis, comprising a sealing disc body with a central through hole and a threaded locking nail with a central hole, wherein the central through hole of the sealing disc body is arranged as a countersunk structure, and the inner wall of the countersunk structure is provided with an internal thread matching the external thread of the threaded locking nail, and a compressible ring is provided at the bottom of the countersunk structure, and when the threaded locking nail is screwed into the central through hole, the compressible ring is squeezed to shrink the through hole in the center of the compressible ring, thereby completing the clamping and fastening of the tether passing through the central through hole.

[0007] As a further improvement, the compressible ring is made of silicone rubber material.

[0008] As a further improvement, a fixing pile with a hole for fixing the end of the tether is provided on the blocking disc body, and the fixing pile with a hole and the threaded locking nail are arranged on the same side of the blocking disc body.

[0009] As a further improvement, the blocking disc body is also provided with a groove for winding a tether.

[0010] As a further improvement, the thread profiles of the internal thread on the inner wall of the countersunk hole structure and the external thread on the thread locking nail are trapezoidal, triangular or semicircular.

[0011] As a further improvement, the shape of the spiral groove of the threaded locking nail is hexagonal, triangular, square, D-shaped, star-shaped or diamond-shaped.

[0012] As a further improvement, the sealing disc body is made of PEEK material.

[0013] As a further improvement, the thread locking nail is made of PEEK material, titanium alloy or stainless steel metal material.

[0014] As another improvement of the present invention, the present invention also provides a heart valve replacement prosthesis, which includes the above-mentioned fastening apex pad of the heart valve replacement prosthesis.

[0015] After adopting such a design, the present invention has at least the following advantages:

[0016] 1. The present invention arranges a compressible ring and a threaded locking pin at the central through hole of the disk body, adopts the principle of thread pressure and deformation of the compression ring, and uses friction and material cross-interlocking to fix the tether, thereby achieving lossless extrusion and tightening of the tether, which is simple, convenient and safer.

[0017] 2. By arranging grooves and fixing piles on the disc body, the end of the tether can be wound and knotted to fix it, which not only ensures the long-term use effect of the tether, but also prevents the floating tether from causing discomfort or other complications to the patient, and has strong stability and reliability.

[0018] 3. The heart valve replacement prosthesis of the present invention has fewer parts for fastening the apex pad, a simple structure, and is easy to produce and process, greatly reducing production costs. It is also easy to assemble, has low requirements for the assembly environment, and has a low risk of bacterial contamination. It will become an improved product that replaces the existing apex pad fastening structure and has good market prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The above is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention, the present invention is further described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0020] Figure 1 It is a schematic structural diagram of the heart valve replacement prosthesis of the present invention.

[0021] Figure 2 It is a three-dimensional structural schematic diagram of the fastening apex pad of the heart valve replacement prosthesis of the present invention.

[0022] Figure 3 It is a schematic diagram of the three-dimensional structure of the disc body for fastening the apex pad of the heart valve replacement prosthesis of the present invention.

[0023] Figure 4 The present invention is a schematic diagram of the cross-sectional structure of a disc body for fastening the apex pad of a heart valve replacement prosthesis.

[0024] Figure 5 It is a schematic structural diagram of a threaded locking nail for fastening the apex pad of a heart valve replacement prosthesis of the present invention.

[0025] Figure 6 It is a schematic cross-sectional structure diagram of the fastening apex pad of the heart valve replacement prosthesis of the present invention in a pre-installed state.

[0026] Figure 7 It is a schematic cross-sectional structure diagram of the fastening apex pad of the heart valve replacement prosthesis of the present invention in the final fastening state. DETAILED DESCRIPTION

[0027] The present invention is a new improvement on the existing apex pad structure, and realizes double-safety fastening of the tether in two ways, and is simple to produce and process, low in cost, and can ensure both short-term and long-term fixation effects, and has a good market prospect. The specific embodiments are as follows.

[0028] Refer to the attached Figure 1As shown, the heart valve replacement prosthesis of this embodiment includes an outer stent 1, an inner stent 2, a tether 3 and an apical pad 4. The outer stent 1 and the inner stent 2 are connected and assembled by plugging, the inner stent 2 and the tether 3 are connected and assembled by buckling + suturing, and the apical pad 4 is used to fasten the tether 3 and block the outer side of the apical membrane after suturing, playing the role of fixing the inner and outer stents and the tether, and blocking the apical membrane.

[0029] Refer to the attached Figures 2 to 7 As shown, the fastening apex pad 4 of the heart valve replacement prosthesis of this embodiment includes a blocking disc body 5 with a central through hole 51, a threaded locking nail 6 with a central hole 61, a compressible ring 7 and a hollow column 8. The central through hole 51, the central hole 61 and the internal through holes of the compressible ring 7 and the hollow column 8 are all coaxially arranged.

[0030] The central through hole 51 of the blocking disc 5 is set as a countersunk structure, and the inner wall of the countersunk structure is provided with an internal thread 52 matching the external thread 62 of the threaded locking nail 6, and the compressible ring 7 is set at the bottom of the countersunk structure. When the threaded locking nail 6 is screwed into the central through hole 51, the compressible ring 7 is squeezed to reduce the through hole inside the compressible ring 7, thereby squeezing the tether 3. When the squeezing deformation reaches a certain degree, the tether is firmly fixed under the action of friction and the deformation and nesting of the rubber compressible ring.

[0031] In this embodiment, the compressible ring 7 is made of a soft material of medical implant grade, preferably a silicone rubber material, and uses its excellent elasticity to clamp and fasten the tether 3 passing through the central through hole 51.

[0032] The internal thread 52 on the inner wall of the countersunk structure has the same thread profile as the external thread on the thread locking nail 6, which can be trapezoidal, triangular or semicircular, preferably trapezoidal, with better load-bearing capacity. The shape of the spiral groove of the thread locking nail 6 is hexagonal, triangular, square, D-shaped, star-shaped or diamond-shaped, etc., which is easy to operate.

[0033] A preferred embodiment is that at least one fixed pile 9 with a hole for fixing the end of the tether 3 is provided on the blocking disc 5, and the fixed pile 9 with a hole and the threaded locking nail 6 are arranged on the same side of the blocking disc 5. The blocking disc 5 is also provided with a groove 10 for winding the tether 3. In this way, the floating tether 3 fixed through the disc can be firstly wound inside the groove 10, and then fixed by knotting through the hole on the fixed pile 9 when it reaches a suitable length, which can achieve secondary fixation of the tether, achieve a double insurance and stable effect, and prevent the floating tether from causing discomfort or other complications to the patient. Of course, the tether 3 directly passing through the disc can also be directly fixed by knotting through the fixed pile with a hole, which can also achieve secondary fixation of the tether. The fixed pile 9 with a hole can also be a fixed pile with a groove, as long as the effect of binding the tether can be achieved.

[0034] The disk body 5 is also provided with a mounting socket 53 connected to an external clamping and conveying tool.

[0035] The occluding disc body 5 described in this embodiment is made of implantable plastic material, such as PEEK (polyetheretherketone) material, to ensure sufficient strength of its internal thread. The larger disc-shaped occluding surface of the occluding disc body 5 can well seal the apical puncture hole, meet the requirements of the apical pad, and also has the advantage of low cost, greatly reducing production costs. The threaded locking nail 6 can also be made of implantable plastic material. At the same time, since the locking nail itself is small in size, it can also be made of metal materials, such as titanium alloy, stainless steel, etc.

[0036] In addition, the processing technology of the plugging disc 5 in this embodiment is also simpler and more convenient, and can generally be completed with traditional machining equipment, and can be achieved with two processes using a three-axis milling machine or engraving machine, with low processing costs and better product stability after mass production. The processing of the silicone rubber compressible ring 7 is made by mold molding, which has stable quality, high output and low cost.

[0037] In the actual operation process of the fastening apical pad 4 of the heart valve replacement prosthesis of this embodiment, the disc body 5 of the apical pad, the compressible ring 7, and the threaded locking nail 6 are pre-assembled, and the pre-fixation of the threaded locking nail 6 and the non-compressed state of the compressible ring 7 are maintained, otherwise the tether 3 is difficult to adjust during the operation. Then, after the length of the tether 3 is adjusted to be appropriate, the threaded locking nail 6 is gradually tightened, the compressible ring 7 is squeezed and deformed, and its internal through hole gradually shrinks. When the squeeze deformation reaches a certain degree, under the action of friction and the deformation and nesting of the compressible ring, the tether 3 is firmly fixed, and the blocking disc body 5 is fixed at the apical puncture hole at the same time, so as to achieve the blocking of the apical puncture hole. Then the end of the floating tether 3 is firstly wound inside the groove 10, and when it reaches the appropriate length, it is then tied and fixed through the hole on the fixing pile 9 to achieve the secondary fixation of the tether.

[0038] The present invention provides a compressible ring and a threaded locking nail at the central through hole of the disk body, adopts the principle of thread pressure and deformation of the compression ring, and uses friction and material cross-interlocking to fix the tether, thereby achieving lossless extrusion and fastening of the tether, which is simple and convenient. In addition, by providing grooves and fixing piles, the end of the tether can be knotted and fixed, which not only ensures the short-term use of the tether fastening, but also ensures the long-term effect of the tether fastening, prevents complications, and has strong stability and reliability.

[0039] In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "upper", "lower", "front", "rear", etc. are based on the directions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as a limitation on the present invention.

[0040] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0041] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Those skilled in the art may make some simple modifications, equivalent changes or modifications using the technical contents disclosed above, which all fall within the protection scope of the present invention.

Claims

1. A fastening apex pad for a heart valve replacement prosthesis, characterized in that: It includes a blocking disk body with a central through hole and a threaded locking nail with a central hole. The central through hole of the blocking disk body is set as a countersunk structure. The inner wall of the countersunk structure is provided with an internal thread matching the external thread of the threaded locking nail. A compressible ring is provided at the bottom of the countersunk structure. When the threaded locking nail is screwed into the central through hole, the compressible ring is squeezed to shrink the through hole in the center of the compressible ring, thereby completing the clamping and tightening of the tether passing through the central through hole.

2. The fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The compressible ring is made of silicone rubber material.

3. The fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The blocking disc body is provided with a fixing pile with a hole or a groove for fixing the end of the tether, and the fixing pile with a hole or a groove and the threaded locking nail are arranged on the same side of the blocking disc body.

4. The fastening apex pad of the heart valve replacement prosthesis according to claim 3, characterized in that: The blocking disc body is also provided with a groove for winding a tether.

5. The fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The thread profiles of the internal thread on the inner wall of the countersunk hole structure and the external thread on the thread locking nail are trapezoidal, triangular or semicircular.

6. The fastening apex pad of the heart valve replacement prosthesis according to claim 5, characterized in that: The shape of the spiral groove of the thread locking nail is hexagonal, triangular, square, D-shaped, star-shaped or rhombus-shaped.

7. The fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The blocking disc body is made of PEEK material.

8. The fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The thread locking nail is made of PEEK material, titanium alloy or stainless steel metal material.

9. A heart valve replacement prosthesis, characterized in that: A fastening apex pad comprising the heart valve replacement prosthesis according to any one of claims 1 to 8.

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