A heart valve replacement prosthesis and a threaded fastening apex pad thereof

Abstract

The invention discloses a threaded fastening apex pad for a heart valve replacement prosthesis, and belongs to the field of medical devices. The apex pad includes a blocking disc body with a central through hole and a threaded locking nail with a central hole. The central through hole of the blocking disc body includes a tightenable through hole surrounded by a multi-petal tapered stud, which is used to penetrate a tether connecting an inner and outer stent in a heart valve replacement prosthesis. The threaded locking nail cooperates with the multi-petal tapered stud to achieve inward extrusion of the multi-petal tapered stud, thereby completing the clamping and fastening of the tether. A fixed pile with a hole for fixing the end of the tether is provided on the blocking disc body. The invention applies pressure through the thread, deforms the multi-petal tapered stud, and fixes the tether by using friction and material cross-interlocking, thereby achieving non-destructive extrusion and fastening of the tether, which is simple, convenient, and safer. In addition, by setting a fixed pile, the end of the tether can be knotted and fixed, which not only ensures the long-term use effect of the tether fastening, but also prevents complications, and has strong stability and reliability.

Description

Technical Field

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

[0002] At present, the best solution to heart valve disease is transapical valve repair or replacement surgery, which is a surgical method that combines the advantages of surgery and interventional surgery and is gradually recognized by the medical community. During the transapical valve repair or replacement surgery, a hole must first be opened 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 The repair prosthesis or replacement prosthesis is then accurately and firmly fixed, and then all the instruments are withdrawn, and finally the apex is sutured.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 ventricles is very high, apical bleeding is a very serious complication after this operation. Once apical bleeding occurs, it will lead to the death of the patient.

[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 threaded apex pad, so that it can simply and conveniently fix the apex pad to the tether by thread tightening, with fewer structural parts, convenient processing, reliable fastening effect, and can further improve the patient's postoperative survival rate, 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 threaded fastening apical pad of a heart valve replacement prosthesis, which can simply and conveniently fix the apical pad to the tether by threaded tightening. It has few structural parts, is easy to process, and has a reliable fastening effect, which can further improve the patient's postoperative survival rate, thereby overcoming the shortcomings of the apical pad of the existing heart valve replacement prosthesis.

[0006] In order to solve the above-mentioned technical problems, the present invention provides a threaded fastening apex pad of a heart valve replacement prosthesis, comprising a sealing disc body with a central through hole and a threaded locking nail with a central hole, the central through hole of the sealing disc body comprising a tightenable through hole surrounded by multi-petal conical studs, which is used to pass through a tether connecting the inner and outer supports in the heart valve replacement prosthesis, the threaded locking nail cooperates with the multi-petal conical studs to achieve inward extrusion of the multi-petal conical studs, thereby completing the clamping and tightening of the tether.

[0007] As a further improvement, the threaded locking nail comprises a tool working end and an internal thread end, and the internal thread end adopts a tapered internal thread structure that cooperates with the multi-petal tapered stud.

[0008] As a further improvement, the threaded locking nail comprises a tool working end and an internal thread end, wherein the internal thread end comprises a cylindrical internal thread structure and an extrusion cone structure for extruding the multi-petal tapered stud inwardly.

[0009] As a further improvement, the multi-petal tapered stud is arranged in the central countersunk hole of the blocking disc body, and the through hole in the middle of the multi-petal tapered stud is coaxial with the central through hole of the blocking disc body.

[0010] As a further improvement, the multi-petal tapered stud is arranged on a limiting disk, the limiting disk is arranged at the bottom of the blocking disk body, and the multi-petal tapered stud passes through the central through hole of the blocking disk body and is coaxial therewith.

[0011] As a further improvement, a limiting extension plate is provided on the outer periphery of the limiting plate, and a limiting groove corresponding to the limiting extension plate is provided on the bottom of the blocking plate body.

[0012] As a further improvement, the tightenable through hole is composed of a 3-petal or 4-petal conical stud, and the inner side of each petal conical stud is provided with engaging teeth.

[0013] As a further improvement, the root of the multi-petal tapered stud has an arc-shaped root cleaning groove.

[0014] 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.

[0015] As a further improvement, the blocking disc body is also provided with a groove for winding a tether.

[0016] As a further improvement, the blocking disc body is made of PE, PEEK, PTFE, PET, PP or PVC.

[0017] As another improvement of the present invention, the present invention also provides a heart valve replacement prosthesis, which includes the threaded fastening apex pad of the above-mentioned heart valve replacement prosthesis.

[0018] After adopting such a design, the present invention has at least the following advantages:

[0019] 1. The present invention provides a tightenable through hole surrounded by multi-petal tapered studs at the central through hole of the disk body, adopts the principle of thread pressure and deformation of the multi-petal tapered studs, 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.

[0020] 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.

[0021] 3. By arranging the multi-petal tapered stud on the limiting disk and arranging it into a separate structure from the disk body, different materials can be selected for the limiting disk and the disk body, ensuring the strength of the thread structure, achieving the purpose of thread tightening and saving costs.

[0022] 4. 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

[0023] 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.

[0024] Figure 1 It is a schematic structural diagram of the heart valve replacement prosthesis of the present invention.

[0025] Figure 2 It is a schematic diagram of the three-dimensional structure of the threaded fastening apex pad of the heart valve replacement prosthesis of the present invention.

[0026] Figure 3 The present invention is a structural side view of a threaded fastening apex pad of a heart valve replacement prosthesis.

[0027] Figure 4 The present invention is a schematic diagram of the cross-sectional structure of a threaded fastening apex pad of a heart valve replacement prosthesis.

[0028] Figure 5 The present invention is a schematic diagram of the disc structure of the threaded fastening apex pad of the heart valve replacement prosthesis.

[0029] Figure 6 The present invention is a schematic diagram of the cross-sectional structure of the disc body of the threaded fastening apex pad of the heart valve replacement prosthesis.

[0030] Figure 7 It is a structural schematic diagram of a threaded locking nail for thread-fastening an apex pad of a heart valve replacement prosthesis of the present invention.

[0031] Figure 8 The present invention is a schematic cross-sectional structure diagram of a threaded locking nail for thread-fastening an apex pad of a heart valve replacement prosthesis.

[0032] Fig. 9 Another embodiment of the threaded fastening apex pad of the heart valve replacement prosthesis of the present invention is shown in a three-dimensional structure diagram Figure 1 .

[0033] Fig.10 Another embodiment of the threaded fastening apex pad of the heart valve replacement prosthesis of the present invention is shown in a three-dimensional structure diagram Figure 2 .

[0034] Fig.11 It is a schematic cross-sectional structure diagram of another embodiment of the threaded fastening apex pad of the heart valve replacement prosthesis of the present invention.

[0035] Fig.12 It is a schematic diagram of the disc structure of another embodiment of the threaded fastening apex pad of the heart valve replacement prosthesis of the present invention.

[0036] Fig.13 It is a schematic diagram of the bottom surface structure of a disc body of another embodiment of a threaded fastening apex pad of a heart valve replacement prosthesis of the present invention.

[0037] Fig.14 It is a three-dimensional structural schematic diagram of a threaded locking nail of another embodiment of a threaded fastening apex pad of a heart valve replacement prosthesis of the present invention.

[0038] Fig.15 The present invention is a schematic cross-sectional view of a threaded locking nail of another embodiment of a threaded fastening apex pad of a heart valve replacement prosthesis.

[0039] Fig.16 It is a three-dimensional structural schematic diagram of a limiting plate in another embodiment of a threaded fastening apex pad of a heart valve replacement prosthesis of the present invention. DETAILED DESCRIPTION

[0040] 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.

[0041] Embodiment 1

[0042] See attached Figure 1 As 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.

[0043] See attached Figures 2 to 8 As shown, the threaded fastening apex pad 4 of the heart valve replacement prosthesis of this embodiment includes a sealing disc body 5 with a central through hole 51, a threaded locking nail 6 with a central hole 61 and a hollow column 7, and the central through hole 51, the central hole 61 and the internal through hole of the hollow column 7 are all coaxially arranged.

[0044] The central through hole 51 of the occluding disc body 5 includes a tightenable through hole surrounded by multi-petal conical studs 52, which is used to pass through the tether 3 connecting the inner and outer stents in the heart valve replacement prosthesis. The threaded locking nail 6 cooperates with the multi-petal conical studs 52 to achieve inward squeezing of the multi-petal conical studs 52, thereby completing the clamping and tightening of the tether 3.

[0045] In this embodiment, the threaded locking nail 6 includes a tool working end 62 and an internal thread end 63, wherein the internal thread end 63 includes a cylindrical internal thread structure 631 and an extrusion cone structure 632 for extruding the multi-petal tapered stud 52 inwardly. The cylindrical internal thread structure 631 first cooperates with the external thread of the multi-petal tapered stud 52, and when the top of the multi-petal tapered stud 52 contacts the extrusion cone structure 632, the top of the multi-petal tapered stud 52 is gradually extruded and deformed, so that the internal through hole is gradually tightened and closed inwardly. The shape of the spiral groove of the tool working end 62 of the threaded locking nail 6 is hexagonal, triangular, square, D-shaped, star-shaped or diamond-shaped, etc., which is easy to operate.

[0046] In this embodiment, the multi-petal tapered stud 52 is disposed in the central counterbore 53 of the blocking disc 5, and the through hole in the middle of the multi-petal tapered stud 52 is coaxial with the central through hole 51 of the blocking disc 5. The multi-petal tapered stud 52 includes a 3-petal or 4-petal tapered stud, and each petal tapered stud has an engaging tooth 57 on the inner side, which is used to better engage with the tether when the multi-petal tapered stud 52 is squeezed inward, increase friction, and further tighten the tether.

[0047] In order to further ensure the deformation and retraction of the multi-petal tapered stud 52 , the root of each tapered stud 52 has an arc-shaped root cleaning groove 54 .

[0048] A preferred embodiment is that at least one perforated fixing pile 8 for fixing the end of the tether 3 is provided on the occluding disc 5, and the perforated fixing pile 8 and the threaded locking nail 6 are arranged on the same side of the occluding disc 5. The occluding disc 5 is also provided with a groove 9 for winding the tether 3. In this way, the floating tether 3 fixed through the disc can be firstly wound inside the groove 9, and then knotted and fixed through the hole on the fixing pile 8 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 fixed by knotting the perforated fixing pile 8, which can also achieve secondary fixation of the tether. The perforated fixing pile 8 can be provided with one hole, or more than two holes, or it can be a grooved fixing pile, as long as the effect of binding the tether can be achieved.

[0049] The disk body 5 is also provided with a mounting socket 55 connected to an external clamping and conveying tool.

[0050] In this embodiment, the occluding disc 5 has an implantable density of about 1 g / cm 3 It is made of plastic materials, such as PEEK (polyetheretherketone), PE (polyethylene, including ultra-high molecular weight polyethylene and highly cross-linked polyethylene), PTFE (polytetrafluoroethylene), PET (polyethylene terephthalate), PP (polypropylene) and PVC (polypropylene), etc. PE material is preferred. The above materials have low structural density, light weight, certain elasticity, and performance that can meet the requirements of apical pad occlusion. Secondly, they are easier to obtain and have the advantage of low cost, which greatly reduces production costs. The apical pad disc material of the existing Tendyne product is PEEK material. The main reason is that the complex and small-sized structure must maintain sufficient strength, and other materials cannot meet the structural requirements. However, this embodiment is not very dependent on the strength requirements of the components, so the material selection is more flexible.

[0051] The thread locking pin in this embodiment is preferably made of PEEK material, which can ensure the strength requirements of the thread structure.

[0052] In the actual operation process of the threaded fastening apical pad 4 of the heart valve replacement prosthesis of this embodiment, the disc body 5 and the threaded locking nail 6 of the apical pad are pre-assembled, and the pre-fixation of the threaded locking nail 6 and the non-extrusion state of the multi-petal tapered stud 52 are maintained, otherwise the tether 3 is difficult to adjust during the operation. Then, after the length of the tether 3 is adjusted appropriately, the threaded locking nail 6 is gradually tightened, the multi-petal tapered stud 52 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 deformation nesting, 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 9, and when it reaches the appropriate length, it is then tied and fixed through the hole on the fixing pile 8 to achieve the secondary fixation of the tether.

[0053] Embodiment 2

[0054] The difference between the second embodiment and the first embodiment is that: Figures 9 to 16 As shown, the internal thread end 63 of the thread locking nail 6 adopts a tapered internal thread structure that matches the multi-petal tapered stud 52. In this way, the tapered internal thread structure directly matches the multi-petal tapered stud 52, and during the rotation of the thread locking nail 6, the multi-petal tapered stud 52 is continuously squeezed and tightened, thereby achieving the purpose of tightening the tether 3.

[0055] Another difference is that the multi-petal tapered stud 52 is arranged on a separate limiting plate 10, the limiting plate 10 is arranged at the bottom of the blocking plate body 5, and the multi-petal tapered stud 52 passes through the central through hole 51 of the blocking plate body 5 and is coaxial therewith. In this way, the limiting plate 10 is installed from the blocking side of the blocking plate body 5, and the threaded locking nail 6 tightens the multi-petal tapered stud 52 from the other side of the blocking plate body 5 to fix the limiting plate 10, and the tether 3 can be tightened by continuously tightening the threaded locking nail 6 and the multi-petal tapered stud 52.

[0056] In this embodiment, the outer periphery of the limiting disk 10 is also provided with a limiting extension plate 11, and the bottom of the blocking disk body 5 is provided with a limiting groove 56 corresponding to the limiting extension plate 11, so as to prevent the limiting disk 10 from rotating circumferentially with the rotation of the threaded locking nail 6, thereby achieving a better fastening effect. It should be pointed out that in this embodiment, the multi-petal tapered stud 52 is set to be a separate structure from the disk body 5, so that the material of the limiting disk 10 can be PEEK material with the same strength as the threaded locking nail 6 to ensure the strength of the threaded structure. The material of the disk body 5 can be selected more flexibly, such as PEEK (polyetheretherketone), PE (polyethylene, including ultra-high molecular weight polyethylene and highly cross-linked polyethylene), PTFE (polytetrafluoroethylene), PET (polyethylene terephthalate), PP (polypropylene) and PVC (polypropylene).

[0057] The other parts of this embodiment are the same as those of the above embodiment and will not be described again.

[0058] It should also be noted that the specific structure of the threaded locking nail 6 in the second embodiment can also be interchanged with the structure of the threaded locking nail 6 in the first embodiment to form two other different embodiments, with flexible and diverse structural assembly and strong adaptability.

[0059] The present invention provides a multi-petal tapered stud and a threaded locking nail matched therewith at the central through hole of the disk body, adopts the principle of thread extrusion deformation, and uses friction and material cross-interlocking to fix the tether, thereby realizing 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.

[0060] The threaded fastening apex pad of the heart valve replacement prosthesis of the present invention utilizes the principles of lateral extrusion and fixed piles, uses friction to constrain the tether, and achieves enhanced fastening by knotting the tether ends, which not only solves the problem of tether fluttering, but also achieves a double fixation effect on the tether, and is good for both short-term and long-term use.

[0061] 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.

[0062] 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.

[0063] 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 threaded fastening apex pad for a heart valve replacement prosthesis, characterized in that: It comprises a blocking disc body with a central through hole and a threaded locking nail with a central hole, wherein the central through hole of the blocking disc body comprises a tightenable through hole surrounded by a multi-petal tapered stud, which is used to pass a tether connecting an inner and outer stent in a heart valve replacement prosthesis, and the threaded locking nail cooperates with the multi-petal tapered stud to achieve inward extrusion of the multi-petal tapered stud, thereby completing the clamping and fastening of the tether; The threaded locking nail comprises a tool working end and an internal thread end, wherein the internal thread end adopts a tapered internal thread structure that matches the multi-petal tapered stud; The multi-petal tapered stud is arranged in the central countersunk hole of the sealing disk body, the through hole in the middle of the multi-petal tapered stud is coaxial with the central through hole of the sealing disk body, and each petal tapered stud is provided with engaging teeth on the inner side, and the root of the multi-petal tapered stud has an arc-shaped root cleaning groove.

2. The threaded fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The multi-petal tapered stud is arranged on a limiting disk, and the limiting disk is arranged at the bottom of the blocking disk body. The multi-petal tapered stud passes through the central through hole of the blocking disk body and is coaxial therewith.

3. The threaded fastening apex pad of the heart valve replacement prosthesis according to claim 2, characterized in that: A limiting extension plate is disposed on the outer periphery of the limiting plate, and a limiting groove corresponding to the limiting extension plate is disposed at the bottom of the blocking plate body.

4. The threaded fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The tightenable through hole is composed of a 3-petal or 4-petal conical stud.

5. The threaded fastening apex pad of the heart valve replacement prosthesis according to any one of claims 1 to 4, characterized in that: The blocking disc body is provided with a fixing pile with a hole for fixing the end of the tether, and the fixing pile with a hole and the threaded locking nail are arranged on the same side of the blocking disc body.

6. The threaded fastening apex pad of the heart valve replacement prosthesis according to claim 5, characterized in that: The blocking disc body is also provided with a groove for winding a tether.

7. The threaded fastening apex pad of the heart valve replacement prosthesis according to claim 6, characterized in that: The blocking disc body is made of PE, PEEK, PTFE, PET, PP or PVC.

8. A heart valve replacement prosthesis, characterized in that: A threaded fastening apex pad comprising the heart valve replacement prosthesis according to any one of claims 1 to 7.

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