A heart valve replacement prosthesis and its needle-threading fastening apex pad

Abstract

The present invention discloses a heart valve replacement prosthesis and a needle-threading and fastening apex pad thereof, belonging to the field of medical devices. The apex pad comprises an occluding disc body and a fixing needle, the occluding disc body comprises a disc surface and a fixing block and a fixing column arranged on one side thereof, a center hole is arranged on the disc surface and the fixing block, and a fixing hole which is perpendicular to and communicates with the center hole is also arranged on the fixing block, the fixing needle is inserted into the fixing hole to fasten the tether, and the fixing column cooperates with the tail of the fixing needle to fix the fixing needle. A guide groove for the fixing needle to penetrate into the fixing hole is arranged on the top of the fixing column. The present invention can simplify the threading and fastening of the tether by the fixing needle through the improvement of the fixing block structure in the occluding disc body and the improved setting of the fixing needle, and can realize the insertion of the fixing needle more intuitively and conveniently, and can realize the full-range fixation of the fixing needle in the pre-installation and final installation states by utilizing the super elastic performance of the fixing needle, thereby ensuring the stability and reliability of the fixing needle in short-term and long-term use.

Description

Technical Field

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

[0002] Human heart valve disease is a serious heart disease with a large number of patients and a high mortality rate. There is currently no conservative treatment method such as specific drugs. Surgical treatment is the best solution at present, such as surgical valve replacement or interventional repair or valve replacement. At present, transapical valve repair or replacement surgery 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 must be delivered to the lesion through this hole. The repair prosthesis or replacement prosthesis must be accurately and firmly fixed again, and then all instruments must be 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 ventricle 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. As disclosed in the prior patent EP3845137A1, 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 the shape is too complicated, and at the same time, they are all very small, and the sizes of each component are mutually restricted. This structure is not only difficult to realize in production, but also very troublesome during assembly. If you are not careful, it will cause parts to be lost, blockage, jamming and other inconvenient operations. If the assembly is not appropriate, it will cause a medical accident on the operating table. This structure not only brings severe challenges to production and processing, but also has mechanical weaknesses. For example, if the protrusion in the bushing fails, the needle will fall out, which can easily lead to failure during long-term use. At the same time, due to the size design of the striker inside, the diameter and height of the apex pad body will inevitably become larger, which will greatly affect 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 needle-threading apex pad, so that it can fix the apex pad to the tether in a simpler and more convenient way, with fewer structural parts, convenient processing, and more firm and reliable, and 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 needle-threaded fastening apical pad of a heart valve replacement prosthesis, so that the apical pad can be fixed to the tether in a simpler and more convenient way, with fewer structural parts, easy processing, and greater firmness and reliability, further improving the patient's postoperative survival rate, thereby overcoming the shortcomings of the existing needle-threaded fastening apical pad of a heart valve replacement prosthesis.

[0006] In order to solve the above-mentioned technical problems, the present invention provides a needle-threading and fastening apical pad of a heart valve replacement prosthesis, comprising a sealing disc body and a fixing needle, the sealing disc body comprising a disc surface and a fixing block arranged on one side of the disc surface, and a fixing column arranged on the same side as the fixing block, the disc surface and the fixing block are provided with central holes that penetrate each other, the central hole is used to insert a tether connecting the inner and outer brackets in the heart valve replacement prosthesis, the fixing block is provided with a fixing hole that is perpendicular to and communicated with the central hole, the fixing needle is inserted into the fixing hole to fasten the tether, and the fixing column cooperates with the tail of the fixing needle to fix the fixing needle.

[0007] As a further improvement, a guide groove is provided at the top of the fixing column for the fixing needle to pass through the fixing hole, and the guide groove and the central axis of the fixing hole are in the same vertical plane.

[0008] As a further improvement, the top surface of the fixing column is 0.2 to 2 mm higher than the top of the fixing hole.

[0009] In a further improvement, the guide groove is configured as an arc-surface longitudinal flat groove that slopes downward from the top surface of the fixing column toward the fixing hole.

[0010] As a further improvement, the fixing needle has a thickness of 0.5 to 2 mm, and a cross-sectional shape of a circle, triangle, square, ellipse, diamond or star.

[0011] As a further improvement, the fixing column can be elastically arranged vertically on the disk surface.

[0012] As a further improvement, a blind hole containing an elastic member is provided on the disk surface, the bottom of the fixing column is fixed inside the blind hole, and the fixing column moves up and down under the action of the elastic member.

[0013] As a further improvement, the fixed needle comprises a needle tip, a needle rod and a needle head, the needle head is an annular rod connected to the tail of the needle rod, and the cross-sectional shape of the fixed column matches the internal annular structure of the annular rod.

[0014] As a further improvement, the internal structure of the annular rod is circular, square, elliptical or triangular.

[0015] Further improvement, the fixed needle includes a needle tip, a needle rod and a needle head, the needle head is an annular rod connected to the tail of the needle rod, the top of the fixed column is provided with a transverse snap-in groove matching the annular rod, the central axis of the transverse snap-in groove is on the same horizontal plane as the central axis of the fixing hole.

[0016] Further improvement, the fixed needle includes a needle tip, a needle rod and a needle head, the needle head adopts a vertical cross bar connected to the tail of the needle rod, the top of the fixed column is provided with a T-shaped snap-in groove matching the needle head, and the central axis of the T-shaped snap-in groove is on the same horizontal plane as the central axis of the fixing hole.

[0017] As a further improvement, the fixing needle is made of a superelastic material such as nickel-titanium alloy or nitinol alloy, and the blocking disc body is made of PE, PEEK, PTFE, PET, PP or PVC.

[0018] As a further improvement, the disk surface, the fixing block and the fixing column are integrally formed, the peripheral structure of the fixing block is rectangular, circular or D-shaped, and the fixing block is also provided with a mounting socket staggered with the fixing hole.

[0019] As another improvement of the present invention, the present invention also provides a heart valve replacement prosthesis, which includes the needle-fastening apex pad of the heart valve replacement prosthesis mentioned above.

[0020] After adopting such a design, the present invention has at least the following advantages:

[0021] 1. The present invention improves the structure of the fixing block in the occluding disc body, combined with the improved settings of the fixing needle and the fixing column, so that the fixing needle can be inserted more simply and more conveniently, and the fixing needle can be inserted more intuitively and conveniently. In addition, by utilizing the super elastic performance of the fixing needle and through the cooperation of the fixing needle and the fixing column, the fixing needle can be fixed in all directions up and down, left and right, and front and back in the pre-installation and final installation states, thereby ensuring the stability and reliability of the fixing needle in short-term and long-term use.

[0022] 2. By setting the height of the fixing column and the thickness of the fixing needle, as well as the setting of the arc-surface longitudinal flat groove, the convenience and accuracy of pre-inserting the fixing needle into the fixing hole are further improved, and the stability of the fixing needle during pre-installation is ensured.

[0023] 3. By improving the needle head of the fixing needle, the needle head structure is flexible and easy to process. The fixing needle is installed in coordination with the fixing column or the card-in groove arranged thereon to achieve all-round fixation of the fixing needle. The fixing methods are diverse to meet different needs during surgery.

[0024] 4. By setting the fixing column as an elastic movable structure, it is easier to insert and fix the fixing needle, making the operation easier during surgery.

[0025] 5. The needle-fastening apical pad of the heart valve replacement prosthesis of the present invention has fewer parts, 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 apical pad fastening structure and has good market prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] 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.

[0027] Figure 1 It is a schematic diagram of the overall structure of the heart valve replacement prosthesis of the present invention.

[0028] Figure 2 It is a three-dimensional structural schematic diagram of the needle-threading and fastening apex pad of the heart valve replacement prosthesis of the present invention.

[0029] Figure 3 It is a schematic diagram of the top view of the structure of the needle-threading and fastening apex pad of the heart valve replacement prosthesis of the present invention.

[0030] Figure 4 It is a schematic cross-sectional structure diagram of the needle-threading and fastening apex pad of the heart valve replacement prosthesis of the present invention.

[0031] Figure 5 It is a schematic cross-sectional structure diagram of the needle-threading and fastening apex pad of the heart valve replacement prosthesis of the present invention (without the fixing needle).

[0032] Figure 6 yes Figure 5 A magnified top view of area A.

[0033] Figure 7 It is a schematic structural diagram of a fixing needle of a heart valve replacement prosthesis of the present invention.

[0034] Figure 8 It is a schematic cross-sectional structure diagram of Embodiment 2 of the needle-threading and fastening apex pad of the heart valve replacement prosthesis of the present invention (without the fixing needle).

[0035] Fig. 9 It is a schematic top view of the structure of Embodiment 3 of the needle-threading and fastening apex pad of the heart valve replacement prosthesis of the present invention.

[0036] Fig.10 yes Fig. 9 Schematic diagram of the cross-sectional structure.

[0037] Fig.11 It is a schematic top view of the structure of Embodiment 3 of the needle-threading and fastening apex pad of the heart valve replacement prosthesis of the present invention (without the fixing needle).

[0038] Fig.12 yes Fig.11 Schematic diagram of the cross-sectional structure. DETAILED DESCRIPTION

[0039] The present invention improves upon the existing apex pad, reduces the number of parts, simplifies production and processing, and makes assembly simpler. It also has better and more reliable short-term and long-term fixation effects, greatly reduces production costs, and has good market prospects. The specific embodiments are as follows.

[0040] Embodiment 1

[0041] 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.

[0042] See attached Figures 2 to 7 As shown, the needle-threading and fastening apex pad 4 of the heart valve replacement prosthesis of this embodiment includes a blocking disc body 5, a fixing needle 6 and a hollow column 7. The blocking disc body 5 includes a disc surface 51 and a fixing block 52 arranged on one side of the disc surface 51, and a fixing column 53 arranged on the same side as the fixing block 52. The disc surface 51 and the fixing block 52 are provided with a central hole 54 that penetrates each other. The hollow column 7 is arranged on the other side of the disc surface 51 and connected to the entrance end of the central hole of the disc surface, and is used to guide the tether 3 connecting the inner and outer stents in the heart valve replacement prosthesis to penetrate into the central hole 54. The fixing block 52 is provided with a fixing hole 55 that is perpendicular to and communicates with the central hole 54. The fixing needle 6 penetrates the fixing hole 55 to fasten the tether 3, and the fixing column 53 cooperates with the tail needle of the fixing needle 6 to fix the fixing needle 6.

[0043] In this embodiment, the fixing column 53 can be cylindrical or truncated cone-shaped, and a guide groove 56 is provided on the top for the fixing needle 6 to penetrate the fixing hole 55. The guide groove 56 and the central axis of the fixing hole 55 are in the same vertical plane, and are used to provide left and right guidance for the fixing needle 6 to enter the fixing hole 55, so as to facilitate the fixing needle to enter the fixing hole smoothly.

[0044] A preferred embodiment is that the top surface of the fixing column 53 is higher than the top of the fixing hole 55, such as a height difference H of 0.2 to 2 mm. In this way, when the fixing needle 6 enters the fixing hole 55 through the guide groove 56, due to the height difference, the fixing needle 6 must be bent and deformed to a certain extent before entering the fixing hole 55. In this way, when the fixing needle 6 enters the fixing hole 55 but does not reach the final position, the existence of the bending deformation resistance can ensure that the fixing needle 6 will not fall out of the fixing hole 55, and the reliability of the fixing needle 6 in the pre-installed state can be guaranteed. The height setting of the fixing column 53 is particularly important. It cannot be too low, otherwise the bending force of the fixing needle is not enough and the stability of the pre-installation cannot be guaranteed. It cannot be too high, otherwise the installation is too laborious or even impossible to install.

[0045] The guide groove 56 can also be configured as a longitudinal flat groove with a downward arc surface that is inclined from the top surface of the fixing column 53 to the fixing hole 55, as shown in the attached Figure 5 and 6 As shown, the insertion and pre-fixation of the fixing needle 6 can be achieved more easily.

[0046] The fixing needle 6 in this embodiment includes a needle tip 61, a needle rod 62 and a needle head 63. The needle head 63 is an annular rod connected to the tail of the needle rod 62. The cross-sectional shape of the fixing column 53 matches the internal annular structure of the annular rod, so that after the fixing needle 6 reaches the final insertion position, the annular rod can be sleeved on the outer periphery of the fixing column 53 and clamped to achieve the final fixation of the fixing needle 6, ensuring that the fixing needle 6 is reliably fixed in the up and down, left and right, front and back directions, not only ensuring the short-term use effect, but also ensuring the long-term use effect of the fixing needle, with strong stability and no risk of dislocation.

[0047] The fixing needle 6 described in this embodiment is made of a superelastic material of nickel-titanium alloy or nitinol alloy, preferably nickel-titanium alloy. The superelastic material can realize bending and deformation of the fixing needle 6 when inserted into the fixing hole 55, and the bending deformation resistance is utilized to realize pre-installation and fixation of the fixing needle. Moreover, after the fixing needle 6 reaches the final insertion position, it can bounce back to the original state, thereby realizing firm fixation of the fixing needle in the final position.

[0048] Specifically, the internal structure of the annular rod of the fixing needle 6 can be circular, square, elliptical, triangular or other shapes, as long as the annular rod can be accurately sleeved on the outer circumference of the fixing column 53.

[0049] The cross-sectional shape of the fixing needle 6 can be circular, triangular, square, elliptical, rhombus, star-shaped or other shapes, and its thickness can be designed according to needs, and generally tends to be smaller than the size of the tether 3. The preferred thickness range of the fixing needle 6 is 0.5-2 mm, and the more preferred value is 1 mm. If the fixing needle is too thin, the hardness is not enough, and it is too soft, it is easy to fall off during the initial installation, which will cause surgical accidents; if the fixing needle is too thick, the hardness is too high, and it is too hard, it is laborious during the needle threading process, increasing the difficulty of needle threading.

[0050] In addition, the disk surface 51 and the fixed block 52 in this embodiment can be a separate structure or an integrally formed structure. The fixed block 52 is also provided with a mounting socket 57 staggered with the fixing hole 55. The peripheral structure of the fixed block 52 can be set to a rectangular structure, or can be set to a circular or D-shaped structure, so that the fixed block 52 can be connected to an external clamping and transmission tool.

[0051] 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, super elasticity, and performance that can better meet the requirements of the apex pad. Secondly, they are easier to obtain and have the advantage of low cost, which greatly reduces production costs. The apex pad disc material of the existing Tendyne product is made of peek material, mainly because the complex and small-sized structure must maintain sufficient strength, and other materials cannot meet the structural requirements. In this embodiment, due to the different needle threading principles, it is not very dependent on the strength requirements of the components, so the material selection is more flexible.

[0052] Moreover, the processing technology of the sealing disc body 5 in this embodiment is also simpler and more convenient. It can generally be completed using traditional machining equipment. It only takes two steps to achieve it using a three-axis milling machine or engraving machine. The processing cost is low, and the stability of the product after mass production is better.

[0053] In the actual operation process of the needle-threading fastening apical pad 4 of the heart valve replacement prosthesis of this embodiment, the disc body 5 and the fixing needle 6 of the apical pad are pre-assembled to ensure that the needle tip does not expose the central hole 54 of the tether 3, otherwise the tether 3 cannot be adjusted during the operation. Then, after the length of the tether 3 is adjusted to a suitable length, the fixing needle 6 is pushed in further, the fixing needle 6 passes through the tether 3, the needle head 63 is sleeved on the outer periphery of the fixing column 53, and the needle rod 62 bears the tension generated by the tether 3 to achieve the fastening of the tether 3, and at the same time, the blocking disc body 5 is fixed at the apical puncture hole to achieve the blocking of the apical puncture hole.

[0054] Embodiment 2

[0055] The difference between this embodiment and the above-mentioned embodiment 1 is that Figure 8 As shown, the fixing column 53 can be elastically and vertically arranged on the disk surface 51, which is more conducive to the pre-installation and final positioning of the fixing needle 6.

[0056] Specifically, the disk surface 51 is provided with a shrinkage blind hole 59 containing an elastic member 58, and the bottom of the fixing column 53 is fixed inside the shrinkage blind hole 59, so that the fixing column 53 can move up and down under the action of the elastic member and can prevent the fixing column 53 from falling out.

[0057] In this way, the needle-threading and fastening apex pad 3 of the present embodiment, when assembling the fixing needle 6, due to the superelasticity of the fixing needle 6 itself combined with the elasticity of the elastic part, the fixing needle 6 can be more easily inserted into the fixing hole 55 of the disk body 5, and by utilizing the rebound force of the elastic part, the fixing needle is more stable during pre-installation and is not easy to fall off.

[0058] The other parts of this embodiment are the same as those of the above embodiment and will not be described again.

[0059] Embodiment 3

[0060] The difference between this embodiment and the above-mentioned embodiment 1 is that Figures 9 to 12 As shown, the top of the fixing column 53 is also provided with a transverse snap-in groove 60 that matches the annular rod of the needle head portion of the fixing needle 6, and the central axis of the transverse snap-in groove 60 is on the same horizontal plane as the central axis of the fixing hole 55. The transverse snap-in groove 60 is used to snap the annular rod of the needle head portion into it when the fixing needle 6 is pushed further into the fixing hole 55 and passes through the tether 3 to reach the final fixed position, so as to fix the fixing needle in the up-down, left-right, front-back directions. And because the central axis of the transverse snap-in groove 60 is on the same horizontal plane as the central axis of the fixing hole 55, it can ensure that the fixing needle 6 is in a naturally straight state, there is no bending resistance, and it does not act in a long-term fatigue state, so that the puncture and fastening effect of the fixing needle is more durable and stable.

[0061] Furthermore, based on the design structure of this embodiment, the needle head of the fixing needle 6 can also adopt a vertical cross bar connected to the needle rod, that is, a T-shaped fixing needle. In this way, the top of the fixing column 53 is set to a T-shaped snap-in groove matching the vertical cross bar, and similarly, the central axis of the T-shaped snap-in groove is on the same horizontal plane as the central axis of the fixing hole, so that the fixing needle can be fixed in the up-down, left-right, and front-back directions.

[0062] In addition, the fixing column 53 in this embodiment can also be set to the same movable fixing column structure as in the second embodiment, which also facilitates installation and achieves the technical effect of stable pre-installation and final positioning of the fixing needle 6.

[0063] The present invention improves the disk structure in combination with the improved settings of the fixing needle and the fixing column, and rationalizes the thickness setting of the fixing needle and the height setting of the fixing column, thereby simplifying the threading of the fixing needle to tighten the tether, and more intuitively and conveniently realizing the tightening of the tether, and achieving all-round fixation in the up-down, left-right, front-back directions. In addition, by utilizing the super elasticity of the fixing needle and through the cooperation of the fixing needle and the fixing column, the pre-installation stability of the fixing needle and the stability of the final state can be achieved, thereby ensuring the stable and reliable technical effect of the fixing needle in both short-term and long-term use.

[0064] 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.

[0065] 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.

[0066] 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 needle-threading fastening apex pad for a heart valve replacement prosthesis, characterized in that: The invention comprises a sealing disc body and a fixing needle, wherein the sealing disc body comprises a disc surface and a fixing block arranged on one side of the disc surface, and a fixing column arranged on the same side as the fixing block, wherein the disc surface and the fixing block are provided with central holes which are interpenetrating with each other, wherein the central hole is used for inserting a tether which connects the inner and outer supports in a heart valve replacement prosthesis, wherein the fixing block is provided with a fixing hole which is perpendicular to and intercommunication with the central hole, wherein the fixing needle is inserted into the fixing hole to fasten the tether, and wherein the fixing column cooperates with the tail of the fixing needle to fix the fixing needle.

2. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: A guide groove for the fixing needle to penetrate into the fixing hole is provided at the top of the fixing column, and the guide groove and the central axis of the fixing hole are in the same vertical plane.

3. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 2, characterized in that: The top surface of the fixing column is 0.2 to 2 mm higher than the top of the fixing hole.

4. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 3, characterized in that: The guide groove is configured as an arc-surface longitudinal flat groove that slopes downward from the top surface of the fixing column toward the fixing hole.

5. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 4, characterized in that: The thickness of the fixing needle is 0.5-2 mm, and the cross-sectional shape is circular, triangular, square, elliptical, diamond or star-shaped.

6. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 4, characterized in that: The fixing column can be elastically and vertically arranged on the disk surface.

7. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 6, characterized in that: The disk surface is provided with a blind hole containing an elastic member, the bottom of the fixing column is fixed inside the blind hole, and the fixing column moves up and down under the action of the elastic member.

8. The needle-fastening apex pad of the heart valve replacement prosthesis according to any one of claims 1 to 7, characterized in that: The fixed needle comprises a needle tip, a needle rod and a needle head. The needle head is an annular rod connected to the tail of the needle rod. The cross-sectional shape of the fixed column matches the internal annular structure of the annular rod.

9. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 8, characterized in that: The inner structure of the annular rod is circular, square, elliptical or triangular.

10. The needle-fastening apex pad of the heart valve replacement prosthesis according to any one of claims 1 to 7, characterized in that: The fixed needle includes a needle tip, a needle rod and a needle head. The needle head is an annular rod connected to the tail of the needle rod. The top of the fixed column is provided with a transverse snap-in groove matching the annular rod. The central axis of the transverse snap-in groove is on the same horizontal plane as the central axis of the fixing hole.

11. The needle-fastening apex pad of a heart valve replacement prosthesis according to any one of claims 1 to 7, characterized in that: The fixed needle includes a needle tip, a needle rod and a needle head. The needle head adopts a vertical cross bar connected to the tail of the needle rod. The top of the fixed column is provided with a T-shaped snap-in groove matching the needle head. The central axis of the T-shaped snap-in groove is on the same horizontal plane as the central axis of the fixing hole.

12. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The fixing needle is made of a superelastic material such as nickel-titanium alloy or nitinol alloy, and the blocking disc body is made of PE, PEEK, PTFE, PET, PP or PVC.

13. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The disk surface, the fixing block and the fixing column are integrally formed, the peripheral structure of the fixing block is rectangular, circular or D-shaped, and the fixing block is also provided with a mounting socket staggered with the fixing hole.

14. A heart valve replacement prosthesis, characterized in that: A needle-fastened apical pad comprising the heart valve replacement prosthesis according to any one of claims 1 to 13.

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