A heart valve replacement prosthesis and its screw-fastened apex pad

Abstract

The present invention discloses a heart valve replacement prosthesis and a screw-fastened apex pad thereof, belonging to the field of medical devices. The apex pad comprises a blocking disc body and a threaded fixing needle, the blocking disc body comprises a disc surface and a fixing block arranged on one side thereof, the disc surface and the fixing block are provided with central holes that are mutually interpenetrating, the side of the fixing block is provided with a threaded hole that cooperates with the threaded fixing needle, the threaded hole is perpendicular to and communicates with the central hole, and is used for the threaded fixing needle to pass through the central hole to complete the fastening of the tether. The threaded fixing needle comprises a needle tip, a needle rod and a threaded needle head, and the needle rod is provided with a plurality of anti-loosening grooves. The present invention enables the threaded fixing needle to be screwed in vertically from the side of the central hole, thereby simplifying the fastening of the tether. Furthermore, by arranging an anti-loosening groove on the needle rod, after the fixing needle passes through the tether, part of the fiber of the tether is embedded in the anti-loosening groove, and a reverse pulling force is applied to the threaded fixing needle to screw out, thereby achieving a good anti-loosening effect, and ensuring the short-term and long-term stability of the threaded fixing needle.

Description

Technical Field

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

[0002] At present, transapical valve repair or replacement surgery is increasingly recognized. The surgery first requires opening a hole in the apex of the heart, then delivering the instruments and products through the hole to the lesion site, then accurately and firmly fixing the repair prosthesis or replacement prosthesis, then withdrawing all the instruments, and finally suturing the apex. 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 the surgery. 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 needs to be further improved. How to create a new heart valve replacement prosthesis and its screw-fastened apex pad, which can solve the problem of fixing the apex pad to the tether with very few parts, and fix firmly, simply and conveniently, and with simple processing and low cost, 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 screw-fastened apical pad of a heart valve replacement prosthesis, so that the fixation of the apical pad to the tether is solved with very few parts, and the fixation is firm, simple and convenient, simple to process, and low in cost, further improving 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 screw-fastened apical pad of a heart valve replacement prosthesis, comprising a sealing disc body and a threaded fixing needle, the sealing disc body comprising a disc surface and a fixing block arranged on one side of the disc surface, 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 side of the fixing block is provided with a threaded hole that cooperates with the threaded fixing needle, the threaded hole is perpendicular to and communicates with the central hole, and is used for the threaded fixing needle to pass through the central hole to complete the fastening of the tether.

[0007] As a further improvement, the threaded fixing needle comprises a needle tip, a needle rod and a threaded needle head, and the threaded needle head matches the internal thread of the threaded hole.

[0008] As a further improvement, the thread specification of the threaded needle head is M2-M5, and the total length of the needle tip and the needle rod is less than the length of the threaded hole.

[0009] As a further improvement, the needle bar is provided with a plurality of anti-loosening grooves.

[0010] As a further improvement, the anti-loosening groove adopts an oblique groove body with the bottom of the groove inclined toward the needle tip.

[0011] As a further improvement, the end of the threaded fixing needle is provided with a slot that cooperates with an external tool, and the slot has a shape of a straight line, a cross, a square, a hexagonal inner shape, a chrysanthemum shape, a cross shape, a straight square or a concave hexagon.

[0012] As a further improvement, the threaded fixing needle is made of metal, ceramic or plastic material, the metal is made of medical implant grade stainless steel, titanium alloy or cobalt-chromium-molybdenum alloy, the ceramic is made of zirconium oxide or aluminum oxide, and the plastic material is made of PEEK or PPSU.

[0013] As a further improvement, the fixing block and the disk 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 threaded hole.

[0014] As a further improvement, the disc body is made of PE, PEEK, PTFE, PET, PP or PVC.

[0015] As another improvement of the present invention, the present invention provides a heart valve replacement prosthesis, which includes the screw-fastened apex pad of the above-mentioned heart valve replacement prosthesis.

[0016] After adopting such a design, the present invention has at least the following advantages:

[0017] 1. The present invention improves the structure of the fixing block in the occluding disc body and improves the threaded fixing needle, thereby realizing that the threaded fixing needle is screwed vertically into the side of the center hole, and the final assembly relationship is formed by the connection method of threading the needle, thereby changing the force direction of the tether, reducing the risk of loosening, simplifying the fastening of the tether, and ensuring the stability and reliability of the fixing needle.

[0018] 2. By improving the needle rod of the threaded fixing needle and setting an anti-loosening groove, after the fixing needle passes through the tether, part of the fiber of the tether is embedded in the anti-loosening groove, giving the fixing needle a reverse pulling force to rotate it out, so that the threaded fixing needle will not rotate outward, thereby achieving a good anti-loosening effect. By improving the oblique groove body, the threaded fixing needle is easier to rotate inward, but not easy to rotate outward, which can better prevent the threaded fixing needle from loosening outward and ensure the long-term stability of the threaded fixing needle.

[0019] 3. The heart valve replacement prosthesis of the present invention has very few threaded fastening apex pad components, only two pieces, with a simple structure and convenient production and processing, which greatly reduces the production cost. 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

[0020] 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.

[0021] Figure 1 It is a schematic diagram of the overall structure of the heart valve replacement prosthesis of the present invention.

[0022] Figure 2 The present invention is a schematic diagram of the three-dimensional structure of the screw-fastened apex pad of the heart valve replacement prosthesis.

[0023] Figure 3 The present invention is a schematic cross-sectional structure diagram of a screw-fastened apex pad of a heart valve replacement prosthesis.

[0024] Figure 4 It is a schematic diagram of the cross-sectional structure of the screw-fastened apex pad of the heart valve replacement prosthesis of the present invention (without the threaded fixing pin).

[0025] Figure 5 It is a schematic structural diagram of a threaded fixing needle of a heart valve replacement prosthesis of the present invention. DETAILED DESCRIPTION

[0026] 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.

[0027] Refer to the 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.

[0028] Refer to the attached Figures 2 to 5 As shown, the screw fastening apex pad 4 of the heart valve replacement prosthesis of this embodiment includes a blocking disc body 5, a threaded 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. 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 54 of the disc surface 51, and is used to guide the tether 3 connecting the inner and outer stents in the heart valve replacement prosthesis to pass into the central hole 54. The side of the fixing block 52 is provided with a threaded hole 53 that cooperates with the threaded fixing needle 6. The threaded hole 53 is perpendicular to and communicates with the central hole 54, and is used for the threaded fixing needle 6 to pass through the central hole 54 to complete the fastening of the tether 3, and the thread of the threaded hole 53 realizes the fixation of the threaded fixing needle 6.

[0029] In this embodiment, the threaded fixing needle 6 comprises a needle tip 61, a needle rod 62 and a threaded needle head 63, and the threaded needle head 63 matches the internal thread of the threaded hole 53. The thread specification of the threaded needle head 63 is selected from M2 to M5. If the thread diameter is too small, the fixing effect is poor and it is easy to deform. If the thread diameter is too large, the entire structure will become larger, which will affect the surgical effect.

[0030] In a preferred embodiment, the needle bar 62 is provided with a plurality of anti-loosening grooves 64, which are annular grooves opened around the circumference of the needle bar 62 and are in the same direction as the tether 3 passing through the center hole. Under the threaded cooperation between the threaded fixing needle 6 and the threaded hole 53, the needle tip 61 and the needle bar 62 pass through the tether 3 in the center hole, and part of the fibers of the tether 3 will be embedded in the anti-loosening grooves 64 of the needle bar 62, which play the role of bearing the tension of the tether and preventing the threaded fixing needle from rotating outwards and causing looseness.

[0031] More preferably, the anti-loosening groove 64 adopts an oblique groove body with the bottom of the groove inclined toward the needle tip, as shown in the attached Figure 5 The right-angled triangle groove is adopted, which is convenient for the thread fixing needle to be screwed inwards, but not easy to be screwed outwards, and can better prevent the thread fixing needle from loosening outwards.

[0032] In order to ensure that the threaded fixing needle 6 is firmly pre-assembled during pre-assembly and does not affect the subsequent surgical operation, the total length of the needle tip 61 and the needle rod 62 in the threaded fixing needle 6 is less than the length of the threaded hole 53. The end of the threaded fixing needle 6 is provided with a slot for matching with an external tool, and the shape of the slot can be straight, cross, square, hexagonal, chrysanthemum, rice, straight square or concave hexagonal.

[0033] The threaded fixing needle 6 in this embodiment can be made of metal materials, such as medical implant grade stainless steel, titanium alloy or cobalt-chromium-molybdenum alloy. It can also be made of ceramic or plastic materials, the ceramic material is zirconium oxide or aluminum oxide, and the plastic material is PEEK (polyetheretherketone) or PPSU (polyphenylene sulfone resin), preferably PEEK material.

[0034] 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 55 staggered with the threaded hole 53. 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.

[0035] 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.

[0036] 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.

[0037] In the actual operation process of the screw-fastened apical pad 4 of the heart valve replacement prosthesis of this embodiment, the disc body 5 and the threaded fixing needle 6 of the apical pad are pre-assembled to ensure that the needle tip does not expose the central hole 54 through which the tether 3 is inserted, 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 threaded fixing needle 6 is further screwed in, and its needle tip 61 and needle rod 62 pass through the tether 3. The tension generated by the tether 3 is carried by the needle rod 62 to achieve the fastening of the tether 3, and at the same time, the blocking disc body 5 is fixed at the apical puncture site to achieve the blocking of the apical puncture site.

[0038] The present invention improves the disk structure and combines the improved setting of the threaded fixing needle to realize that the threaded fixing needle is screwed in vertically from the side, and the final assembly relationship is formed by the connection method of threading the needle, which changes the force direction of the tether, reduces the risk of loosening, simplifies the fastening of the tether, and fixes the threaded fixing needle in all directions, up and down, left and right, and front and back. And by using the anti-loosening groove on the threaded fixing needle, since the fibers of the tether have been embedded in the anti-loosening groove, a pulling force will be applied in the reverse direction, so that the threaded fixing needle will not rotate outward, thereby achieving the anti-loosening effect, improving the stability of the threaded fixing needle, and ensuring the stable and reliable technical effect of the fixing needle in short-term and long-term use.

[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 screw-fastened apical pad for a heart valve replacement prosthesis, characterized in that: The invention comprises a blocking disc body and a threaded fixing needle, wherein the blocking disc body comprises a disc surface and a fixing block arranged on one side of the disc surface, wherein the disc surface and the fixing block are provided with central holes which penetrate each other, wherein the central hole is used to penetrate a tether connecting an inner and outer stent in a heart valve replacement prosthesis, and wherein a threaded hole which cooperates with the threaded fixing needle is provided on the side of the fixing block, wherein the threaded hole is perpendicular to and communicates with the central hole, and is used for the threaded fixing needle to pass through the central hole to complete the fastening of the tether; The threaded fixing needle comprises a needle tip, a needle rod and a threaded needle head, wherein the threaded needle head matches the internal thread of the threaded hole, and the needle rod is provided with a plurality of anti-loosening grooves, wherein the anti-loosening grooves are oblique groove bodies with the bottom of the groove inclined toward the needle tip.

2. The screw-fastened apical pad of a heart valve replacement prosthesis according to claim 1, characterized in that: The thread specification of the threaded needle head is M2-M5, and the total length of the needle tip and the needle rod is less than the length of the threaded hole.

3. The screw-fastened apical pad of the heart valve replacement prosthesis according to claim 1 or 2, characterized in that: The end of the threaded fixing needle is provided with a slot that cooperates with an external tool, and the slot has a shape of a straight line, a cross, a square, a hexagonal inner, a chrysanthemum, a rice shape, a straight square or a concave hexagon.

4. The screw-fastened apical pad of a heart valve replacement prosthesis according to claim 1, characterized in that: The threaded fixing needle is made of metal, ceramic or plastic material. The metal is made of medical implant grade stainless steel, titanium alloy or cobalt-chromium-molybdenum alloy. The ceramic is made of zirconium oxide or aluminum oxide. The plastic material is made of PEEK or PPSU.

5. The screw-fastened apical pad of a heart valve replacement prosthesis according to claim 1, characterized in that: The fixing block and the disk 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 threaded hole.

6. The screw-fastened apical pad of the heart valve replacement prosthesis according to claim 5, characterized in that: The disc body is made of PE, PEEK, PTFE, PET, PP or PVC.

7. A heart valve replacement prosthesis, characterized in that: A screw-fastened apical pad for a heart valve replacement prosthesis comprising the heart valve replacement prosthesis according to any one of claims 1 to 6.

Images