A heart valve replacement prosthesis and its locking and fastening apex pad

Abstract

The present invention discloses a locking and fastening apex pad for a heart valve replacement prosthesis, belonging to the field of medical devices. The apex pad comprises a blocking disc with a central through hole and a position-limiting locking pin with a central hole. The central through hole of the disc is configured as an oblong structure, with guide grooves provided on two distal inner walls and position-limiting grooves provided on two proximal inner walls. The position-limiting locking pin comprises a pin head and a pin shaft, the pin shaft comprising two opposing curved rods, each with a locking protrusion provided on its outer wall. When the position-limiting locking pin rotates under the action of an external force, the bottom end of the curved rod is squeezed inward and tightened until the locking protrusion engages with the position-limiting groove, thereby clamping and fastening the tether. The present invention, through the oblong structure and the position-limiting locking pin, achieves non-destructive compression and fastening of the tether by the locking pin, which is simple, convenient, and safer. A fixing post is also used to secure the end of the tether by knotting, ensuring both short-term and long-term effectiveness, preventing complications, and simplifying operation.

Description

Technical Field

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

[0002] Heart valve disease is increasingly affecting people's health. Currently, the internationally recognized best solution is surgical treatment, among which transapical valve repair or replacement surgery is gradually becoming a surgical method recognized by the medical community. During transapical valve repair or replacement surgery, a hole is first made in the apex of the heart. The instruments and products are then delivered to the affected area through this hole. The repair or replacement prosthesis is then accurately and firmly fixed. All instruments are then removed, and finally the apex is sutured. Generally, the apex of the heart is only sutured and not blocked after surgery. However, because 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 surgery.

[0003] Many renowned medical device manufacturers, both domestically and internationally, have launched products for interventional valve replacement. Abbott's Tendyne product, for example, utilizes an apical pad for apical occlusion, significantly reducing the risk of apical bleeding and significantly improving patient survival. The key component of the Tendyne's apical pad is the needle. Once the tether length is adjusted to the desired level, the needle is threaded through the tether, securing the stent to the valve annulus and securely blocking the apical opening. However, the tether securing structure of the Tendyne's apical pad is overly complex, with numerous components and complex shapes. These components are also extremely small, and their sizes are constrained. This structure is not only difficult to manufacture but also cumbersome during assembly, leading to component loss, blockage, and other operational inconveniences. Improper assembly can lead to medical accidents on the operating table. This structure not only poses significant challenges in production and processing, but also presents mechanical weaknesses, making it prone to failure over time. 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 greatly affect the use effect.

[0004] As can be seen, the apical pads of existing heart valve replacement prostheses still suffer from inconveniences and defects in their structure, methods, and use, and are in urgent need of further improvement. The industry is currently striving to develop a new heart valve replacement prosthesis and its associated locking apical pad, which allows for simple and convenient screwing of the apical pad to secure the tether. This design utilizes minimal components, is easily fabricated, and is secured securely via knotted anchors, resulting in reliable and secure fastening, ensuring both short-term and long-term effectiveness, and further improving patient survival rates. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a locking and fastening apical pad of a heart valve replacement prosthesis, so that the apical pad can be fixed to the tether in a simple and convenient way by screwing. The structural components are very few, the processing is convenient, the fastening effect is reliable, and it is also fixed by knotting through a fixed pile. The fastening effect is reliable and safe, ensuring short-term and long-term effects, and 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] To solve the above technical problems, the present invention provides a locking and fastening apex pad for a heart valve replacement prosthesis, comprising a blocking disc with a central through hole and a limiting locking pin with a central hole. The central through hole of the blocking disc is configured as an oblong structure. Two distal inner walls of the oblong structure are respectively provided with guide grooves communicating with the top end, and two proximal inner walls are respectively provided with limiting grooves. The limiting locking pin comprises a pin head and a pin rod. The pin rod is composed of two oppositely arranged arcuate rods. The outer walls of the arcuate rods are provided with locking protrusions that match the guide grooves and limiting grooves. The limiting locking pin is inserted into the central through hole under the cooperation of the locking protrusions and the guide grooves. When the limiting locking pin rotates under the action of an external force, the bottom ends of the two arcuate rods are squeezed and tightened inwardly under the action of the two proximal inner walls of the oblong structure until the locking protrusions engage with the limiting grooves, thereby completing the clamping and fastening of the tether passing through the central hole.

[0007] As a further improvement, a locking mechanism is provided on the inner sides of the two arc-shaped rods.

[0008] As a further improvement, the locking mechanism adopts a plurality of transverse annular grooves or internal threads arranged on the inner side of each arc-shaped rod.

[0009] As a further improvement, both side ends of each arc-shaped rod are provided with guide edges.

[0010] As a further improvement, the root of each arc-shaped rod has an arc-shaped root cleaning groove.

[0011] As a further improvement, a spiral groove is provided at the end of the nail head of the limiting locking nail, and the shape of the spiral groove is hexagonal, triangular, square, D-shaped or diamond-shaped.

[0012] As a further improvement, the blocking disc body is provided with a fixing pile with a hole or a groove for fixing the end of the tether.

[0013] As a further improvement, the blocking disc body is also provided with a groove for winding a tether.

[0014] As a further improvement, the blocking disc body is made of PEEK material, and the limiting locking pin is made of PEEK material, titanium alloy or stainless steel metal material.

[0015] As another improvement of the present invention, the present invention further provides a heart valve replacement prosthesis, which includes the locking and fastening apex pad of the heart valve replacement prosthesis.

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

[0017] 1. This invention designs the central through-hole of the disc into an oblong structure and the rod portion of the locking pin into two curved rods with a vertical groove in the middle. As the two curved rods rotate within the oblong structure, they are squeezed by the two short inner walls of the oblong. Combined with a locking mechanism, the two curved rods squeeze and tighten the tether, creating a simple, reliable, and highly secure tightening method. Furthermore, the locking protrusion and the retaining groove in the locking mechanism not only prevent the pin from slipping, but also provide force feedback to the operator, ensuring that the pin is securely tightened, greatly facilitating surgical procedures.

[0018] 2. A locking mechanism is provided on the inner side of each arc-shaped rod of the nail rod portion. By utilizing the locking mechanism to intrude into the tether, the tether can be further tightened, thereby improving the fastening reliability of the tether.

[0019] 3. By setting grooves and fixing piles on the disc body, the end of the tether can be wrapped and knotted to fix it, which not only ensures the short-term and 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.

[0020] 4. The heart valve replacement prosthesis of the present invention has very few apical pad fastening components, only two, with a simple structure and easy production and processing, which greatly reduces 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

[0021] 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 embodiments.

[0022] Figure 1 It is a structural schematic diagram of the heart valve replacement prosthesis of the present invention.

[0023] Figure 2 It is a schematic diagram of the three-dimensional structure of the locking and fastening apex pad of the heart valve replacement prosthesis of the present invention.

[0024] Figure 3 It is a schematic cross-sectional structure diagram of the locking and fastening apex pad of the heart valve replacement prosthesis of the present invention (the state when the locking protrusion is inside the guide groove).

[0025] Figure 4 It is a schematic cross-sectional structure diagram of the locking and fastening apex pad of the heart valve replacement prosthesis of the present invention (the state when the locking protrusion is inside the limiting groove).

[0026] Figure 5 It is a schematic diagram of the disc structure of the locking and fastening apex pad of the heart valve replacement prosthesis of the present invention.

[0027] Figure 6 It is a schematic diagram of the cross-sectional structure of the disc body of the locking and fastening apex pad of the heart valve replacement prosthesis of the present invention.

[0028] Figure 7 It is a structural schematic diagram of the position-limiting locking pin for locking and fastening the apex pad of the heart valve replacement prosthesis of the present invention (in a non-extrusion state).

[0029] Figure 8 It is a schematic cross-sectional structure diagram of the position-limiting locking pin for locking and fastening the apex pad of the heart valve replacement prosthesis of the present invention (in a non-extrusion state).

[0030] Figure 9 It is a structural schematic diagram (in squeezed state) of the position-limiting locking pin for locking and fastening the apex pad of the heart valve replacement prosthesis of the present invention.

[0031] Figure 10 It is a schematic cross-sectional structure diagram (in squeezed state) of the position-limiting locking pin for locking and fastening the apex pad of the heart valve replacement prosthesis of the present invention. DETAILED DESCRIPTION

[0032] This invention offers a novel improvement over existing apex pad structures, achieving dual-security fastening of the tether through two methods. It is simple to manufacture and process, low-cost, and ensures both short-term and long-term fixation, thus possessing promising market prospects. Specific embodiments are as follows.

[0033] 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, while the inner stent 2 and the tether 3 are connected and assembled by crimping and suturing. The apical pad 4 is used to fasten the tether 3 and seal against the outside of the apical membrane after suturing, thereby securing the inner and outer stents and the tether and sealing the apical membrane.

[0034] Refer to the attached Figures 2 to 10 As shown, the locking and 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 limiting locking pin 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.

[0035] The central through hole 51 of the blocking disc 5 is configured as an oblong structure, which has at least two long-distance inner walls and two short-distance inner walls, preferably, the two short-distance inner walls are configured in parallel.

[0036] The two distal inner walls of the oblong structure are each provided with a guide groove 52 communicating with the top end, and the two proximal inner walls are each provided with a retaining groove 53. The retaining locking nail 6 comprises a nail head 62 and a nail rod 63. The nail rod 63 comprises two opposing curved rods 64 with a vertical slot therebetween. The outer walls of the curved rods 64 are provided with locking protrusions 65 that mate with the guide grooves 52 and retaining grooves 53. The retaining locking nail 6 is inserted into the central through hole 51 under the cooperation of the locking protrusions 65 and the guide grooves 52. When the retaining locking nail 6 is rotated under the action of an external force, the bottom ends of the two curved rods 64 are squeezed inward by the two proximal inner walls of the oblong structure until the locking protrusions 65 engage with the retaining grooves 53, thereby clamping and securing the tether 3 passing through the central through hole 61.

[0037] The end of the nail head 62 of the position-limiting locking nail 6 is provided with a rotary groove 66 , and the shape of the rotary groove 66 is hexagonal, triangular, square, D-shaped, star-shaped or diamond-shaped, etc., which is easy to operate.

[0038] To further enhance the clamping effect of the limit locking pin, a snap-lock mechanism is provided on the inner side of each curved rod 64. In this embodiment, the snap-lock mechanism utilizes multiple transverse annular grooves 67 disposed on the inner side of each curved rod 64. As the limit locking pin 6 is rotated, the transverse annular grooves 67 deform and tighten inward along with the curved rod 64, engaging the clamped tether 3 and enhancing the tightening effect of the tether 3.

[0039] In this embodiment, multiple transverse annular grooves 67 are distributed from top to bottom along the axial direction of the nail rod, with a number between 1 and 10, forming sharp edges between the annular grooves, but not too sharp to prevent cutting of the tether 3 and causing damage to the tether.

[0040] Of course, the plurality of transverse annular grooves 67 can also be configured as internal threads, which also achieve the same tightening effect on the tether. The locking mechanism can also be provided with a needle or sharp edge provided on the inner side of the bottom end of each arc-shaped rod 64. When the arc-shaped rod 64 deforms inwardly and tightens, the needle or sharp edge can be embedded in the clamped tether 3, thereby further tightening the tether 3 and greatly improving the tightening effect.

[0041] In this embodiment, both side ends of each arc-shaped rod 64 are provided with a planar guide edge 68 , which is used to fit with two parallel and close inner walls of the central through hole 51 , playing a dual guiding role for the smooth installation of the limit locking pin 6 .

[0042] To further enhance the smooth deformation and retraction of the arc rods 64, while ensuring that the base of the arc rods is not broken or damaged and maintaining sufficient elasticity, the base of each arc rod 64 is provided with an arc-shaped root cleaning groove 69. The wall thickness of the root cleaning groove should be controlled between 0.2 and 1.0 mm, ensuring that deformation is easy during surgical operation while preventing damage or breakage.

[0043] In a preferred embodiment, the blocking disc 5 is provided with at least one fixed pile 8 with a hole for fixing the end of the tether 3, and the fixed pile 8 with a hole and the limit locking nail 6 are arranged on the same side of the blocking disc 5. The blocking 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 first wound inside the groove 9, and when it reaches the appropriate length, it can be fixed by knotting through the hole on the fixed pile 8 with a hole, which can achieve a secondary fixation of the tether 3, achieve a double insurance and stable effect, and prevent patient discomfort or other complications caused by the floating tether 3. Of course, the tether 3 that directly passes through the disc 5 can also be fixed by knotting through the fixed pile 8 with a hole, which can also achieve a secondary fixation of the tether. The fixed pile 8 with a hole can be provided with one hole, or two or more holes, or it can be a fixed pile with a groove, as long as it can achieve the effect of binding the tether.

[0044] The disk body 5 is also provided with a mounting socket 55 for connecting with an external clamping and conveying tool.

[0045] In this embodiment, the occluding disc 5 is made of an implantable plastic material, such as PEEK (polyetheretherketone), to ensure sufficient strength for its internal threads. Furthermore, the large, disc-shaped occluding surface of the occluding disc 5 effectively seals the apical puncture, meeting the requirements of an apical pad. It also offers the advantage of low cost, significantly reducing production costs. The position-limiting locking pin 6 can also be made of an implantable plastic material, such as PEEK. Furthermore, due to its relatively small size, the locking pin can also be made of a metal material, such as titanium alloy or stainless steel.

[0046] 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 requires two steps to be completed 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.

[0047] During the actual operation, the locking and fastening apex pad 4 of the heart valve replacement prosthesis of this embodiment is achieved by the locking protrusion 65 of the limiting locking pin 6 corresponding to the guide groove 52 of the central through hole 51 of the disc body, and the guide edge 68 of the limiting locking pin 6 is in contact with the parallel inner wall of the central through hole 51 of the disc body, thereby realizing the double-guide pre-assembly of the disc body 5 and the limiting locking pin 6. At this time, the limiting locking pin 6 is in a non-extrusion state, so that it does not affect the adjustment of the tether 3 during the operation. After the length of the tether 3 is adjusted to the appropriate length, the limited locking nail 6 is rotated. The nail rod portion of the limited locking nail 6 is squeezed and deformed by the inner walls of the two short central through holes, and its internal through hole gradually shrinks. When the limited locking nail 6 is rotated 90 degrees, that is, the locking protrusion 65 enters the limited groove 53, the operator can receive a force feedback due to the locking protrusion 65 falling into the limited groove 53, knowing that the locking nail has been rotated into place. At this time, the internal through hole of the limited locking nail 6 is at its smallest state. The tether is firmly fixed by the friction force and the locking mechanism, and the occluding disc 5 is fixed to the apical puncture hole to achieve the apical puncture hole. The end of the floating tether 3 is then first wrapped inside the groove 9. When it reaches the appropriate length, it is tied and fixed through the hole on the fixing pile 8 to achieve secondary fixation of the tether.

[0048] The locking and fastening apex pad of the heart valve replacement prosthesis of the present invention utilizes the principles of lateral extrusion and fixed piles, adopts friction and assists the locking mechanism to realize the fastening constraint of the tether, and then adopts the method of knotting the end of the tether to realize enhanced fastening, which not only solves the problem of tether fluttering, but also achieves the effect of dual fixation of the tether, and is good for both short-term and long-term use.

[0049] In the description of the present invention, it should be noted that the terms "upper", "lower", "front", "rear", etc., indicating directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they cannot be understood as limiting the present invention.

[0050] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0051] 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 can make some simple modifications, equivalent changes or modifications based on the technical content disclosed above, which all fall within the scope of protection of the present invention.

Claims

1. A locking and fastening apex pad for a heart valve replacement prosthesis, characterized in that: The locking mechanism comprises a locking plate with a central through hole and a limiting locking nail with a central hole, the central through hole of the blocking plate being arranged in an elongated elliptical structure, the two distal inner walls of the elongated elliptical structure being respectively provided with a guide groove communicating with the top end, and the two proximal inner walls being respectively provided with a limiting groove, the limiting locking nail comprising a nail head and a nail rod, the nail rod being composed of two oppositely arranged arcuate rods, the outer wall of the arcuate rod being provided with a locking protrusion matching the guide groove and the limiting groove, the inner sides of the two arcuate rods being provided with a snap lock mechanism, the snap lock mechanism being provided with a plurality of transverse annular grooves or internal threads provided on the inner side of each arcuate rod, the limiting locking nail being inserted into the central through hole under the cooperation of the locking protrusion and the guide groove, the limiting locking nail being rotated 90 degrees under the action of an external force, the bottom ends of the two arcuate rods being squeezed and tightened inwardly under the action of the two proximal inner walls of the elongated elliptical structure until the locking protrusion is engaged with the limiting groove, thereby completing the clamping and fastening of the tether passing through the central hole; Both side ends of each arc-shaped rod are provided with a flat guide edge for fitting with two parallel and close inner walls of the central through hole. The blocking disc body is provided with a fixed pile with a hole for fixing the end of the tether, which is used for knotting and fixing the tether passing through the disc body. The fixed pile with a hole and the limit locking nail are arranged on the same side of the blocking disc body.

2. The locking and fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The root of each arc-shaped rod is provided with an arc-shaped root cleaning groove.

3. The locking and fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The end of the nail head of the position-limiting locking nail is provided with a rotary groove, and the shape of the rotary groove is hexagonal, triangular, square, D-shaped or diamond-shaped.

4. The locking and fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The blocking disc body is also provided with a groove for winding a tether.

5. The locking and 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, and the limiting locking nail is made of PEEK material, titanium alloy or stainless steel metal material.

6. A heart valve replacement prosthesis, characterized in that: A locking and fastening apex pad of a heart valve replacement prosthesis comprising the method according to any one of claims 1 to 5.

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