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 a blocking disc body and a 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 mutually interpenetrating central holes, the fixing block is provided with a fixing mechanism for inserting and fixing the fixing needle, the fixing mechanism comprises an insertion hole perpendicular to and communicating with the central hole and a card slot connected to the insertion hole, the card slot structure is consistent with the structure of the end of the fixing needle, and is used to fix the fixing needle when the fixing needle completes the fastening of the tether. The present invention can simplify the fastening of the tether by the fixing needle, more conveniently realize the insertion of the fixing needle, and utilize the super elastic memory function of the fixing needle to make it easy to operate during surgery, stable and not falling out after surgery, so as to achieve all-round fixation of the fixing needle in the pre-installation and final installation states, and ensure 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] Heart valve disease in the human body is increasingly affecting people's health, with a high mortality rate. There is currently no specific drug for treatment. At present, the best solution recognized internationally is surgical treatment, such as surgical valve replacement or interventional repair or valve replacement. The current 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 the 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 the 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 needs to be further improved. How to create a new heart valve replacement prosthesis and its needle-threading apex pad, so that the apex pad can be fixed to the tether in a simpler and more convenient way, with very few structural parts, simple and convenient processing, easy assembly, and 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. The structural parts are very few, the processing is simple and convenient, the assembly is convenient, and the device is firm and reliable, which further improves 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, the disc surface and the fixing block are provided with central holes that penetrate each other, the central hole is used to penetrate a tether connecting an inner and outer support in a heart valve replacement prosthesis, the fixing block is provided with a fixing mechanism for inserting and fixing the fixing needle, the fixing mechanism comprises an insertion hole that is perpendicular and communicated with the central hole and a card slot connected to the insertion hole, the structure of the card slot is consistent with the end structure of the fixing needle, and is used to fix the fixing needle when the fixing needle penetrates the insertion hole to complete the fastening of the tether.

[0007] As a further improvement, the fixing needle comprises a needle tip, a needle rod and a needle head, wherein the needle head is the terminal structure of the fixing needle, and the needle head is in an I-shape, a C-shape, a square or other irregular shapes.

[0008] As a further improvement, the opening end of the slot is configured as a necking portion, and the width of the necking portion is smaller than the diameter of the fixing pin.

[0009] As a further improvement, the fixing pin is made of a superelastic material such as nickel-titanium alloy or nitinol alloy.

[0010] As a further improvement, the thickness of the fixing needle is 0.5 to 2 mm.

[0011] As a further improvement, the cross-sectional shape of the fixing needle is circular, triangular, square, elliptical, diamond-shaped or star-shaped.

[0012] As a further improvement, the disc body is made of PE, PEEK, PTFE, PET, PP or PVC.

[0013] As a further improvement, the fixing block and the disk surface are integrally formed, and the peripheral structure of the fixing block is rectangular, circular or D-shaped.

[0014] As a further improvement, the fixing block is also provided with a mounting socket staggered with the fixing hole.

[0015] 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.

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

[0017] 1. The present invention simplifies the threading and fastening of the fixing needle by improving the structure of the fixing block in the occluding disc and improving the shape of the fixing needle, making it more convenient to insert the fixing needle. The fixing needle also has a super elastic memory function, which makes it easy to bend and deform under surgical conditions, making it easy to insert. After the operation, as the temperature environment changes, the material hardness increases and it will not fall out. The fixing needle can be stabilized in the pre-installation and final installation states, and can be fixed in all directions up and down, left and right, and front and back. It can not only ensure the short-term use effect of the fixing needle, but also ensure the long-term use effect of the fixing needle, and has strong stability and reliability.

[0018] 2. By setting the needle of the fixing needle into an "X" shape, C shape, square or other irregular shapes, the needle structure is flexible and easy to process, and can achieve precise matching with the fixing slot to achieve all-round fixation up and down, left and right, front and back. The shrinkage setting at the opening end of the slot further ensures the stability and reliability of the fixing needle, and completely avoids the risk of the fixing needle coming out.

[0019] 3. By setting the thickness and size of the fixing needle, the convenience of pre-inserting the fixing needle into the fixing hole is further improved, and the stability of the fixing needle during pre-installation is ensured.

[0020] 4. The heart valve replacement prosthesis of the present invention has only two needle-threading and fastening apex pad components, which are simple in structure and 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

[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 implementation methods.

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

[0023] 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.

[0024] 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.

[0025] 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.

[0026] Figure 5 It is a schematic diagram of the top view of the needle-threading and fastening apex pad of the heart valve replacement prosthesis of the present invention (without the fixing needle).

[0027] Figure 6 It is a schematic structural diagram of a fixing needle of a heart valve replacement prosthesis of the present invention. DETAILED DESCRIPTION

[0028] 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.

[0029] 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.

[0030] Refer to the attached Figures 2 to 6 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. 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 mechanism for inserting and fixing the fixing needle 6. The fixing mechanism includes an insertion hole 55 that is perpendicular to and communicates with the central hole 54 and a clamping groove 56 connected to the insertion hole 55. The structure of the clamping groove 56 is consistent with the end structure needle head of the fixing needle 6, and is used to fix the fixing needle 6 when the fixing needle 6 penetrates the insertion hole 55 to complete the fastening of the tether 3.

[0031] The fixed needle 6 in this embodiment includes a needle tip 61, a needle rod 62 and a needle head 63. The needle head 63 is the end structure of the fixed needle 6. The needle head 63 in this embodiment adopts a "X"-shaped structure, as shown in the attached figure. Figure 6 Of course, the needle 63 can also be C-shaped, square or other irregular shapes, as long as the needle and the slot can be precisely matched to achieve the fixation of the needle in the up-down, left-right, front-back directions.

[0032] In order to further improve the stability of the fixing needle, the opening end of the clamping slot 56 is configured as a constriction, and the width of the constriction is smaller than the diameter of the fixing needle 6, which can better prevent the fixing needle from falling out.

[0033] The fixing needle 6 is made of a superelastic material of nickel-titanium alloy or nitinol alloy with good memory function, preferably nickel-titanium alloy. The superelastic material can realize bending and deformation of the fixing needle 6 when it just penetrates the insertion hole 55, and the fixing needle is arranged between the insertion hole and the top of the card slot. At this time, the fixing needle has a certain resistance to bending and deformation, which can realize the pre-installation and fixation of the fixing needle 6, and after the fixing needle 6 reaches the final insertion position, it can bounce back to the original state, so that the fixing needle needle head 63 falls into the card slot 56, and is firmly fixed in the final position. Moreover, the nickel-titanium alloy material has the characteristic of being easy to bend when the temperature is low during the operation, which facilitates the insertion operation of the fixing needle during the operation, but after the operation is completed, the material hardness becomes larger under the human body temperature condition, ensuring that the fixing needle will not fall out of the card slot, and the stability is high.

[0034] 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.

[0035] 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 insertion 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.

[0036] In this embodiment, the occluding disc 5 has an implantable density of about 1 g / cm 3It 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., and PE material is preferably used. The above materials have low structural density, light weight, and certain elasticity, which can better meet the requirements of apical pad occlusion in terms of performance and area. 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 made of 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. 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.

[0037] 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.

[0038] 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, and the needle head 63 falls into the card slot 56. 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.

[0039] The present invention simplifies the threading of the fixing needle to tighten the tether by improving the disc structure, combining the improved setting of the fixing needle and rationalizing the thickness setting of the fixing needle, and realizes the tightening of the tether in a more intuitive and convenient way, thereby realizing 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 between the fixing needle and the card slot in the fixing mechanism, 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.

[0040] 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.

[0041] 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.

[0042] 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 blocking disc body and a fixing needle, wherein the blocking disc body comprises a disc surface and a fixing block arranged at 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, wherein the fixing block is provided with a fixing mechanism for inserting and fixing the fixing needle, wherein the fixing mechanism comprises an insertion hole which is perpendicular to and communicates with the central hole and a card slot connected to the insertion hole, wherein the structure of the card slot is consistent with the end structure of the fixing needle, and is used to fix the fixing needle when the fixing needle penetrates the insertion hole to complete the tightening of the tether; The fixing needle is made of a superelastic material of nickel-titanium alloy or nitinol alloy, and comprises a needle tip, a needle rod and a needle head, wherein the needle head is the terminal structure of the fixing needle, and the needle head is in an I-shape, C-shape, square or other irregular shapes; The opening end of the slot is configured as a constriction, and the width of the constriction is smaller than the diameter of the fixing pin.

2. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The thickness of the fixing needle is 0.5-2 mm.

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

4. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 1, characterized in that: The blocking disc body is made of PE, PEEK, PTFE, PET, PP or PVC.

5. The needle-fastening apex pad of the heart valve replacement prosthesis according to any one of claims 1 to 4, characterized in that: The fixing block and the disk surface are integrally formed, and the peripheral structure of the fixing block is rectangular, circular or D-shaped.

6. The needle-fastening apex pad of the heart valve replacement prosthesis according to claim 5, characterized in that: The fixing block is also provided with a mounting plug hole which is staggered with the insertion hole.

7. 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 6.

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