A medical patch fixing nail with automatic bending and fixing

Abstract

The present invention discloses a medical patch fixing nail that automatically bends and fixes, and belongs to the field of medical devices. The medical patch fixing nail of the present invention comprises an implantation part and a bending part, wherein the bending part is arranged at the tail of the implantation part, and the bending part has at least two bending arms, and the circumferentially adjacent bending arms are connected together toward the center through a connecting structure, and the bending arms have a bending stress that automatically opens and bends outward after the connecting structure is disconnected or detached. With the medical patch fixing nail, during the firing process of the fixing nail, the connecting structure between the adjacent bending arms is disconnected or peeled off by an instrument, so that the bending arms are bent and tightened to tighten the medical patch, so that the medical patch is stably fixed to the human tissue, and the fixing nail of the structure is easy to be fired continuously by an instrument, which solves the problem that the existing medical patch fixing nail is difficult to fire continuously, further facilitates the surgical operation, shortens the surgical time, and breaks the long-term monopoly of foreign countries on medical patch fixing nails.

Description

Technical Field

[0001] The invention relates to a medical patch fixing nail, and more particularly to an automatically bent and fixed medical patch fixing nail. Background Art

[0002] With the continuous development of material medicine, more and more new materials are entering the medical field as biomedical materials to repair defects in various parts of the human body. Medical patches are a kind of human tissue repair material, which is widely used in general surgery, mainly for the repair of various hernias, such as inguinal hernia and incisional hernia. Due to the particularity of the hernia site, the patch needs to have strong tensile strength without losing softness, and the patch also needs to have an appropriate shape according to the location of the repaired tissue so that it can be stably fixed on the human tissue.

[0003] The fixation of the patch in human tissue is the key to hernia repair surgery. Its fixation effect directly affects the success or failure of the surgery and has a key impact on whether the disease recurs after surgery. If the patch is not firmly fixed, it is easy to cause the patch to loosen or fall off. At present, the fixation of hernia repair patches usually adopts the clinical suture method, that is, the patch is fixed to the tissue through sutures at multiple positions of the patch. However, this suture operation method is inefficient, increases the operation time, requires a high level of operation of the doctor, and the suture effect is not easy to guarantee. At the same time, the patient recovers slowly. With the development of medical devices, an absorbable patch fixation nail has appeared on the market. The fixation nail is injected into the tissue to fix the hernia repair patch. It can penetrate and fix the human soft tissue from multiple angles and directions, has a good fixation effect, improves the efficiency of the operation, reduces the workload of the doctor, and reduces the pain of the patient. For example, the "Applicator system for surgical fasteners" disclosed in Chinese Patent No. ZL201480015432.8 and the "A hernia patch fixation nail and its preparation method" disclosed in Chinese Patent Application No. 201810214855.2, this patch fixation nail has a U-shaped structure, with pointed tips and barbs at the ends of the forks on both sides, and the two forks are inserted into the tissue to fix the patch, with a simple structure and flexible operation. However, due to its structural characteristics, during use, it is necessary to use an implantation tool with two clamping arms, and use the two clamping arms of the tool to clamp the two forks of the fixation nail to provide sufficient rigid support for the two forks; and precisely because of its particularity in operation, it is necessary to take out a fixing clamp one by one during operation, which is not conducive to the use of the instrument for continuous firing and fixation.

[0004] Therefore, it is necessary to design and develop a new type of patch fixing nail to facilitate the continuous firing of the instrument and make the firing action of the instrument simple and reliable. Summary of the invention

[0005] 1. Technical problem to be solved by the invention

[0006] The purpose of the present invention is to provide a medical patch fixing nail that can be automatically bent and fixed. By adopting the technical solution of the present invention, the medical patch fixing nail consists of an implantation part and a bending part. The bending arm of the bending part has a bending stress that automatically opens and bends outward. During the firing process of the fixing nail, an instrument is used to disconnect or peel off the connecting structure between adjacent bending arms, so that the bending arms are bent and tightened to tighten the medical patch, so that the medical patch is stably fixed to the human tissue. In addition, the fixing nail of this structure is easy to be fired continuously by an instrument, which solves the problem that the existing medical patch fixing nails are difficult to fire continuously, further facilitates the surgical operation, shortens the operation time, and alleviates the patient's pain. At the same time, it breaks the long-term monopoly of foreign countries on medical patch fixing nails.

[0007] 2. Technical solution

[0008] In order to achieve the above object, the technical solution provided by the present invention is:

[0009] The present invention discloses an automatically bending and fixing medical patch fixing nail, comprising an implanting portion and a bending portion, wherein the bending portion is arranged at the tail of the implanting portion, and the bending portion has at least two bending arms, and the circumferentially adjacent bending arms are connected together toward the center through a connecting structure, and the bending arms have a bending stress that automatically opens and bends outward after the connecting structure is disconnected or detached.

[0010] Furthermore, the connection structure between the bending arms is a thin wall provided between the circumferentially adjacent bending arms.

[0011] Furthermore, the bending portion has four bending arms, and the four bending arms are connected together through a thin wall to form a "cross" axial opening groove in the middle.

[0012] Furthermore, a notch groove is provided on the outer side of the root of the bending arm.

[0013] Furthermore, the notch groove is a V-shaped groove or a U-shaped groove arranged in an annular direction.

[0014] Furthermore, the bending arm is bent outward at an angle of 90°.

[0015] Furthermore, the implantation part is a nail rod structure with a pointed tip at the front end, and a barb is provided on the implantation part.

[0016] Furthermore, the automatically bending and fixing medical patch fixing nail is made of medical polymer material.

[0017] Furthermore, the medical polymer material is an absorbable biomaterial.

[0018] Furthermore, the implantation portion and the bending portion are integrally injection molded.

[0019] 3. Beneficial effects

[0020] Compared with the existing known technologies, the technical solution provided by the present invention has the following significant effects:

[0021] (1) The present invention discloses an automatically bending and fixing medical patch fixing nail, which comprises an implantation part and a bending part, wherein the bending part is arranged at the tail of the implantation part, and the bending part has at least two bending arms, wherein the circumferentially adjacent bending arms are connected together toward the center by a connecting structure, and the bending arms have a bending stress that automatically opens and bends outward after the connecting structure is disconnected or detached. When the medical patch fixing nail is used, during the firing process of the fixing nail, the connecting structure between the adjacent bending arms is disconnected or peeled off by an instrument, so that the bending arms are bent and tightened to fix the medical patch stably to the human tissue; and, since the medical patch fixing nail only needs to perform two actions, namely, pushing out and disconnecting or peeling off the connecting structure, when firing, the design of the continuous firing instrument is facilitated, and the continuous firing operation of the instrument is facilitated, thereby solving the problem that the existing medical patch fixing nail is difficult to fire continuously, further facilitating the surgical operation, shortening the surgical time, and alleviating the pain of the patient, and at the same time breaking the long-term monopoly of foreign countries on medical patch fixing nails, and having very good economic and social benefits;

[0022] (2) The automatic bending and fixing medical patch fixing nail of the present invention has a connection structure between the bending arms as a thin wall provided between the circumferentially adjacent bending arms, which is simple to manufacture and convenient for cutting with a blade in the instrument when the fixing nail is fired, thereby ensuring the stability of the fixing nail when the fixing patch is fired;

[0023] (3) The present invention is an automatically bending and fixing medical patch fixing nail, wherein the bending portion has four bending arms, and the four bending arms are connected together by a thin wall to form a "cross" axial opening groove in the middle. The four bending arms are designed so that the strength of each bending arm is sufficient and the stress deformation of the bending arm is facilitated, thereby ensuring the structural reliability and stability of the medical patch fixing nail;

[0024] (4) The present invention is an automatically bending and fixing medical patch fixing nail, wherein a notch groove is provided on the outside of the root of the bending arm, and the notch sensitivity and the elasticity of the fixing nail material itself are utilized to enable the bending arm to generate a stable bending stress at the notch groove, thereby ensuring that the bending arm can stably and automatically open and bend outward, and exert a stable buckling force on the medical patch;

[0025] (5) The notch groove of the medical patch fixing nail that can be automatically bent and fixed according to the present invention is preferably a V-shaped groove or a U-shaped groove arranged in a circumferential direction, which makes it easier for the bending arm to bend and deform toward one side of the V-shaped groove or the U-shaped groove. The shape design of the V-shaped groove or the U-shaped groove can further facilitate the design of the bending deformation angle of the bending arm, thereby enabling the bending arm to be better and firmly combined with the medical patch;

[0026] (6) The present invention is an automatically bent and fixed medical patch fixing nail, the implantation portion of which is a nail rod structure with a pointed head at the front end, and a barb is provided on the implantation portion. The pointed head structure facilitates the implantation portion of the fixing nail to be inserted into human tissue, and the barb design improves the firmness of the combination between the implantation portion and the human tissue, thereby preventing the fixing nail from falling off and becoming ineffective;

[0027] (7) The present invention is an automatically bending and fixing medical patch fixing nail, which is made of medical polymer materials, which is convenient for processing and manufacturing the fixing nail, and reduces the manufacturing cost of the fixing nail; and preferably uses absorbable biomaterials, which have good biocompatibility and can be degraded and absorbed by the human body, thereby reducing the foreign body sensation after tissue healing;

[0028] (8) The present invention is an automatically bending and fixing medical patch fixing nail, wherein the implantation part and the bending part are integrally injection molded, and the manufacturing is convenient and efficient. In addition, the injection mold temperature control can realize stable injection stress difference control of the bending arm, so that the bending arm has stable bending stress. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a schematic structural diagram of an automatically bent and fixed medical patch fixing nail of the present invention;

[0030] Figure 2 for Figure 1 Schematic diagram of the cross-sectional structure at AA in the middle;

[0031] Figure 3 The present invention is a schematic diagram of an automatically bent and fixed medical patch fixing nail in an open state of the bending portion.

[0032] Explanation of the symbols in the schematic diagram:

[0033] 1. implantation part; 1-1. pointed tip; 1-2. barb; 2. bending part; 2-1. bending arm; 2-2. thin wall; 3. notch groove. DETAILED DESCRIPTION

[0034] In order to further understand the content of the present invention, the present invention is described in detail in conjunction with the accompanying drawings and embodiments.

[0035] Example

[0036] Combination Figure 1 , Figure 2 and Figure 3 As shown, an automatically bent and fixed medical patch fixing nail of the present embodiment comprises an implantation part 1 and a bending part 2, wherein the bending part 2 is arranged at the tail of the implantation part 1, and the implantation part 1 and the bending part 2 preferably adopt an integrated structure with good structural stability; the implantation part 1 is preferably a nail rod structure with a pointed head 1-1 at the front end, and the implantation part 1 is provided with a barb 1-2, and the pointed head structure is used to facilitate the implantation part 1 of the fixing nail to be inserted into the human tissue, and the barb design is used to improve the firmness of the combination between the implantation part 1 and the human tissue, thereby preventing the fixing nail from falling off and failing; The folding portion 2 has at least two bending arms 2-1, and the circumferentially adjacent bending arms 2-1 are connected together toward the center through a connecting structure. The bending arms 2-1 have a bending stress that automatically opens and bends outward after the connecting structure is disconnected or detached, that is, the bending arms 2-1 have the function of opening outward after the connecting structure is disconnected or detached, so that after the fixing nail is fired, the implant part 1 is firmly combined with the human tissue, and the bending portion 2 opens to press the medical patch (such as a hernia patch, etc.), so that the medical patch is stably fixed in the human tissue.

[0037] The connection structure between the bending arms 2-1 can be implemented in a variety of ways. For example, the connection structure can be a tightening belt or a tightening ring. After the implant part 1 and the bending part 2 are made, the opened bending arms 2-1 (such as Figure 3 The bent arm 2-1 has bending stress after being gathered and has an elastic tendency to open outward. The tightening belt or tightening ring can be connected to the bent portion 2 by gluing, or no additional connection is required. When firing, the tightening belt or tightening ring can be synchronously cut or peeled off by the cutting mechanism in the instrument. After the tightening belt or tightening ring is disconnected or detached, the bent arm 2-1 can be restored under the action of the bending stress. Figure 3The bent arm 2-1 is in the open state shown. The above-mentioned tightening belt or tightening ring structure makes it easier to form the bent arm 2-1, but the subsequent binding and fixing of the bent arm 2-1 is relatively troublesome. It should be understood that the "device" referred to above has at least a nail pushing mechanism and a cutting or stripping mechanism. The nail pushing mechanism is used to push the fixing nail out and fire, and the cutting or stripping mechanism is used to cut or strip the connection structure between the bent arms 2-1. Before the nail pushing mechanism pushes the fixing nail out, the cutting or stripping mechanism will cut or strip the connection structure between the bent arms 2-1, so that after the fixing nail is fired, the bent arm 2-1 can automatically bend and open. As for the specific structural design of the above-mentioned "apparatus", it can be obtained by adopting conventional structural design according to the working principle of the above-mentioned apparatus, such as the nail pushing mechanism can adopt a push rod controlled by a handle, the push rod is slidably arranged in the push tube, and the cutting mechanism or the stripping mechanism is arranged at the tube mouth of the push tube. The cutting mechanism can be a blade corresponding to the connection structure between the bending arms 2-1. When the fixed nail is fired, the blade can cut off the connection structure between the bending arms 2-1 passing through; and the stripping mechanism can be a block corresponding to the connection structure between the bending arms 2-1. When the fixed nail is pushed out and fired, the block blocks the connection structure between the bending arms 2-1 and strips it. Multiple fixed nails can be arranged head to tail in the push tube at one time, so as to realize the continuous firing operation of the fixed nails. Therefore, as a preferred design scheme, in this embodiment, the connection structure between the bending arms 2-1 is a thin wall 2-2 provided between the circumferentially adjacent bending arms 2-1. The thin wall 2-2 is integrally formed on the bending portion 2 when the bending arms 2-1 are formed. The manufacturing is simple and convenient. When firing, only the thin wall 2-2 needs to be cut off, thereby ensuring the stability of the fixing nail firing the fixing patch. When manufacturing, an open groove can be provided in the middle of the bending portion 2 along the axial direction, and the bending portion 2 is divided into the bending arms 2-1 by the open groove. The open grooves are connected circumferentially to form a thin wall 2-2 structure, that is, if a "I"-shaped axial open groove is designed, the bending portion 2 is divided into two bending arms 2-1, and if a "*"-shaped axial open groove is designed, the bending portion 2 is divided into five bending arms 2-1, and so on. The specific design number of the bending arms 2-1 can be selected according to the material and size of the fixing nail. In order to coordinate the strength and stress deformation of the bending arm 2-1, in this embodiment, the bending portion 2 preferably has four bending arms 2-1, and the four bending arms 2-1 are connected together by a thin wall 2-2 to form a "cross" axial opening groove in the middle (such as Figure 2 As shown), four bending arms 2-1 are designed, so that the strength of each bending arm 2-1 is sufficient and the stress deformation of the bending arm 2-1 is facilitated, thereby ensuring the structural reliability and stability of the medical patch fixing nail.

[0038] In order to make the bending arm 2-1 have stable bending stress during manufacturing, in this embodiment, the following specific implementation scheme can be adopted:

[0039] Option 1: If Figure 1As shown, a notch groove 3 is provided on the outside of the root of the bending arm 2-1. Due to the reduction of the root material of the bending arm 2-1, a thin-walled structure is formed at the position of the notch groove 3, which is conducive to the bending of the bending arm 2-1 in the direction of the notch groove 3. The bending stress at the thin wall corresponding to the notch groove 3 can be achieved by the aforementioned method of gathering the bending arm 2-1 toward the center in the open state, so that the bending arm 2-1 always maintains an elastic tendency to open outward, and the bending stress is formed by the material elasticity of the bending arm 2-1 itself. At this time, due to the notch sensitivity and the elasticity of the fixing nail material itself, the bending arm can generate a stable bending stress at the notch groove 3, ensuring that the bending arm 2-1 can be stably and automatically opened and bent outward, and a stable buckling force is applied to the medical patch. The notch groove 3 can be designed as a V-shaped groove or a U-shaped groove arranged in an annular direction. The shape design of the V-shaped groove or the U-shaped groove can further facilitate the design of the bending deformation angle of the bending arm 2-1, thereby enabling the bending arm 2-1 to be better and firmly combined with the medical patch. Specifically, the outward bending angle of the bending arm 2-1 is preferably 90°, which can stably press the medical patch.

[0040] Solution 2: The medical patch fixing nail is preferably manufactured by injection molding, and the material is a medical polymer material, that is, the implant part 1 and the bending part 2 are integrally injection molded, which not only facilitates the processing and manufacturing of the fixing nail and reduces the manufacturing cost of the fixing nail, but also can utilize the injection mold temperature control to achieve stable injection stress difference control of the bending arm 2-1, so that the bending arm has a stable bending stress. That is, during the molding process of the medical patch fixing nail, the internal stress is formed inside the fixing nail by utilizing the cooling sequence of the material in the mold, such as by designing the cooling system and temperature control system in the mold, controlling the cooling speed of the inner and outer sides of the bending arm 2-1 of the fixing nail to be different, that is, controlling the cooling speed of the outer side of the bending arm 2-1 to be smaller than the cooling speed of the inner side, so that the material contraction of the outer side of the bending arm 2-1 is greater than the material contraction of the inner side, thereby causing the bending arm 2-1 to form an outwardly expanding bending stress, and after the thin wall 2-2 is cut off, the bending stress is released, and the automatic bending deformation of the bending arm 2-1 can be achieved under the action of the internal stress (the bending state of the bending arm 2-1 can be referred to Figure 3 shown).

[0041] Of course, in this embodiment, it is further preferred to combine the above-mentioned schemes 1 and 2, and use the notch sensitivity, the elasticity of the material itself and the injection stress difference to realize the bending stress control of the bending arm 2-1, so that the fixing nail can be formed by cutting the thin wall 2-2. Figure 1The state is quickly bent outward and opened, and the patch is effectively fixed. Furthermore, the medical patch fixing nail is preferably designed as an absorbable nail, that is, the above-mentioned medical polymer material is an absorbable biomaterial with good biocompatibility, which can be degraded and absorbed by the human body, reducing the foreign body sensation after tissue healing. The above-mentioned absorbable biomaterial can adopt existing medical absorbable materials, such as the absorbable biomaterial involved in "A hernia patch fixing nail and its preparation method" disclosed in Chinese patent application No. 201810214855.2, so that the medical patch fixing nail degrades slowly in the initial stage of degradation to maintain the structural strength of the fixing nail, and can be metabolized by the human body after degradation and excreted from the body.

[0042] The present invention discloses an automatically bending and fixing medical patch fixing nail, which consists of an implanting part and a bending part. The bending arm of the bending part has a bending stress that automatically opens and bends outwards. During the firing process of the fixing nail, an instrument is used to disconnect or peel off the connecting structure between adjacent bending arms, so that the bending arms are bent and tightened to tighten the medical patch, so that the medical patch is stably fixed to human tissue. In addition, the fixing nail of this structure is easy to be fired continuously by an instrument, which solves the problem that the existing medical patch fixing nails are difficult to fire continuously, further facilitates the surgical operation, shortens the operation time, and alleviates the pain of the patient, while breaking the long-term monopoly of foreign countries on medical patch fixing nails.

[0043] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which the present invention belongs. The terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0044] The present invention and its embodiments are described schematically above, which is not restrictive. The drawings show only one embodiment of the present invention, and the actual structure is not limited thereto. Therefore, if a person skilled in the art is inspired by it and creatively designs a structure and an embodiment similar to the technical solution without departing from the purpose of the invention, they shall all fall within the protection scope of the present invention.

Claims

1. An automatically bent and fixed medical patch fixing nail, characterized in that: The invention comprises an implantation part (1) and a bending part (2), wherein the bending part (2) is arranged at the tail of the implantation part (1), and the bending part (2) has at least two bending arms (2-1), and the bending arms (2-1) adjacent to each other in the circumferential direction are connected together toward the center by a connecting structure, and the bending arms (2-1) have a bending stress that automatically opens and bends outwards after the connecting structure is disconnected or detached; the connecting structure between the bending arms (2-1) is arranged circumferentially adjacent to each other. A thin wall (2-2) between adjacent bending arms (2-1), the thin wall (2-2) being integrally formed on the bending portion (2) when the bending arms (2-1) are formed, and the thin wall (2-2) is cut off when firing; a notch groove (3) is provided on the outside of the root of the bending arm (2-1); the bending portion (2) has four bending arms (2-1), and the four bending arms (2-1) are connected together through the thin wall (2-2) to form a "cross" shaped axial opening groove in the middle.

2. The automatically bending and fixing medical patch fixing nail according to claim 1, characterized in that: The notched groove (3) is a V-shaped groove or a U-shaped groove arranged in an annular direction.

3. The automatically bending and fixing medical patch fixing nail according to claim 1, characterized in that: The bending arm (2-1) is bent outward at an angle of 90°.

4. The automatically bending and fixing medical patch fixing nail according to any one of claims 1 to 3, characterized in that: The implantation part (1) is a nail rod structure having a pointed head (1-1) at the front end, and a barb (1-2) is provided on the implantation part (1).

5. The automatically bending and fixing medical patch fixing nail according to claim 4, characterized in that: The automatically bending and fixing medical patch fixing nail is made of medical polymer material.

6. The automatically bending and fixing medical patch fixing nail according to claim 5, characterized in that: The medical polymer material is an absorbable biomaterial.

7. The automatically bending and fixing medical patch fixing nail according to claim 6, characterized in that: The implantation portion (1) and the bending portion (2) are integrally injection-molded.

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