JPH0556983A - Square suturing needle and production thereof - Google Patents

Abstract

PURPOSE:To improve cutting quality and to prevent giving pains to a patient by forming the grain of the direction intersecting approximately orthogonally with the central axis of the square suturing needle and the grain of the direction along the central axis on the surface constituting the cutting edge of the square suturing needle. CONSTITUTION:The horizontal grain 8 of the direction intersecting approximately orthogonally with the central axis of the square needle and the vertical grain 9 of the direction along the central axis are formed on the surface 2 constituting the cutting edge 3. The horizontal grain 8 and the vertical grain 9 are formed as microgrooves several mum to several tens mum depth. Many pieces of microruggedness 10a, 10b are formed on the surface 2 by the horizontal grain 8 and the vertical grain 9. Slight spacings are, therefore, formed between the biotissue and recessed parts 10a even if the botissue cut by the cutting edge 3 come into pressurized contact with the surface 2 when such square needle is passed into the biotissue. The biotissue is thus prevented from coming into tight contact with the surface 2 over the entire surface thereof. The friction resistance between the biotissue and the square needle is decreased in this way and the operator's feel of cutting is improved.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a square suture needle having a cutting blade and a method for manufacturing the square suture needle.

[0002]

BACKGROUND OF THE INVENTION As a surgical suturing needle, a suturing needle called a taper point type or a round needle having a circular cross section and a sharp needle tip, a triangular cross section or a polygonal shape having a sharper tip, and a sharp tip, A suture needle called a cutting edge type or a square suture needle in which cutting edges are formed on at least two ridges of a polygon is used. The round needle pierces the biological tissue with the needle tip and pushes the pierced hole with the body to suture, and the square suture needle pierces the biological tissue with the needle tip and the pierced hole. Is to be opened with a cutting blade and sewn.

Here, a method for manufacturing the above-mentioned square suture needle will be briefly described. First, a stainless wire having a thickness and length corresponding to the thickness and length of the target square suture needle is pressed or ground at one end, and a blind hole for attaching a suture thread at the other end or The material for the square suture needle is formed by forming the through hole. Next, the tip side surface of the raw material is ground in the longitudinal direction along the central axis of the raw material to form a cutting blade and a needle tip. Further, the material having the cutting blades is bent into a predetermined shape and surface-treated to complete a target square suture needle. In the square suture needle manufactured by the above method, a grind in a direction along the central axis of the square suture needle is formed on the surface forming the cutting blade, and burrs are often attached to the cutting blade. Therefore, chemical polishing or electrolytic polishing is generally performed for the purpose of finishing the ground surface to a mirror surface and removing burrs adhering to the cutting edge. However, even if a plurality of materials are ground under the same conditions, the burrs attached to the cutting edges are not always the same. Therefore, when polishing is performed under the same conditions, Generally, the attachment state of burrs is different in the square suture needle. When performing a suturing operation using such a square suture needle, when the square suture needle is passed through the living tissue, the tissue comes into contact with the entire ground surface to generate a large friction resistance, and There is a problem that the part adheres to the burr and the sharpness is reduced quickly, which gives the practitioner an impression that the piercing property and the sharpness are poor, and causes pain to the patient.

In order to solve the above problem, the applicant of the present invention grinds the surface constituting the cutting blade substantially at right angles to the central axis of the rectangular suture needle, thereby having a uniform shape and less burr adhesion. We have developed a suture needle with a blade and have already applied for a patent (Japanese Patent Application No. 2-260600). According to this suture needle with a blade, a uniform sharpness can be exhibited, and the patient is less in pain.

[0005]

However, even with the above-mentioned suture needle with a blade, the frictional resistance between the tissue and the suture needle during passage of living tissue is large, and the sharpness of the practitioner is further improved. Is required.

An object of the present invention is to further develop the technique of the above-mentioned Japanese Patent Application No. 2-260600, to provide a square suture needle which improves sharpness and which does not cause patient's pain, and the square suture needle It is intended to provide a manufacturing method.

[0007]

In order to solve the above problems, a square suture needle according to the present invention is a square suture needle having a cutting blade, and a central axis of the square suture needle on a surface forming the cutting blade. The eye is formed in the direction substantially orthogonal to the above and the eye in the direction along the central axis is formed. In the square suture needle, it is preferable to form a silicone coating layer on the surface constituting the cutting blade.

The method for manufacturing a square suture needle is such that a material for a square suture needle is formed using an austenitic stainless steel material obtained by cold drawing and stretching a tissue into a fiber shape, and the cutting blade of the material is used. The surface to be formed is ground in a direction substantially orthogonal to the central axis to form a cutting edge, and the surface forming the cutting edge is formed with an eye in a direction substantially perpendicular to the central axis of the rectangular suture needle, and the material is It is characterized in that the boundary of the fibrous tissue is etched by performing electrolytic polishing treatment or chemical polishing treatment to form an eye in the direction along the central axis of the rectangular suture needle on the surface constituting the cutting blade. ..

[0009]

According to the above-mentioned square suture needle (hereinafter referred to as "square needle"), it is possible to reduce the frictional resistance between the square needle and the living tissue and improve the sharpness. That is, by forming eyes in a direction substantially orthogonal to the central axis of the square needle and eyes in the direction along the central axis on the surface forming the cutting edge of the square needle, a large number of minute irregularities are formed on the surface. Can be formed. Therefore, when the square needle passes through the living tissue, even if the tissue contracts and comes into close contact with the surface of the square needle, a minute space is formed between them, which The friction resistance can be reduced. Further, when the silicone coating layer is formed on the surface forming the cutting edge, it is possible to reduce the frictional resistance when the square needle passes through the living tissue. The silicone filled in the large number of recesses formed on the surface forming the cutting edge does not come into direct contact with the tissue when the square needle passes through the living tissue, and therefore, from the surface forming the cutting edge. Does not peel off. Therefore, the durability of the square needle can be improved.

According to the method for manufacturing the square suture needle, the square needle having the eyes in the direction substantially orthogonal to the central axis and the eyes in the direction along the central axis on the surface constituting the cutting blade can be easily manufactured. You can do it. That is, an austenitic stainless steel material that has been subjected to cold wire drawing and has its structure elongated into a fiber shape is used, and by pressing or grinding this material, a material corresponding to the target square needle is formed. ..
Then, by grinding the surface of the material forming the cutting edge in a direction substantially orthogonal to the central axis, the cutting edge is formed and an eye in the direction substantially orthogonal to the central axis of the square needle (hereinafter referred to as "Sideways'). When the material is subjected to electrolytic polishing treatment or chemical polishing treatment, the boundaries (grain boundaries) of the fibrous tissue are etched, and the surface forming the cutting edge has an eye in the direction along the central axis of the square suture needle (hereinafter referred to as " Vertical lines ”). Therefore, the horizontal grain can be formed by grinding the raw material and the vertical grain can be formed by the electrolytic polishing treatment or the chemical polishing treatment regardless of the context in the manufacturing process.

[0011]

EXAMPLE An example of the square needle will be described below with reference to the drawings, and a method of manufacturing the same will also be described. FIG. 1 is a perspective view showing the overall configuration of a square needle, FIG. 2 is an enlarged view of a needle tip portion of the square needle, and FIG. 3 is a cross-sectional view including a cutting blade and taken in a direction orthogonal to the central axis of the square needle. The square needle according to the present invention makes it possible to reduce frictional resistance when passing through the living tissue by forming the horizontal stitches and the vertical stitches on the surface forming the cutting blade. Moreover, the manufacturing method according to the present invention enables the square needle to be manufactured reasonably and easily.

First, the structure of the square needle A will be described with reference to FIGS. In the figure, the square needle A is configured as a triangular needle having a predetermined curved shape. One end of the square needle A is configured as a needle tip 1. Three surfaces 2 (2a, 2b) are formed from the needle tip 1, and a cutting edge 3 is formed on a ridge line where these surfaces 2 intersect. That is, surface 2 is
It has a function as a surface constituting the cutting edge 3.
Any of the ridge lines can be given a function as the cutting edge 3. Further, which of the three ridges is given the function as the cutting edge 3 is determined by what kind of suture site the square needle A is applied to. In this embodiment, the cutting edge 3 having a predetermined length is formed on the two ridge lines formed on both sides of the surface 2a on the inner side of the curve, and the ridge line 4 continuous with the cutting edge 3 has a function as a cutting edge. Without being formed, it is formed as a ridge line for maintaining the triangular shape of the square needle A. The ridgeline formed by intersecting the surfaces 2b on the outside of the curve is formed as a ridge 5 that does not function as a cutting edge. The cutting edge 3
The length of each has different dimensions depending on the function of the square needle A. The other end of the square needle A is configured as a base end surface 6,
A blind hole 7 for attaching a suture (not shown) is formed in the base end surface 6.

As shown in FIG. 2, the surface 2 forming the cutting edge 3
A lateral eye 8 in a direction substantially orthogonal to the central axis of the square needle A and a longitudinal eye 9 in a direction along the central axis are formed in the. The horizontal stitches 8 and the vertical stitches 9 are formed as minute grooves having a depth of several μm to several tens of μm. The horizontal stitches 8 and the vertical stitches 9 may be continuous long grooves or intermittent short grooves.
Further, the horizontal stitches 8 and the vertical stitches 9 are not necessarily formed in parallel, and the individual horizontal stitches 8 or the vertical stitches 9 may intersect with each other. As shown in FIG. 3B, the surface 2 has a large number of minute unevennesses 10a and 10b formed by the horizontal stitches 8 and the vertical stitches 9. Therefore, when the square needle A is passed through the living tissue during the suturing operation, even if the living tissue cut by the cutting blade 3 is pressure-bonded to the surface 2 of the square needle A, the space between the tissue and the recess 10a is reduced. A small gap is formed in the surface of the living body so that the living tissue does not adhere to the entire surface 2. Therefore, the frictional resistance between the living tissue and the square needle A can be reduced, and the practitioner's sharpness can be improved.

FIG. 4 is a partially enlarged sectional view of the surface 2 on which the silicone coating layer 11 is formed by subjecting the square needle A to a silicone coating treatment. As shown in the figure, the silicone coating layer 11 has side lines 8 of the surface 2,
It is formed in a state of being filled in the minute concave portion 10a composed of the vertical lines 9. In the case of the square needle A having the silicone coating layer 11 formed in the recess 10a as described above, the silicone coating layer 11 formed in the recess 10a is not removed even when the square needle A is passed through the living tissue when performing the suturing operation. There is little direct contact with living tissue, and there is little risk of peeling from the surface 2 of the square needle A. Therefore, it is possible to further reduce the frictional resistance between the square needle A and the living tissue and to maintain the reduction effect for a long time. Therefore, the sharpness of the practitioner can be improved and the piercing property and sharpness of the square needle A can be maintained.

Next, a method of manufacturing the square needle A will be described. FIG. 5 is a flowchart showing the manufacturing process. As a suture needle used for suture surgery, thickness 0.027m
It is standardized with dimensions ranging from m to 1.40 mm and lengths from 5 mm to 65 mm. However, with the diversification and miniaturization of surgery, thinner and shorter suture needles are now required. The material of the suture needle is generally stainless steel from the viewpoint of rust resistance, strength, bending resistance, and the like. There are various types of stainless steel, such as austenitic stainless steel, martensitic stainless steel, and precipitation hardening stainless steel, which have their own unique characteristics. Among them, martensitic stainless steel, which can be expected to be hardened by quenching, is often used. However, martensitic stainless steel cannot be expected to have a high degree of rust prevention. In the square needle A according to the present invention, an austenitic stainless steel wire having an excellent rust preventive property is subjected to cold drawing to work-harden the wire and to extend the structure into a fiber.

In the drawing, in the cold drawing step 21, an austenitic stainless steel wire having a normal metallographic structure (normal crystal grains) is cold-drawn at a preset working rate (area reduction rate). This is a process of performing a pulling process. Here, the preset working rate refers to the working rate at which the properties such as hardness and bending resistance of the cold drawn wire are the most suitable values for the suturing needle, and are obtained as a result of various experiments. It is a value. Therefore, in the cold wire drawing step 21, the square needle A having the normal metallographic structure and the target is used.
Select an austenitic stainless steel wire having a thickness calculated from the thickness and the preset working rate. Then, the selected stainless steel wire is subjected to cold drawing to reduce the thickness to a thickness approximately equal to the thickness of the target square needle A, and at the same time, extend the metal structure of the wire into a fiber shape.
In the cold drawing, a die is used to draw an austenitic stainless steel wire in the longitudinal direction, that is, the central axis direction. Therefore, the metallographic structure of the cold-drawn wire is elongated along the central axis direction as shown in FIG.

The forming step 22 is a step of forming the material of the square needle A. In the forming step 22, as shown in FIG. 7, the line reduced in thickness to the thickness of the target square needle A in the cold drawing step 21 is cut according to the length of the target square needle A. Then, the straight needle-shaped material 12 is formed. Then, attach one end of the material 12 to the square needle A.
A blind hole 7 is formed as a base end surface 6 of the above, and the other end is formed into a triangle by pressing or grinding a predetermined length portion as a tip 1 of a square needle A. By going through the molding process 22,
The raw material 12 is formed with a needle tip 1, a surface 2, a cutting edge 3, a ridge line 4, and a portion serving as a base of the ridge 5, respectively.

The horizontal grinding step 23 is a step of forming the needle tip 1 and the cutting edge 3 by grinding the raw material 12 in which the part which is the origin of the square needle A in the forming step 22 is formed. In the lateral grinding step 23, as shown in FIG. 8, the abrasive grains 13b are attached to the flexible base sheet 13a.
As a result, a grinding sheet 13 constituted by adhering white alundum having a particle size of 4 μm to 14 μm is reciprocally transferred in the arrow direction, and a surface formed on the material 12 from a direction substantially orthogonal to the transfer direction of the grinding sheet 13. Press 2 to grind. By sequentially grinding the surfaces 2a and 2b formed on the material 12, the needle tip 1 is formed at the tip of the material 12 and the surfaces 2a and 2b are formed.
The cutting edge 3 is formed on the edge where 2b intersects, and the surface 2a,
It is possible to form the cross stitch 8 composed of a ground stitch on the 2b. In the side lines 8 formed on the surfaces 2a and 2b as described above, the depth of the recess 10a is the grain size of the abrasive grains 13b and the grinding sheet.
It can be set by adjusting the pressing force of the material 12 against the material 13. Further, by grinding the material 12 in a direction substantially orthogonal to the central axis, minute burrs may be attached to the cutting edge 3 formed at the edge where the surfaces 2a and 2b intersect.

The bending step 24 is a step of imparting a bending shape corresponding to the target square needle A to the material 12 on which functional portions such as the needle tip 1 and the cutting edge 2 are formed. In the bending step 24, the blind point 7 formed in the base end surface 6 of the material 12 is not deformed and the needle tip 1
Bending is performed from a side over a predetermined length range. This bending work can be performed by a known method such as press work using a bending piece or press work using male and female dies.

In the polishing treatment step 25, a chemical polishing treatment or an electrolytic polishing treatment is selectively carried out so that the surface 12 of the raw material 12 is subjected to the raw material 12 treatment.
Forming a vertical line 9 along the central axis direction of the cutting edge 3
This is a step of removing burrs adhering to the. In the polishing process 25, the material 12 bent into the predetermined shape in the bending process 24 is immersed in a polishing liquid to perform the polishing process. When the material 12 is polished, the surface of the material 12, especially the grain boundaries of the fibrous metal structure are etched. Therefore, on the surfaces 2a and 2b of the material 12, grain lines 9 are formed along the grain boundaries of the metal structure.
Is formed. The wales 9 are not necessarily parallel to the central axis of the material 12, but are formed in the direction along the central axis. Material 12
The depth of the kerfs 9 formed on the surfaces 2a, 2b is set to a desired value by adjusting the processing conditions such as the concentration of the processing liquid, the processing time, the processing temperature, and the energization amount in the polishing processing. It is possible. Further, as described above, it is possible to remove burrs adhering to the cutting edge 3 in the process of forming the vertical lines 9 on the surfaces 2a, 2b of the material 12.

The washing / drying step 26 is a step of washing the polishing liquid adhering to the surface of the material 12 to stop the progress of etching. In the washing / drying step 26, the material 12 that has been subjected to the polishing treatment step 25 is neutralized and washed with water, and then natural drying or forced drying with hot air is performed. As a result, the polishing liquid adhering to the surface of the material 12 is washed and etching does not proceed. By passing through the above steps 21 to 26, the straight needle-shaped material 12 is formed with the needle tip 1, the cutting edge 3, the ridge 5, and the blind hole 7, and is bent into a predetermined shape. , Face 2
Horizontal stitches 8 and vertical stitches 9 are formed on a and 2b, and the square needle A shown in FIG. 1 is manufactured. Therefore, the square needle A that has undergone the washing / drying step 26 is subjected to a product inspection in the inspection step 28, and a product that has passed the inspection is a product of the square needle A.

The coating step 27 is a step of applying a silicone coating to the surface of the square needle A. In the coating step 27, the square needle A that has been subjected to the washing / drying step 26 is immersed in a silicone solution, and the square needle A taken out of the silicone solution is naturally dried or forcedly dried, whereby the surface of the square needle A is coated with a silicone coating layer. Forming 11. Therefore, the silicone coating layer 11 includes the surface 2a of the square needle A,
It is formed over the entire surface of the concave portion 10a and the convex portion 10b formed on 2b.

The inspection step 28 is a step of inspecting the performance and the like of the square needle A. In the inspection step 28, a functional inspection such as piercing of the square needle A and a visual inspection such as a scratch on the surface and sagging of the cutting edge 3 are performed. Then, the square needle A that has passed the inspection process 28 is shipped as a product.

In the above-mentioned embodiment, the structure for attaching the suture thread to the square needle A has been described as the so-called eyeless needle in which the blind hole 7 is formed in the base end face 6, but the structure is not limited to this structure, and the suture needle is not limited thereto. Needless to say, it may be a so-called eye needle in which a hole column having a spring property is formed at the end of the.

[0025]

As described in detail above, according to the rectangular suture needle of the present invention, the surface of the cutting blade extends in a direction substantially orthogonal to the central axis of the rectangular suture needle, and along the central axis. Since the eyes in the different directions are formed, it is possible to improve the sharpness by reducing the frictional resistance between the rectangular suture needle and the living tissue during the suturing operation. Further, when the silicone coating layer is formed on the surface forming the cutting edge, it is possible to reduce the frictional resistance when the square suture needle passes through the living tissue,
In addition, durability can be improved.

According to the method for manufacturing a square suture needle of the present invention, a square needle having eyes in a direction substantially perpendicular to the central axis and eyes in the direction along the central axis is formed on the surface constituting the cutting blade. It has characteristics such that it can be easily manufactured.

[Brief description of drawings]

FIG. 1 is a perspective view showing the overall configuration of a square needle.

FIG. 2 is an enlarged view of a needle tip portion of a square needle.

FIG. 3 is a cross-sectional view in a direction including a cutting edge and orthogonal to a central axis of a square needle.

FIG. 4 is a partially enlarged cross-sectional view of a surface on which a silicone coating layer is formed.

FIG. 5 is a flowchart showing a manufacturing process.

FIG. 6 is an enlarged view of a stretched metallographic structure.

FIG. 7 is a perspective view of a material formed in a forming process.

FIG. 8 is a perspective view at the time of laterally grinding a material.

[Explanation of symbols]

A is a square needle, 1 is a needle tip, 2, 2a and 2b are faces, 3 is a cutting edge,
4 is a ridge line, 5 is a ridge, 6 is a front end face, 7 is a blind hole, 8 is a side grain,
9 is a vertical grain, 10a is a concave portion, 10b is a convex portion, 11 is a silicone coating layer, 12 is a material, 13 is a grinding sheet, 21 is a cold drawing step, 22 is a forming step, 23 is a lateral grinding step, and 24 is Bending process, 25 is polishing process, 26 is washing and drying process, 27 is coating process, and 28 is inspection process.

Claims (3)

[Claims] 1. A square suture needle having a cutting blade, wherein a surface forming the cutting blade is formed with an eye in a direction substantially orthogonal to a central axis of the rectangular suture needle and an eye in a direction along the central axis. A square suture needle characterized in that 2. The square suture needle according to claim 1, wherein a silicone coating layer is formed on a surface constituting the cutting blade. 3. A material for a square suture needle is formed by using an austenitic stainless steel material obtained by cold drawing to elongate a tissue into a fiber shape, and the surface constituting the cutting edge of the material is used as a central axis. On the other hand, a cutting blade is formed by grinding in a direction substantially orthogonal to the cutting edge, and an eye in a direction substantially perpendicular to the central axis of the rectangular suture needle is formed on the surface forming the cutting blade, and the material is electrolytically polished or chemically polished. The method for producing a rectangular suture needle, characterized in that the boundary of the fibrous tissue is etched by applying the step to form an eye in the direction along the central axis of the rectangular suture needle on the surface constituting the cutting blade.