JP5087784B2 - Suture needle - Google Patents

Description

  The present invention relates to a medical suture needle, and more particularly to a silicone-coated suture needle and a method for manufacturing the same.

  There are various types of medical suturing needles depending on the application. Typical examples include a square needle and a round needle. The square needle is generally used for suturing hard tissues such as skin and muscle, and has a sharply sharpened tip and a pyramidal tapered portion. The ridgeline in this taper part becomes a cutting edge and cuts the structure. A representative example of the square needle is a triangular suture needle.

  The round needle has a trunk portion having a predetermined cross-sectional shape and a conical tapered portion formed on the tip side thereof. The cross-sectional shape of the conical taper portion and the body portion is usually circular, but there are an oval shape having two substantially parallel planes, a shape having four planes, and a drum shape. However, it is not used as a cutting blade with a sharp ridgeline like a square needle.

  The round needle punctures the tissue at the tip of the needle and then enlarges this hole at the tapered portion. However, since there is no cutting edge like a square needle, the tissue is not cut excessively. Therefore, it is possible to prevent the biological tissue of the perforated part from being in close contact with the surface of the thread and leaking body fluid from the sutured part. Because of these characteristics, round needles are mainly used for sutures of blood vessels and soft tissues.

  Whether a round needle or a square needle such as a triangular needle is used, the suture needle is pierced into the patient's living tissue, and the greater the piercing resistance, the greater the pain given to the patient. For this reason, processing for lowering the piercing resistance is performed. In general, silicone is applied as a method of reducing the piercing resistance. As a method of application, a suture needle is put apart in a basket and immersed in a silicone solution. In this case, the silicone is applied to the entire surface of the suture needle.

  As described above, when the suture needle having the entire surface coated with silicone is pierced through the living tissue, the entire portion piercing the living tissue is in close contact with the living tissue. Although the frictional resistance between the silicone and the living tissue is small, if the entire periphery of the suture needle is in close contact, the resistance becomes considerable.

  Therefore, Patent Document 1 (Japanese Patent Application Laid-Open No. 11-701113) proposes forming an uneven surface along the axial direction in the tapered portion at the tip of the round needle. With such a configuration, when the suture needle pierces the living tissue, the concave portion does not come into contact with the living tissue, so that the piercing resistance can be lowered.

Patent Document 1 also proposes applying silicone from above the uneven surface. By applying silicone, the piercing resistance can be further reduced.
JP-A-11-70113

  However, the uneven surface of Patent Document 1 is difficult to apply to square needles such as triangular needles. This is because when forming the uneven surface, the ridge line is also ground, and the cutting edge becomes dull, making it difficult to achieve both the uneven surface and the cutting edge. Further, the depth of the concavo-convex surface is about 40 μm, and when the thickness of the silicone coating layer is more than this, the concavo-convex surface is buried and becomes the same as a flat surface, and the same problem as described above occurs.

  The present invention solves such a problem, and an object of the present invention is to provide a needle that can reduce the piercing resistance of all suture needles, whether round needles or square needles.

  In order to achieve the above object, the suturing needle of the present invention is characterized in that silicone is applied on the surface of the suturing needle at an appropriate interval so that a striped or patchy raised portion exists.

  The silicone is configured to have high adhesion to the metal forming the suture needle, or the silicone is applied and dried, and then the silicone needle is applied to the entire suture needle. be able to.

  Also, after applying a mixture of silicones with different properties and applying them, each silicone is separated and / or dispersed and dried, or a mixture of silicones with different properties is applied and applied. Thereafter, each of the silicones can be dried in a combined state of separated, separated and / or dispersed states.

  The silicone is configured to be a silicone that has high adhesion with the metal forming the suture needle and is easy to cure, or after applying and drying silicone that has high adhesion with the metal and is easy to cure, It is possible to employ a configuration in which silicone having low adhesiveness is hard to be cured and high lubricity is applied.

  In addition, the silicones having different properties have high adhesion with the metal forming the suture needle, and the adhesion between the silicone that is easy to cure and the metal that forms the suture needle is low and difficult to cure, and the lubricity is high. In combination with silicone, or in the case where the concentration is the same, the adhesive force with the metal forming the suture needle is low and hard to cure, and the volume fraction of silicone with high lubricity is formed into the suture needle. It can also be mixed at a ratio higher than the volume ratio of silicone that has high adhesion to metal and is easy to cure.

  In the suturing needle of the present invention, since silicone is applied in a striped or patchy manner, when the suturing needle pierces the living tissue, the living tissue and the suturing needle come into contact with each other at the portion where the silicone is applied. The contact area can be reduced, the piercing resistance can be reduced, and the burden on the patient can be reduced.

  By making the silicone to be applied in a striped or patchy pattern with strong adhesion to the metal of the suture needle, the life of the suture needle can be extended. The puncture resistance can be further reduced by applying a silicone having excellent lubricity after applying a silicone having a strong adhesion to metal.

  When two types of silicones with different properties are mixed and applied to the suture needle, the two types of silicone are separated and / or dispersed after application, or the combination and the separated and / or dispersed state are combined. Solidify in a wet state. The effect similar to the above can be obtained by making one silicone strong in adhesion to metal and making the other excellent in lubricity. By mixing a large volume ratio of silicone that has high lubricity and low adhesion and is hard to cure, it is possible to provide an extra portion that does not bind to the silicone polymer that has high adhesion and is easy to cure. Can be.

  Embodiments of the present invention will be described below with reference to the accompanying drawings.

  FIG. 1 is a perspective view of a triangular suture needle 10 which is an example of the suture needle of the present invention and is a typical square needle. FIG. 2 is an enlarged view of a part of FIG. The triangular suture needle 10 has a curved shape as a whole, and a base 13 having a circular cross section is connected to a triangular pyramid 12 having a sharp tip 11 as a vertex. A hole 14 is formed in the base 13 along the axial direction from the end surface. A suture thread (not shown) is inserted into the hole 14, and the outside of the hole 14 is crimped to fix the suture thread. The ridgeline 12a of the triangular pyramid 12 is a cutting edge. Although there are three ridge lines 12a, there are cases where all of these are used as cutting edges and cases where only a part of the ridge lines 12a are used as cutting edges, which are determined depending on the application.

  A method for manufacturing the triangular suture needle 10 will be briefly described. As the material, austenitic stainless steel is used. Since austenitic stainless steel cannot be hardened, the crystal structure is made fiber-like by repeatedly performing cold drawing, and a desired hardness is obtained by work hardening.

  A round bar-like wire having a desired diameter and hardness by drawing is cut to a desired length. The tip portion of this material is formed into a triangular prism shape by pressing or cutting. A hole 14 is formed in the base 13 by laser processing or drilling. Next, the triangular prism portion is ground to form a triangular pyramid portion 12 having a sharp tip. After that, a bending process is performed and a polishing process is performed.

  Thereafter, a silicone coating is applied. The present invention is characterized by this coating method. Conventional coating is performed by immersing the suture needle in a silicone solution or spraying it with a spray. In either case, the silicone is applied to the entire surface of the suture needle.

  On the other hand, in this invention, as shown in FIG.1 and FIG.2, the silicone 15 is apply | coated so that an appropriate space | interval may be opened and an island-like bulge part may exist. There are several methods as such an application method.

  The first is a spray coating method. In this case, the diameter of the silicone particles fired by the spray gun is set to about several tens of μm, and the spraying time is shortened so that the silicone is not applied to the entire suture needle. At this time, a configuration in which a thin portion and a thick portion of silicone repeatedly exist, a portion where silicone exists and a portion where silicone does not exist repeatedly exists, or both of them can be mixed.

  The second method is a masking method. There are also two types of masking methods. One is a method in which a masking tape having a hole is attached to a suture needle and silicone is applied by spraying or the like. The masking tape is made of a material that does not easily adhere to silicone. The second method is a method in which a resist pattern to which silicone does not adhere is printed on a suture needle, and the resist to which silicone is not attached is removed by chemical treatment after silicone application.

  The silicone to be applied is a metal constituting the triangular suture needle 10, which is stainless steel in this embodiment, but preferably has a high adhesion with the metal. Examples of such silicone include MED-4159, MED-4161, and MED1-4161 manufactured by Nusil Technology.

  The reason why it is desirable to have a high adhesive force is that the silicone 15 is distributed in various ways on the surface of the triangular suture needle 10, but when passing through the biological tissue at the time of suturing, the silicone 15 receives a peeling force due to friction with the biological tissue. Because.

  FIG. 3 is a cross-sectional view showing a state in which the triangular pyramid portion 12 passes through the living tissue 20. Around the triangular pyramid portion 12 of the triangular suture needle 10, there are various portions where the silicone 15 is applied and portions where the silicone 15 is not applied. When such a triangular suture needle 10 pierces the biological tissue 20, the surface 21 of the biological tissue 20 can be formed into a portion that contacts the silicone 15 and a portion that is separated from the triangular pyramid portion 12. The separated part has no frictional resistance, and the area in contact with the silicone 15 is smaller than the surface area of the triangular pyramid part 12, so that the piercing resistance is reduced and the burden on the patient can be reduced.

  Immediately after being applied, the silicone 15 was also present on the ridge line 12a serving as a cutting edge. However, when the living tissue 20 is cut open by the ridge line 12a, the silicone 15 in this portion is also cut open together with the living tissue 20, so that it is almost eliminated from above the ridge line 12a after being used once.

  FIG. 4 is a cross-sectional view of a state in which the base 13 having a circular cross section passes through the living tissue 20. The base 13 does not cut through the living tissue 20 but simply passes through. By applying the silicone 15 to the base 13 in an island shape, the contact area between the base 13 and the living tissue 20 when passing can be reduced, and the passage resistance can be reduced.

  In the above embodiment, the application portion of the silicone 15 is formed in a patch shape, but in FIG. 5, it is formed in a horizontal stripe so as to be orthogonal to the axial direction of the triangular suture needle 10. Moreover, in FIG. 6, it forms in the vertical stripe along the axial direction of the suture needle. In the case of the vertical stripes in FIG. 6, the piercing resistance is lowered as described with reference to FIGS. In the case of FIG. 5, since it goes around along the circumference of the triangular suture needle 10, the puncture resistance is not lowered only by the silicone 15 portion. However, when the triangular suture needle 10 passes through the living tissue 20, several horizontal stripes are present in the living tissue 20. If it does so, since the biological tissue 20 and the triangular suture needle 10 will not contact between the stripes of the silicone 15, the piercing resistance can be reduced.

  In FIG. 5, horizontal stripes orthogonal to the axial direction of the triangular suture needle 10 are used. However, it is sufficient that a stripe pattern is formed, and they may intersect with the axial direction at an angle other than a right angle. In addition, when the silicone 15 is applied in a spiral shape, it is included in the striped pattern here.

  FIG. 7 is a diagram showing another embodiment of the present invention. FIG. 8 is a sectional view of the base 13 of the triangular suture needle 10 of FIG. In this embodiment, after the silicone 15 having high adhesion to the metal forming the suture needle is applied, another silicone 17 is applied to the entire suture needle. Silicone 17 has low adhesion to metal and high lubricity. Examples thereof include MED-360, MED-361, MED-420, and MED-4162 manufactured by Nusil Technology.

  The silicone 17 applied later is also applied onto the previously applied silicone 15. However, when the triangular suture needle 10 is first used, the silicone 17 on the silicone 15 is peeled off. Therefore, the surface of the second and subsequent triangular suture needles 10 is divided into a portion covered with silicone 15 and a portion covered with silicone 17, as shown in FIGS. It should be noted that a portion not covered by either silicone 15 or silicone 17 may be formed.

  The application method of the silicone 17 having high lubricity to be applied later may be a spray method or may be immersed in a silicone solution. Further, the thickness of the silicone 15 and silicone 17 coating layer is preferably such that the silicone 15 is thicker from the viewpoint of reducing the contact surface with the living tissue 20.

  When the triangular suture needle 10 to which the silicone 15 having a high adhesive force and the silicone 17 rich in lubricity are applied penetrates the living tissue 20, the living tissue comes into contact with the silicone 15 and a part of the silicone 17. . Even when the silicone 17 is not applied, the living tissue 20 and the surface of the triangular suture needle 10 may be in direct contact with each other, and the piercing resistance may not be sufficiently reduced. On the other hand, when the silicone 17 is applied, even if a part of the silicone 17 and the living tissue 20 come into contact with each other, the lubricity of the silicone 17 is high, so that the piercing resistance can be lowered. Further, when the body tissue 20 is pierced, the silicone 15 does not peel off due to its strong adhesion, but the silicone 17 peels off little by little by this contact. Such easy peeling also causes a reduction in piercing resistance.

  As another method which can be applied in the same manner as in FIG. 7, there is a method in which a mixture of two types of silicones A and B having different properties is applied by spraying or the like. The two types of silicone applied are separated, dispersed and bonded due to the difference in properties, and then dried and cured. Here, the separation means a state where island-like swelled portions where the silicone of A is cured and island-like swelled portions where the silicone of B is cured are scattered. Dispersion refers to a state in which A and B silicone island-like bulges are approximately the same size and A and B are evenly mixed. One of A and B silicones is the ground, and the other A and B silicones are scattered in the form of islands in the ground, or the surface of the suture needle is covered with the A and B silicones dispersed. Including the state in which the exposed portion disappears. The bond means a state in which A and B silicones are partly chemically bonded. In the present invention, the two types of silicone applied are in a separated and / or dispersed state, or a combination of bonding and separated and / or dispersed state.

  As silicones having different properties, a combination of high and low adhesive strength with the suture needle, or a combination of those that are easy to harden and those that are hard to harden is desirable. A combination of silicone having both a low adhesion property and a property that is difficult to cure is desirable.

  Examples of silicones that have high adhesion to the metal of the suture needle and are easy to cure include Nusil Technology's MED-4159, MED-4161, and MED1-4161.

  Examples of silicones that have excellent lubricity and have low adhesion to the metal of the suture needle and are hard to cure include MED-4162, MED360, MED-361, and MED-420 from Nusil Technology.

  Two kinds of silicones having different properties were mixed in a liquid state with the same concentration, and the volume ratio was a ratio of silicone having high adhesion power 1 to silicone 4 having low adhesion power, and the mixture was stirred and mixed and applied to the suture needle by spraying. . The silicone applied on the triangular suture needle 10 is separated and dispersed on the triangular suture needle 10, and the surface of the triangular suture needle 10 is easily cured and has high adhesion to the metal of the suture needle 15, and these The islands of the silicone 17 bonded to the polymer were separated from the silicone 17 which was hard to cure and filled between them, had excellent lubricity, and had low adhesion to the metal of the suture needle, and cured. After application and drying, a suture needle as shown in FIGS. 7 and 8 was obtained. Drying is preferably performed at 100 ° C to 300 ° C, preferably 150 ° C to 250 ° C.

  In the above embodiment, the triangular suture needle has been described as the suture needle. However, the present invention can also be applied to a round needle or a polygonal suture needle other than a triangle.

It is an example of the suture needle | hook of this invention, and is a perspective view of the triangular suture needle | hook which is one of the square needles. It is the figure which expanded a part of FIG. It is sectional drawing which shows the state which the triangular pyramid part has passed through the biological tissue. It is sectional drawing of the state in which the base which made the circular cross section passes biological tissue. This is an example in which silicone is applied in a horizontal stripe shape. This is an example in which silicone is applied in the form of vertical stripes. It is a figure which shows another Example of this invention. It is sectional drawing of the base of the suture needle | hook of FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Triangular suture needle 11 Tip 12 Triangular pyramid part 12a Ridge line 13 Base part 14 Hole 15 Silicone 17 (Strong adhesion with metal) Silicone 17 (Excellent lubricity) Silicone 20 Biological tissue

Claims (3)

A suturing needle characterized in that silicone is applied on the surface of the suturing needle so that there is a striped or patchy bulge formed by silicone at an appropriate interval. The striped or strip-like raised portion is formed by applying a mixture of silicones having different properties, and applying and then drying in a separated and / or dispersed state for each silicone. The suturing needle according to claim 1 . After applying and applying a mixture of silicones having different properties, the striped or strip-like raised portions are combined in a combined state, separated state and / or dispersed state for each silicone. The suture needle according to claim 1, wherein the suture needle is formed by drying in the applied state.

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