Medical suture needles

Abstract

Conventional surgical needles had low bending strength. [Solution] The object of the present invention is to provide a curved medical suture needle having a needle tip portion having a needle tip for piercing tissue, a shaft portion following the needle tip portion, and a base portion following the shaft portion having the function of connecting suture thread, wherein the shaft portion comprises at least one base surface and at least one non-glare surface, the non-glare surface comprises a plurality of recesses, and the at least one base surface is provided on the curved surface of the shaft portion.

Description

Technical Field

[0001] The present invention relates to a medical suture needle, particularly a medical suture needle having a non-reflective surface on a body portion to be gripped by a needle holder during surgery.

Background Art

[0002] A medical suture needle is composed of a needle tip portion for piercing tissue, a base portion for attaching a suture thread, and a body portion between the needle tip portion and the base portion. Then, the medical suture needle is gripped by a needle holder, and a suturing operation is performed by operating this needle holder.

[0003] When gripping a medical suture needle with a needle holder, if the needle tip portion or the base portion is gripped, there may be problems such as the medical suture needle being damaged, the piercing property being impaired, and the operability being poor, the problem of a decrease in strength against bending, and further the problem that the suture thread detaches and the suturing operation becomes impossible. Therefore, it is necessary to securely grip the body portion formed between the needle tip portion and the base portion.

[0004] Patent Document 1 discloses a surgical needle having a textured profile side surface including a plurality of depressions.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0006] However, since the surgical needle disclosed in Patent Document 1 has indentations 26 from the distal end 52 to the side surface 32, it becomes a starting point for breakage against the stress that is likely to be applied during needle manipulation, and the strength against bending is low.

[0007] The inventors have revealed that when multiple indentations are present on the tip and contour of a surgical needle in a side view, the sharpness and bending strength of the surgical needle are reduced. The inventors have succeeded in improving the sharpness and bending strength of a surgical needle by creating a region between the side surface and the curved surface of the surgical needle in a side view of the tip and shank, thereby completing the present invention. [Means for solving the problem]

[0008] [1] The objective of the present invention is, A needle tip having a needle-like tip for piercing tissue, The body portion following the needle tip portion, A curved medical suture needle having a base portion that is connected to the above-mentioned body portion and has the function of connecting suture threads, The torso mentioned above is, At least one foundational aspect and It has at least one non-glare surface, The above non-glare surface has multiple recesses, The above-mentioned at least one base surface is provided on the curved surface of the body, Medical suture needles The objective is to provide.

[0009] The medical suture needle according to the present invention has high strength against bending, and the needle's reflectivity during surgery is low due to a pair of adjacent or opposing non-glare surfaces, resulting in a good cutting edge.

[0010] [2] In the medical suture needle described in [1], The above foundation surface is, The most protruding part in the vertical direction and At least one shoulder portion extending from the most protruding part in the vertical direction to the non-glare surface, It may also be equipped with.

[0011] [3] In the medical suture needle described in [2], The at least one shoulder may be two shoulders.

[0012] [4] In the medical suture needle according to [3], In a cross-section with respect to the extending direction of the body portion, the length of the perpendicular line to the line segment passing between two transition points from the transition point where it transitions from the most protruding portion in the vertical direction to the shoulder to the non-glare surface from the shoulder may be larger than the average depth of each recess.

[0013] [5] In the medical suture needle according to [4], The at least one non-glare surface may be a pair of adjacent non-glare surfaces, The at least one base surface may be one base surface located between the pair of adjacent non-glare surfaces.

[0014] [6] In the medical suture needle according to [4], The at least one non-glare surface may be a pair of opposing non-glare surfaces, The at least one base surface may be two base surfaces, Each of the two base surfaces may be located between the pair of opposing non-glare surfaces, respectively.

[0015] [7] In the medical suture needle according to any one of [4] to [6], The average depth of each recess may be 30% or less of the diameter of the un-pressed portion before the non-glare surface is formed on the body portion.

[0016] [8] In the medical suture needle according to any one of [1] to [7], The pressing amount of the non-glare surface may be 25% or less of the diameter of the un-pressed portion before the non-glare surface is formed on the body portion.

[0017] [9] In a medical suture needle described in any of [1] to [8], The boundary diameter between the needle tip and the body may be 30 to 70% of the maximum diameter of the body. [Brief explanation of the drawing]

[0018] [Figure 1] Figure 1 shows a right side view of the medical suture needle 1 according to this embodiment. [Figure 2] Figure 2 shows a front view and a right view illustrating the cross-section of the medical suture needle 1 according to this embodiment. [Figure 3] Figure 3 is a schematic cross-sectional view showing cross-section C of the medical suture needle 1 shown in Figure 2. [Figure 4] Figure 4 is a schematic partial right side view for visually illustrating the non-glare surface 21 according to this embodiment. [Figure 5] Figure 5 is a schematic cross-sectional view of the shaft 20 of a medical suture needle 1 according to another embodiment. [Figure 6] Figure 6 shows cross-sectional views of a medical suture needle (A) having a cross-section with four flat surfaces, and medical suture needles (B to D) having base surfaces of varying thicknesses T1 and opposing non-glare surfaces. [Figure 7] Figure 7 illustrates the cross-sectional shape of the body of the test piece used in the repeated bending test. [Modes for carrying out the invention]

[0019] definition For convenience, the specific terms used in this application are gathered here. Unless otherwise specified, all technical and scientific terms used in this application have the same meaning as those generally understood by those skilled in the art to which this invention pertains. Unless otherwise specified in the context, the singular forms "a," "an," and "the" include plural references.

[0020] The numerical ranges and parameters shown in this invention are approximations, although the numerical values ​​shown in specific examples are described as accurately as possible. However, all numerical values ​​inherently contain certain errors that inevitably arise from the standard deviation observed in each test measurement. Furthermore, the term "about" as used herein generally means within 10%, 5%, 1%, or 0.5% of a given value or range. Alternatively, the term "about" means that it is within an acceptable standard error, as considered by those skilled in the art.

[0021] As used herein, the term "side view" means a viewpoint from which the longitudinal shape or curvature of the medical suture needle 1, described later, is most clearly displayed and the non-glare surface 21, described later, is most clearly displayed, and "side view" includes "right side view" and "left side view".

[0022] The embodiments of the present invention will now be described. The following embodiments are illustrative, and the scope of the present invention is not limited to those shown in the following embodiments. In order to avoid repetition and complexity, explanations of similar content will be omitted as appropriate.

[0023] Medical suture needle 1 Figure 1 shows a right side view of the medical suture needle 1 according to this embodiment, and Figure 2 shows a front and right side view illustrating the cross-section of the medical suture needle 1 according to this embodiment. The medical suture needle 1 has a needle tip portion 10 having a needle tip 11 for piercing tissue, a body portion 20 following the needle tip portion 10, and a base portion 30 following the body portion 20 that has the function of connecting suture thread. The medical suture needle 1 is configured as a curved needle, with the entire length from the needle tip portion 10 to the base portion 30 being curved. Multiple types of curved shapes and thicknesses for the medical suture needle 1 are standardized in advance, and the most suitable standard is selected and used according to the area to be sutured. In addition, although the medical suture needle 1 is formed as a curved needle in this embodiment, it may also be a straight needle.

[0024] The materials constituting the medical suture needle 1 are not particularly limited and can be selectively used from among steel wire, martensitic stainless steel, or austenitic stainless steel. In the case of steel wire or martensitic stainless steel, hardening by heat treatment can be expected, but it is difficult to eliminate the occurrence of rust. In the case of austenitic stainless steel, hardening by heat treatment cannot be expected, but there is no risk of rust occurring. Thus, considering the occurrence of rust, it is preferable to use austenitic stainless steel.

[0025] In this embodiment, a material is used in which austenitic stainless steel wire is cold-drawn with a predetermined reduction ratio to achieve high hardness and improve bending strength by elongating the austenitic structure into a fibrous form.

[0026] Needle tip 10 The needle tip 10 has a needle tip 11 formed at its end as a point for piercing tissue, and the diameter increases from the needle tip 11 to the shaft 20. Generally, the length of the needle tip 10 is about 6 to 12 times the diameter of the shaft 20, but other lengths are also provided to suit the intended use of the suture needle. The length of the needle tip 10 is configured to increase as the diameter of the shaft 20 increases.

[0027] Torso 20 The body portion 20 comprises at least one base surface 22 and at least one non-glare surface 21. In one embodiment, the body portion 20 comprises one base surface 22 and two non-glare surfaces 21. In another embodiment, the body portion 20 comprises two base surfaces 22 and two non-glare surfaces 21.

[0028] At least one base surface 22 is provided on the curved surface of the body 20. The curved surface includes an inner curved surface and an outer curved surface. In one embodiment, at least one base surface 22 is provided on the inner curved surface. In another embodiment, at least one base surface 22 is provided on the outer curved surface. In one embodiment, one base surface 22 is provided on either the inner or outer curved surface. In one embodiment, one of two base surfaces 22 is provided on the inner curved surface, and the other of two base surfaces 22 is provided on the outer curved surface.

[0029] The shaft portion 20 is the part that is grasped by the needle holder, and its thickness is set within the range of 0.025 mm to 2.00 mm. The practitioner then selects and uses a medical suture needle 1 with the optimal thickness depending on the affected area to be sutured.

[0030] In one embodiment, the diameter at the boundary B between the needle tip portion 10 and the body portion 20 is 30 to 70% of the maximum diameter of the body portion 20 (for example, a range between two values ​​selected from the group consisting of 30, 35, 40, 45, 50, 55, 60, 65 and 70%).

[0031] In one embodiment, the body portion 20 comprises a pair of opposing non-glare surfaces 21 and two base surfaces 22 (Figures 1 and 2). Each of the two base surfaces 22 is located between the pair of non-glare surfaces 21. The cross-section C of the body portion 20 comprising the pair of opposing non-glare surfaces 21 and the two base surfaces 22 is substantially rectangular.

[0032] Methods for forming the medical suture needle 1 having the above configuration include pressing a material with a circular cross-section to form a rectangle and a non-glare surface 21, and pressing two opposing surfaces of a material with a circular cross-section together to form a base surface 22 and a non-glare surface 21. Both methods can be used. The non-glare surface can be formed by a non-glare treatment (chemical treatment or press processing with a press surface having multiple protrusions).

[0033] The medical suture needle 1 according to this embodiment may be a black medical suture needle. A black medical suture needle can be manufactured from a blackened circular material, or it can be manufactured by blackening the medical suture needle 1 according to this embodiment. A blackened circular material or medical suture needle 1 can be manufactured by a method comprising the steps of: applying a rectangular wave pulse potential to the circular material or medical suture needle 1, which is immersed in an electrolytic aqueous solution, for 40 to 90 minutes to form a colored passivation film on the surface of the circular material or medical suture needle 1; and applying silicone to the circular material or medical suture needle 1 after the pulse potential has been applied (see Japanese Patent Application Publication No. 2022-039463).

[0034] In one embodiment, the amount of pressing of the non-glare surface 21 is 25% or less of the diameter of the unpressed portion before the non-glare surface 21 is formed on the body portion 20 (for example, a range between two values ​​selected from the group consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25%).

[0035] Figure 3 is a schematic cross-sectional view showing the cross-section C of the medical suture needle 1 shown in Figure 2. The non-glare surface 21 is provided with a plurality of recesses 210. In one embodiment, each base surface 22 is provided with a vertically protruding portion 220 (also referred to as the central portion 220) and a pair of shoulder portions 221 extending from both sides of the vertically protruding portion 220 to each non-glare surface 21. The shoulder portions 221 may be flat or curved. The thickness T1 of the base surface 22 is the length of the perpendicular PL to the line segment L that passes between two transition points Pt1 and Pt2, which are transition points from the vertically protruding portion 220 to the shoulder portion 221 in a cross-section of the body portion 20 in the extending direction. The length of the perpendicular PL corresponding to one shoulder portion 221 may be the same as or different from the length of the perpendicular PL corresponding to the other shoulder portion 221. The thickness T1 of the base surface 22 can be rephrased as the distance from the base surface 22 to the non-glare surface 21 in the projection view of the shoulder portion 221 in a side view. The thickness T1 of the base surface 22 is greater than the average depth D1 of each recess 210. In one embodiment, the length of the perpendicular PL corresponding to one shoulder portion 221 is greater than the average depth D1 of each recess 210 of the non-glare surface 210 adjacent to one shoulder portion 221, and the length of the perpendicular PL corresponding to the other shoulder portion 221 is greater than the average depth D1 of each recess 210 of the non-glare surface 210 adjacent to the other shoulder portion 221. The thickness T1 of the base surface 22 may also be the thickness of the thickest part of the base surface 22, and can be rephrased as the cross-sectional thickness from the base surface 22 to the non-glare surface 21.

[0036] The vertically protruding portion 220 shown in Figures 1 to 3 has a flat shape, but may have a convex apex in the direction away from the medical suture needle 1. Furthermore, the vertically protruding portion 220 may be equipped with reinforcing parts (e.g., one or more ribs) to improve grip with a needle holder, provided that these parts do not fall under the definition of a non-glare surface 21 in this embodiment. In one embodiment, the base surface 22 is a glare surface. In another embodiment, the shoulder portion 221 is a glare surface.

[0037] In one embodiment, the average depth D1 of each recess 210 may be 30% or less of the diameter of the unpressed portion before the non-glare surface 21 is formed on the body portion 20 (for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 and 30% or less, and a range between two values ​​selected from the group consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 and 30%).

[0038] Furthermore, the spacing between the bottoms of the recesses 210 may be constant or random. In one embodiment, the average spacing I1 between the bottoms of the recesses 210 is between 0.050 and 0.200 mm (for example, 0.050, 0.055, 0.060, 0.065, 0.070, 0.071, 0.072, 0.073, 0.074, 0.075, 0.076, 0.077, 0.078, 0.079, 0.080, 0.085, 0.090, 0.095). It may also be a range between two values ​​selected from the group consisting of 0.100, 0.110, 0.120, 0.130, 0.140, 0.150, 0.160, 0.170, 0.175, 0.176, 0.177, 0.178, 0.179, 0.180, 0.181, 0.182, 0.183, 0.184, 0.185, 0.190, and 0.200 mm.

[0039] Figure 4 is a schematic partial right side view for visually illustrating the non-glare surface 21 according to this embodiment. The multiple recesses 210 in the non-glare surface 21 are not present on the base surface 22 in a side view. In one embodiment, the multiple recesses 210 in the non-glare surface 21 are not present on the vertically protruding portion 220 and the shoulder portion 221 in a side view. The shape of each recess 210 shown in Figure 4 is rectangular, but is not limited to this, and may be polygonal, circular, or grooved. Also, the recesses 210 shown in Figure 4 are arranged along the longitudinal direction, but are not limited to this, and may be arranged along a reference line having a certain angle with respect to the longitudinal direction.

[0040] FIG. 5 is a schematic cross-sectional view of the body 20 of the medical suture needle 1 according to another embodiment. The body 20 shown in FIG. 5 includes a pair of adjacent non-glare surfaces 21 and one base surface 22. The cross-section of the body 20 including the pair of adjacent non-glare surfaces 21 and one base surface 22 is substantially triangular. One base surface 22 shown in FIG. 5 is an inner curved surface, but one base surface 22 may be an outer curved surface. Even if the body 20 has a substantially triangular cross-section, the thickness T1 of the base surface 22 is greater than the average depth D1 of each recess 210.

[0041] Shank portion 30 The shank portion 30 is a portion for attaching a suture thread (not shown), and there are a suture needle having a through-hole with spring properties corresponding to the function of the suture needle, a suture needle having a stop hole formed in the end face 31 of the shank portion 30, and the like. In the present embodiment, the shank portion 30 is configured as a suture needle having a circular cross-section and a hole for attaching a suture thread formed in the end face 31.

[0042] Other embodiments The body 20 of the medical suture needle 1 according to another embodiment may include at least one non-glare surface 21. The body 20 may further include at least one base surface 22. The base surface 22 may include a most protruding portion 220 in the vertical direction and at least one shoulder portion 221 extending from the most protruding portion 220 in the vertical direction to the non-glare surface 21. The at least one shoulder portion 221 may be two shoulder portions 221.

Example

[0043] Medical suture needles (A) having a cross-section with four flat surfaces and medical suture needles (B to D) having various thicknesses T1 of the base surface and opposing non-glare surfaces were created (see FIG. 6). The medical suture needle (B) has a relationship of T1 (thickness of the base surface) < D1 (average depth of each recess). The medical suture needle (C) has a relationship of T1 > D1. The medical suture needle (D) has a base surface having a convex arc shape in a direction away from the medical suture needle 1, and has a relationship of T1 > D1 and a relationship of T1 of the medical suture needle (C) < T1 of the medical suture needle (D).

[0044] Test pieces of each suture needle were fabricated, and reflection, sharpness, and breakage of each suture needle were examined. Each test piece was manufactured by pressing a SUS302 wire with a diameter of 0.6 mm. The medical suture needle (A) was manufactured by pressing the wire so that four sides thereof would be flat. The medical suture needles (B) and (C) were manufactured by pressing the wire so as to have the relationships of T1 < D1 and T1 > D1, respectively. The non-glare surface was formed by bringing a pressing surface having a plurality of convex portions into contact with the wire. The medical suture needle (D) was manufactured by pressing the wire so that opposing non-glare surfaces would be formed, and not pressing the base surface having a convex arc shape.

[0045] Reflection The reflection of each suture needle is based on the reflectance (= intensity of reflected light / intensity of incident light) from the intensity of incident light and the intensity of reflected light with respect to the non-glare surface (the side surface in the case of the medical suture needle (A)). In this example, the reflection of each suture needle was taken as a relative value when the reflectance of a mirror was 100, less than 2 was rated as "excellent", 2 or more and less than 10 was rated as "good", and 10 or more was rated as "poor".

[0046] Sharpness Permea (registered trademark), a synthetic resin sheet with a thickness of 1.10 mm, was used as the pierced material, and the force (Newton, N) when piercing the pierced material was measured. The sharpness of each suture needle was rated as "excellent" when less than 0.7 N, "good" when 0.7 N or more and less than 1 N, and "poor" when 1 N or more.

[0047] Breakage A 90-degree repeated bending test was performed on the test piece of each suture needle. As shown in FIG. 3, in the experiment, while the body portion of each test piece was held by a vise 100, a force was applied by a driver 101 to the base portion side to apply a repeated bending of approximately 90 degrees, and the number of times until breakage was measured. The number of repeated bendings until breakage was rated as "poor" when 1 and 2, "good" when 3 and 4, and "excellent" when 5 or more.

[0048] The results are shown in Table 1.

[0049]

Table 1

[0050] Medical suture needles (C) and (D) having the relationship of T1 < D1 had excellent test results in terms of reflection, sharpness, and breakage. Based on the above results, in side view, a medical suture needle having a non-glare surface on the side has a high strength of the needle against bending due to the relationship of T1 < D1, a low reflectivity of the needle during the operation due to the non-glare surface, and has a good sharpness.

Explanation of Signs

[0051] 1. The medical suture needle 10. Needle tip part 11. Needle tip 20. Shank 21. Non-glare surface 22. Base surface 30. Shank base 31. End face 100. Vice 101. Driver 210. Recess 220. Most protruding part in the up and down direction 221. Shoulder B. Boundary C. Cross-section D1. Average depth I1. Average interval L. Line segment Pt, Pt1, Pt2. Transition points PL. Perpendicular line T1. Thickness

Claims

1. A needle tip having a needle-like tip for piercing tissue, The body portion following the aforementioned needle tip portion, A curved medical suture needle having a base portion that is connected to the shaft portion and has the function of connecting suture threads, The aforementioned torso is, At least one foundational surface, It has at least one non-glare surface, The non-glare surface has a plurality of recesses, The aforementioned at least one base surface is provided on the curved surface of the body, Medical suture needles.

2. The aforementioned base surface is The most protruding part in the vertical direction and At least one shoulder portion extending from the most protruding part in the vertical direction to the non-glare surface, Equipped with, A medical suture needle according to claim 1.

3. The medical suture needle according to claim 2, wherein the at least one shoulder portion is two shoulder portions.

4. The medical suture needle according to claim 3, wherein, in a cross-section of the torso with respect to its extending direction, the length of the perpendicular from the transition point where the most protruding part in the vertical direction transitions to the shoulder portion to the line segment passing between the two transition points where the shoulder portion transitions to the non-glare surface is greater than the average depth of each recess.

5. The at least one non-glare surface is a pair of adjacent non-glare surfaces. The at least one base surface is a base surface located between the adjacent pair of non-glare surfaces. A medical suture needle according to claim 4.

6. The at least one non-glare surface is a pair of opposing non-glare surfaces. The aforementioned at least one base surface is two base surfaces, Each of the two base surfaces is located between the pair of opposing non-glare surfaces. A medical suture needle according to claim 4.

7. The medical suture needle according to claim 4, wherein the average depth of each recess is 30% or less of the diameter of the unpressed portion before the non-glare surface is formed on the body.

8. The amount of pressing of the non-glare surface is 25% or less of the diameter of the unpressed portion before the non-glare surface is formed on the body of the medical suture needle according to claim 1.

9. The medical suture needle according to claim 1, wherein the boundary diameter between the needle tip and the shank is 30 to 70% of the maximum diameter of the shank.

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