Medical puncture needle and method for manufacturing medical puncture needle

Abstract

To provide a medical puncture needle with which a catheter is easily inserted into the spinal cavity, and a manufacturing method for a medical puncture needle.SOLUTION: A medical puncture needle has a needle tube having a lumen extending in a longitudinal axis direction. The needle tube has at a distal end part a reduced diameter part reducing toward a distal end. In a lateral surface view of the needle tube when the needle tube is directed in the direction where a distance between the longitudinal axis and a distal end of the needle tube is maximum, the needle tube has an extension part extending more to a distal side than a first virtual straight line passing the distal end of the needle tube and a proximal end of the reduced diameter part, and has a recess recessed more to the proximal side than the first virtual straight line on a proximal end side of the reduced diameter part nearer than the extension part. On the first virtual straight line, the distal end of the recess is positioned at a point away for 1 / 3 or more of the distance from the distal end of the needle tube to the proximal end of the reduced diameter part.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a medical puncture needle and a method for manufacturing a medical puncture needle. [Background technology]

[0002] Conventionally, medical needles have been inserted into spinal cavities such as the epidural space or subarachnoid space, for example, into the lumbar vertebrae to inject anesthetics or drain body fluids such as cerebrospinal fluid. For example, Patent Document 1 discloses an epidural anesthesia puncture needle whose tip is bent upward and whose tip surface is an upwardly inclined surface, in which the upper part of the tip surface is a first inclined surface and the lower part is a second inclined surface, and the inclination of the second inclined surface is greater than the inclination of the first inclined surface. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Laid-Open No. 2009-000206 Summary of the Invention [Problem to be solved by the invention]

[0004] With a conventional epidural anesthesia puncture needle such as that described in Patent Document 1, it is possible to insert a catheter into the epidural space through the lumen of the puncture needle and inject an anesthetic from the catheter. However, when puncturing and inserting the catheter into a narrow spinal space such as the epidural space or subarachnoid space, it can be difficult to do so.

[0005] The present invention has been made in light of the above-mentioned problems, and its purpose is to provide a medical puncture needle that makes it easy to insert a catheter into the spinal cavity, and a method for manufacturing such a medical puncture needle. [Means for solving the problem]

[0006] The medical puncture needle according to the embodiment of the present invention, which has been able to solve the above problems, is as follows. [1] A needle tube having a lumen extending in a longitudinal direction, The needle tube has a tapered portion at a distal end portion, the diameter of which decreases toward the distal end, In a side view of the needle tube when the needle tube is oriented in a direction in which the distance between the longitudinal axis and the distal end of the needle tube is greatest, the needle tube has an extending portion that extends distally of a first imaginary line that passes through the distal end of the needle tube and the proximal end of the reduced diameter portion, and has a recess that is recessed proximally from the first imaginary line and is located closer to the proximal end of the reduced diameter portion than the extending portion, A medical puncture needle in which, on the first imaginary line, the distal end of the recess is located at a point that is at least 1 / 3 of the distance from the distal end of the needle tube toward the proximal end of the reduced diameter portion.

[0007] By providing the needle tube with an extension and a recess at predetermined positions, it is possible to reduce the wobble of the catheter when inserting it into the spinal canal through the lumen of the needle tube and to easily guide the catheter toward the recess, which makes it easier to insert the catheter into the spinal canal and reduces the chance of damaging the catheter even if force is applied in the direction of pulling the catheter out.

[0008] Furthermore, the medical puncture needle and the method for manufacturing the medical puncture needle according to the embodiment of the present invention are preferably any one of the following [2] to

[21] . [2] A medical puncture needle according to [1], wherein, in a side view of the needle tube, the angle θ1 formed between the outer edge of the recess at the proximal end of the recess and the first imaginary line is greater than the angle θ2 formed between the outer edge of the recess at the distal end of the recess and the first imaginary line. [3] A medical puncture needle according to [1] or [2], wherein on the first imaginary line, the proximal end of the recess is located at a point more than 2 / 3 of the distance from the distal end of the needle tube to the proximal end of the reduced diameter section. [4] The medical puncture needle according to any one of [1] to [3], wherein the outer edge of the recess is curved in a side view of the needle tube. [5] The reduced diameter portion has an opening edge, The medical puncture needle according to any one of [1] to [4], wherein, in the side view, the proximal end of the extension portion is located distal to a second imaginary line passing through the distal end and the proximal end of the opening edge. [6] The reduced diameter portion has an opening edge, The medical puncture needle according to any one of [1] to [5], wherein the width of the opening edge in a direction perpendicular to the imaginary line segment at a position 1 / 5 of the length of the imaginary line segment from the proximal end to the distal end of the opening edge is at least 0.7 times the width of the opening edge in the perpendicular direction at a position 1 / 2 of the length of the imaginary line segment. [7] The medical puncture needle according to [5] or [6], wherein the opening edge of the recess is chamfered. [8] The medical puncture needle according to [7], wherein the chamfering is a rounded edge. [9] The medical puncture needle according to any one of [1] to [8], wherein the distal end of the needle tube is curved so that the reduced diameter surface of the reduced diameter section faces inward.

[10] The reduced diameter portion is a first reduced diameter section including a proximal end of the reduced diameter section; The medical puncture needle according to any one of [1] to [9], further comprising: a second reduced diameter portion located distal to the first reduced diameter portion and including the distal end of the needle tube.

[11] The recess includes a portion of the first reduced diameter portion, The medical puncture needle according to

[10] , wherein the extension portion includes another part of the first reduced diameter portion and the second reduced diameter portion.

[12] A medical puncture needle according to

[10] or

[11] , wherein, in the side view, the length H1 (mm) of the needle tube in a direction perpendicular to the longitudinal axis direction at the proximal end of the second reduced diameter portion is 0.3 to 0.7 times the length H2 (mm) of the needle tube in the longitudinal axis direction from the proximal end to the distal end of the second reduced diameter portion.

[13] A medical puncture needle according to any one of

[10] to

[12] , wherein, in the side view, the length H1 (mm) of the needle tube in a direction perpendicular to the longitudinal axis direction at the proximal end of the second reduced diameter section is 0.3 to 0.7 times the length H3 (mm) of the needle tube in a direction perpendicular to the longitudinal axis direction at the proximal end of the first reduced diameter section.

[14] In the side view, The angle α1 formed by a third imaginary line passing through the distal end of the needle tube and parallel to the longitudinal axis direction and a fourth imaginary line passing through the proximal end and the distal end of the first reduced diameter portion is The medical puncture needle according to any one of

[10] to

[13] , wherein the angle α2 is 0.60 to 0.99 times the angle formed by a third imaginary line passing through the distal end of the needle tube and parallel to the longitudinal axis direction, and a fifth imaginary line passing through the proximal end and distal end of the second reduced diameter section.

[15] A medical puncture needle according to any one of

[10] to

[14] , wherein a rod-shaped body extending in the longitudinal axis direction is inserted into the inner cavity of the needle tube, and the rod-shaped body has a reduced diameter portion at its distal end.

[16] In the side view, the distal end of the reduced diameter portion of the rod-shaped body is located on a sixth imaginary line passing through the distal end and the proximal end of the second reduced diameter portion of the needle tube, or is located proximal to the sixth imaginary line; and The medical puncture needle according to

[15] , wherein the proximal end of the reduced diameter portion of the rod-shaped body is located on the sixth imaginary line or on the proximal side of the sixth imaginary line.

[17] A medical puncture needle according to

[15] or

[16] , wherein the reduced diameter surface of the reduced diameter portion of the rod-shaped body is not in contact with the needle tube.

[18] The medical puncture needle according to any one of [1] to

[14] , wherein a catheter is inserted into the lumen of the needle tube.

[19] The medical puncture needle according to

[18] , wherein the distal end of the catheter has a plurality of through holes extending from the outer surface to the inner surface.

[20] forming a reduced diameter surface on the distal end of the tubular member; and A method for manufacturing a medical puncture needle, the method comprising the steps of forming another reduced diameter surface at the proximal end of the reduced diameter surface.

[21] The method for manufacturing a medical puncture needle according to

[20] , wherein the other reduced diameter surface has an opening edge, and the method includes a step of polishing the proximal end of the opening edge. [Effects of the Invention]

[0009] According to the present invention, with the above-described configuration, it is possible to provide a medical puncture needle that allows easy insertion of a catheter into the spinal cavity, and a method for manufacturing the medical puncture needle. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a side view of a puncture needle according to a first embodiment. [Figure 2] FIG. 2 is a plan view of the tip of the puncture needle according to the first embodiment. [Figure 3] FIG. 3 is a side view of the tip of the puncture needle according to the first embodiment. [Figure 4] FIG. 4 is a side view of the tip of the puncture needle according to the second embodiment. [Figure 5] FIG. 5 is a side view of the puncture needle according to the second embodiment. [Figure 6] FIG. 6 is a side view of the rod-shaped body. [Figure 7] FIG. 7 is a side view of the puncture needle according to the second embodiment with a rod-shaped body inserted therein. [Figure 8] FIG. 8 is a plan view of the tip of the puncture needle according to the second embodiment with a rod-shaped body inserted therein. [Figure 9] FIG. 9 is a side view of the tip of the puncture needle according to the second embodiment with a rod-shaped body inserted therein. [Figure 10] FIG. 10 is an explanatory view for explaining a state in which a catheter is inserted into the spinal cavity through a puncture needle according to the second embodiment. [Figure 11] FIG. 11 is a side view of the tubular member. [Figure 12] FIG. 12 is a side view of a tubular member having a tapered surface formed thereon. [Figure 13] 13 is a side view of a tubular member having an additional reduced diameter surface formed at the proximal end of the reduced diameter surface of FIG. 12. FIG. [Figure 14] FIG. 14 is a side view of a puncture needle formed by polishing the proximal end of the opening edge of another reduced diameter surface of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. For convenience, component reference numerals may be omitted in the drawings. In such cases, reference should be made to the specification or other drawings. The dimensions of various components in the drawings may differ from their actual dimensions, as priority is given to helping understand the features of the present invention.

[0012] A medical puncture needle according to an embodiment of the present invention has a needle tube with a lumen extending in the longitudinal axis direction, the needle tube having a reduced-diameter section at its distal end that reduces in diameter toward the distal end, and in a side view of the needle tube when the needle tube is oriented in a direction that maximizes the distance between the longitudinal axis and the distal end of the needle tube, the needle tube has an extension section that extends distal to a first imaginary line passing through the distal end of the needle tube and the proximal end of the reduced-diameter section, and has a recess that is recessed proximally from the first imaginary line, closer to the proximal end of the reduced-diameter section than the extension section, and the distal end of the recess is located on the first imaginary line at a point that is more than 1 / 3 of the distance from the distal end of the needle tube to the proximal end of the reduced-diameter section.

[0013] By providing the needle tube with the extension and recess at predetermined positions, when inserting the catheter into the spinal cavity from the lumen of the needle tube, it is possible to reduce the wobble of the catheter and to easily guide the catheter toward the recess, thereby facilitating insertion of the catheter into the spinal cavity.

[0014] The puncture needle according to the first embodiment will be described with reference to Figures 1 to 3. Figure 1 is a side view of the puncture needle according to the first embodiment. Figure 2 is a plan view of the tip of the puncture needle according to the first embodiment. Figure 3 is a side view of the tip of the puncture needle according to the first embodiment.

[0015] 1, a medical puncture needle 11 has a needle tube 10 with a lumen 9 extending in a longitudinal axis direction X. Because the needle tube 10 has the lumen 9, a catheter can be inserted into the spinal cavity through the lumen 9.

[0016] The needle tube 10 has a tapered portion 3 at the distal end 10b, the diameter of which decreases toward the distal end 10B, which makes it easier to insert the distal end 10b of the needle tube 10 into the spinal cavity.

[0017] 1 is a side view of the needle tube 10, in which the needle tube 10 is oriented in a direction in which the distance between the longitudinal axis C and the distal end 10B of the needle tube 10 is greatest. In FIG. 1, the needle tube 10 has an extension portion 5 that extends distally of a first imaginary straight line L1 that passes through the distal end 10B of the needle tube 10 and the proximal end 3A of the reduced diameter section 3. By having the extension portion 5, the needle tube 10 can reduce deviation in the left-right direction relative to the insertion direction when inserting a catheter into the spinal cavity.

[0018] 1, the needle tube 10 has a recess 6 that is recessed proximally from the first imaginary straight line L1, and is located closer to the proximal end 3A of the reduced diameter portion 3 than the extension portion 5. This makes it easier to guide the catheter forward toward the recess 6.

[0019] 1, the distal end 6B of the recessed portion 6 is located at a point on the first imaginary line L1 that is at least one-third of the distance from the distal end 10B of the needle tube 10 to the proximal end 3A of the tapered portion 3 (hereinafter, simply referred to as "distance D"). This allows the above-described effects of the extension portion 5 and the recessed portion 6 to be effectively exhibited. The distal end 6B of the recessed portion 6 is preferably at least two-fifths of the distance D from the distal end 10B of the needle tube 10 to the proximal end 3A of the tapered portion 3, and more preferably at least one-half of the distance D. On the other hand, the distal end 6B of the recessed portion 6 is preferably at most two-thirds of the distance D from the distal end 10B of the needle tube 10 to the proximal end 3A of the tapered portion 3. 1 is a point that is 1 / 3 of the distance D from the distal end 10B of the needle tube 10 toward the proximal end 3A of the tapered portion 3.

[0020] As shown in FIG. 1 , in a side view of the needle tube 10, the angle θ1 formed between the outer edge 6E of the recessed portion 6 at the proximal end 6A of the recessed portion 6 and the first imaginary line L1 is preferably larger than the angle θ2 formed between the outer edge 6E of the recessed portion 6 at the distal end 6B of the recessed portion 6 and the first imaginary line L1. This makes it easier to guide the catheter's traveling direction toward the recessed portion 6. The angle θ1 is preferably 2.0 times or more, preferably 4.0 times or more, more preferably 6.0 times or more, even more preferably 8.0 times or more, and even more preferably 10.0 times or more of the angle θ2. On the other hand, the angle θ1 may be 30 times or less, or may be 20 times or less, of the angle θ2.

[0021] On the first imaginary line L1, the proximal end 6A of the recessed portion 6 is preferably located at a point more than two-thirds of the distance (distance D) from the distal end 10B of the needle tube 10 toward the proximal end 3A of the tapered portion 3. This makes it easier to guide the catheter's traveling direction toward the recessed portion 6. The proximal end 6A of the recessed portion 6 is more preferably located at 7 / 10 or more of the distance D from the distal end 10B of the needle tube 10 toward the proximal end 3A of the tapered portion 3, more preferably at 9 / 10 or more, and most preferably at the proximal end 3A of the tapered portion 3. On the other hand, the proximal end 6A of the recessed portion 6 may be located at 9 / 10 or less of the distance D from the distal end 10B of the needle tube 10 toward the proximal end 3A of the tapered portion 3.

[0022] On the first imaginary line L1, the distal end 5B of the extension portion 5 is preferably located less than 1 / 3 of the distance D from the distal end 10B of the needle tube 10 toward the proximal end 3A of the tapered portion 3, more preferably 1 / 5 or less, and most preferably at the distal end 10B of the needle tube 10. This makes it easier to reduce lateral deviation relative to the insertion direction when inserting the catheter into the spinal cavity. On the other hand, the distal end 5B of the extension portion 5 may be located more than 1 / 10, or may be more than 1 / 5, of the distance D from the distal end 10B of the needle tube 10 toward the proximal end 3A of the tapered portion 3.

[0023] On the first imaginary line L1, the proximal end 5A of the extension portion 5 is preferably at least one-third of the distance D from the distal end 10B of the needle tube 10 toward the proximal end 3A of the tapered portion 3, more preferably at least two-fifths of the distance, and even more preferably at least one-half of the distance. This facilitates reducing lateral deviation relative to the insertion direction when inserting the catheter into the spinal cavity. On the other hand, the proximal end 5A of the extension portion 5 is preferably at most two-thirds of the distance D from the distal end 10B of the needle tube 10 toward the proximal end 3A of the tapered portion 3. Note that, on the first imaginary line L1, the proximal end 5A of the extension portion 5 and the distal end 6B of the recess 6 do not need to be located at the same point; the proximal end 5A may be located closer to the distal end 10B of the needle tube 10 than the distal end 6B.

[0024] On the first imaginary straight line L1, the length from the proximal end 6A to the distal end 6B of the recessed portion 6 is preferably longer than the length from the proximal end 5A to the distal end 5B of the extension portion 5. This makes it easier to guide the direction of travel of the catheter toward the recessed portion 6. Furthermore, on the first imaginary straight line L1, the length from the proximal end 5A to the distal end 5B of the extension portion 5 is preferably at least 0.5 times the length from the proximal end 6A to the distal end 6B of the recessed portion 6. This makes it easier to reduce deviation in the left-right direction relative to the insertion direction when inserting the catheter into the spinal cavity.

[0025] As shown in Fig. 1, the outer edge 6E of the recess 6 is preferably curved in a side view of the needle tube 10. This makes it easier to insert the distal end 10b of the needle tube 10 into the human body. The outer edge 6E of the recess 6 may have a shape in which one ends of multiple line segments are connected to each other, and examples of such shapes include an L-shape, a V-shape, and a V-shape. That is, the recess 6 may have a multi-step tapered shape.

[0026] As shown in FIG. 1, in a side view of the needle tube 10, the outer edge 5E of the extension portion 5 preferably has a shape in which one ends of multiple line segments are connected to each other. That is, the extension portion 5 preferably has a multi-step tapered shape. Examples of the shape of the outer edge 5E of the extension portion 5 include an L-shape, a V-shape, and a V-shape. The outer edge 5E of the extension portion 5 may be composed of one or two line segments.

[0027] As shown in Figures 1 and 2, the tapered portion 3 preferably has an opening edge 7. Furthermore, as shown in Figure 1, in a side view, the proximal end 5A of the extension portion 5 is preferably located distal to a second imaginary straight line L2 passing through the distal end 7B and the proximal end 7A of the opening edge 7. This allows The extension portion 5 can improve the effect of reducing the shaking of the catheter.

[0028] As shown in FIG. 2 , the tapered portion 3 has an opening edge 7. The width W1 of the opening edge 7 in the direction perpendicular to the imaginary line segment L10 at a position 1 / 5 of the length of the imaginary line segment L10 from the proximal end 7A to the distal end 7B of the opening edge 7 is preferably 0.7 times or more the width W2 of the opening edge 7 in the perpendicular direction at a position 1 / 2 of the length of the imaginary line segment L10. This makes it easier to guide the catheter toward the recess 6. The width W1 is more preferably 0.8 times or more the width W2. On the other hand, the width W1 is preferably 1.2 times or less the width W2, and more preferably less than 1.0 times the width W2. This improves the strength of the distal end 10b of the needle tube 10.

[0029] As shown in Figure 2, the length of the imaginary line segment L10 of the opening edge 7 is preferably at least twice the length of the width W2 of the opening edge 7. This makes it easier to insert the catheter into the spinal cavity and reduces the chance of damaging the catheter even if force is applied in the direction of pulling the catheter out. The length of the imaginary line segment L10 of the opening edge 7 may be no more than four times the length of the width W2 of the opening edge 7.

[0030] The opening edge 7 of the recess 6 is preferably chamfered. This makes it less likely that the catheter will get caught on the opening edge 7, making it easier to insert the catheter. The chamfering is preferably R-chamfering or C-chamfering, and R-chamfering is more preferable.

[0031] 2, in the plan view of the tip of the needle tube 10, it is preferable that the outer edge of the needle tube 10 within 0.1 mm from the distal end 10B has an arc-shaped outer edge, which can reduce damage to the dura mater and other tissues caused by puncturing too deeply.

[0032] It is preferable that the diameter of the tapered portion 3 is continuously reduced. That is, as shown in Figures 1 and 3, it is preferable that the reduced diameter surface 3S of the tapered portion 3 does not have a surface parallel to the longitudinal axis direction X in a side view of the needle tube 10.

[0033] 1, the tapered portion 3 preferably has a first tapered portion 1 including the proximal end 3A of the tapered portion 3, and a second tapered portion 2 located distal to the first tapered portion 1 and including the distal end 10B of the needle tube 10. This makes it easier to impart specific functions to each portion.

[0034] 1, it is preferable that the recess 6 includes a part of the first reduced diameter portion 1, and the extension portion 5 includes another part of the first reduced diameter portion 1 and the second reduced diameter portion 2. This makes it easier for the extension portion 5 and the recess 6 to exert the above-mentioned effects.

[0035] As shown in Fig. 1, the outer edge of the first tapered portion 1 is preferably curved. This makes it easier to insert the distal end portion 10b of the needle tube 10 into the human body. The outer edge may also have a shape in which one ends of multiple line segments are connected to each other, such as an L-shape, a V-shape, or a V-shape. That is, the first tapered portion 1 may have a multi-step tapered shape.

[0036] As shown in Fig. 1, the outer edge of the second tapered portion 2 is preferably linear. That is, the second tapered portion 2 is preferably tapered. This makes it easier to pierce the skin with the distal end portion 10b of the needle tube 10. The outer edge of the second tapered portion 2 may have a shape in which one ends of multiple line segments are connected to each other, and examples of such shapes include an L-shape, a V-shape, and a V-shape. That is, the second tapered portion 2 may have a multi-step tapered shape.

[0037] 1, in a side view, the length H1 (mm) of the needle tube 10 in the direction Y perpendicular to the longitudinal axis direction X at the proximal end 2A of the second tapered section 2 is preferably 0.3 to 0.7 times the length H2 (mm) in the longitudinal axis direction X from the proximal end 2A to the distal end 2B of the second tapered section 2. This makes it easier to puncture the human body while maintaining the strength of the second tapered section 2. It is more preferable that the length H1 (mm) be 0.4 to 0.6 times the length H2 (mm).

[0038] 1, in a side view, the length H1 (mm) of the needle tube 10 in the direction Y perpendicular to the longitudinal axis direction X at the proximal end 2A of the second tapered section 2 is preferably 0.3 to 0.7 times the length H3 (mm) of the needle tube 10 in the direction Y perpendicular to the longitudinal axis direction X at the proximal end 1A of the first tapered section 1. This makes it easier to puncture the human body while maintaining the strength of the second tapered section 2. It is more preferable that the length H1 (mm) be 0.4 to 0.6 times the length H3 (mm).

[0039] 3 , in a side view, the angle α1 formed by a third imaginary line L3 passing through the distal end 10B of the needle tube 10 and parallel to the longitudinal axis direction X and a fourth imaginary line L4 passing through the proximal end 1A and the distal end 1B of the first tapered diameter section 1 is preferably 0.60 to 0.99 times the angle α2 formed by the third imaginary line L3 passing through the distal end 10B of the needle tube 10 and parallel to the longitudinal axis direction X and a fifth imaginary line L5 passing through the proximal end 2A and the distal end 2B of the second tapered diameter section 2. This makes it easier to insert the needle tube 10 into the human body while maintaining the strength of the tapered diameter section 3. It is more preferable that the angle α1 be 0.70 to 0.98 times the angle α2.

[0040] The needle tube 10 may be made of metal materials such as stainless steel, aluminum, aluminum alloy, titanium, and titanium alloy.

[0041] It is preferable that a rod-shaped body 20, which will be described later, is inserted into the medical puncture needle 11 according to the first embodiment. For details, please refer to the description of the medical puncture needle 12 according to the second embodiment, which will be described later.

[0042] Next, a puncture needle according to a second embodiment will be described with reference to Figures 4 to 10. Figure 4 is a side view of the tip of the puncture needle according to the second embodiment. Figure 5 is a side view of the puncture needle according to the second embodiment.

[0043] 4 and 5, in the medical puncture needle 12 according to the second embodiment, the distal end 10b of the needle tube 10 is preferably curved so that the reduced diameter surface 3S of the reduced diameter section 3 faces inward. This makes it easier to guide the catheter forward toward the recess 6.

[0044] FIG. 6 is a side view of the rod-shaped body 20, FIG. 7 is a side view of the puncture needle 12 according to the second embodiment with the rod-shaped body 20 inserted, FIG. 8 is a plan view of the tip portion, and FIG. 9 is a side view of the tip portion.

[0045] 7 to 9, a rod-shaped body 20 extending in the longitudinal axis direction X is inserted into the lumen 9 of the needle tube 10, and the rod-shaped body 20 preferably has a reduced-diameter portion 21 at the distal end 20b. By inserting the rod-shaped body 20 into the lumen 9 of the needle tube 10, the amount of biological tissue that enters the lumen 9 when the needle tube 10 is inserted into the body can be reduced. Furthermore, by having the reduced-diameter portion 21 at the distal end 20b of the rod-shaped body 20, the insertion resistance of the rod-shaped body 20 during puncture can be reduced.

[0046] 9 , in a side view, it is preferable that the distal end 21B of the reduced diameter portion 21 of the rod-shaped body 20 is located on a sixth imaginary line L6 passing through the distal end 2B and the proximal end 2A of the second reduced diameter portion 2 of the needle tube 10, or is located more proximal than the sixth imaginary line L6, and the proximal end 21A of the reduced diameter portion 21 of the rod-shaped body 20 is located on the sixth imaginary line L6 or is located more proximal than the sixth imaginary line L6. For example, by having the distal end 21B of the reduced diameter portion 21 located on the sixth imaginary line L6 and the proximal end 21A of the reduced diameter portion 21 located more proximal than the sixth imaginary line L6, the insertion resistance of the rod-shaped body 20 can be reduced. Furthermore, since the distal end 21B of the reduced diameter portion 21 is located proximal to the sixth imaginary line L6 and the proximal end 21A of the reduced diameter portion 21 is located proximal to the sixth imaginary line L6, it is possible to easily make the reduced diameter surface 21S of the reduced diameter portion 21 flush with the reduced diameter surface 3S of the reduced diameter portion 3. This makes it possible to further reduce the insertion resistance of the rod-shaped body 20.

[0047] 8 and 9, it is preferable that the reduced diameter surface 21S of the reduced diameter portion 21 of the rod-shaped body 20 does not contact the needle tube 10. This makes it easier to pull out the rod-shaped body 20 toward the proximal side after the needle tube 10 has been inserted into the human body. As shown in Fig. 8, it is preferable that the reduced diameter surface 21S does not contact the needle tube 10 over the entire circumference.

[0048] 9, the rod-shaped body 20 is preferably curved so that the reduced diameter surface 21S of the reduced diameter portion 21 of the rod-shaped body 20 faces inward. This makes it easier to insert the rod-shaped body 20 into the medical puncture needle 12.

[0049] 5, the needle tube 10 preferably has a gripping member 15 at the proximal end 10a. By inserting the needle tube 10 into the human body while holding the gripping member 15, the needle tube 10 can be easily inserted into the human body. The gripping member 15 may have a flat shape, or may have a pair of wings, for example.

[0050] 5 and 6, the needle tube 10 preferably has a fixing member 16 at the proximal end 10a, and the rod-shaped body 20 preferably has a fixing member 22 at the proximal end 20a. As shown in Fig. 7, after the rod-shaped body 20 is inserted into the needle tube 10, the fixing members 16 and 22 are engaged and fixed, thereby fixing the rod-shaped body 20 in position. Examples of the fixing members 16 and 22 include members each provided with a screw hole or thread, or a keyway or a protrusion along the keyway.

[0051] 6, the cross-sectional area of ​​the rod-shaped body 20 in the direction perpendicular to the longitudinal axis direction X at the distal end 20b is preferably smaller than the cross-sectional area of ​​the rod-shaped body 20 in the direction perpendicular to the longitudinal axis direction X at the center of the longitudinal axis direction X. In other words, it is preferable that the distal end 20b of the rod-shaped body 20 is narrowed, which makes it easier to insert and remove the rod-shaped body 20 into and from the needle tube 10.

[0052] The rod-shaped body 20 is preferably a solid member, which can reduce the amount of biological tissue that is excised when the needle tube 10 is inserted into the body.

[0053] Examples of materials for the rod-shaped body 20 include metal materials such as stainless steel, aluminum, aluminum alloys, titanium, and titanium alloys. The rod-shaped body 20 may also be made of resin such as thermoplastic resin or thermosetting resin. The rod-shaped body 20 may also be made of metal and resin.

[0054] FIG. 10 is an explanatory diagram for explaining a state in which a catheter is inserted into the spinal cavity through the puncture needle 12 according to the second embodiment.

[0055] As shown in Figure 10, it is preferable that a catheter 30 is inserted into the lumen 9 of the needle tube 10. This makes it possible to inject drugs such as anesthetics or to drain bodily fluids such as cerebrospinal fluid through the catheter 30. The catheter 30 may be any material that can be inserted into the lumen 9 of the needle tube 10. Examples of materials for the catheter 30 include polyurethane, silicone, polyethylene, polytetrafluoroethylene, polyvinyl chloride, and composites of these. These may also be surface-coated with a hydrocoating, hydrophilic coating, or the like.

[0056] As shown in Figure 10, after the needle tube 10 is inserted from the lumbar vertebrae or the like into the medullary cavity 41, the catheter 30 is inserted through the lumen 9 of the needle tube 10, whereby the catheter 30 comes into contact with the dura mater 40 and curves. At this time, the recess 6 of the needle tube 10 allows the radius of curvature of the curved portion of the catheter 30 to be increased, thereby reducing the insertion resistance of the catheter 30 toward the recess 6. Furthermore, when the catheter 30 is pulled out of the needle tube 10, the catheter 30 is less likely to come into contact with the recess 6, making it easier to avoid breakage of the catheter 30. Furthermore, when the opening edge 7 of the needle tube 10 is inserted toward the longitudinal direction R of the medullary cavity 41, the extension portion 5 prevents problems such as the catheter 30 shaking or twisting in directions other than the longitudinal direction R.

[0057] 10, the distal end 30b of the catheter 30 preferably has a plurality of through-holes 31 penetrating from the outer surface to the inner surface. This makes it easier to grasp the position of the distal end 30b of the catheter 30 within the intrathecal cavity 41 by the feeling that comes from the distal end 30b of the catheter 30 appropriately catching on the opening edge 7. Furthermore, it is also possible to inject drugs such as anesthetics into the intrathecal cavity 41 through the through-holes 31.

[0058] Next, a method for manufacturing a puncture needle according to an embodiment will be described with reference to Figures 11 to 14. Figure 11 is a side view of a tubular member. Figure 12 is a side view of a tubular member on which a reduced diameter surface is formed. Figure 13 is a side view of a tubular member on which another reduced diameter surface is formed at the proximal end of the reduced diameter surface of Figure 12. Figure 14 is a side view of a puncture needle formed by polishing the proximal end of the opening edge of the other reduced diameter surface of Figure 13.

[0059] 11 to 13, the method for manufacturing a medical puncture needle according to the embodiment includes, in order, the steps of forming a reduced diameter surface 50S at the distal end 50b of a tubular member 50 and forming another reduced diameter surface 51S at the proximal end 50a of the reduced diameter surface 50S. If the needle tip portion is cut later, a larger amount of the tubular member 50 needs to be removed, or it may be difficult to form the needle tip portion, but the above-described order of steps can avoid such problems. Methods for forming the reduced diameter surface 50S and the other reduced diameter surface 51S include wire cutting and grinding with a grindstone, with wire cutting being preferred from the standpoint of workability.

[0060] 14, the other reduced diameter surface 51S has an opening edge 52, and it is preferable to include a step of polishing a proximal end 52a of the opening edge 52. Polishing with a grindstone or the like is effective when forming the recess 6 because it is easy to fine-tune the grinding angle. [Explanation of symbols]

[0061] 1 1st reduced diameter section 1A Proximal end of first reduced diameter section 1B Distal end of first reduced diameter section 2 Second reduced diameter section 2A Proximal end of second reduced diameter section 2B Distal end of second reduced diameter section 3 Reduced diameter section 3A Proximal end of reduced diameter section 3S reduced diameter surface 5 Extension 5A Proximal end of extension 5B Distal end of extension 5E Outer edge of extension 6 recess 6A Proximal end of recess 6B Distal end of recess 6E Outer edge of recess 7 Opening edge 7A Proximal edge of opening 7B Distal edge of opening 9 lumen 10 Needle tube 10B Distal end of needle tube 10a Proximal end of needle tube 10b Distal end of needle tube 10C Longitudinal axis of needle tube 11, 12 Puncture needle 15 Gripping member 16 Fixing member 20 Rod-shaped body 20a Proximal end of rod-shaped body 20b Distal end of rod-shaped body 21 Reduced diameter portion of rod-shaped body 21A Proximal end of reduced diameter section 21B Distal end of reduced diameter section 21S Reducing diameter surface of reduced diameter section 22 Fixing member 30 catheter 30b distal end of catheter 31 Through hole 40 Dura mater 41 Medulla 50 Tubular member 50b distal end of tubular member 50S reduced diameter surface 50a Proximal end of reduced diameter surface 51S Other reduced diameter surfaces 52 Opening edge 52a Proximal end of opening edge C Longitudinal axis L1 First virtual line L2 Second virtual line L3 Third virtual line L4 4th virtual line L5 Fifth imaginary line L6 6th imaginary line L10 Virtual line segment R Longitudinal direction of the medullary cavity X longitudinal axis Y: direction perpendicular to the longitudinal axis

Claims

1. a needle tube having a lumen extending in a longitudinal direction; The needle tube has a tapered portion at a distal end portion, the diameter of which decreases toward the distal end, In a side view of the needle tube, when the needle tube is oriented in a direction in which the distance between the longitudinal axis and the distal end of the needle tube is greatest, the needle tube has an extending portion that extends distally of a first imaginary line that passes through the distal end of the needle tube and the proximal end of the reduced diameter portion, and has a recess that is recessed proximally of the first imaginary line on the proximal end side of the reduced diameter portion than the extending portion, and an angle θ1 formed between an outer edge of the recess at the proximal end of the recess and the first imaginary line is larger than an angle θ2 formed between an outer edge of the recess at the distal end of the recess and the first imaginary line, A medical puncture needle in which, on the first imaginary line, the distal end of the recess is located at a point that is at least 1 / 3 of the distance from the distal end of the needle tube toward the proximal end of the reduced diameter portion.

2. a needle tube having a lumen extending in a longitudinal direction; The needle tube has a tapered portion at a distal end portion, the diameter of which decreases toward the distal end, In a side view of the needle tube when the needle tube is oriented in a direction in which the distance between the longitudinal axis and the distal end of the needle tube is greatest, the needle tube has an extending portion extending distal to a first imaginary line passing through the distal end of the needle tube and the proximal end of the reduced diameter portion, and has a recessed portion recessed proximally from the first imaginary line, on the proximal end side of the reduced diameter portion relative to the extending portion, On the first virtual line, the distal end of the recess is located at a point that is at least one-third of the distance from the distal end of the needle tube to the proximal end of the reduced diameter portion, from the distal end of the needle tube to the proximal end of the reduced diameter portion, The medical puncture needle has an opening edge, and the width of the opening edge in a direction perpendicular to an imaginary line segment at a position 1 / 5 of the length of the imaginary line segment from the proximal end to the distal end of the opening edge is at least 0.7 times the width of the opening edge in the perpendicular direction at a position 1 / 2 of the length of the imaginary line segment.

3. a needle tube having a lumen extending in a longitudinal direction; The needle tube has a tapered portion at a distal end portion, the diameter of which decreases toward the distal end, In a side view of the needle tube when the needle tube is oriented in a direction in which the distance between the longitudinal axis and the distal end of the needle tube is greatest, the needle tube has an extending portion extending distal to a first imaginary line passing through the distal end of the needle tube and the proximal end of the reduced diameter portion, and has a recessed portion recessed proximally from the first imaginary line, on the proximal end side of the reduced diameter portion relative to the extending portion, On the first virtual line, the distal end of the recess is located at a point that is at least one-third of the distance from the distal end of the needle tube to the proximal end of the reduced diameter portion, from the distal end of the needle tube to the proximal end of the reduced diameter portion, the reduced diameter portion has a first reduced diameter portion including a proximal end of the reduced diameter portion, and a second reduced diameter portion located distal to the first reduced diameter portion and including a distal end of the needle tube, a rod-shaped body extending in the longitudinal axis direction is inserted into the inner cavity of the needle tube, and the rod-shaped body has a reduced diameter portion at a distal end thereof; A medical puncture needle in which, when viewed from the side of the needle tube, the distal end of the reduced diameter portion of the rod-shaped body is located on a sixth imaginary line passing through the distal end and proximal end of the second reduced diameter portion of the needle tube, or is located proximal to the sixth imaginary line, and the proximal end of the reduced diameter portion of the rod-shaped body is located on the sixth imaginary line or is located proximal to the sixth imaginary line.

4. a needle tube having a lumen extending in a longitudinal direction; The needle tube has a tapered portion at a distal end portion, the diameter of which decreases toward the distal end, In a side view of the needle tube when the needle tube is oriented in a direction in which the distance between the longitudinal axis and the distal end of the needle tube is greatest, the needle tube has an extending portion extending distal to a first imaginary line passing through the distal end of the needle tube and the proximal end of the reduced diameter portion, and has a recessed portion recessed proximally from the first imaginary line, on the proximal end side of the reduced diameter portion relative to the extending portion, On the first virtual line, the distal end of the recess is located at a point that is at least one-third of the distance from the distal end of the needle tube to the proximal end of the reduced diameter portion, from the distal end of the needle tube to the proximal end of the reduced diameter portion, A rod-shaped body extending in the longitudinal axis direction is inserted into the inner cavity of the needle tube, the rod-shaped body has a reduced diameter portion at its distal end, and the reduced diameter surface of the reduced diameter portion of the rod-shaped body is a medical puncture needle that does not contact the needle tube.

5. The medical puncture needle according to any one of claims 2 to 4, wherein, in a side view of the needle tube, an angle θ1 formed between the outer edge of the recess at the proximal end of the recess and the first imaginary line is larger than an angle θ2 formed between the outer edge of the recess at the distal end of the recess and the first imaginary line.

6. The medical puncture needle according to any one of claims 1 to 5, wherein on the first imaginary line, the proximal end of the recess is located at a point that is more than two-thirds of the distance from the distal end of the needle tube to the proximal end of the reduced diameter section, moving from the distal end of the needle tube toward the proximal end of the reduced diameter section.

7. The medical puncture needle according to any one of claims 1 to 6, wherein an outer edge of the recess is curved in a side view of the needle tube.

8. the reduced diameter portion has an opening edge, The medical puncture needle according to any one of claims 1 to 7, wherein, in the side view, the proximal end of the extension portion is located distal to a second imaginary line passing through the distal end and the proximal end of the opening edge.

9. the reduced diameter portion has an opening edge, 5. The medical puncture needle according to claim 1, wherein the width of the opening edge in a direction perpendicular to an imaginary line segment at a position 1 / 5 of the length of the imaginary line segment from the proximal end to the distal end of the opening edge is at least 0.7 times the width of the opening edge in the perpendicular direction at a position 1 / 2 of the length of the imaginary line segment.

10. The medical puncture needle according to claim 8 or 9, wherein the opening edge of the recess is chamfered.

11. The medical puncture needle according to claim 10, wherein the chamfering is a rounding.

12. The medical puncture needle according to any one of claims 1 to 11, wherein the distal end of the needle tube is curved so that the reduced diameter surface of the reduced diameter section faces inward.

13. The reduced diameter portion is a first reduced diameter section including a proximal end of the reduced diameter section; The medical puncture needle according to claim 1 or 2, further comprising a second reduced diameter portion located distal to the first reduced diameter portion and including the distal end of the needle tube.

14. the recess includes a portion of the first reduced diameter portion, The medical puncture needle according to claim 13, wherein the extension portion includes another part of the first reduced diameter portion and the second reduced diameter portion.

15. In the side view, the length H of the needle tube in a direction perpendicular to the longitudinal axis direction at the proximal end of the second reduced diameter portion １ (mm) is the length H of the second reduced diameter portion in the longitudinal direction from the proximal end to the distal end. ２ 15. The medical puncture needle according to claim 13, wherein the diameter is 0.3 to 0.7 times (mm).

16. In the side view, the length H of the needle tube in a direction perpendicular to the longitudinal axis direction at the proximal end of the second reduced diameter portion １ (mm) is the length H of the needle tube in a direction perpendicular to the longitudinal axis direction at the proximal end of the first reduced diameter portion ３ The medical puncture needle according to any one of claims 13 to 15, wherein the thickness is 0.3 to 0.7 times (mm).

17. In the side view, An angle α1 formed by a third imaginary line passing through the distal end of the needle tube and parallel to the longitudinal axis direction and a fourth imaginary line passing through the proximal end and the distal end of the first reduced diameter portion is The medical puncture needle according to any one of claims 13 to 16, wherein the angle α2 is 0.60 to 0.99 times the angle formed by a third imaginary line passing through the distal end of the needle tube and parallel to the longitudinal axis direction, and a fifth imaginary line passing through the proximal end and distal end of the second reduced diameter section.

18. The medical puncture needle according to any one of claims 13 to 17, wherein a rod-shaped body extending in the longitudinal axis direction is inserted into the inner cavity of the needle tube, and the rod-shaped body has a reduced diameter portion at a distal end.

19. In the side view, a distal end of the reduced diameter portion of the rod-shaped body is located on a sixth imaginary line passing through the distal end and the proximal end of the second reduced diameter portion of the needle tube, or is located proximal to the sixth imaginary line; and The medical puncture needle according to claim 18, wherein the proximal end of the reduced diameter portion of the rod-shaped body is located on the sixth imaginary line or on the proximal side of the sixth imaginary line.

20. The medical puncture needle according to claim 18 or 19, wherein a reduced diameter surface of the reduced diameter portion of the rod-shaped body does not contact the needle tube.

21. The medical puncture needle according to any one of claims 1 to 17, wherein a catheter is inserted into the lumen of the needle tube.

22. 22. The medical puncture needle according to claim 21, wherein the distal end of the catheter has a plurality of through holes extending from the outer surface to the inner surface.

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