JP3569689B2 - Puncture needle and method of manufacturing the same - Google Patents

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a puncture needle including a general injection needle, a biopsy needle, an anesthesia injection needle, and the like, and a method for manufacturing the puncture needle.
[0002]
[Prior art]
A puncture needle used as a conventional general injection needle or the like is obtained by cutting the tip of a puncture needle 1 made of a pipe-shaped material obliquely as shown in FIGS. It has a blade surface 2 formed and a needle base (read as "bread") 4 coupled to a base end. The puncture needle 1 has a circular cross section over the entire length direction. The needle base 4 serves as a base when the puncture needle 1 is attached to the tip of the syringe body. The blade surface 2 is formed to pierce the needle tip into a human body or the like. The blade surface is viewed from the end face side of the puncture needle 1 so that the needle point can be made sharper and more easily pierced. Cutouts 3 are formed on both sides of the distal end of 2. In FIG. 12A, the distal end portion of the puncture needle 1 is shown larger than other portions.
[0003]
FIG. 15 shows a procedure for manufacturing the conventional puncture needle. FIGS. 15A and 15B show a circular pipe having a circular cross section as a material of the puncture needle 1, wherein FIG. 15A shows a side surface and FIG. 15B shows a front surface. As shown in FIGS. 15C and 15D, the pipe has a blade surface 2 formed by cutting one end of the pipe at an angle. In addition, cut portions 3 are formed on both sides of the tip of the blade surface 2, and the blade surface 2 is formed in a sharper shape. Assuming that the formed end of the blade surface 2 is the distal end of the puncture needle 1, the needle base 4 is press-fitted to the proximal end of the puncture needle 1 as shown in FIG. . In FIG. 15E, “l” indicates the depth of connection between the puncture needle 1 and the needle base 4. Thus, the puncture needle is completed.
[0004]
[Problems to be solved by the invention]
When piercing the puncture needle 1 into a human body or the like, the puncture needle 1 is pierced from the sharp tip of the blade surface 2 toward the target. Now, as shown in FIG. 13, assuming that the central axis of the puncture needle 1 is OO and the inclination angle of the blade surface 2 with respect to this central axis is θ, the puncture needle 1 pierced by a human body or the like has an inclined blade surface. 2 cannot move in the direction of the central axis line OO due to the resistance applied thereto, and tends to move in the direction of the line PP forming an angle of θ2 which is an angle smaller than the inclination angle θ. If the puncture needle 1 has a sufficiently high rigidity and can withstand the force of going in the direction of the line PP, the puncture needle 1 can proceed straight, but the puncture needle 1 has a small diameter and a cross section. Since the shape is circular, the rigidity is low, and it tends to proceed in the line PP direction as described above.
[0005]
Therefore, as shown in FIG. 14, if the puncture needle 1 is pierced straight from the surface of the skin 5 such as a human body toward the target 6, the tip of the puncture needle 1 moves in the line PP direction as described above. When trying to proceed, the puncture needle 1 bends in an arc as shown by the line 14A in FIG. Therefore, the degree of bending of the puncture needle 1 is estimated in advance so that the distal end portion reaches the target 6, but skill is required to accurately reach the target.
[0006]
The present invention has been made in order to solve the above-described problems of the related art, and in a puncture needle whose cross-sectional area is extremely limited, by devising such that the rigidity is increased, when inserted into a target, An object of the present invention is to provide a puncture needle capable of reducing bending and a method for manufacturing the puncture needle.
[0007]
[Means for Solving the Problems]
The invention according to claim 1 is a puncture needle having a blade surface formed by cutting the tip obliquely, wherein the cross-sectional shape is an ellipse or an ellipse, and the major axis of the ellipse or the ellipse is The blade surface is formed so as to be inclined in the direction, and the cross section of the blade surface forming portion is circular .
When the tip of the puncture needle is inserted into the target, resistance is applied to the sloped blade surface, and it tries to bend the traveling direction of the tip, but the direction of the force to bend the traveling direction is the elliptical or long shape of the puncture needle. Since the rigidity is increased in the major axis direction of the circular cross section, the puncture needle is less bent.
[0008]
The invention according to claim 2 is characterized in that, in the invention according to claim 1 , the cross section of the base end is circular, and the needle base is connected to the base end .
[0009]
The invention according to claim 3 is a method for manufacturing a puncture needle, wherein one end of a pipe-shaped material is cut obliquely to form a blade surface, and then a core is passed through a hole in the pipe-shaped material. The pipe-shaped material is crushed by leaving the blade surface forming portion from a direction orthogonal to the inclination direction of the blade surface to make the cross-sectional shape elliptical or oblong, and the cross-sectional shape of the blade surface forming portion is circular, The method is characterized in that the core is removed.
According to this manufacturing method, a puncture needle as described in claim 1 can be obtained.
[0010]
According to a fourth aspect of the present invention, in the invention of the third aspect, the other end portion of the pipe-shaped material is crushed by leaving the other end portion of the pipe-shaped material. A needle base is connected to the other end of the shaped material.
[0012]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, embodiments of a puncture needle and a method for manufacturing the puncture needle according to the present invention will be described with reference to the drawings.
1 and 2, a puncture needle 11 made of a pipe-shaped material has a blade surface 12 formed by diagonally cutting it at the tip and a needle base 14 coupled to a base end. It is. The needle base 14 serves as a base when the puncture needle 11 is attached to the tip of the syringe body. The blade surface 12 is formed to pierce the needle tip into a human body or the like. The blade surface is viewed from the end face side of the puncture needle 11 so that the needle tip can be made sharper and more easily pierced. Cutouts 13 are formed on both sides of the distal end portion 12. In FIG. 1, the tip portion of the puncture needle 11 is shown in an enlarged manner than other portions.
[0013]
The puncture needle 11 according to this embodiment is different from the conventional puncture needle in that most of the length direction of the puncture needle 11 is elliptical or oval in cross section. More specifically, the cross-sectional shape of the distal end portion 15 (range indicated by reference symbol Q) of the puncture needle 11 including the blade surface 12 is circular as shown in FIG. The cross-section of the puncture needle 11 in the longitudinal direction (the range indicated by the symbol P) is also elliptical as shown in FIG. 2B. Or it is oval. The major axis direction of the elliptical or elliptical cross-sectional shape coincides with the inclination direction of the blade surface 12. In other words, the blade surface 12 is formed so as to be inclined in the major axis direction of the elliptical or oval shape.
[0014]
According to the puncture needle configured as described above, the rigidity in the major axis direction of the elliptical or elliptical cross section increases. Therefore, when the distal end portion 15 of the puncture needle 11 is inserted into the target, a resistance force is applied to the blade surface 12 forming the slope, and this resistance becomes a force for bending the traveling direction of the distal end. Since the direction of the force to be applied is a direction in which the rigidity is increased in the major axis direction of the elliptical or elliptical cross section of the puncture needle as described above, the bending of the puncture needle is reduced. FIG. 3 schematically shows this state. For example, if the puncture needle 11 is pierced straight from the surface of the skin 5 such as a human body toward the target 6, the puncture needle 11 draws an arc as indicated by reference numeral 11A. Bend. However, the degree of this bend is small, and it is relatively easy to reach the target 6, and it does not require much skill.
[0015]
Next, an embodiment of a method of manufacturing the puncture needle 11 will be described with reference to FIG. FIG. 4A shows a pipe having a circular cross-sectional shape, which is a material of the puncture needle 11. As shown in FIG. 4 (b), one end of the pipe is obliquely cut to form a blade surface 12. Also, cutouts 13 are formed on both sides of the tip of the blade surface 12, so that the blade surface 12 is formed in a sharper shape. The steps up to here are the same as the steps (c) and (d) of the conventional example shown in FIG.
[0016]
Next, as shown in FIG. 4C, a core metal 18 longer than the length of the puncture needle 11 is passed through the puncture needle 11 so that both ends of the core metal 18 protrude from both ends of the puncture needle 11. . The diameter of the core bar 18 is smaller than the hole diameter of the puncture needle 11, and a gap is formed between the core bar 18 and the inner wall surface of the puncture needle 11. In this state, most of the length P of the puncture needle 11 in the length direction excluding the distal end portion of the puncture needle 11 indicated by the reference symbol Q and the base end portion of the puncture needle 11 indicated by the reference symbol R, including the blade surface 12. Crush by press. Thus, the cross-sectional shape of most of the length direction P becomes an ellipse or an ellipse as shown in FIG. 2B. The direction of the press is set so that the major axis direction of the oval or oval coincides with the inclination direction of the blade surface 12, that is, crushes the pipe material from a direction perpendicular to the inclination direction of the blade surface 12. .
[0017]
Assuming that the formed end of the blade surface 12 is the distal end of the puncture needle 11, the end of the puncture needle 11 having a circular cross section indicated by the reference symbol R is a base end, and this base end is as shown in FIG. The needle base 14 is press-fitted or otherwise connected by appropriate connecting means. Thus, the puncture needle is completed.
[0018]
In addition, as shown in FIG. 5, the puncture needle 11 that includes the blade surface 12 and substantially the entire length P of the puncture needle 11 in the longitudinal direction other than the distal end portion of the puncture needle 11 indicated by the reference symbol Q, and thus connects the needle base. The range including the other end of the eleventh portion 11 may be pressed, and the range P may be an elliptical or oval cross-sectional shape. Also in this case, the major axis direction of the ellipse or the ellipse is made to coincide with the inclination direction of the blade surface 12. According to this manufacturing method, since the cross-sectional shape of the connecting portion of the needle base is also elliptical or elliptical, the cross-sectional shape of the receiving hole of the needle base is also elliptical or oblong. Alternatively, the cross-sectional shape of the receiving hole of the needle base may be circular, and the space created between the circular receiving hole and the outer periphery of the puncture needle may be filled with a filler or the like.
[0019]
In the method of manufacturing the puncture needle 11, it is also possible to exchange the step of forming the blade surface and the step of forming the elliptical or elliptical cross-section into front and rear. That is, a metal core is passed through the hole of the pipe-shaped material, and in this state, the pipe-shaped material is crushed to have an oval or elliptical cross-sectional shape, and then the core is removed. The puncture needle can also be manufactured by cutting the portion obliquely in the major axis direction of the elliptical or oval shape to form a blade surface.
[0020]
In order to confirm the operation and effect of the puncture needle according to the present invention, a test was performed in comparison with a conventional puncture needle. Hereinafter, the results will be described with reference to FIGS. First, as shown in FIG. 6, the puncture needle 11 is cantilevered at a certain point and is used as a fulcrum. A load T is applied to the puncture needle at a distance of 25 mm from the fulcrum, and a load of 55 mm is applied to the fulcrum. The load T at the time of displacement of 5 mm in the distance was measured. The load T was applied to the puncture needle 11 according to the present invention in the major axis direction of the elliptical or oval cross section as shown in FIG.
[0021]
FIG. 7 shows an example of a puncture needle used for the above test method, and all have different cross-sectional shapes. The unit of each numerical value is mm. A is an example of a conventional puncture needle having a circular cross-sectional shape, having an outer diameter of 0.68 and an inner diameter of 0.48. BF are examples of the puncture needle according to the present invention. In order to make the conditions similar to those of the conventional example as close as possible, a 0.1 mm thick pipe-shaped material shown in A is crushed, and the crushing amount is changed. The ratio between the major axis and the minor axis is changed as shown in FIGS. In B to F, the outer diameters of the major axis and the minor axis are displayed. B is 0.73 for the major axis, 0.63 for the minor axis, C is 0.81 for the major axis, and 0 for the minor axis. .53, D is 0.85 for the major axis, 0.47 for the minor axis, E is 0.86 for the major axis, 0.46 for the minor axis, F is 0.89 for the major axis, and 0.42 for the minor axis. It is.
[0022]
FIG. 8 shows the test results of the subjects A to F according to the test method shown in FIG. 6, and the vertical axis shows that the test method shown in FIG. , A load T at a distance of 25 mm from the fulcrum is taken. The unit of the load T is gram. As can be seen from FIG. 8, the load T required for displacing a fixed distance is the smallest in a circular cross-sectional shape like a conventional puncture needle, and the cross-sectional shape is an ellipse or like a puncture needle according to the present invention. It can be seen that the load T of the oval type is larger than that of the conventional type, and the load T increases as the ratio of the dimension in the major axis direction to the dimension in the minor axis direction increases.
[0023]
9 to 11 show data obtained by changing the test method. In this test method, as shown in FIG. 9 (a), the puncture needle 11 is cantilevered at a certain point, and this is used as a fulcrum. The load T at the time of displacement of 5 mm at a distance of 110 mm from the fulcrum was measured. As for the puncture needle 11 according to the present invention, as shown in FIG. 9B, the load T was applied in the major axis direction of the elliptical or oval cross section.
[0024]
FIG. 10 shows an example of a puncture needle used for the above test method, and all have different cross-sectional shapes. The unit of each numerical value is mm. A is an example of a conventional puncture needle having a circular cross-sectional shape, having an outer diameter of 2.07 and an inner diameter of 1.87. B and C are examples of the puncture needle according to the present invention, in which the ratio between the major axis and the minor axis is changed by crushing the pipe-shaped material and changing the crushing amount. The outer diameters of the major axis and the minor axis are displayed in both B and C, B is 2.43 for the major axis, 1.62 for the minor axis, C is 2.65 for the major axis, and 1 is the minor axis. .35.
[0025]
FIG. 11 shows the results of tests on the subjects A to C according to the test method shown in FIG. 9, and the vertical axis shows that the test method shown in FIG. , A load T at a distance of 100 mm from the fulcrum is taken. The unit of the load T is gram. As can be seen from FIG. 11, the load T required for displacing a certain distance is the smallest in a circular cross-sectional shape like a conventional puncture needle, and the cross-sectional shape is elliptical like the puncture needle according to the present invention. Or, it can be seen that the load T is larger in the case of an oblong shape than in the conventional case, and that the load T increases as the ratio of the dimension in the long axis direction to the dimension in the short axis direction increases.
[0026]
【The invention's effect】
The puncture needle according to the present invention and the puncture needle manufactured by the method according to the present invention have an elliptical or elliptical cross-sectional shape, and the blade surface is formed by being inclined in the major axis direction of the elliptical or elliptical shape. Have been. When piercing a target from the blade surface, a force is applied to bend the puncture needle on the blade surface, and the direction of this force is the major axis direction of the elliptical or elliptical cross-sectional shape, and the rigidity is enhanced. Since the direction is the direction, the puncture needle is less bent, and the needle tip can easily reach the target.
[Brief description of the drawings]
FIG. 1 is a partially enlarged side view showing an embodiment of a puncture needle according to the present invention.
2A is a cross-sectional view taken along a line AA in FIG. 1, and FIG. 2B is a cross-sectional view taken along a line BB in FIG.
FIG. 3 is a schematic diagram showing a cross-sectional operation and effect when the puncture needle according to the present invention is used.
FIG. 4 is a side view showing an embodiment of the method for manufacturing a puncture needle according to the present invention in the order of steps.
FIG. 5 is a side view showing a modification of the method for manufacturing a puncture needle according to the present invention.
FIG. 6 is a side view showing an example of a test method for confirming the effect of the puncture needle according to the present invention.
FIG. 7 is a cross-sectional view showing various cross-sectional shapes of the puncture needle used in the above-mentioned effect / effect confirmation test.
FIG. 8 is a graph showing the results of the above-mentioned effect-effect confirmation test.
FIG. 9 is a side view showing another example of a test method for confirming the effect of the puncture needle according to the present invention.
FIG. 10 is a cross-sectional view showing various cross-sectional shapes of a puncture needle subjected to the above-mentioned effect / effect confirmation test.
FIG. 11 is a graph showing the results of the above-mentioned effect / effect confirmation test.
12A is a partially enlarged side view showing an example of a conventional puncture needle, and FIG. 12B is a cross-sectional view thereof.
FIG. 13 is an enlarged side view of a distal end portion for explaining a force applied to a blade surface when a conventional puncture needle is used.
FIG. 14 is a schematic diagram showing a cross section of the operation when a conventional puncture needle is used.
FIG. 15 is a side view showing an example of a conventional method for manufacturing a puncture needle in the order of steps.
[Explanation of symbols]
11 puncture needle 12 blade surface 14 needle base 15 tip

Claims (4)

A puncture needle having a blade surface formed by cutting the tip obliquely, wherein the cross-sectional shape is an ellipse or an oval, and the blade surface is inclined in a major axis direction of the ellipse or the ellipse. And a cross-section of the blade surface forming portion is circular . The puncture needle according to claim 1 , wherein a cross section of the proximal end is circular, and a needle base is connected to the proximal end . One end of the pipe-shaped material is cut obliquely to form a blade surface, and then a metal core is passed through the hole of the pipe-shaped material. In this state, the blade surface forming portion is formed in a direction perpendicular to the inclination direction of the blade surface. The puncture needle is characterized in that the cross-sectional shape is made elliptical or oblong by crushing the pipe-shaped material while leaving the cross-section, and the cross-sectional shape of the blade surface forming portion is made circular, and then the core metal is removed. Production method. 4. The pipe-shaped material is crushed by leaving the other end of the pipe-shaped material, so that the cross-sectional shape of the other end of the pipe-shaped material is circular, and a needle base is connected to the other end of the pipe-shaped material. Method for producing a puncture needle.

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