JP4280328B2 - Indwelling needle assembly and inner needle manufacturing method - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an indwelling needle assembly that punctures and indwells a blood vessel, for example, during infusion, and a method for manufacturing an inner needle that constitutes the indwelling needle assembly.
[0002]
[Prior art]
When infusion is performed on the patient, an indwelling needle connected to the infusion line is punctured into the patient's blood vessel, and placed in place. Such an indwelling needle is composed of a hollow outer needle, and when puncturing a patient's blood vessel, a hollow inner needle having a blade surface inclined to the needle tip is inserted into the lumen of the outer needle, The puncture operation is performed with the needle tip protruding from the tip of the outer needle.
[0003]
When the inner needle reaches the blood vessel, the blood flowing in from the opening of the needle tip passes through the lumen of the inner needle and flows into a transparent housing attached to the proximal end portion of the inner needle (flashback). . Thereby, it can confirm that the inner needle secured the blood vessel.
[0004]
At this point, the tip of the outer needle is inserted into the blood vessel by slightly advancing the inner needle and the outer needle.
[0005]
However, in the conventional indwelling needle assembly, since the inner peripheral surface of the distal end portion of the outer needle is in close contact with the outer peripheral surface of the inner needle, blood does not flow between the outer needle and the inner needle. It was not possible to visually confirm that blood vessels were secured by flashback of blood.
[0006]
For this reason, after confirming that the inner needle has secured the blood vessel, an operation to advance the inner needle and the outer needle by a subtle distance was performed according to the operator's feelings and experience, but the blade surface of the inner needle and the outer needle The distance from the tip is slightly different depending on the type, size, manufacturer, etc. of the indwelling needle assembly, and there is also a difference in the thickness of the patient's blood vessel. However, the puncture position of the outer needle with respect to the blood vessel may be too shallow or too deep.
[0007]
[Problems to be solved by the invention]
An object of the present invention is to provide an indwelling needle assembly and an inner needle manufacturing method that are easy to manufacture and can visually recognize that the indwelling needle (outer needle) has secured a blood vessel.
[0008]
[Means for Solving the Problems]
Such an object is achieved by the present inventions (1) to (5) below.
[0009]
(1) An indwelling needle assembly including a hollow outer needle and a metal inner needle that is inserted into the lumen of the outer needle and has a blade surface inclined at the needle tip,
Providing a groove for flowing blood formed by press working along the axial direction of the inner needle from the vicinity of the root portion of the blade surface of the inner needle;
The wall thickness of the inner needle tube is substantially constant over the entire circumference including the groove forming portion,
The vicinity of the boundary between the groove and the outer peripheral surface of the inner needle is rounded,
The maximum depth of the groove is 0.03 to 0.15 mm, the width of the groove is 0.1 to 1 mm,
The outer needle has a reduced-diameter portion having a tapered shape whose outer diameter gradually decreases toward the distal end and having an inner diameter substantially equal to or slightly smaller than the outer diameter of the inner needle,
The proximal end portion of the outer needle with respect to the reduced diameter portion has an inner diameter larger than the outer diameter of the inner needle, thereby forming a tubular gap with the inner needle,
The length of the groove is a length in the range of 1 to 15 mm and exceeding the axial region of the reduced diameter portion,
In the state where the inner needle is inserted into the lumen of the outer needle and the tip of the inner needle protrudes from the distal end opening of the outer needle, the groove faces the reduced diameter portion, and the axial direction of the reduced diameter portion The indwelling needle assembly is configured such that the distal end opening of the outer needle and the gap communicate with each other through the groove.
[0010]
(2) A method for producing a metal inner needle that is used by being inserted through the lumen of a hollow outer needle and has a blade surface inclined at the tip of the needle,
Forming the blade surface;
Press machine having a female mold in which an inner needle insertion groove having a U-shaped cross section and a positioning portion are formed, and a male mold installed above the female mold and having a groove forming convex portion The male mold is collided with the female mold in a state where the inner needle on which the blade surface has been formed is inserted into the groove for inserting the inner needle and is positioned by the positioning portion with reference to the position of the blade surface. And pressing the inner needle to form a groove for flowing blood along the axial direction of the inner needle from the vicinity of the root portion of the blade surface,
In forming the groove, the thickness of the inner needle tube is substantially constant over the entire circumference including the groove forming portion, and the vicinity of the boundary between the groove and the outer peripheral surface of the inner needle is rounded. A method for producing an inner needle, wherein the inner needle is formed to have a tinged shape.
[0011]
(3) A U-shaped positioning portion is provided at one end of the inner needle insertion groove of the female mold, and the blade of the inner needle inserted into the inner needle insertion groove The method for manufacturing an inner needle according to (2), wherein the groove is formed while positioning the surface so that the blade surface faces upward by bringing the surface into contact with the positioning portion.
[0012]
(4) The maximum depth of the groove is 0.03 to 0.15 mm, the width of the groove is 0.1 to 1 mm, and the length of the groove is 1 to 15 mm. ) Manufacturing method of the inner needle.
[0013]
(5) The press pressure in the press work is 50 to 300 kg / cm. ² The method for producing an inner needle according to any one of (2) to (4) above.
[0026]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the indwelling needle assembly and the inner needle manufacturing method of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
[0027]
Figure 1 , Indwelling needle Assembly Example 2 is a plan view showing the configuration near the tip of the inner needle in the indwelling needle assembly shown in FIG. 1, FIG. 3 is a cross-sectional view taken along line AA in FIG. 2, and FIG. 2 is a cross-sectional view taken along line BB in FIG. 2, and FIG. 5 is a vertical cross-sectional view showing a configuration in the vicinity of the distal end portion in a state where the inner needle and the outer needle are assembled. In the following description, the right side in FIGS. 1, 2, 3, and 5 is referred to as a “base end”, and the left side is referred to as a “tip”, and the same applies to other drawings.
[0028]
As shown in FIG. 1 and FIG. , Indwelling needle The assembly 1 includes an outer needle 2 that is an indwelling needle and an inner needle 4 that is used by being inserted into the outer needle 2.
[0029]
The hub 3 is fixed in a liquid-tight manner to the proximal end portion of the outer needle 2. The hub 3 is made of a transparent or translucent resin, and the visibility of the inside 31 is ensured.
[0030]
Further, as shown in FIG. 5, the distal end portion of the outer needle 2 is formed with a reduced diameter portion 21 whose inner diameter is reduced. The inner diameter of the reduced diameter portion 21 is set to be approximately equal to or slightly smaller than the outer diameter of the inner needle 4 to be described later. The inner needle 4 is inserted into the lumen of the outer needle 2 and the needle tip 41 is The inner peripheral surface of the reduced diameter portion 21 is configured to be in close contact with the outer peripheral surface of the inner needle 4 in a state of protruding from the distal end opening 23 of the outer needle 2 (hereinafter referred to as “assembled state”). .
[0031]
Further, the inner diameter of the outer needle 2 is larger than the outer diameter of the inner needle 4 at the proximal end side of the reduced diameter portion 21, and the inner peripheral surface of the reduced diameter portion 21 and the outer peripheral surface of the inner needle 4 in the assembled state. A predetermined gap 22 is formed between the two. The gap 22 becomes a blood flow path.
[0032]
In addition, the front-end | tip part of the outer needle 2 has comprised the taper shape which the outer diameter reduces gradually toward a front-end | tip direction. This makes it possible to puncture a living body easily and with minimal invasiveness.
[0033]
The constituent material of the outer needle 2 is not particularly limited, but for example, various soft resins such as ethylene-tetrafluoroethylene copolymer (ETFE), polyurethane, and polyether nylon resin are preferable.
[0034]
It is preferable that all or part of the outer needle 2 has visibility. Further, an X-ray contrast agent such as barium sulfate or barium carbonate may be blended in the constituent material of the outer needle 2 to provide a contrast function.
[0035]
The inner needle 4 is made of, for example, a metal material such as stainless steel, aluminum or an aluminum alloy, titanium or a titanium alloy, and a sharp needle tip 41 is formed at the tip thereof. The needle tip 41 has a blade surface 42 inclined at a predetermined angle with respect to the axis of the inner needle 4.
[0036]
As shown in FIG. 1, the length of the inner needle 4 is set to such a length that at least the needle tip 41 protrudes from the distal end opening 23 of the outer needle 2 in the assembled state.
[0037]
A hub (housing) 5 is fixed to the proximal end portion of the inner needle 4 in a liquid-tight manner. The hub 5 is preferably made of a transparent or translucent resin, and the visibility of the interior 52 is ensured.
[0038]
A connecting portion 51 having a reduced diameter is formed at the distal end portion of the hub 5. Generally, the connecting portion 51 of the hub 5 is in the proximal end opening of the hub 3 in the assembled state.
[0039]
Examples of the constituent material of the hub 3 and the hub 5 include polyolefins such as polyethylene, polypropylene, and ethylene-vinyl acetate copolymer, polyvinyl chloride, polymethyl methacrylate, polycarbonate, polybutadiene, polyamide, and polyester, respectively.
[0040]
As shown in FIGS. 2 to 5, chamfering is performed on a predetermined portion of the inner needle 4. More specifically, a belt-like chamfered portion that is notched flatly at a portion of the outer peripheral portion of the inner needle 4 that is in close contact with the outer needle 2, that is, a portion that faces the reduced diameter portion 21 of the outer needle 2 in the assembled state. 43 is formed.
[0041]
The chamfered portion 43 is formed by a length b from the vicinity of the base end portion (root portion) of the blade surface 42 along the axial direction of the inner needle 4.
[0042]
The maximum depth a of the chamfered portion 43 is less than the wall thickness of the inner needle 4 tube.
The shape and dimensions of the chamfered portion 43 are not particularly limited as long as they can cover the close contact portion between the inner needle 4 and the outer needle 2, but in the case of the illustrated configuration, the length b is 1 to 20 mm. About 1 to 10 mm is more preferable. The maximum depth a is preferably about 0.01 to 0.2 mm, more preferably about 0.03 to 0.15 mm.
[0043]
Further, the chamfered portion 43 can be formed at any position on the circumference of the outer periphery of the inner needle. However, for reasons such as ease of forming the chamfered portion 43, the root portion (ago portion) of the blade surface 42. It is preferable that the position is in the vicinity.
[0044]
In FIG. 4, the thickness of the tube of the inner needle 4 in the portion where the chamfered portion 43 is formed is thinner than that of the other portions. As in the case of, the thickness of the tube of the inner needle 4 in the chamfered portion 43 can be made substantially equal to the thickness of the other portions, thereby increasing the strength of the chamfered portion 43.
[0045]
By providing the chamfered portion 43 as described above on the inner needle 4, a gap 44 serving as a blood flow path is formed inside the reduced diameter portion 21 in the assembled state, and the distal end of the outer needle 2 is interposed via the gap 44. The opening 23 and the gap 22 communicate with each other to form a continuous blood channel.
[0046]
The greatest advantage of providing the chamfered portion 43 is that it can be easily processed and formed. Details will be described below.
[0047]
The chamfered portion 43 can be formed by plastic processing such as grinding, polishing, laser processing, etching, or pressing. For example, when grooves are formed at the same position instead of the chamfered portion 43 by grinding or polishing, it is necessary to control the relative movement of the grindstone with respect to the workpiece in the three-dimensional directions of length, width, and depth. On the other hand , Chamfer When 43 is formed by the same method, since the chamfered portion 43 has a flat shape, the relative movement direction of the grindstone is controlled only in the two-dimensional direction of the longitudinal direction and the depth direction of the inner needle 4. Is enough. Moreover, a plurality of inner needles 4 can be arranged in a state in which the direction of the blade surface 42 of the inner needle 4 and the tip positions thereof are aligned, and chamfering can be performed simultaneously on these.
[0048]
Accordingly, the chamfered portion 43 can be formed with a processing device having a simpler configuration, the processing accuracy is high, and a plurality of inner needles 4 can be chamfered together, so that productivity is remarkably improved. To do.
[0049]
Next, an example of a usage method (action) of the indwelling needle assembly 1 will be described.
[1] As shown in FIG. 1, the outer needle 2 and the inner needle 4 are assembled in advance.
[0050]
In such an assembled state of the indwelling needle assembly 1, the needle tip 41 projects from the distal end opening 23 of the outer needle 2, and the axial region of the reduced diameter portion 21 is included in the chamfered portion 43 of the inner needle 4.
[0051]
In addition, it is preferable that this process has already been completed when the indwelling needle assembly 1 is used (when the packaging material is opened).
[0052]
[2] The assembled inner needle 4 and outer needle 2 are punctured into a patient's blood vessel (vein or artery).
[0053]
When the needle tip 41 of the inner needle 4 is punctured into a blood vessel, blood flows backward in the inner needle 4 in the proximal direction due to the internal pressure (blood pressure) of the blood vessel, and is introduced into the interior 52 of the hub 5 so as to have visibility. In 5, the flashback can be visually recognized. Thereby, it can be known that the needle tip 41 of the inner needle 4 has secured the blood vessel.
[0054]
When the inner needle 4 and the outer needle 2 are further advanced by a minute distance, the tip of the outer needle 2 is inserted into the blood vessel. As a result, blood flows in from the distal end opening 23, passes through the gap 44, then flows in the gap 22 toward the proximal end, and is introduced into the inside 31 of the hub 3. And this flashback can be visually recognized in the outer needle 2 and the hub 3 which have visibility. Thereby, it can be known that the distal end portion of the outer needle 2 has secured the blood vessel.
[0055]
[3] After that, only the outer needle 2 travels further in the blood vessel and is introduced to a predetermined indwelling position. Then, the outer needle 2 is held with one hand, and the hub 5 is held with the other hand to move in the proximal direction. Pull the inner needle 4 out of the outer needle 2.
[0056]
[4] An infusion line is connected to the hub 3 via a connector (not shown), the outer needle 2 and the hub 3 are fixed with an adhesive tape or the like, and the infusion is supplied. Thereby, the infusion solution is injected into the blood vessel of the patient through the outer needle 2.
[0057]
6 and 7 respectively , Indwelling needle Other of the assembly Example It is a perspective view which shows the structure of the inner needle front-end | tip part which concerns on this, and a longitudinal cross-sectional view which shows the structure of the front-end | tip part vicinity in the assembly state of an inner needle and an outer needle. Shown below in these figures Example 1 to 5 shown above Example The difference will be mainly described.
[0058]
As shown in FIG. 6, a rough surface 45, that is, a surface having a large number of minute irregularities is formed on the outer peripheral surface of the distal end portion of the inner needle 4 by roughening. The formation portion (formation region) of the rough surface 45 in the inner needle longitudinal direction is substantially the same as the chamfered portion 43.
[0059]
As shown in FIG. 7, in the assembled state, the rough surface 45 formed on the inner needle 4 is located at a portion facing the reduced diameter portion 21 of the outer needle 2, and includes an axial region of the reduced diameter portion 21. To do.
[0060]
Such an indwelling needle assembly having a rough surface 45 on the inner needle 4 is also used as follows. Example Is the same as In this case, when the distal end of the outer needle 2 is inserted into the blood vessel in the step [2], blood flows from the distal end opening 23 and passes through a large number of minute recesses in the rough surface 45, and then the gap 22 Flows toward the proximal direction and is introduced into the interior 31 of the hub 3. Then, the flashback can be visually recognized in the outer needle 2 and the hub 3 having visibility, so that it can be known that the distal end portion of the outer needle 2 has secured the blood vessel.
[0061]
The rough surface 45 can be formed only in a part of the outer circumference of the inner needle in the circumferential direction. However, in order to secure as large an area as a blood flow path on the rough surface 45 as shown in the figure, In addition, it is preferable that it is formed all around the inner needle.
[0062]
The roughness of the rough surface 45 is not particularly limited, but the centerline average roughness Ra specified in JIS B 0601 is preferably about 10 to 500 μm, and more preferably about 50 to 200 μm. By setting it as such roughness, a rough surface process is easy and the flow of the blood in the rough surface 45 is fully securable.
[0063]
The greatest advantage of providing the rough surface 45 is that it can be easily processed and formed. Details will be described below.
[0064]
The rough surface 45 can be formed, for example, by masking a region other than the rough surface forming portion of the inner needle 4 and performing sandblasting, shot blasting, etching, or the like.
[0065]
Further, the inner needles 4 are arranged in a state in which the direction of the blade surface 42 of the inner needle 4 and the positions of the tips thereof are aligned, and by the above-described processing method, it is also possible to perform roughing on these simultaneously. Productivity is greatly improved.
[0066]
8 and 9 respectively show the indwelling needle assembly of the present invention. Examples of FIG. 10 is a sectional view taken along line CC in FIG. 9, FIG. 11 is a sectional view taken along line DD in FIG. 9, and FIG. It is a longitudinal cross-sectional view which shows the structure of the front-end | tip part vicinity in the assembly state of an inner needle and an outer needle. Hereinafter, the embodiment shown in these figures is shown in FIGS. Example The difference will be mainly described.
[0067]
As shown in FIGS. 8 to 12, a groove 46 extending along the longitudinal direction of the inner needle 4 is formed on the outer peripheral surface of the distal end portion of the inner needle 4. The formation portion (formation region) of the groove 46 in the longitudinal direction of the inner needle is substantially the same as the chamfered portion 43.
[0068]
As shown in FIG. 12, in the assembled state, the groove 46 formed in the inner needle 4 is located at a portion facing the reduced diameter portion 21 of the outer needle 2 and includes an axial region of the reduced diameter portion 21. .
[0069]
In this case, as shown in FIG. 11, both edge portions 47 of the groove 46, that is, the vicinity of the boundary portion between the groove 46 and the outer peripheral surface of the inner needle 4 is rounded (so-called “R”). preferable. If the edge portion 47 is sharp, the inner needle 4 may be damaged when the inner needle 4 is inserted into the outer needle 2, but the edge portion 47 is rounded in this way. If so, such inconvenience does not occur.
[0070]
Such grooves 46 are , Inner needle 4 Formed by pressing. When the groove 46 is formed by grinding, laser processing, or the like, sharply sharp edges are easily formed on both sides of the groove 46. In order to round the edge, secondary processing such as polishing or deburring is performed. Processing is required and the manufacturing process becomes complicated, but the press For processing When the inner needle 4 is plastically deformed to form the groove 46, the groove 46 having the rounded edge portion 47 can be easily formed without performing the secondary processing.
[0071]
On the inner surface of the inner needle 4 at the portion where the groove 46 is formed, a protruding portion 48 that protrudes into the inner cavity of the inner needle 4 is formed. Thus, as shown in FIG. 11, the thickness of the tube of the inner needle 4 is substantially equal between the portion where the groove 46 is formed and the other portion, that is, substantially over the entire circumference of the tube including the portion where the groove 46 is formed. It is constant. For this reason, there is no decrease in strength in the portion where the groove 46 is formed, and even when the tube of the inner needle 4 is relatively thin, deformation or breakage in the portion where the groove 46 is formed can be effectively prevented.
[0072]
As shown in FIG. 9, the groove 46 is formed for a length d along the axial direction of the inner needle 4 from the vicinity of the base end portion (root portion) of the blade surface 42.
[0073]
The shape and dimensions of the groove 46 are not particularly limited as long as they can cover the close contact portion between the inner needle 4 and the outer needle 2 (the inner peripheral surface of the reduced diameter portion 21). The maximum depth c of 46 is preferably about 0.03 to 0.15 mm, and the length d is preferably about 1 to 15 mm. Further, the width e of the groove 46 is preferably about 0.1 to 1.0 mm, and more preferably about 0.2 to 0.5 mm.
[0074]
Further, the cross-sectional shape, maximum depth, width, and the like of the groove 46 may be the same or changed along the longitudinal direction of the inner needle 4. For example, the groove 46 may have a portion (particularly a proximal portion) whose maximum depth and / or width gradually decreases (or gradually increases) toward the proximal direction.
[0075]
In the example shown in the figure, a protrusion 48 that protrudes into the lumen of the inner needle 4 is formed on the inner surface of the inner needle 4 in the portion where the groove 46 is formed, but there is no such protrusion 48. There may be.
[0076]
Moreover, the groove | channel 46 is not restricted to a linear thing like illustration, For example, what was curved suitably, what meandered, what was formed in the spiral, etc. may be sufficient.
[0077]
A plurality of grooves 46 may be formed, and in this case, the positional relationship between the grooves 46 is arranged parallel to each other, arranged at a predetermined angle, or intersects. Anything can be used. One groove 46 may be branched into a plurality of grooves on the way.
[0078]
According to the plastic working described above, even such a plurality of grooves 46 or complicatedly shaped grooves 46 can be easily formed.
[0079]
The use method of the indwelling needle assembly having the groove 46 in the inner needle 4 is the same as that of the above embodiment. In this case, when the distal end of the outer needle 2 is inserted into the blood vessel in the step [2], blood flows from the distal end opening 23, passes through the inside of the groove 46, and further passes through the gap 22 in the proximal direction. Flows toward the inside 31 of the hub 3. Then, the flashback can be visually recognized in the outer needle 2 and the hub 3 having visibility, so that it can be known that the distal end portion of the outer needle 2 has secured the blood vessel.
[0080]
Hereinafter, a preferred example of a method for manufacturing the inner needle 4 having the groove 46 described above, particularly a method for forming the groove 46 by plastic working (pressing) will be described.
[0081]
First, the blade surface 42 is formed at the end of the tubular body constituting the inner needle 4. The formation method of the blade surface 42 is not particularly limited, and can be performed according to a conventional method such as cutting, grinding, polishing, or laser processing.
[0082]
Next, the grooves 46 are formed using a press 10 as shown in FIG. The press machine 10 includes a main body 100, a female mold (lower mold) 101, and a male mold (upper mold) 102, and the male mold 102 corresponds to the female mold 101 in FIGS. 13 to 16. It is installed so that it can move in the middle and up and down directions.
[0083]
The female mold 101 has a U-shaped groove 104 into which the inner needle 4 is inserted. In this case, the width of the groove 104 is approximately the same as the outer diameter of the inner needle 4 or slightly larger than the outer diameter of the inner needle 4, and the inner needle 4 is laterally (in a direction perpendicular to the pressing direction) during pressing. Prevents crushing.
[0084]
A positioning portion 103 formed in a U-shape (overhang shape) is formed at one end of the groove 104 of the female mold 101. As shown in FIG. 14, when the inner needle 4 is inserted into the groove 104 and the inner needle 4 is moved in the distal direction within the groove 104, the blade surface 42 of the inner needle 4 comes into contact with the positioning portion 103, and the inner needle 4 is positioned so that the blade surface 42 faces upward. Thereby, when pressed with the male mold 102, the groove 46 is formed at an appropriate position, that is, at a position extending in the axial direction of the inner needle 4 from the vicinity of the base end portion (root portion) of the blade surface 42. The
[0085]
The male mold 102 is installed so as to be slidable in the vertical direction in FIG. 13 with respect to the sliding portion 106 of the main body 100. On the lower surface of the male mold 102, a convex portion (projection) 105 for forming the groove 46 in the inner needle 4 is formed. The convex portion 105 extends in parallel with the groove 104 formed in the female mold 101, and the length thereof is substantially equal to the length d of the groove 46 to be formed. The cross-sectional shape of the convex portion 105 is V-shaped (mountain shape).
[0086]
In the state in which the inner needle 4 is inserted into the groove 104 and positioning is performed as described above (the state shown in FIGS. 13 to 15), an operating lever (or handle) (not shown) is operated to operate the male mold 102. 16 is lowered until it collides with the female mold 101, the projection 105 of the male mold 102 presses the tube wall of the inner needle 4 and plastically deforms, as shown in FIG. A groove 46 is formed.
[0087]
At this time, the tube wall of the portion pressed by the convex portion 105 escapes toward the inner cavity side of the inner needle 4 and forms the protruding portion 48, so that the wall thickness of the tube of the inner needle 4 is the portion where the groove 46 is formed. It is almost constant over the entire circumference of the tube.
[0088]
Further, since the outer peripheral surface of the inner needle 4 is regulated by the inner surface of the groove 104, the contour shape (circular shape) of the inner needle 4 is greatly increased, such as the inner needle 4 being flattened with the formation of the groove 46. Will not be damaged.
[0089]
When the groove 46 is formed as described above, the male mold 102 is raised and separated from the male mold 102, and the inner needle 4 is taken out from the groove 104.
[0090]
Such production of the inner needle 4 (formation of the groove 46) can be repeated for a plurality of similar inner needles 4.
[0091]
When the groove 46 is formed by such pressing, the processing conditions are not particularly limited and are appropriately determined according to the conditions such as the material, inner diameter, and thickness of the inner needle 4. 50 ~ 300kg / cm ² Degree is preferred, 100-300 kg / cm ² The degree is more preferable.
[0092]
Further, the positioning method of the inner needle 4 is not limited to that described above. For example, the inner needle 4 is sandwiched and fixed by a chuck (not shown), and the blade surface 42 of the inner needle 4 is secured by one or more cameras. It is also possible to adjust the position where the groove 46 is formed while confirming the direction (position).
[0093]
Further, one groove 46 can be formed by two or more pressing processes. In this case, in each pressing step, the male mold 102 can be appropriately replaced with one having a different shape or formation position of the convex portion 105. Thereby, it becomes possible to form the groove 46 having a more complicated shape.
[0094]
Further, when a plurality of grooves 46 are formed in one inner needle 4, the inner needle 4 may be rotated a predetermined angle in the groove 104 and pressed by the male mold 102 a plurality of times.
[0095]
Further, for example, by using a multi-processing mold, the grooves 46 can be formed in the plurality of inner needles 4 at a time, and productivity can be increased. For example, when the press machine 10 is used, a plurality of grooves 104 are formed in the female mold 101, and a plurality of convex portions 105 corresponding to each groove 104 are formed in the male mold 102. A groove 46 can be formed in the inner needle 4.
[0096]
According to the manufacturing method of the inner needle 4 as described above, the groove 46 having an appropriate shape can be formed at an appropriate position with good reproducibility, and the operation is extremely simple. Therefore, the productivity of the inner needle 4 and the indwelling needle assembly 1 including the inner needle 4 can be improved.
[0097]
FIG. , Indwelling needle Other of the assembly Example FIG. 18 is a cross-sectional view taken along the line GG in FIG. 17. Shown below in these figures Example 1 to 5 shown above Example The difference will be mainly described.
[0098]
In this indwelling needle assembly, the inner needle 4 is a normal one in which the chamfered portion 43, the rough surface 45 or the groove 46 is not formed. A plurality of grooves (gap) 24 extending in the longitudinal direction of the outer needle 2, that is, four grooves 24 in the illustrated configuration are formed at intervals of 90 ° on the inner peripheral surface of the reduced diameter portion 21 of the outer needle 2. (See FIG. 18).
[0099]
Although the depth f of the groove | channel 24 is not specifically limited, Usually, about 0.01-0.5 mm is preferable and about 0.03-0.2 mm is more preferable.
[0100]
The use method of the indwelling needle assembly having the groove 24 in the outer needle 2 is the same as that of the above embodiment. In this case, in step [2], when the distal end of the outer needle 2 is inserted into the blood vessel, blood flows from the distal end opening 23 and passes through each groove 24, and then the gap 22 is directed toward the proximal direction. And is introduced into the inside 31 of the hub 3. Then, the flashback can be visually recognized in the outer needle 2 and the hub 3 having visibility, so that it can be known that the distal end portion of the outer needle 2 has secured the blood vessel.
[0101]
It should be noted that the greatest advantage of providing the groove 24 serving as a blood flow path on the outer needle 2 side is that it can be easily processed and formed. Details will be described below.
[0102]
Since the outer needle 2 is a tubular member and the constituent material is a resin material as described above, the outer needle 2 can be manufactured by extrusion molding. According to this molding method, the groove 24 can be formed at the same time when the outer needle 2 is molded, and there is no additional manufacturing process. In particular, the shape, dimensions, arrangement pattern, and the like of the grooves 24 can be arbitrarily set depending on the shape of a die (a base portion from which molten resin comes out) of an extruder.
[0103]
The formation of the groove 24 for the outer needle 2 is easier than when the metal inner needle 4 is processed.
[0104]
Needless to say, various conditions relating to the groove 24 such as the shape, dimensions, arrangement pattern, and forming method of the groove 24 are not limited to those described above.
[0105]
The indwelling needle assembly of the present invention has been illustrated above. Example However, the present invention is not limited to this, and each member constituting the indwelling needle assembly can be replaced with any member that can exhibit the same function.
[0106]
Further, the chamfered portion 43, the rough surface 45, the groove 46, the groove 24 and the like described above may be formed at a place other than the close contact portion between the outer needle 2 and the inner needle 4, for example, the outer needle 2 or the inner needle 4 It may be formed over almost the entire length.
[0107]
【The invention's effect】
As described above, according to the indwelling needle assembly of the present invention, it is applied to the outer peripheral surface of the inner needle. By the groove by press working Since the blood channel is formed, it can be confirmed by blood flashback that the outer needle has secured the blood vessel. Therefore, the puncture operation to the blood vessel of the indwelling needle can be performed easily and accurately.
[0108]
Moreover, the indwelling needle assembly of the present invention is easy to manufacture and process and has high processing accuracy. In particular, when processing a plurality of inner needles at the same time or manufacturing the outer needles by extrusion molding, the production efficiency is high, such as no increase in the number of manufacturing steps, and thus suitable for mass production.
[0109]
Moreover, according to the manufacturing method of the inner needle of this invention, a groove | channel can be formed in an appropriate position with an appropriate shape by simple operation.
[0110]
In particular, the wall thickness of the inner needle tube is almost constant over the entire circumference including the groove forming portion. So It is possible to prevent the strength of the groove forming portion from being lowered.
[Brief description of the drawings]
[Figure 1] Indwelling needle Assembly Example FIG.
2 is a plan view showing a configuration in the vicinity of a distal end portion of an inner needle in the indwelling needle assembly shown in FIG. 1. FIG.
FIG. 3 is a cross-sectional view taken along line AA in FIG.
4 is a sectional view taken along line BB in FIG. 2. FIG.
FIG. 5 is a longitudinal sectional view showing the configuration near the tip in an assembled state.
[Fig. 6] Indwelling needle Other of the assembly Example It is a perspective view which shows the structure of the inner needle front-end | tip part which concerns on this.
FIG. 7 is a longitudinal sectional view showing the configuration near the tip in an assembled state.
FIG. 8: Indwelling needle assembly of the present invention Examples of It is a perspective view which shows the structure of the inner needle front-end | tip part which concerns on this.
FIG. 9: Indwelling needle assembly of the present invention Examples of It is a top view which shows the structure of the inner needle front-end | tip part which concerns on this.
FIG. 10 is a cross-sectional view taken along the line CC in FIG.
11 is a sectional view taken along line DD in FIG. 9. FIG.
FIG. 12 is a longitudinal sectional view showing the configuration near the tip in the assembled state.
FIG. 13 is a perspective view showing an example of an inner needle manufacturing method.
14 is a cross-sectional view taken along line EE in FIG.
15 is a cross-sectional view taken from the line FF in FIG. 13 (before pressing).
16 is a cross-sectional view taken after the line F-F in FIG. 13 (after pressing).
FIG. 17 Indwelling needle Assembly Example It is a longitudinal cross-sectional view which shows the structure of the front-end | tip part vicinity in the assembly state which concerns on.
18 is a cross-sectional view taken along the line GG in FIG.
[Explanation of symbols]
1 Indwelling needle assembly
2 Outer needle (Indwelling needle)
21 Reduced diameter part
22 gap
23 Tip opening
24 groove
3 Hub
31 Inside
4 Inner needle
41 needle points
42 Blade surface
43 Chamfer
44 Air gap
45 Rough surface
46 groove
47 Edge
48 Protrusion
5 Hub
51 connecting part
52 Inside
10 Press machine
100 body
101 Female mold
102 Male mold
103 Positioning part
104 groove
105 Convex
106 Sliding part

Claims (5)

An indwelling needle assembly composed of a hollow outer needle and a metal inner needle that is inserted into the lumen of the outer needle and has an inclined blade surface at the tip of the needle,
Providing a groove for flowing blood formed by press working along the axial direction of the inner needle from the vicinity of the root portion of the blade surface of the inner needle;
The wall thickness of the inner needle tube is substantially constant over the entire circumference including the groove forming portion,
The vicinity of the boundary between the groove and the outer peripheral surface of the inner needle is rounded ,
The maximum depth of the groove is 0.03 to 0.15 mm, the width of the groove is 0.1 to 1 mm,
The outer needle has a reduced-diameter portion having a tapered shape whose outer diameter gradually decreases toward the distal end and having an inner diameter substantially equal to or slightly smaller than the outer diameter of the inner needle,
The proximal end portion of the outer needle with respect to the reduced diameter portion has an inner diameter larger than the outer diameter of the inner needle, thereby forming a tubular gap with the inner needle,
The length of the groove is a length in the range of 1 to 15 mm and exceeding the axial region of the reduced diameter portion,
In the state where the inner needle is inserted into the lumen of the outer needle and the tip of the inner needle protrudes from the distal end opening of the outer needle, the groove faces the reduced diameter portion, and the axial direction of the reduced diameter portion The indwelling needle assembly is configured such that the distal end opening of the outer needle and the gap communicate with each other through the groove . A method of manufacturing a metal inner needle that is used by being inserted into the lumen of a hollow outer needle and having a blade surface inclined at the tip of the needle,
Forming the blade surface;
Press machine having a female mold in which an inner needle insertion groove having a U-shaped cross section and a positioning portion are formed, and a male mold installed above the female mold and having a groove forming convex portion The male mold is collided with the female mold in a state where the inner needle on which the blade surface has been formed is inserted into the groove for inserting the inner needle and is positioned by the positioning portion with reference to the position of the blade surface. performs press working to the inner needle is lowered until, and forming a groove for the flow of blood from the vicinity of the root portion of the blade surface along the axial direction of the inner needle,
In forming the groove, the thickness of the inner needle tube is substantially constant over the entire circumference including the groove forming portion, and the vicinity of the boundary between the groove and the outer peripheral surface of the inner needle is rounded. A method for producing an inner needle, wherein the inner needle is formed to have a tinged shape. A positioning portion formed in a U-shape is provided at one end of the inner needle insertion groove of the female mold, and the blade surface of the inner needle inserted into the inner needle insertion groove is The inner needle manufacturing method according to claim 2 , wherein the groove is formed while being positioned so that the blade surface faces upward by contacting the positioning portion .   The inner needle according to claim 2 or 3, wherein the maximum depth of the groove is 0.03 to 0.15 mm, the width of the groove is 0.1 to 1 mm, and the length of the groove is 1 to 15 mm. Manufacturing method. Pressing pressure in the press working, 50~300kg / cm ² and the inner needle method for manufacturing according to any one of claims 2 to 4.

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