JP4286589B2 - Introduction needle, introduction needle assembly, and method of manufacturing the introduction needle - Google Patents

Description

【０１２０】
表１に示すように、各実施例で製造した導入針は、いずれも、最大荷重が小さいもの、すなわち、引き裂き強度が低いものであった。
【０１２１】
これに対し、各比較例で製造した導入針は、いずれも、最大荷重が大きいもの、すなわち、引き裂き強度が高いものであった。
【０１２２】
特に、比較例２の導入針は、引き裂きの挙動が一定の強度にならず、その最大値と最小値の差が約１００ｇｆとなり、不安定なものであった。
【０１２３】
また、実施例で製造した導入針は、分割しようとする時以外では、十分な形状安定性を有していた。
【０１２４】
また、上記のように製造した導入針で導入針組立体を作製し、導入針組立体を用いてダミー人形内にＩＶＨカテーテルを導入した後、導入針を分割して取り除いたところ、本発明の導入針では、容易に分割抜去することができた。
【０１２５】
【発明の効果】
以上述べたように、本発明の導入針は、より容易に、かつ、より確実に分割できるものとすることができ、また、保管時や分割抜去する以外の使用時等では、形状を十分保持することができ、不本意に割れてしまうといった不都合を効果的に防止することができる。
また、このような導入針は、簡便な方法で製造することができる。
【図面の簡単な説明】
【図１】本発明の導入針の側面図である。
【図２】図１に示す導入針の外針の横断面図である。
【図３】図１に示す導入針を備えた導入針組立体の側面図である。
【図４】本発明の導入針の製造装置の主要部の縦断面側面図である。
【図５】図４のＸ−Ｘ’における縦断面図である。
【図６】図４のＡ−Ａ’における横断面図である。
【図７】図４のＢ−Ｂ’における横断面図である。
【図８】押出口の正面図である。
【図９】本発明の導入針の外針の横断面図である。
【図１０】本発明の導入針の外針の横断面図である。
【図１１】本発明の導入針の外針の横断面図である。
【図１２】押出口の正面図である。
【図１３】従来のカニューラの側面図である。
【符号の説明】
１ 導入針
２ 外針（管状体）
２１ 中空部
２２ 溝部
２３ 脆弱部
２４ 先端部
３ 外針ハブ
３１ 中空部
３２ 溝部
４ 内針
４１ 針先
４１１ 先端面
４１２ 刃面
５ 内針ハブ
６ シリンジ
８ 管体
１０ 導入針組立体
１１ 製造装置
１２ ハウジング
１３ インダイ
１４ アウトダイ
１５ スパイダー
１６ 空間（搬送路）
１６１、１６２ 流路
１７ 合流部
１８ 成形部
１９ 押出口
２０ 突起部
３０ 気体吹き出し口
４０ 気体流路
１００ 基材のプラスチック
２００ 線条帯[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an introduction needle for introducing a long medical device into the body, an introduction needle assembly, and a method for manufacturing the introduction needle.
[0002]
[Prior art]
For example, when performing central venous therapy (IVH), a cannula (introduction needle) is punctured into a blood vessel, and an IVH catheter or a guide wire is introduced into the blood vessel through this.
[0003]
Such a split cannula includes a hollow outer needle that can be split and a split outer needle hub that is fixed to the proximal end of the outer needle.
[0004]
When this cannula is punctured into a patient's blood vessel, the inner needle is inserted into the outer needle, the needle tip of the inner needle protrudes from the tip of the outer needle, and a syringe is coupled to the rear end of the inner needle hub. Puncture operation is performed in the assembled state. Such an inner needle includes an inner needle having a sharp needle tip at a distal end and an inner needle hub fixed to the proximal end of the inner needle.
[0005]
When the tip of the inner needle enters the inside of the body from the body surface, the pusher of the syringe is pulled to bring the syringe lumen into a negative pressure state. When the needle tip of 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, passes through the inner needle hub lumen, and further into the syringe connected to the rear end side of the blood. Flows in (flashback). Thereby, it can be confirmed (visually recognized) that the inner needle has secured the blood vessel.
[0006]
When this flashback is confirmed, the outer needle is inserted into the blood vessel, and the inner needle is removed from the outer needle. And after inserting the IVH catheter into the outer needle hub and reliably reaching the target site, the outer needle is removed from the blood vessel, divided and removed from the IVH catheter, and a high calorie infusion is administered via the IVH catheter. To do.
[0007]
The split cannula used in this way has been studied for various constituent materials and shapes from the viewpoints of handleability, easy splitting, and the like, and various split cannulas have been proposed (see, for example, Patent Document 1). .
[0008]
As shown in FIG. 13, the split cannula described in Patent Document 1 has a pair of striated strips 200 made of a plastic different from the base plastic 100 in the longitudinal direction thereof. Is divided into two parts by tearing at a location of the strip 200.
[0009]
However, such a divided cannula has a problem that, when an external force is applied during storage, the filament strip is relatively easily cracked or hooked. Further, even when in use, there is a problem that unintentionally cracking or hooking occurs due to an external force other than when it is divided and extracted. In addition, such a divided cannula has a problem that the manufacturing process becomes complicated.
[0010]
[Patent Document 1]
Japanese Patent Publication No. 2-7670 (Claims)
[0011]
[Problems to be solved by the invention]
An object of the present invention is, for example, to provide an introduction needle and an introduction needle assembly that can be easily removed from a catheter or the like when it becomes unnecessary, and a production method capable of producing such an introduction needle. It is to provide.
[0012]
[Means for Solving the Problems]
  Such purposes are as follows (1) to (15This is achieved by the present invention.
[0013]
  (1) An introduction needle for introducing a long medical device into the body,
  Low compatibility with each otherConsists of materials containing two or more different resin componentsThe material is formed into a tubular shape by extrusion.A tubular body,
  Along the longitudinal direction of the tubular body, the tear strength has a weakened portion smaller than other portions, and
  Grooves are provided on the inner peripheral surface and / or outer peripheral surface of the tubular body along the longitudinal direction of the tubular body.And
The fragile portion is composed of a weld line at the time of extrusion molding.An introduction needle characterized by that.
[0015]
  (2The fragile part is overlapped with the groove part or in the vicinity thereof(1)The introduction needle described.
[0016]
  (3) In the cross section of the tubular body, a plurality of the weakened portions are provided,
  One weak part and the other weak part are provided so that it may oppose centering on the central axis of the said tubular body (1)Or (2)The introduction needle described in 1.
[0017]
  (4) In the cross section of the tubular body, a plurality of the groove portions are provided,
  One groove part and the other groove part are provided so as to be substantially opposed to each other about the central axis of the tubular body.3) The introduction needle according to any one of the above.
[0018]
(5) The minimum thickness d of the tube wall of the portion with the groove is 0.04 to 0.15 mm,
The introduction needle according to any one of (1) to (4), wherein the width W of the groove is 0.05 to 0.5 mm.
(6) The introduction needle according to any one of (1) to (5), wherein the material constituting the tubular body includes two types of polyolefins having different carbon numbers from each other.
[0020]
  (7In the cross section of the tubular body, the center angle θ of the shift between the weakened portion and the groove portion is 15 ° or less (1) to (1)6) The introduction needle according to any one of the above.
[0022]
  (8)Construct a tubular bodyThe above materials (1) to (1) are mainly composed of polypropylene and polyethylene.7) The introduction needle according to any one of the above.
[0023]
  (9) The above (the compounding ratio of the polypropylene and the polyethylene is 80:20 to 20:80)8).
[0024]
  (10The introduction needle further includes a hub that can be divided on the proximal end side of the tubular body.9) The introduction needle according to any one of the above.
[0025]
  (11) Above (1) to (10An introduction needle assembly comprising: the introduction needle according to claim 1; and an inner needle inserted into the introduction needle.
[0026]
  (12) Mainly a method for producing an introduction needle for producing an introduction needle using an extrusion method,
  Low compatibility with each otherConveying materials containing two or more different resin components in at least two flow paths;
  Then, while joining the flow path,Has a fragile part composed of weld linesForming a hollow tube,
  A method for producing an introduction needle, wherein a groove is formed in a direction substantially parallel to a conveying direction on an inner peripheral surface and / or an outer peripheral surface of the tubular body.
[0027]
  (13The groove portion is formed in a portion corresponding to an interface of the pipe body when the material merges or in the vicinity thereof (12).
[0028]
  (14A manufacturing device for manufacturing the introduction needle,
  Having at least two flow paths for independently conveying materials containing two or more different resin components;
  A merge portion where at least two of the flow paths merge;
  A molding part for molding the material joined at the joining part as a hollow tube;
  An apparatus for manufacturing an introduction needle, comprising: a groove portion forming portion that forms a groove portion in a direction substantially parallel to the conveying direction on the inner peripheral surface and / or the outer peripheral surface of the tubular body.
[0029]
  (15The groove part forming part is provided so as to form the groove part in or near the part of the tubular body corresponding to the interface of the material that merges in the merge.14).
[0030]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the introduction needle and the introduction needle assembly of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
[0031]
First, the introduction needle of the present invention will be described.
1 is a side view of the introduction needle of the present invention, FIG. 2 is a cross-sectional view of an outer needle of the introduction needle shown in FIG. 1, and FIG. 3 is a side view of the introduction needle assembly including the introduction needle shown in FIG. FIG. In the following description, the right side in FIGS. 1 and 3 is referred to as “base end”, and the left side (needle tip side) is referred to as “tip”.
[0032]
An introduction needle 1 shown in FIG. 1 has an outer needle (tubular body) 2 and an outer needle hub 3 on the proximal end side of the outer needle 2. For example, an IVH catheter is enlarged by a direct puncture method. It is used as a sheath used when introduced into a vein (for example, a subclavian vein).
[0033]
The outer needle 2 has a tube shape having a hollow portion 21 and has a substantially circular cross section as shown in FIG.
[0034]
Further, the outer needle 2 has a groove portion 22 and a fragile portion (weld line) 23.
[0035]
Thus, in the introduction needle 1, the outer needle 2 has both the groove portion 22 and the fragile portion 23. The introduction needle of the present invention can be more easily divided and extracted from, for example, an IVH catheter by a synergistic effect as will be described later by having both the groove portion 22 and the fragile portion 23 together.
[0036]
The groove portion 22 is formed on the outer peripheral surface of the outer needle 2 along the longitudinal direction of the outer needle 2. In the configuration shown in the figure, the pair of groove portions 22 are formed so as to face each other. That is, the pair of groove portions 22 are formed so as to substantially face each other around the central axis O of the outer needle 2. Thereby, for example, the introduction needle 1 can be divided and extracted more easily from an IVH catheter or the like. In addition, such a groove part 22 can be formed by the method explained in full detail later, for example.
[0037]
The width (maximum width) on the peripheral surface (outer peripheral surface) of the outer needle 2 of the groove 22, that is, the width of the groove 22 represented by W in FIG. 2 is preferably 0.05 to 0.5 mm, More preferably, it is 0.1 to 0.3 mm. Thereby, the tearing strength when tearing (dividing) the outer needle 2 can be made appropriate. On the other hand, when the width of the groove 22 is less than the lower limit, the above-described effect may not be sufficiently obtained. On the other hand, if the width of the groove portion 22 exceeds the upper limit value, there is a possibility that unintentional cracking or the like of the outer needle 2 cannot be sufficiently prevented.
[0038]
Moreover, it is preferable that the minimum thickness (thickness represented by d in FIG. 2) of the tube wall of the part with the groove part 22 is 0.04-0.15 mm, and is 0.05-0.12 mm. Is more preferable. Thereby, the outer needle 2 can be reliably divided with a smaller force. In addition, this makes it possible to make the dividing surface of the outer needle 2 cleaner when divided. On the other hand, if the thickness d is less than the lower limit value, it may be difficult to sufficiently maintain the shape of the outer needle 2. On the other hand, if the thickness d exceeds the upper limit, the outer needle 2 may not be divided at a desired position.
[0039]
In the configuration shown in the drawing, the cross section of the groove portion 22 is substantially V-shaped, but is not limited thereto, and may be, for example, substantially U-shaped or other shapes. It may be what constitutes.
[0040]
The fragile portion 23 is a portion having a tear strength smaller than that of other portions, and is constituted by, for example, a weld line formed when the outer needle 2 is manufactured by a method described in detail later.
Such a fragile portion 23 is formed along the longitudinal direction of the outer needle 2.
[0041]
In the present embodiment, as shown in FIG. 2, the pair of fragile portions 23 are formed so as to face each other about the central axis O of the outer needle 2. Thereby, for example, the introduction needle 1 can be divided and extracted more easily and more reliably from an IVH catheter or the like.
[0042]
Moreover, it is preferable that the weak part 23 has overlapped with the said groove part 22, or exists in the vicinity like the structure of illustration. Accordingly, the outer needle 2 can be reliably divided with a smaller force and can be divided at a desired position.
[0043]
Further, the central angle (angle represented by θ in FIG. 2) of the deviation between the fragile portion 23 and the groove portion 22 in the cross section of the outer needle 2 is preferably 15 ° or less, and is 12 ° or less. Is more preferable. Accordingly, the outer needle 2 can be reliably divided with a smaller force and can be divided at a desired position. In addition, this makes it possible to make the dividing surface of the outer needle 2 cleaner when divided. On the other hand, when the angle θ exceeds the upper limit, the above-described effects may not be sufficiently obtained.
[0044]
As described above, the introduction needle of the present invention is characterized by having both the groove portion and the fragile portion. Thus, by having both a groove part and a weak part, it can be divided easily and reliably. In addition, at the time of storage or use other than separating and removing, the shape can be sufficiently retained, and inconveniences such as unintentional cracking can be effectively prevented. In particular, in the present embodiment, since the groove portion and the fragile portion are close to each other, the above-described effect becomes more remarkable.
[0045]
Such an effect cannot be obtained when only one of the groove portion and the fragile portion is provided. For example, when it has only a groove part, it becomes difficult to divide easily. In order that the tubular body (outer needle) can be easily divided only by the groove portion, the minimum thickness of the tube wall in the groove portion must be reduced, but in that case, the shape can be sufficiently maintained. In addition, inconveniences such as unintentional cracking are likely to occur during storage or use other than dividing and removing. Similarly, when only the fragile portion is included, it is difficult to easily divide. In particular, in the case of only the fragile portion, it is very difficult to control the ease of cracking (easy splitting property) by controlling the manufacturing conditions. In addition, it is conceivable that the material can be easily broken by selecting a material or the like, but it is difficult to maintain the shape of the introduction needle (outer needle) sufficiently, and inconveniences such as unintentional cracking are likely to occur. Become.
[0046]
The outer needle 2 has a distal end portion 24 on the distal end side.
The distal end portion 24 has a tapered shape in which the outer diameter gradually decreases in the distal direction, and the taper angle (inclination angle) is further larger than the proximal end side in the vicinity of the distal end of the outer needle 2. With such a configuration, a step formed at a boundary portion between the inner needle 4 and the distal end of the outer needle 2, which will be described later, can be further reduced, and the piercing resistance of the outer needle 2 can be further reduced.
[0047]
For example, when the inner diameter of the outer needle 2 is set to be larger than the outer diameter of the inner needle 4 described later, both the outer diameter and the inner diameter of the outer needle 2 are directed toward the distal end. It may be configured to gradually decrease.
[0048]
Moreover, it is preferable that the thickness of the tube wall of the outer needle 2 other than the part in which the groove part 22 is formed is 0.15-0.3 mm, and it is more preferable that it is 0.18-0.27 mm. Thereby, the shape of the outer needle 2 can be suitably held.
[0049]
Moreover, although the tear strength of the outer needle 2 varies depending on the outer diameter thereof, for example, in the case of the 14G size outer needle 2, it is preferably 150 to 500 gf, and more preferably 200 to 400 gf. If the tear strength is less than the lower limit value, there is a possibility that unintentional cracking or the like may occur due to an external force other than when it is divided and extracted. On the other hand, if the tear strength exceeds the upper limit, the effects of the present invention may not be sufficiently obtained. When the outer needle 2 was split from the proximal end at a splitting speed of 500 mm / min in different directions of 180 ° C., the maximum load applied in the pulling direction was taken as the tear strength.
[0050]
The outer needle hub 3 has a hollow portion 31, which is liquid-tightly fixed (fixed) to the proximal end side of the outer needle 2, and the lumen of the outer needle 2 communicates with the inside of the outer needle hub 3. Yes.
[0051]
Further, the outer needle hub 3 is provided with V-shaped groove portions 32 substantially coaxially with the two groove portions 22 of the outer needle 2. Thereby, after inserting the IVH catheter, the outer needle 2 and the outer needle hub 3 can be torn to the left and right and divided to be removed from the IVH catheter.
[0052]
The outer needle 2 as described above is made of a material containing two or more different resin components.
[0053]
Examples of the resin component include polyethylene, polypropylene, polyurethane, polyester, polyamide, polyether nylon resin, ethylene-vinyl acetate copolymer, fluorine-based resin such as PTFE, ETFE, and PFA. A combination of the above can be used.
[0054]
The material constituting the outer needle 2 preferably includes two or more resin components having low compatibility among the resin components described above, and includes two or more polyolefins having different carbon numbers from each other. More preferably, it is more preferable that it contains polypropylene and polyethylene. Thereby, the outer needle 2 can be divided more easily while sufficiently preventing unintentional cracks and the like of the outer needle 2.
[0055]
The blending ratio of polypropylene and polyethylene in the material is preferably 80:20 to 20:80, more preferably 70:30 to 30:70, and 60:40 to 40:60. Further preferred. Thereby, the introduction needle 1 can be divided more easily while maintaining the strength of the introduction needle 1 as a whole.
[0056]
It should be noted that an X-ray contrast agent such as barium sulfate, barium carbonate, bismuth carbonate, or tungstic acid can be blended as another component in the material as described above to provide a contrast function.
[0057]
The constituent material of the outer needle hub 3 is not particularly limited, but is preferably the same as the constituent material of the outer needle 2. Thereby, the outer needle hub 3 and the outer needle 2 can be more firmly fixed.
[0058]
Next, an introduction needle assembly including the introduction needle 1 as described above will be described.
An introduction needle assembly 10 shown in FIG. 3 includes the introduction needle 1 described above, an inner needle 4 inserted inside the introduction needle 1, an inner needle hub 5 on the proximal end side of the inner needle 4, and an inner needle hub 5. A syringe 6 is provided in the opening on the proximal end side.
[0059]
The inner needle 4 is a hollow needle and is made of, for example, a metal material such as stainless steel, aluminum or an aluminum alloy, titanium or a titanium alloy. A sharp needle tip 41 is formed at the tip of the inner needle 4.
[0060]
Further, a blade surface 412 is formed on at least a part of the tip surface 411 of the needle tip 41. Thereby, the puncture resistance to the blood vessel etc. of the inner needle 4 can be reduced more.
[0061]
The inner needle 4 is inserted into the lumen of the introduction needle 1 and is used in a state where the inner needle hub 5 is fitted to the outer needle hub 3 (not shown). Hereinafter, this state is referred to as an “assembled state”.
[0062]
The outer diameter of the inner needle 4 is set to be approximately equal to or slightly smaller than the inner diameter of the outer needle 2.
[0063]
The proximal end portion of the inner needle 4 is fixed (fixed) to the distal end portion of the inner needle hub 5, and the lumen of the inner needle 4 communicates with the inside of the inner needle hub 5. The inner needle hub 5 is composed of a substantially cylindrical hollow member.
[0064]
Examples of the method for fixing the inner needle 4 to the inner needle hub 5 include a method such as fitting, caulking, fusing, adhesion using an adhesive, or a method using these in combination.
[0065]
The inner needle hub 5 is preferably made of transparent (colorless and transparent), colored transparent or translucent resin, and the internal visibility is ensured. Thereby, when the needle tip 41 of the inner needle 4 secures a blood vessel, it is possible to visually confirm the flashback of the blood flowing through the inner needle 4.
[0066]
A groove having a predetermined length is formed in the inner cavity of the outer needle hub 3, and a protrusion is formed in the vicinity of the tip of the inner needle hub 5, so that the introduction needle assembly 10 is assembled. Then, the structure which a protrusion part is inserted in a groove part and engages may be sufficient. This prevents the outer needle hub 3 (outer needle 2) from rotating relative to the inner needle hub 5 (inner needle 4).
[0067]
Next, an example of how to use the introduction needle 1 will be described in detail.
[1] The introduction needle 1 is in an assembled state, and the tip of the introduction needle 1 is pressed against the patient while holding the inner needle hub 5 and the like by hand, and the epidermis is punctured toward the blood vessel (vein). To do.
[0068]
[2] When the needle tip 41 of the inner needle 4 enters the inside of the body from the epidermis, the pusher of the syringe 6 is pulled to place the lumen of the syringe 6 in a negative pressure state. When the needle tip 41 of the inner needle 4 reaches the inside of the blood vessel, the blood flowing in from the opening of the needle tip 41 passes through the lumen of the inner needle 4 and is coupled to the lumen of the inner needle hub 5 and further to the rear end side thereof. The blood flows into the syringe 6 (flashback). Thereby, it can be known that the needle tip 41 of the inner needle 4 has secured the blood vessel.
[0069]
[3] When the inner needle 4 and the outer needle 2 are further advanced toward the distal end by a minute distance, the distal end portion 24 of the outer needle 2 is inserted into the blood vessel. Thereby, the outer needle 2 secures a blood vessel.
[0070]
[4] Next, while holding the outer needle 2 placed in the blood vessel by hand, the inner needle hub 5 is gripped by the other hand and pulled in the proximal direction. Thereby, the inner needle 4 is extracted from the introduction needle 1.
[0071]
[5] An IVH catheter (not shown) is inserted into the blood vessel through the outer needle 2 from the outer needle hub 3 from which the inner needle 4 has been removed. After the IVH catheter is inserted to a predetermined position, administration of an infusion is started using a high calorie infusion set (not shown) according to a conventional method.
[0072]
At this time, since the introduction needle 1 becomes unnecessary, the introduction needle 1 is extracted from the inside of the blood vessel, divided from the approximate center of the outer needle hub 3 to the tip of the outer needle 2 in the axial direction, and the introduction needle 1 is removed from the IVH catheter. To be disposed of.
[0073]
In addition, the introduction needle | hook of this invention is manufactured by extrusion molding using the manufacturing apparatus which is demonstrated below, for example.
[0074]
DESCRIPTION OF THE PREFERRED EMBODIMENTS The introduction needle manufacturing apparatus and manufacturing method of the present invention will be described below in detail based on preferred embodiments of the accompanying drawings.
[0075]
4 is a longitudinal sectional side view of the main part of the introduction needle (outer needle) manufacturing apparatus, FIG. 5 is a longitudinal sectional view taken along line XX ′ of FIG. 4, and FIG. 6 is taken along line AA ′ of FIG. 7 is a cross-sectional view taken along the line BB ′ of FIG. 4, and FIG. 8 is a front view of the extrusion port. In the following description, the right side in FIGS. 4 and 5 is referred to as “base end”, and the left side is referred to as “tip”.
[0076]
An introduction needle manufacturing apparatus 11 (hereinafter also simply referred to as apparatus 11) shown in FIG. 4 includes a housing 12, an indie 13 installed in the housing 12, an out die 14 installed on the distal end side of the housing 12, A pair of spiders 15 for mounting the indie 13 in the housing 12 is provided.
[0077]
The apparatus 11 has a space (conveyance path) 16 formed by the housing 12 and the indie 13, and the conveyance path 16 is introduced into the housing 12 from the base end side of the apparatus 11 as described above. Such a material containing two or more kinds of resin components is conveyed.
[0078]
The conveyance path 16 is divided into two flow paths 161 and 162 by the pair of spiders 15 described above, as shown in FIGS. As described above, the spider 15 has a role as a partition wall that divides the flow path of the material into a plurality of parts in addition to the role of attaching the indie 13 in the housing 12. The pair of spiders 15 are installed so as to face each other about the central axis of the indie 13.
[0079]
Moreover, the front-end | tip part of the spider 15 forms the confluence | merging part 17 where the two flow paths 161 and 162 mentioned above merge like the structure of illustration. That is, the materials conveyed independently in the flow paths 161 and 162 merge at the merge portion 17. By adopting such a configuration, the introduction needle 1 (outer needle 2) finally obtained has a weld line (fragile portion 23) formed at a portion corresponding to the interface when the conveyed materials merge. Will be.
[0080]
In addition, as shown in the configuration, the apparatus 11 includes a molding unit 18 that molds the material joined at the junction 17 into a space formed by the in-die 13 and the out-die 14 as a hollow tube 8, and the tube 8. And an extrusion port 19 for pushing out the outside of the apparatus 11.
[0081]
Here, the tubular body 8 indicates a molten material conveyed to the molding unit 18 and has a weld line molded by the spider 15.
[0082]
Further, as shown in FIGS. 4 and 8, the device 11 (out die 14) is a protrusion for forming a groove portion on the outer peripheral surface of the tube body 8 in a direction substantially parallel to the conveying direction (extrusion direction). Part (groove part forming part) 20.
[0083]
As shown in FIG. 4, such a protrusion 20 is provided with a predetermined length from the opening portion of the extrusion port 19 toward the base end side. Thereby, the shape of the groove part formed in the tubular body 8 can be controlled more reliably.
[0084]
Further, as shown in FIG. 8, a pair of protrusions 20 are provided, and are provided so as to substantially face each other around the center point of the extrusion port 19.
[0085]
In the illustrated configuration, the protrusion 20 is provided at a position substantially corresponding to the position with the aforementioned spider 15 when viewed in plan from the distal end side. In other words, the protruding portion 20 is provided so as to form a groove portion at or near the portion (weld line) corresponding to the interface of the material to be merged at the aforementioned merge portion 17 of the tube body 8. By setting it as such a structure, the introduction needle | hook 1 obtained exhibits the outstanding outstanding splitting property especially.
[0086]
Moreover, the apparatus 11 has the gas blower outlet 30 which flows gas in the inside of the tubular body 8 extruded in the extrusion port 19. As shown in FIG. In the present embodiment, the gas introduced into the device 11 from a gas supply source (not shown) passes through the gas flow path 40 and from the gas outlet 30 provided at the end portion on the front end side of the indie 13 to the tube body 8. Blown out inside. By adopting such a configuration, the shape of the tubular body 8 extruded from the extrusion port 19 can be more reliably maintained, and as a result, the shape of the introduction needle 1 manufactured using such a tubular body 8 is obtained. Can be controlled more reliably. Moreover, when it is set as such a structure, the pipe body 8 can also be cooled at a moderate speed | rate by controlling the temperature and flow volume of gas.
[0087]
The outer diameter excluding the protrusion 20 of the extrusion port 19 (D in FIG. 8)₁Is not particularly limited, but is preferably about 1 to 3 times the outer diameter of the outer needle 2 as described above.
[0088]
Further, the inner diameter of the extrusion port 19 (D in FIG. 8)₂Is not particularly limited, but is preferably about 1 to 3 times the inner diameter of the outer needle 2 as described above.
[0089]
The diameter of the gas outlet 30 is preferably 1 to 2 mm, and more preferably 1.2 to 1.8 mm. Thereby, the shape of the tubular body 8 extruded from the extrusion port 19 can be more effectively maintained, and as a result, the shape of the introduction needle 1 manufactured using such a tubular body 8 can be controlled more reliably. can do.
[0090]
The material provided to the introduction needle manufacturing apparatus 11 as described above is preferably a material in which the above-described resin components and the like are sufficiently sufficiently dispersed in advance.
[0091]
When manufactured by extrusion molding as described above using such a material, the introduction needle 1 (outer needle 2) is oriented so that the resin component contained in the material is in the extrusion direction (longitudinal direction of the outer needle 2). It will be like that. Thereby, more remarkable easy-dividing properties are exhibited.
[0092]
Further, the material is heated in advance and softened / melted before being supplied to the apparatus 11. Although the temperature of the material at the time of supply is based also on the component which comprises a material, it is preferable that it is 150-250 degreeC, and it is more preferable that it is 180-220 degreeC. When the temperature of the material is lower than the lower limit value, the independently conveyed materials are not fused together at the merging portion 17 and it may be difficult to form the tube body 8. In addition, the device 11 may be clogged. On the other hand, if the temperature of the material exceeds the upper limit, the weld line (fragile portion 23) may not be formed well.
[0093]
The introduction needle manufacturing method using the apparatus 11 as described above is summarized as follows.
[0094]
1. The material softened and melted moderately is put into the apparatus 11 as described above, and is divided into flow paths 161 and 162 by the spider 15.
2. The materials conveyed through the flow paths 161 and 162 merge at the merge section 17.
3. The merged material is formed as a tube 8 in the forming portion.
4). The molded tube body 8 is conveyed to the vicinity of the extrusion port 19, and a groove portion is formed by a projection (groove portion forming portion) provided in the vicinity of the extrusion port 19.
5). The tube body 8 in which the groove portion is formed is solidified in a state in which the tube shape is maintained by extruding the tube body 8 from the extrusion port 19 and flowing gas from the gas blowing port 30 to the inside thereof.
6). The tube body 8 thus solidified is cut into a predetermined length, and the distal end portion and the like are formed into a desired shape by a method such as a tip heating process, whereby the outer needle 2 is obtained.
7. Separately, the outer needle hub 3 molded by injection molding or the like is fixed to the proximal end side of the outer needle 2 by, for example, caulking, fusing (thermal fusing, high frequency fusing, etc.), adhesion with an adhesive, or the like. Introducing needle 1 is obtained.
[0095]
While the introduction needle, the introduction needle main body, the introduction needle manufacturing method and the manufacturing apparatus of the present invention have been described based on the illustrated configuration, the present invention is not limited to these. For example, each part constituting the introduction needle, the introduction needle main body, the introduction needle manufacturing method, and the manufacturing apparatus can be replaced with any configuration that can exhibit the same function. Moreover, arbitrary components may be added.
[0096]
In the above-described embodiment, the groove portion 22 is continuously formed along the longitudinal direction of the outer needle 2. However, the embodiment is not limited thereto, and for example, the groove portion 22 is intermittently formed. There may be.
[0097]
Moreover, although the groove part 22 was demonstrated on the outer peripheral surface of the outer needle 2 in embodiment mentioned above, it was not limited to this, Such a groove part 22 is on the inner peripheral surface of the outer needle 2 It may be formed (see FIG. 9), or may be formed on both the inner peripheral surface and the outer peripheral surface of the outer needle 2 (see FIG. 10).
[0098]
In the above-described embodiment, the outer needle 2 has been described in which a pair of groove portions 22 are formed. However, the present invention is not limited to this, and one outer groove 2 may be formed in which one groove portion 22 is formed. One groove portion 22 may be formed, or four or more groove portions 22 may be formed (see FIG. 11).
[0099]
In the embodiment described above, the outer needle 2 has been described in which a pair of weakened portions 23 are formed. However, the present invention is not limited to this, and one outer weakened portion 23 may be formed. Three or more fragile portions 23 may be formed.
[0100]
The introduction needle of the present invention can be used by inserting a catheter such as an IVH catheter and various medical devices such as a guide wire into the inside thereof.
[0101]
Needless to say, the introduction needle and the introduction needle assembly of the present invention can be applied to various sizes of 10 to 26G.
[0102]
The introduction needle and the introduction needle assembly of the present invention are not limited to those used by being inserted into blood vessels, and are used by being inserted into, for example, the abdominal cavity, thoracic cavity, lymphatic vessel, spinal canal, etc. It can also be applied to things.
[0103]
In the above-described embodiment, the configuration in which the apparatus 11 has two material flow paths has been described. However, the present invention is not limited to this, and may be, for example, three or four or more. .
[0104]
In the above-described embodiment, the configuration in which the device 11 includes the two protrusions 20 has been described. However, the configuration is not limited thereto, and for example, the number may be three or may be four or more.
[0105]
In the above-described embodiment, the configuration in which the protruding portion 20 is provided on the out die 14 has been described. However, the protruding portion 20 may have a configuration (see FIG. 12) provided in the in die 13 or the in die 13. And the structure provided in both the outdies 14 may be sufficient.
[0106]
Moreover, although embodiment mentioned above demonstrated the structure which flows gas into the hollow of the tubular body 8, it is not limited to this, Gas does not need to flow.
[0107]
【Example】
Hereinafter, specific examples of the introduction needle of the present invention will be described.
[0108]
Example 1
Polyethylene and polypropylene were used as materials, and kneaded with a twin-screw kneader so that the blending ratio of polyethylene and polypropylene was 50:50, to produce pellets.
[0109]
Next, the pellets thus produced are extruded using a manufacturing apparatus 11 as shown in FIG. 4 to produce a tubular body, and injection molding is performed on the proximal end side of the tubular body with the same material as the tubular body. The hub formed by the above was fixed to manufacture an introduction needle.
[0110]
(Example 2)
An introduction needle is used in the same manner as in Example 1 except that the manufacturing apparatus 11 used in Example 1 uses an out die in which the length of the protruding portion 20 of the out die 14 (length in the central direction of the extrusion port 19) is different. Manufactured.
[0111]
(Examples 3 to 5)
An introduction needle was produced in the same manner as in Example 1 except that the blending ratio of polyethylene and polypropylene was as shown in Table 1.
[0112]
(Comparative Example 1)
An introduction needle as shown in FIG. 13 was manufactured by extrusion molding (two-color molding). In addition, it manufactured so that the material of the strip 200 might be a mixture of polypropylene: 70% and barium sulfate: 30%, and the material of the other part might be a mixture of polypropylene: 50% and barium sulfate: 50%. . The width of the manufactured introduction needle was 0.3 mm.
[0113]
(Comparative Example 2)
The introduction needle was manufactured in the same manner as in Comparative Example 1 except that the material of the strip 200 was a mixture of polypropylene: 50% and barium sulfate: 50%, and the material of the other part was polypropylene. . The width of the strip was 0.2 mm.
[0114]
(Comparative Example 3)
An introduction needle was manufactured in the same manner as in Example 1 except that only polyethylene was used as the material.
[0115]
(Comparative Example 4)
An introduction needle was manufactured in the same manner as in Example 1 except that the out die 14 of the manufacturing apparatus 11 shown in FIG. As a result, an introduction needle having no groove was obtained.
[0116]
Table 1 shows the material composition, the outer diameter, the inner diameter, the thickness of the tube wall excluding the groove portion, and the minimum thickness of the tube wall at the groove portion of the introduction needles manufactured in each Example and each Comparative Example.
[0117]
[Evaluation]
The introduction needles produced in each Example and each Comparative Example were evaluated as follows.
[0118]
From the base end side of the introduction needle, the maximum load applied in the pulling direction was determined as the tear strength when splitting at a splitting speed of 500 mm / min in different directions of 180 ° C. from each other.
The results are also shown in Table 1.
[0119]
[Table 1]

[0120]
As shown in Table 1, each of the introduction needles manufactured in each example had a small maximum load, that is, a tear strength low.
[0121]
On the other hand, all of the introduction needles manufactured in the respective comparative examples had a large maximum load, that is, a high tear strength.
[0122]
In particular, the introduction needle of Comparative Example 2 was unstable because the tearing behavior did not have a constant strength, and the difference between the maximum value and the minimum value was about 100 gf.
[0123]
In addition, the introduction needle manufactured in the example had sufficient shape stability except when trying to divide.
[0124]
In addition, when the introduction needle assembly was manufactured with the introduction needle manufactured as described above, and the IVH catheter was introduced into the dummy doll using the introduction needle assembly, the introduction needle was divided and removed. The introduction needle could be easily separated and removed.
[0125]
【The invention's effect】
As described above, the introduction needle of the present invention can be divided more easily and more reliably, and it retains its shape sufficiently during storage or use other than division removal. It is possible to effectively prevent inconveniences such as unintentional cracking.
Moreover, such an introduction needle can be manufactured by a simple method.
[Brief description of the drawings]
FIG. 1 is a side view of an introduction needle of the present invention.
2 is a cross-sectional view of an outer needle of the introduction needle shown in FIG.
3 is a side view of an introduction needle assembly including the introduction needle shown in FIG. 1. FIG.
FIG. 4 is a longitudinal sectional side view of a main part of the introduction needle manufacturing apparatus of the present invention.
5 is a longitudinal sectional view taken along the line X-X ′ of FIG. 4;
6 is a cross-sectional view taken along line A-A ′ of FIG. 4;
7 is a cross-sectional view taken along B-B ′ of FIG. 4;
FIG. 8 is a front view of the extrusion port.
FIG. 9 is a cross-sectional view of the outer needle of the introduction needle of the present invention.
FIG. 10 is a cross-sectional view of the outer needle of the introduction needle of the present invention.
FIG. 11 is a cross-sectional view of the outer needle of the introduction needle of the present invention.
FIG. 12 is a front view of the extrusion port.
FIG. 13 is a side view of a conventional cannula.
[Explanation of symbols]
1 Introduction needle
2 Outer needle (tubular body)
21 Hollow part
22 Groove
23 Vulnerable parts
24 Tip
3 Outer needle hub
31 Hollow part
32 Groove
4 Inner needle
41 needle points
411 Tip surface
412 blade surface
5 Inner needle hub
6 Syringe
8 Tube
10 Introduction needle assembly
11 Manufacturing equipment
12 Housing
13 Indai
14 out die
15 Spider
16 space (conveyance path)
161, 162 flow path
17 Junction
18 Molding part
19 Extrusion port
20 Protrusion
30 Gas outlet
40 Gas flow path
100 Base plastic
200 line strip

Claims (10)

An introduction needle for introducing a long medical device into the body,
It is composed of a material containing two or more different resin components having low compatibility with each other, and includes a tubular body formed by extrusion molding the material into a tubular shape,
Along the longitudinal direction of the tubular body, the tear strength has a weakened portion smaller than other portions, and
A groove is provided on the inner peripheral surface and / or outer peripheral surface of the tubular body along the longitudinal direction of the tubular body ,
The introduction needle characterized in that the fragile portion is constituted by a weld line at the time of extrusion molding . The introduction needle according to claim 1, wherein the fragile portion overlaps the groove portion or is in the vicinity thereof. In the cross section of the tubular body, a plurality of the weakened portions are provided,
The introduction needle according to claim 1 or 2 , wherein one fragile portion and the other fragile portion are provided so as to be substantially opposed to each other about the central axis of the tubular body. In the cross section of the tubular body, a plurality of the groove portions are provided,
The introduction needle according to any one of claims 1 to 3 , wherein one groove portion and the other groove portion are provided so as to be substantially opposed to each other about the central axis of the tubular body.   The minimum thickness d of the tube wall in the portion with the groove is 0.04 to 0.15 mm,
  The introduction needle according to any one of claims 1 to 4, wherein a width W of the groove is 0.05 to 0.5 mm.   The introduction needle according to any one of claims 1 to 5, wherein the material constituting the tubular body includes two types of polyolefins having different carbon numbers of monomer components.   The introduction needle according to claim 1, further comprising a hub that can be divided on a proximal end side of the tubular body.   An introduction needle assembly comprising: the introduction needle according to claim 1; and an inner needle inserted into the introduction needle. Mainly a method for producing an introduction needle for producing an introduction needle using an extrusion method,
A material containing two or more different resin components having low compatibility with each other is conveyed in at least two flow paths,
Then, while joining the flow path, forming a hollow tube having a fragile portion constituted by a weld line ,
A method for producing an introduction needle, wherein a groove is formed in a direction substantially parallel to a conveying direction on an inner peripheral surface and / or an outer peripheral surface of the tubular body.   The method for manufacturing an introduction needle according to claim 9, wherein the groove is formed in a portion of the tubular body corresponding to an interface when the material merges or in the vicinity thereof.

Images