JP6220119B2 - Needle - Google Patents

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JP6220119B2
JP6220119B2 JP2012230450A JP2012230450A JP6220119B2 JP 6220119 B2 JP6220119 B2 JP 6220119B2 JP 2012230450 A JP2012230450 A JP 2012230450A JP 2012230450 A JP2012230450 A JP 2012230450A JP 6220119 B2 JP6220119 B2 JP 6220119B2
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tube
needle
piercing
injection needle
piercing tube
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JP2014079479A (en
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英之 二村
英之 二村
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Hoya Corp
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Hoya Corp
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Priority to PCT/JP2013/078269 priority patent/WO2014061768A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0612Eyes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Description

本発明は、注射針に関し、特に医療に用いて好適な注射針に関する。   The present invention relates to an injection needle, and more particularly to an injection needle suitable for medical use.

眼疾患の一つに網膜静脈閉塞症がある。網膜静脈閉塞症は、高血圧や動脈硬化などが原因で、網膜の静脈が詰まって出血を起こす病気である。この疾患は、網膜を障害させ、視力低下などの症状を引き起こす。網膜静脈閉塞症の治療方法としては、抗凝固療法などの内服加療の他に、網膜の出血部位やむくみの多いところにレーザ光を照射して、出血やむくみを網膜下の組織の脈絡膜側に吸収させる方法が知られている。また、網膜静脈閉塞症には中心静脈閉塞症と分枝静脈閉塞症がある。このうち、分枝静脈閉塞症に対しては動静脈交叉部血管外膜鞘切開術などが行われている。ただし、いずれの治療法も対症療法でしかない。   One ocular disease is retinal vein occlusion. Retinal vein occlusion is a disease that causes bleeding due to clogging of the veins of the retina due to high blood pressure and arteriosclerosis. This disease damages the retina and causes symptoms such as vision loss. In addition to internal treatment such as anticoagulant therapy, retinal vein occlusion can be treated by irradiating the retinal hemorrhage site or swelled area with laser light to cause bleeding or swelling to occur on the choroid side of the subretinal tissue. Methods of absorption are known. Retinal vein occlusion includes central vein occlusion and branch vein occlusion. Among these, arteriovenous cross section vascular sheath incision is performed for branch vein occlusion. However, any treatment is only symptomatic.

そこで、網膜の静脈血流の再生をめざして、脳梗塞患者の治療に用いられる血栓溶解剤(t−PA)を直接、網膜の静脈(閉塞血管)に注入する治療法が提案されている。この治療法は、網膜静脈閉塞症の原因となっている血管の詰まりを解消する原因療法とも呼べるもので、特に、網膜静脈閉塞症の患者数が多い高齢化社会においては、当該治療法の早期の確立が強く望まれている。ちなみに、医療用の注射針としては、たとえば、以下の特許文献1および特許文献2に記載されたものが知られている。   Therefore, with the aim of regenerating venous blood flow in the retina, a treatment method has been proposed in which a thrombolytic agent (t-PA) used in the treatment of cerebral infarction patients is directly injected into the retinal vein (occluded blood vessel). This treatment can also be called a causal treatment that eliminates clogging of blood vessels that cause retinal vein occlusion. In particular, in an aging society with a large number of patients with retinal vein occlusion, the treatment method is an early treatment method. The establishment of is strongly desired. Incidentally, as a medical injection needle, what was described in the following patent documents 1 and patent documents 2 is known, for example.

特開2006−280503号公報JP 2006-280503 A 特開2004−290542号公報JP 2004-290542 A

上記の治療法は、網膜の静脈に注射針を刺し、この注射針を通して治療用の液体(以下「治療液」と総称)を静脈に注入する方法である。このため、網膜の静脈に刺通できる注射針を用意する必要がある。しかしながら、網膜の静脈(血管)の太さは直径100μm程度と非常に細いため、これに刺す注射針は更に細く形成する必要がある。このような極細の注射針は、ガラス製のキャピラリチューブであれば作ることも可能であるが、網膜の静脈のような細い血管に刺す注射針の用途にキャピラリチューブを使用するには、以下の点で難がある。   The above-described treatment method is a method in which an injection needle is inserted into a vein of the retina, and a therapeutic liquid (hereinafter referred to as “treatment solution”) is injected into the vein through the injection needle. For this reason, it is necessary to prepare an injection needle that can pierce the vein of the retina. However, since the thickness of the vein (blood vessel) of the retina is very thin with a diameter of about 100 μm, it is necessary to make the injection needle to pierce it thinner. Such an ultra-fine injection needle can be made with a glass capillary tube, but in order to use a capillary tube for an injection needle that pierces a thin blood vessel such as a retinal vein, There are difficulties in terms.

キャピラリチューブは、硬質の脆性材料であるガラスで作られているため、非常に折れやすい性質をもっている。したがって、たとえば、キャピラリチューブを血管に刺した状態で、キャピラリチューブが折れたり、あるいは欠けたりすると、血管の中にガラス片が残ってしまうおそれがある。このため、キャピラリチューブは上記の用途に不向きであった。   Since the capillary tube is made of glass which is a hard brittle material, it has a property of being easily broken. Therefore, for example, if the capillary tube is broken or chipped while the capillary tube is pierced into the blood vessel, a glass piece may remain in the blood vessel. For this reason, the capillary tube was unsuitable for said use.

そこで本発明者は、網膜の静脈のような細い血管でも刺通できる注射針を「金属製の注射針」で実現しようと試みた。ところが、当初は失敗の連続でなかなか思うような注射針を作ることができなかった。特に実現の障害となった点は、以下の3つの要求を同時に満足する必要があったためである。
(1)注射針の外径を細くすること。
(2)注射針の長さを確保すること。
(3)治療液の流通性を確保すること。
Therefore, the present inventor has tried to realize an injection needle that can be pierced even by a thin blood vessel such as a vein of the retina by using a “metal injection needle”. However, at first, I couldn't make a needle that seemed like a series of failures. In particular, the obstacle to realization was that the following three requirements had to be satisfied at the same time.
(1) To reduce the outer diameter of the injection needle.
(2) Ensure the length of the injection needle.
(3) To ensure the circulation of the treatment solution.

上記(1)の要求は、先述したとおり網膜の静脈に注射針を刺通する必要があるためである。上記(2)の要求は、注射針を刺通しようとする網膜の静脈が眼底近くにあるのに対して、注射針は眼球の角膜近くのトロカールを通して眼球内に挿入する必要があり、そこから眼底まで針先を到達させる必要があるためである。上記(3)の要求は、注射針を注射器に装着してプランジャを押圧操作したときに、シリンジ内の治療液を針先から吐出させる必要があるためである。   The requirement (1) is because it is necessary to pierce the retinal vein with the injection needle as described above. The requirement of (2) above is that the retinal vein to be inserted through the injection needle is near the fundus, whereas the injection needle must be inserted into the eyeball through the trocar near the cornea of the eyeball, and from there This is because it is necessary to reach the needle tip. The requirement (3) is because when the syringe needle is attached to the syringe and the plunger is pressed, the treatment liquid in the syringe needs to be discharged from the needle tip.

本発明者は、実際に異なる寸法や構造の注射針をいくつも試作し、それぞれの試作品について眼科医に使い勝手の確認を依頼し、その結果をもとに問題点と原因を考察して改良を行う、といったことを繰り返した。   The inventor actually made several prototypes of needles with different dimensions and structures, asked the ophthalmologist to confirm the usability of each prototype, and based on the results, considered the problem and cause and improved it. Repeated that.

そのような試行錯誤のなかで、本発明者は、針先に付けた極細の管の長さが治療液の流通性(通りやすさ)に想定以上に大きな影響を与えているという事実を知得し、本発明を想到するに至った。   In such trial and error, the present inventor has known the fact that the length of the ultrafine tube attached to the needle tip has a greater influence on the flowability (ease of passage) of the treatment solution than expected. The present invention has been conceived.

本発明の主な目的は、非常に細い血管であっても針管を刺通させ、その針管を通して血管に治療液を注入することができる注射針を提供することにある。   A main object of the present invention is to provide an injection needle that can pierce a needle tube even in a very thin blood vessel and inject a treatment liquid into the blood vessel through the needle tube.

本発明の第1の態様は、
針先に治療液の吐出口を有する針管を備える注射針であって、
前記針管は、前記吐出口が形成された刺通管と、この刺通管よりも太い主針管とを有し、前記主針管の先端部に前記刺通管を設けたものであり、
前記刺通管は、長さが7.0mm未満(ゼロを含まず)、外径が70μm以下(ゼロを含まず)、内径が40μm以下(ゼロを含まず)の寸法条件を満たす
ことを特徴とする注射針である。
The first aspect of the present invention is:
An injection needle provided with a needle tube having a treatment liquid discharge port at the needle tip,
The needle tube has a piercing tube in which the discharge port is formed and a main needle tube that is thicker than the piercing tube, and the piercing tube is provided at the tip of the main needle tube,
The piercing tube has a length condition of less than 7.0 mm (excluding zero), an outer diameter of 70 μm or less (not including zero), and an inner diameter of 40 μm or less (not including zero). It is an injection needle.

本発明の第2の態様は、
前記刺通管は、長さが5.0mm以下(ゼロを含まず)である
ことを特徴とする上記第1の態様に記載の注射針である。
The second aspect of the present invention is:
The piercing tube has a length of 5.0 mm or less (excluding zero). The injection needle according to the first aspect described above, wherein

本発明の第3の態様は、
前記刺通管は、長さが3.0mm以下(ゼロを含まず)である
ことを特徴とする上記第1の態様に記載の注射針である。
The third aspect of the present invention is:
The piercing tube has a length of 3.0 mm or less (excluding zero). The injection needle according to the first aspect described above, wherein

本発明の第4の態様は、
前記刺通管は、外径が40μm以上60μm以下である
ことを特徴とする上記第1〜第3のいずれかに記載の注射針である。
The fourth aspect of the present invention is:
The piercing tube has an outer diameter of not less than 40 μm and not more than 60 μm.

本発明の第5の態様は、
前記刺通管は、内径が20μm以上30μm以下である
ことを特徴とする上記第1〜第4の態様のいずれかに記載の注射針である。
According to a fifth aspect of the present invention,
The piercing tube has an inner diameter of 20 μm or more and 30 μm or less. The injection needle according to any one of the first to fourth aspects.

本発明によれば、非常に細い血管であっても針管を刺通させ、その針管を通して血管に治療液を注入することができる注射針を提供することができる。これにより、網膜静脈閉塞症患者の網膜の静脈血流の再生に有効な治療法の早期確実に寄与することができる。   ADVANTAGE OF THE INVENTION According to this invention, even if it is a very thin blood vessel, a needle tube can be pierced, and the injection needle which can inject | pour therapeutic liquid into a blood vessel through the needle tube can be provided. As a result, it is possible to contribute early and reliably to an effective treatment method for regenerating venous blood flow in the retina of patients with retinal vein occlusion.

本発明の実施の形態に係る注射針の構成例を示す図である。It is a figure which shows the structural example of the injection needle which concerns on embodiment of this invention. 刺通管の取付状態を示す要部断面図である。It is principal part sectional drawing which shows the attachment state of a piercing tube. 刺通管の構造を説明する図である。It is a figure explaining the structure of a piercing tube. 刺通管の作製方法の一例を説明する図である。It is a figure explaining an example of the preparation methods of a piercing tube. 刺通管の断面構造を電子顕微鏡で観察して得られた画像を示す図である。It is a figure which shows the image obtained by observing the cross-section of a piercing tube with an electron microscope. 本発明の他の実施の形態に係る注射針の構成例を示す図(その1)である。It is a figure (the 1) which shows the structural example of the injection needle which concerns on other embodiment of this invention. 本発明の他の実施の形態に係る注射針の構成例を示す図(その2)である。It is FIG. (2) which shows the structural example of the injection needle which concerns on other embodiment of this invention.

以下、本発明の実施の形態について図面を参照しつつ詳細に説明する。
本発明の実施の形態においては、次の順序で説明を行う。
1.注射針の構成
2.注射針の製造方法
3.実施例および比較例
4.実施の形態に係る効果
5.他の実施の形態
6.変形例等
Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
In the embodiment of the present invention, description will be given in the following order.
1. 1. Structure of injection needle 2. Manufacturing method of injection needle Examples and Comparative Examples 4. 4. Effects according to the embodiment Other Embodiments 6. Modifications etc.

<1.注射針の構成>
図1は本発明の実施の形態に係る注射針の構成例を示す図である。図示した注射針1は、主として、針基2と針管3とによって構成されている。針基2は、図示しない注射器に注射針1を取り付ける場合に、この注射器のシリンジ先端に着脱可能に装着される部分である。針基2は、たとえば、ポリプロピレン、ポリエチレン、ポリ塩化ビニルなどの熱可塑性樹脂を用いて形成されている。針基2は、全体的に段付きの円筒状に形成されている。
<1. Structure of injection needle>
FIG. 1 is a diagram showing a configuration example of an injection needle according to an embodiment of the present invention. The illustrated injection needle 1 is mainly composed of a needle base 2 and a needle tube 3. The needle base 2 is a part that is detachably attached to the syringe tip of the syringe when the injection needle 1 is attached to a syringe (not shown). The needle base 2 is formed using, for example, a thermoplastic resin such as polypropylene, polyethylene, or polyvinyl chloride. The needle base 2 is formed in a stepped cylindrical shape as a whole.

針管3は、針基2の先端部に取り付けられている。針管3は、たとえば、ステンレス鋼などの金属を用いて、細い管状に形成されている。針管3は、それぞれ寸法(外径、内径、長さ)の異なる複数の管を組み合わせた多段構造になっている。本実施の形態においては、一例として、主針管31、刺通管32および補強管33を組み合わせた3段構造になっている。なお、針管3を金属で構成する場合は、ステンレス鋼の他にも、たとえばニッケルクロム鋼を用いることが可能である。   The needle tube 3 is attached to the distal end portion of the needle base 2. The needle tube 3 is formed into a thin tubular shape using a metal such as stainless steel, for example. The needle tube 3 has a multistage structure in which a plurality of tubes having different dimensions (outer diameter, inner diameter, length) are combined. In the present embodiment, as an example, a three-stage structure in which the main needle tube 31, the piercing tube 32, and the reinforcing tube 33 are combined. In addition, when the needle tube 3 is made of metal, for example, nickel chrome steel can be used in addition to stainless steel.

主針管31は、3つの管のなかで最も長い管である。主針管31の長さL1は、針基2の先端部からの突出寸法で規定している。主針管31の基部は、針基2の先端部分に接着等によって固定されている。主針管31の外径d1は、刺通管32の外径d2(図3参照)よりも大きく、かつ、補強管33の外径d3よりも小さい寸法、たとえば、0.3mmに設定される。主針管31の長さL1は、注射針1の用途に適した寸法に設定される。ちなみに、本実施の形態においては、医療用のなかでも眼科医療、特に、眼球内に針管3を通して網膜の静脈に刺通させる目的で使用される注射針を想定している。このため、主針管31の長さL1は、眼球の大きさを考慮して、たとえば、針基2の先端部から25mm以上の長さ(好ましくは、27mm前後)を確保するように設定される。   The main needle tube 31 is the longest tube among the three tubes. The length L1 of the main needle tube 31 is defined by a protruding dimension from the distal end portion of the needle base 2. The base portion of the main needle tube 31 is fixed to the tip portion of the needle base 2 by adhesion or the like. The outer diameter d1 of the main needle tube 31 is set to be larger than the outer diameter d2 (see FIG. 3) of the piercing tube 32 and smaller than the outer diameter d3 of the reinforcing tube 33, for example, 0.3 mm. The length L1 of the main needle tube 31 is set to a size suitable for the use of the injection needle 1. By the way, in this embodiment, an injection needle used for the purpose of piercing the veins of the retina through the needle tube 3 in the eyeball, especially in ophthalmic medicine, is assumed among medical uses. For this reason, the length L1 of the main needle tube 31 is set so as to ensure a length of 25 mm or more (preferably around 27 mm) from the distal end portion of the needle base 2 in consideration of the size of the eyeball, for example. .

図2は刺通管の取付状態を示す要部断面図であり、図3は刺通管の構造を説明する図である。なお、図3の(B)は(A)のP部断面を示す拡大図である。刺通管32は、3つの管のなかで最も短く、かつ最も細い管である。刺通管32は、主針管31の先端部に設けられている。刺通管32の基部は、主針管31の先端部に同心状に固定されている。刺通管32の先端部(針先)は、刺通時の抵抗(以下「刺通抵抗」という。)を小さくするために、針管3の中心軸に対して斜めに傾斜し、これによって先鋭な刃面32Cを形成している。   FIG. 2 is a cross-sectional view of a main part showing an attached state of the piercing tube, and FIG. 3 is a view for explaining the structure of the piercing tube. In addition, (B) of FIG. 3 is an enlarged view which shows the P section cross section of (A). The piercing tube 32 is the shortest and thinnest tube among the three tubes. The piercing tube 32 is provided at the distal end portion of the main needle tube 31. The base portion of the piercing tube 32 is concentrically fixed to the distal end portion of the main needle tube 31. The distal end portion (needle tip) of the piercing tube 32 is inclined obliquely with respect to the central axis of the needle tube 3 in order to reduce resistance during piercing (hereinafter referred to as “piercing resistance”), thereby sharpening. A large blade surface 32C is formed.

刺通管32は、一部32Aが主針管31の先端部から突出し、他の部分32Bが主針管31の内部に挿入されている。以降の説明では、刺通管32の一部32Aを「突出部32A」、他の部分32Bを「挿入部32B」という。刺通管32の長さ(全長)L2は、7mm未満(ゼロを含まず)の条件を満たすように設定されている。この条件を適用する理由については後で述べる。突出部32Aの突出寸法L21は、0.3mm以上1.0mm以下に設定されている。突出部32Aの突出寸法L21を0.3mm以上とした理由は、これよりも短くすると、主針管31と刺通管32の外径差に伴う段付き部分の陰に突出部32Aが隠れてしまい、刺通管32の針先部分の位置確認が困難になるためである。ただし、主針管31の先端部分をテーパー加工した場合には、突出部32Aの突出寸法L21を、刺通管32先端の傾斜を考慮して0.15mmとすることが可能である。また、突出部32Aの突出寸法L21を1.0mm以下とした理由は、これよりも長くすると、(1)刺通管32が刺通抵抗に負けて曲がりやすくなる、(2)刺通管32が血管に深く刺さり過ぎて血管および血管下組織を傷つけるおそれがある、ためである。挿入部32Bの挿入寸法L22は、刺通管32の長さL2や先端部の加工方法、突出部32Aの突出寸法L21にもよるが、好ましくは、0.5mm以上3.0mm以下に設定される。   The piercing tube 32 has a part 32 </ b> A protruding from the tip of the main needle tube 31 and the other part 32 </ b> B inserted into the main needle tube 31. In the following description, a part 32A of the piercing tube 32 is referred to as a “projection 32A” and the other part 32B is referred to as an “insertion part 32B”. The length (full length) L2 of the piercing tube 32 is set so as to satisfy the condition of less than 7 mm (not including zero). The reason for applying this condition will be described later. The protrusion dimension L21 of the protrusion 32A is set to 0.3 mm or greater and 1.0 mm or less. The reason why the projecting dimension L21 of the projecting part 32A is 0.3 mm or more is that if it is shorter than this, the projecting part 32A is hidden behind the stepped part due to the outer diameter difference between the main needle tube 31 and the piercing tube 32. This is because it is difficult to confirm the position of the needle tip portion of the piercing tube 32. However, when the tip portion of the main needle tube 31 is tapered, the projecting dimension L21 of the projecting portion 32A can be set to 0.15 mm in consideration of the inclination of the tip of the piercing tube 32. Further, the reason why the projecting dimension L21 of the projecting portion 32A is set to 1.0 mm or less is that if it is longer than this, (1) the piercing tube 32 is easily bent by piercing resistance, and (2) the piercing tube 32. This may cause the blood vessel and the subvascular tissue to be damaged by being deeply stuck in the blood vessel. The insertion dimension L22 of the insertion part 32B depends on the length L2 of the piercing tube 32, the processing method of the tip part, and the projection dimension L21 of the projection part 32A, but is preferably set to 0.5 mm or more and 3.0 mm or less. The

突出部32Aの先端部には、上述した刃面32Cが形成されている。また、刃面32Cと同一の面内には吐出口32Dが開口している。吐出口32Dは、図示しない注射器のプランジャを押し込んだ場合に、その押圧力を受けて治療液が吐出する部分である。治療液は、治療に用いられる液体であれば特に制限はなく、たとえば、薬液、生理食塩水、純水などを挙げることができる。吐出口32Dは、刺通管32の中心軸に沿う流路32E(図3参照)の最下流部に形成されている。刺通管32の外径d2は、70μm以下(ゼロを含まず)の条件を満たすように設定されている。この条件を適用する理由は、刺通管32の外径d2が70μmを超えると、目的とする100μm程度の太さの血管(静脈等)に刺通管32を刺通させることが極めて困難になるためである。この血管に刺通管32を刺通させるときの手技の容易性等を考慮すると、刺通管32の外径d2は60μm以下とすることが好ましい。ただし、刺通管32の外径d2を過度に小さくすると、(1)刺通管32の内径d4の確保が難しくなる、(2)刺通管32が刺通抵抗に負けて曲がりやすくなる、という不具合が生じやすくなる。このため、刺通管32の外径d2は40μm以上とすることが好ましい。   The above-described blade surface 32C is formed at the tip of the protrusion 32A. A discharge port 32D is opened in the same plane as the blade surface 32C. The discharge port 32D is a portion from which the treatment liquid is discharged in response to the pressing force when a plunger of a syringe (not shown) is pressed. The treatment liquid is not particularly limited as long as it is a liquid used for treatment, and examples thereof include a drug solution, physiological saline, and pure water. The discharge port 32D is formed in the most downstream portion of the flow path 32E (see FIG. 3) along the central axis of the piercing tube 32. The outer diameter d2 of the piercing tube 32 is set so as to satisfy the condition of 70 μm or less (not including zero). The reason for applying this condition is that when the outer diameter d2 of the piercing tube 32 exceeds 70 μm, it is extremely difficult to pierce the piercing tube 32 into a target blood vessel (such as a vein) having a thickness of about 100 μm. It is to become. Considering the ease of the procedure when the piercing tube 32 is pierced into the blood vessel, the outer diameter d2 of the piercing tube 32 is preferably 60 μm or less. However, if the outer diameter d2 of the piercing tube 32 is excessively reduced, (1) it becomes difficult to secure the inner diameter d4 of the piercing tube 32, and (2) the piercing tube 32 is easily bent by piercing resistance. It becomes easy to cause the malfunction. For this reason, the outer diameter d2 of the piercing tube 32 is preferably 40 μm or more.

刺通管32の内径(流路32Eの直径)d4は、40μm以下(ゼロを含まず)の条件を満たすように設定されている。この条件を適用する理由は、後述する注射針1の製造方法(特に、刺通管32の作製方法)で採用する引き抜き加工においては、刺通管32の内径d4が刺通管32の外径d2の60%程度又はそれを少し下回る程度の寸法になるためである。刺通管32の内径d4は、単に液体の流通性だけを考慮すれば大きいほうが好ましいものの、上述した刺通管32の外径d2を考慮すると、20μm以上30μm以下とすることが好ましい。   The inner diameter (diameter of the flow path 32E) d4 of the piercing tube 32 is set so as to satisfy the condition of 40 μm or less (not including zero). The reason for applying this condition is that in the drawing process employed in the manufacturing method of the injection needle 1 described later (particularly, the method for producing the piercing tube 32), the inner diameter d4 of the piercing tube 32 is the outer diameter of the piercing tube 32. This is because the dimension is about 60% of d2 or slightly less than d2. The inner diameter d4 of the piercing tube 32 is preferably larger if only the fluidity of the liquid is taken into consideration, but considering the outer diameter d2 of the piercing tube 32 described above, it is preferably 20 μm or more and 30 μm or less.

補強管33は、3つの管のなかで最も太い管である。補強管33は、主針管31を内挿するかたちで針管3の根元側に取り付けられている。補強管33は、針管3の補強目的、特に、針管3全体の剛性を高めるために設けられている。補強管33の基部は、上述した主針管31とともに、針基2の先端部分に接着等によって固定されている。補強管33の長さL3は、たとえば、主針管31の長さL1の1/5以上2/3以下の寸法、より好ましくは、1/3以上1/2以下の寸法に設定するとよい。補強管33の長さL3は、針基2の先端部からの突出寸法で規定している。   The reinforcing pipe 33 is the thickest pipe among the three pipes. The reinforcing tube 33 is attached to the base side of the needle tube 3 so as to insert the main needle tube 31 therein. The reinforcing tube 33 is provided for the purpose of reinforcing the needle tube 3, particularly for increasing the rigidity of the entire needle tube 3. The base portion of the reinforcing tube 33 is fixed to the tip portion of the needle base 2 together with the main needle tube 31 described above by adhesion or the like. The length L3 of the reinforcing tube 33 may be set to, for example, a dimension that is 1/5 or more and 2/3 or less of the length L1 of the main needle tube 31, and more preferably a dimension that is 1/3 or more and 1/2 or less. The length L3 of the reinforcing tube 33 is defined by a protruding dimension from the distal end portion of the needle base 2.

補強管33の外径d3は、主針管31の外径d1にもよるが、たとえば、0.5mmに設定される。補強管33の内径は、補強管33の中に主針管31を通すことができるように、少なくとも主針管31の外径d1よりも大きく設定されている。補強管33は、主針管31の外側に同心状に二重管構造をなすように取り付けられている。なお、補強管33は、本発明において必須の要素ではなく、主針管31の長さや太さにより、必要に応じて設けられるものである。   The outer diameter d3 of the reinforcing tube 33 is set to 0.5 mm, for example, although it depends on the outer diameter d1 of the main needle tube 31. The inner diameter of the reinforcing tube 33 is set to be at least larger than the outer diameter d1 of the main needle tube 31 so that the main needle tube 31 can be passed through the reinforcing tube 33. The reinforcing tube 33 is attached to the outside of the main needle tube 31 so as to form a double tube structure concentrically. The reinforcing pipe 33 is not an essential element in the present invention, and is provided as necessary depending on the length and thickness of the main needle pipe 31.

<2.注射針の製造方法>
次に、注射針1の製造方法について説明する。まず、注射針1の構成部品となる針基2、主針管31、刺通管32、補強管33を用意する。このうち、刺通管32を除く部品は、一般的な医療用の注射針の構成部品と同様の方法(ただし、刃面の形成はなし)で作製可能である。このため、ここでは刺通管32の作製方法について詳しく説明する。
<2. Manufacturing method of injection needle>
Next, a method for manufacturing the injection needle 1 will be described. First, a needle base 2, a main needle tube 31, a piercing tube 32, and a reinforcing tube 33 that are components of the injection needle 1 are prepared. Among these, the parts excluding the piercing tube 32 can be manufactured by the same method as that of a general medical injection needle (however, the blade surface is not formed). For this reason, the manufacturing method of the piercing pipe | tube 32 is demonstrated in detail here.

刺通管32を作製する場合は、まず、目的とする上記外径d2よりも大きな外径を有する、断面円形の金属の管を作製する。具体的には、たとえば、SUS304などステンレス鋼の薄板を丸めて継ぎ目の部分を溶接する。このとき、必要に応じて、継ぎ目部分を研磨する。   When the piercing tube 32 is manufactured, first, a metal tube having a circular cross section having an outer diameter larger than the target outer diameter d2 is manufactured. Specifically, for example, a thin plate of stainless steel such as SUS304 is rolled and the joint portion is welded. At this time, the joint portion is polished as necessary.

次に、上記の金属管を引き抜き加工により細くする。具体的には、図4に示すように、金属管11の中に円錐形のプラグ12を挿入し、このプラグ12の円錐面に沿うようにダイス13に設けられたテーパー形状の穴14に金属管11を通す。そして、この穴14の大径側から小径側に向かって金属管11を引き抜く。これにより、ダイス13の穴14を通して引き抜かれた金属管11の外径は、穴14の小径側の開口寸法と同等の寸法まで細く絞られる。このような引き抜き加工を、たとえば、金属管11の外径が0.5mmくらいに細くなるまで複数回にわたって繰り返す。その後さらに、上記のプラグ12を挿入しない状態で引き抜き加工を複数回にわたって繰り返すことにより、金属管11の外径を所望の寸法(たとえば、50μm)まで細くする。   Next, the metal tube is thinned by drawing. Specifically, as shown in FIG. 4, a conical plug 12 is inserted into the metal tube 11, and a metal is inserted into a tapered hole 14 provided in the die 13 along the conical surface of the plug 12. Pass tube 11 through. Then, the metal tube 11 is pulled out from the large diameter side of the hole 14 toward the small diameter side. Thereby, the outer diameter of the metal tube 11 drawn through the hole 14 of the die 13 is narrowed down to a size equivalent to the opening size of the small diameter side of the hole 14. Such a drawing process is repeated a plurality of times until, for example, the outer diameter of the metal tube 11 is reduced to about 0.5 mm. After that, the outer diameter of the metal tube 11 is reduced to a desired dimension (for example, 50 μm) by repeating the drawing process a plurality of times without inserting the plug 12.

次に、金属管11を所望の長さに切断する。次に、ワイヤーカット放電加工や研削加工等によって、金属管11の針先を先鋭な刃面に加工する。以上の手順により刺通管32が得られる。
なお、注射針1の製造方法の変形例として、主針管31の所定の箇所まで更に引き抜き加工を行い、主針管31と刺通管32が一体となった針を製作することも可能である。
Next, the metal tube 11 is cut into a desired length. Next, the tip of the metal tube 11 is processed into a sharp blade surface by wire cut electric discharge machining, grinding, or the like. The piercing tube 32 is obtained by the above procedure.
As a modified example of the manufacturing method of the injection needle 1, it is possible to further pull out a predetermined portion of the main needle tube 31 to manufacture a needle in which the main needle tube 31 and the piercing tube 32 are integrated.

次に、注射針1の構成部品の組立手順について説明する。
まず、針基2に主針管31を取り付ける。具体的には、針基2の先端側に形成されている貫通孔(不図示)に主針管31の端部を挿入した後、針基2の先端部にディスペンサ等を用いて適量の接着剤を供給する。接着剤としては、たとえば、熱硬化性樹脂または光硬化性樹脂を用いることができる。ただし、この段階では、接着剤を未硬化の状態にしておく。
Next, the assembly procedure of the components of the injection needle 1 will be described.
First, the main needle tube 31 is attached to the needle base 2. Specifically, after inserting the end portion of the main needle tube 31 into a through hole (not shown) formed on the distal end side of the needle base 2, an appropriate amount of adhesive is applied to the distal end portion of the needle base 2 using a dispenser or the like. Supply. As the adhesive, for example, a thermosetting resin or a photocurable resin can be used. However, at this stage, the adhesive is left in an uncured state.

次に、主針管31の先端側から補強管33を嵌め入れるとともに、この補強管33の端部を上記接着剤に接触させた状態で針基2の先端部に突き当てる。その後、加熱または光(紫外線等)の照射によって接着剤を硬化させ、針基2の先端部分に主針管31と補強管33を一緒に固定する。   Next, the reinforcing tube 33 is fitted from the distal end side of the main needle tube 31, and the end portion of the reinforcing tube 33 is abutted against the distal end portion of the needle base 2 in a state of being in contact with the adhesive. Thereafter, the adhesive is cured by heating or irradiation with light (such as ultraviolet rays), and the main needle tube 31 and the reinforcing tube 33 are fixed together at the distal end portion of the needle base 2.

次に、主針管31の先端部に刺通管32の端部(挿入部32Bとなる部分)を挿入する。このとき、刺通管32の突出部32Aが主針管31の先端部から、たとえば0.5mmほど突出するように、刺通管32の端部を主針管31の内部に挿入する。その後、たとえば、レーザ溶接や接着剤などによって主針管31に刺通管32を固定する。レーザ溶接の場合は、刺通管32の挿入部32Bを囲んでいる主針管31の外周面にレーザ光を照射することにより、主針管31の内周面と補強管33の外周面とを溶融によって接合する。レーザ光の照射箇所は、主針管31の円周方向の複数箇所(たとえば、120°の等間隔で3箇所)とすればよい。   Next, the end of the piercing tube 32 (the portion that becomes the insertion portion 32B) is inserted into the distal end of the main needle tube 31. At this time, the end portion of the piercing tube 32 is inserted into the main needle tube 31 so that the protruding portion 32A of the piercing tube 32 protrudes from the distal end portion of the main needle tube 31 by about 0.5 mm, for example. Thereafter, the piercing tube 32 is fixed to the main needle tube 31 by, for example, laser welding or an adhesive. In the case of laser welding, the inner peripheral surface of the main needle tube 31 and the outer peripheral surface of the reinforcing tube 33 are melted by irradiating the outer peripheral surface of the main needle tube 31 surrounding the insertion portion 32B of the piercing tube 32 with laser light. Join by. The number of laser light irradiation locations may be a plurality of locations in the circumferential direction of the main needle tube 31 (for example, three locations at equal intervals of 120 °).

<3.実施例および比較例>
ここで、本発明に係る注射針の実施例と比較例について説明する。この実施例と比較例では、刺通管32の長さ等を除いて、共通の寸法および構造の注射針を採用している。具体的には、主針管31の寸法は、外径(d1)=0.3mm、内径=0.08mm、長さ(L1)=26mmとし、補強管33の寸法は、外径(d3)=0.5mm、長さ(L3)=13mmとした。また、刺通管32の寸法は、外径(d2)=50μm、内径(d4)=20μmとした。そして、実施例に係る注射針では、刺通管32の長さ(L2)を5mmまたは3mm、突出部32Aの突出寸法L21を0.5mm、挿入部32Bの挿入寸法L22を2.5mmとした。これに対して、比較例に係る注射針では、刺通管32の長さ(L2)を7mm、突出部32Aの突出寸法(L21)を0.5mm、挿入部32Bの挿入寸法(L22)を6.5mmとした。
<3. Examples and Comparative Examples>
Here, examples and comparative examples of the injection needle according to the present invention will be described. In this embodiment and the comparative example, the injection needle having the same size and structure is adopted except for the length of the piercing tube 32 and the like. Specifically, the dimensions of the main needle tube 31 are the outer diameter (d1) = 0.3 mm, the inner diameter = 0.08 mm, the length (L1) = 26 mm, and the dimensions of the reinforcing tube 33 are the outer diameter (d3) = 0.5 mm and length (L3) = 13 mm. The dimensions of the piercing tube 32 were set to an outer diameter (d2) = 50 μm and an inner diameter (d4) = 20 μm. In the injection needle according to the example, the length (L2) of the piercing tube 32 is 5 mm or 3 mm, the protrusion dimension L21 of the protrusion 32A is 0.5 mm, and the insertion dimension L22 of the insertion part 32B is 2.5 mm. . On the other hand, in the injection needle according to the comparative example, the length (L2) of the piercing tube 32 is 7 mm, the protrusion dimension (L21) of the protrusion 32A is 0.5 mm, and the insertion dimension (L22) of the insertion part 32B is. It was set to 6.5 mm.

その結果、実施例に係る注射針と比較例に係る注射針を、それぞれ注射器に装着して液体の出具合を確認したところ、次のような違いが認められた。
まず、比較例に係る注射針では、刺通管32の長さを7mmにして試作した100本の注射針のうち、刺通管32の吐出口32Dから液体の吐出を確認できたのは数本程度で、そのすべてで吐出状態が不十分であった。
これに対して、実施例に係る注射針では、刺通管32の長さを5mmにして試作した50本の注射針のうち、その半数程度で刺通管32の吐出口32Dから液体の吐出を確認でき、そのうちの5本くらいは特に吐出状態が良好なものであった。また、刺通管32の長さを3mmにして試作した50本の注射針については、そのすべてで刺通管32の吐出口32Dから液体の吐出を確認でき、しかもそのうちの20本くらいは非常に良好な吐出状態であった。
As a result, when the injection needle according to the example and the injection needle according to the comparative example were respectively attached to the syringe and the condition of the liquid was confirmed, the following difference was recognized.
First, in the injection needle according to the comparative example, out of 100 injection needles prototyped with the length of the piercing tube 32 being 7 mm, the number of liquid discharges from the discharge port 32D of the piercing tube 32 could be confirmed. At this level, the discharge state was insufficient for all of them.
On the other hand, in the injection needle according to the embodiment, the liquid is discharged from the discharge port 32D of the puncture tube 32 by about half of the 50 injection needles prototyped with the length of the puncture tube 32 being 5 mm. The discharge state was particularly good in about 5 of them. Moreover, about 50 injection needles made with a length of the piercing tube 32 of 3 mm, all of them can confirm the liquid discharge from the discharge port 32D of the piercing tube 32, and about 20 of them are very In a good discharge state.

ここで、比較例に係る注射針は、本発明に想到する過程で本発明者が試作した具体的態様の一つである。本発明者は当初、刺通管32を短くすると、その取り扱いが困難になることに加えて、次のような点を懸念した。すなわち、主針管31の先端部に刺通管32を挿入したときの挿入寸法L22を、ある程度長く確保しないと、レーザ溶接等によって刺通管32を固定しても、接合代が不足して接合強度が十分に確保されず、刺通管32が抜けやすくなるのではないかと懸念した。また、それ以外にも、刺通管32の挿入寸法L22が短いと、主針管31に刺通管32を挿入したときの、刺通管32の姿勢が安定しないのではないかと懸念した。特に、刺通管32は細い血管に刺すことを想定したものであるため、万一、刺通管32が主針管31から抜けてしまうと、血管に刺通管32が刺さったままになるか、場合によって血管の中に刺通管32が取り残されてしまうおそれがある。このため、本発明者は当初、刺通管32の長さを7mmに設定した。   Here, the injection needle according to the comparative example is one of the specific modes that the inventor made experimentally in the process of conceiving the present invention. The present inventor initially worried about the following points in addition to making the handling tube 32 difficult when the piercing tube 32 is shortened. That is, if the insertion dimension L22 when the piercing tube 32 is inserted into the distal end portion of the main needle tube 31 is not secured to some extent, even if the piercing tube 32 is fixed by laser welding or the like, the joining allowance is insufficient and I was concerned that the strength would not be sufficiently secured and the piercing tube 32 would be easily pulled out. In addition, if the insertion dimension L22 of the piercing tube 32 is short, there is a concern that the posture of the piercing tube 32 may not be stable when the piercing tube 32 is inserted into the main needle tube 31. In particular, since the piercing tube 32 is supposed to pierce a thin blood vessel, if the piercing tube 32 comes out of the main needle tube 31, does the piercing tube 32 remain stuck in the blood vessel? In some cases, the piercing tube 32 may be left behind in the blood vessel. For this reason, the inventor initially set the length of the piercing tube 32 to 7 mm.

ところが、この試作品(比較例に係る注射針)を注射器に装着して使用したところ、多くの試作品で刺通管32から液体が出ない、つまり刺通管32の中で詰まりが発生した。本発明者は、この原因が「研磨くずによる詰まり」にあるのではないかと考えて、製造方法に改良(研磨方法の工夫、研磨後の洗浄方法の工夫など)を加えてみたが、期待するほどの効果が得られなかった。そこで、先述した点を懸念しつつも、試しに刺通管32の長さをそれまでの半分以下(3mm)に設定して注射針1を試作してみたところ、刺通管32における液体の出具合(流通性)が劇的に改善された。また、主針管31と刺通管32の接合強度に関しても、実用上問題のない程度の強度を確保できていることが分かった。   However, when this prototype (injection needle according to the comparative example) was mounted on a syringe and used, liquids did not come out from the piercing tube 32 in many prototypes, that is, clogging occurred in the piercing tube 32. . The present inventor considered that the cause is “clogging due to polishing litter” and tried to improve the manufacturing method (devise polishing method, improvement of cleaning method after polishing, etc.). The effect was not obtained. Therefore, while anxious about the above-mentioned points, when the length of the piercing tube 32 was set to half or less (3 mm) as a trial and the injection needle 1 was prototyped, the liquid in the piercing tube 32 was measured. The appearance (distribution) has improved dramatically. Further, it was found that the strength of the joint needle between the main needle tube 31 and the piercing tube 32 could be secured to a practically satisfactory level.

上記の試作結果を踏まえて、本発明者は、刺通管32での詰まりの原因を究明するために、刺通管32の断面構造を電子顕微鏡で観察してみた。その結果、図5のような画像(二次電子像)が得られた。この画像から分かるように、刺通管32の内周面には多数の細かな凹凸(引き抜き加工による絞り皺)が存在している。このため、推測ではあるが、刺通管32の内径d4が確保されていても、刺通管32の内部で液体の流通が凹凸によって阻害され、刺通管32が一定以上の長さになったときに、液体の出具合が極端に悪化するものと考えられる。ちなみに、刺通管32の内径d2は、上記の凹凸による山の部分と谷の部分の中間にあたる、平均的な径で規定されるものとする。   Based on the result of the trial production, the present inventor has observed the cross-sectional structure of the piercing tube 32 with an electron microscope in order to investigate the cause of the clogging of the piercing tube 32. As a result, an image (secondary electron image) as shown in FIG. 5 was obtained. As can be seen from this image, a large number of fine irregularities (drawing rods by drawing) exist on the inner peripheral surface of the piercing tube 32. For this reason, although it is speculated, even if the inner diameter d4 of the piercing tube 32 is secured, the flow of the liquid inside the piercing tube 32 is obstructed by the unevenness, and the piercing tube 32 becomes a certain length or longer. It is considered that the liquid appearance is extremely deteriorated. Incidentally, it is assumed that the inner diameter d2 of the piercing tube 32 is defined by an average diameter that is intermediate between the peak portion and the valley portion due to the unevenness.

上記の試作結果からすると、刺通管32における液体の流通性には、刺通管32の長さが想定以上に大きく関係していることが伺える。通常の血管注射に用いられる注射針では、ある程度の太さが確保されているため問題にならなくても、太さ100μm程度の細い血管を想定した刺通管32となると、その細さ故に、内径側での凹凸によって液体の流れが阻害される。特に、本発明者の試作結果では、刺通管32の長さL2が7.0mm以上になると、歩留まりが極端に低くなることが分かった。このため、刺通管32の長さL2に関しては、少なくとも7.0mm未満とする必要があり、好ましくは5.0mm以下の範囲、さらに好ましくは、3.0mm以下の範囲とするのがよい(ただし、L2>0)。   From the result of the trial production described above, it can be seen that the length of the piercing tube 32 is more largely related to the flowability of the liquid in the piercing tube 32 than expected. In the needle used for normal blood vessel injection, even if it does not become a problem because a certain degree of thickness is secured, when it becomes a piercing tube 32 assuming a thin blood vessel of about 100 μm in thickness, because of its thinness, The liquid flow is obstructed by the irregularities on the inner diameter side. In particular, as a result of trial manufacture by the present inventor, it has been found that when the length L2 of the piercing tube 32 is 7.0 mm or more, the yield is extremely reduced. For this reason, the length L2 of the piercing tube 32 needs to be at least less than 7.0 mm, preferably in the range of 5.0 mm or less, and more preferably in the range of 3.0 mm or less ( However, L2> 0).

<4.実施の形態に係る効果>
本発明の実施の形態に係る注射針1においては、太さが100μm程度の細い血管に針管3を刺通させ、この針管3を通して治療液を血管に注入することができる注射針1を提供することができる。また、針管3の構成として、極細の刺通管32を主針管31の先端部に取り付け、かつ主針管31の針基2側を補強管33で補強しているため、針管3全体に適度な剛性をもたせることができる。このため、眼底にある網膜の静脈に対しても、針管3の刺通管32を刺通させ、治療液を注入することができる。したがって、これまでは対症療法でしか治療できないとされていた網膜静脈閉塞症の原因(血管の詰まり等)を、静脈への直接的な治療液の注入によって取り除くことが可能となる。このような原因療法の確立は、特に、網膜静脈閉塞症の患者数が多い高齢化社会において、公益的な観点から非常に有益なものであり、また眼科医療の進歩、発展の観点でも有意義なものとなる。
<4. Effect of Embodiment>
In the injection needle 1 according to the embodiment of the present invention, there is provided the injection needle 1 in which a needle tube 3 is pierced through a thin blood vessel having a thickness of about 100 μm, and a treatment liquid can be injected into the blood vessel through the needle tube 3. be able to. Further, as the configuration of the needle tube 3, an extremely fine piercing tube 32 is attached to the distal end portion of the main needle tube 31, and the needle base 2 side of the main needle tube 31 is reinforced by the reinforcing tube 33. Stiffness can be given. For this reason, the treatment liquid can be injected by inserting the piercing tube 32 of the needle tube 3 into the retinal vein in the fundus. Therefore, it is possible to remove the cause of retinal vein occlusion (eg, clogging of blood vessels), which has been treated only by symptomatic therapy so far, by directly injecting a therapeutic solution into the vein. The establishment of such causal therapy is extremely beneficial from the public interest viewpoint, especially in an aging society with a large number of patients with retinal vein occlusion, and is also meaningful from the viewpoint of advancement and development of ophthalmic medicine. It will be a thing.

<5.他の実施の形態>
図6は本発明の他の実施の形態に係る注射針の構成例を示す図である。図示した注射針1は、先述した実施の形態と比較して、針管3の形状が異なる。すなわち、先述した実施の形態では、針管3が針基2の中心軸に沿って真っ直ぐに延びた形状になっている。これに対して、他の実施の形態では、針管3が針基2の中心軸(図中一点鎖線で示す)に対して曲がった形状になっている。具体的な曲げ方については、特に、図例のように主針管31の途中から傾斜角度θで曲げた構造であってもよいし、あるいは図7に示すように針管3全体を弓形に曲げた構造であってもよい。
<5. Other embodiments>
FIG. 6 is a diagram showing a configuration example of an injection needle according to another embodiment of the present invention. The illustrated injection needle 1 is different in the shape of the needle tube 3 as compared to the above-described embodiment. That is, in the embodiment described above, the needle tube 3 has a shape extending straight along the central axis of the needle base 2. On the other hand, in another embodiment, the needle tube 3 is bent with respect to the central axis of the needle base 2 (indicated by a one-dot chain line in the figure). The specific bending method may be a structure in which the main needle tube 31 is bent at an inclination angle θ from the middle of the main needle tube 31 as shown in the figure, or the entire needle tube 3 is bent into an arcuate shape as shown in FIG. It may be a structure.

上記のように針管3を曲げた形状にした場合は、次のような利点が得られる。すなわち、図7に示すように、眼球21の角膜22近くに固定したカニューラ(不図示)を通して針管3を眼内に挿入し、網膜の静脈に刺通管32を刺通しようとする場合に、針基2を支持する注射器(不図示)の向きを操作することによって、針管3先端の刺通管32を静脈に沿わせて配置することができる。このため、網膜の静脈に刺通管32を刺しやすくなるとともに、実際に刺通管32を刺通させたときにその針先を静脈内に留めやすくなる。また、図示のように針管3全体を弓形に曲げた形状を採用した場合は、主針管31をカニューラに通しやすくなるという利点が得られる。   When the needle tube 3 is bent as described above, the following advantages are obtained. That is, as shown in FIG. 7, when the needle tube 3 is inserted into the eye through a cannula (not shown) fixed near the cornea 22 of the eyeball 21 and the puncture tube 32 is to be inserted into the vein of the retina, By manipulating the direction of a syringe (not shown) that supports the base 2, the piercing tube 32 at the tip of the needle tube 3 can be arranged along the vein. For this reason, it is easy to pierce the retinal vein with the piercing tube 32, and when the piercing tube 32 is actually pierced, the needle tip is easily retained in the vein. Moreover, when the shape which bent the whole needle tube 3 in the shape of a bow as shown in the figure is employ | adopted, the advantage that it becomes easy to let the main needle tube 31 pass to a cannula is acquired.

また、上記実施の形態においては、注射針1を製造する場合に、所望の外径を有する金属管を所望の長さに切断してから、その針先部分をワイヤーカット放電加工や研削加工するとしたが、本発明はこれに限らず、次のような方法を採用することも可能である。   Moreover, in the said embodiment, when manufacturing the injection needle 1, after cut | disconnecting the metal tube which has a desired outer diameter to desired length, when the needle-tip part is wire-cut electrical discharge machining or grinding, However, the present invention is not limited to this, and the following method can also be adopted.

まず、上述した引き抜き加工によって所望の寸法(外径)まで細くした金属管を、最終的に得られる刺通管32の2本分の長さに切断する。次に、その金属管の長さ方向の中間部分をレーザ加工によって斜めに切断する。これにより、1回のレーザ照射による切断によって2本の刺通管32が同時に得られる。その際、レーザ加工としては、非熱加工が可能なパルスレーザ加工、さらに好ましくは、フェムト秒レーザ加工またはピコ秒レーザ加工を採用することが望ましい。その理由は、パルスレーザ加工等を採用した場合は、刺通管32の元になる金属管の切断面のエッジ部分が、熱によってダレたりせずに鋭利に形成され、刺通抵抗が小さくなるためである。また、太さが100μm程度の細い血管を想定して径を細く絞った刺通管32の先端を研磨する場合は、その細さ故に研磨くずの発生やそれによる詰まりなどが懸念されるが、パルスレーザ加工等を採用した場合は、そのような懸念が生じることもない。   First, a metal tube thinned to a desired dimension (outer diameter) by the above-described drawing process is cut into a length corresponding to two piercing tubes 32 finally obtained. Next, an intermediate portion in the length direction of the metal tube is cut obliquely by laser processing. Thereby, the two piercing pipes 32 are obtained simultaneously by the cutting | disconnection by one laser irradiation. At that time, as the laser processing, it is desirable to employ pulse laser processing capable of non-thermal processing, more preferably femtosecond laser processing or picosecond laser processing. The reason for this is that when pulse laser processing or the like is employed, the edge portion of the cut surface of the metal tube that is the base of the piercing tube 32 is sharply formed without being sagted by heat, and the piercing resistance is reduced. Because. In addition, when polishing the tip of the piercing tube 32 whose diameter is narrowed assuming a thin blood vessel with a thickness of about 100 μm, there is a concern about the generation of clogging and clogging due to the thinness. Such a concern does not occur when pulse laser processing or the like is employed.

また、上記のレーザ加工に際しては、たとえば、2本分の長さをもつ複数の金属管を図示しない支持具に並べ、それらの金属管をレーザ加工により順に切断することにより、効率的に作業を進めることができる。また、上記の支持具を用いて、金属管の切断予定部を浮いた状態に支持し、そこにレーザ光を集光させて切断することにより、金属管の切断面の汚染を低減することができる。その理由は、金属管の切断予定部を浮いた状態にして、そこにレーザ光を集光させると、金属管以外の物質の蒸発や飛散が抑えられ、金属管の切断面に他の物質が付着しにくくなるためである。   In the above laser processing, for example, a plurality of metal tubes having a length of two are arranged on a support (not shown), and the metal tubes are sequentially cut by laser processing, thereby performing work efficiently. Can proceed. In addition, by using the above-described support tool, the cutting target portion of the metal tube is supported in a floating state, and the laser beam is condensed and cut to reduce contamination of the cut surface of the metal tube. it can. The reason for this is that when the planned cutting part of the metal tube is in a floating state and the laser beam is focused on the metal tube, evaporation and scattering of materials other than the metal tube can be suppressed, and other materials are present on the cut surface of the metal tube. It is because it becomes difficult to adhere.

また、パルスレーザ加工等を採用する場合は、次のような製造手順を採用することも可能となる。まず、引き抜き加工によって得られた金属管を、取り扱い容易な長さ(たとえば、10mmなど)に切断する。次に、切断した金属管の一部を主針管31内に挿入してレーザ溶接等により固定する。その後、パルスレーザ加工等により金属管の先端部分を所望の長さで斜めに切断する。この手順を採用することにより、外径70μm以下の刺通管32を有する注射針であっても、突出部を短く設定することができる。   Further, when employing pulse laser processing or the like, the following manufacturing procedure can be employed. First, a metal tube obtained by drawing is cut into a length (for example, 10 mm) that is easy to handle. Next, a part of the cut metal tube is inserted into the main needle tube 31 and fixed by laser welding or the like. Thereafter, the tip of the metal tube is cut obliquely at a desired length by pulse laser processing or the like. By adopting this procedure, the protruding portion can be set short even for an injection needle having a piercing tube 32 having an outer diameter of 70 μm or less.

<6.変形例等>
本発明の技術的範囲は上述した実施の形態に限定されるものではなく、発明の構成要件やその組み合わせによって得られる特定の効果を導き出せる範囲において、種々の変更や改良を加えた形態も含む。
<6. Modified example>
The technical scope of the present invention is not limited to the above-described embodiments, and includes various modifications and improvements as long as the specific effects obtained by the constituent elements of the invention and combinations thereof can be derived.

たとえば、上記実施の形態においては、針基2に取り付ける針管3の構造を、主針管31、刺通管32および補強管33を用いた3段構造としたが、本発明はこれに限らない。具体的には、針管3の針基側から針先側に向かって連続的に径(外径、内径)が変化するテーパー形状の針構造とし、その針先部分が上記の寸法条件を満たす刺通管として構成されたものであってもよい。   For example, in the above embodiment, the structure of the needle tube 3 attached to the needle base 2 is a three-stage structure using the main needle tube 31, the piercing tube 32 and the reinforcing tube 33, but the present invention is not limited to this. Specifically, the needle tube 3 has a tapered needle structure in which the diameter (outer diameter, inner diameter) continuously changes from the needle base side toward the needle tip side, and the needle tip portion is a needle structure that satisfies the above dimensional conditions. It may be configured as a through pipe.

また、針基2にフィルタを内蔵し、このフィルタで微細な異物等を捕獲することにより、針管3内(特に、刺通管32内)での詰まりを回避し得る構成を採用してもよい。   Further, a configuration may be adopted in which a clogging in the needle tube 3 (particularly, in the piercing tube 32) can be avoided by incorporating a filter in the needle base 2 and capturing fine foreign matters or the like with this filter. .

また、上記の注射針1は、非常に細い血管に刺通する際に用いて好適なものであるが、本発明はこれに限らず、医療用途全般またはそれ以外の用途にも広く使用することが可能である。   In addition, the above-described injection needle 1 is suitable for use when piercing a very thin blood vessel, but the present invention is not limited to this, and can be widely used for general medical use or other uses. Is possible.

以下、本発明の好ましい態様を付記する。
[付記1]
針先に治療液の吐出口を有する針管を備える注射針であって、
前記針管は、前記吐出口が形成された刺通管と、この刺通管よりも太い主針管とを有し、前記主針管の先端部に前記刺通管を設けたものであり、
前記刺通管は、長さが7.0mm未満(ゼロを含まず)、外径が70μm以下(ゼロを含まず)、内径が40μm以下(ゼロを含まず)の寸法条件を満たし、
前記刺通管の針先部分は、パルスレーザ加工、フェムト秒レーザ加工またはピコ秒レーザ加工によって斜めに切断されている
ことを特徴とする注射針。
Hereinafter, preferred embodiments of the present invention will be additionally described.
[Appendix 1]
An injection needle provided with a needle tube having a treatment liquid discharge port at the needle tip,
The needle tube has a piercing tube in which the discharge port is formed and a main needle tube that is thicker than the piercing tube, and the piercing tube is provided at the tip of the main needle tube,
The piercing tube satisfies the dimensional conditions of a length of less than 7.0 mm (excluding zero), an outer diameter of 70 μm or less (not including zero), and an inner diameter of 40 μm or less (not including zero),
A needle tip portion of the piercing tube is cut obliquely by pulse laser processing, femtosecond laser processing, or picosecond laser processing.

1…注射針
2…針基
3…針管
31…主針管
32…刺通管
32A…突出部
32B…挿入部
32C…刃面
32D…吐出口
33…補強管
DESCRIPTION OF SYMBOLS 1 ... Injection needle 2 ... Needle base 3 ... Needle tube 31 ... Main needle tube 32 ... Puncture tube 32A ... Projection part 32B ... Insertion part 32C ... Blade surface 32D ... Discharge port 33 ... Reinforcement tube

Claims (5)

針先に治療液の吐出口を有する針管を備える注射針であって、
前記針管は、金属製であって、前記吐出口が形成された刺通管と、この刺通管よりも太い主針管とを有し、前記主針管の先端部に前記刺通管を設けたものであり、
前記刺通管は、長さが7.0mm未満(ゼロを含まず)、外径が70μm以下(ゼロを含まず)、内径が40μm以下(ゼロを含まず)の寸法条件を満たす
ことを特徴とする注射針。
An injection needle provided with a needle tube having a treatment liquid discharge port at the needle tip,
The needle tube is made of metal, has a piercing tube in which the discharge port is formed, and a main needle tube that is thicker than the piercing tube, and the piercing tube is provided at a distal end portion of the main needle tube. Is,
The piercing tube has a length condition of less than 7.0 mm (excluding zero), an outer diameter of 70 μm or less (not including zero), and an inner diameter of 40 μm or less (not including zero). And needle.
前記刺通管は、長さが5.0mm以下(ゼロを含まず)である
ことを特徴とする請求項1に記載の注射針。
The injection needle according to claim 1, wherein the piercing tube has a length of 5.0 mm or less (excluding zero).
前記刺通管は、長さが3.0mm以下(ゼロを含まず)である
ことを特徴とする請求項1に記載の注射針。
The injection needle according to claim 1, wherein the piercing tube has a length of 3.0 mm or less (excluding zero).
前記刺通管は、外径が40μm以上60μm以下である
ことを特徴とする請求項1〜3のいずれかに記載の注射針。
The injection needle according to any one of claims 1 to 3, wherein the piercing tube has an outer diameter of 40 µm or more and 60 µm or less.
前記刺通管は、内径が20μm以上30μm以下である
ことを特徴とする請求項1〜4のいずれかに記載の注射針。
The injection needle according to any one of claims 1 to 4, wherein the piercing tube has an inner diameter of 20 µm or more and 30 µm or less.
JP2012230450A 2012-10-18 2012-10-18 Needle Active JP6220119B2 (en)

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JPS5695058A (en) * 1979-12-10 1981-08-01 Toyo Jozo Kk Microosyringe
US5792099A (en) * 1995-02-14 1998-08-11 Decamp; Dennis Syringe and cannula for insertion of viscoelastic material into an eye and method of using same
JP4083425B2 (en) * 2001-01-25 2008-04-30 テルモ株式会社 Liquid injection needle and liquid injection device
JP2004232077A (en) * 2003-01-29 2004-08-19 Kazuyoshi Tsuchitani Method of producing metallic extra fine tube
JP4696284B2 (en) * 2005-01-27 2011-06-08 学校法人 東洋大学 Flexible hollow needle
US8235934B2 (en) * 2007-02-22 2012-08-07 Tokai University Educational System Functional thin tube device

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