WO2013027799A1

WO2013027799A1 - Injection needle

Info

Publication number: WO2013027799A1
Application number: PCT/JP2012/071318
Authority: WO
Inventors: 秀雄川本; まどか堀江; 大谷内　哲也
Original assignee: テルモ株式会社
Priority date: 2011-08-24
Filing date: 2012-08-23
Publication date: 2013-02-28
Also published as: CN203842127U

Abstract

The present invention provides an injection needle which comprises a needle tube having a prescribed thickness, in which the outer diameter ø_o1 of the front end of the needle tube is less than 0.2 mm, the ratio ø_o1/ø_o2 of the outer diameter ø_o1 of the front end relative to the outer diameter ø_o2 of the rear end is 0.49 to 0.64, the section from a predetermined position (A₂) on the base end side of the needle tube to a predetermined position (A₁) on the front end side of the needle tube is a tapered section in which the tube diameter gradually decreases from the rear end outer diameter ø_o2 towards the front end outer diameter ø_o1, and the ratio L₂/L₁ of the length (L₂) of the tapered section relative to the length (L₁) of the front end section from the front end to the predetermined position (A₁) is three or more. The injection needle is a needle of 34 G or less and has a resistance to injection that is equal to or less than a needle which is 1 G greater. Also provided is a drug injection device which comprises this injection needle.

Description

Needle

The present invention relates to an injection needle, particularly an extremely small diameter injection needle.

In recent years, with regard to injection needles, injection needles with a small needle diameter have been developed to alleviate fear and reduce puncture pain. For example, even with a 30 G (gauge) injection needle, if the needle length is short, the bending strength does not decrease so much even if the tube thickness is reduced by 50%, and the needle length for puncturing the skin (the length from the hub) It has been proposed that the length of the 8 mm needle according to ISO 7864: 1993E be shorter than 9 mm (see Patent Document 1).

On the other hand, a small-diameter injection needle has a problem that the needle may be bent at the hub mounting portion, causing needle breakage, and the flow path resistance is increased due to the small inner diameter. For this reason, in the small-diameter injection needle, the diameter on the hub attachment proximal end side is increased to give strength, and the taper is provided from the proximal end side toward the distal end. For example, a 31G injection needle having an outer diameter of 0.25 mm has a minimum inner diameter of only 0.114 mm. If the inner diameter is reduced as the outer diameter decreases, as in the case of known injection needles, the injection rate is reduced at the reduced inner diameter portion. There is a proposal that the needle tube is kept at a constant inner diameter, and only the outer diameter is tapered, and the puncture end is reduced by 1 gauge from the maximum diameter on the proximal end side (see Patent Document 2). Here, an injection needle having a maximum proximal end diameter of 32G (φ0.229 to 0.241 mm), a puncture end of 33G (φ0.203 to 0.216 mm), and a 32G inner diameter of 0.089 mm has been proposed.

Also, a needle with a tapered part has been proposed. For example, an injection needle having a taper of 0.5 to 2 degrees with respect to the long axis in the middle portion of the needle tube having a proximal outer diameter larger than the outer diameter of the distal end (see Patent Document 4), a hub mounting portion of the needle tube, There is an injection needle having a taper in the vicinity thereof (see Patent Document 5, etc.). In these, the tube thickness of the needle tube is constant, the taper portion has the same taper for both the inner and outer diameters, and the tip portion has a constant outer diameter. In particular, in the latter, the outer diameter and the predetermined length of the distal end are set relatively to the entire length of the puncture portion (from the hub to the front side), indicating that the flow resistance is small and a predetermined flow rate is maintained. ing.

As described above, various types of small-diameter needles have been proposed, and the needles that are currently used frequently, such as insulin self-injection, especially for diabetic patients, have a smaller diameter than the conventional 31G (φ0.25 mm). 33G (φ0.2 mm) injection needles have already been put into practical use (see Patent Document 3 etc.). However, a practical product of an injection needle thinner than 33G has not yet appeared.
“G (gauge)” is a number corresponding to a length (in inches) defined by BWG-Birmingham Wire Gauge.

JP-T-2001-527435 JP-T-2004-518516 JP 2003-200218 A Japanese Patent Application Laid-Open No. 2008-200528 JP 2002-291844 A

When further reducing the diameter of the injection needle for the purpose of reducing the puncture pain of the injection needle, problems inherent to the ultrafine needle tube, in particular, the flow path resistance is theoretically inversely proportional to the fourth power of the tube inner diameter. Even when the diameter is reduced to 1G, the injection resistance is remarkably increased, making it difficult to actually inject. An object of the present invention is to provide an injection needle that is a small-diameter needle that can suppress pain given to a patient and the like and has an injection resistance equal to or less than that of a conventional needle.

The present inventor has studied to put into practical use a needle having a small diameter that can suppress pain given to a patient and the like, and has an injection resistance equal to or less than that of a conventional needle, and reduces the thickness of the needle tube. This ensures the flow path in the tube without increasing the flow path resistance, while making the diameter on the proximal end side larger than the diameter of the distal end and shortening the distal end that enters the skin, By providing a relatively long taper portion compared to the product, the strength of the needle can be ensured, and the injection resistance can be equal to or less than that of a needle having a small invasion to the skin and a large G size. The inventors have found that an injection needle can be obtained, and have completed the present invention.

That is, the injection needle according to the present invention comprises a needle tube having a thickness of 0.035 to 0.050 mm, has a puncture blade surface at the distal end, and a rear end on the proximal end that is fixed to the hub has a chemical solution injector. An injection needle that communicates with the chemical container,
The outer diameter φ _o1 of the tip of the needle tube is less than 0.2 mm, and the ratio φ _o1 / φ _o2 to the outer diameter φ _o2 of the rear end of the outer diameter φ _o1 of the tip is 0.49 to 0.64,
Section from a predetermined position A ₂ on the base end side of the needle tube to a predetermined position A ₁ of the distal end side is a taper part pipe diameter from the rear end outer diameter phi _o2 to the tip outer diameter phi _o1 is gradually reduced, and the A ratio L ₂ / L ₁ of the length L ₂ of the taper portion to the length L ₁ of the tip portion from the tip to a predetermined position A ₁ is 3 or more.

The inner diameter φ _i1 of the tip is 0.084 to 0.113 mm.

The outer diameter φ _{o2 of the} rear end is 0.297 to 0.363 mm, and the inner diameter φ _i2 is 0.203 to 0.285 mm.

Wherein the length L ₂ of the tapered portion is 5 ~ 6 mm.

The length L ₁ of the tip is 0.9 to 1.7 mm.

According to the present invention, it is possible to provide an injection needle that is thinner than the conventional thinnest practical injection needle, and therefore has less invasion to the skin and less pain, and has an injection resistance equal to or less than that of the conventional needle.

It is sectional drawing which shows the injection needle of this invention. It is sectional drawing which shows typically the example of 1 aspect of the chemical injection device concerning this invention. It is a partial side view of the chemical | medical solution injection device which concerns on this invention which shows the other example of an injection needle attaching part. FIG. 4 is a cross-sectional view of FIG. 3. It is a figure which shows the example of 1 aspect of the puncture blade tip of the injection needle of this invention.

Hereinafter, the injection needle of the present invention will be specifically described with reference to the drawings of the embodiments. In addition, in each following figure, the same code | symbol shows the same or equivalent part.
FIG. 1 shows an embodiment of the injection needle of the present invention. FIG. 2 is a cross-sectional view schematically showing an embodiment of the chemical liquid injector.
In FIG. 1, the injection needle 1 is inserted into the hole 21b of the hub 21, and is fixed to the hub 21 with the adhesive 3 in the hollow portion 21a.
A chemical liquid injector 2 shown in FIG. 2 includes an injection needle 1 and a container body 20. This embodiment shows an example in which a hub 21 which is an attachment portion of the injection needle 1 is integrated with a cylindrical container 22 which is a chemical solution storage portion 23 of the container body 20, whereby the injection needle 1 is It is directly attached to the tip of the cylindrical container 22 that stores the chemical solution 25. A gasket 26 that slides inside is inserted into the cylindrical container 22, and the drug solution 25 can be discharged from the tip of the injection needle 1 by pressing a plunger 24 attached to the gasket 26. That is, when the injection needle 1 is located in the living body, the drug solution 25 is injected into the living body from the tip of the injection needle 1.
Usable drug solution 25 is a solution, gel, or suspension containing a drug. The drug is not substantially limited as long as it is other than a drug not suitable for transdermal administration.

The injection needle 1 is a needle tube having a thickness of 43 ± 4 μm, and a puncture blade surface 1a is attached to the tip.

The length L ₁ of the tip portion 11 from the tip of the injection needle 1 to the predetermined position A ₁ is preferably 0.9 to 1.7 mm, but the length L ₁ in the embodiment is 1.7 mm.

The outer diameter φ _o1 of the distal end portion 11 of the injection needle 1 is preferably 0.178 to 0.191 mm, and the outer diameter φ _o1 in the embodiment is 0.18 mm.
The length of the outer diameter of the tip corresponding to each gauge number is 33G (0.008 inch) = about 0.203 mm, 34G (0.007 inch) = about 0.178 mm, 35G (in mm conversion). 0.005 inch) = about 0.127 mm, that is, the outer diameter of the tip in the present invention corresponds to 34 G or less.

The inner diameter φ _i1 of the distal end portion 11 is preferably 0.084 to 0.113 mm, and the inner diameter φ _i1 in the embodiment is 0.09 mm.

In the present invention, the length L ₂ (from the position A ₁ to A ₂ ) L ₂ of the tapered portion 12 may be three times or more (L ₂ / L ₁ ≧ 3) with respect to the tip length L ₁ as described above. It is preferably 5 to 6 mm. Implementation the length of the tapered portion 12 (from the position _{A 1} to _{A 2)} in Example _{L 2} is 6 mm.
The length L ₂ of the above as the tapered portion 12, in a preferred embodiment of the present invention, the base end portion of the tapered portion, which is normally housed inside the hub. In this case, the rear end A ₂ of the base end side of the tapered portion 12 may be fixed at the hub 21 (fixed hole 21b), also be in contact with the hub 21 in the cavity 21a present on the hub distal end You may be accommodated without. In the former case, the proximal end 1b of the injection needle 1 may be tapered. In the present invention, the latter embodiment is preferably mentioned, and the portion fixed to the hub 21 preferably has the same constant diameter as the outer diameter φ _o2 of the proximal end 1 b of the injection needle 1.
In the embodiment, the proximal end rear end A ₂ of the tapered portion 12 is located in the cavity portion 21 a of the hub 21. The base end side of the tapered portion 12 rear end A ₂ and the injection needle 1 of the base end 1b (FIG. 2) have the same diameter, thus the bore 21b of the hub 21 showing the manner in which the needle tube of constant diameter is inserted .

The outer diameter phi _o2 at the proximal end side rear _{A 2} of the tapered portion 12 in the embodiment is 0.33 mm, the inner diameter phi _i2 is 0.24 mm.
The taper angle of the taper portion 12 with respect to the long axis of the needle tube center is preferably 0.6 to 0.8 °, and the taper angle in the embodiment is 0.7 °.
The length of the rear end portion 14 from the rear end _{A 2} of the tapered portion 12 to the proximal end 1b of the injection needle 1 is in the embodiment is 7.3 mm.

The total length L ₃ of the puncture portion 13 protruding from the tip A ₃ of the hub 21 of the injection needle 1 (up to the tip of the needle 1) is preferably 4 to 6 mm, and L ₃ in the embodiment is 4 mm.
In a preferred embodiment, the outer diameter φ _i3 of the proximal end (hub distal end A ₃ ) of the puncture portion 13 is smaller than the outer diameter φ _{o2 at} the rear end A ₂ of the tapered portion 12, and the proximal outer diameter φ _o3 is 0. It is preferable that the inner diameter φ _i3 of the base end is 0.0146 to 0.212 mm.
Outer diameter phi _o3 of the proximal end _{A 3} of puncture 13 in the embodiment is 0.24 mm, the inner diameter phi _i3 is 0.015 mm.

The proximal end 1b of the needle tube only needs to communicate with the chemical solution storage portion 23 of the chemical solution injector 2, and may be at the distal end portion of the storage portion 23 or may protrude into the storage portion 23. Accordingly, the total length of the needle tube of the injection needle 1 varies depending on the position of the proximal end 1b of the needle tube and is not particularly limited. However, when the proximal end 1b of the needle tube is at the end of the drug solution storage portion 23, it is 15.7 to 17.0 mm. It is preferable. In this case, the rear end of the rear end A ₂ of the tapered portion 12 to the proximal end 1b of the injection needle 1 corresponds to the fixed portion of the hub 21 (hole 21b), the length is not particularly limited, 7. It is about 3 to 8.3 mm.

The injection needle of the present invention can not only weaken the puncture pain because the tip of the puncture part is thin, but with the above structure, the injection resistance is equal to or less than that of a conventional 1 g large injection needle that is a small diameter injection needle. can do. Specifically, the injection resistance compared with the pressure (mmHg) when the injection needle of the present invention is attached to the chemical injection device and the air is pushed out from the inside of the chemical storage portion is equal to or less than that of the 1G large injection needle.

The method of manufacturing an injection needle according to the present invention includes punching out a plate-like body having a tubular shape developed from a metal thin plate in a state where the metal thin plate and the plate-like body are partially joined to each other. The body is pressed into a tubular body having at least two types of inner diameters, and then a joint between the metal thin plate and the plate-like body is cut to produce a metal tubular body having at least two types of inner diameters. . In the method for producing a metallic tubular body of the present invention, the plate-like body is pressed into a tubular body having at least two kinds of inner diameters, and then a joint portion of the pipe is welded. In the method for producing a metal tubular body according to the present invention, the plate-like body portion corresponding to either the distal end portion or the base end portion to be pressed into the tubular body during the press working is used as the metal tubular body. The central axis of the tubular body being pressed may be made parallel to the plane formed by the metal thin plate by moving it above or below the plane formed by the thin plate. Such a manufacturing method is described in Japanese Patent Application Laid-Open No. 2003-200218.

Since the injection needle of the present invention is manufactured into a tubular body by pressing, the surface roughness of the inner surface of the tubular body according to JIS-B-0601-1994 is not shown without showing the surface state of the metal thin plate which is the starting material. The maximum height Ry (also referred to as maximum height difference Rmax, Rf) is 3 μm or less, preferably 2 μm or less, more preferably 1 μm or less. If the Ry of the inner surface of the tubular body is in the above range, the entire inner surface is smooth and there are no large scratches, so that a tubular body that does not increase the flow path resistance by thinning the needle tube is obtained. The inner surface Ry of the needle tube of the example was 3 μm.

FIG. 5 shows a puncture blade surface of an example which is an embodiment of the puncture blade surface of the injection needle of the present invention. FIG. 5 shows a plan view at the center, a right side view and a left side view on the left and right sides. A cutting edge 52 made of a bevel 57 is used. The blade surface length 59 (l) is preferably 0.8 to 1.2 mm, the second bevel length / the blade surface length (a / l) is 47 to 80%, and the third bevel length / the blade surface length (b / l). ) Is preferably 23 to 45%. When the shape of the puncture blade surface 5 is within this range, the injection resistance of the chemical solution is small and it is difficult to feel pain when puncturing.

FIGS. 3 to 4 show a second embodiment of the medicinal solution injecting device of the present invention, and a side view of a pen type medicinal solution injecting device in which the injection needle mounting portion (hub) is a cap separable from the container main body, and FIG. In the following, differences from the first embodiment will be described, and description of common parts will be omitted.
In this embodiment, except that the injection needle mounting portion (hereinafter referred to as a cap) 4 is separable from the container main body 20 containing the medicinal solution, it is the same as the configuration of the medicinal solution injection device 2 shown in FIG. In some cases, a sealing portion (not shown) made of an elastic member such as rubber is formed at the tip of the container body.

3 to 4, a cylindrical container 42 of the cap 4 is a housing portion 43 whose inner cavity receives the distal end portion of the container main body (not shown) 20, and a screw on the container main body side is provided on the inner periphery of the distal end side. A screw groove 44 that is screwed into the groove and a non-slip groove 45 on the outer periphery are provided.
The injection needle 1 inserted into the hole 46 of the hub 41 protruding from the tip of the cap 4 is fixed with the adhesive 3 in the hollow portion 41a.

The injection needle 1 held by the hub 41 is the same as that described in FIG. 1 of the first embodiment.
In this embodiment, a mode in which the rear end A ₂ on the proximal end side of the tapered portion 12 of the injection needle 1 is located in the hole 46 of the hub 41 is shown.
In use, when the screw groove 44 of the cap 4 is screwed into the container main body screw groove, the proximal end of the injection needle 1 punctures the sealing portion of the container main body and is inserted into the drug solution storage portion 23, and the drug solution is injected into the injection needle 1. It becomes possible to distribute inside.

<Evaluation of injection resistance>
The 34G injection needle of the above example was tested against an existing 33G injection needle (outer diameter φ _o1 0.203 mm). The dimensions of the 33G injection needle (Nermopath manufactured by Terumo Corporation, Nanopath is a registered trademark of Terumo Corporation) used as a reference example for comparison are as follows.
Needle tube thickness = 50 ± 4 μm, tip inner diameter φ _i1 = 0.10 mm, rear end inner diameter φ _i2 = 0.25 mm, tip length L ₁ = 2.5 mm, taper length L ₂ = 3.5 mm, puncture portion Total length L ₃ = 5 mm, rear end length = 10 mm.
The pressure (mmHg) measured when the injection needle was attached to the chemical liquid injector and the air in the chemical liquid container was pressed was measured.
When the pressure measured when the 33G injection needle was attached was 1, the pressure measured when the 34G injection needle of the example was attached was a relative ratio of 0.97, which was less than or equal to 33G.

<Pain assessment>
Evaluation of which of the 34G needle and the 33G needle of the above example was not painful was performed blind (n = 15).
Six people answered that the 33G needle is not painful, whereas nine people answered that the 34G needle is not painful, and the 34G needle is rated less painful It was done.
From this result, it can be expected that the 34G needle is less likely to feel pain than the 33G needle that is less likely to feel pain.

DESCRIPTION OF SYMBOLS 1 Injection needle 1a Puncture blade surface 1b Base end 11 Tip part 12 Taper part 13 Puncture part 14 Rear end part 2 Chemical solution injection apparatus 20 Container main body 21 Hub 21a Cavity part 21b Hole 22 Cylindrical container 23 Drug solution storage part 24 Plunger 25 Drug solution 3 Adhesive 4 Cap 41 Hub 41a Hollow portion 42 Tubular container 43 Housing portion 44 Screw groove 45 Groove 46 Hole 5 Puncture blade surface 51 Point 52 Cutting edge 53 Jaw portion 55 First bevel 56 Second bevel (a) Second bevel length 57 3rd bevel (b) 3rd bevel length 59 Blade face length (l)

Claims

It is a syringe needle having a needle tube having a thickness of 0.035 to 0.050 mm, having a puncture blade surface at the tip, and a rear end on the base end side fixed to the hub communicating with the drug solution storage portion of the drug solution injector. And
The outer diameter φ o1 of the tip of the needle tube is less than 0.2 mm, and the ratio φ o1 / φ o2 to the outer diameter φ o2 of the rear end of the outer diameter φ o1 of the tip is 0.49 to 0.64,
Section from a predetermined position A 2 on the base end side of the needle tube to a predetermined position A 1 of the distal end side is a taper part pipe diameter from the rear end outer diameter phi o2 to the tip outer diameter phi o1 is gradually reduced, and the needle ratio L 2 / L 1 length L 2 of the tapered portion to the length L 1 of the distal portion from the tip to a predetermined position a 1 is 3 or more.
The injection needle according to claim 1, wherein an inner diameter φ i1 of the tip is 0.084 to 0.113 mm.
The injection needle according to claim 1, wherein an outer diameter φ o2 of the rear end is 0.297 to 0.363 mm.
The injection needle according to any one of claims 1 to 3, wherein the length of the tapered portion is 5 to 6 mm.
The injection needle according to any one of claims 1 to 4, wherein the tip has a length of 0.9 to 1.7 mm.
A chemical injection device comprising the injection needle according to any one of claims 1 to 5 and comprising a container body capable of storing a liquid therein and an attachment portion for the injection needle.