Syringe with needle, prefilled syringe, and medical liquid administration tool using the same

Patent metadata

Field	Value
Publication number	US-2016243305-A1
Application number	US-201615145259-A
Country	US
Kind code	A1
Filing date	May 3, 2016
Priority date	Nov 3, 2013
Publication date	Aug 25, 2016
Grant date	—

Abstract

A syringe is disclosed, which includes a needle having an outer cylinder including an outer cylinder body part and a needle fixing part provided at a distal end part of the outer cylinder body part; an injection needle 6 having a puncturing needle tip at a distal end and fixed to the needle fixing part; and a gasket housed in the outer cylinder. The injection needle is such a tapered part holding injection needle that a puncturing time piercing part having a needle tip has an outer diameter of 0.42 mm or less and has a thickness of 0.1 mm or less, or the injection needle is such a small diameter thin injection needle as to have a thickness of 0.04 mm or less. The gasket includes a gasket body and a soft coating provided on a portion that comes into contact with the inner surface of the outer cylinder.

First claim

What is claimed is:

1 . A syringe with needle comprising:
an outer cylinder including an outer cylinder body part and a needle fixing part provided at a distal end part of the outer cylinder body part; an injection needle having a puncturing needle tip at a distal end, a proximal end part of the injection needle being fixed to the needle fixing part of the outer cylinder; and a gasket housed in the outer cylinder and capable of sliding within the outer cylinder in a liquid-tight state, wherein the injection needle is such a tapered part holding injection needle that a puncturing time piercing part having the puncturing needle tip has an outer diameter of 0.42 mm or less and has a thickness of 0.1 mm or less, the tapered part holding injection needle having a proximal end with a greater outer diameter than the puncturing time piercing part, or the injection needle is such a small diameter ultrathin injection needle that a puncturing time piercing part having the puncturing needle tip has an outer diameter of 0.42 mm or less and has a thickness of 0.04 mm or less, the small diameter ultrathin injection needle extending from a distal end to a proximal end with substantially the same outer diameter, and the gasket includes a gasket body made of an elastic body and a soft coating provided on at least a portion that comes into contact with the inner surface of the outer cylinder, the soft coating having a liquid-tight sliding property with respect to the inner surface of the outer cylinder.

2 . The syringe with needle according to claim 1 , wherein
the syringe with needle is configured such that the gasket within the outer cylinder has an initial sliding resistance value around or equal to or less than a maximum value of a dynamic sliding resistance value.

3 . The syringe with needle according to claim 1 , wherein
an inner surface of the injection needle has an average roughness (Ra) of less than 0.3 μm.

4 . The syringe with needle according to claim 1 , wherein
the tapered part holding injection needle is configured such that the outer diameter of the proximal end is greater than the outer diameter of the puncturing time piercing part by 0.05 mm or more.

5 . The syringe with needle according to claim 1 , wherein
the tapered part holding injection needle includes the puncturing time piercing part extending by a predetermined length with substantially the same outer diameter, and a tapered part expanded in diameter in a tapered manner from a proximal end toward a rear end of the puncturing time piercing part.

6 . The syringe with needle according to claim 1 , wherein
the tapered part holding injection needle includes the puncturing time piercing part extending by a predetermined length with substantially the same outer diameter, a tapered part expanded in diameter in a tapered manner from a proximal end toward a rear end of the puncturing time piercing part, and a proximal end part extending by a predetermined length with substantially the same outer diameter from the tapered part.

7 . The syringe with needle according to claim 1 , wherein
the soft coating is formed by a solidified substance of a soft coating forming liquid substance applied to an outer surface of the gasket body.

8 . The syringe with needle according to claim 1 , wherein
the outer cylinder is made of a synthetic resin.

9 . The syringe with needle according to claim 1 , wherein
the tapered part holding injection needle is fixed to the needle fixing part of the outer cylinder at a proximal end side portion of the tapered part.

10 . The syringe with needle according to claim 1 , wherein
the syringe includes a plunger for pressing the gasket.

11 . The syringe with needle according to claim 1 , wherein
a lubricant is not applied to an inner surface of the outer cylinder.

12 . A prefilled syringe comprising:
a syringe with needle comprising:
an outer cylinder including an outer cylinder body part and a needle fixing part provided at a distal end part of the outer cylinder body part;
an injection needle having a puncturing needle tip at a distal end, a proximal end part of the injection needle being fixed to the needle fixing part of the outer cylinder; and
a gasket housed in the outer cylinder and capable of sliding within the outer cylinder in a liquid-tight state, wherein
the injection needle is such a tapered part holding injection needle that a puncturing time piercing part having the puncturing needle tip has an outer diameter of 0.42 mm or less and has a thickness of 0.1 mm or less, the tapered part holding injection needle having a proximal end with a greater outer diameter than the puncturing time piercing part, or the injection needle is such a small diameter ultrathin injection needle that a puncturing time piercing part having the puncturing needle tip has an outer diameter of 0.42 mm or less and has a thickness of 0.04 mm or less, the small diameter ultrathin injection needle extending from a distal end to a proximal end with substantially the same outer diameter, and
the gasket includes a gasket body made of an elastic body and a soft coating provided on at least a portion that comes into contact with the inner surface of the outer cylinder, the soft coating having a liquid-tight sliding property with respect to the inner surface of the outer cylinder;
a seal cap that seals a distal end part of the injection needle; and a medical liquid with which the syringe is filled.

13 . The prefilled syringe according to claim 12 , wherein
the medical liquid has a viscosity of 10 mPa·s or more.

14 . The prefilled syringe according to claim 12 , wherein
the medical liquid is a protein preparation.

15 . The prefilled syringe according to claim 12 ,
a lubricant is not applied to an inner surface of the outer cylinder.

16 . A medical liquid administration tool comprising:
an autoinjector; and a prefilled syringe mounted in the autoinjector, the prefilled syringe comprising:
a syringe with needle comprising:
an outer cylinder including an outer cylinder body part and a needle fixing part provided at a distal end part of the outer cylinder body part;
an injection needle having a puncturing needle tip at a distal end, a proximal end part of the injection needle being fixed to the needle fixing part of the outer cylinder; and
a gasket housed in the outer cylinder and capable of sliding within the outer cylinder in a liquid-tight state, wherein
the injection needle is such a tapered part holding injection needle that a puncturing time piercing part having the puncturing needle tip has an outer diameter of 0.42 mm or less and has a thickness of 0.1 mm or less, the tapered part holding injection needle having a proximal end with a greater outer diameter than the puncturing time piercing part, or the injection needle is such a small diameter ultrathin injection needle that a puncturing time piercing part having the puncturing needle tip has an outer diameter of 0.42 mm or less and has a thickness of 0.04 mm or less, the small diameter ultrathin injection needle extending from a distal end to a proximal end with substantially the same outer diameter, and
the gasket includes a gasket body made of an elastic body and a soft coating provided on at least a portion that comes into contact with the inner surface of the outer cylinder, the soft coating having a liquid-tight sliding property with respect to the inner surface of the outer cylinder;

a seal cap that seals a distal end part of the injection needle; and
a medical liquid with which the syringe is filled.

Assignees

• Terumo Corp

Inventors

• Nakamura Koji
• Oyauchi Tetsuya
• Kumagai Ayumi
• Akiyama Takeshi
• Tamatsukuri Shigeru

Classifications

• A61M5/2033 Primary

  Spring-loaded one-shot injectors with or without automatic needle insertion (multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287) · CPC title

• A61M5/329

  characterised by features of the needle shaft · CPC title

• A61M5/326

  Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user · CPC title

• A61M2205/0238

  the material being a coating or protective layer · CPC title

• A61M5/3286

  Needle tip design, e.g. for improved penetration · CPC title