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

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 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.

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 configured to be fixed to the needle fixing part of the outer cylinder;   a gasket configured to be 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   wherein 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 configured to 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 configured to press 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, and wherein a proximal end part of the injection needle is configured to be fixed to the needle fixing part of the outer cylinder; 
 a gasket configured to be 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 
 wherein 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 configured to seal 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 , wherein 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 configured to be 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 configured to be fixed to the needle fixing part of the outer cylinder; 
 a gasket configured to be 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 
 wherein 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 configured to seal a distal end part of the injection needle; and 
 a medical liquid with which the syringe is filled. 
   
     
     
         17 . The medical liquid administration tool according to  claim 16 , wherein the medical liquid has a viscosity of 10 mPa·s or more. 
     
     
         18 . The medical liquid administration tool according to  claim 16 , wherein the medical liquid is a protein preparation. 
     
     
         19 . The medical liquid administration tool according to  claim 16 , wherein a lubricant is not applied to an inner surface of the outer cylinder.