Prefilled, low particle, sterile disposable syringe for injecting preparations and procedure for manufacture

  • US 6,331,174 B1
  • Filed: 09/15/1995
  • Issued: 12/18/2001
  • Est. Priority Date: 10/27/1994
  • Status: Expired due to Term
First Claim
Patent Images

1. A prefillable, low-particle, sterile, single use syringe for the injection of preparations having a filling volume of less than 5 ml, the syringe comprising:

  • a syringe plunger;

    a piston rod connected to the syringe plunger; and

    a syringe body, the syringe body including;

    a syringe cylinder having a first end and a second end and inner walls defining a cylinder interior and an inner gliding surface, the first end of the cylinder being open for reception of the syringe plunger, the syringe cylinder and the syringe plunger together defining a filling volume within the syringe cylinder of less than 5 ml, the syringe plunger being movable within the syringe cylinder by means of the piston rod;

    a grip formed proximate the first end of the syringe cylinder;

    a tapered syringe head having an outer surface and walls formed integrally as an extension of the second end of the syringe cylinder, the tapered syringe head being formed from the same material as the syringe cylinder and including a conically tapered portion;

    wherein the syringe body is formed of plastic that is gamma-sterilizable and/or ethyleneoxide-sterilizable, without any change causing functional deterioration of chemical and physical properties, in particular brittleness and color;

    wherein the walls of the syringe cylinder and the syringe head are so formed with regard to water vapor permeability that they have a permeability of less than 0.08 g/m2×

    d at the wall thickness of 500 μ

    m, whereby the wall is transparent at least in the area of the syringe cylinder; and

    an injection needle having a first end extending through and integrated directly into the tapered syringe head and indisconnectably fastened therein and a second end extending out of the tapered syringe head proximate the conically tapered portion of the syringe head; and

    a protective cap of a soft material covering the injection needle so that the needle pierces the protective cap and is thereby sealed, the cap having an inner side that is in sealing abutment with the outer surface of the tapered syringe head, so that the outer surface of the needle is also sealed, whereby the protective cap is gamma-sterilizable and/or ethyleneoxide-sterilizable, without any change causing functional deterioration.

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