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

• Current Assignee: Schott AG (Carl-Zeiss-Stiftung)
• Original Assignee: Schott Glaswerke
• Inventors: Spallek, Michael, Reinhard, Michael
• Primary Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/529,195
• Time in Patent Office: 2,286 Days
• Field of Search: 604/239, 604/240, 604/192, 604/265, 604/218, 604/230, 604/232, 604/199, 427/2.3
• US Class Current: 604/232
• CPC Class Codes: A61M 2005/3131 specially adapted for improving sealing or sliding
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/343 Connection of needle cannula to needle hub, or directly to syringe nozzle without a needle hub A61M5/322 takes precedence
• CPC Class Codes: A61M 5/349 using adhesive bond or glues
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 55/02 Sterilising, e.g. of complete packages

Abstract

Prefilled, disposable syringes for injecting preparations with a fill volume of less than 5 ml are typically made of glass. The disposable syringe in this invention avoids the use of glass as a construction material. The body of the syringe with barrel, grip and nozzle is made of transparent, glass-like plastic with a very low gas permeability and is designed to be resistant to gamma rays and/or ethylene oxide gas, whereby the hypodermic needle is directly integrated within the plastic nozzle.

Claims

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.

2. A single use syringe according to claim 1, wherein a portion of the insertion needle is encased in the tapered syringe head.

3. A single use syringe according to claim 2, wherein the portion of the insertion needle that is encased in the tapered syringe head has a non-linear shape so as to provide a positive shape conforming connection between the insertion needle and the tapered syringe head.

4. A single use syringe according to claim 1, wherein a recess is formed in the tapered syringe head and the insertion needle is glued into the recess in the tapered syringe head.

5. A single use syringe according to claim 1, wherein tapered syringe head includes support elements in the form of ridges molded into the tapered syringe head.

6. A single use syringe according to claim 1, wherein the outer surface of the tapered syringe head includes a collar portion, whereby the inner side of the cap is in sealing abutment with the collar portion of outer surface of the tapered syringe head, so that the outer surface of the needle is also sealed.

7. A single use syringe according to claim 1, wherein the syringe cylinder includes an inner and outer layer made of different plastics and wherein one of the layers acts as a barrier to oxygen diffusion and the other layer blocks diffusion of water vapor.

8. A single use syringe according to claim 7, wherein one of the plastic layers consists of a cyclic olefin copolymer (COC).

9. A single use syringe according to claim 7, wherein a further layer of metallic, ceramic or glassy material is provided between the inner and outer layers made of different plastics.

10. A single use syringe according to claim 1, wherein the syringe cylinder and the tapered syringe head are provided with an inner layer made of a metallic, ceramic or glassy material.

11. A single use syringe according to claim 1, wherein the syringe cylinder and the tapered syringe head are provided with an outer layer made of a metallic, ceramic or glassy material.

12. 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 one-piece plastic syringe body, the syringe body including;

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

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

a tapered syringe head portion having walls formed integrally as an extension of the second end of the syringe cylinder portion, the tapered syringe head portion being formed from the same plastic material as the syringe cylinder portion;

an injection needle having a first end extending through and integrated directly into the tapered syringe head portion and a second end extending out of the tapered syringe head portion; 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 walls of the tapered syringe head portion, so that the outer surface of the needle is also sealed.

13. A single use syringe according to claim 12, wherein a portion of the insertion needle is encased in the tapered syringe head portion and the portion of the insertion needle that is encased in the tapered syringe head portion has a non-linear shape so as to provide a positive shape conforming connection between the insertion needle and the tapered syringe head portion.

14. A single use syringe according to claim 12, wherein the walls of the syringe cylinder portion and the syringe head portion 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 portion.

15. A single use syringe according to claim 12, wherein the outer surface of the tapered syringe head portion includes a collar portion, whereby the inner side of the cap is in sealing abutment with the collar portion of outer surface of the tapered syringe head portion, so that the outer surface of the needle is also sealed.

16. A single use syringe according to claim 12, wherein the syringe cylinder portion includes an inner and outer layer made of different plastics and wherein one of the layers acts as a barrier to oxygen diffusion and the other layer blocks diffusion of water vapor.

17. A single use syringe according to claim 16, wherein one of the plastic layers consists of a cyclic olefin copolymer (COC).

18. A single use syringe according to claim 16, wherein a further layer of metallic, ceramic or glassy material is provided between the inner and outer layers made of different plastics.

19. A single use syringe according to claim 12, wherein the syringe body is formed of plastic that is gamma-sterilizable and/or ethyleneoxide-sterilizable, without any change causing any change in brittleness and color.

20. A single use syringe according to claim 12, wherein the protective cap of a soft material covering the injection needle is formed of a material that is gamma-sterilizable and/or ethyleneoxide-sterilizable, without any change causing functional deterioration.