Low silicone glass prefillable syringe

• US 20010039400A1
• Filed: 12/14/2000
• Published: 11/08/2001
• Est. Priority Date: 03/17/1998
• Status: Active Grant

• Current Assignee: Thea E. Lubrecht
• Original Assignee: Thea E. Lubrecht
• Inventors: Lubrecht, Thea E.
• Granted Patent: US 7,141,042 B2
• Time in Patent Office: Days
• US Class Current: 604/193
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61M 2005/3131 specially adapted for improving sealing or sliding
• CPC Class Codes: A61M 2005/31516 reducing dead-space in the syringe barrel after delivery
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

A method for lubricating a sealing member in a drug delivery device includes the steps of washing and rinsing the sealing members in hot deionized water following by drying the sealing members. The dried sealing members are tumbled with polymeric silicone and then irradiated at a target dose between 2.5 and 4.0 Mrads. The irradiated sealing members are then utilized in a variety of drug delivery devices including syringes, pre-filled syringes, drug cartridges, and needleless injector ampules.

Claims

1. A method for making a medicament delivery device having a lubricated sealing member, comprising the steps of:

(a) coating the sealing member with a polymeric silicone having a plurality of polymer molecules; and

(b) irradiating the coated sealing member to thereby adhere the polymeric silicone to the sealing member.

2. The method of

claim 1

further including the steps of performing step (a) on a plurality of sealing members and placing the plurality of coated sealing members in a sealable package and wherein step (b) is performed by exposing the plurality of sealing members and the sealable package to Cobalt irradiation at a target dose between approximately 2.5 and approximately 4.0 Mrads, thereby forming a plurality of crosslinking bonds between a plurality of the polymer molecules.

3. The method of

claim 1

further including the step of placing the coated and irradiated sealing member into a non-lubricated cylindrical glass chamber of a medicament delivery device, the sealing member being slidable within the cylindrical glass chamber and in fluid-tight engagement with an interior wall of the cylindrical glass chamber.

4. The method of

claim 3

further including the step of sterilizing the coated sealing member and the non-lubricated cylindrical glass chamber after placing the coated sealing member into the non-lubricated cylindrical glass chamber.

5. The method of

claim 1

wherein step (b) includes exposing the coated sealing member to a radiation level in the range from approximately 2.5 to 4.0 Mrads.

6. The method of

claim 1

wherein step (a) is performed by tumbling the sealing member with the polymeric silicone.

7. The method of

claim 1

further including the steps of washing the sealing member in deionized water, rinsing the sealing member in deionized water, and then drying the sealing member prior to coating the sealing member.

8. The method of

claim 1

wherein step (a) includes selecting the polymeric silicone from the group of phenyl substituted silicones consisting of dimethyldiphenylpolysiloxane copolymers;

dimethyl, methylphenylpolysiloxane copolymers;

polymethylphenylsiloxane; and

methylphenyl, dimethylsiloxane copolymers.

9. The method of

claim 1

wherein step (a) is performed by coating the sealing member with a polymeric silicone having a viscosity in a range from about 12,500 centistokes to about 100,000 centistokes.

10. A medicament delivery device comprising:

a sealing member body;

a lubricating coating on said sealing member body, said lubricating coating comprising a polymeric silicone having a plurality of polymer molecules that has been irradiated and adhered to said sealing member body.

11. A medicament delivery device as recited in

claim 10

wherein said lubricating coating has been irradiated with Cobalt at a target dose between approximately 2.5 and approximately 4.0 Mrads and wherein at least some of said plurality of molecules are crosslinked to each other.

12. A medicament delivery device as recited in

claim 10

wherein said polymeric silicone is a phenyl substituted silicone selected from the group consisting of dimethyldiphenylpolysiloxane copolymers;

dimethyl, methylphenylpolysiloxane copolymers;

polymethylphenylsiloxane; and

methylphenyl, dimethylsiloxane copolymers.

13. A medicament delivery device as recited in

claim 10

wherein said sealing member body is a stopper.

14. A medicament delivery device as recited in

claim 10

wherein said sealing member body is an O-ring.

15. A medicament delivery device as recited in

claim 10

wherein said polymeric silicone has a viscosity in a range from about 12,500 centistokes to about 100,000 centistokes.

16. A medicament delivery device comprising:

a cylindrical barrel made from a non-lubricated glass and having an interior chamber;

a sealing member body received in said interior chamber in a fluid-tight relationship, said sealing member body being sidable within said interior chamber;

a lubricating coating on said sealing member body, said lubricating coating comprising a polymeric silicone having a plurality of molecules, said lubricating coating having been irradiated after application to said sealing member body, said irradiation adhering said polymeric silicone to said sealing member body;

17. A medicament delivery device as recited in

claim 16

further comprising a medicament and wherein said sealing member body has a first side and a second side and said interior chamber includes a first end and a second end;

said medicament being received in said interior chamber and located between said first end of said interior chamber and said first side of said sealing member body.

18. A medicament delivery device as recited in

claim 17

wherein said sealing member body is a stopper and said second side of said stopper is adapted to receive a plunger for moving said stopper from said second end toward said first end, thereby ejecting said medicament from said interior chamber.

19. A medicament delivery device as recited in

claim 17

wherein said first end includes a seal and said cylindrical barrel comprises a medicament cartridge.

20. A medicament delivery device as recited in

claim 19

wherein said cylindrical barrel comprises a syringe, said first end is adapted to receive a needle cannula and to be in fluid communication with said needle cannula when said needle cannula is received on said first end.