Sealing Members, Articles Using the Same and Methods of Reducing Sticktion

Abstract

The present invention provides rubber sealing members having an exterior surface adapted to sealingly engage an inner surface of a chamber of the medical device, the exterior surface of the sealing member having a coating thereon prepared from a curable composition including: (a) a first organopolysiloxane having at least two alkenyl groups; and (b) a second organopolysiloxane having at least two pendant hydrogen groups, the second organopolysiloxane being different from the first organopolysiloxane, wherein at least one of the first organopolysiloxane, the second organopolysiloxane or an optional third organopolysiloxane of the curable composition comprises a fluoro group.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will best be understood from the following description of specific embodiments when read in connection with the accompanying drawings:

FIG. 1 is a graph of infusion pump actuation force test results at a feed rate of 0.1 ml/hr for a prior art syringe assembly;

FIG. 2 is a graph of infusion pump actuation force test results at a feed rate of 1.0 ml/hr for a prior art syringe assembly;

FIG. 3 is a graph of infusion pump actuation force test results at a feed rate of 10 ml/hr for a prior art syringe assembly;

FIG. 4 is a graph of infusion pump actuation force test results at a feed rate of 0.1 ml/hr for a syringe assembly according to the present invention;

FIG. 5 is a graph of infusion pump actuation force test results at a feed rate of 1.0 ml/hr for a syringe assembly according to the present invention;

FIG. 6 is a graph of infusion pump actuation force test results at a feed rate of 10 ml/hr for a syringe assembly according to the present invention; and

FIG. 7 is a graph of infusion pump actuation force test results at a feed rate of 10 ml/hr for a syringe assembly according to the present invention.

Claims

1. A rubber sealing member for a medical device, the sealing member having an exterior surface adapted to sealingly engage an inner surface of a chamber of the medical device, the exterior surface of the sealing member having a coating thereon prepared from a curable composition comprising: (a) a first organopolysiloxane comprising at least two alkenyl groups; and(b) a second organopolysiloxane comprising at least two pendant hydrogen groups, the second organopolysiloxane being different from the first organopolysiloxane,wherein at least one of the first organopolysiloxane, the second organopolysiloxane or an optional third component of the curable composition comprises at least one fluoro group.

2. The rubber sealing member according to claim 1, wherein the rubber sealing member is selected from the group consisting of a stopper, O-ring, plunger tip and piston.

3. The rubber sealing member according to claim 1, wherein the rubber sealing member is formed from butyl rubber.

4. The rubber sealing member according to claim 1, wherein each alkenyl group of the first organopolysiloxane (a) is independently selected from the group consisting of vinyl, allyl, propenyl, butenyl, pentenyl, hexenyl, heptenyl, octenyl, nonenyl and decenyl.

5. The rubber sealing member according to claim 1, wherein at least one alkenyl group of organopolysiloxane (a) is vinyl.

6. The rubber sealing member according to claim 5, wherein the first organopolysiloxane (a) is (7.0-8.0% vinylmethylsiloxane)-dimethylsiloxane copolymer, trimethylsiloxy terminated.

7. The rubber sealing member according to claim 1, wherein the first organopolysiloxane (a) further comprises at least one fluoro group.

8. The rubber sealing member according to claim 1, wherein the first organopolysiloxane (a) comprises about 5 to about 50 weight percent of the composition.

9. The rubber sealing member according to claim 1, wherein the second organopolysiloxane (b) is represented by the structural formulae (V):

10. The rubber sealing member according to claim 1, wherein the second organopolysiloxane (b) is represented by the structural formulae (VI): HMe2SiO(Me2SiO)pSiMe2H   (VI)

11. The rubber sealing member according to claim 1, wherein the second organopolysiloxane (b) is selected from the group consisting of dimethylhydro terminated polydimethylsiloxanes; methylhydro, dimethylpolysiloxanecopolymers; methylhydro terminated methyloctyl siloxane copolymers; and methylhydro, phenylmethyl siloxane copolymers.

12. The rubber sealing member according to claim 1, wherein the second organopolysiloxane (b) further comprises at least one fluoro group.

13. The rubber sealing member according to claim 1, wherein the second organopolysiloxane (b) comprises about 1 to about 40 weight percent of the composition.

14. The rubber sealing member according to claim 1, wherein the third component is selected from the group consisting of fluorocarbon oligomers, fluorocarbon polymers and fluoro organopolysiloxanes.

15. The rubber sealing member according to claim 1, wherein the third component comprises at least one fluoro group selected from the group consisting of fluorine groups and fluoroalkyl groups.

16. The rubber sealing member according to claim 1, wherein the composition further comprises at least one cyclic siloxane.

17. The rubber sealing member according to claim 16, wherein the at least one cyclic siloxane is selected from the group consisting of octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane.

18. The rubber sealing member according to claim 16, wherein the cyclic siloxane comprises about 5 to about 80 weight percent of the composition.

19. The rubber sealing member according to claim 1, wherein the composition further comprises polydimethylsiloxane.

20. The rubber sealing member according to claim 19, wherein the polydimethylsiloxane comprises about 1 to about 20 weight percent of the composition.

21. The rubber sealing member according to claim 1, wherein the composition further comprises silica.

22. The rubber sealing member according to claim 21, wherein the silica comprises about 1 to about 15 weight percent of the composition.

23. The rubber sealing member according to claim 1, wherein the composition further comprises a catalytic amount of a catalyst for promoting crosslinking of the first organopolysilaxane (a) and the second organopolysiloxane (b).

24. The rubber sealing member according to claim 23, wherein the catalyst is selected from the group consisting of platinum, rhodium and peroxides.

25. The rubber sealing member according to claim 20, wherein the catalyst comprises about 0.001 to about 0.05 weight percent of the composition.

26. A medical device comprising: (a) a chamber comprising an inner surface for containing a medicament; and(b) a rubber sealing member according to claim 1.

27. The medical device according to claim 26, wherein the medical device is selected from the group consisting of syringe assemblies, syringe pumps, drug cartridges, needleless injectors, liquid dispensing devices and liquid metering devices.

28. The medical device according to claim 26, wherein the chamber is formed from glass, metal, ceramic, plastic, rubber or combinations thereof.

29. The medical device according to claim 28, wherein the chamber is prepared from an olefinic polymer.

30. The medical device according to claim 29, wherein the olefinic polymer is selected from the group consisting of polyethylene, polypropylene, poly(1-butene), poly(2-methyl-1-pentene) and cyclic polyolefins.

31. The medical device according to claim 30, wherein the chamber is prepared from a cyclic polyolefin.

32. A method for lubricating the interface between an inner surface of a chamber and an exterior surface of a rubber sealing member of a medical device, comprising the steps of: (a) applying a coating onto the exterior surface of the rubber sealing member, the coating being prepared from a curable composition comprising: (i) a first organopolysiloxane comprising at least two alkenyl groups; and(ii) a second organopolysiloxane comprising at least two pendant hydrogen groups, the second organopolysiloxane being different from the first organopolysiloxane,wherein at least one of the first organopolysiloxane, the second organopolysiloxane or an optional third component of the curable composition comprises at least one fluoro group; and(b) at least partially crosslinking the coating of step (a).

33. A method for reducing breakout force or breakloose force between an inner surface of a chamber and an exterior surface of a rubber sealing member of a medical device, comprising the steps of: (a) applying a coating onto the exterior surface of the rubber sealing member, the coating being prepared from a curable composition comprising: (i) a first organopolysiloxane comprising at least two alkenyl groups; and(ii) a second organopolysiloxane comprising at least two pendant hydrogen groups, the second organopolysiloxane being different from the first organopolysiloxane,wherein at least one of the first organopolysiloxane, the second organopolysiloxane or an optional third component of the curable composition comprises at least one fluoro group; and(b) at least partially crosslinking the coating of step (a).

34. A method for reducing sustaining force between an inner surface of a chamber and an exterior surface of a rubber sealing member of a medical device, comprising the steps of: (a) applying a coating onto the exterior surface of the rubber sealing member, the coating being prepared from a curable composition comprising: (i) a first organopolysiloxane comprising at least two alkenyl groups; and(ii) a second organopolysiloxane comprising at least two pendant hydrogen groups, the second organopolysiloxane being different from the first organopolysiloxane,wherein at least one of the first organopolysiloxane, the second organopolysiloxane or an optional third component of the curable composition comprises at least one fluoro group; and(b) at least partially crosslinking the coating of step (a).

35. A method for reducing breakloose and sustaining forces between an inner surface of a chamber and an exterior surface of a rubber sealing member of a medical device, comprising the steps of. (a) applying a coating onto the exterior surface of the rubber sealing member, the coating being prepared from a curable composition comprising: (i) a first organopolysiloxane comprising at least two alkenyl groups; and(ii) a second organopolysiloxane comprising at least two pendant hydrogen groups, the second organopolysiloxane being different from the first organopolysiloxane,wherein at least one of the first organopolysiloxane, the second organopolysiloxane or an optional third component of the curable composition comprises at least one fluoro group; and(b) at least partially crosslinking the coating of step (a).