Radiation resistant silicone formulations and medical devices formed of same

• US 20070073246A1
• Filed: 07/11/2005
• Published: 03/29/2007
• Est. Priority Date: 07/11/2005
• Status: Active Grant

• Current Assignee: Saint-Gobain Performance Plastics Corporation (Compagnie De Saint-Gobain)
• Original Assignee: Saint-Gobain Performance Plastics Corporation (Compagnie De Saint-Gobain)
• Inventors: Simon, Mark
• Granted Patent: US 7,943,697 B2
• Time in Patent Office: Days
• US Class Current: 604/246
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 39/00 Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use for respiratory devices, e.g. tracheal tubes A61M16/00; artificial heart valves A61F2/24
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: C08G 77/70 Siloxanes defined by use of the MDTQ nomenclature
• CPC Class Codes: C08K 5/54 Silicon-containing compounds C08K5/0091 takes precedence
• CPC Class Codes: C08L 2666/14 Macromolecular compounds according to C08L59/00 - C08L87/00; Derivatives thereof
• CPC Class Codes: C08L 83/00 Compositions of macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing silicon with or without sulfur, nitrogen, oxygen or carbon only; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: Y10T 428/24273 including aperture
• CPC Class Codes: Y10T 428/24314 Slit or elongated
• CPC Class Codes: Y10T 428/24752 Laterally noncoextensive components
• CPC Class Codes: Y10T 428/31663 As siloxane, silicone or silane

Abstract

The disclosure is directed to a sterilized medical device including a non-polymerized blend including a silicone matrix material and a radiation resistant component.

Claims

1. A sterilized medical device comprising a non-polymerized blend including a silicone matrix material and a radiation resistant component.

2. The sterilized medical device of claim 1, wherein the non-polymerized blend comprises a loading of radiation resistant component of about 0.1 wt % to about 10 wt % based on the weight of the silicone matrix material.

3. The sterilized medical device of claim 2, wherein the loading of the radiation resistant component is about 0.5 wt % to about 10 wt %.

6. The sterilized medical device of claim 1, further comprising first and second surfaces in separable contact with each other, the first and second surfaces formed of the non-polymerized blend.

7. The sterilized medical device of claim 1, wherein the sterilized medical device includes an internal passageway for passage of a fluid therethrough.

8. The sterilized medical device of claim 1, wherein the sterilized medical device is a fluid control device.

11. The sterilized medical device of claim 1, wherein the silicone matrix material is formed from non-polar silicone.

13. The sterilized medical device of claim 1, wherein the radiation resistant component is substantially non-reactive with the silicone matrix material.

14. The sterilized medical device of claim 13, wherein the radiation resistant component is substantially non-reactive with the silicone matrix material when exposed to at least about 25 kGy gamma radiation.

17. The sterilized medical device of claim 1, wherein the radiation resistant component comprises fluorosilicone.

19. The sterilized medical device of claim 1, wherein the radiation resistant component comprises phenylsilicone.

21. The sterilized medical device of claim 1, wherein the sterilized medical device exhibits a reseal performance not greater than about 3.

24. The sterilized medical device of claim 21, wherein a post radiation burst pressure is less than about 6 psi.

25. The sterilized medical device of claim 1, wherein the radiation resistant component exhibits a migration performance not greater than about 0.6.

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26-48. -48. (canceled)

49. A medical device comprising:

material and a polar radiation resistant component.

50. The medical device of claim 49, wherein the medical device is a needless intra-venous injection valve.

51. The medical device of claim 49, wherein the polar radiation resistant component is fluorosilicone or phenylsilicone.

52. The medical device of claim 49, wherein a loading of the polar radiation resistant component is about 0.1 wt % to about 20 wt % based on the weight of the non-polar silicone matrix material.

53-57. -57. (canceled)

58. A method of forming a medical device, the method comprising:

preparing a mixture of polyalkylsiloxane precursors and a radiation resistant component to a loading about 0.1 wt % to about 20 wt % of the resistant component based on the weight of the polyalkylsiloxane precursors;

filling a mold with the mixture; and

curing the polyalkylsiloxane precursors to form the medical device.

59. The method of claim 58, wherein the radiation resistant component remains non-polymerized with the polyalkylsiloxane precursors after curing.

63. The method of claim 58, wherein the radiation resistant component is fluorosilicone or phenylsilicone.

64. The method of claim 58, further comprising forming an opening defined by two separably contacting surfaces in the medical device.

68. The method of claim 58, further comprising sterilizing the medical device.

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