Rotationally molded medical articles

• US 20040010225A1
• Filed: 06/24/2003
• Published: 01/15/2004
• Est. Priority Date: 07/18/2001
• Status: Abandoned Application

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Schuessler, David J.
• Application Number:
  US10/603,129
• Publication Number:
  US 20040010225A1
• Time in Patent Office: Days
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2002/3007 Coating or prosthesis-covering structure made of elastic material, e.g. of elastomer
• CPC Class Codes: A61F 2240/004 Using a positive or negative model, e.g. moulds
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: B29C 2791/006 Using vacuum
• CPC Class Codes: B29C 33/0038 with sealing means or the like seals on envelopes used in tyre retreading B29D30/542; for injection moulding footwear B29D35/0045
• CPC Class Codes: B29C 33/58 Applying the releasing agents
• CPC Class Codes: B29C 33/68 Release sheets
• CPC Class Codes: B29C 41/003 characterised by the choice of material
• CPC Class Codes: B29C 41/06 about two or more axes
• CPC Class Codes: B29C 41/38 Moulds, cores or other substrates
• CPC Class Codes: B29C 41/42 Removing articles from moulds, cores or other substrates B29C33/444 and B29C37/0017 take precedence
• CPC Class Codes: B29C 41/50 Shaping under special conditions, e.g. vacuum
• CPC Class Codes: B29K 2083/00 Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: Y10S 425/06 : Vacuum
• CPC Class Codes: Y10S 425/812 : Venting
• CPC Class Codes: Y10T 428/1376 : Foam or porous material containing

Abstract

A system and method for molding the shell of a medical device or other molded article is disclosed. The system includes a multi-axis rotational molding machine in which a mold is mounted. The mold has a cavity in the shape of the article to be molded. The mold seals to hold a vacuum. In operation, silicone or other molding material is inserted into the mold, vacuum is applied to the mold, the mold is rotated about at least two axes and a molding material coats the inside walls of the mold to form the shell or other desired article. A rotationally molded medical article is also disclosed.

Claims

1. A rotational molding system for molding a medical article comprising:

a multi-axis rotational molding machine; and

a mold mounted to said molding machine wherein the interior of said mold defines a cavity in the desired shape of the medical article to be molded.

2. The system according to claim 1 wherein said mold comprises first and second mold pieces matable to form a vacuum-tight seal along mating surfaces between said first and second pieces.

3. The system according to claim 1 wherein said mold comprises a sprue opening fluidly connected to said interior of said mold.

4. The system according to claim 2 wherein one piece of said mold has a hemispherical cavity shape.

5. The system according to claim 1 wherein said interior of said mold is sized to allow for the thickness of a liner to coat an inside surface of said mold.

6. A method for molding a medical article comprising the steps of:

inserting a molding material into a cavity within a mold;

applying a vacuum to said mold;

rotating said molding material in said mold about at least two axes to coat the interior of said mold cavity with said molding material.

7. The method of claim 6 further comprising the steps of:

inserting a liner material into said cavity;

rotating said liner material in said mold about at least two axes to coat the interior of said mold cavity with said liner material.

8. The method according to claim 7 wherein said liner material coats the interior of said mold cavity thereby masking any surface irregularities.

9. The method according to claim 7 wherein said liner material is a thermoplastic selected from the group consisting of polyethylene, polypropylene, nylon and fluoropolymer.

10. The method according to claim 7 wherein said liner material is a thermoset selected from the group consisting of polyester resin, polyurethane and epoxy.

11. The method according to claim 6 wherein said molding material is a room temperature acetoxy-cured silicone dispersion in a solvent.

12. The method according to claim 6 wherein said molding material is a platinum catalyzed heat-cured silicone dispersion in a solvent.

13. The method of claim 7 further comprising the step of separating said liner material from said molding material.

14. The method of claim 13 wherein said liner material is separated from said molding material by dissolving said liner material.

15. The method of claim 13 wherein said liner material is separated from said molding material by melting said liner material.

16. The method of claim 13 wherein said liner material is separated from said molding material by burning said liner material.

17. The method of claim 13 wherein said liner material is separated from said molding material by peeling said liner material from said molding material.

18. The method of claim 6 further comprising the step of removing the medical article from the mold through an opening in the mold left by a sprue.

19. The method of claim 6 further comprising the step of inserting a filler material into said mold cavity.

20. The method of claim 19 further comprising the step of curing said filler material.

21. A system for rotationally molding a medical article comprising:

means for rotating a mold about at least two axes;

means for molding a material within said mold into the form of the medical article;

means for inserting a molding material into said mold; and

means for supplying vacuum to said mold.

22. The system of claim 21 further comprising means for inserting a liner material into said mold.

23. A multi-axis rotationally molded medical article comprising:

a shell defining an interior cavity;

said shell being formed of at least one layer of a silicone selected from the group consisting of room temperature acetoxy-cured silicone and platinum catalyzed heat-cured silicone, and tin catalyzed silicone.

24. The medical article of claim 23 wherein said shell is textured.

25. The medical article of claim 23 wherein said shell is seamless.

26. The medical article of claim 23 wherein said shell is patchless.

27. The medical article of claim 23 where said shell has a thickness of from about 0.005 inches to about 0.06 inches.

28. The medical article of claim 23 further comprising a filler material contained within said interior cavity.

29. The medical article of claim 28 wherein said filler material is a silicone gel.

30. The medical article of claim 28 wherein said filler material is a saline solution.

31. The medical article of claim 28 wherein said filler material is a foam.

32. The medical article of claim 23 further comprising a removable liner.

33. The medical article of claim 31 wherein said liner is a thermoplastic selected from the group consisting of polyethylene, polypropylene, nylon And fluoropolymer.

34. The medical article of claim 31 wherein said liner is a thermoset selected from the group consisting of polyester resin, polyurethane and epoxy.

35. The medical article of claim 23 wherein said article is a medical implant.

36. The medical article of claim 35 wherein said article is a breast implant.

37. The medical article of claim 23 wherein said article is an elastomeric balloon.

38. The medical article of claim 23 wherein said article is a catheter balloon.