Encapsulation device and methods of use

• US 20050015140A1
• Filed: 07/14/2003
• Published: 01/20/2005
• Est. Priority Date: 07/14/2003
• Status: Abandoned Application

• Current Assignee: Nicholas Debeer
• Original Assignee: Nicholas Debeer
• Inventors: deBeer, Nicholas
• Application Number:
  US10/621,730
• Publication Number:
  US 20050015140A1
• Time in Patent Office: Days
• US Class Current: 623/1.210
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/945 hardenable, e.g. stents formed in situ
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30016 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30242 : spherical
• CPC Class Codes: A61F 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/4435 : Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2250/0019 : differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2250/0023 : differing in porosity
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 6/20 : Vas deferens occluders; Fallopian occluders

Abstract

An encapsulation device having an expandable, porous body with a cavity, the body having a sealed end and a sealable end, where the body is configured to receive one or more fluids through a port in the sealable end, the body is configured to expand to conform to a shape of a target, and where the sealable end may be sealed to prevent leakage into the body, and a method if using the encapsulation device, is disclosed. The body may comprise porous membrane including expanded Polytetrafluoroethylene (ePTFE), polyester fiberfill, metal/polymer mesh, and perforated or porous polymer/metal. The target may include a location within the human body. The port in the sealable end is configured to receive a first fluid into the cavity to expand the body to conform to the shape of the target, and the port is further configured to receive a second fluid into the cavity which displaces the first fluid by diffusing the first fluid through the pores in the body and which cures (such as, by an ultraviolet light source) to secure the body to the target. Optionally, the introduction of the second fluid may be unnecessary when the first fluid includes the desired filler material for the encapsulation device.

Claims

1. An encapsulation device, comprising:

an expandable, porous body having a cavity therein, the body having a sealed end and a sealable end, wherein the body is configured to receive one or more fluids through a port in the sealable end, wherein the body is configured to expand to conform to a shape of a target, and wherein the sealable end may be sealed to prevent leakage into the body.

2. The device of claim 1 wherein said body comprises one of expanded Polytetrafluoroethylene (ePTFE), a porous membrane, a polyester fiberfill, a metal mesh, a polymer mesh, a perforated polymer, and a perforated and/or porous metal.

3. The device of claim 1, wherein the target comprises a location within the human body.

4. The device of claim 1, wherein the port in the sealable end receives a first fluid into said cavity to expand the body to conform to the shape of the target, and wherein the port receives a second fluid into said cavity which displaces the first fluid by diffusing the first fluid through the pores in the body and which cures to secure the body to the target.

5. The device of claim 4, wherein the first fluid comprises a saline solution.

6. The device of claim 4, wherein the second fluid comprises one or more of an adhesive, a hydrogel, and a bioactive agent.

7. The device of claim 4, wherein the second fluid is more viscous than the first fluid.

8. The device of claim 4 wherein the second fluid is less viscous than the first fluid.

9. The device of claim 8 wherein said second fluid includes polyvinylpyrrolidone (PVP).

10. The device of claim 4 wherein the first fluid and the second fluid are radiopqaue.

11. The device of claim 1, wherein the body comprises metal having holes.

12. The device of claim 11, wherein the metal comprises nitinol.

13. The device of claim 1, wherein the port in the sealable end comprises a valve configured to open to receive one or more fluids and close to prevent leakage into the body.

14. The device of claim 1, wherein the body includes a wire reinforcement.

15. The device of claim 14 wherein said wire reinforcement includes a support wire positioned substantially within said body.

16. The device of claim 14 wherein said wire reinforcement includes a plurality of anchor wires positioned substantially around the outer surface of said body.

17. The device of claim 14, wherein the wire reinforcement comprises one or more of nitinol, stainless steel, and a structural polymer.

18. The device of claim 14, wherein the wire reinforcement is provided within the body.

19. The device of claim 1, wherein the body comprises a first membrane and a second membrane within the first membrane, wherein the second membrane is more porous than the first membrane.

20. The device of claim 1, wherein the body comprises a first membrane and a second membrane within the first membrane, wherein the first membrane is more porous than the second membrane.

21. An encapsulation device, comprising:

an expandable, porous body having a cavity therein, the body having a sealed end and a sealable end, wherein the body is configured to receive one or more fluids through a port in the sealable end, wherein the body is configured to expand to conform to a shape of a target, wherein the sealable end may be sealed to prevent leakage into the body, wherein said body comprises expanded Polytetrafluoroethylene (ePTFE), and further, wherein the port in the sealable end receives a first fluid into said cavity to expand the body to conform to the shape of the target, and wherein the port receives a second fluid into said cavity which displaces the first fluid by diffusing the first fluid through the pores in the body and which cures to secure the body to the target.

22. The device of claim 21, wherein the target comprises a location within the human body.

23. The device of claim 21, wherein the first fluid comprises a saline solution.

24. The device of claim 21, wherein the second fluid comprises an adhesive.

25. The device of claim 21, wherein the second fluid is more viscous than the first fluid.

26. The device of claim 21, wherein the body comprises metal having holes.

27. The device of claim 26, wherein the metal comprises Nickel Titanium alloy (Nitinol).

28. The device of claim 21, wherein the port in the sealable end comprises a valve configured to open to receive one or more fluids and close to prevent leakage into the body.

29. The device of claim 21, wherein the body comprises a wire reinforcement.

30. The device of claim 29, wherein the wire reinforcement comprises one or more of Nitinol, stainless steel, and a structural polymer.

31. The device of claim 29, wherein the wire reinforcement is provided within the body.

32. The device of claim 21, wherein the body comprises a first membrane and a second membrane within the first membrane, wherein the second membrane is more porous than the first membrane.

33. The device of claim 21, wherein the body comprises a first membrane and a second membrane within the first membrane, wherein the first membrane is more porous than the second membrane.

34. A method of providing an encapsulation device to a desired location, the method comprising:

expanding a porous body to conform to a shape of a target by introducing a first fluid into an opening in the body;

introducing a second fluid into the porous body to displace the first fluid through the porous body; and

allowing the second fluid to cure to secure the porous body to the target.

35. The method of claim 34, further comprising the step of inserting a wire reinforcement into the porous body.

36. The method of claim 35, further comprising the step of securing the wire reinforcement to the interior of the porous body.

37. The method of claim 35, further comprising the step of removing the wire reinforcement from the porous body.

38. The method of claim 34, wherein the body comprises one or more of expanded Polytetrafluoroethylene (ePTFE), porous Polyethylene Terephthalate (PET), and metal with holes formed therein.

39. The method of claim 34, further comprising the step of introducing the body to a location of the target.

40. The method of claim 34, wherein the target comprises a location within the human body.

41. The method of claim 34, wherein the first fluid comprises a saline solution.

42. The method of claim 34, wherein the second fluid comprises an adhesive.

43. The method of claim 34, wherein the second fluid is more viscous than the first fluid.

44. A method of providing an encapsulation device, the method comprising:

introducing a fluid into an opening of a porous body to conform the body to a shape of a cavity of a target location; and

curing the fluid introduced into the porous body at the target location such that the porous body substantially fills the cavity of said target location.

45. The method of claim 44 wherein the target location is in vivo.

46. The method of claim 44 wherein said fluid is a radiopaque agent.

47. The method of claim 44 wherein said fluid is a UV curable adhesive.

48. The method of claim 47 wherein said step of curing includes providing a UV light source to said adhesive.

49. The method of claim 44 wherein said porous body includes a plurality of pores, and further, wherein said introducing step includes the step of weeping at least a predetermined amount of said fluid out of said pores on said porous body at the target location.