Naso-pharyngeal tissue engineering

• US 20070102010A1
• Filed: 10/10/2006
• Published: 05/10/2007
• Est. Priority Date: 10/07/2005
• Status: Abandoned Application

• Current Assignee: Artes Medical USA Inc.
• Original Assignee: Artes Medical USA Inc.
• Inventors: Lemperle, Gottfried, Reinhard, Christopher, Lemperle, Stefan
• Application Number:
  US11/546,578
• Publication Number:
  US 20070102010A1
• Time in Patent Office: Days
• US Class Current: 128/898
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61K 49/048 Microparticles, microbeads, microcapsules, microspheres, i.e. having a size or diameter higher or equal to 1 micrometer
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: C08L 33/12 Homopolymers or copolymers of methyl methacrylate

Abstract

Methods to stiffen nasopharyngeal structures such as the soft palate, the anterior palatine arch, the posterior palatine arch, or a combination thereof are provided. In one embodiment, the present invention involves the injection, through a conventional needle, of PMMA microspheres that induce a fibrotic response to strengthen and stiffen nasopharyngeal structures. Methods of the invention are useful for the treatment for upper airway conditions such as snoring, obstructive breathing and sleep apnea in a subject.

Claims

1. A method for stiffening the nasopharyngeal area of a subject comprising implanting a filler material comprising an acrylic polymer into one or more nasopharyngeal structures consisting of the group:

the soft palate, the anterior palatine arch, and the posterior palatine arch.

2. The method of claim 1 wherein the filler material is implanted by injection.

3. The method of claim 2 wherein the injection is performed with a needle with a gauge from about 18 to about 30 gauge.

4. The method of claim 3 wherein the needle is 28, 29 or 30 gauge.

5. The method of claim 3 wherein the needle is 26 or 27 gauge.

6. The method of claim 3 wherein the needle is about 1 inch in length.

7. The method of claim 3 wherein the needle is curved.

8. The method of claim 1 wherein the filler material comprises microparticles.

9. The method of claim 8 wherein the microparticles are about 25 microns to about 200 microns in diameter.

10. The method of claim 8 wherein the microparticles are about 25 microns to about 100 microns in diameter.

11. The method of claim 8 wherein the microparticles are about 30 microns to about 50 microns in diameter.

12. The method of claim 8 wherein the microparticles are round and smooth.

13. The method of claim 8 wherein the particles are porous or hollow.

14. The method of claim 1 wherein the acrylic polymer comprises polymethylmethacrylate.

15. The method of claim 1 wherein the filler material remains at the implantation site for up to about 6 months.

16. The method of claim 1 wherein the filler material remains at the implantation site for more than 6 months to less than about 3 years.

17. The method of claim 1 wherein the filler material remains at the implantation site for about 3 years or more.

18. The method of claim 1 wherein the filler material further comprises collagen.

19. The method of claim 18 wherein the collagen comprises human collagen.

20. The method of claim 18 wherein the collagen comprises bovine collagen.

21. The method of claim 18 wherein the collagen is at least partially denatured or at least partially cross-linked or both.

22. The method of claim 1 wherein the filler material further comprises a contrast agent.

23. The method of claim 22 wherein the contrast agent comprises metrizamide, iopamidol, iothalamate sodium, iodomide sodium, or meglumine.

24. The method of claim 22 wherein the contrast agent comprises Omnipaque®

, Visipaque®

, or Hypaque-76®

.

25. The method of claim 22 wherein the contrast agent comprises tantalum, tantalum oxide, barium sulfate, gold, tungsten, or platinum.

26. The method of claim 22 wherein further comprising monitoring the implant by imaging the contrast agent.

27. The method of claim 1 wherein the filler material is histocompatible.

28. The method of claim 1 wherein the filler material comprises polymethylmethacrylate microspheres, collagen, a buffer, sodium chloride, and water for injection.

29. The method of claim 28 wherein the filler material further comprises one or more anesthetics selected from the group consisting of:

Articaine, Bupivacaine, Chloroprocaine, Etidocaine, Levobupivacaine, Lidocaine, Mepivacaine, Prilocaine, Procaine, or Tetracaine.

30. The method of claim 29 wherein the filler material comprises about 20% by weight polymethylmethacrylate microspheres and about 80% by weight of a composition comprising about 3.5% purified bovine collagen, about 2.7% phosphate buffer, about 0.9% sodium chloride, about 0.3% lidocaine hydrochloride, and about 92.6% water for injection.

31. The method of claim 30 wherein the microparticles are about 25 microns to about 200 microns in diameter.

32. The method of claim 30 wherein the microparticles are about 25 microns to about 100 microns in diameter.

33. The method of claim 30 wherein the microparticles are about 30 microns to about 50 microns in diameter.

34. The method of claim 30 wherein the microparticles are round and smooth.

35. The method of claim 1 wherein the filler material is implanted in one or more bolus injections.

36. The method of claim 1 wherein the filler material is implanted by a tunneling technique.

37. The method of claim 1 wherein the filler material is implanted in a line.

38. The method of claim 37 wherein the filler material is implanted in a curve that approximates the shape of the biological structure into which it is implanted.

39. The method of claim 1 wherein the filler material is implanted in two or more lines.

40. The method of claim 39 wherein at least two lines are parallel to each other.

41. The method of claim 40 wherein at least two lines intersect each other.

42. The method of claim 1 wherein the filler material is implanted as a pod.

43. The method of claim 33 wherein the pod is reshaped after injection.

44. The method of claim 1 wherein the subject has an upper airway condition.

45. The method of claim 44 wherein the upper airway defect is flaccidity of one or more of the soft palate, the anterior palatine arch, or the posterior palatine arch.

46. The method of claim 45 wherein the upper airway defect results in snoring, obstructive breathing or sleep apnea.

47. A method for stiffening the nasopharyngeal area of a subject comprising implanting a filler material into one or more nasopharyngeal structures consisting of the group:

the soft palate, the anterior palatine arch, and the posterior palatine arch. wherein said filler material comprises one or more of the group consisting of;

polylactic acid, polypropylene, polytetrafluoroethylene (PTFE), polyhydroxyalkanoate, hyaluronic acid, a protein polymer, polysaccharide-based gel, radiation cross-linked hydrogel, cross-linked water-swellable polymer, a pseudoplastic polymer, a bioelastomer, a three-part injectable polymer or a two-part injectable polymer.

48. The method of claim 47 wherein the filler material comprises hollow cylinder pellets.

49. The method of claim 47 wherein the protein polymer comprises keratin, cross-linked blood plasma protein, or a repetitive protein polymer.

50. A method of treating snoring, sleep apnea or obstructive breathing comprising providing a long-lasting implant comprising polymethylmethacrylate microspheres, collagen, a buffer, sodium chloride, and water for injection and injecting said implant into one or more nasopharyngeal structures consisting of the group:

the soft palate, the anterior palatine arch, and the posterior palatine arch.

51. The method of claim 50 wherein the long-lasting implant further comprises one or more anesthetics selected from the group consisting of:

Articaine, Bupivacaine, Chloroprocaine, Etidocaine, Levobupivacaine, Lidocaine, Mepivacaine, Prilocaine, Procaine, or Tetracaine.

52. The method of claim 51 wherein the long-lasting implant comprises about 20% by weight polymethylmethacrylate microspheres and about 80% by weight of a composition comprising about 3.5% purified bovine collagen, about 2.7% phosphate buffer, about 0.9% sodium chloride, about 0.3% lidocaine hydrochloride, and about 92.6% water for injection.

53. The method of claim 50 wherein the microparticles are about 25 microns to about 200 microns in diameter.

54. The method of claim 50 wherein the microparticles are about 25 microns to about 100 microns in diameter.

55. The method of claim 50 wherein the microparticles are about 30 microns to about 50 microns in diameter.

56. The method of claim 50 wherein the microparticles are round and smooth.

57. The method of claim 50 wherein the particles are porous or hollow.

58. The method of claim 50 wherein the collagen comprises human collagen.

59. The method of claim 50 wherein the collagen comprises bovine collagen.

60. The method of claim 50 wherein the collagen is at least partially denatured or at least partially cross-linked or both.

61. The method of claim 50 wherein the filler material further comprises a contrast agent.

62. The method of claim 61 wherein the contrast agent comprises metrizamide, iopamidol, iothalamate sodium, iodomide sodium, or meglumine.

63. The method of claim 61 wherein the contrast agent comprises Omnipaque®

, Visipaque®

, or Hypaque-76®

.

64. The method of claim 61 wherein the contrast agent comprises tantalum, tantalum oxide, barium sulfate, gold, tungsten, or platinum.

65. The method of claim 61 wherein further comprising monitoring the implant by imaging the contrast agent.

66. The method of claim 50 wherein the filler material is histocompatible.