Method for tissue expansion and regeneration using bioresorbable inflatable devices

• US 7,771,482 B1
• Filed: 05/09/2000
• Issued: 08/10/2010
• Est. Priority Date: 05/09/2000
• Status: Expired due to Fees

• Current Assignee: Ben-Zion Karmon
• Original Assignee: Ben-Zion Karmon
• Inventors: Karmon, Ben-Zion
• Primary Examiner(s): Pellegrino; Brian E.
• Application Number:
  US09/567,471
• Time in Patent Office: 3,745 Days
• Field of Search: 606/192, 606/57, 606/60, 606/84, 606 92- 94, 623/23.61, 623/23.67, 623/23.68, 623/23.72, 623/23.74, 623/23.76, 623/17.12, 623/17.17, 623/17.18, 623/23.75, 623/908, 623/8
• US Class Current: 623/17.17
• CPC Class Codes: A61B 17/1673 for the jaw
• CPC Class Codes: A61B 17/1688 for the sinus or nose
• CPC Class Codes: A61B 17/666 for alveolar distraction
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61C 8/0006 Periodontal tissue or bone regeneration support means for endoprosthetic bone substitute or bone graft implants A61F2/2846
• CPC Class Codes: A61C 8/004 inflatable
• CPC Class Codes: A61C 8/0092 for sinus lifting
• CPC Class Codes: A61F 2/2803 for mandibular reconstruction temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071
• CPC Class Codes: A61F 2/2875 Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/2807 Chin implants
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/2882 Malar or zygomatic implants
• CPC Class Codes: A61F 2002/2885 Paranasal implants
• CPC Class Codes: A61F 2002/2889 Maxillary, premaxillary or molar implants
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30062 : (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30074 : stretchable
• CPC Class Codes: A61F 2002/30075 : swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30092 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30115 : circular-O-shaped
• CPC Class Codes: A61F 2002/30242 : spherical
• CPC Class Codes: A61F 2002/30372 : with additional means for limiting said translation
• CPC Class Codes: A61F 2002/3052 : unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30601 : telescopic
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30906 : shot- sand- or grit-blasted
• CPC Class Codes: A61F 2002/30925 : etched
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0057 : stretchable
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0065 : telescopic
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00089 : Zirconium or Zr-based alloys
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00161 : Carbon; Graphite
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00407 : Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: Y10S 623/908 : Bone

Abstract

Bioresorbable inflatable devices and tunnel incision tool and methods for treating and enlarging a tissue or an organ or a tube or a vessel or a cavity. The device is composed of a hollow expanding pouch made of a resorbable material that can be attached to a filling element. The pouch can be filled with a biocompatible materials, one or more times in few days interval, after the insertion of the device. While filling the pouch every few days the tissue expands and the filling material if it is bioactive start to function. The tunnel incision tool composed of a little blade that emerges from the surface of the tool in order to make shallow incisions in the surrounding tissue therefore enabling easy expansion of the tissue. This device and method can be used for example for: horizontal and vertical bone augmentation in the jaws and the tunnel incision tool is used to make shallow incisions in the periosteum when using the tunnel technique, sinus augmentation when the device is placed beneath the Schneiderian tissue, vessels widening if the pouch become a stent etc.

Claims

1. A method for treating bone within a living body comprising:

(a) creating a hole in a periosteal tissue of a bone for insertion of an expandable portion of a container, said bone having a bone surface, said bone surface being touched by a covering tissue of said bone, said covering tissue is selected from the group consisting of periosteal tissue and Schneiderian membrane;

(b) prior to inserting said expandable portion of said container, forming a subperiosteal tunnel between said bone and said periosteal tissue, for insertion of said expandable portion of said container,

(c) inserting through said hole between said bone surface and said covering tissue said expandable portion of said container, the external surface of said expandable portion of said container having at least one region which includes at least one opening which is open sufficiently to allow penetration of bone tissue and blood vessels, said expandable portion of said container includes an area which is less penetrable to tissue than said region;

(d) expanding said expandable portion of said container so that said opening is facing said bone surface and at least part of said area is facing said covering tissue, said expanding of said expandable portion of said container is displacing said area to displace said covering tissue from said bone surface so the distance between said covering tissue to said bone surface is increased to allow bone regeneration between said covering tissue and said bone surface.

2. The method of claim 1, wherein said expanding is performed in a plurality of stages separated by at least a number of hours, each stage incrementally stretching at least one of the periosteal tissues of said bone.

3. The method of claim 1, wherein said area of said container includes a guided bone regeneration membrane located so as to be adjacent to said periosteal tissue.

4. The method of claim 1, wherein said region exhibits a first mean time to dispersion and said area exhibits a second mean time to dispersion longer than said first mean time to dispersion.

5. The method of claim 1, wherein said expandable portion of said container is configured so part of the region facing said periosteal tissue is made from a biocompatible metal and another part of the region facing said periosteal tissue is made from a slowly dissipative bio-dissipative material.

6. The method of claim 1, further comprising, prior to inserting said expandable portion of said container peeling said periosteal tissue from said bone.

7. The method of claim 1, wherein said periosteal tissue is the mucoperiosteal tissue in the jaws.

8. The method of claim 1, wherein said expanding is done by introducing a biocompatible filling material into said container.

9. The method of claim 8, wherein said filling material includes material for promoting the growth of bone tissue.

10. The method of claim 8, wherein said introducing is performed via a filling conduit partially protruding outside the body.

11. The method of claim 10, wherein said filling conduit is connected to said container after said inserting into the tissue.

12. The method of claim 10, wherein said container is inserted inside the body being at least partially inside said filling conduit.

13. The method of claim 8, wherein said region is perforated, having pores which are sufficiently large to allow the ingrowth of bone tissue.

14. The method of claim 13, wherein said expandable portion of said container includes an area which is less penetrable to tissue than said region.

15. The method of claim 14 wherein said area is designed to prevent the filling material from passing through said area.

16. The method of claim 14, wherein said area prevents ingrowth of tissue.

17. The method of claim 14, wherein said area is located at one side of said expandable portion of said container and said region is located at the opposite side to said expandable portion of said container.

18. The method of claim 13, wherein said expandable portion of said container is inserted between said bone and said covering tissue so as to increase the distance between said bone and said covering tissue, said covering tissue is selected from the group consisting of periosteal tissue and Schneiderian membrane, said expanding is done by introducing a biocompatible material that includes a material that promotes bone tissue regeneration into said container.

19. The method of claim 13, wherein said container includes a fixation component to prevent movements of said container.

20. The method of claim 8, further comprising, prior to inserting said expandable portion of said container, forming a path of insertion and a space for said container.

21. The method of claim 8, wherein said hole is the only aperture in the periosteal tissues of said bone through which said container is allowed at least partially to pass through.

22. The method of claim 8, wherein said expandable portion of said container being located between said bone and said periosteal tissue.

23. The method of claim 8, wherein said expanding is displacing at least part of the Schneiderian membrane so said expandable portion of said container being located completely below said part of said displaced Schneiderian membrane and said bone is the maxillary bone.

24. The method of claim 1, wherein said container includes a protruding element designed to protrude through said hole.

25. The method of claim 24, wherein said protruding element includes a sealing means for sealing said protruding element.

26. The method of claim 24, wherein said protruding element includes a hollow screw.

27. The method of claim 1, wherein said area includes at least one biocompatible material selected from the group made up of:

a metal, a metal alloy, a polymer, a copolymer and ceramics.

28. The method of claim 1, wherein said area is facing the Schneiderian membrane and said expanding is displacing said Schneiderian membrane.

29. The method of claim 1, wherein said bone being touched from above by said covering tissue of said bone and from below being touched by a second covering tissue of said bone, said expandable portion of said container is being completely below said covering tissue of said bone and at least partially above said second covering tissue of said bone and inside the body for at least several days.

30. The method of claim 29, wherein said expandable portion of said container is configured to have a first portion which is not perforated and a second portion which is perforated.

31. The method of claim 29, wherein said container includes mechanical component assisting in the enlargement of said expandable portion of said container.

32. The method of claim 29, wherein said covering tissue is the Schneiderian membrane above said bone and said second covering tissue is part of the periosteal tissue of the upper jaw.

33. The method of claim 29, wherein said expandable portion of said container is inserted so at least part of said expandable portion of said container is inside said bone.

34. The method of claim 29, wherein said expandable portion of said container being completely below the displaced part of said covering tissue of said bone.

35. The method of claim 1, wherein said expanding is stretching said periosteal tissue.

36. The method of claim 1, wherein inserting the majority of said container through a hole in said bone, said hole in said bone being surrounded all around by said bone.

37. The method of claim 1, further comprising, prior to inserting said expandable portion of said container peeling said Schneiderian membrane from said bone.

38. The method of claim 36, wherein said expanding is done by introducing a biocompatible filling material into said container.

39. The method of claim 38, wherein said expandable portion of said container is at least partially located in a cavity inside said bone.

40. The method of claim 39, wherein said cavity has at least one place of non-continuity of the bone at the borders of said cavity.

41. The method of claim 40, wherein said expandable portion of said container includes an area which is less penetrable to tissue than said region, said area is facing said non-continuity.

42. The method of claim 41, wherein said area prevents the leakage of said filling material.

43. The method of claim 38, wherein said expandable portion of said container is expanded in a chamber in the body having hard bone tissue at most of the borders of said chamber and softer tissue inside said chamber.

44. The method of claim 43, wherein said introducing is displacing said softer tissue.

45. The method of claim 38, wherein said expandable portion of said container is bounded from one side by said bone surface and from another side by at least one of the soft tissues that were adjacent to said bone before starting the surgical procedure.

46. The method of claim 45, wherein, said expandable portion of said container includes an area which is less penetrable to tissue than said region, said region being placed adjacent to said bone surface and said area being placed facing at least part of said soft tissues.

47. The method of claim 46, wherein said region is a perforated region having pores which are sufficiently large to allow the ingrowth of bone tissue and said area prevents the leakage of said filling material outside said container.

48. The method of claim 38, wherein said filling material includes a first filling material and a second filling material, said container having pores to allow the release of said second filling material while preventing the release of said first filling material.

49. The method of claim 38, wherein said container allows the release of part of said filling material.

50. The method of claim 49, wherein said introducing is done so said part of said filling material is released outside said container.

51. The method of claim 50 wherein said container has pores that are sized according to the filling material to be released.

52. The method of claim 38, wherein said expandable portion of said container is inserted so that the largest diameter of said expandable portion of said container after being expanded is larger than the largest diameter of said hole in said bone.

53. The method of claim 1, wherein inserting the majority of said container through a hole in said bone, said hole in said bone being surrounded substantially all around by said bone.

54. The method of claim 1, wherein said expanding is displacing at least one of the tissues touching said expandable portion of said container from said bone surface.

55. The method of claim 1, wherein said hole in said periosteal tissue is done using a drill to create a round hole.

56. The method of claim 1, wherein inserting the majority of said container through a hole in said bone, said hole in said bone is done using a drill to create a round hole.

57. The method of claim 56, wherein said container includes a filling conduit, the dimension of said hole in said bone fits the dimension of said filling conduit so said filling conduit is touching said hole in said bone substantially all around the borders of said hole in said bone.

58. The method of claim 56, wherein said expanding is done by introducing a biocompatible filling material into said container through a rigid tube, said tube fits the size of said hole in said bone.

59. The method of claim 1, wherein said hole being surrounded all around by said periosteal tissue.

60. The method of claim 1, wherein said expandable portion of said container includes an area which prevents ingrowth of tissue and said region is perforated, having pores which are sufficiently large to allow the ingrowth of bone tissue.

61. The method of claim 1, wherein said covering tissue is the periosteal tissue covering the external surface of said bone.

62. The method of claim 61, wherein said expandable portion of said container includes an area which prevents ingrowth of epithelial tissue and said region is perforated, having pores which are sufficiently large to allow the ingrowth of bone tissue.

63. The method of claim 62, wherein at least part of said expanding is done by introducing a bone growth inducing material into said container.

64. The method of claim 62, wherein said bone is the alveolar ridge and said periosteal tissue is displaced towards the oral cavity.

65. The method of claim 64, wherein at least part of said area is made from a guided bone regeneration membrane and said guided bone regeneration membrane is facing said periosteal tissue.

66. The method of claim 65, wherein at least part of said expanding is done by introducing a bone growth inducing material into said container.

67. The method of claim 61, wherein at least part said expanding is done by introducing a bone growth inducing material into said container.

68. The method of claim 61, wherein said bone is the alveolar ridge and said periosteal tissue is displaced towards the oral cavity.

69. The method of claim 38, wherein said filling material is a bone filler.

70. The method of claim 1, wherein said covering tissue is the Schneiderian membrane and at least part of said area is made from a guided bone regeneration membrane.