Bioresorbable inflatable devices, incision tool and methods for tissue expansion and tissue regeneration

• US 20030105469A1
• Filed: 11/12/2002
• Published: 06/05/2003
• Est. Priority Date: 05/09/2001
• Status: Abandoned Application

• Current Assignee: RegeneEx Ltd.
• Original Assignee: RegeneEx Ltd.
• Inventors: Karmon, Ben-Zion
• Application Number:
  US10/291,477
• Publication Number:
  US 20030105469A1
• Time in Patent Office: Days
• US Class Current: 606/92
• CPC Class Codes: A61B 17/58 for osteosynthesis, e.g. bone plates, screws , setting implements or the like A61B17/14, A61B17/16 take precedence
• CPC Class Codes: A61B 17/666 for alveolar distraction
• 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 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61C 8/0009 Consolidating prostheses or implants, e.g. by means of stabilising pins A61C8/0031 takes precedence
• CPC Class Codes: A61C 8/0092 for sinus lifting

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 or a perforated 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, fixating bone fractures etc.

Claims

1. A method for expanding, stretching, displacing or fixating living tissue comprising:

(i) inserting into the tissue an inflatable element, said inflatable being configured after being filled with a biocompatible material to enable immediate direct contact between said tissue and said biocompatible material; and

(ii) introducing into said inflatable element a quantity of a biocompatible filling material, said introducing being performed in a plurality of stages separated by at least several hours.

2. The method of claim 1, wherein said inflatable element is made at least in part from bio-dissipative material.

3. The method of claim 1, wherein said inflatable element has one region which is sealed.

4. The method of claim 1, wherein said introducing is displacing the tissue.

5. The method of claim 1, wherein said inflatable element has a first region with a first resistance to passage of a given material and a second region with a second resistance to passage of said given material, said second resistance being less than said first resistance.

6. The method of claim 4, wherein said given material includes cells and blood vessels.

7. The method of claim 1, wherein said biocompatible filling material includes a bio-active material.

8. The method of claim 1, wherein said inserting is performed such that said inflatable element is located substantially at a bone-soft tissue interface, said biocompatible filling material including material for promoting the growth of bone such that, subsequent to the contact of said biocompatible filling material with the tissue said material for promoting the growth of bone promotes extension of the bone beyond the initial bone-soft tissue interface.

9. The method of claim 2, wherein said inflatable element is configured to have a first region which exhibits a first mean time to dispersion and a second region which exhibits a second mean time to dispersion longer than said first mean time to dispersion.

10. The method of claim 1, wherein said introducing is performed via a filling conduit partially inserted into the tissue.

11. The method of claim 9, wherein said filling conduit is implemented as a bone implant.

12. The method of claim 1, wherein said inflatable element is configured to take a specific shape as said inflatable element is filled and to resist changes in the shape of said inflatable element as a result of forces coming from outside said inflatable element.

13. The method of claim 1, wherein said inflatable element is configured to expand in a telescopic pattern.

14. The method of claim 1, wherein said inflatable element includes a component assisting in the enlargement of said inflatable element.

15. The method of claim 1, wherein said inflatable element includes at least one region having a first stiffness and a second region having a second stiffness less than said first stiffness so as to define a direction of expansion of said inflatable element.

16. The method of claim 1, wherein said inflatable element is closed by being attached to at least one surface of the tissue such that said inflatable element becomes inflatable after being attached to the tissue.

17. The method of claim 16, wherein said inflatable element is placed beneath the gums.

18. The method of claim 17, wherein said inflatable element includes a rigid element facing the gums, said rigid element being attached to a non rigid element configured so as to grow in a telescopic pattern, said rigid element includes at least one tube being configured to protrude through the gums to the oral cavity, said tube being configured to be sealed with a sealing component.

19. The method of claim 18, wherein said non rigid element is a guided bone regeneration membrane.

20. The method of claim 19, wherein said inflatable element includes at least one elevating mechanism configured to allow displacement of said rigid element from the bone so as to displace the gums.

21. The method of claim 20, wherein said elevating mechanism being an elevating screw, said inflatable element includes at least one elevating nut configured to be threaded on said elevating screw, said elevating nut being configured to be accessible through said tube, said elevating nut being configured to touch said rigid element so as turning said elevating nut results in displacement of said rigid element.

22. The method of claim 21, wherein said elevating screw is hollow and perforated so as to allow insertion of bone augmenting material through the upper region of said elevating screw inside the space of said inflatable element, said upper region of said elevating screw being configured to be accessible through said tube.

23. The method of claim 21, wherein said elevating screw is a dental implant configured to support a dental prosthesis.

24. The method of claim 21, wherein said tube being configured to be detached from said rigid element leaving a hole in said rigid element, said hole being wide enough to allow replacement of at least part of said elevating screw with a bone implant through said hole, said bone implant being connected to said rigid element by a stabilizing element, said stabilizing element includes one region configured to be threaded to the internal threads of said bone implant and a second region configured to be threaded to threads in said rigid element around said hole, said stabilizing element is configured to seal said hole.

25. The method of claim 1, wherein said inflatable element is inserted inside the breast and said biocompatible filling material is fat cells.

26. The method of claim 25, wherein said fat cell are sucked from another region in the body.

27. A method for expanding, stretching, displacing or fixating living tissue comprising:

(a) inserting into the tissue an inflatable element having a first region which is perforated so as to allow penetration of cells and blood vessels and a second region which is resistant to ingrowth of tissue; and

(ii) introducing into said inflatable element a quantity of a biocompatible filling material so as to displace the tissue.

28. The method of claim 27, wherein said inflatable element is made at least in part from bio-dissipative material.

29. The method of claim 27, wherein said introducing is performed in a plurality of stages separated by at least a number of hours, each stage incrementally stretching the tissue.

30. The method of claim 27, wherein said biocompatible filling material includes a bio-active material.

31. The method of claim 27, wherein said biocompatible filling material includes material for promoting the growth of at least one type of tissue.

32. The method of claim 27, wherein said inflatable element is located beneath the Schneiderian membrane of the maxillary sinus or of the nose.

33. The method of claim 27, wherein said inflatable element having one region that can be detached from said inflatable element and taken out of the tissue after filling of said inflatable element so as to enable direct contact between said biocompatible filling material and said tissue.

34. A method for expanding, stretching, displacing or fixating living tissue comprising:

(i) inserting into the tissue an inflatable element, said inflatable element being configured after being filled with a setting biocompatible filling material to fixate the tissue as said setting biocompatible filling material sets; and

(ii) introducing into said inflatable element a quantity of a setting biocompatible filling material.

35. The method of claim 34, wherein said inflatable element is made at least in part from bio-dissipative material.

36. The method of claim 34, wherein said inflatable element has a first region with a first resistance to passage of a given material and a second region with a second resistance to passage of said given material less than said first resistance.

37. The method of claim 34, wherein said inflatable element is configured to take a specific shape as said inflatable element is filled and to resist changes in the shape of said inflatable element as a result of forces coming from outside said inflatable element.

38. The method of claim 34, wherein said inflatable element is configured so as to enable contact between said tissue and said setting biocompatible filling material.

39. The method of claim 34, wherein said inflatable element is configured to fix two tissue fragments in given spatial relation.

40. The method of claim 34, wherein inflatable element has a first region which is perforated to allow not damaging leakage of said biocompatible filling material and a second region which is resistant to leakage of said biocompatible filling material.

41. The method of claim 40, wherein said first region is facing bone and said second region is facing other tissues.

42. The method of claim 41, wherein said inflatable element is inserted into a space inside bone.

43. The method of claim 41, wherein said inflatable element is inserted between two bone fragments.

44. The method of claim 41, wherein said inflatable element is inserted into a crushed vertebra.

45. The method of claim 34, wherein said introducing is displacing the tissue.

46. The method of claim 44, wherein said introducing is displacing the fragments of said crushed vertebra.

47. A device for expanding, stretching, displacing or fixating living tissue comprising:

(i) an inflatable element for insertion into the tissue, said inflatable element includes at least one not-sealed region being configured after being filled with a biocompatible material to enable contact between said tissue and said biocompatible material; and

(ii) means for introducing configured to be accessible from outside the tissue and to allow filling of said inflatable element several times, said means for introducing including sealing means configured to seal said means for introducing.

48. The device of claim 47, wherein said inflatable element is made at least in part from bio-dissipative material.

49. The device of claim 47, wherein said inflatable element has a first region with a first resistance to passage of a given material and a second region with a second resistance to passage of said given material less than said first resistance.

50. The device of claim 47, wherein said inflatable element is configured to take a specific shape as said inflatable element is filled and to prevent changes in the shape of said inflatable element as a result of forces coming from outside said inflatable element.

51. The device of claim 47, wherein said inflatable element is configured to expand in a telescopic pattern.

52. The device of claim 47, wherein said inflatable element includes a component assisting in the enlargement of said inflatable element.

53. The device of claim 47, wherein said inflatable element is configured to be closed by being attached to at least one surface of the tissue such that said inflatable element becomes inflatable after being attached to the tissue.

54. The device of claim 47, wherein said inflatable element is configured to have a first region which exhibits a first mean time to dispersion and a second region which exhibits a second mean time to dispersion longer than said first mean time to dispersion.

55. The device of claim 47, wherein said means for introducing is a filling conduit.

56. The device of claim 55, wherein said filling conduit is implemented as a bone implant.

57. The device of claim 47, wherein said inflatable element includes at least one region having a first stiffness and a second region having a second stiffness less than said first stiffness so as to define a direction of expansion of said inflatable element.

58. The device of claim 47, wherein said inflatable element is formed at least in part from a material which serves as a selective barrier configured to allow at least a first material to traverse said barrier while preventing passage of at least a second material.

59. The device of claim 47, wherein said inflatable element is formed with at least one fixation feature.

60. The device of claim 47, wherein said filling conduit includes a chamber for receiving disinfectant material.

61. The device of claim 53, wherein said inflatable element includes a rigid element, said rigid element being attached to a non rigid element configured so as to expand in a pattern, said rigid element includes at least one tube being configured to protrude through the gums to the oral cavity, said tube being configured to be sealed with a sealing component.

62. The device of claim 61, wherein said non rigid element is a guided bone regeneration membrane.

63. The device of claim 62, wherein said inflatable element includes at least one elevating screw configured to allow displacement of said rigid element.

64. The device of claim 63, wherein said inflatable element includes at least one elevating nut configured to be threaded on said elevating screw, said elevating nut being configured to be accessible through said tube, said elevating nut being configured to touch said rigid element so as turning said elevating nut results in displacement of said rigid element.

65. The device of claim 63, wherein said elevating screw is hollow and perforated so as to allow insertion of bone augmenting material through the upper region of said elevating screw inside the space of said inflatable element, said upper region of said elevating screw being configured to be accessible through said tube.

66. The device of claim 64, wherein said elevating screw is a dental implant configured to support a dental prosthesis.

67. The device of claim 64, wherein said tube is configured to be detached from said rigid element leaving a hole in said rigid element, said hole being wide enough to allow replacement of said elevating screw with a bone implant through said hole, said bone implant being connected to said rigid element by a stabilizing element, said stabilizing element includes one region configured to be threaded to the internal threads of said bone implant and a second region configured to be threaded to threads in said rigid element around said hole, said stabilizing element is configured to seal said hole.

68. A device for expanding, stretching, displacing or fixating living tissue comprising:

(b) an inflatable element configured after being filled with a setting biocompatible filling material to fixate the tissue as said setting biocompatible filling material sets; and

(c) means for introducing into said inflatable element a quantity of said setting biocompatible filling material.

69. The device of claim 68, wherein said inflatable element is made at least in part from bio-dissipative material.

70. The device of claim 68, wherein said inflatable element having a first region with a first resistance to passage of a given material and a second region with a second resistance to passage of said given material less than said first resistance.

71. The device of claim 68, wherein said inflatable element is configured to take a specific shape as said inflatable element is filled and to resist changes in the shape of said inflatable element as a result of forces coming from outside said inflatable element.

72. The device of claim 68, wherein said inflatable element is configured so as to enable contact between said tissue and said setting biocompatible filling material.

73. The device of claim 68, wherein said inflatable element is configured to fix two tissue fragments in given spatial relation.

74. The device of claim 68, wherein said inflatable element has a first region which is perforated to allow not-damaging leakage of said setting biocompatible filling material and a second region which is resistant to leakage of said setting biocompatible filling material.