BIOLOGICAL TISSUE GROWTH THROUGH INDUCED TENSILE STRESS

• US 20080300681A1
• Filed: 12/14/2007
• Published: 12/04/2008
• Est. Priority Date: 06/01/2007
• Status: Active Grant

• Current Assignee: Gino Rigotti, Guido Baroni
• Original Assignee: Gino Rigotti, Guido Baroni
• Inventors: Baroni, Guido, Rigotti, Gino
• Granted Patent: US 8,858,628 B2
• Time in Patent Office: Days
• US Class Current: 623/8
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61H 9/005 Pneumatic massage
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution

Abstract

A tissue expansion device implanted in a non-activated state over a region of desired tissue growth. Once implanted and positioned the device is activated creating a supporting structure that creates a convex shaped dome over the underlying tissue. The convex shaped dome formed by the tissue expansion device places a tensile stress against the underlying tissue that promotes tissue growth. Alone or with the introduction of tissue enhancing agents and/or adipose tissue, new tissue within the convex shaped void grows until a balance is achieved eliminating the induced stress. Periodically the tissue expansion devices is again activated and enlarged creating an even larger void. Again, the newly enlarged void places additional tensile stress on the underlying tissue thus repeating the cycle of new tissue growth. Once the desired amount of tissue growth has been achieved the device is deactivated and removed.

Claims

1. A method for promoting human tissue generation, comprising:

providing a tissue expansion device, said tissue expansion device being expandable between a deflated state and a progressively expanded state and wherein the progressively expanded state forms a convex shape having an interior region and wherein a tissue layer interfacing with the interior region experiences tensile stress promoting tissue growth;

positioning the tissue expansion device in the deflated state over a region of desired tissue growth; and

expanding the tissue expansion device progressively by injecting fluid into the tissue expansion device.

2. The method of claim 1 wherein a plurality of injections expand the tissue expansion device by inflating at least one inflatable vessel within the tissue expansion device to maintain a constant state of tensile stress within the region of desired tissue growth as tissue growth occurs.

3. The method of claim 2 wherein the at least one inflatable vessel is a single toroidal vessel configured in a concentric spiral.

4. The method of claim 1 further comprising:

responsive to achieving a desired amount of tissue generation, deflating the tissue expansion device to the deflated state through fluid withdrawal; and

removing the tissue expansion device.

5. The method of claim 1 further comprising introducing pharmaceutical stimuli into the tissue layer experiencing tensile stress.

6. The method of claim 1 further comprising introducing an agent into the tissue layer experiencing tensile stress, wherein the agent is selected from a group consisting of stem cell in-situ cultures, progenitor cells, adipose-derived stem cells, endothelial cell precursors, proliferating cells, differentiation-committed cells, regenerative cells, and growth factors.

7. The method of claim 1 further comprising introducing a specimen including adipose tissue into the tissue layer experiencing tensile stress.

8. The method of claim 7 further comprising,

centrifuging harvested adipose tissue to separate adipose tissue from water content and from oil produced by destruction of damaged adipocytes forming centrifuged adipose tissue;

maintaining natural, three-dimensional scaffold of the centrifuged adipose tissue; and

injecting the centrifuged adipose tissue into the tissue layer experiencing tensile stress.

9. The method of claim 1 further comprising,

separating harvested adipose tissue into a first portion and a second portion;

centrifuging the first portion of the adipose tissue separating the adipose tissue from water content and from oil produced by destruction of damaged adipocytes forming a centrifuged first portion;

maintaining natural, three-dimensional scaffold of the centrifuged first portion of adipose tissue;

combining the second portion of adipose tissue with the centrifuged first portion of adipose tissue forming a combined portion; and

injecting the combined portion of adipose tissue into the tissue layer experiencing tensile stress.

10. The method of claim 1 further comprising affixing the tissue expansion device to the exterior surface of the skin over the region of desired tissue growth wherein affixing includes bonding the tissue expansion device to skin forming an airtight seal.

11. The method of claim 1 further comprising implanting the tissue expansion device within layers of tissue in human anatomy of the region of desired tissue growth.

12. A device for promoting tissue growth, the device comprising:

an inner membrane;

an outer membrane wherein the inner membrane and the outer membrane form an inner surface and an outer exterior surface of the device respectively; and

at least one inflatable vessel, wherein the at least one inflatable vessel is encased within the outer membrane and the inner membrane and wherein inflating the at least one inflatable vessel causes the device to create tensile stress throughout a region of tissue underlying the inner surface of the device thereby promoting tissue growth.

13. The device of claim 12 wherein inflation of the at least one inflatable vessel causes the device to form a convex shape capable of supporting distributed loads on the exterior surface and wherein the convex shape defines an interior region underlying the inner surface possessing a lower differential pressure with respect to the exterior of the exterior surface that induces a tensile stress on underlying tissue thereby promoting tissue growth.

14. The device of claim 12 wherein the at least one inflatable vessel is a single elongated vessel configured as a concentric spiral.

15. The device of claim 12 wherein the at least one inflatable vessel is a plurality of toroidal inflatable vessels of increasing diameter encased within the inner and outer membranes and configured concentrically about a common axis.

16. The device of claim 12 wherein the at least one inflatable vessel comprise structural members configured to shape and support the device under distributed loading on the outer surface.

17. The device of claim 12, further comprising an access site capable of progressively inflating or deflating the at least one inflatable vessel through injections.

18. The device of claim 12, wherein the inner surface of the device is affixed to skin covering the region forming an airtight seal.

19. A system for promoting an area of targeted growth of living tissue, the system comprising:

a tissue expansion device having a collapsible support structure, wherein the collapsible support structure is collapsed during initial placement and removal of the tissue expansion device over the area of targeted growth of living tissue, wherein after initial placement the collapsible support structure is activated to cause the tissue expansion device to form a convex shape having an interior surface, and wherein tissue interfacing with the interior surface of the convex shape is drawn toward the interior surface placing the area of targeted growth of living tissue under a tensile force thereby promoting tissue growth; and

an agent injected into the area of target growth of living tissue wherein said agent promotes tissue growth.

20. The system of claim 19 wherein said agent includes a pharmaceutical stimuli introduced into the area of targeted growth of living tissue.

21. The system of claim 19 wherein the agent is selected from a group consisting of stem cell in-situ cultures, progenitor cells, adipose-derived stem cells, endothelial cell precursors, proliferating cells, differentiation-committed cells, regenerative cells, and growth factors.

22. The system of claim 19 wherein said agent is an adipose tissue specimen formed by centrifuging harvested adipose tissue to separate adipose tissue from water content and from oil produced by destruction of damaged adipocytes forming centrifuged adipose tissue while maintaining natural, three-dimensional scaffold of the centrifuged adipose tissue.

23. The system of claim 19 wherein said agent is an adipose tissue specimen formed by separating harvested adipose tissue into a first portion and a second portion, centrifuging the first portion of the adipose tissue to separate the adipose tissue from water content and from oil produced by destruction of damaged adipocytes forming a centrifuged first portion, maintaining natural, three-dimensional scaffold of the centrifuged and separated first portion of adipose tissue, and combining the second portion of adipose tissue with the centrifuged and separated first portion of adipose tissue.

24. The system of claim 19 wherein said agent is an adipose tissue specimen enhanced with a stem cell culture.

25. The system of claim 24 wherein the adipose tissue specimen includes stem cells maintained in their natural three-dimensional scaffold.

26. The system of claim 19 wherein the tissue expansion device is externally affixed to the area of targeted growth of living tissue by forming an airtight seal between the tissue expansion device and skin.

27. The system of claim 19 wherein the tissue expansion devise is implanted between an inner and outer layer of cutaneous tissue of the area of targeted growth of living tissue.

28. The system of claim 19, wherein the tissue expansion device includes:

an inner membrane; and

an outer membrane, wherein the collapsible support structure is connectively interposed between the inner membrane and the outer membrane.

29. The system of claim 28 wherein the collapsible support structure includes at least one inflatable vessel.

30. The system of claim 29 wherein the at least one inflatable vessel is a plurality of toroidal vessels of increasing diameter encased within the inner and outer membrane and configured concentrically about a common axis.

31. The system of claim 28 wherein the at least one inflatable vessel is an elongated toroidal tube connectively interposed within the inner and outer membrane and configured as a concentric spiral.

32. The system of claim 27 wherein the at least one inflatable vessel can be deflated through removal of fluid from the at least one inflatable vessel prior to removal.

33. The system of claim 19, further comprising an access site wherein the collapsible support structure is progressively activated by injections of fluid.

34. A method for treating capsular contracture of an implant, the method comprising:

injecting an agent including an adipose tissue specimen into a region of tissue substantially adjacent to capsular tissue surrounding the implant; and

placing the region of tissue under a tensile stress for a period of time.

35. The method of claim 34 wherein the adipose tissue specimen is formed by separating harvested adipose tissue into a first portion and a second portion, centrifuging the first portion of adipose tissue to separate adipose tissue from water content and from oil produced by destruction of damaged adipocytes forming a centrifuged first portion of adipose tissue, maintaining natural, three-dimensional scaffold of the centrifuged and separated first portion of adipose tissue, and combining the second portion of adipose tissue with the centrifuged and separated first portion of adipose tissue.

36. The method claim of 34 wherein the adipose tissue specimen is formed by centrifuging harvested adipose tissue to separate adipose tissue from water content and from oil produced by destruction of damaged adipocytes while maintaining natural, three-dimensional scaffold of the harvested adipose tissue.

37. The method of claim 34 wherein the tensile stress is caused by application of a tissue expansion device having a collapsible support structure, wherein the collapsible support structure is collapsed during initial placement and removal of the tissue expansion device over the region of tissue, wherein after initial placement the collapsible support structure is activated to cause the tissue expansion device to form a convex shape having an interior surface, and wherein tissue interfacing with the interior surface of the convex shape is drawn toward the interior surface placing the region of tissue under a tensile force that promotes tissue growth.

38. The method of claim 37 wherein the tissue expansion device is affixed to an exterior surface of skin over the region of tissue forming an airtight seal between the tissue expansion device and the exterior surface of skin.

39. The method of claim 34 wherein placing includes partially deflating the implant.

40. The method of claim 34 wherein the agent is selected from a group consisting of stem cell in-situ cultures, progenitor cells, adipose-derived stem cells, endothelial cell precursors, and other proliferating cells, differentiation-committed cells, and regenerative cells.