Biological tissue growth through induced tensile stress

• US 8,858,628 B2
• Filed: 12/14/2007
• Issued: 10/14/2014
• Est. Priority Date: 06/01/2007
• Status: Expired due to Fees

• Current Assignee: Gino Rigotti, Guido Baroni
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Baroni, Guido, Rigotti, Gino
• Primary Examiner(s): IWAMAYE, ANDREW MICHAEL
• Application Number:
  US11/957,083
• Publication Number:
  US 20080300681A1
• Time in Patent Office: 2,496 Days
• Field of Search: 623/7, 623/8, 623 2364- 2376, 604/164.03, 606191-194, 606/198, 606/201, 606/202, 424/572, 424/574, 435/271
• 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 comprising

an inner membrane,

an outer membrane, and

an inflatable spiral vessel, encased within the inner membrane and the outer membrane,

the vessel being expandable upon inflation thereof between a substantially planar deflated state and an inflated state in the form of a dome having a vertex with the outer membrane positioned external to the dome and the inner membrane positioned internal to the dome;

implanting the tissue expansion device between tissue layers of a patient while the vessel is in the deflated state such that the inner membrane interfaces a region of desired tissue growth; and

inflating the vessel to the inflated state such that a convex void is formed between the region of desired tissue growth and the inner membrane and under the entire inner membrane such that the entire tissue expansion device is located outside of the convex void, thereby promoting tissue growth in the region of desired tissue growth.

2. The method of claim 1 further comprising:

deflating the vessel; and

removing the tissue expansion device from the patient.

3. The method of claim 1 further comprising introducing pharmaceutical stimuli into the region of desired tissue growth.

4. The method of claim 1 further comprising introducing an agent into the region of desired tissue growth, 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.

5. The method of claim 1 further comprising introducing a specimen including adipose tissue into the region of desired tissue growth.

6. The method of claim 5 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 a three-dimensional scaffold of the centrifuged adipose tissue; and

injecting the centrifuged adipose tissue into the region of desired tissue growth.

7. The method of claim 1 further comprising

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

centrifuging the first portion;

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

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

combining the second portion with the centrifuged first portion thereby forming a combined portion; and

injecting the combined portion into the region of desired tissue growth.

8. A method for promoting tissue generation, comprising:

providing a tissue expansion device, said tissue expansion device comprising

an inner membrane,

an outer membrane, and

at least one inflatable vessel encased within the inner membrane and the outer membrane,

the tissue expansion device being expandable upon inflation of the at least one inflatable vessel, between a substantially planar state and a dome-shaped state having a dome with a vertex with the outer membrane positioned external to the dome and the inner membrane positioned internal to the dome;

implanting the tissue expansion device between tissue layers of a patient while the tissue expansion device is in the planar state such that the inner membrane interfaces a region of desired tissue growth; and

inflating the at least one vessel to expand the tissue expansion device to the dome shaped state such that a convex void is formed under the inner membrane and between the inner membrane and the region of desired tissue growth such that the region of desired tissue growth and the inner membrane form borders of the convex void, wherein the entire tissue expansion device is located outside of the convex void, thereby promoting tissue growth in the region of desired tissue growth.

9. The method of claim 8 wherein the at least one inflatable vessel is a concentric spiral vessel.

10. The method of claim 8 wherein the at least one inflatable vessel is a plurality of toroidal inflatable vessels.

11. The method of claim 10 wherein the plurality of toroidal inflatable vessels are vessels having increasing diameter and configured concentrically about a common axis.

12. The method of claim 8, wherein the step of implanting includes implanting the device in a human breast.

13. The method of claim 8 further comprising introducing pharmaceutical stimuli into the region of desired tissue growth.

14. The method of claim 8 further comprising introducing an agent into the region of desired tissue growth, 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.

15. The method of claim 8 further comprising introducing a specimen including adipose tissue into the region of desired tissue growth.

16. The method of claim 8 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 a three-dimensional scaffold of the centrifuged adipose tissue; and

injecting the centrifuged adipose tissue into the region of desired tissue growth.