Tissue expander and method

• US 4,574,780 A
• Filed: 11/13/1984
• Issued: 03/11/1986
• Est. Priority Date: 11/13/1984
• Status: Expired due to Term

• Current Assignee: Ernest K. Manders
• Original Assignee: Ernest K. Manders
• Inventors: Manders, Ernest K.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US06/670,623
• Time in Patent Office: 483 Days
• Field of Search: 128/1 R, 3/1, 3/36, 604/96-103
• US Class Current: 128/898
• 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

Abstract

A soft tissue expander device adapted to be implanted beneath a layer of skin and subcutaneous tissue and filled with fluid to differentially expand the overlying tissue including methods for differentially expanding soft tissue and treating male pattern baldness.

Claims

1. A soft tissue expander device comprising a flexible base and an expandable cover joined to the periphery of the base to define a fluid tight chamber between the cover and base, a fluid injection port communicating with the interior of the chamber for admitting fluid into the chamber to expand the cover, the cover including a first limited expansion portion expandable by initial fluid injected through the port and into the chamber from a collapsed position overlying the base to a taut position a distance above the base and a differential expansion portion adjacent said limited expansion portion expandable by said initial injected fluid from a collapsed position overlying the base said distance above the base, said limited expansion portion including limiting means preventing further expansion of such portion beyond said taut position by fluid injected into the chamber in addition to the initial injected fluid and said differential expansion portion including expansion means permitting further expansion of such portion beyond said distance whereby upon implantation of the base and collapsed cover beneath a soft tissue layer of skin and subcutaneous tissue injection of fluid through the port and into the cavity first expands both the first and second cover portions together with the tissue overlying such portions said distance above the base and then expands the second cover portion together with the tissue overlying the second cover portion only beyond said distance to form a differentially expanded tissue flap.

2. A device as in claim 1 wherein each cover portion joins edges of the base and extends over the base between such edges.

3. A device as in claim 2 wherein the base is elongate and one of the portions is located at one end of the base.

4. A device as in claim 2 wherein the differential expansion portion is formed from an elastomer material and is bulbous in shape when such portion is fully expanded.

5. A device as in claim 4 wherein the differential expansion portion extends beyond the periphery of the base when fully expanded.

6. A device as in claim 1 wherein the cover is formed from an elastomer material.

7. A device as in claim 6 wherein the thickness of the differential expansion portion is essentially uniform.

8. A device as in claim 6 wherein the differential expansion portion is thinner than the limited expansion portion.

9. A device as in claim 8 wherein the thickness of the differential expansion portion decreases in a direction away from the limited expansion portion.

10. A device as in claim 6 wherein when the chamber is collapsed both portions are folded on top of the base, and both portions are taut following injection of initial fluid into the chamber.

11. A device as in claim 6 wherein both portions are folded on top of the base when the chamber is collapsed, and the limited expansion portion is taut and the differential expansion portion is folded following injection of initial fluid into the chamber.

12. A device as in claim 1 wherein the base of elongate, one cover portion overlies one end of the base and is joined to the side edges and one end thereof and the other portion extends across the base and is joined to the side edges of the base.

13. A device as in claim 1 wherein the port is secured to the limited expansion portion of the cover.

14. A device as in claim 1 wherein the base is dimensionally stable.

15. A device as in claim 6 wherein said base is elongate, said portions each overlie one end of the base, and the port is located in said limited expansion portion.

16. A device as in claim 15 including a shallow recess formed in one edge of the base adjacent the differential expansion portion whereby such device may be fitted within a pocket extending beneath hair bearing scalp with the limited expansion portion beneath occiputal scalp, the differential expansion portion beneath the temporal scalp and the recess fitted around the top of the ear.

37. A device as in claim 13 wherein the cover is formed of an elastomer material.

38. A device as in claim 37 wherein the thickness of the differential expansion portion is essentially uniform.

39. A device as in claim 37 wherein the differential expansion portion is thinner than the limited expansion portion.

40. A device as in claim 39 wherein the thickness of the differential expansion portion decreases in a direction away from the limited expansion portion.

41. A device as in claim 37 wherein when the device is collapsed both portions are folded, and both portions are taut following injection of initial fluid into the chamber.

42. A device as in claim 37 wherein when the device is collapsed both portions are folded, and the limited expansion portion is taut and the differential expansion portion is folded following injection of initial fluid into the chamber.

17. An expander device adapted to be implanted beneath a soft tissue layer of skin and subcutaneous tissue and to differentially expand the overlying skin and tissue in two steps, comprising a flexible base and an expandable cover joined to the peripheral edge of the base to define a fluid tight chamber between the cover and base, a fluid injection port communicating with the interior of the chamber for admitting fluid into the chamber to expand the cover, the cover including a limited expansion portion and a differential expansion portion adjacent said limited expansion portion, said limited expansion portion including means preventing expansion beyond a taut position and the differential expansion portion including means permitting expansion beyond the taut position of the limited expansion portion, the device having a collapsed position when implanted with the cover overlying the base, a partially expanded position where fluid injected through the port and into the chamber expands the limited expansion portion of the cover a distance above the base to the taut position and the differential expansion portion of the cover a corresponding distance above the base, and a fully expanded position where further fluid injected through the port and into the chamber moves the differential expansion portion a further distance above the base beyond the limited expansion portion without further moving the limited expansion portion above the base whereby the skin and subcutaneous tissue overlying the cover are differentially expanded.

18. A device as in claim 17 wherein the base is elongate, the cover is formed from an elastomer material, and one cover portion overlies an end of the base.

19. A device as in claim 18 wherein the differential expansion portion is taut when the device is partially expanded.

20. A device as in claim 18 wherein the differential expansion portion is folded when the device is partially expanded.

21. A device as in claim 18 wherein the inlet port extends through the limited expansion portion.

22. A device as in claim 18 including a shallow recess formed in one edge of the base to permit the device to be implanted within a pocket below skin and subcutaneous tissue with the recess extending around an adjacent anatomical feature.

23. A device as in claim 22 wherein the recess is adjacent the differential expansion portion.

24. A surgical method of expanding and applying soft tissue by use of a soft tissue expander device having an expandable cover comprising the step of:

(a) Separating a layer of skin and subcutaneous soft tissue connected to surrounding skin and soft tissue from underlying support tissue to form a pocket;

(b) Placing a collapsed soft tissue expander device in the pocket with the cover of the device facing the separated tissue layer;

(c) Forcing the cover against the separated tissue to expand the tissue layer substantially uniformally away from the underlying tissue;

(d) Retaining a first portion of the cover in the expanded position and further forcing a second portion of the cover against the overlying portion of the separated tissue layer to further expand such overlying portion only;

(e) Collapsing and removing the soft tissue expander device from the pocket;

(f) Severing edges of the expanded layer from surrounding soft tissue to form a differentially expanded tissue flap; and

(g) Flattening and applying the tissue flap to a recipient area larger than the area of the separated layer.

25. The method of claim 24 including the steps of retaining one edge of the tissue flap connected to surrounding tissue, moving the flap away from the edge so that it overlies an adjacent recipient area and applying the flap to such area.

26. The method of claim 24 including the steps of completely severing the tissue flap from the surrounding soft tissue and applying the flap to a remote recipient area.

27. The method of treating male pattern baldness using a pair of soft tissue expander devices comprising the steps of:

(a) Forming pockets on both sides of the head between the skull and adjacent layers of hair-bearing occiputal and hair-bearing temporal scalp;

(b) Placing a soft tissue expander device in each pocket;

(c) Differentially expanding the devices in the pockets to form a differentially expanded hair-bearing scalp layer above each device with the length of the expanded temporal scalp being greater than the length of the expanded occiputal scalp;

(d) Collapsing and removing the soft tissue expander devices from the pockets;

(e) Removing the bald scalp area between the expanded scalp layers on each side of the head;

(f) Severing the upper, anterior and posterior edges of the expanded scalp layers from the adjacent scalp tissue to form flaps;

(g) Drawing the severed flaps upwardly around the head so that the flaps join at the center line and cover the former bald area; and

(h) Applying the flaps to underlying tissue.

28. The method of claim 27 including the steps of expanding the temporal scalp layers anteriorly and drawing the flaps anteriorly to provide a forward hair line.

29. The method of claim 27 including the steps of forming a single vertical incision through the scalp at the center of the occiput, and separating hair-bearing scalp extending anteriorly to either side of the incision past the occiput and into the temporal area from underlying tissue prior to expansion.

30. The method of claim 29 including the steps of separating temporal hair-bearing scalp from underlying tissue closely surrounding the tops of the ears and expanding the temporal hair-bearing scalp located immediately above the ears.

31. A soft tissue expander device adapted to be implanted collapsed beneath a soft tissue layer of skin and subcutaneous tissue, the device comprising flexible wall means defining a fluid impervious chamber, and an injection port communicating with the interior of the chamber for admitting fluid into the chamber to expand the chamber, said wall means including an expandable cover in contact with the layer of skin and subcutaneous tissue when the device is implanted, the cover including a first limited expansion portion expandable by initial fluid injected through the port and into the chamber from a collapsed implantation position to a taut position above the collapsed position and a second differential expansion portion adjacent said limited expansion portion expandable by said initial injected fluid with the limited expansion portion above the collapsed implantation position, said limited expansion portion including limiting means preventing further expansion of such portion beyond said taut position by further fluid injected into the chamber in addition to the initial injected fluid and said differential expansion portion including expansion means permitting further expansion of such portion by said further fluid whereby fluid injected through the port and into a chamber of an implanted device first expands both the first and second cover portions together with the tissue overlying such portions and then further expands the second cover portion together with the tissue overlying the second cover portion only to form a differentially expanded tissue flap.

32. A device as in claim 31 wherein one cover portion extends across the cover.

33. A device as in claim 31 wherein said limited expansion portion extends across the cover.

34. A device as in claim 33 wherein the differential expansion portion is formed from an elastomer material and is bulbous in shape when such portion is fully expanded.

35. A device as in claim 31 wherein both cover portions extend across the cover.

36. A device as in claim 31 wherein the flexible wall means is elongate when collapsed and one of the portions is located at one end thereof.

43. A device as in claim 31 wherein the device is elongate when collapsed, one cover portion is at one end of the device and the other cover portion is at the other end of the device and both cover portions extend across the cover.

44. A device as in claim 31 wherein the port is formed in the limited expansion portion of the cover.

45. A device as in claim 31 wherein the port is remote from the flexible wall means.

46. A device as in claim 31 wherein the wall means includes a dimensionally stable base.