Systems and methods for a tissue expander

• US 9,399,122 B2
• Filed: 12/09/2015
• Issued: 07/26/2016
• Est. Priority Date: 04/09/2013
• Status: Active Grant

• Current Assignee: Reconstructive Technologies, Inc. (Integra LifeSciences Holdings Corporation)
• Original Assignee: Reconstructive Technologies, Inc. (Integra LifeSciences Holdings Corporation)
• Inventors: Mosharrafa, Tamir M., Mosharrafa, Ali M.
• Primary Examiner(s): LYNCH, ROBERT A
• Application Number:
  US14/963,641
• Publication Number:
  US 20160082235A1
• Time in Patent Office: 230 Days
• US Class Current: 1/1
• 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 2/52 Mammary prostheses brassieres A41C3/00
• CPC Class Codes: A61F 2002/523 Multiple breast forms made of several concentric breast-shaped layers nested into one another
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Methods and systems for a tissue expander according to various aspects of the present invention may function in conjunction with an extended tissue expander, such as an extended tissue expander to be temporarily implanted into a patient to form a pocket for a permanent implant. Systems and methods according to various aspects of the present invention may comprise an extended tissue expander configured to increase and/or customize the size and/or shape of a tissue pocket beyond the size and/or shape provided by a conventional tissue expander. The extended tissue expander may comprise a tissue expander coupled to an extension portion. In one embodiment, the extended tissue expander may preserve a breast pocket with a desired teardrop shape that does not need extensive surgical modification before placement of a final breast implant or a tissue flap. In another embodiment, the extended tissue expander may be modified to the precise dimensions of a final breast implant for the simple exchange of the extended tissue expander for the final breast implant.

Claims

1. An extended tissue expander for filling with a filler material and implantation in the breast area of a patient, comprising:

a breast tissue expander, comprising;

a shell defining a closed interior volume configured to retain the filler material, wherein the shell comprises;

an expandable anterior shell; and

a substantially nonexpandable posterior section, wherein the posterior section comprises an integrated portion of the shell; and

a port disposed through the shell and into the interior volume; and

an extension portion coupled to the breast tissue expander, wherein the extension portion;

extends beyond a medial edge and a lateral edge of the breast tissue expander to a distance of less than about 10% of the height of the fully expanded breast tissue expander; and

extends superiorly above an upper boundary of the fully expanded breast tissue expander to;

a distance up to about 50% of the height of the fully expanded breast tissue expander, so dimensioned to reach the superior boundary of the breast area in the patient.

2. The extended tissue expander of claim 1, wherein the extension portion extends superiorly above the upper boundary of the fully expanded breast tissue expander to a distance of about 50% of the height of the fully expanded breast tissue expander.

3. The extended tissue expander of claim 1, wherein the extension portion extends below an inferior border of the breast tissue expander when the breast tissue expander is substantially deflated.

4. The extended tissue expander of claim 3, wherein the inferior border of the breast tissue expander is below an inferior border of the extension portion when the breast tissue expander is in an at least partially inflated state.

5. The extended tissue expander of claim 1, wherein the extension portion comprises a substantially round shape.

6. The extended tissue expander of claim 1, wherein the thickness of the extension portion is tapered.

7. The extended tissue expander of claim 1, wherein the extension portion has a substantially uniform thickness.

8. The extended tissue expander of claim 1, wherein the extension portion comprises a maximum thickness of at least about 1.5 millimeters.

9. The extended tissue expander of claim 1, wherein the extension portion has a maximum thickness of about 1.5 to about 2 millimeters.

10. The extended tissue expander of claim 1, wherein the extension portion comprises a trimmable material.

11. The extended tissue expander of claim 1, wherein the extension portion comprises a resilient material.

12. The extended tissue expander of claim 1, wherein the extension portion comprises a single piece of silicone.

13. The extended tissue expander of claim 12, wherein the extension portion further comprises a reinforcement material embedded into the single piece of silicone, wherein the reinforcement material enhances a resilience of the silicone.

14. The extended tissue expander of claim 1, wherein the extension portion comprises multiple layers of silicone.

15. The extended tissue expander of claim 14, wherein the extension portion further comprises a reinforcement material at least one of (a) embedded into one or more of the multiple layers of silicone and (b) disposed between two or more adjacent layers of silicone.

16. The extended tissue expander of claim 1, wherein the extension portion further comprises a reinforcement material.

17. The extended tissue expander of claim 16, wherein the reinforcement material comprises an embedded suturable surgical fabric.

18. The extended tissue expander of claim 16, wherein the extension portion further comprises a reinforcement material arranged in a radial pattern from a focal point in a lower pole of the extension portion and spreading outwardly toward the extension portion'"'"'s outer edge.

19. An extended tissue expander for receiving a fluid for forming a final encapsulated breast pocket within an anatomic boundary of a patient'"'"'s breast area that is configured to receive a pre-selected final breast implant or a tissue flap, the extended tissue expander comprising:

a breast tissue expander, comprising;

a shell configured to retain the fluid, wherein the shell comprises;

a substantially nonexpandable backing;

an expandable anterior shell coupled to the backing, wherein the anterior shell is integrated with the nonexpandable backing and extends anteriorly therefrom; and

a port disposed through the shell;

wherein the shell expands anteriorly substantially evenly as the fluid is post-operatively added to the shell through the port; and

an approximately round extension portion coupled to the breast tissue expander, wherein the extension portion;

extends beyond a medial edge and a lateral edge of the breast tissue expander in a fully expanded state to a distance of less than about 10% of the height of the breast tissue expander in the fully expanded state;

extends superiorly beyond an upper boundary of the breast tissue expander in the fully expanded state to a distance of up to about 50% of the height of the breast tissue expander in the fully expanded state, so dimensioned to reach the superior boundary of the breast area in the patient;

has a substantially uniform thickness of about 1.5 to 2 millimeters;

substantially resiliently resumes its round shape after bending; and

maintains an extended open pocket superiorly to the breast tissue expander to substantially correlate the dimensions of the extended tissue expander to at least one of;

the dimensions of the final encapsulated breast pocket that extends to the anatomic boundary of the patient'"'"'s breast area; and

the dimensions of the pre-selected final breast implant to provide a tight breast pocket for the pre-selected final breast implant.

20. The extended tissue expander of claim 19, wherein the pre-selected final breast implant is a form stable, highly-cohesive silicone gel breast implant.

21. The extended tissue expander of claim 19, wherein the extension portion comprises a single piece of silicone.

22. The extended tissue expander of claim 21, wherein a reinforcement material is embedded into the single piece of silicone for shape retention.

23. The extended tissue expander of claim 19, wherein the extension portion comprises multiple layers of silicone that are coupled together.

24. The extended tissue expander of claim 23, wherein a reinforcement material is at least one of (a) embedded into one or more of the multiple layers of silicone and (b) disposed between two or more adjacent layers of silicone.

25. The extended tissue expander of claim 19, wherein the extension portion further extends below an inferior border of the breast tissue expander when the breast tissue expander is in a deflated state.

26. The extended tissue expander of claim 25, wherein the inferior border of the breast tissue expander is below an inferior border of the extension portion when the breast tissue expander is in an at least partially inflated state.

27. The extended tissue expander of claim 19, wherein the extension portion further comprises a reinforcement material arranged in a radial pattern from a focal point in a lower pole of the extension portion and spreading outwardly toward the extension portion'"'"'s outer edge.

28. A method for forming a final encapsulated breast pocket within an anatomic boundary of a patient'"'"'s breast area that is configured to receive a pre-selected final breast implant or a tissue flap, comprising:

forming an initial breast pocket in the patient'"'"'s breast area; and

inserting an extended tissue expander into the initial breast pocket,

wherein the extended tissue expander includes;

a breast tissue expander, comprising;

a shell defining a closed interior volume configured to retain a filler material, wherein the shell comprises;

an expandable anterior shell; and

a substantially nonexpandable posterior section, wherein the anterior shell is integrated with the posterior section and extends anteriorly therefrom; and

a port disposed through the shell and into the interior volume; and

an extension portion coupled to the breast tissue expander, wherein the extension portion;

extends beyond a medial edge and a lateral edge of the breast tissue expander to a distance of less than about 10% of the height of the fully expanded breast tissue expander; and

extends superiorly above an upper boundary of the fully expanded breast tissue expander to a distance up to about 50% of the height of the fully expanded breast tissue expander, wherein the distance of superior extension of the extension portion above the upper boundary of the fully expanded breast tissue expander corresponds to the superior boundary of the breast area in the patient.

29. The method for forming a final encapsulated breast pocket of claim 28, further comprising trimming the extension portion to fit a desired final encapsulated breast pocket.

30. The method for forming a final encapsulated breast pocket of claim 28, further comprising suturing the extension portion to the patient.