METHOD AND DEVICE FOR SUSPENSION, LIFTING, AND AUGMENTATION OF THE BREAST, FACE, AND NECK

Abstract

The present invention provides a method and device for support of tissues post-surgery, including augmentation and shaping of tissue. The invention provides a non-silicon substrate material which is shaped to support tissue of a subject during the post-surgical recovery period.

Claims

1. A method of supporting tissue of a breast in a subject comprising: a) contacting a flexible, non-silicone material with the breast tissue, the material being configured such that it forms circumferential coverage of the breast tissue for elevation, lifting, augmenting and support of the breast tissue when attached; b) attaching the material to a position on the pectoral muscle below the breast; c) stretching the material upward and attaching the material to a position on the pectoral muscle above the breast, thereby providing elevation; and d) attaching the material to the chest musculature medial and lateral to the breast mound providing a circumferential support for the breast mound, lifting and support of the breast tissue.

2. The method of claim 1, wherein the material is a synthetic or naturally occurring, material.

3. The method of claim 2, wherein the material comprises acellular dermal matrix or a polymer material or silk material.

4. The method of claim 2, wherein the material is an absorbable biocompatible material or a permanent material.

5. The method of claim 2, wherein the material is TIGR® Matrix, AlloDerm®, Seri® Surgical Scaffold, or Phasix Mesh®.

6. The method of claim 1, wherein the subjects a human.

7. The method of claim 1, wherein the subject is in need of a breast reconstruction, a breast reduction, a breast lift, or breast augmentation.

8. The method of claim 3, wherein the polymer material is a mesh material.

9. The method of claim 8, wherein the mesh is made from more than one type of polymer.

10. The method of claim 1, wherein the material is attached via sutures.

11. The method of claim 8, wherein the material is in the form of a sheet or the shape of the tissue to be supported.

12. The method of claim 11, wherein the sheet has one or more incisions to allow for sizing of the sheet with the breast.

13. The method of claim 12, wherein the sheet comprises an incision on each of two opposite lateral sides.

14. The method of claim 11, wherein the sheet is from about 5-20 cm by about 10-30 cm.

15. The method of claim 14, wherein the material is from about 10×15 cm or 20×30 cm.

16. The method of claim 8, wherein the material is generally conical, frustroconical, hemispherical, or teardrop shaped.

17. The method of claim 16, wherein the material shape is prefabricated.

18. The method of claim 8, wherein the material comprises fibers that absorb quickly and material that absorbs more slowly over time.

19. The method of claim 1, wherein the material forms complete or incomplete circumferential coverage of the breast tissue.

20. A synthetic or naturally occurring material for supporting tissue in a subject in need thereof, comprising a bioabsorbable material being configured such that it provides elevation, lifting and support of the tissue when implanted into the subject.

21. The material of claim 20, wherein the material comprises acellular dermal matrix, or a polymer material or silk material.

22. The material of claim 20, wherein the material is an absorbable biocompatible material or a permanent material.

23. The material of claim 20, wherein the material is TIGR® Matrix, AlloDerm®, Seri® Surgical Scaffold, or Phasix Mesh®.

24. The material of claim 20, wherein the material is shapeable into a 3-D structure for supporting tissue.

25. The material of claim 24, wherein the material is a sheet with 4 sides, wherein each of 2 opposite lateral sides contain an incision for sizing the material in the subject.

26. The material of claim 24, wherein the material is generally conical, frustroconical, hemispherical, or teardrop shaped.

27. The material of claim 26, wherein the material shape is prefabricated.

28. The material of claim 20, wherein the material is coated with one or more agents that promote collagen formation or cellular ingrowth.

29. A method of supporting, lifting and augmenting neck tissue in a subject comprising: a) contacting a flexible, non-silicone material with the tissue, the material being configured such that it forms supportive coverage of the tissue for elevation, lifting, augmentation and support of the tissue when attached; b) attaching the material to a lower position, the lower position being the platysma muscle of the neck; and c) stretching the material upward and attaching the material to an upper position, the upper position being the mastoid periosteum or sternocleidomastoid muscle or supportive structure of the face, thereby providing elevation, lifting, augmentation and support of the neck tissue.

30. A method of supporting, lifting and augmenting facial tissue in a subject comprising: a) contacting a flexible, non-silicone material with the tissue, the material being configured such that it forms supportive coverage of the tissue for elevation, lifting and support of the tissue when attached; b) attaching the material to a lower position, the lower position being facial subcutaneous fat or a lower portion of the superficial muscular aponeurotic system; and c) stretching the material upward and attaching the material to an upper position, the upper position being deep temporal fascia, orbital rim tissue, or an upper portion of the superficial muscular aponeurotic system, thereby providing elevation, lifting and support of the facial tissue.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0025] The various embodiments will be described in detail with reference to the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. References made to particular examples and implementations are for illustrative purposes, and are not intended to limit the scope of the invention or the claims.

[0026] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

[0027] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0028] The present invention provides a method and device for support of tissues post-surgery, including augmentation, lifting and shaping of tissue. The invention provides a non-silicon substrate material which is shaped to support tissue of a subject during the post-surgical recovery period.

[0029] The method of the invention may be adapted for supporting or augmenting the shape of tissue in a subject, such as breast, neck and facial tissue.

[0030] Generally, the method includes, contacting a flexible, non-silicone material with the tissue of the subject, wherein the material is configured such that it forms supportive coverage of the tissue for elevation, lifting and support of the tissue when attached. The material is then attached to a lower position and then stretched upward and attached at an upper position, thereby providing elevation, lifting, augmentation and support of the tissue.

[0031] With regard to supporting breast tissue, the material is attached to a position on the pectoral muscle below the breast (or lower breast tissue) and stretched upward and attach to a position on the pectoral muscle above the breast. It is also attached to the chest musculature medial and lateral to the breast mound providing a circumferential support for the breast mound. As to supporting neck tissue, the material is attached to a lower position, the lower position being the platysma muscle of the neck, and then stretched upward and attached to an upper position, the upper position being the mastoid periosteum or sternocleidomastoid muscle, or supportive structures of the face. As to supporting facial tissue, the material is attached to a lower position, the lower position being facial subcutaneous fat or a lower portion of the superficial muscular aponeurotic system, and then stretched upward and attached to an upper position, the upper position being deep temporal fascia, orbital rim tissue, or an upper portion of the superficial muscular aponeurotic system. In various embodiments, attachment may be via suture, bone screw or any method generally known in the art. The material may also be used in a single piece to support both the face and neck, attaching to the platysma of the neck and SMAS or facial fat below and stretching the material and fixing it above to the mastoid periosteum, and deep supporting structures of the face and neck.

[0032] The material may have a prefabricated shape or be custom shaped upon implantation. Generally, for the breast the material may be conical, frustroconical, hemispherical, or teardrop shaped. In one embodiment, the material is in the form of a sheet and shaped upon implantation by providing incisions in the sheet and folding the sheet to produce a 3D-structure configured to provide supportive coverage to tissue. For example, the sheet may include an incision on each of two opposite lateral sides of the sheet and folded and attached in a manner that produces a generally conical shape. For the face and neck, the material may be cut according to template shapes or custom trimmed to accommodate individual facial and neck contours and shapes.

[0033] The material may be composed from a variety of materials. In embodiments, the material may include acellular dermal matrix, or a polymer material, such as a mesh. The material may be an absorbable biocompatible material or a permanent material. Ideally materials include TIGR® Matrix, AlloDerm®, Seri® Surgical Scaffold, or Phasix Mesh®, Additionally, the material may be coated with one or more agents that promote collagen formation or ingrowth of cellular matrix in to the material.

[0034] It should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the scope of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0035] Although the present invention has been described with reference to specific details of certain embodiments thereof, it will be understood that modifications and variations are encompassed within the spirit and scope of the invention. Accordingly, the invention is limited only by the following claims.