Absorbable implants for plastic surgery

Patent metadata

Field	Value
Publication number	US-9636211-B2
Application number	US-201514813454-A
Country	US
Kind code	B2
Filing date	Jul 30, 2015
Priority date	Jul 11, 2013
Publication date	May 2, 2017
Grant date	May 2, 2017

Abstract

Absorbable implants for breast surgery that conform to the breast parenchyma and surrounding chest wall have been developed. These implants support newly lifted breast parenchyma, and/or a breast implant. The implants have mechanical properties sufficient to support a reconstructed breast, and allow the ingrowth of tissue into the implant as it degrades. The implants have a strength retention profile allowing the support of the breast to be transitioned from the implant to regenerated host tissue, without significant loss of support. Three-dimensional implants for use in minimally invasive mastopexy/breast reconstruction procedures are also described, that confer shape to a patient's breast. These implants are self-reinforced, can be temporarily deformed, implanted in a suitably dissected tissue plane, and resume their preformed three-dimensional shape. The implants are preferably made from poly-4-hydroxybutyrate (P4HB) and copolymers thereof. The implants have suture pullout strengths that can resist the mechanical loads exerted on the reconstructed breast.

First claim

We claim:

1. A breast implant with a first three dimensional shape conforming to the breast of a patient in a lifted position to match a contour of the lower pole of the patient's breast, and avoid covering the nipple-areolar complex (NAC) and the upper pole of the patient's breast,
the implant comprising:
a thin flexible mesh; and
a reinforced outlying border element along the perimeter of the mesh,
wherein the implant is deformable for implantation and resumes its first three dimensional shape following implantation.

2. The breast implant of claim 1 wherein the outlying border is a continuous ring.

3. The breast implant of claim 1 wherein its first three dimensional shape is one of a partial dome and canoe-like shape.

4. The breast implant of claim 1 wherein each material of the mesh and/or outlying border is absorbable.

5. The breast implant of claim 1 wherein the implant has an inwardly curving interior.

6. The breast implant of claim 1 wherein the implant has a length ranging from 12-24 cm.

7. The breast implant of claim 1 further comprising a plurality of tabs radially extending from the body of the implant.

8. The breast implant of claim 7 wherein at least one of the tabs has a width ranging from 1 to 2 cm respectively.

9. The breast implant of claim 7 wherein the plurality of tabs comprises at least three tabs extending from an edge of the body.

10. The breast implant of claim 7 comprising rounded corners.

11. The breast implant of claim 7 further comprising a plurality of sutures extending through the tabs and for securing the tabs to supportive tissue, causing the breast to be secured in the lifted position.

12. The breast implant of claim 1 wherein the tabs extend from sides of the body.

13. The breast implant of claim 1 comprising a height 0.5 to 2 cm less than a nipple to inframammary fold distance after mastopexy.

14. The breast implant of claim 1 having a height ranging from 5 to 10 cm.

15. The breast implant of claim 1 comprising a width 1 to 2 cm less than a width of the patient's breast after mastopexy.

16. The breast implant of claim 1 wherein the mesh comprises poly-4-hydroxybutryate.

17. The breast implant of claim 1 wherein the mesh comprises a silk-based material.

18. The breast implant of claim 1 wherein the mesh comprises a blend of polymers.

19. An implant for securing a breast of a patient in a lifted position having a three dimensional shape conforming to the contour of the lower pole of the patient's breast, without covering the nipple-areolar complex (NAC) and the upper pole of the patient's breast,
the implant comprising a thin planar body having a thin flexible support structure and a reinforced outlying border, wherein the implant can be temporarily deformed and resume the three dimensional shape.

20. The implant of claim 19 wherein the implant is absorbable.

21. The implant of claim 19 wherein the implant does not stretch more than 30% of its original length.

22. The implant of claim 19 wherein the implant has a suture pullout strength greater than 10 N.

23. The implant of claim 19 wherein the implant supports a pressure of at least 0.1 kPa.

24. The implant of claim 19 wherein the implant can withstand a load of at least 5 N.

25. The implant of claim 19 wherein the bending stiffness of the is less than 100 gram cm (100 Taber Stiffness Units).

26. The implant of claim 19 wherein the implant has an areal density of 5 to 800 g/m 2 .

27. The implant of claim 19 wherein the implant can be rolled into a cylindrical shape and resume the three dimensional shape unaided.

28. The implant of claim 19 further comprising at least one tab.

29. The implant of claim 19 wherein the thin planar body comprises a knitted mesh, fabric, woven construct, non-woven construct, braided construct, porous scaffold, porous film, laminate, nanospun, electrospun, or melt-blown construct.

30. The implant of claim 19 further comprising at least one retainer.

31. The implant of claim 19 wherein the body is adapted to promote tissue ingrowth and absorption.

32. The implant of claim 31 wherein the body comprises pores having pore diameters equal to or greater than 50 microns.

33. The implant of claim 31 wherein the body has a strength retention time greater than one month.

34. The implant of claim 33 wherein the body has a strength retention time of up to one year.

Assignees

• Tepha Inc

Inventors

• Felix Fabio
• Fosco Antonio
• Martin David P
• Moses Arikha
• Van Natta Bruce
• Rizk Said
• Williams Simon F

Classifications

• D04H1/728

  by electro-spinning {(electro-spinning methods and apparatus D01D5/0007)} · CPC title

• B29L2031/7532

  Artificial members, protheses · CPC title

• A61L27/58

  Materials at least partially resorbable by the body · CPC title

• A61F2210/0061

  swellable · CPC title

• A61L27/56

  Porous materials, {e.g. foams or sponges} · CPC title