Absorbable implants for plastic surgery

Patent metadata

Field	Value
Publication number	US-9532867-B2
Application number	US-201414329760-A
Country	US
Kind code	B2
Filing date	Jul 11, 2014
Priority date	Jul 11, 2013
Publication date	Jan 3, 2017
Grant date	Jan 3, 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 in-growth 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. An absorbable implant for plastic surgery procedures comprising a porous biodegradable polymeric scaffold formed into an anatomical shape, two-dimensional shape, three-dimensional shape, and/or asymmetric shapes, minimizing any buckling or bunching of the implant upon placement, with one or more of the following properties:
(a) the implant has a suture pullout strength (peak load (kg) at which the implant fails to retain a suture) of the absorbable implant is greater than 10 N;
(b) the scaffold can support a pressure of at least 0.1 kPa;
(c) the implant can withstand a load of at least 5 N;
(d) an average pore diameter of at least 10 μm;
(e) the implant is compliant and the bending stiffness of the scaffold is less than 100 gram cm (100 Taber Stiffness Units); and
(f) the scaffold cannot stretch more than 30% of its original length.

2. The implant of claim 1 , wherein the suture pullout strength of the absorbable implant is greater than 20 N.

3. The implant of claim 1 , wherein the implant can withstand a load of at least 15 N.

4. The implant of claim 1 , wherein the absorbable implant can withstand a load of at least 60 N.

5. The implant of claim 1 , the bending stiffness of the scaffold is less than 10 Taber Stiffness Units.

6. The implant of claim 1 , wherein the bending stiffness of the scaffold less than 1 Taber Stiffness Unit.

7. The implant of claim 1 , wherein the scaffold has two or more of the properties selected from the group consisting of the bending stiffness of the scaffold is less than 100 gram cm, the scaffold cannot stretch more than 30% of its original length, and the scaffold can withstand a load of at least 5 N, wherein the suture pullout strength of the absorbable implant is greater than 10 N, and more preferably greater than 20 N.

8. The implant of claim 1 , which, when implanted is infiltrated with the host's cells and undergoes a controlled resorption such that the implant is replaced with regenerated host tissue.

9. The implant of claim 8 , wherein the regenerated host tissue can support a load of at least 5 N after 78 weeks in vivo.

10. The implant of claim 8 , wherein the implant retains at least 20% of its initial burst pressure 12 weeks after implantation.

11. The implant of claim 8 , wherein the implant after implantation and infiltration of host tissue can withstand a pressure of at least 0.1 kPa.

12. The implant of claim 1 , wherein the implant further comprises one or more bioactive agents.

13. The implant of claim 1 , wherein the implant further comprises one or more coatings, additives or therapeutic, prophylactic or diagnostic agents.

14. The implant of claim 1 , wherein the implant can be stretched up to 30% in one or more directions to place tension on the host tissue.

15. The implant of claim 1 , wherein the implant is designed to contour to the host's tissue without forming wrinkles or bunching.

16. The implant of claim 1 , wherein the implant does not interfere with radiographic imaging.

17. The implant of claim 1 , wherein the implant has been sterilized by ethylene oxide, electron beam, or gamma-irradiation.

18. The implant of claim 1 , wherein the implant is deployed into an anatomical shape after implantation.

19. The implant of claim 18 , wherein the implant comprises seam lines or is embossed to help the implant conform to an anatomical shape.

20. The implant of claim 1 , wherein the implant is used in facial plastic surgery procedures.

21. The implant of claim 1 , wherein the scaffold is formed from a mesh, non-woven, woven, film, laminate, electrospun fabric, foam, thermoform, or combinations thereof.

22. The implant of claim 21 , wherein the scaffold comprises a monofilament mesh.

23. The implant of claim 1 , wherein the scaffold comprises poly-4-hydroxybutyrate or copolymer thereof.

24. The implant of claim 1 , wherein the scaffold comprises a polymer containing one or more of the following monomers: glycolic acid, glycolide, lactic acid, lactide, 1,4-dioxanone, trimethylene carbonate, 3-hydroxybutyric acid, or ε-caprolactone, or comprises silk.

25. The implant of claim 1 , wherein the implant has been manufactured by one or more processes selected from the group consisting of particular leaching, phase separation, film formation, thermal forming, thermal or solution bonding of fibers, entanglement of staple fibers, solution spinning, weaving, knitting, three-dimensional printing, and cutting using scissors, blades, thermal knives, or lasers.

26. A method of manufacturing the implant of claim 1 , using one or more processes selected from the group consisting of particular leaching, phase separation, film formation, thermal or solution bonding of fibers, entanglement of staple fibers, solution spinning, melt extrusion, weaving, knitting, three-dimensional printing, and cutting using scissors, blades, thermal knives, or lasers.

27. A method of forming a scaffold for making the implant of claim 1 , the method comprising the steps of:
providing a split metal form consisting of an inwardly curving half and a mating outwardly curving half wherein there is a semicircular groove in the outlying border of the inwardly curving half;
placing a filament, thread, strand, string, fiber, yarn, wire, film, tape, tube, fabric, felt, mesh, multifilament, or monofilament in the semicircular groove so that it forms a ring around the outlying border of the inwardly curving half;
draping a polymeric material over the inwardly curving half of the metal form;
placing the mating outwardly curving half of the metal form over the polymeric material,
clamping the two halves of the split metal form together to form a block; heating the block;
cooling the block;
disassembling and removing the polymeric shape from the block, and
trimming the outlying border of the compressed extrudate.

28. The method of claim 27 , wherein the semicircular groove is in the outlying border of the outwardly curving half of the metal form instead of the inwardly curving half, and a filament, thread, strand, string, fiber, yarn, wire, film, tape, tube, fabric, felt, mesh, multifilament, or monofilament is placed in the groove on the outwardly curving half of the metal form.

29. The method of claim 27 , wherein the scaffold is a monofilament mesh.

30. The method of claim 29 , wherein the monofilament mesh comprises poly-4-hydroxybutyrate or copolymer thereof, and a monofilament extrudate of poly-4-hydoxybutyrate or copolymer is used to reinforce the outlying border.

31. The method of claim 30 , wherein the block is heated using hot water at 56° C. for 5 minutes, and cooled by placing in a water bath at ambient temperature.

32. A method of implanting the implant of claim 1 comprising delivering the implant by a minimally invasive technique.

33. The method of claim 32 ,
wherein the implant is delivered using a crescent, donut, lollipop, or anchor mastopexy procedure.

34. The method of claim 32 ,
wherein the implant is temporarily deformed, and delivered using an inserter device into a dissected tissue plane.

35. The method of claim 32 wherein the implant is delivered using an inserter device through an IMF incision.

36. An absorbable implant for plastic surgery procedu

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

• A61F2210/0066

  shrinkable · CPC title

• B29L2031/7532

  Artificial members, protheses · CPC title

• B29C48/25

  Component parts, details or accessories; Auxiliary operations · CPC title

• A61F2/0063 Primary

  Implantable repair or support meshes, e.g. hernia meshes · CPC title