Body augmentation device

Patent metadata

Field	Value
Publication number	US-10022475-B2
Application number	US-201715409544-A
Country	US
Kind code	B2
Filing date	Jan 19, 2017
Priority date	May 1, 2014
Publication date	Jul 17, 2018
Grant date	Jul 17, 2018

Abstract

Systems and methods are disclosed for body augmentation by mixing hyaluronic acid (HA) with polyvinyl alcohol (PVA) to form an HA-PVA hydrogel; and exposing the HA-PVA hydrogel to one or more freeze-thaw cycles or to an amount of radiation effective to crosslink the HA to the PVA to crosslink the HA to the PVA.

First claim

What is claimed is:

1. A method for body augmentation, comprising:
storing a non-toxic biocompatible material;
storing a biocompatible polymer having a multi-phase mixture with a predetermined controlled release of selected pharmaceutical substance to modulate soft tissue response to the polymer;
mixing the biocompatible material and polymer to cross-link the mixture by exposing HA-PVA (hyaluronic acid-polyvinyl alcohol) hydrogel to an amount of ionizing radiation providing a radiation dose effective to crosslink the HA to the PVA and providing a mask; and
augmenting soft tissue with the cross-linked mixture.

2. The method of claim 1 , wherein the polymer comprises one of: hyaluronic acid, polyvinyl alcohol, collagens, PEG, hyaluronic acids, celluloses, proteins, saccharides, biodegradable and bioresorbable biocompatible materials.

3. The method of claim 1 , comprising mixing an anti-inflammatory compound or an antiproliferative compound.

4. The method of claim 1 , comprising injecting the cross-linked mixture directly into breast tissue or into a breast implant to augment the soft tissue.

5. A method of making a cross-linked hydrogel comprising:
storing a biocompatible material and storing a biocompatible polymer having a multi-phase mixture with a predetermined controlled release of selected pharmaceutical substance to modulate soft tissue response to the polymer;
mixing hyaluronic acid (HA) with polyvinyl alcohol (PVA) to form an HA-PVA (hyaluronic acid-polyvinyl alcohol) hydrogel; and
exposing the HA-PVA hydrogel to an amount of energy effective to crosslink the HA and the PVA and to sterilize the container content.

6. The method of claim 1 , wherein the exposing comprises performing one or more freeze-thaw cycles to HA-PVA (hyaluronic acid-polyvinyl alcohol) hydrogel.

7. The method of claim 1 , comprising performing one or more freeze-thaw cycles to HA-PVA (hyaluronic acid-polyvinyl alcohol) hydrogel and then autoclaving the HA-PVA hydrogel.

8. The method of claim 1 , comprising first autoclaving the HA-PV hydrogel and then performing one or more freeze-thaw cycles to HA-PVA hydrogel.

9. The method of claim 1 , comprising exposing the HA-PVA hydrogel to sterilize the container content.

10. The method of claim 9 , comprising exposing the irradiated HA-PVA hydrogel to a temperature above the melting point of a PVA crystalline phase to produce a cross-linked hydrogel.

11. The method of claim 9 , wherein the ionizing radiation is X-ray, e-beam, gamma radiation or beta particles.

12. The method of claim 1 , comprising providing an irradiation mask, a step mask, or a gradient mask.

13. The method of claim 9 , comprising performing at least one freeze-thaw cycle to the HA-PVA hydrogel.

14. The method of claim 1 , comprising mixing a slow release anti-inflammatory agent to the HA-PVA hydrogel.

15. The method of claim 1 , comprising:
dissolving the HA-PVA hydrogel in a solvent;
heating the HA-PVA hydrogel to a temperature elevated above the melting point of the PVA and inducing gelation of vinyl polymer at a rate to form crystalline physical associations in the HA-PVA hydrogel;
exposing the physically associated vinyl polymer hydrogel to a dose of radiation effective to produce covalent crosslinks; and
autoclaving the HA-PVA hydrogel to remove physical associations and forming a covalently cross-linked HA-PVA hydrogel.

16. A method, comprising
storing a non-toxic biocompatible material and a biocompatible polymer having a multi-phase mixture with a predetermined controlled release of selected pharmaceutical substance to modulate soft tissue response to the polymer;
mixing the biocompatible material and polymer to cross-link the mixture;
forming a biocompatible cross-linked polymer having an interpenetrating polymer network (IPN) including:
cross-linking a heteropolysaccharide to form a single cross-linked material; and
performing one or more additional cross-linkings on the single cross-linked material to form a multiple cross-linked material,
wherein the multiple cross-linked material has one or more IPN regions resisting biodegradation in a human body than the single cross-linked material and one or more single cross-linked extensions radiating out from the IPN, wherein the combination of the IPN and the extension provide one or more of: biodegradation resistance, soft touch feeling, ease of insertion into the human body and augmenting soft tissue with the cross-linked mixture.

17. The method of claim 1 , comprising dispensing ciproflaxin uniformly throughout the HA-PVA hydrogel.

18. The method of claim 1 , wherein the mixing comprises adding one or more of: an anesthetics, a lidocaine, a compound to reduce or eliminate acute inflammatory reactions, and a composition selected from the group consisting of steroids, corticosteroids, dexamethasone, triamcinolone.

19. The method of claim 16 , comprising:
mixing hyaluronic acid (HA) with polyvinyl alcohol (PVA) to form an HA-PVA hydrogel; and
exposing the HA-PVA hydrogel to one or more freeze-thaw cycles or to an amount of radiation effective to crosslink the HA to the PVA.

20. The method of claim 19 , wherein the radiation comprises X-ray, e-beam, gamma radiation or beta particles.

Assignees

• Nguyen Phi
• Phan Loc
• Tran Bao
• Nguyen Thuan
• Bui Duy

Inventors

• Nguyen Phi
• Phan Loc
• Tran Bao
• Nguyen Thuan
• Bui Duy

Classifications

• A61L2430/04

  for mammary reconstruction · CPC title

• A61M5/31596

  comprising means for injection of two or more media, e.g. by mixing · CPC title

• A61L27/16

  obtained by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• C08J3/28

  Treatment by wave energy or particle radiation · CPC title

• A61F2/12

  Mammary prostheses · CPC title