Body augmentation device

Patent metadata

Field	Value
Publication number	US-2017232148-A1
Application number	US-201715409544-A
Country	US
Kind code	A1
Filing date	Jan 19, 2017
Priority date	May 1, 2014
Publication date	Aug 17, 2017
Grant date	—

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; and augmenting soft tissue with the cross-linked mixture.

2 . The method of claim 1 , wherein the polymer comprises one of: halyuronic 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:
mixing hyaluronic acid (HA) with polyvinyl alcohol (PVA) to form an HA-PVA 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 the HA-PVA hydrogel.

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

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

9 . The method of claim 1 , comprising exposing the HA-PVA hydrogel to an amount of ionizing radiation providing a radiation dose effective to crosslink the HA to the PVA and 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 9 , 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 . The method of claim 1 , comprising 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.

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 . A method of making a cross-linked hydrogel 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 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
• Miba Medical Inc

Inventors

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

Classifications

• A61L2400/06

  Flowable or injectable implant compositions · CPC title

• A61L27/16

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

• A61L2430/04

  for mammary reconstruction · CPC title

• A61M5/31596

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

• C08J2405/08

  Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof · CPC title