Fluidic Tissue Augmentation Compositions and Methods

• US 20070212385A1
• Filed: 03/13/2006
• Published: 09/13/2007
• Est. Priority Date: 03/13/2006
• Status: Abandoned Application

• Current Assignee: Kythera Biopharmaceuticals, Inc. (Abbvie Incorporated)
• Original Assignee: Kythera Biopharmaceuticals, Inc. (Abbvie Incorporated)
• Inventors: David, Nathaniel
• Application Number:
  US11/276,759
• Publication Number:
  US 20070212385A1
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61K 2800/81 Preparation or application process involves irradiation
• CPC Class Codes: A61K 2800/91 Injection
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 8/02 characterised by special physical form
• CPC Class Codes: A61K 8/042 Gels
• CPC Class Codes: A61K 8/65 Collagen; Gelatin; Keratin; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/735 Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61N 2005/0661 : ultraviolet
• CPC Class Codes: A61N 2005/0663 : Coloured light
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61P 19/04 : for non-specific disorders of the connective tissue
• CPC Class Codes: A61Q 19/08 : Anti-ageing preparations

Abstract

Compositions and method for augmenting tissue after delivery to localized area. The compositions include a hydrogel and a dermal filler. The hydrogel can polymerize and/or crosslink upon a first trigger event. The dermal filler can also optionally crosslink upon a second trigger event.

Claims

1. An injectable tissue augmentation composition comprising:

a) at least one fluidic biocompatible moiety capable of selective solidifying upon suitable conditions at physiological conditions;

b) at least one different fluidic biocompatible moiety optionally capable of selective solidifying upon suitable conditions at physiological conditions, wherein if the different fluidic biocompatible moiety of subpart b) is capable of said selective solidifying, it is incapable of selective solidifying under conditions suitable for selective solidifying of the moiety in subpart a)

2. The injectable tissue augmentation composition of claim 1 where the fluidic biocompatible moiety of subpart a) selectively solidifies in the presence of light.

3. The injectable tissue augmentation composition of claim 1 wherein the fluidic biocompatible moiety of subpart a) is a hydrogel forming moiety.

4. The injectable tissue augmentation composition of claim 1 wherein the hydrogel forming moiety is derivatized to selectively solidify in the presence of a light wavelength which substantially penetrates mammalian skin below the epidermis;

and, the fluidic biocompatible moiety incapable of subpart b) is substantially incapable of selective solidifying in the presence of a light wavelength which penetrates human skin.

5. The injectable tissue augmentation composition of claim 1 wherein the hydrogel forming moiety is selectively degradable in situ.

6. The injectable tissue augmentation composition of claim 1 wherein

the fluidic biocompatible moiety of subpart a) is a hydrogel forming moiety capable of photoinitiated solidifying under physiological conditions, further capable of selective degradation in situ;

and,

The biocompatible moiety of subpart b) is selected from among a polyamino acid containing moiety, a polysaccharide moiety, and a glycoprotein moiety.

7. An injectable tissue augmentation composition comprising:

(a) a hydrogel forming moiety

(i) capable of selective solidifying under physiologic conditions in the presence of a wavelength of light capable of penetrating through human skin of a thickness of between about 1-2 mm, optionally in the presence of a plastic mold; and

,

(ii) is selectively degradable in situ; and

(b) a second moiety selected from among a collagen or collagen-derivative containing moiety;

a hyaluronic acid or hyaluronic acid derivative containing moiety, a chondroitin or chondroitin derivative containing moiety.

8. A photofiller consisting essentially of a hydrogel and a hyaluronic acid containing dermal filler.

9. A kit comprising

(a) a first prefilled syringe containing a photopolymerizing hydrogel forming moiety;

and

(b) a second prefilled syringe containing a dermal filler,

and optionally a transparent mold wherein the concavity in the mold is in the shape of a body part.

10. A kit of claim 9 wherein the dermal filler contains hyaluronic acid.

11. A method for augmenting tissue in a predetermined shape comprising

(a) applying a moldable tissue augmentation composition to the tissue for which augmentation is desired;

(b) either prior to or in conjunction with step a), applying a mold to the skin covering the tissue for which augmentation is desired, wherein the concavity of the mold is in a predetermined shape so that the tissue augmentation material; and

,

(c) after applying the tissue augmentation composition, increasing the solidity of the tissue augmentation material so that it is no longer moldable and holds the shape of concavity of the externally applied mold.

12. A method of claim 11 wherein the moldable tissue augmentation material is comprised of a hydrogel and a hyaluronic acid composition and a light source is used to increase the solidity.

13. A method of claim 11 wherein the mold is prepared using a computer program capable of transmitting three dimensional coordinates of the predetermined shape to an device which prepares a tangible mold reflecting the three dimension coordinates.

14. A method for altering the shape of a nose bridge comprising to a predetermined shape comprising applying a moldable tissue augmentation composition to the nose bridge in the presence of a mold of the predetermined shape, and increasing the solidity of the tissue augmentation composition so applied so that it is no longer substantially moldable and the tissue augmentation so applied maintains the shape of the concavity of the mold.

15. A method for facial sculpting comprising

(a) predetermining the final shape of the sculpted face by using digital three dimensional information to prepare a mold having a concavity of the precise dimensions of the final sculpted face;

(b) using the mold so prepared as a guide, inject tissue augmentation material capable of increasing in solidity with appropriate conditions in situ under physiologic conditions to form the shape of the mold;

(c) applying conditions to increase the solidity of the tissue augmentation material so that it maintains the shape of the mold concavity.

16. A method of claim 15 wherein the tissue augmentation material is a hydrogel forming composition capable of controllable degradation.

17. A method of claim 16 wherein the tissue augmentation material also contains hyaluronic acid or a derivative thereof.