Fluidic Tissue Augmentation Compositions and Methods

• US 20080038306A1
• Filed: 03/12/2007
• Published: 02/14/2008
• Est. Priority Date: 03/13/2006
• Status: Abandoned Application

• Current Assignee: Kythera Biopharmaceuticals, Inc. (Abbvie Incorporated), Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: David, Nathaniel
• Application Number:
  US11/685,094
• Publication Number:
  US 20080038306A1
• 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. A kit comprising

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

and

(b) a second prefilled syringe containing at least one dermal filler, and optionally a transparent mold wherein the inner surface of the mold is in the shape of a body part.

2. The kit of claim 1 wherein the at least one photopolymerizing hydrogel forming moiety is selected from the group consisting poly(lactic acid) (PLA), poly(glycolic acid) (PGA), and their copolymers, poly(lactic-co-glycolic acid) (PLGA), Polyethylene glycol diacrylate (PEG-DA), poly(ethylene oxide) (PEO), Pluronic, (PEO-PPO-PEO), poly(ethylene oxide)diacrylate (PEODA), polyalkylene oxides, polyethylene glycols, polyethylene oxides, partially or fully hydrolyzed polyvinylalcohols, poly(vinylpyrrolidone), poly(t-ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide) block copolymers (poloxamers and meroxapols), propylene glycol, trimethylene glycols, mono-, di- and tri-polyoxyethylated glycerol, mono- and di-polyoxy-ethylated propylene glycol, and mono- and di-polyoxyethylated trimethylene glycol;

polyoxyethylated sorbitol, polyoxyethylated glucose;

polyacrylic acid, polymethacrylic acid, poly(hydroxyethylmethacrylate), poly(hydroxyethylacrylate), poly(methylalkylsulfoxide methacrylate), poly(methylalkylsulfoxide acrylate), polymaleic acid;

polyacrylamide, poly(methacrylamide), poly(dimethylacrylamide), poly(N-isopropyl-acrylamide);

poly(olefinic alcohol), poly(N-vinyl lactams), poly(N-vinyl caprolactam), polyethylene glycol/poly(N-isopropylacrylamide);

polyoxazolines, poly(methyloxazoline), poly(ethyloxazoline), polyvinylamines, polyacrylamide (PAA), poloxamines, carboxymethyl cellulose, and hydroxyalkylated celluloses.

3. The kit of claim 2 wherein the at least one photopolymerizing hydrogel forming moiety comprises polyethylene glycol derivatized with diacrylate.

4. The kit of claim 1 wherein the at least one dermal filler is selected from the group consisting of collagens, hyaluronic acid, elastins, laminins, fibronectins, chondroitin sulfate, keratin sulfate, hyaluronic acid, heparan sulfate, chondroitin sulfate, amylose, maltodextrin, amylopectin, starch, dextran, heparin, dermatan sulfate, dextran sulfate, pentosan polysulfate, and chitosan.

5. The kit of claim 4 wherein the at least one dermal filler comprises hyaluronic acid.

6. The kit of claim 1 further comprising an initiator of crosslinking.

7. The kit of claim 6 wherein the initiator is eosin.

8. The kit of claim 1 wherein the at least one photopolymerizing 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 at least one dermal filler is substantially incapable of selective solidifying in the presence of a light wavelength which penetrates human skin.

9. The kit of claim 1 wherein the at least one photopolymerizing hydrogel forming moiety is selectively degradable in situ.

10. The kit of claim 1 wherein the mold is pre-prepared using a computer program capable of transmitting three dimensional coordinates of the predetermined shape to a device which prepares a tangible mold reflecting the three dimensional coordinates.

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

(a) injecting a moldable tissue augmentation composition into the tissue for which augmentation is desired;

(b) applying a mold externally to skin covering the tissue for which augmentation is desired, wherein an inner concave surface of the mold is in a predetermined shape wherein applying the tissue augmentation composition will bring the skin into contact with the inner concave surface of the mold; and

,

(c) increasing the solidity of the tissue augmentation material whereby the tissue augmentation material holds the shape of the inner concave surface of the externally applied mold.

12. The method of claim 11 wherein the moldable tissue augmentation material comprises a hydrogel and a dermal filler.

13. The method of claim 11 wherein the dermal filler is chosen from the group consisting of collagens, hyaluronic acid, elastins, laminins, fibronectins, chondroitin sulfate, keratin sulfate, hyaluronic acid, heparan sulfate, chondroitin sulfate, amylose, maltodextrin, amylopectin, starch, dextran, heparin, dermatan sulfate, dextran sulfate, pentosan polysulfate, and chitosan.

14. The method of claim 13 wherein the dermal filler is hyaluronic acid.

15. The method of claim 11 wherein the wherein the hydrogel is selected from the group consisting of poly(lactic acid) (PLA), poly(glycolic acid) (PGA), and their copolymers, poly(lactic-co-glycolic acid) (PLGA), Polyethylene glycol diacrylate (PEG-DA), poly(ethylene oxide) (PEO), Pluronic, (PEO-PPO-PEO), poly(ethylene oxide)diacrylate (PEODA), polyalkylene oxides, polyethylene glycols, polyethylene oxides, partially or fully hydrolyzed polyvinylalcohols, poly(vinylpyrrolidone), poly(t-ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide) block copolymers (poloxamers and meroxapols), propylene glycol, trimethylene glycols, mono-, di- and tri-polyoxyethylated glycerol, mono- and di-polyoxy-ethylated propylene glycol, and mono- and di-polyoxyethylated trimethylene glycol;

polyoxyethylated sorbitol, polyoxyethylated glucose, polyacrylic acid, polymethacrylic acid, poly(hydroxyethylmethacrylate), poly(hydroxyethylacrylate), poly(methylalkylsulfoxide methacrylate), poly(methylalkylsulfoxide acrylate), polymaleic acid, polyacrylamide, poly(methacrylamide), poly(dimethylacrylamide), poly(N-isopropyl-acrylamide), poly(olefinic alcohol), poly(N-vinyl lactams), poly(N-vinyl caprolactam), polyethylene glycol/poly(N-isopropylacrylamide);

polyoxazolines, poly(methyloxazoline), poly(ethyloxazoline), polyvinylamines, polyacrylamide (PAA), poloxamines, carboxymethyl cellulose, and hydroxyalkylated celluloses.

16. The method of claim 15 wherein the hydrogel is polyethylene glycol diacrylate.

17. The method of claim 11 wherein the increasing the solidity of the tissue augmentation material is initiated by a light source

18. The method of claim 17 wherein the light source has a wavelength of 400-550 nm.

19. The method of claim 17 wherein the initiation by a light source is performed transdermally.

20. The method of claim 17 wherein the initiation by a light source is performed subdermally.

21. The method of claim 11 wherein the mold is pre-prepared using a computer program capable of transmitting three dimensional coordinates of the predetermined shape to a device which prepares a tangible mold reflecting the three dimensional coordinates.

22. The method of claim 11 wherein the applying of the mold to the skin is performed before applying the moldable tissue augmentation material.

23. The method of claim 11 wherein the applying of the mold to the skin is performed at the same time as applying the moldable tissue augmentation material.

24. 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 an inner surface comprising the precise dimensions of the final sculpted face;

(b) injecting tissue augmentation material capable of increasing in solidity in situ upon physiologically compatible initiation using the mold as a guide to form the shape of sculpted face; and

(c) applying the physiologically compatible initiation to increase the solidity of the tissue augmentation material to maintain the shape of the inner surface of the mold.

25. The method of claim 24 wherein the tissue augmentation material comprises a hydrogel and a dermal filler.

26. The method of claim 25 wherein the dermal filler is chosen from the group consisting of collagens, hyaluronic acid, elastins, laminins, fibronectins, chondroitin sulfate, keratin sulfate, hyaluronic acid, heparan sulfate, chondroitin sulfate, amylose, maltodextrin, amylopectin, starch, dextran, heparin, dermatan sulfate, dextran sulfate, pentosan polysulfate, and chitosan.

27. The method of claim 25 wherein the wherein the hydrogel is selected from the group consisting of poly(lactic acid) (PLA), poly(glycolic acid) (PGA), and their copolymers, poly(lactic-co-glycolic acid) (PLGA), Polyethylene glycol diacrylate (PEG-DA), poly(ethylene oxide) (PEO), Pluronic, (PEO-PPO-PEO), poly(ethylene oxide)diacrylate (PEODA), polyalkylene oxides, polyethylene glycols, polyethylene oxides, partially or fully hydrolyzed polyvinylalcohols, poly(vinylpyrrolidone), poly(t-ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide) block copolymers (poloxamers and meroxapols), propylene glycol, trimethylene glycols, mono-, di- and tri-polyoxyethylated glycerol, mono- and di-polyoxy-ethylated propylene glycol, and mono- and di-polyoxyethylated trimethylene glycol;

polyoxyethylated sorbitol, polyoxyethylated glucose, polyacrylic acid, polymethacrylic acid, poly(hydroxyethylmethacrylate), poly(hydroxyethylacrylate), poly(methylalkylsulfoxide methacrylate), poly(methylalkylsulfoxide acrylate), polymaleic acid, polyacrylamide, poly(methacrylamide), poly(dimethylacrylamide), poly(N-isopropyl-acrylamide);

poly(olefinic alcohol), poly(N-vinyl lactams), poly(N-vinyl caprolactam), polyethylene glycol/poly(N-isopropylacrylamide), polyoxazolines, poly(methyloxazoline), poly(ethyloxazoline), polyvinylamines, polyacrylamide (PAA), poloxamines, carboxymethyl cellulose, and hydroxyalkylated celluloses.

28. The method of claim 25 wherein the tissue augmentation material comprises polyethylene glycol diacrylate and hyaluronic acid.

29. The method of claim 24 wherein the physiologically compatible initiation is light.

30. The method of claim 29 wherein the light has a wavelength of 400-550 nm.

31. The method of claim 29 wherein the light is applied transdermally.

32. The method of claim 29 wherein the light is applied subdermally.

33. The method of claim 24 wherein the mold is pre-prepared using a computer program capable of transmitting three dimensional coordinates of the predetermined shape to a device which prepares a tangible mold reflecting the three dimensional coordinates.

34. The method of claim 24 wherein the applying of the mold to the skin is performed before applying the moldable tissue augmentation material.

35. The method of claim 24 wherein the applying of the mold to the skin is performed at the same time as applying the moldable tissue augmentation material.