IMPLANTABLE TISSUE COMPOSITIONS AND METHOD

• US 20110177150A1
• Filed: 03/29/2011
• Published: 07/21/2011
• Est. Priority Date: 08/26/2004
• Status: Abandoned Application

• Current Assignee: Pathak Holdings, LLC
• Original Assignee: Pathak Holdings, LLC
• Inventors: Thigle, Sanjav M., Pathak, Chandraskekhar P.
• Application Number:
  US13/075,039
• Publication Number:
  US 20110177150A1
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/3612 Cartilage, synovial fluid
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3633 : Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3641 : characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3683 : subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3687 : characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/38 : containing added animal cells organs or tissue containing native cells A61L27/36
• 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: A61P 21/02 : Muscle relaxants, e.g. for tetanus or cramps
• CPC Class Codes: A61P 25/04 : Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/24 : Antidepressants
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/00 : Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Novel implantable tissue fixation methods and compositions are disclosed. Methods and compositions of tissue, fixed using polymeric and/or variable length crosslinks, and di- or polymercapto compounds are described. Also described are the methods and compositions wherein the tissue is fixed using biodegradable crosslinkers. Methods and compositions for making radio-opaque tissue are also described. Methods and compositions to obtain a degradable implantable tissue-synthetic biodegradable polymer composite are also described. Compositions and methods of incorporating substantially water-insoluble bioactive compounds in the implantable tissue are also disclosed. The use of membrane-like implantable tissue to make an implantable drug delivery patch are also disclosed. Also described are the compositions and methods to obtain a coated implantable tissue. Medical applications implantable tissue such as heart valve bioprosthesis, vascular grafts, meniscus implant, drug delivery patch are also disclosed.

Claims

1. A bioprosthetic article comprising an implantable tissue coated with a composition selected from a group consisting of covalently crosslinked hydrogel and non-polymeric coating materials.

2. The article of claim 1 wherein the implantable tissue, before coating, is chosen from the group consisting of decellularized tissue, chemically modified tissue, and crosslinked tissue.

3. The article of claim 2 wherein the crosslinked tissue is obtained by a process chosen from the group consisting of glutaraldehyde crosslinking, ethyl-3-(3-dimethylaminopropyl carbodiimide (EDC) crosslinking, dye mediated photooxidation crosslinking, and hexamethylene diisocyanate crosslinking.

4. The article of claim 1 wherein the hydrogel comprises polymers formed on the tissue by condensation polymerization.

5. The article of claim 1 wherein the hydrogel comprises a reaction product of reactive precursor species that comprise nucleophilic functional groups and reactive precursor species that comprise electrophilic functional groups.

6. The article of claim 1 wherein the hydrogel comprises polymers formed on the tissue by free radical polymerization.

7. The article of claim 6 wherein the hydrogel comprises a polymer polymerized from a monomer chosen from the group consisting of acrylates, methacrylates, acrylamides, methacrylamide vinyl ethers, and n-vinyl pyrrolidinone.

8. The article of claim 1 wherein the hydrogel is biodegradable.

9. The article of claim 8 wherein the hydrogel comprises a polymer polymerized from a monomer chosen from the group consisting of lactide, glycolide, and caprolactone.

10. The article of claim 1 wherein the hydrogel is formed by crosslinking and polymerization of polyethylene glycol based water soluble macromonomers.

11. The article of claim 1 wherein the tissue is has two opposing sides joined by a thickness, with the coating being on each of the two opposing sides.

12. The article of claim 1 wherein the coating has a thickness of between about 5 micron to about 2 nm thick.

13. The article of claim 1 wherein the tissue comprises bovine pericardium, porcine pericardium, equine pericardium, porcine submucosa arterial tissue, vein tissue, ureter tissue, corneal tissue, an aortic root, meniscus tissue, ligaments, basal membrane, bladder tissue, tendons, cartilage, heart valve tissue, demineralized bone, placenta, umbilical cord tissue, skin tissue, cadaver tissue, and dura mater.

14. The article of claim 1 further comprising a drug for release after implantation.

15. The article of claim 14 wherein a drug is selected from the group consisting of antiviral agents;

antiinfectives, antibiotics;

antipruritics;

antipsychotics;

cholesterol- or lipid-reducing agents;

cell cycle inhibitors;

anticancer agents;

antiparkinsonism drugs;

HMG-CoA inhibitors;

antirestenosis agents;

antiinflammatory agents;

antiasthmatic agents;

anthelmintic;

immunosuppressives;

muscle relaxants;

antidiuretic agents;

vasodilators;

nitric oxide;

nitric oxide-releasing compounds;

beta-blockers;

hormones;

antidepressants;

decongestants;

calcium channel blockers;

growth factors, bone growth factors, bone morphogenic proteins;

wound healing agents;

analgesics and analgesic combinations;

local anesthetic agents;

antihistamines;

sedatives;

angiogenesis-promoting agents;

angiogenesis-inhibiting agents; and

tranquilizers.

16. The article of claim 1 wherein the tissue comprises a groove or hole, wherein said groove and/or said hole comprises a drug delivery composition.

17. The article of claim 16 wherein the drug delivery composition comprises a member chosen from the group consisting of a bioerodible polymer, a biodegradable polymer, a solid drug matrix, and a liquid drug.

18. The article of claim 1 wherein the coating coats only a portion of the tissue.

25. The article of claim 1 wherein the non-polymeric material is solid or liquid.

26. The article of claim 1 wherein the non-polymeric material is selected from the group consisting of bone wax, fatty acids, stearic acid. oleic acid, sugar derivatives, sucrose acetate, mineral oil, peanut oil, cotton seed oil, tocopherol, vitamin E, vitamin E acetate and polyethylene glycol.

27. A method of treating a patient comprising applying the bioprosthetic article of claim 1 to the patient for post operative adhesion prevention or as a hernia patch.

19. A process of preparing a bioprosthetic article comprising applying monomers or polymers to a surface of an implantable tissue and reacting the monomers or polymers on the surface to form a hydrogel.

20. The process of claim 19 wherein the implantable tissue, before coating, is chosen from the group consisting of decellularized tissue, chemically modified tissue and crosslinked tissue.

21. The process of claim 19 wherein the reaction comprises condensation polymerization of the polymers.

22. The process of claim 19 wherein the reaction comprises free radical polymerization of the monomers.

23. The process of claim 19 wherein the hydrogel is biodegradable.

24. The process of claim 19 wherein the hydrogel is formed by crosslinking and polymerization of polyethylene glycol based water soluble macromonomers.