CA2429168A1 - Method for restoring a damaged or degenerated intervertebral disc - Google Patents
Method for restoring a damaged or degenerated intervertebral disc Download PDFInfo
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- CA2429168A1 CA2429168A1 CA002429168A CA2429168A CA2429168A1 CA 2429168 A1 CA2429168 A1 CA 2429168A1 CA 002429168 A CA002429168 A CA 002429168A CA 2429168 A CA2429168 A CA 2429168A CA 2429168 A1 CA2429168 A1 CA 2429168A1
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- nucleus pulposus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/20—Polysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/722—Chitin, chitosan
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
- A61K31/765—Polymers containing oxygen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/52—Hydrogels or hydrocolloids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/54—Biologically active materials, e.g. therapeutic substances
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
- A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2002/444—Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2002/4445—Means for culturing intervertebral disc tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2002/445—Intervertebral disc tissue harvest sites
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/64—Animal cells
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
Abstract
The present invention relates to a minimally-invasive method for restoring a damaged or degenerated intervertebral disc at an early stage. The method comprises the step of administering an injectable in situ setting formulatio n in the nucleus pulposus of the damaged or degenerated disc of a patient. The formulation once injected combines with nucleus matters and host cells, and becomes viscous or gels in situ within the annulus fibrosus of the disc for increasing the thickness and volume of the damaged or degenerated disc. The formulation is retained within the disc for providing restoration of the damaged or degenerated disc.
Claims (76)
1. A method for restoring a damaged or degenerated intervertebral disc, said method comprising the step of:
a) administering percutaneously an injectable in situ setting formulation in the nucleus pulposus of the damaged or degenerated disc of a patient for increasing the thickness of the damaged or degenerated disc, said solution becoming viscous, pasty or turning into a gel or solid, in situ within the disc, is retained within the annulus fibrosus of the disc for providing restoration of the damaged or degenerated disc.
a) administering percutaneously an injectable in situ setting formulation in the nucleus pulposus of the damaged or degenerated disc of a patient for increasing the thickness of the damaged or degenerated disc, said solution becoming viscous, pasty or turning into a gel or solid, in situ within the disc, is retained within the annulus fibrosus of the disc for providing restoration of the damaged or degenerated disc.
2. The method of claim 1, wherein said injectable in situ setting formulation once administered mixes and combines in situ nucleus matters and host cells.
3. The method of claim 1, wherein said injectable in situ setting formulation turns into a gel in situ.
4. The method of claim 1, wherein said injectable in situ setting formulation is a thermogelling solution.
5. The method of claim 1, wherein said injectable in situ setting formulation comprises an in situ self gelling cellulosic, polysaccharide or/and polypeptidic aqueous solution.
6. The method of claim 1, wherein said injectable in situ setting formulation comprises a thermogelling cellulosic, polysaccharide or/and polypeptidic aqueous solution.
7. The method of claim 1, wherein said injectable in situ setting formulation comprises a thermogelling aqueous solution containing at least chitosan.
8. The method of claim 1, wherein said injectable in situ setting formulation comprises a thermogelling aqueous solution containing at least one phosphate salt.
9. The method of claim 1, wherein said injectable in situ setting formulation comprises a polymeric aqueous solution covalently crosslinkable into an aqueous gel in situ.
10. The method of claim 1, wherein said injectable in situ setting formulation contains chondroitin sulfate, or hyaluronic acid, or polyethylene glycol), or a derivative thereof.
11. The method of claim 1, wherein said injectable in situ setting formulation comprises:
a) 0.1 to 5.0% by weight of a water soluble cellulosic, polysaccharide or polypeptidic or a derivative thereof, or a mixture thereof; and b) i)1.0 to 20% by weight of a salt of polyol or sugar selected from .
the group comprising mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or ii)1.0 to 20% by weight of a salt selected from the group comprising phosphate, carbonate, sulfate, sulfonate, and the like.
wherein said solution has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
a) 0.1 to 5.0% by weight of a water soluble cellulosic, polysaccharide or polypeptidic or a derivative thereof, or a mixture thereof; and b) i)1.0 to 20% by weight of a salt of polyol or sugar selected from .
the group comprising mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or ii)1.0 to 20% by weight of a salt selected from the group comprising phosphate, carbonate, sulfate, sulfonate, and the like.
wherein said solution has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
12. The method of claim 1, wherein said injectable in situ setting formulation comprises:
a) 0.1 to 5.0% by weight of chitosan or collagen or a derivative thereof, or a mixture thereof; and b) i) 1.0 to 20% by weight of a salt of polyol pr sugar selected from the group consisting of mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or.
ii) 1.0 to 20% by weight of a salt selected from the group comprising phosphate, carbonate, sulfate, sulfonate, and the like;
wherein said solution has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
a) 0.1 to 5.0% by weight of chitosan or collagen or a derivative thereof, or a mixture thereof; and b) i) 1.0 to 20% by weight of a salt of polyol pr sugar selected from the group consisting of mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or.
ii) 1.0 to 20% by weight of a salt selected from the group comprising phosphate, carbonate, sulfate, sulfonate, and the like;
wherein said solution has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
13. The method of claim 1, wherein said injectable in situ setting formulation comprises:
a) 0.1 to 5.0% by weight of chitosan or collagen or a derivative thereof, or a mixture thereof; and b) i) 1.0 to 20% by weight of a salt of polyol or sugar selected from the group consisting of mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or ii)1.0 to 20% by weight of a salt selected from the group comprising phosphate, carbonate, sulfate, sulfonate, and the like; and d) 0.01 to 10% by weight of a water-soluble chemically reactive organic compound;
wherein said formulation has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 4 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
a) 0.1 to 5.0% by weight of chitosan or collagen or a derivative thereof, or a mixture thereof; and b) i) 1.0 to 20% by weight of a salt of polyol or sugar selected from the group consisting of mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or ii)1.0 to 20% by weight of a salt selected from the group comprising phosphate, carbonate, sulfate, sulfonate, and the like; and d) 0.01 to 10% by weight of a water-soluble chemically reactive organic compound;
wherein said formulation has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 4 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
14. The method of claim 11, 12 or 13, wherein said salt is a mono-phosphate dibasic salt of glycerol selected from the group consisting of glycerol-2-phosphate, sn-glycerol 3-phosphate and L-glycerol-3-phosphate salts.
15. The method of claim 11, 12 or 13, wherein said salt is a mono-phosphate dibasic salt and said polyol is selected from the group consisting of histidinol, acetol, diethylstilbestrol, indole-glycerol, sorbitol, ribitol, xylitol, arabinitol, erythritol, inositol, mannitol, and glucitol or a mixture thereof.
16. The method of claim 11, 12 or 13, wherein said salt is a mono-phosphate dibasic salt and said sugar is selected from the group consisting of fructose, galactose, ribose, glucose, xylose, rhamnulose, sorbose, erythrulose, deoxy-ribose, ketose, mannose, arabinose, fuculose, fructopyranose, ketoglucose, sedoheptulose, trehalose, tagatose, sucrose, allose, threose, xylulose, hexose, methylthio-ribose, and methylthio-deoxy-ribulose, or a mixture thereof.
17. The method of claim 11, 12 or 13, wherein said salt is a mono-phosphate dibasic salt and said polyol is selected from the group consisting of palmitoyl-glycerol, linoleoyl-glycerol, oleoyl-glycerol, and arachidonoyl-glycerol, or a mixture thereof.
18. The method of claim 11, 12 or 13, wherein said formulation comprises an aqueous solution selected from the group consisting of chitosan-.beta.-glycerophosphate, chitosan-.alpha.-glycerophosphate, chitosan-glucose-1-glycero-phosphate, and chitosan-fructose-6-glycerophosphate.
19. The method of claim 11, 12 or 13, wherein said formulation comprises methyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl-methylcellulose, or the like, or a mixture thereof.
20. The method of claim 1, wherein said injectable formulation comprises a biocompatible physiologically safe polymer.
21. The method of claim 20, wherein said polymer is polymerized or covalently crosslinked after being injected in situ.
22. The method of claim 1, wherein said injectable formulation is a dispersion comprising a nonsoluble solid component.
23. The method of claim 22, wherein said nonsoluble solid component comprises microparticles, microbeads, microspheres or granules.
24. The method of claim 1, wherein said injectable in situ setting formulation is nonaqueous and comprises an organic solvent.
25. The method of any one of claims 1 to 24, wherein said injectable in situ setting formulation comprises at least one fatty acid, said fatty acid being selected from the group consisting of oleate, palmitate, myristate, stearate, palmitoleate, and vaccenate, or the like, or a derivative thereof.
26. The method of any one of claims 1 to 24, wherein the fatty acid is mixed with a metabollcally absorbable solvent or liquid vehicle to reduce viscosity and allow injectability.
27. The method of claims 1, wherein said formulation contains at least one bioactive agent or drug.
28. The method of claim 27, wherein said bioactive agent or drug is a cell stimulant.
29. The method of claim 28, wherein the cell stimulant is selected from the group consisting of growth factors and cytokines.
30. The method of claim 1, wherein the injectable formulation comprises living tissue cells prior to administration.
31. The method of any one of claims 1 to 30, wherein the injectable formulation comprises living tissue cells adhered onto a solid substrate.
32. The method of claim 1, wherein the injectable formulation is flowable, but has a viscosity above 10 mPa.s at the time of administration.
33. The method of claim 1, wherein the nucleus pulposus is excised prior to administering the formulation.
34. The method of claim 1, wherein the restoration of the degenerated or damaged intervertebral disc provides a more biomechanically stable spine.
35. A nucleus pulposus formulation comprising at least one fatty acid, wherein said formulation forms a solid material in situ, said material allowing to increase the thickness of a damaged or degenerated disc, said solution being retained within the annulus fibrosus of the disc for providing restoration of the damaged or degenerated disc.
36. The nucleus pulposus formulation of claim 35, wherein the fatty acid is selected from the group consisting of oleate, palmitate, myristate, stearate, palmitoleate, and vaccenate, or the like, or a derivative thereof.
37. The nucleus pulposus formulation of claim 35, wherein said formulation comprises a metabolically absorbable solvent.
38. The nucleus pulposus formulation of claim 37, wherein said metabolically absorbable solvent is selected from the group consisting of water, triacetin, alcohol, glycerol, and lactate based solvent, or the like.
39. A nucleus pulposus formulation comprising:
a) 0.1 to 5.0% by weight of a water-soluble polymer selected from the group consisting of cellulosic, polysaccharide and polypeptidic, and b) 1.0 to 20% by weight of a water-soluble salt selected from the group consisting of phosphate, glycerol-phosphate, glucose-phosphate, and fructose phosphate, or the like, wherein said formulation has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
a) 0.1 to 5.0% by weight of a water-soluble polymer selected from the group consisting of cellulosic, polysaccharide and polypeptidic, and b) 1.0 to 20% by weight of a water-soluble salt selected from the group consisting of phosphate, glycerol-phosphate, glucose-phosphate, and fructose phosphate, or the like, wherein said formulation has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
40. A nucleus pulposus formulation comprising:
a) 0.1 to 5.0% by weight of a water soluble cellulosic, polysaccharide or polypeptidic or a derivative thereof, or a mixture thereof; and b) i)1.0 to 20% by weight of a salt of polyol or sugar selected from the group consisting of mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or ii)1.0 to 20% by weight of a salt selected from the group consisting of phosphate, carbonate, sulfate, and sulfonate, or the like.
wherein said formulation has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
a) 0.1 to 5.0% by weight of a water soluble cellulosic, polysaccharide or polypeptidic or a derivative thereof, or a mixture thereof; and b) i)1.0 to 20% by weight of a salt of polyol or sugar selected from the group consisting of mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or ii)1.0 to 20% by weight of a salt selected from the group consisting of phosphate, carbonate, sulfate, and sulfonate, or the like.
wherein said formulation has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
41. A nucleus pulposus formulation comprising:
a) 0.1 to 5.0% by weight of chitosan or collagen or a derivative thereof, or a mixture thereof; and b) i) 1.0 to 20% by weight of a salt of polyol or sugar selected from the group consisting of mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or ii) 1.0 to 20% by weight of a salt selected from the group consisting of phosphate, carbonate, sulfate, and sulfonate, or.
the like;
wherein said formulation has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
a) 0.1 to 5.0% by weight of chitosan or collagen or a derivative thereof, or a mixture thereof; and b) i) 1.0 to 20% by weight of a salt of polyol or sugar selected from the group consisting of mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or ii) 1.0 to 20% by weight of a salt selected from the group consisting of phosphate, carbonate, sulfate, and sulfonate, or.
the like;
wherein said formulation has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
42. A nucleus pulposus formulation comprising:
a) 0.1 to 5.0% by weight of chitosan or collagen or a derivative thereof, or a mixture thereof; and b) i) 1.0 to 20% by weight of a salt of polyol or sugar selected from the group consisting of mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or ii)1.0 to 20% by weight of a salt selected from the group consisting of phosphate, carbonate, sulfate, and sulfonate, or the like; and c) 0.01 to 10% by weight of a water-soluble chemically reactive organic compound;
wherein said formulation has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 4 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
a) 0.1 to 5.0% by weight of chitosan or collagen or a derivative thereof, or a mixture thereof; and b) i) 1.0 to 20% by weight of a salt of polyol or sugar selected from the group consisting of mono-phosphate dibasic salt, mono-sulfate salt and a mono-carboxylic acid salt of polyol or sugar; or ii)1.0 to 20% by weight of a salt selected from the group consisting of phosphate, carbonate, sulfate, and sulfonate, or the like; and c) 0.01 to 10% by weight of a water-soluble chemically reactive organic compound;
wherein said formulation has a pH ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 4 to 70°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
43. The nucleus pulposus formulation of any one of claims 39 to 42;
wherein said formulation comprises 0.1 to 3.0% of a chitosan, and 1.0 to 10% of a water-soluble phosphate salt, wherein said formulation has a pH
ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 40°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
wherein said formulation comprises 0.1 to 3.0% of a chitosan, and 1.0 to 10% of a water-soluble phosphate salt, wherein said formulation has a pH
ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 40°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
44. The nucleus pulposus formulation of any one of claims 39 to 41, wherein said formulation comprises 0.1 to 3.0% of a chitosan, and 1.0 to 10% of a water-soluble phosphate salt, and 0.01 to 5% of a water-soluble chemically reactive organic compounds, wherein said formulation has a pH
ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 40°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
ranging from 6.5 to 7.4, and turns into a gel within a temperature range from 20 to 40°C, said gel having a physiologically acceptable consistency for increasing the thickness of the disc, providing a mechanical support once injected in the disc.
45. The nucleus pulposus formulation of claims 39, wherein said polymer is a methyl-cellulose, a hydroxyethyl-cellulose, a hydroxypropyl-cellulose, a hydroxypropyl methylcellulose, a chitosan or a collagen, or a mixture thereof.
46. The nucleus pulposus formulation of claims 39, wherein said salt is a sodium or magnesium salt.
47. The nucleus pulposus formulation of any one of claims 40 to 42, wherein said formulation comprises a mono-phosphate dibasic salt.
48. The nucleus pulposus formulation of any one of claims 40 to 42, wherein said formulation comprises a glycerophosphate salt.
49. The nucleus pulposus formulation of claim 43 or 44, wherein said water-soluble phosphate salt is a dibasic phosphate salt.
50. The nucleus pulposus formulation of claim 49, wherein said phosphate salt is selected from the group consisting of sodium phosphate and magnesium phosphate or the like.
51. The nucleus pulposus formulation of claim 44, wherein said water-soluble chemically reactive organic compound is reactive toward free amine groups.
52. The nucleus pulposus formulation of claim 44, wherein said water-soluble chemically reactive organic compound is a functionalized poly(ethylene glycol).
53. The nucleus pulposus formulation of claim 44, wherein said water-soluble chemically reactive organic compound is a monofunctional methoxy poly(ethylene glycol).
54. The nucleus pulposus formulation of claim 44, wherein said water-soluble chemically reactive organic compound is a multifunctional poly(ethylene glycol).
55. The nucleus pulposus formulation of claim 44, wherein said water-soluble chemically reactive organic compound is selected from the group consisting of aldehyde, anhydride acid, azide, azolide, carboimide, carboxylic acid, epoxide, esters, glycidyl ether, halide, imidazole, imidate, succinimide, succinimidyi ester, acrylate and methacrylate, or a mixture thereof.
56. Use of a formulation as defined in any one of claims 39 to 44, for restoring a damaged or degenerated intervertebral disk.
57. The use of claim 56, wherein said nucleus pulposus formulation further comprises a nonsoluble particulate material.
58. The use of claim 57, wherein said nucleus pulposus formulation further comprises a biodegradable organic particulate material.
59. The use of claim 58, wherein said biodegradable organic particulate material is made of an absorbable polymer.
60. The use of claim 59, wherein said absorbable polymer is selected from the group consisting of poly(lactic acid), poly(glycolic acid), poly(lactic-co-glycolic), poly(lactones), poly(orthoesters), poly(anhydrides), and poly(carbonates), or the like.
61. The use of claim 58, wherein said biodegradable organic particulate material is made of gelatin, collagen, or the like.
62. The use of claim 57, wherein said nucleus pulposus formulation further comprises an inorganic or mineral particulate material.
63. The use of claim 62, wherein said inorganic or mineral particulate material is selected from the group consisting of bioglass, calcium phosphate, and calcium carbonate, or the like.
64. The use of claim 56, wherein said nucleus pulposus formulation further comprises cells.
65. The use of claim 64, wherein said cells are autologous.
66. The use of claim 64, wherein said cells are modified.
67. The use of claim 64, wherein said cells are stem cells or chondrocytes.
68. The use of claim 56, wherein said nucleus pulposus formulation further comprises a bioactive or pharmaceutical agent.
69. The use of claim 68, wherein said bioactive or pharmaceutical agent is a cell stimulant, a cell preservative, or a cell differentiation factor.
70. The use of claim 68, wherein said bioactive or pharmaceutical agent is a cytokine or a growth factor.
71. The use of claim 68, wherein said bioactive or pharmaceutical agent is an anti-pain or anti-inflammation drug.
72. The use of claim 56, wherein said nucleus pulposus formulation mixes with biochemicals and living matters in situ.
73. The use of claim 56, wherein said nucleus pulposus formulation forms a viscous, gel, pasty or solid material in situ.
74. The use of claim 56, wherein said nucleus pulposus formulation has a viscosity above 10 mPa.s at the time of administration.
75. The use of claim 56, for decompressing the injected, intervertebral disc.
76. The use of claim 56, for stabilizing the spine of a patient.
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US60/248,568 | 2000-11-16 | ||
PCT/CA2001/001623 WO2002040070A2 (en) | 2000-11-15 | 2001-11-15 | Method for restoring a damaged or degenerated intervertebral disc |
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CA2429168A1 true CA2429168A1 (en) | 2002-05-23 |
CA2429168C CA2429168C (en) | 2010-06-08 |
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CA2429168A Expired - Fee Related CA2429168C (en) | 2000-11-15 | 2001-11-15 | Method for restoring a damaged or degenerated intervertebral disc |
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EP (1) | EP1335687B1 (en) |
AU (1) | AU2002221370A1 (en) |
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DE (1) | DE60125973D1 (en) |
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-
2001
- 2001-11-15 CA CA2429168A patent/CA2429168C/en not_active Expired - Fee Related
- 2001-11-15 EP EP01996398A patent/EP1335687B1/en not_active Expired - Lifetime
- 2001-11-15 DE DE60125973T patent/DE60125973D1/en not_active Expired - Lifetime
- 2001-11-15 AU AU2002221370A patent/AU2002221370A1/en not_active Abandoned
- 2001-11-15 US US10/416,947 patent/US20040091540A1/en not_active Abandoned
- 2001-11-15 WO PCT/CA2001/001623 patent/WO2002040070A2/en active IP Right Grant
-
2008
- 2008-08-04 US US12/185,417 patent/US20090030525A1/en not_active Abandoned
-
2015
- 2015-12-17 US US14/972,882 patent/US20160101214A1/en not_active Abandoned
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Publication number | Publication date |
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EP1335687A2 (en) | 2003-08-20 |
WO2002040070A2 (en) | 2002-05-23 |
CA2429168C (en) | 2010-06-08 |
US20040091540A1 (en) | 2004-05-13 |
EP1335687B1 (en) | 2007-01-10 |
US20090030525A1 (en) | 2009-01-29 |
DE60125973D1 (en) | 2007-02-22 |
US20160101214A1 (en) | 2016-04-14 |
AU2002221370A1 (en) | 2002-05-27 |
WO2002040070A3 (en) | 2002-10-03 |
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