METHOD FOR RESTORING A DAMAGED OR DEGENERATED INTERVERTEBRAL DISC
First Claim
1. A method for restoring a damaged or degenerated intervertebral disc, said method comprising the step of:
- 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 formulation becoming viscous, or 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,wherein said injectable in situ setting formulation comprises;
a) 0.1 to 5.0% by weight of a water soluble cellulose, polysaccharide or polypeptide, 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;
orii) 1.0 to 20% by weight of a salt selected from the group comprising phosphate, carbonate, sulfate and sulfonate.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 increasing the thickness of the disc, providing a mechanical support once injected in the disc.
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Accused Products
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 formulation in the nucleus pulposus of the damaged or degenerated disc of the 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.
107 Citations
31 Claims
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1. A method for restoring a damaged or degenerated intervertebral disc, said method comprising the step of:
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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 formulation becoming viscous, or 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, wherein said injectable in situ setting formulation comprises; a) 0.1 to 5.0% by weight of a water soluble cellulose, polysaccharide or polypeptide, 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;
orii) 1.0 to 20% by weight of a salt selected from the group comprising phosphate, carbonate, sulfate and sulfonate. 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 increasing the thickness of the disc, providing a mechanical support once injected in the disc. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A method for restoring a damaged or degenerated intervertebral disc, said method comprising the step of:
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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 formulation becoming viscous, or 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, wherein said injectable in situ setting formulation comprises; a) 0.1 to 5.0% by weight of chitosan or collagen, 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;
orii) 1.0 to 20% by weight of a salt selected from the group comprising phosphate, carbonate, sulfate and sulfonate; 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 increasing the thickness of the disc, providing a mechanical support once injected in the disc.
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29. A method for restoring a damaged or degenerated intervertebral disc, said method comprising the step of:
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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 formulation becoming viscous, or 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, wherein said injectable in situ setting formulation comprises; a) 0.1 to 5.0% by weight of chitosan or collagen, 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;
orii) 1.0 to 20% by weight of a salt selected from the group comprising phosphate, carbonate, sulfate and sulfonate; 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 increasing the thickness of the disc, providing a mechanical support once injected in the disc.
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30. 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.
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31. A nucleus pulposus formulation comprising:
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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.
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Specification