Claims for Patent: 8,123,787

Summary for Patent: 8,123,787

Title:	Method of treating scoliosis using a biological implant
Abstract:	The present invention is a bone growth stimulating and promoting cytokine type biological implant preferably comprising PTH coated with a controlled release biodegradable coating that is implanted preferably in the concave side of a scoliotically curved spine in combination with a bone growth inhibiting type biological implant preferably comprising methotrexate or like anti-metabolite coated with a controlled release biodegradable coating that is implanted preferably in the convex side of a scoliotically curved spine. The insertion of the biological implant is highly non-invasion, especially as compared to more conventional spine surgical methods, and the biological implant does not decrease spinal mobility or spinal range of motion.
Inventor(s):	Ogilvie; James W. (Brighton, UT), Ward; Kenneth (Salt Lake City, UT), Nelson; Lesa M. (Park City, UT)
Assignee:
Application Number:	12/341,289
Patent Claims:	1. A method of treating a scoliotically curved spine in a patient being determined to be at risk of scoliosis curve progression comprising placing at least one of a growth stimulant, a medication, and a biological therapy on a concave side of said curve formed in said spine, wherein said biological therapy defines a dissolvable bone growth stimulant biological implant coated with a dissolvable coating, wherein determining said patient is at risk of scoliosis curve progression further defines a determination of genetic predisposition wherein DNA of said patient includes a plurality of genetic markers having an association with adolescent idiopathic scoliosis contained therein and wherein said risk is determined by performing logistic regression on said plurality of adolescent idiopathic scoliosis associated genetic markers. 2. The method of claim 1, wherein said biological therapy comprises an implant of at least one of a Parathyroid hormone, a Fibroblast growth factor, an androgen, an Insulin-like Growth Factor, an Estrogen, a Transforming Growth Factor, and an inorganic phosphate. 3. The method of claim 1, wherein said biological therapy defines an implant that is inserted into said patient by placing said biological therapy into an implantation apparatus and causing said biological therapy to move from said implantation apparatus into said patient. 4. The method of claim 3, wherein said implantation apparatus defines a trocar. 5. The method of claim 1, wherein said method includes at least one of the following steps comprising determining said patient is at risk of scoliosis curve progression in response to performing a calculation based on at least one scoliosis associated biological marker being detected in a biological sample of said patient, joining at least one mechanical implant to a first vertebra and to a second vertebra of the spine of said patient, and applying a brace to said patient. 6. The method of claim 5, wherein said at least one scoliosis associated biological marker defines an adolescent idiopathic scoliosis associated biological marker, and wherein joining at least one mechanical implant to a first vertebra and to a second vertebra of said spine further defines joining a first fastener to a first scoliotic vertebra and a second fastener to a second scoliotic vertebra on a concave side of a curve formed in a scoliotic spine, joining at least one mechanical implant with said first fastener and said second fastener, and expanding said at least one mechanical implant between said first scoliotic vertebra and said second scoliotic vertebra such that a distraction force is provided between said first scoliotic vertebra and said second scoliotic vertebra, and wherein applying a brace to said patient further defines providing an external brace having no more than three principal load applying contact points; fitting said brace to said patient; and treating said spine of said patient by periodic brace adjustments. 7. A method of treating an uninjured non-osteoarthritic osteophyte-free spine in a vertebrate patient having at least one scoliosis associated biological marker identified in DNA of said patient having an association with adolescent idiopathic scoliosis contained therein comprising performing logistic regression on said adolescent idiopathic scoliosis associated biological marker; and placing at least one of a growth stimulant, a growth inhibitor, a medication, and a biological therapy proximate said spine of said patient, wherein said biological therapy defines at least one of a dissolvable bone growth stimulant implant coated with a dissolvable coating and a dissolvable bone growth inhibitor implant coated with a dissolvable coating, wherein said growth promoting biological implant is inserted between a first scoliotic vertebra and a second scoliotic vertebra on concave side of a curve of said spine, and wherein said growth inhibiting biological implant is inserted between said first scoliotic vertebra and said second scoliotic vertebra on convex side of said curve of said spine. 8. The method of claim 7, wherein said at least one biological therapy defines at least one of a bone growth promoting implant and a growth inhibiting implant. 9. The method of claim 7, wherein said at least one biological therapy includes at least one bone growth promoting implant and at least one bone growth inhibiting implant. 10. The method of claim 7, wherein said spine includes a curve formed therein. 11. The method of claim 7, wherein said spine defines a scoliotic spine. 12. The method of claim 7, wherein said at least one biological therapy defines a bone growth promoting implant, and wherein said spine includes a curve formed therein, and wherein said at least one bone growth promoting implant is inserted proximate a concave side of said curve of said spine. 13. The method of claim 12, wherein said spine defines a scoliotic spine, and wherein said biological therapy is inserted between a first scoliotic vertebra and a second scoliotic vertebra on said concave side of said curve of said scoliotic spine. 14. The method of claim 12, wherein said spine defines a scoliotic spine. 15. The method of claim 7, wherein said at least one biological therapy includes at least one bone growth promoting implant and at least one bone growth inhibiting implant, and wherein said spine includes a curve formed therein, and wherein said at least one bone growth promoting implant is inserted proximate a concave side of said curve of said spine, and wherein said at least one bone growth inhibiting implant is inserted proximate a convex side of said curve of said spine. 16. The method of claim 15, wherein said spine defines a scoliotic spine. 17. The method of claim 7, wherein said biological therapy comprises an implant of at least one of a Parathyroid hormone, a Fibroblast growth factor, an androgen, an Insulin-like Growth Factor, an Estrogen, a Transforming Growth Factor, an inorganic phosphate, and an anti-metabolite. 18. The method of claim 7, wherein said biological therapy defines an implant that is inserted into said patient by placing said biological therapy into an implantation apparatus and causing said biological therapy to move from said implantation apparatus into said patient. 19. The method of claim 18, wherein said implantation apparatus defines a trocar. 20. The method of claim 7, wherein said method includes at least one of the following steps comprising determining said patient is at risk of scoliosis development or scoliosis curve progression, joining at least one mechanical implant to a first vertebra and to a second vertebra of said spine, and applying a brace to said patient. 21. The method of claim 20, wherein determining said patient is at risk of scoliosis development or scoliosis curve progression further defines the result of a screening test wherein a scoliosis related condition risk value is derived by performing a calculation based on at least one adolescent idiopathic scoliosis associated biological marker being detected in a biological sample of said patient, and wherein joining at least one mechanical implant to a first vertebra and to a second vertebra of said spine further defines joining a first fastener to a first scoliotic vertebra and a second fastener to a second scoliotic vertebra on a concave side of a curve formed in a scoliotic spine, joining at least one mechanical implant with said first fastener and said second fastener, and expanding said at least one mechanical implant between said first scoliotic vertebra and said second scoliotic vertebra such that a distraction force is provided between said first scoliotic vertebra and said second scoliotic vertebra, and wherein applying a brace to said patient further defines providing an external brace having no more than three principal load applying contact points; fitting said brace to said patient; and treating said spine of said patient by periodic brace adjustments. 22. A method of treating a scoliotic spine in a vertebrate patient being determined to be at risk of spine curve progression in response to performing a calculation based on at least one scoliosis associated biological marker being detected in a biological sample of said patient comprising placing at least one of a growth stimulant, a growth inhibitor, a medication, and a biological therapy proximate said scoliotic spine of said patient, wherein said at least one biological therapy includes at least one bone growth promoting implant and at least one bone growth inhibiting implant, wherein said bone growth promoting implant defines at least one of a dissolvable bone growth stimulant coated with a dissolvable coating and said bone growth inhibiting implant defines at least one of a dissolvable bone growth inhibitor coated with a dissolvable coating, wherein said spine includes a curve formed therein, wherein said at least one bone growth promoting implant is inserted proximate a concave side of said curve of said spine, and wherein said at least one bone growth inhibiting implant is inserted proximate a convex side of said curve of said spine; and joining at least one mechanical implant to a first vertebra and to a second vertebra of said spine, and applying a brace to said patient. 23. The method of claim 22, wherein said at least one biological therapy defines at least one of a bone growth promoting implant and a growth inhibiting implant. 24. The method of claim 22, wherein said at least one biological therapy includes at least one bone growth promoting implant and at least one bone growth inhibiting implant. 25. The method of claim 22, wherein said at least one biological therapy defines a bone growth promoting implant, and wherein said spine includes a curve formed therein, and wherein said at least one bone growth promoting implant is inserted proximate a concave side of said curve of said spine. 26. The method of claim 22, wherein said biological therapy is inserted on a concave side of a curve formed in said scoliotic spine. 27. The method of claim 22, wherein said biological therapy comprises an implant of at least one of a Parathyroid hormone, a Fibroblast growth factor, an androgen, an Insulin-like Growth Factor, an Estrogen, a Transforming Growth Factor, an inorganic phosphate, and an anti-metabolite. 28. The method of claim 22, wherein said biological therapy defines an implant that is inserted into said patient by placing said biological therapy into an implantation apparatus and causing said biological therapy to move from said implantation apparatus into said patient. 29. The method of claim 28, wherein said implantation apparatus defines a trocar. 30. The method of claim 22, wherein said at least one scoliosis associated biological marker defines an adolescent idiopathic scoliosis associated biological marker, and wherein joining at least one mechanical implant to a first vertebra and to a second vertebra of said spine further defines joining a first fastener to a first scoliotic vertebra and a second fastener to a second scoliotic vertebra on a concave side of a curve formed in a scoliotic spine, joining at least one mechanical implant with said first fastener and said second fastener, and expanding said at least one mechanical implant between said first scoliotic vertebra and said second scoliotic vertebra such that a distraction force is provided between said first scoliotic vertebra and said second scoliotic vertebra, and wherein applying a brace to said patient further defines providing an external brace having no more than three principal load applying contact points; fitting said brace to said patient; and treating said spine of said patient by periodic brace adjustments. 31. The method of claim 22, wherein determining said patient is at risk of scoliosis curve progression further defines a determination of genetic predisposition wherein the DNA of said patient includes a plurality of genetic markers having an association with adolescent idiopathic scoliosis contained therein and wherein said risk is determined by performing logistic regression on said plurality of adolescent idiopathic scoliosis associated genetic markers. 32. A method of implanting a biological implant comprising selecting a vertebrate patient having plurality of adolescent idiopathic scoliosis associated genetic markers in the DNA of said patient; determining said patient is at risk of scoliosis development or scoliosis curve progression, wherein determining said patient is at risk of scoliosis curve progression further defines performing logistic regression on said plurality of scoliosis associated genetic markers; implanting said biological implant into said patient, wherein said biological implant defines at least one of a dissolvable bone growth stimulant coated with a dissolvable coating and a dissolvable bone growth inhibitor coated with a dissolvable coating, wherein the spine of said patient defines a scoliotic spine, and wherein said growth promoting biological implant is inserted between a first scoliotic vertebra and a second scoliotic vertebra on concave side of a curve of said scoliotic spine, and wherein said growth inhibiting biological implant is inserted between said first scoliotic vertebra and said second scoliotic vertebra on convex side of said curve of said scoliotic spine; and joining at least one mechanical implant to a first vertebra and to a second vertebra of the spine of said patient, and applying a brace to said patient. 33. The method of claim 32, wherein said biological implant defines a bone growth modulating biological implant. 34. The method of claim 32, wherein said biological implant is inserted proximate the spine of said patient. 35. The method of claim 32, wherein said at least one biological implant defines at least one of a bone growth promoting implant and a growth inhibiting implant. 36. The method of claim 32, wherein said at least one biological implant includes at least one bone growth promoting implant and at least one bone growth inhibiting implant. 37. The method of claim 32, wherein the spine of said patient includes a curve formed therein. 38. The method of claim 32, wherein the spine of said patient defines a scoliotic spine. 39. The method of claim 32, wherein said at least one biological implant defines a bone growth promoting implant, and wherein the spine of said patient includes a curve formed therein, and wherein said at least one bone growth promoting implant is inserted proximate a concave side of said curve of said spine. 40. The method of claim 39, wherein said spine defines a scoliotic spine, and wherein said biological implant is inserted between a first scoliotic vertebra and a second scoliotic vertebra on said concave side of said curve of said scoliotic spine. 41. The method of claim 39, wherein said spine defines a scoliotic spine. 42. The method of claim 32, wherein said at least one biological implant includes at least one bone growth promoting implant and at least one bone growth inhibiting implant, and wherein the spine of said patient includes a curve formed therein, and wherein said at least one bone growth promoting implant is inserted proximate a concave side of said curve of said spine, and wherein said at least one bone growth inhibiting implant is inserted proximate a convex side of said curve of said spine. 43. The method of claim 42, wherein said spine of said patient defines a scoliotic spine. 44. The method of claim 32, wherein said biological implant comprises at least one of a Parathyroid hormone, a Fibroblast growth factor, an androgen, an Insulin-like Growth Factor, an Estrogen, a Transforming Growth Factor, an inorganic phosphate, and an anti-metabolite. 45. The method of claim 32, wherein said biological implant is inserted into said patient by placing said biological implant into a biological implantation apparatus and causing said biological implant to move from said biological implantation apparatus into said patient. 46. The method of claim 45, wherein said biological implantation apparatus defines a trocar. 47. The method of claim 32, wherein determining said patient is at risk of scoliosis development or scoliosis curve progression further defines the result of a screening test wherein a scoliosis related condition risk value is derived by performing a calculation based on at least one scoliosis associated biological marker being detected in a biological sample of said patient, and wherein joining at least one mechanical implant to a first vertebra and to a second vertebra of said spine further defines joining a first fastener to a first scoliotic vertebra and a second fastener to a second scoliotic vertebra on a concave side of a curve formed in a scoliotic spine, joining at least one mechanical implant with said first fastener and said second fastener, and expanding said at least one mechanical implant between said first scoliotic vertebra and said second scoliotic vertebra such that a distraction force is provided between said first scoliotic vertebra and said second scoliotic vertebra, and wherein applying a brace to said patient further defines providing an external brace having no more than three principal load applying contact points; fitting said brace to said patient; and treating said spine of said patient by periodic brace adjustments. 48. A method of treating a vertebrate subject having at least one scoliosis associated biological marker identified in the DNA of said subject, comprising placing at least one of a growth stimulant, a growth inhibitor, a medication, and a biological therapy on a concave side of a curve formed in the spine of said subject, joining at least one mechanical implant to a first vertebra and to a second vertebra of the spine of said subject, and applying a brace to said subject, wherein said scoliosis associated biological marker defines an adolescent idiopathic scoliosis associated biological marker, and wherein said biological therapy defines at least one dissolvable bone growth stimulant biological implant coated with a dissolvable coating and at least one dissolvable bone growth inhibiting biological implant coated with a dissolvable coating, and wherein said at least one dissolvable bone growth stimulant biological implant coated with a dissolvable coating is inserted proximate a concave side of said curve of said spine, and wherein said dissolvable bone growth inhibiting biological implant coated with a dissolvable coating is inserted proximate a convex side of said curve of said spine. 49. The method of claim 48, wherein said scoliosis associated biological marker defines an adolescent idiopathic scoliosis associated biological marker. 50. The method of claim 48, wherein said biological therapy defines at least one of a dissolvable bone growth stimulant biological implant coated with a dissolvable coating and a dissolvable bone growth inhibiting biological implant coated with a dissolvable coating. 51. The method of claim 50, wherein said bone growth stimulant comprises at least one of a Parathyroid hormone, a Fibroblast growth factor, an androgen, an Insulin-like Growth Factor, an Estrogen, a Transforming Growth Factor, and an inorganic phosphate.

Details for Patent 8,123,787

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2024-10-28