Methods of treating degenerative bone conditions

• US 9,550,010 B2
• Filed: 06/30/2011
• Issued: 01/24/2017
• Est. Priority Date: 07/02/2010
• Status: Active Grant

• Current Assignee: Agnovos Healthcare, LLC
• Original Assignee: Agnovos Healthcare, LLC
• Inventors: Schulz, Olaf, Howe, James, Swaim, Rick, Huber, Bryan, Batts, Joel, Harness, David, Belaney, Ryan
• Primary Examiner(s): Kwon, Brian-Yong
• Application Number:
  US13/173,701
• Publication Number:
  US 20120004594A1
• Time in Patent Office: 2,035 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1668 for the upper femur A61B17/164 takes precedence
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61L 15/28 Polysaccharides or their derivatives A61L15/225 takes precedence
• CPC Class Codes: A61L 24/0042 Materials resorbable by the body
• CPC Class Codes: A61L 24/02 containing inorganic materials
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/12 Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61M 1/743 by changing the cross-section of the line, e.g. flow regulating valves A61M1/7413 takes precedence
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463

Abstract

Methods and articles of manufacture for treating patients with degenerative bone are provided. The methods are useful to improve bone quality in a localized area of a degenerative bone (e.g., osteopenic or osteoporotic bone), such as by improving BMD to be substantially similar to BMD in an average, healthy individual at the age of peak BMD. The methods can comprise forming a void in a localized area of the degenerative bone and filling the void with a bone regenerative material that causes generation of new, healthy, natural bone material. The articles of manufacture can comprise kits formed of various materials useful in the inventive methods for improving bone quality.

Claims

1. A method of treating a human patient suffering from a degenerative bone condition, the degenerative bone condition being either osteoporosis or osteopenia, comprising:

forming a void in a localized area of a bone of a human patient that has been diagnosed with the degenerative bone condition, the localized area being intact bone prior to the forming step; and

filling at least a portion of the formed void with a bone regenerative material, which comprises calcium phosphate, calcium sulfate, demineralized bone matrix (DBM), or a combination thereof, wherein the calcium phosphate, calcium sulfate, DBM, or the combination thereof is in an amount effective to facilitate formation of new, non-degenerated bone material into and throughout at least the portion of the void that has been filled with the bone regenerative material, wherein the bone regenerative material does not include a TGF-β

isoform in an amount sufficient to facilitate formation of new, non-degenerated bone material into and throughout the portion of the void, wherein the bone regenerative material is flowable when it is filled into the formed void, and wherein the bone for void formation is selected from a group consisting of hip, femur, radius, ulna, humerus, tibia, and a vertebra that is located between a first immediately adjacent intact vertebra on one side of the vertebra and a second immediately adjacent intact vertebra on the other side of the vertebra.

2. The method of claim 1, wherein the bone regenerative material further comprises an osteoinductive material, osteoconductive material, osteogenic material, osteopromotive material, anti-osteoporotic material, or osteophilic material.

3. The method of claim 1, wherein the bone regenerative material comprises calcium sulfate.

4. The method of claim 3, wherein the bone regenerative material further comprises calcium phosphate.

5. The method of claim 4, wherein the bone regenerative material further comprises tricalcium phosphate granules.

6. The method of claim 1, wherein the bone regenerative material comprises a material exhibiting a multi-phasic resorption profile in vivo.

7. The method of claim 1, wherein the bone regenerative material comprises a material exhibiting a bi-phasic resorption profile in vivo.

8. The method of claim 1, wherein the bone regenerative material comprises a material exhibiting a tri-phasic resorption profile in vivo.

9. The method of claim 1, wherein the bone regenerative material hardens in vivo.

10. The method of claim 1, wherein the newly formed, non-degenerated bone material has a T-score measured by Dual Energy X-ray Absorptiometry (DEXA) that is greater than 0.

11. The method of claim 1, wherein the new bone material has a T-score measured by Dual Energy X-ray Absorptiometry (DEXA) that is greater than −

1.0.

12. The method of claim 1, wherein the new bone material has a T-score measured by Dual Energy X-ray Absorptiometry (DEXA) that is greater than −

0.5.

13. The method of claim 1, wherein the bone regenerative material facilitates formation of new bone material in the area of the bone adjacent the formed void, the new bone material in the area of the adjacent bone having a T-score measured by Dual Energy X-ray Absorptiometry (DEXA) that is greater than 0.

14. The method of claim 1, wherein the BMD in the localized area of the bone is increased such that a T-score measured by Dual Energy X-ray Absorptiometry (DEXA) for the newly formed, non-degenerated bone material is greater than the T-score of the bone prior to void formation.

15. The method of claim 14, wherein the T-score of the bone prior to void formation is less than −

1.0 and the newly formed, nondegenerated bone material has a T-score of greater than −

1.0.

16. The method of claim 14, wherein the T-score of the newly formed, nondegenerated bone material is at least 0.5 units greater than the T-score of the bone prior to void formation.

17. The method of claim 14, wherein the T-score of the bone prior to void formation is less than −

1.0 and the newly formed, nondegenerated bone material has a T-score of at least −

0.5.

18. The method of claim 14, wherein the T-score of the bone prior to void formation is less than −

1.0 and the newly formed, nondegenerated bone material has a T-score of at least 0.

19. The method of claim 14, wherein the increase in BMD in the localized area of the bone is maintained for a time of at least 1 year measured from the time of new bone material formation.

20. The method of claim 1, wherein, after filling the at least portion of the formed void with the bone regenerative material, new bone material is formed within the void over time and at least a portion of the bone regenerative material is resorbed.

21. The method of claim 20, wherein a BMD profile is created in the localized area of a bone such that a T-score, as measured by Dual Energy X-ray Absorptiometry (DEXA), increases from an initial score of less than −

1.0, as measured prior to forming the void, to a maximum score of at least 5.0 within a time of about 1 week to about 18 weeks from the time of filling the at least portion of the formed void with the bone regenerative material and decreases over time to a score of about −

1.0 to about 2.0.

22. The method of claim 21, wherein the T-score decreases over time to a score of about −

0.5 to about 2.0.

23. The method of claim 22, wherein the T-score decreases to a score of about −

0.5 to about 2.0 within a time of about 6 weeks to about 12 months after achieving the maximum T-score.

24. The method of claim 21, wherein the BMD profile in the localized area of the bone is such that T-score remains in the range substantially corresponding to normal bone of about −

1.0 to about 2.0 for a time of at least 1 year after the normal range is achieved.

25. The method of claim 1, wherein the localized area of the degenerative bone is remodeled, to be substantially identical to normal bone in that whereby the bone material in the localized area before forming the void has a T-score, as measured by Dual Energy Xray Absorptiometry (DEXA), of less than −

1.0 indicating bone degeneration, and new bone material present after remodeling has a T-score of greater than −

1.0 indicating the bone in the localized area has been remodeled to be substantially identical to normal bone.

26. The method of claim 25, wherein the new bone material present after remodeling has a T-score of at least −

0.5.

27. The method of claim 25, wherein the new bone material present after remodeling has a T-score of at least 0.

28. The method of claim 25, wherein the new bone material present after remodeling has a T-score of about −

0.5 to about 2.

29. The method of claim 1, wherein the method restores vertebral body height or corrects angular deformity in a fractured vertebra that is osteopenic or osteoporotic by causing in-growth of new bone material that has a T-score, as measured by Dual Energy X-ray Absorptiometry (DEXA), of greater than −

1.0.

30. The method of claim 29, wherein the T-score of the new bone material is at least −

0.5.

31. The method of claim 1, wherein the method steps are carried out using instruments from a kit comprising a drill arranged for forming a channel of a defined diameter through a portion of the bone, a debridement probe, and an amount of the bone regenerative material suitable for filling the at least portion of the formed void in the localized area of the bone.

32. The method of claim 31, wherein the method steps are carried out according to an instruction set included with the kit that instructs how to use the kit components to treat the patient suffering from the degenerative bone condition.

33. The method of claim 1, wherein the bone regenerative material further includes a biologically active agent.

34. The method of claim 1, wherein the bone regenerative material comprises a mixture of a calcium sulfate dehydrate phase characterized by a first in vivo resorption rate, a brushite phase characterized by a second in vivo resorption rate slower than the first in vivo resorption rate, and a β

-tricalcium phosphate granule phase characterized by a third in vivo resorption rate slower than the second in vivo resorption rate.

35. The method of claim 1, wherein the bone regenerative material is formed from a particulate composition comprising:

i) an a-calcium sulfate hemihydrate powder at a concentration of at least about 50 weight percent based on the total weight of the particulate composition; and

ii) a combination of two calcium phosphate powders capable of reacting to form brushite in the presence of an aqueous solution.

36. The method of claim 35, wherein the a-calcium sulfate hemihydrate is present in the particulate composition at a concentration of at least about 70 weight percent based on the total weight of the particulate composition.

37. The method of claim 35, wherein the particulate composition further comprises β

-tricalcium phosphate granules.

38. The method of claim 37, wherein the β

-tricalcium phosphate granules are present in the particulate composition at a concentration of about 8 to about 12 weight percent based on the total weight of the particulate composition.

39. The method of claim 1, wherein the bone for void formation is selected from a group consisting of a hip bone, innominate bone, coxal bone, and a portion of the femur including a head, neck, greater trochanter, lesser trochanter or Ward'"'"'s area of a femur.

40. The method of claim 1, wherein the bone regenerative material consists essentially of calcium sulfate, calcium phosphate, and tricalcium phosphate granules and exhibits a tri-phasic profile in vivo.

41. The method of claim 1, wherein the step of forming a void comprises drilling or channeling into the interior of the localized area of the bone.

42. The method of claim 1, wherein the step of forming a void comprises breaking apart the bone materials at the localized area of the bone.

43. The method of claim 1, wherein step of forming a void comprises removing at least a portion of the bone material at the localized area of the bone.