Methods and instruments for treating pseudoarthrosis

• US 20040064058A1
• Filed: 10/24/2003
• Published: 04/01/2004
• Est. Priority Date: 10/24/2001
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William F.
• Granted Patent: US 8,002,775 B2
• Time in Patent Office: Days
• US Class Current: 600/506
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

Methods, instruments, and kits for treating spinal pseudoarthrosis are provided. In one embodiment, a method includes delivering to a location of spinal pseudoarthrosis an effective amount of an osteoinductive composition that includes an injectible osteoinductive composition that includes an injectible osteoinductive composition in a pharmaceutically acceptable carrier. In other embodiments, cannulated drills 10, 10′, 10″ and surgical instrument assemblies, 50, 50′ including a drill and a syringe 60 and 60′ wherein the syringe has a distal end that is matingly engaged to a proximal end of the drill are provided The drill and other instruments, instrument assemblies, and kits formed therefrom may advantageously be used in a method for treating pseudoarthrosis.

Claims

1. A method of treating pseudoarthrosis, comprising:

identifying a site of spinal pseudoarthrosis; and

delivering to a location of the pseudoarthrosis an effective amount of injectible osteoinductive composition, in a pharmaceutically acceptable carrier, effective for promoting bone growth for treating said pseudoarthrosis.

2. The method of claim 1, wherein said osteoinductive composition comprises a bone morphogenetic protein.

3. The method of claim 2, wherein said bone morphogenetic protein is selected from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, a mixture thereof and a heterodimer thereof.

4. The method of claim 3, wherein said bone morphogenetic protein is a recombinant protein.

5. The method of claim 4, wherein said recombinant protein is selected from the group consisting of rhBMP-2, rhBMP-7, a mixture thereof and a heterodimer thereof.

6. The method of claim 1, wherein said osteoinductive composition comprises an adenovirus capable of eliciting intracellular production of a LIM mineralization protein.

7. The method of claim 6, wherein said LIM mineralization protein is LMP-1.

8. The method of claim 1, wherein said carrier is a calcium phosphate cement.

9. The method of claim 1, wherein said carrier is selected from the group consisting of a resorbable cement, carboxymethylcellulose, polylactic acid, polyglycolic acid, alternating copolymers of polylactic acid and polyglycolic acid, hyaluronic acid, glycosaminoglycan and mixtures thereof.

10. The method of claim 1, wherein said delivering comprises:

advancing an elongated member having a proximal end, a distal end and a lumen extending longitudinally therethrough to said location of pseudoarthrosis; and

advancing said osteoinductive composition through said lumen of said elongated member to said location of pseudoarthrosis.

11. The method of claim 10, wherein said elongated member is connected to a osteoinducive composition delivery device.

12. The method of claim 10, wherein said elongated member comprises at least one bone removing surface.

13. The method of claim 1, further comprising forming at least one channel in a tissue mass at the location of the spinal pseudoarthrosis.

14. The method of claim 1, wherein said location of pseudoarthrosis has a pseudoarthrotic mass, said method further comprising creating a channel in the bone adjacent the pseudoarthrotic mass, and delivering said osteoinductive composition such that it extends from the channel within the bone on one side of the fibrous tissue of the pseudoarthrotic mass, through a fibrous tissue and into the channel created in the bone on the opposing side of the fibrous tissue.

15. The method of claim 1, wherein said location of spinal pseudoarthrosis has a pseudoarthrotic mass and said pseudoarthrotic mass is located at an interbody fusion site.

16. The method of claim 1, wherein said location of pseudoarthrosis has a pseudoarthrotic mass and said pseudoarthrotic mass is located at a transverse process fusion site of one or more vertebral bodies.

17. The method of claim 1 wherein said pseudoarthrotic mass is located proximal to a bone fracture.

18. The method of claim 17 wherein the bone fracture has at least partially healed.

19. The method of claim 1 wherein said pseudoarthrotic mass is located proximal to a long bone.

20. A method of treating spinal pseudoarthrosis in a patient, comprising:

advancing a first elongated member having a proximal end, a distal end and a lumen extending longitudinally therethrough to a location of spinal pseudoarthrosis in the patient; and

advancing an injectible osteoinductive composition through said lumen of said first elongated member to said location, said osteoinductive composition comprising an osteoinductive factor in a pharmaceutically acceptable carrier.

21. The method of claim 20, wherein said advancing a first elongated member comprises advancing said first elongated member into fibrous tissue of a pseudoarthrotic mass of said location.

22. The method of claim 20, wherein said first elongated member has a distal end with at least one bone cutting edge.

23. The method of claim 20, wherein said first elongated member has a plurality of apertures extending along at least a portion of a length of said first elongated member.

24. The method of claim 20, wherein said location of spinal pseudoarthrosis has a pseudoarthrotic mass, said method further comprising creating a channel in a bone adjacent the pseudoarthrotic mass, and delivering said osteoinductive composition such that it extends from the channel within the bone on one side of a fibrous tissue of the pseudoarthrotic mass, through the fibrous tissue and into the channel created in the bone on the other side of the fibrous tissue.

25. The method of claim 20, wherein said method further comprises:

advancing a second elongated member to a location of spinal pseudoarthrosis prior to advancing said first elongated member, said second member having a proximal end, a distal end and a lumen extending longitudinally therethrough, said distal end having at least one bone cutting edge; and

retracting said second elongated member.

26. The method of claim 25, wherein said second elongated member has a plurality of apertures extending along at a length of said second elongated member.

27. A method of treating spinal pseudoarthrosis in a patient, comprising:

advancing an elongated member -into a pseudoarthrotic mass in said patient, said elongated member having a proximal end, a distal end and a lumen extending longitudinally therethrough, said distal end of said member having at least one bone cutting edge; and

advancing an osteoinductive composition through said lumen of said elongated member to said pseudoarthritic mass, said osteoinductive composition extending across said pseudoarthrotic mass, said osteoinductive composition comprising an osteoinductive factor in a pharmaceutically acceptable carrier and effective in promoting bone growth for treating said spinal pseudoarthrosis.

28. The method of claim 27, wherein said osteoinductive composition includes cells transformed with a nucleotide sequence encoding an osteoinductive factor, said nucleotide sequence operably connected to a promoter sequence, whereby said osteoinductive factor is produced in vivo.

32. The drill of claim 27, further comprising an elongated obturator, said obturator slidably disposed in said lumen of said elongated member.

33. The drill of claim 27, wherein said elongated member has a plurality of apertures extending along its length.

29. A cannulated drill, comprising an elongated member formed of a biocompatible material and having a proximal end, a distal end, an inner surface, and an outer surface, said inner surface defining a lumen, said lumen extending along the length of said elongated member and sized to receive an elongated obturator, said distal end of said elongated member having at least one bone cutting edge, said proximal end of said elongated member having a connector configured for matingly engaging a distal end of a syringe to said proximal end of said elongated member.

30. The drill of claim 29, wherein said elongated member is cylindrical.

31. The drill of claim 29, wherein said elongated member is formed of a biocompatible metallic material.

34. A surgical instrument assembly, comprising:

a cannulated drill, said drill comprising an elongated member formed of a biocompatible material and having a proximal end, a distal end, an inner surface, and an outer surface, said inner surface defining a lumen, said lumen extending along the length of said elongated member, said distal end having at least one bone cutting edge, said proximal end having a connector for matingly engaging a distal end of a syringe to said proximal end of said elongated member; and

a syringe, said syringe having a housing defining a cavity, said housing having a proximal end and a distal end, said distal end of said syringe matingly engageable to said proximal end of said elongated member, said lumen of said elongated member and said cavity of said housing in fluid communication when said distal end of said syringe is matingly engaged to said proximal end of said elongated member.

35. The assembly of claim 34, further comprising a plunger having a plunger head, said cavity of said housing adapted to receive said plunger.

36. The assembly of claim 34, wherein said connector is a luer-lock connector.

37. The assembly of claim 34, wherein said elongated member has a plurality of apertures extending along a length of said elongated member.

38. A kit for treating pseudoarthrosis, comprising:

a cannulated drill, said drill comprising an elongated member formed of a biocompatible material and having a proximal end, a distal end, an inner surface, and an outer surface, said inner surface defining a lumen, said lumen extending along the length of said elongated member, said distal end having at least one bone cutting edge, said proximal end having a connector for matingly engaging a distal end of a syringe to said proximal end of said elongated member;

an elongated obturator sized to fit within said lumen of said drill; and

a syringe, said syringe having a housing defining a cavity, said housing having a proximal end and a distal end, said distal end of said syringe matingly engageable to said proximal end of said elongated member, said lumen of said elongated member and said cavity of said housing in fluid communication when said distal end of said syringe is matingly engaged to said proximal end of said elongated member.