Use of morphogenetic proteins to treat human disc disease

• US 7,435,260 B2
• Filed: 06/25/2004
• Issued: 10/14/2008
• Est. Priority Date: 08/13/1999
• Status: Expired due to Fees

• Current Assignee: Anova Corp.
• Original Assignee: Anova Corp.
• Inventors: Ferree, Bret A.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/876,792
• Publication Number:
  US 20040230310A1
• Time in Patent Office: 1,572 Days
• Field of Search: 623 1711- 1716, 623/925, 606/91
• US Class Current: 623/17.11
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• 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 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4445 Means for culturing intervertebral disc tissue
• CPC Class Codes: A61F 2002/445 Intervertebral disc tissue harvest sites
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/3658 Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442
• CPC Class Codes: A61L 27/3856 Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

Bone morphogenetic proteins (BMPs) are introduced into an affected intervertebral disc without the inclusion of disc cells. The inventions applies to all known and yet-to-be developed or discovered BMPs, including BMP-1, -2, -3, -4, -5, -6, -7, -8, -9, -10, . . . BMPn. The BMP(s) may be obtained from natural and/or recombinant sources. The BMP(s) may be introduced using any surgical technique, including percutaneous or laparoscopic approaches. As one delivery mechanism, a passageway may be formed through the annulus, with the substances then being introduced through the passageway. Alternatively, a carrier may be sewn or otherwise adhered to the inside or outside of the existing annulus using standard surgical procedures. Additional therapeutic substances such as culture medium, growth factors, differentiation factors, hydrogels, polymers, antibiotics, anti-inflammatory medications, or immunosuppressive medications could be introduced in conjunction with the BMP(s).

Claims

1. A method treating human disc disease, comprising the steps of:

providing a slurry of a dose of a bone morphogenetic protein (BMP) and a carrier; and

introducing the slurry into an intervertebral disc through a passageway formed in an annulus of the vertebral disc.

2. The method of claim 1, further including the step of introducing the BMP through a percutaneous or laparoscopic procedure.

3. The method of claim 1, further including the step of adding one or more therapeutic substances to the dose of a BMP.

4. The method of claim 3, wherein the therapeutic substances include one or more of the following:

culture media, growth factors, differentiation factors, hydrogels, polymers, antibiotics, anti-inflammatory medications, or immunosuppressive medications.

5. The method of claim 1, wherein the dose is from 0.04 micrograms to 32 mg.

6. The method of claim 1, wherein the BMP is recombinantly generated BMP.

7. A method treating human disc disease, comprising:

providing a slurry of a dose of a recombinantly generated bone morphogenetic protein and a carrier; and

introducing the slurry into an intervertebral disc.

8. The method of claim 7, further comprising introducing the recombinantly generated bone morphogenetic protein through a percutaneous or laparoscopic procedure.

9. The method of claim 7, further comprising adding one or more therapeutic substances to the dose of a recombinantly generated bone morphogenetic protein.

10. The method of claim 9, wherein the therapeutic substances include one or more of the following:

culture media, growth factors, differentiation factors, hydrogels, polymers, antibiotics, anti-inflammatory medications, or immunosuppressive medications.

11. The method of claim 7, wherein the dose is from 0.04 micrograms to 32 mg.

12. A method treating human disc disease, comprising:

providing a sponge carrier and a dose of a bone morphogenetic protein in contact with the sponge carrier; and

adhering the sponge carrier to the outside of an existing intervertebral disc annulus.

13. The method of claim 12, wherein the bone morphogenetic protein is recombinantly generated bone morphogenetic protein.

14. The method of claim 12, further comprising adding one or more therapeutic substances to the dose of a bone morphogenetic protein in contact with the sponge carrier.