Method and device for treating intervertebral disc herniations

• US 6,805,715 B2
• Filed: 05/16/2002
• Issued: 10/19/2004
• Est. Priority Date: 10/09/2001
• Status: Expired due to Fees

• Current Assignee: PMT Corporation
• Original Assignee: PMT Corporation
• Inventors: Reuter, Merrill W., Reuter, Gerald L., Rehder, Carey D.
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Priddy, Michael B.
• Application Number:
  US10/147,580
• Publication Number:
  US 20030069641A1
• Time in Patent Office: 887 Days
• Field of Search: 623/17-1-
• US Class Current: 623/17.12
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30672 temporary
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A method and device for treating human intervertebral disc herniations using an endoscopic procedure. An access port is opened into and through the annulus of a disc to remove nucleus pulposus. Laser light fibers may then be passed through an endoscopic guide tube to anneal the inner surface of the disc annulus. Next, a balloon assembly with a valve is placed via the guide tube into the created disc space. The balloon is filled with a fluid to occupy the disc interspace or to maintain some degree of distraction of the created disc space. Post surgery, after fibrocollagenous tissue has grown into the disc space, a second endoscopic procedure is performed to remove the balloon assembly. Fluid is removed to collapse the balloon structure and then removed via the guide tube. The ingrowth of fibrocollagenous tissue will continue to fill the void formerly occupied by the balloon structure. The minimally invasive procedure of the invention allows for short term recovery and early return to normal activity.

Claims

1. In a method for treating a herniated intervertebral disc utilizing an endoscopic procedure, comprising the steps of:

a) creating an access port in the annulus of the herniated disc;

b) removing nucleus pulposus from the disc through said access port and creating a disc space;

c) inserting and inflating a balloon structure in said disc space;

d) allowing the growth of fibrocartilegenus tissue in said disc space; and

e) removing said balloon structure between one month and three years and subsequent the ingrowth of said fibrocartilegenus tissue.

2. The method of claim 1, wherein the disc space and the access port in the annulus are treated prior to step c).

3. The method of claim 2, wherein a powdered hydroxyapatite cell culture material or a homologous tissue cell culture seeding is placed in the disc space and wherein the access port is annealed by means of laser irradiation after step b).

4. The method of claim 1, wherein said access port provided has a diameter between 2.0 mm and 6.0 mm and wherein said balloon structure occupies or distracts said disc space.

5. The method of claim 1, wherein said balloon structure includes a radiolucent material.

6. The method of claim 1, wherein said balloon structure provided comprises a flexible balloon member and a nubbin portion and further wherein a valve member is positioned in said nubbin member.

7. The method of claim 6, wherein said balloon structure is filled with a physiological fluid.

8. A method of treating a herniated intervertebral disc comprising:

a) utilizing an endoscopic procedure and creating an access port having a diameter between 2.0 mm and 6.0 mm in the annulus of the herniated disc;

b) removing the nucleus pulposus of said herniated disc to thereby reduce pressure caused by the herniation and thereby creating a disc space;

c) annealing the inner surface of the annulus by means of laser irradiation;

d) inserting a flexible balloon assembly through said annulus and into the disc space and inflating the balloon in the disc space;

e) permitting fibrocartiligenous tissue to grow in the disc space; and

f) removing the balloon from the disc space.

9. The method of claim 8, wherein the access port created has a diameter of approximately 2.5 to 3.5 mm.

10. The method of claim 8, wherein the flexible balloon has a nubbin and a valve in said nubbin and wherein the nubbin is placed within in the access port of the annulus of the affected intervertebral disc.

11. The method of claim 10, wherein at least a portion of said balloon assembly is radiolucent.

12. The method of claim 8, wherein a second endoscopic surgery procedure is performed to remove the balloon assembly.

13. The method of claim 8, wherein hydroxyapatite is infused into the intervertebral disc space prior to the balloon assembly placement, said hydroxyapatite to facilitate the ingrowth of tissue in the disc space.

14. The method of claim 8, wherein said endoscopic procedure includes incising the skin and passing an endoscopic guide tube therethrough.

15. The method of claim 14, wherein said guide tube is a long radiolucent needle-like probe having an internal diameter of approximately 2.5 millimeters.

16. The method of claim 14, wherein said endoscopic instrument is removed after the insertion of the balloon assembly and whereby the incision is closed by a suture, bonding agent or an adhesive bandage.

17. The method of claim 14, wherein an imaging technique is utilized to guide the endoscopic guide tube.

18. The method of claim 8, wherein said flexible balloon assembly is expanded with physiological normal saline.

19. The method of claim 8, wherein powdered hydroxyapatite, cell culture material or a homologous tissue cell culture seeding is placed in the disc space prior to the placement of the balloon assembly to facilitate the ingrowth of structural tissue.

20. The method of claim 8, wherein said flexible balloon assembly occupies or distracts the disc space.

21. The method of claim 8, wherein the balloon assembly is removed from the disc space between one month to three years after insertion.

22. The method of claim 21, wherein the balloon is deflated and removed via a guide tube and through the port in the annulus.

23. A method for treating a herniated intervertebral disc utilizing an endoscopic procedure, comprising the steps of:

a) creating an access port in the annulus of the herniated disc;

b) removing nucleus pulposus from the disc through said access port and creating a disc space;

c) annealing said disc space and said access port by means of laser irradiation;

d) placing a powdered hydroxyapatite cell culture material or a homologous tissue cell culture seeding in said disc space; and

e) inserting and inflating a balloon structure in said disc space.

24. The method of claim 23, wherein said balloon structure is removed from said disc space subsequent the ingrowth of fibrocartilegenus tissue in said disc space.

25. The method of claim 23, wherein said balloon structure is inflated to occupy or distract said disc space.

26. The method of claim 23, wherein said balloon structure provided comprises a flexible balloon member and a nubbin portion and further wherein a valve member is positioned in said nubbin member and wherein said balloon structure is filled with a physiological fluid.

27. The method of claim 23 wherein said balloon structure includes a radiolucent material.

28. The method of claim 23, wherein said access port provided has a diameter between 2.0 mm and 6.0 mm and wherein said endoscopic procedure includes incising the skin and passing an endoscopic guide tube therethrough, wherein an imaging technique is utilized to guide the endoscopic guide tube and wherein a second endoscopic surgery procedure is performed to remove the balloon assembly.

29. The method of claim 23, wherein said balloon structure includes a radiolucent material.

30. A method for treating a herniated intervertebral disc utilizing an endoscopic procedure, comprising the steps of:

a) creating an access port in the annulus of the herniated disc,

b) removing nucleus pulposus from the disc through said access port and creating a disc space;

c) inserting and inflating a balloon structure in said disc space, said balloon structure provided being comprised of a flexible balloon member and a nubbin portion having a valve member; and

d) filling said balloon structure with a physiological fluid.

31. The method of claim 30, wherein said balloon structure is removed from said disc space subsequent the ingrowth of fibrocartilegenus tissue in said disc space.

32. The method of claim 30, annealing the disc space and the access port in the annulus by means of laser irradiation after step b) and placing a powdered hydroxyapatite cell culture material or a homologous tissue cell culture seeding in said disc space.

33. The method of claim 30, wherein said access port provided has a diameter between 2.0 mm and 6.0 mm and wherein said endoscopic procedure includes incising the skin and passing an endoscopic guide tube therethrough, wherein an imaging technique is utilized to guide the endoscopic guide tube and wherein a second endoscopic surgery procedure is preformed to remove the balloon assembly.

34. The method of claim 30, wherein said flexible balloon assembly is expanded with physiological normal saline.

35. The method of claim 30, wherein said flexible balloon assembly is inflated to occupy or distract the disc space.