Interspinous distraction devices and associated methods of insertion

• US 20060089654A1
• Filed: 10/25/2005
• Published: 04/27/2006
• Est. Priority Date: 10/25/2004
• Status: Active Grant

• Current Assignee: Zimmer Biomet Spine, Inc. (Zimvie Incorporated)
• Original Assignee: Lanx Medical, Inc.
• Inventors: Lins, Robert E., Lins, Loren E., Simovitch, Harvey
• Granted Patent: US 8,007,517 B2
• Time in Patent Office: Days
• US Class Current: 606/90
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image

Abstract

In various exemplary embodiments, the present invention provides a plurality of novel interspinous distraction devices and associated methods of insertion. The interspinous distraction devices of the present invention are designed and configured to effectively treat such conditions as lumbar spinal stenosis and degenerative disc disease. Advantageously, the interspinous distraction devices of the present invention may be inserted through conventional open procedures, typically requiring a relatively large incision and a general anesthetic, or through novel minimally-invasive procedures, typically requiring only a local anesthetic. These novel minimally-invasive procedures and related enabling devices are also disclosed and described herein.

Claims

1. An interspinous distraction device for treating such conditions as lumbar spinal stenosis and degenerative disc disease, the interspinous distraction device comprising:

a body assembly configured to be disposed between adjacent spinous processes of the spinal column of a patient, wherein the body assembly is sized such that the body assembly distracts the adjacent spinous processes apart; and

a plurality of attachment arms selectively extending outwardly from the body assembly in the direction of each of the adjacent spinous processes, the plurality of attachment arms configured to be disposed about a portion of each of the adjacent spinous processes and securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.

2. The interspinous distraction device of claim 1, wherein the body assembly has a height of between about 4 mm and about 20 mm, a width of between about 10 mm and about 25 mm, and a thickness of between about 10 mm and about 20 mm.

3. The interspinous distraction device of claim 1, wherein the body assembly has a shape selected from the group consisting of substantially rectangular, substantially square, substantially oval, substantially circular, and a combination thereof.

4. The interspinous distraction device of claim 1, wherein the body assembly comprises a circumferential wall defining an interior void.

5. The interspinous distraction device of claim 4, wherein a portion of each of the plurality of attachment arms passes through an opening in the circumferential wall of the body assembly.

6. The interspinous distraction device of claim 4, wherein the body assembly further comprises a filler plug disposed within the interior void defined by the circumferential wall of the body assembly.

7. The interspinous distraction device of claim 1, wherein the exterior of the body assembly comprises one or more friction surfaces selected from the group consisting of one or more ridged surfaces, one or more grooved surfaces, one or more corrugated surfaces, one or more pebbled surfaces, and a combination thereof, the one or more friction surfaces configured to securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.

8. The interspinous distraction device of claim 1, wherein the exterior of the body assembly comprises one or more fin structures configured to securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.

9. The interspinous distraction device of claim 1, wherein each of the plurality of attachment arms has a length of between about 4 mm and about 20 mm.

10. The interspinous distraction device of claim 1, wherein each of the plurality of attachment arms is selectively extendable outwardly from/retractable inwardly into the body assembly.

11. The interspinous distraction device of claim 1, wherein the body assembly and the plurality of attachment arms each comprise a material selected from the group consisting of a medically-implantable, corrosion-resistant metal;

a medically-implantable, corrosion-resistant metal alloy;

a medically-implantable plastic;

a medically-implantable ceramic; and

a combination thereof.

12. A dilation tube system for providing minimally-invasive surgical access to a portion of the spinal column or the like, the dilation tube system comprising:

a hollow dilation tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis, wherein the first end of the dilation tube comprises a cut-away portion for providing access from an interior portion of the dilation tube to an exterior portion of the dilation tube in a direction perpendicular to the longitudinal axis of the dilation tube.

13. The dilation tube system of claim 12, further comprising a hollow guide tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis disposed concentrically within the dilation tube, wherein the first end of the guide tube comprises an elbow portion for providing access from an interior portion of the guide tube to an exterior portion of the guide tube in a direction perpendicular to the longitudinal axis of the guide tube through the cut-away portion of the dilation tube.

14. The dilation tube system of claim 13, wherein the dilation tube and the guide tube each have a cross-sectional shape selected from the group consisting of substantially circular, substantially oval, substantially square, substantially rectangular, substantially triangular, and a combination thereof.

15. The dilation tube system of claim 13, wherein the dilation tube and the guide tube each have a diameter of between about 18 mm and about 22 mm.

16. The dilation tube system of claim 13, wherein the dilation tube and the guide tube each comprise a material selected from the group consisting of a medically-implantable, corrosion-resistant metal;

a medically-implantable, corrosion-resistant metal alloy;

a medically-implantable plastic;

a medically-implantable ceramic; and

a combination thereof.

17. The dilation tube system of claim 13, further comprising a plurality of additional dilation tubes, each of the plurality of additional dilation tubes having a diameter that is smaller than the diameter of the dilation tube, wherein each of the plurality of additional dilation tubes is selectively and temporarily disposed concentrically within the dilation tube.

18. A method for inserting an interspinous distraction device for treating such conditions as lumbar spinal stenosis and degenerative disc disease, the method for inserting the interspinous distraction device comprising:

disposing a body assembly between adjacent spinous processes of the spinal column of a patient, wherein the body assembly is sized such that the body assembly distracts the adjacent spinous processes apart; and

extending a plurality of attachment arms outwardly from the body assembly, the plurality of attachment arms disposed about a portion of each of the adjacent spinous processes and securely holding the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.

19. The method for inserting the interspinous distraction device of claim 18, wherein the body assembly has a height of between about 4 mm and about 20 mm, a width of between about 10 mm and about 25 mm, and a thickness of between about 10 mm and about 20 mm.

20. The method for inserting the interspinous distraction device of claim 18, wherein the body assembly has a shape selected from the group consisting of substantially rectangular, substantially square, substantially oval, substantially circular, and a combination thereof.

21. The method for inserting the interspinous distraction device of claim 18, wherein the body assembly comprises a circumferential wall defining an interior void.

22. The method for inserting the interspinous distraction device of claim 21, wherein a portion of each of the plurality of attachment arms passes through an opening in the circumferential wall of the body assembly.

23. The method for inserting the interspinous distraction device of claim 21, further comprising disposing a filler plug within the interior void defined by the circumferential wall of the body assembly.

24. The method for inserting the interspinous distraction device of claim 18, wherein the exterior of the body assembly comprises one or more friction surfaces selected from the group consisting of one or more ridged surfaces, one or more grooved surfaces, one or more corrugated surfaces, one or more pebbled surfaces, and a combination thereof, the one or more friction surfaces configured to securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.

25. The method for inserting the interspinous distraction device of claim 18, wherein the exterior of the body assembly comprises one or more fin structures configured to securely hold the body assembly in place relative to each of the adjacent spinous processes of the spinal column of the patient.

26. The method for inserting the interspinous distraction device of claim 18, wherein each of the plurality of attachment arms has a length of between about 4 mm and about 20 mm.

27. The method for inserting the interspinous distraction device of claim 18, wherein each of the plurality of attachment arms is selectively extendable outwardly from/retractable inwardly into the body assembly.

28. The method for inserting the interspinous distraction device of claim 18, wherein the body assembly and the plurality of attachment arms each comprise a material selected from the group consisting of a medically-implantable, corrosion-resistant metal;

a medically-implantable, corrosion-resistant metal alloy;

a medically-implantable plastic;

a medically-implantable ceramic; and

a combination thereof.

29. The method for inserting the interspinous distraction device of claim 18, wherein the body assembly is disposed between adjacent spinous processes of the spinal column of the patient through a hollow dilation tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis, wherein the first end of the dilation tube comprises a cut-away portion for providing access from an interior portion of the dilation tube to an exterior portion of the dilation tube in a direction perpendicular to the longitudinal axis of the dilation tube.

30. The method for inserting the interspinous distraction device of claim 29, wherein the body assembly is disposed between adjacent spinous processes of the spinal column of the patient through a hollow guide tube having a first end, a second end, a given cross-sectional shape, and a longitudinal axis disposed concentrically within the dilation tube, wherein the first end of the dilation tube comprises an elbow portion for providing access from an interior portion of the guide tube to an exterior portion of the guide tube in a direction perpendicular to the longitudinal axis of the guide tube through the cut-away portion of the dilation tube.

31. An interspinous distraction device for treating such conditions as lumbar spinal stenosis and degenerative disc disease, the interspinous distraction device comprising:

a body assembly configured to be disposed between adjacent spinous processes of the spinal column of a patient, wherein the body assembly is sized such that the body assembly distracts the adjacent spinous processes apart; and

a band configured to be disposed about the adjacent spinous processes of the spinal column of the patient and engage the body assembly, wherein the band is sized such that the adjacent spinous processes are stabilized with respect to one another.

32. The interspinous distraction device of claim 31, wherein the band has a circumferential length of between about 60 mm and about 150 mm.

33. A tool for inserting an interspinous distraction device through a dilation tube having a laterally-oriented opening, the tool comprising:

a shaft portion having a first end and a second end;

a handle portion attached to the first end of the shaft portion; and

a cutting portion attached to the second end of the shaft portion, the cutting portion comprising a cutting edge that is substantially directed towards the first end of the shaft portion.

34. A tool for inserting an interspinous distraction device through a dilation tube having a laterally-oriented opening, the tool comprising:

a shaft portion having a first end and a second end;

a handle portion attached to the first end of the shaft portion; and

a plurality of paddles attached to the second end of the shaft portion, the plurality of paddles operable for distracting apart adjacent spinous processes of a spinal column of a patient in response to selective actuation of the handle portion.

35. A tool for inserting an interspinous distraction device through a dilation tube having a laterally-oriented opening, the tool comprising:

a shaft portion having a first end and a second end;

a handle portion attached to the first end of the shaft portion; and

a sizing portion attached to the second end of the shaft portion, the sizing portion selectively sized to fit between adjacent spinous processes of a spinal column of a patient, thereby determining the size of a space between the adjacent spinous processes of the spinal column of the patient.

36. The tool of claim 35, wherein the sizing portion is attached to the second end of the shaft portion at a non-parallel angle to the shaft portion.