PERCUTANEOUS SPINAL STENOSIS TREATMENT

• US 20080103504A1
• Filed: 10/10/2007
• Published: 05/01/2008
• Est. Priority Date: 10/30/2006
• Status: Abandoned Application

• Current Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Smith, Scott, Miller, Eric, Bleich, Jeffery, SCHMITZ, Gregory
• Application Number:
  US11/870,370
• Publication Number:
  US 20080103504A1
• Time in Patent Office: Days
• US Class Current: 606/79
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2090/0427 Prevention of contact
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4893 Nerves

Abstract

A method for percutaneously removing ligamentum flavum tissue in a spine to treat spinal stenosis may involve percutaneously advancing a distal portion of a tissue removal cannula into the ligamentum flavum tissue, uncovering a side-opening aperture disposed on the distal portion of the cannula to expose a tissue cutter disposed in the cannula, and cutting ligamentum flavum tissue using the tissue cutter while the aperture is uncovered. A device for percutaneously removing ligamentum flavum tissue in a spine to treat spinal stenosis may include a cannula including a side-facing aperture, an aperture cover slidably coupled with the cannula and configured to advance and retract to cover and uncover the aperture, and a tissue cutter slidably disposed within the cannula and configured to extend through the aperture to cut ligamentum flavum tissue.

Claims

1. A method for percutaneously removing ligamentum flavum tissue in a spine to treat spinal stenosis, the method comprising:

percutaneously advancing a distal portion of a tissue removal cannula into the ligamentum flavum tissue;

uncovering a side-opening aperture disposed on the distal portion of the cannula to expose a tissue cutter disposed in the cannula; and

cutting ligamentum flavum tissue using the tissue cutter while the aperture is uncovered.

2. A method as in claim 1, wherein uncovering the aperture comprises retracting an inner cannula through the tissue removal cannula.

3. A method as in claim 1, wherein cutting ligamentum flavum tissue comprises cutting tissue using a tissue cutter selected from the group consisting of blades, abrasive surfaces, files, rasps, saws, planes, electrosurgical devices, bipolar electrodes, monopolar electrodes, thermal electrodes, cold ablation devices, rotary powered mechanical shavers, reciprocating powered mechanical shavers, powered mechanical burrs, lasers, ultrasound devices, cryogenic devices, and water jet devices.

4. A method as in claim 3, wherein the ligamentum flavum tissue is cut using a radiofrequency device, and wherein the method further comprises, before the uncovering step, activating the radiofrequency device.

5. A method as in claim 1, further comprising, before the uncovering step:

articulating the distal portion of the cannula relative to the proximal portion; and

advancing the articulated distal portion at least partway into an intervertebral foramen of the spine.

6. A method as in claim 1, further comprising extending the cutter out of the aperture before the cutting step.

7. A method as in claim 1, further comprising removing the cut ligamentum flavum tissue through the cannula.

8. A method as in claim 7, wherein removing the cut tissue comprises applying suction to the cannula.

9. A method as in claim 7, wherein removing the cut tissue comprises:

engaging the cut tissue with the tissue cutter or a separate tissue engaging member; and

retracting the tissue cutter or tissue engaging member through the cannula.

10. A method as in claim 1, further comprising introducing a substance through the side-facing aperture of the cannula, the substance selected from the group consisting of a hemostatic agent, an analgesic, an anesthetic and a steroid.

11. A method as in claim 1, further comprising, before the cutting step:

activating a nerve stimulator coupled with the distal portion of the cannula; and

monitoring for response to the activation.

12. A method as in claim 1, further comprising deploying a shield between the cannula and non-target tissue before the cutting step.

13. A method as in claim 12, further comprising, before the cutting step:

activating a nerve stimulator coupled with the shield; and

monitoring for response to the activation.

14. A method for percutaneously removing ligamentum flavum tissue in a spine to treat spinal stenosis, the method comprising:

percutaneously advancing a distal portion of a tissue removal cannula into the ligamentum flavum tissue;

activating at least a first nerve stimulator coupled with the distal portion of the cannula;

monitoring for response to the activation;

uncovering a side-opening aperture disposed on the distal portion of the cannula to expose a tissue engaging member disposed in the cannula;

engaging ligamentum flavum tissue with the tissue engaging member; and

cutting ligamentum flavum tissue with a tissue cutter disposed in or on the cannula.

15. A method as in claim 14, further comprising, before the uncovering step:

activating at least a second nerve stimulator coupled with the distal portion of the cannula apart from the first nerve stimulator;

monitoring for response to activation; and

comparing an amount of activation required to illicit a response using the first nerve stimulator with an amount of activation required to illicit a response using the second nerve stimulator.

16. A method as in claim 14, wherein cutting the ligamentum flavum tissue comprises advancing an inner cannula having a sharp distal end and disposed around the tissue engaging member and within the tissue removal cannula.

17. A method for percutaneously removing ligamentum flavum tissue in a spine to treat spinal stenosis, the method comprising:

coupling a flexible distal portion of a tissue removal cannula with one end of a guidewire;

pulling the flexible distal portion into the ligamentum flavum tissue by pulling the guidewire;

uncovering a side-opening aperture disposed on the distal portion of the cannula to expose a tissue cutter disposed in the cannula; and

cutting ligamentum flavum tissue using the tissue cutter.

18. A method as in claim 17, further comprising applying tensioning force to the tissue removal cannula and the guidewire, before the cutting step, to urge the aperture against the ligamentum flavum tissue.

19. A method for percutaneously removing ligamentum flavum tissue in a spine to treat spinal stenosis, the method comprising:

percutaneously advancing a flexible distal portion of a tissue removal device into at least one of an epidural space or a ligamentum flavum of the spine;

activating an energy delivery member disposed on or in the distal portion of the tissue removal device; and

cutting ligamentum flavum tissue with the activated energy delivery member.

20. A method as in claim 19, wherein advancing the distal portion comprises pulling the distal portion behind a guidewire.

21. A method as in claim 19, wherein the distal portion is advanced at least partway into an intervertebral foramen of the spine.

22. A method as in claim 19, wherein activating the energy delivery member comprises activating a member selected from the group consisting of electrosurgical devices, bipolar electrodes, monopolar electrodes, thermal electrodes, cold ablation devices, lasers, ultrasound devices and cryogenic devices.

23. A method as in claim 19, wherein cutting the tissue comprises retracting the energy delivery member through tissue.

24. A method as in claim 19, wherein cutting the tissue comprises advancing the energy delivery member through tissue.

25. A device for percutaneously removing ligamentum flavum tissue in a spine to treat spinal stenosis, the device comprising:

a cannula having a proximal end, a tissue-penetrating distal end, and a side-facing aperture closer to the distal end than the proximal end;

an aperture cover slidably coupled with the cannula and configured to advance and retract to cover and uncover the aperture; and

a tissue cutter slidably disposed within the cannula and configured to cut ligamentum flavum tissue through the aperture while the aperture is uncovered.

26. A device as in claim 25, wherein the aperture cover comprises an inner cannula slidably disposed in the tissue removal cannula.

27. A device as in claim 25, wherein a distal portion of the cannula is articulatable relative to a proximal portion of the cannula.

28. A device as in claim 25, wherein the tissue cutter is selected from the group consisting of blades, abrasive surfaces, files, rasps, saws, planes, electrosurgical devices, bipolar electrodes, monopolar electrodes, thermal electrodes, cold ablation devices, rotary powered mechanical shavers, reciprocating powered mechanical shavers, powered mechanical burrs, lasers, ultrasound devices, cryogenic devices, and water jet devices.

29. A device as in claim 25, wherein the tissue cutter is configured to extend out of the aperture.

30. A device as in claim 25, wherein the tissue cutter is configured to engage cut ligamentum flavum tissue and to be retracted through the cannula to remove the engaged tissue.

31. A device as in claim 25, further comprising a suction connector for coupling the proximal end of the cannula with a suction device for removing cut tissue through the cannula.

32. A device as in claim 25, further comprising at least a first nerve stimulator coupled with the cannula at or near the aperture.

33. A device as in claim 32, further comprising at least a second nerve stimulator coupled with the cannula, wherein the first nerve stimulator is disposed generally on the same side of the cannula as the aperture and the second nerve stimulator is disposed between about 90 degrees and about 180 degrees away from the first stimulator along a circumference of the cannula.

34. A device as in claim 25, further comprising a shield coupled with the cannula for preventing the cutter from contacting non-target tissue.

35. A device for percutaneously removing ligamentum flavum tissue in a spine to treat spinal stenosis, the device comprising:

a cannula having a proximal end, a tissue-penetrating distal end, and a side-facing aperture closer to the distal end than the proximal end;

a tissue-engaging member disposed within the cannula and adapted to engage tissue via the aperture;

an aperture cover slidably coupled with the cannula and configured to advance and retract to cover and uncover the aperture, the cover having a sharp, tissue cutting edge to cut tissue engaged by the tissue-engaging member; and

a nerve stimulation member coupled with the cannula adjacent or near the aperture.

36. A device for percutaneously removing ligamentum flavum tissue in a spine to treat spinal stenosis, the device comprising:

an elongate body having a proximal portion, a flexible distal portion, and a side-facing aperture disposed on the distal portion, wherein the distal portion is configured to be passed percutaneously into at least one of an epidural space or a ligamentum flavum of the spine; and

an energy delivery member disposed within the elongate body and configured to extend through the aperture to cut ligamentum flavum tissue.

37. A device as in claim 36, wherein the distal portion of the body is configured to pass at least partway into an intervertebral foramen of the spine.

38. A device as in claim 36, further including a guidewire coupling member disposed on the distal portion of the elongate body for pulling the distal portion into the spine.

39. A device as in claim 36, wherein the energy delivery member is selected from the group consisting of electrosurgical devices, bipolar electrodes, monopolar electrodes, thermal electrodes, cold ablation devices, lasers, ultrasound devices and cryogenic devices.

40. A device as in claim 36, wherein the energy delivery member is slidably disposed within the elongate body and is configured to be advanced through the aperture.

41. A device as in claim 40, wherein the energy delivery member comprises a wire loop electrode.

42. A device as in claim 36, wherein the elongate body further comprises a lumen through which cut ligamentum flavum tissue may be removed.

43. A device as in claim 42, further comprising a suction device couplable with the elongate body for removing the cut ligamentum flavum tissue through the lumen.

44. A device as in claim 43, further comprising an irrigation device couplable with the elongate body for passing fluid through the lumen.

45. A device as in claim 42, further comprising a substance disposed in the lumen for delivery through the aperture, wherein the substance is selected from the group consisting of a hemostatic agent, an analgesic, an anesthetic and a steroid.

46. A device as in claim 36, further comprising at least a first nerve stimulator coupled with the distal portion of the elongate body.

47. A device as in claim 46, further comprising at least a second nerve stimulator coupled with the distal portion of the elongate body apart from the first nerve stimulator.

48. A device as in claim 36, further comprising a shield coupled with the elongate body for preventing the energy delivery member from contacting non-target tissue.

49. A system for percutaneously removing ligamentum flavum tissue in a spine to treat spinal stenosis, the system comprising:

a tissue removal device, comprising;

an elongate body having a proximal portion, a flexible distal portion, and a side-facing aperture disposed on the distal portion, wherein the distal portion is configured to be passed percutaneously into at least one of an epidural space or a ligamentum flavum of the spine; and

an energy delivery member disposed within the elongate body and configured to extend through the aperture to cut ligamentum flavum tissue; and

an energy source removably couplable with the tissue removal device for supplying energy to the energy delivery member.

50. A system as in claim 49, wherein the tissue removal device further includes a guidewire coupling member disposed on the distal portion of the elongate body for pulling the distal portion into the spine.

51. A system as in claim 49, further including a guidewire configured to couple with the guidewire coupling member.

52. A system as in claim 51, further including a handle removably couplable with the guidewire for pulling the guidewire from outside a patient.

53. A system as in claim 49, wherein the elongate body further comprises a lumen through which cut ligamentum flavum tissue may be removed.

54. A system as in claim 53, further comprising a suction device for removing the cut ligamentum flavum tissue through the lumen.

55. A system as in claim 54, further comprising an irrigation device for passing fluid through the lumen.