SPINAL ACCESS SYSTEM AND METHOD

• US 20090018507A1
• Filed: 07/09/2008
• Published: 01/15/2009
• Est. Priority Date: 07/09/2007
• Status: Abandoned Application

• Current Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Arcenio, Gregory B., Leguidleguid, Roy, Bleich, Jeffery L., Wallace, Michael P., Schmitz, Gregory P., Miller, Eric C.
• Application Number:
  US12/170,392
• Publication Number:
  US 20090018507A1
• Time in Patent Office: Days
• US Class Current: 604/164.30
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/3443 with means for adjusting the length of a cannula
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2090/08021 of the patient or his organs

Abstract

Described herein are devices and systems for accessing a spine and particularly the epidural region of the spine and methods of using these systems and devices to access the spine or regions of the spine. In particular, cannulas that may be anchored to the ligamentum flavum or the periosteum are described. Ligamentum flavum access tools are also described. These tools may be used with (or without) an anchoring cannula to penetrate the ligamentum flavum and provide access to the epidural space without risk of injury to other structures within the epidural space. The devices, methods and systems described herein are particularly useful in minimally invasive surgical (MIS) uses. The devices, methods and systems described herein may be used for performing spinal decompressions and other spinal procedures.

Claims

1. A method for accessing a spine of a patient, the method comprising:

advancing a cannula into the patient to contact a distal end of the cannula with spinal tissue including at least one of ligamentum flavum or vertebral periosteum;

removeably attaching the distal end of the cannula to at least one of the ligamentum flavum, periosteum and/or bone;

advancing a flexible guide member through the cannula and through at least one of the ligamentum flavum or vertebral periosteum to position a distal portion of the guide member in the epidural space of the spine; and

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

2. The method of claim 1, further comprising forming an opening in the ligamentum flavum using a ligamentum flavum access tool within the cannula.

3. A method as in claim 1, wherein the cannula is advanced along with an epidural needle, with the cannula disposed over the needle as a sheath, the method further comprising removing the needle before advancing the guide member through the cannula.

4. A method as in claim 3, wherein removing the needle comprises:

ejecting the epidural needle proximally to remove a tip of the needle from the epidural space; and

sliding the needle proximally out of the cannula.

5. A method as in claim 1, wherein the cannula is advanced along with a blunt stylet, with the cannula disposed over the stylet as a sheath, the method further comprising removing the stylet before advancing the guide member through the cannula.

6. A method as in claim 1, wherein attaching the distal end of the cannula to the tissue comprises turning the cannula about its longitudinal axis in a first direction to couple one or more barbs disposed on its distal end with the tissue.

7. A method as in claim 6, further comprising turning the cannula about its longitudinal axis in a second direction, opposite the first direction, to release the cannula from the tissue, after advancing the guide member into the intervertebral foramen.

8. A method as in claim 1, further comprising, before advancing the guide member, advancing a rigid, blunt, cannulated probe through the cannula to position a distal end of the probe in the epidural space, wherein the guide member is advanced through the rigid probe.

9. A method as in claim 1, further comprising:

advancing a guidewire through the guide member to pass through the intervertebral foramen and out the patient'"'"'s skin;

releasing the cannula from the spinal tissue; and

removing the cannula and the guide member from the patient, leaving the guidewire in place, extending into the patient, through the intervertebral foramen, and back out the patient.

10. A method as in claim 9, further comprising:

coupling a tissue removal device with the guidewire;

advancing the tissue removal device at least partway into the intervertebral foramen, using the guidewire; and

performing a tissue removal procedure in the patient'"'"'s spine.

11. A method as in claim 1, further comprising transmitting stimulating current to at least one electrode disposed on the curved guide member to help determine a position of the guide member relative to nerve tissue.

12. A method as in claim 11, wherein transmitting the current comprises:

transmitting a first current to a first electrode disposed on an inner curvature surface of the guide member; and

transmitting a second current to a second electrode disposed on an outer curvature surface of the guide member.

13. A method as in claim 11, further comprising, before the transmitting step, advancing a sheath comprising at least one electrode over the guide member into the epidural space of the spine.

14. A method as in claim 1, further comprising, before advancing the guide member:

advancing at least one additional cannula over the attached cannula;

removeably attaching the additional cannula to the spinal tissue;

removing the cannula from the tissue; and

withdrawing the cannula through the additional cannula.

15. A method for accessing a spine of a patient, the method comprising:

advancing a cannula into the patient to contact a distal end of the cannula with spinal tissue including at least one of ligamentum flavum or vertebral periosteum;

removeably attaching the distal end of the cannula to at least one of the ligamentum flavum, periosteum and/or bone;

advancing a guide member through the cannula and through at least one of the ligamentum flavum or vertebral periosteum to position a distal portion of the guide member in the epidural space of the spine; and

advancing a guidewire through the guide member and at least partway into an intervertebral foramen of the spine.

16. A method for accessing an intervertebral foramen of a spine of a patient, the method comprising:

removeably attaching a distal end of a first tissue locking cannula to spinal tissue including at least one of ligamentum flavum or vertebral periosteum and/or bone;

passing at least a second tissue locking cannula over the first cannula;

removeably attaching a distal end of the second cannula to the spinal tissue;

removing the first cannula through the second cannula;

advancing a probe through the second cannula to position a distal portion of the probe in an epidural space of the patient'"'"'s spine;

advancing a curved, at least partially flexible, cannulated guide member through the probe, such that when the distal portion exits the cannula it assumes a preformed curved shape; and

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

17. A method as in claim 16, further comprising:

advancing a guidewire through the guide member to pass through the intervertebral foramen and out the patient'"'"'s skin;

removing the probe from the patient;

releasing the second cannula from the spinal tissue; and

removing the cannula from the patient, leaving the guidewire in place, extending into the patient, through the intervertebral foramen, and back out the patient.

18. A method as in claim 17, further comprising, before advancing the probe:

passing at least a third tissue locking cannula over the second cannula;

removeably attaching a distal end of the third cannula to the spinal tissue; and

removing the second cannula through the third cannula.

19. A method as in claim 18, further comprising, before advancing the probe:

passing at least a fourth tissue locking cannula over the third cannula;

removeably attaching a distal end of the fourth cannula to the spinal tissue; and

removing the third cannula through the fourth cannula.

20. A system for accessing a spine of a patient, the system comprising:

at least one tissue locking cannula having multiple barbs disposed at one end for removeably attaching to spinal tissue including at least one of ligamentum flavum or vertebral periosteum and/or bone; and

a curved, at least partially flexible, cannulated guide member slideably passable through the cannula and having a distal portion configured to change from a straight shape within the cannula to a curved shape upon exiting the cannula, wherein the distal portion has a radius of curvature configured to position the distal portion at least partway into an intervertebral foramen of the spine when advanced through the cannula.

21. A system as in claim 20, wherein the barbs of the tissue locking cannula are configured so that they do not penetrate through the tissue.

22. A system as in claim 21, further comprising a rigid, cannulated probe slide ably passable through the cannula, wherein the curved guide member slide ably passes through the probe.

23. A system as in claim 22, wherein the guide member passes through an end aperture of the probe.

24. A system as in claim 22, wherein the guide member passes through a side aperture of the probe.

25. A system as in claim 22, further comprising at least one guidewire for passing through the guide member.

26. A system as in claim 25, further comprising a syringe for attaching to a proximal portion of the epidural needle.

27. A system as in claim 25, further comprising a tissue removal device removeably couplable with the guidewire for passing into the patient to remove spinal tissue.

28. A system as in claim 21, wherein the tissue locking cannula has an outer diameter of between 1 mm and 20 mm.

29. A system as in claim 28, wherein the barbs of the cannula face in one direction and attach to tissue by pressing the barbs against the tissue and turning the cannula along its longitudinal axis in a first direction.

30. A system as in claim 28, wherein the barbs release from tissue by turning the cannula along its longitudinal axis in a second direction opposite the first direction.

31. A system as in claim 21, wherein the guide member includes a rounded, atraumatic distal tip.

32. A system as in claim 21, wherein the at least one tissue locking cannula comprises multiple cannulas of different diameter, wherein a first cannula fits within a second cannula, and the second cannula fits within at least a third cannula.

33. A ligamentum flavum access tool device comprising:

an outer hypotube having a distal cutting edge; and

an inner member comprising an atraumatic tissue contacting region that is movable within the outer hypotube, and extends from the outer hypotube;

wherein the inner member is configured to secure to a patient'"'"'s ligamentum flavum; and

a sensor to detect entry into the epidural space.

34. The device of claim 33, wherein the sensor comprises a loss of resistance detector configured to determine when the inner member is within the epidural space.

35. The device of claim 33, wherein the inner member comprises a vacuum port configured to provide a vacuum for securing the inner member to the ligamentum flavum.

36. The device of claim 33, further comprising at least one support element extendable from the inner member when the inner member is within the epidural space.

37. The device of claim 33, wherein the atraumatic tissue contacting region of the inner member includes a distal head and a proximal neck that has a smaller diameter than the distal head, wherein the ligamentum flavum may be secured around the proximal neck after the distal head has penetrated the ligamentum flavum.

38. The device of claim 33, further comprising a threaded region on an outer surface of the device that is configured to mate with a cannula so that the device may be controllably advanced within the cannula by rotation.

39. The device of claim 33, further comprising an internal threaded region in communication with the inner atraumatic tissue contacting member so that it may be moved relative to the outer hypotube.

40. A ligamentum flavum access tool device comprising:

an elongate body;

a distal tip member comprising an atraumatic tissue contacting region configured as a leading head;

a cutting surface that is located proximal to the distal tip member; and

a loss of resistance detector, configured to determine when the distal tip member is within the epidural space.

41. The device of claim 40, wherein the cutting surface is located on a proximal side of the leading head of the distal tip member.

42. The device of claim 40, wherein the cutting surface is a cutting edge of a hypotube in which the distal tip member may axially move.

43. The device of claim 40, further comprising at least one support element extendable from the distal tip member when the distal tip member is within the epidural space.

44. The device of claim 40, wherein the distal tip member is axially movable relative to the cutting surface.

45. The device of claim 40, further comprising a threaded region on an outer surface of the device that is configured to mate with a cannula so that the device may be controllably advanced within the cannula by rotation.

46. The device of claim 40, further comprising an internal threaded region in communication with the distal tip member so that the distal tip member may be moved relative to the cutting surface.

47. A method of accessing the spine of a patient comprising:

anchoring the distal end of a cannula in contract with a patient'"'"'s ligamentum flavum;

advancing a ligamentum flavum access tool within the cannula in a controlled manner;

penetrating the ligamentum flavum with the ligamentum flavum access tool to access the epidural space; and

forming an opening in the ligamentum flavum with the ligamentum flavum access tool.

48. A method of accessing the spine of a patient comprising:

anchoring the distal end of a cannula in contract with the patient'"'"'s ligamentum flavum;

advancing a ligamentum flavum access tool distally within the cannula in a controlled manner, wherein the ligamentum flavum access tool comprises

an outer hypotube having a distal cutting edge, and

an inner member comprising an atraumatic tissue contacting region that is movable within the outer hypotube, and extends distally from the outer hypotube;

securing the ligamentum flavum to the atraumatic tissue contacting region of the ligamentum flavum access tool; and

cutting an opening in the ligamentum flavum with the cutting edge of the proximal hypotube.

49. The method of claim 48, wherein the step of securing the ligamentum flavum to the atraumatic tissue contacting region of the ligamentum flavum access tool comprises deploying one or more support elements from the atraumatic tissue contacting region when atraumatic tissue contacting region is within the epidural space.

50. The method of claim 48, wherein the step of securing the ligamentum flavum to the atraumatic tissue contacting region of the ligamentum flavum access tool comprises penetrating the ligamentum flavum with the atraumatic tissue contacting region until the atraumatic tissue contacting region is within the epidural space as determined by the loss of resistance detector.

51. The method of claim 48, wherein the step of cutting an opening in the ligamentum flavum comprises moving the atraumatic tissue contacting region secured to the ligamentum flavum proximally so that the ligamentum flavum is cut by the cutting edge of the outer hypotube.

52. The method of claim 48, wherein the step of cutting an opening in the ligamentum flavum comprises moving the cutting edge of the outer hypotube distally relative to the atraumatic tissue contacting region secured to the ligamentum flavum.

53. The method of claim 48, further comprising removing the ligamentum flavum access tool from the cannula.

54. The method of claim 48, wherein the step of anchoring the distal end of the cannula comprises removeably attaching the distal end of the cannula to the ligamentum flavum.

55. The method of claim 48, wherein the step of anchoring the distal end of the cannula comprises anchoring the cannula to a surgical access platform.

56. The method of claim 48, wherein the step of advancing the ligamentum flavum access tool comprises rotating the tool relative to the cannula to advance the tool along a threaded region.

57. A method of accessing the spine of a patient comprising:

anchoring the distal end of a cannula in contract with the ligamentum flavum;

advancing a ligamentum flavum access tool distally within the cannula in a controlled manner, wherein the ligamentum flavum access tool comprises

a proximal cutting surface,

a distal tip member comprising an atraumatic tissue contacting region configured as a leading head, and

a loss of resistance detector;

penetrating the ligamentum flavum with the atraumatic leading head of the tip region until the atraumatic leading head accesses the epidural space as determined by the loss of resistance detector;

cutting the ligamentum flavum with the proximal cutting surface; and

removing the ligamentum flavum access tool from the cannula.

58. The method of claim 57, wherein the step of anchoring the distal end of the cannula comprises removeably attaching the distal end of the cannula to the ligamentum flavum.

59. The method of claim 57, wherein the step of anchoring the distal end of the cannula comprises anchoring the cannula to a surgical access platform.

60. The method of claim 57, wherein the step of advancing the ligamentum flavum access tool comprises rotating the tool relative to the cannula to advance the tool along a threaded region.

61. The method of claim 57, wherein the step of cutting the ligamentum flavum with the proximal cutting surface comprises compressing the ligamentum flavum between the distal tip member and the proximal cutting surface.

62. The method of claim 57, wherein the step of cutting the ligamentum flavum with the proximal cutting surface comprises retracting the distal tip member so that the proximal cutting surface can engage the ligamentum flavum.

63. The method of claim 57, further comprising deploying one or more support elements from the distal tip member when the distal tip member is within the epidural space.

64. A method of accessing the spine of a patient comprising:

anchoring the distal end of a cannula in contract with the ligamentum flavum;

advancing a ligamentum flavum access tool distally within the cannula in a controlled manner, wherein the ligamentum flavum access tool comprises

a proximal hypotube having an expandable distal end, and

a distal tip member comprising an atraumatic leading head;

penetrating the ligamentum flavum with the atraumatic leading head of the tip region until the expandable distal end of the hypotube spans the ligamentum flavum; and

dilating the expandable distal end of the hypotube to expand an opening in the ligamentum flavum.

65. The method of claim 64, wherein the step of dilating the expandable distal end of the hypotube comprises withdrawing the distal tip member proximally through the hypotube to expand the distal end of the hypotube.

66. The method of claim 64, further comprising removing the ligamentum flavum access tool from the cannula.

67. The method of claim 64, further comprising removing the atraumatic leading head from the hypotube to allow access to the patient'"'"'s epidural space through the cannula.

68. The method of claim 64, wherein the step of penetrating the ligamentum flavum comprises determining when the distal end of the hypotube has entered the epidural space.

69. The method of claim 64, wherein the step of anchoring the distal end of the cannula comprises removeably attaching the distal end of the cannula to the ligamentum flavum.

70. The method of claim 64, wherein the step of anchoring the distal end of the cannula comprises anchoring the cannula to a surgical access platform.

71. The method of claim 64, wherein the step of advancing the ligamentum flavum access tool comprises rotating the tool relative to the cannula to advance the tool along a threaded region.