Tissue modification barrier devices and methods

• US 20070213734A1
• Filed: 04/17/2006
• Published: 09/13/2007
• Est. Priority Date: 03/13/2006
• Status: Abandoned Application

• Current Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Saadat, Vahid, Yurchenco, James, Drews, Michael, Leguidleguid, Ronald, Bleich, Jeffery, Bleam, Jeffery, Spisak, Steven
• Application Number:
  US11/405,859
• Publication Number:
  US 20070213734A1
• Time in Patent Office: Days
• US Class Current: 606/79
• 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 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• 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 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/32006 with a cutting strip, band or chain, e.g. like a chainsaw
• 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

A method for preventing unwanted damage to tissue in a spine of a patient during a tissue modification procedure may involve: advancing at least a distal portion of at least one barrier member over at least one guide member into an epidural space of the patient'"'"'s spine; positioning at least an expanded portion of the barrier member between target tissue and non-target tissue; and performing at least one tissue modification procedure on the target tissue, using at least one tissue modification device. Generally, at least part of the barrier member may be disposed between the tissue modification device and the non-target tissue to prevent unwanted damage to the non-target tissue. In various embodiments, at least part of a barrier member may be advanced through a sheath- or catheter-like delivery device and may either automatically expand or be expandable from a collapsed configuration to an expanded configuration.

Claims

1. A method for preventing unwanted damage to tissue in a spine of a patient during a tissue modification procedure, the method comprising:

advancing a distal portion of a delivery device into an epidural space of the patient'"'"'s spine;

exposing at least a portion of at least one barrier member out of the distal portion of the delivery device, wherein at least a portion of the barrier member is changeable from a collapsed configuration in the delivery device to an expanded configuration outside the delivery device;

positioning at least part of the exposed barrier member between target tissue and non-target tissue in the spine; and

performing at least one tissue modification procedure on the target tissue, using at least one tissue modification device, wherein at least part of the barrier member is disposed between the at least one tissue modification device and the non-target tissue to prevent unwanted damage to the non-target tissue.

2. A method as in claim 1, further comprising advancing the at least one barrier member through the delivery device.

3. A method as in claim 2, wherein the at least one barrier member is advanced through the delivery device over at least one guide member selected from the group consisting of guidewires, rails, tracks and lengthwise impressions.

4. A method as in claim 3, wherein at least two guide members are used, the method further comprising orienting the barrier member relative to the target and non-target tissues using the guide members.

5. A method as in claim 1, wherein exposing the barrier member from the delivery device causes it to change automatically from the collapsed to the expanded configuration.

6. A method as in claim 1, further comprising causing at least part of the exposed barrier member to change from the collapsed to the expanded configuration.

7. A method as in claim 6, wherein causing the barrier member to change from the collapsed to the expanded configuration comprises performing an action selected from the list consisting of pulling one or more actuators to remove one or more constraining members, pushing a rigid rod to remove one or more constraining members, changing the positions of multiple interacting members in the barrier member, unfolding the barrier, unfurling the barrier, stretching the barrier between two or more scaffolding members, advancing a proximal portion of the barrier into a distal portion, retracting a distal portion of the barrier into a proximal portion, activating a spring mechanism, inflating one or more bladders disposed within the barrier member and exposing the barrier member to fluid.

8. A method as in claim 1, wherein positioning the at least one barrier member comprises passing at least a distal portion of the barrier member at least partially into an intervertebral foramen.

9. A method as in claim 1, wherein performing at least one procedure on the patient'"'"'s spine comprises using at least one surgical tool selected from the list consisting of a rongeur, a curette, a scalpel, one or more cutting blades, a scissors, a forceps, a probe, a rasp, a file, an abrasive element, one or more small planes, an electrosurgical device, a bipolar electrode, a unipolar electrode, a thermal electrode a rotary powered mechanical shaver, a reciprocating powered mechanical shaver, a powered mechanical burr, a laser, an ultrasound crystal, a cryogenic probe, and a pressurized water jet.

10. A method as in claim 9, further comprising using the barrier member to guide the at least one surgical tool to a position for performing the at least one procedure.

11. A method as in claim 1, wherein performing at least one procedure comprises:

contacting at least one tissue modifying member of the tissue modification device with the target tissue;

applying at least one of anchoring force and tensioning force to proximal and distal portions of the tissue modification device to urge the tissue modifying member(s) against the target tissue; and

modifying the target tissue using the tissue modifying member(s).

12. A method as in claim 1, further comprising applying force to the barrier member to urge at least one tissue modifying member of a tissue modification device against the target tissue.

13. A method as in claim 12, wherein the at least one barrier member comprises an elongate, at least partially flexibly barrier member, and wherein applying force to the barrier member comprises applying at least one of anchoring force and tensioning force to proximal and distal portions of the barrier member.

14. A method as in claim 1, wherein the non-target tissue comprises at least one of nerve, blood vessel, intervertebral disc, bone and ligament.

15. A method as in claim 1, further comprising visualizing an area for performing the at least one procedure, using an elongate, flexible visualization device extended through a lumen in at least one of the delivery device and the barrier member.

16. A method as in claim 1, further comprising delivering an electric current to at least one of the target and non-target tissue via at least one of the barrier member, the delivery device and the tissue modification device.

17. A method as in claim 16, further comprising monitoring an effect of the electric current on the tissue by observing at least one of patient feedback, muscle or limb movement, electromyelographic (EMG) monitoring and somatosensory evoked potentials (SSEP).

18. A method as in claim 1, further comprising introducing fluid to an area for performing the at least one procedure through one or more lumens in at least one of the delivery device and the barrier member.

19. A method as in claim 1, further comprising removing tissue debris from the patient, using the barrier member as a conduit.

20. A method for preventing unwanted damage to tissue in a spine of a patient during a tissue modification procedure, the method comprising:

advancing at least a distal portion of at least one barrier member over at least one guide member into an epidural space of the patient'"'"'s spine;

positioning at least an expanded portion of the barrier member between target tissue and non-target tissue; and

performing at least one tissue modification procedure on the target tissue, using at least one tissue modification device, wherein at least part of the barrier member is disposed between the at least one tissue modification device and the non-target tissue to prevent unwanted damage to the non-target tissue.

21. A method as in claim 20, wherein advancing the barrier member comprises advancing through a delivery device.

22. A method as in claim 20, wherein the barrier member is advanced over at least two guide members, the method further comprising orienting the barrier member relative to the target and non-target tissues using the guide members.

23. A method as in claim 20, further comprising expanding at least part of the barrier member from a collapsed configuration to an expanded configuration.

24. A method as in claim 23, wherein expanding at least part of the barrier member comprises performing an action selected from the list consisting of pulling one or more actuators to remove one or more constraining members, pushing a rigid rod to remove one or more constraining members, changing the positions of multiple interacting members in the barrier member, unfolding the barrier, unfurling the barrier, stretching the barrier between two or more scaffolding members, advancing a proximal portion of the barrier into a distal portion, retracting a distal portion of the barrier into a proximal portion, activating a spring mechanism, inflating one or more bladders disposed within the barrier member and exposing the barrier member to fluid.

25. A method as in claim 20, wherein positioning the at least one barrier member comprises passing at least the distal portion of the barrier member at least partially into an intervertebral foramen.

26. A method as in claim 20, wherein performing at least one procedure on the patient'"'"'s spine comprises using at least one surgical tool selected from the list consisting of a rongeur, a curette, a scalpel, one or more cutting blades, a scissors, a forceps, a probe, a rasp, a file, an abrasive element, one or more small planes, an electrosurgical device, a bipolar electrode, a unipolar electrode, a thermal electrode a rotary powered mechanical shaver, a reciprocating powered mechanical shaver, a powered mechanical burr, a laser, an ultrasound crystal, a cryogenic probe, and a pressurized water jet.

27. A method as in claim 26, further comprising using the barrier member to guide the at least one surgical tool to a position for performing the at least one procedure.

28. A method as in claim 20, wherein performing at least one procedure comprises:

contacting at least one tissue modifying member of the tissue modification device with the target tissue;

applying at least one of anchoring force and tensioning force proximal and distal portions of the tissue modification device to urge the tissue modifying member(s) against the target tissue; and

modifying the target tissue using the tissue modifying member(s).

29. A method as in claim 20, further comprising applying force to the barrier member to urge at least one tissue modifying member of a tissue modification device against the target tissue.

30. A method as in claim 29, wherein the at least one barrier member comprises an elongate, at least partially flexibly barrier member, and wherein applying force to the barrier member comprises applying at least one of anchoring force and tensioning force to proximal and distal portions of the barrier member.

31. A method as in claim 20, wherein the non-target tissue comprises at least one of nerve, blood vessel, intervertebral disc, bone and ligament.

32. A method as in claim 20, further comprising visualizing an area for performing the at least one procedure, using an elongate, flexible visualization device extended through a lumen in at least one of a barrier member delivery device and the barrier member.

33. A method as in claim 20, further comprising delivering an electric current to at least one of the target and non-target tissue via at least one of the barrier member, the delivery device and the tissue modification device.

34. A method as in claim 33, further comprising monitoring an effect of the electric current on the tissue by observing at least one of patient feedback, muscle or limb movement, electromyelographic (EMG) monitoring and somatosensory evoked potentials (SSEP).

35. A method as in claim 20, further comprising introducing fluid to an area for performing the at least one procedure through one or more lumens in at least one of a barrier member delivery device and the barrier member.

36. A method as in claim 20, further comprising removing tissue debris from the patient, using the barrier member as a conduit.

37. A method for preventing unwanted damage to tissue of a patient during a tissue modification procedure, the method comprising:

advancing at least a distal portion of a delivery device into the patient and to a position between or adjacent target tissue and non-target tissue;

advancing at least a distal portion of at least one barrier member over at least one guide member to a position between or adjacent target tissue and non-target tissue in the patient;

exposing at least a portion of the at least one barrier member out of the distal portion of the delivery device, wherein at least a portion of the barrier member is changeable from a collapsed configuration in the delivery device to an expanded configuration outside the delivery device; and

performing at least one tissue modification procedure on the target tissue, using at least one tissue modification device, wherein at least part of the barrier member is disposed between the at least one tissue modification device and the non-target tissue to prevent unwanted damage to the non-target tissue.

38. A barrier device for preventing unwanted damage to tissue of a patient during a tissue modification procedure, the device comprising:

at least one shape changing portion changeable from a collapsed configuration, to facilitate passage into the patient, to an expanded configuration, to facilitate protection of non-target tissue;

at least one elongate portion extending beyond the shape changing portion, the elongate portion having a low profile to facilitate passage of the barrier device into the patient and a length sufficient to extend from an opening on the patient'"'"'s skin to an area at or near target and non-target tissues; and

at least one guide feature extending along at least a portion of the barrier to allow the barrier to be passed into the patient over at least one guide member,

wherein the barrier device has an overall length sufficient to pass from a first opening on the patient'"'"'s skin and between the target and non-target tissues.

39. A device as in claim 38, wherein the device has an overall length, size and configuration to allow it to extend from the first opening on the patient'"'"'s skin, into an epidural space of the patient'"'"'s spine, and between target and non-target tissues in the spine.

40. A device as in claim 39, wherein the overall length of the device is sufficient to allow it to further extend from outside the patient, through the first opening, between the target and non-target tissues, and out the patient through a second opening on the patients skin.

41. A device as in claim 38, wherein the at least one elongate portion comprises:

a proximal elongate portion extending from a proximal end of the shape changing portion; and

a distal elongate portion extending from a distal end of the shape changing portion.

42. A device as in claim 38, further comprising a barrier delivery device through which the barrier device may be passed into the patient.

43. A device as in claim 42, wherein the barrier delivery device is selected from the group consisting of sheaths and catheters.

44. A device as in claim 42, wherein the shape changing portion changes shape automatically when released from the barrier delivery device.

45. A device as in claim 44, wherein the shape changing portion comprises a super-elastic or shape memory material.

46. A device as in claim 44, wherein the shape changing portion is foldable to assume the collapsed configuration and unfolds to assume the expanded configuration upon release from the delivery device.

47. A device as in claim 38, further comprising at least one actuator coupled with the shape changing portion to change it from its collapsed to its expanded configuration.

48. A device as in claim 47, wherein the at least one actuator is selected from the group consisting of zippers, a tear strips, pull wires, expandable scaffolds, inflatable bladders, umbrellas and expandable stents.

49. A device as in claim 47, wherein the at least one actuator extends from one end of the shape changing portion.

50. A device as in claim 47, wherein the at least one actuator comprises two actuators extending from opposite ends of the shape changing portion.

51. A device as in claim 38, wherein the at least one guide feature is selected from the group consisting of guidewire lumens, rails, tracks and lengthwise impressions.

52. A device as in claim 51, wherein the at least one guide feature comprises at least two guidewire lumens extending along at least the shape changing portion, and wherein an area of the shape changing portion between the two guidewire lumens has a sufficient stiffness to prevent the shape changing portion from twisting.

53. A device as in claim 38, further comprising at least one additional guide feature configured to facilitate guidance of one or more tissue modification devices along the barrier member.

54. A device as in claim 38, wherein the at least one guide feature is configured to allow passage of at least one tissue modification device along the barrier member.

55. A device as in claim 38, further comprising at least one conductive electrode coupled with the barrier device for delivering electric current to at least one of the target and non-target tissue.

56. A device as in claim 55, further comprising at least one monitoring device coupled with the barrier device for monitoring an effect of the electric current on the tissue, the monitoring device selected from the group consisting of EMG monitoring devices and SSEP monitoring devices.

57. A device as in claim 38, wherein at least the shape changing portion of the barrier device comprises:

a front surface for facing one or more tissue modification devices for performing a procedure in the spine; and

a back surface for facing one or more non-target tissues.

58. A device as in claim 57, wherein the front and back surfaces have different shapes to facilitate positioning of the barrier member between target and non-target tissues to protect the non-target tissue.

59. A device as in claim 38, wherein the shape changing portion comprises a window and the at least one elongate portion comprises two elongate tubular extensions extending from opposite ends of the window.

60. A device as in claim 38, wherein the shape changing portion comprises an expandable scaffold.

61. A device as in claim 60, wherein the shape changing portion further comprises one or more pieces of material coupled with the scaffold.

62. A device as in claim 38, wherein the shape changing portion comprises:

a plurality of longitudinal support members; and

one or more pieces of material coupled with support members.

63. A device as in claim 38, wherein the shape changing portion comprises at least one of a hydrogel material, a wire mesh, an expandable stent and an inflatable bladder.