SOFT TISSUE ACCESS APPARATUS AND METHODS FOR SPINAL SURGERY

• US 20110112373A1
• Filed: 10/29/2010
• Published: 05/12/2011
• Est. Priority Date: 11/10/2009
• Status: Abandoned Application

• Current Assignee: Baxano Surgical, Inc.
• Original Assignee: TranS1 Incorporated (Baxano Surgical, Inc.)
• Inventors: Avidano, Eugene E., Feiler, Frederic C. JR., Ainsworth, Stephen D.
• Application Number:
  US12/916,463
• Publication Number:
  US 20110112373A1
• Time in Patent Office: Days
• US Class Current: 600/207
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072

Abstract

Disclosed are surgical tools, tool sets and methods for percutaneously accessing and preparing treatment sites within the spine for subsequent treatment procedures. The treatment site may be avertebral motion segments in the lumbar and sacral regions of the spine. The tool set may a retraction device for retracting bowel from a sacrum. The device can induce a collapsible enclosure that defines a chamber. The collapsible enclosure can have a collapsed configuration and an expanded configuration. In some arrangements, the chamber is filled with an inflation media. The expanded configuration defines a working channel positioned between the sacrum and the bowel and extending over or through at least a portion of the device.

Claims

1. A retraction device for retracting bowel from a sacrum, the device comprising a collapsible enclosure that defines a chamber, the collapsible enclosure having a collapsed configuration and an expanded filled configuration when the chamber is filled with a fluid, the expanded filled configuration defining a working channel positioned between the sacrum and the bowel and extending over or through at least a portion of the device.

2. The retraction device of claim 1, wherein the device forms a barrier extending between the sacrum and the bowel to define a working space between the sacrum and the bowel.

3. The retraction device of claim 2, wherein the device in the expanded inflated configuration has a generally flat rectangular shape that has a depth, a width and a length, wherein the depth is less than the width which is less than the length and wherein the length of the collapsible enclosure is oriented along an insertion axis of the device.

4. The retraction device of claim 2, wherein the device in the expanded inflated configuration comprises a distal portion with a generally flat rectangular shape and a proximal portion with a generally flat trapezoidal shape, wherein the collapsible enclosure has a depth, a first width, a second width and a length, wherein the depth is less than the first width which is less than the length, wherein the first width is disposed along the distal portion and is generally constant, wherein the second width is disposed along the proximal portion and is tapered inwardly in the distal to proximal direction, wherein the length of the device is orientated along a longitudinal axis of the elongated inserter.

5. The retraction device of claim 1, in combination with an elongated inserter that has a distal end and a proximal end, the proximal end of the inserter including a handle and the distal end of the inserter coupled to the device.

6. The retraction device of claim 5, further comprising an interface on the device, wherein the inserter can be coupled to the interface

7. The retraction device of claim 6, wherein the collapsible enclosure has a first side and a second side that extend in a longitudinal direction that is generally parallel to a longitudinal axis of the inserter and wherein the inserter is positioned between the first and second sides.

8. The retraction device of claim 5, wherein the first and second sides are folded towards the inserter when the collapsible enclosure is in the collapsed configuration and expand away from the inserter in the inflated configuration.

9. The retraction device of claim 1, further comprising a surgical tool for insertion into the working channel.

10. The retraction device of claim 1, further comprising an elongate tube in fluid communication with the chamber.

11. The retraction device of claim 10, further comprising a valve connected to the elongate tube.

12. The retraction device of claim 1, wherein device forms a plurality of chambers.

13. The retraction device of claim 12, wherein each of the plurality of chambers are connected to elongate tube in fluid communication with the chamber.

14. The retraction device of claim 13, further comprising a valve connected to each elongate tube.

15. The retraction device of claim 1, wherein the chamber is baffled or corrugated.

16. The retraction device of claim 1, wherein the device forms a channel is extending from a proximal end of the device to a distal end of the device in the expanded inflated configuration.

17. The retraction device of claim 16, wherein the channel has a generally U-shaped cross-section.

18. The retraction device of claim 16, wherein the channel is generally tubular in shape.

19. The retraction device of claim 16, further comprising a funnel-shaped proximal portion that is in fluid communication with the channel at a proximal end of the device.

20. The retraction device of claim 16, further comprising inflatable rib structures.

21. The retraction device of claim 16, wherein at least a portion of a distal end of the device forms a beveled surface and the channel forms an opening in the beveled surface.

22. The retraction device of claim 1, in combination with a tubular retractor comprising a malleable distal tip.

23. The retraction device of claim 1, wherein a distal face of the device is conformable to the sacrum.

24. The retraction device of claim 1, wherein a distal face of the device is beveled without respect to a longitudinal axis of the device.

25. A method of providing access to a target site on a sacrum of a patient;

the method comprising the steps of;

inserting a retraction device comprising an inflatable structure into a presacral space between a bowel of the patient and the sacrum;

expanding the inflatable structure with an inflation media, such that the inflatable enclosure expands to retract the bowel from the sacrum to create a working space; and

inserting a surgical tool into the working space created between at least portion of the inflatable structure and the sacrum.

26. The method of claim 25, further advancing a guide pin into the presacral space towards the sacrum.

27. The method of claim 26, wherein the guide pin is advanced into the prescral space after the retraction device is inserted into the presacral space.

28. The method of claim 26, wherein the guide pin is advanced into the prescral space before the retraction device is inserted into the presacral space.

29. The method of claim 25, further comprising the step of repositioning the inflatable structure after the inflatable structure is expanded.

30. The method of claim 25 further comprising the steps of:

at least partially emptying the inflatable structure of the inflation media;

repositioning the inflatable structure within the presacral space; and

refilling the inflatable structure with inflation media.

31. The method of claim 25, wherein the step of inserting the inflatable structure into a presacral space comprises positioning the inflatable structure adjacent a sacral promontory.

32. The method of claim 25, wherein the step of inserting a surgical tool into the working space created between the inflatable structure and the sacrum comprises inserting the surgical tool through a channel formed at least partially by the inflatable device.

33. The method of claim 25, further comprising dissecting the presacral space before the step of inserting the retraction device.

34. The method of claim 25, wherein expanding the inflatable structure dissects the presacral space.

35. A method of providing access to a target site on the sacrum of the patient, the method comprising the steps of:

inserting an inserter carrying an inflatable device into a presacral space between a bowel and a sacrum such that a valve and at least a portion of an inflation tube coupled to the inflatable device;

attaching the valve to a source of inflation media; and

filling the inflatable device with the inflation media to expand the collapsible enclosure and retract the bowel from the sacrum.

36. The method of claim 35, further comprising repositioning the inflatable device within the presacral space by manipulating the inserter.

37. The method of claim 35, further comprising the steps of:

at least partially emptying the inflatable device of the inflation media;

repositioning the inflatable device within the presacral space by manipulating the inserter;

refilling the chamber with inflation media; and

removing the inserter from the inflation device.

38. The method of claim 35, wherein the step of inserting the inflatable device into a presacral space comprises positioning the inflatable device adjacent a sacral promontory.

39. The method of claim 35, comprising inserting a surgical tool into the space created between the inflatable device and the sacrum.

40. The method of claim 35, comprising inserting a surgical tool into a channel created extending through at least a portion of the inflatable device

41. A method of providing access to a target site on a sacrum of a patient;

the method comprising the steps of;

inserting at least part of a retraction device comprising an inflatable structure that defines a channel into a presacral space between a bowel of the patient and the sacrum; and

inflating the inflatable structure with an inflation media, such that the inflatable enclosure expands to retract the bowel from the sacrum and enlarge the channel defined through the retraction device to define a working space.

42. The method of claim 41, further comprising the step of inserting a surgical tool through the channel to the sacrum.

43. The method of claim 41, wherein the step of inserting at least a part of the retraction device further comprises sliding the retraction device over a guide wire.

44. The method of claim 41, wherein the step of inserting at least a part of the retraction device further comprises using a control tool coupled to the retraction device to adjust the position of the retraction device.

45. A kit for providing retracting bowel from a sacrum, the kit comprising an inflatable retraction device, an inflation device, an insertion tool, a tubular retractor and a fixation wire.