Method and apparatus for providing access to a presacral space

• US 8,034,055 B2
• Filed: 05/28/2009
• Issued: 10/11/2011
• Est. Priority Date: 12/13/1999
• Status: Expired due to Fees

• Current Assignee: Mis Ip Holdings LLC
• Original Assignee: TranS1 Incorporated (Baxano Surgical, Inc.)
• Inventors: Cragg, Andrew H.
• Primary Examiner(s): Philogene; Pedro
• Application Number:
  US12/473,999
• Publication Number:
  US 20090234399A1
• Time in Patent Office: 866 Days
• Field of Search: 606/79, 606/80, 606/86.A, 606/86.R, 606/247, 606/279, 606/108, 128/898, 604/181, 604/28, 604/186
• US Class Current: 606/86.00R
• CPC Class Codes: A61B 17/1631 Special drive shafts, e.g. flexible shafts A61B17/1642, A61B17/164 take precedence
• CPC Class Codes: A61B 17/1671 for the spine
• 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 17/3472 for bones, e.g. intraosseus injections

Abstract

Methods and apparatus for providing percutaneous access to the presacral space in a minimally invasive, low trauma, manner. A number of related methods and surgical tool sets form a percutaneous pathway from an incision through the patient'"'"'s skin adjacent to the coccyx and inserting an elongated guide assembly through the incision to locate the guide assembly against the anterior surface of the sacrum to access a presacral target point. The provision of the percutaneous pathway described herein allows for the introduction of therapeutic devices or media, diagnostic instruments, and/or drug delivery to the presacral space.

Claims

1. A method of providing access to a presacral space, the method comprising:

making an incision through the patient'"'"'s skin adjacent to the coccyx;

inserting an elongated instrument through the incision in a cephalad direction toward an anterior presacral space, the instrument having an instrument proximal end and an instrument distal end; and

advancing the instrument distal end in the cephalad direction without entering bone until the instrument distal end is at a target area within the anterior presacral space.

2. The method of providing access to a presacral space of claim 1, wherein the presacral space is in a pelvis.

3. The method of providing access to a presacral space of claim 1, further comprising visualizing the step of advancing the instrument distal end in the cephalad direction fluoroscopically.

4. The method of providing access to a presacral space of claim 1, wherein the instrument further comprises a blunt tip tubular member.

5. The method of providing access to a presacral space of claim 1, wherein the step of providing an instrument further comprises providing a trocar having a trocar lumen within a stiff trocar body extending from a proximal trocar end to a distal trocar end as said instrument.

6. The method of providing access to a presacral space of claim 1, wherein the step of providing an instrument further comprises providing a guide sheath having a guide sheath lumen within a flexible guide sheath body extending from a proximal guide sheath end to a distal guide sheath end as said instrument.

7. The method of providing access to a presacral space of claim 1, further comprising:

providing a dilatation catheter;

providing an enlarged diameter anterior tract sheath having a tract sheath lumen extending between proximal and distal anterior tract sheath ends;

advancing the dilatation catheter to the target;

expanding the dilatation catheter to an expanded configuration to dilate presacral tissue between an anterior sacral surface and the skin incision;

advancing the enlarged diameter anterior tract sheath lumen over the dilatation catheter to position the anterior tract sheath between the target area and the skin incision; and

reducing the dilatation catheter to a reduced configuration and withdrawing the dilatation catheter from the anterior tract sheath lumen, whereby the anterior tract sheath lumen provides the anterior, presacral, percutaneous tract through the patient'"'"'s presacral space.

8. The method of providing access to a presacral space of claim 1, further comprising:

providing a guidewire having a guidewire body extending between a guidewire proximal end and a guidewire distal end;

advancing a tubular member to the target area whereby the tubular member provides a percutaneous tract over or through the tubular member from the incision site to the target area within the anterior presacral space;

extending the guidewire through a lumen in said tubular member to locate the guidewire distal end at the target area; and

removing the tubular member while maintaining the guidewire aligned with the target area, whereby the guidewire provides a percutaneous tract for over the wire passage extending from the skin incision to the target area.

9. The method of providing access to a presacral space of claim 8, further comprising:

providing a tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the guidewire and extending between proximal and distal dilator body ends;

passing the dilator over the guidewire toward the target area to dilate the tissue surrounding the guidewire body; and

withdrawing the tissue dilator from the guidewire body upon completion of dilation.

10. The method of providing access to a presacral space of claim 9, further comprising:

providing an enlarged diameter anterior tract sheath having a tract sheath lumen extending between proximal and distal anterior tract sheath ends; and

inserting said anterior tract sheath through said enlarged anterior tissue tract to position said enlarged diameter anterior tract sheath distal end at the target area.

11. The method of providing access to a presacral space of claim 8, further comprising:

passing a first tissue dilator over the guidewire toward the target area to dilate the tissue surrounding the guidewire body, the providing a first tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the guidewire and extending between proximal and distal first tissue dilator body ends;

passing a second tissue dilator over first tissue dilator and the guidewire toward the target area to further dilate the tissue surrounding the guidewire body, the second tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the first tissue dilator body and extending between proximal and distal second tissue dilator body ends; and

withdrawing the first and second tissue dilators from the guidewire body upon completion of dilation.

12. The method of providing access to a presacral space of claim 1, further comprising inserting an endoscope for visualization of the presacral space.

13. A method of providing access to a presacral space, the method comprising:

making an incision through the patient'"'"'s skin adjacent to the coccyx;

inserting an elongated instrument through the incision in a cephalad direction toward an anterior presacral space without entering bone, the instrument having an instrument proximal end and an instrument distal end;

advancing the instrument distal end in the cephalad direction until the instrument distal end is at a target area within the presacral space;

advancing a distal end of a tubular member to the target area, whereby the tubular member provides a percutaneous tract over or through the tubular member from the incision site to the target area within the anterior presacral space; and

advancing an endoscope through the tubular member percutaneous tract to visualize the target area.

14. The method of providing access to a presacral space of claim 13, wherein the presacral space is proximate the pelvis.

15. The method of providing access to a presacral space of claim 13 wherein the instrument further comprises a blunt tip tubular member.

16. The method of providing access to a presacral space of claim 13, wherein the step of providing an instrument further comprises providing a trocar having a trocar lumen within a stiff trocar body extending from a proximal trocar end to a distal trocar end as said instrument.

17. The method of providing access to a presacral space of claim 13, wherein the step of providing an instrument further comprises providing a guide sheath having a guide sheath lumen within a flexible guide sheath body extending from a proximal guide sheath end to a distal guide sheath end as said instrument.

18. The method of providing access to a presacral space of claim 13, further comprising:

providing a dilatation catheter;

providing an enlarged diameter anterior tract sheath having a tract sheath lumen extending between proximal and distal anterior tract sheath ends;

advancing the dilatation catheter to the target;

expanding the dilatation catheter to an expanded configuration to dilate presacral tissue between an anterior sacral surface and the skin incision;

advancing the enlarged diameter anterior tract sheath lumen over the dilatation catheter to position the anterior tract sheath between the target area and the skin incision; and

reducing the dilatation catheter to a reduced configuration and withdrawing the dilatation catheter from the anterior tract sheath lumen, whereby the anterior tract sheath lumen provides the anterior, presacral, percutaneous tract through the patient'"'"'s presacral space.

19. The method of providing access to a presacral space of claim 13, further comprising:

providing a guidewire having a guidewire body extending between a guidewire proximal end and a guidewire distal end;

extending the guidewire through a lumen in said tubular member to locate the guidewire distal end at the target area; and

removing the tubular member while maintaining the guidewire aligned with the target area, whereby the guidewire provides a percutaneous tract for over the wire passage extending from the skin incision to the target area.

20. The method of providing access to a presacral space of claim 19, further comprising:

providing a tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the guidewire and extending between proximal and distal dilator body ends;

passing the dilator over the guidewire toward the target area to dilate the tissue surrounding the guidewire body; and

withdrawing the tissue dilator from the guidewire body upon completion of dilation.

21. The method of providing access to a presacral space of claim 20, further comprising:

providing an enlarged diameter anterior tract sheath having a tract sheath lumen extending between proximal and distal anterior tract sheath ends; and

inserting said anterior tract sheath through said enlarged anterior tissue tract to position said enlarged diameter anterior tract sheath distal end at the target area.

22. The method of providing access to a presacral space of claim 19, further comprising:

passing a first tissue dilator over the guidewire toward the target area to dilate the tissue surrounding the guidewire body, the providing a first tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the guidewire and extending between proximal and distal first tissue dilator body ends;

passing a second tissue dilator over first tissue dilator and the guidewire toward the target area to further dilate the tissue surrounding the guidewire body, the second tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the first tissue dilator body and extending between proximal and distal second tissue dilator body ends; and

withdrawing the first and second tissue dilators from the guidewire body upon completion of dilation.

23. An assembly for accessing an anterior presacral space for therapeutic or diagnostic assessment of the anterior presacral space, comprising:

an elongated instrument including an elongated tubular member having a tubular member lumen extending between a proximal tubular member end and a distal tubular member end, the distal tubular end configured to insert through an incision through the patient'"'"'s skin adjacent the coccyx, whereby the tubular member provides a percutaneous tract over or through the tubular member from the incision site to a target area within the anterior prersacral space;

an expandable dilation catheter with an expanded configuration and a reduced configuration, the expanded configuration configured to dilate presacral tissue between an anterior sacral surface and the skin incision, the reduced configuration configured for the withdrawal of the dilation catheter from an anterior tract sheath lumen; and

an enlarged diameter anterior tract sheath having a tract sheath lumen extending between proximal and distal anterior tract sheath ends, the enlarged diameter anterior tract sheath lumen configured to slide into the dilated presacral tissue and establishing a lumen between an anterior sacral surface and the skin incision.

24. The elongated instrument of claim 23, wherein the anterior presacral space is within a pelvis.

25. The elongated instrument of claim 23, further comprising a fluoroscopic visualization device for visualizing the advancement of the instrument in the cephalad direction in to the presacral space.

26. The elongated instrument of claim 23, further comprising an endoscope for visualization of the presacral space.

27. The elongated instrument of claim 23, further comprising a blunt tip tubular member.

28. The elongated instrument of claim 23, further comprising a trocar having a trocar lumen within a stiff trocar body extending from a proximal trocar end to a distal trocar end as said tubular member.

29. The elongated instrument of claim 23, further comprising a sheath having a sheath lumen within a flexible sheath body extending from a proximal sheath end to a distal sheath end as said tubular member.

30. The elongated instrument of claim 23, whereby the anterior tract sheath lumen provides an anterior, presacral, percutaneous tract through the patient'"'"'s presacral space;

the enlarged diameter anterior tract sheath lumen configured to slide over the dilatation catheter to position the anterior tract sheath between the target area and the skin incision.

31. The elongated instrument of claim 23, further comprising a guidewire having a guidewire body extending between a guidewire proximal end and a guidewire distal end, the guidewire configured to extend through said tubular member lumen to locate the guidewire distal end at the target area, whereby the guidewire provides a percutaneous tract for over the wire passage extending from the skin incision to the target area.

32. The elongated instrument of claim 31, further comprising a tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the guidewire and extending between proximal and distal dilator body ends, the tissue dilator configured for movement over the guidewire toward the anterior target area to dilate the tissue surrounding the guidewire body.

33. The elongated instrument of claim 32, further comprising an enlarged diameter anterior tract sheath having a tract sheath lumen extending between proximal and distal anterior tract sheath ends configured for insertion through said enlarged anterior tissue tract to position said enlarged diameter anterior tract sheath distal end at the target area.

34. The elongated instrument of claim 31, further comprising:

a first tissue dilator configured to be slideable over the guidewire toward the target area to dilate the tissue surrounding the guidewire body, the first tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the guidewire and extending between proximal and distal first tissue dilator body ends; and

a second tissue dilator configured to slide over the first tissue dilator and the guidewire toward the target area to further dilate the tissue surrounding the guidewire body, the second tissue dilator having a dilator body of a dilation diameter and a dilator lumen having a dilator lumen diameter sized to receive the first tissue dilator body and extending between proximal and distal second tissue dilator body ends.