Devices and methods for tissue access

• US 7,918,849 B2
• Filed: 10/15/2005
• Issued: 04/05/2011
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Spinal Elements, Inc.
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Spisak, Steven A., Bleich, Jeffery L.
• Primary Examiner(s): Peffley; Michael
• Assistant Examiner(s): HUPCZEY, JR, RONALD JAMES
• Application Number:
  US11/251,205
• Publication Number:
  US 20060089633A1
• Time in Patent Office: 1,998 Days
• Field of Search: 606/1, 606 32- 50, 606/53, 606/79, 606/82, 606/105, 606/177, 606/263, 607115-117, 607/48, 607/43, 607/99, 607/152, 600/554, 600/548, 600/541, 604/22
• US Class Current: 606/32
• CPC Class Codes: A61B 1/3135 for examination of the epidural or the spinal space
• CPC Class Codes: A61B 17/149 Chain, wire or band saws
• 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 17/29 Forceps for use in minimally invasive surgery
• 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 17/32053 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 17/320758 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 17/3401 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 17/3421 Cannulas
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/320004 : abrasive
• CPC Class Codes: A61B 2017/320044 : Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/32006 : with a cutting strip, band or chain, e.g. like a chainsaw
• CPC Class Codes: A61B 2017/3445 : used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3447 : Linked multiple cannulas
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/08021 : of the patient or his organs
• CPC Class Codes: A61B 90/04 : Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery protection of eyes against laser radiation A61F9/022
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61F 2/0045 : Support slings
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin

Abstract

Methods are provided for access to a compressed space in the spinal anatomy. These methods may be used for selective surgical removal of tissue, e.g., for enlargement of diseased spinal structures, such as impinged lateral recesses and pathologically narrowed neural foramen. In one variation, tissue may be ablated, resected, removed, or otherwise remodeled by standard small endoscopic tools delivered into the epidural space. In one variation, a tissue abrasion device is provided. A cannulated probe may be placed through the neural foramina of the spine and used to position a guidewire around the anterior border of a facet joint. Once properly positioned, a medical practitioner may use the guidewire with an abrasion device to enlarge the lateral recess and neural foramina. A nerve stimulator may be provided to reduce a risk of inadvertent neural abrasion.

Claims

1. A method to achieve access to a compressed space in spinal anatomy, the method comprising:

advancing a distal portion of a cannulated probe via a surgical incision towards a lateral recess and a neural foramen in a patient;

extending a first end of a second element from a distal end of the cannulated probe and through the neural foramen and at least partially around an anterior portion of a facet joint and posterior to a spinal disc;

extending the first end of the second element out of the patient, wherein a portion of the second element remains curved around the facet joint; and

delivering an electric current using the cannulated probe to assess the position of the cannulated probe relative to neural tissue.

2. The method of claim 1, where the second element comprises a device selected from the group consisting of a guidewire and a needle.

3. The method of claim 1, where the second element is preconfigured to have a curved shape.

4. The method of claim 1, where the second element is steerable.

5. The method of claim 1, further comprising using image guidance, an epidural endoscope or visualization technique to advance at least one of the distal portion of the cannulated probe or the second element.

6. The method of claim 1, further comprising withdrawing the cannulated probe from the patient.

7. The method of claim 1, further comprising attaching a tissue modification device to the ends the first or a second end of the second element to guide advancement of the tissue modification device into the spinal anatomy.

8. The method of claim 7, where the tissue modifying device comprises a device selected from the group consisting of an abrasion element, a cutting element, a shaving element, an ablation element.

9. The method of claim 1, where the cannulated probe comprises more than one lumen.

10. The method of claim 1, where the cannulated probe comprises a device selected from an epidural needle, an epidural probe, a cannulated Woodson probe, cannulated ball-tipped probe, cannulated hockey stick probe, and an epidural endoscope having a working channel.

11. The method of claim 1, where the cannulated probe is steerable.

12. The method of claim 1, wherein the step of extending the first end of the second element out of the patient comprises extending the first end of the second element out of the patient such that the distal end of the second element pierces the skin of a patient.

13. The method of claim 1, wherein the step of extending the first end of the second element out of the patient comprises extending the first end of the second element out of the patient through a surgical incision.

14. The method of claim 1, wherein the step of extending the first end of the second element out of the patient comprises pulling the first end of the second element out of the patient.

15. The method of claim 1, wherein a second end of the second element extends out of the patient through the surgical incision when the first end of the second element extends out of the patient and a portion of the second element remains curved around the facet joint.

16. The method of claim 1, wherein the second element is nitinol.

17. The method of claim 1, wherein the cannulated probe comprises an inner cannula having a first end and an outer cannula having a first end.

18. The method of claim 17, wherein the inner cannula is preconfigured to have a curved shape.

19. The method of claim 17, wherein at least a portion of the inner cannula is nitinol.

20. The method of claim 17, further comprising the step of extending the first end of the inner cannula out of the distal end of the outer cannula and toward the neural foramen.

21. The method of claim 20, wherein the step of extending the first end of a second element from the first end of the cannulated probe comprises extending the first end of a second element from the first end of the inner cannula.

22. The method of claim 17, wherein the step of delivering an electric current using the cannnulated probe comprises delivering an electric current using the inner cannula to assess the position of the inner cannula relative to neural tissue.

23. A method to achieve access to a compressed space in spinal anatomy, the method comprising:

advancing a distal portion of a cannulated probe via a first surgical incision towards a lateral recess and a neural foramen in a patient, wherein the cannulated probe comprises an inner cannula having a distal end and an outer cannula having a distal end;

pushing the distal end of the inner cannula out of the distal end of the outer cannula and extending the distal end of the inner cannula further toward the neural foramen;

pushing a distal end of an elongate member out of the distal end of the inner cannula and through the neural foramen and around an anterior portion of a facet joint and posterior to a spinal disc; and

pushing the distal end of the elongate member out of the patient at a second location, wherein a portion of the elongate member remains curved around the facet joint while a proximal end of the elongate member extends out of the patient through the first surgical incision.

24. The method of claim 23, further comprising positioning a tissue modifying device within the neural foramen using the elongate member, wherein the tissue modifying device is selected from the group consisting of an abrasion element, a cutting element, a shaving element, and an ablation element.

25. The method of claim 23, further comprising the step of delivering an electric current using the cannnulated probe to assess the position of the elongate member relative to neural tissue.

26. A method to achieve access to a compressed space in spinal anatomy, the method comprising:

advancing a distal portion of a cannulated probe via a first surgical incision towards a lateral recess and a neural foramen in a patient;

pushing a distal end of a guidewire from a distal end of the cannulated probe, further advancing the distal end of the guidewire through the neural foramen and around an anterior portion of a facet joint and posterior to a spinal disc;

pushing the distal end of the guidewire out of the patient via a second incision, wherein a portion of the guidewire remains curved around the facet joint while a proximal end of the guidewire extends out of the patient through the first surgical incision;

removably coupling a distal end of a device to the proximal end of the guidewire outside of the patient after passing the guidewire through the neural foramen and around an anterior portion of a facet joint and posterior to a spinal disc; and

pulling the device through the neural foramen using the guidewire, wherein the device is selected from the group consisting of a stimulation element, an abrasion element, a cutting element, a shaving element, and an ablation element.

27. The method of claim 26, wherein the device is an electrical stimulation element and the method further comprises the step of delivering an electric current using the electrical stimulation device to assess the position of the guidewire relative to neural tissue.

28. The method of claim 27, further comprising the step of pulling a tissue modification device through the neural foramen using the guidewire after the step of delivering an electric current, wherein the tissue modifying device is selected from the group consisting of an abrasion element, a cutting element, a shaving element, and an ablation element.

29. A method to achieve access to a compressed space in spinal anatomy, the method comprising:

advancing a distal portion of a cannulated probe via a surgical incision towards a lateral recess and a neural foramen in a patient;

extending a first end of a second element from a distal end of the cannulated probe and through the neural foramen and at least partially around an anterior portion of a facet joint and posterior to a spinal disc;

extending the first end of the second element out of the patient, wherein a portion of the second element remains curved around the facet joint; and

delivering an electric current using the second element to assess the position of the second element relative to neural tissue.

30. A method to achieve access to a compressed space in spinal anatomy, the method comprising:

advancing a distal portion of a cannulated probe via a surgical incision towards a lateral recess and a neural foramen in a patient;

extending a first end of a second element from a distal end of the cannulated probe and through the neural foramen and at least partially around an anterior portion of a facet joint and posterior to a spinal disc;

extending the first end of the second element out of the patient, wherein a portion of the second element remains curved around the facet joint;

attaching a tissue modification device to at least one of the ends of the second element to guide advancement of the tissue modification device into the spinal anatomy, where the tissue modifying device comprises a device selected from the group consisting of an abrasion element, a cutting element, a shaving element, an ablation element; and

coupling the tissue modifying device to an apparatus having at least one gear adapted to move the tissue modifying device.