Devices and methods for tissue modification

• US 8,192,435 B2
• Filed: 10/15/2005
• Issued: 06/05/2012
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Spinal Elements, Inc.
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Bleich, Jeffery L., Hlavka, Edwin J., Saadat, Vahid, Spisak, Steven A., Miller, David R., Yurchenco, James
• Primary Examiner(s): Truong, Kevin T
• Assistant Examiner(s): BOLES, SAMEH RAAFAT
• Application Number:
  US11/251,199
• Publication Number:
  US 20060095059A1
• Time in Patent Office: 2,425 Days
• Field of Search: 606/79, 606/85, 606/103, 606/110, 606/119, 606/131, 606/163, 606171-176, 606/167
• US Class Current: 606/79
• 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 and apparatus are provided for selective surgical removal of tissue, e.g., for enlargement of diseased spinal structures. The current invention includes specific tools that enable safe tissue modification in epidural space, including a barrier that separates the area where tissue modification will take place from adjacent vulnerable neural and vascular structures. In one variation, a tissue abrasion device is provided including a thin belt or ribbon with an abrasive cutting surface. The device optionally may be placed within a protective sheath that exposes the abrasive surface of the ribbon only in the area where tissue removal is desired.

Claims

1. A surgical tissue removal system, comprising:

a flexible elongate body that is adapted to conform with the target anatomy, the body having at least one blade edge, where the flexible elongate body is a thin, flat, ribbon shaped flexible body that further comprises a profile having a width that is substantially greater than a height;

a region at the proximal end of the flexible elongate body configured to be pulled proximally to draw the blade edge proximally across impinging tissue;

a guidewire connector at the distal end of the flexible elongate body configured to removably connect to the end of a guidewire so that the end of the guidewire hooks into the guidewire connector at the distal end of the flexible elongate body so that the guidewire and flexible elongate body can be pulled toward the target anatomy to bend the flexible elongate body against the target anatomy and can be pulled distally to draw the cutting blade distally across impinging tissue, wherein the guidewire connector is configured to connect the flexible elongate body to the end of a guidewire while the flexible elongate body is pulled both proximally and distally and the blade edge is pulled proximally and distally across the impinging tissue to cut the impinging tissue; and

a barrier having at least one window, where the flexible body is slidably located within the barrier such that when the elongate body moves within the barrier, the blade edges move across the window.

2. The tissue removal system of claim 1, where the at least one blade edge comprises a plurality of blade edges that are formed by openings in the flexible elongate body.

3. The tissue removal system of claim 1, where the blade edges comprise a shape selected from the group consisting of a serrated edge, a scalloped edge and a smooth edge.

4. The tissue removal system of claim 1, where the width of the flexible elongate body varies along the length of the elongate body.

5. The tissue removal system of claim 1, where the barrier is coupled to at least one of a vacuum source to provide suction or an irrigation source.

6. The tissue removal system of claim 1, where at least a portion of the flexible elongate body includes a lubricious layer.

7. The tissue removal system of claim 1, where at least a portion of the barrier includes a lubricious layer.

8. The tissue removal system of claim 1, further comprising at least one measuring element coupled to the elongate body.

9. The tissue removal system of claim 8, where the at least one measuring element comprises a sensor or a sound.

10. The tissue removal system of claim 1, wherein the flexible elongated body further comprises at least one electrode.

11. The tissue removal system of claim 1, wherein the barrier further comprises at least one electrode.

12. The system of claim 1, wherein the blade edge is flush with a surface of the elongate body.

13. The system of claim 1, further comprising:

a distal handle configured to couple to the distal end of the flexible elongate body; and

a proximal handle configured to couple to the proximal end region of the flexible elongate body, wherein the distal handle and the proximal handle are configured to allow the body to be reciprocated proximally and distally to cut tissue.

14. The system of claim 13, wherein the distal handle is configured to connect to the guidewire while the proximal end of the guidewire is connected to the distal end of the flexible elongate body.

15. The system of claim 1, wherein the guidewire connector region is configured to hook the flexible elongate body to the end region of the guidewire.

16. The system of claim 1, wherein the blade edge is a v-shaped blade edge.

17. The system of claim 1, wherein the at least one blade edge comprises a plurality of discrete sharpened blade edges for cutting through tissue and bone.

18. A surgical tissue removal system, comprising:

a flexible elongate body that is adapted to conform with the target anatomy, the body having at least one blade edge extending from one surface of the flexible elongate body, where the flexible elongate body is a thin, flat, ribbon shaped flexible body that further comprises a profile having a width that is substantially greater than a height;

a region at the proximal end of the flexible elongate body configured to be pulled proximally to draw the blade edge proximally across impinging tissue; and

a guidewire connector on the flexible elongate body configured to removably connect to the end of a guidewire so that the end of the guidewire connects into the guidewire connector at the distal end of the flexible elongate body so that the guidewire and flexible elongate body can be pulled toward the target anatomy to bend the flexible elongate body against the target anatomy and can be pulled distally to draw the blade edge distally across impinging tissue, wherein the guidewire connector is configured to connect the flexible elongate body to the end of a guidewire while the flexible elongate body is pulled both proximally and distally and the blade edge is pulled proximally and distally across the impinging tissue to cut the impinging tissue.

19. The tissue removal system of claim 18, where the flexible elongate body is configured to pass through a subject'"'"'s spinal foramen.

20. The tissue removal system of claim 18, where the blade edges comprise a shape selected from the group consisting of a serrated edge, a scalloped edge and a smooth edge.

21. The tissue removal system of claim 18, where the at least one blade edge comprises a plurality of paired blade edges where each blade edge in the paired blade edges intersects another.

22. The tissue removal system of claim 18, where the at least one blade edge comprises a plurality of blade edges located on the surface of the flexible elongate body near the end of the flexible elongate body comprising the guidewire connector so that the end of the flexible elongate body opposite of the guidewire connector does not include a blade edge.

23. The tissue removal system of claim 18, where the at least one blade edge comprises a plurality of blade edges and where the plurality of blade edges comprise a plurality of blade edges located on the surface of the flexible elongate body near the center of the flexible elongate body so that the ends of the flexible elongate body do not include any blade edges.

24. The tissue removal system of claim 18, where the width of the flexible elongate body varies along the length of the flexible elongate body.

25. The tissue removal system of claim 18, where at least a portion of the flexible elongate body includes a lubricious layer.

26. The tissue removal system of claim 18, further comprising a motor coupled to at least a portion of the elongate body.

27. The tissue removal system of claim 18, further comprising at least one measuring element coupled to the elongate body.

28. The tissue removal system of claim 27, where the at least one measuring element comprises a sensor or a sound.

29. The tissue removal system of claim 18, wherein the flexible elongated body further comprises at least one electrode.

30. The system of claim 18, further comprising:

a distal handle configured to couple to the distal end of the flexible elongate body; and

a proximal handle configured to couple to the proximal end region of the flexible elongate body, wherein the distal handle and the proximal handle are configured to allow the body to be reciprocated proximally and distally to cut tissue.

31. The system of claim 30, wherein the distal handle is configured to connect to the guidewire while the proximal end of the guidewire is connected to the distal end of the flexible elongate body.

32. The system of claim 18, wherein the guidewire connector region is configured to hook the flexible elongate body to the end region of the guidewire.

33. The system of claim 18, wherein the blade edge is a v-shaped blade edge.

34. The system of claim 18, wherein the at least one blade edge comprises a plurality of discrete sharpened blade edges for cutting through tissue and bone.

35. The system of claim 18, the body having an axial length and a plurality of blade edges arranged in rows extending from one surface of the flexible elongate body, wherein the rows are disposed transverse to the axial length of the elongate body and the rows are separated by gaps that extend transverse to the axial length of the elongate body.

36. The system of claim 35, wherein each row is separated by a gap having a width equal to about from 100 micrometers to about 5 cm.

37. The system of claim 35, wherein each row is separated by a gap having a width equal to about 100 micrometers.

38. The system of claim 35, wherein the rows of blade edges are distributed along the length of the elongate body.