Mechanical tissue modification devices and methods

• US 8,430,881 B2
• Filed: 04/17/2006
• Issued: 04/30/2013
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Mis Ip Holdings LLC, Spinal Elements, Inc.
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Bleich, Jeffery L., Saadat, Vahid, Leguidleguid, Roy, Bleam, Jefferey
• Primary Examiner(s): Truong, Kevin T
• Assistant Examiner(s): BATES, DAVID W
• Application Number:
  US11/405,848
• Publication Number:
  US 20070213733A1
• Time in Patent Office: 2,570 Days
• Field of Search: 606 79- 85
• 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
• 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 device for modifying one or more tissues in a patient'"'"'s spine may include: an elongate, at least partially flexible body having a proximal portion and a distal portion, wherein at least the distal portion has dimensions that allow it to be passed into an epidural space and between target and non-target tissues of the spine; at least one movable blade disposed along one side of the elongate body; at least one actuator coupled with the at least one blade and disposed at or near the proximal or distal portion of the body for moving the blade(s) to modify one or more target tissues, wherein the at least one actuator is configured to move the blade(s) without significantly translating the elongate body proximally or distally; and means at or near the proximal and distal portions of the elongate body for facilitating application of at least one of anchoring force and tensioning force to the body to urge the at least one blade against the target tissue.

Claims

1. A method for modifying tissue in a patient, the method comprising:

advancing a flexible distal portion of an elongate tissue modification device into a patient and along a curved path between a target tissue and a non-target tissue, and advancing a flexible distal portion of a guidewire coupled with the flexible distal portion of the elongate tissue modification device outside the patient through a location that is separate from a location where the device was advanced into the patient;

positioning a movable blade disposed along one side of the flexible distal portion of the elongate tissue modification device adjacent the target tissue such that the blade faces the target tissue and does not face the non-target tissue;

urging the movable blade against the target tissue by fixing the distal end of the elongate tissue modification device relative to the patient and pulling a proximal end of the elongate tissue modification device in a proximal direction; and

moving the movable blade towards a second blade to cut the target tissue without significantly translating the elongate tissue modification device in the proximal direction or a distal direction.

2. A method as in claim 1, wherein the step of advancing comprises advancing the flexible distal portion into an epidural space of the patient'"'"'s spine.

3. A method as in claim 1, wherein the step of advancing further comprises advancing the flexible distal portion into a spinal channel of the patient.

4. A method as in claim 1, wherein the step of advancing comprises advancing the flexible distal portion into a patient'"'"'s intervertebral foramen of the patient.

5. A method as in claim 1, wherein the step of moving the movable blade comprises modifying at least one of a ligamentum flavum or a bone of the patient.

6. A method as in claim 1, wherein the step of moving the movable blade further comprises cutting the target tissue to reduce impingement of the target tissue on at least one of a spinal cord, a branching nerve, a dorsal root ganglia, and a vascular tissue in the spine of the patient.

7. A method as in claim 1, wherein the step of urging the movable blade against the target tissue comprises applying a tensioning force or an anchoring force to a first handle and a second handle, the first handle coupled with the elongate tissue modification device at or near the proximal end and the second handle coupled with the elongate tissue modification device at or near the distal end.

8. A method as in claim 1, wherein the step of urging the movable blade against the target tissue comprises:

deploying one or more anchoring members located at or near the distal portion of the elongate tissue modification device within the patient; and

applying a tensioning force to a handle coupled with the proximal end of the elongate tissue modification device.

9. A method as in claim 1, wherein the second blade is an opposing stationary blade.

10. A method as in claim 1, wherein the step of moving the movable blade comprises moving the movable blade laterally, relative to a long axis of the elongate tissue modification device.

11. The method of claim 1, wherein positioning the movable blade comprises positioning a window on the side of the flexible distal portion of the elongate tissue modification device so that the window is adjacent to the target tissue and the movable blade may access the target tissue through the window.

12. A method for modifying spinal tissue to treat spinal stenosis, the method comprising:

advancing a flexible distal portion of an elongate tissue modification device into a patient'"'"'s intervertebral foramen of the patient'"'"'s spine, wherein the elongate tissue modification device comprises a movable blade disposed along one side of the flexible distal portion of the elongate tissue modification device, further wherein the movable blade is movable relative to a second blade on the elongate tissue modification device;

positioning the movable blade adjacent a target tissue;

urging the movable blade against the target tissue by fixing the distal portion of the elongate tissue modification device relative to the patient and pulling a proximal end region of the elongate tissue modification device in a proximal direction; and

actuating the movable blade of the elongate tissue modification device to cut the target tissue, so that the movable blade moves towards the second blade without significantly translating the elongate tissue modification device in the proximal direction or in a distal direction; and

advancing a guidewire into the patient at a first location, through the intervertebral foramen of the spine, and back out of the patient at a second location so that opposite ends of the guidewire extend out of the patient.

13. A method as in claim 12, wherein the step of advancing the flexible distal portion of the elongate tissue modification device comprises coupling the elongate tissue modification device and the guidewire, and advancing the elongate tissue modification device using the guidewire.

14. A method as in claim 12, wherein the second blade is stationary.

15. A method as in claim 12, wherein the step of actuating the movable blade comprises triggering a handle portion at the proximal end of the elongate tissue modification device.

16. A method as in claim 12, further comprising:

moving the flexible distal portion of the elongate tissue modification device in the intervertebral foramen of the patient; and

actuating the movable blade again to cut tissue.

17. The method of claim 12, wherein positioning the movable blade comprises positioning a window on the side of the flexible distal portion of the elongate tissue modification device so that the window is adjacent to the target tissue and the movable blade may access the tissue through the window.

18. A method for modifying tissue in a patient, the method comprising:

advancing a flexible distal portion of an elongate tissue modification device into the patient and along a curved path between a target tissue and a non-target tissue, and advancing the flexible distal portion of the elongate tissue modification device outside the patient through a location that is separate from a location where the device was advanced into the patient;

positioning a movable blade disposed along one side of the elongate tissue modification device adjacent the target tissue such that the movable blade faces the target tissue and does not face the non-target tissue;

urging the movable blade against the target tissue by fixing the distal portion of the elongate tissue modification device relative to the patient and pulling a proximal end of the elongate tissue modification device in a proximal direction; and

moving the movable blade towards a second blade to cut the target tissue without significantly translating the elongate tissue modification device in the proximal direction or in a distal direction.

19. A method for modifying tissue in a patient, the method comprising:

advancing a flexible distal portion of an elongate tissue modification device into the patient and along a curved path between a target tissue and a non-target tissue;

positioning a movable blade disposed along one side of the flexible distal portion of the elongate tissue modification device adjacent the target tissue such that the movable blade faces the target tissue and does not face the non-target tissue;

urging the movable blade against the target tissue by fixing the distal portion of the elongate tissue modification device relative to the patient and pulling a proximal end of the elongate tissue modification device in a proximal direction and applying a tensioning force or an anchoring force to a first handle and a second handle, the first handle coupled with the elongate tissue modification device at or near the proximal end and the second handle coupled with the elongate tissue modification device at or near the distal portion; and

moving the movable blade towards a second blade to cut the target tissue without significantly translating the elongate tissue modification device in the proximal direction or in to distal direction.

20. A method for modifying tissue in a patient, the method comprising:

advancing a curved, rigid distal portion of an elongate tissue modification device into the patient and along a curved path between a target tissue and a non-target tissue;

positioning a movable blade disposed along one side of the distal portion of the elongate tissue modification device adjacent the target tissue such that the movable blade faces the target tissue and does not face the non-target tissue;

urging the movable blade against the target tissue by fixing the distal portion of the elongate tissue modification device relative to the patient and pulling a proximal end of the elongate tissue modification device in a proximal direction; and

moving the movable blade towards a second blade to cut the target tissue without significantly translating the elongate tissue modification device in the proximal direction or in a distal direction.

21. A method as in claim 20, wherein the step of advancing comprises advancing the curved distal portion into an epidural space of the patient'"'"'s spine.

22. A method as in claim 20, wherein the step of advancing further comprises advancing the curved distal portion into a spinal channel of the patient.

23. A method as in claim 20, wherein the step of advancing comprises advancing the curved distal portion toward a patient'"'"'s intervertebral foramen.

24. A method as in claim 20, wherein the step of moving the movable blade comprises modifying at least one of a ligamentum flavum of the patient and a bone of the patient.

25. A method as in claim 20, wherein the step of moving the movable blade further comprises cutting the target tissue to reduce impingement of the target tissue on at least one of a spinal cord, a branching nerve, a dorsal root ganglia, and a vascular tissue in the patient'"'"'s spine.

26. A method for modifying spinal tissue to treat spinal stenosis, the method comprising:

advancing a curved, rigid distal portion of an elongate tissue modification device toward a patient'"'"'s intervertebral foramen of the spine, wherein the elongate tissue modification device comprises a movable blade disposed along one side of the distal portion of the elongate tissue modification device, further wherein the movable blade is movable relative to a second blade on the elongate tissue modification device;

positioning the movable blade adjacent a target tissue;

urging the movable blade against the target tissue by fixing the distal portion of the elongate tissue modification device relative to the patient and pulling a proximal end region of the elongate tissue modification device in a proximal direction; and

actuating the movable blade of the elongate tissue modification device to cut the target tissue, so that the movable blade moves towards a second blade without significantly translating the elongate tissue modification device in the proximal direction or in a distal direction.

27. A method as in claim 26, wherein the step of moving the movable blade comprises modifying at least one of a ligamentum flavum of the patient and a bone of the patient.

28. A method as in claim 26, wherein the step of moving the movable blade further comprises cutting the target tissue to reduce impingement of the target tissue on at least one of a spinal cord, a branching nerve, a dorsal root ganglia, and a vascular tissue in the spine of the patient.