Flexible tissue removal devices and methods

• US 8,062,298 B2
• Filed: 03/16/2007
• Issued: 11/22/2011
• Est. Priority Date: 10/15/2005
• Status: Active Grant

• Current Assignee: Mis Ip Holdings LLC, Spinal Elements, Inc.
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Leguidleguid, Roy, Spisak, Steven A., Bleich, Jeffrey L., Schmitz, Gregory P., Bleam, Jefferey
• Primary Examiner(s): Barrett; Thomas C.
• Assistant Examiner(s): BATES, DAVID W
• Application Number:
  US11/687,558
• Publication Number:
  US 20070225703A1
• Time in Patent Office: 1,712 Days
• Field of Search: 606/79, 606/82, 606/85
• 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 17/149 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 17/1757 for the spine
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• 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 for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/320004 abrasive
• 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 tissue in a patient may include: an elongate body having a rigid proximal portion and a flexible distal portion having first and second major surfaces; a proximal handle coupled with the proximal portion of the body; one or more tissue modifying members disposed along the first major surface of the distal portion of the body; a guidewire coupled with and extending from the distal portion of the body; and a distal handle removably couplable with the guidewire outside the patient.

Claims

1. A method for removing target tissue from a patient, the method comprising:

advancing a guidewire into the body and around the target tissue so that the proximal end of the guidewire extends from a first position outside of the patient'"'"'s body and the distal end of the guidewire extends from a second position outside of the patient;

coupling the proximal end of the guidewire to a tissue modification device outside of the body after advancing the guidewire into the body, wherein the tissue modification device is for removing tissue and comprises an elongate flexible body having a plurality of blades extending therefrom;

pulling the tissue modification device behind the guidewire to position it along a path between the target tissue and non-target tissue, wherein the proximal end of the guidewire remains within the body; and

advancing the blades into the target tissue by manually reciprocating the elongate body axially along the path while a portion of the guidewire remains within the body.

2. A method as in claim 1, wherein the target tissue comprises ligament tissue disposed over bone, wherein the method further comprises applying pulling force at or near opposite ends of the elongate body to urge the blades into the ligament tissue, such that at least one of the blades contacts the bone beneath the ligament.

3. A method as in claim 2, further comprising reciprocating the elongate body to remove a portion of the bone.

4. A method as in claim 2, wherein the elongate body of the tissue modification device is pulled into an intervertebral foramen of the patient'"'"'s spine, wherein the target ligament tissue comprises ligamentum flavum, and wherein the non-target tissue comprises neural tissue.

5. A method as in claim 4, further comprising steering the elongate body sideways within the intervertebral foramen during the advancing step.

6. A method as in claim 4, wherein at least some of the blades are angled relative to the longitudinal axis of the elongate body, and wherein advancing the blades through the target tissue causes cantilevered ends of the blades to ride along the bone to cause the elongate body to move sideways within the intervertebral foramen.

7. A method as in claim 1, wherein the elongate body is advanced percutaneously into the patient by pulling the device behind the guidewire.

8. A method as in claim 1, further comprising inhibiting damage to the non-target tissue with an atraumatic surface of the elongate body configured to contact the non-target tissue when the blades contact target tissue.

9. A method as in claim 1, further comprising collecting cut tissue between at least some of the blades.

16. The method of claim 1, wherein the tissue modification device further comprises a plurality of laterally offset, cantilevered blades extending therefrom.

17. The method of claim 16, wherein at least two if the plurality of laterally offset, cantilevered blades extend from opposite edges of the body.

18. The method of claim 1, further comprising the step of advancing the blades through the target tissue by manually reciprocating the elongate body axially along the path so as to form laterally offset cuts in the target tissue.

20. The method of claim 1, wherein the step of reciprocating the elongate body axially along the path comprises the step of alternately applying a manual pulling force to a handle at a distal end of the tissue modification device and applying a manual pulling force to a handle a proximal end of the tissue modification device such that the distal handle and the proximal handle of the tissue modification device move in opposite directions with respect to the outside of the patient'"'"'s body.

21. The method of claim 20, wherein the distal handle and the proximal handle of the tissue modification device move in opposite directions with respect to the outside of the patient'"'"'s body such that one handle moves toward the body while the other handle moves away from the body.

25. The method of claim 1, wherein the step of coupling the proximal end of the guidewire comprises coupling the proximal end of the guidewire to a tapered distal end region of the tissue modification device.

26. The method of claim 1, wherein the step of coupling the proximal end of the guidewire comprises coupling the proximal end of the guidewire to a distal end region of the tissue modification device, wherein the proximal end of the tissue modification device comprises an elongate rigid shaft from which the elongate flexible body extends.

10. A method for removing ligamentum flavum tissue in a spine of a patient to treat spinal stenosis, the method comprising:

pulling a flexible elongate body of a tissue modification device for removing tissue along a curved path through an intervertebral foramen in the spine, between ligamentum flavum and neural tissue, wherein the tissue modification device comprises a plurality of blades coupled with a first major surface of the elongate body;

reciprocating the elongate body to remove ligamentum flavum tissue while the plurality of blades remain within the patient'"'"'s body by alternately applying a manual pulling force to a handle at a distal end of the tissue modification device and applying a manual pulling force to a handle a proximal end of the tissue modification device such that the distal handle and the proximal handle of the tissue modification device move in opposite directions with respect to the outside of the patient'"'"'s body; and

inhibiting damage to the neural tissue with an atraumatic second major surface of the elongate body opposite the first major surface.

19. The method of claim 10, wherein the tissue modification device comprises a plurality of laterally offset blades coupled with a first major surface of the elongate body, wherein each blade is substantially in-line with a longitudinal axis of the elongate body, and wherein each blade is substantially vertical relative to a the first major surface.

22. The method of claim 10, wherein the distal handle and the proximal handle of the tissue modification device move in opposite directions with respect to the outside of the patient'"'"'s body such that one handle moves toward the body while the other handle moves away from the body.

11. A method for removing target tissue from a patient, the method comprising:

advancing a guidewire into the body and around the target tissue so that the proximal end of the guidewire extends from a first position outside of the patient'"'"'s body and the distal end of the guidewire extends from a second position outside of the patient;

coupling the proximal end of the guidewire to a tissue modification device outside of the body after advancing the guidewire into the body, wherein the tissue modification device comprises an elongate flexible body having a plurality of blades separated by openings through the elongate flexible body;

pulling the tissue modification device behind the guidewire to position it along a path between the target tissue and non-target tissue, wherein the proximal end of the guidewire remains within the body; and

manually reciprocating the blades into the target tissue while a portion of the guidewire remains within the body by pulling the elongate body axially proximally and distally along the path so as to cut the target tissue.

12. The method of claim 11, further comprising collecting cut tissue passing through the openings through the elongate flexible body.

13. The method of claim 11, wherein the step of advancing the guidewire comprises advancing the guidewire through an intervertebral foramen in the spine, between ligamentum flavum and neural tissue.

14. The method of claim 11, further comprising coupling a handle to the distal end of the guidewire.

15. The method of claim 11, wherein the step of manually reciprocating the blades comprises alternately pulling on the guidewire to pull the blades distally and pulling on a handle on the proximal end of the tissue modification device to pull the blades proximally.

23. The method of claim 11, wherein the step of manually reciprocating the blades into the target tissue comprises the step of alternately applying a manual pulling force to a handle at a distal end of the tissue modification device and applying a manual pulling force to a handle a proximal end of the tissue modification device such that the distal handle and the proximal handle of the tissue modification device move in opposite directions with respect to the outside of the patient'"'"'s body.

24. The method of claim 23, wherein the distal handle and the proximal handle of the tissue modification device move in opposite directions with respect to the outside of the patient'"'"'s body such that one handle moves toward the body while the other handle moves away from the body.

27. The method of claim 11, wherein the step of coupling the proximal end of the guidewire comprises coupling the proximal end of the guidewire to a tapered distal end region of the tissue modification device.

28. The method of claim 11, wherein the step of coupling the proximal end of the guidewire comprises coupling the proximal end of the guidewire to a distal end region of the tissue modification device, wherein the proximal end of the tissue modification device comprises an elongate rigid shaft from which the elongate flexible body extends.