Tissue removal with at least partially flexible devices

• US 8,062,300 B2
• Filed: 03/16/2007
• Issued: 11/22/2011
• Est. Priority Date: 05/04/2006
• Status: Active Grant

• Current Assignee: Spinal Elements, Inc.
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Schmitz, Gregory P., Bleich, Jeffrey L., Spisak, Steven A., Leguidleguid, Roy, Bleam, Jefferey
• Primary Examiner(s): Barrett, Thomas C.
• Assistant Examiner(s): BATES, DAVID W
• Application Number:
  US11/687,548
• Publication Number:
  US 20070260252A1
• Time in Patent Office: 1,712 Days
• Field of Search: 606/79, 606/82, 606/85
• US Class Current: 606/85
• 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 2017/32006 with a cutting strip, band or chain, e.g. like a chainsaw

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 system for modifying tissue in a patient, the system comprising:

a tissue modification device comprising;

an elongate body having a proximal portion, and a flexible distal portion having opposing first and second major surfaces extending longitudinally;

one or more tissue modifying members disposed along the first major surface, wherein the second major surface is an atraumatic surface; and

a guidewire coupler near the distal end of the body configured to retain the proximal end of a guidewire relative to the guidewire coupler so that the tissue modification device may be pulled distally by pulling the guidewire distally and so that the tissue modification device may be released from the guidewire by pushing the guidewire proximally;

a proximal handle configured to couple with the proximal portion of the tissue modification device;

a guidewire configured to couple to the tissue modification device; and

a distal handle configured to couple with the guidewire outside of the patient.

2. The system of claim 1, wherein the tissue modification device is configured to modify spinal tissue, and wherein the tissue modification device is configured to extend into the patient'"'"'s body, along a curved path through an intervertebral foramen of the spine, and out of the patient'"'"'s body, such that at least part of the flexible distal portion of the elongate body of the device extends into the intervertebral foramen, and the proximal and distal handles reside outside the patient.

3. The system of claim 2, wherein a height of the tissue modifying member(s) is greater than a thickness of a ligamentum flavum of the spine.

4. The system of claim 1, wherein the tissue modifying member(s) are selected from the group consisting of uni-directional blades, bi-directional blades, teeth, hooks, barbs, pieces of wire saw, wires, meshes, woven material, knitted material, braided material, planes, graters, raised bumps, other abrasive surfaces, other abrasive materials and deliverable substances adhered to or formed in the first major surface.

5. The system of claim 1, wherein the tissue modifying member(s) are fixedly attached to or formed in the first major surface.

6. The system of claim 1, wherein the tissue modifying member(s) are moveably attached to or formed in the first major surface, and wherein the tissue modification device further comprises an actuator coupled with the tissue modifying member(s) and extending to the proximal handle for actuating the tissue modifying member(s).

7. The system of claim 1, wherein the elongate body is at least partially hollow, wherein the distal portion is flatter than the proximal portion, and wherein the tissue modifying members comprise blades formed in the first major surface of the distal portion.

8. The system of claim 1, wherein the guidewire coupler comprises a cavity for containing a shaped tip of the guidewire, and wherein the guidewire comprises at least one shaped tip for fitting within the cavity.

9. The system of claim 1, further comprising a material disposed over a portion of the elongate body distal portion to provide the distal portion with smooth edges.

10. The system of claim 9, wherein the material comprises a polymeric cover disposed over the distal portion with one or more openings through which the tissue modifying member(s) protrude.

11. The system of claim 1, wherein the tissue modification device is further configured to collect tissue removed by the tissue modifying member(s).

12. The system of claim 1, further comprising a tissue collection chamber formed in or attached to the elongate body.

13. The system of claim 1, wherein the guidewire coupler is configured to releaseably couple to the guidewire.

14. The system of claim 1, wherein the guidewire coupler is configured to retain the proximal end of the guidewire relative to the guidewire coupler so that the tissue modification device may be urged against the tissue so that the tissue modification device forms a bend against the target tissue to modify the tissue by pulling on the proximal end of the elongate body while pulling distally on the guidewire.

15. A device for modifying tissue in a patient, the device comprising:

an elongate body comprising;

a rigid proximal portion;

a flexible distal portion; and

an intermediate flexible portion disposed between the proximal and distal portions and having opposing first and second major surfaces extending longitudinally;

one or more tissue modifying members disposed along the first major surface of the intermediate portion of the body but not the second major surface; and

a guidewire coupler near the distal end of the body configured to retain the proximal end of a guidewire relative to the guidewire coupler so that the tissue modification device may be pulled distally by pulling the guidewire distally and so that the tissue modification device may be released from the guidewire by pushing the guidewire proximally.

16. A device as in claim 15, wherein the device is configured to modify spinal tissue, and wherein the device is configured to extend into the patient'"'"'s body, along a curved path through an intervertebral foramen of the spine, and out of the patient'"'"'s body, such that at least part of the flexible intermediate portion of the elongate body of the device extends into the intervertebral foramen.

17. A device as in claim 15, wherein at least the proximal and intermediate portions of the elongate body are at least partially hollow, thus forming at least one lumen.

18. A device as in claim 17, wherein the at least one lumen comprises at least one of a suction lumen and an irrigation lumen.

19. A device as in claim 17, further including at least one tissue transport member slidably disposed within the lumen and configured to remove tissue out of the device.

20. A device as in claim 19, wherein the tissue transport member comprises one or more flexible wires having tissue collection portions disposed under the tissue modifying member(s) of the device.

21. A device as in claim 20, wherein the tissue collection portions are selected from the group consisting of shaped portions of the wire(s), adhesive coating(s) on the wire(s), tissue collecting material(s) on the wire(s) and adhesive material(s) used to make the wire(s) themselves.

22. A device as in claim 19, wherein the tissue transport member comprises a piece of tissue adhering material disposed under the tissue modifying member(s) of the device.

23. A device as in claim 19, wherein the tissue transport member comprises a removable tissue collection chamber disposed under the tissue modifying member(s) of the device.

24. A device as in claim 19, wherein the tissue transport member comprises at least one unidirectional valve for allowing tissue to pass through the shaft toward the proximal handle while preventing the cut tissue from passing through the valve(s) toward the tissue modifying member(s) of the device.

25. A device as in claim 15, wherein at least part of the elongate body is sufficiently flexible to be compressible, such that tissue may be moved through the elongate body by compressing the compressible portion.

26. A device as in claim 15, further comprising a tissue collection chamber formed in or attached to the elongate body.

27. The system of claim 15, wherein the guidewire coupler is configured to releaseably couple to the guidewire.

28. The system of claim 15, wherein the guidewire coupler is configured to retain the proximal end of the guidewire relative to the guidewire coupler so that the tissue modification device may be urged against the tissue so that the tissue modification device forms a bend against the target tissue to modify the tissue by pulling on the proximal end of the elongate body while pulling distally on the guidewire.

29. A kit for modifying tissue in a patient, the kit comprising:

a tissue modification device, comprising;

a rigid shaft having a proximal end and a distal end;

a flexible substrate extending from the distal end of the shaft;

a proximal handle coupled with the shaft at or near its proximal end;

one or more tissue modifying members disposed along one side of the substrate; and

a guidewire coupler disposed on the substrate configured to retain the proximal end of the guidewire relative to the guidewire coupler so that the tissue modification device may be pulled distally by pulling the guidewire distally and so that the tissue modification device may be released from the guidewire by pushing the guidewire proximally;

a guidewire configured to couple with the guidewire coupler; and

a distal handle removably couplable with the guidewire outside the patient.

30. A kit as in claim 29, wherein the tissue modification device and guidewire, coupled together, are configured to extend into the patient'"'"'s body, along a curved path through an intervertebral foramen of the spine, and out of the patient'"'"'s body, such that at least part of the flexible substrate extends into the intervertebral foramen, and the proximal and distal handles reside outside the patient.

31. A kit as in claim 29, further comprising at least one probe for passing the guidewire between target and non-target tissues in a patient.

32. A kit as in claim 31, wherein the probe comprises a needle.

33. A kit as in claim 31, wherein the probe comprises a curved, cannulated probe.

34. A kit as in claim 31, further comprising a flexible guide member for passing through the probe, wherein the guide member has an inner diameter selected to allow passage of the guidewire therethrough.

35. A kit as in claim 29, wherein the device further comprises a tissue collection chamber configured to collect tissue.

36. A kit as in claim 35, wherein the device further comprises tissue transport means configured to transport the collected tissue through the device.

37. A device for modifying tissue,

with a proximal handle at the substantially proximal end of the device with a flexible distal portion of the device configured for tissue modification, such that when the user simultaneously pulls on both the proximal and distal ends of the device the flexible portion of the device is pulled under tension against a target tissue with a rigid portion of the device between a handle and the flexible portion of the device

with the flexible portion of the device containing tissue modification elements along a first surface that is opposite from an atraumatic second surface on the other side of the first surface

with a guidewire coupler at the distal end of the flexible portion configured to retain the proximal end of the guidewire relative to the guidewire coupler so that the tissue modification device may be pulled distally by pulling the guidewire distally and so that the tissue modification device may be released from the guidewire by pushing the guidewire proximally.

38. A device as in claim 37, where the target tissue is spinal tissue in at least one of the central spinal canal, the lateral recess or the neural foramen.

39. A device as in claim 37, where each tissue modification element comprises at least one of a blade, an abrasive, a plane, a saw, a hook, a spike, an electrode, a hemostatic agent, an anti-inflammatory agent, or an analgesic.

40. A device as in claim 37, where the tissue modification elements are covered during insertion.

41. A device, as in claim 37, where the tissue modification elements are covered when not pulled under tension against target tissues.

42. A device, as in claim 37, where the tissue modification elements are covered by a portion of the device that moves with the flexible portion of the device.

43. A device, as in claim 37, where the tissue modification elements are covered by a portion of the device that moves independently of the flexible portion of the device.

44. A device as in claim 37, where the tissue modification elements are sharp blades, extending at angles from the flexible portion of the device to which they are attached.

45. A system for removing a target tissue of a patient, the system comprising:

a distal elongate flexible portion having a first end and a second end with an axis therebetween, the flexible portion having a first surface extending along the axis and a second surface opposite the first surface, wherein the flexible portion is axially bendable in a first lateral orientation;

a proximal portion extendable from the flexible portion configured so that movement of the proximal portion can shift the first surface toward a target region of the target tissue;

a tissue modifying member disposed along the first surface to effect removal of the target region of the target tissue, wherein the second surface comprises an atraumatic surface; and

a guidewire coupler at the distal end of the flexible portion configured to retain the proximal end of a guidewire relative to the guidewire coupler so that the tissue modification device may be pulled distally by pulling the guidewire distally and so that the tissue modification device may be released from the guidewire by pushing the guidewire proximally.

46. The system of claim 45, further comprising a handle configured to connect to the proximal portion so that tension can be applied to the first end by pulling the proximal portion manually from outside the patient so as to urge the first surface against the target tissue when the flexible member bends over the target tissue in the first orientation.

47. The system of claim 46, wherein the proximal portion couples the handle to the flexible portion such that applying torque to the handle outside the body portion rotates the flexible portion about the axis so as to shift an orientation of the first surface toward a target region of the target tissue when the system is deployed for use.

48. The system of claim 47, the target tissue having a convex surface defining an outward orientation and an inward orientation, wherein the first surface is bordered by first and second opposed edges, wherein the rotation of the shaft portion can counteract a tension-induced rolling of the flexible body portion about the axis when the first edge is inward of the second edge.

49. The system of claim 46, further comprising a distal handle configured to be coupled with a second end of the flexible portion such that the flexible portion can be manually tensioned by simultaneous pulling, from outside the patient, on the first and second, ends and can be axially moved along a curving path within the patient by relative movement between the handles, the curving path including the bend over the target tissues.

50. The system of claim 49, wherein the tissue modifying member comprises a plurality of axially oriented blades extending from the first surface, the handles configured for reciprocating the tissue modifying member along the curved path and against the target tissue by sequentially pulling on the first and second handles so that the cutting edges incise the target tissue.