Tissue Access Guidewire System and Method

• US 20080086034A1
• Filed: 08/29/2006
• Published: 04/10/2008
• Est. Priority Date: 08/29/2006
• Status: Abandoned Application

• Current Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Leguidleguid, Roy, Bleich, Jeffery L., Bleam, Jefferey, Schmitz, Gregory
• Application Number:
  US11/468,252
• Publication Number:
  US 20080086034A1
• Time in Patent Office: Days
• US Class Current: 600/210
• CPC Class Codes: A61B 1/3135 for examination of the epidural or the spinal space
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1611 the two jaw elements being integral with respective elongate shaft elements
• 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 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A method and system for guiding at least a portion of a surgical device to a desired position between two tissues in a patient'"'"'s body involves coupling a guidewire to the device and pulling the distal end of the guidewire to guide at least a portion of the surgical device to a desired position between the two tissues. The surgical device generally includes one or more guidewire coupling members and may comprise a tissue access device. A system may include a guidewire and a surgical device. In some embodiments, a guidewire, a tissue access device, and one or more additional devices to use with the access device may be provided. Methods, devices and systems may be used in open, less-invasive or percutaneous surgical procedures, in various embodiments.

Claims

1. A tissue access device for providing access to target tissue in a patient'"'"'s body while protecting non-target tissue, the device comprising:

a shaft having a proximal portion, a distal portion, and at least one lumen passing longitudinally through at least the proximal portion to allow passage of at least one additional device therethrough;

at least one side-facing aperture in at least one of the proximal and distal shaft portions, through which the at least one additional device may be exposed to the target tissue; and

a guidewire coupling member on the distal portion of the shaft for coupling with a guidewire to allow the tissue access device to be pulled behind the guidewire to position its distal portion between the target and non-target tissues with the aperture facing the target tissue.

2. A device as in claim 1, wherein part of the shaft is rigid and part of the shaft is flexible.

3. A device as in claim 2, wherein the distal portion is at least partially flexible.

4. A device as in claim 3, wherein the flexible distal portion is steerable from a relatively straight configuration to a curved configuration, the device further comprising at least one steering actuator extending from the proximal portion to the distal portion.

5. A device as in claim 1, wherein the lumen passes through both the proximal and distal portions, and wherein the aperture is in the distal portion.

6. A device as in claim 1, wherein the lumen passes through only the proximal portion, and wherein the aperture is positioned in a distal region of the proximal portion, such that when part of the additional device passes through the aperture, it is located above the distal portion of the shaft.

7. A device as in claim 1, further comprising at least one electrode coupled with at least one surface of the distal portion of the shaft and configured to stimulate nerve tissue.

8. A device as in claim 1, wherein the guidewire coupling member is configured to removably couple with a shaped member at one end of a guidewire.

9. A device as in claim 1, further comprising a handle coupled with a proximal end of the proximal portion.

10. A system for providing access to target tissue in a patient'"'"'s body while protecting non-target tissue, the system comprising:

a tissue access device comprising;

a shaft having a proximal portion, a distal portion, and at least one lumen passing longitudinally through at least the proximal portion to allow passage of at least one additional device therethrough;

at least one side-facing aperture in at least one of the proximal and distal shaft portions, through which the at least one additional device may be exposed to the target tissue; and

a guidewire coupling member on the distal portion of the shaft for coupling with a guidewire to allow the tissue access device to be pulled behind the guidewire to position its distal portion between the target and non-target tissues with the aperture facing the target tissue; and

a guidewire configured to couple with the guidewire coupling member.

11. A system as in claim 10, wherein the guidewire comprises a sharp distal tip and a shaped member on a proximal tip for coupling with the guidewire coupling member.

12. A system as in claim 10, further comprising at least one additional device configured to pass through the tissue access device to expose at least an active portion of the additional device through the side-facing aperture.

13. A system as in claim 12, wherein the at least one additional device is selected from the group consisting of tissue cutting devices, tissue ablation devices, tissue abrasion devices, other tissue removal devices, other tissue modification devices, tissue storage devices, tissue transport devices, drug delivery devices, implant delivery devices, material delivery devices, visualization devices and diagnostic devices.

14. A system as in claim 10, further comprising an anchoring device for coupling the shaft of the tissue access device with a structure outside the patient to stabilize the tissue access device.

15. A system as in claim 10, further comprising an anchoring device for coupling the shaft of the tissue access device with a structure inside the patient to stabilize the tissue access device.

16. A system as in claim 10, wherein the tissue access device further comprises a handle coupled with a proximal end of the proximal shaft portion.

17. A system as in claim 10, further comprising a guidewire handle for coupling with the guidewire outside the patient to facilitate pulling on the guidewire to apply tensioning force.

18. A method for providing access to target tissue in a patient'"'"'s body while protecting non-target tissue, the method comprising:

passing a guidewire between the target and non-target tissues;

coupling the guidewire with a guidewire coupling member on a distal portion of a tissue access device; and

pulling the guidewire through the patient'"'"'s body to pull the distal portion of the tissue access device between the target and non-target tissues such that a side-facing aperture of the tissue access device faces the target tissue,

wherein, when the distal portion of the access device is positioned between the target and non-target tissues, a proximal portion of the device extends outside the patient, such that at least one tissue modification device may be passed through at least the proximal portion to expose one or more tissue modifying members through the side-facing aperture.

19. A method as in claim 18, further comprising identifying at least the non-target tissue before passing the guidewire.

20. A method as in claim 18, further comprising:

advancing a first tissue modification device through the tissue access device to expose at least one tissue modification member of the device through the side-facing aperture of the access device;

pulling the guidewire and at least one of the tissue access device and the tissue modification device to urge the at least one tissue modification member against the target tissue; and

activating the tissue modification member(s) to modify the target tissue while protecting the non-target tissue with the distal portion of the access device.

21. A method as in claim 20, further comprising:

removing the first tissue modification device from the patient'"'"'s body, through the access device;

advancing a second tissue modification device through the tissue access device to expose at least one tissue modification member of the device through the side-facing aperture of the second access device;

pulling the guidewire and at least one of the tissue access device and the second tissue modification device to urge the at least one tissue modification member against the target tissue; and

activating the tissue modification member(s) to modify the target tissue.

22. A method as in claim 20, wherein activating the tissue modification member(s) comprises actuating at least one actuation member on a handle of the tissue access device.

23. A method as in claim 18, further comprising coupling the tissue access device with a structure outside the patient, using at least one anchoring device, to stabilize the access device.

24. A method as in claim 18, further comprising coupling the tissue access device with a structure inside the patient, using at least one anchoring device, to stabilize the access device.

25. A method as in claim 18, further comprising activating at least one electrode on the distal portion of the tissue access device to confirm placement of the distal portion between the target and non-target tissues.