Insulated pedicle access system and related methods

• US 7,942,826 B1
• Filed: 06/06/2006
• Issued: 05/17/2011
• Est. Priority Date: 06/06/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Finley, Eric, Arambula, Jared, Kim, Albert, Pothier, Albert, Martinelli, Scot, Scholl, Thomas
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/448,237
• Time in Patent Office: 1,806 Days
• Field of Search: 600562-567, 600/554, 600/547, 606/79, 606/80, 606/167, 604/263, 604/198, 607/116
• US Class Current: 600/554
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves
• 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: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A pedicle access system including a cannula, a stylet, and a removable T-handle. The pedicle access system may be used to percutaneously approach the pedicle, initiate pilot hole formation, and conduct a stimulation signal to the target site for the purposes of performing a pedicle integrity assessment during the pilot hole formation. To do this, the cannula and stylet are locked in combination and inserted through an operating corridor to the pedicle target site, using the T-handle to facilitate easy movement and positioning of the cannula/stylet combination. A stimulation signal may be applied during pilot hole formation to conduct the pedicle integrity assessment. In a significant aspect, the T-handle may be detached from the cannula/stylet combination to facilitate the use of various surgical tools as necessary.

Claims

1. A system for use in a medical procedure, comprising:

an access needle, including;

an elongated needle element having a shaped tip advanceable into a bony structure of a patient'"'"'s spine;

an elongated cannula lockingly mateable with said needle element and having a lumen to slidably receive said needle element therethrough such that said shaped tip of said needle element extends distally beyond a distal end of said cannula;

an insulative sheath disposed about the exterior of said cannula, wherein said insulative sheath is coupled to an attachment element situated near a proximal end of said cannula, the attachment element including an exterior surface defining a lumen enclosing a distal portion of the cannula and a distal portion of the insulative sheath, the attachment element including at least one longitudinally running slot and the proximal portion of the insulative sheath including at least one tab extending into the slot;

a locking mechanism that selectively locks said needle element and said cannula together when said needle element is fully received in said cannula; and

a handle attachable to at least one of said needle element and said cannula;

wherein said access needle has a contact element coupleable to a source of electrical stimulation and in electrical communication with at least one of said shaped tip and said distal end of said cannula such that a stimulation signal is deliverable to a target region of said bony structure to perform a pedicle integrity assessment when said access needle is in contact with said bony structure.

2. The system of claim 1, wherein said handle is removable.

3. The system of claim 1, wherein said contact element is a conductive surface on at least one of said needle element, cannula, and handle, said contact element being engageable by a stimulation clip comprising said stimulation source.

4. The system of claim 1, wherein said insulative sheath is slidable along the exterior of said cannula between a first position and a second position.

5. The system of claim 1, wherein a distal end of said insulative sheath is adapted to engage a surface of said bony structure when said needle element and cannula are advanced into said bony structure such that said insulative sheath slides relative to said cannula as said needle element and cannula are advanced deeper into said bony structure exposing the exterior of said cannula to the interior of the bony structure.

6. The system of claim 1, wherein said insulative sheath is biased to a first position in which the exterior of the cannula is least exposed.

7. The system of claim 1, wherein said locking mechanism comprises a lock collar.

8. The system of claim 1, wherein said handle is adapted to matingly engage an instrument in a fixed position relative to said handle.

9. The system of claim 8, wherein said instrument is at least one of a clip to couple said access needle to said source of electrical stimulation and a sensor for monitoring the angular orientation of the access needle during use.

10. A surgical instrument, comprising:

an elongated needle element including a shaped tip advanceable into a bony structure of a patient'"'"'s spine;

a handle coupled to said needle element to facilitate manipulation of said surgical instrument via a user;

a cannula having a lumen that slidably receives said needle element therein, the cannula having an exterior that is insulated over a majority of the length of said cannula, and wherein said needle element and said cannula are lockingly engageable when said needle element is fully received within said cannula; and

an insulative sheath slidable along the exterior of said cannula between a first position and a second position wherein said insulated sheath is coupled to an attachment element situated near a proximal end of the cannula, the attachment element including an exterior surface defining a lumen enclosing a distal portion of the cannula and a distal portion of the insulative sheath, the attachment element including at least one longitudinally running slot and the proximal portion of the insulative sheath including at least one tab extending into the slot; and

wherein at least one of said cannula and said handle includes a contact element in electrical communication with at least one of said shaped tip of said needle element and a distal end of said cannula, said contact element being coupleable with an electrical source to transmit an electrical stimulation current from said electrical source to said at least one of said shaped tip of said needle element and said distal end of said cannula and into a hole formed in said bony structure by said instrument.

11. The surgical instrument of claim 10 wherein a locking collar is utilized to lockingly engage said needle element and said cannula.

12. The surgical instrument of claim 10, wherein said insulative sheath is biased to a first position in which the exterior of the cannula is least exposed.

13. The surgical instrument of claim 10, wherein said insulated sheath is spring biased to the first position in which the exterior of the cannula is least exposed.

14. A system for use in a medical procedure, comprising:

an access needle including;

an elongated needle element having a shaped tip advanceable into a bony structure of a patient'"'"'s spine;

an elongated cannula lockingly mateable with said needle element and having a lumen to slidably receive said needle element therethrough such that said shaped tip of said needle element extends distally beyond a distal end of said cannula;

an insulative sheath disposed about the exterior of said cannula, wherein said insulative sheath is coupled to an attachment element, said attachment element defining a lumen enclosing a portion of said cannula and a portion of said insulative sheath, said attachment element including at least one longitudinally running slot and the proximal portion of said insulative sheath including at least one tab extending through said slot;

a locking mechanism that selectively locks said needle element and said cannula together when said needle element is fully received in said cannula; and

a handle attachable to at least one of said needle element and said cannula;

wherein said access needle is coupleable to a source of electrical stimulation and in electrical communication with at least one of said shaped tip and said distal end of said cannula such that a stimulation signal is deliverable to a target region of said bony structure to perform a pedicle integrity assessment when said access needle is in contact with said bony structure.

15. The system of claim 14, wherein said handle is removable.

16. The system of claim 14, wherein a conductive surface on at least one of said needle element, cannula, and handle, is engageable by a stimulation clip comprising said stimulation source.

17. The system of claim 14, wherein said insulative sheath is slidable along the exterior of said cannula between a first position and a second position.

18. The system of claim 14, wherein the distal end of said insulative sheath is adapted to engage a surface of said bony structure when said needle element and cannula are advanced into said bony structure such that said insulative sheath slides relative to said cannula as said needle element and cannula are advanced deeper into said bony structure exposing the exterior of said cannula to the interior of the bony structure.

19. The system of claim 14, wherein said insulative sheath is biased to a first position in which the exterior of the cannula is least exposed.

20. The system of claim 14, wherein said locking mechanism comprises a lock collar.

21. The system of claim 14, wherein said handle is adapted to matingly engage an instrument in a fixed position relative to said handle.

22. The system of claim 21, wherein said instrument is at least one of a clip to couple said access needle to said source of electrical stimulation and a sensor for monitoring the angular orientation of the access needle during use.

23. A system for use in a medical procedure, comprising:

an access needle including;

an elongated needle element having a shaped tip advanceable into a bony structure of a patient'"'"'s spine;

an elongated cannula lockingly mateable with said needle element and having a lumen to slidably receive said needle element therethrough such that said shaped tip of said needle element extends distally beyond a distal end of said cannula;

an insulative sheath disposed about the exterior of said cannula, wherein said insulative sheath is spring-biased to a first position in which the exterior of the cannula is least exposed;

a locking mechanism that selectively locks said needle element and said cannula together when said needle element is fully received in said cannula; and

a handle attachable to at least one of said needle element and said cannula;

wherein said access needle is coupleable to a source of electrical stimulation and in electrical communication with at least one of said shaped tip and said distal end of said cannula such that a stimulation signal is deliverable to a target region of said bony structure to perform a pedicle integrity assessment when said access needle is in contact with said bony structure.

24. The system of claim 23, wherein said handle is removable.

25. The system of claim 23, wherein a conductive surface on at least one of said needle element, cannula, and handle, is engageable by a stimulation clip comprising said stimulation source.

26. The system of claim 23, wherein said insulative sheath is slidable along the exterior of said cannula between said first position and a second position.

27. The system of claim 23, wherein a distal end of said insulative sheath is adapted to engage a surface of said bony structure when said needle element and cannula are advanced into said bony structure such that said insulative sheath slides relative to said cannula as said needle element and cannula are advanced deeper into said bony structure exposing the exterior of said cannula to the interior of the bony structure.

28. The system of claim 23, wherein said insulative sheath is coupled to an attachment element, the attachment element defining a lumen enclosing a portion of the cannula and a distal portion of the insulative sheath, the attachment element including at least one longitudinally running slot and the proximal portion of the insulative sheath including at least one tab extending into said slot.

29. The system of claim 23, wherein said locking mechanism comprises a lock collar.

30. The system of claim 23, wherein said handle is adapted to matingly engage an instrument in a fixed position relative to said handle.

31. The system of claim 30, wherein said instrument is at least one of a clip to couple said access needle to said source of electrical stimulation and a sensor for monitoring the angular orientation of the access needle during use.