Insulated pedicle access system and related methods

• US 8,784,330 B1
• Filed: 05/17/2011
• Issued: 07/22/2014
• Est. Priority Date: 06/06/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: NU Vasive Incorporated
• Inventors: Scholl, Thomas, Kim, Albert, Arambula, Jared, Martinelli, Scot, Finley, Eric, Pothier, Albert
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/109,981
• Time in Patent Office: 1,162 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 elongated needle element including a shaped tip advanceable into a bony structure of a patient'"'"'s spine;

an elongated cannula lockingly mateable with said needle element;

an elongated sheath disposed about the exterior of said cannula, wherein said elongated sheath is non-compressible and slideable between a first position and a second position; and

a handle configured to attach to at least one of said needle element and said cannula to allow a user to manipulate said system;

wherein at least one of said needle element, said cannula, and said handle includes a contact element in 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 at least one of said shaped tip and said distal end and into a hole formed in said bony structure.

2. The system of claim 1, wherein said cannula further comprises a lumen to slideably receive said needle element therethrough such that said shaped tip of said needle element extends distally beyond a distal end of said cannula.

3. The system of claim 1, wherein said elongated sheath is coupled to an attachment element situated near a proximal end of said cannula, said attachment element including an exterior surface defining a lumen enclosing a distal portion of the cannula and a distal portion of the insulative sheath.

4. The system of claim 3, wherein said attachment element includes at least one longitudinally running slot and the proximal portion of the elongated sheath includes at least one tab extending into the slot.

5. The system of claim 1, wherein a distal end of said elongated sheath is adapted to engage a surface of said bony structure when said cannula and said needle element are advanced into said bony structure such that said elongate 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 said bony structure.

6. The system of claim 1, wherein said elongated sheath is coated with a nonconductive material.

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

8. The system of claim 7, wherein said bias is a spring-bias.

9. The system of claim 1, further comprising a lock collar dimensioned to lock said needle and said cannula in place relative to one another.

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

an access needle including;

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

a handle configured to be lockingly mateable with said needle element to allow a user to manipulate said system; and

an insulative sheath disposed about the exterior of said needle, wherein said insulative sheath is non-compressible and slideable between a first position and a second position;

wherein said access needle has a contact element coupleable to a source of electrical stimulation and in electrical communication with said shaped tip 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.

11. The system of claim 10, wherein said insulative sheath comprises an elongated cylinder, the elongated cylinder further comprising a lumen to slideably receive said needle element therethrough such that said shaped tip of said needle element extends distally beyond a distal end of said sheath.

12. The system of claim 10, wherein said insulative sheath is coated with a nonconductive material.

13. The system of claim 11, wherein said distal end of said insulative sheath is adapted to engage a surface of said bony structure when said needle element is advanced into said bony structure such that said insulative sheath slides relative to said needle element as said needle element is advanced deeper into said bony structure.

14. The system of claim 10, wherein said insulative sheath is biased to said first position in which the distal end of said needle element is least exposed.

15. The system of claim 14, wherein said bias is a spring bias.

16. The system of claim 14, wherein said needle element is at least partially exposed when said insulative sheath is in said second position.

17. The system of claim 10, wherein said contact element is included on said needle element.

18. The system of claim 10, wherein said contact element is included on said handle.