# US 8,784,330 B1 · Insulated pedicle access system and related methods

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- Number: US 8,784,330 B1
- Document ID: US8784330B1
- Status: Granted
- Kind: B1
- Application number: 13/109,981
- Filed: 2011-05-17
- Granted: 2014-07-22
- Earliest claimed: 2005-06-06
- Assignees: Nu Vasive, Inc.
- Applicants: Thomas Scholl; Albert Kim; Jared Arambula; Scot Martinelli; Eric Finley; Albert Pothier
- Inventors: Thomas Scholl; Albert Kim; Jared Arambula; Scot Martinelli; Eric Finley; Albert Pothier
- Web page: https://patentgrep.com/patent/US8784330B1

## CPC

- A61B 5/296: for electromyography [EMG]
- A61B 5/05: Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves (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)
- A61B 5/395: Details of stimulation, e.g. nerve stimulation to elicit EMG response
- A61B 5/4893: {Nerves}
- A61B 17/1671: {for the spine}
- A61B 17/3421: {Cannulas}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 17/3472: {for bones, e.g. intraosseus injections}
- A61B 5/4504: {Bones (A61B5/4547 takes precedence)}
- A61B 17/70: Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
- 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)}
- A61B 2017/0046: {with a releasable handle; with handle and operating part separable}
- A61B 2017/00469: {for insertion of instruments, e.g. guide wire, optical fibre}
- A61B 2017/347: {Locking means, e.g. for locking instrument in cannula}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 3)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 7)

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

### Claim 9 (depends on 1)

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

### Claim 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.

### Claim 11 (depends on 10)

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.

### Claim 12 (depends on 10)

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

### Claim 13 (depends on 11)

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.

### Claim 14 (depends on 10)

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.

### Claim 15 (depends on 14)

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

### Claim 16 (depends on 14)

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

### Claim 17 (depends on 10)

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

### Claim 18 (depends on 10)

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