IP Library › Granted Patent US 11,337,630
Granted Patent B2
US 11,337,630 · App. 15/881,624 · Granted May 24, 2022

Directional dilator for intraoperative monitoring

Inventors: Jonathan D. Spangler (Del Mar, CA); Forrest Samuel (San Diego, CA)
Assignee: NuVasive, Inc.
A61B5/24A61B5/389A61B5/4893
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Quick Facts
Patent No.
US 11,337,630
App. No.
15/881,624
Filed
Jan 26, 2018
Granted
May 24, 2022
Kind
B2
Art Unit
3791
USPC
600/554
Abstract

A stationary dilator has one or more electrodes in the distal region that are rotatable around the longitudinal axis of the dilator. The one or more electrodes are operable to deliver electrical stimulation signals to tissue through which the dilator is passed. The stimulation signals can be used for determining nerve directionality and optionally nerve proximity during surgical procedures involving the presence of neural structures.

Claims (56)

1. A stationary directional dilator, comprising:

a first tubular structure having a first proximal end, a first distal end, and a first inner lumen extending between said first proximal end and said first distal end; and

a second tubular structure longitudinally fixed with and rotatably coupled to said first tubular structure, said second tubular structure having:

a second proximal end;

a second distal end defining a beveled surface;

a second inner lumen extending between said second proximal end and said second distal end; and

a directional electrode located at said beveled surface of the second distal end and configured to transmit an electric signal to surrounding tissue when said directional electrode is in electrical communication with an intraoperative monitor,

wherein said second structure is dimensioned to be rotated relative to the first tubular structure to thereby change a direction that the directional electrode is aimed in order to determine a direction of nerves located in said tissue relative to said first tubular structure as said first tubular structure and said second structure are advanced through said tissue.

2. The stationary direction dilator of claim 1 , wherein said proximal end of said first tubular structure is dimensioned to receive at least a portion of said proximal end of said second structure.

3. The stationary directional dilator of claim 1 , wherein said proximal end of said second structure includes a collar dimensioned to be selectively rotated by a user relative to the first tubular structure to change the direction that the directional electrode is aimed.

4. The stationary directional dilator of claim 3 , wherein said collar is positioned adjacent to the proximal end of said first tubular structure.

5. The stationary directional dilator of claim 3 , wherein said collar is housed at least partially within the proximal end of said first tubular structure.

6. The stationary directional dilator of claim 5 , further comprising:

a cap dimensioned to retain said collar of said proximal end of said second structure within said proximal end of said first tubular structure; and

an electrical coupler extending from said cap and in electrical communication to the electrode, the electrical coupler being configured to establish the electrical communication between the electrode and the intraoperative monitor when said electrical coupler is connected to the intraoperative monitor.

7. The stationary directional dilator of claim 1 , wherein said second structure includes a collar at said second proximal end, a ring at said second distal end, and a tubular structure extending between said collar and said ring, wherein said directional electrode is disposed on said ring.

8. The stationary directional dilator of claim 1 , further comprising an electrical coupler in electrical communication to the electrode, the electrical coupler being configured to establish the electrical communication between the directional electrode and the intraoperative monitor when said electrical coupler is connected to the intraoperative monitor.

9. The stationary directional dilator of claim 1 , wherein said directional electrode is rotated automatically by a user activating a drive mechanism capable of rotating said second structure relative to said first tubular structure.

10. The stationary directional dilator of claim 1 , wherein at least one of said first tubular structure and said second structure is configured with at least one of audio and visual emission capabilities to transmit an audio indicia or a visual indicia to a user to communicate information pertaining to a distance or the direction of the nerves located in said tissue relative to said first tubular structure.

11. The stationary directional dilator of claim 1 ,

wherein the second structure includes a circumferential recess having a circumferential recessed electrode surface in electrical communication with the directional electrode;

wherein the circumferential recess divides a collar at the second proximal end into a proximal collar portion and a distal collar portion;

wherein the stationary directional dilator comprises:

a proximal electrode marker disposed at the proximal collar portion; and

a distal electrode marker disposed at the distal collar portion; and

wherein the proximal electrode marker, the distal electrode marker, and the electrode are aligned.

12. The stationary directional dilator of claim 1 , further comprising:

a previously placed additional dilator extending through the second inner lumen.

13. A method comprising:

advancing a first tubular dilator through tissue in a human subject;

rotating a second structure longitudinally fixed with, rotatably coupled to, and disposed at least partially within said first tubular dilator such that a directional electrode disposed on a beveled distal end of said second structure changes a direction in which the directional electrode faces, thereby changing a direction in which the directional electrode emits an electrical signal into said tissue via the directional electrode; and

iteratively changing the direction in which the electrode faces by rotating said second structure relative to said first tubular dilator until said electrical signal emitted from said directional electrode causes nerve tissue to innervate based on the electrical signal; and

passing a surgical implant through a lumen of the second structure.

14. The method of claim 13 , further comprising:

coupling an electrical connector to a circumferential recessed electrode near a proximal end of the second structure, the circumferential recessed electrode being in electrical communication with the directional electrode,

wherein said directional electrode is coupled to an electromyographic intraoperative monitor via the circumferential recessed electrode.

15. The method of claim 13 , further comprising:

equipping at least one of said first tubular structure and said second structure with at least one of audio and visual emission capabilities; and

communicating to a user at least one of audio and visual information pertaining to at least one of distance and direction of the nerve tissue relative to said first tubular structure.

16. The method of claim 13 , further comprising:

placing an initial dilator; and

removing the initial dilator before passing the surgical implant through the lumen,

wherein advancing the first tubular dilator through the tissue in the human subject includes:

advancing the first tubular dilator over the initial dilator such that the initial dilator is within the lumen of the second structure.

17. An apparatus comprising:

an outer dilator defining a first inner lumen;

an electrode structure longitudinally fixed with and disposed at least partially within the first inner lumen such that the electrode structure can rotate relative to the outer dilator, wherein the electrode structure defines a second inner lumen, a proximal end and a distal end;

a directional electrode disposed at a beveled surface of the distal end of the electrode structure;

a circular collar disposed at the proximal end of the electrode structure, wherein the circular collar defines a circumferential recess having a circumferential recessed electrode surface in electrical communication with the electrode, wherein the circumferential recess divides the collar into a proximal collar portion and a distal collar portion;

a proximal electrode marker disposed at the proximal collar portion; and

a distal electrode marker disposed at the distal collar portion,

wherein the proximal electrode marker, the distal electrode marker, and the electrode are aligned.

18. The apparatus of claim 17 , further comprising:

an intraoperative monitor; and

an electrical connector in electrical communication with the intraoperative monitor,

wherein the electrical connector is clipped or clamped into the recess such that the electrical connector is in electrical communication with the electrode surface, thereby placing the electrode disposed at the distal end of the electrode structure in electrical communication with the intraoperative monitor.

Assignments (2)
SECURITY INTEREST Recorded Feb 28, 2020
From: NUVASIVE, INC.; NUVASIVE CLINICAL SERVICES MONITORING, INC.; NUVASIVE CLINICAL SERVICES, INC.; NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 052918/0595 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 13, 2018
From: SPANGLER, JONATHAN D.; SAMUEL, FORREST
To: NUVASIVE, INC.
Reel/Frame 046079/0789 →
Continuity (3)
Continuation 13830508 · Mar 14, 2013
Provisional Application 61612195 · Mar 16, 2012
Related Publication 20180160923A1 · Jun 14, 2018