Dilation system and method of using the same

Patent metadata

Field	Value
Publication number	US-9387009-B2
Application number	US-68167108-A
Country	US
Kind code	B2
Filing date	Oct 6, 2008
Priority date	Oct 5, 2007
Publication date	Jul 12, 2016
Grant date	Jul 12, 2016

Abstract

Directional sequential and blunt stimulating dilation systems ( 10 ) and related methods for accessing a patient's spine ( 2 ) though the patient's psoas muscle ( 4 ) include sequential directional dilators ( 30, 40 ) or a blunt stimulating dilator ( 100, 100 ′) with at least one channel formed therein. Neural elements or nerves ( 9 ) of the psoas muscle are preferably mapped using a stimulating probe ( 20 ). The stimulating probe is inserted through the psoas muscle toward the patient's spine. The directional sequential dilators may be inserted to dilate the tissue on any side of the stimulating probe without significantly impacting tissue on the opposite side of the stimulating probe, which may be located, proximate the neural elements. The dilators are rendered directional by having bores ( 35, 45 ), by means of which they can be inserted over each other and over the probe, which are offset from their longitudinal axes ( 31, 41 ).

First claim

The invention claimed is:

1. A directional sequential dilation system for dilating away from a nerve of a patient's anatomy, the directional sequential dilation system comprising:
a stimulating probe having a probe axis;
a first directional dilator including a first longitudinal axis, a first bore having a length extending from a proximal end to a distal end of the first directional dilator and a first channel formed in an outer surface of the first directional dilator and extending from the proximal end to the distal end so as to be in communication with the first bore along an entirety of the length of the first bore, the first bore having a first bore axis, the first longitudinal axis offset from the first bore axis; and
a second directional dilator including a second longitudinal axis, a second bore having a length extending from a proximal end to a distal end of the second directional dilator and a second channel formed in an outer surface of the second directional dilator and extending from the proximal end to the distal end so as to be in communication with the second bore along an entirety of the length of the second bore, the second bore having a second bore axis, the second longitudinal axis offset from the second bore axis; the stimulating probe removably receivable in the first bore and the first directional dilator removably receivable in the second bore.

2. The directional sequential dilation system of claim 1 , wherein the probe axis is coaxial with the first bore axis in an assembled configuration.

3. The directional sequential dilation system of claim 1 , wherein the first longitudinal axis is coaxial with the second bore axis in an assembled configuration.

4. The directional sequential dilation system of claim 1 , further comprising:
a first tip located at the distal end of the first directional dilator, the first longitudinal axis passing through the first tip; and
a second tip located at the distal end of the second directional dilator, the second longitudinal axis passing through the second tip.

5. The directional sequential dilation system of claim 4 , further comprising:
a plurality of first depth indicators located on a first outer surface of the first directional dilator, the plurality of first depth indicators extending on the first outer surface generally perpendicular to the first longitudinal axis, respectively, the plurality of first depth indicators defining a plurality of first distances between the first tip and the plurality of first depth indicators, respectively; and
a plurality of second depth indicators located on a second outer surface of the second directional dilator, the plurality of second depth indicators extending on the second outer surface generally perpendicular to the second longitudinal axis, respectively, the plurality of second depth indicators defining a plurality of distances between the second tip and the plurality of second depth indicators, respectively.

6. The directional sequential dilation system of claim 1 , wherein the first and second dilators include first and second grips located at proximal ends thereof, respectively.

7. The directional sequential dilation system of claim 1 , wherein the first directional dilator has a first length and the second directional dilator has a second length, the first length being greater than the second length.

8. The directional sequential dilation system of claim 7 , wherein the stimulating probe has a probe length, the probe length being greater than the first length and the second length.

9. The directional sequential dilation system of claim 1 , wherein the first directional dilator has a first diameter and the second directional dilator has a second diameter, the second diameter being greater than the first diameter.

10. A method of forming an access opening through a psoas muscle to a patient's spine using a directional sequential dilation system having a stimulating probe, a first directional dilator and a second directional dilator to avoid a nerve, each of the first directional dilator and the second directional dilator having a longitudinal axis, a bore with a length extending from a proximal end to a distal end, a bore axis that is offset from the longitudinal axis, and a channel formed in an outer surface thereof and extending from the proximal end to the distal end so as to be in communication with the bore along an entirety of the length of the bore, the method comprising the steps of:
(a) laterally inserting the stimulating probe into the psoas muscle;
(b) transmitting an electrical pulse via an EMG into the stimulating probe in order to locate a safe zone in the psoas muscle;
(c) laterally inserting the stimulating probe through the psoas muscle such that a probe tip is proximate the patient's spine;
(d) inserting the first directional dilator through the psoas muscle and toward the patient's spine guided by sliding engagement of the stimulating probe with the bore of the first directional dilator and with the channel of the first directional dilator positioned between the nerve and the longitudinal axis of the first directional dilator; and
(e) inserting the second directional dilator through the psoas muscle toward the patient's spine guided by sliding engagement of the first directional dilator with the bore of the second directional dilator and with the channel of the second directional dilator positioned between the nerve and the longitudinal axis of the second directional dilator.

11. The method of claim 10 , comprising the further step of:
(f) inserting a retractor over the second directional dilator.

12. The method of claim 10 , comprising the further step of:
(f) confirming via intra-operative fluoroscopy the location of the safe zone prior to step (c).

Assignees

• Fatone Peter
• Randall Brandon
• Depuy Synthes Products Inc

Inventors

• Fatone Peter
• Randall Brandon

Classifications

• A61B5/0492

  Human Necessities · mapped topic

• A61B17/3417

  Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating (syringe needles A61M5/32; dilators A61M29/00) · CPC title

• A61B17/3421 Primary

  Cannulas · CPC title

• A61B2017/003

  Steerable · CPC title

• A61B17/1757

  for the spine · CPC title