Lead insertion devices and associated systems and methods

• US 9,308,022 B2
• Filed: 12/10/2012
• Issued: 04/12/2016
• Est. Priority Date: 12/10/2012
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Chitre, Yougandh, Walker, Andre B., Sharma, Vivek
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US13/710,341
• Publication Number:
  US 20140163655A1
• Time in Patent Office: 1,219 Days
• Field of Search: 606/129
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3417 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 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: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

Insertion devices and associated systems and methods for the percutaneous placement of patient leads are disclosed herein. A system in accordance with a particular embodiment includes a cannula having a lumen and a first dilator. The first dilator can be positioned within the lumen and the first dilator and the cannula can be used to create a percutaneous entry point. An additional dilator can be positioned over the first dilator and advanced into the percutaneous entry point to expand the percutaneous entry point. A final dilator can be inserted into the patient and two leads can be advanced into the patient through the final dilator.

Claims

1. A system for implanting a plurality of medical devices in a patient through a single percutaneous entry point, the system comprising:

a cannula having a cannula lumen extending therethrough, the cannula lumen having an inside diameter;

a first dilator having an outside diameter smaller than the inside diameter of the cannula lumen, the first dilator positionable within the cannula lumen to prevent coring upon insertion of the cannula and the first dilator into the patient to produce the percutaneous entry point; and

at least one additional dilator, including a final dilator, wherein each additional dilator includes a dilator lumen having an inside diameter larger than an outside diameter of a preceding dilator, wherein each additional dilator is positionable over a preceding dilator to expand the percutaneous entry point, and wherein the final dilator includes a lumen having an elliptical cross-section shape.

2. The system of claim 1, further comprising two leads, each lead having a diameter, and wherein the lumen of the final dilator includes a width along a first cross-sectional axis that is greater than the sum of the diameters of the leads.

3. The system of claim 1 wherein a distal end of the cannula includes a beveled tip having a shovel shape.

4. The system of claim 3 wherein a distal end of the first dilator includes a beveled tip having a shovel shape positioned to align with the beveled tip of the cannula.

5. The system of claim 1 wherein the first dilator includes a beveled tip and a removeable hub, wherein the cannula includes a beveled tip, and wherein the removeable hub is positioned to align the beveled tip of the cannula with the beveled tip of the dilator.

6. The system of claim 1 wherein the first dilator includes a mapping contact positioned to detect intrathecal penetration.

7. A system for implanting a plurality of medical devices in a patient through a single preculaneous entry point,the system comprising:

a cannula having a cannula lumen extending therethrough, the cannula lumen having an inside diameter;

a first dilator having an outside diameter smaller than the inside diameter of the cannula lumen, the first dilator positionable within the cannula lumen to prevent coring upon insertion of the cannula and the first dilator into the patient to produce the percutaneous entry point;

at least pne addition dilator, including a final dilator,wherein each additional diator includes a dilator lumen having an inside diameter larger than an outside diameter of a preceding dilator, wherein each additional dilator is positionable over a preceding dilator to expand the percutaneous entry point;

and

two leads, each lead having a diameter, wherein the final dilator includes a lumen having an elliptical cross-sectional shape, and wherein a diameter along a first axis of the dilator lumen is greater than the sum of the diameters of the leads.

8. A patient system comprising:

two leads positionable to deliver electrical therapy signals, each lead having a diameter;

an insertion needle including a cannula and a stylet, wherein the cannula includes a cannula lumen having an inside diameter, and the stylet includes an outside diameter smaller than the inside diameter of the cannula lumen;

a first dilator having an outside diameter smaller than the inside diameter of the cannula lumen and positionable within the cannula lumen; and

at least one additional dilator, including a final dilator, wherein each additional dilator includes a dilator lumen having an inside diameter larger than an outside diameter of a preceding dilator, wherein each additional dilator is positionable over a preceding dilator to expand a percutaneous entry point, and wherein the final dilator includes a dilator lumen having an inside diameter or width greater than the sum of the diameters of the leads.

9. The system of claim 8 wherein the final dilator has an elliptical cross-sectional shape, wherein the width is a first width along a first cross-sectional axis, and wherein the lumen of the final dilator includes a second width along a second cross-sectional axis that is smaller than the first width and larger than the diameter of either of the two leads.

10. The system of claim 8 wherein the distal end of the cannula and the distal end of the first dilator form a beveled tip having a shovel shape.