Apparatus and method for positioning, implanting and using a stimulation lead

Patent metadata

Field	Value
Publication number	US-12318609-B2
Application number	US-202218035760-A
Country	US
Kind code	B2
Filing date	Nov 17, 2022
Priority date	Nov 17, 2021
Publication date	Jun 3, 2025
Grant date	Jun 3, 2025

Abstract

An introducing device for locating a tissue region and deploying an electrode is shown and described. The introducing device may include an outer sheath. An inner sheath may be disposed within the outer sheath. The inner sheath may be configured to engage an implantable electrode. In an example, the inner sheath may comprise a stimulation probe having an uninsulated portion at or near a distal end of the delivery sheath. A sheath or needle may be coupled to a power source or stimulation signal generating circuitry at a proximal end. A clinician may control application of the stimulation signal to a tissue region via a sheath or needle.

First claim

What is claimed is:

1. A lead introducer system comprising:
a housing;
an outer sheath fixed relative to the housing and at least a portion of which extending external to the housing;
an intermediate sheath positioned in and moveable relative to the outer sheath;
an inner sheath;
a lead positioned in the inner sheath, wherein the inner sheath is positioned in and moveable relative to the intermediate sheath and the outer sheath; and
an actuator biasingly engaged with the intermediate and inner sheaths, wherein upon actuation the inner sheath and the lead are moveable together relative to the intermediate sheath and are deployed into tissue, wherein actuation comprises deploying the inner sheath and lead into a targeted tissue region, anchoring the lead into the targeted tissue region, and automatically withdrawing the inner sheath from the anchored lead automatically and in a single actuation.

2. The lead introducer system of claim 1 , wherein, upon actuation, the inner sheath and the lead are moveable in a distal direction.

3. The lead introducer system of claim 2 , wherein, upon actuation, the inner sheath and the intermediate sheath are retractable in a proximal direction.

4. The lead introducer system of claim 3 , wherein movement of the inner sheath and the lead in the distal direction and retraction of the inner sheath and the intermediate sheath occur in sequence.

5. The lead introducer system of claim 3 , wherein retraction of the inner sheath and the intermediate sheath occurs automatically after movement of the inner sheath and the lead in the distal direction.

6. The lead introducer system of claim 1 , wherein the lead is configured to anchor into tissue upon movement in a distal direction and remain positioned in the exact place as the inner sheath and the intermediate sheath are withdrawn.

7. The lead introducer system of claim 1 , wherein the housing includes one or more grips.

8. The lead introducer system of claim 1 , wherein the lead introducer system can be operated using one hand.

9. A lead introducer system comprising:
a housing configured to be held by a single hand of a user;
an outer sheath fixed relative to the housing at least a portion of which extending external to the housing;
an inner sheath;
a lead held by the inner sheath, the inner sheath engaged with the outer sheath to move within the outer sheath;
an actuator biasingly engaged with the inner sheath wherein upon actuation of the actuator, the inner sheath moves toward a targeted tissue region and moves away from the targeted tissue region; and
an intermediate sheath, wherein the inner sheath is nestable within the intermediate sheath and the intermediate sheath is nestable within the outer sheath, wherein upon actuation, the inner sheath and the lead are moveable together relative to the intermediate sheath, wherein the actuation comprises deploying the inner sheath and lead into the targeted tissue region, anchoring the lead into the targeted tissue region, and automatically withdrawing the inner sheath from the anchored lead automatically and in a single actuation.

10. The lead introducer system of claim 9 , wherein, upon actuation, the inner sheath and the intermediate sheath are retractable together in a proximal direction.

11. The lead introducer system of claim 9 further comprising a test electrode that is insertable into the targeted tissue region, wherein the lead is positionable in the exact place of the test electrode through actuation of the introducer system.

12. The lead introducer system of claim 9 , wherein the actuator is a slide button.

13. A lead introducer system comprising:
a housing configured to be held by a single hand of a user;
an outer sheath fixed relative to the housing and at least a portion of which extending external to the housing;
an inner sheath;
a lead held by the inner sheath, the inner sheath engaged with the outer sheath to move within the outer sheath;
an actuator biasingly engaged with the inner sheath wherein upon actuation of the actuator, the inner sheath moves toward a targeted tissue region and moves away from the targeted tissue region;
an intermediate sheath wherein the inner sheath and the lead are moveable together relative to the intermediate sheath; and
a test electrode that is insertable into the targeted tissue region, wherein the lead is positionable in the exact place of the test electrode through actuation of the actuator, wherein the actuation comprises deploying the inner sheath and lead into the targeted tissue region, anchoring the lead into the targeted tissue region, and automatically withdrawing the inner sheath from the anchored lead automatically and in a single actuation.

14. The lead introducer system of claim 13 wherein the inner sheath is nestable within the intermediate sheath and the intermediate sheath is nestable within the outer sheath.

15. The lead introducer system of claim 13 , wherein the actuator is a slide button.

Assignees

• Spr Therapeutics Inc

Inventors

• Boggs Joseph W
• Wongsarnpigoon Amorn
• Debock Matthew G
• Mcgee Meredith J
• Sell Devin
• Strother Robert B
• Groszek Joey
• Crosby Nathan D

Classifications

• A61N1/37241

  providing test stimulations · CPC title

• A61N1/0502

  Skin piercing electrodes · CPC title

• A61B17/3468 Primary

  for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069) · CPC title

• A61B2090/0811

  for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument · CPC title

• A61B2090/0807

  Indication means · CPC title