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

Patent metadata

Field	Value
Publication number	US-11135437-B2
Application number	US-201715665909-A
Country	US
Kind code	B2
Filing date	Aug 1, 2017
Priority date	Oct 15, 2015
Publication date	Oct 5, 2021
Grant date	Oct 5, 2021

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. The outer sheath 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 the outer sheath.

First claim

The invention claimed is:

1. A system for testing, positioning, introducing and deploying a lead for percutaneous peripheral nerve stimulation, the system comprising:
an introducing sheath having a hub, a shaft with an inner lumen, and a distal portion with a terminal opening;
a testing needle having a hub with a first electrical connector, a shaft with an optional inner lumen and including one or more bevels, wherein the testing needle is selectively fitted in a coaxial relationship within the introducing sheath;
an introducing needle having a hub with a second electrical connector, a shaft, a distal portion including one or more bevel(s) forming a terminal opening, and an open-coiled helical stimulation lead having a conductive distal anchor and an integrated electrode, wherein the shaft comprises an inner lumen of sufficient diameter to contain the open-coiled helical stimulation lead;
wherein the conductive distal anchor is carried within the introducing needle such that the anchor bends over a first edge of the terminal opening of the introducing needle, allowing the lead to self-anchor upon withdrawal of the introducing needle;
wherein the testing needle is of greater length than the introducing sheath;
wherein the introducing needle and introducing sheath are capable of locking together, whereupon they may be removed simultaneously while the self-anchoring lead is deployed.

2. The system according to claim 1 , wherein the bevel in at least one of the introducing needle and the testing needle form an angle between 1 degrees and 89 degrees relative to the longitudinal axis of introducer needle.

3. The system according to claim 1 , wherein an edge along the terminal opening of the introducing needle is rounded such that forces applied to the anchor of the stimulation lead are distributed over the surface of the terminal opening edge during introduction, positioning and deployment.

4. The system according to claim 3 , wherein the rounded portion of the edge comprises either 1-99% or 30-50% of the edge of the terminal opening formed by the bevel.

5. The system according to claim 3 , wherein the rounded portion of the edge is steeper on the inner portion of the lumen than on an outer portion of the needle causing the anchor to be directed away from an outer face of the introducer needle.

6. The system according to claim 3 , wherein the rounded portion of the edge is steeper on the outer portion of the needle than on an inner portion of the lumen causing the anchor to be directed towards an outer face of the introducer needle.

7. The system according to claim 3 , wherein the rounded portion of the edge is evenly distributed or smoothly rounded between an inner portion of the lumen and an outer portion of the needle.

8. The system according to claim 1 , wherein at least a portion of the introducing needle protruding beyond the terminal opening of the introducer sheath is treated so as to enhance echogenicity and/or visualization with clinical imaging techniques.

9. The system according to claim 1 , wherein at least a portion of the testing needle protruding beyond the terminal opening of the introducing sheath is treated so as to enhance echogenicity and/or visualization with clinical imaging techniques.

10. The system according to claim 1 , wherein at least a portion of the introducing sheath is treated so as to enhance echogenicity and/or visualization with clinical imaging techniques.

11. The system according to claim 1 , wherein a proximal end of the testing needle comprises the first electrical connector that is mechanically and electrically mated to the testing needle.

12. The system according to claim 1 , wherein the testing needle is coated with an insulating material except for an exposed, electrically conductive portion of the needle having an exposed surface area of between 1 mm 2 and 200 mm 2 in proximate to a distal tip of the testing needle.

13. The system according to claim 1 , wherein a proximal end of the introducing needle comprises the second electrical connector that is mechanically and electrically mated to the introducing needle.

14. The system according to claim 13 , wherein the introducing needle is coated with an insulating material except for an exposed, electrically conductive portion of the needle having an exposed surface area of between 1 mm 2 and 200 mm 2 in proximate to a distal tip of the introducing needle.

15. The system according to claim 1 , wherein the introducing sheath is coated with an insulating material along its length.

16. The system according to claim 1 , wherein a proximal opening of the introducing sheath is incorporated into a hub with textured surfaces.

17. The system according to claim 16 , wherein a proximal end of the testing needle is incorporated into a hub with textured surfaces.

18. The system according to claim 17 , wherein the hub of the testing needle and the hub of the introducing sheath reversibly lock together.

19. The system according to claim 16 , wherein the proximal end of the introducing needle is incorporated into a hub with textured surfaces.

20. The system according to claim 19 , wherein the hub of the introducing needle and the hub of the introducing sheath irreversibly lock together.

21. The system according to claim 1 , wherein the introducing sheath is coated with a lubricious coating to reduce friction between the introducing sheath and the introducing needle or testing needle.

22. The system according to claim 1 , wherein the introducing needle may be selectively fitted in a coaxial relationship within the introducing sheath in place of the testing needle.

23. The system according to claim 1 , wherein the introducing sheath and introducing needle are percutaneously insertable into a body.

Assignees

• Spr Therapeutics Inc

Inventors

• Boggs Joseph W
• Wongsarnpigoon Amorn
• Debock Matthew G
• Mcgee Meredith J
• Sell Devin
• Strother Robert B

Classifications

• A61B2017/3407

  including a base for support on the body · CPC title

• A61N1/36017

  with leads or electrodes penetrating the skin · CPC title

• A61N1/37241 Primary

  providing test stimulations · CPC title

• A61N1/37205

  Microstimulators, e.g. implantable through a cannula · CPC title

• A61N1/36071

  Pain · CPC title