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

Patent metadata

Field	Value
Publication number	US-2022016432-A1
Application number	US-202117492091-A
Country	US
Kind code	A1
Filing date	Oct 1, 2021
Priority date	Oct 15, 2015
Publication date	Jan 20, 2022
Grant date	—

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

1 . A system for testing, positioning, introducing and deploying a lead for percutaneous peripheral nerve stimulation, the system comprising:
a delivery sheath having a distal opening and comprising a stimulation probe and an outer sheath having a distal opening; an inner deployment mechanism, selectively carried within the outer sheath, including an inner sheath and an open-coiled helical stimulation lead having a conductive distal anchor and an integrated electrode; and wherein the stimulation probe delivers test stimulation without deploying the distal anchor; and wherein the conductive distal anchor is released out of the delivery sheath when the inner deployment mechanism and outer sheath are moved in to a releasing position and subsequently retracted in concert.

2 . The system according to claim 1 , wherein the delivery sheath includes at least one bevel.

3 . The system according to claim 2 , wherein the distal opening includes a fully rounded edge to prevent sharp contact with any portion of the stimulation lead coming into contact with the rounded edge.

4 . The system according to claim 2 , wherein the distal opening includes an ovally rounded edge with a variable radius.

5 . The system according to claim 1 , wherein at least a portion of an outer surface of the delivery sheath is coated, textured, or marked to increase echogenicity or visualization.

6 . The system according to claim 1 , wherein at least a portion of the outer surface of the inner deployment mechanism is coated, textured, or marked to increase echogenicity or visualization.

7 . The system according to claim 1 , wherein an electrical connector is integral to the electrically conductive test needle in the proximity of the proximal end of the needle such that the electrical connector is mechanically and electrically mated to the needle.

8 . The system according to claim 1 , wherein an insulative coating is applied to any conductive or metallic surfaces making contact with the stimulation lead.

9 . The system according to claim 1 , wherein the proximal opening of the introducing sheath is incorporated into an ergonomic, light-weight hub with textured surfaces that provide grip and control during insertion.

10 . The system according to claim 1 , wherein the delivery sheath includes an ergonomic and/or textured handle.

11 . The system according to claim 1 , wherein the inner deployment mechanism includes an ergonomic and/or textured handle.

12 . The system according to claim 11 , further comprising a lock that selectively prevent the inner deployment mechanism from moving relative to the delivery sheath.

13 . The system according to claim 1 , further comprising a control with a lever or locking mechanism activated by twisting, pushing, clicking, rolling, or sliding to selectively secure the inner deployment mechanism with the delivery sheath.

14 . The system according to claim 1 , wherein a lubricious coating is provided along a portion of the delivery sheath and/or inner deployment mechanism.

15 . The system according to claim 1 , wherein the distal opening includes a rounded edge to prevent sharp contact with any portion of the stimulation lead coming into contact with the rounded edge.

16 . The system according to claim 1 , wherein the distal opening includes an ovally rounded edge with a variable radius.

17 . The system according to claim 10 , further comprising a lock that selectively prevent the inner deployment mechanism from moving relative to the delivery sheath.

18 . A system for testing, positioning, introducing and deploying a lead for percutaneous peripheral nerve stimulation, the system comprising:
a self-anchoring, open-coiled helical stimulation lead having a conductive distal anchor and an integrated electrode; an introducing needle with an inner lumen of sufficient diameter to contain the stimulation lead, and including a distal portion having one or more bevels forming a terminal opening; an introducing sheath with an inner lumen of sufficient diameter to contain the introducing needle and the conductive distal anchor of the stimulation lead and including a distal portion forming a terminal opening; a testing needle with an optional inner lumen, a distal portion having one or more bevels, and an outer diameter sufficiently small enough to be received by the inner lumen of the introducing sheath; wherein an anchor portion of the lead protrudes from the lumen of the introducing needle, forming a bend over a first edge of the terminal opening of the introducing needle.

19 . The system according to claim 18 , wherein the bevel in at least one of the introducing needle and the testing needle form an angle between 5 degrees and 75 degrees relative to the longitudinal axis of introducer needle.

20 . The system according to claim 18 , 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.

21 . The system according to claim 20 , wherein the rounded portion of the edge comprises either 5-75% or 30-50% of the edge of the terminal opening formed by the bevel.

22 . The system according to claim 20 , 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.

23 . The system according to claim 20 , 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.

24 . The system according to claim 20 , 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.

25 . The system according to claim 18 , 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.

26 . The system according to claim 18 , 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.

27 . The system according to claim 18 , wherein at least a portion of the introducing sheath is treated so as to enhance echogenicity and/or visualization with clinical imaging techniques.

28 . The system according to claim 18 , wherein a proximal end of the testing needle includes an electrical connector that is mechanically and electrically mated to the testing needle.

29 . The system according to claim 18 , 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 100 mm 2 in proximate to a distal tip of the testing needle.

30 . The system according to claim 18 , wherein a proximal end of the introducing needle includes an electrical connector that is mechanically and electrically mated to the introducing needle.

31 . The system

Assignees

• Spr Therapeutics Inc

Inventors

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

Classifications

• A61B17/3468

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

• A61B2017/3407

  including a base for support on the body · CPC title

• A61B2017/3413

  guided by ultrasound · CPC title

• A61N1/0558

  Anchoring or fixation means therefor · CPC title

• A61N1/36071

  Pain · CPC title