Systems and method for anchoring a lead for neurostimulation of a target anatomy

• US 10,369,354 B2
• Filed: 05/16/2017
• Issued: 08/06/2019
• Est. Priority Date: 05/17/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barner, Paul Keith
• Primary Examiner(s): Wehrheim, Lindsey G
• Application Number:
  US15/596,761
• Publication Number:
  US 20170333702A1
• Time in Patent Office: 812 Days
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3754 Feedthroughs
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A lead having proximal and distal ends. At the distal end, a first branch includes a first biasing member and a first insulation covering. The first biasing member is disposed within the first insulation covering, which in turn includes a first inner surface. At the distal end, a second branch includes a second biasing member and a second insulation covering. The second biasing member is disposed within the second insulation covering, which in turn includes a second inner surface. The branches define a receiving channel and a stimulation region. The biasing members are movable away from each other to receive a target anatomy through the receiving channel and biasly movable toward each other to retain the target anatomy within the stimulation region. An electrode is disposed on one or both of the inner surfaces adjacent to the stimulation region, and is operable to stimulate the target anatomy.

Claims

1. An electrical stimulation lead having a proximal end and a distal end, the lead comprising:

at the distal end of the lead, a first branch having a first biasing member and a first insulation covering, the first biasing member disposed within the first insulation covering, the first insulation covering having a first inner surface;

at the distal end of the lead, a second branch having a second biasing member and a second insulation covering, the second biasing member disposed within the second insulation covering, the second insulation covering having a second inner surface,

wherein the first and second branches define a receiving channel and a stimulation region proximal to the receiving channel,

wherein the first and second biasing members are, upon application of a force to separate the first and second biasing members, movable away from each other to receive a target anatomy through the receiving channel and, upon removal of the force, are biased to automatically move back toward each other to retain the target anatomy within the stimulation region; and

at least one electrode disposed on one or both of the first inner surface or the second inner surface, the at least one electrode disposed adjacent to the stimulation region, wherein the at least one electrode is operable to electrically stimulate the target anatomy.

2. The lead of claim 1, wherein the first and second biasing members comprise a shape memory material.

3. The lead of claim 2, wherein the shape memory material is nitinol.

4. The lead of claim 1, wherein at least one of the first or second biasing member is electrically coupled to at least one of the at least one electrode.

5. The lead of claim 1, further comprising a plurality of conductors disposed in one or both of the first or second insulation coverings.

6. The lead of claim 1, wherein the first branch includes a first hook portion.

7. The lead of claim 6, wherein the second branch includes a second hook portion.

8. The lead of claim 7, wherein the first and second hook portions define the receiving channel.

9. An electrical stimulation system comprising:

the lead of claim 1; and

a control module coupleable to the lead, the control module having a housing and an electronic subassembly disposed in the housing.

10. An electrical stimulation lead having a proximal end and a distal end, the lead comprising:

at the distal end of the lead, a first biasing member having a first branch and a second branch extending distally from the first branch;

at the distal end of the lead, a second biasing member having a third branch and a fourth branch extending distally from the third branch,

wherein the second and fourth branches are angled to define a receiving channel and a throat region with a throat width,

wherein the first and third branches define a stimulation region proximal to the receiving channel,

wherein the first and second biasing members are, upon application of a force to separate the first and second biasing members, movable away from each other to increase the throat width and receive a target anatomy through the throat region, and

wherein the first and second biasing members are, upon removal of the force, are biased to automatically move back toward each other to retain the target anatomy within the stimulation region; and

at least one electrode disposed on one or both of the first or second biasing members, the at least one electrode disposed adjacent to the stimulation region, wherein the at least one electrode is operable to electrically stimulate the target anatomy.

11. The lead of claim 10, wherein the first and second biasing members comprise a shape memory material.

12. The lead of claim 11, wherein the shape memory material is nitinol.

13. An electrical stimulation lead having a proximal end and a distal end, the lead comprising, the lead comprising:

a housing located at the distal end of the lead;

an anchor member having a first configuration disposed within the housing;

a lumen coupled to the housing; and

an anchor actuation device extending through the lumen and directly coupled to the anchor member, wherein the anchor actuation device is movable to distally urge the anchor member out of the housing into a deployed configuration in a vicinity of a target anatomy, and wherein the anchor member entangles with patient tissue to secure the lead in the vicinity of the target anatomy.

14. The lead of claim 13, wherein the anchor member is made from nitinol.

15. The lead of claim 13, wherein at anchor member is a ribbon member that is helically wound when in an un-deployed configuration.

16. The lead of claim 13, wherein the anchor member is a coil-shaped anchor member.

17. The lead of claim 16, wherein the coil-shaped anchor member includes a pigtail-shaped configuration when in a deployed configuration.

18. The lead of claim 17, wherein the pigtail-shaped configuration engages a patient'"'"'s tissue in a vicinity of the target anatomy for neurostimulation.

19. The lead of claim 13 wherein the anchor actuation device is movable to retract the anchor member into an un-deployed configuration.

20. An electrical stimulation system comprising:

the lead of claim 13; and

a control module coupleable to the lead, the control module having a housing and an electronic subassembly disposed in the housing.