Implantable Lead

• US 20140031837A1
• Filed: 10/03/2013
• Published: 01/30/2014
• Est. Priority Date: 04/04/2011
• Status: Active Grant

• Current Assignee: Curonix Company Limited
• Original Assignee: Stimwave Technologies Incorporated (Stimwave LLC)
• Inventors: Perryman, Laura Tyler, Larson, Patrick, Andresen, Chad
• Granted Patent: US 9,220,897 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An implantable wireless lead includes an enclosure, the enclosure housing: one or more electrodes configured to apply one or more electrical pulses to a neural tissue; a first antenna configured to: receive, from a second antenna and through electrical radiative coupling, an input signal containing electrical energy, the second antenna being physically separate from the implantable neural stimulator lead; one or more circuits electrically connected to the first antenna, the circuits configured to: create the one or more electrical pulses suitable for stimulation of the neural tissue using the electrical energy contained in the input signal; and supply the one or more electrical pulses to the one or more electrodes, wherein the enclosure is shaped and arranged for delivery into a subject'"'"'s body through an introducer or a needle.

Claims

1. An implantable lead for modulating excitable tissue in a body of a patient comprising

an enclosure shaped and configured for delivery into the patient'"'"'s body through an introducer or needle;

one or more electrodes housed within the enclosure and configured to apply one or more electrical impulses to excitable tissue;

a first antenna housed within the enclosure and configured to receive, from a second antenna through electrical radiative coupling, an input signal containing electrical energy, the second antenna being physically separate from the implantable lead; and

a circuit coupled to the first antenna and the electrodes and configured to generate the electrical impulses suitable for modulation of excitable tissue using the electrical energy contained in the input signal and to supply the electrical impulses to the electrode.

2. The implantable lead of claim 1 wherein the enclosure comprises a fixed length for the electrodes and the circuit of no greater than 14 cm and an additional portion that can be adjusted to any length a portion to space the electrodes from the excitable tissue after the implantable lead has been delivered into the patient'"'"'s body.

3. The implantable lead of claim 1 wherein the enclosure comprises a cylindrical or semi-cylindrical shape and the electrodes are directionally configured to direct a current associated with the electrical impulses in a direction that is substantially perpendicular to the excitable tissue.

4. The implantable lead of claim 3 wherein the electrodes comprise a cylindrical or semi-cylindrical array of electrodes.

5. The implantable lead of claim 1 wherein the excitable tissue is associated with the spinal column.

6. The implantable lead of claim 1 wherein the electrodes comprise two to sixteen electrodes, each having a longitudinal length of about 1.0 to 6.0 mm and a width of about 0.4 to 3.0 mm.

7. The implantable lead of claim 6 wherein the electrodes are spaced between about 1 mm to 6 mm apart and have a combined surface area of between about 0.8 mm² to 60.00 mm².

8. The implantable lead of claim 1 wherein the lead comprises a paddle-styled lead having a concave shape configured to secure a lateral position on the excitable tissue after the lead has been delivered into the patient'"'"'s body.

9. The implantable lead of claim 1 wherein the enclosure has a height of about 1.3 mm to 2.0 mm and a width of about 2.0 mm to 4.0 mm.

10. The implantable lead of claim 8 wherein the enclosure has a concave profile between about 1.0 mm to 1.5 mm and a concave edge of about 0.2 mm to 0.3 mm.

11. The implantable lead of claim 8 wherein the lateral position is with regard to a dorsal aspect of a spinal cord of the patient.

12. The implantable lead of claim 1 wherein the enclosure is sized and shaped for delivery into an epidural space of the patient'"'"'s body.

13. The implantable lead of claim 1 wherein the enclosure is sized and shaped for delivery through a tuohy need having a diameter no larger than gauge 14.

14. The implantable lead of claim 1 wherein the enclosure further comprises a lumen configured to receive a navigating stylet for delivery of the implantable lead into the patient'"'"'s body.

15. The implantable lead of claim 1 wherein the enclosure comprises a rounded distal tip with a length of between about 0.5 mm to 2.0 mm.

16. The implantable lead of claim 1 wherein the enclosure comprises a pointed distal tip having a length of between about 2.0 to 6.0 mm.

17. The implantable lead of claim 1 further comprising a plurality of antenna coupling contacts housed within the enclosure and electrically coupled to the antenna and the circuits, wherein the antenna coupling contacts are configured to electrically couple the antenna with tissue surrounding the enclosure.

18. The implantable lead of claim 17 wherein the antenna coupling contacts comprise 2 to 8 antenna coupling pairs located proximal to the electrode within the enclosure.

19. The implantable lead of claim 17 wherein the antenna coupling contacts each have a longitudinal length of about 1.0 mm to 6.0 mm and a width of about 1.0 mm to 2.5 mm.

20. The implantable lead of claim 17 wherein the antenna coupling contacts are spaced between about 30 and 80 mm apart.

21. The implantable lead of claim 1 wherein the circuits are flexible circuits capable of undergoing a bend radius of under 0.5 mm.

22. The implantable lead of claim 21 wherein the flexible circuits each comprise a waveform conditioning circuit configured to provide a stimulation waveform to the electrode.

23. A method for modulating excitable tissue in a body of a patient comprising:

implanting one or more electrodes at a target site adjacent to or near excitable tissue within the patient'"'"'s body;

delivering an input signal from a location exterior to the patient'"'"'s body to the electrodes through electrical radiative coupling, the input signal containing electrical energy;

generating one or more electrical impulses from the input signal; and

applying the electrical impulses through the electrodes to the excitable tissue, the electrical impulses being sufficient to modulate the excitable tissue.

24. The method of claim 23 wherein the implantable step is carried out by advancing the one or more electrodes through an introducer.

25. The method of claim 24 wherein the introducer is a needle.

26. The method of claim 23 further comprising spacing the electrodes from the excitable tissue during the applying step.

27. The method of claim 23 wherein the applying step is carried out by applying the electrical impulses in a direction substantially perpendicular to the excitable tissue.

28. The method of claim 25 wherein the needle is a tuohy needle having a size of no larger than gauge 14.