Implantable lead

• US 10,238,874 B2
• Filed: 09/20/2017
• Issued: 03/26/2019
• 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 David
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US15/709,962
• Publication Number:
  US 20180008828A1
• Time in Patent Office: 552 Days
• Field of Search: 607116, 606 33
• 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 neural stimulator for modulating neural tissue in a patient, the implantable neural stimulator comprising:

an enclosure shaped and configured for delivery into the patient'"'"'s body through an introducer or needle, the enclosure including an extension tubing shaped to conform to a curvature of the patient'"'"'s spinal cord, the enclosure housing;

one or more electrodes configured to apply one or more electrical pulses to the subject'"'"'s neural tissue associated with the patient'"'"'s spinal cord;

a first antenna configured to;

receive, wirelessly from a second antenna through electrical radiative coupling, an input signal containing electrical energy, the second antenna being physically separate from the implantable neural stimulator; and

a circuit coupled to the first antenna and the electrodes and configured to;

generate the one or more electrical pulses suitable for modulation of neural tissue solely using the electrical energy contained in the input signal received wirelessly from the second antenna; and

supply the one or more electrical pulses to the one or more electrodes.

2. The implantable wireless stimulator device of claim 1, wherein the extension tubing is shaped concavely to conform to the curvature of the patient'"'"'s spinal cord.

3. The implantable wireless stimulator device of claim 2, wherein the concavely shaped extension tubing has a dorsal aspect with a bend radius between about 0.6 mm and about 3.0 mm.

4. The implantable wireless stimulator device of claim 1, wherein the extension tubing includes between one and ten or more orbital lumens, each with an inner diameter between about 0.1 mm and about 0.6 mm, and an outer diameter between about 0.8 mm and about 1.4 mm.

5. The implantable wireless stimulator device of claim 4, wherein the extension tubing includes a center lumen that accommodates a navigating stylet during the delivery of the enclosure into the subject'"'"'s body through an introducer or a needle.

6. The implantable wireless stimulator device of claim 5,

wherein the extension tubing with one or more orbital lumens is fused with a single-lumen extension tubing, and wherein the extension tubing with one or more orbital lumens is located more proximally than the single-lumen extension tubing.

7. The implantable wireless stimulator device of claim 6, wherein the waveform conditioning circuitry comprises one or more diodes, one or more resistors, and one or more capacitors.

8. The implantable wireless stimulator device of claim 6, wherein the waveform conditioning circuitry comprises:

charge balance circuitry to reduce a risk of corrosion of the electrodes, and isolation circuitry.

9. The implantable wireless stimulator device of claim 1, wherein the enclosure further houses antenna coupling contacts, wherein the circuit includes waveform conditioning circuitry, wherein the antenna coupling contacts are connected by conducting wires to the antenna and the waveform conditioning circuitry, wherein the conducting wires are each enclosed in a respective orbital lumen, wherein the waveform conditioning circuitry uses the electrical contained in the input signal to create the one or more electrical pulses for application at the one or more electrodes to modulate neural tissue.

10. The wireless stimulator device of claim 9, wherein the antenna coupling contacts are located proximal, relative to the electrodes, in the enclosure.

11. The wireless stimulator device of claim 1, wherein a portion of the enclosure leaves the electrodes in a non-direct contact with the neural tissue after the wireless neural stimulator has been delivered into the subject'"'"'s body.

12. The wireless stimulator device of claim 1, wherein the electrodes are made of at least one of:

platinum, platinum-iridium, gallium-nitride, titanium-nitride, iridium-oxide, or combinations thereof.

13. The wireless stimulator device of claim 1, wherein the enclosure has an external coating of biocompatible polymer, the polymer includes at least one of:

polymethymethacrylate (PMMA), polydimethylsiloxane (PDMS), parylene, polyurethance, polytetrafluoroethylene (PTFE), or polycarbonate.

14. The wireless stimulator device of claim 1, wherein the enclosure has an external coating of silicone elastomer.

15. The wireless stimulator device of claim 1, wherein at least one of the antennas is constructed as a conductive trace contained on one of the circuits.

16. The wireless stimulator device of claim 1, wherein at least one of the antennas is fabricated as a conductive wire connected to one of the circuits.

17. The wireless stimulator device of claim 2, wherein the circuit is flexible and placed proximal, relative to the electrodes, in the enclosure.

18. A method for modulating a patient'"'"'s neural tissue, the method comprising:

delivering an enclosure into a patient'"'"'s such that one or more electrodes of an implantable neural stimulator is implanted at a target site adjacent to or near the patient'"'"'s spinal cord to modulate neural tissue, the implantable neural stimulator comprising;

the enclosure including an extension tubing shaped to conform to a curvature of the patient'"'"'s spinal cord, the enclosure housing;

one or more electrodes configured to apply one or more electrical pulses to the subject'"'"'s neural tissue;

a first antenna; and

a circuit electrically connected to the first antenna; and

wirelessly delivering, through radiative coupling and from a second antenna exterior to the patient'"'"'s body, an input signal containing electrical energy to the first antenna of the implantable neural stimulator implanted at the target site such that one or more electrical pulses are generated solely from the electrical energy contained in the input signal wireless delivered through radiative coupling from the exterior location; and

wherein the generated electrical pulses are applied through the electrodes to modulate the neural tissue.

19. The method of claim 18, wherein the enclosure includes one center lumen and at least one orbital lumen, and wherein the enclosure is delivered into the patient'"'"'s body by using a navigating stylet that slides inside the center lumen of the enclosure.

20. The method of claim 18, wherein delivering an enclosure includes advancing the one or more electrodes through an introducer.