Spinal cord stimulator system

• US 9,550,062 B2
• Filed: 03/14/2014
• Issued: 01/24/2017
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Globus Medical, Inc.
• Inventors: Khalil, Saif, Angara, Raghavendra, Curtis, Miles, Biele, Christopher, Fellmeth, Daniel
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US14/213,430
• Publication Number:
  US 20140277266A1
• Time in Patent Office: 1,047 Days
• Field of Search: 607/46
• US Class Current: 1/1
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• 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 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/3754 Feedthroughs
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Spinal cord stimulation (SCS) system having a recharging system with self alignment, a system for mapping current fields using a completely wireless system, multiple independent electrode stimulation outsource, and IPG control through software on Smartphone/mobile device and tablet hardware during trial and permanent implants. SCS system can include multiple electrodes, multiple, independently programmable, stimulation channels within an implantable pulse generator (IPG) providing concurrent, but unique stimulation fields. SCS system can include a replenishable power source, rechargeable using transcutaneous power transmissions between antenna coil pairs. An external charger unit, having its own rechargeable battery, can charge the IPG replenishable power source. A real-time clock can provide an auto-run schedule for daily stimulation. A bi-directional telemetry link informs the patient or clinician the status of the system, including the state of charge of the IPG battery. Other processing circuitry in current IPG allows electrode impedance measurements to be made.

Claims

1. A spinal cord stimulation device comprising:

an implantable pulse generator comprising;

a circuit assembly housed in a casing, the circuit assembly including a plurality of output capacitors positioned within the implantable pulse generator, only one application specific integrated circuit (ASIC) and a microcontroller, wherein the circuit assembly further comprises a plurality of timing generators and an arbitrator that is designed to suppress activity from one or more of the timing generators when one or more of the timing generators are active;

at least one rechargeable implantable battery housed in the casing and operably connected with the circuit assembly;

an external charger comprising;

a primary charging coil;

at least one battery; and

a circuit board operably connected with the primary coil and the at least one rechargeable battery,

wherein the at least one rechargeable battery in the implantable pulse generator is recharged using transcutaneous power transmissions between the primary charging coil and the secondary charging coil,

wherein the only one application specific integrated circuit comprises an analog and a digital circuit, and

wherein the only one application specific integrated circuit comprises circuitry configured to generate a high speed burst pulse that is combined with a stimulation pulse to generate a bursted bi-phasic pulse train.

2. The spinal cord stimulation device of claim 1, wherein the transcutaneous power transmissions between the primary charging coil and the secondary charging coil induce voltage into the secondary charging coil and the voltage is rectified and used to charge the battery.

3. The spinal cord stimulation device of claim 1, wherein capacitors are electrically configured with at least one of the secondary charging coil and the primary charging coil so that the primary and secondary charging coils resonant at a common frequency.

4. The spinal cord stimulation device of claim 1, further comprising an alignment sensor to denote when the primary charging coil and the secondary charging coil are properly aligned, wherein the alignment sensor is configured to provide feedback to indicate alignment.

5. The spinal cord stimulation device of claim 4, wherein the feedback can be audible, visual, or a combination thereof.

6. The spinal cord stimulation device of claim 4, wherein the distance between the primary coil and the secondary coil changes the impedance of both the primary coil and the secondary coil and reflected impedance is measured and compared to a fixed threshold.

7. The spinal cord stimulation device of claim 4, wherein alignment can be sensed up to a distance between the primary coil and the secondary coil of up to 30 mm.

8. The spinal cord stimulation device of claim 1, wherein the at least one rechargeable battery has zero-volt technology.

9. The spinal cord stimulation device of claim 1, wherein the at least one external charger battery is rechargeable.

10. The spinal cord stimulation device of claim 1, wherein a Ferrite back-plate is positioned relative to the primary charging coil.

11. The spinal cord stimulation device of claim 1, wherein the primary charging coil is comprised of Litz wire and the secondary charging coil is comprised of wound coated copper magnet wires, the secondary charging coil connected to a capacitor to make a series resonance tank circuit.

12. The spinal cord stimulation device of claim 1, further comprising a battery status notification system including a telemetry link between the implantable pulse generator and a clinician programmer.

13. The spinal cord stimulation device of claim 1, the external charger further comprising:

a Class-E amplifier to produce an alternating current in the primary coil.