Spinal cord stimulator system

• US 10,016,602 B2
• Filed: 03/14/2014
• Issued: 07/10/2018
• 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): Evanisko, George
• Application Number:
  US14/213,266
• Publication Number:
  US 20140277264A1
• Time in Patent Office: 1,579 Days
• 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 for delivering electrical stimulation therapy to a spinal cord, said device comprising:

an implantable pulse generator comprising;

a circuit board housed in a casing, the circuit board including an application specific integrated circuit (ASIC) and a microcontroller, wherein the ASIC is configured to receive digital data from the microcontroller, wherein the ASIC is configured to perform all of the signal processing necessary for electrical stimulation and generate signals for electrical stimulation pulses based on said signal processing, wherein the ASIC is configured to handle all power management of the implantable pulse generator, and wherein the microcontroller is configured to remain powered down until the ASIC sends a signal to the microcontroller to power up; and

a secondary coil housed in the casing;

a rechargeable battery housed in the casing and operably connected with the circuit board and the secondary charging coil;

a plurality of electrodes configured to be wired to the implantable pulse generator, wherein the plurality of electrodes are configured to send the electrical pulses to the spinal cord; and

an external charger comprising;

a primary charging coil;

at least one battery; and

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

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

wherein the ASIC is configured to send a hardware interrupt signal to a pin of the microcontroller, and

wherein the microcontroller is configured to poll the ASIC to determine the cause of the interrupt signal sent by the ASIC.

2. The spinal cord stimulation device of claim 1, further comprising one or more leads, wherein the plurality of electrodes are wired to the circuit board via the one or more leads.

3. The spinal cord stimulation device of claim 1 is further configured to be operable at a controlled amplitude at any value within +12.7 mA to −

12.7 mA.

4. The spinal cord stimulation device of claim 3, wherein the electrical pulses have a length of between 10 μ

S to 2000 μ

S.

5. The spinal cord stimulation device of claim 3, wherein the electrical pulses have a frequency between 0.5 Hz and 1200 Hz.

6. The spinal cord stimulation device of claim 1, wherein the electrical pulses are biphasic.

7. The spinal cord stimulation device of claim 1, wherein the ASIC further comprises a timing generator.

8. The spinal cord stimulation device of claim 1, wherein the ASIC further comprises a power level shifter circuit.

9. The spinal cord stimulation device of claim 1, further comprising a power good (PG) line between the microcontroller and the ASIC.

10. The spinal cord stimulation device of claim 1, wherein the secondary charging coil is housed in the casing.

11. The spinal cord stimulation device of claim 10, wherein the secondary charging coil is configured to charge the rechargeable battery.

12. The spinal cord stimulation device of claim 11, wherein the secondary charging coil is an induction coil.

13. The spinal cord stimulation device of claim 1, wherein the implantable pulse generator further comprises an RF radio antenna which allows the implantable pulse generator to communicate with a remote dongle in order to send commands associated with programming the signals for electrical stimulation pulses.