Systems, devices and methods that affect neural tissue through the delivery of a pulsed radio frequency signal generated by an implantable medical device

• US 10,117,580 B1
• Filed: 10/06/2017
• Issued: 11/06/2018
• Est. Priority Date: 05/06/2017
• Status: Active Grant

• Current Assignee: SynerFuse, Inc.
• Original Assignee: SynerFuse, Inc.
• Inventors: Puryear, Harry, Cox, Timothy J., Samson, Serafin Y., Peyman, Nazmi, Souresrafil, Omid, Molnar, Gregory F.
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): Avigan, Adam
• Application Number:
  US15/727,554
• Publication Number:
  US 20180317771A1
• Time in Patent Office: 396 Days
• CPC Class Codes: A61B 17/7001 Screws or hooks combined with longitudinal elements which do not contact vertebrae A61B17/7058 takes precedence
• CPC Class Codes: A61B 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00075 Motion
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2018/00339 Spine, e.g. intervertebral disc
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/08 : Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/3605 : Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36057 : adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36062 : Spinal stimulation
• CPC Class Codes: A61N 1/36071 : Pain
• CPC Class Codes: A61N 1/36135 : using physiological parameters
• CPC Class Codes: A61N 1/36171 : Frequency
• CPC Class Codes: A61N 1/37223 : Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia

Abstract

Radio frequency (RF) energy is transmitted through the application of a RF signal to an external RF energy interface, where the RF signal oscillates at a frequency in an energy transmission band. The transmitted RF energy is received at an implanted medical device, and energy derived from the received RF energy is stored in a direct current (DC) energy storage component of the device. A therapeutic output signal is generated from the stored energy and delivered by the implantable medical device to a patient through one or more electrodes. The therapeutic output signal is configurable to provide either one of RF stimulation therapy and RF ablation therapy, and comprises pulses of an RF signal oscillating at a frequency in a therapy band that is greater than the energy transmission band.

Claims

1. A pain management system, comprising:

an external device configured to transmit radio frequency (RF) energy through the application of a RF signal to an external RF energy interface, wherein the RF signal oscillates at a frequency in an energy transmission band; and

an implantable medical device comprising;

one or more electrodes configured to be implanted in, on, or adjacent a target area of nerves,

an implantable RF energy interface configured to receive energy from the external RF energy interface over a wireless energy link,

an energy storage component configured to store the energy, and a RF therapy controller coupled to the energy storage component and the one or more electrodes, the RF therapy controller programmatically configured to;

1) selectively generate each of three different types of a therapeutic output signal from the stored energy, the three different types of the therapeutic output signal comprising an RF stimulation therapy output signal, an RF heat therapy output signal, and an RF ablation therapy output signal, wherein each of the three different types of the therapeutic output signal comprises an RF signal oscillating at a frequency in a therapy band that is greater than the energy transmission band, and

2) deliver the therapeutic output signal to the one or more electrodes;

wherein the RF stimulation therapy output signal comprises pulses of the RF signal configured to generate an alternating current field at or near the target area at a current level sufficient to modulate neural signals by altering or interrupting transmission of action potentials by one or more nerves while maintaining the target area below a first temperature;

wherein the RF heat therapy output signal comprises pulses of the RF signal or a continuous RF signal configured to generate an alternating current field at or near the target area sufficient to increase the temperature of the target area to a value within a temperature range that is above the first temperature in order to provide analgesic heat to alleviate pain without causing nerve cell necrosis; and

wherein the RF ablation therapy output signal comprises pulses of the RF signal configured to generate a voltage field at or near the target area sufficient to elevate the temperature at the target area to a value within a temperature range that is above the first temperature to induce necrosis in cells at the target area.

2. The system of claim 1, wherein the energy transmission band is in a range of 40-60 KHz and the therapy band is in a range of 100-600 KHz.

3. The system of claim 1, wherein the external device is configured to transmit continuous RF energy through the application of a continuous RF signal to the external RF energy interface.

4. The system of claim 1, wherein the external device is further configured to transmit RF energy through the application of a RF signal that oscillates at a frequency in a diathermy band less than the therapy band.

5. The system of claim 4, wherein the diathermy band is in a range of 40-60 KHz.

6. The system of claim 1, wherein the therapy band is in a range of 100-600 KHz, and the RF stimulation therapy output signal comprises a pulse train having a pulse frequency between 1 Hz and 10 KHz, a pulse amplitude between 0.3 mA and 20 mA, a pulse width of between 5 μ

sec and 250 μ

sec.

7. The system of claim 6, wherein a duration of the RF stimulation therapy output signal is in a range of 20-30 minutes.

8. The system of claim 1, wherein the therapy band is in a range of 100-600 KHz, and the RF ablation therapy output signal comprises a pulse train, having a duty cycle up to 50%, a pulse amplitude between 45V and 60V, and a pulse width of 0.050 msec.

9. The system of claim 8, wherein a duration of the RF ablation therapy output signal is in a range of 140-220 seconds.

10. The system of claim 1, wherein the therapy band is in a range of 100-600 KHz, and the RF heat therapy output signal comprises a pulse train has a duty cycle between 50 and 95%, a single electrode pulse amplitude between 1 mA and 50 mA, a pulse train duration of between continuous and 50% of time.

11. The system of claim 10, wherein the duration of the RF heat therapy output signal is in a range of 20-30 minutes.

12. The system of claim 1, wherein the RF therapy controller comprises:

an RF modality controller;

an RF signal generator; and

an energy supply controller configured to receive a control signal from the RF modality controller and to, based on the control signal, output energy to the RF signal generator at an energy level and in an on/off cycle pattern than defines one or more parameters of a selected one of the three different types of the therapeutic output signal.

13. The pain management system of claim 1, wherein the implantable medical device comprises a housing configured to enclose the RF therapy controller, and to be mechanically coupled to a hardware component of an orthopedic implant device.

14. The pain management system of claim 1, wherein the controller is configured to selectively generate the three different types of a therapeutic output signal in series in the following order:

RF stimulation therapy output signal, followed by either of RF heat therapy output signal and RF ablation therapy output signal.

15. The pain management system of claim 1, wherein the controller is configured to simultaneously generate at least two different types of therapeutic output signals, and deliver a first of the different types therapeutic output signals to a first pair of electrodes and a second of the different types therapeutic output signals to a second pair of electrodes.

16. An implantable medical device configured for chronic implant, the device comprising:

one or more electrodes configured to be implanted in, on, or adjacent a target area of nerves;

an RF energy interface configured to receive energy from an external RF energy interface over a wireless energy link;

an energy storage component coupled to the RF energy interface through charging circuitry and configured to store the energy; and

a RF therapy controller coupled to the energy storage component and the one or more electrodes, the RF therapy controller programmatically configured to;

1) selectively generate each of three different types of a therapeutic output signal from the stored energy, the three different types of the therapeutic output signal comprising an RF stimulation therapy output signal, an RF heat therapy output signal, and an RF ablation therapy output signal, wherein each of the three different types of the therapeutic output signal comprises an RF signal oscillating at a frequency in a therapy band, and

2) deliver the therapeutic output signal to the one or more electrodes;

wherein the RF stimulation therapy output signal comprises pulses of the RF signal configured to generate an alternating current field at or near the target area at a current level sufficient to modulate neural signals by altering or interrupting transmission of action potentials by one or more nerves while maintaining the target area below a first temperature;

wherein the RF heat therapy output signal comprises pulses of the RF signal or a continuous RF signal configured to generate an alternating current field at or near the target area sufficient to increase the temperature of the target area to a value within a temperature range that is above the first temperature in order to provide analgesic heat to alleviate pain without causing nerve cell necrosis; and

wherein the RF ablation therapy output signal comprises pulses of the RF signal configured to generate a voltage field at or near the target area sufficient to elevate the temperature at the target area to a value within a temperature range that is above the first temperature to induce necrosis in cells at the target area.

17. The device of claim 16, wherein the therapy band is in a range of 100-600 KHz.

18. The device of claim 16, wherein the RF stimulation output comprises a pulse train having a pulse frequency between 1 Hz and 10 KHz, a pulse amplitude between 0.3 mA and 20 mA, a pulse width of between 5 μ

sec and 250 μ

sec.

19. The device of claim 16, wherein the RF heat output comprises a pulse train has a duty cycle between 50 and 95%, a single electrode pulse amplitude between 1 mA and 50 mA, a pulse train duration of between continuous and 50% of time.

20. The device of claim 16, wherein the RF ablation output comprises a pulse train, having a duty cycle up to 50%, a pulse amplitude between 45V and 60V, and a pulse width of 0.050 msec.

21. A method of delivering radio frequency (RF) therapy to a patient, comprising:

transmitting RF energy through the application of a RF signal to an external RF energy interface, wherein the RF signal oscillates at a frequency in an energy transmission band;

receiving the RF energy at an RF energy interface of an implanted medical device;

storing energy derived from the received RF energy in a direct current (DC) energy storage component of the implanted medical device;

generating, at an RF therapy controller of the implanted medical device, a selected one of three different types of a therapeutic output signal from the stored energy, the three different types of the therapeutic output signal comprising an RF stimulation therapy output signal, an RF heat therapy output signal, and an RF ablation therapy output signal, wherein each of the three different types of the therapeutic output signal comprises an RF signal oscillating at a frequency in a therapy band that is greater than the energy transmission band; and

delivering the therapeutic output signal to one or more electrodes implanted in, on, or adjacent a target area of nerves;

wherein the RF therapy controller is programmatically configured to;

selectively generate each of the RF stimulation therapy output signal, the RF heat therapy output signal, and the RF ablation therapy output signal;

wherein the RF stimulation therapy output signal comprises pulses of the RF signal configured to generate an alternating current field at or near the target area at a current level sufficient to modulate neural signals by altering or interrupting transmission of action potentials by one or more nerves while maintaining the target area below a first temperature;

wherein the RF heat therapy output signal comprises pulses of the RF signal or a continuous RF signal configured to generate an alternating current field at or near the target area sufficient to increase the temperature of the target area to a value within a temperature range that is above the first temperature in order to provide analgesic heat to alleviate pain without causing nerve cell necrosis; and

wherein the RF ablation therapy output signal comprises pulses of the RF signal configured to generate a voltage field at or near the target area sufficient to elevate the temperature at the target area to a value within a temperature range that is above the first temperature to induce necrosis in cells at the target area.

22. The method of claim 21, wherein the RF energy interface and the DC energy storage component are configured to continue to receive RF energy from the external RF energy interface and store the RF energy while the RF therapy controller generates a selected one of the three different types of a therapeutic output signal.

23. The method of claim 21, wherein the energy transmission band is in a range of 40-60 KHz and the therapy band is in a range of 100-600 KHz.

24. The method of claim 21, wherein the energy is transmitted through the application of a continuous RF signal to the external RF energy interface.

25. The method of claim 21, further comprising selecting RF stimulation therapy output for generation and delivery, and subsequent to the delivery of RF stimulation therapy output, selecting RF ablation therapy output for generation and delivery.

26. The method of claim 21, wherein the one or more of the electrodes are located in, on or adjacent a target area of nerves.

27. The method of claim 26, wherein the target area of nerves comprises a dorsal root ganglion (DRG).