Apparatus and method for spinal cord stimulation to treat pain

• US 9,421,378 B2
• Filed: 05/20/2014
• Issued: 08/23/2016
• Est. Priority Date: 06/14/2013
• Status: Active Grant

• Current Assignee: Biotronik SE & Company KG
• Original Assignee: Biotronik SE & Company KG
• Inventors: Lian, Jie, Muessig, Dirk
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US14/282,115
• Publication Number:
  US 20140371811A1
• Time in Patent Office: 826 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3614 based on impedance measurement

Abstract

A spinal cord stimulation device having a stimulation unit for generation and delivery of stimulation pulses, a control unit for controlling the stimulation unit with respect to stimulation intensity and an autonomic nervous system (“ANS”) sensing unit that is configured to generate ANS indicating signals that represent an increased sympathetic tone or an increased parasympathetic tone, respectively. The control unit is configured to control the intensity of respective stimulation pulses depending on a respective ANS indicating signal as generated by said ANS sensing unit.

Claims

1. A spinal cord stimulation device comprising:

a stimulation unit for generation and delivery of stimulation pulses;

a control unit for controlling the stimulation unit with respect to stimulation intensity; and

an autonomic nervous system (“

ANS”

) sensing unit that is configured to generate ANS indicating signals representing an increased sympathetic tone or an increased parasympathetic tone, respectively, said control unit being configured to control the intensity of respective stimulation pulses depending on a respective ANS indicating signal as generated by said ANS sensing unit,

wherein the ANS sensing unit is configured to generate said ANS indicating signals from respiration signals that represent respiration activity, and wherein the ANS sensing unit is further configured to determine from the respiration signals inspiration and expiration phases and to generate respiration phase indicating signals accordingly,

wherein the control unit is configured to dynamically adjust the stimulation intensity by means of varying stimulation frequency, pulse width or pulse amplitude, or a combination thereof, in synchronization with received respiration phase indicating signals, such that high intensity stimulation pulses are delivered at increased sympathetic tone whereas lower intensity stimulation pulses are delivered at increased parasympathetic tone.

2. The spinal cord stimulation device according to claim 1, wherein the control unit is configured to control the intensity of respective stimulation pulses such that relatively higher intensity stimulation pulses are generated in case of ANS indicating signals representing an increased sympathetic tone and relatively lower intensity stimulation pulses are generated in case of ANS indicating signals representing an increased parasympathetic tone.

3. The spinal cord stimulation device according to claim 2, wherein said control unit is configured to control the intensity of respective stimulation pulses depending on respective respiration phase indicating signals received from said ANS sensing unit.

4. The spinal cord stimulation device according to claim 3, wherein the ANS sensing unit comprises means to detect respiration signals and identify different phases of the respiration and to generate a respiration indicating signal accordingly, wherein the different phases of the respiration include inspiration, expiration, post-inspiration pause, and post-expiration pause.

5. The spinal cord stimulation device according to claim 1, wherein the control unit is configured to control the intensity of respective stimulation pulses depending on a respective respiration phase indicating signal such that relatively higher intensity stimulation pulses are delivered at inspiration phases and relatively lower intensity stimulation pulses are delivered at expiration phases.

6. The spinal cord stimulation device according to claim 1, further comprising a respiration sensing unit that is connected to said ANS sensing unit and is configured to sense values of an electric parameter which are depending on a respective respiration phase.

7. The spinal cord stimulation device according to claim 6, wherein said respiration sensing unit comprises an impedance sensing unit that is configured to sense a transthoracic impedance and generate transthoracic impedance signals that represent values of sensed transthoracic impedance.

8. The spinal cord stimulation device according to claim 6, wherein said ANS sensing unit in combination with said respiration sensing unit is configured to continuously analyze acquired transthoracic impedance signals to detect different phases of the respiratory cycle and to determine respiration parameters including respiration rate, tidal volume and/or minute ventilation.

9. The spinal cord stimulation device according to claim 6, wherein said control unit is configured to modulate the stimulation pulses'"'"' intensity by running a closed loop control algorithm using at least one of respiration rate, tidal volume and minute ventilation.

10. A spinal cord stimulation device comprising:

a stimulation unit for generation and delivery of stimulation pulses;

a control unit for controlling the stimulation unit with respect to stimulation intensity; and

an autonomic nervous system (“

ANS”

) sensing unit that is configured to generate ANS indicating signals representing an increased sympathetic tone or an increased parasympathetic tone, respectively, said control unit being configured to control the intensity of respective stimulation pulses depending on a respective ANS indicating signal as generated by said ANS sensing unit,

wherein the ANS sensing unit is configured to generate said ANS indicating signals from respiration signals that represent respiration activity, and wherein the ANS sensing unit is further configured to determine from the respiration signals inspiration and expiration phases and to generate respiration phase indicating signals accordingly, said control unit being configured to control the intensity of respective stimulation pulses in synchronization with respective respiration phase indicating signals received from said ANS sensing unit,

wherein the control unit is configured to dynamically adjust the stimulation intensity by means of varying stimulation frequency, pulse width or pulse amplitude, or a combination thereof, in synchronization with received respiration phase indicating signals, such that high intensity stimulation pulses are delivered at increased sympathetic tone whereas lower intensity stimulation pulses are delivered at increased parasympathetic tone.

11. The spinal cord stimulation device according to claim 10, wherein the ANS sensing unit comprises means to detect respiration signals and identify different phases of the respiration and to generate a respiration indicating signal accordingly, wherein the different phases of the respiration include inspiration, expiration, post-inspiration pause, and post-expiration pause.

12. The spinal cord stimulation device according to claim 10, further comprising a respiration sensing unit that is connected to said ANS sensing unit and is configured to sense values of an electric parameter which are depending on a respective respiration phase.

13. The spinal cord stimulation device according to claim 12, wherein said respiration sensing unit comprises an impedance sensing unit that is configured to sense a transthoracic impedance and generate transthoracic impedance signals that represent values of sensed transthoracic impedance.

14. The spinal cord stimulation device according to claim 12, wherein said ANS sensing unit in combination with said respiration sensing unit is configured to continuously analyze acquired transthoracic impedance signals to detect different phases of the respiratory cycle and to determine respiration parameters including respiration rate, tidal volume and/or minute ventilation.

15. The spinal cord stimulation device according to claim 12, wherein said control unit is configured to modulate the stimulation pulses'"'"' intensity by running a closed loop control algorithm using at least one of respiration rate, tidal volume and minute ventilation.

16. A spinal cord stimulation device comprising:

a stimulation unit for generation and delivery of stimulation pulses;

a control unit for controlling the stimulation unit with respect to stimulation amplitude; and

an autonomic nervous system (“

ANS”

) sensing unit that is configured to generate ANS indicating signals representing an increased sympathetic tone or an increased parasympathetic tone, respectively, said control unit being configured to control the amplitude of respective stimulation pulses depending on a respective ANS indicating signal as generated by said ANS sensing unit,

wherein the control unit is configured to control the amplitude of respective stimulation pulses such that relatively higher amplitude stimulation pulses are generated in case of ANS indicating signals representing an increased sympathetic tone and relatively lower amplitude stimulation pulses are generated in case of ANS indicating signals representing an increased parasympathetic tone.

17. The spinal cord stimulation device recited in claim 16, wherein the ANS sensing unit is configured to generate said ANS indicating signals from respiration signals that represent respiration activity, and wherein the ANS sensing unit is further configured to determine from the respiration signals inspiration and expiration phases and to generate respiration phase indicating signals accordingly, said control unit being configured to control the amplitude of respective stimulation pulses depending on respective respiration phase indicating signals received from said ANS sensing unit.

18. A spinal cord stimulation device comprising:

a stimulation unit for generation and delivery of stimulation pulses;

a control unit for controlling the stimulation unit with respect to stimulation amplitude; and

an autonomic nervous system (“

ANS”

) sensing unit that is configured to generate ANS indicating signals representing an increased sympathetic tone or an increased parasympathetic tone, respectively, said control unit being configured to control the amplitude of respective stimulation pulses depending on a respective ANS indicating signal as generated by said ANS sensing unit,

wherein the control unit is configured to control the amplitude of respective stimulation pulses depending on a respective respiration phase indicating signal such that relatively higher amplitude stimulation pulses are delivered at inspiration phases and relatively lower amplitude stimulation pulses are delivered at expiration phases.