Systems and methods for adjusting electrical neuromodulation therapy in medication therapeutic window

• US 9,421,376 B2
• Filed: 12/16/2013
• Issued: 08/23/2016
• Est. Priority Date: 12/21/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Lui, Mun Pook, Kothandaraman, Sridhar
• Primary Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US14/107,979
• Publication Number:
  US 20140180349A1
• Time in Patent Office: 981 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

A neuromodulation system and method for managing electrical neuromodulation therapy for a patient in conjunction with administering a pharmacological agent to the patient. Electrical energy is delivered to a target tissue region of the patient, thereby electrically modulating the target tissue region providing therapy to the patient. The energy level of the electrical energy delivered to the tissue is automatically varied inversely to the effect of the pharmacological agent on the patient during a therapeutic window. An absorption level of the pharmacological agent in the patient may be continually detected, and the energy level of the delivered electrical energy automatically varied based on the detected absorption level of the pharmacological agent during a therapeutic window.

Claims

1. A neuromodulation system for managing electrical neuromodulation therapy for a patient in conjunction with administering a pharmacological agent to the patient, the neuromodulation system comprising:

output modulation circuitry configured for delivering electrical energy to a target tissue region of the patient, thereby electrically modulating the target tissue region and providing therapy to the patient;

a sensor configured for detecting an absorption level of the pharmacological agent in a body of the patient;

monitoring circuitry operably connected to the sensor and configured for continually monitoring the absorption level of the pharmacological agent in the patient; and

a controller/processor configured for automatically instructing the output modulation circuitry to vary an energy level of the electrical energy delivered to the tissue during a therapeutic window based on the monitored absorption level of the pharmacological agent.

2. The neuromodulation system of claim 1, wherein the monitored absorption level of the pharmacological agent is relatively high during a first time period of the therapeutic window and relatively low during a second time period subsequent to the first time period, and the controller/processor is configured for automatically instructing the output modulation circuitry to deliver the electrical energy to the tissue at a relatively low level during the first time period and at a relatively high level during the second time period.

3. The neuromodulation system of claim 1, wherein the electrical energy comprises pulsed electrical energy, and the controller/processor is configured for automatically instructing the output modulation circuitry to automatically vary the level of the electrical energy by adjusting a pulse width of the pulsed electrical energy.

4. The neuromodulation system of claim 1, further comprising a user interface configured for receiving a user input, wherein the controller/processor is configured for triggering the automatic instruction of the output modulation circuitry to vary the energy level of the electrical energy delivered to the tissue in response to the user input.

5. The neuromodulation system of claim 1, wherein the output modulation circuitry is configured to generate a continuous modulating waveform.

6. The neuromodulation system of claim 1, wherein the output modulation circuitry is configured to generate a pulse train under control of control logic to provide a specified shape.

7. The neuromodulation system of claim 1, wherein the output modulation circuitry is configured to deliver the electrical energy in inverse proportion to the detected absorption level.

8. The neuromodulation system of claim 1, wherein the output modulation circuitry is configured for delivering pulse trains, and the controller/processor is configured for automatically instructing the output modulation circuitry to automatically vary the pulse train based on the monitored absorption level of the pharmacological agent.

9. The neuromodulation system of claim 1, wherein the electrical energy comprises pulsed electrical energy, and the controller/processor is configured for automatically instructing the output modulation circuitry to automatically vary the level of the electrical energy by adjusting a pulse amplitude of the pulsed electrical energy.

10. The neuromodulation system of claim 1, further comprising memory storing a pre-defined electrical modulation curve, wherein the controller/processor is configured for automatically instructing the output modulation circuitry to vary the energy level of the electrical energy delivered to the tissue in accordance with the pre-defined electrical modulation curve.

11. A method for managing electrical neuromodulation therapy for a patient in conjunction with administering a pharmacological agent to the patient, the method comprising:

delivering electrical energy to a target tissue region of the patient, thereby electrically modulating the target tissue region providing therapy to the patient;

continually detecting an absorption level of the pharmacological agent in the patient wherein continually detecting the absorption level includes using a sensor configured for detecting the absorption level in a body of the patient; and

automatically varying an energy level of the electrical energy delivered to the tissue based on the detected absorption level of the pharmacological agent during a therapeutic window.

12. The method of claim 11, wherein continually detecting the absorption level of the pharmacological agent in the patient comprises detecting a relatively high absorption level of the pharmacological agent during a first time period of the therapeutic window and detecting a relatively low absorption level during a second time period subsequent to the first time period, and the energy level of the electrical energy delivered to the tissue is relatively low during the first time period and relatively high during the second time period.

13. The method of claim 11, wherein the electrical energy delivered to the tissue comprises pulsed electrical energy, the energy level of which is automatically varied by adjusting a pulse width of the pulsed electrical energy.

14. The method of claim 11, wherein the automatic varying of the energy level of the electrical energy delivered to the tissue is immediately triggered in response to a user input.

15. The method of claim 11, wherein automatically varying the energy level of the electrical energy includes delivering the electrical energy in inverse proportion to the detected absorption level.

16. The method of claim 11, wherein delivering electrical energy includes delivering a continuous modulating waveform.

17. The method of claim 11, wherein delivering electrical energy includes delivering a pulse train under control of control logic to provide a specified shape.

18. The method of claim 11, wherein delivering electrical energy includes delivering pulse trains, and automatically varying the energy level includes automatically vary the pulse train based on the detected absorption level of the pharmacological agent.

19. The method of claim 11, wherein the electrical energy delivered to the tissue comprises pulsed electrical energy that is automatically varied by adjusting a pulse amplitude of the pulsed electrical energy.

20. The method of claim 11, wherein the energy level of the electrical energy delivered to the tissue is automatically varied in accordance with a pre-defined electrical modulation curve.