METHODS AND DEVICES FOR CONTROLLING BATTERY LIFE IN AN IMPLANTABLE PULSE GENERATOR

• US 20090018607A1
• Filed: 03/17/2008
• Published: 01/15/2009
• Est. Priority Date: 03/15/2007
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Crowley, Thomas Patrick, Hagen, Jeffrey J.
• Granted Patent: US 8,150,521 B2
• Time in Patent Office: Days
• US Class Current: 607/44
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Methods, devices, and systems for controlling an implantable pulse generator for activation of a nerve or receptor are provided. In particular, the method, devices, and systems embodying features of the present invention control the energy output of a battery in an implantable pulse generator for stimulation of the baroreflex system of the patient.

Claims

1. A method of controlling an implantable pulse generator for baroreflex activation, comprising:

applying electrical power from the pulse generator to a nerve or a receptor;

monitoring the energy level of the pulse generator; and

changing the operation of the pulse generator to adjust the electrical power output of the pulse generator while maintaining adequate physiological response.

2. The method of claim 1, further comprising monitoring the physiological response to a change in operation of the pulse generator.

3. The method of claim 1, wherein adjusting the electrical power output is in response to the energy level being monitored.

4. The method of claim 1, wherein monitoring the energy level of the pulse generator comprises monitoring the voltage of the pulse generator.

5. The method of claim 1, wherein monitoring the energy level of the pulse generator comprises monitoring the current drain of the pulse generator.

6. The method of claim 1, wherein monitoring the energy level of the pulse generator includes producing a signal representative of the energy level of the pulse generator in response to the energy level of the pulse generator reaching a first threshold energy level.

7. The method of claim 1, wherein monitoring the energy level of the pulse generator includes producing a signal representative of the energy level of the pulse generator prior to the energy level of the pulse generator reaching a first threshold energy level.

8. The method of claim 6, wherein changing the operation of the pulse generator comprises reducing energy consumption of the pulse generator in response to the signal representative of the energy level of the pulse generator while maintaining adequate baroreflex response.

9. The method of claim 8, further comprising monitoring the energy level of the pulse generator until the energy level reaches a second threshold level and generating a signal representative of the energy level of the pulse generator.

10. The method of claim 9, further comprising changing the power output of the pulse generator in response to the signal representative of the energy level of the pulse generator to further reduce energy consumption of the pulse generator while maintaining adequate baroreflex response.

11. A method of controlling the energy output of a battery in an implantable pulse generator for activation of a baroreflex activation device, the method comprising:

establishing a therapy regimen including a plurality of dose regimens for stimulating a baroreflex of a patient, wherein at least one dose regimen requires a lower power consumption than at least one other dose regimen;

monitoring the energy level of the battery;

applying electrical power output from the implantable pulse generator to the baroreflex activation device, the electrical output being responsive to at least one of the dose regimens; and

changing the dose regimen at least once to lower electrical consumption of the battery when the battery energy falls below a threshold energy level.

12. The method of claim 11, wherein the changing of the dose regimen results in gradually decreasing the administration of the therapy to the patient, wherein decreasing the therapy in a gradual manner avoids any adverse clinical effects due to abrupt therapy withdrawal.

13. The method of claim 11, wherein the method further comprises:

alerting the patient and/or the healthcare provider when the battery energy falls below the threshold energy level.

14. The method of claim 11, wherein the monitoring of the energy level of the battery comprises monitoring the voltage of the battery.

15. The method of claim 14, wherein the changing of the dose regimen comprises changing one or more characteristics of pulses generated by the generator which are responsive to the dose regimen.

16. The method of claim 15, wherein the pulse characteristic includes one or more of duty cycle, pulse amplitude, pulse width, pulse frequency, pulse separation, pulse waveform, pulse polarity, and pulse phase.

17. The method of claim 15, wherein changing of the dose regimen to lower electrical power consumption of the battery is performed in multiple steps.

18. The method of claim 15, wherein the monitoring step includes interpreting a signal representative of the energy level of the battery.

19. The method of claim 18, wherein the signal representative of the energy level of the battery instructs the changing of the dose regimen when the battery energy falls below the threshold energy.

20. The method of claim 17, wherein the changing of the dose regimen to lower the energy consumption of the battery in multiple steps continues until the battery has reached its end of life and is depleted of energy.

21. An implantable pulse generator for activation of a baroreflex response in a patient, comprising:

a source of electrical energy for applying electrical power to the nerve or receptor;

an energy monitor for monitoring the energy level of the pulse generator; and

means for changing the operation of the pulse generator to adjust the electrical power output of the pulse generator while maintaining adequate nerve or receptor response.

22. The pulse generator of claim 21, wherein the energy monitor is configured to monitor the voltage of the device.

23. The pulse generator of claim 21, wherein the energy monitor is configured to monitor the current drain of the pulse generator.

24. The pulse generator of claim 21, wherein the pulse generator is configured to change its power output to reduce energy consumption of the pulse generator while maintaining adequate baroreflex response.

25. An implantable pulse generator for stimulating a baroreflex system of a patient, comprising:

a battery for providing electrical energy for use by the implantable pulse generator;

a detector for detecting energy level of the battery; and

a pulse generator having a circuitry for generating stimulation pulses to the baroreflex system of the patient;

the pulse generator having multiple modes of operation for delivery of pulses, the modes being responsive to energy level of the battery, the implantable pulse generator further configured for changing at least once to a mode requiring lower electrical consumption of the battery when the energy level of the battery falls below a threshold energy level.

26. The implantable pulse generator of claim 25, further including:

a memory system in communication with the processor and the battery, the memory configured for storing information regarding a therapy regimen, the therapy regimen including a plurality of dose regimens for stimulating the baroreceptor system of the patient, wherein at least one dose regimen requires a lower power consumption than at least one other dose regimen.

27. The implantable pulse generator of claim 26, further including a processor for controlling the mode of operation, wherein the mode of operation is at least once changed to lower electrical consumption of the battery when the battery energy falls below the threshold energy.

28. The implantable pulse generator of claim 26, wherein the dose regimen requiring the lower power consumption corresponds to the mode requiring lower electrical consumption of the battery when the energy level of the battery falls below a threshold energy level.

29. The implantable pulse generator of claim 25, wherein the implantable pulse generator is connectable to a baroreflex activation device locatable proximate one or more baroreceptors of the patient, for delivery of output energy from the implantable pulse generator to the baroreceptor region.

30. A method of controlling an implantable pulse generator for baroreflex activation, comprising:

providing an implantable pulse generator; and

providing instructions for controlling the implantable pulse generator, the instructions comprising;

applying electrical power from the pulse generator to a nerve or a receptor;

monitoring the energy level of the pulse generator; and

changing the operation of the pulse generator to adjust the electrical power output of the pulse generator while maintaining adequate physiological response.

31. A method of controlling the energy output of a battery in an implantable pulse generator for activation of a baroreflex activation device, the method comprising:

providing an implantable pulse generator including a battery;

providing instructions for controlling the energy output of the battery, comprising;

establishing a therapy regimen including a plurality of dose regimens for stimulating a baroreflex of a patient, wherein at least one dose regimen requires a lower power consumption than at least one other dose regimen;

monitoring the energy level of the battery;

applying electrical power output from the implantable pulse generator to the baroreflex activation device, the electrical output being responsive to at least one of the dose regimens; and

changing the dose regimen at least once to lower electrical consumption of the battery when the battery energy falls below a threshold energy level.