Coordinated therapy for disordered breathing including baroreflex modulation

• US 7,596,413 B2
• Filed: 06/08/2004
• Issued: 09/29/2009
• Est. Priority Date: 06/08/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Lee, Kent, Libbus, Imad, Ni, Quan
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US10/863,827
• Publication Number:
  US 20050288729A1
• Time in Patent Office: 1,939 Days
• Field of Search: 607 1- 5, 607/9, 607/15, 607/26, 607/42, 607 44- 46, 607/48, 128/200.24, 128/204.18, 128/204.21, 128/204.23
• US Class Current: 607/42
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension

Abstract

An approach to providing disordered breathing therapy involves the use of a plurality of therapy devices to deliver a coordinated disordered breathing therapy regimen to the patient. The plurality of disordered breathing devices includes at least a therapy device that delivers an electrical stimulation therapy modulating a patient'"'"'s baroreflex response. Other therapy devices may include a cardiac electrical stimulation device, an external respiratory therapy device, and/or other therapy devices used in the treatment of disordered breathing. A therapy controller coordinates the therapies delivered by the plurality of therapy devices.

Claims

1. A method of providing disordered breathing therapy to a patient, comprising:

delivering a plurality of therapies to treat disordered breathing, including at least a first therapy utilizing electrical stimulation that modulates a patient'"'"'s baroreflex response, and including a second therapy different from the first therapy;

sensing one or more conditions associated with the patient;

determining, from the one or more sensed conditions, an efficacy of at least one therapy of the first and second therapies in treating disordered breathing;

determining, from the one or more sensed conditions, an impact on the patient other than the efficacy of the at least one therapy;

modifying the at least one therapy if the efficacy is determined to be acceptable and the impact is determined to be unacceptable.

2. The method of claim 1, wherein the impact on the patient relates to the patient'"'"'s sleep quality, and the coordinating is carried out to enhance the patient'"'"'s sleep quality.

3. The method of claim 2, wherein the sleep quality is determined at least in part by measuring a level of fragmentation of the patient'"'"'s sleep.

4. The method of claim 2, wherein the sleep quality is determined at least in part by sensing arousals of the patient from sleep.

5. The method of claim 2, wherein the sleep quality is determined at least in part by receiving patient-reported assessments of sleep quality.

6. The method of claim 2, wherein the modifying modifies the at least one therapy to deliver less aggressive therapy to enhance the patient'"'"'s sleep quality.

7. The method of claim 1, wherein the impact on the patient relates to the patient'"'"'s discomfort during therapy, and the modifying is carried out to reduce the patient'"'"'s discomfort during therapy.

8. The method of claim 1, wherein the delivering, sensing, and modifying steps are provided at least in part by an implantable device, wherein the impact on the patient relates to a service life of the implantable device, and wherein the modifying is carried out to enhance the service life of the implantable device.

9. The method of claim 1, further comprising:

delivering at least one cardiac pacing therapy to the patient;

wherein the impact on the patient relates to interactions between the plurality of therapies to treat disordered breathing and the at least one cardiac pacing therapy.

10. The method of claim 9, wherein the modifying is carried out to reduce the interactions.

11. The method of claim 10, wherein the modifying includes delivering the first therapy during a refractory period of the patient'"'"'s heart.

12. The method of claim 1, wherein the second therapy includes non-excitatory electrical stimulation of the patient'"'"'s heart.

13. The method of claim 1, wherein the second therapy includes sub-capture threshold electrical stimulation of the patient'"'"'s heart.

14. The method of claim 1, wherein the second therapy includes overdrive pacing of the patient'"'"'s heart.

15. The method of claim 1, wherein the second therapy includes a patient-external respiratory therapy.

16. The method of claim 15, wherein the impact of the second therapy on the patient relates to whether the patient has used the external respiratory therapy.

17. The method of claim 1, wherein coordinating delivery includes delivering the first and second therapies for predetermined periods of time.

18. The method of claim 1, wherein modifying includes shifting from the first to the second therapy.

19. A disordered breathing therapy system at least a portion of which is adapted for implantation in a patient, the system comprising:

a plurality of therapy devices, each therapy device configured to deliver a disordered breathing therapy different from disordered breathing therapies delivered by others of the therapy devices;

a plurality of sensors capable of sensing at least one condition associated with the patient; and

a therapy controller coupled to the plurality of therapy devices and to the plurality of sensors, the therapy controller configured to;

determine from the at least one condition an efficacy of at least one therapy of the disordered breathing therapies in treating disordered breathing;

determine from the at least one condition an impact on the patient other than the efficacy of the at least one therapy; and

modify the at least one therapy if the efficacy is determined to be acceptable and the impact is determined to be unacceptable;

wherein at least one of the therapy devices includes a baroreflex stimulator configured to deliver an electrical stimulation therapy modifying the patient'"'"'s baroreflex response.

20. The system of claim 19, wherein at least the baroreflex stimulator and the therapy controller are adapted for implantation in the patient.

21. The system of claim 19, wherein the at least one condition includes a condition that relates to the patient'"'"'s sleep quality, and wherein the therapy controller is configured to modify the at least one therapy so as to enhance the patient'"'"'s sleep quality.

22. The system of claim 21, wherein the sleep quality is determined at least in part by measuring a level of fragmentation of the patient'"'"'s sleep.

23. The system of claim 21, wherein the sleep quality is determined at least in part by sensing arousals of the patient from sleep.

24. The system of claim 21, wherein the sleep quality is determined at least in part by receiving patient-reported assessments of sleep quality.

25. The system of claim 21, wherein the therapy controller modifies the at least one therapy by delivering less aggressive therapy to enhance the patient'"'"'s sleep quality.

26. The system of claim 19, wherein the impact on the patient relates to the patient'"'"'s discomfort during therapy, and the therapy controller is adapted to reduce the patient'"'"'s discomfort during therapy.

27. The system of claim 19, wherein at least the baroreflex stimulator and the therapy controller are part of an implantable device, and wherein the impact on the patient relates to a service life of the implantable device, and wherein the therapy controller is adapted to enhance the service life of the implantable device.

28. The system of claim 19, further comprising:

a cardiac pacing therapy device coupled to the therapy controller;

wherein the impact on the patient relates to interactions between the plurality of therapy devices configured to deliver the disordered breathing therapies and the cardiac pacing therapy device.

29. The system of claim 28, wherein the therapy controller is configured to reduce the interactions between the plurality of therapy devices configured to deliver the disordered breathing therapies and the cardiac pacing therapy device.

30. The system of claim 29, wherein the therapy controller is configured to deliver the electrical stimulation therapy modifying the patient'"'"'s baroreflex response during a refractory period of the patient'"'"'s heart.

31. The system of claim 19, wherein the plurality of therapy devices includes a device configured to deliver non-excitatory electrical stimulation of the patient'"'"'s heart.

32. The system of claim 19, wherein the plurality of therapy devices includes a device configured to deliver sub-capture threshold electrical stimulation of the patient'"'"'s heart.

33. The system of claim 19, wherein the plurality of therapy devices includes a device configured to deliver overdrive pacing of the patient'"'"'s heart.

34. The system of claim 19, wherein the plurality of therapy devices includes an external respiratory therapy device.

35. The system of claim 34, wherein the therapy controller is configured to modify the at least one therapy based on whether the patient has used the external respiratory therapy device.

36. The system of claim 19, wherein the therapy controller is configured to modify the at least one therapy by shifting from one to another of the plurality of therapy devices upon sensing that the patient is asleep.