Therapy using perturbation and effect of physiological systems

• US 8,406,868 B2
• Filed: 04/26/2011
• Issued: 03/26/2013
• Est. Priority Date: 04/29/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Buschman, Hendrik Peter Johan, Burnes, John Edward, Cornelussen, Richard N. M., Hill, Michael Roland Scott, Kornet, Lilian, Ordelman, Simone Cornelia Maria Anna, Veltink, Petrus Hermanus
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/094,231
• Publication Number:
  US 20110270342A1
• Time in Patent Office: 700 Days
• Field of Search: 607/2
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371

Abstract

Methods for treating a patient and further to devices for performing such treatment, e.g., methods and devices to perturb at least one physiological system and deliver therapy to the patient based on the effects of such perturbation. For example, a method for using an implantable medical device is disclosed that involves delivering electrical stimuli to an efferent nerve associated with the selected organ. Afferent electrical activity is monitored during delivery of electrical stimuli to the efferent nerve, the monitored afferent electrical activity includes an indirect component of a compound action potential (CAP). A status of the selected organ is assessed based upon the indirect component. A determination is made as to whether to deliver therapy to the selected organ in response to assessing the status of the selected organ.

Claims

1. A device for use in treatment of a patient comprising:

perturbation apparatus configured to perturb at least one physiological system of a patient, wherein the perturbation apparatus comprises at least one electrode to stimulate the patient'"'"'s vagus nerve;

monitoring apparatus configured to monitor physiological parameters of the patient, wherein the monitoring apparatus comprises at least one electrode to monitor the electrical activity of the patient'"'"'s vagus nerve;

a sensing module coupled to the monitoring apparatus and configured to receive the monitored physiological parameters;

a therapy delivery module configured to deliver therapy to the patient; and

a control module coupled to the perturbation apparatus, to the sensing module, and to the therapy delivery module, and configured to;

perturb at least one physiological system of the patient using the perturbation apparatus by at least delivering electrical stimulation to the patient'"'"'s vagus nerve,

monitor electrical activity from the vagus nerve, wherein the electrical activity includes at least one direct component and an indirect component of a compound action potential (CAP), wherein the indirect component is not in direct response to the delivered electrical stimulation as indicated by a latency between the electrical stimulation delivered to the patient'"'"'s vagus nerve and the indirect component;

provide a response index comprising data representative of an effect on the indirect component of the monitored electrical activity of the vagus nerve in response to one or more perturbations to the at least one physiological system,

assess a status of the patient'"'"'s heart by comparing the response index with the indirect component monitored after perturbing the at least one physiological system of the patient, and

determine whether to deliver therapy to the patient using the therapy delivery module based on the assessed status of the patient'"'"'s heart.

2. The device of claim 1, wherein the data representative of the effect on the indirect component of the monitored electrical activity of the vagus nerve comprises data representative of an expected latency between a perturbation of the at least one physiological system and the indirect component of the monitored electrical activity of the vagus nerve associated with the heart.

3. The device of claim 1, wherein the data representative of the effect on the indirect component of the monitored electrical activity of the vagus nerve comprises data representative of an expected baseline effect on the heart caused by a perturbation to the at least one physiological system.

4. The device of claim 1, wherein the data representative of the effect on the indirect component of the monitored electrical activity of the vagus nerve comprises data representative of an expected relationship between a perturbation of the at least one physiological system and the indirect component of the monitored electrical activity of the vagus nerve associated with the heart.

5. The device of claim 1, wherein the indirect component of the electrical activity of the vagus nerve comprises afferent electrical activity of the vagus nerve.

6. The device of claim 1, wherein the control module is configured to deliver therapy to the patient based on the assessed status of the patient'"'"'s heart by at least one of initiating the delivery of therapy to the patient'"'"'s heart and adjusting the therapy being delivered to the patient'"'"'s heart.

7. The device of claim 1, wherein the control module is configured to deliver therapy to the patient based on the status of the patient'"'"'s heart by delivering at least one of vagal stimulation and heart pacing therapy.

8. A method for use in treatment of a patient, the method comprising:

perturbing at least one physiological system of the patient;

monitoring physiological parameters of the patient, wherein monitoring physiological parameters of the patient comprises monitoring electrical activity of at least one nerve associated with a selected organ of the patient, wherein the electrical activity includes at least one direct component and an indirect component of a compound action potential (CAP), wherein the indirect component is not in direct response to the perturbance as indicated by a latency between the perturbance to the at least one physiological system and the indirect component;

providing a response index comprising data representative of an effect on the indirect component of the monitored electrical activity of the at least one nerve associated with the selected organ in response to one or more perturbations to the at least one physiological system;

assessing a status of the selected organ by comparing the response index with the indirect component monitored after perturbing at least one physiological system of the patient; and

determining whether to deliver therapy to the patient based on the assessed status of the selected organ.

9. The method of claim 8, wherein the selected organ comprises the heart.

10. The method of claim 8, wherein the selected organ comprises one of the kidney, the stomach, the gastrointestinal tract, and one or more muscles.

11. The method of claim 8, wherein the data representative of the effect on the indirect component of the monitored electrical activity of the at least one nerve associated with the selected organ comprises data representative of an expected latency between a perturbation of the at least one physiological system and the indirect component of the monitored electrical activity of the at least one nerve associated with the selected organ.

12. The method of claim 8, wherein the data representative of the effect on the indirect component of the monitored electrical activity of the at least one nerve associated with the selected organ comprises data representative of expected baseline effects on the selected organ in response to the perturbation to at least one physiological system.

13. The method of claim 8, wherein the data representative of the effect on the indirect component of the monitored electrical activity of the at least one nerve associated with the selected organ comprises data representative of an expected relationship between a perturbation of the at least one physiological system and the indirect component of the monitored electrical activity of the at least one nerve associated with the selected organ.

14. The method of claim 8, wherein the indirect component of the electrical activity of the at least one nerve associated with the selected organ of the patient comprises afferent electrical activity, and wherein monitoring electrical activity selected organ of the patient comprises monitoring afferent electrical activity.

15. A method for use in treatment of a patient, the method comprising:

perturbing at least one physiological system of the patient, wherein perturbing at least one physiological system of the patient comprises delivering electrical stimulation to the patient'"'"'s vagus nerve;

monitoring physiological parameters of the patient, wherein monitoring physiological parameters of the patient comprises monitoring electrical activity of the patient'"'"'s vagus nerve comprising at least one direct component and an indirect component, wherein the indirect component is not in direct response to the delivered electrical stimulation as indicated by a latency between the delivery of the electrical stimulation to the patient'"'"'s vagus nerve and the indirect component;

providing a response index comprising data representative of an effect on the indirect component of the monitored electrical activity of the vagus nerve in response to one or more perturbations to the vagus nerve;

assessing a status of the patient'"'"'s heart by comparing the response index with the indirect component monitored after perturbing at least one physiological system of the patient; and

delivering therapy to the patient based on the assessed status of the patient'"'"'s heart.

16. The method of claim 15, wherein the data representative of the effect on the indirect component of the monitored electrical activity of the vagus nerve comprises data representative of an expected latency between a perturbation of the at least one physiological system and the indirect component of the monitored electrical activity of the vagus nerve.

17. The method of claim 15, wherein the data representative of the effect on the indirect component of the monitored electrical activity of the vagus nerve comprises data representative of an expected baseline effect on the heart in response to the perturbation to the at least one physiological system.

18. The method of claim 15, wherein the data representative of the effect on the indirect component of the monitored electrical activity of the vagus nerve comprises data representative of an expected relationship between a perturbation of the at least one physiological system and the indirect component of the monitored electrical activity of the vagus nerve.

19. The method of claim 15, wherein the indirect component of the electrical activity of the vagus nerve comprises afferent electrical activity, and wherein monitoring electrical activity of patient'"'"'s vagus nerve comprises monitoring afferent electrical activity of the patient'"'"'s vagus nerve.

20. The method of claim 15, wherein delivering therapy to the patient based on the assessed status of the patient'"'"'s heart comprises at least one of:

initiating the delivery of therapy to the patient'"'"'s heart, and

adjusting the therapy being delivered to the patient'"'"'s heart.

21. The method of claim 15, wherein delivering therapy to the patient based on the status of the patient'"'"'s heart comprises delivering at least one of vagal stimulation and heart pacing therapy.