Contingent cardio-protection for epilepsy patients

Patent metadata

Field	Value
Publication number	US-12377269-B2
Application number	US-202117557576-A
Country	US
Kind code	B2
Filing date	Dec 21, 2021
Priority date	Aug 31, 2012
Publication date	Aug 5, 2025
Grant date	Aug 5, 2025

Abstract

Disclosed are methods and systems for treating epilepsy by stimulating a main trunk of a vagus nerve, or a left vagus nerve, when the patient has had no seizure or a seizure that is not characterized by cardiac changes such as an increase in heart rate, and stimulating a cardiac branch of a vagus nerve, or a right vagus nerve, when the patient has had a seizure characterized by cardiac changes such as a heart rate increase.

First claim

What is claimed:

1. A method of treating a medical condition in a patient using an implantable medical device, the implantable medical device including a first electrode coupled to a first cranial nerve structure and a second electrode coupled to a second cranial nerve structure, where the first cranial nerve structure is a left portion of a cranial nerve and the second cranial nerve structure is a right portion of the cranial nerve, the method comprising:
providing a first electrical signal to the first cranial nerve structure of the patient using a first polarity configuration, the first electrical signal is configured to induce action potentials, wherein a charge accumulates as a result of the first electrical signal;
switching from the first polarity configuration to a second polarity configuration upon termination of the first electrical signal;
providing a second electrical signal to the second cranial nerve structure in the second polarity configuration, the second electrical signal is configured to induce action potentials in the second cranial nerve structure where at least a portion of the second electrical signal comprises the accumulated charge from the first electrical signal;
administering to the patient a responsiveness test and comparing a result of the responsiveness test to a baseline responsiveness test;
determining a first state, a second state, a third state, or a fourth state from a comparison of the result of the responsiveness test to the baseline responsive test; and
initiating a second therapy or issuing a warning based on the comparison of the result of the responsiveness test to the baseline responsiveness test.

2. The method of claim 1 , wherein one or more processors are configured to transmit a signal to one or more of the first electrode and the second electrode to increase a sympathetic tone to increase the heart rate of the patient via the second therapy based on a first state determination.

3. The method of claim 1 , wherein one or more processors are configured to transmit a signal to one or more of the first electrode and the second electrode to decrease a parasympathetic tone to increase the heart rate of the patient the second therapy based on a second state determination.

4. The method of claim 1 , wherein one or more processors are configured to transmit a signal to one or more of the first electrode and the second electrode to decrease a sympathetic tone to decrease the heart rate of the patient via the second therapy based on a third state determination.

5. The method of claim 1 , wherein one or more processors are configured to transmit a signal to one or more of the first electrode and the second electrode to increase a parasympathetic tone to decrease the heart rate of the patient the second therapy based on a fourth state determination.

6. The method of claim 1 , further comprising a seizure detection unit capable of analyzing at least one body data stream to determine an epileptic seizure status.

7. The method of claim 1 , further comprising:
collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor;
determining an autonomic index; and
detecting a change in the autonomic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of cardiovascular signals, respiratory signals, skin signals, pupillary signals, temperature signals, peristaltic signals, autonomic nerve or ganglia signals, and two or more thereof.

8. The method of claim 1 , further comprising:
collecting body data of the patient by at least one of an electrocardiography (EKG) device, an accelerometer, an inclinometer, a pupillometer, a face or body temperature monitor, a skin resistance monitor, a sound sensor, or a pressure sensor;
determining an autonomic index; and
detecting a change in a neurologic index of the patient by analyzing at least one set of signals received from the patient and selected from a signal group consisting of brain signals, cranial nerve signals, spinal cord signals, peripheral nerve signals, body kinetic, position and force signals, and two or more thereof.

9. The method of claim 1 , wherein the responsiveness test includes a first test of responsiveness having a first difficulty level, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second difficulty level.

10. The method of claim 1 , wherein the responsiveness test includes a first test of responsiveness having a first duration, and, based on the patient's responsiveness according to the first test, selecting and administering a second test of responsiveness having a second duration.

11. The method of claim 1 , wherein the test of responsiveness tests a cognitive function of the patient, wherein the cognitive function is selected from a cognitive function group consisting of an attention; a reaction time; a verbal, a non-verbal and a procedural short-term memory; a verbal, a non-verbal and a procedural long-term memory; a language fluency and comprehension; a visuo-spatial functions; an auditory discrimination; a visual discrimination; an abstract reasoning; calculations; or two or more thereof.

12. The method of claim 1 , further comprising, based on the patient's responsiveness, instructing an external device to change an operating state thereof.

13. The method of claim 1 , wherein the test of responsiveness further comprises a test to determine a patient's capacity to perform a purposeful response.

14. The method of claim 1 , wherein the test of responsiveness includes testing at least one of a reflex, a motor, or cognitive functions of the patient.

15. The method of claim 1 , wherein at least one responsiveness parameter includes at least one of (i) a duration of a change in the patient's responsiveness; (ii) a magnitude of a change in the patient's responsiveness, (iii) a time interval from an indication of a detection of an epileptic seizure to a change in the patient's responsiveness, (iv) a type of change in the patient's responsiveness, (v) an estimation of a seizure severity; (vi) a classification of a seizure into clinical or subclinical; (vii) a classification of a clinical seizure into simple partial, complex partial, or generalized; (viii) an assessment of efficacy of a therapy for the patient's medical condition; (ix) an assessment of a state of a disease and formulation of a prognosis for the patient; (x) an estimation of a risk of injury or death for the patient; and (xi) two or more thereof.

Assignees

• Osorio Ivan
• Flint Hills Scient Llc

Inventors

• Osorio Ivan

Classifications

• A61N1/36139

  with automatic adjustment · CPC title

• A61N1/36053 Primary

  adapted for vagal stimulation (A61N1/36114 takes precedence) · CPC title

• A61N1/36185

  Selection of the electrode configuration · CPC title

• A61N1/36117

  for treating hypertension · CPC title

• A61N1/0556

  Cuff electrodes · CPC title