Neurostimulation method and system to treat apnea

Patent metadata

Field	Value
Publication number	US-9333351-B2
Application number	US-201314108161-A
Country	US
Kind code	B2
Filing date	Dec 16, 2013
Priority date	Dec 16, 2013
Publication date	May 10, 2016
Grant date	May 10, 2016

Abstract

Methods and systems are provided to deliver a neural stimulation therapy to treat apnea episodes. The methods and systems detect a respiratory pattern of a patient and identify a type associated with the respiratory pattern. A sleep stage is detected that the patient is experiencing and the method and system identify when the sleep stage warrants therapy. When the respiratory pattern corresponds to an apnea episode (AE) and the sleep stage warrants therapy, the methods and systems deliver an apnea episode terminating neuro-stimulation (AET-NS) therapy configured to terminate the AE. A type of AE therapy that is delivered may be based on the sleep stage that was detected. The methods and systems may determine whether the AET-NS therapy successfully terminated the AE, and, if not, adjust the AET-NS therapy and deliver a new AET-NS therapy.

First claim

What is claimed is:

1. A neural stimulation (NS) device for treating apnea episodes, comprising:
a respiration sensor configured to detect a respiratory pattern of a patient and to output respiratory pattern signals;
a respiration analysis (RA) module configured to determine when the respiratory pattern signals indicate an apnea episode (AE);
a sleep stage (SS) sensor configured to detect a sleep stage that the patient is experiencing and to output a SS signal;
a sleep state analysis (SSA) module configured to identify when the sleep stage warrants therapy based on the SS signal; and
a therapy module configured to deliver an apnea episode terminating neuro-stimulation (AET-NS) therapy, when the AE is detected and the sleep stage warrants therapy, wherein the AET-NS therapy is configured to terminate the AE.

2. The NS device of claim 1 , wherein the therapy module determines a type of AET-NS therapy to be delivered based on the sleep stage that was detected, wherein the AET-NS therapy is configured to shift the patient from one sleep stage to a different sleep stage.

3. The NS device of claim 1 , wherein the respiration sensor detects a new respiratory pattern following delivery of a prior AET-NS therapy, the respiration analysis module is configured to determine whether the prior AET-NS therapy successfully terminated the AE, the therapy module configured to adjust the AET-NS therapy and deliver a new AET-NS therapy when the prior AET-NS therapy was not successful in terminating the AE.

4. The NS device of claim 1 , wherein the therapy module is configured to automatically increase the AET-NS therapy when the AET-NS therapy does not successfully terminate the AE.

5. The NS device of claim 1 , wherein the therapy module is configured to automatically decrease the AET-NS therapy when the AET-NS therapy causes excessive paresthesia that wakes up the patient.

6. The NS device of claim 1 , wherein the RA module is configured to determine whether the AET-NS therapy caused paresthesia sufficient to end the AE, and the SSA module is configured to determine when the AET-NS therapy did not wake up the patient, the therapy module configured to adjust the AET-NS therapy based on whether the AET-NS therapy ended the AE and whether the AET-NS therapy woke up the patient.

7. The NS device of claim 1 , further comprising a communications input configured to communicate with an external device, the external device having a user input configured to permit the patient or a physician to enter program information to increase and decrease the AET-NS therapy.

8. The NS device of claim 1 , further comprising a transceiver to transmit from the NS device, to an external device, at least one of a number of AE occurring in a select period of time, a duration of at least one AE, a number of times that the AET-NS therapy is delivered, a count of a success rate of the AET-NS therapy, and a history of the sleep stages in which the AET-NS therapy was delivered.

9. The NS device of claim 1 , further comprising an external device with a display configured to present at least one of an AE history information, AET-NS therapy history information or termination results to a patient or physician and permitting the patient or physician to adjust the AET-NS therapy based on the at least one of an AE history information, AET-NS therapy history information or termination results.

10. The NS device of claim 1 , wherein the therapy module is configured to iteratively adjust the AET-NS therapy, under control of the patient or physician, in order to determine a select AET-NS therapy that induces a sufficient level of paresthesia to terminate the AE without fully awakening the patient.

11. A neural stimulation (NS) device for treating apnea episodes, comprising:
a respiration sensor configured to detect a respiratory pattern of a patient and to output respiratory pattern signals;
a respiration analysis (RA) module configured to determine when the respiratory pattern signals indicate an apnea episode (AE);
a sleep stage (SS) sensor configured to detect a sleep stage that the patient is experiencing and to output a SS signal;
a sleep state analysis (SSA) module configured to identify when the sleep stage warrants therapy based on the SS signal; and
a therapy module configured to deliver stimulation pulses to a nerve system of a patient when the AE is detected and the sleep stage warrants therapy, wherein the stimulation pulses are configured to terminate the AE.

12. The NS device of claim 11 , wherein the stimulation pulses are configured to induce a sufficient level of paresthesia sufficient to terminate the AE without fully awakening the patient.

13. The NS device of claim 11 , wherein the therapy module is configured to:
induce a first level of paresthesia by delivering stimulation pulses based on a first sleep stage being detected; and
induce a second level of paresthesia by delivering stimulation pulses based on a second sleep stage being detected, wherein the first and second levels of paresthesia are different.

14. The NS device of claim 11 , wherein the therapy module is configured to induce paresthesia at one or more first locations based on a first sleep stage being detected and induce paresthesia at one or more second locations based on a second sleep stage being detected, wherein the first and second locations are different.

15. The NS device of claim 11 , wherein the therapy module is configured to automatically increase at least one of an amplitude, frequency, and location of the stimulation pulses when the stimulation pulses do not successfully terminate the AE.

16. The NS device of claim 11 , wherein the therapy module is configured to automatically decrease at least one of an amplitude, frequency, and location of the stimulation pulses when the stimulation pulses cause excessive paresthesia that wakes up the patient.

17. The NS device of claim 11 , wherein the RA module is configured to determine whether the stimulation pulses caused paresthesia sufficient to end the AE, and the SSA module is configured to determine when the stimulation pulses did not wake up the patient, the therapy module configured to adjust the stimulation characteristics of the stimulation pulses based on whether the stimulation pulses ended the AE and whether the AET-NS therapy woke up the patient.

18. The NS device of claim 11 , further comprising an external device with a display configured to present at least one of an AE history information, stimulation pulses history information or termination results to a patient or physician and permitting the patient or physician to adjust the stimulation pulses based on the at least one of an AE history information, AET-NS therapy history information or termination results.

19. The NS device of claim 11 , wherein the therapy module is configured to iteratively adjust the stimulation pulses, under control of the patient or physician, in order to determine a select stimulation pulses that induces a sufficient level of paresthesia to terminate the AE without fully awakening the patient.

Assignees

• Pacesetter Inc

Inventors

• Arnold Edith
• Gupta Kritika
• Karst Edward
• Keel Allen
• Nabutovsky Yelena
• Shah Riddhi

Classifications

• A61N1/37247

  User interfaces, e.g. input or presentation means · CPC title

• A61N1/36139

  with automatic adjustment · CPC title

• A61N1/3611 Primary

  Respiration control (stimulating respiratory organs A61N1/3601) · CPC title