Breathing disorder detection and therapy delivery device and method

• US 8,467,876 B2
• Filed: 10/15/2003
• Issued: 06/18/2013
• Est. Priority Date: 10/15/2003
• Status: Active Grant

• Current Assignee: RMX, LLC (ASHINC Corp.)
• Original Assignee: RMX, LLC (ASHINC Corp.)
• Inventors: Tehrani, Amir J.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): ALTER, ALYSSA MARGO
• Application Number:
  US10/686,891
• Publication Number:
  US 20050085865A1
• Time in Patent Office: 3,534 Days
• Field of Search: 607/42, 607/20, 607/116, 600/534
• US Class Current: 607/42
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36132 using patient feedback

Abstract

A device and method are provided for managing the treatment of a patient with respiratory disorders or symptoms. Respiratory parameters are sensed and recorded and communicated to an external device to provide information to a patient and/or provider for further treatment or diagnosis. Also respiratory disorders such as apnea or hypoventilation may be treated by electrically stimulating the diaphragm muscle or phrenic nerve in response to a sensed respiratory parameter or characteristic.

Claims

1. A device for managing respiration patient having a sleep breathing disorder comprising:

at least one electrode in electrical communication with a diaphragm or phrenic nerve tissue of a patient'"'"'s body configured to sense respiration;

a control unit in electrical communication with the at least on electrode and whereby the control unit receives sensed respiration activity,

wherein the control unit is programmed to identify the intrinsic breathing cycle of the patient and create an intrinsic baseline profile thereof;

wherein the control unit is further programmed to generate an electrical stimulation signal in response to the sensed respiration and deliver the electrical stimulation signal through the at least one electrode to the diaphragm or phrenic nerve tissue, wherein said control unit is programmed to deliver an electrical stimulation signal comprising a burst or series of pulses during an existing inspiration to adjust the breathing cycle of said patient,

wherein the control unit is further programmed to monitor the adjusted breathing cycle of the patient, compare it against the patient'"'"'s baseline intrinsic level and when the breathing is not at a desired level, to then adjust one or more parameters of the electrical stimulation signal and provide stimulation with each breath to incrementally adjust until the breathing cycle is further adjusted to reach the desired level, and

wherein the electrical stimulation signal is configured to elicit a diaphragm response by stimulating to increase an existing inspiration duration which supplements a breath.

3. The device of claim 1 or 2 wherein the control unit is further programmed to elicit an inspiration rate different from an intrinsic inspiration rate.

4. The device of claim 1 wherein the control unit is programmed to deliver a stimulation signal to the tissue through the at least one electrode to elicit a slow elongated inspiration.

5. The device of claim 1 wherein the control unit is programmed to deliver a stimulation signal to the tissue through the at least one electrode to elicit a fast, short inspiration.

6. The device of claim 1 or 2 wherein the control unit is further programmed to deliver low level sequential stimulations.

7. The device of claim 1 or 2 wherein the control unit is configured to deliver a stimulation signal that is directed to manipulating blood gases to thereby treat disordered breathing.

8. The device of claim 1 or 2 wherein said control unit is further programmed so that when the breathing has reached the desired level, the stimulation signal is no longer delivered.

2. A device for managing respiration of a patient comprising:

at least one electrode in electrical communication with a diaphragm or phrenic nerve tissue of a patient'"'"'s body, wherein at least one of said electrodes is configured to sense respiration;

a control unit in electrical communication with the at least one electrode whereby the control unit receives respiration activity sensed by at the least one electrode,

wherein the control unit is programmed to generate an electrical stimulation signal in response to the sensed respiration and deliver the electrical stimulation signal through the at least one electrode to the diaphragm or phrenic nerve tissue, wherein said control unit is programmed to deliver the electrical stimulation signal as a burst or series of pulses during an existing inspiration to adjust the breathing cycle of said patient,

wherein the control unit is further programmed to monitor the adjusted breathing cycle of the patient and compare against the patient'"'"'s intrinsic level and to then adjust one or more parameters of the electrical stimulation signal to incrementally adjust with each breath until the breathing cycle is further adjusted to reach a desired level, and

wherein the electrical stimulation signal is configured to elicit a diaphragm response by stimulating to supplement an existing inspiration volume of a breath.