Method and apparatus for optimizing the continuous positive airway pressure for treating obstructive sleep apnea

• US 5,535,739 A
• Filed: 06/07/1995
• Issued: 07/16/1996
• Est. Priority Date: 05/07/1992
• Status: Expired due to Term

• Current Assignee: NELLCOR PURITAN BENNETT, New York University
• Original Assignee: NELLCOR PURITAN BENNETT, New York University
• Inventors: Norman, Robert G., Rapoport, David M., Gruenke, Roger A.
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): RACITI, ERIC
• Application Number:
  US08/482,866
• Time in Patent Office: 405 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23, 128/204.26, 128/205.18, 128/207.18, 128/716, 128/717, 128/718-726, 73/204.21, 73/195, 73/861.52, 73/861.61
• US Class Current: 128/204.23
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 16/0677 Gas-saving devices therefor
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/08 Other bio-electrical signals
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/62 Posture
• CPC Class Codes: A61M 39/228 with a tubular diaphragm constrictable by radial fluid force
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

In the treatment of obstructive sleep apnea a method and apparatus are disclosed for optimizing the controlled positive pressure to minimize the flow of air from a flow generator while still ensuring that flow limitation in the patient'"'"'s airway does not occur. In particular, the invention relates to a breathing device and method of use to adjust a controlled positive pressure to the airway of a patient by detecting flow limitation from analysis of an inspiratory flow waveform. Once the presence of flow limitation has been analyzed, the system determines an action to take for adjustment of the controlled positive pressure. The pressure setting is raised, lowered or maintained depending on whether flow limitation has been detected and on the previous actions taken by the system. The preferred breathing apparatus consists of a flow generator, a flow sensor, an analog to digital converter, a microprocessor, and a pressure controller, a patient supply hose, a nasal fitting, and, optionally, a pressure transducer. Using the method of the present invention, the microprocessor adjusts the air pressure in the patient supply hose when flow limitation is detected in the airway of the patient.

Claims

1. A device for detecting flow limitation in the airway of a patient, comprising:

a nasal fitting in fluid communication with the airway of a patient, said nasal fitting having an inlet and a flow restrictor positioned between the inlet and the airway of the patient;

a sensor in fluid communication with said nasal fitting at a position between said restrictor and the airway of the patient and configured to generate first data values representative of an inspiratory flow of ambient air to the patient;

a microprocessor configured to determine whether the first data values indicate a flow limitation in the patient and to generate second data values representative of a flow limitation; and

computer memory configured to store the first data values generated by said flow sensor and the second data values generated by said microprocessor.

2. The device of claim 1, further comprising a position sensor configured to generate third data values representative of the physical position of the patient, wherein said computer memory is further configured to store the third data values.

3. The breathing device of claim 1, further comprising an oximeter configured to generate fourth data values representative of the oxyhemoglobin saturation level of the blood of the patient, wherein said computer memory is further configured to store the fourth data values.

4. The device of claim 1, wherein said flow sensor is further configured to generate fifth data values representative of an expiratory flow of ambient air from the patient, and said computer memory is further configured to store the fifth data values.

5. The device of claim 1, wherein said microprocessor includes processing means for correlating the stored data values with a sinusoidal contour, analyzing the stored data values for flatness, analyzing the stored data values for respiratory effort, and analyzing the stored data values for relative flow magnitude.

6. A method for diagnosing a patient having obstructive sleep apnea, comprising the steps of:

providing a patient with a diagnostic breathing device for use at the home of a patient while the patient is asleep;

storing first data values representative of the inspiratory flow of air to the airway of the patient while the patient is using the diagnostic breathing device;

analyzing the first data values to determine the presence of flow limitation in the airway of the patient;

providing the patient with a self-adjusting therapy breathing device for use at the home of a patient while the patient is asleep;

storing second data values representative of the inspiratory flow of air to the airway of the patient and third data values representative of the pressure in the airway of the patient while the patient is using the self-adjusting therapy breathing device;

analyzing the second data values to determine the amount of flow limitation in the airway of the patient; and

providing, when the third data values indicate large pressure fluctuations, a self-adjusting therapy breathing device to the patient for use at home while sleeping.

7. The method of claim 6, further comprising the step of providing, when the third data values do not indicate large pressure fluctuations, a constant positive airway pressure breathing device to the patient for use at home while sleeping.

8. The method of claim 6, further comprising the step of referring the patient to a sleep lab when the first data values do not indicate that a flow limitation was present in the patient.

9. The method of claim 6, further comprising the step of referring the patient to a sleep lab when the second data values and the third data values do not indicate that the patient was restored to normal breathing.