WO2007015833A2

WO2007015833A2 - Wireless apparatus for monitoring respiration

Info

Publication number: WO2007015833A2
Application number: PCT/US2006/027771
Authority: WO
Inventors: Michael Vosch
Original assignee: Telzuit Technologies, Llc
Priority date: 2005-07-20
Filing date: 2006-07-19
Publication date: 2007-02-08
Also published as: TW200726440A; WO2007015833A3

Abstract

A wireless apparatus includes a sealed housing capable of being temporarily adhered to a patient's chest. A power source provides power and a microprocessor is connected to input ports on said housing for connecting sensor outputs therein, said plurality of input ports operably connected with said microprocessor for sending sensor output signals thereto. A wireless transmitter operably associated with said microprocessor is capable of sending wireless signals containing data from the sensor output signals. A respiration sensor is positionable adjacent the nares of the patient and operably connected to an input port of said plurality of input ports to thereby send respiration sensor output signals to said microprocessor. A blood sensor effective for sensing blood oxygen saturation level through the skin of the patient is operably connected to an input port of said plurality of input ports to thereby send blood sensor output signals to said microprocessor.

Description

WIRELESS APPARATUS FOR MONITORING RESPIRATION

Related Application

This application claims priority from co-pending U.S. Application Serial No. 60/701,016, which was filed on July 20, 2005, and which is incorporated herein by reference in its entirety.

Field Of The Invention

This invention relates to medical monitoring apparatuses and, more specifically, to a wireless device for monitoring sleep apnea.

Background Of The Invention

Sleep apnea is a condition in which the affected person stops breathing for periods of time during sleep. Sleep apnea is relatively frequent in the population and may become sufficiently severe to affect the person's health or even cause unexpected death. Conditions which produce sleep apnea include cardiopulmonary obstructive disorders, anatomic changes in the respiratory airways and these may be associated with aging or other medical problems, and neurologic or neuromuscular disorders, although neurologic causes are the least frequent underlying condition of sleep apnea.

Treatment of sleep apnea depends first upon accurate diagnosis as to the severity of the problem. Such diagnosis has, typically, required that the patient be monitored during sleep at a sleep disorders center. It will be easily appreciated that for the patient, having to sleep in unfamiliar surroundings while attached to various monitors, is to say the least an uncomfortable, logistically challenging and expensive affair.

Sleep apnea affects an estimated 12 to 25 million Americans with less than twenty five percent of them being aware of it. The present wireless patch device and system will aid in making the diagnosis of this condition more convenient, less expensive, and less intrusive to the patient

Summary Of The Invention With the foregoing in mind, the present invention advantageously provides a wireless monitoring patch or relatively thin plastic panel which may be adhered to a patient's skin, preferably over the chest, for collecting physiological data that may be used to diagnose sleep apnea. The invention allows monitoring for sleep apnea in any setting chosen by the patient, for example, in the patient's home, rather than in a sleep laboratory. This monitoring flexibility enhances the likelihood of a correct diagnosis by allowing the patient to undergo monitoring in a comfortable setting of his/her own choice, rather than in the typical impersonal medical facility. As illustrated in FIGS. 1-3, which are intended to be non-limiting examples, the present invention comprises an electrode array patch having a plurality of sensor inputs. This patch may alternatively be referred to as a thin and relatively flexible plastic sheet or housing which holds or contains the components of the invention. The patch is adhered to the skin of the patient to be monitored, preferably over the patient's chest. Adhering the patch may be by a coating or adhesive disposed on a surface of the patch during manufacturing or which may be applied when preparing the patient for monitoring.

Those skilled in these medical arts will recognize that biosensors such as cardiac electrodes require making intimate contact with the patient through an uninterrupted medium capable of allowing passage of the weak electrical signals being sensed. When the present invention is employed strictly in its sleep apnea sensing mode, without cardiac electrodes, it is not necessary that the patch be adhered to the patient and it may be secured to the patient by any effective alternative means sufficient for preventing the respiration and blood sensors from being dislodged during sleep. Inclusion of cardiac electrodes in the patch will allow correlation of not only respiration data and blood oxygen saturation level, but also of cardiac rhythm data, so that a complete picture of sleep apnea may be analyzed. Furthermore, the invention may also be of use as an adjunct in studies of the sleep/dream pattern of patients, in exercise physiology studies, and in other situations where the patient's respiration may require monitoring.

Brief Description Of The Drawings Some of the features, advantages, and benefits of the present invention having been stated, others will become apparent as the description proceeds when taken in conjunction with the accompanying drawings in which:

FIG. 1 is a patch for wireless monitoring of sleep apnea according to an embodiment of the present invention;

FIG. 2 is a schematic diagram illustrating the apparatus of the invention; and

FIG. 3 illustrates the device of the present invention in use by a patient.

Detailed Description of the Preferred Embodiment The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. This invention may,, however, be embodied in many different forms and should not be construed as limited to the illustrated embodiments set forth herein. Rather, these illustrated embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. In a first embodiment, the present invention provides a wireless apparatus for monitoring respiration in a patient. The apparatus comprises a patch 10, power source 12, microprocessor 14, a plurality of input ports, a wireless transmitter 16 and antenna 18, a respiration sensor 20 and a blood sensor 22. The patch 10 is a relatively thin and flexible sealed housing having a surface capable of being temporarily adhered to a patient's chest. The power source 12 is positioned in said housing 10 for providing power and, for example, could be one or more Panasonic Br3032 batteries, or a similar battery with about 2500 hours of capacity. As shown in FIG. 1, the wireless patch 10 includes one or more batteries 12 as a power source and an electronics package which includes the components illustrated in FIG. 2, all of which are as known in the art and may be purchased as commercially available components. A microprocessor 14 is associated with said housing 10 and connected to said power source 12, the microprocessor being capable of converting sensed electrical signals into digital signals for processing. A plurality of input ports is positioned on said housing for connecting sensor outputs therein, said plurality of input ports operably connected with said microprocessor 14 for sending sensor output signals thereto. A wireless transmitter 16 is operably associated with said microprocessor 14 so as to be capable of sending wireless signals containing data from the sensor output signals. A respiration sensor 24 is positionable adjacent the nares of the patient, as shown in FIG. 3, and is operably connected to an input port 20 of said plurality of input ports to thereby send respiration sensor output signals to said microprocessor 14. A blood sensor 26 effective for sensing blood oxygen saturation level through the skin of the patient is operably connected to an input port 22 of said plurality of input ports to thereby send blood sensor output signals to said microprocessor 14.

FIG. 1 depicts a wireless patch IO according to the present invention as described above. Reference number 20 indicates an input port for the respiration sensor, which is preferably a dual thermocouple having a single output. A thermocouple suitable for this invention includes a dual thermocouple single output similar to MultiFlowT, Two Sensors-Single Channel, part number 602353 obtainable from Rochester Electro-Medical. Such a thermocouple sensor is shown schematically in use in FIG. 3, positioned adjacent the patient's nares. A thermocouple respiration sensor 24 is as known in the art and is also shown schematically in FIG. 3 adjacent the nares of the patient. Because the respiration sensor 24 preferably includes two thermocouples with one output, the thermocouples are placed to each cover one side of nares of the subject patient, so as to measure change in temperature in the air as the patient breathes in and out his/her nose. In the described apparatus, the housing 10 preferably comprises a thin plastic sheet having one or more sealed pockets for apparatus components. An adhesive may be applied to at least a portion of said housing's surface for temporarily adhering the apparatus to the patient's skin. Alternatively, at least a portion of said housing's surface may contain or be coated with a composition effective for temporarily adhering the apparatus to the patient's skin. Preferably, the respiration sensor 24 comprises one or more thermocouples effective in sensing temperature changes at the patient's nares. In the apparatus the blood sensor 24 relies on infrared sensing of oxygen saturation level in the patient's blood. More specifically, the blood sensor 24 senses blood oxygen saturation level through the patient's earlobe.

The invention further comprises an associated device (not shown) having a receiver for receiving wireless signals from said wireless transmitter. The associated device most preferably includes sufficient memory storage for recording sensor data contained in the wireless signal over a predetermined period of time and may include or consist of a relay device having a transceiver for receiving wireless signals from said wireless transmitter and for relaying data contained in said wireless signals to a remote apparatus capable of data processing, storage, display or a combination thereof, for example, to a computer network accessible over a wireless signal. The relay device may be selected from a personal digital assistant, a telephone which may be a cellular phone, or even a personal computer disposed with wireless capability. It should be understood that relaying may be either wired or wireless, or both.

Those skilled in the art will appreciate several aspects of the invention, for example, that the various electronic components should be chosen for minimum power consumption, and that the transmitters and/or transceivers may operate in the common industrial/scientific/medical range of the wireless spectrum, such as from 900-960 MHz, or others. Also, that the wireless signals may be in standard formats such as code division multiple access (CDMA), time division multiple access (TDMA), global system for mobile communications (GSM), and AMPS/ANALOG. Further, that typical gels for use in the electrodes include the well known HydraGel and SoNdGeI, both of which are trademarks for proprietary compositions of electrically conductive gels. Shown schematically in FIG. 3 is an SPO2 sensor 26 which measures percent oxygen saturation of the hemoglobin in the patient's blood. This sensor 26 is an infrared detector as known in the art, and reads directly through the patient's earlobe. A sensor which may be used in the invention is Model a220 from Hong Kong Ascend Medical Co., Ltd. Element 14 in FIG. 1 indicates an input port connector for receiving output from the SPO₂ ear clip sensor 26 which is connected thereto.

In another embodiment of the invention, as noted above, the SPO₂ ear clip sensor 26 is an infrared (IR) detector and transmitter which is used to determine the SPO₂ level of the blood. Those skilled in the art will recognize that SPO₂ is an abbreviation for the oxygen saturation level of hemoglobin. This IR transmitter/detector 26 is placed on either side of the ear lobe and reads the oxygen saturation level of hemoglobin in the circulation through the ear lobe. In this embodiment, the rest of the patch 10 functions as a heart monitor patch to allow for a full 12 lead ECG. As shown in FIG. 2, elements 28, 30, 32, 34 and 36 are either input ports for electrodes or the electrodes themselves (not shown) related to the heart monitoring functions of the present patch. The cardiac sensing electrodes are as also described in co-pending U.S. Patent Application Serial No. 10/476,437, which is incorporated herein by reference in its entirety. In this embodiment of the invention, data obtained through the respirations monitoring lead 24 and the SPO₂ lead 26, also shown in FIG. 2, may be correlated with both heart function and sleep apnea detection. FIG. 2 provides a schematic diagram of an apparatus of the invention, as well as illustrating the general method employed. The depiction of FIG. 2 shows the functional layout of the components for the present invention, as described above.

It should be understood that the wireless patch 10 of the present invention temporarily adheres to the body of the patient, preferably over the chest area, and generates a wireless signal, preferably a composite Bluetooth signal, to thereby send monitoring data to a personal digital assistant (a PDA), computer or to a cell phone for data storage and later re-transmission to a diagnostic center. The present wireless patch and system will allow doctors to perform sleep apnea studies while the patient remains at home in his/her normal environment.

In the drawings and specification, there have been disclosed a typical preferred embodiment of the invention, and although specific terms are employed, the terms are used in a descriptive sense only and not for purposes of limitation. The invention has been described in considerable detail with specific reference to these illustrated embodiments. It will be apparent, however, that various modifications and changes can be made within the spirit and scope of the invention as described in the foregoing specification and as defined in the appended claims.

Those skilled in the art will recognize that while the invention has been described in terms of its utility for monitoring for sleep apnea, the invention will also be useful in monitoring patients who may have other conditions in which an abnormal respiratory pattern may be present, or in which breathing stops, for example, sudden infant death syndrome (SIDS). Accordingly, it is intended that the scope of this invention extend to cover those conditions as well. Similarly, the invention is equally applicable to animal subjects experiencing these medical conditions and should not be limited exclusively to humans.

Claims

THAT WHICH IS CLAIMED:

1. A wireless apparatus for monitoring respiration in a patient, the apparatus comprising: a relatively thin and flexible sealed housing having a surface capable of being temporarily adhered to a patient's chest; a power source positioned in said housing for providing power; a microprocessor associated with said housing and connected to said power source; a plurality of input ports on said housing for connecting sensor outputs therein, said plurality of input ports operably connected with said microprocessor for sending sensor output signals thereto; a wireless transmitter operably associated with said microprocessor so as to be capable of sending wireless signals containing data from the sensor output signals; a respiration sensor positionable adjacent the nares of the patient and operably connected to an input port of said plurality of input ports to thereby send respiration sensor output signals to said microprocessor; and a blood sensor effective for sensing blood oxygen saturation level through the skin of the patient and operably connected to an input port of said plurality of input ports to thereby send blood sensor output signals to said microprocessor.

2. The apparatus of claim 1, wherein said housing comprises a thin plastic sheet having one or more sealed pockets for apparatus components.

3. The apparatus of claim 1, wherein an adhesive is applied to at least a portion of said housing's surface for temporarily adhering the apparatus to the patient's skin.

4. The apparatus of claim 1, wherein at least a portion of said housing's surface contains an adhesive effective for temporarily adhering the apparatus to the patient's skin.

5. The apparatus of claim 1, wherein said respiration sensor further comprises one or more thermocouples effective in sensing temperature changes at the patient's nares.

6. The apparatus of claim 1, wherein said blood sensor relies on infrared sensing of oxygen saturation level in the patient's blood.

7. The apparatus of claim 1, wherein said blood sensor senses blood oxygen saturation level through the patient's earlobe.

8. The apparatus of claim 1, further comprising an associated device having a receiver for receiving wireless signals from said wireless transmitter.

9. The apparatus of claim 8, wherein said associated device includes sufficient memory storage for recording sensor data contained in the wireless signal over a predetermined period of time.

10. The apparatus of claim 1, further comprising a relay device having a transceiver for receiving wireless signals from said wireless transmitter and for relaying data contained in said wireless signals to a remote apparatus capable of data processing, storage, display or a combination thereof.

11. The apparatus of claim 10, wherein said relay device is selected from a personal digital assistant and a telephone.

12. The apparatus of claim 10, wherein relaying may be wired or wireless.

13. A wireless patient monitoring apparatus comprising: a relatively thin and flexible panel having one or more pockets for therein containing components of the apparatus and a surface which may be temporarily adhered to a patient's chest; a power source carried by said panel; a microprocessor connected to said power source; a plurality of input ports operably connected with said microprocessor; a wireless transmitter operably linked with said microprocessor; one or more respiration sensors effective for detecting temperature variations adjacent the nares of the patient and operabiy connected to an input port of said plurality of input ports; a blood oxygen sensor effective for sensing blood oxygen saturation level through an earlobe of the patient and operably connected to an input port of said plurality of input ports; and a plurality of electrodes sufficient for sensing an electrical signal generated by the patient's heart when said plurality of electrodes is properly positioned on the patient, said plurality of electrodes operably linked with said microprocessor.

14. The apparatus of claim 13, wherein said panel comprises a thin plastic sheet having one or more compartments for apparatus components.

15. The apparatus of claim 13, wherein said panel comprises a thin plastic sheet having one or more sealed compartments containing apparatus components.

16. The apparatus of claim 13, wherein a coating is applied to at least a portion of said housing's surface for temporarily adhering the apparatus to the patient's skin.

17. The apparatus of claim 13, wherein at least a portion of said housing's surface contains an adhesive effective for temporarily adhering the apparatus to the patient's skin.

18. The apparatus of claim 13, wherein said respiration sensor further comprises one or more thermocouples effective in sensing temperature changes at the patient's nares.

19. The apparatus of claim 13, wherein said blood sensor relies on infrared sensing of oxygen saturation level in the patient's blood.

20. The apparatus of claim 13, wherein said blood sensor senses blood oxygen saturation level through the patient's earlobe.

21. The apparatus of claim 13, further comprising an associated device having a receiver for receiving wireless signals from said wireless transmitter.

22. The apparatus of claim 21, wherein said associated device includes sufficient memory storage for recording sensor data contained in the wireless signal over a predetermined period of time.

23. The apparatus of claim 13, further comprising a relay device having a transceiver for receiving wireless signals from said wireless transmitter and for relaying data contained in said wireless signals to a remote site for data display, analysis, storage or a combination thereof.

24. The apparatus of claim 23, wherein said relay device is selected from a personal digital assistant and a telephone.

25. The apparatus of claim 23, wherein relaying may be wired or wireless.