Title of Invention

"BIO-MASK WITH INEGRAL SENSORS"

Abstract

A breathing mask (10) for use in monitoring a patient, providing sensors (25,26) built in to the mask (10) for ease of application to a patient such that donning the mask (10) places all the required sensors on the patient. The mask has a perimeter (12) with a soft pliable material with sensors (25) therein or contacting The patient's skin and making an airtight seal. The mask (10) also has sensors (26) on the body of the mask and on associated straps or caps. The sensors (25,26) can be used for monitoring the patient's EMG.EEG.EOG.ECG, surface blood pressure .temperature, pulse, blood oxygen .position of the patient, activity level of the patient, sounds and gas pressure in the mask (10).

Full Text

2 "Biomask with Integral Sensors" 3 6 Background of the Invention 7 8 Field of the Invention 9 10 This invention relates to a breathing mask with built in sensors for monitoring 11 patients with sleep apnea, breathing disorders for use during anesthesia or ventilation 12 support. 13 14 Description of the Related Art 15 16 Masks such as shown in patent 5,243,971 for applying a positive pressure to 17 patients with apnea and other breathing disorders have been developed. These masks 18 provide seals for preventing air from escaping from the mask at the junction of the 19 mask and face. Other types of masks for gas delivery to a patient are also in common 20 use. 21 Measuring air flows to a patient has been accomplished by metering sensors in 22 the air supply connected to the mask as in patent 5,503,146 or bv belts around the 23 patients chest to measure his breathing as in patent 5,131,399. 24 Some devices such as in patent 5,507,716 provide sensors combined with / 25 sleep masks for covering the eyes of a patient. However there is no known example of 1 sensors built into breathing masks for monitoring or studying patients with breathing 2 disorders. 3 Currently if a patient is to be carefully monitored a plurality of electrodes or 4 sensors would have to be individually applied to the patient and wired to recording 5 equipment. The plurality of sensors and tangle of ensuing wires impede the usage of 6 such monitoring equipment. Sensors providing useful information include Electro- 7 encephalogram (EEG), electromyography (EMG), electro-oculogram (EOG), electro- 8 cardiogram (ECG), Pulse Transit Time (PTT), gas flow sensors, temperature sensors, 9 microphones, blood oxygen meters, blood pressure sensors, pulse sensors, patient 10 movement, position, light, activity sensors, mask leakage, mask pressure, eye 11 movement by polyvinylidene flouride-(PVD) or Piezo, and other means of gathering 12 data about the patient or his environment. 13 It is very inconvenient for the patient and the health care worker to attach a 14 series of different devices to a patient to monitor a plurality of different parameters 15 simultaneously. Therefore a single device for easily measuring a plurality of 16 parameters is desired. 17 1 g Summary of the Invention 19 20 The invention relates to providing sensors in breathing masks to make it easy 21 to monitor a patient. The mask has a soft pliable seal material around its perimeter in 22 contact with the patient's face to form a secure seal therewith. Sensors may be 23 recessed into the soft pliable seal material at the surface for contact with the skin of 24 the user when the mask is applied to the user's face. The wiring for the sensors may 25 be inside the soft pliable seal material insulating the wires from damage during use of 1 the mask. Many sensors can be incorporated into the mask. Sensors may be placed on 2 the perimeter or on other portions of the mask not in contact with the skin. Sensors 3 may also be placed on straps or caps used in conjunction with the masks or on other 4 devices used with the mask. 5 Monitoring of patients with sleep disorders, breathing disorders or for 6 anesthesia is made easier and more convenient for the patient and for the health care 7 provider since all the sensors needed are built into a mask which is easily and quickly 8 placed on the patient with all the wiring to the sensors integral with the mask and 9 accessed by a single plug. 10 The types of sensors on or in the mask and straps or caps connected to the 11 mask include but are not limited to oximetery sensors, patient position sensors, eye 12 movement sensors, leak detection sensors, EEG, EMG, EOG, ECG, PTT, 13 microphones, pulse, blood pressure, oxygen saturation, temperature, movement 14 sensors, position sensors, light sensors, leak detection sensors and gas delivery 15 sensors. 16 Connections to outside sources of gases delivered to the mask are by a gas 17 nozzle hook up on the mask. A connection to electrical power and data output cables 18 are by a plug in to a cable connecting to the mask. Alternatively batteries in the mask 19 and telemetry equipment in the mask can provide power and transmission of the data 20 to a microprocessor or computer. For portability the microprocessor can be attached 21 to the mask or be carried by the patient. Similarly a bottle of gas may be connected to 22 the mask and carried by the patient to allow mobility of the patient while wearing the 23 mask. 24 Unique applications for the bio-mask include the capability to apply 25 anesthesia-depth monitoring while administering anesthesia gas to a subject. The 1 ability to monitor the patient non-invasively with the bio-mask while at the same time 2 administering the anesthesia gas to the patient provides a bio-feedback function for 3 immediate and responsive anesthesia depth of the subject. The bio-mask can be used 4 to determine the subject's sleep state by applying standard sleep staging criteria, such 5 as that of R&K rules and/or the application of diagnostic techniques which analyze a 6 number of EEG signals, such as Bispectral Analysis. The invention is unique in its 7 capability to apply such analysis with the minimal-invasive application of a subject 8 breathing mask. 9 R&K rules refer to "A Manual of Standardized Terminology, Technicques and 10 Scoring System for Sleep Stages of Human Subject" by Rechtschaffen and Anothony 11 Kales, Editors 1968 which is hereby made a part hereof and incorporated herein by 12 reference. 13 14 Objects of the Invention 15 16 It is an object of the invention to monitor a patient. 17 It is an object of the invention to provide data needed to help treat a patient. 18 It is an object of the invention to provide sensors for monitoring a patient in or 19 on a breathing mask or on its associated parts. 20 It is an object of the invention to regulate the flow of gasses to a patient based 21 on the data obtained from monitoring the patient. 22 It is an object of the invention to diagnose the patient based on data obtained 23 from monitoring the patient. 24 It is an object of the invention to easily and quickly apply all the sensors 25 needed for monitoring the patient. 1 Other objects, advantages and novel features of the present invention will 2 become apparent from the following detailed description of the invention when 3 considered in conjunction with the accompanying drawing. 4 5 Brief Description of the Drawings 6 7 Fig. 1 shows a schematic view of the zones for sensors on the inside surface of a soft 8 pliable material on the perimeter of the breathing mask. 9 Fig. 2 shows a view of the sensors and wiring inside the soft pliable material on the 10 perimeter of the breathing mask. 11 Fig. 3 shows a side schematic view of the sensors and the wiring inside of the soft 12 pliable material on the perimeter of the breathing mask. 13 Fig 4 shows a side schematic view of the straps connected to the mask with sensors 14 embedded in the straps and the mask. 15 Fig. 5 shows a schematic view of the sensor zones on the perimeter of the breathing 16 mask. 17 Fig. 6 shows a schematic view of the sensors on the inside surface of a breathing 18 mask. 19 Fig. 7 shows a side schematic view of the mask with sensors on the surface of the 20 mask. 21 22 Description of the Preferred Embodiments 23 24 Fig. 1 shows the inside of mask 10 including the perimeter surface 12 which 25 contacts the patient's face. The perimeter surface 12 has a plurality of zones 20. Each 1 zone 20 having a sensor 25 in a recess 29 for measuring a parameter of the patient to 2 be monitored or other data such as gas leakage. Other sensors 26 are on the mask 10 3 but not in contact with the patient's skin. These sensors 26 measure patient data or 4 related data such as ambient light, gas pressure in the mask or ambient temperature. 5 The mask 10 has a gas connector 14 for connecting a hose 32 to provide a gas to the 6 mask 10 and a mask interface connector 16 for plugging in a cable 30 for a power 7 supply and for data transmission. 8 In some embodiments of the invention the sensors 25 do not require an outside 9 source of power as the sensors such as heat sensors and light sensors generate current. 10 The mask perimeter surface 12 is preferably made out of a soft pliable 11 material such as silicone rubber for making a good sealing contact with the face of the 12 patient to prevent gas leakage. The material should be soft and pliable enough to 13 follow the contours of the face. The perimeter surface preferably has recesses 29 on 14 the surface for the insertion of sensors 25 so that the sensors can make contact with 15 the patient's skin when the mask is pressed against the patient's face. 16 As seen in Fig. 3 a sensor or electrode 25 attachment to the mask 10 preferably 17 utilizes a rubber compound 28 such as silicon or other food grade type rubber 18 embedded with carbon or other conductive materials for electrical contact of skin to 19 the mask. As shown in Fig. 2 the recesses 29 are large enough to have room to make 20 electrical connections to leads 27, which are buried in the soft pliable material under 21 the perimeter surface 12. The leads 27 are thus protected from damage and electrically 22 insulated. Preferably the sensors 25 will plug into the leads 27 or printed circuits in 23 the recesses 29. The leads 27 are preferably on printed circuits embedded in the mask 24 or fine wires embedded in the mask and connect the sensors 25 to the mask interface 25 connector 16. 1 Fig. 5 shows conductive material 40 on the surface in zones 20, such as carbon 2 embedded silicon, can be used on the surface of the perimeter 12 of mask 10 in 3 separate zones 20 to conduct the electrical surface energy from the patient's face. The 4 conductive material 40 is preferably moisture activated to improve the its electrical 5 conductivity when in contact with the skin. The conductive material 40 may be 6 applied for all electrode 25 contacts in all zones 20. Alternatively electrodes 25 may 7 directly contact the patients face. The electrodes may also be inside of the soft pliable 8 material on the perimeter 12 of the mask 10. 9 Fig. 4 shows a side view of the mask 10 and straps 35 used to keep the mask 10 in place on a patient. The straps 35 have sensors 25 connected to leads 27, which 11 connect the sensors to the mask interface connector 16 and to cable 30 for 12 transmitting data to a computer or other device. The sensors 25 in the straps 35 may 13 be electro-encephalogram EEG sensors for measuring brain waves. The straps 35 may 14 be replaced with a cap having sensors therein. Alternatively a chin strap 37 may be 15 used having sensors 25. 16 Fig. 5 shows an example of the types of sensors 25 used in zones 20 around 17 the perimeter of the mask 10. Physiological signals from a patient's skin potential are 18 detected by sensors in the zones 20 around perimeter 12 of mask 10. Conductive 19 electrode paste 40 may be used to improve the electrical contact between the sensors 20 25 and the surface of the skin. The conductive paste 40 can assist in reducing the 21 impedance between the face and the electrical output from the sensors 25 in zones 20. 22 The conductive paste 40 may also assist in preventing gas leaks. 23 As an example of a mask sensor layout the following sensors and their 24 functions are described. However many other types of sensors and arrangements of 25 the sensors are possible. 1 Zone 50 is an electro-oculogram (EOG) to obtain electrical eye movement 2 reference signals from over the bridge of the nose. 3 Zone 51 is an EOG to detect electrical eye movement signals for the inner left 4 eye and zone 61 is designated for electrical eye movement signals for the inner right 5 eye. Eye movement data is related to stages of sleep such as rapid eye movement 6 REM, which indicates a deep sleep state and dreaming. 7 Zone 52 is designated for an EOG to detect electrical eye movement signals 8 for the outer left eye and zone 62 is designated for electrical eye movement signals for 9 the outer right eye. 10 Zone 53 is designated for electro-myography (EMG) to detect electrical l ] signals from muscle contractions in the upper left chin. Zone 63 is correspondingly 12 for the upper right chin. Zones 54 and 64 are for the lower left and lower right chin 13 respectively. The amplitude of the chin signals is proportional to the relaxation state 14 and subsequent sleep state of the patient. 15 Zone 55 is the EMG for the upper left lip, giving information about sleep 16 stages. It is proportional to the relaxation and sleep states of the patient. Zone 65 is the 17 EMG for the upper right lip. l g Zone 56 is the EMG for the left nasal inner mask it also provides signals for 19 the lip movements and is proportional to the relaxation and sleep states of the patient. 20 Similarly zone 66 is for the right nasal inner mask EMG. 21 Zones 57 and 67 are for the oral left and oral right outer mask EMG signals 22 which are also proportional to the relaxation and sleep states of the patient. 23 Zone 70 is for pressure sensor ports for airflow determination. 24 Microphone 80 on the mask detects the patients breathing or snoring sounds. 1 Fig. 6 shows an alternate embodiment where two sensors 58 and 68 are used 2 to find the patient's electrocardiogram ECG. This data is also useful for monitoring a 3 patient. The patient's heart functions provide a lot of useful data about the patient's 4 condition. Pulse Transit Time (PTT) is the time it takes ECG pulses to travel from the 5 heart to a sensor such as a sensor placed on the head, on a finger tip, or on the ear. 6 PTT sensors can be in the mask, on sensors connected to the mask, or sensors used in 7 conjunction with the mask. PTT measurements are used to determine patient arousals 8 and qualitative blood pressure variation. 9 Thermal sensor 81 is used on the inside surface of the mask to detect nasal 10 breathing. Thermal sensor 82 is used on the outside surface of the mask to detect oral 11 breathing. The thermal sensitivity of the sensors 81 and 82 on the surface of the mask 12 10 opposite the nose or mouth indicates if the patient is breathing through his nose or 13 mouth. The thermal sensors 81, 82 may alternatively be placed on the inside of the 14 mask 10, on the outside of the masklO, or inside of the material of mask 10 for 15 detecting breathing. The thermal sensors 81, 82 may be a thermistor material, a 16 thermocouple material or any other temperature sensitive material. The thermal l? sensors 81, 82 may be coatings on the inside of the mask, the outside of the mask or in 18 the mask. The thermal sensors 81, 82 detect heat, which is proportional to the amount 19 of breathing. 20 It is important to detect oral breathing for undetected or partially undetected 21 oral breathing effects the integrity of the patient breathing gas breath monitoring and 22 subsequently compromises the idea gas delivery to the patient. It is important to detect 23 mouth breathing to assist in diagnosis of sleep disordered breathing. Further, control 24 of a mask nasal ventilation is effected by mouth breathing. ! A pressure sensor 84 measures the pressure inside of the mask to indicate if 2 there is positive pressure inside of the mask and how much. A pressure drop may 3 indicate a leak. 4 A surface reflective oximetry sensor 85 on the inside of the mask detects the 5 patients pulse rate and oxygen saturation. 6 A surface blood pressure sensor 90 on the perimeter 12 of the masklO in 7 contact with the patient can be used to monitor the patients blood pressure. 8 A thermistor 91 on the perimeter 12 of the mask 10 in contact with the patient 9 can be used to monitor the patients temperature. 10 A patient recycled air detection system having a sensor 95 on the inside 11 surface of the mask detects the amount expired air from the patient remaining in the 12 mask 10. High levels of expired gas in the mask indicates the mask is not being 13 flushed out and may lead to problems if not enough fresh gas is introduced. 14 A patient back gas occurrence detector 97 in the mask hose connector 14 15 detects the amount of expired gas in the mask returning with newly delivered gas. 16 Fig. 7 shows thermal sensors 83 such as thermistors or thermocouples on the 17 inside or outside of the mask adjacent the perimeter 12. These sensors can be attached 18 to a thermally conductive material 92 around the perimeter of the mask 10. 19 Alternatively the thermally conductive material may be on portions of the perimeter. 20 This thermally sensitive material can be on the inside surface of mask 10, the outside 21 surface of mask 10 or embedded within the mask material. Detection of a temperature 22 change by thermal sensors 83 or thermal sensors 83 on thermally conductive material 23 92 correlates with mask leakage around the perimeter. The thermally sensitive 24 material may be a thermally sensitive material in the mask on the inside of the mask, 25 on the outside of the mask or on the perimeter of the mask. The thermally sensitive 1 material may be a thermistor, a thermocouple, or any other thermally sensitive 2 material. 3 Gases leaking from the mask 10 will cause a temperature change associated 4 with the thermally conductive material 92 and sensors 83 and allow a healthcare 5 specialist real-time monitoring of leak status or post monitoring status of mask 6 leakage. In some instances this can be life saving where a patient's gas delivery is 7 critical and in other cases the leakage incidence can assist in the diagnosis of a patient. 8 This assistance may be in the form of alerting a health care specialist that the gas 9 delivery was subject to leakage and this may affect patient treatment and patient 10 diagnostic conditions. In other instances the gas leakage detection can allow the gas ] i delivery system to automatically compensate for the gas leakage. 12 A light sensitive resistor 86 on the outside surface of the mask 10 indicates the 13 ambient lighting conditions of the patient. 14 Position sensors 87 indicate position or activity of the patient. For example 15 these sensors show if the patient is lying down and is motionless. Such a sensor may 16 be a moving ball across switch contacts, or mercury sensor switches. 17 Body movement sensor 88 can be a PVD or piezo material or micro 18 mechanical to detect the patients body movements extent and rate to determine a 19 wake versus rest state. 20 All of the above sensors may send data by telemetry rather than by cable 30. 21 All of the above collected data may be used to monitor a patient for a variety 22 of uses including sleep studies, anesthesia and sleep apnea. 23 The data collected can be converted to a serial data stream to allow a single 24 wire to interface all the sensors. The sensors may provide data to adjust gas delivery 25 to the patient. 1 Gain and filtering adjustments to the signals may be used to condition the 2 signals close to source for optimal noise and signal performance. 3 An electrical bias to sensors such as a patient position sensors, thermal 4 conductive zones, microphones, or light dependent resistor may be applied. 5 A computer may process the data or simply store the data to from the 6 monitoring sensors in the mask or straps attached thereto. The monitoring data may be 7 used to diagnose a patient, provide feedback to machines attached to the patient, 8 increase or decrease air supplies to a patient or perform other functions. 9 An example of EEG data controlling in a bio-feedback application the delivery 10 of gas to a patient may be when a patient has a nasal ventilation device such as a 11 ventilator Continuous Positive Air Pressure (CPAP), Bi-Positive Air Pressure 12 (BIPAP), Variable Positive Air Pressure (VPAP), Sleep Linked Positive Air Pressure 13 (SPAP) and the EEG electrodes provide one of the vital signs of if the patient is 14 asleep. Gas is only applied to the mask when the patient is deemed to be asleep. This 15 function is more sophisticated, sensitive to patient comfort and commercially viable 16 than delay ramp systems used on some ventilation systems. 17 hi ventilation devices that use delay ramps the user sets a time of the system 18 allocates a time and ramps up the gas pressure delivery to the patient so that the 19 application of gas does not have as much disturbing affect on the user and adversely 20 effect his ability to sleep. 21 The sensors in the mask 10 are better able to determine when the patient is 22 actually asleep before applying assisted nasal ventilation. Premature application of 23 pressure can prevent the patient from sleeping due to the added discomfort of positive 24 pressure. 1 The mask 10 may be made such that it is a sterile disposable unit for medical 2 use thus lowering costs of treatment by not needing to sterilize masks for new patients 3 and providing a more sterile treatment than reusable masks. 4 Obviously, many modifications and variations of the present invention are 5 possible in light of the above teachings. It is therefore to be understood that, within 6 the scope of the appended claims, the invention may be practiced otherwise than as 7 specifically described. 8 What is claimed is: We claim : 1. A breathing mask for monitoring a patient during gas delivery comprising; a body having an internal surface, an external surface, and a perimeter surface shaped to form a seal around the patient's nose and mouth; and at least one EEG sensor extended from the mask and positioned to detect brain activity. 2. The breathing mask as claimed in claim 1, wherein the perimeter surface is adapted to detect muscle activity. 3. The breathing mask as claimed in claim 1, wherein the perimeter surface is adapted to detect ECG. 4. The breathing mask as claimed in claim 1, and further comprising a flow sensor connected to the internal surface. 5. The breathing mask as claimed in claim 1, further the comprising an oxygen saturation sensor extended from the mask. 6. The breathing mask as claimed in claim 1, wherein the perimeter surface is adapted to detect eye movements. 7. A nasal ventilation mask comprising; a body having an internal surface, an external surface, and a perimeter surface adapted to form seal around a patient's nose, an airhose extending from the body; and at least one EMG sensor connected to the body and positioned to detect muscle activity relating to a sleep state. 8. The mask as claimed in claim 7, and further comprising a first sensor positioned on the internal surface for detecting nasal breathing and a second sensor positioned on the external surface for detecting oral breathing. 9. The mask as claimed in claim 8, wherein the first and second sensors are thermal sensors. 10. The mask as claimed in claim 7, and comprising at least one EEG sensor positioned on the perimeter surface. 11. The mask as claimed in claim 7 and comprising at least one EOG sensor positioned on the perimeter surface. 12. The mask as claimed in claim 7 wherein a portion of the perimeter surface is comprised of a conductive carbonized rubber material. 13. The mask as claimed in claim 7 and comprising a plurality of straps coupled to the body, the straps having at least one sensor positioned thereon. 14. The mask as claimed in claim 7 and comprising a position sensor coupled to the body. \5. The mask as claimed in claim 7 and comprising a microphone coupled to the body. 16. The mask as claimed in claim 7 wherein the perimeter surface is adapted to sense air leaks. 17. The mask as claimed in claim 7, and further comprising a patient recycled air detection system positioned on the internal surface. 18. A nasal ventilation mask assembly comprising: a nasal mask adapted to form a seal around a patient's nose; an EEG sensor coupled to the mask so as to be positioned on a patient's forehead upon application of the nasal mask. 9. The mask as claimed in claim 18 and comprising a computer in communication with the sensors, the computer adapted to determine arousal. 20. The mask as claimed in claim 18 and comprising a computer in communication with the sensors, the computer adapted to determine sleep-state. 21. The mask as claimed in claim 18 and comprising an EMG sensor coupled to the nasal mask. 22. A breathing mask for monitoring a patient during gas delivery comprising; a body having an internal surface, an external surface, and a perimeter surface shaped to form a seal around the patient's nose and mouth; and at least one CEG sensor coupled to the body so as to be positioned on a top portion of a patient's head upon application of the body to a patient. 23. A breathing mask for monitoring a patient during gas delivery comprising; a body having an internal surface, an external surface, and a perimeter surface shaped to form a seal around the patient's nose and mouth; and at least one EEG sensor coupled to the body so as to be positioned on a patient's forehead upon application of the body to a patient. 24. A breathing mask for monitoring a patient during gas delivery substantially as herein described with reference to the foregoing description and accompanying drawings.

Documents:

in-pct-2002-00604-del-abstract.pdf

in-pct-2002-00604-del-claims.pdf

in-pct-2002-00604-del-correspondence-others.pdf

in-pct-2002-00604-del-correspondence-po.pdf

in-pct-2002-00604-del-description (complete).pdf

in-pct-2002-00604-del-drawings.pdf

in-pct-2002-00604-del-form-1.pdf

in-pct-2002-00604-del-form-19.pdf

in-pct-2002-00604-del-form-2.pdf

in-pct-2002-00604-del-form-3.pdf

in-pct-2002-00604-del-form-5.pdf

in-pct-2002-00604-del-gpa.pdf

in-pct-2002-00604-del-petition-137.pdf

in-pct-2002-604-del-Form-16-(30-03-2012).pdf