Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
  • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
  • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
  • A61B5/0245—Detecting, measuring or recording pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals
  • A61B5/02455—Detecting, measuring or recording pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals provided with high/low alarm devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
  • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
  • A61B5/0803—Recording apparatus specially adapted therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
  • A61B5/0809—Detecting, measuring or recording devices for evaluating the respiratory organs by impedance pneumography
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
  • A61B5/0816—Measuring devices for examining respiratory frequency
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
  • A61B5/091—Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4845—Toxicology, e.g. by detection of alcohol, drug or toxic products
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/6813—Specially adapted to be attached to a specific body part
  • A61B5/6823—Trunk, e.g., chest, back, abdomen, hip
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
  • A61B5/7271—Specific aspects of physiological measurement analysis
  • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient ; user input means
  • A61B5/7405—Details of notification to user or communication with user or patient ; user input means using sound
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient ; user input means
  • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient ; user input means
  • A61B5/7475—User input or interface means, e.g. keyboard, pointing device, joystick
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/74—Details of notification to user or communication with user or patient ; user input means
  • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays

Definitions

• This invention is directed to devices and systems for monitoring respiration. Specifically, the invention is also directed to devices and systems for monitoring reparation using impedance.
• Patient monitoring is essential because it provides warning to patient deterioration and allows for the opportunity of early intervention, greatly improving patient outcomes.
• modern monitoring devices can detect abnormal heart rhythms, blood oxygen saturation, and body temperature, which can alert clinicians of a deterioration that would otherwise go unnoticed.
• the first patient monitors were used on patients during surgery. As patient outcomes were shown to improve, monitoring of vital signs spread to other areas of the hospital such as the intensive care unit and the emergency department. For instance, pulse oximetry was first widely used in operating rooms as a method to continuously measure a patient's oxygenation non-invasively. Pulse oximetry quickly became the standard of care for the administration of general anesthetic and subsequently spread to other parts of the hospital, including the recovery room and intensive care units. The Growing Need for Improved Patient Monitoring
• Physiological scores such as the Mortality Probability Model (MPM), the Acute Physiology and Chronic Health Education (APACHE), the Simplified Acute
• Physiological Score SAPS
• TISS Therapeutic Intervention Scoring System
• Respiratory rate is recognized as a vital indicator of patient health and is used to assess patient status.
• respiratory rate alone fails to indicate important physiological changes, such as changes in respiratory volumes.
• Metrics derived from continuous volume measurements have been shown to have great potential for determining patient status in a wide range of clinical applications.
• there are currently no adequate systems that can accurately and conveniently determine respiratory volumes which motivates the need for a non-invasive respiratory monitor that can trace changes in breath volume.
• a patient's respiratory status is monitored with methods such as spirometry and end tidal C0 2 measurements. These methods are often inconvenient to use and inaccurate. While end tidal CO2 monitoring is useful during anesthesia and in the evaluation of intubated patients in a variety of environments, it is inaccurate for non- ventilated patients.
• the spirometer and pneumotachometer are limited in their measurements are highly dependent on patient effort and proper coaching by the clinician. Effective training and quality assurance are a necessity for successful spirometry. However, these two prerequisites are not necessarily enforced in clinical practice like they are in research studies and pulmonary function labs. Therefore, quality assurance is essential to prevent misleading results.
• Spirometry is the most commonly performed pulmonary function test.
• the spirometer and pneumotachometer can give a direct measurement of respiratory volume. It involves assessing a patient's breathing patterns by measuring the volume or the flow of air as it enters and leaves the patient's body. Spirometry procedures and maneuvers are standardized by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Spirometry can provide important metrics for evaluating respiratory health and diagnosing respiratory pathologies.
• ATS American Thoracic Society
• ERS European Respiratory Society
• Spirometry can provide important metrics for evaluating respiratory health and diagnosing respiratory pathologies.
• the major drawback of mainstream spirometers is that they require the patient to breathe through a tube so that the volume and/or flow rate of his breath can be measured. Breathing through the apparatus introduces resistance to the flow of breath and changes the patient's breathing pattern.
• Impedance-based respiratory monitoring fills an important void because current spirometry measurements are unable to provide continuous measurements because of the requirement for patient cooperation and breathing through a tube. Therefore, there is a need for a device that provides near- real-time information over extended periods of time (vs. spirometry tests which last a minute or less) in non-intubated patients that can show changes in respiration related to a provocative test or therapeutic intervention.
• spirometry contains systematic errors that ruin breathing variability measurements.
• Useful measurements of breath by breath patterns and variability have been shown to be compounded by airway attachments such as a facemask or mouthpiece.
• Other less intrusive techniques such as thermistors or strain gauges have been used to predict changes in volume, but these methods provide poor information on respiratory volume.
• Respiratory belts have also shown promise in measuring respiration volume, but groups have shown that they are less accurate and have a greater variability than measurements from impedance pneumography. Therefore, a system that can measure volume for long periods of time with minimal patient and clinician interaction is needed.
• Preoperative care is centered on identifying what patient characteristics may put the patient at risk during an operation and minimizing those risks. Medical history, smoking history, age, and other parameters dictate the steps taken in preoperative care.
• pulmonary function tests such as spirometry are performed which give the more information to determine whether the patient can utilize the ventilator. Chest x-rays may also be taken. However, these tests cannot be replicated mid- surgery, or in narcotized patients or those who cannot or will not cooperate. Testing may be uncomfortable in a postoperative setting and disruptive to patient recovery.
• End tidal CO2 is another useful metric for determining pulmonary state of a patient.
• the value is presented as a percentage or partial pressure and is measured continuously using a capnograph monitor, which may be coupled with other patient monitoring devices. These instruments produce a capnogram, which represents a waveform of CO2 concentration.
• Capnography compares carbon dioxide concentrations within expired air and arterial blood. The capnogram is then analyzed to diagnose problems with respiration such as hyperventilation and hypoventilation.
• Trends in end tidal CO2 are particularly useful for evaluating ventilator performance and identifying drug activity, technical problems with intubation, and airway obstruction.
• ASA Anesthesiologists
• the present invention overcomes the problems and disadvantages associated with current strategies and designs and provides new tools and methods for monitoring patients.
• the inventive device is preferably a continuous noninvasive respiratory monitor that provides quantitative and graphical information for Minute Ventilation (MV), Tidal Volume (TV), and Respiratory Rate (RR).
• MV Minute Ventilation
• TV Tidal Volume
• RR Respiratory Rate
• the device requires the clinician to perform a single point calibration with a spirometer or ventilator on each patient before using the device. Doing this step enables accurate volumetric measurement for MV and TV.
• collection of baseline data of normal breathing is required with subsequent delivery of a near-real time calculation and display of respiration (TV and MV) as a percent of the individual's normal baseline.
• TV and MV near-real time calculation and display of respiration
• the inventive device removes the need for patient-specific calibration with a ventilator or obtaining a normal baseline and enables the use of the technology for patients that are not previously on a ventilator or do not have normal breathing or cannot cooperate with collecting a normal baseline. This enables the use of the device on patients in respiratory distress or after sedation or other therapy or manipulation.
• the device Based on feedback from clinical studies accumulated over the past 3 years with extensive clinical data collection, the device removes the need for this single point calibration or normal baseline reference in the invention.
• the modification to the device allows accurate respiratory volume data to be provided to the user without the need for the single-point calibration or normal baseline reference.
• the device is a noninvasive respiratory monitor that graphically displays lung volume against time and reports Respiratory Rate, Tidal Volume and Minute Ventilation without the need for single point calibration or a normal baseline reference.
• the proposed invention consists of:
• Bioimpedance measurement system A stabilized high frequency current generator is connected to PadSet electrodes via a Patient Cable. Electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to a computing device.
• the invention utilizes a computing device which performs signal processing and calibration, and runs the graphical user interface (GUI).
• GUI graphical user interface
• the computing device takes user input from a touch screen through a virtual keyboard and mouse.
• the GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate.
• other computer systems or devices including a microprocessor such as an embedded or single-board computer, a cellular phone, or any computing device may be used.
• Electrodes An electrode set to be placed on the torso. It delivers current and records impedance measurements. In a preferred embodiment, this is a printed circuit padset with a single connector to enable easy and accurate placement.
• the device is intended for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (more than 21 years old) patients.
• the device is used for pediatric or neonatal patients.
• the device is used in the home or other ambulatory settings.
• the device is used in fitness, wellness or observation environments where the measurements would be of value to the without the input from a healthcare professional.
• the measurements from the proposed invention are used as an adjunct to other clinical information.
• the measurements are utilized for decision support, either automated or directed to healthcare professionals, care givers or the individual being measured.
• One embodiment of the invention is directed to a respiratory monitoring system.
• the system comprises a computing device and an electrode padset adapted to be coupled to a patient.
• the computing device comprises a processor, at least one graphical user interface (GUI) in communication with the processor, and at least one sensor input in communication with the processor.
• the electrode padset is couplable to the sensor input, receives an electrical signal from the computing device, and detects bioimpedance signals through the torso of the patient.
• the processor determines one or more of minute ventilation (MV), percent of MV predicted, tidal ventilation (TV), percent of TV predicted, respiratory rate (RR), and percent of RR predicted in real time based on the detected bioimpedance signals without the need for either calibration to known values or a baseline collected during normal ventilation and without patient cooperation.
• the GUI outputs the determined one or more of minute ventilation (MV), percent of MV predicted, tidal ventilation (TV), percent of TV predicted, respiratory rate (RR), and percent of RR predicted in real time.
• the system provides an indication of at least one of hyperventilation, normal ventilation, and hypoventilation.
• the system provides an indication of at least one hypoventilation, change in respiratory signal waveform, change in inspiratory expiratory ratio, and development of an inspiratory plateau, based on opioid induced respiratory depression.
• the computing device is adapted to provide continuous measurement of ventilation within one minute of entering patient demographics into the device. The demographics are preferably at least one of height, weight and gender of the patient.
• the computing device is adapted to provide continuous measurement of ventilation without the need for patient specific calibration to a ventilator or a baseline when the patient is breathing normally.
• the computing device is adapted to provide continuous measurement of ventilation as soon as the electrodes are attached to the device and without entering demographic data.
• no patient cooperation or control over the patient's breathing is required.
• no calibration of the device to a known ventilator, spirometer, or pneumotachometer reading is required.
• the computing device preferably further comprises a HR-RR cutoff filter.
• the HR-RR cutoff filter filters respiratory and cardiac signals based on a predetermined heat rate cutoff point.
• the heart rate cutoff point is one of 30, 40, 50, or 60 beats per minute (bpm).
• the heart rate cutoff point is based on at least one of patient demographics, MV or percentages of predicted MV, and the rapid shallow breathing index.
• the heart rate cutoff point is preferably entered manually or is automatically updated by the computing device.
• the HR-RR cutoff filter provides at least one of a measure of the gain of the impedance signal, a scaling factor for an absolute value of an impedance trace displayed on the GUI, an indication of a decrease in tidal volume, an indication of sedation level, and a diagnosis of respiratory disease.
• the system further comprises at least one audible or visual alarm.
• the at least one audible or visual alarm set based on at least one of patient disease state, physician assessment, clinical or treatment environment, physiologic measurements, or an external reference.
• the at least one audible or visual alarm is adaptive.
• the predicted MV is preferably calculated based on patients' height, weight, and gender.
• the predicted MV calculation further comprises at least one of patient-specific physiology, anatomy, morphology, or topology.
• the system is adapted for use on a patient who is one of awake, unconscious, alert, in extremis, intubated on a ventilator, in respiratory distress, or after sedation.
• the system is non-invasive.
• the system preferably further comprises a patient cable coupling the electrode padset to the computing device, wherein the patient cable is adapted to transmit a high frequency current to the patient via the electrode padset.
• Figure 1 A front view of an embodiment of the device of the invention.
• Figure 2 A rear view of an embodiment of the device of the invention.
• Figure 3 An embodiment of the patient cable.
• Figure 4 An embodiment of the electrode padset.
• Figure 5 An embodiment of a preferred placement of the electrode padset on the torso.
• FIGS. 6A-E Embodiments of a Graphical User Interface (GUI).
• GUI Graphical User Interface
• the proposed invention is a noninvasive respiratory monitor that graphically displays lung volume against time and reports Minute Ventilation, Tidal Volume and Respiratory Rate without the need for calibration with a ventilator, spirometer, or pneumotachometer and without the need for obtaining a normal baseline. This enables the use of the technology for patients that are not previously on a ventilator or do not have normal breathing or cannot cooperate with collecting a normal baseline.
• the proposed invention consists of:
• Bioimpedance measurement system A stabilized high frequency current generator is connected to PadSet electrodes. Electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the processing device.
• a processing device e.g. a tablet, smartphone, computer, dedicated device, microprocessor, or other computing device performs signal processing and calibration, and runs the graphical user interface (GUI).
• GUI graphical user interface
• the processing device takes user input from a touch screen through a virtual keyboard and mouse.
• the GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate.
• Electrodes An electrode set to be placed on the torso. It delivers current and records impedance measurements.
• the monitor preferably has unit dimensions of 12 inches (h) x 12 inches (w) x 6 inches (d) and a unit weight of 8 lbs, however the unit can be of another dimension.
• the length of the Patient Cable is approximately 8 feet, however the cable can be of another length.
• the length of the PadSet is adjustable to fit a wide range of patients.
• the data is collected and transmitted wirelessly to a device such as a cellphone screen, smart watch, pager, or other portable receiver.
• the user interface is preferably a display with a LED backlight, a pointing device, and/or a capacitive touchscreen.
• the device preferably has measurement accuracy as follows:
• MV Minute Ventilation
• TV Tidal Volume
• Respiratory Rate (RR) Better than 5% or one breath per minute
• the device preferably outputs an ANSI/AAMI 60601-1 compliant Patient Auxiliary Current.
• the padset components may be sterile and autoclaved or gas sterilized.
• the device itself is not intended for patient contact and is not intended to be used inside the sterile field.
• the Electrode PadSet is intended for contact with the skin for up to 24 hours.
• the Electrode Padset may be in contact with the skin for up to one week.
• the PadSet is preferably manufactured from Polyester (PE). On the PadSet, there may be foam donuts which contact the patient and are made from polyester.
• the PadSets use a biocompatible glycerin hydrogel for electrical integrity of the connection with the patient.
• the Operating Temperature Range is of the monitor is 40-90 °F and the Operating Humidity Range is 20-80% (noncondensing) with a Storage Temperature Range of -4- 149°F and a Storage Humidity Range is 20-80% (noncondensing).
• the exposed surfaces of the monitor and cables may be wiped with disinfectant.
• the display screen may be cleaned with a commercial grade cleaning solution.
• the system has a preferred Power Requirement of Input Voltage and Frequency of 100-240 V, 50/60 Hz, and Power Consumption of ⁇ 600 W.
• the device can preferably be used in the following environments: ICU, procedural sedation, monitored anesthesia care, non-operating room anesthesia, perioperative environment, operating room, general hospital floor, clinic, long term nursing facility, home, gym, rehabilitation center, or any other environment where one would want to perform respiratory monitoring.
• the proposed invention reports Low MV, which is the definition of hypoventilation (Respiratory Depression). Monitoring MV with the proposed invention helps detect Respiratory Depression.
• the proposed invention provides an indication of Respiratory Compromise.
• the MV measurement provided by the device preferably helps detect and assess
• the device preferably reports High MV, which is the definition of hyperventilation, providing insight into respiratory failure, diffusion gradient, sepsis and other conditions associated with an increased work of breathing.
• High MV is the definition of hyperventilation, providing insight into respiratory failure, diffusion gradient, sepsis and other conditions associated with an increased work of breathing.
• the device preferably provides objective data about respiratory status that may improve patient safety.
• the device preferably alerts clinicians to changes in respiratory status at the bedside or remotely.
• the device preferably provides additional respiratory information in non-intubated patients, which can enhance patient safety.
• the device preferably measures and displays one or more of a quantitative assessment of minute volume, tidal volume, advanced respiratory parameters, general respiratory status and changes in respiratory status for a patient who has had no previous respiratory monitoring.
• the patient when monitoring begins, the patient may be anywhere on the spectrum of hypoventilation, normal ventilation, hyperventilation or exhibit any of a variety of breathing patterns.
• continuous measurement of ventilation is provided within one minute of entering the patient demographics into the monitor.
• the device preferably provides continuous monitoring of ventilation as soon as the electrodes are attached to the device, with no requirement for demographic data.
• the device preferably has sufficient accuracy and ease of use, with only the entry of height, weight and gender into the device and no requirement for a baseline when the patient is breathing normally or a calibration with a measurement from a ventilator or spirometer or pneumotachometer, the device preferably provides for the first time a device that can be used when a patient is in one or more of the following clinical scenarios: is in extremis, has significant respiratory distress, has frank respiratory failure, has apneic episodes, has experienced a respiratory arrest, has experienced a cardiac arrest, has had a significant cardiac arrhythmia, has cardiac failure, is hyperventilating from sepsis, has hyperventilation due to hypoxia from a pulmonary embolism or other causes, has hyperventilation or hypoventilation from unknown causes.
• the device preferably reports Low MV, which is the definition of hypoventilation (respiratory depression, respiratory compromise).
• the device preferably identifies patients experiencing or at-risk for opioid induced respiratory depression.
• the device preferably provides an indication of a patient's basic opioid sensitivity by quantitating absolute value of MV or change in MV after an administered dose or doses of opioid, and because there is no need for collecting a baseline or calibrating, use of the device can be initiated after the opioid is administered, to assess and quantitate hypoventilation (respiratory depression, respiratory compromise).
• monitoring with the device is preferably initiated in a patient with suspected respiratory compromise or suspected opioid overdose and is monitored accurately during evaluation and/or resuscitation.
• Data from the proposed invention is used by the caregiver on a patient that has been clinically assessed to have respiratory compromise or the potential for respiratory compromise (either hypoventilation or hyperventilation) to initiate treatment and observe the effect of one or more of stimulation, positioning, opioid or benzodiazepine reversal, oxygen administration, CPAP, BiPAP, furosemide, high flow oxygen, or other respiratory therapy.
• the device preferably provides a method to risk stratify patients without the need for calibration or the collection of a baseline measurement (e.g. the 80/40 method, where patients who had sustained MV ⁇ 80 % MV PRED for more than 2 min prior to the opioid dose are considered "At-Risk" and patients who sustained MV ⁇ 40 % MV PRED for at least 2 minutes within the 15 minutes following the opioid dose are considered to have "Low MV" or be "Un-Safe”).
• the device preferably supports an 80/40 risk stratification method after a surgical procedure to help detect patients at risk for opioid induced respiratory depression without the need for a baseline prior to sedation or a calibration to the ventilator.
• this risk stratification could only be done after the patient was calibrated preoperatively with a spirometer or a normal baseline collected, or interoperatively calibrated with a ventilator.
• the invention enables the stratification to be done on any post-operative patient, where the respiratory status has been modified and often compromised by anesthetics, opioids or sedatives.
• This embodiment enables the identification of which patients are at risk for respiratory depression in the post-operative setting including the identification of patients at risk for respiratory depression on the general hospital floor.
• information as to the patient's respiratory status will be communicated to the central nursing station or phone carried by the nurse or other care giver.
• the information related to patient respiratory status and risk is communicated by a nurse call system.
• the information is relayed by any wired or wireless connection to a centralized location for independent analysis or pairing with other physiologic, demographic and laboratory information.
• the proposed invention helps identify patients at risk for opioid induced respiratory depression with greater than 70% sensitivity, greater than 75% sensitivity, greater than 80% sensitivity, more preferably greater than 85% sensitivity, and most preferably greater than 90% sensitivity.
• the proposed invention helps identify patients who will not develop opioid induced respiratory depression with greater than 70% sensitivity, greater than 75% sensitivity, greater than 80% sensitivity, greater than 85% sensitivity, more preferably greater than 90% sensitivity and most preferably greater than 95% sensitivity accuracy post operatively.
• the accuracy of the device preferably permits use without individual calibration of the device to a patient specific baseline or to a known ventilator, spirometer, or pneumotachometer reading and without the need for patient cooperation.
• the device preferably no patient cooperation or control over patient's breathing is necessary (either by the patient or external ventilator) to provide measurements of respiratory performance. This allows the monitor to be used in any patient condition (awake, alert, in extremis, intubated on a ventilator, etc.).
• the device reports not only MV, TV and RR but also a percent predicted MV based on patient size.
• patient demographics of one or more of height, weight, gender are input into the device and predicted MV calculated based on a formula such as ideal body weight or body surface area.
• the calculated MV PRED is then used to convert the measured MV based on the real-time signal of a patient's respiration to a percent of their predicted minute ventilation (%MVPRED) and provide the care giver with an indication of respiratory status that is corrected for patient size and gender and enables the establishment of protocols based on the percent of normal ventilation.
• %MVPRED predicted minute ventilation
• the device preferably identifies patients with MV ⁇ 40% as being at increased risk for respiratory depression.
• the device preferably helps measure the effectiveness of an airway maneuver during procedural sedation on respiratory status, without the need for previous calibration or baseline.
• the device preferably helps indicate the need for an airway maneuver during procedural sedation.
• the device preferably helps quantify the effect of sedatives and opioids on respiratory status during procedural sedation.
• the device preferably can accurately report minute volume, percent predicted minute volume without the need for a pre-procedure baseline or individual calibration.
• the device preferably helps quantify the effect of anesthetics on respiratory status during sedation and the implementation of the device can be initiated following delivery of a sedative or anesthetic.
• the device preferably measurements are more reliably available compared to capnography measurements during procedural sedation/monitored anesthesia care/and non-operating room anesthesia.
• the device preferably helps identify Respiratory Depression for patients receiving PCA opioids.
• the device preferably helps assess respiratory status for patients receiving PCA opioids.
• the device preferably measures the effects of benzodiazepines on respiratory status.
• the device preferably measures the effects of opioids on respiratory status and can be immediately initiated on an uncooperative patient in respiratory distress or frank respiratory failure and used to report improvement or deterioration in a quantitative way.
• the device can preferably form the basis of an individualized pain management protocol.
• the device preferably drives a drug overdose protocol and be used to evaluate the efficacy of Narcan therapy in a drug overdose, prompt additional dosing, or determine the need for intubation.
• the device preferably measures the effects of neuro muscular blockade agents on respiratory status.
• the device preferably measures the effects of anesthetics on respiratory status.
• the device preferably provides an MV measurement that is an earlier indicator of Respiratory Depression than Sp02.
• the proposed invention MV measurement has better sensitivity and reliability than capnometry when detecting Respiratory Depression.
• the device MV measurement has better sensitivity and reliability than capnometry when detecting changes in respiratory status.
• the device MV measurement has better sensitivity and specificity than respiratory rate at defining respiratory depression, hypoventilation, respiratory compromise.
• the proposed invention identifies respiratory depression in approximately 80% of patients missed by respiratory rate measurements alone in multiple environments including hospital floor, PACU, endoscopy.
• the device's truncal electrode placement preferably minimizes the incidence of nuisance alarms.
• the default filter used for the separation of cardiac and respiratory signal during the pre-processing of the impedance data in the cleared device was set at a rate of 40 bpm.
• the cardiac signal has a base frequency (heart rate) which can be lower than 40 bpm.
• respiratory rate may be higher than 40.
• customized filtering is available to allow the device to better separate respiratory and cardiac signals.
• This customized filtering can be implemented as either adaptable filter or a filter bank containing filters with various HR/RR cutoff points (e.g. 30, 40, 50, 60, etc. bpm, see figure 6E).
• the RR/HR cutoff is based on to patient size either continuously (larger patients have smaller cutoff, for example) or as a step function (e.g. adult vs pediatrics, weight based, height based, BSA based).
• the HR/RR cutoff is based on one of the selection criteria such as patient height and weight and refined by actual measurements of either HR or RR or both.
• the cutoff is based on the HR and RR and refined by patient size. In either case HR and/or expected RR for size can be manually input from an external device, or from clinical assessment or calculated from inputs of HR and RR into the device (e.g.
• the HR is determined using one or more of frequencies within the signal, difference from known RR frequency, ratio to RR frequency, and difference in size of change of impedance by HR vs RR.
• % MV predicted or MV can be used to define the HR/RR cutoff in real time (e.g.
• the proposed device could warn user to check and input correct HR if RR exceeds pre-defined limits (e.g. >35 for adults, >50 for pediatric patients, etc.) or could adjust the cutoff automatically.
• the breath detection algorithm is continuously updated with the ratio of HR to RR.
• the device preferably could use the cutoff point or HR/RR ratio or a combination of the two to determine or automatically set the gain of the impedance signal when presenting the impedance-based respiratory trace or the interval upon which the scaling (gain, or conversion factor, or scaling coefficient) of this trace is calculated.
• the relative size of cardiac signal (associated with HR as identified by the filter) can be compared to the relative size of the respiratory signal to produce a scaling factor/gain for the absolute value of the impedance trace (y-axis) when displayed on the screen.
• the relative size of the cardiac signal can be entered or estimated based on a measure of stroke volume by other means or assumed to be 70cc for an average adult or related to BSA, BMI or height, etc.
• the size of the HR signal vs RR signal or a change in the relative size of HR signal vs RR signal is preferably indicative of a general decrease in Tidal Volume in the respiratory trace and may be used to trigger changes to the breath detection algorithm optimized for smaller volumes.
• the device could use the HR/RR cutoff, or ratio of inhalation duration to exhalation duration (I/E ratio), or a combination of the two, to indicate level of sedation or diagnosis of respiratory disease.
• the duration of prolonged plateau at end-inspiration indicates opioid induced sedation (see figures 6A-C).
• the duration of the plateau is used to adjust the HR/RR cutoff.
• the duration of the breath to breath interval as defined from the end- expiration to end-expiration or the interval between the end of expiration and the beginning of inspiration.
• the device can preferably use entered TV or MV measurements (in volume sync mode) in combination with measured or entered HR and/or cardiac signal to help adjust the HR/RR filter cutoff to better differentiate RR from HR.
• both the TV and RR are entered from the ventilator, BiPAP, spirometer, pneumotachometer or another device. If MV is entered from ventilator and RR is entered from ventilator and RR is different from ventilator RR, the HR/RR filter or breath detection algorithm is adjusted.
• the device may automatically select, prompt or receive information to select a filter with a lower cutoff point to shift the transition band away from the HR, effectively placing the HR within the stop-band of the newly selected filter, improving the accuracy of the RR counting.
• MV PRED predicted MV
• MV PRED can be further adjusted to account for patient- specific physiology, anatomy, morphology, or topology.
• athletes with high BMI will have an elevated MV PRED when compared to sedentary obese patients with similar BMI.
• patients with chronic lung disease will have higher MV PRED than healthier patients of the same height, weight, and gender due to the diminished capability of their lungs to exchange oxygen and C02, thus increasing their "baseline" respiratory needs.
• the current device uses pre-defined standard alarm limits based on predicted MV calculated as a function of patients' size (height and weight).
• the alarm limits are adaptive based on one or more of: patient disease state (thyroid, diabetes, COPD, etc.), physician assessment, clinical or treatment environment (ICU, home, hyperbaric chamber, ventilator use, BIPAP use, CPAP use, use of high flow oxygen, negative pressure ventilation, alternate ventilation such as high-frequency or oscillator, ECMO, etc.), additional physiologic measurements (BP, HR, EtC02, Sp02, fluid levels, etc.) or an external reference (CPAP, ventilator, PFT test, etc.).
• patient disease state thyroid, diabetes, COPD, etc.
• physician assessment clinical or treatment environment
• ICU home, hyperbaric chamber, ventilator use, BIPAP use
• CPAP use use of high flow oxygen, negative pressure ventilation, alternate ventilation such as high-frequency or oscillator, ECMO, etc.
• additional physiologic measurements BP, HR, EtC02,
• the Wright/Haloscale Respirometer' s intended use is: the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and post-operative recovery. It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit or spontaneously breathing or mechanically ventilated patients.
• the Philips Intellivue Monitors' is intended for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities.
• the MP20, MP30, MP40 and MP 50 are additionally intended for use in transport situations within healthcare facilities. ST Segment monitoring is restricted to adult patients only.
• the transcutaneous gas measurement (tcp02 / tcpC02 is restricted to neonatal patients only. (Note: The Philips monitor can monitor many physiological variables. For this sake of this test, only the breathing frequency function is applicable.)
• the instant device uses bioimpedance measurements and calculates volume and respiratory rate values.
• the Wright/Haloscale Respirometer uses an in-line turbine to measure flow and calculates volume and flow.
• the Philips Intellivue Monitor uses impedance measurement for measuring respiration rate.
• Accuracy of measurements can be determined by clinical studies that simultaneously measure patient's ventilation with both the instant device and the Wright/Haloscale Respirometer. A stop watch was used to determine actual respiratory rate. The study was a clinical experiment because bioimpedance measurements must be conducted in a living human.
• a clinical study compared simultaneous measurements from the instant device with Basic Monitoring and the Wright/Haloscale Respirometer. (Respiratory rate was calculated using a stop watch.) Twenty subjects representing a broad range of intended patients participated in the study. (Age range: 22-80, BMI range: 18.7-41.8 with 9 female, 11 male). The study involved two sessions for each subject, an initial session in which electrodes were applied and each subject performed twenty breathing tests. Tidal volume, minute ventilation, and respiratory rate were measured simultaneously by the instant device and the Wright spirometer. Each subject returned twenty-four hours after the first session with the original electrodes still attached. A second set of twenty breathing tests were performed.
• the instant device is substantially equivalent in intended use, safety, and effectiveness to the instant device and to the Wright/Haloscale Respirometer.
• Figure 1 depicts an embodiment of a preferred device 100 of the invention.
• device 100 comprises an outer case 105 and a touch screen 110. While a touch screen is shown other forms of input devices (e.g. keyboards, mice, microphones) may be used to input information into device 100.
• Figure 2 is a rear view of device 100.
• Device 100 may additionally include input ports 115A-C, power connector 120, and pole clamp 125.
• Device 100 may additionally include audible or visual alerting systems such as speakers or lights.
• Device 100 may be capable of connecting to a local and/or wide area network either by wired connection and/or wirelessly.
• ports 115A-C are depicted device 100 may contain any number of ports.
• ports 115A-C are adapted to connect to, receive information from, and/or control peripheral devices (e.g. ventilators, EKG machines, spirometers, and other medical devices) as well as sensors.
• Ports 115A-B may all be the same type of port or may be different types of port (e.g. USB ports, proprietary ports, serial or parallel ports, fire wire ports, and ethernet ports).
• device 100 may be adapted to connect to cable 330 depicted in figure 3.
• Cable 330 is preferably adapted to couple padset 440 (depicted in figure 4) with device 100 and send signals from and to padset 440.
• Cable 330 may be a proprietary cable with proprietary connectors or may be a general-purpose cable (e.g. a USB cable).
• padset 440 may be able to communicate with device 100 wirelessly.
• Figure 5 depicts a preferred placement of padset 440 on a human torso. Other configurations and placement of padset 440 are also possible.
• Figures 6A-E depict screen shots of the graphical user interface (GUI) of device 100.
• the GUI may display a graph of the patient's breathing 650, the patient's MV and predicted MV 655 and an associated graph 657, the patient's TV 660 and an associated graph 663, and the patient's RR 665 and an associated graph 667.
• various displays within the GUI may be selectable to provide more information.
• the GUI may be customizable. For example, different data can be displayed in different locations within the GUI, more data may be added to the GUI or removed from the GUI. Furthermore, more or fewer icons may be displayed on the GUI.
• the example patient shown in figure 6A is a patient that has had no opioid effect on their respiration.
• the example patient shown in figure 6B is a patient whose respiration has plateaued due to an opioid.
• the example patient shown in figure 6C is a patient whose respiration has plateaued for a prolonged period of time due to an opioid. Additionally, figure 6C shows the cardiac signal superimposed on the respiration signal.
• Figure 6D depicts an example of a menu within the GUI the menu shown depicts choices for setting alarms due to MV/TV/RR as well as periods of No Breath Detected. These choices can be set by a care giver based on the patient being monitored or set automatically by the device based on the data received.
• the menu has an option for setting a custom RR-HR Cutoff as disclosed herein.

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• 2017
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