DEVICES AND METHODS FOR RESPIRATORY VARIATION MONITORING BY MEASUREMENT OF RESPIRATORY VOLUMES, MOTION AND VARIABILITY
First Claim
Patent Images
1. A device for assessing a patient, the device comprising:
- a sensor for acquiring a physiological signal from a patient functionally connected to a programmable element;
wherein the programmable element;
obtains a calibration coefficient;
automatically adjusts the acquisition circuitry; and
analyzes the physiological signal to provide an assessment of at least one respiratory parameter of a patient.
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Accused Products
Abstract
This invention is directed to devices and methods for assessing a patient. The devices have at least one impedance measuring element functionally connected to a programmable element, programmed to analyze an impedance measurement, and to provide an assessment of at least one respiratory parameter of the patient. Preferably the device includes electronics which aid in calibration, signal acquisition, conditioning, and filtering.
129 Citations
65 Claims
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1. A device for assessing a patient, the device comprising:
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a sensor for acquiring a physiological signal from a patient functionally connected to a programmable element; wherein the programmable element; obtains a calibration coefficient; automatically adjusts the acquisition circuitry; and analyzes the physiological signal to provide an assessment of at least one respiratory parameter of a patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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2. The device of claim 1, wherein the calibration coefficient is based on at least one of:
- bioelectrical impedance analysis of the patient, the demographic information for the patient, calculated from physiological measurements of the patient, measured ECG signals of the patient, baseline impedance levels of the patient, measurements from a spirometer, and measurements from a ventilator.
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3. The device of claim 1, further comprising one or more remote probes placed on the thorax or abdomen of the patient.
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4. The device of claim 1, wherein the at least one respiratory parameter is associated with a measurement of one or more of the patient'"'"'s respiratory rate, the patient'"'"'s respiratory pressure, the patient'"'"'s respiratory flow, the patient'"'"'s end tidal CO2, the patient'"'"'s sublingual CO2, and the patient'"'"'s intensity of respiration.
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5. The device of claim 1, wherein the at least one respiratory parameter is associated with a measurement that assesses variability, variation, or complexity in at least one of the patient'"'"'s respiratory rate, the patient'"'"'s respiratory pressure, the patient'"'"'s respiratory flow, a patient'"'"'s end tidal CO2, the patient'"'"'s sublingual CO2, and the patient'"'"'s intensity of respiration.
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6. The device of claim 1, wherein the at least one respiratory parameter is associated with a measurement of at least one of the shape of the patient'"'"'s respiratory curve, change in the shape of the patient'"'"'s respiratory curve, a respiratory curve based on the patient'"'"'s inhaled volume, a respiratory curve based on the patient'"'"'s exhaled volume, a respiratory curve based on the patient'"'"'s inhaled pressure, a respiratory curve based on the patient'"'"'s exhaled pressure, a respiratory curve based on the patient'"'"'s inhaled flow, a respiratory curve based on the patient'"'"'s exhaled flow, a respiratory curve based on motion of the patient'"'"'s chest as measured by imaging, a respiratory curve based on motion of the patient'"'"'s chest as measured by contact sensors placed on the chest, a respiratory curve based on motion of the patient'"'"'s abdomen as measured by imaging, a respiratory curve based on motion of the patient'"'"'s abdomen as measured by contact sensors placed on the abdomen, a respiratory curve based on motion of both the patient'"'"'s chest and abdomen as measured by imaging, a respiratory curve based on motion of the patient'"'"'s chest and abdomen as measured by contact sensors placed on the chest and abdomen, variation of the patient'"'"'s interbreath intervals, phase lag between the patient'"'"'s impedance and volume signal, variation of phase lag between the patient'"'"'s impedance and volume signal, and combinations thereof.
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7. The device of claim 1, wherein the at least one respiratory parameter is associated with a measurement that assesses variability, variation, or complexity at least one of the shape of the patient'"'"'s respiratory curve, change in the shape of the patient'"'"'s respiratory curve, a respiratory curve based on the patient'"'"'s inhaled volume, a respiratory curve based on the patient'"'"'s exhaled volume, a respiratory curve based on the patient'"'"'s inhaled pressure, a respiratory curve based on the patient'"'"'s exhaled pressure, a respiratory curve based on the patient'"'"'s inhaled flow, a respiratory curve based on the patient'"'"'s exhaled flow, a respiratory curve based on motion of the patient'"'"'s chest as measured by imaging, a respiratory curve based on motion of the patient'"'"'s chest as measured by contact sensors placed on the chest, a respiratory curve based on motion of the patient'"'"'s abdomen as measured by imaging, a respiratory curve based on motion of the patient'"'"'s abdomen as measured by contact sensors placed on the abdomen, a respiratory curve based on motion of both the patient'"'"'s chest and abdomen as measured by imaging, a respiratory curve based on motion of the patient'"'"'s chest and abdomen as measured by contact sensors placed on the chest and abdomen, variation of the patient'"'"'s interbreath intervals, phase lag between the subject'"'"'s impedance and volume signal, variation of phase lag between the subject'"'"'s impedance and volume signal, and combinations thereof.
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8. The device of claim 1, wherein the assessment of at least one physiological measurement of the patient comprises at least one measurement selected from the group consisting of a calculation or estimation of the patient'"'"'s viability, of the patient'"'"'s injury severity, an assessment of the patient'"'"'s likelihood of collapsing, an assessment of the patient'"'"'s likelihood of suffering respiratory failure, an assessment of the patient'"'"'s depth of anesthesia, an assessment of the patient'"'"'s drug dosage level, an assessment of the patient'"'"'s likelihood of cardiopulmonary failure, an assessment of the likelihood of equipment failure for equipment associated with treating the patient, and combinations thereof.
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9. The device of claim 1, further comprising at least one impedance measuring element having one or more remote probes, wherein the programmable element is further programmed to analyze one or more remote probe data sets collected from the one or more remote probes.
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10. The device of claim 9, wherein an impedance measurement is based on a plurality of remote probe data sets, and wherein the programmable element is further programmed or configured to enhance at least one of the plurality of remote probe data sets, or to stabilize at least one of the plurality of remote probe data sets, or to analyze each of the plurality of remote probe data sets for dynamic range and signal to noise ratio (SNR) values.
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11. The device of claim 1, wherein the at least one respiratory parameter is recorded for one of a duration of 30 seconds, continuously, intermittently, up to at least 10 of the subject'"'"'s breaths, up to at least 100 of the subject'"'"'s breaths, or up to at least 1000 of the subject'"'"'s breaths.
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12. The device of claim 1, further comprising one or more acoustic producing devices and one or more acoustic recording devices to gather acoustic measurements, wherein the acoustic measurements are used in conjunction with impedance data to increase signal to noise ratio.
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13. The device of claim 1, wherein the at least one respiratory measurement is further analyzed by a method selected from the group consisting of a linear method, a nonlinear method, an entropy method, a similarity of distributions and fractal dimensions method, a variability analysis method, a complexity analysis method, and combinations thereof.
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14. The device of claim 13, wherein the further analysis of the at least one respiratory parameter comprises correlating the at least one respiratory parameter with a predefined respiratory condition.
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15. The device of claim 1, wherein the assessment determines an index of respiratory sufficiency which is used as a diagnostic or monitoring tool.
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16. The device of claim 1, wherein the acquisition circuitry is adjusted with a ventilator or spirometer so that the assessed respiratory volume of the patient is within one of 20%, 10%, 5%, or 2% of a measured respiratory volume of a patient using a ventilator or spirometer.
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17. The device of claim 1, wherein the acquisition circuitry is adjusted using one or more of demographic, impedance, and anatomic data so that the assessed respiratory volume of the patient is within one of 40%, 30%, 20%, 10%, 5%, or 2% of a measured respiratory volume of a patient using standard spirometry or ventilator.
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18. The device of claim 1, further comprising a patient controlled analgesia system coupled to the programmable element.
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19. The device of claim 18, wherein the programmable element, based on the assessed at least one respiratory parameter, at least one of determines the effect of one or more drugs or medical interventions on the patient, provides information supporting extubating the patient, suggests extubating the patient, provides information supporting adjusting the patient'"'"'s therapies or medications, suggests adjusting the patient'"'"'s therapies or medications, provides information supporting adjusting ventilator settings, suggests adjusting ventilator settings, provides information supporting adjusting weaning the patient off ventilation, suggests weaning the patient off ventilation, provides information to assesses a patients status before, during, or after surgery or medical procedure, monitors for air leaks, monitors for improper ventilation, monitors exercise, monitors stress levels, and monitors disease or medical condition.
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20. The device of claim 1, further comprising an alarm that delivers an alert upon detection of predetermined changes in the at least one respiratory parameter or upon detection of inadequate contact with the patient.
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21. The device of claim 1, further comprising two demodulators, wherein the first demodulator filters a signal with a generator signal as a carrier and the second demodulator filters the signal with 90-degree phase rotating circuitry before demodulation.
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22. The device of claim 1, further comprising simultaneously measuring an electrocardiogram or impedance cardiography and impedance pneumography.
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23. The device of claim 1, further comprising at least one probe implanted in the body.
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24. The device of claim 1, wherein the sensor is a bipolar or tetrapolar impedance sensor with one or more measurement channels placed on the abdomen or thorax of the patient.
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25. The device of claim 24, wherein the calibration coefficient is derived from one or more of the following patient specific measurements:
- total body impedance, bioelectrical impedance measurements, average or baseline impedance on the measurement channel, ECG signal acquired at various locations, anthropomorphic measurements.
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26. The device of claim 1, further comprising adaptive electronics controlled by a microprocessor and different amplifiers, wherein the adaptive electronics maintain the gains on the different amplifiers to prevent the signal from going out of range.
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27. The device of claim 26, wherein the microprocessor tracks and adjusts the set gains at each of the amplifiers.
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28. The device of claim 1, wherein the programmable element controls, via a closed loop, at least one of a ventilator, an analgesia device, a medical device, or a therapy device.
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29. The device of claim 1, wherein the at least one respiratory measurement is combined with at least one of pulse oximety or capnography.
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2. The device of claim 1, wherein the calibration coefficient is based on at least one of:
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30. A method for assessing a patient, comprising:
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acquiring a physiological signal from a patient functionally connected to a programmable element; obtaining a calibration coefficient; automatically adjusting the acquisition circuitry; and analyzing the physiological signal to provide an assessment of at least one respiratory parameter of a patient. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57)
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31. The method of claim 30, wherein the calibration coefficient calculation is based on at least one of:
- bioelectrical impedance analysis of the patient, the demographic information for the patient, calculated from physiological measurements of the patient, measured ECG signals of the patient, baseline impedance levels of the patient, measurements from a spirometer, and measurements from a ventilator.
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32. The method of claim 30, further comprising placing one or more remote probes on the thorax or abdomen of the patient.
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33. The method of claim 30, wherein the at least one respiratory parameter is associated with a measurement of one or more of the patient'"'"'s respiratory rate, the patient'"'"'s respiratory pressure, the patient'"'"'s respiratory flow, the patient'"'"'s end tidal CO2, the patient'"'"'s sublingual CO2, and the patient'"'"'s intensity of respiration.
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34. The method of claim 30, wherein the at least one respiratory parameter is associated with a measurement that assesses variability, variation, or complexity in at least one of the patient'"'"'s respiratory rate, the patient'"'"'s respiratory pressure, the patient'"'"'s respiratory flow, a patient'"'"'s end tidal CO2, the patient'"'"'s sublingual CO2, and the patient'"'"'s intensity of respiration.
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35. The method of claim 30, wherein the at least one respiratory parameter is associated with a measurement of at least one of the shape of the patient'"'"'s respiratory curve, change in the shape of the patient'"'"'s respiratory curve, a respiratory curve based on the patient'"'"'s inhaled volume, a respiratory curve based on the patient'"'"'s exhaled volume, a respiratory curve based on the patient'"'"'s inhaled pressure, a respiratory curve based on the patient'"'"'s exhaled pressure, a respiratory curve based on the patient'"'"'s inhaled flow, a respiratory curve based on the patient'"'"'s exhaled flow, a respiratory curve based on motion of the patient'"'"'s chest as measured by imaging, a respiratory curve based on motion of the patient'"'"'s chest as measured by contact sensors placed on the chest, a respiratory curve based on motion of the patient'"'"'s abdomen as measured by imaging, a respiratory curve based on motion of the patient'"'"'s abdomen as measured by contact sensors placed on the abdomen, a respiratory curve based on motion of both the patient'"'"'s chest and abdomen as measured by imaging, a respiratory curve based on motion of the patient'"'"'s chest and abdomen as measured by contact sensors placed on the chest and abdomen, variation of the patient'"'"'s interbreath intervals, phase lag between the patient'"'"'s impedance and volume signal, variation of phase lag between the patient'"'"'s impedance and volume signal, and combinations thereof.
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36. The method of claim 30, wherein the at least one respiratory parameter is associated with a measurement that assesses variability, variation, or complexity at least one of the shape of the patient'"'"'s respiratory curve, change in the shape of the patient'"'"'s respiratory curve, a respiratory curve based on the patient'"'"'s inhaled volume, a respiratory curve based on the patient'"'"'s exhaled volume, a respiratory curve based on the patient'"'"'s inhaled pressure, a respiratory curve based on the patient'"'"'s exhaled pressure, a respiratory curve based on the patient'"'"'s inhaled flow, a respiratory curve based on the patient'"'"'s exhaled flow, a respiratory curve based on motion of the patient'"'"'s chest as measured by imaging, a respiratory curve based on motion of the patient'"'"'s chest as measured by contact sensors placed on the chest, a respiratory curve based on motion of the patient'"'"'s abdomen as measured by imaging, a respiratory curve based on motion of the patient'"'"'s abdomen as measured by contact sensors placed on the abdomen, a respiratory curve based on motion of both the patient'"'"'s chest and abdomen as measured by imaging, a respiratory curve based on motion of the patient'"'"'s chest and abdomen as measured by contact sensors placed on the chest and abdomen, variation of the patient'"'"'s interbreath intervals, phase lag between the subject'"'"'s impedance and volume signal, variation of phase lag between the subject'"'"'s impedance and volume signal, and combinations thereof.
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37. The method of claim 30, wherein the assessment of at least one physiological measurement of the patient comprises at least one measurement selected from the group consisting of a calculation or estimation of the patient'"'"'s viability, of the patient'"'"'s injury severity, an assessment of the patient'"'"'s likelihood of collapsing, an assessment of the patient'"'"'s likelihood of suffering respiratory failure, an assessment of the patient'"'"'s depth of anesthesia, an assessment of the patient'"'"'s drug dosage level, an assessment of the patient'"'"'s likelihood of cardiopulmonary failure, an assessment of the likelihood of equipment failure for equipment associated with treating the patient, and combinations thereof.
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38. The method of claim 30, further comprising placing one or more remote probes on the patient and analyzing one or more remote probe data sets collected from the one or more remote probes.
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39. The method of claim 38, wherein an impedance measurement is based on a plurality of remote probe data sets, and further comprising enhancing at least one of the plurality of remote probe data sets, or stabilizing at least one of the plurality of remote probe data sets, or analyzing each of the plurality of remote probe data sets for dynamic range and signal to noise ratio (SNR) values.
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40. The method of claim 30, wherein the at least one respiratory parameter is recorded for one of a duration of 30 seconds, continuously, intermittently, up to at least 10 of the subject'"'"'s breaths, up to at least 100 of the subject'"'"'s breaths, or up to at least 1000 of the subject'"'"'s breaths.
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41. The method of claim 30, further comprising gathering acoustic measurements, wherein the acoustic measurements are used in conjunction with impedance data to increase signal to noise ratio.
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42. The method of claim 30, wherein the at least one respiratory measurement is further analyzed by a method selected from the group comprising a linear method, a nonlinear method, an entropy method, a similarity of distributions and fractal dimensions method, a variability analysis method, a complexity analysis method, and combinations thereof.
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43. The method of claim 42, wherein the further analysis of the at least one respiratory parameter comprises correlating the at least one respiratory parameter with a predefined respiratory condition.
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44. The method of claim 30, wherein the assessment determines an index of respiratory sufficiency which is used as a diagnostic or monitoring tool.
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45. The method of claim 30, wherein the acquisition circuitry is adjusted with a ventilator or spirometer so that the assessed respiratory volume of the patient is within one of 20%, 10%, 5%, or 2% of a measured respiratory volume of a patient using a ventilator or spirometer.
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46. The method of claim 30, wherein the acquisition circuitry is adjusted using one or more of demographic, impedance and anatomic data so that the assessed respiratory volume of the patient is within one of 40%, 30%, 20%, 10%, 5%, or 2% of a measured respiratory volume of a patient using standard spirometry or ventilator.
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47. The method of claim 30, further comprising a patient controlled analgesia system coupled to the programmable element.
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48. The method of claim 47, wherein the programmable element, based on the assessed at least one respiratory parameters, at least one of determines the effect of one or more drugs or medical interventions on the patient, provides information supporting extubating the patient, suggests extubating the patient, provides information supporting adjusting the patient'"'"'s therapies or medications, suggests adjusting the patient'"'"'s therapies or medications, provides information supporting adjusting ventilator settings, suggests adjusting ventilator settings, provides information supporting adjusting weaning the patient off ventilation, suggests weaning the patient off ventilation, provides information to assesses a patients status before, during, or after surgery or medical procedure, monitors for air leaks, monitors for improper ventilation, monitors exercise, monitors stress levels, and monitors disease or medical condition.
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49. The method of claim 30, further comprising initiating an alert upon detection of predetermined changes in the at least one respiratory parameter or upon detection of inadequate contact with the patient.
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50. The method of claim 30, further comprising filtering a first signal with a generator signal as a carrier and filtering a second signal with 90-degree phase rotating circuitry before demodulation.
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51. The method of claim 30, further comprising simultaneously measuring an electrocardiogram or impedance cardiography and impedance pneumography.
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52. The method of claim 30, wherein the sensor is a bipolar or tetrapolar impedance sensor with one or more measurement channels placed on the abdomen or thorax of the patient.
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53. The method of claim 52, wherein the calibration coefficient is derived from one or more of the following patient specific measurements:
- total body impedance, bioelectrical impedance measurements, average or baseline impedance on the measurement channel, ECG signal acquired at various locations, anthropomorphic measurements.
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54. The method of claim 30, further comprising controlling adaptive electronics by a microprocessor, wherein the adaptive electronics maintain the gains on different amplifiers to prevent the signal from going out of range.
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55. The device of claim 54, wherein the microprocessor tracks and adjusts the set gains at each of the amplifiers.
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56. The device of claim 30, wherein the programmable element controls, via a closed loop, at least one of a ventilator, an analgesia device, a medical device, or a therapy device.
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57. The device of claim 30, wherein the at least one respiratory measurement is combined with at least one of pulse oximety or capnography.
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31. The method of claim 30, wherein the calibration coefficient calculation is based on at least one of:
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58. A device for assessing a patient, the device comprising:
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one or more acoustic producing devices; one or more acoustic recording devices to gather acoustic properties; and a programmable element to monitor the acoustic properties and convert the acoustic properties into acoustic data of the lungs and thorax; wherein the programmable element uses the acoustic data to estimate lung volumes. - View Dependent Claims (59, 60, 61)
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59. The device of claim 58, wherein the one or more acoustic producing devices switches between discrete frequencies or broadcasts broad spectrum noise or both.
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60. The device of claim 58, wherein the programmable element analyzes sounds produced by the patient to determine and monitor pulmonary diseases.
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61. The device of claim 58, wherein impedance data is combined with the acoustic data to diagnose or monitor diseases.
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59. The device of claim 58, wherein the one or more acoustic producing devices switches between discrete frequencies or broadcasts broad spectrum noise or both.
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62. A method of assessing a patient, comprising one or more computers:
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emitting an acoustic signal into the patient; recording the acoustic signal transmitted through the patient; monitoring the transmitted acoustic signal; determining the acoustic properties of the lung and thorax from the acoustic signal; and estimating long volumes based on the acoustic signal. - View Dependent Claims (63, 64, 65)
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63. The method of claim 62, wherein the acoustic signal switches between discrete frequencies or broadcasts broad spectrum noise or both.
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64. The method of claim 62, further comprising analyzing sounds produced by the patient to predict pulmonary diseases.
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65. The method of claim 62, wherein impedance data is combined with the acoustic data to diagnose or monitor diseases.
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63. The method of claim 62, wherein the acoustic signal switches between discrete frequencies or broadcasts broad spectrum noise or both.
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Specification
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Current AssigneeRespiratory Motion, Inc. (Senzime AB (publ))
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Original AssigneeRespiratory Motion, Inc. (Senzime AB (publ))
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InventorsFreeman, Jenny E., Panasyuk, Alexander, Panasyuk, Svetlana V., Toy, James F. IV, Lalli, Michael, Mattfolk, Alexander, Jahnke, Charles, Steiger, Nathaniel, Nagpal, Arvil, Bokhenik, Roman, Karcz, Anita
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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current600/301
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CPC Class CodesA61B 2560/0223 of calibration, e.g. protoc...A61B 2560/0238 Means for recording calibra...A61B 2562/0215 Silver or silver chloride c...A61B 5/0022 Monitoring a patient using ...A61B 5/0024 for multiple sensor units a...A61B 5/0036 including treatment, e.g., ...A61B 5/0205 Simultaneously evaluating b...A61B 5/02055 Simultaneously evaluating b...A61B 5/021 Measuring pressure in heart...A61B 5/024 Detecting, measuring or rec...A61B 5/02416 using photoplethysmograph s...A61B 5/053 Measuring electrical impeda...A61B 5/0535 Impedance plethysmography f...A61B 5/0803 Recording apparatus special...A61B 5/0809 by impedance pneumographyA61B 5/0816 Measuring devices for exami...A61B 5/087 Measuring breath flowA61B 5/091 Measuring volume of inspire...A61B 5/14542 for measuring blood gases A...A61B 5/318 Heart-related electrical mo...A61B 5/369 : Electroencephalography [EEG...A61B 5/4848 : Monitoring or testing the e...A61B 5/6823 : Trunk, e.g., chest, back, a...A61B 5/7278 : Artificial waveform generat...A61B 5/7282 : Event detection, e.g. detec...A61B 5/746 : Alarms related to a physiol...A61M 11/00 : Sprayers or atomisers speci...A61M 16/0006 : with means for creating vib...A61M 16/0051 : with alarm devicesA61M 16/026 : specially adapted for predi...A61M 16/0463 : combined with suction tubes...A61M 2016/0036 : in the breathing tube and u...A61M 2205/0238 : the material being a coatin...A61M 2205/18 : with alarmA61M 2205/3375 : Acoustical, e.g. ultrasonic...A61M 2205/3569 : sublocal, e.g. between cons...A61M 2205/3592 : using telemetric means, e.g...A61M 2205/50 : with microprocessors or com...A61M 2230/005 : Parameter used as control i...A61M 2230/06 : Heartbeat rate onlyA61M 2230/08 : Other bio-electrical signalsA61M 2230/10 : Electroencephalographic sig...A61M 2230/205 : partial oxygen pressure (P-O2)A61M 2230/30 : Blood pressure A61M2230/04 ...A61M 2230/65 : Impedance, e.g. conductivit...A61M 5/14276 : specially adapted for impla...A61M 5/168 : Means for controlling media...G16H 20/30 : relating to physical therap...G16H 20/40 : relating to mechanical, rad...G16H 40/40 : for the management of medic...G16H 40/63 : for local operationG16Z 99/00 : Subject matter not provided...