Classifications

• • 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 for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/024—Measuring pulse rate or heart rate
  • A61B5/02405—Determining heart rate variability
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring blood gases
• • 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
  • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
• • 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
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes with alarm devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2503/00—Evaluating a particular growth phase or type of persons or animals
  • A61B2503/04—Babies, e.g. for SIDS detection
  • A61B2503/045—Newborns, e.g. premature baby monitoring
• • 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 for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/024—Measuring pulse rate or heart rate
  • A61B5/02416—Measuring pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
• • 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
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2202/00—Special media to be introduced, removed or treated
  • A61M2202/02—Gases
  • A61M2202/0208—Oxygen
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/18—General characteristics of the apparatus with alarm
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/27—General characteristics of the apparatus preventing use
  • A61M2205/273—General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
  • A61M2205/502—User interfaces, e.g. screens or keyboards
  • A61M2205/505—Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
  • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
  • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2230/00—Measuring parameters of the user
  • A61M2230/005—Parameter used as control input for the apparatus
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2230/00—Measuring parameters of the user
  • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
  • A61M2230/06—Heartbeat rate only
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2240/00—Specially adapted for neonatal use

Definitions

• ANS function is measured to inform clinicians as to optimal supplemental oxygen dosing facilitating environmental adaption after preterm birth while minimizing toxicity from overdosing that may be occurring with the current strategy of uniformly targeting higher saturation ranges.
• oxygen saturation for preterm infants is dynamically targeted by monitoring the HRV and/or measuring the PRM in a preterm infant and adjusting an oxygen saturation target range for the preterm infant. It will be appreciated that adjusting the oxygen saturation target range is or can be based on the HRV measurement and/or PRM. In various embodiments, the HRV measurement and/or PRM is evaluated against a pre-established threshold, and if the HRV measurement and/or PRM meets or exceeds the pre-established threshold, the oxygen saturation target range is adjusted.
• Figs.1 and 2 are flow diagrams illustrating exemplary methods in accordance with embodiments of the present disclosure.
• Fig.3 is a schematic diagram of an exemplary system in accordance with embodiments of the present disclosure.
• Fig.4 is a schematic diagram of an exemplary device or machine upon which one or more aspects of embodiments of the present disclosure can be implemented or run.
• Figs.5 and 6 are flow diagrams illustrating exemplary methods in accordance with embodiments of the present disclosure.
• Detailed Description of Embodiments The foregoing and other aspects of the present disclosure will now be described in more detail with respect to the description and methodologies provided herein. It should be appreciated that the disclosure can be embodied in different forms and should not be construed as limited to the embodiments set forth herein.
• adjusting the oxygen saturation target range is or can be based on the HRV measurement.
• the method can optionally determine if the HRV measurement meets or exceeds a pre-established threshold, as at 54 and indicated in dashed lines. If the HRV measurement does not meet or exceed a pre-established threshold, the method returns to 50. If the HRV measurement meets or exceed a pre-established threshold, the method proceeds to 52. In various embodiments, the method can further optionally re-adjust the oxygen saturation range, for example, based on an alert conveying the oxygen saturation target range, and/or at regular time intervals based on the HRV measurement, as indicated in dashed lines at 56.
• the patient’s probability of the outcome can be multiplied by a benefit or utility associated with the outcome, and the quantities can be summed separately for low and high oxygen saturation target range groups.
• the oxygen saturation target range can be selected that maximizes the total utilities or benefits associated with the predicted outcomes.
• a benefit associated with certain healthcare related outcomes is a Quality Adjusted Life Year (QALY), and the calculations would be similar to those above for costs and would finish with selecting the oxygen saturation target range that maximizes expected QALYs.
• a linear interpolation can be used to estimate the probability of some or all of the morbidities associated with oxygen saturation target ranges that lie on a continuum.
• the monitoring device 12 may communicate raw measurements over the network 20 to a personal computing device 18, wherein the personal computing device 18 employs a processor and programming to establish thresholds, conduct determinations and issue one or more alerts based on the determinations in accordance with the present disclosure.
• the oxygenation device 14 employs a processor and programming to establish thresholds, conduct determinations, issue alerts and mechanically or electronically operate and adjust supplemental oxygen and/or oxygen saturation range on ventilation device 16 in accordance with the present disclosure.
• the oxygenation device 14 and/or ventilation device 16 can provide a bedside display of real-time PRM to inform dynamic prescribing of oxygenation saturation targets during the administration of supplemental oxygen in accordance with the present disclosure.
• the network 20 can be a local area network (LAN), a wide area network (WAN), a public network such as the Internet, or a private network.
• the devices 12, 14, 18 and/or system/device 22 are configured to connect to the network 20 or remote communications link in any suitable manner. In various embodiments, such a connection is accomplished via: a conventional phone line or other data transmission line, a digital subscriber line (DSL), a T-1 line, a coaxial cable, a fiber optic cable, a wireless or wired routing device, a mobile communications network connection (such as a cellular network or mobile Internet network), or any other suitable medium.
• system/device 22 is an online-accessible cloud portal or server.
• one or more computer systems or one or more hardware processors can be configured by software to perform certain operations as described herein.
• the device 100 can be a classic von Neumann computer architecture wherein instructions 124 are stored in non-volatile memory 106 and then loaded into a microprocessor 102.
• the volatile memory 104 can be used as temporary storage (i.e., a cache), to improve performance.
• Communication between the various subsystems in the device 100 is accomplished by a shared communications bus 108.
• the instructions 124 cause the microprocessor 102 to effect one or more aspects of the present invention.
• Examples of device 100 include devices 12, 14, 16, 18 and 22 in Fig.3.
• another exemplary method dynamically targets oxygen saturation for preterm infants.
• the method includes, as at 80, monitoring, via a monitoring device such as device 12 in Fig.3, the heart rate in a preterm infant.
• PRM in the preterm infant is determined.
• an oxygen saturation target range for the preterm infant is adjusted. It will be appreciated that measuring the pulmonary resilience is or can be based on the HRV measurement. It will further be appreciated that adjusting the oxygen saturation target range is or can be based on the PRM.
• the method can optionally determine if the PRM meets or exceeds a pre-established threshold, as at 84 and indicated in dashed lines.
• the method returns to 80. If the PRM meets or exceed a pre-established threshold, the method proceeds to 86.
• additional variables such as gestational age, birth weight, sex, maternal factors (e.g., race/ethnicity, antenatal steroid use, etc.), concomitant medications and interventions, and comorbidities, can be employed along with PRM measurements to assess oxygen saturation target range.
• the present disclosure contemplates a variety of different systems each having one or more of a plurality of different features, attributes, or characteristics.
• one or more thresholds can be established for monitored conditions. When a measurement threshold is matched or exceeded, an alert can be generated. In various embodiments, alerts take the form of detected event communications indicating a met or exceeded threshold. The alert can provide a recommended course of action, for example. In various embodiments, the alert can provide instructions to an autonomous device to take instructed action. As examples of the above, the device can be set to issue an alert in the form of a detected event communication when the received monitoring data exceeds a pre-established threshold for the device. The device can issue a detected event communication when the threshold is exceeded at a specific time, or over a set period of time, for example.
• the presently disclosed device and system can be connected to a cloud-based program where the generation and dissemination of alerts such as detected event communications is performed.
• a multitude of devices according to the present disclosure can be displayed on a map or building location such as a NICU to provide relative location on a building floor plan, for example.
• the monitoring device 12 can be securely configured and monitored via a cloud-based portal such as a system 22, which may be hosted by a third party, for example. Connections to the portal can be established via HTTPS, for example. Administrators can edit device settings, define sensor thresholds and create and edit event rules to trigger other applications and devices, for example. Account settings control groups, individual users and permissions to define who has access to the portal account.
• An account can contain maps for multiple buildings or locations, so all devices can be managed through a single login.
• a processor need not be placed or secured within the monitoring device.
• raw data collected via the monitoring device and/or system as described herein can be transmitted to a cloud-based portal (e.g., 22) and the processing and subsequent actions can thereby be performed remotely.
• the system can operate so as to receive data from one or more monitors or measuring devices, process the data such as by performing determinations, calculations and other analysis as described herein, assess whether an applied threshold has been met, and if a threshold has been met, trigger appropriate actions, such as alerts, communications and other actions as described herein.
• the system can further learn from and improve operations via a learning and/or neural network according to various embodiments.
• a display associated with a computing device such as 12, 14, 18, 22 can display event indicators if one or more defined thresholds is triggered.
• the processor of the monitoring device is configured to execute the events, messages, or commands represented by such data or signals in conjunction with the operation of the monitoring device. It will be appreciated that any combination of one or more computer readable media may be utilized.
• the computer readable media may be a computer readable signal medium or a computer readable storage medium.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Physics & Mathematics (AREA)
• Veterinary Medicine (AREA)
• General Health & Medical Sciences (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Public Health (AREA)
• Engineering & Computer Science (AREA)
• Animal Behavior & Ethology (AREA)
• Molecular Biology (AREA)
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• Medical Informatics (AREA)
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• Cardiology (AREA)
• Physiology (AREA)
• Optics & Photonics (AREA)
• Emergency Medicine (AREA)
• Pulmonology (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• Medical Treatment And Welfare Office Work (AREA)

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• 2023
  • 2023-06-06 EP EP23736519.2A patent/EP4536069A1/de active Pending
  • 2023-06-06 JP JP2024573431A patent/JP2025522423A/ja active Pending
  • 2023-06-06 WO PCT/US2023/024530 patent/WO2023244462A1/en not_active Ceased
  • 2023-06-06 CN CN202380045715.6A patent/CN119277988A/zh active Pending
  • 2023-06-06 CA CA3259021A patent/CA3259021A1/en active Pending
  • 2023-06-06 KR KR1020257001151A patent/KR20250022830A/ko active Pending
  • 2023-06-06 AU AU2023295185A patent/AU2023295185A1/en active Pending

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