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EP-4493244-B1 - AN APPARATUS FOR VENTILATING A PATIENT OR TREATING A PATIENT EXPERIENCING RESPIRATORY DISTRESS

EP4493244B1EP 4493244 B1EP4493244 B1EP 4493244B1EP-4493244-B1

Inventors

  • Harvey, Brian P.
  • WONG, Aaron S.
  • COCHRAN, Jack E.
  • BECK, GEORGE
  • LECROY, DORIAN
  • CHANEY, Tyler R.
  • HUDAK, Jesse A.
  • PETTYS, RICHARD L.
  • SOLAREWICZ, Konrad S.
  • AJAZ, RIZWAN
  • SMOOT, David J.

Dates

Publication Date
20260506
Application Date
20230316

Claims (15)

  1. An apparatus for ventilating a patient or treating a patient experiencing respiratory distress, the apparatus comprising: a portable ventilator (900, 2364), comprising: a housing (902); a mechanical ventilation apparatus, disposed within the housing, for providing mechanical ventilation to the patient, comprising: a gas flow generator (912, 1053) disposed within the housing, and a gas delivery apparatus (910), disposed at least partially within the housing, coupled with the gas flow generator, the gas delivery apparatus comprising: a rigid pneumatic manifold (1050), comprising an exhalation channel and an inhalation channel, configured to couple with a breathing circuit extending from the housing and configured to interface with the patient at least in part for delivery of gas to the patient, and at least one electrical circuit board (1052), comprising at least one pressure sensor and at least two flow sensors comprising a first flow sensor and a second flow sensor, the at least one electrical circuit board being fixedly joined with the pneumatic manifold such that the first flow sensor is capable of measuring a first gas flow rate through the exhalation channel and such that the second flow sensor is capable of measuring a second gas flow rate through the inhalation channel; and a controller (918), disposed within the housing, the controller comprising a processor (920) and a memory (916), the controller being configured to control the mechanical ventilation apparatus of the portable ventilator in providing the mechanical ventilation to the patient.
  2. The apparatus of claim 1, wherein the at least one pressure sensor (914) comprises a first pressure sensor and a second pressure sensor, and wherein the at least one electrical circuit board is configured such that the first pressure sensor is capable of measuring a first gas pressure through the exhalation channel and such that the second pressure sensor is capable of measuring a second gas pressure through the inhalation channel.
  3. The apparatus of claim 1, wherein the at least one pressure sensor (914) comprises a first, a second, a third and a fourth pressure sensor, and wherein the at least one electrical circuit board is configured such that the first and second pressure sensors are capable of measuring a first gas pressure through the exhalation channel and such that the third and fourth pressure sensors are capable of measuring a second gas pressure through the inhalation channel.
  4. The apparatus of claim 1, wherein the at least one electrical circuit board and the pneumatic manifold are configured so as to be joined so as to create a fixed but flexible gas leak-free seal between the pneumatic manifold and at least one pressure sensor and between the pneumatic manifold and each of the at least two flow sensors.
  5. The apparatus of claim 4, wherein one of: the fixed but flexible gas leak-free seal comprises at least one O-ring; the fixed but flexible gas leak-free seal comprises at least one gasket; or the fixed but flexible gas leak-free seal has a temperature tolerance range of at least between 0 and 40 degrees Celsius.
  6. The apparatus of any preceding claim, wherein the at least one electrical circuit board is rigid.
  7. The apparatus of any preceding claim, wherein the portable ventilator (900) comprises an exhalation valve (440, 801, 1910) configured for use in restriction of gas flow through at least a portion of the exhalation channel; and, optionally, wherein the exhalation valve (440, 801, 1910) is configured for use, during the providing of the mechanical ventilation to the patient, in maintaining specified exhalation periods and in maintaining a specified baseline airway pressure, BAP.
  8. The apparatus of claim 7, wherein the exhalation valve (440, 801, 1910) is one of: a proportional valve; a pneumatically actuated valve; and a diaphragm valve.
  9. The apparatus of any preceding claim, wherein the gas flow generator comprises a blower (436, 912), and, optionally, the gas flow generator comprises a centrifugal blower.
  10. The apparatus of claim 9, wherein the portable ventilator is configured such that all gas flow generated by the blower (436, 912) is delivered into an inhalation limb of the breathing circuit.
  11. The apparatus of claim 7, wherein the portable ventilator (900) comprises, disposed within the housing, an exhalation valve pressure regulator (404, 1054, 1202, 1302, 1502) configured for use in providing a specified actuation pressure to the exhalation valve.
  12. The apparatus of any preceding claim, wherein the portable ventilator (900) comprises, disposed within the housing, an air characterizer (1501) comprising the at least one electrical circuit board.
  13. The apparatus of claim 11, wherein the portable ventilator (900) comprises, disposed within the housing, an air characterizer (1501) comprising the at least one electrical circuit board, and wherein the exhalation valve pressure regulator and the air characterizer are configured to fixedly join so as to form at least a portion of an exhalation valve control channel extending from the exhalation valve pressure regulator to the air characterizer.
  14. The apparatus of claim 7, wherein the portable ventilator (900) comprises, disposed within the housing, an air characterizer (1501) comprising the at least one electrical circuit board, wherein the exhalation valve is disposed within the breathing circuit (452, 610, 812, 913) and wherein the apparatus comprises an exhalation valve control tube extending from the breathing circuit to within the housing of the portable ventilator and configured for use in providing actuation pressure to the exhalation valve.
  15. The apparatus of claim 14, comprising a patient airway pressure measurement tube extending from the breathing circuit to within the housing of the portable ventilator and configured for use in allowing measuring of a patient airway pressure using at least a second pressure sensor disposed within the housing; and wherein the apparatus comprises a connector, the connector comprising: a first port configured for attachment of an exhalation limb of the breathing circuit; a second port configured for attachment of an inhalation limb of the breathing circuit; a third port configured for attachment of the exhalation valve control tube; and a fourth port configured for attachment of the patient airway measurement tube; wherein the connector is configured to fixedly attach to the portable ventilator so as to couple the exhalation limb of the breathing circuit with the exhalation channel of the pneumatic manifold, to couple the inhalation limb of the breathing circuit with the inhalation channel of the pneumatic manifold, to couple the exhalation valve control tube with the pneumatic manifold, and to couple the patient airway measurement tube with the pneumatic manifold.

Description

BACKGROUND Respiratory distress is a common patient complaint that can sometimes signal a medical emergency. By some accounts, respiratory distress is a major complaint in approximately 12% of EMS calls. In an associated emergency response, responders may be posed with a number of complex but critical patient care related challenges, including, for example, providing mechanical ventilation in difficult settings. Responding care providers may face a wide range of response settings, including pre- and out-of-hospital settings, from common indoor and outdoor public and private spaces to out-of-hospital settings that could even include battlefield or mass injury event settings. Other settings could include ambulance or other transportation contexts, hospital or emergency room arrival, hand-off and transitional contexts, or other inhospital or emergency room settings. In such settings, the responding care providers, sometimes with limited training or experience and with distractions, must urgently provide life-saving care, which may include providing mechanical ventilation, for substantial periods of time. The scope or effectiveness of their potentially life-saving interventions may be governed or limited based on the features of the equipment that they are able to carry with them and use at the scene. Such features may include, for example, portability, simplicity, ease of use, integration, efficiency, and reliability under potentially unstable, diverse or extreme physical conditions or other circumstances. US2021308400A1 discloses a ventilator system including: a control system having a controller and a user interface; and a pneumatic system having an inspiratory channel and an expiratory channel. The inspiratory channel further comprises a blower connected to an oxygen source, wherein the blower is configured to be controlled by the controller, and to deliver oxygen and/or air to a patient via the inspiratory channel. The expiratory channel includes an exhaust valve configured to be controlled by the controller and an outlet. The pneumatic system further includes a plurality of sensors configured to provide oxygen measurements, pressure measurements, and flow measurements. The controller is configured to receive a user input via the user interface for controlling a treatment regimen for the patient, and to control the blower and the exhaust valve according to the treatment regimen. WO2021077173A1 discloses a sensor module assembly for a respiratory therapy apparatus which may be configured for a seal-based securement within a respiratory therapy device that includes a separable pneumatic block to make assembly or replacement more efficient. The sensor module assembly may include a flow manifold. The flow manifold may have an inlet and an outlet and a main pneumatic path between the inlet and the outlet. The assembly may have a sensor module with sensor(s) on a printed circuit board. The sensor module may be pneumatically and fixedly coupled to the flow manifold. The inlet of the flow manifold may be configured for removable coupling with an outlet of the pneumatic block assembly. Moreover, the outlet of the flow manifold may be configured for removable coupling with a pneumatic path of a housing panel of the respiratory therapy apparatus. The pneumatic path is adapted for supplying breathable gas to a patient interface. US2020139067A1 discloses a system for preventing cross-contamination in single-limb ventilators. In one embodiment, the system includes an airflow generator connected in-line to a humidifier, a first check valve and a patient interface by a gas flow circuit. A controller is electrically coupled to the airflow generator, and a cartridge is connected to the gas flow circuit between a first point downstream of the humidifier and a second point upstream of the patient interface. The cartridge includes a bacteria filter and the first check valve. A method for preventing cross-contamination in single-limb ventilators and a method for providing gaseous flow through a single-limb ventilator are also described. US2021205554A1 discloses a respiratory treatment apparatus configured to provide a flow of breathable gas to a patient, including a breathable air outlet, an outside air inlet, and an pneumatic block module, wherein the pneumatic block module includes: a volute assembly including an inlet air passage, a mount for a blower and an outlet air passage; the blower being mounted in the mount such that an impeller of the blower is in a flow passage connecting the inlet air passage and the outlet air passage; a casing enclosing the volute assembly, wherein air passages within the casing connect air ports on the volute assembly, wherein the inlet air passage of the volute assembly is in fluid communication with the outside air inlet and the outlet air passage of the volute assembly is in fluid communication with the air outlet. WO2021211350A2 discloses a medical breathing gas delivery system design emplo