APPARATUS FOR DEFINING CPAP VENTILATION WITH A MINIMUM VOLUME
20220160990 · 2022-05-26
Inventors
Cpc classification
A61M16/0003
HUMAN NECESSITIES
A61M2016/0036
HUMAN NECESSITIES
A61M16/024
HUMAN NECESSITIES
A61M2205/52
HUMAN NECESSITIES
International classification
A61M16/20
HUMAN NECESSITIES
A61M16/00
HUMAN NECESSITIES
A61M16/08
HUMAN NECESSITIES
Abstract
A ventilator for respiration gas supply, comprising a respiration gas source, a control unit, a memory, a pressure sensor and/or a flow sensor, an exchangeable respiration gas tube, at least one connection stub for the respiration gas tube, a patient interface and a valve. The control unit is set up to use signals from the pressure sensor and/or flow sensor to ascertain the patient's respiration phase and to ascertain the patient's current tidal volume during successive inhalations and exhalations and to compare a first set volume threshold for the tidal volume with the current tidal volume and to determine whether the latter is below the former and if so, to react by driving the respiration gas source to set a second pressure for the respiration gas for inhalation and driving the respiration gas source to set the CPAP pressure for the respiration gas for exhalation.
Claims
1. A ventilator for respiration gas supply, wherein the ventilator comprises a respiration gas source, a control unit, a memory, a pressure sensor device and/or a flow sensor device, an exchangeable respiration gas tube, at least one connection stub for the respiration gas tube and a patient interface, wherein the control unit drives the respiration gas source to set an essentially constant CPAP pressure which is maintained independently of a patient's respiration phase, and wherein the control unit is set up and configured to use signals from the pressure sensor device and/or the flow sensor device to ascertain the patient's respiration phase—inhalation and exhalation, to ascertain the patient's current tidal volume during successive inhalations and exhalations, to compare at least a first set volume threshold for a tidal volume with a current tidal volume, to determine whether the current tidal volume is below the first set volume threshold, and if so to react by driving the respiration gas source to set a second pressure (IPAP) for a respiration gas for inhalation driving the respiration gas source to set the CPAP pressure for a respiration gas for exhalation.
2. The ventilator of claim 1, wherein the control unit is set up and configured to increase the second pressure (IPAP) stepwise until the set volume threshold for the tidal volume has been attained.
3. The ventilator of claim 2, wherein the control unit increases the second pressure (IPAP) from one inhalation to an immediately subsequent inhalation.
4. The ventilator of claim 3, wherein the control unit lowers the second pressure (IPAP) stepwise again when the set volume threshold for the tidal volume has been exceeded.
5. The ventilator of claim 1, wherein the control unit lowers the second pressure (IPAP) to the CPAP pressure level when the set volume threshold for the tidal volume has been exceeded in a set manner and in this respect again drives the respiration gas source to set an essentially constant CPAP pressure which is maintained independently of the patient's respiration phase.
6. The ventilator of claim 1, wherein the ventilator has at least one valve disposed in a respiration gas tube or in the ventilator.
7. The ventilator of claim 6, wherein the respiration gas tube in the event of a changeover from a CPAP mode to an IPAP mode remains on the ventilator, and the patient valve is switched by the control unit for IPAP mode.
8. The ventilator of claim 6, wherein the valve is opened or closed depending on the respiration phase.
9. The ventilator of claim 6, wherein the valve is closed in an inhalation and is driven in a controlled manner in an exhalation, being opened intermittently to assure exhalation.
10. The ventilator of claim 6, wherein the patient's respiration is identified by the control unit from a progression of a flow signal from the flow sensor device, and the valve is actuated depending on the flow signal (as a trigger).
11. The ventilator of claim 10, wherein limits are recorded or can be set for the flow signal and/or for a pressure signal, where the limits are the trigger sensitivity.
12. The ventilator of claim 6, wherein the control unit drives the respiration gas source to assure maintenance of the CPAP pressure level during switching operations of the valve.
13. The ventilator of claim 1, wherein the control unit at least intermittently lowers the CPAP pressure when the patient's respiration is identified as exhalation by the control unit from a progression of the flow signal from the flow sensor device.
14. The ventilator of claim 1, wherein the control unit at least intermittently raises the CPAP pressure (pursed-lip breathing) when the patient's respiration is identified as exhalation by the control unit from a progression of the flow signal from the flow sensor device.
15. The ventilator of claim 6, wherein the control unit can set the CPAP pressure to pressure values below 4 hPa since, by virtue of the valve, CO.sub.2 in exhaled air is reliably flushed out even at low pressures.
16. The ventilator of claim 6, wherein the control unit for CPAP mode keeps the valve closed in an inhalation and drives it in a controlled manner in an exhalation and opens it intermittently in order to assure exhalation, where the patient's respiration is identified by the control unit from a progression of the flow signal from the flow sensor device and the valve is actuated depending on the flow signal (as a trigger), where a maintenance of the CPAP pressure level is assured during switching operations of the valve by driving of the respiration gas source.
17. The ventilator of claim 1, wherein a patient having difficulty in breathing (effortful inhalation) is identified by the control unit from a progression of the flow signal or of the pressure signal, and the control unit drives the respiration gas source at a set respiration gas flow or respiration gas pressure when a progression of the flow signal or of the pressure signal leads to identification of effortful inhalation by the patient.
18. The ventilator of claim 1, wherein a pressure of a respiration assistance and a volume are adjustable.
19. The ventilator of claim 1, wherein a pressure of a respiration assistance and an inhalation time Ti are adjustable.
20. The ventilator of claim 6, wherein, for exhalation, the valve is opened briefly, such that pressure is released, and the valve is then closed.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0081] The invention is explained in greater detail below by way of exemplary embodiments with reference to the drawings, in which
[0082]
[0083]
[0084]
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0085] The particulars shown herein are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show details of the present invention in more detail than is necessary for the fundamental understanding of the present invention, the description in combination with the drawings making apparent to those of skill in the art how the several forms of the present invention may be embodied in practice.
[0086]
[0087] The ventilator for respiratory gas supply 1 comprises a respiratory gas source 2, a control unit 3, a memory 5, a pressure sensor device 7 and/or a flow sensor device 8, a respiratory gas tube 11 and a patient interface 4, in the form here of a ventilation mask 41. The ventilator additionally has an operating unit 20 and a display 21. The ventilator additionally has two stubs 221, 222 for the respiratory gas tube 11. One stub 221 is set up for the connection of the respiratory gas tube 11 in the form of a one-tube valve system 111. A leakage tube 113 may also be connected to this stub 221 (see
[0088] In addition, the inhalatory branch of the twin-tube system 112 may be connected to this stub 221. The other stub 222 serves for connection of the exhalatory branch of the twin-tube system 112 (not shown).
[0089] The ventilator is set up and designed for respiration gas supply 1, comprising a respiration gas source 2, a control unit 3, a memory 5, a pressure sensor device 7 and/or a flow sensor device 8, an exchangeable respiration gas tube 11, at least one connection stub 221, 222 for the respiration gas tube and a patient interface 4, wherein the control unit 3 drives the respiration gas source 2 to set an essentially constant CPAP pressure which is maintained independently of the patient's respiration phase, and wherein the control unit 3 is set up and designed to use the signals from the pressure sensor device 7 and/or the flow sensor device 8 [0090] to ascertain the patient's respiration phase—inhalation and exhalation, [0091] to ascertain the patient's current tidal volume during successive inhalations and exhalations, [0092] to compare at least a first set volume threshold for the tidal volume with the current tidal volume, [0093] to determine whether the current tidal volume is below the first volume threshold, [0094] and if so to react by [0095] driving the respiration gas source 2 to set a second pressure (IPAP) for the respiration gas for inhalation [0096] driving the respiration gas source 2 to set the CPAP pressure for the respiration gas for exhalation.
[0097]
[0098] In the leakage tube 113, an exhalation system 171 is used to continuously purge the CO2-containing exhaled air 200.
[0099] In the one-tube valve system and in the twin-tube valve system, the patient's exhalation is controlled via a valve 17.
[0100] In the twin-tube system 112, the valve 17 is disposed in the ventilator. The exhaled air is guided via a part-tube to the exhalation input stub 222 of the ventilator and thence released into the environment via the valve 17. For this purpose, the valve opens with every exhalation. The valve is closed with every inhalation. A pressure measurement tube 271 measures the pressure in the two-tube system.
[0101] In the one-tube valve system 111, the valve 17 is disposed in or on the tube 11.
[0102] The valve 17 has, for example, three fundamental gas pathways, and an opening provided with a sealing membrane. The gas pathways are a closable exhalatory gas pathway, an inhalatory gas pathway that points to the ventilator and through which inhalatory respiration gas flows, and a patient gas pathway that points to the patient interface. Inhalatory respiration gas flows through the patient gas pathway in inhalation, and exhalatory respiration gas in exhalation. The exhalatory gas pathway communicates with the opening that can be completely closed or opened by means of the membrane.
[0103] The opening and sealing membrane are covered in
[0104] The valve may be pneumatically operated and/or controlled. No matter whether it is disposed in the ventilator or on the tube, the valve is subject, for example, to a control pressure that opens or closes the valve. The valve has a sealing membrane which is subject to a control pressure that opens or closes the valve, with the control pressure generated by the respiration gas source 2 and guided through a control tube (not shown) to the valve 17.
[0105] A pressure measurement tube 271 measures the pressure in the tube adjacent to the valve. The control pressure is generated by the respiration gas source 2 and is guided to the valve via a control tube (not shown). The control pressure here is guided first, for example, to the internal valve 17 disposed adjacent to the exhalation input stub 222. The pressure can also be guided thence to the second valve 17 (in the one-tube system). A blocker (not shown) opens or blocks the pathway to the one-tube valve system 111.
[0106] For the one-tube system, a pressure stub 25 is disposed on the ventilator housing, to which the control pressure is applied. A pressure tube 251 guides the control pressure to the valve 17. The pressure stub 25 may be closed in order to prevent a pressure drop when the system is not in use.
[0107] Adjacent to the stub 221 is also disposed a stub 27 for a measurement of pressure. Pneumatically assigned to the stub 27 in the respirator is a pressure sensor. A pressure measurement tube 271 may be adapted to the stub 27, and this determines the pressure in the tube in the region (in flow direction) upstream of or beyond the valve 17.
[0108] Adjacent to the stub 222 may also be disposed a stub for a manometer. Pneumatically assigned to the stub in the respirator is a pressure sensor. A pressure measurement tube 271 may be adapted to the stub, which determines the pressure in the exhalatory tube or in the region (in flow direction) upstream of or beyond the valve. This measurement of pressure is advisable in order to determine and optionally to control compliance with the set pressure for the exhalation.
[0109] According to the invention, the valve 17 may be electronically controlled. In that case, it is supplied with energy, for example, via a cable connection from the ventilator or via a battery disposed adjacent to the valve.
[0110] Alternatively, the valve may be electrically operated and/or controlled; for example, the membrane is then moved against the opening by means of an electrically operated actuator.
[0111] Alternatively, the valve may be operated and/or controlled electrically, for example as an axial voice coil actuator. These consist of a permanent magnet in a movable tubular coil made of wire present in a ferromagnetic cylinder. When current flows through the coil, it becomes magnetized and repels the magnets. In this way, movement inward and outward and back and forth is generated. Further advantages of linear VCA motors are their bidirectionality and the presence of permanent magnets and magnetic hold-on coils. They make it possible to remain at one end of the stroke when the power supply is interrupted—in order to ensure, for example, that valves in the event of power failure remain open or closed. VCAs are accelerated uniformly and rapidly within the stroke, virtually without hysteresis.
[0112] The valve in the tube and/or the valve in the ventilator may be electrically controlled.
[0113] In this configuration, the ventilator is set up, for example, for CPAP mode 61.
[0114] According to the user's selection or in an automatically activated manner, the control unit 3 activates the CPAP therapy mode 61. The respiration gas source 2 is driven here to set a constant CPAP pressure. The CPAP pressure is preferably maintained independently of the respiration phase.
[0115] In the changeover to CPAP mode 61, the respiration gas tube 11 remains on the ventilator 1. The patient valve 17 is switched over here by the control unit for the setting of CPAP mode 61.
[0116] The valve 17 is closed in inhalation and driven in a controlled manner in exhalation and intermittently opened in order to assure breathing-out.
[0117] For this purpose, the patient respiration is identified by the control unit 3 from the progression of the flow signal of the flow sensor device 8, and the valve 17 is actuated depending on the flow signal (as trigger).
[0118] Limits are recorded or can be set for the flow signal. The limits represent the changeover between inhalation and exhalation, and hence serve as trigger signals for the driving of the valve 17. According to the invention, a pressure trigger is also possible, or a combination of the two trigger options. In the case of a pressure trigger, inhalation is recognized by the control unit in that the pressure drops slightly, and exhalation is recognized in that the pressure rises slightly. Limits are recorded or can be set for the pressure signal. The limits represent the changeover between inhalation and exhalation, and hence serve as trigger signals for the driving of the valve 17.
[0119] The control unit 3 controls the respiration gas source, for assurance of the maintenance of the CPAP pressure level, during the switchover operations of the valve 17.
[0120] The control unit 3 lowers the CPAP pressure, for example at least intermittently, when the patient's breathing is identified as exhalation by the control unit 3 from the progression of the flow signal of the flow sensor device 8. This makes it more pleasant for the patient to breathe out.
[0121] The control unit 3 raises the CPAP pressure alternatively, for example at least intermittently (pursed-lip breathing), when the patient's breathing is identified as exhalation by the control unit 3 from the progression of the flow signal of the flow sensor device 8. The elevated pressure allows closed regions of the lung to be opened up;
[0122] complete exhalation is then possible.
[0123] The control unit 3 can also set the CPAP pressure to pressure limits below 4 hPa since, by virtue of valve 17, in accordance with the degree of opening of the valve, CO2 in the exhaled air is reliably flushed out even at low pressures.
[0124]
[0125] In
[0126] In phase 1, the CPAP pressure (of 4 hPa) is applied, and the patient breathes spontaneously. In phase 1, it is apparent that the CPAP pressure on the mask varies slightly at the changeover from inhalation 241 to exhalation 242 (see
[0127] With every commencement of exhalation 242, the pressure rises above the target pressure since the patient develops a positive flow (into the mass) with their spontaneous breathing that the pressure regulator is unable to respond to as quickly.
[0128]
[0129] It becomes clear from a comparison of
[0130] In
[0131] Plotted in
[0132] It is apparent from the progression of the mask pressure in
[0133] The current pressure differential from the previous breath (CPAP or varying IPAP level) is apparent [0134] a. from a table that assigns a pressure increase to the differential (target to actual volume or target to actual SpO.sub.2 or target to actual CO.sub.2) (stored in the memory) [0135] b. from a value set by a user that assigns a pressure increase to the differential (target to actual volume or target to actual SpO.sub.2 or target to actual CO.sub.2) [0136] c. from a combination of a) and b) [0137] d. from a (self-taught) algorithm with the aid of estimating the (patho)physiological response to an increase in pressure, taking account of all input parameters, pressure, flow, volume, frequency, SpO.sub.2, etCO.sub.2.
[0138] In the case of exceedance of the target volume (tidal volume or minute volume) or in the case of exceedance of the target oxygen saturation SpO.sub.2 or in the case that the etCO.sub.2 value (final exhalatory CO.sub.2 value) in the respiration gas goes below the target, there is a changeover to an IPAP pressure lower than the previously set IPAP (the CPAP value remains the EPAP), or a changeover back to the CPAP pressure.
[0139] The current pressure differential from the IPAP of the previous breath is apparent [0140] a. from a table that assigns a pressure decrease to the differential (target to actual volume or target to actual SpO.sub.2 or target to actual CO.sub.2) (stored in the memory) [0141] b. from a value set by a user that assigns a pressure decrease to the differential (target to actual volume or target to actual SpO.sub.2 or target to actual CO.sub.2) [0142] c. from a combination of a) and b) [0143] d. from a (self-taught) algorithm with the aid of estimating the (patho)physiological response to a decrease in pressure, taking account of all input parameters, pressure, flow, volume, frequency, SpO.sub.2, etCO.sub.2). [0144] To sum up, the present invention provides:
[0145] 1. A ventilator for respiration gas supply, wherein the ventilator comprises a respiration gas source, a control unit, a memory, a pressure sensor device and/or a flow sensor device, an exchangeable respiration gas tube, at least one connection stub for the respiration gas tube and a patient interface, wherein the control unit drives the respiration gas source to set an essentially constant CPAP pressure which is maintained independently of a patient's respiration phase, and wherein the control unit is set up and configured to use signals from the pressure sensor device and/or the flow sensor device [0146] to ascertain the patient's respiration phase—inhalation and exhalation, [0147] to ascertain the patient's current tidal volume during successive inhalations and exhalations, [0148] to compare at least a first set volume threshold for a tidal volume with a current tidal volume, [0149] to determine whether the current tidal volume is below the first set volume threshold, [0150] and if so to react by [0151] driving the respiration gas source to set a second pressure (IPAP) for a respiration gas for inhalation [0152] driving the respiration gas source to set the CPAP pressure for a respiration gas for exhalation.
[0153] 2. The ventilator of item 1, wherein the control unit is set up and configured to increase the second pressure (IPAP) stepwise until the set volume threshold for the tidal volume has been attained.
[0154] 3. The ventilator of item 1 or item 2, wherein the control unit increases the second pressure (IPAP) from one inhalation to an immediately subsequent inhalation.
[0155] 4. The ventilator of any one of the preceding items, wherein the control unit lowers the second pressure (IPAP) stepwise again when the set volume threshold for the tidal volume has been exceeded.
[0156] 5. The ventilator of any one of the preceding items, wherein the control unit lowers the second pressure (IPAP) to the CPAP pressure level when the set volume threshold for the tidal volume has been exceeded in a set manner and in this respect again drives the respiration gas source to set an essentially constant CPAP pressure which is maintained independently of the patient's respiration phase.
[0157] 6. The ventilator of any one of the preceding items, wherein the ventilator has at least one valve disposed in a respiration gas tube or in the ventilator.
[0158] 7. The ventilator of any one of the preceding items, wherein the respiration gas tube in the event of a changeover from a CPAP mode to an IPAP mode remains on the ventilator, and the patient valve is switched by the control unit for IPAP mode.
[0159] 8. The ventilator of item 6, wherein the valve is opened or closed depending on the respiration phase.
[0160] 9. The ventilator of item 6, wherein the valve is closed in an inhalation and is driven in a controlled manner in an exhalation, being opened intermittently in order to assure exhalation.
[0161] 10. The ventilator of item 6, wherein the patient's respiration is identified by the control unit from a progression of a flow signal from the flow sensor device, and the valve is actuated depending on the flow signal (as a trigger).
[0162] 11. The ventilator of item 10, wherein limits are recorded or can be set for the flow signal and/or for a pressure signal, where the limits are the trigger sensitivity.
[0163] 12. The ventilator of item 6, wherein the control unit drives the respiration gas source to assure maintenance of the CPAP pressure level during switching operations of the valve.
[0164] 13. The ventilator of any one of the preceding items, wherein the control unit at least intermittently lowers the CPAP pressure when the patient's respiration is identified as exhalation by the control unit from a progression of the flow signal from the flow sensor device.
[0165] 14. The ventilator of any one of the preceding items, wherein the control unit at least intermittently raises the CPAP pressure (pursed-lip breathing) when the patient's respiration is identified as exhalation by the control unit from a progression of the flow signal from the flow sensor device.
[0166] 15. The ventilator of item 6, wherein the control unit can set the CPAP pressure to pressure values below 4 hPa since, by virtue of the valve, CO.sub.2 in exhaled air is reliably flushed out even at low pressures.
[0167] 16. The ventilator of item 6, wherein the control unit for CPAP mode keeps the valve closed in an inhalation and drives it in a controlled manner in an exhalation and opens it intermittently in order to assure exhalation, where the patient's respiration is identified by the control unit from a progression of the flow signal from the flow sensor device and the valve is actuated depending on the flow signal (as a trigger), where a maintenance of the CPAP pressure level is assured during switching operations of the valve by driving of the respiration gas source.
[0168] 17. The ventilator of any one of the preceding items, wherein a patient having difficulty in breathing (effortful inhalation) is identified by the control unit from a progression of the flow signal or of the pressure signal, and the control unit drives the respiration gas source at a set respiration gas flow or respiration gas pressure when a progression of the flow signal or of the pressure signal leads to identification of effortful inhalation by the patient.
[0169] 18. The ventilator of any one of the preceding items, wherein a pressure of a respiration assistance and a volume are adjustable.
[0170] 19. The ventilator of any one of the preceding items, wherein a pressure of a respiration assistance and an inhalation time Ti are adjustable.
[0171] 20. The ventilator of item 6, wherein, for exhalation, the valve is opened briefly, such that pressure is released, and the valve is then closed.
[0172] 21. The ventilator of any one of the preceding items, wherein a trigger sensitivity is adjustable in 3 to 15 stages.
[0173] 22. The ventilator of any one of the preceding items, wherein a trigger block time (in a range of 0.1 to 10 seconds) can be set, where the patient's respiration efforts are ignored by the control unit for a duration of the trigger block time.
[0174] 23. The ventilator of any one of the preceding items, wherein the control unit drives the respiration gas source to set a respiration gas pressure in a range of 0-90 mbar, preferably 1-80 mbar, more preferably 2-60 mbar.
[0175] 24. The ventilator of item 6, wherein the ventilator comprises a pressurized gas source and at least one pressure tube that guides a control pressure to the valve.
[0176] 25. The ventilator of item 24, wherein the respiration gas source is the pressurized gas source.
[0177] 26. The ventilator of any one of the preceding items, wherein the respiration gas tube is a one-tube system with valve.
[0178] 27. The ventilator of any one of the preceding items, wherein the respiration gas tube is a two-tube system with valve.
[0179] 28. The ventilator of any one of the preceding items, wherein the respiration gas tube is a two-tube system with an assigned valve, the valve being adjacent to a stub in a ventilator housing.
[0180] 29. The ventilator of any one of the preceding items, wherein a patient valve is designed so as to be removable from a receptacle in a housing, where the patient valve comprises a membrane that may be subject to a control pressure in order to block or to clear a flow of respiration gas through the valve.
[0181] 30. The ventilator of item 6, wherein the valve has a sealing membrane which is subject to a control pressure that opens or closes the valve, where the control pressure is generated by the respiration gas source and is guided to the valve via a control tube.
[0182] 31. The ventilator of item 6, wherein the valve is electrically operated.
[0183] 32. The ventilator of any one of the preceding items, wherein the patient interface is present in the form of a nasal cannula or flow cannula, of a nose plug or mask, or of a tracheostomy connector.