Classifications

• • 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. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/0057—Pumps therefor
  • A61M16/0066—Blowers or centrifugal pumps
  • A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• • 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. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
  • A61M16/022—Control means therefor
  • A61M16/024—Control means therefor including calculation means, e.g. using a processor
  • A61M16/026—Control means therefor including calculation means, e.g. using a processor specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• • 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. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/10—Preparation of respiratory gases or vapours
  • A61M16/105—Filters
  • A61M16/106—Filters in a path
  • A61M16/107—Filters in a path in the inspiratory path
• • 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. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
  • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
  • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
  • A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor

Definitions

• the invention relates generally to the delivery of a breathing gas to an airway of a patient, and more particularly, to the delivery of a breathing gas coordinated with the breathing cycle of the patient.
• Obstructive sleep apnea is an airway breathing disorder caused by relaxation of the muscles of the upper airway to the point where the upper airway collapses or becomes obstructed by these same muscles. It is known that obstructive sleep apnea can be treated through the application of pressurized air to the nasal passages of a patient. The application of pressurized air forms a pneumatic splint in the upper airway of the patient thereby preventing the collapse or obstruction thereof.
• CPAP regimens including, for example, mono-level CPAP and bi-level CPAP.
• Mono-level CPAP involves the constant application of a single therapeutic or medically prescribed CPAP level. That is, through the entire breathing cycle, a single therapeutic positive air pressure is delivered to the patient. While such a regimen is successful in treating obstructive sleep apnea, some patients experience discomfort when exhaling because of the level of positive air pressure being delivered to their airways during exhalation.
• CPAP has been useful in the treatment of obstructive sleep apnea and other respiratory related illnesses such as, for example, chronic obstructive pulmonary disease and neuro-muscular disorders affecting the muscles and tissues of breathing
• CPAP has been useful in the treatment of obstructive sleep apnea and other respiratory related illnesses such as, for example, chronic obstructive pulmonary disease and neuro-muscular disorders affecting the muscles and tissues of breathing
• a method of providing a breathing gas includes: a) sensing a sensed parameter associated with delivery of the breathing gas, b) changing a control parameter associated with a flow/pressure control element in response to a difference between the sensed parameter and a first predetermined sensed parameter value during a first portion of a current breathing cycle, c) determining a transition from the first portion to a second portion of the current breathing cycle based at least in part on the changing control parameter, d) changing the control parameter to cause a first change in the sensed parameter during the second portion of the current breathing cycle based at least in part on the determined transition, and e) changing the control parameter to cause a second change in the sensed parameter during a third portion of the current breathing cycle based at least in part on the first predetermined sensed parameter value.
• Figure 1 is a functional block diagram illustrating one embodiment of a system for delivering a breathing gas.
• Figure 4 is a graph illustrating a valve step position and mask pressure over time for another embodiment of the system.
• Figure 5 is a graph illustrating a valve step position and mask pressure over time for yet another embodiment of the system.
• Figure 6 is another embodiment of a system for delivering a breathing gas.
• Figures 7A-7C illustrate another embodiment of a control process for the system.
• Figures 8A-8C illustrate a lung flow, valve step position, control pressure and sensed pressure over time for the embodiment of the system illustrated in Figure 6.
• logic includes but is not limited to hardware, firmware, software and/or combinations of each to perform a function(s) or an action(s), and/or to cause a function or action from another component.
• logic may include a software controlled microprocessor, discrete logic such as an application specific integrated circuit (ASIC), or other programmed logic device.
• ASIC application specific integrated circuit
• Logic may also be fully embodied as software.
• Blood state includes any state or combination of states where air is drawn into the lungs and/or expelled from the lungs.
• a first breathing state may be associated with drawing air into the lungs and a second breathing state may be associated with expelling air from the lungs.
• a breathing state can have one or more sub-states.
• the start of inhalation can be a breathing state and the end of inhalation can be another breathing state, with the range therebetween defining one or more other breathing states.
• the start and end of exhalation, and the range there between can also be defined by one or more breathing states.
• FIG. 1 block diagram 100 illustrating one embodiment of a system is shown.
• the system has a controller 102 with control logic 104, a blower 106, a variable position poppet valve 108 with a bi-directional stepper motor and a pressure sensor 112.
• a flow path 110 provides a path for a flow of breathable gas from the valve 108 to a patient interface 114.
• Patent interface 114 can be any nasal mask, face mask, cannula, or similar device.
• Pressure sensor 112 senses a parameter of the breathing gas such as the pressure in flow path 110, which is associated with and indicative of the pressure in the patient interface 114.
• the controller 102 is preferably processor-based and can include various input/output circuitry including analog-to-digital (AfD) inputs and digital-to-analog (D/ A) outputs.
• the controller 102 sends valve step position data 116 to the valve 108 to control its position and the sensor 112 sends pressure data 118 back to the controller 102 to be read.
• the valve step position is preferably defined by the stepper motor specification and can include step positions that are less than 1 step or a whole step. Generally, the valve step position can range from any negative number to any positive number.
• One preferable valve step position range includes 0 to 100, where step position 0 is associated with a fully closed valve position and step 100 is associated with a fully open valve position. Therefore, for a given blower speed and valve configuration, each valve step position can be determined to be equivalent to an approximate pressure change (e.g., a valve step position equals a pressure change of 0.2 cm H 2 O.)
• the controller 102 opens the valve 108 and sets the blower 106 to a speed that produces a predetermined pressure at its output.
• This predetermined pressure is generally set to a medically prescribed positive pressure for a patient plus an additional pressure of, for example, 5 cm H 2 O, via a pressure-to-speed look-up table that is stored in the memory of the controller 102. While an additional pressure of 5 cm H 2 O has been described, other pressures including no additional pressure can be chosen as well.
• the medically prescribed positive pressure is typically a pressure that is above the ambient pressure. For example, the prescribed pressure may range from 4 to 20 cm H 2 O.
• the controller 102 uses the step position of the valve 108 to modulate the output pressure through both a closed loop and an open loop control.
• the closed loop control is a function of sensed pressure and the open loop control is a function of time. Together, these control loops direct the operation of the system through the breathing cycle of a patient. It should also be noted that the closed loop and open loop control can also be based on other parameters such as, for example, instantaneous and average flow rates, temperature of the gases in the patient interface, and/or composition of the gases (e.g. CO 2 ) in the patient interface.
• an average valve step position is determined and maintained or updated, hi step 206, the controller 102 determines if a pressure drop has been sensed. This is preferably accomplished by comparing the presently sensed pressure with the immediately preceding sensed pressure. If the presently sensed pressure is less, then a pressure drop has occurred and the flow proceeds to block 208. In block 208, the controller 102 increments the valve step position to compensate for the pressure drop. Incrementing the valve step position has the effect of increasing the flow and pressure of the breathing gas delivered from the valve's output. The step position is changed iteratively until the error or difference between the sensed pressures is minimized.
• the controller 102 seeks to maintain a constant pressure in the flow path 112 until patient exhalation is sensed.
• the difference between the instantaneous and average valve position is integrated over time and stored in memory. The summation of six such integrations is used to determine the start of an inhalation breathing state by determining if the summation is greater than a start of inhalation threshold (blocks 212 and 214). If the summation is greater than the threshold, the start of the inhalation breathing state has occurred and a timer begins the measurement of the inhalation breathing state in block 216. This measurement continues until a peak valve step position has been found in block 218.
• the peak valve step position is determined by comparing the previous valve step position to the present valve step position and saving in memory the step position that is greater as the peak valve step position. If the peak valve step position remains unchanged for some time period (e.g., 80 ms), then the controller 102 assumes that the peak valve step position has occurred for this inhalation phase and stops the inhalation breathing state time measurement in block 220.
• the peak valve step position is a threshold indicative of the imminent end of the inhalation breathing state.
• Block 222 the controller 102 tests to determine if a pressure increase has occurred by reading the pressure signal. If a pressure increase has occurred after a peak valve step position has been found, then the inhalation breathing state is imminently ending. Block 224 decrements the valve position to lower the flow and pressure provided so as to maintain a constant pressure in the air flow path. This is once again accomplished by an iterative process by which the error between the presently sensed pressure and the previously sensed pressure is minimized. Block 226 tests to determine if the inhalation breathing state has ended by comparing two variables, VAR 1 and VAR 2 . These variables are defined as follows:
• VAR 1 (Inst. Step Position)-(Avg. Step Position)
• VAR 2 [(Peak Step Position) - (Avg. Step Position)] * Threshold
• the pressure signal is read in block 232 and the valve step position is incremented according to a pressure loading function.
• the pressure loading function reads the present pressure and returns over time the output pressure to the medically prescribed positive pressure, where the system once again looks for a start of inhalation breathing state.
• a positive pressure is provided during the inhalation phase of a breathing cycle to assist the patient in inhalation and a lower pressure is provided during the exhalation phase of a breathing cycle to allow the patient to exhale against a lower pressure.
• Such a system provides a level of comfort over other types of Continuous Positive Airway Pressure delivery in that the patient is not required to exhale against the same pressure used during inhalation for any appreciable period of time.
• FIG. 3 a chart illustrating a valve step position curve 300 and an output pressure curve 302 as a function of time is shown. The two curves have been overlaid to more clearly illustrate the synchronization between pressure and valve step position. The operation description will now be reviewed with reference to the curves of Figure 3.
• a pressure drop is sensed by the pressure sensor 112.
• This pressure drop causes the system to further open the valve 108 in a step-wise fashion to compensate for the drop in pressure caused by patient inhalation.
• the system attempts to maintain an output pressure substantially equivalent to the medically prescribed positive pressure.
• Each step position of the valve is equivalent to a known approximate pressure change (e.g., 0.2 cm H 2 O).
• the difference between the sensed pressure and the set pressure i.e., the medically prescribed positive pressure
• generates an error value which the system attempts to minimize by appropriately adjusting the valve step position, which appropriately adjusts the pressure delivered.
• State 0 occurs when the valve step position is increased and triggers a fixed time period which leads to State 1. During this fixed time period, the difference between the instantaneous valve step position and the average valve step position is integrated over 6 time intervals. Figure 3 shows only 3 intervals for the sake of clarity. If the summation of these 6 integrations is greater than a threshold value, then a patient inhalation is assumed and an inhalation timer is started that measures the time of inhalation.
• This inhalation time measurement is terminated when a peak valve step position has been reached in State 2.
• the peak valve step position is determined by comparing the previous valve step position to the present valve step position and saving in memory the step position that is greater as the peak valve step position. If the peak valve step position remains unchanged for some time period (e.g., 80 ms), then the system assumes that the peak valve step position has occurred for this inhalation phase.
• the system closes the variable position valve 108 so as to provide a lower pressure at its output.
• the valve 108 can be quickly and linearly closed (e.g., with a fixed slope of 3 ms/step) by reducing the valve step position to, for example, position 0 (i.e., closed) or some other position.
• position 0 i.e., closed
• the system now provides a lower pressure than that used during inhalation. This makes it easier for the patient to exhale.
• the system is in open-loop control and does not vary the valve step position based on pressure or any other parameter.
• the valve remains in its step position during this fixed time period.
• the time period can be 2.5 times the previously determined inhalation time (i.e., time from State 1 to State 2). This is the pressure unloading portion of the system operation.
• the breathing state of the patient can be detected. If the instantaneous valve step position is above the average valve step position, the patient is inhaling. If the instantaneous valve step position is below the average valve step position, the patient is exhaling. To reduce premature or erratic triggering, the average valve step position can be offset above its true value for inhalation detection and below its true value for exhalation detection.
• FIG. 6 Illustrated in Figure 6 is another embodiment of the invention in the form of system 600.
• System 600 is similar to system 100 ( Figure 1) except that the variable position valve 108 is in a venting position with respect to flow path 110.
• controller 102 includes control logic 602.
• breathing gas output by blower 106 travels within flow path 110 to the patient interface 114.
• Variable position valve 108 is positioned so that it can divert breathing gas from flow path 110 and patient interface 114.
• the step position of valve 108 is controlled by logic 602. While the embodiment of Figure 6 has been described with reference to a flow/pressure control element in the form of a variable position valve 108 and a sensor element in the form of a pressure sensor 112, the flow/pressure control and sensor elements can include other types of devices.
• the flow/pressure control element can be a variable speed blower, a variable speed blower in combination with a linear valve or solenoid valve, a variable speed blower in combination with a stepper motor controlled variable position valve, a variable speed blower in combination with a linear valve or solenoid valve and a stepper motor controlled variable position valve, or any other suitable combination of these components.
• the sensor element can include a flow sensor, temperature sensor, infra-red light emitter/sensor, motor current sensor, or motor speed sensor alone or in combination with the pressure sensor. The data generated from these sensor(s) is fed back to the controller 102 for processing.
• Figures 7A-C illustrate flowcharts directed to one embodiment of control logic
• the controller 102 closes the valve 108 and sets the blower 106 to a speed that produces a predetermined pressure at its output.
• This predetermined pressure is generally set to a medically prescribed positive pressure for a patient, plus an additional pressure component, via a pressure-to-speed look-up table that is stored in the memory of the controller 102.
• the additional pressure component can be a percentage of the set pressure or some other value.
• the additional pressure component is provided so that the medically prescribed positive pressure can be delivered under most if not all patient demand scenarios.
• the medically prescribed positive pressure is typically a pressure that is above the ambient pressure. For example, the prescribed pressure can range from 4 to 20 cm H 2 O.
• Present means present valve step position
• Previous means previous median valve step position
• Median means median valve step position.
• the logic may initially cycle through several breathing states in determining the above values. [0048] Once the upper and lower breathing rate thresholds are determined, the valve step position is monitored for breathing rate determination. Referring to Figure 7C, the slope of the valve step change is determined in block 742. This may be accomplished by comparing the present and one or more previous valve step positions over time. If the slope of the valve step position is negative in block 744, the logic advances to block 746. Otherwise, the logic loops back to blocks 742 or 704 to continue processing until the next valve step change.
• a pressure error is generated by comparing the set pressure to the pressure read by the pressure sensor 112 in block 706.
• the pressure error is used to generate a valve step error, which can be according to the following:
• Verror (Perror * P) + (D el ⁇ or * D) + (S erTor * S)
• V er ror is the valve step error
• P eiT or is the pressure error
• D eiTo r is the pressure error difference between the present and the previous pressure error calculation
• S error is the summation of the pressure errors
• PID Proportional Integral Derivative
• Block 710 tests to determine whether the valve step error is greater than or equal to zero. If so, the logic advances to block 712 where the valve step position is incremented one or more steps so as to try to reduce the error. Otherwise, the logic advances to block 714 where the valve step position is decremented one or more steps to try and reduce the error. It should be noted that the valve step position employed by the logic may or may not equal one step of the stepper motor that controls the movement of the valve. For example, one valve step may be equal to a half step movement of the valve's stepper motor. [0051] After either steps 712 or 714, the logic advances to block 716 where the valve step is monitored for a peak valve step position. In one embodiment, the logic determines the inhalation threshold according to the following:
• the logic determines the peak valve step position.
• the peak valve step position is determined by comparing the present valve step position to the previous valve step position and choosing the greater value. [0052] In block 718, the logic determines the unload threshold according to the following:
• Phrase is the peak valve step position from one or more previous breath cycles
• Median is the median valve step position
• T is a percent unloading trigger value that is determined from a look-up table based on the determined breaths per minute.
• a breaths per minute based look-up table is shown below in Table 1 :
• a "T (% unloading)" value closer to zero (0) would lower the unload threshold bringing it closer to the median valve step position, thus causing the triggering of a pressure reduction later with respect to the valve step position.
• the larger the "Breaths per minute” value the larger the “T (% unloading)” value.
• one or more “Breaths per minute” values may have the same or different "T (% unloading)" values associated therewith.
• the logic tests to determine whether the valve step position has fallen below the unload threshold. If not, the logic loops back to block 702 to continue the active PID servo control of the valve step position. If so, the logic advances to block 722. hi block 722, the logic determines the unload pressure and the pressure decrease control waveform and associated pressure settings. Also, a decrease timer is set. In one embodiment, the unload pressure is determined as follows:
• the logic determines, for example, 195 pressure settings that define the control waveform for the pressure setting reduction down to the unload pressure setting. These pressure settings are used by the active PID servo control.
• the 195 pressure settings are governed by a pressure decrease timer (e.g., 780 ms).
• the control waveform for the unload period can be defined by a ramp down portion and a hold portion. The ramp down portion may include 10 pressure settings that sequentially reduce the pressure setting from the therapeutic pressure setting to the unload pressure setting in, for example, 40 ms comprised of, for example, ten 4 ms increments.
• the hold portion maintains the pressure setting at the unload pressure setting over, for example, 740 ms comprised of, for example, 185 four ms periods. It should be noted that other values may be chosen and the described values are merely meant to illustrate one embodiment of the invention. It should also be noted that the sensed pressure can be used to re-determine or adjust the control waveform during the ramping and/or hold portions of the unload period.
• block 724 the valve step position is adjusted in an attempt to have the sensed pressure follow the pressure settings of the determined control waveform for the pressure setting reduction down to the unload pressure setting.
• block 724 uses the same logic as blocks 706-714 because the active PID servo control is used to correct the valve step position as the pressure settings of the control waveform are used for the desired pressure setting.
• each of the pressure settings defines a "Set Pressure" that is compared to the sensed pressure to generate a pressure error that is used by the active PID servo control.
• the logic advances to block 732. If not, the logic advances to block 728 where it determines whether the unload pressure setting in the control waveform has been reached. If the pressure decrease timer has expired, the logic advances to block 732 where it prepares for pressure reloading back up to the medically prescribed positive pressure. If the unload pressure setting has not been reached in block 728, the logic loops back to block 724 and continues the active PID servo control of the valve step position according to the pressure settings of the control waveform. If the unload pressure setting has been reached in block 728, the logic advances to block 730 where the unload pressure setting is maintained through the active PID servo control of the valve step position until the pressure decrease timer expires.
• the logic determines whether the unload pressure setting in the control waveform has been reached. If the pressure decrease timer has expired, the logic advances to block 732 where it prepares for pressure reloading back up to the medically prescribed positive pressure. If the unload pressure setting has not been reached in block 728, the logic loops back to
• the logic executes block 732 where it determines the pressure increase control waveform and associated pressure settings. Also, a pressure increase timer is set. hi one embodiment, the logic determines, for example, 100 pressure settings that define the control waveform for the pressure increase up to the medically prescribed positive pressure (therapeutic pressure). This waveform is based on the pressure setting at the expiration of the decrease timer and the medically prescribed positive pressure. In one embodiment, the pressure increase timer may be set to 400 ms. hi one embodiment, the control waveform for the load period can be defined by a ramp up portion.
• block 734 the valve step position is adjusted in an attempt to have the sensed pressure follow the pressure settings of the determined control waveform for the pressure setting increase up to the medically prescribed positive pressure setting.
• block 734 uses the same logic as blocks 706-714 and 724 because the active PID servo control is used to correct the valve step position as the pressure settings of the control waveform are used for the desired pressure setting.
• the logic advances to block 700 wherein the pressure is set to the medically prescribed positive pressure. If not, the logic advances to block 738 where it determines whether the medically prescribed positive airway pressure setting (e.g., therapeutic pressure setting) in the control waveform has been reached. If the medically prescribed positive pressure setting has not been reached in block 738, the logic loops back to block 734 and continues the active PID servo control of the valve step position according to the pressure settings of the control waveform. If the therapeutic pressure has been reached in block 738, the logic advances to block 740 where the medically prescribed positive pressure setting is maintained through the active PID servo control of the valve step position until the pressure increase timer expires.
• the medically prescribed positive airway pressure setting e.g., therapeutic pressure setting
• FIGs 8A-8C the lung flow, valve step position, control pressure and sensed pressure over time for the embodiment illustrated in Figure 6 are shown.
• Figure 8 A illustrates the flow of breathing gas into and out of the lung over time.
• Figure 8B illustrates the valve step position over time, along with the median valve step, upper and lower breathing rate (BR) thresholds, inhalation threshold, and unload threshold. The use of these values and thresholds have been described with reference to the logic of Figures 7A-7C.
• Figure 8C illustrates the control pressure waveform that determines the pressure settings and the sensed pressure by the system.
• the PID servo controller tries to maintain the set pressure, which is the medically prescribed positive pressure for the patient. This causes the valve step position to change due to patient demand, which increases to a peak valve step position and then decreases. During this phase, the peak valve step position is monitored and the median valve step position is calculated. When the valve step position falls below the unload threshold, the unload pressure is determined along with the pressure decrease control waveform and associated pressure settings that are used by the active PID servo control to reduce the pressure down to the unload pressure. A pressure decrease timer is also started.
• system 700 operates in the same manner as system 600 which is described above in references to Figures 6, 7A-C, and 8A-C. Moreover, options, variations, and alternatives described above in regard to system 600 are equally suitable for system 700, except where they conflict with diverting the breathing gas to the non-ambient input 704. hi other embodiment, one or more additional filters between the filter 704 and the blower 106 may be provided.
• valve step position can be changed according to non ⁇ linear function as an alternate, addition or in combination with linear functions.
• Alternate or additional parameters of the flow gas can be sensed including flow rates through the use of flow sensors to modulate valve step position.
• the direction of flow and/or the change in flow rates e.g., instantaneous and average
• the invention in its broader aspects, is not limited to the specific details, the representative apparatus, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of the applicant's general inventive concept.

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• Health & Medical Sciences (AREA)
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• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
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• Respiratory Apparatuses And Protective Means (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• Control Of Fluid Pressure (AREA)

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• 2005
  • 2005-06-20 WO PCT/US2005/021638 patent/WO2006009939A2/en active Application Filing
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