The present application relates to medical diagnostics devices, more particularly to devices that measure respiratory parameters such as airway resistance.
One known method and the device for measuring airway resistance are known from Applicant's PCT/CA2014/051073 filed on 6 Nov. 2014 and published as WO2015/066812 on 14 May 2015. According to this reference, the subject exhales quietly into the flowmeter with distal end initially closed by the shutter. During the occlusion stage, pressure inside closed flowmeter increases. After pressure exceeds predetermined pressure, the shutter is opened, and the device measures the post-occlusion air flow spike. Airway resistance is calculated based on data on occlusion pressure and air flow waveforms.
The device described in the earlier patent application can operate with one gauge sensor which measures positive pressure with respect to ambient during occlusion and negative pressure with respect to ambient caused by air flow after the shutter release. Due to Bernoulli's effect, drop in pressure (negative pressure relative to ambient) caused by increased air velocity through restriction in the flow tube pulls in (entrains) air through the port. This entrainment effect can be created for example in Venturi or Pitot tube. Traditional calibration process determines relation between negative pressure and air flow through the tube.
One object of the proposed solutions is to propose a design of the flowmeter with a disposable flow tube and part of the shutter which are in direct contact with exhaled air and protect the rest of the device from potential contamination with harmful viruses.
Another object of some embodiments is to improve performance of the flowmeter by increasing of pressure response versus flow and simplifying linearization of the device.
In the drawings:
Disposable Flow Tube
One of possible embodiments of the respiratory device is illustrated in
The seal between the flow tube 1 and the shutter 2 can be improved by providing a gasket. The shutter 2 and/or the permanent electro-mechanical module can have a holder or support for the disposable shutter, such as a frame or hinge mechanism to support the disposable part while operating as shutter. In the embodiment illustrated in
During the measurements, the flow tube 1 is attached to the electro-mechanical module such that gauge pressure sensor 3 is in pneumatic connection with the flow tube. Pneumatic port 4 of the tube is connected to the input of the sensor 3 through the adaptor 5.
To avoid propagation of the viruses which may be present in air flow, filter 6 is attached to the flow tube 1 between inner surface of the tube and pneumatic port 4.
Because the flow rate through the sensor 3 is small in this configuration, the filter can pose relatively high resistance without adversely affecting flow or pressure measurements using the sensor 3.
With such configuration of the device, electro-mechanical module which may include also micro-controller 7 and shutter mechanism 8 is isolated from exhaled air and protected from contamination.
In the embodiment of
The micro-controller 7 can alternatively comprise a data interface, for example a Bluetooth wireless link, so that signal collection and/or processing can be performed using a separate unit such as a smartphone, tablet or personal computer. This allows for the user interface to be external to the reusable module. The permanent electro-mechanical module can have a battery that can be rechargeable.
It will be appreciated that the reusable module can include an independent user interface, such as an audio signal and/or signal lights and/or a small display, for interacting with the user during trials. The final measurement can be communicated to the user in a variety of ways. In some cases, only a comparative measurement is required, so the result can be communicated with a very simple indicator (visual or audio). Text to speech can also be used to communicate a measurement in audio form instead of a visual display. Result data can also be communicated by a data link, while patient interaction is done using indicators (audio or visual) on the device itself.
While the shutter release mechanism 8 shown is a magnetic release mechanism, a user actuated mechanical trigger can be provided. If desired, the micro-controller can signal to an audio transducer an audio signal to prompt the user to use the trigger mechanism.
The shutter control is illustrated as an electro-magnetic release, however, a mechanical release mechanism using a piezo-electric actuator, electric motor, solenoid, etc. can also be contemplated. A manual release can also be used, although with greater need for operator cooperation and thus a risk for measurement error.
In the embodiment of
In the embodiment of
One variant is to measure the volume of air that is able to be drawn from sensor 3 into tube 1 during the largest exhalation expected. Then the volume of the passage from sensor 3 to the tube 1 can be arranged to be bigger than what the one or more exhalation trials could transport back from sensor 3 any possible virus or microbe. A labyrinth passage between tube 1 and port 4 could be provided. This would replace the need for the filter 6.
Following quantitative example demonstrates possibility to build such labyrinth. Assume that pressure in the flow tube during occlusion monotonically increases from zero to 1000 Pa in 1 second. Calorimetric type thermal sensor with pneumatic impedance of 50 kPa*s/ml is used to measure said pressure. Volume of air leaking through the sensor during occlusion is about 0.01 ml. If the capillary with cross section of 2×2 mm is built around the flow tube with outer diameter of 2 cm, its volume is 0.25 ml. Even one loop of such capillary having volume 25 times bigger than the volume leaking from the flow tube during occlusion can protect the sensor from contamination. Note that during post-occlusion cycle, air flows in opposite direction—from the sensor into the flow tube.
A second variant is to arrange the sensor 3 in the disposable tube 1 and to provide an electrical connection between the reusable module and the disposable tube 1. In this case, the filter 6 is not required. This variant is not optimal because the sensor 3 also must keep information on its individual calibration. Therefore memory circuitry would still be needed and the reusable module would also need to read the memory to retrieve the calibration data (or otherwise the processor 7 would need to obtain the calibration data), or the sensor 3 would still need to have a processor to calibrate its signal so that the flow data was adjusted by the calibration data. This can increase the cost of the disposable tube 1.
In the embodiment of
Baffle for Improved Flow Measurement Response
The flow tube was characterized without baffle and with baffle 9 having height of 1 mm.
The arrangement of a baffle in a flow tube is known per se from PCT patent publication WO01/18496 A2 published 15 Mar. 2001 (see for example FIG. 8A).
In both cases of baffle and no baffle, the generated pressure is close to the square function of flow.
It was experimentally found that there is optimal value of the baffle height for the tube with certain geometry.
Additional advantage of the baffle with intermediate height is that pressure noise caused by flow turbulence is lower than for the bigger baffle.
It is assumed that for the flow tube of Venturi type generating entrainment pressure, baffle with optimal geometry (height) must be found. Tube design optimization may include experimental characterisation of the tubes with different baffles and experimental selection of the baffle design which provides the highest sensitivity with optimal pressure noise. Alternatively theoretical simulation of the flow tube can be done to determine optimal design.
Gauge sensor 3 operates as was described above and measures pressure during occlusion stage and post-occlusion flow spike. Data from the sensor 3 are used for calculation of airway resistance. Sensor 12 can be used to determine direction of flow through the tube 1. With this flowmeter, it is possible to provide multiple airway resistance measurements during spontaneous breathing. After occlusion stage and post-occlusion flow spike, the subject continues spontaneous breathing through the flow tube. Sensor 12 together with sensor 3 can determine end of inspiration and generate signal for shutter closing. Airway resistance measurements can be repeated automatically multiple times at the beginning of exhalation.
The flow tube with baffle having optimized sensitivity and noise can be made in a non-disposable form in accordance with an embodiment similar to
It should be noted that additional technical solutions may be used by those skilled in the art to improve and extend some features of the device. For example the flow tube can be attached to specially designed mouthpiece to provide optimal and comfortable usage by the subject. Alternatively the proximal end of the flow tube can be specially shaped to better fit mouth of the subject.
This application is a continuation of U.S. patent application Ser. No. 15/222,396 filed on Jul. 28, 2016 that claims priority of U.S. provisional patent application 62/197,624 filed Jul. 28, 2015, the specification of which is hereby incorporated by reference.
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Entry |
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U.S. Appl. No. 15/222,396 office action dated Jan. 11, 2018. |
Number | Date | Country | |
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62197624 | Jul 2015 | US |
Number | Date | Country | |
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Parent | 15222396 | Jul 2016 | US |
Child | 16400578 | US |