The invention relates to a flow sensor using a microelectromechanical sensing (MEMS) device, and more particularly, to a MEMS-based flow sensor for use in a ventilation apparatus, such as a continuous positive airway pressure (CPAP) machine or a variable positive airway pressure (VPAP) machine.
Ventilation and respiration machines have been used for many years in hospitals, assisted living quarters, and other locations. Respiratory ailments and issues continue to abound, rendering such machines a continuing necessity.
Further, a large percentage of the population suffers from some form of respiratory issue during sleep, such as, for example, sleep apnea. For example, it is estimated that between four and nine percent of middle-aged men and between two and four percent of middle-aged women suffer from some form of sleep apnea. Many such sufferers utilize ventilation and/or respiratory machines to assist in their nighttime sleeping. Two types of such machines are a continuous positive airway pressure (CPAP) machine and a variable positive airway pressure (VPAP) machine.
It is important to be able to accurately determine the flow rate of ventilation and/or respiratory machines. Due to the complex nature of breathing and the change in direction and speed of air flow during breathing, it is very difficult to determine flow rates along a spectrum of flow regimes from a very low flow rate to a very high flow rate.
With some of these concerns in mind, an improved ventilation system and methodology would be welcome in the art.
An embodiment of the invention provides a flow sensor assembly. The flow sensor assembly includes a flow conduit configured to allow fluid flow, a flow disrupter configured to impart a disturbance to the fluid flow, a first sensor disposed within the flow conduit at a first position, the first sensor being responsive to the disturbance of the fluid flow and being configured to generate signals responsive to the disturbance of the fluid flow, and a processor operably connected to the first sensor, wherein the processor is configured to determine a flow rate for the fluid flow through the flow conduit based on a first algorithm determining an amplitude of the fluid flow in a first flow regime and a second algorithm determining a frequency of the fluid flow in a second flow regime.
An aspect of the flow sensor assembly embodiment provides a flow conduit configured to allow fluid flow, a flow disrupter configured to impart a disturbance to the fluid flow, wherein the flow disrupter comprises a first part separated from a second part by a flow separator, first and second sensors respectively disposed within the flow conduit at first and second positions which are symmetrically located relative to the flow disrupter, the sensors being responsive to the disturbance of the fluid flow and being configured to generate signals responsive to the disturbance of the fluid flow, and a processor operably connected to the sensors, wherein the processor is configured to determine a flow rate and a direction for the fluid flow through the flow conduit based on a first algorithm determining an amplitude of the fluid flow in a first flow regime and a second algorithm determining a frequency of the fluid flow in a second flow regime.
An embodiment of the invention provides a method for fabricating a ventilation assembly. The method includes providing a flow conduit configured to allow fluid flow, locating a flow disrupter within the flow conduit, the flow disrupter being configured to impart a disturbance to the fluid flow, disposing a first sensor within the flow conduit at a first position, the first sensor being responsive to the disturbance of the fluid flow and being configured to generate signals responsive to the disturbance of the fluid flow, and operably connecting a processor to the first sensor, wherein the processor is configured to determine a flow rate for the fluid flow through the flow conduit based on a first algorithm determining an amplitude of the fluid flow in a first flow regime and a second algorithm determining a frequency of the fluid flow in a second flow regime.
An embodiment of the invention provides a method for fabricating a snore detector. The method includes providing a flow conduit configured to allow fluid flow, locating a flow disrupter within the flow conduit, the flow disrupter being configured to impart a disturbance to the fluid flow, disposing a first sensor within the flow conduit at a first position and a second sensor within the flow conduit at a second position, the first and second sensors being responsive to snoring and the disturbance of the fluid flow and being configured to generate signals characteristic of snoring and the disturbance of the fluid flow, placing a fan in fluid communication with the flow conduit, wherein the fan is configured to be activated only upon the detected presence of snoring, placing a flexible tube in fluid communication with the fan, placing a mask in fluid communication with the flexible tube, wherein the mask is configured to be worn by a person, and operably connecting a processor to the first and second sensors, wherein the processor is configured to determine characteristics indicative of snoring
An embodiment of the invention provides a snore detecting assembly, which includes a flow conduit configured to allow fluid flow, a flow disrupter configured to impart a disturbance to the fluid flow, a first sensor disposed within the flow conduit at a first position and a second sensor disposed within the flow conduit at a second position, the first and second sensors being responsive to sound and to the disturbance of the fluid flow and being configured to generate signals characteristic of the sound and the disturbance of the fluid flow, and a processor operably connected to the first and second sensors, wherein the processor is configured to distinguish between signals characteristic of the disturbance to the fluid flow and signals characteristic of sound.
These and other features, aspects and advantages of the present invention may be further understood and/or illustrated when the following detailed description is considered along with the attached drawings.
The present specification provides certain definitions and methods to better define the embodiments and aspects of the invention and to guide those of ordinary skill in the art in the practice of its fabrication. Provision, or lack of the provision, of a definition for a particular term or phrase is not meant to imply any particular importance, or lack thereof; rather, and unless otherwise noted, terms are to be understood according to conventional usage by those of ordinary skill in the relevant art.
Unless defined otherwise, technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which this invention belongs. The terms “first”, “second”, and the like, as used herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. Also, the terms “a” and “an” do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item, and the terms “front”, “back”, “bottom”, and/or “top”, unless otherwise noted, are merely used for convenience of description, and are not limited to any one position or spatial orientation. If ranges are disclosed, the endpoints of all ranges directed to the same component or property are inclusive and independently combinable (e.g., ranges of “up to about μwt. %, or, more specifically, about 5 wt. % to about 20 wt. %,” is inclusive of the endpoints and all intermediate values of the ranges of “about 5 wt. % to about 25 wt. %,” etc.).
The modifier “about” used in connection with a quantity is inclusive of the stated value and has the meaning dictated by the context (e.g., includes the degree of error associated with measurement of the particular quantity). Reference throughout the specification to “one embodiment”, “another embodiment”, “an embodiment”, and so forth, means that a particular element (e.g., feature, structure, and/or characteristic) described in connection with the embodiment is included in at least one embodiment described herein, and may or may not be present in other embodiments. In addition, it is to be understood that the described inventive features may be combined in any suitable manner in the various embodiments.
The assembly 110 includes a pair of sensing elements 120, 126. Each of the sensing elements 120, 126 is positioned within a conduit 112 that has an upstream opening 114 and a downstream opening 116. It should be understood that the terms “upstream” and “downstream” are relative terms that are related to the direction of flow 118. Thus, in some embodiments, if the direction of flow 118 extends from element 116 to element 114, then element 116 would be the upstream opening and element 114 would be the downstream element. For ease of description, the upstream side of the flow sensor assembly 110 will be the side closest to the opening 114 and the downstream side of the assembly will be the side closest to the opening 116.
A flow disrupter 134 is positioned equidistant between the sensing elements 120, 126. Further, the sensing elements 120, 126 are mounted on a printed circuit board (PCB) 132 at, respectively, first and second positions 122, 128. The purpose of the flow disrupter 134 is to form turbulence within the flow stream, such as, for example, waves or eddies. In so doing, the sensors 120, 126 can take measurements and send signals to, respectively signal conditioners 124, 130. The signal conditioners 124, 130 condition the signals by, for example, filtering or amplifying them, prior to sending the signals on to anti-aliasing filters and a processor (not shown) for analysis.
The locations of the first and second positions 122, 128, the shape of the flow disrupter 134, the positioning of the flow disrupter 134 relative to the sensors 120, 126 and within the conduit 112, and the size and positioning of the PCB 132 are all interrelated factors. For example, if the downstream sensor 126 is positioned too close to the flow disrupter 134, it will not pick up any of the turbulent vertices caused by the flow disrupter because it will be too far upstream to be able to detect the formation of such vertices. Conversely, if the downstream sensor 126 is positioned too far from the flow disrupter 134, it also will not pick up any of the turbulent vertices because they would have decayed to the point of being undetectable.
There are regions, located at a distance from the flow disrupter 134, at which the sensors 120, 126 are appropriately sited. These regions have a geometrical relationship wherein the error in the sensor reading is minimized. The relationship between error and the distance the sensor is from the flow disrupter is shown in the graph on
The characteristics, or vertices, of flow that can be determined are flow speed, flow direction, the pressure of the flow, the temperature of the flow, the change in velocity of the flow, the change in pressure of the flow, and the heat transfer of the flow. Thus, the sensors 120, 126 can be any form of sensor capable of sensing any one or more of these vertices. For example, the sensing elements 120, 126 may be configured to determine pressure, temperature, change in pressure, change in temperature, or change in flow rate. In one embodiment, the sensors 120, 126 are pressure sensors. In another embodiment, the sensors 120, 126 are heaters. In yet another embodiment, the sensing elements 120, 126 are microelectromechanical devices.
The presence of two sensors 120, 126 is not necessary. A single sensor instead may be used. However, the presence of two sensors does provide certain benefits. For example, ascertaining the direction of a flow of fluid is impossible with a single sensor. Thus, for applications where determining the direction of flow is needed, two sensors would be required. Further, there is a certain amount of ambient noise in the turbulent flow of fluid. Signals from a single sensor cannot differentiate ambient noise from other noise caused by turbulence, and hence there may be more inherent error from a flow sensor apparatus having only one sensor. Signals from a pair of sensors, on the other hand, can parse out ambient noise from noise caused by the turbulence itself, thus decreasing the amount of error inherent in the analysis of the signals.
The flow disrupter 234 may be positioned orthogonal to the fluid flow direction through the conduit. For example, as shown in
With specific reference to
Alternatively, a secondary flow disrupter 542 may be positioned near one of the sensors 120, 126. For one flow direction, the secondary flow disrupter will affect the DC values of one of the sensors, while in the opposite flow direction there will be no effect to the DC values of either of the sensors. For example, for a flow direction 544, the illustrated secondary flow disrupter 542 will affect the DC value of the sensor 126 but will not have an, or will have a negligible, effect on the sensor 120. For a flow direction 546, the illustrated secondary flow disrupter 542 will not affect the DC values of either sensor 120, 126.
In a third embodiment, direction of flow can be determined simply through the acknowledgement that the flow disrupter 134 will create, due to its presence, a higher flow downstream than is found upstream. Thus, the upstream sensor (126 for flow direction 544, 120 for flow direction 546) will record a lower flow rate than the downstream sensor.
While the PCB 132 may have arms as shown in
The conduit further may include a straightener section 650. The straightener section 650serves to condition the flow through the conduit. As illustrated in
As illustrated schematically in
There is an ambient pressure Pamb in the fluid flow 856 entering the flow sensor assembly 110. The fan 858 is provided to create a higher pressure PM that is used to facilitate the movement of a fluid through the tube 864 to the mask 866. There will be a pressure drop along the tube 864 between the higher pressure PM at the fan 858 and the lower pressure PP at the patient. A goal of the ventilation assembly 800 is to maintain a constant PP. A processor 867 is provided to assist in that goal.
As noted before, in ventilation apparatuses the flow rate is constantly changing. For such apparatuses used to treat sleep apnea, for example, the rate of air will change from a high rate (during normal inhalation/exhalation) to a zero flow rate (during periods of time when the patient has stopped breathing). It has been determined that there are essentially three flow rate regimes that can be analyzed. As illustrated in
Next, with reference to
Once the direction of the flow has been determined, either through the algorithm 1200 or the algorithm 1300, then a determination is made as to whether the direction of flow δ is greater than zero. If the direction of flow δ is greater than zero, then the flow of Dχ is determined by the flow Di algorithm 1400. If the direction of flow δ is not greater than zero, then the flow of DΦ is determined by the flow Di algorithm 1400. Once the flow of D102 is determined, then the AB′ for the flow of Dχ is updated by algorithm 1500 and δ and the flow rate for the flow of Dχ (Qχ) are determined. Once the flow of Dφ is determined, then the AB′ for the flow of Dφ, which is determined by algorithm 1600 of
Algorithm 1200 determines the direction of a high flow regime of flow. Upon initialization, an amplitude of the voltage VAC,χout of the signal, determined from N number of samples of Vχout taken by the sensors 120, 126, is obtained. Also, an amplitude of the voltage VAC,φout of the signal, determined from N number of samples of Vφout taken by the sensors 120, 126, is obtained. Then, a determination is made as to whether the amplitude of the voltage Vφout minus the amplitude of Vχout is greater or less than zero. If greater than zero, then the flow of Dχ is determined by the flow Di algorithm 1400. If not greater than zero, then the flow of Dφ is determined by the flow Di algorithm 1400.
Algorithm 1300 determines the direction of a low flow regime of flow. Upon initialization, a direct current value of the voltage VDC,χout of the signal, determined from N number of samples of Vχout taken by the sensors 120, 126, is obtained. Also, an a temperature corrected voltage VDC,χout is determined. Then, a direct current value of the voltage VDC,φout of the signal, determined from N number of samples of Vφout taken by the sensors 120, 126, is obtained. A temperature corrected voltage VDC,φout is also determined. Then, a determination is made as to whether the temperature corrected voltage VDC,χout minus the temperature corrected voltage VDC,φout is greater or less than zero. If greater than zero, then the flow of Dχ is determined by the flow Di algorithm 1400. If not greater than zero, then the flow of Dφ is determined by the flow Di algorithm 1400.
In algorithm 1400, after initialization a determination is made as to whether the signals represent high flow, for example, the very high flow regime 1080 (
The fast Fourier transform peak detection is performed through bi-linear fitting. In
In update AB′ algorithm 1500, a high flow is determined. The update AB′ algorithm 1600 utilizes voltages for low flow VDCout,fl and voltages for high flow VDCout,fh to solve the following equations:
In the two above equations, the left-hand sides of the equations contain variables that are either measured or otherwise known through calibration techniques. Further, the low flow Q of Equation 1 and the high flow Q of Equation 2 are also known. Thus, there are two equations with two unknowns, namely A and B′, allowing for the solving of both unknowns in near real-time. Knowing A and B′ in near real-time allows for those values to be plugged into the algorithm 1700 to solve for Q.
In an alternative embodiment, the equations to be solved for in algorithm 1600 include a more explicit temperature correction. Specifically, the equations to be solved for in algorithm 1600 may be:
V
out,fl
DC
+γT
flow,fl
=A+B′Q
n
fl Equation 3:
V
out,fh
DC
+γT
flow,fh
=A+B′Q
fh
n Equation 4:
Temperature corrected values assist in providing a more accurate assessment of flow rates.
In another embodiment, the equations to be solved in algorithm 1600 are altered to include a nth order polynomial. Specifically, the equations to be solved in algorithm 1600 may be:
Another embodiment of the invention includes a rapid response to changes in flow rates. By “rapid response” is meant a response that occurs within ten milliseconds of a change across an entire dynamic range in a flow rate. If the rapid response embodiment is incorporate within a CPAP machine, for example, the importance of such a response is fairly evident. Upon a patient entering a pattern where his breathing is disrupted, a rapid response, i.e., activation of a fan, would create a rapid change in the CPAP operation in response to the change in breathing pattern.
The rapid response to changes in the flow rate can be accomplished in several ways. For example, in one aspect, the frequency of the flow rate can be calculated, using a fast Fourier transform, to ascertain a rapid change in flow rates.
Alternatively, the amplitude of the signals from the sensors. By reviewing the output of the sensors, the amplitude of the signals can be ascertained. If a large amplitude change is seen, then a presumption can be made that the flow rate may be changing quickly. Any one of Equations 1-6 can be utilized to determine flow rates based on the sensors alone, and then subsequent flow rates as determined by the sensors can be reviewed. Once the determined flow rates from the sensors approach the flow rates calculated using fast Fourier transforms (FFT), FFTs can be used from that point on to continue tracking the changing flow rates.
Alternatively, two FFTs can be run in parallel. One FFT run would be the normal, long FFT. The other FFT would be a quick one using only the most recent values. For example, the long FFT may utilize 4,096 separate points of data in its calculations, while the quick FFT may only utilize 512 points. If the flow rate changes rapidly, the quick FFT will provide good resolution.
In another embodiment, zero crossing based frequency determination is used instead of fast Fourier transforms. In yet another embodiment, a special noise reduction and averaging algorithm is used in addition to the zero crossing to render the noise vulnerability of the zero crossing based algorithms.
In yet another embodiment, a phase locked loop approach is used instead of the fast Fourier transforms for the demodulation and the determination of the flow velocity. In yet another embodiment, a double phase locked loop is used instead of single phase locked loop.
In yet another embodiment, an adaptive notch filter-based or Kalman filter-based signal processing method is used for the demodulation of the sensor signal and the determination of the flow velocity.
In yet another embodiment, time-resolved and frequency-resolved demodulation and determination of the flow rate is obtained by the use of wavelet transforms and wavelet analysis.
An embodiment of the invention utilizes the flow sensor system as a snore detection system. Referring once again to
If the flow sensor assembly 110 is being used in a CPAP or VPAP machine, the sensors 126, 120 can further detect the sound of snoring. If the person using the flow sensor assembly 110 begins to snore, both of the sensors 126, 120 will detect the sound and the output of both sine generators 130, 124 will include a sine wave. Thus, the presence of a sine wave in both sine generators 130, 124 is indicative of snoring.
To cancel out the sound, the output of sine generator 130 can be subtracted from the output of sine generator 124 to arrive at the sine wave for just the vertices in the flow. Alternatively, one can analyze the output spectrum of the sine generator 130 to find the characteristic peaks of snoring, which are found in certain frequency ranges. The characteristic frequency peaks for snoring have been studied. See, for example, Beck, R., et al., The acoustic properties of snores, Eur. Respir. J., 8, p. 2120-2128 (1995); Dalmasso, F., et al., Snoring: analysis, measurement, clinical implications and applications, Eur. Respir. J., 9, 146-159 (1996); Fiz, J. A., et al., Acoustic analysis of snoring sound in patients with simple snoring and obstructive sleep apnoea, Eur. Respir. J., 9, p. 2365-2370 (1996); Quinn, S. J., et al., The differentiation of snoring mechanisms using sound analysis, Clinical Otolaryngology & Allied Sciences, V. 21, I. 2, 119-123 (April 2007); Schäfera, J., et al., Digital signal analysis of snoring sounds in children, Int'l J. of Pediatric Otorhinolaryngology, V. 20, I. 3, 193-202 (December 1990); Saunders, N. C., et al., Is acoustic analysis of snoring an alternative to sleep nasendoscopy?, Clinical Otolaryngology & Allied Sciences, V. 29, I. 3, 242-246 (June 2004); and Agrawal, S., et al., Sound frequency analysis and the site of snoring in natural and induced sleep, Clinical Otolaryngology & Allied Sciences, V. 27, I. 3, 162-166 (June 2002).
Conversely, since the signals of flow can be separated out from the signals of snoring, the signals of snoring can be isolated and looked for. Specifically, by adding the outputs of the two sine generators 130, 124 and then subtracting out the absolute value of the difference of the outputs of the two sine generators 130, 124,
(130out+124out)−|130out−124out|
the result are the signals for sound, i.e., snoring.
Since the signals for snoring can be isolated out, a processor 867 (
While the invention has been described in detail in connection with only a limited number of embodiments, it should be readily understood that the invention is not limited to such disclosed embodiments. Rather, the invention can be modified to incorporate any number of variations, alterations, substitutions or equivalent arrangements not heretofore described, but which are commensurate with the spirit and scope of the invention. For example, while embodiments have been described in terms that may initially connote singularity, it should be appreciated that multiple components may be utilized. Additionally, while various embodiments of the invention have been described, it is to be understood that aspects of the invention may include only some of the described embodiments. Accordingly, the invention is not to be seen as limited by the foregoing description, but is only limited by the scope of the appended claims.