CN107961042B - Intelligent expiration sampling method and device - Google Patents
Intelligent expiration sampling method and device Download PDFInfo
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- A61B2010/0083—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements for taking gas samples
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Abstract
The invention relates to an intelligent sampling method and device, wherein the sampling method comprises the following steps: the complexity of the driving program is simplified by adopting a differential algorithm adjustment and an early intervention means, so that the micro adjustment is realized, and the flow change is flattened; an iterative algorithm is adopted to match with a subject to find a proper rule, so that the flow is adjusted harmoniously and smoothly through man-machine interaction; the sampling device includes: the device comprises a breathing filtering module, a flow control module, a gas emptying device, a gas collecting device, a sensor, a control unit, an interface and the like, wherein during expiration, air flow is fed back to the control unit through the sensor to control the flow control module to adjust required flow, after the air flow is emptied through the emptying device, the air flow enters the gas collecting device to complete a sampling process, the flow control module performs man-machine interaction operation and parameter setting according to an intelligent flow control algorithm adopted by signal change of the sensor, and the interface is used for performing man-machine interaction operation and parameter setting.
Description
Technical Field
The invention relates to an intelligent expiration sampling method and device used in the field of endogenous expiration gas detection.
Background
Studies have shown that there are many components in exhaled breath that can help one get a good understanding of the metabolic processes of certain diseases and have an indicative effect on certain diseases, even the presence of the causative agents of certain diseases. In research and clinical settings, examples of gases present in expired air include Nitric Oxide (NO), carbon monoxide (CO), hydrogen sulfide (H) 2 S), hydrogen (H) 2 ) Methane (CH) 4 ) Carbon dioxide (CO) 2 ) Oxygen (O) 2 ) And volatile organic compounds VOC, etc.
However, in order to obtain reliable, repeatable measurements, strict control over the flow rate, pressure and time of the exhaled breath is necessary. For example, in the technical standard of exhaled breath NO determination established by the american society of thoracic (ATS) and european society of respiratory (ERS) in combination in 2005, a subject is required to be at least 5cmH 2 The expiratory pressure of O is maintained at a constant expiratory flow rate of 50mL/s for 10s (adult) or 6s (child). Typical exhalation flow rates for humans are approximately in the range of 200-300 ml/s. This requirement to maintain a flow rate of 50mL/s presents certain difficulties for both children and adults with partly respiratory diseases.
In order to reduce the difficulty of expiratory flow control, the applicable population of expiratory tests is expanded, and a device for expiratory flow control is generally adopted to assist a subject to complete the expiratory test meeting the requirements. For example, current commercialization techniques (e.g., aerocrine published patent CN105916538A and Sunvou published patent CN 103487295B) and non-commercialization techniques (e.g., other published patents CN203539351U, US9687178B2, CN102395934a and CN101458250 a) provide two means of constant regulation of expiratory flow, both self-powered and electrically powered. Whichever means, to ensure that the expiratory flow rate is constant at the designed value, the flow rate adjustment of the expiratory test generally comprises: (1) The device adjusts the opening of the valve according to the measured flow rate of the exhaled air of the subject and the set adjusting speed, when the flow rate is higher, the valve is closed, and when the flow rate is lower, the valve is opened; simultaneously prompting the change of the flow rate of the subject through images or sound and light; (2) The subject will generally change his/her own effort to exhale according to the device's visual or audible cues for changes in flow rate, with higher flow rates decreasing the blowing force and lower flow rates increasing the blowing force. The problem thus arises that the regulation of the device and the subject has a time difference or hysteresis effect, or even a reverse regulation, in many cases less than optimal flow rate control results, even leading to failure. Statistics of near million clinical expiration test data we found that the techniques of self-contained and electrically-powered expiratory flow rate adjustment did not actually significantly improve the success rate of patient testing. The self-standing type has the following problems: 1) After the mechanical structure is used for a long time, the performance cannot be ensured, particularly, the original parts such as a spring and the like are easy to be in an environment with high humidity in an expiration test, and failures such as rust and the like appear; 2) The mechanical structure has large processing difficulty (high requirement on small aperture and high precision), the production and adjustment difficulty is high, and the structure cannot be repaired once the processing fails. The following problems exist with the electric type: 1) When the force is blown, the resistance is overlarge, the steering engine can be quickly closed to the minimum, so that the resistance of the air path is overlarge, and the continuous expiration of a subject can be difficult; 2) When the subject continuously exhales, the subject can unconsciously adjust the expiratory force to cause the expiratory pressure to change, and at the moment, the resistance adjusting speed can not keep up in time, so that the flow curve is unstable.
In fact, most people with dyspnea are tested by exhalations, and the device needs professional guidance, so that the success rate is slightly high, if the professional guidance is not performed, the success rate is very low. Because of poor effect, most of the expiratory test equipment on the market at present is not provided with the expiratory speed regulating devices or is not provided with the expiratory speed regulating devices.
In order to solve the problem, the invention introduces intellectualization, replaces manual professional guidance, and can successfully exhale and sample people with dyspnea, designs and uses an intelligent exhale flow rate adjusting device based on a man-machine interaction algorithm, ensures the synchronization harmony of man-machine exhale flow rate adjustment, and achieves nearly 100% exhale test success rate.
Disclosure of Invention
The invention provides an intelligent expiration sampling method and device aiming at the problems. The convenience and the effectiveness of the patient in the expiration sampling process are greatly improved. The invention designs two algorithm models, performs intelligent expiration sampling, and designs an expiration sampling device to realize the intelligent expiration sampling.
Because of the subject breath sampling process, as shown in fig. 1, without intervention on the breath flow curve, the subject is prone to large fluctuation, breath sampling is prone to exceeding the range of flow requirements, and sampling failure is prone to occur.
The human-computer interaction self-adaptive algorithm model constructed by the invention comprises the following steps: an adaptive algorithm is designed to achieve the functions of early intervention and micro flow regulation. As shown in FIG. 1, Q is the ordinate of the graph, deltat is the abscissa of the graph, deltat is the slope of the curve in the graph, deltaQ is the system setting a decision value, Q t For real-time flow value, Q 50 Flow value of 50mL/s, Q o The matching flow value set for the system is R is the passing caliber of the system gas circuit, R is the diameter of the regulating position of the flow regulating valve core of the system gas circuit, L is the distance for the assumed gas to pass through, gamma is the system constant, delta is the system flow measurement constant,
ΔQ＝(Q t -Q 50 )-Q o
Q t ＝δπ(R 2 -r 2 )L
approximating the local rate of change of the flow as a linear description, the derivative algorithm may approximate how the value of the flow Q changes when the time value changes little enough. For example, the change delta t of t tends to be infinity hours, and is then recorded as infinitesimal dt; the variation Deltar of r tends to be infinity hours, then is denoted as a micro-element dr,
if the time dt of the early intervention is set and must be implemented from the evacuation segment, it can be set to 1ms, where dt is fixed, so the formula can be simplified as:
K x 、K y are all preset constants of the system. The differential algorithm shows that C and R, r are in a linear relationship, namely the flow rate change rate and the gas passing caliber are in a linear relationship, so that the complexity of a driving program can be simplified, the driving program can be intervened in advance, the micro adjustment is realized, the flow rate change is flattened, and the human-computer interaction experience is improved. Greatly improves the effectiveness of breath sampling.
The man-machine interaction self-adaptive algorithm model constructed by the method comprises the following steps: and establishing a model of a human-computer interaction algorithm, and performing interaction with a subject by a driving control algorithm of the linear stepping motor (301). The driving control algorithm comprises three aspects of iterative learning, convergence analysis and robustness analysis. In the motion process of the linear stepping motor (301), the pressure value changes, the whole system is a nonlinear system, the pressure value changes at different displacement positions are different, the interference of human expiration is involved, the classical PID control algorithm cannot be matched in real time to carry out smooth adjustment, or the problems of adjustment lag and the like are solved, and the expiratory sampling requirement is difficult to meet.
And constructing a dynamic mathematical model of the sampling device. Selecting variables
x 1 ＝Q
x 2 ＝L
x 3 ＝t
Wherein x is 1 For the flow value Q, x measured by the sensor (200) 2 Is the motion displacement L, x of the linear stepping motor (301) 3 To adjust the time t generated. The system output y is the actual flow Q 'exhaled by the person'
y＝x 1
Model parameter K in t 、K Q 、C L 、T L 、T Q Are all preset constants of the system.
The system dynamic process is described as follows:
y(t)＝f(x(t)，t)+f(x(L)，L)
where x (t) corresponds to the time state of the system and x (L) corresponds to the displacement output signal of the system.
And (5) establishing an iterative control process. The iteration number is represented by n, and the equation is as follows when the nth iteration is operated:
y n (t)＝f(x n (t)，t)+f(x n (L)，L)
wherein x is n (t) time corresponding to the current systemState, x n (L) a displacement output signal corresponding to the current system.
In contrast to the desired output:
S n ＝y d (t)-y n (t)
wherein y is d (t) is a system initial value. Initial value y of system d (t) and the initial control x (L) are determined, and a determination S is made n If the system requirements are met, continuing to iterate until the S requirements set by the system expectations are met. However, the whole iterative process is controlled by time t, which is set to an ergonomic time.
The reaction time of human body's sense organ after receiving external stimulus is called human body reaction time. The visual simple reaction time of common people is 0.2-0.25s; the response time of hearing is 0.12-0.15s. Because the nerve transmission speed of a person generally has an refractory period of about 0.5s, the intermittent operation gap period requiring sensory guidance is generally greater than 0.5s, the complex selective reaction time is generally 1-3s, and the complex judgment and the operation reaction time of personnel are longer; in addition, because some patients exist in the crowd to which the breath sampling device is applicable, the reaction time of general patients needs to be prolonged by about 30% when long-term investigation and data acquisition are performed.
According to the intelligent sampling method, the intelligent sampling algorithm model is built, so that the adjusting speed is consistent with the reaction speed of a person in the sampling process, the matching is smooth, and the sampling convenience is improved. Meanwhile, two algorithms can be fused, and an artificial intelligent sampling algorithm is constructed.
The invention relates to an expiration sampling device, which adopts the intelligent sampling algorithm model established above. The device internal functional structure comprises: comprises a shell structural component, a breathing filtering module, a flow control module, a gas sampling and evacuating component, a sensor, a control unit component, a human-computer interface component and the like. The flow control module (300) consists of a venturi tube (203), a conical valve core (303), a linear stepping motor (301) and a gas circuit board (305); the conical valve core (303) is arranged on the shaft of the linear stepping motor (301), and a first sealing ring (302) and a second sealing ring (304) are arranged on the conical valve core (303); the venturi tube (203) is connected with the sensor (200) for signal acquisition; the air channel plate (305) is matched with the conical valve core (303) and is provided with an air inlet (311) and an air outlet (312), and can be seen in fig. 3.
The sensor (200) is used for detecting the parameter change from inhalation to exhalation and transmitting the parameter change as a signal, the detected signal is a flow rate signal, a pressure signal and the like, judging the exhalation state of a subject, carrying out flow regulation feedback and the like, the detected signal is an O2 content, a CO2 content and the like, judging the state of the exhaled air of the subject, judging the positions of dead space gas, large airway gas, small airway gas, alveolar gas and the like, and carrying out flow regulation, evacuation setting, sampling setting and control.
The respiratory filter module (100) is fast connected with the pipeline by adopting a pipe connecting piece (804), is inserted into the lower shell (801) and is fixed by a spiral cover (802), and the spiral cover (802) is unscrewed to facilitate fast plug and pull replacement, as shown in fig. 2. The gas sampling and evacuating part consists of a three-way electromagnetic valve (401) and a sampling interface (402), and can be seen in fig. 2; the sensor and control unit component consists of a hose (201), a sensor element (202), a venturi tube (203) and a control unit (600); the human-computer interface component consists of a display screen upper cover (701), a display screen (702), a display screen lower cover (703), keys (704) and a key circuit board (705); the shell structure part comprises a lower shell (801), a spiral cover (802), an upper shell (803), a pipe connecting piece (804), a fixing piece (805), a rechargeable battery (806) and other structures.
Through the design of the device, when the maximum diameter of the conical needle valve (303) is designed to be 4mm, the resistance of the device is 10cmH when the conical needle valve (303) advances to the maximum opening and closing position of the valve during the expiration process 2 O, the resistance when the conical needle valve (303) retreats to the minimum valve opening and closing position is 5cmH 2 O, ensure that the exhalation resistance can be controlled to be 5-10cmH in the whole exhalation process 2 O。
The sampling process of the invention is as follows: the subject breathes in clean air and exhales after adopting respiratory filtration module (100), the air current passes through venturi (203) and reaches gas circuit board (305), the air current carries out flow regulation control through the effect of gas circuit board (305) and toper case (303), reach three solenoid valve (401) after the air current passes through gas circuit board (305), set for program control and empty through the intelligent sampling algorithm model of setting up, sample after the evacuation is accomplished, the air current passes through three solenoid valve (401) and reaches sampling interface (402), sampling interface (402) are connected with the sampling bag with gaseous collection in the sampling bag. The control unit (600) monitors and controls flow regulation in the whole sampling process, and the interface (700) displays the expiration process and the sampling reminding function.
At present, a human-computer interaction algorithm and an intelligent sampling device are designed for visual feedback, and the optimal matching time is achieved by matching a subject.
The installation, cooperation and working principle of the flow control component of the invention are as follows:
the specific installation sequence can be seen from fig. 4, the conical valve core (303) is installed on the linear stepping motor (301), the linear stepping motor (301) is installed on the air circuit board (305), small holes are formed in the air circuit board (305), flow control adjustment is carried out by matching with the conical valve core (303), the venturi tube (203) is installed at the front end of the air circuit board (305), and two acquisition ports A and B on the venturi tube (203) are respectively connected to the interfaces A and B on the sensor element (202). The venturi tube (203) is adopted to measure the pressure difference of the gas, the italian physicist Giovanni Battista Venturi is adopted, and the diameter of section A is D A The diameter of the section B is D B Design requirement D A <D B The pressure difference between the two sections is measured, and the flow can be obtained by using the Bernoulli's theorem equation. A first sealing ring (302) is arranged on the conical valve core (303) and is matched with the gas circuit board (305) to open and close the pipeline; and a second sealing ring (304) is arranged on the linear stepping motor (301) and matched with the gas circuit board (305) to seal, so that no leakage in the expiration process is ensured.
Flow regulation control of the sampling device: the conical valve core (303) is matched with the air channel plate (305) to perform flow regulation control, and the conical design of the conical needle valve (303) meets the design requirement of man-machine interaction. The conical needle valve (303) is of a long conical structure, and the gas flow can be regulated by regulating the depth of the conical needle valve (303) inserted into the gas circuit board (305). The maximum diameter of the conical needle valve (303) is designed to be 4mm, when the taper is smaller, the effective movement distance of the linear stepping motor (301) is longer, and when the taper is larger, the effective movement distance of the linear stepping motor (301) is shorter; the most suitable taper needs to be designed to meet the ergonomic time requirement of the linear stepper motor (301) drive distance. The effective adjustment distance corresponding to each taper is shown in figure 5. Considering a combination of the reaction time required by the person, the linear step increment of the linear stepper motor (301), and the number of Pulses Per Second (PPS), the cone angle of 30 ° is preferred in fig. 5.
Therefore, compared with the self-operated and electric expired air sampling device, the invention has the greatest advantages that the intelligent sampling algorithm is adopted to design, and the sampling device is designed on the basis, so that the manufacturing is simple, the sampling is convenient, and the success rate is greatly improved. These features and advantages will be apparent from the following detailed description.
Drawings
FIG. 1 is an intelligent sample flow curve.
Fig. 2 is a block diagram of an breath sampling device.
Fig. 3 is an exploded view of the breath sampling device of the present invention.
Fig. 4 is a diagram of the structure of the expiratory flow regulation control in fig. 3.
Fig. 5 shows a graph of expiratory flow versus distance of movement for different tapers.
Detailed Description
The invention is adopted to sample the expired air, collect the nitric oxide which is expired by the human body, and cooperate with a Sunvou-CA2122 type Nacoulomb expired air analyzer to measure the nitric oxide.
Embodiment one: according to the off-line sampling technology of nitric oxide recommended in ATS/ERS (advanced technology for measuring NO) technical standard guide, the sampling process is as follows: the expiratory flow is required to be 45mL/s-55mL/s, and the expiratory resistance of the emptying and sampling channels is controlled to be 5-20cmH 2 O range. And (3) performing mode setting before expiration, sampling the expiration of the subject, sucking clean air, observing sampling feedback displayed by a screen, and performing a matching test until the sampling is successful. According to the requirements of the invention, design and manufacture a prototype, perform crowd simulation test, invent the prototype and the methodThe Sunvou-CA2122 nano coulomb exhalation analyzer tests on line, and the electronic sampler of the electronic regulator scheme performs contrast experience, and the experience data can be seen in the table I.
Form-subject actual experience scoring
After sampling, the inventive model machine uses Sunvou-CA2122 nano coulomb exhalation analyzer to analyze, and uses the electronic sampler to sample and analyze, the specific test data can be seen in the following table II.
Comparison of exhaled nitric oxide test values for Subjects
From experience results, the invention model machine is obviously improved compared with an online (Sunvou-CA 2122) and electronic sampler, and all subjects can sample successfully at one time. The consistency of the detection result meets the clinical index requirements with the detection result of the nitric oxide in the exhaled breath of an online (Sunvou-CA 2122) and electronic sampler.
Embodiment two: as described in the first embodiment, the device of the present invention can be simplified, and the modules of the reserved flow control module (300), the sensor (200), the control unit (600) and the like are implanted into the nano coulomb expiratory hydrogen analyzer (Sunvou-CA 2122), so that the device can be manufactured into an intelligent expiratory sampling analysis device, and the sampling success rate is improved, and the cost and the volume are obviously increased.
Embodiment III: as described in the first embodiment, the flow range can be set, for example, the flow of 180mL/s-220mL/s of the exhalation is required, the through path can be designed to be increased, and the evacuation valve can be designed to be increased, so that the detection of the exhalation of the small airway can be performed; by adopting the design scheme of adding the evacuation valve, the flow range sampling of 45-55mL/s can be carried out. This design also meets the requirements set forth above.
Embodiment four: as described in the first embodiment, the visual man-machine interaction interface is adopted for display, or the visual man-machine interaction interface can be designed as an acoustic prompt such as voice, and man-machine interaction design is performed in a manner such as hearing, for example, reminding is realized in a manner such as acoustic size change, or feedback is performed by adopting an acoustic prompt, and the design also meets the requirements.
Fifth embodiment: as in the first embodiment, a breath hold reminding function can be added to increase the evacuation time, and the sensor is used for measuring O in real time during the exhalation process 2 And CO 2 The concentration is equal, and the stage of judging the expiration can be performed at different parts (H can be performed) in expiration, at the end of expiration and the like 2 、CH 4 、H 2 S, CO, etc.), and has a far-reaching significance for clinical judgment.
The design, prototype test and the like in the above embodiments can show that the invention can improve the convenience, safety and effectiveness of test analysis.
The invention is not limited to the embodiments shown and described, but any variations and modifications are intended to be within the scope of the appended claims.
Claims (5)
1. An expired air sampling method for use in the expired air detection field, characterized by: the sampling method comprises an early intervention means and a driving control algorithm, wherein the early intervention means comprises the steps of leading a flow rate change C to be in line with a gas passing caliber through a differential algorithm, and specifically comprises the steps of setting the time dt of the early intervention to be fixed and being implemented from an emptying section, wherein the differential algorithm is as follows:
wherein R is the passing caliber of a system gas circuit, gamma is the diameter of a flow regulating valve core regulating position of the system gas circuit, L is the distance of supposed gas passing, t is time, gamma is a system constant, delta is a system flow measurement constant, K x 、K y Are all preset constants of the system; the driving control algorithm comprises the steps of designing and matching with a subject, and is characterized in that a proper rule is searched, and the dynamic process of the system is described as follows: y (t) =f (x (t), t) +f (x (L), where x (t) corresponds to the time state of the system and x (L) corresponds to the systemA displacement output signal; the iteration control process is established, n is used for representing the iteration times, and the equation is as follows when the nth iteration runs: y is n (t)＝f(x n (t)，t)+f(x n (L), L), wherein x n (t) corresponds to the time status of the current system, x n (L) corresponding to the displacement output signal of the current system, and enabling the initial value y of the system d (t) and the current value y n Difference S of (t) n ＝y d (t)-y n (t) by n repeated runs, S n Reaching the preset value of the system, the whole iterative process t sets the time conforming to the ergonomic requirement.
2. An intelligent sampling device, characterized in that the intelligent sampling device uses the breath sampling method according to claim 1, and the intelligent sampling device comprises a breath filtering module (100), a sensor (200), a flow control module (300), a gas collecting device (400), a gas evacuating device (500), a control unit (600) and an interface (700), and is characterized in that: -said sensor (200) for detecting a parameter change representing inhalation to exhalation and signaling the parameter change; the control unit (600) receives signals transmitted by the sensor (200) and controls the flow control module (300), and is connected with and controls the gas evacuation device (500) and the gas collection device (400); the interface (700) is connected with the control unit (600) for input operation and parameter setting; the flow control module (300) consists of a venturi tube (203), a conical valve core (303), a linear stepping motor (301) and a gas circuit board (305); the conical valve core (303) is arranged on the shaft of the linear stepping motor (301), and a first sealing ring (302) and a second sealing ring (304) are arranged on the conical valve core (303); the venturi tube (203) is connected with the sensor (200) for signal acquisition; the air channel plate (305) is matched with the conical valve core (303) and is provided with an air inlet (311) and an air outlet (312).
3. An intelligent sampling device according to claim 2, wherein: the signal detectable by the sensor (200) is: flow, pressure, O 2 Content of CO 2 The content is as follows.
4. An intelligent sampling device according to claim 2, wherein: can effectively control the expiratory resistance to 5-10cmH 2 O。
5. An intelligent sampling device according to claim 2, wherein: the respiratory filter module (100) can be conveniently and rapidly plugged and replaced.
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| US20230293043A1 (en) * | 2020-07-01 | 2023-09-21 | Shenzhen Breatha Biotechnology Co. Ltd | Handheld exhaled gas collection device |
| CN113219042A (en) * | 2020-12-03 | 2021-08-06 | 深圳市步锐生物科技有限公司 | Device and method for analyzing and detecting components in human body exhaled air |
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