WO2020058985A1 - Système de spiromètre portatif - Google Patents

Système de spiromètre portatif Download PDF

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Publication number
WO2020058985A1
WO2020058985A1 PCT/IN2019/050199 IN2019050199W WO2020058985A1 WO 2020058985 A1 WO2020058985 A1 WO 2020058985A1 IN 2019050199 W IN2019050199 W IN 2019050199W WO 2020058985 A1 WO2020058985 A1 WO 2020058985A1
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Prior art keywords
differential pressure
pressure sensor
cabinet
spirometer
hand held
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PCT/IN2019/050199
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English (en)
Inventor
Amrit Dixit
Swadesh K Singh
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DIXIT Amrit
Swadesh K Singh
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Publication of WO2020058985A1 publication Critical patent/WO2020058985A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs

Definitions

  • the present invention relates to in general to devices and systems used to assess how well human lungs work by measuring how much air a person inhales and in particular to a hand held spirometer system which is compact, cost effective and easy to use.
  • Spirometry is a reliable method of identifying obstructive illnesses, i.e. chronic obstructive pulmonary disease (COPD), reversible disease, i.e. Asthma and restrictive disease, i.e. pulmonary fibrosis. It can be used to grade the severity of COPD.
  • COPD chronic obstructive pulmonary disease
  • Asthma reversible disease
  • restrictive disease i.e. pulmonary fibrosis
  • Pulmonary function testing is indicated for all persons in whom there are symptoms and a positive response to a suitable respiratory questionnaire, an example of which is shown in Table 1 given later in this description. It is especially indicated in persons with complaints of shortness of breath.
  • spirometry provides a baseline of performance values for comparison with results of future tests. The impact of air pollution on non-smokers may also be detected by such comparison.
  • ventilator function testing include the following: to measure the extent of pulmonary function impairment; to help determine the type of impairment, such as restrictive, obstructive or a combination of the two; to study possible effectiveness of bronchodilator therapy and the degree of air obstruction reversibility; for pre-operative evaluation, especially for surgical procedures on the chest or upper abdomen; to follow the course of a patient's disease; and to establish baseline ventilator function.
  • electronic devices available for ventilator function testing suitable for rapid testing of a large number of subjects with uniform accuracy. Instead of a bellows or water-sealed bell, they use hot wire anemometers, thermistors, thermocouples, pneumotachograph or turbines to detect flow and electronically calculate volumes. They can measure, calculate, display and print out results, some including percentage of predicted normal values in a fraction of the time required by earlier apparatus.
  • a Venturi tube is a tube which is narrower in the middle than it is at the ends. When the fluid flowing through the tube reaches the narrow part, it speeds up. It then exerts less pressure. By taking the pressure difference between the two sections, it is possible to assess information on the flow rate.
  • the problem associated with the venture meter is that it does not create pressure difference when the air flow rate is small.
  • the airflow perturbation device is a potentially inexpensive system for measuring respiratory resistance.
  • the APD consists of a mouth pressure transducer and a pneumotach whose end is attached to a rotating wheel.
  • an APD device In an APD device, a rotating wheel is placed in the flow path, turned using a small motor. It perturbs airflow and mouth pressure by a small amount. Such small charges in airflow and mouth pressure are sensed by the APD and used to evaluate respiratory resistance. Resistance values are displayed on a small digital display located on the front face of the APD. Data analysis is done in“real time” and the average values of the last few perturbations are displayed. This is handheld device and easy to carry. We have made the hand held device to measure the pulmonary function test of the patient who are suffering from the respiratory diseases.
  • a spirometer device must take several problems for standardizing spirometry into account, which are required to be incorporates in the device.
  • the problem of spirometry standardization is considered after analysing the standard of ATS/ERS (2005) and prospective requirements for spirometers of three levels have been proposed. The possibility of flow sensors to meet these requirements have been considered.
  • results are usually given in both raw data (liters, liters per second) and percent predicted i.e. the test result as a percentage of the "predicted values" for the patients of similar characteristics (height, age, sex, and sometimes race and weight). Generally speaking, results nearest to 100% predicted are the most normal, and results over 80% are often considered normal. Multiple publications of predicted values have been published based on various studies conducted and may be calculated based on age, sex, weight and ethnicity. [0014] However, the results may vary from person to person depending on his/her resistance to allergens, family history, smoking habits, environmental conditions etc. Thus, interpretation is generally done by qualified medical professionals taking all these factors of patient history into consideration, rather than through an automated system. The interpretation of the results can vary depending on the physician and the source of the values predicted.
  • Chronic respiratory disease management requires both long term and short term action, mainly medication. Achieving steady state control is a continuous process and a possibly life threatening exacerbation can take place unexpectedly within hours. Physicians have entrusted patients to self-report on symptoms and act accordingly, especially in case of an attack. Given that self-reported symptoms are used to base decisions on self-medication and hospital admissions and that physicians depend on those reports for further therapy, there has been a long effort to quantify them. To this extent, several non-medically certified devices have been administered to patients, so that they can base decisions and track records. The initial quantification effort has been the PEF meter, a mechanically operated device, which can record the maximum flow that a patient can exhale. Lately, electronic versions have appeared with the added benefits of accuracy and record tracking.
  • a hot-wire transducer-based prototype digital spirometer is known, which is operated under constant voltage mode. But it can only allow for unidirectional measurement of airflow with temperature compensation. To improve the linearity, accuracy and functions, further modification of the analogue circuit is underway. New development of flow sensors by using MEMS technology has allowed the significant size reduction for hand-held devices.
  • Various spirometer systems are in existence and are patented. Some have a large mechanical system, which cannot be taken from one place to another easily.
  • a personal spirometer is also known. However, this device structure is not convenient to operate, is bulky in nature and does not offer easy portability. This device works on the principle of turbine flow measurement technique, which requires a certain minimum air pressure to move the turbine so that the flow can be measured.
  • the primary object of the invention is to provide a hand held spirometer system which is light weight and easy to operate.
  • Another object of the invention is to provide a hand held spirometer system which is a low cost device with high accuracy.
  • a further object of the invention is to provide a hand held spirometer system which is robust, portable and can be operated by the patient himself.
  • a hand held spirometer system comprises of a spirometer body and a differential pressure sensor cabinet operationally connected by a communication cable via USB port.
  • the lower body structure of the spirometer body holds a microcontroller board, an LCD Module, a battery and USB connections. Its upper body structure accommodates a TFT colour display and a power on/off switch.
  • the differential pressure sensor cabinet has a top part joined through suitable fasteners to a bottom part to form the cabinet.
  • the cabinet accommodates a differential pressure circuitry, a differential pressure sensor and a thin film mesh membrane which is placed in a cavity, sandwiched between the two parts.
  • the differential pressure sensor has two incoming points. One incoming point each is connected to the top part and the bottom part. A hole is provided in each mouthpiece at a distance of 5mm from the thin film membrane such that some amount of air can travel to the sensor input.
  • the differential pressure sensor cabinet has a sensor connectivity point, from where the communication cable travels to the microcontroller board.
  • the differential pressure sensor has a range of -7kpa to 7kpa.
  • the differential pressure sensor cabinet has an inlet for air to reach the sensor.
  • a curved shape is provided on the edge of the sensor cabinet for ease of use.
  • An analogue to digital converter unit is provided in the microcontroller for converting the analogous signal generated by the differential pressure sensor to digital signal for storing in an array.
  • a process for measuring major pulmonary function parameters using the hand held spirometer system as described above comprises of initializing pressure sensor, time constant and LCD display; defining array for storing subject spirometry data and number of samples; collecting 50 samples for error corrections and calculating error data; instructing patient to start respiration process as instructed by professional; collecting the differential pressure data (V) in an array; applying filter to collected sample values and converting the voltage values to corresponding pressure values; calculating flow rate from the equation; calculating Max and Min flow rate and their positions from the flow rate value; calculating starting and ending positions of force expiratory flow rate from the flow rate array; calculating FVC and FEV from the starting and ending of force expiration flow rate data via integration with time constant; and displaying the result of PEF(L/sec), FVC(L), FEVl(F) and FEV1/FVC (%) in the
  • Figure 1 shows the Expiration Flow Rate v/s Time Curve.
  • Figure 2 is the Force Expiration v/s Time Curve.
  • Figure 3 shows a typical Flow Volume loop or Spirogram of a patient.
  • Figures 4a and 4b show examples of obstructive pulmonary defects with a low forced expiratory volume in one second. In both cases, TEC is normal and flows are less than expected over the entire volume range.
  • Figure 4c is an example of a typical restrictive defect.
  • the TEC is low and the flow is higher than expected at a given lung volume.
  • Figure 4d is an example of a typical mixed defect, characterised by a low TEC and a low FEV1/VC ratio.
  • Figure 5a shows the spirometer base cabinet.
  • Figure 5b shows the upper cover of the spirometer base cabinet.
  • Figure 5c shows two parts of the differential pressure sensor cabinet, also shown in figures 8a and 8b.
  • Figure 6 shows the differential pressure sensor circuit diagram.
  • Figure 7 shows the electronic circuit diagram of the spirometer.
  • Figure 8a is the front view of one part of the differential pressure sensor cabinet.
  • Figure 8b is a perspective view of the second part of the differential pressure sensor cabinet.
  • Figure 9 shows the updated mouthpiece of the spirometer.
  • Figure 10 shows the flow diagram of the operation of the spirometer according to the invention.
  • Figure 11 is a block diagram of the spirometer system.
  • Figure 12 is a photographic representation of a prototype of the hand-held spirometer system according to the present invention. DETAILED DESCRIPTION OF THE INVENTION
  • Pulmonary function testing is prescribed for all persons who have symptoms and a positive response to a suitable respiratory questionnaire given in Table 1 below. It should be especially recommended for persons with complaints of shortness of breath. In any person, particularly smokers and asthmatics, spirometry provides a baseline of performance values for comparison with results of future tests. The impact of air pollution on non-smokers may be detected by such comparison.
  • Ease of operation The spirometer of the present invention has been designed for particular simplicity of operation, which is a major drawback of the prior art devices. To achieve this, it uses the thin film-based spirometer technique. In this, the respiratory air is passed through a thin film mesh membrane where the resistance of the thin film creates a pressure difference in the sensor body. This pressure difference is measured by the device and the flow rate is calculated. This makes the overall operation very simple. The patient just takes the mouthpiece in the mouth and starts inhaling the air. Once the inhalation is complete and the display shows the start sign, the patient needs to blow out the air forcefully until all the air comes out from the lung, followed by forceful inhalation to form the volume loop. The result is displayed on the LCD screen after the test.
  • the spirometer of the present invention has a lighter weight compared to its prior art hand held devices for easy operability.
  • the present device uses thin film structure, whereby the overall sensor body becomes light.
  • the electronics part uses touch screen display and a microcontroller board with battery. This makes the overall system very handy and light weight.
  • a good spirometer provides rapid results or real time results, graphical displays showing the input and output waveforms like differential pressure curve, expiration volume time curve and flow volume loop. These features are very necessary for the medical professional to understand the actual condition of the patients.
  • the developed spirometer uses MEMS sensors to measure the differential pressure. This is a low cost high accuracy sensor. A low cost high functionality microcontroller is used in this device. These reduce the cost of the device. [0061] Additional features: The spirometer of the present invention has the following additional features in a dynamically controllable walker system:
  • the structure of the spirometer is designed such that every patient, whether child, young aged and old aged group, can comfortably use it.
  • the use of compact electronics system makes the spirometer robust and accurate.
  • the spirometer has two parts i.e. sensor part or mouthpiece and processing part.
  • the sensor which is mounted with the mouthpiece structure is used for the collection of the respiratory signal of the patient.
  • the hand held spirometer system according to the present invention is based on the differential pressure flow measurement technique.
  • the device is basically divided in two major sections.
  • the mechanical structure of the spirometer consists of the mouthpiece structure and cabinet.
  • a board contains the voltage regulator circuit which steps the voltage down to the desired levels and a 9V battery for power supply.
  • the sensor mounting board is also placed in the mouthpiece where a thin film structure is connected to the inputs of the differential pressure sensor.
  • the mouthpiece is designed in such a way that it should be comfortable for the patient to use it and perform inspiration and expiration as required.
  • the dimensions of the cabinet are
  • the electronic board consists of a microcontroller, TFT screen, power circuit and other components which make the spirometer system complete.
  • Electronic Circuitry
  • the electronic part consists of a pressure sensor circuitry shown in figure 6 and the main microcontroller board.
  • the pressure sensor circuit provides the differential pressure data to the main microcontroller board as shown in figure 10 (block diagram).
  • the microcontroller’s analogue pin receives the data sent by the pressure sensor circuit.
  • the digital data is stored in the array.
  • the array data is then sent to the digital filter for filtration.
  • the filtered data is processed for the flow rate calculation as per algorithms.
  • the curves are displayed in the TFT screen and the results are also displayed there.
  • the display shows Flow Volume loop i.e. spirogram, and Expiration Curve.
  • the results of the PFT parameters like FVC (L), FEVl(L), FEV1/FVC and PEF(L/s) are also displayed there.
  • FIG. 5a shows the mechanical structure of the spirometer body.
  • the lower body structure (1) shown in figure 5a, holds the microcontroller board, an LCD Module, a battery (2) and USB connections (3).
  • the upper body structure (4) of the body shown in figure 5b accommodates a TFT (thin film transistor) colour display (15) and a power on/off switch (14).
  • the approximate overall dimensions of the exemplary prototype unit shown in these figures are 130mm x 60mm x 40mm.
  • Figure 5c shows two parts of the differential pressure sensor cabinet.
  • the top part (7) together with the bottom part (8) forms the pressure sensor cabinet. It accommodates a differential pressure circuitry, a pressure sensor and a thin film mesh membrane (5).
  • the thin film membrane (5) is placed, sandwiched between the two parts, in cavity (6). This membrane creates the resistance to air flow in the mouthpiece.
  • Two mouthpieces (13), best shown in figure 9, are also fitted into cavity (6). The two mouthpieces are held there by part (7) and part (8), as best shown in figure 12.
  • the differential pressure sensor has two incoming points. Each of the sensor incoming points is connected with part (10) present in both the parts (7) and (8).
  • a hole is provided in each mouthpiece (13) at a distance of 5mm from the thin film membrane (5). These holes are synchronous with part (10) so that some amount of air can travel to the sensor input. The patient blows air from the mouthpiece while holding the structure of the device formed by joining part (7) with part (8).
  • a sensor connectivity point (9) is provided in the differential pressure sensor cabinet structure, shown in both parts (7) and (8).
  • the communication cable travels to the microcontroller board from this point.
  • the assembly of all the parts described above makes the complete sensor body structure.
  • the differential pressure sensing element and circuitry is placed within the structure.
  • the overall dimensions of the exemplary sensor body structure shown are l20mm x 50mm x 40mm.
  • Figures 6 and 7 show the differential pressure sensor circuit diagram and the electronic circuit diagram of the spirometer.
  • Figures 8a and 8b are views of two parts of the differential pressure sensor cabinet structure, also shown in figure 5c, which are joined together through suitable fasteners to form the whole pressure sensor cabinet.
  • the sensor cabinet is designed to be handy and comfortable for the use of patients.
  • the dimensions are reduced to just the required length and width so that the sensor circuitry can be accommodated within the body easily.
  • the overall dimensions of the exemplary structure are l20mm x 32mm x 40mm.
  • the cavity (6) holds the mouthpiece structure.
  • An inlet (11) is provided in the differential pressure sensor cabinet for air to reach the sensor.
  • a curved shape (12) is provided on the edge of the sensor cabinet so that it is easy to use.
  • a communication cable is connected from the pressure sensor circuit to the microcontroller board via FTSB port.
  • Figure 9 represents the mouthpiece (13) according to the invention. Two such are fitted in cavity (6) of the differential pressure sensor cabinet.
  • Figure 10 is a flow diagram of the process of using the hand held spirometer according to the present invention. This process is to be followed for obtaining accurate results from the spirometer.
  • Figure 11 is a block diagrammatic representation of the hand held spirometer system.
  • Figure 12 is a photographic representation of an exemplary prototype of the spirometer system. However, it is to be clearly understood that the actual system might differ in looks and dimensions, and all such deviations are within the scope of the present description.
  • the spirometer device has various functions.
  • the device measures the four major parameters of the respiratory disease diagnosis. They are Force vital capacity (FVC) in liters, Forced Expiratory Volume in one second (FEV1 Liters), FEV1/FVC ratio and Peak Expiratory Flow (PEF).
  • FVC Force vital capacity
  • FEV1 Liters Forced Expiratory Volume in one second
  • FEV1/FVC ratio Peak Expiratory Flow
  • the device is equipped with a mouthpiece arrangement as discussed in the previous part, where a differential pressure sensor having a range of -7kpa to 7kpa is provided.
  • the differential pressure sensed by the pressure sensor when the patient blows the air, as instructed by the doctor or professional, is acquired by the microcontroller unit via USB cable.
  • the signal coming from the differential pressure sensor is analogous in nature.
  • the analogue to digital converter unit of the microcontroller converts the analogue data into digital data and stores it in an array. Now the stored data is digitally filtered and processed for calculation of the parameters.
  • the spirometer device has 9cm TFT colour display which shows the spirogram and expiration curves.
  • the device is very compact in nature. The techniques used and the electronics are very simple and take very less space. This makes the device robust and handy so that one can take it from one place to another. The principle and algorithm for PFT parameters are given below.
  • the design is based on thin film mesh membrane which creates differential pressure while inspiration or expiration. The pressure difference is measured with the differential sensor.
  • the flow rate is proportional to the differential pressure with a film resistance. This concept is utilized to calculate the flow rate and from the flow rate curve various lung volumes are calculated.
  • volume V (Litters) is calculated by the integration of flow rate over specific time duration.
  • V j F dt
  • the FEV1 is the volume of air that can be blown out by a person at a maximal speed and effort after a full inspiration in starting 1 second.
  • Figure 2 shows the Force Expiration v/s Time Curve.
  • FEV1/FVC % The ratio of the Forced expiratory volume in starting 1 second to the forced vital capacity is denoted by FEV1/FVC. This provides the value from which the lung status is analysed.
  • % FEV1/FVC FEVl/FVC*l00; Peak Expiratory Flow (PEF):
  • This parameter shows the maximum flow rate obtained during forced expiration and is given in Litter/second.
  • V Tidal Volume (TV)—the amount of air inhaled or exhaled during a single breath without forced conditions.
  • V Inspiratory Reserve Volume the maximum additional air that can be inhaled at the end of a normal inspiration.
  • V Expiratory Reserve Volume Refers to the maximum volume of air that can be exhaled at the end of a normal expiration.
  • V Forced Inspiratory Vital Capacity (FI VC)— The maximum air volume that can be inhaled.
  • a graphic record of lung function in which the amount of gas inhaled and exhaled is recorded on the horizontal axis and the rate at which the gas moves on the vertical axis. It is used to detect abnormalities in pulmonary function such as that accompanying restrictive or obstructive lung disease.
  • Figure 3 shows the flow volume loop or spirogram.
  • Asthma is defined as a reversible obstructive defect. Therefore, a patient with an FEV1/FVC ratio ⁇ 80% can be given a bronchodilator (e.g. albuterol) and the spirometry can be repeated. If the FEV1 increases by more than 12%, it is indicative of reversible airway disease. If the FEV1 does not increase by more than 12%, it is considered non-reversible or fixed airway disease (e.g. COPD). Because asthma is a reversible obstructive defect, the spirometry may be normal at the time of evaluation. In instances where asthma is strongly considered yet the spirometry is normal, a methacholine challenge may be needed.
  • a bronchodilator e.g. albuterol
  • a patient inhales one or more concentrations of methacholine, and results of spirometry before and after the inhalations are measured.
  • the amount of methacholine needed to elicit a drop of 20% in the FEV 1 (known as the PD20) is obtained.
  • a restrictive defect is defined by a decreased total lung capacity (TLC). Spirometry cannot measure residual volume (RV) nor TLC, and therefore cannot definitively answer this question. Rather, if the forced vital capacity (FVC) is less than 80% and does not reverse with bronchodilators, it indicates that a restrictive disease might be present, and that further testing is needed (see lung volumes below).
  • the flow volume loop may suggest a restrictive defect by a constricted appearance, but as with obstructive defects may appear normal. An obstructive and restrictive defect can co-exist in the same patient.
  • the low cost, handheld spirometer as described above provides rapid results of pulmonary function tests like FVC(L), FEVl(L), FEVl/FVC(%) and PEF(L/s).
  • the device according to the present invention projects the results on its colour graphical display. Inspiratory, expiratory, flow-volume loop and volume time curves are displayed by the device. These results help a physician understand the condition of the patient’s lung.
  • the severity of the disease can be recognized by the device.
  • the device is easy to handle and operate.
  • the structure and functionality are very simple and can be operated by even an unskilled person after a simple training.
  • the sensor body structure is made in such a way that it is handy for inspiration or expiration of the air so that there is no obstruction in air flow.
  • a local battery setup is provided to power the spirometer and make it a standalone device. It can also be connected to power banks, personal computers and power adapters.
  • the device can be connected to a personal computer system which can collect the data from the serial port of the device. This data can be processed for further investigations.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
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Abstract

La présente invention concerne un système de spiromètre portatif comprenant un corps de spiromètre et une armoire de capteur de pression différentielle fonctionnellement reliée par un câble de communication par l'intermédiaire d'un port USB. Le corps de spiromètre présente une structure de corps inférieure (1) qui maintient une carte de microcontrôleur, un module LCD, une batterie (2) et des connexions USB (3). Sa structure de corps supérieure (4) loge un affichage de couleur TFT (15) et un commutateur de mise sous tension/hors tension (14). L'armoire de capteur de pression différentielle présente une partie supérieure (7) qui est jointe à travers des attaches appropriées à une partie inférieure (8) pour former l'armoire. L'armoire accueille un circuit de pression différentielle, un capteur de pression différentielle et une membrane à maille à film fin (5) qui est placée dans la cavité (6), prise en sandwich entre les deux parties.
PCT/IN2019/050199 2018-09-18 2019-03-12 Système de spiromètre portatif WO2020058985A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6176833B1 (en) * 1994-07-13 2001-01-23 Desert Moon Development Biodegradable air tube and spirometer employing same
US7063669B2 (en) * 2002-05-16 2006-06-20 Dynamic Mt Ag Portable electronic spirometer
US20130317379A1 (en) * 2012-05-22 2013-11-28 Sparo Labs Spirometer system and methods of data analysis

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6176833B1 (en) * 1994-07-13 2001-01-23 Desert Moon Development Biodegradable air tube and spirometer employing same
US7063669B2 (en) * 2002-05-16 2006-06-20 Dynamic Mt Ag Portable electronic spirometer
US20130317379A1 (en) * 2012-05-22 2013-11-28 Sparo Labs Spirometer system and methods of data analysis

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