A SPIROMETER WITH FEEDBACK UNIT AND A CONTROL METHOD

THEREOF

Field of The Invention

The present invention relates to a spirometer with feedback unit and a control method whereby lung capacity and functions are measured, which guides the patient in pulmonary function tests, informs the patient that s/he should start the test, transfers the transactions that should be carried out to the patient visually and vocally, enables the patient to see intensity of breath and success ratio during inspiration and expiration.

Background of the Invention

Today, pulmonary function test (PFT) is used for measuring lung capacities of patients; verifying presence or absence of pulmonary diseases (for example, for detection of abnormal symptoms, physical examination, or other laboratory findings); measuring occupational and environmental factors (for example, for detection of a damage caused by smoking or inhaling dusty or toxic materials); evaluating response to the treatment administered (for example, after bronchodilator application, after steroids, cardiac drugs, lung resection, transplantation, pulmonary rehabilitation); estimating risks difficult to be estimated in surgical procedures (for example, pulmonary resection, sternotomy, etc.); and as a follow-up test of known diseases (for example, for detecting respiratory, cardiac and neuromuscular diseases).

PFT is performed by a device called as spirometer. Spirometer measures values of (FVC, FEV1 , PEF, flow volume ring), maximum voluntary ventilation (MVV), maximal inspiratory / expiratory pressures (MIP / MEP), airway resistance (Raw) and compliance (C), functional residual capacity (FRC), total lung capacity (TLC), residual volume (RV) FRC / TLC ratio, minute ventilation, alveolar ventilation and dead space, ventilation distribution, and diffusion capacity upon the patient makes different breathing manoeuvres.

In cardiac and pulmonary diseases, PFT is done in order to understand lung health of persons and to diagnose diseases. Capacity of lungs and functional status thereof are measured by PFT. PFT is frequently preferred by doctors for following-up and determining the course of disease, effectivity of treatment, and pre-determining risks of respiratory complications based on general anesthesia and surgery in short of breath, asthma, and chronic obstructive respiratory disease (COPD) diseases. Volume of air that can be taken by lungs and rate of air flow that is generated by strong respiratory activity performed while breathing in and out, are measured by using spirometer in these tests.

While performing PFT, the patient sits with his/her nose closed so that no air is coming through the nose. The doctor or the technician (the authorized person) performing the test inputs data of the patient such as age, gender, height, weight, race information and medical history into the computer. Then, the patient starts breathing in and out through the mouth by using the spirometer device. During the test, the authorized person ensures that the test is performed in accordance with the criteria by asking the patient to take a deep breath, breathe out fast and completely and continue exhaling process for 6 seconds according to acceptability criteria of the test. PFT is completed under technician supervision and according to the instructions of the technician. In PFT, the rate at which the patient breathes in is measured and thus values of lung volume are calculated. In application of the test, the patient has to work in cooperation with the authorized person so that the values obtained are correct and the test result is valid. The authorized person should be trained and experienced about the test and the spirometer device and to establish harmonious relationships between the patient and the technician who is authorized person well. If the patient or the does not meet the requirements of the test correctly, the test results may be misleading.

In PFT, as the patient blows air to the spirometer, the volume, intensity, and flow of air at different times are measured. Parameters of "forced vital capacity" (FVC) and "forced expiratory volume in one second" (FEV1) are mostly used in dynamic ventilation tests. In the mentioned tests, the volume of air exhaled from the lungs by breathing out enforcedly, quickly and deeply is measured. The volume of air expired by the patient in the first second is measured by FEV1 value. The FEV value is used in volume-time graphic. The patient's volume of expiration by time is visualized by means of the volume-time graphic and it is examined by making comparison where it is located in the required curve. Also, the flow-time curve is examined in PFT. Volume-time curve is created by measuring the expiration of the patient and the flow generated within the spirometer device. The flow-volume curve is used for an interpretation of the factors affecting the flow occurring in airways. The top of the flow-volume curve indicates the maximum expiratory flow rate (peak expiratory flow (PEF)). PEF value indicates diameter of large airways and activity of respiratory muscles. Evaluation and interpretation of PFT result are performed through the comparison of the measured values to the "expected values". The expected values used in test evaluation are obtained as a result of studies carried out with healthy persons of different age, gender, height, weight, and race groups. While carrying out the PFT evaluation, it should be primarily controlled whether the patient performs the respiratory processes necessary for the test properly or not. In addition to this, the duration of the patient's expiration and whether the breathing is done in accordance with the flow-volume curve should be controlled. If the patient cannot perform the action correctly, reliability of the values obtained will be questioned. Today, PFT is performed in company with a doctor or technician. The technician notifies the patient about how to breathe in/out by means of voice commands such as "take a deep breath, blow out fast, continue, inhale deeply" throughout the test. And the patient tries to perform the test transaction through the instructions of the technician. At the same time, the technician follows up the patient's test from the computer and continues giving necessary instructions to the patient. In the state of the art, spirometer is used for PFT and the patient blows towards the spirometer according to the instructions to be received from the technician. The technician tells the patient in what way and how intensely to blow, time of blowing in the form of instructions one by one. And the patient blows towards the spirometer according to the instructions of the technician. At the same time, the technician continuously notifies the patient of how to continue the test through instructions by following up the volume and the flow of the air breathed in/out by the patient over a graphic by a computer. The patient manages the test process according to the incoming instructions. In order to reach correct results about the patient in pulmonary function test, the technician needs to manage the test process very well and the patient needs to perform each instruction instantly. Because of these difficulties, adaptation of patients - particularly the ones who performs pulmonary function test for the first time - to the test is not easy. The patient cannot respond to each instruction of the technician instantly, quickly. And this causes the test to yield false results about the patient. The test is repeated for eight times, at most until correct results are obtained and the test process takes longer.

In PFT performed in the state of the art, test devices wherein airflows are measured by means of pneumatic systems and various sensors are used. Current devices usually carry out measurement on the basis of the fact that the airflow passing through the turbines located inside thereof rotates the propeller and the flow is calculated by measuring each rotation by means of electronic sensors. This measurement can be efficient under the pre-condition that the patient performs the test correctly. However, current devices lack physical units which would enable the patient to understand whether the test was performed correctly and which would provide a physical interaction with the patient. Although digital animations are used in some state-of-the-are test devices, uses thereof are not effective since they do not apply to all groups of patients. The most important problem encountered in the state of the art is that coordination between the patient and the technician is not sufficient, the patient cannot see the transaction that s/he should carry out during the test simultaneously by himself/herself and follow it. In this application wherein understanding the test directly affects efficiency and success of the test, decrease of comprehensibility in current products - in other words the communication difficulty between the technician and the patient - poses the most significant technical problem. Due to this problem, test period per patient gets longer and success rate of tests decrease.

To sum up, in current applications there is no spirometer whereby a patient is guided automatically, and feedback is received in relation to the test, which increases concentration of the patient for the test and a method for operating the spirometer as desired.

Objectives of the Invention

An objective of the present invention is to realize a spirometer with a feedback unit and a control method thereof which ensures that pulmonary function tests are performed in a more comprehensible, easier and faster way. Another objective of the present invention is to realize a spirometer with a feedback unit and a control method thereof which enables a patient to see the transactions that s/he should cany out in pulmonary function tests and to monitor intensity of respiration visually during the test. A further objective of the present invention is to realize a spirometer with feedback unit and a control method thereof which enables a patient and a technician to see the volume of and the intensity of air occurring during respiration at the same time.

Yet another objective of the present invention is to realize a spirometer with feedback unit and a control method thereof which lead the patients to make a blowing analogy that they know in order to eliminate the factors causing anxiety and stress for patients and therefore affecting validity of the test in a negative way. Still another objective of the present invention is to realize a spirometer with feedback unit and a control method thereof which enables to prevent communication problems from creating negative affect on test results by strengthening communication between the patient and the technician during pulmonary function test.

Yet another objective of the present invention is to realize a spirometer with feedback unit and a control method thereof which has two different interfaces such that they will give simpler and more comprehensible information to the patient and whereas they will give more comprehensive and technical information to the operator.

A further objective of the present invention is to realize a spirometer with feedback unit and a control method thereof which enables to shorten the time of pulmonary function test and to test more patients per unit time.

Still another objective of the present invention is to realize a spirometer with feedback unit and a control method thereof which enables operators to obtain higher operating performance by resolving the difficulties of the test.

Short Description of the Invention The invention of the application - which is a pulmonary function test device aiming to make pulmonary function test easier in terms of both patients and operators and providing this complicated test in a simple language that can be understood even by a person who sees it for the first time - consists of essentially: a feedback unit whereon there are lights for physical interaction and that is connected to any processing unit such as computer, smart tablet, smartwatch or smart phone; and a blow unit that communicates with the feedback unit over wired or wireless communication protocol.

Detailed Description of the Invention

"A spirometer with feedback unit and a control method thereof realized to fulfill the objectives of the present invention is shown in the figures attached, in which:

Figure 1 is a perspective view of the spirometer with feedback unit.

Figure 2 is a perspective view of the spirometer with feedback unit from a different point of view.

Figure 3 is a perspective view of the spirometer.

Figure 4 is a perspective view of the feedback unit and the feedback means.

Figure 5 is a perspective view of the spirometer with feedback unit.

Figure 6 is a perspective view of the spirometer with feedback unit.

Figure 7 is a schematic view of the steps of the spirometer control method.

Figure 8 is a view of the flow-volume curve expected from a healthy person.

Figure 9 is a view of the flow-volume curve expected from a healthy person and a flow- volume obtained as a result of test.

Figure 10 is a view of the volume-time curve expected from a healthy person. The components of the spirometer with feedback unit and the control method thereof are individually numbered, where the numbers refer to the following: 1. Spirometer with feedback unit

2. Spirometer

21. Holding area

22. Blow mouthpiece

23. Charge indicator

24. Charge connection

3. Feedback unit

31. Body

32. Control unit

33. Screen

34. Keypad

35. Charge housing

36. Communication unit

37. Speaker output

4. Feedback means

41. Level indicator

B. Computer

100. Spirometer control method

The spirometer with feedback unit (1) which guides the patient in pulmonary function tests, transfers the transactions that should be carried out to the patient, enables the patient to see intensity of breath and success ratio during inspiration and expiration comprises:

- at least one spirometer (2) which is used in breathing process;

- at least one feedback unit (3) which is adapted for communicating in a wired or wireless way, calculating the volume and flow of air applied to the spirometer (2) by time, and dividing the total volume and flow of air proportionately according to the feedback means (4) number;

- at least one feedback means (4) wherein the light level of the level indicator (41) located on thereof changes according to the data received from the feedback unit (3) and which enables the patient to see the success ratio during the test.

The innovative spirometer with feedback unit (1) is used in pulmonary function tests. Anthropometric characteristics of a patient to be subjected to a test such as age, gender, height, weight and race are input to the spirometer with feedback unit (1) or the computer (B), tablet. The spirometer with feedback unit (1) or the computer (B) selects the volume-time and the flow- volume curves expected, in other words required in a healthy person, according to the characteristics of the patient and compares them with the values obtained from the patient during the test.

In one embodiment of the invention, the patient performs the breathing process by means of the spirometer (2) during the test. The spirometer (2) preferably comprises at least one holding area (21), at least one blow mouthpiece (22), at least one charge indicator (23) and at least one charge connection (24). The user preferably holds the spirometer (2) from the holding area (21) which is located in the middle section of the spirometer (2). The holding area (21) is designed ergonomically to fit hands of users regardless of their age and gender.. There are preferably small embossed textures on the holding area (21). These small protrusions ensure frictional force on the surface and prevent the spirometer (2) from slip down from the user's hand by composing a rough surface on the holding area (21). There is blow mouthpiece (22) at the end of the spirometer (2). The user breathes in/out from the blow mouthpiece (22) and provides the air necessary for the test process from the blow mouthpiece (22). There is preferably a piece similar to a propeller or a plate inside the spirometer (2). The propeller rotates when the user (patient) breathes in/out from the blow mouthpiece (22) and the air flow and intensity during the respiration is measured according to the rotation direction and intensity of the propeller. The respiration intensity of the user, in other words the air volume and the air flow occurring inside the spirometer (2), is measured by means of the propeller. The propeller generates signal according to the air flow and intensity, the flow or voltage value is used as output signal. According to the breath intensity of the user, in other words according to the air occurring inside the spirometer (2), the flow or voltage value provided by the propeller changes and the air flow and intensity are detected according to the said output signal. The spirometer (2) is adapted for transmitting the data of air flow and intensity, which is obtained according to the movement of the propeller, to the feedback unit (3) in a wired or wireless way. There is preferably a transmitter-receiver inside the spirometer (2) and the data about the air flow and intensity is transmitted to the feedback unit (3) by means of the said transmitter-receiver. In the spirometer (2), there is preferably a power supply (battery, cell). The power supply supplies the sensor and the other electronic circuit components. The power supply is preferably rechai-geable. Terminals of the power supply are connected to the charge connection (24) and the charge connection (24) is located on the spirometer (2) body. It is ensured to charge the power supply from the charge connection (24). Thus, the spirometer (2) is used wirelessly and such that it is rechargeable. Charge status and charge level of the power supply are monitored from the charge indicator (23). The charge indicator (23) indicates the charge level of the power supply and informs the user. Use of cable is also possible in terms of data transfer and use of power supply. During the pulmonary function test, the user breathes in/out by means of the spirometer (2). The propeller located inside the spirometer (2) rotates and generates signal according to the volume and the intensity of the user's breath. The said data are transmitted to the feedback unit (3) by means of the said transmitter-receiver in a wired or wireless way. The feedback unit (3) is adapted for calculating the air volume and the air flow received from the spirometer (2) by time and dividing them proportionately. In a preferred embodiment of the invention, the feedback unit (3) comprises: the body (31), the control unit (32), the screen (33), the keypad (34), the charge housing (35) and the communication unit (36). The body (31) ensures that the components remain together in a closed way. Preferably, the control unit (32) and the communication unit (36) are located inside the body (31 ); the screen (33), the keypad (34) and the charge housing (35) are located on the body (31 ). The feedback unit (3) is adapted such that it will communicate with the spirometer (2) and the computer (B) in a wired or wireless way.

During pulmonary function test, anthropometric data of the patient is entered to the computer (B) and/or the feedback unit (3). The anthropometric data of the patient is entered to the feedback unit (3) over the keypad (34) or the screen (33) located on the body (31). In one embodiment of the invention, the screen (33) and the keypad (34) are touch-sensitive and the keypad (34) is included inside the screen (33). In another embodiment of the invention, the keypad (34) is located out of the screen (33) and it is in the form of a piece apart from the screen (33). The screen (33) and the keypad (34) are used for inputting the patient's data, carrying out calibration transactions, updating the programmes, making adjustments.

In one embodiment of the invention, the anthropometric data of the patient is entered to the computer (B) and this data is transmitted to the feedback unit (3) by means of the computer (B). In the said embodiment, use of the screen (33) and the keypad (34) is not compulsory and the feedback unit (3) preferably does not comprise the screen (33) and the keypad (34).

In a preferred embodiment of the invention, the spirometer (2) is charged by means of the feedback unit (3). It is ensured by the charge housing (35) located on the body (31) of the feedback unit (3) that the spirometer (2) is charged. The charge housing (35) is preferably in the form of an inward groove from the body (31) surface. The charge housing (35) is preferably as wide as the spirometer (2) and its height is less than the height of the spirometer (2). The charge housing (35) enables the spirometer (2) to be carried when it is not used and to charge the spirometer (2). The charge connection (24) located on the spirometer (2) is correspond to the electrical supply circuit ports located inside the charge housing (35) and they are supplied from mains or another electric supply.

Communication of the feedback unit (3) with a device similar to the spirometer (2) and the computer (B), tablet, smart phone is provided directly by the control unit (32) or over the communication unit (36). The anthropometric data of the patient are transferred to the control unit (32) over a device similar to the feedback unit (3) and/or the computer (B), tablet. The control unit (32) receives the curves of volume-time, flow-volume expected from a healthy person from the database according to the data of the patient. The database is located inside the feedback unit (3) and/or the computer. After detecting the expected curves of volume-time, flow-volume according to the anthropometric data of the patient; the control unit

(32) determines each feedback means (4) to represent which points on the curves, in other words for which air intensity and air flow value it will correspond to. Thus, it is determined by the control unit (32) at which air intensity and air flow value each feedback means (4) will be active or passive.

The control unit (32) compares the graphic values expected for the patient (values required in a healthy person) with the value obtained as a result of the test applied to the patient. The control unit (32) places the patient's results revealed after the test onto the expected graphic values. It is recorded in the control unit (32) for which diseases or health result the shifts generated in the test results will correspond to. The control unit (32) detects which health problem the values - obtained as a result of the test - will be according to the shift points on the graphic. The control unit (32) is adapted for determining problems of the patient related to respiratory functions and giving health advices according to the test results with the said comparison. The control unit (32) lists the medical condition of the patient and possible diagnoses by comparing the test results, expected values of the patient. After determining the medical condition of the patient and diagnosing possible diseases, the control unit (32) indicates these data on the screen (33) and transfers them to a device such as remote computer, tablet, smartphone and smartwatch by the communication unit (36). In one embodiment of the invention, the control unit (32) is adapted for transmitting the test results and possible disease diagnoses to doctors, patients or those concerned by electronic mail. In one embodiment of the invention, the feedback unit (3) comprises at least one speaker output (37). With the speaker output (37), audio warning is given to the patient or technician.

Measurements such as air volume, air flow made by the spirometer (2) is transmitted to the control unit (32) over the communication unit (36) or directly. The control unit (32) divides the data that it receives from the spirometer (2) proportionately according to the values and preferred number. The control unit (32) divides the data that it receives from the spirometer (2) such as air volume, air flow to the feedback means (4) number preferably and determines at which air intensity and air flow value each feedback means (4) will be active or passive. The control unit (32) determines at which point of the curves of expected values (expected curve of volume-time, flow-time) the patient is located according to the respiration intensity of her/him. The control unit (32) generates signal that will make the feedback means (4) active or passive according to the point where the patient is locates in the curve of volume-time, flow-time instantly. The control unit (32) brings the level of difficulty of a next feedback up to a level suitable for the patient's performance by learning the data that it obtains every time the patient performs the test. In one embodiment of the invention, the feedback means (4) is preferably located on the feedback unit (3). The feedback means (4) comprises preferably at least one level indicator (41). The level indicator (41) preferably has a length as much as the length of the feedback means (4) and it enables to be understood until which level the light flashes. There is preferable light source of LED inside the feedback means (4). The light source located inside the feedback means (4) becomes active or passive according to the signal received from the control unit (32), in other words the feedback means (4) light flashes on and off according to the signal received from the control unit (32).

In one embodiment of the invention, light of each feedback means (4) flashes on and off completely in turn according to the signal received from the control unit (32). In this embodiment, each feedback means (4) is made active or passive separately. In other words, lights of the feedback means (4) flashes on and off one by one based on respiration of the patient. The test is completed successfully when the patient flashes off or on the lights of all feedback means (4). According to the respiration intensity of the patient, the control unit (32) flashes on or off the lights of the feedback means (4) in a preferred turn. Thus, the patient can see his/her respiration intensity visually and also can follow-up for how long s/he can continue this respiration intensity from the feedback means (4). In an alternative embodiment of the invention, lights of all feedback means (4) flashes on or off at the same time gradually according to the signal received from the control unit (32). In this embodiment, all feedback means (4) flashes on or off at the same time. All feedback means (4) are made active or passive at the same time. In other words, lights of the feedback means (4) are activated at the same time according to the respiration of the user and levels of the lights of the feedback means (4) change according to the respiration intensity of the patient. For example lights of all feedback means (4) flashes on completely before the patient starts the test and light levels of the feedback means (4) decrease from top to bottom as the respiration intensity of the patient increases and when the patient completes the test successfully, lights of the feedback means (4) decrease up to the lowest level and the lights are made passive. In this embodiment, when the patient flashes on the light of the feedback means (4) completely - in other words the light level indicator (41) reaches the top level or the light level indicator (41 ) reaches the lowest level - the test is completed successfully. According to the respiration intensity of the patient, the control unit (32) flashes off or on the light of the feedback means (4) in a preferred turn. Thus, the patient can see his/her respiration intensity visually and also can follow-up for how long s he can continue this respiration intensity from the feedback means (4).

In one embodiment of the invention, the feedback unit (3) is adapted such that it can receive the signals externally. In this embodiment, the technician connects to the feedback unit (3) via a device such as computer, tablet, smartphone and controls the feedback means (4) by instructions given externally.

It is very easy to use and operate the innovative spirometer with feedback unit (1). The spirometer with feedback unit (1) compares the pulmonary function values of healthy persons of different characteristics with the values of the person tested. The spirometer with feedback unit (1 ) provides guidance for the patients necessary for the test by the feedback means (4) contained. It flashes on or off the lights of the feedback means (4) according to the respiration intensity of the patient. Thus, patient can follow-up the transaction required to be done during the test or his/her respiration intensity visually from the feedback means (4). The patient follows-up the transaction required to be done visually by seeing that s/he has flashed on or off the lights located on the feedback means (4) as a result of the blowing transaction.

Operation and control of the spirometer with feedback unit (1) is provided by the spirometer control method (100).

A spirometer control method (100) which guides the patient in pulmonary function tests, transfers the transactions that should be carried out to the patient, enables the patient to see intensity of breath and success ratio during inspiration and expiration comprises steps of:

- inputting the anthropometric data of the patient to the computer (B) or the feedback unit (3) (101);

- extracting the curves of volume-time, flow-volume expected for the patient by means of the feedback unit (3) or the computer (B) (102);

- the feedback unit (3) determining at which values of air intensity, air flow the feedback means (4) will be made active or passive according to the curves of volume-time, flow-volume expected (103);

- the feedback unit (3) following-up the respiration values of the patient

(104);

- flashing off or on the lights of the feedback means (4) one by one or all together according to the respiration values of the patient (105);

- giving warning message to the patient when the test is finished ( 106).

With the innovative spirometer control method (100), it is decided on in what way to indicate the values of air-time and flow-volume received from the spirometer (2) to the patient visually. In pulmonary function test, first of all data (anthropometric) of the patient to be tested such as age, gender, height, weight, race information and medical history input into the computer (B), a device similar to tablet, smart phone, smart watch or the feedback unit (3) (101). According to the anthropometric data of the patient, respiration intensity that should be provided by the patient is determined. The curves of volume-time, flow- volume expected for the patient are extracted by means of the feedback unit (3) or the computer (B) (102). The said curves yield the results that should be obtained in consequence of the test.

The expected curves of volume-time, flow-volume belonging to the patient are provided by the feedback unit (3) or a device similar to the computer (B) connected externally. The expected curves of volume-time, flow-volume belonging to the patient are provided by the feedback unit (3) or transferred to the feedback unit (3). After receiving the said data, the feedback unit (3) divides the expected curves of volume-time, flow- volume to the feedback means (4) number. Thus, the feedback unit (3) determines at which values of air intensity, air flow the feedback means (4) will be made active or passive (103). The feedback unit (3) continuously reads out the respiration values related to the test from the spirometer (2). Thus, the feedback unit (3) follows-up the respiration values of the patient (104) instantly. Starting from the moment when the feedback unit (3) starts the test, the lights of the feedback means (4) are flashed off or on one by one or all together according to the respiration values of the patient (105). As soon as the test is finished, the feedback unit (3) gives warning message to the patient that the test is finished (106).

Warning levels of the feedback means (4), information of at which stage the test is and motivation of the patient for the test are provided with the innovative spirometer control method (100).