WO2019074459A2

WO2019074459A2 - A development of a body of an ultrasonic spirometer

Info

Publication number: WO2019074459A2
Application number: PCT/TR2018/050478
Authority: WO
Inventors: Merthan OZTURK; Kerem YASAR; Ahmet OGUZ; Burak SONMEZ; Ahmet Burak AKTAS; Kadir Tayyip TASLICA
Original assignee: Inofab Saglik Teknolojileri Anonim Sirketi
Priority date: 2017-09-11
Filing date: 2018-09-11
Publication date: 2019-04-18
Also published as: WO2019074459A3

Abstract

The present invention pertains to developments of a body of a spirometer that is applicable for use in pulmonary function tests that can be conveniently used by individuals, in other words, users who are bereft of any medical training and experience. With this invention, a spirometer, which comprises a tube that secures the battery cap in its place in order to eliminate the risk of conducting a pulmonary function test without using a tube or applies pressure so as to provide an electrical connection, is developed. A peripheral protrusion is also disclosed, which allows the mouthpiece to be grasped at a location close to the body ergonomically and according to the usual habits of users.

Description

A DEVELOPMENT OF A BODY OF AN ULTRASONIC SPIROMETER

Technical Field

The present invention pertains to developments of a body of a spirometer that is applicable for a specialist-assisted use in pulmonary function tests or can be conveniently used by individuals, in other words, users who are bereft of any medical training and experience.

Prior Art

Various devices are known in the documents numbered US7618235, US7383740 and US20110092840, which allow measuring of an air flow rate in order to evaluate pulmonary functions of a user. When measuring the air flow rate, the volume of air inhaled and exhaled during inspiration and expiration can be determined as well.

It is also important for monitoring pulmonary functions of users if such devices that measure the air flow rate are conveniently portable for users, if they can be properly used by the users bereft of any experience, and the parts of said devices through which the air passed is measured are removable in order to be cleaned or replaced, and also if they do not need any routine calibration. Due to the aforesaid factors, ultrasonic spirometers have significant advantages for the users who are bereft of any medical training. Uses of household spirometers have become widespread with developed mobile medical services. Household versions of these devices used in clinics have been already released to the market. On the other hand, the measuring accuracy of these types of devices is not at the same level as that of clinical type products.

Some ultrasonic spirometers used for medical purposes are disclosed in documents numbered US5419326, US5647370, JP2013250254 and US2010145213. However, these ultrasonic spirometers do not have a compact and ergonomic nature such as to be conveniently portable and usable by users. One of the measurement methods used in ultrasonic spirometers is the "first edge" measurement technique. In said method, a signal formed of an ultrasonic wave at one or more than one wavelength is transmitted from a transmitter to a receiver. Measuring process is carried out as the time counter being started once the transmitter transmits the ultrasonic signal is stopped at a breakpoint of zero occurring on the receiver following the first half wave. This breakpoint of zero is formed after amplitude of the first half wave occurring on the receiver exceeds a determined value. As the flow rate within the spirometer increases, spreading direction of the ultrasonic signal transmitted from the transmitter to the receiver shifts in a downstream direction, and strikes to a point at a distance from the center of the receiver when the signal reaches the receiver. The striking point becomes distant from the center as the flow rate increases. The distance between the center and the striking point of the signal to the receiver, which increases with the flow rate, generates a voltage signal with low amplitude in proportion to the distance on the receiver. When considered that a signal at a length of only one wavelength is transmitted from the transmitter, if this signal occurring on the receiver drops below a triggering point, the signal cannot be sensed and measured on the receiver.

When more than one ultrasonic signal at a wavelength is transmitted from the transmitter, a first edge is not capable of generating a voltage signal with sufficient amplitude on the receiver at high flow rates. Therefore, the triggering point is not exceeded on any one of the waves periodically reaching after a first wave strikes to the receiver. However, in this case, the time counter started once the signal is transmitted from the transmitter stops when following peak points of the periodical signal strike the receiver and an energy is transmitted to the receiver, which is at a sufficient level to be transmitted to the receiver from a peak point with a sufficient amplitude, rather than when the signal initially reaches the receiver. The time counter is stopped and a shift occurs in measurement after the same periodical duration as that of triggering.

Correcting these shifts in software not only requires additional software effort but also poses a threat to the proper operating of the time-critical algorithms carried out in a microprocessor. The measurements dramatically reduce the accuracy of the spirometer, which are carried out when the triggering point is exceeded in the following periods instead of the given first zero breakpoint of the signal or rather than when the signal that is transmitted onto the receiver falls below the triggering point. Accordingly, so as to preserve the measurement accuracy against the signal losses occurring based on air movements in ultrasonic spirometers, operating ultrasonic receivers-transmitters with high voltages leads to high energy consumptions and cost increases, and minimizes operating life of the device.

In order to avoid the signal losses occurring during high flow, a document numbered US4914959 discloses that the receivers-transmitters are placed with an anti- downstream deviation. This solution can only provide an improvement in measurements carried out for a unidirectional flow. However, spirometers require a measurement in which the flow can be measured in both directions. In addition to that, as air ducts of spirometers are configured such as to be adaptable to mouth sizes of individuals, their cross sections have a suitable size to fit in a mouth. Moreover, in another document numbered US4914959, it is disclosed that a very low signal falls onto the transmitter at a section area of an air duct of a spirometer suitable to fit in a mouth of an individual wherein the spirometer is configured so as to have a minimalistic design to allow an angle at 55 degrees between the line linking the sensors disclosed therein and an air duct to be ergonomic, which does not enable using the first edge measurement method at all. Furthermore, any further document numbered US4914959 discloses that the first edge measurement method is not advantageous for using at a section area of an air duct of a spirometer suitable to fit in a mouth of an individual wherein the spirometer is configured so as to have a minimalistic design to allow a deviation angle of 10 degrees of the sensors described therein to be ergonomic. The reason for this is it is necessary to reduce the angle between an imaginary line combining sensors and an air duct direction in order to enable the signals coming out of the transmitter as the cross section becomes narrower to fall onto the receiver.

The examples presented above are given as an example for the spirometers known in the literature. In addition to these, a Turkish Patent application numbered 2017/04582 discloses a spirometer that has been developed by Inofab. The spirometer according to the aforesaid application comprises a tube that fits in an air duct and enables ultrasonic receivers-transmitters to operate without being affected by the contaminants within an air flow. Aims of the Invention

An aim of the invention is to develop a spirometer that can be actuated with a replaceable battery or batteries.

Another aim of the invention is to develop a spirometer that comprises a tube and mouthpiece to hinder the access to the batteries during active use.

Another further aim of the invention is to develop a spirometer that requires the closing of the battery cap before the tube is secured in its place.

Another aim of the invention is to develop a spirometer comprising a tube that secures the battery cap in its place, such as to eliminate the risk of conducting a pulmonary function test without using a tube or applies a pressure so as to provide an electrical connection.

The present invention also aims to develop a spirometer that comprises a peripheral protrusion on a body of the device to allow the mouthpiece to be grasped at a close location to the body that does not have contact with the mouth such that the mouthpiece is held economically and according to the habits of users.

Definitions of the Drawings Illustrating the Invention

The drawings and corresponding definitions of the same are as follows, which will only encourage better understanding of a spirometer developed according to the present invention.

Figure 1 is a schematically side view of a spirometer according to the invention.

Figure 2 is a schematically side view of a spirometer according to the invention, which also shows some components of the device within its body.

Figure 3 is a schematically side view of a spirometer according to the invention, which a lso shows some components of the device within its body when a tube is partially placed. Figure 4 is a schematically top view of the body when a battery cap is in the closed position. The tube retaining the battery cap in this position is not shown.

Figure 5 is a schematically top view of the body when the battery cap is in an open position.

Figure 6 is another schematically top view of the body when the battery cap is in an open position.

Definitions of the Components of the Invention

To ensure a better understanding of the spirometer developed with the invention, the components and parts presented in figures are represented with individual numbers, corresponding definitions of all numbers are as follows.

1. Spirometer

2. Tube 2a. Inlet end

3. Receiver-transmitter

4. Body

5. Mouthpiece

6. Battery cap

7. Battery

8. Cap track

9. Spring

10. Conductor

11. Protrusion Detailed Description of the Invention

Spirometer (1) according to the invention that is capable of being actuated with a replaceable battery or more than one battery (7) basically comprises; a removable tube (2) that defines a flow direction (i) and, forms an air duct extending from an inlet end (2a) corresponding to the mouth of a user through the said flow direction (i) and allows an air passing through this air duct during exhalation of the user, two ultrasonic receiver-transmitters (3) that are directed to a volume retained within the tube (2) such that they would remain on a measurement line (ii) passing through said air duct, that are in different locations through the flow direction (i), and that allow conducting a measurement on the air flow within the tube (2) by mutually reading the signals that they generate.

A mouthpiece (5) integrated to the tube (2) is further provided.

The components receiver-transmitters (3) that are briefly mentioned above need a power supply to operate. To this aim, one or more than one battery (7) that would be embedded within the body (4) of the spirometer (1) is used. Said batteries (7) are located in the ultrasonic receiver-transmitter (3) section that is located close to a bottom section, which is also the deepest volume within the body (4). Thus, the batteries (7) are ensured such as to be embedded within the volume of the body (4) without any need of extending the length of the body (4).

A battery cap (6) covering the batteries (7) do not need to stay in an opened position as an attempt to access batteries (7) is not a very repetitive action. Accordingly, the battery cap (6) is disposed on the body (4) such that it would be covered by the tube (2) that is attached to the body (4) from above and the mouthpiece (5) together.

It is eliminated for some oral secretions and moist air streams reach to the batteries (7) by means of the mouthpiece (5) covering the battery cap (6). As in standard battery holders, it is possible for the batteries (7) not to become distant from their contact points and to be pushed with springs applying a pressure in an upward direction from the bottom in order to tightly secure them in their places. The battery cap (6) moves in a lateral direction within a cap track (8) to prevent the mouthpiece (5) from being moved upward as well with the effect of said pressure. The batteries (7) can be reached through the sliding the battery cap (6) within the cap track (8) towards the air flow duct in which the tube (2) is provided. However, to achieve such an access to the batteries (7), the tube (2) needs to be removed from its own place by gripping the mouthpiece (5).

When the batteries (7) are not covered with the battery cap (6), if an electrical connection is not provided as well, the spirometer (1) is not capable of operating. In this case, the users who lack experience/attention will need to remember to put the battery cap (6) in its place before every use, which blocks the air flow duct moving in a direction of the air flow duct. However, this would not be enough to deter the users who lack experience/attention from using the spirometer (1). Since, once the device generates a signal meaning that it is ready to operate after providing an electrical conductivity, the user would most probably blow into the air duct.

The tube (2) needs to be used in order to enable the users to test their pulmonary functions accurately and in order for the receiver-transmitters (3) within the spirometer (1) to be protected from moist breath. To this aim, a spring (9) is provided on a side of the cap track (8) wherein the spring continuously pushes the battery cap (6) towards the air duct up to 1-5 mm. With the effect of this spring (9), both the battery cap (6) would not fit in its own place, and also a connection between the conductors (10) provided to transmit a current of the battery (7) would be lost. In these two cases, the user would need to use the tube (2), to push the battery cap (6) into its place, and to prepare the spirometer (1) for use.

To make it fit in its own place, a face of the battery cap (6) facing the air duct can be designed to be inclined such that it would become distant from the air duct from its face far from the mouthpiece (5) to its face facing to the mouthpiece (5).

The mouthpiece (5) has a peripheral protrusion (11) on its side closer to the body to provide a grip portion besides the portions that can be contaminated by oral secretions after contacting the mouth of a user during when the mouthpiece (5) and the tube (2) are removed from their places after use in accordance with the habits of users. By means of said protrusion (11), the body (4) and the mouthpiece (5) are divided into two parts with a manually perceivable ridge.

In order to enable the tube (2) to be inserted properly, both the tube (2) and the air duct have sections that overlap and are asymmetrical relative to at least one line passing through their centers. Said sections are preferably designed in the shape of a parallelogram whose corners on its only one edge is rounded, particularly a rectangle whose corners on its only one edge is rounded.

Claims

1. A spirometer (1) that is capable of being actuated with one or more than one replaceable battery (7) comprising, a removable tube (2) that defines a flow direction (i) and, forms an air duct extending from an inlet end (2a) corresponding to mouth of a user through said flow direction (i) and allows air passing through this air duct during exhalation of the user, two ultrasonic receiver-transmitters (3) lying along a measurement line (ii) passing through said air duct and directed to a volume retained within the tube (2), located in different locations along the flow direction (i), and allow conducting measurements on the air flow within the tube (2) by reciprocally reading the signa ls that they generate, a mouthpiece (5) integrated to the tube (2) one or more than one battery (7) provided in the ultrasonic receiver- transmitter (3) section located near the bottom within the body (4), a battery cap (6) covering the batteries (7), characterized in that said battery cap (6) is provided on a top face of the body (4) such that it would be covered by the mouthpiece (5).

2. A spirometer (1) according to Claim 1, characterized in that the battery cap (6) movable in a lateral direction within a cap track (8) and allows access to the batteries (7) by sliding within the cap track (8) towards the air flow duct.

3. A spirometer (1) according to Claim 2, characterized by a spring (9) which pushes the battery cap (6) towards the air flow duct.

4. A spirometer (1) according to Claim 3, characterized by conductors (10) for transmitting the current of the batteries (7), which do not contact each other when the battery cap (6) is not inserted in its place.

5. A spirometer (1) according to Claim 3, characterized by a battery cap (6) whose face that faces the air duct is inclined such that its distance to the air duct increases from the face distant to the mouthpiece (5) towards the face facing the mouthpiece (5).

6. A spirometer (1) according to Claim 1, characterized by a peripheral protrusion (11) that is provided on the side of the mouthpiece (5) proximal to the body.

7. A spirometer (1) according to Claim 1, characterized with the tube (2) and the air duct having sections that overlap each other and are asymmetrical relative to at least one line passing through their centers.