FIELD

The present disclosure relates to the field of medical devices. Particularly, the present disclosure relates to assay devices for detection of sputum in spit samples. DEFINITION

As used in the present disclosure, the following terms are generally intended to have the meaning as set forth below, except to the extent that the context in which they are used indicate otherwise.

The term “Sputum” refers to a mucous material from the lungs that is produced (brought up) by coughing.

The term “Leucocyte” refers to white blood cells or white corpuscle is a cellular component of the blood that lacks hemoglobin, has a nucleus, and defends the body against infection and disease.

BACKGROUND The background information herein below relates to the present disclosure but is not necessarily prior art.

Roughly one-third of the world's population has been infected with Mycobacterium tuberculosis, with new infections occurring in about 1% of the population each year. Tuberculosis is the second-most common cause of death from infectious disease (after those due to HIV/AIDS). Hopes of totally controlling the disease have been dramatically dampened because of a number of factors, one of the most important reason is misdiagnosis due to pseudo-sputum sampling. Due to pseudo-sputum sampling, i.e. false negative results of rapid test like AFB (Acid Fast Bacillus) staining are of challenge in front of the physician.

Sputum comes in a variety of colors and forms. Fresh sputum originating from the lungs should contain pathogens if the person is suffering from a pulmonary infection or condition which are suspecting for Tuberculosis. Sputum generally accumulates in the lungs as a result from the progression of such an infection.

Once the sputum is collected, the physician sends the sample to a clinical laboratory for analysis to determine if there are any possible acid fast bacilli present within the sample. Unfortunately, between 40-60% of the samples acquired from a person in need of treatment thereof, contain only saliva and not a significant amount of sputum to test for acid fast bacilli (AFB). Since the analysis of saliva samples without sputum results false negative AFB, this thereby delays person care/treatment. Medical industry and the person suffer from wastage of money and time because of unsatisfactory sputum samples. Further, clinical laboratories, hospitals, and physicians may charge heavy for the analysis of unsatisfactory samples, but also may charge indirectly for repeated tests until a subsequent satisfactory sample has been obtained. Further, the person has to collect repeated samples and again visit laboratories, thus wasting time as well as money in this whole process. Therefore, there is a need of device for determining presence or absence of sputum in a spit sample and that alleviates the aforementioned drawbacks.

OBJECTS

Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows: It is an object of the present disclosure to ameliorate one or more problems of the prior art or to at least provide a useful alternative.

An object of the present disclosure is to provide a single time use device to identify sputum.

Another object of the present disclosure is to provide a single time use device that offers rapid confirmation of the sputum in a spit sample. Still another object of the present disclosure is to provide a single time use device to identify sputum in a spit sample that is user friendly.

Yet another object of the present disclosure is to provide a single time use device to identify sputum which is portable and lightweight.

Still another object of the present disclosure is to provide a single time use device which facilitates the separation of saliva from the spit sample.

Yet another object of the present disclosure is to provide a single time use device which indicates the health state of the spit sample. Still another object of the present disclosure is to provide a single time use device to identify sputum which offers easy transportation of sputum.

Still another object of the present disclosure is to provide a single time use device to identify sputum which facilitates to use the device as a sample collection container. Other objects and advantages of the present disclosure will be more apparent from the following description when read in conjunction with the accompanying figures, which are not intended to limit the scope of the present disclosure.

SUMMARY

The present disclosure relates envisage a single time use device to identify sputum. The device comprises a hollow container, a perforated loose net element, a lid and a sensing element.

The container is defined by side walls, an open mouth and a base. The perforated loose net element is fitted to the side walls between the mouth and the base of the container. The perforated loose net configured to receive a spit sample and retain the sputum in a fluid pocket form within the net element and release the saliva below the net element into the base of the container. The lid has a probe provided at an operative inner surface thereof. The probe is configured to abut the perforated loose net element in an operative configuration of the container when the lid is secured to the mouth. The lid is configured to be removably secured to the mouth of the container. The sensing element is secured to an operative tip of the probe. Further, the hollow container is configured to receive the spit sample. The perforated net element is attached to the walls of the container. The perforated loose net element is selected from a group consisting of a nylon mesh filter, a woven mesh filter, a knitted mesh filter. The hollow container is divided into top compartment and a bottom compartment by means of the perforated loose net element. The sputum remains in the fluid pocket of the top compartment and the saliva pass through the perforation of the net element in to the bottom compartment.

In an embodiment, the perforated loose net element () is a ring-like structure configured with a loose net therein. In another embodiment, the perforated loose net element is fusion bonded to the walls of the container. In an embodiment, the perforated loose net element is adhesively and solvent bonded to the walls of the container wherein the adhesives and solvents are selected from a group consisting of cyanoacrylates, acrylics, epoxies, urethanes, elastomers, silicones and combination thereof. In an embodiment, the perforated loose net element is configured to be permeable to wash solution and saliva and impermeable to the sputum.

In an embodiment, the fluid pocket is shaped as hammock in an operative configuration of the device.

Further, the sensing element is configured to come in contact with the fluid pocket and further configured to change its color to indicate the presence of the sputum sample. The sensing element is composed of pyrrole amino acid ester, Diazonium salt, Buffer and non- Reactive ingredients.

The pyrrole amino acid ester is configured to react with esterases of leucocytes to form 3hydroxy-5phenyl pyrrole, which in turn reacts with diazonium salts to change the color of the sensing element.

In an embodiment, the sensing element is configured with a chromic material.

Advantageously, the device provides preliminary confirmation of sputum and thereby the health state of the spit sample. Also, the device facilitates the separation of the saliva from the spit sample, as the device configured with the perforated loose net element. Further, the device is provided with the lid, therefore the same device can be also used as the sample collection tube.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING

A single time use device to identify sputum of the present disclosure will now be described with the help of the accompanying drawing, in which: Figure 1 illustrate a view of a hollow container in a upright position with a perforated loose net element attached within the circumference of the hollow container and a lid provided with a probe and a sensing element attached therewith. Figure 2 illustrates a view of a lid having a sensing element attached therewith, in accordance with an embodiment of the present disclosure.

Figure 3 illustrates a top view of a hollow container with a perforated loose net element attached therewith and a lid provided with a probe and a sensing element attached therewith in accordance with an embodiment of the present disclosure and

Figure 4 illustrates a operative position of the device in which hollow container with probe abutting the perforated loose net element in an operative configuration of the device in accordance with an embodiment of the present disclosure.

LIST OF REFERENCE NUMERALS 1 Lid

2 Sensing Element

3 Probe

4 Container

4a Top container 4b Bottom container

5 Inner Surface

6 Perforated loose net Element

7 Fluid pocket DETAILED DESCRIPTION Embodiments, of the present disclosure, will now be described with reference to the accompanying drawing.

Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open ended transitional phrases and therefore specify the presence of stated features, elements, modules, units and/or components, but do not forbid the presence or addition of one or more other features, elements, components, and/or groups thereof.

When an element is referred to as being "mounted on," “engaged to,” "connected to," or "coupled to" another element, it may be directly on, engaged, connected or coupled to the other element. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed elements.

Typically, sputum collected by the path labs mostly contains saliva .i.e. between 40-60% of the samples acquired from an infected person in need of treatment thereof; contain only saliva but not the significant concentration of the sputum to examine. Therefore, the analysis of saliva samples without sputum results in false medical results and thereby delaying the treatment or care of the infected person. Also, due to false medical report, the infected person suffers huge wastage of money as well as time because of the unsatisfactory sputum samples. Moreover, the repeated medical examination as suggested by the medical practitioner also cost huge as well as takes lots of time of the infected person. Therefore, a device is required for determining the presence or absence of the sputum in a spit sample.

The present disclosure envisages a single time use device to identify sputum in a spit sample. The device to identify sputum (herein after referred as “device 100”) will now be described with reference to Figure 1-4.

An embodiment of the present disclosure will now be described with reference to the Figure 1. The device 100 comprises a hollow container 4, a lid 1, a perforated loose net element 6, a probe 3 and a sensing element 2. The Figure 1 illustrate the view of the hollow container 4 in an upright position with the perforated loose net element 6 attached within the circumference of the hollow container 4 and the lid 1 provided with the probe 3 and the sensing element 2 attached therewith. The container 4 is defined by side walls, an open mouth and a base. The container 4 is configured to receive the spit sample to be tested for the presence or absence of sputum. The perforated loose net element 6 is operatively attached to the walls of the container 4. The net element 6 is acting as a filter for the spit sample. The loose net element 6 is configured to receive the spit sample and retain the sputum in a fluid pocket 7 within the net element 6 and release the saliva below the net element 6 into the base of the container.. Also, the mouth of the container 4 is provided with a plurality of external threads.

In an embodiment, the container 4 is made of an autoclavable material.

In another embodiment, the container 4 is made of non-reactive material which is biocompatible with the spit sample.

In an embodiment, the fluid pocket is shaped as hammock in an operative configuration of the device 100.

In an embodiment, the container 4 is made of a material consisting of borosilicate and quartz, polypropylene, non-toxic polystyrene, and the combination thereof, which is non-reactive to the spit sample.

In still another embodiment, the container 4 is made as transparent.

Further, the perforated loose net element 6 is a ring-like structure configured with a loose net therein. The perforated loose net element 6 is rigidly attached to the inner periphery of the walls of the container 4. The perforated loose net element 6 is configured to be permeable to wash solution and saliva and impermeable to sputum. The hollow container 4 is divided into a top compartment 4a and a bottom compartment 4b by means of the perforated loose net element 6. The sputum remains in the fluid pocket 7 of the top compartment 4a and the saliva pass through the perforation of the net element 6 in to the bottom compartment 4b.

In an embodiment, the perforated loose net element 6 is adhesively and solvent bonded to the walls of the container 4, wherein the adhesives and solvents are selected from a group consisting of cyanoacrylates, acrylics, epoxies, urethanes, elastomers, silicones and combination thereof. In an embodiment, the perforated loose net element 6 is fusion bonded to the walls of the container 4.

In another embodiment, the perforated loose net element 6 is selected from a group consisting of a nylon mesh filter, a woven mesh filter, a knitted mesh filter. Further, the lid 1 is provided with a probe 3 and configured to be removably secured to the mouth of the container 4. The probe 3 is operatively attached to an inner surface 5 of the lid. The probe 3 is configured to abut the net element 6 in an operative configuration of the container 4 when the lid 1 is secured to the mouth. The sensing element 2 is attached to an operative tip of the probe 3. Figure 2 illustrates the view of the lid 1 having the sensing element 2 attached therewith, in accordance with an embodiment of the present disclosure.

In an embodiment, the probe 3 is integrally built with the lid 1. In another embodiment, the probe 3 is adhesively attached or fusion bonded to the inner surface of the lid 1.

Further, the sensing element 2 is configured to abut the fluid pocket 7 formed in the loose net element 6 in an operative configuration of the container 4 and further configured to change its color to indicate the presence of the sputum sample. The fluid pocket 7 preferably consists of the separated sputum of the spit sample. The sensing element 2 is configured to identify a substance present in the sputum and absent in saliva, or present in saliva and absent in the sputum. The Figure 3 illustrates the view of the hollow container 4 with the perforated loose net element 6 attached therewith and the lid 1 provided with the probe 3 and the sensing element 2 attached therewith in accordance with an embodiment of the present disclosure.

In an exemplary embodiment, the sensing element 2 configures to identify the presence of leucocytes in the sputum which is absent in saliva.

In an embodiment, the shape of sensing element 2 is rectangular, triangular, or any suitable geometric shape. In an embodiment, the sensing element 2 is in the form strips, absorbable paper or net attached to the operative tip of the probe 3.

In another embodiment, the sensing element 2 is made of bio-compatible materials.

Further, the sensing element 2 is composed of pyrrole amino acid ester, Diazonium salt, Buffer and non-Reactive ingredients. The pyrrole amino acid ester is configured to react with esterases of leucocytes to form 3hydroxy-5phenyl pyrrole, which in turn reacts with diazonium salts to change the color of the sensing element.

In an embodiment, the sensing element 2 is configured with a chromic material.

The test is to be carried out only after removal of the lid 1. Once the lid 1 is removed, the person has to spit into the hollow container 4 to allow the spit sample to rest it on the perforated net element 6. The sputum is allowed to concentrate on the net element 6 under the action of gravity and the saliva gets settled down to the base of the container 4. In an operative configuration of the device 100, the lid 1 is fitted to the mouth of the container 4. The Figure 4 illustrates the operative position of the device in which hollow container with probe abutting the perforated net element in an operative configuration of the device in accordance with an embodiment of the present disclosure.

In an embodiment, the lid 1 is click fitted on the mouth of the container 4. In another embodiment, the lid 1 is screwed on the mouth of the container 4. In still another embodiment, the lid 1 is press fitted on the mouth of the container 4.

In an embodiment, the sputum is subjected to wash under hypertonic saline to increase the concentration of the sputum in the device 100.

Further, in the operative configuration of the device 100, the probe 3 has the sensing element 2 which abuts to the fluid pocket 7 ; thereby it determines the presence or absence of sputum in the spit sample and indicates the health of the spit sample. After testing the sample, one may close the mouth of the hollow container 4 by using the lid 1 and prevent the sample from contamination. The lid 1 ensures safe transport of the sample to a hospital or test laboratory for further tests without spilling out the sample.

Thus, the device 100 possibly be used for collecting justified sputum sample. The device 100 can be used as a sample collection tube for justified sputum to help for effective diagnosis of pulmonary infection or any other respiratory disorder or infection in suspected patients. Further, the device 100 is available to a person for sample collection via laboratory, where he can be diagnosed in time by self-rejection of sample in case collection is unsatisfactory.

Advantageously, the device 100 saves cost as well as time of repeated testing which get requisite due to unsatisfactory sample collection. The device 100 enhances non-in vasive diagnosis of respiratory pathogens associated with pulmonary diseases or condition which are suspecting for Tuberculosis or respiratory infection. The device 100 contributes for controlling worldwide spread disease of Mycobacterium Tuberculosis.

In an embodiment, the device 100 facilitates rapid and inexpensive detection of sputum in the spit sample by color visibility. Once the specimen is determined to include a sufficient amount of sputa, the sample is further analyzed to determine the presence of respiratory pathogens associated with pulmonary diseases or condition which are suspecting for Tuberculosis, or any other respiratory disorder or infection.

The foregoing description of the embodiments has been provided for purposes of illustration and not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.

TECHNICAL ADVANCEMENTS AND ECONOMICAL SIGNIFICANCE

The present disclosure described herein above has several technical advantages including, but not limited to, the realization of the single time use device to identify sputum, that:

• saves cost as well as time of repeated testing which get requisite due to unsatisfactory sample collection;

• facilitates rapid and inexpensive detection of sputum in the spit sample by simple color transition;

• provides a portable and lightweight device;

• is convenient to use, thereby user friendly;

• is inexpensive; and

• facilitates a user to know presence or absence of sputum in his spit sample, thereby allowing him to take decision for further tests.

The foregoing description of the specific embodiments so fully reveals the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, or group of elements, but not the exclusion of any other element, or group of elements.

While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.