Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[See section 10, Rule 13]

“A NOVEL MECHANISM AND DEVICE FOR SALIVA SAMPLE COLLECTION & EXTRACTION USING ORAL SWABS”

TECHNOCULTURE RESEARCH PRIVATE LIMITED, an Indian Company of Flat No. 303 B, Nutan Tower Kbagh, Karbigahiya, Patna, Bihar—800020, India

THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED. 

FIELD OF INVENTION

[1] The invention relates to the field of bio-medical technology, particularly to an devices/ method for the collection of saliva from the subjects.

BACKGROUND

[2] Detection and diagnosis of various diseases mandatorily involve the steps of collection of samples from subjects. Often the blood, stool, and urine samples are collected from the subjects which are further processed and used for the diagnosis and detection of disease. Saliva samples can be collected using an absorbent material such as a swab. Swabs typically made of cotton in the form of buds/swabs are used to absorb the sample collected from the body of a subject.

[3] The state-of-the-art process of saliva sample collection through saliva swabs involves several complicated steps. Starting with sanitizing the user’s hand, tearing out the swab packaging, placing swab inside the mouth without touching the swab, keeping it inside that swab for a few minutes, targeting and keeping the saliva-saturated swab inside the sample storage container, sealing the container, and storing the container in -20◦C until further processing. During the process, there is a chance of contaminating the sample and mishandling by the user even though the user guide is provided to the user. The user may/may not be able to follow all the provided steps as given in the user guideor may find it difficult to follow. Saliva swabs are typically composed of spongy, cellular materials with a large amount of void volume. The spongy material’s void volume allows for liquid absorption and capture. Saliva swabs must ensure that it does not cause a negative effect on the volume and nature of the saliva sample to be captured. This involves a careful choice of material through experimental analysis to ensure effective sample collection. Due to the spongy, cellular material, the swab can easily be squeezed inside the mouth by the user. So, the saliva collected by the swab may accidentally be desorbedcertain amount of saliva, and the required volume might not capture for further process. Also, there can be a large variability in the saliva volume captured within the saliva swab that can hamper the downstream applications. The state of the art of saliva swabs may involve multiple negative human interactions. Saliva swabs are dry, odorless, tasteless pieces of spongy materials with rough surfaces. These physical properties lead to an unpleasant and unnatural interaction with an individual at the time of swabbing as well as after swabbing. The state of the art of saliva swabs, steps, and apparatus involved in collecting the saliva sample from the swab is lengthy, costly, and may require some experienced personnel and efforts. A standard syringe and sample storage vial are generally used to collect the saliva. Sometimes centrifugation is required to extract the sample from the swab. There is some chance of mishandling and contaminating the saliva sample during the sample collection process. The steps involved in that process are; taking out the swab from the storage container, placing that swab inside the syringe, and applying a huge amount of pressure to release the saliva sample from the swab, collecting the extracted saliva sample in a vial for further processing and finally discarding the sample storage container, and syringe along with the swab. The first three steps, start with sanitizing the user’s hand, tearing out the swab packaging using hands, and placing the collection tool/device inside the mouth without touching the swab. During the tearing of the swab package process, there will be a chance to drop the swab, and it will be wasted or contaminated. Again, it will be very complicated without as the user needs to put that swab into the mouth for swabbing process. The user needs to be extremely cautious and precise to avoid contamination, which may not be possible for all users such as a patient having certain conditions such as neurological conditions, children, or elderly persons.

[4] Several states of art have tried to address the exiting limitations of the saliva collection process by providing methods or devices that at least tries to overcome certain to the above stated limitations. US11229421B2, published on 14th March 2019 discloses a device configured for the collection of oral fluids comprising: a collecting member, the collecting member comprising a flexible intra oral member and a rigid member, wherein the flexible intra oral member comprises at least one opening, and a sealed evacuated sample container, the sealed evacuated sample container comprising a seal wherein, the collecting member is configured such that, when the flexible intra oral member is present in an oral cavity and when being sucked, a negative pressure inside the flexible intra oral member is provided which enables the collection of oral fluids within the flexible intra oral member; and the sealed evacuated sample container is configured to activate when the seal of the sealed evacuated sample container is penetrated by a rigid, hollow structure capable of breaking or penetrating the seal of the sample container so that collected oral fluids are transferred from said flexible intra oral member to said sealed evacuated sample container by activation of a vacuum pressure in the sealed evacuated sample container. The oral member comprises latex rubber. The device as disclosed in complicated in design and does not give a solution to the usage of an oral member which can feel dry inside the mouth of the user and result in unpleasant interaction. This can be counterproductive and an adequate amount of saliva will not be secreted by the user for collection. Besides due the complicated design of the sample device the cost may go up for the user and may not be economical for the user or the design may not be easily manufactured in an industrial set-up.

[5] US2021/0196246A published on 1st June 2021 discloses a device for the collection of saliva, comprising a base comprising a body, a suction source disposed within the body, a tip removably attached to the base, the tip having a channel therethrough and an inlet to the channel, a filter material supported by the tip on a fluid path from the inlet of the tip, the filter material selected to allow passage of a target biomarker in a saliva sample; and a collection chamber disposed on the fluid path downstream of the filter material, the suction source in fluid communication with the fluid path to draw saliva through the inlet of the tip and through the filter material to the collection chamber. The device may be undesirable for use for certain users because of the suction process and may be difficult to use for patients/user with dry mouths.

[6] US8287809 published on 16th October 2012 discloses an absorbent collection device for use in testing an analyte from an oral sample collected comprising a collector wand having an absorbent positioned so that the collector can absorb an oral sample from the inside of the mouth when said collector is inserted inside the mouth of the test subject; a scent or odor capable of stimulating saliva production disposed on the said collector in such a manner that the subject's saliva production is stimulated when said collector is inserted inside the mouth of said test subject; wherein the scent or odor is positioned so that it remains outside of the mouth during the collection of the sample and does not interfere with the collection process, and remains generally in front of the test Subject's nasal passage during an oral sample collection procedure. Principally the swab is designed to enhance production through odor only using so that odor remains outside of the mouth during the collection of the sample. The patent in general in the background discusses the problem of dry mouth and not the production of enough saliva for testing purposes. The method/device disclosed makes use of impregnation of a scent or odor into the plastic material used in a device to collect saliva so that a scented clip which isattached to the collection device and is positioned on the collection device is to be maintained outside of the mouth while the sample is collected. The device does not give any indication to the user if enough saliva sample has been collected in the saliva collection process. Further, a collector has an absorbent material such as a sponge that can still feel very dry in the mouth and may have an unpleasant feeling for the user and may be a hindrance to the user.

[7] The state-of-the-art process of saliva sample collection through saliva involves several complicated steps and does not address the negative interaction that a subject might have in using a dry swab collector device. Further the available devices do not address the problem of giving any indication to the user whether sufficient saliva sample has been collected in the process and by the device. An innovative design and mechanism can be implemented to minimize the steps and simplify the process and ensure enough saliva collection by the process/ device.

OBJECT OF THE INVENTION

[8] The primary objective of the invention is to design a saliva swab collector that addresses the problems of the prior art and is an easy-to-use, simple, provide a pleasant experience during the process of the saliva collection by a subject, and is an economical device.

[9] Another objective of the present invention is to provide a saliva swab collector that can stimulate saliva production by a user.

[10] Still another objective of the present invention is to have a feedback mechanism in the saliva swab collector device that would give a clear indication to the user that adequate saliva is collected by the device and the process of saliva collection is complete.

[11] Another objective of the current invention is to overcome the negative interaction that a subject face while collecting saliva with the state-of-the-art method or devices such as dry mouth.

[12] Yet another objective of the current invention is to provide saliva collecting that stimulate saliva production that can be easily collected by the swab in adequate amounts by the user.

[13] Another objective of the current invention is to make a cost-efficient device through the proposed minimalistic design of a one-step biological sample collection, extraction, and processing device.

[14] Yet another objective of the current invention is to minimize the chances of contamination during the saliva sample collection or storage of the sample and reduces the chance of human error.

[15] Yet another objective of the current invention is to provide a feedback mechanism to the user to indicate that the swabbing process is complete.

[16] Another objective of the current invention is to design the swab in such a manner so that it minimizes the possibility of chewing or compression of a spongy component by the user's teeth, tongue, or lips.

[17] Another object of the present invention is to extract saliva from the swab in the

SUMMARY OF THE INVENTION:

[18] The current state of the art provides methods, systems, and a single-unit device for saliva collection comprisingabsorbing unit comprising a porous spongy component wherein the spongy component has an edible aroma core; a rigid outer covering encasing the spongy component; anda plunger wherein the edible aroma core contains an edible aroma compound contained in a saliva dissolvable component, wherein the spongy component is flavored and the flavor of the spongy component is different from that of the edible aroma core.

[19] In another aspect, the current invention discloses a method wherein the user swabs the mouth until a feedback mechanism is realized, wherein the indicated stop point for saliva collection by the user is when the user can taste a different flavor or a second flavor from the first flavor of the swab.

BRIEF DESCRIPTION OF FIGURES:

[20] The above-mentioned objectives and descriptions, features, aspects, and advantages of the present invention will become better understood when the following detailed description is read with reference to the accompanying figures in which like characters represent like parts throughout the figures, wherein:
[21] Figure 1 depicts conventional saliva collection process through oral swabbing which is complicated and causes errors like contamination and mishandling;
[22] Figure 2 depicts the collection of the swab sample by a user with ease. The saliva swab of the present invention is shaped like a lollipop and gently place inside the mouth for the saliva extraction process. The simple contamination-free packaging and handling are also depicted;
[23] Figure 3 depicts an optimized G3 filleted rigid outer covering encasing the spongy component in one embodiment of the invention. The plunger stick-based sample extraction mechanism is also depicted.
[24] Figure 4 depicts a cross-section view of a swab embodiment where the plunger wherein the plunger is held at position A during the sample collection process and the plunger is held at position B during the extraction of the sample in a sample processing machine.;
[25] Figure 5 depicts the feedback mechanism working of a swab embodiment where the user places the swab inside the mouth to provide an adequate amount of saliva sample. It also describes how the saliva-dissolvable component, dissolves and comes in contact with the inside mouth surface.
[26] Figure 6 depicts the various embodiments of the present invention where the rigid member covering encases the spongy componentso that it is capableof inhibiting chewing or compression of the spongy component by the user's teeth, tongue, or lips.

Further, skilled artisans will appreciate those elements in the figures illustrated for simplicity and may not have been necessarily drawn to scale. For example, the flow charts illustrate the method in terms of the most prominent steps involved to help to improve understanding of the aspects of the present invention. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the figures by conventional symbols, and the figures may show only those specific details that are pertinent to understanding the embodiments of the present invention so as not to obscure the figures with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

DETAILED DESCRIPTION

[27] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the figures and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be restrictive thereof.

[28] Reference throughout this specification to “an aspect”“another aspect” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrase “in an embodiment”, “in another embodiment” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment

[29] The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such process or method. Similarly, one or more devices or sub-systems or elements or structures or components proceeded by "comprises... a" does not, without more constraints, preclude the existence of other devices or other sub-systems or other elements or other structures or other components or additional devices or additional sub-systems or additional elements or additional structures or additional components.

[30] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The system, methods, and examples provided herein are illustrative only and not intended to be limiting.

[31] The state-of-the-art saliva sampling leads to the collection of a largely variable amount of saliva being produced due to various factors such as hydration level, ambient temperature, immune status, diseases, etc.In presence of appetizing smell and taste saliva can be stimulated, however simultaneously because of this stimulation - human beings have an impulse response to swallow the secreted saliva. In conventional saliva swabbing, the user is given a fixed duration for which the saliva swab is to be placed in the mouth for collection of saliva. This time-based collection however is one of the factors leading to large variability in the volume of saliva collected by such sample collectionkits.

[32] Users may have different propensities toward saliva production, different levels of oral hydration as well as other biological factors affecting their abilities to produce saliva. Ideally, a saliva sampling system should produce a low variability in the quantity as well as the quality of the collected saliva samples irrespective of the variability. Saliva production may variate with various physiological conditions of the human users. The different mouth or immune or infectious disease conditions are there (like dry mouth or xerostomia, swallowing difficulties or dysphagia, salivary gland dysfunction associated with different diseases such as sjogren syndrome, sialadenitis and iatrogenic diseases, dietary change and aging, dental caries and oral infections), can cause variability in the excreted saliva volume. The variations from the profiles of mood states (POMS) like depression, anger, or fatigue may affect the salivary secretions. Any kind of psychological stress, can directly affect the salivary volume.

[33] Figure 1 (100) shows the conventional saliva collection process through oral swabbing which is complicated and causes errors like contamination and mishandling. This figure shows user-facing difficulties and challenges using conventional oral Swabs [102]. The traditional oral Swab [102] has plastic packaging [106] around it. Tearing the plastic packaging [106] sometimes the user may find difficult tohandle, or damage the swab or waste it. After collecting the saliva sample the user needs to open the lid of the Sample collection vial [104] and put that conventional oral Swab [102] having saliva, inside that vial without touching the conventional oral Swab [102]. For some patients It might be complicated to target and put that conventional oral Swab [102] into the Sample collection vial [104]. During this process there is a higher chance to contaminate the sample in conventional oral Swab [102] containing saliva, as it may come in contact with the top outer opening of the Sample collection vial [104], or accidentally mishandling and wasting the sample by squeezing to take out the saliva volume by the teeth of the user.

[34] The volume of saliva in the oral cavity depends on the several factors such as stimulation, circadian rhythm, diet, age, if the subject during the collection or sampling is on any medication and hydrogen (H+) ion concentration of the saliva. The concentration of hydrogen ions plays a significant role in the bio-physicochemical processes taking place in the oral cavity. Saliva pH is not a significantly changes under the influence of various factors (salivary secretion rate, daily cycle, diet, systemic diseases, and vegetative nervous system). The pH of mixed saliva is 6.38 (from 5.8 to 7.5) on average. These factors can also be altered due to the pathological conditions like periodontal disease. The stimulation by the ambient flavor is useful to induce salivary secretions even in users prone to under-secretion. However, it can greatly help users have some kind of feedback mechanism to know that the process of collection of the saliva sample by the intended device is complete. Most of the state-of-the-art available kits do not address this problem in the prior art. The user is provided a device (with a swab) for the collection of the saliva samples. Usually, these kits/devices come with in-built instructions to collect saliva swabs for an intended period. The time fixed by the instructions provided with the device/kit to the user may/may not be helpful if the user has a condition such as a dry mouth. Moreover, the dry probe may add to the difficulties of the user in the collection of a saliva sample.

[35] The state of the art of saliva swabs devices, methods, and apparatus involved in collecting the saliva sample from the swab is lengthy, costly, and require experience and effort. A standard syringe and sample storage vial are generally used to collect the saliva. Sometimes centrifugation is required to extract the sample from the swab. There are chances of mishandling and contaminating the saliva sample. The general steps involved in the collection of the saliva involve taking out the swab from the storage container, keeping the swab inside the syringe, applying huge pressure to release the saliva sample from the swab, collecting the extracted saliva sample in a vial for further processing and finally discarding the sample storage container and syringe along with the swab.

[36] The simplification of designing saliva swabs can be achieved such that after saliva collection keeping inside that swab for a few minutes. It is desirable to achieve a method wherein a user simply puts the swab inside the sample storage container for further processing, holding the stick in one hand without using additional components/ or two hands to avoid contamination. Another challenge with saliva collection devices is that due to the spongy cellular structures, the swab can easily be squeezed inside the mouth by the user. So, the saliva collected by the swab releases back some amount of saliva sample collected, and the required volume might not be captured for further process. So, there is still large variability in the saliva volume captured within the saliva swab that can hamper the downstream applications. In order to overcome these challenges, there must be a rigid outer covering encasing the spongy component which will restrict the squeezing of the swab inside the mouth. However, several other problems are associated with providing a rigid outer covering encasing the spongy component, such as it can slow down the rate of saliva absorption process by the swab due to minimizing the exposed surface area of the saliva swab. The state of the art of saliva swabs discloses a rigid outer covering casing that involves multiple negative human interactions. Saliva swabs are dry, odorless, tasteless, spongy materials with rough surfaces. These physical properties lead to an unpleasant and unnatural interaction with an individual at the time of swabbing as well as after swabbing. To overcome the above-discussed problems, the design of the rigid outer covering casing by the the inventors of the present invention designed such that the user can experience a pleasant interaction at the time of swabbing which also helps in inducing the saliva production during the process of saliva sample collection and enables to collect an adequate amount of saliva sample.

[37] One aspect of the present invention discloses a saliva swab comprising: an absorbing unit comprising a material-like spongy component wherein the spongy component has an edible aroma core; a rigid outer covering encasing the spongy component; and a plunger. wherein the edible aroma core contains a strong edible aroma compound contained in a saliva-dissolvable component.

[38] Figure 2(200) showsthe collection of the swab sample by a user with ease. The saliva swab [202] of the present invention is shaped like a lollipop and gently place inside the mouth for the saliva extraction process. The simple contamination-free packaging [204] and handling are also depicted. Users can pull up the contamination-free packaging [204] by inserting one finger into the contamination-free packaging gripping hole[206] and using another hand to grip the swab stick or plunger [208], after that just simply place it inside the mouth by holding theswab stick orplunger[208] without contaminating the saliva swab [202]. After saliva sample collection users can just simply hold the swab stick or plunger[208] using their hand and proceed for storing it in a container or further process.

[39] In one embodiment of the invention the spongy component is flavored and the flavor of the spongy component is different from that of the edible aroma core.

[40] In yet another embodiment of the present invention, the plunger may be composed of a material selected from a group comprising plastics (polystyrene or polypropylene), paper, wood and metal wires (aluminum or stainless steel). The saliva dissolvable component may include any flavor molecule in any form factor. For example, mostly it may contain menthol crystals and flavor molecules for tamarind, lime, etc. Also, it can be selected from a group strongflavoring agents comprising vanillin, ethylvanillin, acetovanillone, manzanate, diacetyl, acetyl propionyl, acetoin, isoamyl acetate, benzaldehyde, cinnamaldehyde, ethyl propionate, methyl anthranilate, limonene, ethyl decadienoate, allyl hexanoate, ethyl maltol, 2,4-dithiapentane, methyl salicylate, and the likes.

[41] Cetylpyridinium chloride (CPC) is a cationic quaternary ammonium compound used in some types of mouthwashes, toothpaste, lozenges, throat sprays, breath sprays, and nasal sprays. It is an antiseptic that kills bacteria and other microorganisms. It is effective in preventing dental plaque and reducing gingivitis. Cetylpyridinium chloride (CPC) can be used as an edible aroma compound. The molecule has antimicrobial properties which work as an antiseptic that kills bacteria and other microorganisms while saliva sample collection from the mouth.

[42] The swab of the present invention can be made of any absorbent material which can be disposed of at the distal end of the handle. As understood by a person skilled in the art there are many absorbent materials that can be used for the purpose. In the embodiment, as shown, in Figure 2, the absorbent comprises a sponge, but the swab can be made of any other suitable hydrophilic polymers e.g., cotton, cellulose, PVA sponge, chemical treated PVA sponge and others that absorb and expand when wet. The description that follows relates to the use of a sponge and is only exemplary of the adsorbents that can be utilized in the invention. In still another embodiment of the present invention the spongy component may be composed of a material selected from a group comprising expanded polyethylene, crosslinked polyethylene, cotton, and electrospun fibers. The spongy component absorbs saliva of the required volume/amount of saliva. The saliva-dissolvable component dissolves as soon as it comes in contact with saliva. The saliva-dissolvable component may be made of edible material.

[43] In another embodiment of the present invention, the edible aroma compounds may be selected from a group comprising vanillin, ethylvanillin, acetovanillone, manzanate, diacetyl, acetyl propionyl, acetoin, isoamyl acetate, benzaldehyde, cinnamaldehyde, ethyl propionate, methyl anthranilate, limonene, ethyl decadienoate, allyl hexanoate, ethyl maltol, 2,4-dithiapentane, methyl salicylate, and the likes. The edible aroma compounds should be lighter and completely different from the saliva-dissolvable component flavor for different swabs combinations.

[44] In one aspect of the present invention a method of collecting saliva samples comprising the steps of inserting the saliva sample collection device into the mouth; holding the saliva sample collection device in the mouth until a user can taste a first flavor; andtaking the saliva sample collection device out of the mouth after the user can taste a second flavor.

[45] For the sample collection device to be user-friendly and safe, it is important that there are no sharp edges in the handle or device that can hurt a user during the saliva collection process, the inventors of the present invention designed a device that does not have sharp edges to avoid any problems to the user during the saliva collection process. Continuity in mechanical engineering is a term coined to define when there is a connection or contact between two surfaces or surface components, particularly in modeling. Continuity is defined as the flow of curves/surfaces. Surface continuity can be defined as the ways in which two surfaces meet. Surface modeling is the art of building complex geometrical features, and is used to create continuous organic shapes, therefore the meeting point of two surfaces/ junctions between surfaces is important.

[46] The 'smoothness' of a junction, where one surface meets another surface, is expressed/ defined using the term 'G'- Geometry'. In general, more alike surfaces lead to more smooth adjoining surfaces flow. If two surfaces are not touching, they have no continuity which can be represented as the surfaces having ‘No-G”. The G3 which is having an acceleration of curvature/torsion continuity which is roughly defined as the amount of change in the curvature, over the length of the curve. G3 is looking for balance on the rate of curvature – in other words, the max value of the curvature hits its peak about the middle of the transition area.

[47] Fillet is a rounding of an interior or exterior corner of a part design. Fillet geometry, when on an interior corner is a line of concave function, whereas a fillet on an exterior corner is a line of a convex function, where the fillets are typically referred to as rounds. The present invention discloses G3 fillets at each corner of the rigid outer covering casing as well as theplunger or swab stick. The outer surface of the rigid outer covering casing and the plungeror swab stick is fabricated as very smooth with a biocompatible material. The biocompatible material used in the invention can be medical grade silicon, plastics (polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polymethylmethacrylate (PMMA)), and ceramics (alumina, bioglass, hydroxyapatite, and zirconia). In another embodiment of the present invention, the rigid outer covering may be composed of a material selected from a group comprising plastics (polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polymethylmethacrylate (PMMA) and polystyrene (PS).

[48] Figure 3 depicts an optimized G3 filleted rigid outer covering [302] encasingthe spongy component [304] in one embodiment of the invention. The swab stick or plunger [306] or plunger stick-based saliva sample extraction mechanism is also depicted. After the collection of the saliva sample by the user using the saliva swab [308] further sample extraction is carried out. The saliva swab [308] is placed on a machine-friendly sample collection/storage/processing device [310]. On the swab stick or plunger[306] or plunger stick, a load (around 30 N to 50 N) [312] is applied to push the spongy component [304] to extract all saliva samples by squeezing through the saliva collection port/hole/channel [314] and store or further process in machine friendly sample collection/storage/processing device chamber [316].

[49] The combination of the rigid outer covering casing and the inside saliva swab position is optimized by design and repeated experiments. The present invention discloses a rigid outer covering casing designed like a syringe. The swab stick or the plunger acts like a one-way liner retraction mechanism that pushes the saliva swab from one end to extract the saliva captured by the swab. The process of saliva collection is simplified in the present invention by taking out the swab stickor plunger from the mouth and pushing the plunger toward the rigid outer covering casing, so the saliva gets extracted from the other end and collected for further processing. Initially, the plunger is locked in a position maintaining fully rigid constraints with the rigid outer covering casing. Breaking the constraint and the lock requires a significant amount of force which can only be applied by placing the innovative swab in a jig, shown in figure-3. The plunger resolves two things, it acts like a stick to hold the swab like a lollypop and the same stick acts like a plunger while extracting the saliva sample from the swab. One of the major advantages of this saliva swab mechanism is that it can easily be implemented in any system; it can be manually operated or automated. The design of the parts of the mechanism is easily fabricated in two parts of injection molding and easily assembled through snap/press fitting of both sticks and the one-way linear retraction mechanism incorporated with the rigid outer covering casing.

[50] Figure 4(400) shows a cross-section view of a saliva swab [402] embodiment where the swab stickor plunger [404] or plunger stick wherein the plunger stick [404] is held at a rigid or lock position [shown in Figure- 4(A)] by a temporary lock geometry [406]. During the sample, the extraction process, a load (around 30 N to 50 N) [408] is applied on the swab stickor plunger [404] to push the spongy component [410] to extract all saliva samples by squeezing through the saliva collection port/hole/channel [412]. Inside the G3 filleted rigid outer covering [414], a plurality of lock teeth [416] is provided for maintaining the one-way linear retraction mechanism of the saliva swab [402]. For that reason, the swab stickor plunger [404] is bound to travel one way (downwards). Figure - 4(B) shows how the swab stickor plunger [404] travels downward to push the spongy component [410] to extract the saliva sample from it in a sample processing machine.

[51] Figure 4 a cross-section view of a swab embodiment where the plunger wherein the plunger is held at position A during the sample collection process and the plunger is held at position B during the extraction of the sample in a sample processing machine. The saliva swab can be easily fitted into a sample processing machine for easy saliva sample extraction and the plunger may be pushed mechanically with a force of 30-50Newton to entirely extract the saliva sample form the swab. The force required to push the plunger of the saliva sample device may be 30 newton to 50 newton which requires usually more force than that exerted by human hands and thus prevents the pushing of the plunger accidentally by the patient/user during the saliva collection process. At the same time the saliva absorbed in the saliva swab can be easily and completely extracted when using the saliva sample processing machine/unit. The shape of the saliva sample device is such that it easily fits in a sample extracting/processing unit or machine. Thus, in one embodiment of the invention a force of 30-50Newton is required to push the plunger and squeeze out the saliva sample absorbed in the swab.

[52] Figure 5(500) depicts the feedback mechanism working of a swabembodimentwhere the user places the saliva swab [502] inside the mouth by holding theswab stick or plunger[504], to provide an adequate amount of saliva sample. It also describes how the saliva-dissolvable component/layer inside the core or the edible aroma core [506], dissolves and comes in contact with the inside mouth surface over time. Figure - 5(a) shows a user just put the saliva swab inside the mouth. In figure - 5(b) shows how the saliva dissolves the edible aroma core. Figure - 5(b) shows how the edible aroma core flavour comes in contact with the user's taste buds [508].

[53] One of the embodiments of the invention is described in figure - 6 (600) shows the rigid outer covering member capable of inhibiting chewing or compression of spongy component by the user's teeth, tongue, or lips.Figure 6showsthe various embodiments of the present invention where the saliva swabs [602] having swab stickor plunger [604] with a rigid member covering [606] encases the spongy component [608] having edible aroma core [610] inside so that it is capable of inhibiting chewing or compression of the spongy component [608] by the user’s teeth, tongue, or lips.

[54] These rigid members must be designed such that they perform their function without inhibiting direct fluidic interaction between fluids in the mouth and the spongy component, which causes efficient saliva collection by the swab. The rigid outer covering can be of any shape including round, oval, triangle, square, rectangle and the likes. The rigid outer covering may or may not fully cover the spongy component. In figure -6A, the rigid outer covering member can be made of hard G2/G3 filleted porous, hydrophilic, smooth surface material through which the saliva passes and is captured by the flavored spongy component containing edible aroma core contains an edible aroma compound containing a saliva dissolvable component. In figure -6B, the rigid outer covering member can be made of hard G2/G3 filleted, soft, hydrophilic material, and have multiple holes, through which the outer surface of the flavored spongy component containing edible aroma core contains an edible aroma compound contained in a saliva dissolvable component, exposed and makes direct interaction while saliva collection. In figure -6C, the rigid outer covering member can be made of hard G2/G3 filleted, hydrophilic, smooth surface material, having capillary holes or via’s through which the saliva passes and is captured by the flavored spongy componentcontaining edible aroma core contains an edible aroma compound containing a saliva dissolvable component. In figure -6D, the rigid outer covering member is the outer casing of the flavored spongy component can be made of hard G2/G3 filleted porous, hydrophilic, smooth surface material through which the saliva passes and is captured by the inner flavored spongy component containing edible aroma core contains an edible aroma compound containing a saliva dissolvable component.

The feedback mechanism of the swabbing process

[55] Most of the swabs, in the state of the art, feel very dry and hinder the process of saliva secretion by the user. Furthermore, a user has no link as to how long a swab should be used for adequate collection of saliva sample. An inbuilt mechanism for saliva collection in the saliva swab can greatly aid the process of saliva collection. The present invention for this reason discloses a spongy material at the distal end of the swab collecting device which is flavored. The use of a flavored spongy material aids greatly in the production of adequate saliva. The user is instructed to continue the swabbing process till they taste the edible aroma core. The taste of the inner core of the saliva is different than that of the outer swab material, once the user tastes a different flavor from the first flavor, it is an indication that the user can stop the swabbing process. During the swabbing process, the saliva-dissolvable-component inside the swab gets dissolved and the component dissolves will then release the inner edible core. The user once taste the inner edible core, he/she is instructed that the swabbing process is complete and they can pull out the device from the mouth. Thus, the saliva swab of the current invention has a built-in feedback mechanism to indicate the user that the process of saliva sample collection is complete. In one aspect of the present invention method of collecting saliva sample using the device is disclosed, said method comprising the steps, inserting the saliva sample collection device into the mouth; holding the saliva sample collection device in the mouth, the user will experience a flavor of spongy component and later, taking the saliva sample collection device out of the mouth when a user tastes an inner edible core (second flavor). In one embodiment of the invention, the first flavor is the flavor of a spongy component and the second flavor is of edible aroma core. This produces a nontemporal feedback mechanism that captures atleast a predefined minimum volume of saliva in the swab.

[56] While specific language has been used to describe the disclosure, any limitations arising on account of the same are not intended. As would be apparent to a person in the art, various working modifications may be made to the method in order to implement the inventive concept as taught herein. The figures and the foregoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment. For example, orders of processes described herein may be changed and are not limited to the manner described herein. Moreover, the actions of any flow diagram need not be implemented in the order shown; nor do all of the acts necessarily need to be performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts. The scope of embodiments is by no means limited by these specific examples. Numerous variations, whether explicitly given in the specification or not, such as differences in structure, dimension, and use of material, are possible. The scope of embodiments is at least as broad as given by the following claims.
, Claims:We claim:

1. A saliva swab device(202, 308, 402, 502, 602)comprising:
a. absorbing unit comprising a porous spongy component (304, 608, 410) wherein the spongy component (304, 608, 410) has an edible aroma core (506, 610);
b. a rigid outer covering (302, 414, 606) encasing the spongy component; and
c. a plunger (208, 306, 404, 504, 604).
wherein the edible aroma core (506, 610) contains an edible aroma compound contained in a saliva dissolvable component.
wherein the spongy component is flavored and the flavor of the spongy component(304, 608, 410) is different from that of the edible aroma core (506, 610).

2. The device as claimed in claim 1, wherein therigid outer covering (302, 414, 606) encases the spongy component fully or partially.

3. The device as claimed in claim 1, wherein the rigidouter covering (302, 414, 606) is composed of a material selected from a group comprising plastics (polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polymethylmethacrylate (PMMA) and polystyrene (PS)).

4. The device as claimed in claim 1, wherein the plunger (208, 306, 404, 504, 604) is composed of a material selected from a group comprising plastics (polystyrene or polypropylene), paper, wood, and metal wires (aluminum or stainless steel).

5. The device as claimed in claim 1, wherein the saliva dissolvable component is composed of a material selected from a group comprising flavoring compound selected from a group comprising menthol crystals, tamarind, lime, vanillin, ethylvanillin, acetovanillone, manzanate, diacetyl, acetyl propionyl, acetoin, isoamyl acetate, benzaldehyde, cinnamaldehyde, ethyl propionate, methyl anthranilate, limonene, ethyl decadienoate, allyl hexanoate, ethyl maltol, 2,4-dithiapentane, methyl salicylate, cetylpyridinium chloride (CPC) and the likes.

6. The device as claimed in claim 1, wherein spongy component (304, 608, 410)is composed of a material selected from a group comprising expanded polyethylene, crosslinked polyethylene, cotton, and electro spun fibers.

7. The device as claimed in claim 1, wherein the spongy component(304, 608, 410)absorbs saliva sample.

8. The device as claimed in claim 1, wherein the edible aroma core (506, 610)compoundsis selected from a group comprising vanillin, ethylvanillin, acetovanillone, manzanate, diacetyl, acetyl propionyl, acetoin, isoamyl acetate, benzaldehyde, cinnamaldehyde, ethyl propionate, methyl anthranilate, limonene, ethyl decadienoate, allyl hexanoate, ethyl maltol, 2,4-dithiapentane, methyl salicylate.

9. The device as claimed in claim 1, wherein the saliva dissolvable component dissolves as soon as it comes in contact with the saliva.

10. The device as claimed in claim 1, wherein the rigid outer covering(302, 414, 606)is made of hard G2/G3 filleted, soft, hydrophilic material, with multiple holes and/or capillary holes.

11. A method of collecting saliva sample using the device as claimed in claim 1 comprising the steps;
a. inserting the saliva sample collection device (202, 308, 402, 502, 602) into the mouth;
b. holding the saliva sample collection device (202, 308, 402, 502, 602) in the mouth until a user can taste a first flavor; and
c. taking the saliva sample collection device (202, 308, 402, 502, 602) out of the mouth after the user can taste a second flavor.

12. The method as claimed in claim 11, wherein the first flavor is the flavor of spongy component and the second flavor is of edible aroma core.

13. The device as claimed in claim 1, wherein a force of 30-50Newton is required to push the plunger and squeeze out the saliva sample absorbed in the swab.

14. The device as claimed in claim 1, wherein the device fits into a sample processing unit completely for further processing of the saliva sample.

Dated this 27th day of April, 2023