DESC:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
TESTING DEVICE
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF THE INVENTION
[1] The present disclosure relates to a testing device. More particularly, the present invention relates to a sample collection and diagnostic device.
BACKGROUND OF THE INVENTION
[2] Rapid diagnostic testing plays a critical role in detecting various diseases, pathogens, and substances in medical, research, and security fields. The diagnostic systems are widely used for point-of-care diagnostics, including detecting infectious diseases, drug screening, and environmental testing. To meet the needs of growing public health demands, integrated test strip technologies which are simple-to-use, and can deliver rapid test results safely and cost-effectively, are needed. Further, the diagnostic systems should cater to a wide range of diseases or analytes in a non-invasive manner. As the key to all disease prevention is early detection, accurate and early detection using rapid tests can have a major impact in reducing disease incidence.
[3] With the availability of rapid test technologies, general practitioners and healthcare professionals see an opportunity to provide testing opportunities in non-traditional testing sites, such as in the privacy of the patient's home, in nursing homes, remote clinic settings and even over the counter in a pharmacy environment.
[4] However, conventional rapid test technologies rely on multiple components, including separate sample collection tools, buffer tubes, and/or test strips. These components are generally packaged separately in a kit, which require manual handling and multiple procedural steps. The complexity of the process often leads to errors, especially when untrained individuals handle the tests. Users must manually transfer the collected sample into a buffer solution and then apply the treated sample to a separate test strip. The aforementioned steps are time-consuming and may introduce several points of potential failure, including increasing the risk of contamination, inaccurate sample volumes, and inconsistent results. Additionally, mishandling or spillage during sample transfer may compromise the accuracy of the test and pose a safety hazard for the user and the surrounding environment.
[5] Hence, there arises a need for a rapid testing device that overcomes the drawbacks of the conventional devices.
SUMMARY OF THE INVENTION
[6] The present invention relates to an integrated sample collection and diagnostic device. The device includes a body, a gripper component and a sampling stick. The body has at least a fluid chamber and a release chamber. The fluid chamber stores a solution to maintain an integrity of a sample. The gripper component is housed in the release chamber. The gripper component has a seal configured to separate the solution and a test strip. The gripper component is provided to lift the seal. The sampling stick is used to collect the sample. The sampling stick with the sample is housed in the fluid chamber. The test strip is configured to display a test result upon removal of the seal.
[7] In an embodiment, the gripper component of the device includes an extended tab, a cap, a hole, a stem, and a head. The extended tab is configured to lock the gripper component with the body. The cap is provided to operate the gripper component and is coupled to the extended tab. The hole is in the extended tab and is configured to lock the extended tab with the body. The stem is coupled to the cap and extends to the bottom end of the body. The head is positioned at the end of the stem and disposed in the release chamber of the body. The head is configured to house the seal.
[8] In another embodiment, the gripper component includes a roller, a gripping portion, a hole, a stem and a head. The roller is positioned at a first end of the gripper component. The gripping portion is provided on the outer surface of a roller and configured to roll the roller. The hole is provided at the center of the roller and configured to couple with the pin of the body. The stem is coupled to the roller and extends to the bottom of the body. The head is provided at the end of the stem and positioned on the release chamber of the body. The head is configured to accommodate the seal.
[9] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[10] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[11] FIG. 1 depicts a perspective view of a device 1, in accordance with an embodiment of the present invention.
[12] FIG. 2 depicts an exploded view of the device 1, in accordance with an embodiment of the present invention.
[13] FIG. 3A depicts a perspective view of the body 2 of the device 1, in accordance with an embodiment of the present invention.
[14] FIG. 3B depicts a top view of the body 2 of the device 1, in accordance with an embodiment of the present invention.
[15] FIG. 4 depicts a perspective view a gripper component 3 of the device 1, in accordance with an embodiment of the present invention.
[16] FIG. 5 depicts a perspective view a locking pin 4 of the device 1, in accordance with an embodiment of the present invention.
[17] FIG. 6 depicts a perspective view of a sampling stick 5 of the device 1, in accordance with an embodiment of the present invention.
[18] FIG. 7A depicts a cross-sectional view of the device 1, in accordance with an embodiment of the present invention.
[19] FIG. 7B depicts an assembled top view of the device 1, in accordance with an embodiment of the present invention.
[20] FIG. 8 depicts a flowchart of an exemplary method 800 of using the device 1, in accordance with an embodiment of the present invention.
[21] FIG. 9A depicts a perspective view of a device 11, in accordance with an alternative embodiment of the present invention.
[22] FIG. 9B depicts an exploded view of the device 11, in accordance with an alternative embodiment of the present invention.
[23] FIG. 10A depicts a cross-sectional view of the device 11, in accordance with an alternative embodiment of the present invention.
[24] FIG. 10B depicts a sampling stick 15 disposed within the body 12 of the device 11 in accordance with an alternative embodiment of the present invention.
[25] FIG. 11 depicts a perspective view for a device 21 having a body 22 with one chamber for placing a sampling stick 25 in accordance with another embodiment of the present invention.
[26] FIG. 12 depicts a flow diagram of an exemplary process 1200 of using the device 11 in accordance with another embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[27] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[28] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[29] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[30] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[31] The present disclosure relates to a testing device (or device). The device is used for conducting a diagnostic test using a test sample. The sample may be a solution containing a predefined level of an analyte. The sample can be sourced from a body fluid including, but not limited to, urine, saliva, plasma, serum, blood, stool, or spinal fluid. Additionally, or optionally, the sample may be diluted using a treatment solution including, but not limited to, water, a pH buffer, or a protein buffer, etc.
[32] The device of the present disclosure finds use in the field of diagnostics. Specifically, the device can be used in for example, professional laboratories, home or the like for testing a sample. The device of the present disclosure can be used for diverse applications such as rapid antigen test kits, rapid antibody test kits and/or testing kits in the field of healthcare, research, diagnostic testing, etc. as it can rapidly and efficiently detect various analytes or the like.
[33] The present disclosure provides an integrated diagnostic device comprising multiple distinct chambers designed to streamline and simplify the process of diagnostic testing. The device has an integrated design that includes multiple compartments enclosed within a single body. This expedites the test procedure and outcome as few simple steps are involved in operating the device. Further, the integrated design ensures accuracy and minimizes contamination risks, notching a significant advancement in diagnostic technology. The compact size and the design of the device enhance the user experience by offering exceptional ease of handling, lightweight, portability, efficient space utilization, and can be used on-the-go.
[34] The device of the present disclosure includes one or more test strips in such a manner that to perform a test, a solution (containing the analyte) comes in contact with the test strip inside the device itself. The test strip can be observed for the test result through a transparent portion provided on the device. Thus, the user of the device is not required to perform the test on a bench while handling a plurality of reagents or the like. Accordingly, the device provides safety to the user performing the tests.
[35] The device of the present disclosure is designed such that rapid testing is performed with enhanced efficiency and convenience. The device uses a telescopic sampling stick, which can be extended and modified based on the requirements of sample collection. Therefore, the device is user-friendly for various types of sample collection and testing.
[36] Now referring to the figures, Fig. 1 depicts a perspective view and Fig. 2 depicts an exploded view of a device 1 for sample testing. The device 1 has a first end 1a and a second end 1b. The device 1 includes a plurality of components operationally coupled to each other. The device 1 includes, without limitation, a body 2, a gripper component 3, a locking pin 4, a sampling stick 5, a test strip 6, a seal 7, an opening 9, etc.
[37] Fig. 3A depicts a perspective view and Fig. 3B depicts a top view of the body 2 of the device 1, in accordance with an embodiment of the present invention. The body 2 may have a pre-defined shape including, but not limited to, cuboidal, elongated squircle, cylindrical, etc. In an exemplary embodiment, the body 2 is cuboidal. The body 2 is made of a material including, but not limited to, plastic, polymer, fiber, thermoplastic, etc. In an embodiment, the body 2 is made of plastic. In an embodiment, the length of the body 2 may range between 80 mm and 175 mm, and the width of the body 2 may range between 30 mm and 70 mm. In an exemplary implementation, the length and the width of the body 2 are 120 mm and 50 mm, respectively.
[38] The body 2 of the device 1 has a first side 2y and a second side 2z. Further, the body 2 of the device 1 includes a top end and a bottom end. The body 2 includes a plurality of walls 2a, a first edge 2b, a plurality of chambers 2c, at least one hole 2d and a cut-out 2e. The body 2 has an outer surface defined by the plurality of walls 2a. In an exemplary embodiment, the body 2 has four walls 2a. As shown in Fig. 3A, each one of the walls 2a has a first edge 2b. At least one wall 2a is transparent allowing the user to view the test result displayed on the test strip 6 that is housed inside the storage chamber (described later).
[39] At least one of the walls 2a is provided with the hole 2d towards the first side 2y of the body 2. The hole 2d extends throughout the width of one of the walls 2a. The hole 2d helps in securing the gripper component 3 within at least one chamber 2c of the body 2 using the locking pin 4. The hole 2d may have a diameter depending upon the size of the locking pin 4.
[40] At least one of the walls 2a is provided with at least one cut-out 2e towards the top end of the body 2. The cut-out 2e helps in securing the sampling stick 5 with the body 2. The cut-out 2e may have dimensions depending upon the size of corresponding jaws of the sampling stick 5. In an exemplary embodiment, the body 2 is provided with two cut-outs 2e disposed towards the top end of the opposite walls of the body 2.
[41] The body 2 includes a plurality of chambers 2c as shown in Fig. 3B. In an exemplary embodiment, the body 2 includes four chambers, namely, a dry chamber 2c1, a fluid chamber 2c2, a release chamber 2c3, and a storage chamber 2c4. The chambers 2c may extend axially along at least a portion of the length of the body 2.
[42] In an exemplary embodiment, the dry chamber 2c1 and the fluid chamber 2c2 are positioned adjacent to each other. The storage chamber 2c4 is disposed towards the first side 2y of the body 2. The release chamber 2c3 is positioned between the storage chamber 2c4 and at least one of the dry chamber 2c1 or the fluid chamber 2c2. Other arrangements of the four chambers 2c of the body 2 are within the scope of the teachings of the present disclosure.
[43] The dry chamber 2c1 of the body 2 is provided to house the sampling stick 5. In an embodiment, the dry chamber 2c1 is used to store the sampling stick 5 before sample collection. The fluid chamber 2c2 is provided for storing a solution to maintain an integrity of a sample. The solution may be selected from but not limited to, reagents, reactants, etc. depending on the test procedure being performed using the device 1. The sampling stick 5 may be disposed within the fluid chamber 2c2 after a sample is collected for proper mixing of the sample with the solution. The release chamber 2c3 is provided to house the gripper component 3. The release chamber 2c3 facilitates controlled release of the sample-solution mixture onto the test strip 6. The storage chamber 2c4 is provided to hold one or more test strips 6. The wall of the storage chamber 2c4 towards the first side 2y may be transparent, facilitating the user to observe test results.
[44] Fig. 4 depicts a gripper component 3 of the device 1, in accordance with an embodiment of the present invention. The gripper component 3 is made of a material including, but not limited to, plastic, polymer, fiber, thermoplastic, rubber, etc. In an embodiment, the gripper component 3 is made of plastic. The dimensions of gripper component 3 may be chosen based on configurations of the body 2. In an embodiment, the length of the gripper component 3 may range between 75 mm and 170 mm. In an exemplary implementation, the length of the gripper component 3 is 115 mm.
[45] The gripper component 3 has a first end 3y and a second end 3z. The gripper component 3 includes, without limitation, an extended tab 3a, a cap 3b, a hole 3c, a stem 3d, a head 3e, etc. In an exemplary embodiment, the extended tab 3a is partially disposed within the storage chamber 2c4 and the stem 3d is partially disposed within the release chamber 2c3. The extended tab 3a and the stem 3d may thus act as two arms 3a and 3d of the gripper component 3 which are inserted into respective chambers. The extended tab 3a and the stem 3d are connected to the cap 3b at the first end 3y of the gripper component 3.
[46] The extended tab 3a may be have a shape, such as, without limitation, cylindrical, cuboidal, cube, etc. In an example implementation, the extended tab 3a is cuboidal. The extended tab 3a provides structural support to the gripper component 3 and helps to lock the gripper component 3 with the body 2. The extended tab 3a includes a hole 3c. The hole 3c extends throughout the width of the extended tab 3a. The hole 3c aligns with the hole 2d of the body 2 once the gripper component 3 is disposed in the body 2. The locking pin 4 is provided in the hole 3c and the hole 2d of the body 2 to lock the extended tab 3a with the respective wall of the body 2.
[47] The hole 3c may have a diameter depending upon the size of the locking pin 4. The dimensions of extended tab 3a may be chosen based on configurations of the storage chamber 2c4. In an embodiment, the length of the gripper component 3 may range between 75 mm and 170 mm. In an exemplary implementation, the length of the gripper component 3 is 115 mm. The gripper component 3 may be made of a biocompatible material, including, without limitation, plastic, polymer, rubber, etc. In an example implementation, the gripper component 3 is made of plastic.
[48] The cap 3b helps a user to operate the gripper component 3 by inserting and removing the gripper component 3 from the body 2. The cap 3b is designed to facilitate a comfortable grip for the user. In the depicted embodiment, the cap 3b have multiple parallel ridges provided on its top surface, that facilitate a better grip for the user and allows easier grip of the gripper component 3. Other designs such as, grooves, undulations, or the like, instead of, or in addition to, the ridges that facilitate easy and comfortable grip, are covered within the teachings of the present invention.
[49] The stem 3d extends from the cap 3b downwards towards the second end 3z. The stem 3d may have a length depending upon the depth of the release chamber 2c3 of the body 2. The stem 3d may be made of a material including, but not limited to, plastic, polymer, rubber, etc. In an embodiment, the stem 3d is made of plastic. The width of the stem 3d may be same or less than the width of the cap 3b. The stem 3d is coupled to the head 3e towards the second end 3z of the gripper component 3. The stem 3d suspends the head 3e in the release chamber 2c3 of the body 2 at a desired length.
[50] The head 3e is configured to fluidically couple the fluid chamber 2c2 and the storage chamber 2c4. The head 3e may have a pre-defined shape including, but not limited to, square, rectangle, oval, hexagonal, heptagonal, etc. In an exemplary embodiment, the head 3e is square. The dimension of the head depends on the dimension of the release chamber 2c3.The head 3e may be hollow, solid, porous etc. In an embodiment, the head 3e is hollow. The head 3e of gripper component 3 is removably coupled to the seal 7. The gripper component 3 is configured to lift the seal 7.
[51] The seal 7 can be removed and/or replaced, for example, as and when there is suspicion of contamination. The seal 7 prevents fluidic communication of the fluid chamber 2c2 with the storage chamber 2c4 via the release chamber 2c3. The seal 7 is configured to separate the solution of the fluid chamber 2c2 and the test strip 6 of the storage chamber 2c4. The seal 7 is made of a flexible material including, but not limited, rubber, foam, polymer, etc. In an exemplary embodiment, the seal 7 is made of rubber. The dimension of the seal 7 is similar to the head 3e such that the seal 7 sit into the hollow space of the head 3e.
[52] The test strip 6 (shown in Fig. 2) is disposed within the storage chamber 2c4 of the body 2. The test strip 6 is configured to display a test result upon removal of the seal 7. The test strip 6 has a thin and porous structure. The test strip 6 is coated with specific chemical reagents such as antibodies, reagents or the like. The coating on the test strip 6 interacts with the antigens or analytes or like present in the sample. The conjugates formed on the test strip 6 indicated the presence or absence of target molecules in the sample.
[53] Fig. 5 depicts a locking pin 4 of the device 1, in accordance with an embodiment of the present invention. The locking pin 4 helps to lock the extended tab 3a of the gripper component 3 to the storage chamber 2c4 of the body 2. The locking pin 4 is made of a material including, but not limited to, plastic, polymer, fiber, rubber, etc. In an embodiment, the locking pin 4 is made of plastic. The locking pin 4 includes, without limitation, a first portion 4a and a second portion 4b. The first portion 4a may have a shape, such as, without limitation, spherical, spheroid, oval, rounded, cuboidal, cylindrical, etc. In an embodiment, the first portion 4a is spheroid. In an exemplary embodiment, the locking pin 4 includes a plurality of ridges 4a1 provided circumferentially around the first portion 4a for enabling a user to grip and interact with the locking pin 4.
[54] The second portion 4b extends vertically outward from the first portion 4a, forming a T-shaped structure. The second portion 4b may have a shape, such as, without limitation, tubular, cylindrical, cuboidal etc. In an exemplary embodiment, the second portion 4b is cylindrical. At least a portion of the second portion 4b is configured to be disposed within the hole 2d of the body 2 and the hole 3c of the gripper component 3. The locking pin 4 thus secures the gripper component 3 to the body 2. When the extended tab 3a of gripper component 3 is disposed within the storage chamber 2c4 of the body 2, the second portion 4b of the locking pin 4 secures the gripper component 3 with the body 2 of the device 1. Accordingly, the locking pin 4 may be removed from the device 1 before lifting the gripper component 3 away from the body 2.
[55] Fig. 6 depicts a perspective view of a sampling stick 5 of the device 1, in accordance with an embodiment of the present invention. The sampling stick 5 is made of a material including, but not limited to, plastic, polymer, fiber, thermoplastic, etc. In an embodiment, the sampling stick 5 is made of plastic. The sampling stick 5 has a first end 5y and a second end 5z. The sampling stick 5 is configured to collect a sample. The sampling stick 5 includes a handle 5a, at least one flexible finger gripping portions 5b, a leak proof seal 5c, an elongated portion 5d, etc.
[56] The handle 5a is provided at the first end 5y of the sampling stick 5. The handle 5a includes a body with an ergonomic shape, which enables a user to grip and collect samples comfortably. The handle 5a is provided with a gripping surface for a user to hold and interact with the sampling stick 5. The handle 5a has a shape, such as, without limitation, cuboidal, cylindrical, tubular etc. In an embodiment, the handle 5a is cylindrical. The dimensions of the handle 5a may be chosen based on procedural requirements. In an embodiment, the length of the handle 5a may range between 1 mm and 15 mm. In an exemplary implementation, the length of the handle 5a is 5 mm.
[57] The flexible finger gripping portions 5b are positioned adjacent to the handle 5a towards the first end 5y of the sampling stick 5. The flexible finger gripping portions 5b extend away from the handle 5a and along the length of the body 2 (or chambers of the body 2). Each flexible finger gripping portion 5b is provided with at least one jaw 5b1 that complements the cut-out 2e of the body 2. The flexible finger gripping portions 5b enable the jaws 5b1 to flex either away or towards the body 2. The jaws 5b1 latch on to the cut-out 2e of the body 2 when the sampling stick 5 is at least partially disposed within at least one of the dry chamber 2c1 or the fluid chamber 2c2, thereby, securing the sampling stick 5 with the body 2 of the device 1.
[58] The shape of the leak proof seal 5c may be without limitation, square, rectangle, etc. In an exemplary embodiment, the leak proof seal 5c complements the combined shape of the dry chamber 2c1 and the fluid chamber 2c2. The leak proof seal 5c is made of a material including, but not limited to, plastic, polymer, rubber, etc. In an embodiment, the leak proof seal 5c is made of plastic. The leak proof seal 5c prevents any leakage of the solution from the dry chamber 2c1 and/or fluid chamber 2c2 of the device 1. The leak proof seal 5c also helps to prevent entry of foreign particles/contaminants into the dry chamber 2c1 and/or fluid chamber 2c2 of the device 1.
[59] The elongated portion 5d extends longitudinally from the leak proof seal 5c to the second end 5z of the sampling stick 5. The elongated portion 5d of the sampling stick 5 is fixedly coupled to the leak proof seal 5c at an offset such that the user may selectively insert the elongated portion 5d in either of the dry chamber 2c1 or the fluid chamber 2c2 when latching the jaws 5b1 with the cut-outs 2e. For example, the user may flip the sampling stick 5 sideways to insert the elongated portion 5d within either of the dry chamber 2c1 or the fluid chamber 2c2. The elongated portion 5d may have a length corresponding to at least partially the depth of the dry chamber 2c1 and/or the fluid chamber 2c2 of the device 1. The elongated portion 5d may be of shape including, but not limited to hollow tube, solid tube, rectangular stick etc. The elongated portion 5d is made of a material including, but not limited to, plastic, polymer, fiber, etc. In an embodiment, the elongated portion 5d is made of plastic.
[60] Additionally or optionally, the elongated portion 5d of the sampling stick 5 may telescopically extend up to a predefined length. The telescoping extension of the elongated portion 5d may help the user to easily collect sample from hard-to-reach areas. The dimensions of elongated portion 5d may be chosen based on configurations of the body 2. In an embodiment, the length of the elongated portion 5d may range between 70 mm and 175 mm, and the diameter of the elongated portion 5d may range between 3 mm and 10 mm. In an exemplary implementation, the length and the diameter of the elongated portion 5d are 130 mm and 5 mm, respectively.
[61] The elongated portion 5d has a free end portion 5d1 positioned at the second end 5z of the sampling stick 5. The free end portion 5d1 includes a textured surface. The textured surface may have a pattern including, but not limited to, granular pattern, circular grooved pattern, zig-zag grooved pattern, etc. In an exemplary embodiment, the textured surface of the free end portion 5d1 has a plurality of granular projections. The free end portion 5d1 is provided for collecting the sample from without limitation, throat, nose, or other body parts during sample collection. Alternatively, the free end portion 5d1 of the elongated portion 5d is provided with a swab, for example, a cotton swab.
[62] Fig. 7A depicts a cross-sectional view and Fig. 7B depicts an assembled top view of the device 1, in accordance with an embodiment of the present invention. The opening 9 is provided at the bottom end of the body 2. The fluid chamber 2c2, the release chamber 2c3 and the storage chamber 2c4 may be fluidically coupled to each other via a plurality of the opening 9 allowing the solution to flow within the chambers 2c. The seal 7 of the gripper component 3 slidably seals and unseals the opening 9 between the fluid chamber 2c2, the release chamber 2c3 and the storage chamber 2c4.
[63] An embodiment of assembly of the device 1 is now explained. The extended tab 3a of the gripper component 3 is partially disposed within the storage chamber 2c4, while the stem 3d is at least partially disposed within the release chamber 2c3 of the body 2. The hole 2d of the body 2 is aligned with the hole 3c of the gripper component 3 and coupled using the second portion 4b of the locking pin 4. At least a partial portion of the second portion 4b is disposed within each of the hole 2d of the body 2 and the hole 3c of the gripper component 3. The first portion 4a of the locking pin 4 is disposed outside of the said hole 2d and hole 3c to prevent the pin from slipping out, providing a secure coupling. The seal 7 is seated within the head 3e of the gripper component 3, preventing fluidic coupling between the fluid chamber 2c2 and the storage chamber 2c4 via the release chamber 2c3. When the locking pin 4 is removed, the cap 3b of the gripper component 3 is lifted, causing the seal 7 to move away from the opening 9, thereby allowing solution flow between the chambers.
[64] The cut-out 2e of the body 2 is aligned with the flexible finger gripping portions 5b of the sampling stick 5, securing the sampling stick 5 within at least one of the dry chamber 2c1 or the fluid chamber 2c2. The jaws 5b1 of the flexible finger gripping portions 5b latch onto the cut-out 2e, preventing unintended displacement of the sampling stick 5. The elongated portion 5d of the sampling stick 5 extends into either the dry chamber 2c1 or the fluid chamber 2c2, depending on the position of the user’s placement. The leak-proof seal 5c of the sampling stick 5 is positioned to complement the shape of the dry chamber 2c1 and fluid chamber 2c2, ensuring a tight seal to prevent leakage of the solution from the fluid chamber 2c2. The coupling of the sampling stick 5, the gripper component 3, and the locking pin 4 ensures controlled sample collection, secure containment of the test buffer solution, and precise initiation of the testing process when activated.
[65] FIG. 8 depicts an exemplary method 800 to operate the device 1 to collect and test a sample. The sample may be at least one of urine, saliva, plasma, serum, blood, spinal fluid, or hazardous materials. The method 800 commences by obtaining a device 1 with the sampling stick 5 disposed inside the dry chamber 2c1 of the body 2.
[66] At step 801, the sampling stick 5 is removed from the dry chamber 2c1 of the body 2. For this, the flexible finger gripping portions 5b are pressed by a user to unlatch the jaws 5b1 from the cut-out portions 2e of the body 2. Thereafter, the sampling stick 5 is removed from the dry chamber 2c1.
[67] At step 803, the elongated portion 5d of the sampling stick 5 is used to collect a sample for testing. In an exemplary embodiment, the elongated portion 5d of the sampling stick 5 is at least partially placed inside the throat, nose, or other body parts for the collection of body fluids based on the required testing or diagnostics. The free end portion 5d1 of the elongated portion 5d helps in collection of the sample.
[68] At step 805, the sampling stick 5 along with the collected sample is placed inside the fluid chamber 2c2 of the body 2. Thereafter, the jaws 5b1 are latched onto the cut-outs 2e of the body 2 to secure the sampling stick 5 to the body 2 of the device 1.
[69] At step 807, the collected sample is mixed with the solution contained in the fluid chamber 2c2. For proper mixing of the collected sample with the solution contained in the fluid chamber 2c2, the device 1 is physically shaken by the user.
[70] At step 809, the locking pin 4 is gradually removed from the device 1 to unsecure the gripper component 3 from the body 2. The locking pin 4 is pulled away from the hole 2d of the body 2 and hole 3c of the gripper component 3.
[71] At step 811, the gripper component 3 is at least partially removed from the release chamber 2c3. The seal 7 is disposed inside the release chamber 2c3 and is configured to open the opening 9 by sliding towards the first end 1a. This fluidically couples the fluid chamber 2c2, release chamber 2c3 and the storage chamber 2c4. As a result, the solution from the fluid chamber 2c2 flows out through the release chamber 2c3 and comes in contact with the test strip 6 disposed inside the storage chamber 2c4. The test strip 6 tests the presence of one or more analytes present in the solution.
[72] At step 813, the results of the test are displayed visually on the test strip 6 after a pre-defined time period. The pre-defined time period depends on the type of test and the sample collected for the test.
[73] Fig. 9A depicts a perspective view and Fig. 9B depicts an exploded view of a device 11 in accordance with an alternative embodiment of the present invention. The device 11 includes a body 12, a sampling stick 15, at least one of test strip 16, a seal 17, a gripper component 18, etc. The device 11 is structurally and functionally analogous to the device 1 except that a new embodiment of the gripper component 18 is disclosed. Accordingly, the body 12 of the device 11 is modified to accommodate the gripper component 18. The gripper component 18 is functionally similar to the gripper component 3, i.e., the gripper component 18 helps to selectively establish fluidic coupling between the chambers of the device 11 (described later).
[74] The body 12 of the device 11 is shown is Fig. 9B. The body 12 is structurally similar to body 2 unless disclosed otherwise. The body 12 includes, without limitation, a plurality of walls 12a, a first edge 12b, a dry chamber 12c1, a fluid chamber 12c2, a release chamber 12c3, at least one cut-out 12e, a pin 14, test strip 16, an opening 19 (shown in Fig. 10A), etc.
[75] In an exemplary embodiment, the body 12 has four walls 12a. The dry chamber 12c1 and the fluid chamber 12c2 are structurally and functionally similar to the dry chamber 2c1 and fluid chamber 2c2 of the device 1, hence the description is not repeated for the sake of brevity and can be referred therefrom. The release chamber 12c3 of the body 12 houses both the test strips 16 and at least a portion of the gripper component 18.
[76] The first edge 12b of the body 12 is provided with a cavity 12d to rotatably receive the gripper component 18 over the pin 14. The pin 14 is fixedly coupled to the body 12 such that the gripper component 18 is freely rotatable over the pin 14. The pin 14 may have a cylindrical shape. The pin 14 may have a length such that it can accommodate the gripper component 18. The pin 14 is made of a material including, but not limited to, plastic, polymer, fiber, etc. In an embodiment, the pin 14 is made of plastic.
[77] The gripper component 18 has a first end 18y and a second end 18z. The gripper component 18 includes the roller 18a, a gripping portion 18b, a hole 18c, a stem 18d, and a head 18e. The gripper component 18 is made of a material including, but not limited to, plastic, polymer, fiber, thermoplastic, etc. In an exemplary embodiment, the gripper component 18 is made of thermoplastic. The dimensions of gripper component 18 may be chosen based on the configurations of the body 2. In an embodiment, the length of the gripper component 18 may range between 90 mm and 190 mm. In an exemplary implementation, the length of the gripper component 18 is 130 mm.
[78] The roller 18a is positioned at the first end 18y of the gripper component 18. The roller 18a is provided with the hole 18c at the center. The hole 18c extends uniformly throughout the width of the roller 18a. The pin 14 is disposed through the hole 18c such that the roller 18a is rotatable with respect to the pin 14. Th hole 18c may have a diameter depending upon the size of the pin 14. The dimensions of extended tab 3a may be chosen based on configurations of the release chamber 2c3 and the length of the pin 14.
[79] The roller 18a includes a gripping portion 18b on the outer surface of the roller 18a. The gripping portion 18b may have a rough surface, small projections/grooves, etc. Other designs such as, ridges, undulations, or the like that facilitate an easy and comfortable grip, are covered within the teachings of the present invention. The gripping portion 18b is provided for a user to place fingers and roll the roller 18a. The roller 18a may optionally include a circular groove 18a1. The circular groove 18a1 may help to collect (or wind) at least a portion of the stem 18d when the roller 18a is rotated to pull the head 18e from within the release chamber 12c3.
[80] The stem 18d extends from the first end 18y to the second end 18z. The stem 18d couples the roller 18a at the first end 18y and to the head 18e at the second end 18z. The stem 18d may at least partially be disposed within the release chamber 12c3. The stem 18d may have a length depending upon the depth of the release chamber 12c3 of the body 12. In an embodiment, the stem 18d extends to the bottom of the body 12. The stem 18d may be made of a flexible material including, but not limited to, nylon, polypropylene, rubber, etc. In an exemplary embodiment, the stem 18d is made of nylon.
[81] In an exemplary embodiment, as shown in Fig. 9A, the stem 18d includes a single filament for at least a portion of its length and the stem 18d includes two or more filaments for the remaining portion of its length to provide stability to the head 18e at the second end 18z. Other functionally equivalent structures of the stem 18d are within the scope of the teachings of the present disclosure. The stem 18d suspends the head 18e in the release chamber 12c3 of the body 12 at a desired length.
[82] The head 18e is configured to accommodate the seal 17. The head 18e and the seal 17 are structurally and functionally similar to head 3e and seal 7 of the device 1, respectively, so the description is not repeated for the sake of brevity and can be referred therefrom.
[83] The test strip 16 (shown in Fig. 9B) of the device 11 is structurally and functionally similar to the test strip 6 of the device 1. The test strip 16 may have a pre-defined length corresponding to the size of the device 11 and/or the depth of the release chamber 12c3. The test strip 16 is disposed within the release chamber 12c3 along with a portion of the gripper component 18. The test strip 16 interacts with the collected sample and provides a visual indication to the user for presence and/or absence of a pre-defined analyte or the like. The wall of the body 12 that is adjacent to the release chamber 12c3 may be at least partially transparent to enable the user to observe the visual indication of the test strip 16.
[84] Fig. 10A depicts a cross-sectional view of the device 11, in accordance with an alternative embodiment of the present invention. Fig. 10B depicts a sampling stick 15 disposed within the body 12 of the device 11 in accordance with an alternative embodiment of the present invention. The sampling stick 15 may be disposed within at least one of the dry chamber 12c1 or the fluid chamber 12c2 as shown in Fig. 10B. The sampling stick 15 includes a handle 15a, at least one flexible finger gripping portions 15b, a leak proof seal 15c, a stem portion 15d, etc. The sampling stick 15 and the openings 19 are structurally and functionally similar to the sampling stick 5 and opening 9 of the device 1, respectively, so the description is not repeated for the sake of brevity and can be referred therefrom.
[85] Fig. 11 depicts a perspective view for a device 21 having a body 22 with one chamber for placing a sampling stick 25 in accordance with another embodiment of the present invention. The device 21 is structurally and functionally similar to the device 11. The device 21 includes, without limitation, a body 22, a sampling stick 25, at least one test strip (not shown), a gripper component 28, etc. The body 22 of the device 21 includes a fluid chamber 22c2 and a release chamber (not shown). The body 22 of the device 21 does not include any dry chamber, as described with respect to device 1, 11. The sampling stick 25 includes a handle 25a, at least one flexible finger gripping portions 25b, a leak proof seal 25c, a stem portion 25d, etc. The sampling stick 25 is structurally and functionally similar to the sampling stick 5 and sampling stick 15 of device 1 and 11, respectively. The sampling stick 25 of the device 21 is disposed within the fluid chamber 22c2 before as well as after the sample is collected. Accordingly, a stem 25d of the sampling stick 25 is not offset (as shown in Fig. 10B), i.e., the stem 25d is at a center of the sampling stick 25.
[86] FIG. 12 depicts a flow diagram of an exemplary method 1200 of using the device 11 (or device 21), in accordance with another embodiment of the present invention. The method 1200 commences by obtaining a device 11 with the sampling stick 15 disposed inside the dry chamber 12c1.
[87] At step 1201, the sampling stick 15 is removed from the dry chamber 12c1 of the body 12. For this, the flexible finger gripping portion 15b are pressed by a user to unlatch the jaws 15b1 from the cut-out portions 12e of the hollow body 12. Thereafter, the sampling stick 15 is removed from the dry chamber 12c1.
[88] At step 1203, the stem portion 15d of the sampling stick 15 is used to collect a sample for testing. In an exemplary embodiment, the stem portion 15d of the sampling stick 15 is at least partially placed inside the throat, nose, or other body parts for the collection of body fluids based on the required testing or diagnostics. The free end portion of the stem portion 15d helps in collection of the sample.
[89] At step 1205, the sampling stick 15 along with the collected sample is placed inside the fluid chamber 12c2. Thereafter, the jaws 15b1 are latched onto the cut-outs 12e of the body 12 to secure the sampling stick 15 to the body 12 of the device 11.
[90] At step 1207, the collected sample is mixed with the solution contained in the fluid chamber 12c2. For proper mixing of the collected sample with the solution contained in the fluid chamber 12c2, the device 11 is physically shaken by the user.
[91] At step 1209, the roller 18a of the gripper component 18 is gently rolled to pull the stem 18d from the release chamber 12c3. The seal 17, disposed within the release chamber 12c3, slidably opens the openings 19 (as shown in Fig. 10A) and fluidically couples the fluid chamber 12c2, and the release chamber 12c3 such that the solution contained in the fluid chamber 12c2 flows out into the release chamber 12c3 and comes in contact with the test strip 16 disposed inside the release chamber 12c3. The test strip 16 is started for the presence of one or more analytes present in the solution.
[92] At step 1211, the results of the test are displayed visually on the test strip 16 after a pre-defined time period. The pre-defined time period depends on the type of test and the sample collected for the test.
[93] The proposed device presents several advantages over conventional rapid testing methods. The device offers a streamlined solution for sample collection, mixing, and testing with enhanced efficiency and accuracy. The device ensures a fully integrated process, significantly reducing the risk of contamination and minimizing the chances of human error. The device includes a secure and enclosed mechanism, facilitating precise sample handling and eliminating the need for multiple separate components. Additionally, the compact and user-friendly design of the device simplifies the diagnostic process, making it more accessible for both professional and home-based testing. Overall, the device enhances reliability, usability, and accuracy, addressing critical challenges such as procedural complexity, contamination risks, and inconsistent test results, thus improving overall diagnostic efficiency compared to conventional methods.
[94] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. ,CLAIMS:We claim
1. An integrated diagnostic device (1, 11) comprising:
a. a body (2) including at least a fluid chamber (2c2) and a release chamber (2c3), the fluid chamber (2c2) including a solution to maintain an integrity of a sample;
b. a gripper component (3) housed in the release chamber (2c3), the gripper component (3) including a seal (7) configured to separate the solution and a test strip (6); and
c. a sampling stick (5) configured to collect the sample, the sampling stick (5) with the sample is housed in the fluid chamber (2c2);
wherein, the gripper component (3) is configured to lift the seal (7);
wherein, the test strip (6) is configured to display a test result upon removal of the seal (7).
2. The device (1, 11) as claimed in claim 1, wherein the body (2) includes a storage chamber (2c4) disposed towards a first side (2y) of the body (2), the storage chamber (2c4) being configured to hold one or more test strips (6).
3. The device (1, 11) as claimed in claim 1, wherein the body (2) includes a dry chamber (2c1) positioned adjacent to the fluid chamber (2c2), the dry chamber (2c1) being configured to house the sampling stick (5) without the sample.
4. The device (1, 11) as claimed in claim 1, wherein the body (2) includes a plurality of opening (9) at a bottom end of the body (2), configured to fluidically couple the fluid chamber (2c2), the release chamber (2c3) and the storage chamber (2c4).
5. The device (1, 11) as claimed in claim 1, wherein the body (2) includes a pin (14).
6. The device (1, 11) as claimed in claim 1, wherein the gripper component (3) includes:
a. an extended tab (3a) configured to lock the gripper component (3) with the body (2);
b. a cap (3b) to operate the gripper component (3) and coupled to the extended tab (3a);
c. a hole (3c) in the extended tab (3a), configured to lock the extended tab (3a) with the body (2);
d. a stem (3d) coupled to the cap (3b) and extends to the bottom end of the body (2); and
e. a head (3e) provided at the end of the stem (3d) and positioned in the release chamber (2c3) of the body (2), the head (3e) configured to house the seal (7).
7. The device (1, 11) as claimed in claim 5, wherein the extended tab (3a) is coupled to the body (2) via a locking pin (4).
8. The device (1, 11) as claimed in claim 1, wherein the sampling stick (5) includes at least one flexible finger gripping portion (5b).
9. The device (1, 11) as claimed in claim 1, wherein the sampling stick (5) includes a leak proof seal (5c).
10. The device (1, 11) as claimed in claim 1, wherein the gripper component (18, 28) includes:
a. a roller (18a) positioned at a first end (18y) of the gripper component (18);
b. a gripping portion (18b) provided on the outer surface of a roller (18a) and configured to roll the roller (18a);
c. a hole (18c) provided at the center of the roller (18a) and configured to couple with the pin (14) of the body (2);
d. a stem (18d) coupled to the roller (18a) and extends to the bottom of the body (2); and
e. a head (18e) provided at the end of stem (18d) and positioned on the release chamber (12c3) of the body (2); and the head (18e) configured to accommodate the seal (7).