Modular cartridge for measuring one or more electrolytes in a sample of body fluid

The modular cartridge for electrolyte analyzers addresses the maintenance-intensive issues of conventional devices by allowing independent replacement of reagent, sensor, and sampler modules, reducing costs and extending shelf life through RFID tracking.

WO2025109377A1PCT designated stage expired Publication Date: 2025-05-30DIASYS DIAGNOSTICS INDIA PVT LTD
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Patent Information

Application Number
PCT/IB2024/050233
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-11-24
Filing Date
2024-01-10
Publication Date
2025-05-30

AI Technical Summary

Technical Problem

Conventional electrolyte analyzers require regular replacement of reagents and sensors, leading to maintenance-intensive processes and high costs, as the whole cartridge needs to be replaced even if only one consumable is exhausted.

Method used

A modular cartridge design for electrolyte analyzers, where the reagent module, sensor module, and sampler module are independently replaceable, securely plugged into a cartridge body, and equipped with RFID labels for tracking usage and shelf life.

Benefits of technology

The modular cartridge reduces maintenance costs and time by allowing individual module replacements, extending the shelf life of the device, and providing easy tracking of consumables, thus making healthcare diagnostics more affordable.

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Abstract

The present disclosure elaborates upon a modular cartridge 100 adapted for use in an electrolyte analyser for measuring one or more electrolytes in a sample, wherein the modular cartridge 100 comprises an reagent module 102 configured to store at least one of one or more calibrants and one or more reference reagents, a sensor module 104 comprising one or more sensors 116 responding to the one or more electrolytes, a sampler module 106 comprising a sampler configured to draw at least one of the sample and the one or more reagents, and a cartridge body 124, wherein the reagent module 102, the sensor module 104 and the sampler module 106 are placed inside the cartridge body 124 in a manner such that the reagent module 104, the sensor module 104 and the sampler module 106 are independently replaceable.
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Description

MODULAR CARTRIDGE FOR MEASURING ONE OR MORE ELECTROLYTES IN A SAMPLE OF BODY FLUIDTECHNICAL FIELD

[0001] The present invention pertains to the field of diagnostic devices. In particular, it pertains to a modular cartridge adapted for use in an electrolyte analyser for measuring one or more electrolytes in a sample of body fluid.BACKGROUND

[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Conventional devices such as analyser for measuring electrolytes in a sample of a body fluid include sensors, sampler, reagents, valves and tubings, that require a periodic maintenance. Further, in conventional devices, consumables such as reagents and sensors have to be replaced on a regular basis, therefore making the conventional devices maintenance intensive. To reduce the maintenance time and cost, certain devices have been developed in which consumables are contained in cartridges. However, the duration of the replacement of these consumables are different. The reagents have short shelf life of at least three months and are expensive. Whereas, the sensors require replacement after 3-6 months or 400 samples, whichever would be earlier. Thus, to replace any one of the consumables, the whole cartridge has to be replaced in conventional analysers.

[0004] Thus, to overcome the drawbacks associated with the conventional devices, and to provide healthcare diagnostics at affordable costs, there is need for a device having a modular cartridge that is easy to maintain and does not require periodic replacement of consumables such as reagents and sensors.OBJECTS OF THE PRESENT INVENTION

[0005] Some of the objects of the present disclosure, which at least one embodiment herein satisfies are as listed herein below.

[0006] An object of the present invention is to a device for measuring one or more electrolytes that overcomes drawbacks of conventional devices used for measuring electrolytes.

[0007] Another object of the present invention is to provide a device for measuring electrolytes that does not require replacement of reagents and sensors on a regular basis.

[0008] Another object of the present invention is to provide a device for measuring electrolytes that is easy to maintain.

[0009] Another object of the present invention is to provide a device for measuring electrolytes that provides easy replacement of the sensor module without need of replacing reagent module and the sampler module.

[0010] Yet another object of the present invention is to provide a device for measuring electrolytes that has low-replacement cost.

[0011] Yet another object of the present invention is to provide a device for measuring electrolytes in which the modules of the modular cartridge can be independently replaced.

[0012] The foregoing and other objects, features, and advantages of the present invention will become readily apparent upon further review of the following detailed description of the preferred embodiment as illustrated in the accompanying drawings.SUMMARY OF THE PRESENT INVENTION

[0013] The present invention pertains to the field of healthcare diagnostic devices. In particular, it pertains to a modular cartridge adapted for use in an electrolyte analyser for measuring one or more electrolytes in a sample of body fluid.

[0014] According to an aspect, the present disclosure relates to a modular cartridge adapted for use in an electrolyte analyser for measuring one or more electrolytes in a sample, wherein the modular cartridge comprises an reagent module configured to store at least one of one or more calibrants and one or more reference reagents in one or more calibrant bags, and store generated waste in a waste bag provided in the reagent module, a sensor module comprising one or more sensors responding to the one or more electrolytes, a sampler module comprising a sampler configured to draw at least one of the sample and the one or more reagents, and a cartridge body, wherein the reagent module, the sensor module and the sampler module are placed inside the cartridge body in a manner such that the sensor module and the sampler module are securely plugged in to the reagent module, and wherein the reagent module, the sensor module and the sampler module are independently replaceable.

[0015] In an aspect, insertion of the modular cartridge in the electrolyte analyser results in coupling of a sample port provided on the electrolyte analyser to the modular cartridge.

[0016] In an aspect, the reagent module may include a pump tube configured to transport the sample to the sample module, upon insertion of the modular cartridge in the electrolyteanalyser, the pump tube is adapted to be fluidically coupled to a pump in the electrolyte analyser provided to pump the sample from the sample port to the sampler.

[0017] In an aspect, the reagent module may include a second Radio Frequency Identification (RFID) label to store usage and shelf life of the reagent module in a real time.

[0018] In an aspect, the sampler module may include a valve tubing for push-pull pinching of a solenoid provided in the electrolyte analyser.

[0019] In an aspect, the sensor module may further include a first Radio Frequency Identification (RFID) label to store and track usage and shelf-life related to the sensor module.

[0020] In an aspect, the one or more sensors responsive to the one or more electrolytes may include sensors for testing a combination of at least one or more of sodium (Na), Potassium (K), Chloride (Cl) and Lithium (Li) ions.

[0021] In an aspect, the sampler may be selected from at least one of: manual sampler and motorized sampler.

[0022] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

[0023] Within the scope of this application, it is expressly envisaged that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, in the claims and / or in the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments, unless such features are incompatible.BRIEF DESCRIPTION OF DRAWINGS

[0024] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. The diagrams are for illustration only, which thus is not a limitation of the present disclosure.

[0025] FIG. 1 illustrates a block diagram showing configuration of various modules of a modular cartridge, in accordance with an embodiment of the present disclosure.DETAILED DESCRIPTION OF THE PRESENT INVENTION

[0026] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such details as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0027] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0028] It should be emphasized that the term “comprises / comprising” when used in this specification is taken to specify the presence of stated features, steps or components but does not preclude the presence or addition of one or more other features, steps, components or groups thereof.

[0029] Embodiments explained herein relate to a modular cartridge adapted for use in an electrolyte analyser for measuring one or more electrolytes in a sample of body fluid.

[0030] According to an embodiment, the present invention discloses a modular cartridge adapted for use in an electrolyte analyser for measuring one or more electrolytes in a sample, wherein the modular cartridge comprises an reagent module configured to store at least one of one or more calibrants and one or more reference reagents in one or more calibrant bags, and store generated waste in a waste bag provided in the reagent module, a sensor module comprising one or more sensors responding to the one or more electrolytes, a sampler module comprising a sampler configured to draw at least one of the sample and the one or more reagents, and a cartridge body, wherein the reagent module, the sensor module and the sampler module are placed inside the cartridge body in a manner such that the sensor module and the sampler module are securely plugged in to the reagent module, and wherein the reagent module, the sensor module and the sampler module are independently replaceable.

[0031] In an embodiment, insertion of the modular cartridge in the electrolyte analyser results in coupling of a sample port provided on the electrolyte analyser to the modular cartridge.

[0032] In an embodiment, all the modules of the modular cartridge may be located within a cartridge body in such a manner that the sensor module and the sampler module are plugged into the reagent module to form a module-in-module integration.

[0033] In an embodiment, the reagent module may comprise a pump tube configured to transport the sample to the sample module, upon insertion of the modular cartridge in the electrolyte analyser, the pump tube is adapted to be fluidically coupled to a pump in the electrolyte analyser provided to pump the sample from the sample port to the sampler.

[0034] In an embodiment, the sensor module may include a first Radio Frequency Identification (RFID) label to store and track usage and shelf-life related to the sensor module.

[0035] In an embodiment, the one or more sensors responsive to the one or more electrolytes include sensors for testing a combination of at least one or more of sodium (Na), Potassium (K), Chloride (Cl) and Lithium (Li) ions.

[0036] In an embodiment, the one or more sensor may be selected from but not limited to NaKCl, NaKCapH, NakLi.

[0037] In an embodiment, the sampler module may include a valve tubing for push-pull pinching of a solenoid provided in the electrolyte analyser.

[0038] FIG. 1 illustrates a block diagram showing configuration of various components of a modular cartridge 100, in accordance with an embodiment of the present disclosure.

[0039] Referring to FIG.l, in an embodiment, the present disclosure relates to a modular cartridge 100 adapted for use in an electrolyte analyser for measuring one or more electrolytes in a sample, wherein the modular cartridge 100 comprises an reagent module 102 configured to store at least one of one or more calibrants and one or more reference reagents in one or more calibrant bags 108, and store generated waste in a waste bag 110 provided in the reagent module 102, a sensor module 104 includes one or more sensors 116 responding to the one or more electrolytes, a sampler module 106 includes a sampler 120 configured to draw at least one of the sample and the one or more reagents, and a cartridge body 126.

[0040] In an embodiment, the reagent module 102, the sensor module 104 and the sampler module 106 are placed inside the cartridge body in a manner such that the sensor module 104 and the sampler module 106 are securely plugged in to the reagent module 102, wherein the reagent module 102, the sensor module 104 and the sampler module 106 are independently replaceable.

[0041] In an embodiment, insertion of the modular cartridge 100 in the electrolyte analyser results in coupling of a sample port provided on the electrolyte analyser to the modular cartridge 100.

[0042] In an embodiment, the reagent module 102 is configured to store at least one of one or more calibrants and one or more reference reagents, wherein the one or more referencereagents are selected from the group of aqueous salt reagents consisting sodium chloride, potassium chloride and calcium chloride.

[0043] In an embodiment, the reagent module 102 may be configured with a waste bag 110 to store waste.

[0044] In an embodiment, the reagent module 102 may include a pump tube 112 configured to transport the sample to the sample module, upon insertion of the modular cartridge 100 in the electrolyte analyser, the pump tube 112 is adapted to be fluidically coupled to a pump in the electrolyte analyser provided to pump the sample from the sample port to the sampler.

[0045] In an embodiment, the reagent module 102 may further include a second Radio Frequency Identification (RFID) label 114 to store data related to usage and shelf life of the reagent module 102 in a real time.

[0046] In an embodiment, the sensor module includes one or more sensors 116, wherein the one or more sensors 116 responsive to the one or more electrolytes include sensors for testing a combination of at least one or more of sodium (Na), Potassium (K), Chloride (Cl) and Lithium (Li) ions. Further, the sensor module may be configured with a first Radio Frequency Identification (RFID) label 118 to store and track usage and shelf-life related to the sensor module 104.

[0047] In an embodiment, the sampler module 106 comprises a sampler (120) configured to draw at least one of the samples and the one or more reagents that are stored in the one or more calibrant bags. In some embodiments, the sampler may be a manual sampler. The sampler module 106 may include a valve tubing 122 for push-pull pinching of a solenoid provided in the electrolyte analyser. In another embodiment, the sampler may be a motorized sampler.

[0048] In an embodiment, the modular cartridge comprises a cartridge body securing the reagent module, the sensor module and the sampler module in such a manner that the sensor module 104 and the sampler module 106 are securely plugged in to the reagent module 102, and the reagent module 102, the sensor module 104 and the sampler module 106 are independently replaceable.

[0049] In an embodiment, the sampler 120 is coupled to the reagent module 102 using a silicon valve 126.

[0050] Thus, the present invention provides a modular cartridge for measuring one or more electrolytes in a sample of a body fluid that provides accurate results, with minimum requirement of maintenance in terms of replacement of one or more reagents and one or more sensors on a regular basis. Further, the proposed modular cartridge has adequate shelf life.Therefore, the present invention provides a modular cartridge adapted for use in electrolyte analyser that provides provision to change the sensor module in case, the clinical tester requires different versions of the sensors, without replacing the reagent and the sampler module.

[0051] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.

[0052] Reference numeral of the components of the modular cartridge are discussed herein:ADVANTAGES OF THE INVENTION

[0053] The present invention exhibits the following advantages:

[0054] The present invention overcomes the problems associated with the existing devices used for measuring electrolytes.

[0055] The present disclosure provides a device for measuring electrolytes that does not require replacement of reagents and sensors on a regular basis.

[0056] The present disclosure provides a device for measuring electrolytes that is easy to maintain.

[0057] The present disclosure provides a device for measuring electrolytes that provides easy replacement of the sensor module without need of replacing reagent module and the sampler module.

[0058] The present disclosure provides a device for measuring electrolytes that has low- replacement cost.

Claims

We Claim:

1. A modular cartridge (100) adapted for use in an electrolyte analyser (100) for measuring one or more electrolytes in a sample, wherein the modular cartridge (100) comprising: a reagent module (102) configured to store at least one of one or more calibrants and one or more reference reagents in one or more calibrant bags (108), and store generated waste in a waste bag (110) provided in the reagent module (102); a sensor module (104) comprising one or more sensors (116) responding to the one or more electrolytes; a sampler module (106) comprising a sampler (120) configured to enable withdrawal of at least one of the samples and the one or more reagents, and a cartridge body (124) comprising the reagent module (102), the sensor module (104) and the sampler module (106) for measuring one or more electrolytes in a sample, wherein the sensor module (104) and the sampler module (106) are securely plugged in to the reagent module (102), and wherein the reagent module (102), the sensor module (104) and the sampler module (106) are independently replaceable.

2. The modular cartridge (100) as claimed in claim 1, wherein insertion of the modular cartridge (100) in the electrolyte analyser results in coupling of a sample port provided on the electrolyte analyser to the modular cartridge (100).

3. The modular cartridge (100) as claimed in claim 1, wherein the reagent module (102) comprises: a pump tube (112) configured to transport the sample to the sample module (106), upon insertion of the modular cartridge (100) in the one or more electrolyte analyser (100), wherein the pump tube (112) is adapted to be fludically coupled to a pump in the electrolyte analyser provided to pump the sample from the sample port to the sampler.

4. The modular cartridge (100) as claimed in claim 1, wherein the sampler is selected from at least one of: manual sampler and motorized sampler.

5. The modular cartridge (100) as claimed in claim 1, wherein the sensor module (104) comprises a first Radio Frequency Identification (RFID) label (118) to store and track usage and shelf-life related to the sensor module (104).

6. The modular cartridge (100) as claimed in claim 1, wherein the one or more sensors (116) responsive to the one or more electrolytes include sensors for testing a combination of at least one or more of sodium (Na), Potassium (K), Chloride (Cl) and Lithium (Li) ions.

7. The module cartridge (100) as claimed in claim 1, wherein the sampler (120) is coupled to the reagent module (102) using a silicon valve (126).

8. The modular cartridge (100) as claimed in claim 1, wherein the sampler module (106) includes a valve tubing (122) for push-pull pinching of a solenoid provided in the electrolyte analyser.

9. The modular cartridge (100) as claimed in claim 1, wherein the one or more reagents are selected from the group of aqueous salt reagents consisting sodium chloride, potassium chloride and calcium chloride.

10. The modular cartridge (100) as claimed in claim 1, wherein the reagent module (102) comprises a second RFID label (114) to store data related to usage and shelf life of the reagent module (102) in a real time.

Citation Information

Patent Citations

  • Electrolyte analyzer

    CN103616527A

  • A modular all in one cartridge for testing electrolytes in a sample of body fluid

    WO2020174273A1