Sensor assemblies and devices and methods for activating sensor assemblies

Abstract

A sensor assembly for a biological sample analyzer includes a reference fluid container configured to house a reference fluid; a channel configured to transport a sample; a membrane located between the reference fluid and the channel; a septum sealing the membrane from the reference fluid; and a septum breaching mechanism configured to breach at least a portion of the septum as the sensor assembly engages a biological sample analyzer to allow the reference fluid to contact the membrane. These and other devices and methods are disclosed herein.

Description

SENSOR ASSEMBLIES AND DEVICES AND METHODS FOR ACTIVATING SENSOR ASSEMBLIES

[0001] This application claims benefit under 35 USC § 119(e) of U.S. Provisional Application No. 63 / 670,388, filed July 12, 2024. The entire contents of the above-referenced patent application are hereby expressly incorporated herein by reference. FIELD

[0002] The present disclosure relates to sensor assemblies and devices and methods for activating sensor assemblies in biological sample analyzers. BACKGROUND

[0003] Biological sample analyzers may include replaceable sensor assemblies that perform measurements on biological samples. For example, sensor assemblies may include a reference fluid (e.g., an electrolyte of a known ion concentration) and a membrane that is semipermeable to ions within the reference fluid and any biological sample to be analyzed. During operation of a biological sample analyzer, a biological sample and the reference fluid contact the membrane within the sensor assembly to generate a voltage potential difference used to determine ion concentration within the biological sample.

[0004] When sensor assemblies are shipped or stored with the reference fluid in contact with the membrane, various reactions may occur that result in premature wear of the sensor assemblies or inaccurate test results. Therefore, a need exists for a sensor assembly that can be shipped and stored without the reference fluid in contact with the membrane.SUMMARY

[0005] According to a first aspect, a sensor assembly for a biological sample analyzer is provided. The sensor assembly includes a reference fluid container configured to house a reference fluid; a channel configured to transport a sample; a membrane located between the reference fluid container and the channel; a septum sealing the membrane from the reference fluid; and a septum breaching mechanism configured to breach at least a portion of the septum as the sensor assembly engages a biological sample analyzer to allow the reference fluid to contact the membrane.

[0006] In another aspect, a biological sample analyzer is provided. The biological sample analyzer includes an opening configured to receive a sensor assembly, the sensor assembly comprising: a reference fluid container configured to house a reference fluid; a channel configured to transport a sample; a membrane located between the reference fluid container and the channel; a septum sealing the membrane from the reference fluid; and a septum breaching mechanism configured to breach at least a portion of the septum as the sensor assembly engages the biological sample analyzer by way of the opening to allow the reference fluid to contact the membrane. The biological sample analyzer further includes an activation mechanism configured to activate the septum breaching mechanism to breach the septum when the sensor assembly engages the biological sample analyzer.

[0007] In a further aspect, a method of activating a sensor assembly for a biological sample analyzer is provided. The method includes providing a sensor assembly having: a reference fluid container housing a reference fluid; a channel configured to transport a sample; a membrane located between the reference fluid container and the channel; and a septum sealing the membrane from the reference fluid. The method further includes engaging the sensor assembly with abiological sample analyzer; and breaching at least a portion of the septum to cause the reference fluid to contact the membrane in response to the sensor assembly engaging the biological sample analyzer.

[0008] Still other aspects, features, and advantages of this disclosure may be readily apparent from the following description and illustration of example embodiments, including the best mode contemplated for carrying out the disclosure. This disclosure may also be capable of other and different embodiments, and its several details may be modified in various respects, all without departing from the scope of the disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The drawings described below are provided for illustrative purposes and are not necessarily drawn to scale. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. The drawings are not intended to limit the scope of the disclosure in any way.

[0010] FIG. 1A illustrates a perspective view of a biological sample analyzer in an open state with a sensor assembly located in a tray according to one or more embodiments.

[0011] FIG. 1B illustrates the biological sample analyzer of FIG. 1A in a closed state wherein the sensor assembly has engaged the biological sample analyzer according to one or more embodiments.

[0012] FIGS. 1C-1E illustrate schematic diagrams of the analyzer of FIG. 1A as a sensor assembly and a reagent assembly are loaded therein according one or more embodiments provided herein.

[0013] FIG. 2A illustrates a perspective view of a sensor assembly used in biological sample analyzers according to one or more embodiments.

[0014] FIG. 2B illustrates the sensor assembly of FIG. 2A with a cover removed to expose a reference fluid according to one or more embodiments.

[0015] FIG. 3 illustrates sensor arrays in the sensor assembly of FIG. 2A according to one or more embodiments.

[0016] FIG. 4A illustrates a partial cutaway view of a portion of a sensor assembly for use in a biological sample analyzer wherein a septum in the sensor assembly has not been breached according to one or more embodiments.

[0017] FIG. 4B illustrates the sensor assembly of FIG. 4A after the septum in the sensor assembly has been breached according to one or more embodiments.

[0018] FIG. 5A illustrates a portion of a sensor assembly wherein a septum in the sensor assembly has not been breached and no biological sample is present in the sensor assembly according to one or more embodiments.

[0019] FIG. 5B illustrates the sensor assembly of FIG. 5A with the septum breached, but wherein the reference fluid is not contacting a membrane according to one or more embodiments.

[0020] FIG. 5C illustrates the sensor assembly of FIG. 5B with the reference fluid passing through the septum and contacting the membrane according to one or more embodiments.

[0021] FIG. 5D illustrates the sensor assembly of FIG. 5C with the reference fluid contacting a side of the membrane and a biological sample contacting the other side of the membrane according to one or more embodiments.

[0022] FIG. 6 illustrates the sensor assembly of FIG. 5D wherein an actuator mechanism has breached the septum according to one or more embodiments.

[0023] FIG. 7A illustrates a partial cutaway view of a portion of a sensor assembly for use in a biological sample analyzer wherein a septum in the sensor assembly has not been breached and a lever is configured to breach the septum according to one or more embodiments.

[0024] FIG. 7B illustrates the sensor assembly of FIG. 7A wherein the septum has been breached by a cutter attached to the lever according to one or more embodiments.

[0025] FIG. 8A illustrates a partial cutaway view of a portion of a sensor assembly for use in a biological sample analyzer wherein a septum in the sensor assembly includes a weak portion according to one or more embodiments.

[0026] FIG. 8B illustrates the sensor assembly of FIG. 8A after the weak portion in the septum has been breached according to one or more embodiments.

[0027] FIG. 9A illustrates a partial cutaway view of a portion of a sensor assembly for use in a biological sample analyzer wherein a member within the sensor assembly includes a heating tip configured to breach a septum according to one or more embodiments.

[0028] FIG. 9B illustrates the sensor assembly of FIG. 9A after the heating tip has heated and breached the septum according to one or more embodiments.

[0029] FIG. 9C illustrates an alternative sensor assembly in which a vibrating mechanism is employed to breach a septum according to one or more embodiments.

[0030] FIG. 10A illustrates a partial cutaway view of a portion of a sensor assembly for use in a biological sample analyzer wherein a heating element is located proximate a septum and wherein the heating element is configured to breach the septum according to one or more embodiments.

[0031] FIG. 10B illustrates the sensor assembly of FIG. 10A after the heating element heated and breached the septum according to one or more embodiments.

[0032] FIG. 11A illustrates a partial cutaway view of a portion of another sensor assembly for use in a biological sample analyzer wherein a heating element is located proximate a septum and wherein the heating element is configured to breach the septum according to one or more embodiments.

[0033] FIG. 11B illustrates the sensor assembly of FIG. 11A after the heating element heated and breached the septum according to one or more embodiments.

[0034] FIG. 12A illustrates a partial cutaway view of a portion of another sensor assembly for use in a biological sample analyzer wherein a force applied to a bladder is configured to breach the septum according to one or more embodiments.

[0035] FIG. 12B illustrates the sensor assembly of FIG. 12A after the force applied to the bladder caused a member to breach the septum according to one or more embodiments.

[0036] FIGS. 13A-13F illustrate different configurations of cutters used to breach septums in sensor assemblies according to one or more embodiments.

[0037] FIG. 14 illustrates a flowchart of a method of activating a sensor assembly for a biological sample analyzer according to one or more embodiments. DETAILED DESCRIPTION

[0038] Independent of the grammatical term usage, individuals with male, female or other gender identities are included within the term.

[0039] Biological sample analyzers may use replaceable sensor assemblies to perform tests on biological samples. The sensor assemblies may include a reference fluid that comes into fluid communication with a first side of a membrane. The reference fluid may be an electrolyte with a known or fixed concentration of ions (or another suitable calibration reagent). A second and opposite side of the membrane iscapable or configured to be in fluid communication with biological samples.

[0040] The reference fluid may cause adverse reactions within the sensor assemblies if the reference fluid contacts the membrane for long periods such as during shipping and storage of the sensor assemblies. To overcome this issue, the sensor assemblies and methods described herein provide a septum to prevent fluid communication between the reference fluid and the membrane (e.g., during shipping and / or storage). Upon engagement of the sensor assemblies with the biological sample analyzers, the septum is breached and the reference fluid comes into fluid communication with the membrane. These and other sensor assemblies, biological sample analyzers and methods are described below with reference to FIGS. 1A-14. While described primarily with regard to biological samples, it will be understood that embodiments provided herein may be employed with other samples such as reagents, salt solutions, or the like.

[0041] Reference is now made to FIG. 1A, which illustrates a perspective view of a biological sample analyzer 100 in an open state with a sensor assembly 104 configured to be received therein. The sensor assembly 104 may receive a biological sample, such as a blood sample, and may facilitate testing of the biological sample for chemicals or other properties as described herein. In some embodiments, non- biological samples may be analyzed. Reference is also made to FIG. 1B, which illustrates the analyzer 100 of FIG. 1A in a closed state wherein the sensor assembly 104 has engaged the analyzer 100 as described herein.

[0042] The sample introduced into the analyzer 100 may comprise a biological material taken from a subject, for example, such as a bodily fluid, infection, or abscess collected from the subject. Bodily fluids include but are not limited to urine, whole blood, blood serum, blood plasma,saliva, cerebrospinal fluid, pleural fluid, dialysate fluid, nasopharyngeal swabs, vaginal swabs, tears, tissues, and the like. The samples may further include any suitable buffers, diluents, or the like as needed or desired for the particular sample. In some embodiments, the samples may comprise a blood sample, which may be a whole blood sample comprising plasma and whole blood cells, a plasma sample, or a serum sample. The whole blood sample may comprise red blood cells, platelets and the like. In other embodiments, the blood samples may comprise a plasma sample.

[0043] The analyzer 100 may include an enclosure 106 for housing and supporting multiple sample analyzing components and / or modules (not shown). These components may include a sample receiving assembly, fluidic tubing assemblies, displays, processors, and other components configured to operate the analyzer 100. A sensor assembly 104 may be receivable in the enclosure 106. In some embodiments, the enclosure 106 may include or receive a tray 108 in an opening 109 as well as a reagent assembly 114. The sensor assembly 104 may be receivable in the tray 108. In other embodiments, the sensor assembly 104 may be receivable directly into the enclosure 106.

[0044] The analyzer 100 may be in the open state when the sensor assembly 104 is loaded into, removed from, or not engaged with the analyzer 100. The analyzer 100 may be in the closed state when the sensor assembly 104 is engaged in or within the analyzer 100. The analyzer 100 may be in the closed state when the sensor assembly 104 is electrically connected with the analyzer 100 or in a state where a reference fluid (e.g., reference fluid 206 - FIG. 2B) in the sensor assembly 104 is released to perform testing of a sample. In the embodiment of FIG. 1A, the sensor assembly 104 is received in the tray 108, which is receivable in the opening 109. When the tray 108 is extended from the enclosure 106, the analyzer 100may be in the open state. As the tray 108 is received in the opening 109, the analyzer 100 may change to the closed state and the sensor assembly 104 may engage with the analyzer 100 as described herein.

[0045] The reagent assembly 114 may be received into the opening 109 of the analyzer 100. The reagent assembly 114 may hold one or more reagent fluids used to analyze samples. The reagents may be provided in reservoirs, such as sealed bags or bottles (not shown), for example. The reagent assembly 114 may comprise one or several reservoirs pre-filled with process liquids having known compositions (e.g., one or more wash solutions, calibration solutions and / or quality control solutions as known to a person skilled in the art such as QC1, QC2, QC3, CRL3 (S1940), CRL2 (S1930), RINSE / CAL1 (S1920), and / or the like). Other chemicals may be provided dependent on the analysis to be performed.

[0046] FIGS. 1C-1E illustrate schematic diagrams of the analyzer 100 as sensor assembly 104 and reagent assembly 114 are loaded therein in accordance with one or more embodiments provided herein. Specifically, FIG. 1C illustrates the analyzer 100 prior to loading of the sensor assembly 104 and reagent assembly 114 into the analyzer 100. As described further below, as the sensor assembly 104 is loaded into the analyzer 100, the sensor assembly 104 (e.g., via a septum breaching mechanism 116 of the sensor assembly 104) may interact with the analyzer 100 (e.g., via an activating mechanism 118 of the analyzer 100) so that the sensor assembly 104 becomes activated. Activation may include, for example, reference fluid being released in the sensor assembly 104 so that testing of a sample may be performed. As shown in FIG. 1C, the sensor assembly 104 and reagent assembly 114 are loaded into the analyzer 100 by moving in the -X direction. As shown in FIGS. 1D and 1E, as the sensor assembly 104 enters the analyzer 100, the septum breaching mechanism 116 interactswith the activating mechanism 118 of the analyzer 100. Examples and operation of the septum breaching mechanism 116 and activating mechanism 118 are described below.

[0047] Additional reference is made to FIGS. 2A and 2B, which illustrate embodiments of the sensor assembly 104. FIG. 2A illustrates a perspective view of an embodiment of the sensor assembly 104. FIG. 2B illustrates the sensor assembly 104 of FIG. 2A with a cover 200 of a reference fluid container 202 removed. The reference fluid container 202 may hold a reference fluid 206. The sensor assembly 104 may include sensors (e.g., sensor arrays 300 - FIG. 3), which are used to contact a biological sample that is to be analyzed. The sensor assembly 104 may be a modular unit that is removable from the analyzer 100 as described herein. The sensor assembly 104 may be in direct or indirect communication with a computing unit (not shown) which may collect, store, and analyze analytical test results from the sensors. After delivery of a biological sample to the sensor assembly 104, the analyzer 100 may introduce the fluids from the reagent assembly 114 to the biological sample and prepare to analyze the biological sample.

[0048] The sensor assembly 104 may include a housing 208 that may form the reference fluid container 202. As shown in FIGS. 2A-2B, in some non-limiting embodiments, the housing 208 is illustrated as being substantially rectangular in shape. However, the housing 208 can be any shape capable of accomplishing the presently disclosed and / or claimed concept(s), including, without limitation, circular, triangular, square, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal, or any polygonal shape. Further, the housing 208 may be constructed of any suitable materials including opaque and / or transparent and / or translucent material(s), including, without limitation, synthetic and / or naturally-occurring or derived polymers (bothorganic and / or inorganic), such as, by way of example only, thermoplastic polymer(s), thermoset polymer(s), elastomer(s), and / or synthetic fiber(s) such as low-density polyethylene, high density polyethylene, polystyrene, polyvinylchloride, styrene butadiene, polyacrylics, polyvinyl acetate, acrylic, acrylic acid, and acrylate polymers, and combinations thereof.

[0049] The cover 200 may support a reference electrode (e.g., reference electrode 400 - FIG. 4A) such that the reference electrode 400 extends into the reference fluid container 202 and / or the reference fluid 206. The reference electrode 400 may be, for example, a silver chloride coated silver wire. The reference fluid 206 may be disposed in the reference fluid container 202 such that the reference fluid 206 contacts the reference electrode 400. The reference fluid 206 may be an electrolyte solution, such as a potassium chloride solution or some equivalent formulation. Other reference fluids and / or reference electrodes may be employed.

[0050] The housing 208 may support fluid channels (not shown in FIGS. 2A-2B) that channel the biological samples and / or the reagent fluids. The housing 208 may support circuitry (not shown) that may be used to analyze the biological samples. The circuitry may be electrically coupled to one or more electrical contacts 210 that may electrically couple the circuitry to components in the analyzer 100 (FIG. 1A). The analyzer 100 may include electrically conductive pins or the like (not shown) that are configured to electrically contact the electrical contacts 210. The electrical contacts 210 may be located in a sensor containment space 212 that may be formed in the housing 208.

[0051] Additional reference is made to FIG. 3, which illustrates a perspective view of two sensor arrays 300 that may be located in the sensor containment space 212. The embodiments of the sensor assembly 104 described herein include two sensor arrays 300. Other embodiments of the sensorassembly 104 may include more or fewer sensor arrays. The sensor arrays 300 are referred to individually as a first sensor array 300A and a second sensor array 300B. In some embodiments, the first sensor array 300A may be a potentiometric sensor and the second sensor array 300B may be an amperometric sensor. Each of the sensor arrays 300 may have a top side 304 and a bottom side 306. The electrical contacts 210 (FIGS. 2A and 2B) may be located on the top side 304 and a biological sample may contact the bottom side 306. For example, the housing 208 and components affixed to the housing 208 may have channels configured to transport biological samples to the bottom sides 306 of the sensor arrays 300.

[0052] Additional reference is made to FIGS. 4A-4B, which illustrate partial cutaway views of a portion of the sensor assembly 104. The sensor assembly 104 may include the reference electrode 400 extending into the reference fluid 206. The reference electrode 400 may pass through the cover 200. In some embodiments, the reference electrode 400 may not extend through the cover 200, but may be electrically coupled to a conductor located external to the sensor assembly 104 and contactable by a conductor (not shown) in the analyzer 100.

[0053] The reference electrode 400 may be used to measure electrolytes, which are determined by potentiometric measurements, a form of electrochemical analysis. In potentiometry, a potential or voltage is measured between two electrodes in a biological sample. These potentials can be produced when a metal and ions of that metal are present in the biological sample. By using a membrane 402 (described in greater detail below) that is semipermeable to the ions, different concentrations of the ions can be separated. A constant voltage is applied to the reference electrode 400. The difference in voltage between the reference electrode 400 and measuring electrodes (e.g., the electrical contacts 210 of FIGS. 2A and 2B) is used to calculate the concentration ofions in the biological sample. In the embodiment of FIG. 4A, the reference fluid 206 is not in contact with the membrane 402. As described herein, the reference fluid 206 contacts the membrane 402 when a septum 406 is breached (e.g., as shown in FIG. 4B). Breaching includes, but is not limited to, piercing, removing, damaging, and peeling the septum 406 to expose the membrane 402 to the reference fluid 206. The drawings illustrate membrane 402 being horizontal for illustration purposes only. In some embodiments, the membrane 402 may be vertical or otherwise oriented when the sensor assembly 104 is engaged within the analyzer 100.

[0054] Additional reference is made to FIGS. 5A-5D, which illustrate a portion 500 of the sensor assembly 104 with the reference fluid 206 and a biological sample 506 (FIG. 5D) located in a channel 508. FIG. 5B illustrates the portion 500 with the septum 406 being pierced, but the reference fluid 206 is not yet contacting the membrane 402. In some embodiments, when the septum 406 is pierced (breached), the reference fluid 206 contacts the membrane 402. FIG. 5C illustrates the portion 500 with the reference fluid 206 passing through the septum 406. FIG. 5D illustrates the portion 500 with the reference fluid 206 contacting the membrane 402 and the biological sample 506 in the channel 508 and contacting the membrane 402. The channel 508 may have a first end 510 coupled to a biological sample input (not shown) and a second end 512 coupled to a biological sample outlet (not shown).

[0055] The channel 508 may contact the sensor arrays 300 (FIG. 3). In the embodiment of FIGS. 5A-5D, a first end 510 of the channel 508 is proximate the first sensor array 300A and the second sensor array 300B. Thus, in the embodiment of FIGS. 5A-5D, the biological sample 506 first contacts the sensor arrays 300. The biological sample 506 may then contact a first side of the membrane 402 and the reference fluid 206 may contact a second opposite side of the membrane 402.

[0056] The reference fluid 206 and the biological sample 506 contact the membrane 402 and form an ionic and / or electrical connection with one another at the membrane 402. For example, the reference fluid 206 forms a liquid junction with the biological sample 506 at or near the membrane 402. A liquid junction is a boundary between two electrolyte solutions (e.g., the reference fluid 206 and the biological sample 506) of different compositions, across which arises a potential difference, referred to as a liquid junction potential. The membrane 402 may be a porous region (having one or more pores or holes) permitting the flow of ions by diffusion but limiting fluid flow to define a restricted diffusion type liquid junction. In some embodiments, the membrane 402 may be positioned between the reference fluid container 202 and the channel 508 and defines a region of the liquid junction. Thus, the membrane 402 fluidically separates (i.e., limits or prevents fluid flow, but permits ion flow) the reference fluid container 202 from the biological sample 506 in the channel 508.

[0057] The membrane 402 may be formed of and / or may be treated with (e.g., coated) with one or more suitable materials, such as a polymer material, for example. In some embodiments, all or part of the membrane 402 may be a hydrophilic material. In yet other embodiments, all or part of the membrane 402 may be treated (e.g., coated) with a hydrophilic material. A membrane formed of or comprising a hydrophilic material advantageously enhances the membrane to wet-up to its operational functionality and helps prevent bubble formation, and therefore helps maintain stability of the liquid junction at the membrane 402. Suitable nonexclusive examples of materials for the membrane 402 or the membrane coating include, for example, polypropylene, polyethylene, polyvinylchloride and modified polyvinylchloride, and any similar hydratable polymeric membrane known to those skilledin the art. Other suitable nonexclusive examples of materials may be cellulose acetate or a porous glass or ceramic or the like. Instead of homogenous membranes, heterogenous membranes may also be used. The term heterogenous membrane herein refers to a membrane formed of and / or treated (e.g., coated) with at least two different materials.

[0058] In some embodiments, to enhance wet-up, the side of the membrane 402 facing the channel 508 may have higher hydrophilicity than the side of the membrane 402 facing the reference fluid container 202. The side of the membrane 402 facing the reference fluid container 202 may comprise a hydrophobic material or may comprise a material having lower hydrophilicity compared to the side of the membrane 402 facing the channel 508. Alternatively, in other embodiments, the side of the membrane 402 facing the reference fluid container 202 may have higher hydrophilicity than the side of the membrane 402 facing the channel 508.

[0059] The sensor assembly 104 may be stored and shipped with the reference fluid 206 contained in the reference fluid container 202. The membrane 402 may be sealed to prevent contact with the reference fluid 206 during storing and shipping and until operationally desired. That is, the septum 406 is provided to seal or separate the reference fluid 206 from the membrane 402 until the sensor assembly 104 is to be used. When the reference fluid 206 is to contact the membrane 402, the septum 406 may be breached, such as pierced or removed. The septum 406 may be made of a material that seals the reference fluid 206, is able to be breached, and does not interfere with the testing. For example, the septum 406 may be a rubber or other polymer. Because of small fluid spaces used in the sensor assembly 104, a bubble may form between the reference fluid 206 and the membrane 402 upon breaching the septum 406. The bubble may prevent the membrane 402 fromwetting-up and may result in measurement errors of the sensor assembly 104.

[0060] A wicking member 410 may be configured to be in fluid communication with the reference fluid container 202 (such as, but not limited to, being positioned in the reference fluid container 202) and may be arranged to contact a surface of the membrane 402. The wicking member 410 may be configured to be sealed from the reference fluid 206 until the septum 406 is breached. The wicking member 410 may also be configured to draw the reference fluid 206 into contact with the membrane 402 when the septum 406 is breached as shown in FIGS. 4B and 5C. After the septum 406 is breached, the wicking member 410 may be configured to make fluid contact between the reference fluid 206 with the membrane 402, and thus is configured to maintain the liquid junction.

[0061] In FIGS. 4A-4B, the wicking member 410 is illustrated as being a strip positioned in the sensor assembly 104 wherein one end or surface of the wicking member 410 is in contact with the membrane 402. For example, the wicking member 410 may be arranged to contact at least a portion of the surface of the membrane 402 facing the reference fluid container 202. The wicking member 410 may absorb the reference fluid 206 and draw the reference fluid 206 to the surface of the membrane 402. By drawing the reference fluid 206 into contact with the membrane 402, the wicking member 410 helps prevent bubble formation and therefore helps maintain and / or create the liquid junction at the membrane 402, thereby reducing measurement errors.

[0062] In some embodiments, the wicking member 410 may be a hydrophilic material or may be coated with a hydrophilic material. Alternatively, the wicking member 410 may be formed of and / or may be coated with a combination of hydrophobic and hydrophilic materials, wherein the hydrophilic material portion is exposed to the reference fluid 206 during operationof the sensor assembly 104. As used herein, “wicking member” may refer to any substance or material, matrix, mixture or complex having an open structure, such as an open mesh. For example, the wicking member 410 may be formed of a woven and / or non-woven (extruded) material(s) made from filament fibers or may be formed of a sintered material (e.g., a non- fibrous material made of a plurality of pellets such as polymer or metal pellets). Other materials may include, for example, cellulose, polyester, nylon, aramid, polyethylene, and / or glass fibers and are among the many fibers available that are suitable for the applications. Suitable materials for the wicking member 410 include Hi-Flow™ Plus Membrane and SureWick® Pad Materials commercially available from EMD Millipore Corporation, Billerica, MA.

[0063] Reference is made to FIGS. 4A and 4B again, which provide details of embodiments of the sensor assembly 104 and an embodiment of a septum breaching mechanism 414. The septum breaching mechanism 414 may include a detent or spring mechanism 416 located proximate the septum 406. A first end 420 of a member 418 may be positioned proximate or in contact with a platform 422 of the spring mechanism 416. A second end 426 of the member 418 may be located proximate a surface 428 of a cam 430. During operation of the analyzer 100 (FIG. 1A), the second end 426 of the member 418 may contact the surface 428 of the cam 430. The member 418 may be movable in the Y direction as the second end 426 contacts the surface 428 of the cam 430 as described herein. A bladder 427 or the like may seal the member 418 to prevent the reference fluid 206 from seeping past the member 418. In some embodiments, the second end 426 of the member 418 may terminate in the bladder 427. Movement of the member 418 may then be achieved by applying a force to the bladder 427.

[0064] The sensor assembly 104 may be movable in the X direction relative to the cam 430 when the sensor assembly 104engages the analyzer 100. For example, the cam 430 may be fixed to a chassis (not shown) or the like within the analyzer 100 (FIG. 1). As the sensor assembly 104 moves in the -X direction, the surface 428 of the cam 430 may cause the member 418 to move in the -Y direction to apply a force onto the spring mechanism 416.

[0065] The spring mechanism 416 illustrated in FIGS. 4A and 4B may be flexible and may deform as shown in FIG. 4B when a force in the -Y direction is applied to the platform 422 of the spring mechanism 416 by the member 418 (such as through interaction with the cam 430 as the sensor assembly 104 engages the analyzer 100). As described in greater detail below, the member 418 may move in the -Y direction and cause the spring mechanism 416 to deflect. In some embodiments, the spring mechanism 416 may at least partially return to its original configuration after the force is removed or reduced.

[0066] A surface of the platform 422 opposite the member 418 may have a cutter 424 attached thereto. In some embodiments, the cutter 424 may be formed into the platform 422 of the spring mechanism 416. In some embodiments, the cutter 424 may be a blade or the like that is configured to breach the septum 406 by piercing the septum 406. The sensor assembly 104 may have devices other than the cutter 424 that are configured to breach the septum 406.

[0067] The sensor assembly 104 may have a channel 440 similar to the channel 508 of FIGS. 5A-5D that is configured to transfer a biological sample throughout the sensor assembly 104. The channel 440 may be configured to transfer the biological sample to be in contact with the membrane 402 and the sensor arrays 300 (FIG. 3). The channel 440 also may be configured to transfer the biological sample to other components in the sensor assembly 104. As shown in FIG. 4B, when the septum 406 is breached, the biological sample may be in fluid communication with the reference fluid 206 via themembrane 402 and the wicking member 410. A gasket 434 may prevent the reference fluid 206 from directly contacting any biological sample in the channel 440.

[0068] With additional reference to FIG. 1A, the sensor assembly 104 may be transported to the analyzer 100 in a dry state (meaning that the septum 406 is intact and not breached). The tray 108 may be opened and the sensor assembly 104 may be placed into the tray 108. The tray 108 may then be closed as shown in FIG. 1B so that the sensor assembly 104 engages the analyzer 100. During the engagement, the septum 406 may be breached as described herein. For example, in some embodiments, after the sensor assembly 104 is loaded into the tray 108, the tray 108 may be closed, causing the second end 426 (FIGS. 4A and 4B) of the member 418 to engage the cam 430 (positioned within the analyzer 100) so as to move member 418 in the -Y direction and to cause cutter 424 to breach the septum 406. The analyzer 100 may have other methods of engaging the sensor assembly 104 with the analyzer 100. For example, in some embodiments, the sensor assembly 104 may be placed directly into an opening (not shown) in the analyzer 100 without the use of the tray 108.

[0069] Reference is made to FIGS. 4A and 5A, which show the sensor assembly 104 prior to engaging the analyzer 100. The septum 406 has not been breached, so the reference fluid 206 is not in contact with the wicking member 410, the membrane 402, or the biological sample. In the example of FIG. 4A, the sensor assembly 104 has not moved in the -X direction to cause the second end 426 of the member 418 to contact the surface 428 of the cam 430.

[0070] As shown in FIGS. 4B and 5B, upon engagement of the sensor assembly 104 with the analyzer 100, the septum breaching mechanism 414 breaches the septum 406. In the embodiments of FIGS. 4B and 5B, the cutter 424 breaches (e.g., pierces) the septum 406 when the sensor assembly 104 engagesthe analyzer 100. In the embodiment of FIG. 4B, the second end 426 of the member 418 contacts the surface 428 of the cam 430 (e.g., attached to the analyzer 100) as the sensor assembly 104 moves in the -X direction relative to the cam 430. This movement of the sensor assembly 104 causes the member 418 to move in the -Y direction as the sensor assembly 104 engages the analyzer 100. Movement of the member 418 in the -Y direction in turn may cause the spring mechanism 416, and specifically the platform 422, to deform as shown in FIGS. 4B and 5B. The deformation causes the cutter 424 to breach the septum 406, which exposes the wicking member 410 and the membrane 402 to the reference fluid 206.

[0071] In the embodiment of FIG. 5B, rather than employing a cam as an activating mechanism, an alternative activating mechanism 520 causes the member 418 to move in the -Y direction as the sensor assembly 104 engages the analyzer 100 as described herein. The activating mechanism 520 may include a servo motor or the like that moves the member 418 in the -Y direction. In some embodiments, in addition to or in place of the cutter 424, the septum 406 may be breached by, for example, an electrical piercer or vibration (e.g., ultrasound) signal which is configured to cause the septum 406 to breach and expose the membrane 402 to the reference fluid 206 when the sensor assembly 104 engages the analyzer 100. In some embodiments, the activating mechanism 520 may vibrate the cutter 424 to breach the septum 406. In some embodiments, loading the sensor assembly 104 into the analyzer 100 may activate the activating mechanism 520, such as by providing power to a servo motor, a vibrating mechanism, an electrical piercer associated with member 418 or the like (not separately shown).

[0072] When the septum 406 is breached, the septum 406 may be referred to as being in an open position. When the septum 406 is breached, the reference fluid 206 may be in fluidcommunication with the wicking member 410 and the membrane 402. This communication exposes the wicking member 410 to the reference fluid 206, which in turn facilitates drawing of the reference fluid 206 to the membrane 402 for enhanced wet-up and reduced bubble formation.

[0073] The wicking member 410 assists and enhances the wet- up of the membrane 402 for improved operation of the sensor assembly 104. For example, the wicking member 410 enhances the wet-up cycle of the sensor assembly 104 and reduces or prevents bubble formation over the membrane 402. Specifically, the wicking member 410 draws the reference fluid 206 towards the membrane 402, thereby improving complete fluid coverage of the areas surrounding the membrane 402, which helps to prevent bubble formation, as well as to push any formed bubbles away from the membrane 402, thus improving wet-up of the membrane 402. Because the wicking member 410 draws the reference fluid 206 towards the membrane 402, the wicking member 410 advantageously facilitates and maintains contact of the reference fluid 206 with the membrane 402, thereby improving the creation and maintenance of the liquid junction in the open position.

[0074] The presence of the wicking member 410 may reduce or prevent the formation of bubbles over the membrane 402 during the testing cycle of the sensor assembly 104 due to the hydrophilic nature of the materials of the wicking member 410. The wicking member 410 may also reduce or prevent the formation of bubbles due to the exclusion and / or reduction of convective fluid motion over the membrane 402, where convective fluid motion could disadvantageously introduce gas (hence bubbles) as the reference fluid 206 heats up (e.g., to 37°C) during some testing cycles. Heating of the reference fluid 206 changes (e.g., decreases) the gas solubility and may lead to the evolution of gases (e.g., oxygen and nitrogen) from the reference fluid 206, thereby disadvantageouslyprompting the formation of gas bubbles at or near the membrane 402. After a predetermined number of tests of biological samples, the sensor assembly 104 may be removed from the analyzer 100 as a modular unit.

[0075] In some embodiments, the reference fluid 206 may contact the wicking member 410 after the cutter 424 or other device used to breach the septum 406 is removed from the breached septum 406 as shown in FIG. 5C. For example, when the cutter 424 is located in the septum 406, the cutter 424 may form a seal in the septum 406 and prevent the reference fluid 206 from contacting the wicking member 410. In the embodiment of FIG. 4B, as the sensor assembly 104 is moved further in the -X direction relative to the cam 430, the second end 426 of the member 418 may contact the surface 429 of the cam 430, which enables the member 418 to move in the +Y direction as the sensor assembly 104 moves in the -X direction. That is, the second end 426 of the member 418 maintains contact with the surface 429 of the cam 430 by moving in the +Y direction due to the restoring force of the spring mechanism 416. This movement enables the spring mechanism 416 to at least partially reform to the original configuration of FIG. 4A, which removes the cutter 424 from the septum 406 (similar to as shown in FIG. 5C). Thus, the cutter 424 does not seal the septum 406 and enables the reference fluid 206 to contact the wicking member 410. In some embodiments, placing the sensor assembly 104 in the tray 108 (FIG. 1A) of analyzer 100 and closing the tray 108 may cause the member 418 to travel along surface 428 of cam 430 to breach the septum 406 and then transition and travel along surface 429 of cam 430 to remove the cutter 424 from the septum 406 due to the motion of closing the tray 108.

[0076] At this point, the septum 406 has been breached and the reference fluid 206 is in fluid communication with or has wet-up the wicking member 410. Thus, the analyzer 100 is readyto use the sensor assembly 104 to analyze a biological sample. A user of the analyzer 100 may introduce the biological sample into the analyzer 100 for testing by the sensor assembly 104 (via channel 440 in FIGS. 4A and 4B or via channel 508 in FIGS. 5A-5D). With reference to FIG. 5D, the biological sample 506 is transferred to the membrane 402 and sensor arrays 300 by way of the channel 508, which enables the analyzer 100 to perform the appropriate tests on the biological sample 506.

[0077] The septum 406 has been described in FIG. 4B as being breached by mechanical devices such as by use of the cam 430 in conjunction with the member 418. In the embodiments of FIGS. 5A-5B, the activating mechanism 520 may use different methods to move the member 418 to breach the septum 406. As described, the activating mechanism 520 may include a servo motor or electronic actuator that moves the member 418 into contact with the septum 406 (FIG. 5B) in response to signals received at the activating mechanism 520. In some embodiments, when the sensor assembly 104 engages the analyzer 100, a switch or other device (not shown) transmits a signal (and / or power) to the activating mechanism 520, which causes the activating mechanism 520 to move the member 418 so as to breach the septum 406. Once breached, the member 418 may retract due to the restoring force of the spring mechanism 416 to allow reference fluid 206 to travel through the breached septum. A similar embodiment is shown in FIG. 6, which illustrates the sensor assembly 104 of FIG. 5D without the spring mechanism 416 of FIGS. 4A-4B. In this embodiment, the activating mechanism 520 may hold the member 418 in selected positions relative to the septum 406 so the spring mechanism 416 is not required to support the cutter 424 or retract the cutter 424 from the septum 406. For example, the activating mechanism 520 may move the member 418 toward or away from the septum 406. In some of these embodiments, the cutter 424 may be coupled directly to the member 418 as shown in FIG. 6. Inother embodiments, the member 418 may have a pin (not shown) that pierces or breaches the septum 406.

[0078] Additional reference is made to FIGS. 7A-7B, which illustrate the sensor assembly 104 wherein the septum breaching mechanism 414 includes a lever 700 rather than the spring mechanism 416 of FIGS. 4A-4B. The lever 700 may be made from a deformable material (e.g., an elastically deformable material such as a thin metal, plastic, or the like). In the embodiment of FIG. 7A, the first end 420 of the member 418 is proximate a platform 702 of the lever 700. As the sensor assembly 104 moves in the -X direction, the surface 428 of the cam 430 applies a force to the member 418, which causes the member 418 to move in the -Y direction as shown in FIG. 7B. The platform 702 may then deflect in the -Y direction so that the cutter 424 breaches the septum 406.

[0079] In some embodiments, the lever 700, such as the platform 702, may at least partially reform to the configuration of FIG. 7A as the sensor assembly 104 is moved further in the -X direction relative to the cam 430. For example, the second end 426 of the cam 430 may contact the surface 429, which enables the member 418 to move in the +Y direction as the lever 700 returns to its original shape as shown in FIG. 7A. This creates a wider path for the reference fluid 206 to be in fluid communication with the wicking member 410 and the membrane 402.

[0080] In some embodiments, the septum 406 may have a weak portion wherein breaching the septum 406 includes breaking the septum 406 at the weak portion. Reference is made to FIGS. 8A and 8B, which illustrate the sensor assembly 104 wherein the septum 406 has a weak portion 800 that may be broken to breach the septum 406. In the embodiment of FIGS. 8A and 8B, the septum 406 may be attached to a structure, such as one or more walls shown as a first wall 804 and a second wall 806. In some embodiments, the first wall 804 and the second wall 806 may bea single continuous wall. The weak portion 800 may be a portion of the septum 406 that is weak or weakly attached to the first wall 804 or the second wall 806. Alternatively or additionally, the weak portion 800 may be thinner than the remainder of the septum 406.

[0081] When the member 418 moves in the -Y direction and contacts the septum 406, the weak portion 800 may break causing the septum 406 to breach as described herein and as shown in FIG. 8B. In other embodiments, the septum 406 may be scored to provide the weak portion 800 or otherwise weakened. The first end 420 of the member 418 may be blunt and may push the septum 406 to break or breach the septum 406. Because the septum 406 has the weak portion 800, the septum 406 may not need to be pierced as described above. However, in some embodiments, the first end 420 of the member 418 may be sharp, such as in the form of a cutter, to pierce the septum 406 in situations where the weak portion 800 of the septum 406 does not break.

[0082] In other embodiments, the first end 420 of the member 418 may include a heating element or the like that heats the septum 406. Reference is made to FIGS. 9A and 9B, which illustrate the first end 420 of the member 418 being or including a heating element 900. As the sensor assembly moves in the -X direction to engage the analyzer 100, the second end 426 of the member 418 may contact a power source 904 as shown in FIG. 9B. The contact conducts power to the heating element 900, which heats the septum 406. The septum 406 may be made of a heat-shrink material that shrinks when heated or a material that is otherwise breached when heated by the heating element 900.

[0083] In some embodiments, a vibrating device, such as an ultrasonic device may be attached to the first end 420 of the member 418 and may be used to breach the septum 406 as shown in FIG. 9C. For example, instead of the heating element 900,the member 418 may include a vibrating device 902, which may be activated by the second end 426 of the member 418 contacting the power source 904. Upon activation, the vibrating device 902 may generate vibrations that breach the septum 406 (e.g., by tearing the septum 406, by detaching the septum 406 from the first wall 804 or second wall 806, etc.).

[0084] Another embodiment of a heating element 1000 used to breach the septum 406 is illustrated in FIGS. 10A-10B. The heating element 1000 may be attached to the septum 406. In some embodiments, the heating element 1000 may receive power by way of the member 418 and a power source 904 of the analyzer 100 positioned to contact the member 418 when the sensor assembly 104 engages the analyzer 100. For example, the member 418 may conduct electricity to the heating element 1000, which causes the heating element 1000 to heat and breach the septum 406 as shown in FIG. 10B. In other embodiments, the member 418 may include an inductor configured to inductively transfer power to the heating element 1000. Another source of electromagnetic energy may be used to transfer power to the heating element 1000. In some embodiments, the source of electromagnetic energy may be located external to the sensor assembly 104 (e.g., within the enclosure 106 of the analyzer 100).

[0085] In yet other embodiments shown in FIGS. 11A-11B, a portion 1100 of the septum 406 may be located adjacent or over a heating element 1104. When the sensor assembly 104 engages the analyzer 100, the heating element 1104 may breach at least the portion 1100 of the septum 406 as shown in FIG. 11B (e.g., by melting and / or shrinking the portion 1100). In some embodiments, a conductor or the like may provide power (e.g., from the analyzer 100) to the heating element 1104 upon engagement of the sensor assembly 104 with the analyzer 100. In other embodiments, the power source 904 may provide power, such as electromagnetic power, to the heating element 1104upon engagement of the sensor assembly 104 with the analyzer 100.

[0086] Additional reference is made to FIGS. 12A-12B, which illustrate an embodiment of the sensor assembly 104 wherein a force applied to the bladder 427 causes the member 418 to move and breach the septum 406. The embodiment of FIGS. 12A-12B may be similar to the embodiment of FIGS. 4A-4B, but the member 418 is located within the sensor assembly 104 and may be located proximate the bladder 427. Thus, there may not be any moving parts extending through the housing 208 and into the reference fluid container 202 except a portion of the bladder 427. The bladder 427 may be a flexible material (e.g., polytetrafluorethylene, silicone, thermoplastic, etc.) or another suitable material) that seals the reference fluid container 202, such as from external fluids.

[0087] As the sensor assembly 104 moves in the -X direction to engage the analyzer 100, a second member 1200 may contact the cam 430 (e.g., one or both located in the analyzer 100), which causes the second member 1200 to move in the -Y direction and deform the bladder 427. The deformation causes the member 418 to breach the septum 406. Thus, the septum 406 is breached while the reference fluid container 202 remains sealed. Other devices, such as the mechanism 520 of FIG. 5A may be used to deform the bladder 427 (e.g., via a motor).

[0088] Additional reference is made to FIGS. 13A-13F which illustrate different configurations of the cutter 424 (FIGS. 4A, 4B, 6) that may be employed to pierce (e.g., breach) the septum 406. For example, in some embodiments, any of the cutters illustrated in FIGS. 13A-13F may be used for the cutter 424. The different cutters may be selected depending on the material of the septum 406. The cutter 424 may be formed from any suitable material (e.g., metal, sheet metal, plastic, etc.).

[0089] FIG. 13A illustrates a cutter 1300 that has a single blade 1302 with a single edge 1304. The blade forms a point 1306. The edge 1304 and the point 1306 are configured to pierce (e.g., breach) the septum 406. FIG. 13B illustrates a cutter 1310 that has a single blade 1312 having two edges 1314 that form a cutting edge 1316. The cutting edge 1316 forms a point 1318. The point 1318 may pierce the septum 406 and the cutting edge 1316 may tear the septum 406 to generate a large opening that enables more of the reference fluid 206 to contact the membrane 402.

[0090] FIG. 13C illustrates a cutter 1320 having a first blade 1322 and a second blade 1324. The angle between the first blade 1322 and the second blade 1324 may be less than 90° (although a 90° angle may be used). The first blade 1322 may include a first cutting edge 1326 and a second cutting edge 1328 that converge at a point 1330. The point 1330 in conjunction with the first cutting edge 1326 and the second cutting edge 1328 pierce and breach the septum 406. The use of the first blade 1322 and the second blade 1324 may form a large opening when the cutter 1320 breaches the septum 406.

[0091] FIG. 13D illustrates a cutter 1340 that is similar to the cutter 1320. The cutter 1340 may have a first blade 1342 and a second blade 1344. The angle between the first blade 1342 and the second blade 1344 may be greater than 90°. The first blade 1342 may include a first cutting edge 1346 and a second cutting edge 1348 that converge at a point 1350. The point 1350 in conjunction with the first cutting edge 1346 and the second cutting edge 1348 pierce and breach the septum 406. The use of the first blade 1342 and the second blade 1344 may form an opening that is larger than an opening formed by the cutter 1320.

[0092] FIG. 13E illustrates a cutter 1360 having a first blade 1362, a second blade 1364, and a third blade 1366. In some embodiments, the angle between the first blade 1362 andthe second blade 1364, and the angle between the second blade 1364 and the third blade 1366, may each be 90° or less. The first blade 1362 may have a first cutting edge 1368, the second blade 1364 may have a second cutting edge 1370, and the third blade 1366 may have a third cutting edge 1372 that all converge at a point 1374. The cutter 1360 may form a large hole in the septum 406.

[0093] FIG. 13F illustrates a cutter 1380 having blades that are separated by greater angles than the blades 1362, 1364, 1366 of the cutter 1360. The cutter 1380 may have a first blade 1382, a second blade 1384, and a third blade 1386. The angle between each of the first blade 1382, the second blade 1384, and the third blade 1386 may be about 120°. Other angles may be used. The first blade 1382 may have a first cutting edge 1388, the second blade 1384 may have a second cutting edge that is not illustrated, and the third blade 1386 may have a third cutting edge 1392 that all converge at a point 1394. The cutter 1380 may form a larger hole in the septum 406 than the cutter 1360 of FIG. 13E.

[0094] Reference is now made to FIG. 14 which illustrates a method 1400 of activating a sensor assembly (e.g., sensor assembly 104) for a biological sample analyzer (e.g., biological sample analyzer 100). The method 1400 includes, in block 1402, providing a sensor assembly having: a reference fluid container (e.g., reference fluid container 202) housing a reference fluid (e.g., reference fluid 206); a channel (e.g., channel 440) configured to transport a sample (e.g., biological sample 506); a membrane (e.g., membrane 402) located between the reference fluid container and the channel; and a septum (e.g., septum 406) sealing the membrane from the reference fluid. The method 1400 includes, in block 1404, engaging the sensor assembly with a biological sample analyzer. For example, the sensor assembly 104 may be loaded into the tray 108 (FIG. 1A) of the analyzer 100 and the tray108 may be closed to engage the sensor assembly 104 with the analyzer 100. The method 1400 includes, in block 1406, breaching at least a portion of the septum to cause the reference fluid to contact the membrane in response to the sensor assembly engaging the biological sample analyzer. For example, as the sensor assembly 104 enters the analyzer 100, the member 418 may interact with the analyzer 100 via an activating mechanism (e.g., via cam 430, alternative activating mechanism 520, power source 904, or the like generally referred to as activating mechanism 118 in FIGS. 1C- 1E) to breach the septum 406. Likewise, the analyzer 100 may employ an activating mechanism (e.g., a power supply) to supply power to a heating element 1104 in the embodiment of FIGS. 11A and 11B. The member 418, spring mechanism 416, cutter 424, lever 700, heating element 900, vibrating device 902, heating element 1000, heating element 1104, etc., may comprise or form part of a “septum breaching mechanism” configured to breach at least a portion of the septum as the sensor assembly engages a biological sample analyzer to allow the reference fluid to contact the membrane (generally referred to as septum breaching mechanism 116 in FIGS. 1C-1E).

[0095] While the disclosure is susceptible to various modifications and alternative forms, specific method and apparatus embodiments have been shown by way of example in the drawings and are described in detail herein. It should be understood, however, that the particular methods and apparatus disclosed herein are not intended to limit the disclosure.

[0096] While the articles, compositions and methods of the inventive concept(s) have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the articles, compositions and / or methods and in the steps or in the sequence of steps of the methods described herein without departing from the concept and scope of the inventiveconcept(s). All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the scope and concept of the inventive concept(s) as defined by the appended claims.

[0097] The use of the word “a” or “an” may mean “one,” but may also be consistent with the meaning of “one or more,” “at least one,” and “one or more than one.”

[0098] The term “wet-up” as used herein will be understood to refer to the hydration process (e.g., of a membrane) from installation of a sensor assembly in a biological sample analyzer to a point at which a stable signal is obtained out of calibration reagents (e.g., a reference fluid). A stable signal may be obtained when a liquid junction is formed and maintained. Gas bubbles formed at or near the membrane during wet-up may negatively affect the stability of the signal by hindering formation or maintenance of the liquid junction. Thus, improving wet-up as described herein includes obtaining and / or maintaining a stable signal and hence a liquid junction at the membrane free of or with reduced gas bubbles.

[0099] The phrase “capable or configured to be in fluidic communication” as used herein refers to a direct or indirect fluidic communication between two elements / compartments that allows for flow of fluid and / or ions therebetween. In addition, the phrase “capable or configured to be in fluidic communication” includes instances where a flow point between two elements / compartments may be sealed or otherwise plugged, but the two elements / compartments are capable of having fluid communication therebetween upon puncture, piercing, or other breaching of a septum formed therein or therebetween. NON-LIMITING ILLUSTRATIVE EMBODIMENTS

[0100] The following is a list of non-limiting embodiments of the inventive concepts disclosed herein:

[0101] An illustrative sensor assembly for a biological sample analyzer, comprising: a reference fluid container configured to house a reference fluid; a channel configured to transport a sample; a membrane located between the reference fluid container and the channel; a septum sealing the membrane from the reference fluid; and a septum breaching mechanism configured to breach at least a portion of the septum as the sensor assembly engages a biological sample analyzer to allow the reference fluid to contact the membrane.

[0102] The illustrative sensor assembly of any one of the preceding illustrative embodiments, wherein the septum breaching mechanism comprises a cutter movable from a first position to a second position as the sensor assembly engages a biological sample analyzer, wherein the cutter breaches the septum when the cutter moves from the first position to the second position to enable the reference fluid to contact the wicking member.

[0103] The illustrative sensor assembly of any one of the preceding illustrative embodiments, further comprising a member configured to contact the biological sample analyzer when the sensor assembly engages the biological sample analyzer and, in response thereto, causes the cutter to move from the first position to the second position.

[0104] The illustrative sensor assembly of any one of the preceding illustrative embodiments, wherein the cutter comprises a blade.

[0105] The illustrative sensor assembly of any one of the preceding illustrative embodiments, further comprising a lever, wherein the cutter is coupled to the lever, wherein the lever is configured to move in response to the sensor assembly engaging the biological sample analyzer, and wherein the movement of the lever causes the cutter to move from the first position to the second position.

[0106] The illustrative sensor assembly of any one of the preceding illustrative embodiments, wherein the septum breaching mechanism comprises: a spring mechanism; and a cutter attached to the spring mechanism and configured to breach the septum, wherein a force is applied to the spring mechanism when the sensor assembly engages the biological sample analyzer, the force causing the spring mechanism to deform from a first configuration to a second configuration wherein the cutter breaches the septum when the spring mechanism is in the second configuration.

[0107] The illustrative sensor assembly of any one of the preceding illustrative embodiments, wherein further engagement of the sensor assembly with the biological sample analyzer reduces the force applied to the spring mechanism, and wherein the reduced force causes the spring mechanism to at least partially return to the first configuration and at least partially removes the cutter from the septum.

[0108] The illustrative sensor assembly of any one of the preceding illustrative embodiments, further comprising a member configured to contact the spring mechanism, wherein the member is movable between at least a first position and a second position, and wherein movement of the member from the first position to the second position causes the spring mechanism to deform from the first configuration to the second configuration, wherein the member is configured to contact a cam in the biological sample analyzer, wherein the contact causes the member to move between the first position and the second position.

[0109] The illustrative sensor assembly of any one of the preceding illustrative embodiments, wherein the septum is at least partially made from a heat shrink material, and further comprising a heating element located proximate the septum, wherein the heating element heats the septum when the sensorassembly engages the biological sample analyzer, and wherein the heat breaches the septum.

[0110] The illustrative sensor assembly of any one of the preceding illustrative embodiments, wherein the heating element receives power when the sensor assembly engages the biological sample analyzer.

[0111] The illustrative sensor assembly of any one of the preceding illustrative embodiments, wherein the septum breaching mechanism comprises a vibrating device, wherein vibrations generated by the vibrating device breach the septum.

[0112] The illustrative sensor assembly of any one of the preceding illustrative embodiments, wherein the vibrating device is an ultrasonic device.

[0113] The illustrative sensor assembly of any one of the preceding illustrative embodiments, wherein the septum comprises a weak portion configured to be breached by the septum breaching mechanism.

[0114] The illustrative sensor assembly of any one of the preceding illustrative embodiments, further comprising a wicking member configured to draw the reference fluid towards the membrane when the wicking member is exposed to the reference fluid.

[0115] An illustrative biological sample analyzer, comprising: an opening configured to receive a sensor assembly, the sensor assembly comprising: a reference fluid container configured to house a reference fluid; a channel configured to transport a sample; a membrane located between the reference fluid container and the channel; a septum sealing the membrane from the reference fluid; and a septum breaching mechanism configured to breach at least a portion of the septum as the sensor assembly engages the biological sample analyzer by way of the opening to allow the reference fluid to contact the membrane; and an activation mechanismconfigured to activate the septum breaching mechanism to breach the septum when the sensor assembly engages the biological sample analyzer.

[0116] The illustrative biological sample analyzer of any one of the preceding illustrative embodiments, wherein the sensor assembly further comprises a wicking member configured to draw the reference fluid towards the membrane when the wicking member is exposed to the reference fluid.

[0117] The illustrative biological sample analyzer of any one of the preceding illustrative embodiments, wherein the septum breaching mechanism comprises a member configured to breach the septum upon application of a force to the member, and wherein the activating mechanism is configured to apply the force to the member when the sensor assembly engages the biological sample analyzer.

[0118] The illustrative biological sample analyzer of any one of the preceding illustrative embodiments, wherein the activating mechanism is further configured to reduce the force applied to the member.

[0119] The illustrative biological sample analyzer of any one of the preceding illustrative embodiments, wherein the septum breaching mechanism comprises a heating element, wherein heat generated by the heating element breaches the septum; and wherein the activating mechanism is configured to activate the heating element when the sensor assembly engages the biological sample analyzer.

[0120] The illustrative biological sample analyzer of any one of the preceding illustrative embodiments, wherein the septum breaching mechanism comprises a vibrating device, wherein vibrations generated by the vibrating device breach the septum; and wherein the activating mechanism is configured to activate the vibrating device when the sensor assembly engages the biological sample analyzer.

[0121] An illustrative method of activating a sensor assembly for a biological sample analyzer, comprising: providing a sensor assembly having: a reference fluid container housing a reference fluid; a channel configured to transport a sample; a membrane located between the reference fluid container and the channel; and a septum sealing the membrane from the reference fluid; engaging the sensor assembly with a biological sample analyzer; and breaching at least a portion of the septum to cause the reference fluid to contact the membrane in response to the sensor assembly engaging the biological sample analyzer.

[0122] The illustrative method of any one of the preceding illustrative embodiments, wherein the breaching comprises piercing the septum.

[0123] The illustrative method of any one of the preceding illustrative embodiments, wherein the sensor assembly includes a cutter and wherein breaching the septum comprises moving the cutter from a first position to a second position to breach the septum.

[0124] The illustrative method of any one of the preceding illustrative embodiments, wherein the breaching comprises removing at least a portion of the septum.

[0125] The illustrative method of any one of the preceding illustrative embodiments, wherein the breaching comprises heating at least a portion of the septum.

[0126] The illustrative method of any one of the preceding illustrative embodiments, wherein the breaching comprises vibrating at least a portion of the septum.

Claims

WHAT IS CLAIMED IS:

1. A sensor assembly for a biological sample analyzer, comprising: a reference fluid container configured to house a reference fluid; a channel configured to transport a sample; a membrane located between the reference fluid container and the channel; a septum sealing the membrane from the reference fluid; and a septum breaching mechanism configured to breach at least a portion of the septum as the sensor assembly engages a biological sample analyzer to allow the reference fluid to contact the membrane.

2. The sensor assembly of claim 1, wherein the septum breaching mechanism comprises a cutter movable from a first position to a second position as the sensor assembly engages a biological sample analyzer, wherein the cutter breaches the septum when the cutter moves from the first position to the second position to enable the reference fluid to contact the membrane.

3. The sensor assembly of claim 2, further comprising a member configured to contact the biological sample analyzer when the sensor assembly engages the biological sample analyzer and, in response thereto, causes the cutter to move from the first position to the second position.

4. The sensor assembly of claim 2, wherein the cutter comprises a blade.

5. The sensor assembly of claim 2, further comprising a lever, wherein the cutter is coupled to the lever, wherein the lever is configured to move in response to the sensor assembly engaging the biological sample analyzer, and wherein movement of the lever causes the cutter to move from the first position to the second position.

6. The sensor assembly of claim 1, wherein the septum breaching mechanism comprises: a spring mechanism; and a cutter attached to the spring mechanism and configured to breach the septum, wherein a force is applied to the spring mechanism when the sensor assembly engages the biological sample analyzer, the force causing the spring mechanism to deform from a first configuration to a second configuration wherein the cutter breaches the septum when the spring mechanism is in the second configuration.

7. The sensor assembly of claim 6, wherein further engagement of the sensor assembly with the biological sample analyzer reduces the force applied to the spring mechanism, and wherein the reduced force causes the spring mechanism to at least partially return to the first configuration and at least partially removes the cutter from the septum.

8. The sensor assembly of claim 6, further comprising a member configured to contact the spring mechanism, wherein the member is movable between at least a first position and a second position, and wherein movement of the member from the first position to the second position causes the spring mechanism to deform from the first configuration to the second configuration.

9. The sensor assembly of claim 8, wherein the member is configured to contact a cam in the biological sample analyzer, wherein the contact causes the member to move between the first position and the second position.

10. The sensor assembly of claim 1, wherein the septum is at least partially made from a heat shrink material, and further comprising a heating element located proximate the septum, wherein the heating element heats the septum when the sensor assembly engages the biological sample analyzer, and wherein the heat breaches the septum.

11. The sensor assembly of claim 10, wherein the heating element receives power when the sensor assembly engages the biological sample analyzer.

12. The sensor assembly of claim 1, wherein the septum breaching mechanism comprises a vibrating device, wherein vibrations generated by the vibrating device breach the septum.

13. The sensor assembly of claim 12, wherein the vibrating device is an ultrasonic device.

14. The sensor assembly of claim 1, wherein the septum comprises a weak portion configured to be breached by the septum breaching mechanism.

15. The sensor assembly of claim 1, further comprising a wicking member configured to draw the reference fluid towards the membrane when the wicking member is exposed to the reference fluid.

16. A biological sample analyzer, comprising:an opening configured to receive a sensor assembly, the sensor assembly comprising: a reference fluid container configured to house a reference fluid; a channel configured to transport a sample; a membrane located between the reference fluid container and the channel; a septum sealing the membrane from the reference fluid; and a septum breaching mechanism configured to breach at least a portion of the septum as the sensor assembly engages the biological sample analyzer by way of the opening to allow the reference fluid to contact the membrane; and an activating mechanism configured to activate the septum breaching mechanism to breach the septum when the sensor assembly engages the biological sample analyzer.

17. The biological sample analyzer of claim 16, wherein the sensor assembly further comprises a wicking member configured to draw the reference fluid towards the membrane when the wicking member is exposed to the reference fluid.

18. The biological sample analyzer of claim 16, wherein the septum breaching mechanism comprises a member configured to breach the septum upon application of a force to the member, and wherein the activating mechanism is configured to apply the force to the member when the sensor assembly engages the biological sample analyzer.

19. The biological sample analyzer of claim 18, wherein the activating mechanism is further configured to reduce the force applied to the member.

20. The biological sample analyzer of claim 16, wherein the septum breaching mechanism comprises a heating element, wherein heat generated by the heating element breaches the septum; and wherein the activating mechanism is configured to activate the heating element when the sensor assembly engages the biological sample analyzer.

21. The biological sample analyzer of claim 16, wherein the septum breaching mechanism comprises a vibrating device, wherein vibrations generated by the vibrating device breach the septum; and wherein the activating mechanism is configured to activate the vibrating device when the sensor assembly engages the biological sample analyzer.

22. A method of activating a sensor assembly for a biological sample analyzer, the method comprising: providing a sensor assembly having: a reference fluid container housing a reference fluid; a channel configured to transport a sample; a membrane located between the reference fluid container and the channel; and a septum sealing the membrane from the reference fluid; engaging the sensor assembly with a biological sample analyzer; and breaching at least a portion of the septum to cause the reference fluid to contact the membrane in response to the sensor assembly engaging the biological sample analyzer.

23. The method of claim 22, wherein the breaching comprises piercing the septum.

24. The method of claim 22, wherein the sensor assembly includes a cutter and wherein breaching the septum comprises moving the cutter from a first position to a second position to breach the septum.

25. The method of claim 22, wherein the breaching comprises removing at least a portion of the septum.

26. The method of claim 22, wherein the breaching comprises heating at least a portion of the septum.

27. The method of claim 22, wherein the breaching comprises vibrating at least a portion of the septum.

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