Sensor cartridge assembly with reduced number of components for use in biological sample analyzers

Abstract

A sensor cartridge for use in a biological sample analyzer includes an assembly of components wherein + / - dimensional manufacturing tolerances in each of the components can be compensated such that a liquid flow path within the sensor cartridge is formed with air-tight and / or liquid-tight seals and / or conforms to prespecified dimensions upon assembly of the components. A gasket that forms part of a liquid fluid path is overmolded onto a fluid reservoir extension member to reduce part count while improving assembly tolerances and simplifying the sensor assembly process. The assembly of components may include a strategically positioned spring pad configured to compensate for various degrees of + / - dimensional manufacturing tolerances of the components. Numerous other aspects are provided.

Description

SENSOR CARTRIDGE ASSEMBLY WITH REDUCED NUMBER OF COMPONENTS FOR USE IN BIOLOGICAL SAMPLE ANALYZERS

[0001] This application claims benefit under 35 USC § 119(e) of U.S. Provisional Application No. 63 / 847,942, filed July 21, 2025 and U.S. Provisional Application No. 63 / 691,796, filed September 6, 2024. The entire contents of the above- referenced patent applications are hereby expressly incorporated herein by reference. FIELD

[0002] This disclosure relates to a sensor cartridge for use in a biological sample analyzer that measures a fluid property in a biological sample or an aqueous solution. BACKGROUND

[0003] A sensor cartridge may be an assembly of components that includes one or more sensors for measuring one or more fluid properties (e.g., physical parameters and / or chemical constituents) in a small volume of a biological sample or another aqueous solution (e.g., a non-biological sample). The biological sample may be, e.g., whole blood, blood serum, blood plasma, saliva, urine, cerebrospinal fluid, interstitial fluid, pleural fluid, dialysate fluid, and the like. Such sensors may measure, e.g., pH, partial pressure of one or more gases (e.g., oxygen (pO2), carbon dioxide (pCO2), etc.), electrolyte concentrations (e.g., sodium (Na+), potassium (K+), calcium (Ca2+), etc.), and / or other analyte concentrations (e.g., glucose, lactate, BUN (blood urea nitrogen), creatine, etc.).

[0004] The sensor cartridge may include a small-volume liquid flow path for receiving and directing a liquid sample to the sensor(s). To provide high measurement accuracy of the sensor(s), the liquid flow path should have air-tight and / orliquid-tight seals and flow path dimensions that conform to predetermined specifications. This ensures that a sufficient and known volume of liquid flows through the liquid flow path to the sensor(s). However, in some cases, assembly of the sensor cartridge components may result in distorted or inconsistent liquid flow path dimensions and / or ineffective air and / or liquid sealing of the liquid flow path.

[0005] Accordingly, improved component assembly of sensor cartridges is desired. SUMMARY

[0006] In some embodiments, a method of assembling a sensor cartridge for use in a biological sample analyzer includes: providing a cartridge base; positioning a plurality of components over the cartridge base, the plurality of components including a fluid reservoir extension member having an overmolded gasket that forms at least a portion of a liquid flow path for transporting a biological sample within the sensor cartridge; positioning a connector over at least a portion of the plurality of components; and attaching the connector to the cartridge base.

[0007] In some embodiments, a method includes: forming a fluid reservoir extension member for use in a sensor cartridge of a biological sample analyzer; and overmolding a gasket on the fluid reservoir extension member, the fluid reservoir extension member and gasket forming at least a portion of a liquid flow path for transporting a biological sample within the sensor cartridge.

[0008] In some embodiments, a sensor cartridge for use in a biological sample analyzer is provided that includes: a cartridge base; a plurality of components positioned over the cartridge base, the plurality of components including a fluid reservoir extension member having an overmolded gasket, wherein the fluid reservoir extension member and overmoldedgasket form at a least a portion of a liquid flow path for transporting a biological sample within the sensor cartridge; and a connector positioned over at least a portion of the plurality of components and attached to the cartridge base.

[0009] Still other aspects, features, and advantages of this disclosure may be readily apparent from the following detailed description and illustration of a number of example embodiments and implementations, including the best mode contemplated for carrying out the invention. 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 invention. For example, although described herein with respect to a sensor cartridge for biological sample analyzers, this disclosure may be applicable to other types of component assemblies where dimensions and / or air and / or liquid sealing of internal structures is / are important. This disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the appended claims below. BRIEF DESCRIPTION OF DRAWINGS

[0010] The drawings described below are 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 invention in any way.

[0011] FIG. 1A illustrates a perspective view of a biological sample analyzer in an open state with a sensor cartridge received in a tray according to one or more embodiments.

[0012] FIG. 1B illustrates a perspective view of the biological sample analyzer of FIG. 1A in a closed statewherein the sensor cartridge has engaged the biological sample analyzer according to one or more embodiments.

[0013] FIG. 2 illustrates a simplified exploded perspective view of a first group of components of a sensor cartridge according to embodiments provided herein.

[0014] FIG. 3 illustrates a simplified exploded perspective view of a second group of sensor cartridge components including the assembled first group according to embodiments provided herein.

[0015] FIG. 4 illustrates a perspective view of an example liquid flow path according to embodiments provided herein.

[0016] FIG. 5 illustrates an alternative first group of sensor cartridge components according to one or more embodiments.

[0017] FIG. 6 illustrates an alternative second group of sensor cartridge components according to one or more embodiments.

[0018] FIG. 7A illustrates a third group of sensor cartridge components according to one or more embodiments.

[0019] FIG. 7B illustrates an alternative third group of sensor cartridge components according to one or more embodiments.

[0020] FIG. 8 illustrates an assembled sensor cartridge that includes the assembled third group or alternative third group of sensor cartridge components according to one or more embodiments.

[0021] FIG. 9 illustrates a cross section of stacked sensor cartridge components of the sensor cartridge of FIG. 8 taken along section line 9-9 of FIG. 8 according to one or more embodiments.

[0022] FIG. 10 illustrates a method of assembling a sensor cartridge for use in a biological sample analyzer according to one or more embodiments.

[0023] FIG. 11 illustrates a method of forming a component of a sensor cartridge for use in a biological sample analyzer according to one or more embodiments.

[0024] FIG. 12 illustrates an example mold which may be employed to overmold a gasket onto a fluid reservoir extension member according to one or more embodiments.

[0025] FIG. 13 illustrates another method of assembling a sensor cartridge for use in a biological sample analyzer according to one or more embodiments. DETAILED DESCRIPTION

[0026] A biological sample analyzer may include a sensor cartridge for performing one or more analyses on biological samples. A sensor cartridge may be an assembly of components that may include one or more sensors, a reference fluid reservoir, and a small-volume liquid flow path for receiving and directing a biological sample to the sensor(s). The liquid flow path may be formed by the assembly of two or more components (e.g., by coupling a gasket to a molded extension member that extends from the reference fluid reservoir). The liquid flow path may include an inlet, an outlet, one or more horizontal channels, one or more vertical channels, and one or more openings to allow, e.g., the biological sample to contact the sensor(s). To ensure high measurement accuracy of the sensor(s) in view of the small liquid volumes used of a biological sample or an aqueous solution, the liquid flow path should have liquid-tight and / or air-tight seals and the flow path dimensions (lengths, widths, and heights) should conform to predetermined dimensions such that a sufficient, uniform, and known volume of biological liquid flows through the liquid flow path to the sensor(s).

[0027] Assembly of sensor cartridge components may be performed by automated equipment having preset parameters that may include, e.g., the amount of force applied to the stack ofcomponents, the amount of torque applied to screw fasteners, etc. The preset parameters may be based on nominal height / thickness dimensions of each of the components. However, each component of the sensor cartridge may have a + / - dimensional manufacturing tolerance that may adversely affect the assembly of those components. For example, height / thickness dimensions below nominal values (e.g., components are thinner) may result in under-compression of the assembled components, while height / thickness dimensions above nominal values (e.g., components are thicker) may result in over-compression of the assembled components. Under-compression or over-compression may result in distorted liquid flow path dimensions and / or ineffective air and / or liquid sealing of the liquid flow path.

[0028] In accordance with one or more embodiments, the number of separate components used to form a sensor cartridge may be reduced through use of one or more overmolding processes. For example, in some embodiments, following formation of a molded extension member that extends from a reference fluid reservoir, a gasket may be overmolded onto the molded extension member to form an extension member / gasket unit. By forming a single extension member / gasket unit prior to sensor assembly, the alignment tolerances between these components (during sensor cartridge assembly) are eliminated. Only the part tolerances remain. This approach reduces the number of independent components employed and simplifies sensor cartridge assembly by removing process steps (e.g., as the extension member and gasket are already coupled together).

[0029] Additionally, in some embodiments, the assembly of a sensor cartridge may include a strategically placed spring pad that compensates for + / - dimensional manufacturing tolerances of the sensor cartridge components. In one or more embodiments, the spring pad may be overmolded onto a cartridge base of the sensor cartridge assembly (e.g., following formation of the cartridge base and prior to sensor cartridgeassembly). This further simplifies the sensor cartridge assembly process and reduces alignment errors during assembly.

[0030] These and other embodiments are described below with reference to FIGS. 1A-13.

[0031] FIGS. 1A and 1B illustrate a biological sample analyzer 100 in an open state and a closed state, respectively, according to one or more embodiments. The biological samples introduced into the biological sample analyzer 100 may be a bodily fluid, such as, e.g., urine, whole blood, blood serum, blood plasma, saliva, cerebrospinal fluid, pleural fluid, dialysate fluid, and the like. Note that non-biological samples (e.g., aqueous solutions) may also be tested by biological sample analyzer 100 for various fluid properties or concentrations of substances therein. The samples may be mixed with reagents, buffers, diluents, and / or the like as needed or desired for preserving and / or analyzing a particular sample.

[0032] In some embodiments, biological sample analyzer 100 may include an enclosure 102, a sensor cartridge 104 receivable in a tray 108, and a reagent assembly 110 receivable in an opening 112 of the enclosure 102. In some embodiments, sensor cartridge 104 may be receivable directly in enclosure 102 via, e.g., a dedicated slot or receptacle. Enclosure 102 may house and support multiple sample analyzing components and / or modules (not shown). These components may include one or more of a sample receiving assembly, fluidic tubing assemblies, displays, processors, memories, transceivers, and other components configured to operate biological sample analyzer 100.

[0033] Sensor cartridge 104 may include one or more sensors and a reference fluid. Sensor cartridge 104 may receive a small volume of a biological sample and may facilitate one or more analyses by measuring electrical or optical signals responsive to a fluid property of the biological sample. (Non-biological samples may also be analyzed.) The measured signals are then processed by biological sample analyzer 100 to determine a presence and / or quantity of the fluid property, such as, e.g., one or more analytes and / or other chemical constituents and / or physical parameters of the biological sample, such as, e.g., pH, partial pressure of one or more gases, one or more electrolytes, and one or more other analytes (e.g., glucose, lactate, BUN (blood urea nitrogen), creatine, etc.).

[0034] Reagent assembly 110 may include a plurality of reagent fluids used to analyze the biological samples. The reagents may be provided in reservoirs, such as sealed bags or bottles (not shown) and added to the biological samples. Reagent assembly 110 may also include other process liquids such as suitable buffers, preservatives, diluents, etc. The specific reagents and process liquids included in reagent assembly 110 may depend on the particular analyses performed by biological sample analyzer 100.

[0035] In the open state (FIG. 1A), one or both of tray 108 and reagent assembly 110 are extended outward from enclosure 102 to allow removal and replacement of sensor cartridge 104 and / or reagent assembly 110. In the closed state (FIG. 1B), tray 108 and reagent assembly 110 are each received in enclosure 102 and are operably (e.g., electrically and / or physically) connected to biological sample analyzer 100.

[0036] FIG. 2 illustrates a first group 200 of sensor cartridge components according to one or more embodiments. First group 200 includes a cartridge base 214, a spring pad 216, and a reservoir subassembly 218. Reservoir subassembly 218 includes a fluid reservoir 218FR and an extension 218EX extending from and adjacent to the fluid reservoir 218FR. Extension 218EX may be integrally formed with (e.g., molded with) fluid reservoir 218FR or formed separately (e.g., molded separately from) and attached to fluid reservoir 218FR.

[0037] Reservoir subassembly 218 may be formed with any suitable materials including, e.g., different types of polymers including FRPs (fiber reinforced polymers) and / or metals. In some embodiments, reservoir subassembly 218 may be formed from acrylonitrile butadiene styrene (ABS) or a similar material. Extension 218EX may have, e.g., a nominal thickness / height dimension 218T ranging from 1.0 mm to 2.0 mm with a + / - dimensional manufacturing tolerance of, e.g., + / - 0.1 mm or + / - 5% to 10%. Fluid reservoir 218FR may be filled with a reference fluid and may include a reference electrode 218RE that extends into fluid reservoir 218FR to contact the reference fluid. Reference electrode 218RE may be part of the electrochemical measurement system of the sensor cartridge and may be, e.g., a silver chloride coated silver wire. The reference fluid may be an electrolyte solution, such as a potassium chloride solution or an equivalent solution. Other fluid reservoir dimensions, reference fluids, and / or reference electrodes may be employed.

[0038] Cartridge base 214 may be formed with any suitable materials, such as, e.g., different types of polymers including FRPs (fiber reinforced polymers), ABS, and / or metals. In some embodiments, cartridge base 214 may be formed via a two-shot injection molding process (wherein two liquified plastic materials are used to create one part). Cartridge base 214 may include ridge features 214RF (three labeled) that form perimeter sections on cartridge base 214 configured to receive spring pad 216 there within. Other configurations of ridge features 214RF are possible (e.g., four corner sections). Also, other structures for receiving and positioning spring pad 216 on cartridge base 214 are possible (e.g., a complete perimeter structure or a number of posts for receiving spring pad 216 with corresponding holes). In still other embodiments, spring pad 216 may be molded as part of cartridge base 214 via a two-shot mold and, thus,cartridge base 214 may have no ridges or structures for receiving spring pad 216. That is, cartridge base 214 may be formed via a first molding process and spring pad 216 may be molded onto cartridge base 214 via a second molding process (e.g., overmolded). Overmolding spring pad 216 onto cartridge base 214 simplifies the sensor cartridge assembly process and reduces alignment errors during sensor cartridge assembly (e.g., because the cartridge base and spring pad are coupled together prior to sensor cartridge assembly).

[0039] In some embodiments, cartridge base 214 may have a nominal thickness / height dimension 214T ranging from 1.0 mm to 3.0 mm with a + / - dimensional manufacturing tolerance of, e.g., + / - 0.1 mm or + / - 3% to 10%.

[0040] Spring pad 216 is advantageously configured to compensate for various degrees of + / - dimensional manufacturing tolerances of the thickness / height dimension of each the stacked components in the assembly of the sensor cartridge within specified manufacturing tolerances of each the thickness / height dimensions. That is, upon assembly of the components, the liquid flow path formed within the sensor cartridge (described in more detail below in connection with FIG. 4) has air-tight or liquid-tight seals and / or conforms to prespecified flow path dimensions (e.g., lengths, widths, and / or heights). Spring pad 216 may be formed from a moldable, compressible rubber material, such as, e.g., a thermoplastic elastomer or a thermoset polymer, that is “softer” or more flexible / compressible than each of the other stacked components of the sensor cartridge assembly such that spring pad 216 will absorb more of the dimensional manufacturing tolerances than any of the other stacked components. Spring pad 216 may have a hardness value measured with the Shore durometer type A scale that, in some embodiments, may range from 25 to 60. The type A scale is typically used for softer materials. In other embodiments,spring pad 216 may have type D scale hardness values. In some embodiments, spring pad 216 may have an uncompressed thickness / height dimension 216T that, based on the total range of + / - dimensional manufacturing tolerances of the thickness / height dimension of each of the stacked components in the sensor cartridge assembly, may range from 1.0 mm to 3.0 mm. Other values of thickness / height dimension 216T are possible depending on the dimensional manufacturing tolerances of the stacked components and the spring pad 216 hardness value. The length and width of spring pad 216 may depend on the length and width of extension 218EX and other components (described below) that form the liquid flow path. In some embodiments, spring pad 216 may have a length ranging from, e.g., 20 mm to 30 mm and a width ranging from, e.g., 10 mm to 15 mm based on liquid flow path components having a maximum length ranging from, e.g., 20 mm to 35 mm and a maximum width ranging from, e.g., 10 mm to 15 mm. Other cartridge base and / or spring pad dimensions may be employed.

[0041] FIG. 3 illustrates a second group 300 of sensor cartridge components according to one or more embodiments. Second group 300 includes the assembled first group 200, a gasket 320, and first and second sensor circuit boards 322A and 322B. As shown in FIG. 3, spring pad 216 is strategically positioned on cartridge base 214 within ridge features 214RF (one labeled). In some embodiments, an adhesive may be used to secure spring pad 216 to cartridge base 214. In other embodiments, spring pad 216 may be friction fit within ridge features 214RF. In yet other embodiments, spring pad 216 may be overmolded onto cartridge base 214. Reservoir sub-assembly 218 is positioned over and onto spring pad 216 and cartridge base 214. More particularly, fluid reservoir 218FR and extension 218EX are each positioned over and onto a respective portion of spring pad 216 and cartridge base 214. In some embodiments, fluid reservoir 218FR and extension 218EX may beseparate parts, each positioned over and onto a respective portion of spring pad 216 and cartridge base 214.

[0042] First and second sensor circuit boards 322A and 322B may each be used to measure a different fluid property in a liquid sample (e.g., biological or aqueous solution). In some embodiments, first sensor circuit board 322A may be a potentiometric sensor, and second sensor circuit board 322B may be an amperometric sensor. Other sensor types may be employed. Each sensor circuit board 322A, 322B may have a top side 324TS, an opposite bottom side 324BS, and a plurality of electrical contacts 326 (only four labeled) located respectively the top sides 324TS. A liquid sample may be configured to contact bottom side 324BS of each of sensor circuit boards 322A and 322B, wherein another plurality of electrical contacts (not shown) may be located. In some embodiments, only a single sensor circuit board (e.g., sensor circuit board 322A, 322B, or another sensor circuit board) or more than two sensor circuit boards may be included in a sensor cartridge 104, depending on the number and / or types of analyses to be performed by biological sample analyzer 100. In some embodiments, each of sensor circuit boards 322A and 322B may have a nominal thickness / height dimension 322T ranging from 1.0 mm to 2.0 mm with a + / - dimensional manufacturing tolerance of, e.g., + / - 0.25 mm or + / - 10% to 25%. Other sensor board dimensions may be employed.

[0043] Gasket 320 may be configured to receive first and second sensor circuit boards 322A and 322B thereon. In some embodiments, gasket 320 may have cutout areas 328A and 328B and borders 329 configured to receive and surround first and second sensor circuit boards 322A and 322B. Cutout areas 328A and 328B may have respective bottom openings 330A and 330B for allowing a liquid sample to contact the bottom side contacts of first and second sensor circuit boards 322A and 322B. Gasket 320 may be made with or of a flexible fluid resistantmaterial capable of forming liquid-tight and / or gas-tight seals. In some embodiments, gasket 320 may comprise Viton™ (a fluoropolymer elastomer and synthetic rubber compound). Other suitable fluoroelastomer materials may be used. In embodiments in which gasket 320 is overmolded onto extension 218EX (described below), gasket 320 may comprise a thermoplastic elastomer such as a styrene-based thermoplastic elastomer, a polyurethane-based thermoplastic elastomer, a thermoplastic vulcanizate, a polyamide-based thermoplastic elastomer, or the like. In some embodiments, gasket 320 may have a nominal thickness / height dimension 320T ranging from 0.5 mm to 1.5 mm with a + / - dimensional manufacturing tolerance of, e.g., + / - 0.2 mm or + / - 10% to 40%. Other gasket dimensions may be used. Note that the hardness value of spring pad 216 may be selected in conjunction with the hardness value of gasket 320. That is, if a higher durometer material (i.e., a harder material) is used for gasket 320, a higher durometer material can be used for spring pad 216 provided that the spring pad 216 material is still more flexible / compressible than gasket 320 such that spring pad 216 will still absorb more of the dimensional manufacturing tolerances than the other stacked components.

[0044] In some embodiments, gasket 320 and extension 218EX may have corresponding features that form a liquid flow path when gasket 320 and extension 218EX are assembled together. The features may include liquid flow path side walls, tops, and / or bottoms. For example, extension 218EX may include features 332, which may form liquid flow path side walls upon assembly with gasket 320. Additionally, in some embodiments, portions of spring pad 216 may also form portions (e.g., bottoms) of a liquid flow path upon assembly with gasket 320 and extension 218EX, as now described in connection with FIG. 4.

[0045] FIG. 4 illustrates an example liquid flow path 400 formed by corresponding features (e.g., sidewalls, tops, and / or bottoms) of gasket 320, extension 218EX, and spring pad 216 upon assembly according to one or more embodiments. Liquid flow path 400 may include inlet 434; horizontal channels 436, 438, 440, 442, and 444; vertical channels 437, 439, and 441; and outlet 445 (not all channels of liquid flow path 400 labeled to maintain clarity). Horizontal channel 436 may have a top 436T formed by first sensor circuit board 322A, sidewalls 436SW formed by gasket 320, and a bottom 436B formed by extension 218EX. Horizontal channel 438 may have a top 438T and sidewalls 438SW formed by extension 218EX, and a bottom 438B formed by spring pad 216. In other embodiments, bottom 438B alternatively may be formed by cartridge base 214 via an absence of or hole in spring pad 216 at that location. Horizontal channel 440 may have a top 440T formed by second sensor circuit board 322B, sidewalls 440SW formed by gasket 320, and a bottom 440B formed by extension 218EX. Horizontal channel 442 may have a top 442T and sidewalls 442SW formed by extension 218EX, and a bottom 442B formed by spring pad 216. Similarly, horizontal channel 444 may have a top 444T and sidewalls 444SW formed by extension 218EX, and a bottom 444B formed by spring pad 216. Vertical channels 437, 439, and 441 may each have sidewalls (not labeled) formed by extension 218EX and bottoms (not labeled) formed by spring pad 216. In other embodiments, liquid flow paths may have other suitable configurations and top, sidewall, and bottom features formed by two or more of the sensor cartridge components.

[0046] FIG. 5 illustrates an alternative first group 500 of sensor cartridge components according to one or more embodiments. Alternative first group 500 includes cartridge base 214, spring pad 216, and reservoir subassembly 218 with extension 218EX and gasket 320. Unlike the embodiment of first group 200 of FIG. 2, spring pad 216 is overmolded ontocartridge base 214 and gasket 320 is overmolded onto extension 218EX during the manufacturing of these components. As stated, by forming a single spring pad / cartridge base unit and / or a single extension member / gasket unit prior to sensor assembly, the alignment tolerances between the components of these units (during sensor cartridge assembly) are eliminated. Only the part tolerances remain. This approach reduces the number of independent components employed and simplifies sensor cartridge assembly by removing process steps (e.g., as the spring pad and cartridge base and / or the extension member and gasket are already coupled together). An example molding process for overmolding gasket 320 onto extension 218EX is described below with reference to FIGS. 11 and 12.

[0047] FIG. 6 illustrates an alternative second group 600 of sensor cartridge components according to one or more embodiments. Alternative second group 600 includes the assembled alternative first group 500 (e.g., spring pad 216 coupled to cartridge base 214 and extension 218EX with overmolded gasket 320 coupled to spring pad 216) and first and second sensor circuit boards 322A and 322B. As stated, in some embodiments, spring pad 216 may be overmolded onto cartridge base 214. Reservoir sub-assembly 218 is positioned over and onto spring pad 216 and cartridge base 214. More particularly, fluid reservoir 218FR and extension 218EX are each positioned over and onto a respective portion of spring pad 216 and cartridge base 214 with gasket 320 (which is overmolded onto extension 218EX).

[0048] As described above, first and second sensor circuit boards 322A and 322B may each be used to measure a different fluid property in a liquid sample (e.g., biological or other solution). In some embodiments, first sensor circuit board 322A may be a potentiometric sensor, and second sensor circuit board 322B may be an amperometric sensor. A liquid sample may be configured to contact bottom side 324BS of each of sensorcircuit boards 322A and 322B, wherein another plurality of electrical contacts (not shown) may be located. In some embodiments, only a single sensor circuit board (e.g., sensor circuit board 322A, 322B, or another sensor circuit board) or more than two sensor circuit boards may be included in a sensor cartridge 104, depending on the number and / or types of analyses to be performed by biological sample analyzer 100.

[0049] Gasket 320 may be configured to receive first and second sensor circuit boards 322A and 322B thereon and may include cutout areas 328A and 328B and borders 329 configured to receive and surround first and second sensor circuit boards 322A and 322B. Cutout areas 328A and 328B may have respective bottom openings 330A and 330B for allowing a liquid sample to contact the bottom side contacts of first and second sensor circuit boards 322A and 322B. Gasket 320 may be made with or of a flexible fluid resistant material capable of forming liquid-tight and / or gas-tight seals (as described previously).

[0050] In some embodiments, gasket 320 and extension 218EX may have corresponding features that form a liquid flow path when gasket 320 is overmolded on extension 218EX. The features may include liquid flow path side walls, tops, and / or bottoms. Additionally, in some embodiments, portions of spring pad 216 may also form portions (e.g., bottoms) of a liquid flow path upon assembly with gasket 320 and extension 218EX (e.g., as described above with reference to FIG. 4).

[0051] FIG. 7A illustrates a third group 700A of sensor cartridge components according to one or more embodiments. Third group 700A includes the assembled second group 300 (described in FIG. 3) and a connector 750. As shown in FIG. 7A, the assembly of second group 300 includes gasket 320 positioned over and on top of extension 218EX, and first and second sensor circuit boards 322A and 322B positioned over and on top of gasket 320 and into respective cutout areas 328A and 328B of gasket 320, surrounded by borders 329 of gasket 320.FIG. 7B illustrates an alternative third group 700B of sensor cartridge components according to one or more embodiments. Alternative third group 700B includes the assembled alternative second group 600 (described in FIG. 6) and connector 750. As shown in FIG. 7B, the assembly of alternative second group 600 includes gasket 320 overmolded onto extension 218EX, and first and second sensor circuit boards 322A and 322B positioned over and on top of gasket 320 and into respective cutout areas 328A and 328B of gasket 320, surrounded by borders 329 of gasket 320.

[0052] In FIGS. 7A and 7B, connector 750 is configured to be positioned over and on top of first and second sensor circuit boards 322A and 322B, gasket 320, extension 218EX, a portion of spring pad 216, and a portion of cartridge base 214 (i.e., the portions of spring pad 216 and cartridge base 214 not occupied by fluid reservoir 218FR). Connector 750 includes electrical contacts 726 (only three labeled) that are configured to electrically connect to electrical contacts 326, respectively, of first and second sensor circuit boards 322A and 322B. In alternative embodiments, connector 750 may include through-holes (e.g., in place of electrical contacts 726) that upon installation allow electrical connectors from biological sample analyzer 100 to pass there through to electrically contact first and second sensor circuit boards 322A and 322B. Connector 750 is configured to be attached to cartridge base 214 in any suitable manner, such as, e.g., via welding (at, e.g., attachment points 954 (see FIG. 9)), any suitable fasteners or snap-in features (again at, e.g., attachment points 954), adhesives, etc., as known in the art. In some embodiments, fluid reservoir 218FR may include a pair of alignment features 752 configured to mate with corresponding alignment features (e.g., slots or cutouts configured to receive alignment features 752) on connector 750 (not shown) to facilitate proper positioning of connector 750prior to attachment. Connector 750 may be constructed of any suitable materials including the same materials as reservoir sub-assembly 218. In some embodiments, connector 750 may have a nominal thickness / height dimension 750T ranging from 5.0 mm to 20.0 mm with a + / - dimensional manufacturing tolerance of, e.g., + / - 0.1 mm or + / - 0.5% to 2%.

[0053] FIG. 8 illustrates an assembled sensor cartridge 804 that includes the assembled third group 700A or 700B according to one or more embodiments. Sensor cartridge 804, which is an embodiment of sensor cartridge 104, may be a modular unit removable from biological sample analyzer 100 as described herein in connection with sensor cartridge 104. Sensor assembly 804 may be in direct or indirect communication with a computing unit (not shown) of biological sample analyzer 100 that may collect, store, and analyze analytical test results from the sensors of sensor circuit boards 322A and 322B. Electrical contacts 726 of connector 750 are configured to electrically connect to corresponding electrical contacts, pins, or connectors in biological sample analyzer 100 upon installation of sensor cartridge 804 therein. Electrical contacts 726 may receive power from biological sample analyzer 100 to power first and second sensor circuit boards 322A and 322B and / or to transfer measured signal values to biological sample analyzer 100 for analysis.

[0054] FIG. 9 illustrates a cross section 900 of stacked sensor cartridge components of sensor cartridge 804 taken along section line 9-9 of FIG. 8 according to one or more embodiments. Stacked sensor cartridge components advantageously includes spring pad 216 that compensates for various degrees of + / - dimensional manufacturing tolerances of the thickness / height dimension of each of the other components in the assembly of sensor cartridge 804 within the respective specified + / - manufacturing tolerances of the other components. As shown in FIG. 9, the other components includecartridge base 214, extension 218EX, gasket 320, first and second sensor circuit boards 322A and 322B, connector 750, and fluid reservoir 218FR (not shown in FIG. 9). Note that extension 218EX may have a different length and / or width (i.e., greater or less) than spring pad 216, and gasket 320 may have a different length and / or width (i.e., greater or less) than extension 218EX and / or spring pad 216. That is, the lengths and / or widths of the stacked components do not need to be the same.

[0055] Spring pad 216 is configured via its uncompressed thickness / height dimension 216T, materials used in its construction, and physical properties thereof (e.g., Shore durometer hardness value) to compress as needed such that each of the other components having either its minimum height / thickness value or its maximum height / thickness value within its specified + / - manufacturing tolerances, or any height / thickness value there between, will result in a liquid flow path formed within the sensor cartridge upon attachment of connector 750 to cartridge base 214 that conforms to the prespecified flow path dimensions and / or has air-tight and / or liquid-tight seals.

[0056] For example, if each of the other components has its minimum height / thickness value, the uncompressed thickness / height dimension 216T compensates for the difference between the nominal height / thickness values and the minimum height / thickness values of the other components such that attachment of connector 750 to cartridge base 214 results in a liquid flow path conforming to the prespecified flow path dimensions and / or having air-tight and / or liquid-tight seals.

[0057] Similarly, if each of the other components has its maximum height / thickness value, spring pad 216 has a maximum compressed thickness / height dimension 216T that compensates for the difference between the nominal height / thickness values and the maximum height / thickness values of the othercomponents such that attachment of connector 750 to cartridge base 214 also results in a liquid flow path conforming to the prespecified flow path dimensions and / or having air-tight and / or liquid-tight seals.

[0058] Furthermore, if each of the other components has a height / thickness value between its minimum and maximum values, including its nominal height / thickness value, spring pad 216 is configured to compress a corresponding amount such that attachment of connector 750 to cartridge base 214 results in a liquid flow path conforming to the prespecified flow path dimensions and / or having air-tight and / or liquid-tight seals.

[0059] FIG. 10 illustrates a method 1000 of assembling a sensor cartridge for use in a biological sample analyzer according to one or more embodiments. The biological sample analyzer may be, e.g., biological sample analyzer 100 (FIGS. 1A-B). At process block 1002, method 1000 may include providing a cartridge base. For example, referring to FIG. 2, cartridge base 214 may be provided. Other suitable cartridge bases may alternatively be provided.

[0060] At process block 1004, method 1000 may include receiving a spring pad on the cartridge base. For example, the spring pad may be, e.g., spring pad 216 as shown in FIG. 2. In some embodiments, the spring pad may be received within ridge features forming perimeter sections configured to receive the spring pad on the cartridge base, such as ridge features 214RF on cartridge base 214.

[0061] At process block 1006, method 1000 may include positioning a plurality of components over and onto the spring pad and the cartridge base. The plurality of components may include, e.g., a reservoir sub-assembly, a gasket, and a sensor circuit board, such as, e.g., reservoir sub-assembly 218 (FIG. 2), gasket 320 (FIG. 3), and sensor circuit board 322A or 322B (FIG. 3). Additionally or alternatively, other components may be included. The cartridge base and theplurality of components may each have height / thickness dimensions subject to specified manufacturing tolerances. For example, each may have a specified manufacturing tolerance of their nominal height / thickness dimension based on their method of manufacture and material.

[0062] And method 1000 may include at process block 1008 positioning a connector over at least a portion of each of the plurality of components and attaching the connector to the cartridge base. In some embodiments, the connector may be connector 750 shown in FIG. 7A or 7B. The connector may also have a height / thickness dimension subject to specified manufacturing tolerances. Upon the attachment of the connector to the cartridge base, the spring pad compensates for variations in the height / thickness dimensions (within the specified manufacturing tolerances) of the cartridge base, the plurality of components, and the connector such that a liquid flow path formed within the sensor cartridge conforms to prespecified flow path dimensions. In some embodiments, the spring pad compensation for variations in the height / thickness dimensions (within the specified manufacturing tolerances) may also result in the liquid flow path having air-tight and / or liquid-tight seals.

[0063] FIG. 11 illustrates a method 1100 of forming a component of a sensor cartridge for use in a biological sample analyzer according to one or more embodiments. The biological sample analyzer may be, e.g., biological sample analyzer 100 (FIGS. 1A-B). At process block 1102, method 1100 may include forming a fluid reservoir extension member for use in a sensor cartridge of a biological sample analyzer. For example, referring to FIG. 2, extension 218EX of fluid reservoir 218FR may be formed with a suitable molding process employing a thermoplastic polymer such as acrylonitrile butadiene styrene. Other fluid reservoir extension member materials may be used.

[0064] At process block 1104, method 1100 may include overmolding a gasket on the fluid reservoir extension member, the fluid reservoir extension member and gasket forming at least a portion of a liquid flow path for transporting a biological sample within the sensor cartridge. For example, as shown in FIG. 5, gasket 320 may be overmolded onto extension 218EX after extension 218EX has been formed. The fluid reservoir extension member and overmolded gasket may form a portion of the liquid flow path (e.g., horizontal channels 436 and / or 440 in FIG. 4).

[0065] FIG. 12 illustrates an example mold 1200 that may be employed to overmold gasket 320 onto extension 218EX according to one or more embodiments. With reference to FIG. 12, mold 1200 includes an outer housing 1202 (see dashed lines) sized to fit over extension 218EX during molding of gasket 320 thereon. Mold 1200 also includes raised areas 1204a and 1204b for defining cutout areas 328A and 328B, respectively, of gasket 320. Additionally, mold 1200 has raised channel features 1206a and 1206b for defining openings 330A and 330B, respectively, of gasket 320. Other mold configurations may be employed.

[0066] To allow formation of gasket 320 onto extension 218EX, extension 218EX should be formed from a material that is compatible with the molding process employed for gasket 320. For example, gasket 320 should be formed from a material that will adhere / bond to extension 218EX during the molding process. Additionally, extension 218EX should remain structurally stable during gasket molding. That is, extension 218EX should be formed from a material having a higher melting temperature than the temperature employed to mold gasket 320 onto extension 218EX.

[0067] In some embodiments, gasket 320 may be formed from a thermoplastic elastomer such as a styrene-based thermoplastic elastomer, a polyurethane-based thermoplastic elastomer, athermoplastic vulcanizate, a polyamide-based thermoplastic elastomer, or the like, while extension 218EX may be formed from a thermoplastic polymer such as acrylonitrile butadiene styrene. Other gasket and / or extension member materials may be employed.

[0068] FIG. 13 illustrates another method of assembling a sensor cartridge (referred to as method 1300) for use in a biological sample analyzer according to one or more embodiments. With reference to FIG. 13, in block 1302, method 1300 includes providing a cartridge base (e.g., cartridge base 214). In block 1304, method 1300 includes positioning a plurality of components over the cartridge base, the plurality of components including a fluid reservoir extension member having an overmolded gasket that forms at least a portion of a liquid flow path for transporting a biological sample within the sensor cartridge (e.g., extension 218EX with overmolded gasket 320 in FIG. 5). In block 1306, method 1300 includes positioning a connector over at least a portion of the plurality of components (e.g., connector 750 in FIG. 7B). In block 1308, method 1300 includes attaching the connector to the cartridge base (e.g., as shown in FIG. 8).

[0069] Overmolding gasket 320 onto extension 218EX forms a portion of the liquid flow path through sensor cartridge 104, reduces the number of components within sensor cartridge 104, simplifies assembly of sensor cartridge 104, and simplifies and improves component alignment (e.g., as the overmolded gasket 320 will have a tighter tolerance with respect to extension 218EX than would exist if separate components were employed).

[0070] While this 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 apparatusdisclosed herein are not intended to limit the disclosure or the following claims.

[0071] Independent of the grammatical term usage, individuals with male, female or other gender identities are included within the term. ILLUSTRATIVE EMBODIMENTS

[0072] The following provides a non-limiting list of illustrative embodiments of this disclosure:

[0073] An illustrative method of assembling a sensor cartridge for use in a biological sample analyzer, the method comprising: providing a cartridge base; positioning a plurality of components over the cartridge base, the plurality of components including a fluid reservoir extension member having an overmolded gasket that forms at least a portion of a liquid flow path for transporting a biological sample within the sensor cartridge; positioning a connector over at least a portion of the plurality of components; and attaching the connector to the cartridge base.

[0074] The illustrative method of any one of the proceeding illustrative embodiments, wherein the overmolded gasket comprises a thermoplastic elastomer.

[0075] The illustrative method of any one of the proceeding illustrative embodiments, wherein the overmolded gasket comprises a styrene-based thermoplastic elastomer, a polyurethane-based thermoplastic elastomer, a thermoplastic vulcanizate, or a polyamide-based thermoplastic elastomer.

[0076] The illustrative method of any one of the proceeding illustrative embodiments, wherein the fluid reservoir extension member comprises a thermoplastic polymer.

[0077] The illustrative method of any one of the proceeding illustrative embodiments, wherein the fluid reservoir extension member comprises acrylonitrile butadiene styrene.

[0078] The illustrative method of any one of the proceeding illustrative embodiments, further comprising positioning a spring pad over the cartridge base and wherein: the cartridge base, the plurality of components, and the connector each have a height / thickness dimension subject to a specified manufacturing tolerance; and the spring pad compensates for variations in the height / thickness dimensions within the specified manufacturing tolerances by having a compressible height / thickness such that a liquid flow path formed within the sensor cartridge conforms to prespecified flow path dimensions upon the attaching.

[0079] The illustrative method of any one of the proceeding illustrative embodiments, wherein positioning the spring pad over the cartridge base comprises overmolding the spring pad on the cartridge base.

[0080] The illustrative method of any one of the proceeding illustrative embodiments, wherein the spring pad compensates for variations in the height / thickness dimensions within the specified manufacturing tolerances such that the liquid flow path has air-tight or liquid-tight seals.

[0081] The illustrative method of any one of the proceeding illustrative embodiments, wherein positioning the plurality of components over the cartridge base comprises: positioning a reservoir sub-assembly over and onto the spring pad and the cartridge base, the reservoir sub-assembly having a fluid reservoir and the fluid reservoir extension member with the overmolded gasket adjacent the fluid reservoir; and positioning a sensor circuit board on top of the overmolded gasket.

[0082] The illustrative method of any one of the proceeding illustrative embodiments, wherein the overmolded gasket and the fluid reservoir extension member each have corresponding features that form at least a portion of the liquid flow path.

[0083] An illustrative method comprising: forming a fluid reservoir extension member for use in a sensor cartridge of a biological sample analyzer; and overmolding a gasket on the fluid reservoir extension member, the fluid reservoir extension member and gasket forming at least a portion of a liquid flow path for transporting a biological sample within the sensor cartridge.

[0084] The illustrative method of any one of the proceeding illustrative embodiments, wherein the gasket comprises a thermoplastic elastomer.

[0085] The illustrative method of any one of the proceeding illustrative embodiments, wherein the gasket comprises a styrene-based thermoplastic elastomer, a polyurethane-based thermoplastic elastomer, a thermoplastic vulcanizate, or a polyamide-based thermoplastic elastomer.

[0086] The illustrative method of any one of the proceeding illustrative embodiments, wherein the fluid reservoir extension member comprises a thermoplastic polymer.

[0087] The illustrative method of any one of the proceeding illustrative embodiments, further comprising: molding a cartridge base for the sensor cartridge; and overmolding a spring pad over the cartridge base, the spring pad configured to compensate for variations in height / thickness dimensions within specified manufacturing tolerances of components of the sensor cartridge by having a compressible height / thickness such that a liquid flow path formed within the sensor cartridge conforms to prespecified flow path dimensions upon assembly of the sensor cartridge.

[0088] The illustrative method of any one of the proceeding illustrative embodiments, wherein the spring pad comprises a thermoplastic elastomer or a thermoset polymer.

[0089] An illustrative sensor cartridge for use in a biological sample analyzer, the sensor cartridge comprising: a cartridge base; a plurality of components positioned over thecartridge base, the plurality of components including a fluid reservoir extension member having an overmolded gasket, wherein the fluid reservoir extension member and overmolded gasket form at a least a portion of a liquid flow path for transporting a biological sample within the sensor cartridge; and a connector positioned over at least a portion of the plurality of components and attached to the cartridge base.

[0090] The illustrative sensor cartridge of any one of the proceeding illustrative embodiments, further comprising: a spring pad over the cartridge base; wherein the cartridge base, the plurality of components, and the connector each have a height / thickness dimension subject to a specified manufacturing tolerance; and wherein the spring pad compensates for variations in the height / thickness dimensions within the specified manufacturing tolerances by having a compressible height / thickness such that a liquid flow path formed within the sensor cartridge conforms to prespecified flow path dimensions.

[0091] The illustrative sensor cartridge of any one of the proceeding illustrative embodiments, wherein the spring pad is overmolded over the cartridge base.

[0092] The illustrative sensor cartridge of any one of the proceeding illustrative embodiments, wherein: the overmolded gasket comprises a thermoplastic elastomer; the fluid reservoir extension member comprises a thermoplastic polymer; and the spring pad comprises a thermoplastic elastomer or a thermoset polymer.

Claims

CLAIMS What is claimed is:

1. A method of assembling a sensor cartridge for use in a biological sample analyzer, the method comprising: providing a cartridge base; positioning a plurality of components over the cartridge base, the plurality of components including a fluid reservoir extension member having an overmolded gasket that forms at least a portion of a liquid flow path for transporting a biological sample within the sensor cartridge; positioning a connector over at least a portion of the plurality of components; and attaching the connector to the cartridge base.

2. The method of claim 1, wherein the overmolded gasket comprises a thermoplastic elastomer.

3. The method of claim 2, wherein the overmolded gasket comprises a styrene-based thermoplastic elastomer, a polyurethane-based thermoplastic elastomer, a thermoplastic vulcanizate, or a polyamide-based thermoplastic elastomer.

4. The method of claim 2, wherein the fluid reservoir extension member comprises a thermoplastic polymer.

5. The method of claim 4, wherein the fluid reservoir extension member comprises acrylonitrile butadiene styrene.

6. The method of claim 1, further comprising positioning a spring pad over the cartridge base and wherein: the cartridge base, the plurality of components, and the connector each have a height / thickness dimension subject to a specified manufacturing tolerance; andthe spring pad compensates for variations in the height / thickness dimensions within the specified manufacturing tolerances by having a compressible height / thickness such that a liquid flow path formed within the sensor cartridge conforms to prespecified flow path dimensions upon the attaching.

7. The method of claim 6, wherein positioning the spring pad over the cartridge base comprises overmolding the spring pad on the cartridge base.

8. The method of claim 6, wherein the spring pad compensates for variations in the height / thickness dimensions within the specified manufacturing tolerances such that the liquid flow path has air-tight or liquid-tight seals.

9. The method of claim 6, wherein positioning the plurality of components over the cartridge base comprises: positioning a reservoir sub-assembly over and onto the spring pad and the cartridge base, the reservoir sub-assembly having a fluid reservoir and the fluid reservoir extension member with the overmolded gasket adjacent the fluid reservoir; and positioning a sensor circuit board on top of the overmolded gasket.

10. The method of claim 9, wherein the overmolded gasket and the fluid reservoir extension member each have corresponding features that form at least a portion of the liquid flow path.

11. A method comprising: forming a fluid reservoir extension member for use in a sensor cartridge of a biological sample analyzer; and overmolding a gasket on the fluid reservoir extension member, the fluid reservoir extension member and gasketforming at least a portion of a liquid flow path for transporting a biological sample within the sensor cartridge.

12. The method of claim 11, wherein the gasket comprises a thermoplastic elastomer.

13. The method of claim 12, wherein the gasket comprises a styrene-based thermoplastic elastomer, a polyurethane-based thermoplastic elastomer, a thermoplastic vulcanizate, or a polyamide-based thermoplastic elastomer.

14. The method of claim 12, wherein the fluid reservoir extension member comprises a thermoplastic polymer.

15. The method of claim 11, further comprising: molding a cartridge base for the sensor cartridge; and overmolding a spring pad over the cartridge base, the spring pad configured to compensate for variations in height / thickness dimensions within specified manufacturing tolerances of components of the sensor cartridge by having a compressible height / thickness such that a liquid flow path formed within the sensor cartridge conforms to prespecified flow path dimensions upon assembly of the sensor cartridge.

16. The method of claim 15, wherein the spring pad comprises a thermoplastic elastomer or a thermoset polymer.

17. A sensor cartridge for use in a biological sample analyzer, the sensor cartridge comprising: a cartridge base; a plurality of components positioned over the cartridge base, the plurality of components including a fluid reservoir extension member having an overmolded gasket, wherein the fluid reservoir extension member and overmolded gasket form ata least a portion of a liquid flow path for transporting a biological sample within the sensor cartridge; and a connector positioned over at least a portion of the plurality of components and attached to the cartridge base.

18. The sensor cartridge of claim 17, further comprising: a spring pad over the cartridge base; wherein the cartridge base, the plurality of components, and the connector each have a height / thickness dimension subject to a specified manufacturing tolerance; and wherein the spring pad compensates for variations in the height / thickness dimensions within the specified manufacturing tolerances by having a compressible height / thickness such that a liquid flow path formed within the sensor cartridge conforms to prespecified flow path dimensions.

19. The sensor cartridge of claim 18, wherein the spring pad is overmolded over the cartridge base.

20. The sensor cartridge of claim 18, wherein: the overmolded gasket comprises a thermoplastic elastomer; the fluid reservoir extension member comprises a thermoplastic polymer; and the spring pad comprises a thermoplastic elastomer or a thermoset polymer.

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