Gaskets for sensor assemblies in biological sample analyzers

Abstract

In some embodiments, a gasket for a sensor assembly of a biological sample analyzer is provided. The gasket includes a first surface and a second surface, the second surface opposite the first surface; an inlet configured to receive a sample; an outlet configured to dispense the sample; and a first opening in fluidic communication with the inlet and bounded by a ridge extending beyond the first surface, the first opening configured to deliver the sample received at the inlet to at least a portion of a first sensor array of a sensor assembly. Numerous other embodiments are provided.

Description

GASKETS FOR SENSOR ASSEMBLIES IN BIOLOGICAL SAMPLE ANALYZERS

[0001] This application claims benefit under 35 USC § 119(e) of U.S. Provisional Application No. 63 / 670,431, 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 gaskets for use in sensor assemblies in biological sample analyzers. BACKGROUND

[0003] Biological sample analyzers are designed to use a small volume of a biological sample for testing purposes. To achieve this, the analyzers transport biological samples from a sampling device to sensors and ultimately to a waste container. The biological samples are placed in contact with sensors to perform certain tests. The sensors and other testing devices are located in sensor assemblies that may be removable from the biological sample analyzers.

[0004] In conventional sensor assemblies, housings in the sensor assemblies have channels, holes, and the like that transport the biological samples to specific areas for testing. These housings are costly to manufacture. Therefore, a need exists for a sensor assembly that has minimal channels, holes, and the like formed in the housing to transport biological samples.SUMMARY

[0005] According to a first aspect, a gasket for a sensor assembly of a biological sample analyzer is provided. The gasket includes a first surface and a second surface, the second surface opposite the first surface; an inlet configured to receive a sample; an outlet configured to dispense the sample; and a first opening in fluidic communication with the inlet and bounded by a ridge extending beyond the first surface, the first opening configured to deliver the sample received at the inlet to at least a portion of a first sensor array of a sensor assembly.

[0006] In another aspect, a gasket for a sensor assembly of a biological sample analyzer is provided. The gasket includes a first surface and a second surface, the second surface opposite the first surface; an inlet configured to receive a sample; an outlet configured to dispense the sample; a first opening bounded by a first ridge extending beyond the first surface, the first opening configured to be adjacent at least a portion of a first sensor array of a sensor assembly, the first opening in fluidic communication with the inlet; a second opening bounded by a second ridge extending beyond the first surface, the second opening configured to be adjacent at least a portion of a second sensor array of the sensor assembly, the second opening in fluidic communication with the outlet; and a first channel fluidically coupling the first opening to the second opening.

[0007] In a further aspect, a gasket is provided. The gasket includes a first surface and a second surface opposite the first surface, wherein the first surface is configured to be located adjacent a surface of a sensor assembly of a biological sample analyzer; an inlet formed in the second surface and configured to receive a sample; an outlet formed in the second surface and configured to dispense the sample; a first opening bounded by a first ridge extending beyond thefirst surface, the first opening configured to be adjacent at least a portion of a first sensor array of the sensor assembly, the first opening being in fluidic communication with the inlet; a second opening bounded by a second ridge extending beyond the first surface, the second opening configured to be adjacent at least a portion of a second sensor array of the sensor assembly, the second opening in fluidic communication with the outlet; a first channel fluidically coupling the first opening to the second opening; and a third opening configured to be in fluidic communication with a membrane of the sensor assembly, the third opening in fluidic communication with the second opening and the outlet.

[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 hasengaged the biological sample analyzer according to one or more embodiments.

[0012] FIG. 2A illustrates a perspective view of a sensor assembly having two sensor arrays used in biological sample analyzers according to one or more embodiments.

[0013] FIG. 2B illustrates the sensor assembly of FIG. 2A with a cover removed to expose a reference fluid according to one or more embodiments.

[0014] FIG. 2C illustrates a side elevation view of the sensor assembly of FIG. 2B according to one or more embodiments.

[0015] FIG. 2D illustrates a top plan view of the sensor assembly of FIG. 2B showing channels of a gasket relative to sensor arrays and other components of the sensor assembly according to one or more embodiments.

[0016] FIG. 3 illustrates sensor arrays used in the sensor assembly of FIG. 2A according to one or more embodiments.

[0017] FIG. 4 illustrates a schematic diagram showing an example of a fluid path in the gasket of FIG. 2D according to one or more embodiments.

[0018] FIG. 5A illustrates a top perspective view of an embodiment of the gasket of FIG. 2D showing a biological sample located within openings of the gasket according to one or more embodiments.

[0019] FIG. 5B illustrates a side elevation view of the gasket of FIG. 5A showing portions of the gasket extending beyond a first surface of the gasket and features extending from a second surface of the gasket according to one or more embodiments.

[0020] FIG. 5C illustrates a front perspective cross-sectioned view of the gasket of FIG. 5A taken along line 5C-5C in FIG. 5A according to one or more embodiments.

[0021] FIG. 5D illustrates a top plan view of the gasket of FIG. 5A according to one or more embodiments.

[0022] FIG. 5E illustrates a top perspective view of an embodiment of the gasket of FIG. 5A showing sensor arrays contacting first and second openings of the gasket according to one or more embodiments. DETAILED DESCRIPTION

[0023] Independent of the grammatical term usage, individuals with male, female or other gender identities are included within the term.

[0024] Biological sample analyzers use replaceable sensor assemblies to perform tests on biological samples. The sensor assemblies may include a reference fluid that comes into fluidic communication with a first side of a membrane. A second and opposite side of the membrane is capable or configured to be in fluidic communication with biological samples. Sensor arrays within sensor assemblies are placed so they are in fluid contact with the biological samples. Testing includes measuring various signal responses through the biological samples between the reference fluid and the sensor arrays.

[0025] Conventional sensor assemblies include a housing having a plurality of holes, channels, and openings that transport the biological samples through the sensor assemblies. A flat or slab gasket seals the holes and openings relative to a base plate or the like. Fabricating the holes and openings is expensive and time consuming and complicates construction and alignment of components. Unlike conventional sensor assemblies, the sensor assemblies described herein include a feature rich gasket that minimizes the number of holes and openings required in the sensor assembly housing and reduces part count.

[0026] The inventive concepts disclosed and / or claimed herein generally relate to sensor assemblies for biological sampleanalyzers that include a feature rich gasket rather than a flat or slab gasket. The sensor assemblies may include a reference fluid container containing a reference fluid, one or more sensors, a membrane capable or configured to be in fluidic communication with the reference fluid container and biological samples, and a gasket (e.g., a feature rich gasket) having at least one opening configured to expose at least one sensor array to a biological sample.

[0027] As stated, the gasket may be a feature rich gasket, such as a three-dimensional gasket, having at least one opening configured to expose the samples to at least one sensor array. The gasket may include at least one channel configured to transfer the samples to various locations in the sensor assembly.

[0028] The gasket may include a first surface and an opposite second surface. An inlet in the gasket may be configured to receive a biological sample and an outlet in the gasket may be configured to dispense the biological sample from the gasket. The gasket may include one or more openings configured to allow the biological sample to contact at least a portion of one or more sensor arrays. A first opening may be bounded by a first ridge extending beyond the first surface, wherein the first opening may be configured to receive a sample and provide the sample access to (e.g., allow a fluid sample to contact) at least a portion of a first sensor array. For example, a sample located in the first opening may be exposed to the first sensor array in order to perform testing on the sample.

[0029] In some embodiments, the gasket may include a second opening that may be bounded by a second ridge extending beyond the first surface. The second opening may be configured to receive a sample and provide the sample access to (e.g., allow a fluid sample to contact) at least a portion of a second sensor array. The second opening may expose the sample to thesecond sensor array that is used to perform tests on the sample. The first opening and / or the second opening may be configured to be in fluidic communication with a first side of a membrane of a sensor assembly. A second opposite side of the membrane may be configured to be in fluidic communication with the reference fluid. The second opening may be in fluidic communication with the outlet. A channel may fluidically couple the first opening to the second opening.

[0030] The feature rich gasket transfers liquids, including samples, between components of a sensor assembly using a minimal number of holes and channels formed in the housing and a reduced number of components. While described primarily with regard to biological samples, it will be understood that the gasket configurations provided herein may be employed with other samples such as reagents, salt solutions, or the like. The use of the feature rich gasket simplifies manufacturing of sensor assemblies and, thus, reduces costs of the sensor assemblies. These and other gaskets, sensor assemblies, biological sample analyzers, and methods are described with reference to FIGS. 1A-5D.

[0031] 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 located therein. The sensor assembly 104 may receive biological samples, such as blood samples, and may facilitate testing of the biological samples for chemicals or other properties as described herein. 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 been engaged in the analyzer 100 as described herein.

[0032] The samples introduced into the analyzer 100 may comprise biological materials taken from a subject, such as, for example, bodily fluids. Bodily fluids may include but are not limited to urine, whole blood, blood serum, blood plasma,saliva, cerebrospinal fluid, pleural fluid, dialysate fluid, nasopharyngeal fluid, vaginal fluid, tears, 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, a sample 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, for example. A whole blood sample may comprise red blood cells, platelets and the like.

[0033] 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. The sensor assembly 104 may be receivable in the enclosure 106. In addition, the enclosure 106 may include or receive a tray 108 positioned in an opening 109 and a reagent assembly 114 positioned within the opening 109. 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.

[0034] The analyzer 100 may be in the open state (FIG. 1A) when the sensor assembly 104 is removed from the analyzer 100 or when the sensor assembly is not engaged in the analyzer 100 (e.g., when the tray 108 is opened as shown in FIG. 1A). The analyzer 100 may be in the closed state (FIG. 1B) when the sensor assembly 104 is engaged in the analyzer 100 (e.g., when the tray 108 is closed as shown in FIG. 1B). For example, the sensor assembly 104 may be electrically connected with the analyzer 100 or a reference fluid (e.g., reference fluid 206 - FIG. 2B) in the sensor assembly 104 may be released to perform testing on samples.

[0035] The reagent assembly 114 may be received into the analyzer 100 via the opening 109. The reagent assembly 114holds a plurality of reagent fluids used to analyze samples. The reagents may be provided in reservoirs, such as sealed bags or bottles (not shown). 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.

[0036] Additional reference is made to FIGS. 2A and 2B, which illustrate embodiments of the sensor assembly 104 provided herein. 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 230 including a first sensor array 232 and a second sensor array 234 described below), which are used to contact a biological sample that is to be analyzed using the sensor assembly 104. In some embodiments, 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 sample to the sensor assembly 104, the analyzer 100 may introduce the fluids from the reagent assembly 114 to a sample in preparation for analysis of the sample.

[0037] 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 (both organic 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.

[0038] The cover 200 may support a reference electrode 209 such that the reference electrode 209 extends into the reference fluid container 202 and / or the reference fluid 206. The reference electrode 209 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 209. The reference fluid 206 may be an electrolyte solution, such as a potassium chloride solution or some equivalent formulation.

[0039] The housing 208 may include sensor arrays 230 that may be used to analyze biological samples. The sensor arrays 230 may include electrical contacts 210 that may electrically couple the sensor arrays 230 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 sensors (e.g., sensor arrays 230) may be positioned near a lower surface 212 of the housing 218 and the electrical contacts 210may be located in a sensor containment space 229 formed in the housing 208.

[0040] The sensor assembly 104 includes a gasket 220 that may be, in some embodiments, a feature rich gasket. Feature rich gaskets may be three dimensional gaskets that may include ports, ridges, seals, channels, and other features that are configured to transport liquids to components of the sensor assembly 104. In some embodiments, the gasket 220 may be made from a thermoplastic elastomer material. Other gasket materials may be used. Gasket features may extend in three dimensions as described herein. The gasket 220 may include a first surface 222 (e.g., an upper surface) and an opposite second surface 224 (e.g., a lower surface). The first surface 222 of the gasket 220 may be located adjacent the lower surface 212 of the housing 208 and at least a portion of the first surface 222 of the gasket 220 may seal against at least a portion of the lower surface 212 of the housing 208 of the sensor assembly 104.

[0041] In some embodiments, the sensor assembly 104 may include a base 226 located adjacent the gasket 220. The base 226 may have an upper surface 227 and a lower surface 228, wherein the gasket 220 may be located between the upper surface 227 of the base 226 and the lower surface 212 of the housing 208. The base 226 may be affixed to the lower surface 212 of the housing 208 by connectors or the like (not shown). The connectors may apply a force between the gasket 220 and the lower surface 212 of the housing 208 to cause at least one portion of the gasket 220 to seal against at least a portion of the lower surface 212 of the housing 208. In other embodiments, the sensor assembly 104 may not include the base 226. For example, the sensor assembly 104 may be located on an object proximate the second surface 224 of the gasket 220 that forces the gasket 220 against the lower surface 212 of the housing 208. In other embodiments, the gasket 220 may includeone or more rigid portions (not shown) that force one or more less rigid portions of the gasket 220 to seal against the lower surface 212 of the housing 208. For example, rigid portions of the second surface 224 of the gasket 220 may force the first surface 222 of the gasket 220 against the lower surface 212 of the housing 208.

[0042] As stated, the sensor assembly 104 may include the sensor containment space 229 configured to contain at least one or more sensor arrays 230. The sensor containment space 229 may be configured to receive one or more electrical connectors (not shown) that electrically connect to the sensor arrays 230. In the embodiments illustrated herein, the sensor assembly 104 may include a first sensor array 232 and a second sensor array 234. In other embodiments, the sensor assembly 104 may include a single sensor array or more than two sensor arrays.

[0043] Additional reference is made to FIG. 3, which illustrates a perspective view of the sensor arrays 230 that may be located in the sensor containment space 229 of the sensor assembly 104 (FIGS. 2A, 2B, and 2D). The sensor arrays 230 are referred to individually as the first sensor array 232 and the second sensor array 234. In some embodiments, the first sensor array 232 may be a potentiometric sensor and the second sensor array 234 may be an amperometric sensor. Other types of sensors may be employed. Each of the sensor arrays 230 may have a top side 304 and an opposite bottom side 306. The electrical contacts 210 may be located on the top side 304. The biological sample may contact the bottom side 306. Contacts (not shown) configured to contact the biological samples may be located on the bottom side 306 of the sensor arrays 230. For example, the gasket 220 may have channels and openings (shown as dashed lines in FIG. 2D) configured to transport the biological samples to at least portions of the bottom sides 306 of the sensor arrays 230.

[0044] With additional reference to FIG. 2D, which is a top plan view of the housing 208, portions of the gasket 220 proximate the sensor arrays 230 may include openings, shown as dashed openings 248 and 252, that transport liquid (e.g., a biological sample) to the sensor arrays 230 as described further below. The gasket 220 may include features such as channels, openings, etc., that transport liquids throughout the sensor assembly 104. Some of these features are shown as dashed lines in FIG. 2D. For example, the gasket 220 may have an inlet 238 configured to receive samples and an outlet 240 configured to discharge samples. The gasket 220 may include a channel 246 coupling the inlet 238 to the first opening 248. The first opening 248 may expose a sample to at least a portion of the bottom side 306 (FIG. 3) of the first sensor array 232. In some embodiments, the inlet 238 may be directly coupled to the first opening 248 and the gasket 220 may not include the channel 246. In the embodiment of FIG. 2D, at least a portion of the first sensor array 232 may be located adjacent the first opening 248. The exposure of the first sensor array 232 to the first opening 248 enables samples to contact the first sensor array 232. Thus, the first sensor array 232 is able to perform tests on the samples.

[0045] A channel 250 may couple the first opening 248 and the second opening 252 together. The second opening 252 may expose a sample to at least a portion of the bottom side 306 (FIG. 3) of the second sensor array 234 (e.g., at least a portion of the second sensor array 234 may be located adjacent the second opening 252). The exposure of the second sensor array 234 to a sample enables the sample to contact the second sensor array 234. Thus, the second sensor array 234 is able to perform tests on samples.

[0046] A channel 256 formed in the gasket 220 may fluidically couple the second opening 252 to a membrane 258. As described herein, the membrane 258 may be in fluidic communication withthe reference fluid 206 (FIG. 2B). A channel 260 may fluidically couple the membrane 258 to the outlet 240. In some embodiments, the membrane 258 may be external to the gasket 220. As the sample is transported through the sensor assembly 104, the membrane 258 may be exposed to the sample by way of an opening 261.

[0047] Additional reference is made to FIG. 4, which illustrates a schematic diagram of channels in the gasket 220. The gasket 220 may include channels other than the channels shown in FIG. 4. As shown, the inlet 238 may be coupled to the first opening 248 of gasket 220 by way of a channel 246. The first opening 248 may be wider than the channel 246 to enable samples to contact at least a portion of the bottom side 306 of the first sensor array 232. The first opening 248 may be coupled to the second opening 252 via the channel 250. The second opening 252 may be wider than the channel 246 and other channels so that samples may contact at least a portion of the bottom side 306 of the second sensor array 234. The channel 256 may be configured to couple to a first side of the membrane 258. The second (opposite) side of the membrane 258 may be in fluid communication with the reference fluid 206 (FIGS. 2B and 4) by way of a wicking member 400.

[0048] In operation, samples enter the inlet 238 and pass to the first opening 248 and the second opening 252, respectively, contacting the bottom sides 306 of the first sensor array 232 and the second sensor array 234. The samples may then contact the membrane 258 where the samples may be influenced by the reference fluid 206. The sensor arrays 232, 234 may then test the samples with the use of other devices (not shown). The tests may include signal responses between the sensor arrays 232, 234 and the reference electrode 209 (FIG. 2A).

[0049] Additional reference is made to FIGS. 5A-5C, which illustrate different views of the gasket 220 in accordancewith embodiments provided herein. FIG. 5A illustrates a top perspective view of an embodiment of the gasket 220 with a sample 500 located within openings and channels of the gasket 220. FIG. 5B illustrates a side elevation view of the gasket 220 showing portions of the gasket 220 extending from the first surface 222 and the second surface 224. FIG. 5C illustrates a perspective cross-sectioned view of the gasket 220 taken along line 5C-5C in FIG. 5A.

[0050] The first opening 248 may be bounded by a first ridge 504 that extends beyond the first surface 222. A top of the first ridge 504 may include a first sealing surface 506 that is configured to contact the bottom surface 306 (FIGS. 3, 4, and 5E) of the first sensor array 232 (FIG. 2D) to prevent the sample 500 from leaking from the gasket 220 when the gasket 220 contacts the bottom surface 306 (FIGS. 3, 4, and 5E) of the first sensor array 232. The second opening 252 also may be bounded by a second ridge 510 that extends beyond the first surface 222. A top of the second ridge 510 may include a second sealing surface 512 that is configured to contact the bottom surface 306 (FIGS. 3, 4, and 5E) of the second sensor array 234 (FIG. 2D) of the sensor assembly 104 to prevent the sample 500 from leaking from the gasket 220 when the gasket 220 contacts the bottom surface 306 (FIGS. 3, 4, and 5E) of the second sensor array 234. In some embodiments, the first sealing surface 506 and / or the second sealing surface 512 may include an adhesive configured to adhere the first sealing surface 506 and / or the second sealing surface 512 to the bottom surfaces 306 of sensor arrays 232, 234, respectively. The inlet 238 and the outlet 240 both may extend beyond or from the second surface 224 of the gasket 220 and may be configured to couple to items that transport the sample 500.

[0051] As shown in FIG. 5B, the first opening 248 (via the ridge 504) may extend beyond the first surface 222 by a height H51, which may be about 0.75 to 1.25 mm. The channel 256and / or other channels may extend beyond the first surface 222 by a height H52, which may be about 0.7 to 1.1 mm. The gasket 220 may have a thickness T51 of about 1.1 to 1.9 mm between the first surface 222 and the second surface 224. Other heights H51, heights H52, and / or gasket thicknesses T51 may be employed.

[0052] Additional reference is made to FIG. 5D which illustrates a top plan view of an embodiment of the gasket 220. In some embodiments, at least a portion of the first ridge 504, the second ridge 510, and / or other features extending beyond the first surface 222 may be surrounded by troughs. As shown in FIGS. 5A, 5C, and 5D, the first ridge 504 may be surrounded by a first trough 530 and the second ridge 510 may be surrounded by a second trough 532. The troughs 530, 532 may extend into the first surface 222 of the gasket 220. The troughs 530, 532 may enhance the flexibility of the first ridge 504 and the second ridge 510 relative to the first surface 222. Example dimensions for the troughs 530, 532 range from about 0.5 mm to 1.0 mm in width and about 0.5 mm to 1.0 mm in depth. Other dimensions may be employed for the troughs 530, 532. In some embodiments, the troughs 530, 532 may be eliminated. For example, compression of the gasket 220 may be adjusted through changes in wall cross section (e.g., changes in the thickness of ridges 504, 510).

[0053] The dimensions described herein are example dimensions and may be based on test data and / or numerical modeling. These example gasket dimensions have been found to allow the gasket 220 to compress without movement or obstruction of flow paths.

[0054] As shown in FIG. 5D, the gasket 220 may have a length L51 and a width W51. In some embodiments, the length L51 may be between about 40 mm and 54 mm. In other embodiments, the length L51 may be between about 45 mm and 49 mm. In yet other embodiments, the length L51 may be between about 47.0 mm and 48.0 mm. In some embodiments, the width W51 may be betweenabout 10 mm and 30 mm. In other embodiments, the width W51 may be about 20 mm. Other lengths L51 and / or widths W51 may be employed.

[0055] The first sealing surface 506 and the second sealing surface 512 may be wide enough to provide integrity to the first ridge 504 and the second ridge 510 to seal the first opening 248 and the second opening 252 to the bottom surfaces 306 of the sensor arrays 232, 234, respectively, of the sensor assembly 104. For example, FIG. 5E illustrates a top perspective view of an embodiment of the gasket 220 of FIG. 5A showing bottom surface 306 of sensor arrays 232, 234 (in phantom) contacting first and second openings 248, 252, respectively, according to one or more embodiments. Membrane 258 (in phantom) is also shown contacting opening 261 of gasket 220. The dimensions of the first ridge 504 and the second ridge 510 may depend on the properties of the gasket material used and the pressures applied by the biological sample 500. In some embodiments, the first sealing surface 506 and the second sealing surface 512 may have a width W52 that may vary throughout the circumference of the first opening 248 and the second opening 252. In some embodiments, the width W52 may be or have an average of between about 0.24 mm and 0.44 mm. In other embodiments, the width W52 may be or have an average of about 0.36 mm. Other widths W52 may be employed.

[0056] The first opening 248 and the second opening 252 may have dimensions that enable the sample 500 to contact at least portions of the sensor arrays 232, 234 (FIG. 2B) as described herein. As shown in FIG. 5D, the ends of the first opening 248 and the second opening 252 may be tapered to direct the sample 500 to appropriate areas. For example, the second opening 252 may have a first end 520 and a second end 522. The first end 520 may be located proximate the channel 250 and may receive the sample 500 from the first opening 248. The taper of the first end 520 may disperse the sample 500 evenly on at least aportion of the second sensor array 234 (FIG. 2B). In some embodiments, the second end 522 may also be tapered and may direct the sample 500 to the channel 256. The first end 520 and / or the second end 522 may be curved to accommodate physical structures of the sensor assembly 104 or to better direct the sample 500.

[0057] Parallel portions 526 of the first opening 248 and the second opening 252 may be configured to be below at least portions of the sensor arrays 230 (FIG. 2B) when used with the sensor assembly 104. The parallel portions 526 may each have a constant width or a substantially constant width W53. In some embodiments, the width W53 of each opening may be an average width. The width W53 of each opening may be dependent on the widths of the sensor arrays 230 and other factors. In some embodiments, the width W53 of each opening may be between about 1.0 cm and 2.0 cm. In other embodiments, the width W53 may be about 1.54 cm. Other widths may be employed.

[0058] The lengths L52 of the first opening 248 and the second opening 252 may be the same or substantially the same. The length L52 of each opening, in some embodiments, may be between 2.0 cm and 4.0 cm. In other embodiments, the length of each opening may be about 3.0 cm. The length L52 of each opening may be long enough to enable the sample 500 to contact the sensor arrays 230 using a minimal amount of the biological sample 500. Other lengths for the first and / or second opening 248, 252 may be employed.

[0059] Some of the channels used to transport liquids via the gasket 220 may include two or more conduits. For example, the channel 256 (FIG. 5D) may include at least a first conduit 536 and a second conduit 538. The use of multiple conduits enables a larger volume of liquid to be transferred while maintaining a low profile or thickness T51 (FIG. 5B) of the gasket 220. The channel 250 (FIG. 5D) may also include a plurality of conduits.

[0060] In the embodiment of FIG. 5D, the inlet 238 may be fluidically coupled directly to the first opening 248, so no channel is needed between the inlet 238 and the first opening 248. In a similar manner, the outlet may be in direct fluid communication with the opening 261, so no channel is needed between the opening 261 and the outlet 240.

[0061] 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 inventive concept(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.

[0062] 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 and / or ions flow therebetween. NON-LIMITING ILLUSTRATIVE EMBODIMENTS

[0063] The following is a list of non-limiting embodiments of the inventive concepts disclosed herein:

[0064] An illustrative gasket for a sensor assembly of a biological sample analyzer, the gasket comprising: a first surface and a second surface, the second surface opposite the first surface; an inlet configured to receive a sample; anoutlet configured to dispense the sample; and a first opening in fluidic communication with the inlet and bounded by a ridge extending beyond the first surface, the first opening configured to deliver the sample received at the inlet to at least a portion of a first sensor array of a sensor assembly.

[0065] The illustrative gasket of any one of the preceding illustrative embodiments, further comprising: a second opening; and a first channel fluidically coupling the first opening to the second opening; wherein the second opening is configured to deliver the sample to at least a portion of a second sensor array, the second opening in fluidic communication with the outlet.

[0066] The illustrative gasket of any one of the preceding illustrative embodiments, wherein the inlet extends beyond the second surface.

[0067] The illustrative gasket of any one of the preceding illustrative embodiments, wherein the outlet extends beyond the second surface.

[0068] The illustrative gasket of any one of the preceding illustrative embodiments, wherein the first surface is configured to be adjacent a surface of a sensor assembly of a biological sample analyzer.

[0069] The illustrative gasket of any one of the preceding illustrative embodiments, wherein the ridge is configured to form a seal between the first opening and the surface of the sensor assembly.

[0070] The illustrative gasket of any one of the preceding illustrative embodiments, wherein the gasket is molded from a thermoplastic elastomer.

[0071] The illustrative gasket of any one of the preceding illustrative embodiments, wherein the first opening is elongated and has a parallel portion with a width between 1.0 mm and 2.0 mm.

[0072] The illustrative gasket of any one of the preceding illustrative embodiments, wherein the ridge has a width of between 0.32 mm and 0.40 mm.

[0073] An illustrative gasket for a sensor assembly of a biological sample analyzer, the gasket comprising: a first surface and a second surface, the second surface opposite the first surface; an inlet configured to receive a sample; an outlet configured to dispense the sample; a first opening bounded by a first ridge extending beyond the first surface, the first opening configured to be adjacent at least a portion of a first sensor array of a sensor assembly, the first opening in fluidic communication with the inlet; a second opening bounded by a second ridge extending beyond the first surface, the second opening configured to be adjacent at least a portion of a second sensor array of the sensor assembly, the second opening in fluidic communication with the outlet; and a first channel fluidically coupling the first opening to the second opening.

[0074] The illustrative gasket of any one of the preceding illustrative embodiments, further comprising a third opening configured to be in fluidic communication with a membrane of a sensor assembly, the third opening in fluidic communication with the second opening and the outlet.

[0075] The illustrative gasket of any one of the preceding illustrative embodiments, wherein at least one of the inlet and the outlet extends beyond the second surface.

[0076] The illustrative gasket of any one of the preceding illustrative embodiments, wherein the first surface is configured to be located adjacent a surface of a sensor assembly of a biological sample analyzer.

[0077] The illustrative gasket of any one of the preceding illustrative embodiments, wherein: the first ridge is configured to form a seal between the first opening and the first sensor array of the sensor assembly; and the secondridge is configured to form a seal between the second opening and the second sensor array of the sensor assembly.

[0078] The illustrative gasket of any one of the preceding illustrative embodiments, wherein at least one of the first opening and the second opening is elongated and has a parallel portion with a width between 1.0 mm and 2.0 mm.

[0079] The illustrative gasket of any one of the preceding illustrative embodiments, wherein at least one of the first and the second ridge has a width of between 0.32 mm and 0.40 mm.

[0080] An illustrative gasket comprising: a first surface and a second surface opposite the first surface, wherein the first surface is configured to be located adjacent a surface of a sensor assembly of a biological sample analyzer; an inlet formed in the second surface and configured to receive a sample; an outlet formed in the second surface and configured to dispense the sample; a first opening bounded by a first ridge extending beyond the first surface, the first opening configured to be adjacent at least a portion of a first sensor array of the sensor assembly, the first opening being in fluidic communication with the inlet; a second opening bounded by a second ridge extending beyond the first surface, the second opening configured to be adjacent at least a portion of a second sensor array of the sensor assembly, the second opening in fluidic communication with the outlet; a first channel fluidically coupling the first opening to the second opening; and a third opening configured to be in fluidic communication with a membrane of the sensor assembly, the third opening in fluidic communication with the second opening and the outlet.

[0081] The illustrative gasket of any one of the preceding illustrative embodiments, wherein at least one of the inlet and the outlet extends beyond the second surface.

[0082] The illustrative gasket of any one of the preceding illustrative embodiments, wherein the first ridge is configured to form a seal between the first opening and the first sensor array of the sensor assembly and the second ridge is configured to form a seal between the second opening and the second sensor array of the sensor assembly.

[0083] The illustrative gasket of any one of the preceding illustrative embodiments, wherein the gasket is molded from a thermoplastic elastomer.

[0084] 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.

Claims

WHAT IS CLAIMED IS:

1. A gasket for a sensor assembly of a biological sample analyzer, the gasket comprising: a first surface and a second surface, the second surface opposite the first surface; an inlet configured to receive a sample; an outlet configured to dispense the sample; and a first opening in fluidic communication with the inlet and bounded by a ridge extending beyond the first surface, the first opening configured to deliver the sample received at the inlet to at least a portion of a first sensor array of a sensor assembly.

2. The gasket of claim 1, further comprising: a second opening; and a first channel fluidically coupling the first opening to the second opening; wherein the second opening is configured to deliver the sample to at least a portion of a second sensor array, the second opening in fluidic communication with the outlet.

3. The gasket of claim 1, wherein the inlet extends beyond the second surface.

4. The gasket of claim 1, wherein the outlet extends beyond the second surface.

5. The gasket of claim 1, wherein the first surface is configured to be adjacent a surface of a sensor assembly of a biological sample analyzer.

6. The gasket of claim 5, wherein the ridge is configured to form a seal between the first opening and the surface of the sensor assembly.

7. The gasket of claim 1, wherein the gasket is molded from a thermoplastic elastomer.

8. The gasket of claim 1, wherein the first opening is elongated and has a parallel portion with a width between 1.0 mm and 2.0 mm.

9. The gasket of claim 1, wherein the ridge has a width of between 0.32 mm and 0.40 mm.

10. A gasket for a sensor assembly of a biological sample analyzer, the gasket comprising: a first surface and a second surface, the second surface opposite the first surface; an inlet configured to receive a sample; an outlet configured to dispense the sample; a first opening bounded by a first ridge extending beyond the first surface, the first opening configured to be adjacent at least a portion of a first sensor array of a sensor assembly, the first opening in fluidic communication with the inlet; a second opening bounded by a second ridge extending beyond the first surface, the second opening configured to be adjacent at least a portion of a second sensor array of the sensor assembly, the second opening in fluidic communication with the outlet; and a first channel fluidically coupling the first opening to the second opening.

11. The gasket of claim 10, further comprising a third opening configured to be in fluidic communication with a membrane of a sensor assembly, the third opening in fluidic communication with the second opening and the outlet.

12. The gasket of claim 10, wherein at least one of the inlet and the outlet extends beyond the second surface.

13. The gasket of claim 10, wherein the first surface is configured to be located adjacent a surface of a sensor assembly of a biological sample analyzer.

14. The gasket of claim 13, wherein: the first ridge is configured to form a seal between the first opening and the first sensor array of the sensor assembly; and the second ridge is configured to form a seal between the second opening and the second sensor array of the sensor assembly.

15. The gasket of claim 10, wherein at least one of the first opening and the second opening is elongated and has a parallel portion with a width between 1.0 mm and 2.0 mm.

16. The gasket of claim 10, wherein at least one of the first and the second ridge has a width of between 0.32 mm and 0.40 mm.

17. A gasket comprising: a first surface and a second surface opposite the first surface, wherein the first surface is configured to be located adjacent a surface of a sensor assembly of a biological sample analyzer;an inlet formed in the second surface and configured to receive a sample; an outlet formed in the second surface and configured to dispense the sample; a first opening bounded by a first ridge extending beyond the first surface, the first opening configured to be adjacent at least a portion of a first sensor array of the sensor assembly, the first opening being in fluidic communication with the inlet; a second opening bounded by a second ridge extending beyond the first surface, the second opening configured to be adjacent at least a portion of a second sensor array of the sensor assembly, the second opening in fluidic communication with the outlet; a first channel fluidically coupling the first opening to the second opening; and a third opening configured to be in fluidic communication with a membrane of the sensor assembly, the third opening in fluidic communication with the second opening and the outlet.

18. The gasket of claim 17, wherein at least one of the inlet and the outlet extends beyond the second surface.

19. The gasket of claim 17, wherein the first ridge is configured to form a seal between the first opening and the first sensor array of the sensor assembly and the second ridge is configured to form a seal between the second opening and the second sensor array of the sensor assembly.

20. The gasket of claim 17, wherein the gasket is molded from a thermoplastic elastomer.

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