Cutting subassembly and conditioning assembly for environment

Abstract

The invention relates to improvement of an environment for microbiological testing. Exemplary embodiments provide a uniquely configured tray containing an environmental conditioning material, such as a deoxidant material, for use with a cartridge assembly. Further, some embodiments provide a cutting mechanism that allows the tray to be reliably destroyed, thereby exposing the material therein to the environment. Some embodiments may cut the material with specially configured cutter teeth, which may be easily deployed by twisting or pushing two portions of the cartridge assembly.

Description

[0001] Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 378,334, filed on October 4, 2022, the entire contents of which are incorporated herein by reference in their entirety. Background Art

[0003] Microbial contamination testing is usually performed in a sealed environment (such as a test box). The sample can be exposed to a growth matrix in the environment, and any microbial colonies in the sample can grow for a period of time. After a period of time, the colonies are identified and quantified.

[0004] Some microbiological tests are performed in an anaerobic (low or no oxygen) environment. In order to perform such tests, oxygen must usually be removed from the environment. This can be achieved by using oxygen scavenger materials.

[0005] Unfortunately, successfully deploying the purge material in an environment can be difficult. The purge material must be isolated from the air prior to deployment, but it must be exposed to the test environment after assembly (e.g., after the various parts of the box are placed together). The packaging used to isolate the purge material must be strong enough so that it does not accidentally expose the material to the air when being handled, but at the same time must be able to be easily and reliably opened in the sterile environment of the box. In addition, no matter which packaging is used, it needs to be filled with the purge material, again in a way that avoids exposing the purge material to the air as much as possible. Summary of the invention

[0006] In certain embodiments, the present application relates to the improvement of anaerobic (low oxygen or oxygen-free) environment for microbial testing and the use of test materials to regulate the environment. Exemplary embodiments may provide a tray of a unique configuration, which contains deoxidizer materials or other environmental conditioning materials for use with a cassette assembly. In addition, some embodiments provide a cutting mechanism that allows the tray to be reliably destroyed, thereby exposing the internal scavenging materials to the environment. Some embodiments can cut the material with a specially configured cutter tooth, which can be easily deployed by twisting or pushing the two parts of the cassette assembly.

[0007] In one aspect, a cutter for a cassette assembly includes a tray with a seal and a lid on the top. The cutter may include an annular planar surface with one or more openings and at least one flexible cutter tooth extending away from the axial top of the planar surface. The flexible cutter tooth may be configured to interact with the lid to bend the flexible cutter tooth. The size of the cutting tip on each of the at least one flexible cutter tooth may be designed so that when engaged with the lid, the cutting tip penetrates the seal on the tray.

[0008] The size of at least one cutter tooth can be further designed such that when not engaged with the lid, the cutting tip is disposed within one of the openings and does not extend beyond the axial bottom of the cutter.

[0009] At least one cutter tooth can be configured to dock with an inclined surface on the lid of the cartridge assembly to force the cutting tip into the seal.

[0010] The cutter can be a ring separate from the lid.

[0011] The sealing material can be foil.

[0012] One or more flexible cutter teeth can include a plurality of teeth arranged generally around the circumference of the cutter.

[0013] The cutter can be configured to penetrate the foil when a relative torsional movement occurs between the lid and the remainder of the cartridge assembly and / or when a relative pushing movement occurs between the lid and the remainder of the cartridge assembly.

[0014] The size and shape of the cutter can be designed to surround the internal test environment of the cartridge assembly.

[0015] The cutter can further include a toothless region configured to receive a tool.

[0016] An exemplary method can include assembling the above-described cutter to the cartridge assembly and positioning the lid onto the cartridge assembly to cause the cutting tip to penetrate the seal.

[0017] Positioning the lid can include pushing the lid over the remainder of the cartridge assembly.

[0018] The method can further include aligning one or more inclined surfaces on the lid with at least one flexible cutter tooth of the cutter.

[0019] The method can further include twisting the lid over the remainder of the cartridge assembly. Twisting the lid can cause one or more inclined surfaces on the lid to rotate into at least one flexible cutter tooth of the cutter.

[0020] The method can further include placing a tray in a recess in the cartridge assembly.

[0021] Assembling the cutter to the cartridge assembly can include placing the cutter on top of the tray.

[0022] Positioning the lid onto the cartridge assembly can create an airtight seal.

[0023] The method can further include deploying a tool on the toothless region of the cutter.

[0024] The method can further include aligning a protrusion on the axial bottom of the cutter with a cutout portion of the tray.

[0025] In one aspect, a tray assembly for a cassette component can be provided. The assembly can include a tray configured to receive an oxygen scavenger material. The size and shape of the tray can be designed to fit into a recess in a microbial test cassette. The assembly can further include a seal configured to create an airtight seal on one side of the tray, and one or more fill ports configured to receive the oxygen scavenger material.

[0026] The tray assembly can also include a shelf configured to be disposed inside the tray. A foam insert can be configured to sit on the molded shelf and prevent material from leaving the tray when the seal is penetrated.

[0027] The seal can be a foil or a breathable membrane. The seal can include an adhesive disposed around the edge of the seal. In some embodiments, the seal can be heat welded.

[0028] The tray can be configured to generally surround an internal test environment of the cassette component. For example, the tray assembly can be "C" shaped. One or more fill ports can include at least one fill port disposed at each end of the "C" shape.

[0029] The tray assembly can also include an airtight seal disposed over the one or more fill ports.

[0030] The tray assembly can also include an annular foil cutter configured to penetrate the seal.

[0031] Exemplary methods include providing the above-described tray assembly, filling the tray with material through one or more fill ports, and applying a seal to seal the tray.

[0032] The method can also include deploying a shelf inside the tray.

[0033] The method can also include deploying a foam insert on top of the shelf, the foam insert being configured to prevent material from leaving the tray when the seal is penetrated.

[0034] The method can also include disposing an adhesive around the edge of the seal. The seal can be sealed to the tray with the adhesive. In some embodiments, sealing the seal can include applying heat to activate a thermosensitive adhesive or heat welding a polymeric adhesive.

[0035] The tray can include multiple fill ports, and filling the tray can include adding an oxygen scavenger material to each of the fill ports. One or more of the fill ports can be sealed.

[0036] The method can also include deploying a cutter on top of the tray subassembly. The cutter can be pushed or twisted to cause the cutter to penetrate the seal.

[0037] Other technical features can be readily seen by those skilled in the art from the following drawings, description, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] To facilitate the identification of any discussion of a particular element or act, the most significant digit in the reference numeral refers to the figure number in which that element was first introduced.

[0039] Figure 1 An exemplary cassette assembly according to one embodiment is shown.

[0040] Figure 2 is a close-up of a portion of a cross-sectional view of a cassette assembly according to one embodiment.

[0041] Figure 3 is a close-up of a portion of a cross-sectional view of a cassette assembly according to one embodiment.

[0042] Figure 4 is a perspective view of a foil cutter 106 according to one embodiment.

[0043] Figure 5A is a top view of a foil cutter 106 according to one embodiment.

[0044] Figure 5B is according to one embodiment along Figure 5A A side view of the foil cutter 106 taken along line A-A in

[0045] Figure 5C is according to one embodiment along Figure 5A A side view of the foil cutter 106 taken along line B-B in

[0046] Figure 5D is a close-up of detail C (cutter teeth 402) according to one embodiment.

[0047] Figure 6 is a sectional side view showing the cutting action of the foil cutter 106 according to an exemplary embodiment.

[0048] Figure 7 is an exploded view of an exemplary tray assembly 700 according to one embodiment.

[0049] Figure 8 is a perspective view depicting the assembled tray assembly 700 from the top according to one embodiment.

[0050] Figure 9 is a perspective view depicting the assembled tray assembly 700 from the bottom according to one embodiment.

[0051] Figure 10 is a bottom view of the assembled tray assembly 700 according to one embodiment.

[0052] Figure 11 is a flowchart depicting an exemplary method for creating a limited oxygen environment in a cartridge assembly according to one embodiment.

[0053] Figure 12 Shows an example portion of a cutter tooth arrangement with a polymer support arm according to one embodiment.

[0054] Figure 13 Shows an exemplary cutter head as seen from the front according to one embodiment.

[0055] Figure 14 Shows an exemplary cutter head with a flat profile according to one embodiment.

[0056] Figure 15 Shows an exemplary cutter head with a curved profile according to one embodiment.

[0057] Figure 16 Shows an example of how a metal cutter head can be formed by die cutting, stamping, or photolithography according to one embodiment.

[0058] Figure 17 Shows an exemplary element from Figure 16 a sheet.

[0059] Figure 18 Shows how, according to one embodiment, Figure 17 an element can be adapted to a foil cutter.

[0060] Figure 19 Depicts an example foil cutter with a ring structure according to one embodiment. Detailed Description

[0061] Microbial testing can be performed in an environment that can be created (e.g.,) in a cartridge assembly. In some embodiments, the present application relates to techniques for deploying materials in such cartridge assemblies in a reliable and easy-to-use manner. Exemplary embodiments can provide trays with unique configurations that contain deoxygenating materials or other environment-regulating chemicals for use with the cartridge assembly. Further embodiments provide cutting mechanisms that allow the tray to be reliably breached, thereby exposing the internal materials to the environment. Some embodiments can cut the material with specially configured cutter teeth that can be easily deployed by twisting or pushing two parts of the cartridge assembly. Thus, the cartridge assembly can be closed, and as part of the action for closing the assembly, the tray can be breached. In the case where the material is a scavenging material, this exposes the scavenging material to the environment, thereby creating anaerobic conditions in the cartridge assembly.

[0062] Although the embodiments described below apply a specific configuration suitable for use with the depicted cassette assembly, those of ordinary skill in the art will recognize that providing such a specific configuration is for illustrative purposes. The described cutter and / or tray may assume different shapes or sizes depending on the environment in which they are to be deployed. The cutter and / or tray may be used alone to obtain the illustrated advantages or together to achieve additional synergies. Additionally, the cutter and tray need not be deployed only in the context of microbial testing, but may be widely applicable to any situation where materials can be held in a tray and deployed using a cutter. The tray may be used for other applications than creating an anaerobic environment, but more generally may be used for environmental conditioning using desiccants, gases, and / or chemicals that react to create an environment that meets the specific needs of the organism to be detected.

[0063] Figure 1 An example of the cassette assembly 100 is shown in Figure 2 and Figure 3 a cross-sectional side view. The cassette assembly 100 may provide a sterile environment for testing. In some embodiments, the cassette assembly 100 may provide an anaerobic environment or an environment with a limited amount of oxygen.

[0064] In Figure 1 , from top to bottom, the exemplary cassette assembly 100 includes a lid 102, an O-ring 104, an optional foil cutter 106, a tray assembly 700, a mid-body assembly 108, a membrane filter 118, a second O-ring 110, and a base assembly 112.

[0065] The base assembly 112 forms the bottom-most portion of the cassette assembly 100 and serves as a support structure to which other components can be mounted. The size and shape of the base assembly 112 may be designed to be accommodated in a suitable testing or analysis device.

[0066] The membrane filter 118 may be disposed on the base assembly, between the base assembly 112 and the mid-body assembly 108. The membrane filter 118 may be part of a media pad sized and shaped to be received by a corresponding recess in the base assembly 112. The membrane filter 118 may be any suitable filter and may have characteristics (such as the desired porosity) selected based on a particular application (e.g., the size of the microorganism of interest to be captured by the membrane filter 118). In some embodiments, multiple membrane filters 118 may be provided, which may include multiple different types of membrane filters 118.

[0067] The target fluid for analysis can pass through the membrane filter 118 and enter the base assembly 112. The base assembly 112 can include a drain port 116 that allows the fluid to be removed from the cartridge assembly 100 after filtration. The drain port 116 can include an opening in a portion of the base assembly 112 that is disposed inside the cartridge assembly 100, and this opening is connected to a specially shaped outlet on the outside of the cartridge assembly 100. The size and shape of the outlet can be designed to mate with a drain manifold that receives the removed fluid and conveys it to an appropriate processing location.

[0068] An O-ring 110 can be provided between the base assembly 112 and the middle body assembly 108 to prevent fluid from leaking out and thus bypassing the membrane filter 118. The middle body assembly 108 includes a middle body inlet 114 that allows the target fluid (or fluids) to be analyzed to enter the cartridge assembly 100. The middle body inlet 114 can include an opening in a portion of the middle body assembly 108 that is disposed inside the cartridge assembly 100, and this opening is connected to an opening on the outside of the cartridge assembly 100. A structure for sealing the cartridge assembly 100, such as a rubber diaphragm, can be provided within the middle body inlet 114. To allow the target fluid to enter the cartridge assembly 100, a needle can be used to pierce the structure in the middle body inlet 114 and convey the fluid at a relatively high pressure.

[0069] The shape of the top of the middle body assembly 108 can be designed to accommodate a tray assembly 700, which can include scavenging materials that (e.g.) absorb oxygen or other reagents in the cartridge assembly 100, as described herein, to create environmental conditions. More generally, the tray assembly can include desiccants, gases, or chemicals that react to create an environment to meet the specific needs of the organisms to be detected. For example, the tray can hold a desiccant to create a very dry environment suitable for the target microorganism. Similarly, the tray can hold materials for creating a sulfur-rich environment required for a particular microorganism. In some embodiments, multiple tray assemblies can be deployed to create the desired environmental conditions. For example, one tray can hold a desiccant, and another tray can hold a reagent to create a dry and sulfur-rich environment.

[0070] The top of the mid-body assembly 108 can be designed to accommodate the tray assembly 700, which can include scavenging materials that (e.g.) absorb oxygen or other reagents in the cartridge assembly 100, as described herein, to create environmental conditions. More generally, the tray assembly can include desiccants, gases, or chemicals that react to create an environment to meet the specific needs of the biological to be detected. In some embodiments, multiple tray assemblies can be deployed to create the desired environmental conditions. In some embodiments, the top of the tray assembly 700 can be covered with a foil that holds the scavenging material in place and protects it from external air until the tray assembly 700 is deployed in the cartridge assembly 100. In other embodiments, a breathable material sock can be used instead of an airtight foil. In some embodiments, such a breathable sock can be used when using environmental conditioning materials. To release the scavenging material or environmental conditioning material, the cartridge assembly 100 can be equipped with a foil cutter 106 that is designed to penetrate the foil or breathable sock and allow the scavenging material to scavenge the environment within the sealed cartridge assembly 100 or allow the environmental conditioning material to condition the environment.

[0071] Using a breathable barrier can eliminate the need for heat-activated adhesives and allow ultrasonic or heat welding of the tray seal. The breathable barrier also allows the use of environmental conditioning materials that would otherwise react with metal foil seals. The breathable barrier can be transparent or translucent to enable viewing of items in the tray, such as indicators of seal integrity. The breathable barrier is not limited to filling the tray through a fill port like a foil seal. The breathable barrier can be integrated into the shelves on the tray and can thus reduce the number of parts required.

[0072] To seal the cartridge assembly 100, an O-ring 104 can be placed on top of the mid-body assembly 108, and then the entire assembly can be covered with a lid 102. As Figure 2 and Figure 3 shown, the O-ring 104 forms a seal between the mid-body assembly 108 and the lid 102 and prevents fluid from leaking from the top of the cartridge assembly 100 (and seals the interior of the cartridge assembly 100 to allow materials to condition the environment).

[0073] As Figure 2 and Figure 3 further shown, the mid-body assembly 108 can include a mid-body assembly bottom plate 202 that extends radially inward from the inner peripheral wall 204 of the mid-body assembly 108 towards the interior of the cartridge assembly 100. The mid-body assembly bottom plate 202 can be inclined towards the membrane filter 118 to urge fluid towards the membrane filter 118.

[0074] Although the exemplary embodiments have been described with reference to the depicted cassette component configurations for purposes of illustration, those skilled in the art will recognize that other types of cassette components (having more, fewer, or different configured parts) or other sterile environments may also be used.

[0075] Figure 4 FIG. 4 is a perspective view of a foil cutter 106 according to one embodiment. Note that although for ease of discussion herein such an element is referred to as a foil cutter, the tray is not limited to being sealed with foil. If another sealing material is used, a cutter configured to break that type of sealing material may be constructed in accordance with the principles described below.

[0076] As shown, the foil cutter 106 takes the form of a ring having a generally planar surface 404 through which one or more openings are provided. One or more cutter teeth 402 are attached to the planar surface 404 and extend axially away from the planar surface 404. The cutter teeth 402 may be non-rigid such that when they are subjected to a force, they are capable of bending and thereby extending into the openings. In use, the action of the lid may cause the cutter teeth 402 to contact one or more protrusions, which forces the cutter teeth downward and into the foil seal of the tray assembly (this action will be discussed in more detail below).

[0077] The foil cutter 106 includes at least one cutter tooth 402, but preferably includes a plurality of cutter teeth spaced about the circumference of the foil cutter 106. In this way, the foil cutter 106 can break the foil seal of the tray assembly at multiple locations simultaneously, thereby exposing the purge material uniformly throughout the environment.

[0078] Nevertheless, the cutter teeth 402 need not be provided around the entire circumference; for example, Figure 4 FIG. 5 depicts a foil cutter 106 having a portion 406 without cutter teeth 402. This portion may be used as a mounting point for a tool or other feature that extends above the test area (e.g., into the area above the mid-body assembly floor 202).

[0079] In some embodiments, the portion 406 without cutter teeth may include one or more alignment protrusions 408. As Figure 7 shown, the tray may not be completely annular but rather have a cutout portion such that the tray presents a "C" shape. The alignment protrusions 408 may be aligned with the cutout portion of the tray, and the teeth 402 may be configured such that when the foil cutter 106 is aligned in this manner via the alignment protrusions 408, the bevel 602 (see Figure 6 ) is placed directly above the teeth 402 (to push in an engagement configuration) or next to the teeth 402 (such that when the lid rotates, the bevel 602 engages the teeth 402).

[0080] Figure 5A is a top view of a foil cutter 106 according to one embodiment. Figure 5B - 5D Depicts various details of the foil cutter 106.

[0081] For example, Figure 5B (depicting a side view of the foil cutter 106 taken along line A-A in Figure 5A ) shows the cutter teeth 402. As shown, the teeth 402 extend away from the main planar surface of the foil cutter 106 in the axial direction. For reference and ease of discussion, in Figure 5B , the left side of the figure is considered to be axially upward, and the planar surface facing the left side of the image is considered to be the top of the foil cutter 106. The planar surface on the right side of the image is considered to be the bottom and faces the axially downward direction.

[0082] As Figure 5C and Figure 5D more clearly seen, the teeth 402 of the foil cutter 106 extend into openings in the planar surface. The axial top side of the teeth 402 can be configured to mate with a beveled surface on the lid (see Figure 6 ). The surface can be smooth to provide less resistance in a twist-activated embodiment; alternatively, the surface can be provided with one or more protrusions or tactile elements that provide feedback to the user when the teeth 402 engage and bend against the bevel. For example, the teeth 402 can be configured to resist or click when engaging the bevel to inform the user that the teeth have engaged and penetrated the seal.

[0083] The axial bottom side of the teeth 402 can terminate at a cutting tip 502 that is configured to penetrate the seal of the tray assembly when the beveled surface is pushed downward against the top of the teeth 402. This causes the cutting tip 502 to extend downward through the opening and past the axial bottom of the foil cutter 106 (i.e., the bottom side of the planar surface), below which the seal of the tray can be located.

[0084] Figure 6 is a cross-sectional side view showing the cutting action of the foil cutter 106 according to an exemplary embodiment.

[0085] The tray assembly 700 is fitted into a corresponding recess in the mid-body assembly 108 and has a foil seal 604 on top. The foil cutter 106 is located on top of the mid-body assembly 108 and the tray assembly 700. When the teeth 402 are not engaged (as shown in Figure 6 ), the cutting tip 502 does not extend beyond the bottom surface of the foil cutter 106.

[0086] The lid 102 is placed on top of the mid-body assembly 108 and the foil cutter 106. The lid 102 includes one or more bevels 602 that are configured to engage with the teeth 402. The size and / or shape of the teeth 402 can be selected in conjunction with the configuration of the bevels 602 such that when the teeth 402 engage with the bevels 602, the teeth 402 extend a sufficient distance below the bottom surface of the foil cutter 106 so that the cutting tip 502 can contact and fully penetrate the seal of the tray assembly 700 when deployed into the mid-body assembly 108.

[0087] The teeth 402 can penetrate the foil seal 604 in a variety of ways. For example, in one embodiment, the user can twist the lid 102 relative to the mid-body assembly 108 and the base assembly 112, which can be locked together and move as a unit. The foil cutter 106 can move with the mid-body assembly 108 / base assembly 112. When the lid 102 is twisted, a relative twisting motion 606 is created that causes the bevels 602 to rotate on the teeth 402 (or vice versa). The shape of the bevels 602 causes the teeth 402 to be pushed downward and bent, thereby pushing the cutting tip 502 into the foil seal 604 and penetrating it (thus exposing the scavenging material contained in 700).

[0088] In another embodiment, the lid 102 can be aligned with the foil cutter 106 (e.g., by using alignment features to place the lid 102 on the cartridge and / or by slightly rotating the lid 102 until the alignment features engage to indicate that the bevels 602 are aligned with the teeth 402), and then the lid is pushed to cause the bevels 602 to engage with the teeth 402. In this embodiment, there is a relative pushing motion 610 between the lid 102 and the mid-body assembly 108 / base assembly 112, which can move with the foil cutter 106. The pushing motion can cause the bevels 602 (which can be aligned with the teeth 402) to bend the teeth 402 and push the cutting tip 502 into the foil seal 604.

[0089] In other embodiments, the material in the tray can be activated in other ways. For example, the material can be magnetically activated. A magnetic element can apply a magnetic field that either actuates the element or acts on the material to activate the material. Additionally, the material can be activated by environmental conditions such as temperature or humidity. For example, a wax motor or another mechanism can be used to convert temperature into mechanical actuation to achieve activation. Pressure can also be used to effect actuation of the seal or activation of the material. Additionally, a button activation mechanism can be used to activate the material.

[0090] Figure 7 is an exploded view of an exemplary tray assembly 700 according to one embodiment.

[0091] The tray assembly 700 can include a tray 704 into which materials can be added. The size and shape of the tray 704 can be designed to fit into a corresponding recess in the mid-body assembly 108. The tray 704 can be annular or substantially annular (e.g., "C"-shaped), and its size and shape can be designed to at least partially correspond to the size and shape of the foil cutter 106. By providing an annular tray 704, the materials can be disposed around most or all of the perimeter of the area where the sample will be tested, which allows for uniform distribution when the foil cutter 106 pierces the foil seal 604.

[0092] The axial top side of the tray assembly 700 is sealed by a foil seal 604 (although other types of sealing materials besides foil can also be used). The foil seal 604 can be annular, and its size and shape are designed to fit onto the top of the tray 704. The edge of the foil seal 604 can be coated with an adhesive material (such as a heat-activated adhesive material) to allow the foil seal 604 to be fixed to the tray 704 and create an airtight seal on the upper surface.

[0093] The axial bottom side of the tray 704 includes one or more fill ports (not visible in Figure 7 ; see Figure 9 ). Materials can be added to the tray 704 through the fill ports, and then the fill ports can be sealed in an airtight manner.

[0094] When the foil seal 604 is pierced during use, purge materials preferably do not leave the tray 704 and contaminate the sample being tested. Accordingly, an exemplary embodiment provides a rack 608, which can be a molded rack (e.g., formed of plastic or another suitable material). The rack 608 can accommodate a foam insert 702 that is located on the rack 608 and whose size and shape are designed to prevent purge materials (contained at the bottom of the tray 704) from leaving through the perforations in the foil seal 604.

[0095] Figure 8 is a perspective view depicting the assembled tray assembly 700 from the top according to one embodiment.

[0096] Meanwhile, Figure 9 the assembled tray assembly 700 is shown from the bottom according to one embodiment. Figure 9 A fill port 902 disposed at the bottom of the anaerobic tray 704 is shown through which materials can be introduced into the tray 704.

[0097] The fill port 902 is also visible in Figure 10 which depicts another bottom view of the assembled tray assembly 700.

[0098] Figure 11is a flowchart depicting an exemplary method for creating an environment in a cassette assembly according to one embodiment.

[0099] In block 1102, a user may provide a tray assembly that includes at least one anaerobic tray and a sealing element (such as a foil ring coated with an adhesive at its edge).

[0100] In block 1104, the user may optionally assemble the tray by placing an optional molded rack and foam insert into the tray. As explained above, these components may be provided to prevent the deoxidizer material from leaking into the test environment when the sealing element is pierced.

[0101] In block 1106, the top of the tray may be sealed. For example, if the sealing element is a foil ring coated with a heat-sensitive adhesive, the foil ring may be placed on top of the anaerobic tray and heat may be applied to activate the adhesive. The user may optionally test the seal to ensure it is airtight.

[0102] In block 1108, the user may flip the tray to expose the bottom fill port and may fill the tray with material through the fill port. When the tray is filled, the tray may be manipulated (e.g., rotated, tapped, etc.) to ensure the material is distributed throughout the tray.

[0103] After a predetermined amount of scavenging material has been added to the tray, in block 1110, the fill port may be sealed. The fill port may be sealed with foil in a manner similar to the foil seal on the top of the tray, or another sealing means (e.g., a plug) may be used. The user may test the seal on the fill port to ensure it is airtight.

[0104] In block 1112, the base assembly, membrane, and midbody assembly may be deployed. For example, the base assembly may be placed on a suitable surface in the test area, and the membrane (and / or media pad) may be placed on the base assembly. An O-ring may be placed at a position around the circumference of an appropriate portion of the base assembly. Then the midbody assembly may be lowered onto the base assembly so that the O-ring creates a seal and / or locks the midbody assembly to the base assembly.

[0105] In block 1114, the user may place the filled tray assembly in a corresponding recess in the midbody assembly. The foil cutter 106 may be placed on top of the tray.

[0106] In block 1116, the lid may be deployed on the cassette assembly. This may involve setting an O-ring at a suitable location on the midbody assembly and then securing the lid to the inner or outer circumference of the O-ring.

[0107] The lid can initially be partially fixed such that the foil cutter 106 does not engage with the bevel 602 to penetrate the foil seal 604. The cartridge assembly can be moved to the position to be filled or tested, and then the lid can be fully fixed. Depending on the actuation mechanism of the foil cutter 106, the lid can be pushed to close or can be twisted. In either case, closing the lid can cause the bevel 602 to engage with the teeth 402, thereby pushing the cutting tip 502 into the foil seal 604. The cutting tip 502 penetrates the foil seal 604 and exposes the material to the now-sealed interior environment of the cartridge.

[0108] In the block 1118, a fluid delivery device can be inserted into the inlet of the mid-body assembly. For example, the inlet can include a rubber diaphragm. The rubber diaphragm can be pierced with a needle, and the fluid can be delivered to the inlet through the needle. The fluid can be delivered through one or more tubes attached to the needle or through another suitable delivery device.

[0109] The fluid can pass through the membrane. Then, the fluid can be released through an outlet in the base assembly. After releasing the fluid, a growth matrix can be set near the membrane (e.g., through the mid-body inlet or another suitable inlet), and the cartridge assembly can be placed for a predetermined period of time for culturing. Any microbial growth on the growth matrix can then be measured (e.g., by imaging the growth matrix through the lid, which can be optically transparent).

[0110] In some embodiments, a hybrid design can be used where a polymer can be used for the support arms of the cutter teeth. One of the advantages of using polymer support arms is that the polymer support arms enable the cutter head to rebound after cutting. This can simplify the design of the foil cutter 106 and avoid accidental cutting.

[0111] Figure 12 An example portion of a cutter tooth device 1200 with polymer support arms is shown. The cutter head 1204 is formed of a suitable metal, but the support arms 1202 are made of a polymer such as plastic. The advantage of using a metal cutter head 1204 is that, compared to the case where the cutter tooth assembly is formed entirely of polymer, the metal cutter head can be formed to produce a larger hole. The resulting larger hole can enable more efficient clearance. A fully plastic cutter generally cannot pierce or cut a breathable membrane, while a metal cutter head can cut a breathable membrane. As shown, the cutter head 1204 is arrow-shaped. The combination of the support arms 1202 and the metal cutter head 1204 is more cost-effective in terms of production cost than a fully metal cutter tooth arrangement.

[0112] Figure 13 The cutter head 1300 is shown as seen from the front. The cutter head includes a portion 1304 connected to the support arm, a neck 1306, and an arrow portion 1302 for tearing the foil or other sealing layer in the cartridge assembly. Figure 14Shows a cutter head 1400 with a flat profile. This view includes an arrow portion 1402 and a neck 1404. Figure 15 Shows an alternative arrangement of the cutter head 1500, where the front portion 1502 has a curved profile instead of a flat profile. The neck 1504 is also shown.

[0113] Figure 16 Shows an example of how a metal cutter head can be formed by die cutting, stamping, or photoetching. As shown, a metal sheet 1600 has been processed to produce a plurality of elements 1606 that are connected to a top 1602 and a metal portion 1604 (only partially shown). As Figure 17 shown, the element 1700 includes a protrusion 1702.

[0114] Figure 18 Shows how such an element can be adapted to a foil cutter 106, such as described above. The cutting edge 1802 is inserted and mounted into a groove 1806 of an inclined surface 1804. The cutting edge 1802 can be configured to have a friction fit with the groove 1806, or an alternative retaining means can be provided to securely connect the cutting edge 1802 to the groove 1806. Figure 19 Depicts an example foil cutter 1900 having a ring structure 1902. The element 1904 has been installed. The protrusion 1906 remains in place, and the cutting edge 1908 is located in a groove of the inclined surface. Once the cutting edge 1908 is securely mounted, the protrusion 1906 can be removed, such as by trimming off the excess.

[0115] Some embodiments may use the phrases "one embodiment" or "an embodiment" and their derivatives to describe. These terms mean that the specific features, structures, or characteristics described in connection with the embodiment are included in at least one embodiment. The phrase "in one embodiment" that appears in different places in the specification does not necessarily refer to the same embodiment. Additionally, unless otherwise stated, the above features are considered to be combinable arbitrarily. Thus, any individually discussed feature can be combined with each other, unless it is noted that these features are incompatible with each other.

[0116] Generally referring to the symbols and terms used herein, the detailed description herein can be presented in accordance with program processes executed on a computer or a computer network. These process descriptions and representations are the most effective way for those skilled in the art to communicate the essence of their work to other technicians in the field.

[0117] The terms "coupled" and "connected" and their derivatives may be used to describe some embodiments. These terms are not necessarily intended as synonyms for each other. For example, the terms "connected" and / or "coupled" may be used to describe some embodiments to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" may also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other.

[0118] It should be emphasized that the abstract is provided to enable the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Additionally, in the foregoing detailed description, it can be seen that for the purposes of efficient disclosure, various features are combined in a single embodiment. The method of the present disclosure should not be construed as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as reflected in the appended claims, the inventive subject matter lies in less than all of the features of a single disclosed embodiment. Accordingly, the following claims are hereby incorporated into the detailed description, where each claim stands on its own as a separate embodiment. In the appended claims, the terms "including" and "wherein" are used as the plain-English equivalents of the respective terms "comprising" and "wherein". Additionally, the terms "first", "second", and "third", etc. are used merely as labels and are not intended to impose numerical requirements on their objects.

[0119] The foregoing includes examples of the disclosed architecture. Of course, it is not possible to describe all possible combinations of components and / or methods, but one of ordinary skill in the art will recognize that many other combinations and permutations are possible. Accordingly, the novel architecture is intended to cover all such alterations, modifications, and variations that fall within the spirit and scope of the appended claims.

Claims

1. A tray assembly for a cartridge assembly, the tray assembly comprising: A tray configured to receive an oxygen scavenging material, the tray sized and shaped to fit into a recess in a microbial test cartridge; A seal configured to create an airtight seal on one side of the tray; And One or more fill ports configured to receive the oxygen scavenging material.

2. The tray assembly according to claim 1, further comprising a rack configured to be disposed inside the tray.

3. The tray assembly according to claim 2, further comprising a foam insert configured to be located on the molded rack and prevent the oxygen scavenging material from leaving the tray when the seal is penetrated.

4. The tray assembly according to claim 1, wherein the seal is a foil.

5. The tray assembly according to claim 1, wherein the seal includes an adhesive disposed around the edge of the seal.

6. The tray assembly according to claim 1, wherein the tray is "C" shaped.

7. The tray assembly according to claim 6, wherein the one or more fill ports include at least one fill port disposed at each end of the "C" shape.

8. The tray assembly according to claim 1, wherein the tray is configured to substantially surround the internal test environment of the cartridge assembly.

9. The tray assembly according to claim 1, further comprising an airtight seal disposed on the one or more fill ports.

10. The tray assembly according to claim 1, further comprising an annular foil cutter configured to penetrate the seal.

11. A method, comprising: Providing a tray assembly according to claim 1; Filling the tray with an oxygen scavenging material through one or more fill ports; And Applying a seal to seal the tray.

12. The method according to claim 11, further comprising deploying a rack inside the tray.

13. The method according to claim 12, further comprising deploying a foam insert on top of the rack, the foam insert configured to prevent the oxygen scavenging material from leaving the tray when the seal is penetrated.

14. The method according to claim 11, further comprising disposing an adhesive around the edge of the seal.

15. The method according to claim 14, further comprising sealing the seal to the tray with the adhesive.

16. The method according to claim 15, wherein sealing the seal includes applying heat to activate a thermosensitive adhesive or applying heat for heat welding to seal the seal.

17. The method according to claim 11, wherein the tray includes a plurality of fill ports, and filling the tray includes adding the oxygen scavenging material to each of the fill ports.

18. The method according to claim 11, further comprising sealing the one or more fill ports.

19. The method according to claim 11, further comprising deploying a cutter on top of the tray sub-assembly.

20. The method according to claim 19, further comprising twisting or pushing the cutter to penetrate the seal with the cutter.

Images