The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate disclosed embodiments and, together with the description, serve to explain the disclosed embodiments. In the drawings:
Exemplary embodiments are described with reference to the accompanying drawings. While examples and features of disclosed principles are described herein, modifications, adaptations, and other implementations are possible without departing from the spirit and scope of the disclosed embodiments. Exemplary embodiments described herein may be independent of each other. Also, the words “comprising,” “having,” “containing,” and “including,” and other similar forms are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items. It should also be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. For convenience, the term “disclosed embodiments” or “exemplary embodiment” may be used herein to refer to a single embodiment or multiple embodiments of the disclosure.
Fluids, such as reagent materials, are often packaged and stored in vials. Multiple vials can then be packaged and stored in a cartridge format to improve usability. Such cartridge-based reagents often contain multiple forms of packaging within the cartridge system. For example, the reagents may be directly packaged in a primary container (e.g., a vial having a stopper). The primary container may be contained within a secondary container (e.g., a plastic housing or cartridge). Accordingly, an automated probe system may interface with the primary or secondary container during use (e.g., to aspirate material from the primary container).
Additionally, an automated probe system may perform multiple tests using reagents stored in the same primary containers, requiring multiple aspirations from these primary containers. Multiple aspirations may require repeated penetrations of stoppers sealing the primary containers. But repeated penetrations of conventional stoppers can reduce the reliability of automated probe systems using such stoppers. Repeated penetrations of conventional stoppers can cause stopper coring and fragmentation, which can interfere with reagent aspiration, and can expose reagent materials in the primary container to the ambient environment (e.g., through air holes in the stopper), which can reduce the lifetime, following the initial penetration of the stopper, of the reagent materials stored inside the primary container (e.g., the onboard stability of the reagent materials).
Additionally, automated probe systems can exhibit reagent wastage when used with conventional primary containers. Such systems may aspirate reagents using a probe advanced into the primary containers. The probe tip may not contact the bottom of the primary containers, to avoid damaging or blocking the probe (or the containers). Accordingly, the probe may be unable to aspirate reagents remaining at the bottom of the primary containers, below the probe tip. The remaining reagent, often referred to as “dead volume,” may be considered lost material and may be thrown out.
Additionally, automated probe systems can be used with a broad range of primary container stoppers. Such stoppers may be composed of various materials and have varying dimensions. However, conventional automated probe systems accommodate a single piercing probe and may therefore be unable to reliably pierce various types of stoppered containers.
Additionally, conventional combinations of primary and secondary containers may use space inefficiently. For example, a rectangular cartridge may store cylindrical reagent vials, resulting in some volume of the rectangular cartridge being unused or wasted.
The disclosed cartridges, containers, and/or probes (and systems, methods, and devices of using such cartridges, containers, and/or probes), independently or in combination, can improve upon conventional designs as follows: An improved cartridge assembly can allow an automated probe system to access the containers packaged therein without removing the containers from the cartridge assembly. An improved cartridge assembly can accommodate variously sized and shaped containers so as to minimize unused cartridge assembly volume. An improved cartridge assembly can align the cartridge assembly and the containers stored therein with the automated probe system to ensure accurate penetrations of the stoppers and accurate aspirations. The repeated penetration can be accurately at the same location of the stopper to reduce stopper fragmentation. An improved primary container stopper can support repeated probe penetration with reduced stopper coring and fragmentation. The improved stopper can self-seal after probe withdrawal, improving preservation and extending the onboard stability of the reagents stored in the primary container (e.g., from about 2 weeks to about 4 weeks). The stopper may self-seal by ensuring that the probe pierces the same exact location on the stopper each time the probe penetrates the stopper. By driving the probe to find the initial piercing location and preventing creating multiple piercing spots on the stopper, the stopper may be able to self-seal even after multiple penetrations. An improved container for storing reagents can be shaped to minimize dead volume. An improved probe system can include a multi-mode probe suitable for piercing primary container stoppers of various sizes, materials, and/or types.
The present disclosure relates generally to cartridge assemblies, containers, and/or probes suitable for use in testing, e.g., diagnostic testing including but not limited to medical (disease/drug), chemical, and/or biological testing/analysis, and systems, devices, and methods of using such cartridges, containers, and/or probes in such testing. Although the present disclosure describes multiple aspects (e.g., containers, probes, cartridge assemblies, etc.) that can be implemented in combination in a system, each aspect can be used independently with systems and devices that are not described in this disclosure (e.g., conventional systems and devices). A benefit arising from implementation one of the multiple aspects can be independent of the implementation of another of the multiple aspects. The present disclosure merely describes the various aspects in a related manner for convenience.
As discussed in further detail below, various embodiments of cartridge assemblies for accurate positioning and access of containers and components stored therein are provided. The cartridge assemblies, consistent with the embodiments of the present disclosure, can support alignment of an automated probe system, conventional or as described in the present disclosure, with assemblies and containers packaged within the cartridge assemblies, where such assemblies and containers can be conventional or have one or more features described in the present disclosure. Accordingly, the disclosed cartridge assemblies can support accurate positioning of an automated probe system. which may reduce stopper fragmentation when the probe punctures the stoppers of the containers. For example, when a probe, such as a probe with a rounded tip, punctures a stopper at a location where the stopper was punctured previously, there is a reduction in friction and a reduction in the tearing of the stopper, thereby minimizing fragmentation. By positionally aligning the probe to the cartridge assembly and accessing the contents within containers, tolerance stacking issues that could lead to inaccuracy and repeatability issues may be eliminated. Moreover, the rounded tip of the probe may also allow the probe to locate the location on the stopper that has previously been pierced without a sharp edge digging into the stopper. The rounded tip may also guide the probe into the previously pierced location, thereby reducing stopper fragmentation. In some embodiments, independent of the alignment functionalities, the cartridge assemblies may comprise cavities capable of accommodating various types, sizes, and/or diameters of containers. For example, the cartridge assemblies may be configured to interchangeably accommodate cylindrical containers and oblong containers, or containers of other shapes.
Additionally, various embodiments of a probe system, such as an automated probe system, for penetrating a stopper of a container are provided, the stopper or container being conventional or including features of the present disclosure. The probe system, consistent with the embodiments of the present disclosure, may include a dual-mode probe system having an inner probe and an outer probe. In some embodiments, the inner probe and the outer probe of the probe system may be independently actuatable. Whether the inner probe or the outer probe penetrates the stopper can depend on a type of the container. In some implementations, the outer probe can be used to penetrate containers including relatively thicker stoppers, or containers intended to be penetrated relatively few times (e.g., blood sample containers, or other sample containers). The inner probe can be used to penetrate containers having relatively thinner stoppers, or containers intended to be penetrated many times (e.g., reagent containers, or the like). As used herein, the term “probe” may be used interchangeably with the term “needle.” The term “probe” may refer to the probe system, or a specific component therein such as a needle. For example, the term “probe” may refer to a needle comprising a thin, hollow metal tube through which fluid can be aspirated and dispensed. Accordingly, the term “probe” may refer generally to a needle or any elongated component comprising a hollow cavity that is capable of puncturing, piercing, and penetrating a structure and aspirating material through the hollow cavity. According to another embodiment of the present disclosure, the inner probe can be used to penetrate containers including relatively thicker stoppers, or containers intended to be penetrated relatively few times, and the outer probe can be used to penetrate containers having relatively thinner stoppers, or containers intended to be penetrated many times.
Various embodiments of a stopper for a container are provided. The stopper, consistent with the embodiments of the present disclosure, may be configured to reduce and/or minimize stopper fragmentation when repeatedly penetrated by a probe. The stopper can be configured to seal, and self-seal after being penetrated, a container or vial for storing lyophilized materials. In some embodiments, the stopper may be made of a halogenated butyl rubber material such as bromobutyl such that the stopper can self-seal after penetration. Additionally or alternatively, the stopper, consistent with the embodiments of the present disclosure, may include a bulb-shaped internal cross-section, which may allow the stopper to be repeatedly penetrated without creating substantial stopper fragmentation.
Moreover, various embodiments of a container for storing and packaging materials, such as reagent materials, are provided. The container, consistent with the embodiments of the present disclosure, may be configured to reduce the dead volume of material remaining at the bottom of the container below the furthest reach of a probe. In some embodiments, for example, the container may be shaped to pool material on the bottom surface of the container (e.g., pooling material toward the center of the interior lower surface), thereby enabling a probe to aspirate more of the material in the container and reducing dead volume as compared to a conventional base design (e.g., as in the right image depicted in
The present disclosure relates generally to cartridges, containers, and/or probes, and systems, devices, and methods of using such cartridges, containers, and/or probes in testing, e.g., diagnostic testing. For example, a container for storing materials can have a stopper and, more particularly, a pierceable lyophilization stopper that is capable of being repeatedly penetrated using an aspiration needle without stopper fragmentation. The stopper may self-seal after each penetration, extending the onboard stability of the materials in the container. The present disclosure also relates generally to a probe assembly for piercing a container and, more particularly, to a dual-mode probe assembly for piercing a container and/or aspire materials from the container. Each mode of the probe can be used for a different purpose, e.g., piercing and aspiring different containers or materials. At least one mode of the probe is designed such that the probe in this mode can repeatedly pierce a container without causing excessive fragmentation of the stopper of the container or preventing self-sealing of the stopper. Additionally, the present disclosure relates generally to a container and, more particularly, to a container with a bottom surface that is configured to pool fluid in a center. The pooling can help aspiration of the material from the container and can reduce material waste. The present disclosure further relates to a cartridge assembly and, more particularly, to a cartridge assembly that is capable of automatically aligning the cartridge assembly and a container accommodated therein with a probe assembly. The automation can increase test throughput, reduce human incurred error, and reduce human burdens on carrying out the tests.
Although the present disclosure describes multiple aspects, e.g., containers, probes, cartridges, etc. that can be implemented in a system altogether, each aspect can be used independently with systems and devices that are not described in this disclosure, e.g., conventional systems and devices. For example, the stoppers of the containers having the stoppers described herein can be used in a system or device that do not implement any of the probes, cartridges, or container bottom designs as described herein. Likewise, the probes, cartridge systems, and the containers with the bottom surface as described herein can each be independently used without regard to each other. The benefits provided by each aspect is independent of implementing the other aspects in the same system. The present disclosure merely describes the various aspects in a related manner for convenience.
Turning now to the drawings,
As illustrated in
Accuracy and precision in penetrating the stopper 120 may reduce stopper fragmentation. Accurate alignment such that probe 112 penetrates a center of stopper 120 instead of a side wall of stopper 120 may be important in reducing stopper fragmentation, as repeatedly piercing a side wall of stopper 120 may cause stopper fragmentation. Precise alignment may increase the likelihood that each penetration of stopper 120 by probe 112 occurs at the same location (e.g., through the same hole) on the stopper 120. When multiple penetrations occur in close proximity (but not at same location), fragments can separate from the stopper 120. Such fragments may interfere with aspiration of reagents. In some instances, separation of a fragment may cause a non-sealing hole to form in stopper 120, exposing reagents to the environment. Thus accurate and precise probe targeting can reduce fragmentation of stopper 120 and improve the on-board stability of reagents stored in the container 106.
In some embodiments, second housing 104 may further comprise means for securing one or more containers 106 within the cartridge assembly when the second housing is coupled to the first housing. In some embodiments, the securing means can be configured to apply a force vertically downward on one or more containers 106 accommodated within cartridge assembly 100. In some embodiments, the applied force may be reduced when a container (or an opening of the container) is aligned coaxially with openings on the top surface of second housing 104. Thus, the securing means can both secure the one or more containers 106 within the cartridge assembly 100 can align the one or more containers 106 with the openings (and thus with the proximal end of probe assembly 110).
In some embodiments, the securing means can include a plurality of protrusions, such as the plurality of spring features 118, positioned circumferentially around each of the plurality of opening of alignment features 108. The spring features 118, for example, may be biased vertically downward and may be configured to apply a force vertically downward. Accordingly, when one or more containers 106 are accommodated in cartridge assembly 100, the plurality of spring features 118 positioned circumferentially around the alignment features 108 may be configured to apply a force vertically downward on top of the one or more containers 106. In this manner, the plurality of spring features 118 can secure the one or more containers 106 inside cartridge assembly 100. In some embodiments, the plurality of spring features 118 may be manufactured using plastic and may be flexible. In various embodiments, the securing means can include compressible foam, plastic, rubber, metal, or other materials. Such materials can be positioned between the one or more containers 106 and the second housing when the second housing 104 is coupled to the first housing 102. The materials can be attached to the second housing 104 or to disposed around the neck of the one or more containers 106. When the second housing 104 is coupled to the first housing, the materials can be compressed and therefore provide aligning forces and force vertically downward onto the one or more containers 106.
Additionally, or alternatively, the first housing 102 may comprise a plurality of aligning means, similar to spring features 118, that are configured to apply force inward to the sidewalls of one or more containers 106 accommodated within the cartridge assembly 100. In some embodiments, the applied force may be reduced when a container (or an opening of the container) is aligned the cavity (or with an opening of the cartridge assembly). Thus, the aligning means can secure the one or more containers 106 in a desired position within the cartridge assembly 100. In some embodiments, the container (or opening of the container) can be coaxially aligned with the cavity (or with an opening of the cartridge assembly).
As explained previously, none of the alignment features 108, spring features 118, or circular openings 116 of the cartridge assembly is limited to any other aspects, e.g., the probe configurations, the stopper configurations, or the primary container configurations of the present disclosure. The cartridge-probe alignment features described above can be applied to any conventional probes, stoppers, or primary containers.
Referring now to
In some embodiments, a spring system, e.g., one integrated with the cartridge assembly, can be configured to apply force to sidewalls of one or more containers packaged therein. In this manner, the integrated spring system can secure the one or more containers in a desired position within the cartridge assemblies. By way of example, as illustrated in
In some embodiments, each cavity 206 may comprise an insert manufactured separately from the cartridge assembly and affixed to the first housing of the cartridge assembly. The inserts may be manufactured using, for example, plastic, metal, compressible foam, rubber, or other flexible materials that could apply a force horizontally or inward onto the side walls of one or more containers stored therein. Accordingly, the insert may align the one or more containers to a probe assembly.
In various embodiments, the aligning means can include compressible foam, plastic, rubber, metal, or other materials. Such materials can be positioned between the one or more containers 106 and the sidewalls of the cavities within the cartridge assemblies. The materials can be attached to the second housing or to disposed around the one or more containers 106. When the second housing is coupled to the first housing, the materials can be compressed and therefore provide aligning forces onto the sidewalls of the one or more containers 106.
As illustrated in
While
As shown in
In some embodiments, cartridge assemblies may comprise between 2 and 20 cavities configured to accommodate containers.
Referring now to
As illustrated in
In some embodiments, the rounded tip 510 of the inner needle 508 may reduce stopper fragmentation when the inner needle 508 repeatedly punctures a stopper of a container. For example, the rounded tip 510 may guide the inner needle 508 into a previously pierced location on the stopper, thereby reducing stopper fragmentation. Additionally, when the inner needle 508 punctures a stopper at a location where the stopper was punctured previously, there may be a reduction in friction and therefore a reduction in the tearing of the stopper, thereby reducing fragmentation. Moreover, the rounded tip 510 of the inner needle 508 may also allow the inner needle 508 to locate the location on the stopper that has previously been pierced without a sharp edge digging into the stopper.
In some embodiments, the probe system 500 may comprise a dual-mode piercing probe for piercing a stopper of a container. Accordingly, one of the outer needle 502 and the inner needle 508 may be actuated to puncture a stopper of a container based on the type of container and/or the type of stopper. By way of example, as illustrated in
Additionally, or alternatively, as illustrated in
Referring now to
In some embodiments, stopper 900 may comprise a hollow cavity 908 extending through the plug portion 904 and into the disk portion 902. The hollow cavity 908, the plug portion 904, and the disk portion 902 may be positioned coaxial relative to each other. In some embodiments, the disk portion 902 may comprise a pierceable membrane 912 disposed over the proximal end of the hollow cavity 908, and the pierceable membrane 912 may be coaxial with the hollow cavity 908. As illustrated in
In some embodiments, stopper 900 may comprise an integral hinge means for enabling repeated penetration of the stopper using, for example, an aspiration needle or probe without causing stopper fragmentation. Such integral hinge means may comprise a molding undercut in the body of stopper 900. For example, as shown in
In some embodiments, stopper 900 may comprise a rectangular cutout 924 on at least one portion of a sidewall of the plug portion 904. The rectangular cutout 924 may have a height in a range of about 3 mm to about 10 mm and a width in a range of about 0.5 mm to about 10 mm. In other embodiments, stopper 900 may comprise one or more protrusions 914 at a top surface of the disk portion 902. For example, stopper 900 may comprise a plurality of protrusions 914 spaced apart from each other at the top surface of the disk portion 902. In some embodiments, the plurality of protrusions 914 may not overlap the pierceable membrane 912.
As discussed above, the molding undercut of stopper 900 having a bulb-shaped interior cross-section 910 may facilitate a large number of repeated penetrations of stopper 900 by, for example, an automated aspiration needle or probe system while minimizing stopper fragmentation. The bulb-shaped interior cross-section 910 and the reduced thickness at the pierceable membrane 912, for example, may reduce contact areas between the needle or probe and stopper 900. Furthermore, the bulb-shaped interior cross-section 910 may increase the radius of the pierceable membrane 912, while ensuring that plug portion 904 remains thick enough to seal the container. The protrusion of cross-section 910 into disk portion 902 can reduce the thickness of pierceable membrane 912, while ensuring that flange 960 remains thick enough to seal the container. For example, the flange 960 may comprise a rubber viscoelastic material that may flow into any surface voids in the container when compressed. Flange 960 may need to be compressed a certain percentage to maintain a suitable seal, imposing a minimum thickness requirement on flange 960. Absent the bulb-shaped interior cross-section 910, the minimum thickness of the flange 960 could constrain the thickness of the pierceable membrane 912. The increased radius and decreased thickness afforded by the integral hinge-like mechanism can support gradual deformation of the pierceable membrane 912 when contacted by the needle or probe. Accordingly, when the needle or probe penetrates stopper 900 at the pierceable membrane 912, the bulb-shaped interior cross-section 910 and the reduced thickness at the pierceable membrane 912 may create an integral hinge-like mechanism with a low contact area interface between the needle and stopper 900 along the direction of the needle penetration compared to a thick membrane. The low contact area interface can reduce friction between the needle and the membrane and can allow the pierceable membrane 912 to repeatedly “open” without creating substantial fragmentation. The integral hinge-like mechanism afforded by the bulb-shaped interior cross-section 910 and the reduced thickness at the pierceable membrane 912 may allow the pierceable membrane 912 to flex when the needle or probe pushes on the pierceable membrane 912. As the pierceable membrane 912 flexes downward, an already-pierced hole on stopper 900 may open, thereby reducing the friction between the probe and stopper 900 as the probe slides through the hole. The reduction of friction may, thus, support reduction in stopper fragmentation. In conventional, commercially available stoppers for lyophilized products, the internal geometry is usually tapered or rectangular with straight sidewalls. The internal geometry in conventional stoppers does not support the flexing enabled by the integral hinge-like mechanism in stopper 900. Because stopper 900 may be repeatedly penetrated (e.g., about 10 to about 1000 repeated penetrations) rather than penetrated only once or twice, the integral hinge-like mechanism afforded by the bulb-shaped interior cross-section 910 and the reduced thickness at the pierceable membrane 912 may support a reduction in stopper fragmentation.
The ratio of the maximum width 922 to the minimum width 926, the pierceable membrane thickness 920, and the radius 916 can be tuned to reduce fragmentation of the stopper. Particularly for aspiration needles or probes with a rounded tip, such as rounded tip 510 of
By way of example,
Referring now to
In some embodiments, container 1100A may also comprise one or more protrusions 1104A disposed on an exterior bottom surface of the base 1102A. In some embodiments, the one or more protrusions 1104A may comprise flat bottom surfaces, and the one or more protrusions 1104A may be configured to substantially surround the convex center 1106A. In some embodiments, a maximum height 1120 of the protrusions 1104A may be equal to or greater than a height 1118 of the convex center 1106A such that when the base 1102A is lying flat on a surface, the protrusions 1104A contacting the surface may provide stability to the container. In some implementations, when the height 1120 is greater than the height 1118, the convex center 1106A may not contact the surface when the container is placed on a flat surface. In some embodiments, a maximum height of the protrusions may equal the height of convex center 1106A, such that when the base 1102A is lying flat on a surface both the protrusions 1104A and the convex center 1106A contact the surface. Accordingly, the one or more protrusions 1104A may allow container 1100A to remain stable on a flat surface, even with the convex center 1106A protruding from the bottom surface of the base 1102A.
In some embodiments, the container may be oblong in shape, rather than cylindrical like container 1100A. For example, container 1100B may have an oblong shape. Container 1100B may comprise a base 1102B comprising a hollow cavity 1108B. Container 1100B may also comprise a cylindrical structure including a neck portion 1110B extending vertically upward from the base 1102B and a top portion 1112B extending vertically upward from the neck portion 1110B. The cylindrical structure may form an opening and may extend vertically upward from the base 1102B. The outer dimension of the base 1102B (e.g., a major axis of base 1102B) may be greater than an outer diameter of the cylindrical structure, including the neck portion 1110B and the top portion 1112B. In some embodiments, the base 1102B may comprise a molded fluid-centering design: a bottom surface with a convex center 1106B protruding from the bottom surface in a direction away from the hollow cavity 1108B such that the convex center 1106B may be configured to pool material inside the container, such as reagent material, towards the convex center 1106B. In some embodiments, the convex center 1106B may protrude in a range of about 1 mm to about 3 mm in height 1122 from the bottom surface of the base 1102B in the direction away from the hollow cavity 1108B. Accordingly, material will pool towards the convex center 1106B of container 1100B, minimizing dead volume and enabling an aspiration needle or probe to aspirate more material from container 1100B than from a flat-bottomed container of equivalent volume.
In some embodiments, the base 1102B of container 1100B may be oblong in shape such that an outer dimension of the base 1102B is a major axis of the oblong. In some embodiments, the base 1102B may comprise one or more indentations 1114B along a first sidewall and one or more indentations 1114B along a second sidewall (not shown) opposite the first sidewall. In some embodiments, container 1100B may also comprise one or more protrusions 1104B disposed on an exterior bottom surface of the base 1102B. In some embodiments, the one or more protrusions 1104B may comprise flat bottom surfaces, and the one or more protrusions 1104B may be configured to substantially surround the convex center 1106B. In some embodiments, a maximum height of the protrusions 1104B may be greater than a height of the convex center 1106B such that when the base 1102B is lying flat on a surface, the protrusions 1104B contact the surface and prevent the convex center 1106B from contacting the surface. In some embodiments, a maximum height 1124 of the protrusions 1104B may equal to or greater than the height 1122 of convex center 1106B, such that when the base 1102B is lying flat on a surface, the protrusions 1104B contacting the surface may provide stability to the container. In some implementations, when the height 1124 is greater than the height 1122, the convex center 1106B may not contact the surface when the container is placed on a flat surface. Accordingly, the one or more protrusions 1104B may allow container 1100B to remain stable on a flat surface even with the convex center 1106B protruding from the bottom surface of the base 1102B.
Referring now to
In some embodiments, container 1400A may also comprise one or more protrusions 1404A disposed on an exterior bottom surface of the base 1402A. The one or more protrusions may comprise, for example, one or more ridges positioned around the convex center 1406A. For example, the one or more protrusions 1404A may be configured to substantially surround the convex center 1406A. In some embodiments, a maximum height of the protrusions 1404A may be greater than a height of the convex center 1406A such that when the base 1402A is lying flat on a surface, the protrusions 1404A contact the surface and the convex center 1406A does not contact the surface. In some embodiments, a maximum height of the protrusions 1404A may equal to the height of convex center 1406A, such that when the base 1402A is lying flat on a surface, both the protrusions 1404A and the convex center 1406A contact the surface. Accordingly, the one or more protrusions 1404A may allow container 1400A to remain stable on a flat surface even with the convex center 1406A protruding from the bottom surface of the base 1402A.
In some embodiments, the container may be oblong in shape, rather than cylindrical like container 1400A. For example, container 1400B may have an oblong shape. Container 1400B may comprise a base 1402B comprising a hollow cavity 1408B. Container 1400B may also comprise a cylindrical structure including a neck portion (similar to neck portion 1110B in
In some embodiments, the base 1402B of container 1400B may be oblong in shape such that an outer dimension of the base 1402B is a major axis of the oblong. In some embodiments, the base 1402B may comprise one or more indentations 1414 along a first sidewall and one or more indentations 1414 along a second sidewall opposite the first sidewall. In some embodiments, container 1400B may also comprise one or more protrusions 1404B disposed on an exterior bottom surface of the base 1402B. In some embodiments, the one or more protrusions 1404B may comprise one or more ridges positioned around the convex center 1406B. For example, the one or more protrusions 1404B may be configured to substantially surround the convex center 1406B. In some embodiments, a maximum height of the protrusions 1404B may be equal to or greater than a height of the convex center 1406B such that when the base 1402B is lying flat on a surface, the protrusions 1404B contacting the surface may provide stability to the container. In some implementations, when the height of the protrusions 1404B is greater than the height of the convex center 1406B, the convex center 1406B may not contact the surface when the container 1400B is placed on a flat surface. Accordingly, the one or more protrusions 1404B may allow container 1400B to remain stable on a flat surface even with the convex center 1406B protruding from the bottom surface of the base 1402B. While
The embodiments may further be described using the following clauses:
1. A pierceable stopper for a container, comprising: a plug portion configured to seal an opening of a container; and a disk portion disposed on top of the plug portion, the disk portion comprising a flange extending radially beyond an outer diameter of the plug portion, wherein a hollow cavity extends through the plug portion and into the disk portion, a proximal end of the hollow cavity having a bulb-shaped interior cross-section, wherein the hollow cavity, the plug portion, and the disk portion are positioned coaxial relative to each other, and wherein the disk portion comprises a pierceable membrane disposed over the proximal end of the hollow cavity, wherein the pierceable membrane is coaxial with the hollow cavity, and wherein a thickness of the pierceable membrane is less than a thickness of the flange.
2. The pierceable stopper of clause 1, wherein the thickness of the pierceable membrane is in a range of about 0.5 mm to about 2.0 mm.
3. The pierceable stopper of any one of clauses 1 to 2, wherein the pierceable membrane curves into a sidewall of the proximal end of the hollow cavity.
4. The pierceable stopper of any one of clauses 1 to 3, wherein a minimum radius of curvature of a transition between the pierceable membrane and a sidewall of the proximal end of the hollow cavity is greater than about 1 mm.
5. The pierceable stopper of any one of clauses 1 to 4, wherein a ratio of a maximum width of the bulb-shaped interior cross-section to a minimum interior width of the hollow cavity is in a range of about 1.0 to about 2.0.
6. The pierceable stopper of any one of clauses 1 to 5, further comprising a rectangular cutout on at least one portion of a sidewall of the plug portion.
7. The pierceable stopper of any one of clauses 1 to 6, wherein a height of the bulb-shaped interior cross-section is between 3 mm and 8 mm.
8. A lyophilization stopper for a container, comprising: a body comprising an integral hinge means for enabling repeated penetration of the lyophilization stopper using an aspiration needle without stopper fragmentation; and a flange extending radially beyond an outer diameter of the body.
9. The lyophilization stopper of clause 8, wherein the integral hinge means comprises a molding undercut in the body.
10. The lyophilization stopper of any one of clauses 8 to 9, wherein the integral hinge means comprises a hollow cavity in the body having a bulb-shaped interior cross-section.
11. The lyophilization stopper of any one of clauses 8 to 10, wherein the integral hinge means comprises a pierceable membrane having a thickness in a range of about 0.5 mm to about 2.0 mm.
12. The lyophilization stopper of any one of clauses 8 to 11, wherein the body comprises at least one of molded halogenated butyl or molded silicone.
13. A probe assembly for piercing a container, comprising: a first needle comprising a hollow cavity and a pointed tip at a proximal end of the first needle; and a second needle disposed inside the hollow cavity of the first needle, the second needle comprising a rounded tip at a proximal end of the second needle, wherein the first needle and the second needle are positioned coaxial relative to each other, wherein the first needle and the second needle are independently actuatable, wherein the first needle is configured to move from a first position to a second position when actuated, and wherein the second needle is configured to move from a third position to a fourth position when actuated.
14. The probe assembly of clause 13, wherein: when actuated, one of the first needle and the second needle is configured to move to puncture a stopper of a container, the first needle is configured to move to puncture the stopper when the container is identified as a sample container, and the second needle is configured to move to puncture the stopper when the container is identified as a reagent container.
15. A container, comprising: a base comprising a hollow cavity; and a cylindrical structure forming an opening and extending vertically upward from the base, wherein an outer dimension of the base is greater than an outer diameter of the cylindrical structure, and wherein the base comprises a bottom surface with a convex center protruding from the bottom surface in a direction away from the hollow cavity, the convex center being configured to pool fluid in the container towards the convex center.
16. The container of clause 15, wherein the cylindrical structure includes a neck portion extending vertically upward from the base and a top portion extending vertically upward from the neck portion, an outer diameter of the top portion being greater than an outer diameter of the neck portion.
17. The container of any one of clauses 15 to 16, further comprising one or more protrusions disposed on an exterior bottom surface of the base, wherein the one or more protrusions are configured to substantially surround the convex center.
18. The container of clause 17, wherein a maximum height of the one or more protrusions is greater than a height of the convex center.
19. The container of any one of clauses 15 to 18, wherein the base is oblong in shape, the outer dimension of the base being a major axis of the oblong, and wherein the base comprises one or more indentations along a first sidewall and one or more indentations along a second sidewall.
20. The container of any one of clauses 15 to 19, wherein the convex center protrudes in a range of about 1 mm to about 3 mm in height from the bottom surface of the base in the direction away from the hollow cavity.
21. A cartridge assembly, comprising: a first housing comprising a first set of cavities, the first set of cavities being configured to accommodate one or more containers; and a second housing configured to be coupled to the first housing, the second housing comprising a second set of cavities, wherein the second set of cavities corresponds to the first set of cavities when the second housing is coupled to the first housing, wherein the second housing comprises a plurality of alignment features corresponding to the first set of cavities and the second set of cavities, wherein each of the plurality of alignment features is positioned coaxial to a center of a corresponding cavity of the first set of cavities and the second set of cavities, and wherein each of the plurality of alignment features is configured to mate with a component at a proximal end of a probe assembly.
22. The cartridge assembly of clause 21, wherein the plurality of alignment features comprises a plurality of openings on a top surface of the second housing, wherein each of the plurality of openings comprises a plurality of protrusions positioned circumferentially around each of the plurality of openings.
23. The cartridge assembly of any one of clauses 21 to 22, wherein the plurality of protrusions are biased vertically downward such that the plurality of protrusions are configured to apply a force vertically downward on top of the one or more containers accommodated in the first housing and the second housing.
24. The cartridge assembly of any one of clauses 21 to 23, wherein a plurality of the first set of cavities and corresponding cavities of the second set of cavities are configured to accommodate a single container or a plurality of containers when the first housing is coupled to the second housing.
25. The cartridge assembly of clause 24, wherein the single container is oblong in shape.
26. The cartridge assembly of any one of clauses 21 to 25, wherein the plurality of alignment features are configured to align the cartridge assembly with the probe assembly when the plurality of alignment features mate with the component at the proximal end of the probe assembly.
27. A cartridge assembly, comprising: a first housing comprising a first set of cavities, the first set of cavities being configured to accommodate one or more containers; a second housing configured to be coupled to the first housing, the second housing comprising a second set of cavities, wherein the second set of cavities corresponds to the first set of cavities when the second housing is coupled to the first housing; and wherein the cartridge assembly comprises, for each cavity of the second housing, means for aligning the cartridge assembly and a container accommodated in the cavity with a mating component at a proximal end of a probe assembly.
28. The cartridge assembly of clause 27, wherein the means for aligning the cartridge assembly and the container accommodated in the cavity comprise a means for securing the container within the cartridge assembly when the second housing is coupled to the first housing.
29. The cartridge assembly of any one of clauses 27 to 28, wherein the first housing comprises, for each cavity of the first housing, means for aligning the container accommodated in the cavity with a center of the cavity.
30. The cartridge assembly of any one of clauses 27 to 29, wherein a plurality of the first set of cavities and corresponding cavities of the second set of cavities are configured to accommodate a single container or a plurality of containers when the first housing is coupled to the second housing.
31. The cartridge assembly of clause 30, wherein the plurality of the first set of cavities and the corresponding cavities of the second set of cavities are configured to accommodate a single container, the single container being oblong in shape.
32. The cartridge assembly of any one of clauses 30 to 31, wherein the plurality of the first set of cavities and the corresponding cavities of the second set of cavities are configured to accommodate a single container, a volume of the single container being between 4 ml and 60 ml.
Moreover, while illustrative embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations or alterations based on the present disclosure. The elements in the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the steps of the disclosed methods can be modified in any manner, including by reordering steps or inserting or deleting steps. It is intended, therefore, that the specification and examples be considered as example only, with a true scope and spirit being indicated by the following claims and their full scope of equivalents.