CA2951696A1 - Devices and methods for use with a sample container - Google Patents
Devices and methods for use with a sample container Download PDFInfo
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- CA2951696A1 CA2951696A1 CA2951696A CA2951696A CA2951696A1 CA 2951696 A1 CA2951696 A1 CA 2951696A1 CA 2951696 A CA2951696 A CA 2951696A CA 2951696 A CA2951696 A CA 2951696A CA 2951696 A1 CA2951696 A1 CA 2951696A1
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- sample container
- sample
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- container
- force application
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L9/00—Supporting devices; Holding devices
- B01L9/06—Test-tube stands; Test-tube holders
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/02—Adapting objects or devices to another
- B01L2200/023—Adapting objects or devices to another adapted for different sizes of tubes, tips or container
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/08—Ergonomic or safety aspects of handling devices
- B01L2200/087—Ergonomic aspects
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/18—Means for temperature control
- B01L2300/1883—Means for temperature control using thermal insulation
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L7/00—Heating or cooling apparatus; Heat insulating devices
- B01L7/04—Heat insulating devices, e.g. jackets for flasks
Abstract
Devices and methods are provided for use with one or more sample containers. This non-limiting example of the device comprises a first portion shaped to contain at least a portion of the sample container; a second portion configured for user handling and force application; and a guide portion sized and shaped to be received in a channel of a bulk sample container; wherein the first portion and second portion are sized to minimize thermal transfer between a user and the sample container.
Description
DEVICES AND METHODS FOR USE WITH A SAMPLE CONTAINER
BACKGROUND
[00011 Analyte testing and resulting measurements are often used in clinical settings to provide a medical practitioner with data for use in medical decision making.
The method of obtaining such analyte measurements typically involves some type of sample collection from. the subject. The collected sample m.ay include blood, urine, or other liquid sample. The collection and processing of such samples can present certain challenges to the personnel in charge of sample collection, preparation, and/or handling.
INCORPORATION BY REFERENCE
[00021 All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.
COPYRIGHT
[00031 This document contains material subject to copyright protection.
The copyright owner (Applicant herein) has no objection to facsimile reproduction of the patent documents and disclosures, as they appear in the US Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. The following notice shall apply: Copyright 2013-2015 Theranos, Inc.
SUMMARY
100041 The disadvantages associated with the prior art are overcome by at least some embodiments described herein.
100051 In one embodiment, a device is provided for use with a sample container. This non-limiting example of the device comprises a first portion shaped to contain at least a portion of the sample container; a second portion configured for user handling and force application; and a guide portion sized and shaped to be received in a channel of a bulk sample container; wherein the first portion and second portion are sized to minimize thermal transfer between a user and the sample container.
100061 in another embodiment, a device is provided for use with a sample container.
This non-limiting example of the device comprises a first portion shaped to contain at least a portion of the sample container; a second portion configured for user handling and force application from a proximal end of the device; and a guide portion.
100071 in another embodiment, a device is provided for use with a sample, such as but not limited to a bodily fluid sample. This non-limiting example of the device comprises a first portion defining a sample container; a second portion configured for user handling and force application from a proximal end of the device; and a guide portion.
100081 Optionally, any of the embodiments herein may be adapted with one or more of the following. For example, the first portion may define a cavity for holding the sample container. Optionally, the second portion defines at least a bottom surface of the device.
Optionally, the second portion defines a grip surface on the device.
Optionally, the second portion defines an indented grip feature on the device. Optionally, the guide portion defines at least one interface surface that is configured to contact at least a portion of the channel.
Optionally, the guide portion has a cross-sectional shape matching a channel cross-sectional shape. Optionally, the second portion has at least one flat side to prevent undesired rolling of the device when placed on a side surface. Optionally, the channel comprises an access channel.
Optionally, the channel comprises a guide channel. Optionally, the first portion and second portion comprise a thermally insulating material. Optionally, the first portion and second portion provide a dual function device that is both a device alignment guide and a reduced thermal conductivity user handling surface. Optionally, the first portion defines a plurality of openings configured to show the sample container when the sample container is positioned therein.
Optionally, the first portion defines view windows into a container holding area of the device.
Optionally, the sample container has a length along a longitudinal axis that is less than a length along a longitudinal axis of the device. Optionally, a cartridge is provided that is sized to receive the sample container, wherein the sample container has a length allowing the sample container to be placed substantially fully within the cartridge while the sample container is in a non-horizontal orientation. Optionally, the device has a length along a longitudinal axis that is less than a height of the cartridge. Optionally, a cartridge is provided that is sized to receive the
BACKGROUND
[00011 Analyte testing and resulting measurements are often used in clinical settings to provide a medical practitioner with data for use in medical decision making.
The method of obtaining such analyte measurements typically involves some type of sample collection from. the subject. The collected sample m.ay include blood, urine, or other liquid sample. The collection and processing of such samples can present certain challenges to the personnel in charge of sample collection, preparation, and/or handling.
INCORPORATION BY REFERENCE
[00021 All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.
COPYRIGHT
[00031 This document contains material subject to copyright protection.
The copyright owner (Applicant herein) has no objection to facsimile reproduction of the patent documents and disclosures, as they appear in the US Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. The following notice shall apply: Copyright 2013-2015 Theranos, Inc.
SUMMARY
100041 The disadvantages associated with the prior art are overcome by at least some embodiments described herein.
100051 In one embodiment, a device is provided for use with a sample container. This non-limiting example of the device comprises a first portion shaped to contain at least a portion of the sample container; a second portion configured for user handling and force application; and a guide portion sized and shaped to be received in a channel of a bulk sample container; wherein the first portion and second portion are sized to minimize thermal transfer between a user and the sample container.
100061 in another embodiment, a device is provided for use with a sample container.
This non-limiting example of the device comprises a first portion shaped to contain at least a portion of the sample container; a second portion configured for user handling and force application from a proximal end of the device; and a guide portion.
100071 in another embodiment, a device is provided for use with a sample, such as but not limited to a bodily fluid sample. This non-limiting example of the device comprises a first portion defining a sample container; a second portion configured for user handling and force application from a proximal end of the device; and a guide portion.
100081 Optionally, any of the embodiments herein may be adapted with one or more of the following. For example, the first portion may define a cavity for holding the sample container. Optionally, the second portion defines at least a bottom surface of the device.
Optionally, the second portion defines a grip surface on the device.
Optionally, the second portion defines an indented grip feature on the device. Optionally, the guide portion defines at least one interface surface that is configured to contact at least a portion of the channel.
Optionally, the guide portion has a cross-sectional shape matching a channel cross-sectional shape. Optionally, the second portion has at least one flat side to prevent undesired rolling of the device when placed on a side surface. Optionally, the channel comprises an access channel.
Optionally, the channel comprises a guide channel. Optionally, the first portion and second portion comprise a thermally insulating material. Optionally, the first portion and second portion provide a dual function device that is both a device alignment guide and a reduced thermal conductivity user handling surface. Optionally, the first portion defines a plurality of openings configured to show the sample container when the sample container is positioned therein.
Optionally, the first portion defines view windows into a container holding area of the device.
Optionally, the sample container has a length along a longitudinal axis that is less than a length along a longitudinal axis of the device. Optionally, a cartridge is provided that is sized to receive the sample container, wherein the sample container has a length allowing the sample container to be placed substantially fully within the cartridge while the sample container is in a non-horizontal orientation. Optionally, the device has a length along a longitudinal axis that is less than a height of the cartridge. Optionally, a cartridge is provided that is sized to receive the
2 sample container, wherein the sample container has a length allowing the sample container to be placed substantially fully within the cartridge while the sample container is in a non-horizontal orientation. Optionally, the sample container comprises a septa in at least one end of the container, wherein the septa defines a re-sealable fluid access port.
Optionally, the sample container comprises a liquid impermeable, gas permeable vent. Optionally, the sample container comprises a vent.
100091 it should be understood that embodiments in this disclosure may be adapted to have one or more of the features described below. In one nonlimiting example, other non-blood samples can be used in the container, such as but not limited to semen, vaginal fluid, or other liquid sample.
100101 In at least another embodiment described herein, a device is provided for use with a sample, the device comprising: a first portion defining a sample container;
a second portion configured for user handling and force application from a proximal end of the device.
[0011) In at least another embodiment described herein, a method is provided for use with a sample, the method comprising: using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device.
[00121 In at least another embodiment described herein, a method is provided for use with a sample, the method comprising: using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 200 microliters or less.
100131 In at least another embodiment described herein, a method is provided for use with a sample, the method comprising: using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 300 microliters or less.
100141 in at least another embodiment described herein, a method is provided for use with a sample, the method comprising: using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application
Optionally, the sample container comprises a liquid impermeable, gas permeable vent. Optionally, the sample container comprises a vent.
100091 it should be understood that embodiments in this disclosure may be adapted to have one or more of the features described below. In one nonlimiting example, other non-blood samples can be used in the container, such as but not limited to semen, vaginal fluid, or other liquid sample.
100101 In at least another embodiment described herein, a device is provided for use with a sample, the device comprising: a first portion defining a sample container;
a second portion configured for user handling and force application from a proximal end of the device.
[0011) In at least another embodiment described herein, a method is provided for use with a sample, the method comprising: using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device.
[00121 In at least another embodiment described herein, a method is provided for use with a sample, the method comprising: using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 200 microliters or less.
100131 In at least another embodiment described herein, a method is provided for use with a sample, the method comprising: using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 300 microliters or less.
100141 in at least another embodiment described herein, a method is provided for use with a sample, the method comprising: using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application
3 from a proximal end of the device, wherein the sample container has an internal volume of about 400 microliters or less.
100151 in at least another embodiment described herein, a method is provided for use with a sample, the method comprising: using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 500 microliters or less.
100161 Optionally, any of the embodiments herein may be adapted with one or more of the following. For example, a device at least one technical feature from one or more of the embodiments herein. Optionally, a method may comprise at least any two technical features from one or more of the embodiments herein. Optionally, a device may comprise at least one technical feature from one or more of the embodiments herein. Optionally, a device may comprise at least one or more two technical features from one or more of the embodiments herein. Optionally, a system may comprise at least one technical feature from one or more of the embodiments herein. Optionally, a system may comprise at least any two technical features from one or more of the embodiments herein.
100171 This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
BRIEF DESCRIPTION OF THE DRAWINGS
100181 Figures 1 A to IB show perspective views of one embodiment as described herein.
100191 Figures 2A to 2B show perspective views of another embodiment as described herein.
100201 Figures 3A to 3C show perspective views of other embodiments as described herein.
100211 Figures 4A to 4B show perspective views of other embodiments as described herein.
100221 Figures 5A to 5C show various views of embodiments as described herein.
100151 in at least another embodiment described herein, a method is provided for use with a sample, the method comprising: using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 500 microliters or less.
100161 Optionally, any of the embodiments herein may be adapted with one or more of the following. For example, a device at least one technical feature from one or more of the embodiments herein. Optionally, a method may comprise at least any two technical features from one or more of the embodiments herein. Optionally, a device may comprise at least one technical feature from one or more of the embodiments herein. Optionally, a device may comprise at least one or more two technical features from one or more of the embodiments herein. Optionally, a system may comprise at least one technical feature from one or more of the embodiments herein. Optionally, a system may comprise at least any two technical features from one or more of the embodiments herein.
100171 This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
BRIEF DESCRIPTION OF THE DRAWINGS
100181 Figures 1 A to IB show perspective views of one embodiment as described herein.
100191 Figures 2A to 2B show perspective views of another embodiment as described herein.
100201 Figures 3A to 3C show perspective views of other embodiments as described herein.
100211 Figures 4A to 4B show perspective views of other embodiments as described herein.
100221 Figures 5A to 5C show various views of embodiments as described herein.
4
5 PCT/US2015/035893 100231 Figures 6A to 7B show methods of using sample containers to engage larger containers according to various embodiments herein.
100241 Figure 8 shows a perspective view of a cartridge configured to receive at least one sample container according to an embodiment as described herein.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
100251 it is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. It may be noted that, as used in the specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a material" may include mixtures of materials, reference to "a compound" may include multiple compounds, and the like.
References cited herein are hereby incorporated by reference in their entirety, except to the extent that they conflict with teachings explicitly set forth in this specification.
100261 In this specification and in the claims which follow, reference will be made to a number of terms which shall be defined to have the following meanings:
100271 "Optional" or "optionally" means that the subsequently described circumstance may or may not occur, so that the description includes instances where the circumstance occurs and instances where it does not. For example, if a device optionally contains a feature for a sample collection unit, this means that the sample collection unit may or may not be present, and, thus, the description includes both structures wherein a device possesses the sample collection unit and structures wherein sample collection unit is not present.
100281 As used herein, the terms "substantial" means more than a minimal or insignificant amount; and "substantially" means more than a minimally or insignificantly. Thus, for example, the phrase "substantially different", as used herein, denotes a sufficiently high degree of difference between two numeric values such that one of skill in the art would consider the difference between the two values to be of statistical significance within the context of the characteristic measured by said values. Thus, the difference between two values that are substantially different from each other is typically greater than about 10%, and may be greater than about 20%, preferably greater than about 30%, preferably greater than about 40%, preferably greater than about 50% as a function of the reference value or comparator value.
100291 As used herein, a "sample" may be but is not limited to a blood sample, or a portion of a blood sample, may be of any suitable size or volume, and is preferably of small size or volume, in some embodiments of the assays and methods disclosed herein, measurements may be made using a small volume blood sample, or no more than a small volume portion of a blood sample, where a small volume comprises no more than about 5 mL; or comprises no more than about 3 mL; or comprises no more than about 2 mL; or comprises no more than about 1 mL;
or comprises no more than about 500 p.L; or comprises no more than about 250 lit; or comprises no more than about 100 AL; or comprises no more than about 75 L; or comprises no more than about 50 AL; or comprises no more than about 35 L; or comprises no more than about 25 pL;
or comprises no more than about 20 lit; or comprises no more than about 15 AL;
or comprises no more than about 10 gL; or comprises no more than about 8 L; or comprises no more than about 6 I..; or comprises no more than about 5 lit; or comprises no more than about 4 AL; or comprises no more than about 3 pL; or comprises no more than about 2 jaL; or comprises no more than about 1 AL; or comprises no more than about 0.8 nt; or comprises no more than about 0.5 AL; or comprises no more than about 0.3 tit; or comprises no more than about 0.2 nt; or comprises no more than about 0.1111.4 or comprises no more than about 0.05111.4 or comprises no more than about 0.01 pL.
100301 As used herein, the term "point of service location" may include locations where a subject may receive a service (e.g. testing, monitoring, treatment, diagnosis, guidance, sample collection, ID verification, medical services, non-medical services, etc.), and may include, without limitation, a subject's home, a subject's business, the location of a healthcare provider (e.g., doctor), hospitals, emergency rooms, operating rooms, clinics, health care professionals' offices, laboratories, retailers [e.g. pharmacies (e.g., retail pharmacy, clinical pharmacy, hospital pharmacy), drugstores, supermarkets, grocers, etc.], transportation vehicles (e.g. car, boat, truck, bus, airplane, motorcycle, ambulance, mobile unit, fire engine/truck, emergency vehicle, law enforcement vehicle, police car, or other vehicle configured to transport a subject from one point to another, etc.), traveling medical care units, mobile units, schools, day-care centers, security screening locations, combat locations, health assisted living residences, government offices, office buildings, tents, bodily fluid sample acquisition sites (e.g. blood collection centers), sites
100241 Figure 8 shows a perspective view of a cartridge configured to receive at least one sample container according to an embodiment as described herein.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
100251 it is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. It may be noted that, as used in the specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a material" may include mixtures of materials, reference to "a compound" may include multiple compounds, and the like.
References cited herein are hereby incorporated by reference in their entirety, except to the extent that they conflict with teachings explicitly set forth in this specification.
100261 In this specification and in the claims which follow, reference will be made to a number of terms which shall be defined to have the following meanings:
100271 "Optional" or "optionally" means that the subsequently described circumstance may or may not occur, so that the description includes instances where the circumstance occurs and instances where it does not. For example, if a device optionally contains a feature for a sample collection unit, this means that the sample collection unit may or may not be present, and, thus, the description includes both structures wherein a device possesses the sample collection unit and structures wherein sample collection unit is not present.
100281 As used herein, the terms "substantial" means more than a minimal or insignificant amount; and "substantially" means more than a minimally or insignificantly. Thus, for example, the phrase "substantially different", as used herein, denotes a sufficiently high degree of difference between two numeric values such that one of skill in the art would consider the difference between the two values to be of statistical significance within the context of the characteristic measured by said values. Thus, the difference between two values that are substantially different from each other is typically greater than about 10%, and may be greater than about 20%, preferably greater than about 30%, preferably greater than about 40%, preferably greater than about 50% as a function of the reference value or comparator value.
100291 As used herein, a "sample" may be but is not limited to a blood sample, or a portion of a blood sample, may be of any suitable size or volume, and is preferably of small size or volume, in some embodiments of the assays and methods disclosed herein, measurements may be made using a small volume blood sample, or no more than a small volume portion of a blood sample, where a small volume comprises no more than about 5 mL; or comprises no more than about 3 mL; or comprises no more than about 2 mL; or comprises no more than about 1 mL;
or comprises no more than about 500 p.L; or comprises no more than about 250 lit; or comprises no more than about 100 AL; or comprises no more than about 75 L; or comprises no more than about 50 AL; or comprises no more than about 35 L; or comprises no more than about 25 pL;
or comprises no more than about 20 lit; or comprises no more than about 15 AL;
or comprises no more than about 10 gL; or comprises no more than about 8 L; or comprises no more than about 6 I..; or comprises no more than about 5 lit; or comprises no more than about 4 AL; or comprises no more than about 3 pL; or comprises no more than about 2 jaL; or comprises no more than about 1 AL; or comprises no more than about 0.8 nt; or comprises no more than about 0.5 AL; or comprises no more than about 0.3 tit; or comprises no more than about 0.2 nt; or comprises no more than about 0.1111.4 or comprises no more than about 0.05111.4 or comprises no more than about 0.01 pL.
100301 As used herein, the term "point of service location" may include locations where a subject may receive a service (e.g. testing, monitoring, treatment, diagnosis, guidance, sample collection, ID verification, medical services, non-medical services, etc.), and may include, without limitation, a subject's home, a subject's business, the location of a healthcare provider (e.g., doctor), hospitals, emergency rooms, operating rooms, clinics, health care professionals' offices, laboratories, retailers [e.g. pharmacies (e.g., retail pharmacy, clinical pharmacy, hospital pharmacy), drugstores, supermarkets, grocers, etc.], transportation vehicles (e.g. car, boat, truck, bus, airplane, motorcycle, ambulance, mobile unit, fire engine/truck, emergency vehicle, law enforcement vehicle, police car, or other vehicle configured to transport a subject from one point to another, etc.), traveling medical care units, mobile units, schools, day-care centers, security screening locations, combat locations, health assisted living residences, government offices, office buildings, tents, bodily fluid sample acquisition sites (e.g. blood collection centers), sites
6 at or near an entrance to a location that a subject may wish to access, sites on or near a device that a subject may wish to access (e.g., the location of a computer if the subject wishes to access the computer), a location where a sample processing device receives a sample, or any other point of service location described elsewhere herein.
100311 Referring now to Figures IA and 1B, non-limiting examples of devices for use with sample containers are shown. Figure IA shows one embodiment of a sample container 10 at least partially surrounded by an adapter 20. It should be understood that the adapter 20, in the present embodiment, is configured to have an outer peripheral surface that is sized to engage a channel, cavity, or other feature on larger sample container. This allows the sample container 10 to be received in a channel sized for a larger container while the sample container 10 can be disengaged from the adapter 20 so that the sample container 10, with its smaller form factor, can be received in a cartridge where it is desirable that the sample container 10 occupy a minimum footprint, minimum volume, or other size requirement. Although Figure IA shows an adapter 20 with a circular cross-sectional shape for a sample container 10 with a circular cross-sectional shape, it should be understood that other embodiments may have a sample container 10 with one peripheral cross-sectional shape that is received by an adapter 20 with a different peripheral cross-sectional shape. Optionally, some embodiments may have an adapter 20 with both the inner and outer peripheral surfaces having cross-sectional shapes that do not match the shape of the sample container 10.
100321 By way of non-limiting example, one embodiment of container 10 can be sized to have an internal volume of about 100 uL or less. Optionally, another embodiment of container is sized to have an internal volume of about 150 uL or less. Optionally, another embodiment of container 10 is sized to have an internal volume of about 200 uL or less.
Optionally, another embodiment of container 10 is sized to have an internal volume of about 250 uL
or less.
Optionally, another embodiment of container 10 is sized to have an internal volume of about 300 uL or less. Optionally, another embodiment of container 10 is sized to have an internal volume of about 350 uL or less. Optionally, another embodiment of container 10 is sized to have an internal volume of about 400 uL or less. Optionally, another embodiment of container 10 is sized to have an internal volume of about 450 uL or less. Optionally, another embodiment of container 10 is sized to have an internal volume of about 500 uL or less.
Optionally, another embodiment of container 10 is sized to have an internal volume of about 600 uL
or less.
100311 Referring now to Figures IA and 1B, non-limiting examples of devices for use with sample containers are shown. Figure IA shows one embodiment of a sample container 10 at least partially surrounded by an adapter 20. It should be understood that the adapter 20, in the present embodiment, is configured to have an outer peripheral surface that is sized to engage a channel, cavity, or other feature on larger sample container. This allows the sample container 10 to be received in a channel sized for a larger container while the sample container 10 can be disengaged from the adapter 20 so that the sample container 10, with its smaller form factor, can be received in a cartridge where it is desirable that the sample container 10 occupy a minimum footprint, minimum volume, or other size requirement. Although Figure IA shows an adapter 20 with a circular cross-sectional shape for a sample container 10 with a circular cross-sectional shape, it should be understood that other embodiments may have a sample container 10 with one peripheral cross-sectional shape that is received by an adapter 20 with a different peripheral cross-sectional shape. Optionally, some embodiments may have an adapter 20 with both the inner and outer peripheral surfaces having cross-sectional shapes that do not match the shape of the sample container 10.
100321 By way of non-limiting example, one embodiment of container 10 can be sized to have an internal volume of about 100 uL or less. Optionally, another embodiment of container is sized to have an internal volume of about 150 uL or less. Optionally, another embodiment of container 10 is sized to have an internal volume of about 200 uL or less.
Optionally, another embodiment of container 10 is sized to have an internal volume of about 250 uL
or less.
Optionally, another embodiment of container 10 is sized to have an internal volume of about 300 uL or less. Optionally, another embodiment of container 10 is sized to have an internal volume of about 350 uL or less. Optionally, another embodiment of container 10 is sized to have an internal volume of about 400 uL or less. Optionally, another embodiment of container 10 is sized to have an internal volume of about 450 uL or less. Optionally, another embodiment of container 10 is sized to have an internal volume of about 500 uL or less.
Optionally, another embodiment of container 10 is sized to have an internal volume of about 600 uL
or less.
7 100331 Figure IA also shows that the adapter 20, in one embodiment, only covers a portion of the sample container 10, such as but not limited to not extending along an entire length of the sample container 10. Some embodiments may additionally, or alternatively, only cover a portion of the perimeter of the sample container 10. For example, some embodiments may have cutouts in the outer peripheral surface of the adapter 20 so that the adapter 20 does not define a continuous surface around at least a portion of the perimeter of sample container 10. In such a non-limiting example, there may be some cost savings, materials saving, or the like while substantially allowing the sample container 10 to have an expanded perimeter or other external shape to facilitate interaction with another device. Although the sample container 10 and adapter 20 combination is typically used to engage a channel or cavity of a larger sample container (not shown), it should be understood that the sample container 10 and adapter 20 combination can also be used to engage other devices and is not limited to sample containers.
100341 As seen in Figure 1A, this embodiment of the sample container 10 shows that some containers 10 may include or be used with a structure with at least one resealable access feature, such as but not limited to a pierceable septa, self-sealing port, or similar structure that allows for a piercing element to enter but then be able to provide a fluid tight seal after the piercing element is removed.
[00351 Referring now to Figure 1B, another embodiment of an adapter 30 for use with a sample container 10 will now be described. In this non-limiting example, the adapter 30 covers at least a portion of the sample container 10. In one embodiment, the adapter 30 covers only a portion and not all of the side wall length of the sample container 10. Figure 1B shows that the adapter 30 has an outer cross-sectional shape that is different from the inner cross-sectional shape. In the present non-limiting example, the adapter 30 has an outer cross-sectional shape that is square and an inner cross-sectional shape that is circular. Of course, these shapes are exemplary and the shapes are not limited to those shown. For example, some embodiments may have oval outer cross-sectional shape and a square inner cross-sectional shape. Other combinations of shapes are possible and are not excluded. In one non-limiting example, the inner cross-sectional shape is configured (such as but not limited to shape and/or size) to engage the sample container 10 while the outer cross-sectional shape is configured (such as but not limited to shape and/or size) to engage an opening, cavity, or receiving location of another device or container. In one embodiment, the outer cross-sectional shape is configured to one that
100341 As seen in Figure 1A, this embodiment of the sample container 10 shows that some containers 10 may include or be used with a structure with at least one resealable access feature, such as but not limited to a pierceable septa, self-sealing port, or similar structure that allows for a piercing element to enter but then be able to provide a fluid tight seal after the piercing element is removed.
[00351 Referring now to Figure 1B, another embodiment of an adapter 30 for use with a sample container 10 will now be described. In this non-limiting example, the adapter 30 covers at least a portion of the sample container 10. In one embodiment, the adapter 30 covers only a portion and not all of the side wall length of the sample container 10. Figure 1B shows that the adapter 30 has an outer cross-sectional shape that is different from the inner cross-sectional shape. In the present non-limiting example, the adapter 30 has an outer cross-sectional shape that is square and an inner cross-sectional shape that is circular. Of course, these shapes are exemplary and the shapes are not limited to those shown. For example, some embodiments may have oval outer cross-sectional shape and a square inner cross-sectional shape. Other combinations of shapes are possible and are not excluded. In one non-limiting example, the inner cross-sectional shape is configured (such as but not limited to shape and/or size) to engage the sample container 10 while the outer cross-sectional shape is configured (such as but not limited to shape and/or size) to engage an opening, cavity, or receiving location of another device or container. In one embodiment, the outer cross-sectional shape is configured to one that
8 minimizes "rolling" of the container and adapter when they are placed in a substantially horizontal configuration on a work surface such as a table. As seen in Figure 1B, the thickness of the adapter 30 can also be configured to allow for the smaller container 10 to fit in a larger opening with the adapter 30 acting as a guide to align the container 10 to engage a needle, tube, or other connector for the other device. In one embodiment, the guide portion has a size and shape closer to the cross-sectional shape of the receiver R in the bulk container. Optionally, it may be as long as the container 10. Optionally, it is less than 1/2 of the length of the container 10.
As seen, the container 10 may have an outer circumference or perimeter outline smaller than the outer circumference or perimeter outline of the guide portion.
[00361 Referring now to Figures 2A and 2B, still further embodiments of adapters 40 and 50 will now be described. Figure 2A shows one non-limiting example of an adapter 40 for use with a sample container 10. The sample container 10 may be a cylindrical vessel that may be used to contain a sample fluid therein. The adapter 40 in this non-limiting example may have a handling feature 42 on a portion of the adapter 40. Optionally, some embodiments may include a support feature 44 (shown in phantom) that allows the adapter 40 to self-standing in a vertical or substantially vertical configuration. In this non-limiting example, the support feature 44 may be a support piece with at least one planar surface and that has a cross-sectional shape such as but not limited to rectangular, circular, or other shaped. Similar to the embodiments of Figures I A
and 1B, the adapter 40 may have different or same inner and outer cross-sectional shapes.
[00371 Figure 2B shows an embodiment wherein the adapter 50 has a reduced height support feature 54. Figure 2B is a cross-sectional view that is configured to allow easier visualization of the sample S in the sample container 10. The embodiment of Figure 23 has a bottom mounted support feature 54 that enables force application as indicated by arrow 56. This may be helpful for facilitating placement and/or movement of the sample container 10 into an external device.
[00381 Figures 3A to 3C show still further embodiments of adapters having different outer cross-sectional shapes. Figure 3A shows an adapter 60 having a "ridged"
exterior having a plurality of circular outer cross-sections of different diameters. Figure 3B
shows an adapter 70 with a gear tooth shaped outer cross-section. Figure 313 shows an adapter 80 with a flower shaped outer cross-section. As seen in these embodiments, the inner cross-sectional shape remains one with a circular cross-section to facilitate engagement with a vessel such as but not
As seen, the container 10 may have an outer circumference or perimeter outline smaller than the outer circumference or perimeter outline of the guide portion.
[00361 Referring now to Figures 2A and 2B, still further embodiments of adapters 40 and 50 will now be described. Figure 2A shows one non-limiting example of an adapter 40 for use with a sample container 10. The sample container 10 may be a cylindrical vessel that may be used to contain a sample fluid therein. The adapter 40 in this non-limiting example may have a handling feature 42 on a portion of the adapter 40. Optionally, some embodiments may include a support feature 44 (shown in phantom) that allows the adapter 40 to self-standing in a vertical or substantially vertical configuration. In this non-limiting example, the support feature 44 may be a support piece with at least one planar surface and that has a cross-sectional shape such as but not limited to rectangular, circular, or other shaped. Similar to the embodiments of Figures I A
and 1B, the adapter 40 may have different or same inner and outer cross-sectional shapes.
[00371 Figure 2B shows an embodiment wherein the adapter 50 has a reduced height support feature 54. Figure 2B is a cross-sectional view that is configured to allow easier visualization of the sample S in the sample container 10. The embodiment of Figure 23 has a bottom mounted support feature 54 that enables force application as indicated by arrow 56. This may be helpful for facilitating placement and/or movement of the sample container 10 into an external device.
[00381 Figures 3A to 3C show still further embodiments of adapters having different outer cross-sectional shapes. Figure 3A shows an adapter 60 having a "ridged"
exterior having a plurality of circular outer cross-sections of different diameters. Figure 3B
shows an adapter 70 with a gear tooth shaped outer cross-section. Figure 313 shows an adapter 80 with a flower shaped outer cross-section. As seen in these embodiments, the inner cross-sectional shape remains one with a circular cross-section to facilitate engagement with a vessel such as but not
9 limited to sample container 10. As seen in Figures 3A to 3C, by having the outer cross-sectional shape differ from the inner cross-sectional shape, the shape of the sample container 10 can be configured not to limit the type of cavity shape that the container 10 can be used with. Figures 3A to 3C also show that the adapter can be configured to have at least two different inner diameter cavities such as at least a first dimension 90 and at least a second dimension 92.
100391 Referring now to Figures 4A and 4B, still further embodiments are shown of a sample container adapter. in this embodiment of Figure 4A, at least one portion 110 of the adapter 100 is shaped, sized, or otherwise configured to match an opening or cavity in another device or object. As seem in Figure 4A, other parts 120 of the adapter 100 can have at least one of a different shape, a different size, or both. Figure 4A also shows that this embodiment of adapter 100 includes at least one open view area 130 that allows a sample container 10 in the adapter 100 to be visually observed. This may be helpful in visualizing the sample level in the container 10. This may also be helpful in providing a qualitative assessment of the sample fluid in the container 10. Adapter 100 can also have an indented grip feature 140 that can facilitate handling of the adapter 100 by a user, particularly by a gloved user wherein the manual dexterity of the user may be reduced. As seen in Figure 4A, the interior 106 of the adapter 100 can be shaped to match a contour of the sample container 10 to be placed therein.
[00401 Referring now to Figure 4B, a still further embodiment of a sample container adapter will now be described. The embodiment of adapter 150 in Figure 4B is similar to the adapter 100 show in Figure 4A. Figure 4B shows that the lower portion 152 is a flat surface without an indented surface as seen in the embodiment of Figure 4A. In some embodiments, having a flat surface may be simpler to manufacture. A flat surface may also be easier to clean or sterilize. Similarly, an interface portion 154 may be sized, shaped, or otherwise configured to engage a cavity, opening, or other receiving area in an external device or container.
100411 Figure 5A shows yet another embodiment similar to that of Figure 4A, except that this embodiment further shows that one or more surfaces can be shaped to facilitate user handling of the adapter 160. In this non-limiting example, at least one surface 162 is contoured to accommodate a user's digit. Although not limited to the above, these finger feature(s) can facilitate the handling of the adapter, particularly if the adapter is sized to hold containers smaller than the typical vacuum container. This non-limiting embodiment also shows that at least one side surface 164 of the adapter 160 can also be shaped such as but not limited to being contoured, textured, andlor otherwise configured to facilitate handling by a user.
100421 Figures 4A, 4B, and 5A also show that at least some embodiments described herein, the cross-sectional shape of a first portion the adapter is different from at least the cross-sectional shape of a second portion of the adapter. In this manner, a shape that may be selected for one purpose, such as but not limited to being a guide into a recess or cavity, can be combined with a second shape that may be selected for another purpose, such as but not limited to preventing the adapter from rolling when adapter is placed on a surface in horizontal configuration. By way of non-limiting example, one embodiment may have a round cross-sectional shape that is combined on the adapter to have a second cross-sectional shape with at least one flat, substantially flat, and/or concave surface to prevent rolling when the adapter is in a lateral orientation.
100431 Figures 5B and 5C show cross-sectional views of at least two other cross-sectional shapes 170 and 180 that may be suitable to satisfy the role of anti-rolling cross-section by having at least one anti-rolling surface 172 and 182 respectively.
100441 Thermal issue(s) can also be addressed through the use of adapter such as but not limited to those shown in the figures herein. The type of sample being collected can be, but is not limited to, biological waste fluid. Handling waste fluid can instill some nausea, negative feeling, or other negative reaction in some users handling such samples. In one non-limiting example, a sample of waste fluid such as urine is typically at a temperature higher than ambient temperature. Although this does not usually happen, user handling this sample may harbor some less-than-fully positive feeling of having to handle this type of sample.
This less-than-fully feeling may be amplified when the user can feeling the warmth of the sample through their skin or through their gloves by way of direct contact with the wall of the sample container.
100451 Having the adapter places a thermally insulating barrier between the user and the sample container. Due to the lack of direct contact with the walls of the sample container, the user is provided a more hygienic sensation when handling such samples. In some embodiments, the user can still visually observe the sample in the container, not having to feel the increased temperature can mitigate any amplification of a less-than-fully positive feeling of having to handle this type of sample.
100461 it should be understood that although many samples herein use sample containers that are separable from the adapter, it should understood that integrally formed sample containers and adapters (such as but not limited to being a single piece) are not excluded and may be alternative embodiments.
100471 Referring now to Figures 6A to 6B, one embodiment of an external sample collector C with a receptor R is shown for receiving a traditional sample collection tube T. in this non-limiting example, the sample collection tube T is configured to be lowered into the receptor R to withdraw sample from the external sample collector C and the raised above the collector C as indicated by arrow 200.
[00481 Figure 6B shows that in at least one embodiment herein, an adapter such as but not limited to adapter 40 can be used with a sample container 10 to withdraw sample from the external sample collector C. As seen in Figure 6B, the combination of the sample container 10 and the adapter 40 are lowered and raised as indicated by arrow 202. By way of non-limiting example, the sample container 10 may have an initial interior volume under vacuum conditions, and this vacuum force draws sample into the container 10 when the container 10 is in fluid communication with the container C. Optionally, a syringe-type unit or other force can be used to draw sample from external sample collector C into the container 10.
[00491 As seen in Figure 6B, the container 10 is significantly smaller than the traditional collection tube T. in one embodiment, the container 10 has an internal volume at least about 10x smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about llx smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about 12x smaller than an internal volume of tube T.
Optionally, the container 10 has an internal volume at least about 13x smaller than an internal volume of tube T.
Optionally, the container 10 has an internal volume at least about 14x smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about 15x smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about 9x smaller than an internal volume of tube T. Optionally, the container
100391 Referring now to Figures 4A and 4B, still further embodiments are shown of a sample container adapter. in this embodiment of Figure 4A, at least one portion 110 of the adapter 100 is shaped, sized, or otherwise configured to match an opening or cavity in another device or object. As seem in Figure 4A, other parts 120 of the adapter 100 can have at least one of a different shape, a different size, or both. Figure 4A also shows that this embodiment of adapter 100 includes at least one open view area 130 that allows a sample container 10 in the adapter 100 to be visually observed. This may be helpful in visualizing the sample level in the container 10. This may also be helpful in providing a qualitative assessment of the sample fluid in the container 10. Adapter 100 can also have an indented grip feature 140 that can facilitate handling of the adapter 100 by a user, particularly by a gloved user wherein the manual dexterity of the user may be reduced. As seen in Figure 4A, the interior 106 of the adapter 100 can be shaped to match a contour of the sample container 10 to be placed therein.
[00401 Referring now to Figure 4B, a still further embodiment of a sample container adapter will now be described. The embodiment of adapter 150 in Figure 4B is similar to the adapter 100 show in Figure 4A. Figure 4B shows that the lower portion 152 is a flat surface without an indented surface as seen in the embodiment of Figure 4A. In some embodiments, having a flat surface may be simpler to manufacture. A flat surface may also be easier to clean or sterilize. Similarly, an interface portion 154 may be sized, shaped, or otherwise configured to engage a cavity, opening, or other receiving area in an external device or container.
100411 Figure 5A shows yet another embodiment similar to that of Figure 4A, except that this embodiment further shows that one or more surfaces can be shaped to facilitate user handling of the adapter 160. In this non-limiting example, at least one surface 162 is contoured to accommodate a user's digit. Although not limited to the above, these finger feature(s) can facilitate the handling of the adapter, particularly if the adapter is sized to hold containers smaller than the typical vacuum container. This non-limiting embodiment also shows that at least one side surface 164 of the adapter 160 can also be shaped such as but not limited to being contoured, textured, andlor otherwise configured to facilitate handling by a user.
100421 Figures 4A, 4B, and 5A also show that at least some embodiments described herein, the cross-sectional shape of a first portion the adapter is different from at least the cross-sectional shape of a second portion of the adapter. In this manner, a shape that may be selected for one purpose, such as but not limited to being a guide into a recess or cavity, can be combined with a second shape that may be selected for another purpose, such as but not limited to preventing the adapter from rolling when adapter is placed on a surface in horizontal configuration. By way of non-limiting example, one embodiment may have a round cross-sectional shape that is combined on the adapter to have a second cross-sectional shape with at least one flat, substantially flat, and/or concave surface to prevent rolling when the adapter is in a lateral orientation.
100431 Figures 5B and 5C show cross-sectional views of at least two other cross-sectional shapes 170 and 180 that may be suitable to satisfy the role of anti-rolling cross-section by having at least one anti-rolling surface 172 and 182 respectively.
100441 Thermal issue(s) can also be addressed through the use of adapter such as but not limited to those shown in the figures herein. The type of sample being collected can be, but is not limited to, biological waste fluid. Handling waste fluid can instill some nausea, negative feeling, or other negative reaction in some users handling such samples. In one non-limiting example, a sample of waste fluid such as urine is typically at a temperature higher than ambient temperature. Although this does not usually happen, user handling this sample may harbor some less-than-fully positive feeling of having to handle this type of sample.
This less-than-fully feeling may be amplified when the user can feeling the warmth of the sample through their skin or through their gloves by way of direct contact with the wall of the sample container.
100451 Having the adapter places a thermally insulating barrier between the user and the sample container. Due to the lack of direct contact with the walls of the sample container, the user is provided a more hygienic sensation when handling such samples. In some embodiments, the user can still visually observe the sample in the container, not having to feel the increased temperature can mitigate any amplification of a less-than-fully positive feeling of having to handle this type of sample.
100461 it should be understood that although many samples herein use sample containers that are separable from the adapter, it should understood that integrally formed sample containers and adapters (such as but not limited to being a single piece) are not excluded and may be alternative embodiments.
100471 Referring now to Figures 6A to 6B, one embodiment of an external sample collector C with a receptor R is shown for receiving a traditional sample collection tube T. in this non-limiting example, the sample collection tube T is configured to be lowered into the receptor R to withdraw sample from the external sample collector C and the raised above the collector C as indicated by arrow 200.
[00481 Figure 6B shows that in at least one embodiment herein, an adapter such as but not limited to adapter 40 can be used with a sample container 10 to withdraw sample from the external sample collector C. As seen in Figure 6B, the combination of the sample container 10 and the adapter 40 are lowered and raised as indicated by arrow 202. By way of non-limiting example, the sample container 10 may have an initial interior volume under vacuum conditions, and this vacuum force draws sample into the container 10 when the container 10 is in fluid communication with the container C. Optionally, a syringe-type unit or other force can be used to draw sample from external sample collector C into the container 10.
[00491 As seen in Figure 6B, the container 10 is significantly smaller than the traditional collection tube T. in one embodiment, the container 10 has an internal volume at least about 10x smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about llx smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about 12x smaller than an internal volume of tube T.
Optionally, the container 10 has an internal volume at least about 13x smaller than an internal volume of tube T.
Optionally, the container 10 has an internal volume at least about 14x smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about 15x smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about 9x smaller than an internal volume of tube T. Optionally, the container
10 has an internal volume at least about 8x smaller than an internal volume of tube T.
Optionally, the container 10 has an internal volume at least about 7x smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about 6x smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about 5x smaller than an internal volume of tube T.
100501 By way of non-limiting example, this reduced size can be beneficial so that the container 10 will occupy a smaller height, footprint, or volume when inserted into a cartridge or into an external device. In this non-limiting example, the adapter 40 can adapt the size and/or shape of the container 10 in at least one dimension to facilitate fitment of the container 10 in the receptor R. In Figure 6B, the sample container 10 has a diameter that is smaller than the diameter of the receptor R. Figure 6B also shows that the height of the sample container 10 is significantly less than that of a traditional collection tube T. In this non-limiting example, the adapter 40 can also extend the outer dimension of the sample container 10 along its longitudinal axis. The opening 11 may be a resealable opening in the sample container 10 can be used to connect with a tubular structure in the sample collector C or other similar structure.
100511 Figures 7A and 7B show the sample collection tube T and the sample container 10 in a lowered position to engage the receptor R. In some embodiments, the sample collection tube T and the sample container 10 can be further lowered into receptor R.
Optionally, instead of using a container 10 that contains a vacuum or reduced pressure atmosphere therein to pull sample into the container 10, another embodiment of container 10 may use a reverse-plunger design wherein a bottom surface of the container 10 is movable (like a plunger P) as indicated by arrow 312. The bottom surface is initially closer to the opening 11 and as the needle or other item in container C engages the opening 11, it also pushes the movable bottom surface of container 10 as the container is pushed into the receptor R. The movement of the bottom surface of container 10 will create suction that will pull sample into the container 10. Optionally, some embodiments may have a hardened core 310 as shown in Figure 6C that facilitates engagement with the needle N or other fluid connector in container C.
100521 Referring now to Figure 8, a still further embodiment is shown wherein the sample container 10 (shown removed from the adapter) is configured to be coupled with a support assembly such as but not limited to a cartridge 250 as indicated by arrow 252. In this non-limiting example, the cartridge 250 may include a plurality of other vessels, which may each be in an opening, well, cavity, or other holding location 100. Some embodiments may position a tool such as but not limited to a liquid handling tip, pipette tip, and/or reaction vessel in one of the locations 100. As seen in Figure 8, a fluid handling apparatus such as but not limited to a pipette P may be used to move fluid from one location 100 to another location on the cartridge 250 or to a location not on the cartridge 250. Figure 8 also shows that some embodiments of cartridge 250 may also include an area 260 that is not in the same plane as openings for the other locations 100. Optionally, the area 260 may be at a plane above the plane of the other locations 100. Optionally, the area 260 may be at a plane below the plane of the other locations 100.
Optionally, some embodiments may have at least one area above a plane of the majority of locations 100 and at least one area below a plane of the majority of locations 100. Some embodiments may have a touch-off pad or other liquid removing component in area 260 that may be used to remove excess liquid from the tip that might impact liquid transfer accurate if excess liquid is unintentionally brought along.
100531 As seen in Figure 8, there may also be at least one opening, well, cavity, or other holding location 110 that may be sized different to accommodate a sample container such as but not limited to a container 10 as described herein. Some embodiments may include at least one other sample holding location 120 that may be configured to hold another type of sample for use with analysis. By way of non-limiting example, one embodiment may have a urine sample in container 10 in location 110 and a blood sample in one or more containers sized to fit in location 120. Optionally, some embodiments may size and/or shape the opening at locations 110 and/or 120 to accommodate the container(s) and any holder attached to or integrated with the container(s). It should be understood that other embodiments may be sized to have openings to accommodate three or more sample containers. In one non-limiting example, there may be a lid (not shown for ease of illustration) that covers all, a majority, or portions of the cartridge 250.
Some embodiment may have a lid with cutouts that expose the locations 110 and/or 120 or any other sample container location even when the lid is close to facilitate placement of the sample container(s) in the locations without having to open the lid which may be covering reagents or other vessels. Some embodiments of the cartridge are configured to be inserted into one or more analytical or sample processing device(s). It should be understood that in many embodiments, in addition to having one or more samples, the cartridge also contains all reagents that are to be used to process the one or more samples. Optionally, the cartridge can also contain all reagents and handling disposables (pipette tips, cuvettes, etc...) that may be used to process the one or more samples.
100541 While the invention has been described and illustrated with reference to certain particular embodiments thereof, those skilled in the art will appreciate that various adaptations, changes, modifications, substitutions, deletions, or additions of procedures and protocols may be made without departing from the spirit and scope of the invention. For example, with any of the above embodiments, it should be understood that some embodiment may have a rotating fin device on the holder such as that which may be similar to that of Figure 5A, wherein the outer holder may have fins movable from collapsed to extended position. For example, when inserting the container into a cartridge, the fin(s) defining the holder can move from an extended position (which prevented the container from rolling or falling over) to a collapsed position to allow for insertion of the container into a cartridge. In this manner, a device with foldable, collapsible, or otherwise reconfigurable structure can be used to provide an expanded configuration when outside the cartridge and a reduced-size configuration when in the cartridge.
Although many of the embodiments herein discuss the sample as a urine sample, it should be understood that this is for ease of illustration and that the container is not restricted to that use and can be configured for use with other liquid sample(s).
[00551 Additionally, concentrations, amounts, and other numerical data may be presented herein in a range format. It is to be understood that such range format is used merely for convenience and brevity and should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. For example, a size range of about 1 nm to about 200 nm should be interpreted to include not only the explicitly recited limits of about 1 nm and about 200 nm, but also to include individual sizes such as 2 nm, 3 nm, 4 nm, and sub-ranges such as 10 mu to 50 nm, 20 urn to 100 nm, etc....
100561 The publications discussed or cited herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. All publications mentioned herein are incorporated herein by reference to disclose and describe the structures and/or methods in connection with which the publications are cited. The following applications are fully incorporated herein by reference for all purposes: U.S. Patent Application Ser. No. 62/011,572.
100571 While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. Any feature, whether preferred or not, may be combined with any other feature, whether preferred or not. The appended claims are not to be interpreted as including means-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase "means for." It should be understood that as used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the"
includes plural reference unless the context clearly dictates otherwise. For example, a reference to "an assay" may refer to a single assay or multiple assays. Also, as used in the description herein and throughout the claims that follow, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise. Finally, as used in the description herein and throughout the claims that follow, the meaning of "or" includes both the conjunctive and disjunctive unless the context expressly dictates otherwise. Thus, the term "or" includes "and/or" unless the context expressly dictates otherwise.
Optionally, the container 10 has an internal volume at least about 7x smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about 6x smaller than an internal volume of tube T. Optionally, the container 10 has an internal volume at least about 5x smaller than an internal volume of tube T.
100501 By way of non-limiting example, this reduced size can be beneficial so that the container 10 will occupy a smaller height, footprint, or volume when inserted into a cartridge or into an external device. In this non-limiting example, the adapter 40 can adapt the size and/or shape of the container 10 in at least one dimension to facilitate fitment of the container 10 in the receptor R. In Figure 6B, the sample container 10 has a diameter that is smaller than the diameter of the receptor R. Figure 6B also shows that the height of the sample container 10 is significantly less than that of a traditional collection tube T. In this non-limiting example, the adapter 40 can also extend the outer dimension of the sample container 10 along its longitudinal axis. The opening 11 may be a resealable opening in the sample container 10 can be used to connect with a tubular structure in the sample collector C or other similar structure.
100511 Figures 7A and 7B show the sample collection tube T and the sample container 10 in a lowered position to engage the receptor R. In some embodiments, the sample collection tube T and the sample container 10 can be further lowered into receptor R.
Optionally, instead of using a container 10 that contains a vacuum or reduced pressure atmosphere therein to pull sample into the container 10, another embodiment of container 10 may use a reverse-plunger design wherein a bottom surface of the container 10 is movable (like a plunger P) as indicated by arrow 312. The bottom surface is initially closer to the opening 11 and as the needle or other item in container C engages the opening 11, it also pushes the movable bottom surface of container 10 as the container is pushed into the receptor R. The movement of the bottom surface of container 10 will create suction that will pull sample into the container 10. Optionally, some embodiments may have a hardened core 310 as shown in Figure 6C that facilitates engagement with the needle N or other fluid connector in container C.
100521 Referring now to Figure 8, a still further embodiment is shown wherein the sample container 10 (shown removed from the adapter) is configured to be coupled with a support assembly such as but not limited to a cartridge 250 as indicated by arrow 252. In this non-limiting example, the cartridge 250 may include a plurality of other vessels, which may each be in an opening, well, cavity, or other holding location 100. Some embodiments may position a tool such as but not limited to a liquid handling tip, pipette tip, and/or reaction vessel in one of the locations 100. As seen in Figure 8, a fluid handling apparatus such as but not limited to a pipette P may be used to move fluid from one location 100 to another location on the cartridge 250 or to a location not on the cartridge 250. Figure 8 also shows that some embodiments of cartridge 250 may also include an area 260 that is not in the same plane as openings for the other locations 100. Optionally, the area 260 may be at a plane above the plane of the other locations 100. Optionally, the area 260 may be at a plane below the plane of the other locations 100.
Optionally, some embodiments may have at least one area above a plane of the majority of locations 100 and at least one area below a plane of the majority of locations 100. Some embodiments may have a touch-off pad or other liquid removing component in area 260 that may be used to remove excess liquid from the tip that might impact liquid transfer accurate if excess liquid is unintentionally brought along.
100531 As seen in Figure 8, there may also be at least one opening, well, cavity, or other holding location 110 that may be sized different to accommodate a sample container such as but not limited to a container 10 as described herein. Some embodiments may include at least one other sample holding location 120 that may be configured to hold another type of sample for use with analysis. By way of non-limiting example, one embodiment may have a urine sample in container 10 in location 110 and a blood sample in one or more containers sized to fit in location 120. Optionally, some embodiments may size and/or shape the opening at locations 110 and/or 120 to accommodate the container(s) and any holder attached to or integrated with the container(s). It should be understood that other embodiments may be sized to have openings to accommodate three or more sample containers. In one non-limiting example, there may be a lid (not shown for ease of illustration) that covers all, a majority, or portions of the cartridge 250.
Some embodiment may have a lid with cutouts that expose the locations 110 and/or 120 or any other sample container location even when the lid is close to facilitate placement of the sample container(s) in the locations without having to open the lid which may be covering reagents or other vessels. Some embodiments of the cartridge are configured to be inserted into one or more analytical or sample processing device(s). It should be understood that in many embodiments, in addition to having one or more samples, the cartridge also contains all reagents that are to be used to process the one or more samples. Optionally, the cartridge can also contain all reagents and handling disposables (pipette tips, cuvettes, etc...) that may be used to process the one or more samples.
100541 While the invention has been described and illustrated with reference to certain particular embodiments thereof, those skilled in the art will appreciate that various adaptations, changes, modifications, substitutions, deletions, or additions of procedures and protocols may be made without departing from the spirit and scope of the invention. For example, with any of the above embodiments, it should be understood that some embodiment may have a rotating fin device on the holder such as that which may be similar to that of Figure 5A, wherein the outer holder may have fins movable from collapsed to extended position. For example, when inserting the container into a cartridge, the fin(s) defining the holder can move from an extended position (which prevented the container from rolling or falling over) to a collapsed position to allow for insertion of the container into a cartridge. In this manner, a device with foldable, collapsible, or otherwise reconfigurable structure can be used to provide an expanded configuration when outside the cartridge and a reduced-size configuration when in the cartridge.
Although many of the embodiments herein discuss the sample as a urine sample, it should be understood that this is for ease of illustration and that the container is not restricted to that use and can be configured for use with other liquid sample(s).
[00551 Additionally, concentrations, amounts, and other numerical data may be presented herein in a range format. It is to be understood that such range format is used merely for convenience and brevity and should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. For example, a size range of about 1 nm to about 200 nm should be interpreted to include not only the explicitly recited limits of about 1 nm and about 200 nm, but also to include individual sizes such as 2 nm, 3 nm, 4 nm, and sub-ranges such as 10 mu to 50 nm, 20 urn to 100 nm, etc....
100561 The publications discussed or cited herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. All publications mentioned herein are incorporated herein by reference to disclose and describe the structures and/or methods in connection with which the publications are cited. The following applications are fully incorporated herein by reference for all purposes: U.S. Patent Application Ser. No. 62/011,572.
100571 While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. Any feature, whether preferred or not, may be combined with any other feature, whether preferred or not. The appended claims are not to be interpreted as including means-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase "means for." It should be understood that as used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the"
includes plural reference unless the context clearly dictates otherwise. For example, a reference to "an assay" may refer to a single assay or multiple assays. Also, as used in the description herein and throughout the claims that follow, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise. Finally, as used in the description herein and throughout the claims that follow, the meaning of "or" includes both the conjunctive and disjunctive unless the context expressly dictates otherwise. Thus, the term "or" includes "and/or" unless the context expressly dictates otherwise.
Claims (35)
1. A device for use with a sample container, the device comprising:
a first portion shaped to contain at least a portion of the sample container;
a second portion configured for user handling and force application; and a guide portion sized and shaped to be received in a channel of a bulk sample container;
wherein the first portion and second portion are sized to minimize thermal transfer between a user and the sample container.
a first portion shaped to contain at least a portion of the sample container;
a second portion configured for user handling and force application; and a guide portion sized and shaped to be received in a channel of a bulk sample container;
wherein the first portion and second portion are sized to minimize thermal transfer between a user and the sample container.
2. A device for use with a sample container, the device comprising:
a first portion shaped to contain at least a portion of the sample container;
a second portion configured for user handling and force application from a proximal end of the device; and a guide portion.
a first portion shaped to contain at least a portion of the sample container;
a second portion configured for user handling and force application from a proximal end of the device; and a guide portion.
3. A device for use with a sample, the device comprising:
a first portion defining a sample container;
a second portion configured for user handling and force application from a proximal end of the device; and a guide portion.
a first portion defining a sample container;
a second portion configured for user handling and force application from a proximal end of the device; and a guide portion.
4. The device of any one of the foregoing wherein the first portion defines a cavity for holding the sample container.
5. The device of any one of the foregoing claims wherein the second portion defines a bottom surface of the device.
6. The device of any one of the foregoing claims wherein the second portion defines a grip surface on the device.
7. The device of any one of the foregoing claims wherein the second portion defines an indented grip feature on the device.
8. The device of any one of the foregoing claims wherein the guide portion defines at least one interface surface that is configured to contact at least a portion of the channel.
9. The device of any one of the foregoing claims wherein the guide portion has a cross-sectional shape matching a channel cross-sectional shape.
10. The device of any one of the foregoing claims wherein the second portion has at least one flat side to prevent undesired rolling of the device when placed on a side surface.
11. The device of any one of the foregoing claims wherein the channel comprises an access channel.
12. The device of any one of the foregoing claims wherein the channel comprises a guide channel.
13. The device of any one of the foregoing claims wherein the first portion and second portion comprise a thermally insulating material.
14. The device of any one of the foregoing claims wherein the first portion and second portion provide a dual function device that is both a device alignment guide and a reduced thermal conductivity user handling surface.
15. The device of any one of the foregoing claims wherein the first portion defines a plurality of openings configured to show the sample container when the sample container is positioned therein.
16. The device of any one of the foregoing claims wherein the first portion defines view windows into a container holding area of the device.
17. The device of any one of the foregoing claims wherein the sample container has a length along a longitudinal axis that is less than a length along a longitudinal axis of the device.
18. The device of any one of the foregoing claims further comprising a cartridge sized to receive the sample container, wherein the sample container has a length allowing the sample container to be placed substantially fully within the cartridge while the sample container is in a non-horizontal orientation.
19. The device of any one of the foregoing claims wherein the device has a length along a longitudinal axis that is less than a height of the cartridge.
20. The device of any one of the foregoing claims further comprising a cartridge sized to receive the sample container, wherein the sample container has a length allowing the sample container to be placed substantially fully within the cartridge while the sample container is in a non-horizontal orientation.
21. The device of any one of the foregoing claims wherein the sample container comprises a septa in at least one end of the container, wherein the septa defines a re-sealable fluid access port.
22. The device of any one of the foregoing claims wherein the sample container comprises a liquid impermeable, gas permeable vent.
23. The device of any one of the foregoing claims wherein the sample container comprises a vent.
24. A device for use with a sample, the device comprising:
a first portion defining a sample container;
a second portion configured for user handling and force application from a proximal end of the device.
a first portion defining a sample container;
a second portion configured for user handling and force application from a proximal end of the device.
25. A method for use with a sample, the method comprising:
using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device.
using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device.
26. A method for use with a sample, the method comprising:
using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 200 microliters or less.
using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 200 microliters or less.
27. A method for use with a sample, the method comprising:
using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 300 microliters or less.
using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 300 microliters or less.
28. A method for use with a sample, the method comprising:
using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 400 microliters or less.
using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 400 microliters or less.
29. A method for use with a sample, the method comprising:
using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 500 microliters or less.
using a sample container having a first portion and a second portion, wherein the second portion configured for user handling and force application from a proximal end of the device, wherein the sample container has an internal volume of about 500 microliters or less.
30. A method comprising at least one technical feature from any of the prior claims.
31. A method com.prising at least any two technical features from any of the prior claims.
32. A device comprising at least one technical feature from any of the prior claims.
33. A device comprising at least any two technical features from any of the prior claims.
34. A system comprising at least one technical feature from any of the prior claims.
35. A system comprising at least any two technical features from any of the prior claims.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462011572P | 2014-06-13 | 2014-06-13 | |
| US62/011,572 | 2014-06-13 | ||
| PCT/US2015/035893 WO2015192145A2 (en) | 2014-06-13 | 2015-06-15 | Devices and methods for use with a sample container |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2951696A1 true CA2951696A1 (en) | 2015-12-17 |
Family
ID=54834579
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2951696A Pending CA2951696A1 (en) | 2014-06-13 | 2015-06-15 | Devices and methods for use with a sample container |
Country Status (3)
| Country | Link |
|---|---|
| CA (1) | CA2951696A1 (en) |
| MX (1) | MX2016016232A (en) |
| WO (1) | WO2015192145A2 (en) |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6358476B1 (en) * | 1999-09-23 | 2002-03-19 | Sharon A. Innamorato | Microcollection tube assembly |
| US20020121139A1 (en) * | 2001-03-02 | 2002-09-05 | Purpura Paul E. | Adapter for holding a sample container to facilitate sensing of liquid level in the sample container |
| US7569190B2 (en) * | 2006-09-05 | 2009-08-04 | Siemens Healthcare Diagnostics Inc. | Micro-sample cup rack adapter |
-
2015
- 2015-06-15 WO PCT/US2015/035893 patent/WO2015192145A2/en active Application Filing
- 2015-06-15 MX MX2016016232A patent/MX2016016232A/en unknown
- 2015-06-15 CA CA2951696A patent/CA2951696A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| WO2015192145A2 (en) | 2015-12-17 |
| MX2016016232A (en) | 2017-07-05 |
| WO2015192145A3 (en) | 2016-02-04 |
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