Patent Application
20110308336
The invention relates generally to apparatuses and methods for collecting and transferring biological specimens.
Devices for the collection and transport of biological specimens or samples have frequently been utilized by specially trained personnel, in a laboratory setting, to facilitate diagnosis and treatment of abnormal conditions. Recently, untrained persons have begun handling biological specimens, outside of laboratory settings, for example, in a physician's office or a private residence. However, to obtain accurate analytical results and protect the health and safety of persons handling the specimen, it is important to control how a specimen is manipulated during handling.
Historically, a biological specimen might be obtained by providing a user with the necessary components to collect, transfer, and/or transport the specimen. In some instances, the components may be provided to the user in a kit. A typical kit may include an assortment of components, for example, collection vessels, specimen containers, and transfer devices, hereinafter, collectively referred to as specimen handling tools or tools. The contents of a particular kit may vary depending on the application for which the kit is intended. For example, a kit designed for lipid analysis may contain tubes to collect blood; while a kit designed for certain genetic tests may include a buccal (cheek) swab.
Kits employing trays are available for a variety of applications. The trays may be either simple or compartmentalized and, typically, are used to organize the various components of the kit. However, one of the problems with these kits is that the specimen container(s) is not held in an upright, vertical position within the tray, during specimen handling (i.e. collection, assay, or transport). Instead, a user must either hold the specimen container or position a specialized specimen container, for example, a container with a flat bottom, on some other surface, such as a counter-top. This is undesirable because the user's dexterity to perform additional tasks may be inhibited. Further, the specimen container may be easily overturned contaminating the sample and/or the user's environment. Moreover, a specialized specimen container may require additional specimen handling steps because the container is not compatible with standard laboratory equipment. There is a need in the art for a biological specimen kit, and methods of using the kit, that provide the means to prevent contamination of a user or specimen, while simplifying handling procedures.
Therefore, it would be an improvement in the art to provide a kit having a tray designed to position and retain a specimen container in an upright position within the tray during specimen handling. It would be a further improvement to provide a method of collecting a biological specimen using a tray that prevents contamination of a specimen or user's environment. A tray for biological specimen collection, having at least one opening for receiving a specimen container therein during transport or analysis, is a further improvement in the art.
The invention includes a kit for collecting and transporting biological specimens. The kit may include a tray having a plurality of openings or recesses, with at least one opening for receiving a specimen container in an upright position. The kit may include an external housing for receiving components of the kit including, for instance, a tray, instructional or directional materials, and transporting or mailing materials. Optionally, the kit may include packaging materials for containing a tray during transport to a remote or alternate location. The kit may also include the means for performing an analytical evaluation at the site of specimen collection.
The invention includes a tray designed and configured to facilitate correct specimen handling by any user. For example, the tray may stabilize a specimen container, positioned within an opening of the tray, during specimen collection, analysis, or transport. The tray may include a plurality of openings, compartments, or recesses, in which one or more specimen handling tools may be situated. At least one of the openings in the tray may include ribs, for example, to facilitate a press-fit with an upright specimen container. Additionally, one or more of the openings in the tray may, optionally, have a bottom surface having a non-zero slope. One or more of the openings in the tray may conform to a specimen handling tool to be positioned therein.
The invention also includes methods of collecting a biological specimen using a tray designed and configured to position and hold specimen handling tools. The methods may include collecting a biological specimen from an untrained user. The methods may include moving a specimen container between recumbent and upright orientations. The methods may include transferring a specimen between one or more receptacles. The methods may include transporting a specimen, supported within a tray, to a different location, for example, a remote testing facility.
The present invention provides methods of collecting and manipulating biological specimens and apparatuses for handling biological specimens that have advantages over currently known specimen handling systems, methods, and devices. It will be appreciated by those skilled in the art that the embodiments described in this disclosure, while illustrating certain specific and exemplary embodiments, are not intended to limit the scope of the invention or of the appended claims. Those of ordinary skill in the art will also understand that various combinations or modifications of the disclosed embodiments may be made without departing from the scope of the invention.
As used herein, the term “user” means and includes any person collecting, analyzing, or transporting a biological specimen, for example, medical and laboratory personnel, as well as, untrained or at-home individual use.
As used herein, the term “biological specimen” means and includes any portion of material, exemplifying a whole, that is derived from a biological source, such as an animal, plant, or microorganism, to be used in analysis. A biological specimen may include, for example, tissue, blood, or urine taken from a human source.
As used herein, the terms “specimen container” and “collection vessel” mean and include any receptacle in which a biological specimen may be held or contained without compromising the integrity of the specimen or the container. A specimen container or collection vessel may include, for example, a vial, a cup, a tube, a jar, or a pouch.
As used herein, the term “upper surface” means and includes the portion of the tray parallel to an underlying support surface and spaced apart from the underlying surface by sidewalls. As used herein, the term “base” means and includes the portion of the tray adjacent to an underlying support surface, upon which the tray may rest.
As used herein, the term “horizontal” means and includes an orientation in which the major axis of a tool is parallel to or in the plane of the upper surface of the tray. As used herein, the term “upright” means and includes an orientation in which the major axis of a tool is generally orthogonal or perpendicular to the plane of the upper surface of the tray. In some instances, “upright” may refer to a vertical orientation, while in other instances, the orientation may be such that the major axis of the tool intersects the upper surface of the tray at an angle which is substantially vertical (between 75 and 105 degrees).
As used herein, the term “recumbent” means and includes an orientation in which the major axis of a tool may be angled relative to the plane of the upper surface of the tray and wherein the angle is less than ninety degrees. For example, recumbent, as used herein, may refer to a range of orientations from lying flat (horizontal) to substantially declined.
The upper surface 14 of the frame 12 may have instructions and/or identifying marks printed/imprinted thereon. Further, the upper surface 14 of the frame 12 may have a plurality of openings or recesses formed therein. The plurality of openings may be arranged such that none of the plurality of openings is in contact with another of the plurality of openings. The plurality of openings may be substantially the same size. Alternatively, the plurality of openings may be of different sizes. In some embodiments, at least one of the plurality of openings is of a different size than at least another of the plurality of openings. The openings may be sized and configured to receive a variety of components, including specimen handling tools, provided with a biological test kit. One or more of the plurality of openings in the upper surface 14 may be sized and configured to maintain a tool in a recumbent position within the frame 12. Additionally, at least one of the openings in the upper surface 14 may be sized and configured to retain a tool in an upright position (the major axis of the tool perpendicular to or intersecting the plane of the upper surface 14 of the tray 10) within the frame 12.
As shown in
The opening 20 may form a recess or compartment defined by opposing sidewalls 22 and a bottom surface 24. The sidewalls 22 may extend various depths between the upper surface 14 and the bottom surface 24 of the opening. For example, the sidewalls 22 may depend from the upper surface 14 a depth sufficient to retain the specimen container within the frame 12 until removed by the user. By way of example and not limitation, the sidewalls 22 may depend from the upper surface 14 a depth of about one-quarter to about one-half of the external diameter of the specimen container to be stored therein (i.e. an upper portion of the specimen container extends above the upper surface when the specimen container is positioned therein). In other examples, the sidewalls 22 may depend from the upper surface 14 a depth equal to or greater than the external diameter of the specimen container to be stored therein (i.e. an upper portion of the specimen container is coplanar with or recessed relative to the upper surface when the specimen container is positioned therein). Further, the sidewalls 22 may depend different depths from one portion of the opening to another. For example, the sidewalls 22 may depend a first distance in one portion of the opening 20 and a second greater distance in another portion of the opening 20. In other embodiments, the depth the sidewalls depend from the upper surface 14 may continuously increase or decrease along the entire length of the opening 20.
The sidewalls 22 of the opening 20 may be aligned or may comprise one or more offset portions. In an embodiment, the sidewalls 22 may include one or more regions 23 wherein the distance between the sidewalls 22 along one portion of the opening 20 is greater than the distance between the sidewalls 22 along another portion of the opening 20. For example, the opening 20 may be sized and configured to receive a specimen container 40 having a first dimension and a cap 42, associated with the specimen container, having a second different dimension. (
The opening 20 may also be defined by a bottom surface 24. The bottom surface 24 of the opening 20 may be flat or planar. In the alternative, the bottom surface 24 of the opening 20 may have a curvature. In some embodiments, the bottom surface 24 of the opening 20 may conform to a specimen container positioned therein. Further, in some embodiments, the bottom surface 24 may be parallel to the plane of the upper surface 14 of the tray 10. In other embodiments, the bottom surface 24 may be slanted relative to the plane of the upper surface 14 of the tray 10 (i.e. have a non-zero slope). For example, the bottom surface 24 may have a slope sufficient to cause preservative fluid, optionally present in the container, to flow toward, and be confined in, a lower portion of the specimen container that is positioned within the opening 20. An embodiment of a tray 10 having a slanted bottom surface is illustrated in
With continued reference to
As illustrated in
The opening 28 may include sidewalls and a bottom surface having substantially similar characteristics as described above with respect to the other openings 20, 26. Specifically, as described above, the sidewalls of the opening may be aligned, tapered, have offset portions, or combinations thereof. The bottom surface may be flat, curved, or conform to the specimen collection vessel. Moreover, the bottom surface may be either slanted relative to the upper surface 14 of the frame 12, or parallel to the upper surface 14 of the frame 12. The depth from the upper surface 14 of the frame 12 that the sidewalls depend may be uniform or may vary. For example, the sidewalls of the opening 28 may depend from the upper surface 14 a depth of about one-quarter to about one-half of the major diameter of the specimen collection vessel to be stored therein. In other examples, the sidewalls of opening 28 may depend from the upper surface 14 a depth equal to or greater than the diameter of the specimen collection vessel to be stored therein. Additionally, the sidewalls of the opening 28 may depend a first depth in one region and another depth in at least another region. In some embodiments, each of the plurality of openings 20, 26, 28 has a depth such that a top surface of the specimen handling tool contained therein is coplanar with the upper surface 14 of the frame 12. In other embodiments, each of the plurality of openings 20, 26, 28 has a depth such that a top surface of the specimen handling tool contained therein is recessed relative to the upper surface 14 of the frame 12. In still further embodiments, each of the plurality of openings has a depth such that at least a portion of the specimen handling tool contained therein extends vertically above the upper surface 14 of the frame 12. Additionally, each of the plurality of openings 20, 26, 28 may include one or more notches 25 to allow a user access to grasp a specimen handling tool when it is seated within the openings.
The tray 10 of the present invention may comprise at least one opening or recess in the upper surface 14 that is sized and configured to retain a tool in an upright position within the frame 12. Referring again to
The sidewalls 32 of the opening 30 may be vertically tapered, i.e. continuously converging from the upper surface 14 of the frame 12 towards the base 16 of the frame 12, such that the diameter of the opening at the bottom is less than the diameter of the opening at the top (i.e. near the upper surface 14 of the frame 12). Further, the dimensions of the opening 30 may be increased or decreased to accommodate specimen containers of various sizes.
The sidewalls 32 of the opening 30 may depend from the upper surface 14 a depth sufficient to retain a specimen handling tool in the upright position. For example, the sidewalls 32 may depend from the upper surface 14 of the frame 12 to a depth equal to about one-third of the length of the major axis of the specimen container. In other examples, the sidewalls 32 may depend from the upper surface 14 of the frame 12 to a depth less than about one-half of the length of the major axis of the specimen container. In still other examples, the sidewalls 32 may depend from the upper surface 14 substantially the entire width of the sides 18 of the frame 12, terminating immediately above the base 16 of the frame 12. In yet other examples, the depth of the sidewalls 32 is determined in relation to the specimen container to be used. For example, certain specimen containers provide markings, e.g. graduated reference numerals, for reference by the user during specimen handling. The specimen container may also include a volume indicator comprising a window through which the specimen in the container may be viewed. It is desirable that such markings and indicators are visible above the upper surface 14 of the frame 12. Accordingly, the depth of the sidewalls 32 of the opening 30 may be adjusted to insure that reference features on a specimen container positioned therein are adequately displayed.
The opening 30 may include a bottom surface, wherein an outer perimeter of the bottom surface is coincident with the sidewalls. The bottom surface may be flat, rounded, or conforming to the specimen container. The bottom surface may act as a secondary containment in case of specimen spillage during collection, transfer, or analysis. In some embodiments, an absorbent material may overlie the bottom surface. The bottom surface may be useful in avoiding contamination of the user's environment by preventing any specimen that escapes the specimen container from contacting an underlying support surface (e.g. countertop). In some embodiments, the opening 30 may lack a bottom surface. When opening 30 is without a bottom surface, the sidewalls 32 may terminate at or above the plane of the base 16 of the frame 12, and a bottom portion of the specimen container may extend below the sidewalls 32 when the specimen container is positioned within the opening 30.
The tray 10 may comprise a plurality of openings or compartments (20, 26, 28) for receiving a plurality of instrument handling tools, such as, a specimen container, a specimen transfer apparatus, and a specimen collection vessel. A specimen container may include any receptacle capable of retaining a specimen without leaking or degradation. A transfer apparatus may comprise any tool useful for moving a specimen from one location to another. In some embodiments, the transfer apparatus may comprise a plastic disposable pipette. In other embodiments, the transfer apparatus may comprise a glass pipette and rubber bulb. In still further embodiments, the transfer apparatus may comprise a spatula, a swab or similar instruments in the art. The specimen collection vessel may comprise any receptacle suitable for collection of a biological specimen from a user. For example, the specimen collection vessel may comprise a cup, a bottle, a jar, a tube, a pouch, a syringe, and other collection vessels. The specimen collection vessel may include a closure mechanism for sealing the vessel, for example a threaded lid.
As shown in
In some embodiments, the upper surface 14 of the tray 10 may be recessed relative to the top or upper surface of the sidewalls 36 of the external housing 34. Accordingly, additional components of the kit (e.g. instructions, packaging materials, etc.) may overlie the tray 10, without extending vertically beyond the top of the sidewalls 36 of the external housing 34. In other embodiments, at least a portion of the upper surface 14 of the tray 10 may be coplanar with an upper surface of the sidewalls 36 of the external housing 34. In addition, the external housing 34 may include a lid 38. The lid 38 may be attached to or contiguous with at least one sidewall 36 of the external housing 34. Alternatively, the lid 38 may be separate from the external housing 34. A separate lid 38 should be capable of associating with the external housing 34, in order to confine the components of the kit, including the tray 10, within the external housing 34. The lid 38, optionally, may have instructions for using the kit printed thereon. Likewise, one or more of the sidewalls 36 of the external housing 34, optionally, may have instructions for using the kit printed thereon.
Also disclosed, are methods of using a test kit and tray, as described herein, to collect a biological specimen. In particular, the present invention includes a method of collecting a biological specimen using a tray having at least one opening configured to position a specimen container in an upright orientation. A test kit comprising an external housing 34, a tray 10, and a plurality of specimen handling tools seated within openings or recesses in the tray is provided to a user. The test kit may include a means for analysis of the specimen at the site of collection and/or packaging materials for transport of the specimen to a remote location for analysis. The user may be a trained or untrained person, and the test kit may be provided at various locations (e.g. physician's office, user's home, medical lab). Prior to use, the tray of the kit may display a plurality of specimen handling tools, seated in a recumbent position, within a plurality of openings in the upper surface of the tray. In addition, providing the tray may comprise providing a tray having one or more openings, without a tool seated therein, configured to position a specimen handling tool vertically within the tray (
The user may place the external housing 34 of the test kit on a supporting surface, such as a table or countertop. The user may open the test kit by lifting or removing the lid 38 of the external housing 34. In some embodiments, the user performs specimen collection while the tray 10 is located within the external housing 34. In other embodiments, the user may remove the tray 10 from the external housing 34 and position the tray 10 upon a supporting surface. A user may remove at least one specimen container 40 (
The user may remove the specimen collection vessel 44 from the tray 10 and prepare the vessel 44 for receiving the specimen. The user may then introduce a biological specimen into the vessel 44. How the specimen is acquired and introduced into the specimen collection vessel will vary depending on the type of specimen collected. The user may be provided information on how to collect the specimen in instructions optionally included with the kit. Once the specimen has been received into the vessel 44, the specimen transfer apparatus 46 may be removed from the tray 10. Further, the cap 42 may be removed from the specimen container 40. Using the specimen transfer apparatus 46 the user may transfer at least a portion of the biological specimen from the specimen collection vessel 44 to the specimen container 40, which is held upright within the tray 10. The user may transfer enough of the specimen to fill the specimen container 40. In other examples, the user may transfer enough of the specimen to fill a portion of the specimen container 40, for example, up to a designated volume. A designated volume may be indicated with one or more reference markings on the specimen container 40 that are visible above the upper surface 14 of the tray 10. The cap 42 may be replaced onto the specimen container 40, to confine the specimen within the container 40.
Once the specimen has been collected, the user may either perform an analysis on the specimen immediately or the user may transport the specimen to a remote testing facility, or a combination thereof. For example, the user may introduce a test card into the specimen container, which may indicate, usually by color, the presence or absence of an analyte. In another example, the user may return the specimen container 40 to the first opening 20 in the tray and transport the specimen container 40, in the tray 10, to a remote testing facility. In this example, the specimen container is maintained in a recumbent orientation within the tray during transport. Alternatively, the specimen container may be transported while in the upright position within the tray.
In an embodiment of the present invention, packaging materials comprising an envelope or pouch, an absorbent pad, and labeling materials are provided in the kit. The absorbent pad may comprise any absorbent or desiccant material capable of taking in liquid, especially the type of liquid of the specimen. The user may enclose the absorbent pad and the tray (containing the specimen) within the envelope. A label may be affixed to the exterior of the envelope, and/or to the exterior of the specimen container, and the user may mail the combination of the envelope, tray, and specimen container (with specimen) to a testing facility. In other examples, once the specimen container 40 has been appropriately filled, it is removed from the tray 10, labeled, and enclosed in packaging materials provided in the kit (optionally) for safe transfer to a remote testing facility.
The following provides a nonlimiting example of an embodiment of the present invention as described in this disclosure. A user (e.g. untrained) may purchase a home test kit, from a pharmacy or general store, for the purpose of diagnosing, for example, a sexually transmitted disease. When ready to perform the test, the home user may remove the tray (10) from the box (34) and place the tray on a support surface, a bathroom countertop, for example. The kit may include, among other things, a test tube and cap (40, 42), a disposable pipette (46), and a standard sample cup and lid (44) displayed in a recumbent position within openings in the surface of the tray (10), as described above. The test tube may contain a small amount of preservative for maintaining the specimen post collection. The home user may remove the test tube from its recumbent position in the tray and rotate the tube into an upright orientation. The home user positions the test tube coaxially into the designated opening (30) in the tray by applying a downward force along the major axis of the tube while in position over the opening. The home user may loosen the cap of the test tube.
The home user may remove the sample cup from within the tray and collect a biological specimen. For example, using the opened cup, the user may interrupt a stream of urine produced by the user, thereby, collecting a volume of urine in the sample cup. The user may remove the pipette from the tray and use it to transfer a quantity of urine from the sample cup to the opened test tube, held vertically within the tray. The home user may transfer enough urine to fill the test tube to a volume indicated by a reference marking on the tube. The user replaces the cap on the test tube to confine the urine inside and prevent spills or cross-contamination. A label, optionally provided in the kit, may be affixed to a surface of the test tube. The user may dispose of the sample cup, and pipette. The test tube, containing the specimen, may be restored to a recumbent position within the tray, for example, seated in the original opening from which it was removed. The user may seal the tray and specimen within an envelope containing an absorbent material. The envelope may be labeled and transported to a remote testing facility so that laboratory personnel may analyze the specimen for indicators of a sexually transmitted disease.
While the present invention has been describe herein with respect to certain preferred embodiments, those of ordinary skill in the art will recognize that the invention is not so limited. Rather many additions, deletions, and modifications may be made without departing from the scope of the invention as hereinafter claimed. In addition, features of one embodiment may be combined with features of another embodiment while still being within the scope of the invention as contemplated by the inventor.
This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61/397,895, filed on Jun. 16, 2010, the entire disclosure of which is incorporated herein by this reference.
| Number | Date | Country | |
|---|---|---|---|
| 61397895 | Jun 2010 | US |
