CN112831410A

CN112831410A - Process tube and carrier tray

Info

Publication number: CN112831410A
Application number: CN202110187647.XA
Authority: CN
Inventors: 米迦勒·J·鲍曼; 布伦特·波尔; 艾德·贝尔辛格
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2013-03-15
Filing date: 2013-03-15
Publication date: 2021-05-25
Also published as: JP6387387B2; EP2969211A1; ES2744596T3; US11433397B2; KR102121852B1; BR112015022459B1; AU2020220176A1; CA2905204A1; AU2013381879A1; BR112015022459A2; EP2969211B1; MX2015011194A; US20190151854A1; AU2020220176B2; JP2016515805A; AU2013381879B2; KR20150132849A; WO2014143044A1; CA2905204C; AU2018264066B2

Abstract

The present invention provides systems and methods to safely and efficiently store and transport process tubes (102) in a carrier tray (300) prior to and during amplification of nucleic acids included in the process tubes (102). The disclosed process tube (102) includes a securing region having an annular ridge (204), a neck (228), and a protrusion (212). The securing region of the process tube (102) may secure the process tube (102) in the port of the load-bearing tray (300), but still allow the process tube (102) to adjust or float to align the process tube (102) into the rigid heating aperture (402) of the thermal cycler (400).

Description

Process tube and carrier tray

The present application is a divisional application of a patent application (international application date 2013, 3, 15, application number 201380075541.4, entitled "process tube and carrying tray").

Background

Technical Field

The technology described herein relates generally to process tubes and carrier trays for amplification processes and methods of making and using the process tubes and carrier trays in which the process tubes are safely stored for transport and handling.

Prior Art

The medical diagnostic industry is a key element of today's medical infrastructure. Currently, however, in vitro diagnostic assays have become a bottleneck in patient care regardless of daily routine. It is believed that diagnostic assays on biological samples can be broken down into several key steps, and it is often desirable to automate one or more of the steps. For example, biological samples such as those obtained from a patient can be used in nucleic acid amplification experiments to amplify a target nucleic acid (e.g., DNA, RNA, etc.) of interest. Polymerase Chain Reaction (PCR) performed in a thermal cycling apparatus is one such amplification experiment used to amplify samples of interest.

Once amplified, the presence of the target nucleic acid or an amplified product of the target nucleic acid (e.g., a target amplicon) can be detected, wherein the presence of the target nucleic acid and/or the target amplicon is used to identify and/or quantify the presence of the target (e.g., a target pathogen, a gene mutation or alteration, etc.). Often, nucleic acid amplification experiments involve multiple steps that may include nucleic acid extraction and preparation, nucleic acid amplification, and target nucleic acid detection.

In many nucleic acid-based diagnostic experiments, once obtained, a biological, environmental or other sample to be analyzed is mixed with reagents for processing. The processing may include combining extracted nucleic acids from the biological sample with amplification and detection reagents, such as probes and fluorescein. Currently, processing samples for amplification is a time consuming and labor intensive step.

Processing of samples for amplification is often performed in dedicated process tubes that are used to hold the extracted DNA sample before and after the amplification process. In some examples, the process tube is placed directly in a thermal cycler for amplification. In some examples, to simplify the steps, the process tubes are first placed in a tube rack for pre-amplification processing (such as filling the tubes with amplification reagents, drying the reagents, and labeling the tubes by hot stamping the tubes). The process tubes are often removed from the tube rack by a laboratory technician and placed separately and individually in contact with the heating units of the thermocycler. Placing process tubes separately in a thermocycler is inefficient, time consuming, and can be difficult to automate. Further, the process is susceptible to human error.

In some examples, racks including process tubes may be placed directly in the thermal cycler. However, this approach also has drawbacks because the process tube may move in the rack during handling and transport and therefore will likely not be properly aligned with the heater of the thermal cycler. Additional intervention must be performed by a laboratory technician to align the tube and fit the tube into the heater of the thermal cycler. Furthermore, if the process tube is not fixedly connected to the rack, the process may shift, be pulled up and out of the rack by the stamping device during the marking of the process tube.

Many of the difficulties in handling and transporting process tubes in racks stem from the shape of the tubes typically used in the amplification process. The process tube is often conical in shape with a larger outer diameter at the top of the process tube than at the bottom of the process tube. Some process tubes are cylindrical in shape, having a constant diameter from top to bottom. The port of the rack in which the process tube is placed must have a diameter that is larger than the maximum outer diameter of the process tube (at the top of the process tube). To account for tolerances associated with manufacturing process tubes and racks, the ports in the rack are often significantly larger than the outer diameter of the process tubes, allowing the tubes to move around in the rack and potentially fall out. The process tube can be tilted to one side or the other without a fixed fit in the rack. In the case of multiple process tubes located in a rack, tilting the process tubes may hit each other and damage and/or cause loss of the samples and/or reagents stored therein. Furthermore, it can be very difficult to align differently angled process tubes into the rigid heaters of the thermocycler.

Thus, there is a need for process tubes and trays that fit together securely to allow safe and efficient handling and transport of the process tubes prior to and during amplification. In addition, there is a need for process tubes that still have the ability to adjust or float in the tray to facilitate alignment with the heaters of the thermal cycler.

The discussion of background art herein is included to explain the context of the invention described herein. This is not to be taken as an admission that any of the material referred to was published, known or part of the common general knowledge as at the priority date of any of the claims.

Disclosure of Invention

Certain embodiments disclosed herein provide process tubes having a securing region that includes an annular ridge, a protrusion, and a neck between the ridge and the protrusion. The process tube also includes a body extending below the projection and a top ring extending vertically upward from the annular ridge, the top ring defining an opening to the tube.

In some embodiments, the outer surface of the neck can be parallel to a longitudinal axis through the process tube. The protrusion may include an apex, an upward slope from the apex to the neck, and a downward slope from the apex to the body. The angle of the up-slope on the protrusion may be steeper than the angle of the down-slope on the protrusion. The annular ridge of the process tube can have an upper surface, a lower surface, and an outer surface. The protrusion may have an outer diameter greater than an outer diameter of the neck. The annular ridge may have an outer diameter greater than an outer diameter of the protrusion. The process tube can further include a base below the body, the base defining a bottom of the process tube.

Certain embodiments disclosed herein include a process tube strip having a plurality of process tubes. The plurality of process tubes are connected by a ledge that abuts the annular ridge of the plurality of tubes.

Certain embodiments provide a process tube having an annular ridge extending laterally from the tube, the annular ridge including an upper surface, a lower surface, and an outer surface. The process tube may include a top ring extending vertically upward from an upper surface of the annular ridge, the top ring defining an opening to the process tube. The process tube may further include an annular protrusion extending laterally from the process tube at a location on the tube below the annular ridge. The projection may have an apex, a ramp-up portion, and a ramp-down portion. The process tube can include a neck between the annular ridge and the protrusion, a body below the protrusion, and a base defining a bottom of the tube.

Embodiments of the disclosed process tube can be configured to fit securely in a load-bearing tray. The load-bearing tray may have a rack and a base, such that the rack has a plurality of ports through a top of the rack, and the ports have an inner wall. In certain embodiments, the projections of the disclosed process tubes can have an outer diameter that is larger than the diameter of the ports in the load-bearing tray. The neck of the process tube can have an outer diameter that is smaller than the diameter of the port in the load-bearing tray. The process tube can fit securely into the port of the load-bearing tray.

In certain embodiments of the process tube, the lower surface of the annular ridge of the process tube may rest on the exterior of the stent top, and the upper slope of the protrusion may rest on the bottom edge of the inner wall of the port. A gap may exist between the neck of the process tube and the inner wall of the port, and the gap may allow the process tube to tilt or adjust in the port of the load-bearing tray.

Other embodiments of the present invention provide systems having a load-bearing tray with a plurality of ports therethrough and a process tube with a securing area. The securing region of the process tube can include an annular ridge, a neck, and a protrusion. The securing region of the process tube can fit securely in the port of the load-bearing tray. In this system, the annular ridge and the protrusion of the process tube can have an outer diameter that is larger than the diameter of the port of the load-bearing tray, and the neck of the process tube can have an outer diameter that is smaller than the diameter of the port. When the process tube is securely fitted in the port of the load tray, the process tube may be tilted or adjusted in the port of the load tray.

Drawings

Fig. 1A shows an isometric view of an exemplary process tube strip as described herein.

FIG. 1B is a side plan view of the process tube strip of FIG. 1A.

FIG. 1C is a top view of the process tube strip of FIG. 1A.

Fig. 1D shows an isometric view of another exemplary process tube strip as described herein.

Fig. 1E shows an isometric view of another exemplary process tube strip as described herein.

Fig. 2A is an isometric view of an exemplary single process tube as described herein.

FIG. 2B is a cross-sectional view of the process tube of FIG. 2A taken along line 2B in FIG. 1C.

Fig. 3A illustrates an exemplary carrying tray as described herein.

FIG. 3B illustrates a plurality of exemplary process tube strips in the carrier tray of FIG. 3A.

FIG. 4 is a cross-sectional view of 12 process tubes positioned in a carrier tray prior to securing the process tubes in the carrier tray.

FIG. 5 is a cross-sectional view of two exemplary process tubes positioned in a carrier tray prior to securing the process tubes in the carrier tray.

FIG. 6A is a cross-sectional view of the process tube of FIG. 4 taken along line 6A in FIG. 3B after the process tube is secured in the carrier tray.

Fig. 6B is a cross-sectional view of the strip of process tubes positioned in the carrier tray, taken along line 6B in fig. 3B, after the process tubes are secured in the carrier tray.

FIG. 7 is a cross-sectional view of the process tube of FIG. 5 positioned in a carrier tray after the process tube is secured in the carrier tray.

Fig. 8 is an isometric view of an exemplary heater assembly of the thermal cycler.

FIG. 9 is a cross-sectional view of an exemplary process tube positioned in a heating bore of a heater assembly as described herein.

Detailed Description

Before the embodiments are further described, it is to be understood that this invention is not limited to particular embodiments described, as such may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

It is understood that every intervening value, to the tenth of the unit of the range of values is set to the lower limit, unless the context clearly dictates otherwise, any other stated or intervening value, between the upper and lower limit of that range and in that stated range, is encompassed within the embodiments. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the embodiments, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding any two of those included limits are also included in the embodiments.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the embodiments belong. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the embodiments, the preferred methods and materials are now described.

It must be noted that, as used herein and in 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 method" includes a plurality of such methods and equivalents thereof known to those skilled in the art, and so forth.

Throughout this specification and the claims that follow, the word "comprise", and variations such as "comprises" and "comprising", are not intended to exclude other additives, components, integers or steps.

The process tubes and carrier trays described herein may be used together to provide a safe and efficient system for preparing, storing, and transporting process tubes prior to use in a thermal cycler and also for accurately and securely positioning process tubes in a thermal cycler during an amplification procedure.

Fig. 1A shows an isometric view of an exemplary process tube strip 100 according to embodiments described herein. FIG. 1B is a side plan view of the process tube strip of FIG. 1A. FIG. 1C is a top view of the process tube strip of FIG. 1A. As shown in fig. 1A-1C, process tube strip 100 is a collection of process tubes 102, which process tubes 102 are connected together by connector tabs 104. The example process tube strip 100 can also include a top end tab 106 representing the top of the process tube strip 100, as shown in fig. 1A-1C, and a bottom end tab 108 representing the bottom of the process tube strip 100. The process tube strip 100 shown in fig. 1A-1C includes eight process tubes 102 coupled together in the process tube strip 100. However, those skilled in the art will immediately recognize that in other embodiments, process tube strip 100 may include, for example, any other number of process tubes, such as 40, 30,20,19,18,17,16,15,14,13,12,11,10,9,7,6,5,4,3, or 2 process tubes 102 connected in process tube strip 100. Embodiments of process tube strip 100 can include markings or indicia on the upper surfaces of top end tab 106 and bottom end tab 108. In one embodiment, the top end tab 106 may be labeled with an "a" indicating the top of the process tube strip 100, and the bottom end tab 108 may be labeled with a letter of the alphabet corresponding to the number of process tubes 102 in the process tube strip 100 (e.g., "H" may be labeled on the bottom end tab 108 of the process tube strip 100 for a process tube strip 100 having eight process tubes 102 connected together in the process tube strip 100). However, the skilled artisan will readily recognize that various other characters, for example, alphanumeric characters such as "1" and "8" may also be readily used to mark the top and bottom projections of the process tube strip 100 to accomplish the same purpose. Thus, the top and

bottom end tabs

106, 108 can be used to indicate the top and bottom of the process tube 102 and the number of process tubes 102 in the process tube strip 100. Additionally, the

end tabs

106, 108 may be marked with a color marking, a bar code, or some other indication to identify, for example, the contents of the process tube 102, the type of experiment performed in the process tube strip 100, and the date and location of the product of the process tube strip 100.

FIG. 1D is another embodiment of process tube strip 100 that includes ridge extensions 110 on each process tube 102. FIG. 1E is an additional embodiment of the process tube strip 100 that includes a tube label 112 positioned on the ridge extension 110 of each process tube 102. These embodiments are described in further detail below.

The process tube 102 can be a vessel for or containing a solid or liquid. For example, the process tube 102 can hold reagents and/or samples, such as a nucleic acid sample to be used in an amplification experiment. The cross-section of process tube 102 can be circular, but other cross-sections are possible and consistent. The process tube 102 may be manufactured via a unitary construction, although in some examples, the process tube may be constructed of two or more components that are fused or otherwise joined together in a suitable manner. Generally, the process tube 102 has an opening configured to receive/receive a pipette tip for depositing and/or retrieving fluids in the process tube 102.

In some embodiments, process tube 102 can be constructed from polypropylene or other thermoplastic polymers known to those skilled in the art. Alternatively, process tube 102 can be constructed of other suitable materials, such as polycarbonate, and the like. In some embodiments, the polypropylene is advantageously pigmented, such as titanium dioxide, zinc oxide, zirconium oxide, or calcium carbonate. Preferably, process tube 102 uses materials to be manufactured such that the process tube does not fluoresce and thus does not interfere with the detection of amplified nucleic acids in process tube 102.

Fig. 2A and 2B show isometric and cross-sectional views, respectively, of an exemplary single process tube 102. Connector tabs 104 are shown in FIG. 2A connecting process tube 102 to other process tubes 102 on either side of process tube 102. In fig. 2B, connector lug 104 is shown to include a connection groove 232 on the underside of the connector lug. In some embodiments, the connection groove 232 provides a separation point to easily separate different process tubes 102 connected as part of the process strip 100. The process tubes 102 may be separated by the end user to mix and match with different process tubes 102 having different drying reagents and the process tubes are re-arranged in the carrier tray 300 to match the necessary operations of the amplification experiments in the thermal cycler. Connector tab 104 can also be positioned between process tube 102 at the end of process tube strip 100 and either top end tab 106 or bottom end tab 108. The connector tabs 104 allow the end process tube 102 to be easily removed and also to be mixed and mated with process tubes 102 from other process tube strips 100 or used separately in a thermal cycler.

As shown in fig. 2A and 2B, the process tube 102 can have a top ring 202, the top ring 202 defining an opening 226 at the top of the process tube 102. The top ring 202 extends around the circumference of the opening 226. As part of process tube 102, annular ridge 204 extends laterally outward from the lateral side of process tube 102 below top ring 202. In this manner, top ring 202 extends upwardly from upper surface 206 of annular ridge 204. In addition to upper surface 206, annular ridge 204 is defined by an outer surface 208 and a lower surface 210. Below the circular ridge 204 is a neck 228 of the process tube 102 that extends vertically from the circular ridge 204 parallel to the longitudinal axis 230 of the process tube 102. As shown in fig. 2B, the exterior of the process tube 102 at the neck can be parallel to a longitudinal axis 230 running vertically through the process tube 102. In another embodiment, the outer neck 228 may be angled with respect to the longitudinal axis 230 to assist in removing the process tube 102 from the injection mold during the manufacturing process.

Below the neck 228 of the example process tube 102 shown in fig. 2A-2B is a projection 212 that extends laterally from the side of the process tube 102. The projection 212 is defined by an upwardly sloping portion 214 when extending from the neck 228 to an apex 215 of the projection 212. The apex 215 of the projection 212 has the largest outer diameter of the projection 212, and then the projection 212 includes a down-slope 216 that extends down the exterior of the process tube 102 from the apex 215. The upper angled portion 214 of the projection 212 is angled away from the longitudinal axis 230 and the lower angled portion 216 is angled rearwardly toward the longitudinal axis 230. In some embodiments, as shown in fig. 2A-2B, the angle of the up-slope 214 on the protrusion is steeper than the angle of the down-slope 216 on the protrusion 212. The down-slope 216 of the projection 212 merges with a longer body portion 218 of the process tube 102. The body 218, such as the downslope 216 of the projection 212, is inclined toward the longitudinal axis 230, but has a less steep angle than the downslope 215 of the projection 212. Body 218 extends to a base 220 of process tube 102. The base 220 includes an annular bottom ring 224 on the bottom of the process tube 102 that is defined by a pocket 222 in the bottom of the process tube 102. In the present embodiment, top ring 202, annular ridge 204, neck 228, protrusion 212, and body 218 are coaxial with longitudinal axis 230.

The annular ridge 204, neck 228, and protrusion 212 together define the securing area 200 of the process tube 102. As described in detail below, the securing area 200 provides a way to easily and securely attach the process tube 102 (or a plurality of process tubes 102 in the form of a process strip 100) to a carrying tray for transport and subsequent handling in the heater of a thermal cycler.

As described above, the process tube 102 may be manufactured as a strip 100 of tubes 102 that passes through the connector tabs 104 to be connected together. Multiple process tube strips 100 may then be securely inserted into the carrier tray 300. Fig. 3A illustrates an exemplary carrying tray 300. As shown in fig. 3A, the carrier tray 300 may receive a plurality of ports 306 in a rack 302 of the carrier tray 300. A plurality of ports 306 may be configured to receive individual process tubes 102, and the number of ports 306 in a column of the carrier tray 300 may advantageously be designed to fit the length of the process tube strip 100. Thus, the number of ports 306 in the y-direction can be designed to correspond to the number of process tubes 102 in the process tube strip 100. In one embodiment, the carrier tray 300 may have eight ports 306 in the y-direction, such that a process tube strip 100 including eight process tubes 102 may be inserted and secured in the y-direction in the ports 306 of the carrier tray 300.

In one embodiment, the port 306 in the load-bearing tray 300 is oval in shape with a larger cross-sectional diameter in the y-direction. In this manner, the larger diameter cross-section of the oval ports 306 are aligned in the same direction as the process tube strip 100 when inserted into the carrier tray 300.

Fig. 3B shows a plurality of process tube strips 100 securely assembled in an exemplary carrier tray 300. Once the process tubes 102 are securely inserted in the carrier tray 300, the assay reagents, such as amplification and detection reagents, can be added to the process tubes 102 in an automated fashion. In some embodiments, liquid reagent may be pipetted into a separate process tube 102, and then the carrier tray 300 may optionally be placed in a blower to dry the liquid reagent in the bottom of the process tube, as a solid that forms the shape of the inner base 220 of the process tube 102. In some embodiments, the liquid reagent is not dried in the process tube 102. In some embodiments, each process tube 102 in the carrier tray 300 can be deposited with the same reagent. In other embodiments, some or each process tube 102 in the process tube strip 100 can be filled with a different reagent or sample.

Once filled with the desired reagent, for example, after drying the reagent in embodiments where the reagent is dried, or only after depositing the reagent in embodiments where the reagent is not dried, the process tube 102 can be labeled with an indicator to identify the contents of the process tube 102 (e.g., the particular reagent). In some embodiments, the marking of the process tube 102 can be accomplished by hot stamping the top ring 202 of the process tube 102 with a particular color that indicates the contents (e.g., reagents) of the process tube 102. The top ring 202 also provides a surface to which an adhesive seal may be applied to seal the opening 226 of the process tube 102.

As discussed above, FIG. 1D shows process tube strip 100 wherein each process tube 100 includes a ridge extension 110 extending from one side of annular ridge 204 of process tube 100. Ridge extension 110 provides additional surface area on annular ridge 204 for marking individual process tubes 102. In one embodiment, ridge extensions 110 may be pre-marked with an alphanumeric identifier (e.g., a, B, C, etc. or 1,2,3, etc.) to identify individual process tubes 102 in process tube strip 100. In one embodiment, instead of hot stamping the top ring 202 after depositing reagent in the process tube 102, the ridge extensions 110 of the process tube 102 may be hot stamped, or otherwise marked, to identify the contents of the process tube 102 (e.g., reagent). In addition, a 2-D barcode (ink or laser) may be printed directly on the ridge extensions 110.

As shown in fig. 1E, the individual process tubes 102 of the process tube strip 100 may include a tube label 112 attached to the top of the ridge extension 110. The label 112 may be used in conjunction with or in conjunction with marking (e.g., hot stamping) the top ring 202 of the process tube 102 to identify the contents, such as reagents, in a particular process tube 102. The tag 112 may be a 2-dimensional matrix barcode (e.g., a QR code or Aztec code) encoded with data that identifies the contents of the associated process tube 102. In using the label 112 to indicate the contents of the process tube 102, a camera (e.g., a CCD camera) may be used to scan and verify the contents of the process tube 102 and ensure that the correct amplification experiment is being performed with the associated reagents. The camera can effectively and quickly verify the contents of each process tube 102 by reading the tag 112, thus avoiding a user from possibly mistakenly pairing incorrect reagents with a particular amplification experiment for a prescribed polynucleotide sample.

In some examples, the same reagent may be added to each process tube in the carrier tray 300. In one example, each tube strip 100 may include eight process tubes 102 and then the tube strips may be securely fit into a 96-port carrier tray 300. The same reagent may then be added to each of the 96 process tubes in the carrier tray 300. If all process tubes 102 are provided with the same reagent, all process tubes 102 in the entire carrier tray 300 can be hot stamped using the same color. Multiple carrier trays 300 may be stacked and transported together to an end user. In some embodiments, each or some of the process tubes 102 in the tube strip 100 can include a different reagent. In this case, process tubes 102 that include the same reagent may be labeled with the same color. Different colors may be used to identify process tubes 102 that include different reagents.

The end user may require different stamping process tubes 102 to run different amplification experiments with different reagents provided. In some examples, an end user may need to use different reagents in an amplification experiment, and as such, the carrier tray 300 of the process tube 102 having all of the same reagents may not be used. In this case, the end user may remove one or more process tube strips 100 from a single color carrier tray 300 and exchange the one or more process tube strips with a different color process tube strip 100 in a different carrier tray 300 to achieve the required number and type of reagents for a given amplification experiment. It is also contemplated that a manufacturer may provide end users with carrier trays 300 having differently colored process tube strips 100.

The end user may further improve the collection of different reagents in an amplification experiment by separating the individual process tube strips 100 at the connection groove 232 between the process tubes 102. For example, the eight tube process tube strip 100 may be divided into a smaller set of 1,2,3,4,5,6, or 7 process tubes 102 of process tubes 102. Separating the process tube strip 100 allows an end user to include process tubes 102 of different reagents in the same column of the carrier tray 300.

As described above, FIG. 3B provides an illustration of the process tube 102 when it has been securely fitted into the load-bearing tray 300. FIG. 4 is a cross-sectional view of 12 process tubes 102 positioned in a carrier tray 300 prior to securing the process tubes 102 in the carrier tray 300. This view is similar to the cross-sectional view 6A shown in fig. 3, but shows the process tube 102 resting in the port 306 of the load-bearing tray 300 prior to securing the process tube 102 in the load-bearing tray 300. As shown in fig. 3B and 4, the carrying tray 300 has a base 304 and a shelf 302, the base 304 being wider and longer than the shelf 302 and thus having a larger planar surface area than the shelf 302. The rack 302 carrying the tray 300 includes rack sides 308 and a rack top 310. The rack top 310 is a horizontal, flat portion of the rack 302 and covers the top of the load-bearing tray 300. The holder top 310 includes an outer surface 312 and an inner surface 314. Because the base 304 of the load-bearing tray 300 is wider and longer than the cradle 302, the base 304 includes a bridge 320 running horizontally connecting the cradle side 308 with the base side 305. The bridge 320 includes an inner side 322. The cradle 302 extends downwardly from a cradle top 310 on the load-bearing tray 300 at a cradle side 308 and joins a base 304 of the load-bearing tray 300 at a bridge 320. As shown in fig. 4, the process tubes 102 of the process tube strip 100 may be positioned in ports 306 in the rack 302 of the carrier tray 300.

FIG. 5 is an enlarged cross-sectional view of two example process tubes 102 positioned in an example carrier tray 300 prior to securing the process tubes 102 in the carrier tray 300. The process tubes 102 can rest in the ports 306 of the carrier tray 300 before securing the process tubes 102 in the carrier tray 300. The outer diameter of the body 218 of the process tube 102 is smaller than the diameter of the port 306 so that the body 218 of the process tube 102 can be inserted through the port 306. The projection 212 on the process tube 102 has a diameter that is larger than at least one diameter of the port 306. For example, in the example where the port 306 is elliptical, the smaller diameter of the port 306 (e.g., the width diameter in the x-direction of fig. 3A and 3B) is smaller than the diameter of the protrusion 212. In some embodiments, the larger diameter of the port 306 (e.g., the length diameter in the y-direction of fig. 3A and 3B) may be larger than the diameter of the protrusion 212. Thus, when the body 218 of a process tube 102 is inserted into the port 306, the body 218 enters the underside region of the carrier tray 300, but the top of the process tube 102, including the securing region 200 (including the protrusion 212, neck 228 and annular ridge 204) and the top ring 202, is prevented from entering the port 306. In this manner, the protrusion 212 rests on the top edge 318 of the port 306. More specifically, the down-slope 216 of the tab 212 rests on the port top edge 318.

In some embodiments, the apex 212 of the protrusion 212 is rounded with a constant outer diameter. For an oval port 306, in one embodiment, the port 306 may have a length diameter that is greater than a width diameter. In this embodiment, the diameter width (in the x-direction) of port 306 may be smaller than the diameter of apex 215 of protrusion 212. Thus, at the protrusion 212, the process tube 102 rests on the top edge 318 of the port 306. In one embodiment, the length diameter (in the y-direction) of the port 306 may be larger than the diameter of the apex 215 of the projection 212. Thus, a smaller gap (in the y-direction) on both ends of port 306 is provided which facilitates easier securing of process tube 102 in port 306 and, if desired, easier removal of process tube 102 from port 306. In other embodiments, the port 306 may be circular, having a constant diameter.

With the process tube 102 resting in the port 306 against the port top edge 318, a force may be applied to the top of the process tube 102 to press the process tube 102 further into the port 306 to secure the process tube 102 in the port 306 of the load-bearing tray 300. The force securing process tube 102 into access port 306 may be applied to top ring 202 of process tube 102 or the force may be applied to upper surface 206 of raised annular ridge 204.

Securing the process tube 102 in the port 306 first involves applying sufficient force to the top of the process tube 102 to urge the down-sloped portion 216 of the projection 212 into the port 306. The down-slope 216 is angled toward the longitudinal axis 230 of the process tube 102. As continued pressure is applied to the top of the process tube 102, the down-slope 216 of the projection 212 slides down the port top edge 318 until the apex 215 of the projection 212 reaches the port top edge 318. The port top edge 318 may be spherical or sloped to facilitate the travel of the protrusion 212 through the port 306.

As the process tube 102 is pushed into the port 306, the portion of the lower bevel 216 of the projection 212 that has entered the port 306 does not contact the port inner wall 316 because the lower bevel 216 is angled toward the longitudinal axis 230. The downward sloping portion 216 of the protrusion 212 gradually widens (increasing in outer diameter) as the downward sloping portion 216 extends upward toward the apex 215 of the protrusion 212. The wider the diameter of the down-slope 216, the greater the resistance to pushing the process tube 102 into the port 306. Thus, a resistive force is generated that resists the force applied to push the process tube 102 into the port 306. The resistance against process tube 102 increases (and the force used to push process tube 102 increases) and process tube 212 enters port 306 farther down. The resistance against the process tube 102 continues to increase until the apex 215 of the projection 212 reaches the port top edge 318.

In one embodiment of the load tray 300 having oval shaped ports 306, the larger diameter of the ports 306 in the y-direction may more easily allow the process tubes 102 to be pushed into the ports 306 and secured in the load tray 300, thus reducing the force used to secure the process tubes. The elliptical port 306 may provide additional space (e.g., a gap) between the protrusion 212 of the process tube 102 and the port interior 316 on both ends that allows the process tube 102 to bend and elongate in the y-direction and compress in the x-direction.

Once all of the down-ramps 216 pass the port top edge 318 and the apex 215 of the projections pass the port top edge 318, the apex 215 of the projections 212 contact the port inner wall 316. Apex 215 is the widest portion (largest outer diameter) of projection 212. As apex 215 is fitted through port 306 and pressed against port inner wall 316, process tube 102 experiences the greatest tension and is most bent. As continued force is applied to the top of the process tube 102, the apex 215 is forced to slide down the port inner wall 316 until the apex 215 completely passes the port 306 at the bottom edge 319 of the port 306. Once the apex 215 breaks the bottom edge 319, the tension on the process tube 102 is released and the process tube 102 securely "snaps" into place in the access port 306 and is secured in the carrying tray 300. The force used to secure each process tube 102 of the process tube strip 100 in the load-bearing tray 300 may range from 0.7 pounds of force to about 1.7 pounds of force. In one embodiment, the force used to insert and secure process tube 102 into port 306 may be about 1 pound of force. In one embodiment, the force used to secure process tube 102 in port 306 may be about 1.18 pounds of force.

The carrier tray 300 may be advantageously designed for efficient stacking and transport of the carrier tray 300. The load-bearing tray 300 may be constructed of a polycarbonate resin thermoplastic. Referring to fig. 3,4 and 5, the carrying tray 300 may include a bridge 320 at the top of the base 220. The bridge 320 provides a platform upon which the lower surface 326 of another empty carrying tray 300 may be positioned. When two carrying trays 300 are stacked on top of each other, the bridging interior 322 of the top carrying tray 300 rests on the rack top 310 of the bottom carrying tray 300 and the lower surface 326 of the top carrying tray 300 to rest on the bridging portion 320 of the bottom carrying tray 300.

When the carrier trays 300 are filled with process tube strips 100, the carrier trays can be effectively stacked in a similar manner. The body 218 of the process tube 102 in the top load tray 300 can be placed in the opening 226 of the process tube 102 in the top load tray 300. Similarly, a process tube 102 in the top carrier tray 300 can further receive the body 218 of the process tube 102 in another carrier tray 300 to be stacked thereover.

FIG. 6A is a cross-sectional view taken along line 6A in FIG. 3B of the 12 process tubes 102 shown in FIG. 4. Fig. 6A shows process tube 102 now secured in carrier tray 300. The orientation of cross-section 6A in fig. 3B provides a view of 12 process tubes 102, each from a different process tube strip 100. FIG. 6B is a cross-sectional view of the entire process tube strip 100 positioned in the carrier tray 300, taken along line 6B in FIG. 3B, after the process tubes 102 are secured in the carrier tray 300. As shown in fig. 6B, the cross-sectional diameter of the elliptical port 306 in the y-direction may be larger than the diameter of the protrusion 212.

FIG. 7 is a close-up view of two process tubes 102 shown in FIG. 6A and corresponding to the process tubes 102 of FIG. 5 after the process tubes 102 are secured in the carrier tray 300. As shown in fig. 7, the cross-sectional diameter of the elliptical port in the x-direction may be smaller than the diameter of the protrusion 212. When apex 215 of projection 212 breaches bottom edge 319, upturned portion 214 of projection 212 contacts and catches bottom edge 319 of port 306 at the bottom of securing region 200. Also, as apex 215 breaks through bottom edge 319, lower surface 210 of raised annular ridge 204 contacts and catches with stent top exterior 312 of stent 302 at the top of fixation area 200. At the top of fixation area 200, raised annular ridge 204 is wide enough at least two points near port 306 that raised annular ridge 204 cannot pass through port 306. In one embodiment, annular ridge 204 may have a diameter large enough to cover all points near port 306. For example, annular ridge 204 may have a diameter that is greater than the width diameter and the length diameter of port 306. The height of securement region 200 (from lower surface 210 of annular ridge 204 to the location on upper ramp 214 of protrusion 212) corresponds approximately to the height of port 306 between port top edge 318 and port bottom edge 319.

As shown in FIG. 7, the neck 228 of the process tube 102 can have an outer diameter that is smaller than the diameter of the port 306, creating a gap 324 between the process tube 102 and the port inner wall 314. In one embodiment, the outer diameter of the neck 228 may be a fixed circular diameter. Since the shape of port 306 may be elliptical and port 306 has a larger length diameter on one side and a smaller width diameter on the other side, the width of gap 324 may vary between the length side (y-direction) and the width side (x-direction) of port 306. For example, the dimension of gap 324 on each length side of port 306 may be about twice the dimension of the gap on each width side of port 306.

Gap 324 provides an adjustment point for process tube 102 in fixed area 200. Gap 324 exists primarily between neck 228 and port inner wall 316 of process tube 102, but gap 324 also exists along a portion of upper ramp 214 of projection 212 and along a portion of lower surface 210 of annular ridge 204. The gap 324 is slightly enlarged at the top of the securing region 200 because the rounded corners of the port top edge 318 provide additional distance between the port 306 and the neck 228 of the process tube 102. Even when the process tube 102 is secured in the port 306, the gap 324 may provide some freedom of movement to the process tube 102 in the port 306 of the load tray 300.

Because the point of contact between the upper bevel 214 of the tab 212 and the port bottom edge 319 can be adjusted as the process tube 102 needs to be tilted, the process tube 102 can be adjusted in the port 306 while being held securely in the port 306. When the process tube 102 is tilted, the location of the point of contact between the securing area 200 of the process tube 102 and the port 306 of the load pallet 300 will adjust. For example, when the process tube is tilted to one side, the point of contact between the upper bevel 214 and the port bottom edge 319 on one side of the process tube 102 moves closer to the top of the upper bevel 214; on the other side of the tube, the other point of contact moves closer to the bottom of the ramp 214 (closer to the apex 215). Similar adjustments can be made at the top of the fixed area 200 so that the neck 228 can be inclined toward the spherical port top edge 318 on one side of the process tube 102 and can be inclined away from the port top edge 318 on the other side of the process tube 102.

The gap 324 allows the process tube 102 to be adjusted when multiple process tubes are placed into the carrier tray 100 as part of the process tube strip 100. Because of the possible manufacturing variations of the carrier trays 300 and the process tubes 102, each carrier tray 300 may be sized slightly differently and each process tube 102 may fit differently in the carrier tray 300. Given that process tubes 102 are often connected together as part of a process tube strip 102 when inserted into a carrier tray 300, it may be that manufacturing variations in the carrier tray 300 and process tubes 102 may prevent the precise placement of the entire process tube strip 100 in the carrier tray 300 without mitigating considerations. For example, because the process tubes 102 may be misaligned in the x-direction (lateral) or the y-direction (back-and-forth), accurate insertion of the process tubes 102 into the carrier tray 300 at one end of the process tube strip 100 may prevent accurate insertion of the process tubes 102 into the carrier tray 300 at the other end of the process tube strip 100. Despite misalignment, even if the rigid process tube strip 100 is pushed into the port 306 of the carrier tray 300, the rigid connection of the process tube 102 may prevent the process tube 102 from lying flat on the carrier tray 300, which may prevent the hot stamping process.

The present invention addresses these problems in a number of ways, including allowing the process tube 102 to tilt and adjust in the port 306 as the process tube strip 100 is manipulated and inserted into the load-bearing tray 300. Because the gap 324 allows this movement, the process tube 102 can be tilted and adjusted in the port 306. The elliptical shape of the port 306 also enhances the adjustment available in the y-direction. Also, the connector tabs 104 that connect the process tubes 102 are thin and flexible enough to allow for maneuverability and adjustment between individual process tubes 102 when inserting the process tubes into the carrier tray 300. Additionally, coupling groove 232 (shown in FIG. 2B) on connector boss 104 allows for increased flexibility between individual process tubes 102 when inserting the process tubes into port 306. In this manner, the gap 324, the oval port 306, and the connector tab 104 give the process tube 102 the ability to adjust and always lie flat on the carrier tray 300 when the process tube strip 100 is inserted into the carrier tray 300. Furthermore, the ability of the process tube 102 to be tilted or adjusted in the carrier tray 300 facilitates insertion of the process tube 102 into a heater of a thermal cycler, as described in more detail below.

When the process tube 102 is secured in the port 306 of the load-bearing tray 300, the process tube 102 may undergo a process when ready for use in a thermal cycler. Liquid reagents can be introduced into the fixed process tube 102. The process tubes 102 in the carrier tray 300 can be subjected to heat or other processes for drying or lyophilization to dry the liquid reagents in the process tubes 102. Although secured in the carrier tray 300, the process tubes 102 may also be hot stamped to mark the process tubes 102, indicating the type of reagent added to the process tubes 102. The hot stamping may be in the form of a color that is stamped on top ring 202 and/or annular ridge 204.

The process of applying force to secure the process tube 102 in the port 306 of the carrier tray 300, the process of inputting liquid reagent into the secured process tube 102, the process of drying the liquid reagent in the process tube 102, and the process of thermally stamping the process tube 102 in the carrier tray 300 can all be automated and performed at the site of production and assembly of the process tube 102 and carrier tray 300. The assembled carrier tray 300 including the prepared process tubes 102 may then be shipped to an end user for additional processing, such as depositing the extracted nucleic acid sample in the process tubes 102 prior to performing an amplification experiment of the sample in the process tubes 102 in a thermal cycler. The extracted nucleic acid sample is added to the process tube 102 to reconstitute the dried reagent to allow the reagent to associate with the nucleic acid sample in the reconstituted solution.

As described above, an end user may remove one or more process tube strips 100 from a single color carrier tray 300 and exchange the one or more process tube strips with a different color process tube strip 100 in a different carrier tray 300 to achieve the required number and type of reagents for a given amplification experiment. The force used to remove the process tube strip 100 may be about half the force used to insert the process tube strip. In one embodiment, the insertion force for process tube strip 100 may have a range of about 0.7 to 1.7 lbf, and the removal force for process tube strip 100 may have a range of about 0.3 to 0.8 lbf. In one embodiment, the insertion force for process tube strip 100 may be about 1 lbf and the removal force for process tube strip 100 may be about 0.5 lbf. In one embodiment, the force used to secure process tube strip 100 in port 306 may be about 1.18 lbf and the force used to remove the process tube strip is 0.60 lbf. Specifying the insertion and removal forces for the process tube strip 100 ensures that the process tube strip 100 is not unduly difficult to insert into or remove from the carrier tray 300, and also prevents the process tube strip 100 from falling out of the carrier tray under normal operating conditions.

It is noted that the same carrier tray 300 (containing process tubes 102) in which the mixing of reagents and nucleic acid samples is performed may be fed directly into the thermal cycler. Thus, the end user does not need to mix the reagents and nucleic acids in one tube and then transfer the mixed solution to another tube, or even move the first tube to another tray. In the present invention, the process tubes 102 comprising reagents and immobilized in the carrier tray 300 can receive a sample, such as a nucleic acid sample, and then can be input into a thermal cycler for an amplification experiment without removing the process tubes 102 from the carrier tray 300.

It is also contemplated that solid reagents may be added to the process tube 102 in addition to or instead of liquid reagents. It is also contemplated that empty process tubes 102 and carrier trays 300 may be provided to the end user, and that the end user may deposit solid or liquid reagents in the process tubes 102 prior to adding the nucleic acid sample.

The securing force, the force required to securely push the process tube 102 into the port 306, may be applied to multiple (or all) process tubes 102 in the carrier tray 300 simultaneously. Alternatively, the securing force may be applied to the individual process tubes 102 one at a time, respectively, as desired. The securing force may be applied in an automated manner and may be performed simultaneously with automated steps of filling the process tube 102 with reagent and hot stamping the process tube 102. In some examples, the same equipment may be used for hot stamping and applying a securing force to the process tube 102. Alternatively, a separate device may be used for hot stamping and applying the securing force.

When separate securement force devices and hot stamping devices are used, a securement force may first be applied to secure the process tube 102 in the port 306 of the load-bearing tray 300 prior to hot stamping the top ring 202 of the process tube 102. In some examples, an automated hot stamping apparatus may stick to the top ring 202 of the process tube 102 when pressure is applied to the top ring 202. Because of the novel method in which the process tube 102 in the embodiments described herein is secured in the carrier tray 300, the process tube 102 is not pulled up and out of the carrier tray 300 when the hot stamping apparatus is pulled away from the stamped process tube 102. Furthermore, because the process tubes 102 are secured in the carrier tray 300, the process tubes 102 can be transported without the risk of the process tubes 102 falling out of the carrier tray 300. Embodiments disclosed herein also advantageously overcome other problems that exist in other PCR tube trays, such as bundling tubes on one side of the tray or tubes out of alignment with the tray.

Fig. 8 is an isometric view of an exemplary heater assembly 400 for use in a thermal cycler (not shown). Amplification experiments (such as PCR or isothermal amplification) can be performed in a thermocycler. The heater assembly 400 is part of the temperature cycling subsystem of the thermal cycler and may work in conjunction with other subsystems of the thermal cycler, such as a detection subsystem. The exemplary heater assembly 400 shown in fig. 8 is a 96-well assembly including 96 heating wells 402, although other assemblies are contemplated (e.g., 48-well assemblies, etc.). The heater assembly 400 includes a flat top surface 404 between a heating aperture 402 and a side surface 410. Each heating hole 402 is conical in shape, and each heating hole 402 is formed by an inner wall 406 and a hole bottom 412. The heating holes 402 in the heater assembly 400 are arranged in an array of 8 rows and 12 columns to correspond to the spatial arrangement of the process tubes 102 in the carrier tray 300.

Each heating bore 402 can receive a process tube 102. The carrier tray 300 can be placed directly over the heater assembly 400 in the thermal cycler to place all of the process tubes 102 in the carrier tray 300 in the heater assembly 400 simultaneously. Not shown in fig. 8 is the necessary circuit surrounding the housing of the heater assembly 400 or providing heat to the heating aperture 402.

Because of the possible manufacturing variations of the carrier trays 300 and the process tubes 102, each carrier tray 300 may be sized slightly differently and each process tube 102 may fit differently in the carrier tray 300. If the process tubes 102 are rigidly connected to the carrier tray 300, manufacturing tolerances may prevent all of the process tubes in the 96-tube carrier tray 300 from being accurately placed in the heater holes 402. For example, fitting the process tube 102 in the heating bore 402 on one side of the heater assembly 400 may prevent the process tube 102 from being accurately and securely placed in its corresponding heating bore 402 on the other side of the heater assembly 400. As described above, because of the gap 324 between the port inner wall 316 and the securing region 200 of the process tube 102, the process tube 102 is able to float or adjust slightly when secured in the carrying tray 300. The coupling grooves 232 (shown in FIG. 2B) on the connector tabs 104 also allow flexibility between individual process tubes 102 when the process tubes are inserted into the heating bores 402. Allowing the process tube 102 to float in the port 306 of the load-bearing tray 300 allows the process tube 102 to adjust position to fit accurately and securely into the heating bore 402 of the heater assembly 400.

FIG. 9 is a cross-sectional view of two exemplary process tubes 102 positioned in a heating bore 402 of a heater assembly 400. When the process tube 102 is placed in the heating bore 402, the body 218 of the process tube 102 physically contacts and mates with the inner wall 406 of the heating bore 402. In some embodiments, the heated bore 402 is deeper than the body 218 of the process tube 102 such that the base 220 of the process tube 102 does not extend to the bore bottom 412 when the process tube 102 is secured in the port 306 of the carrier tray 300 and the carrier tray 300 is positioned above the heater assembly 400. In this manner, a gap 414 is created between the base 220 and the well bottom 412 of the process tube 102. The gap 414 ensures that the body 218 of the process tube 102 remains in physical contact with the bore inner wall 406; if the base 220 of the process tube 102 first falls to the bottom in the heating well bottom 412 before the body 218 contacts the well inner wall 406, a gap may exist between the wall 406 and the body 218 of the process tube 102 and result in poor heat transfer between the heating well 402 and the process tube 102. Thus, the gap 414 below the process tube 102 ensures that a gap does not exist between the wall 406 and the body 218 of the process tube 102. The heating bore 402 may surround the body 218 of the process tube 102 and provide uniform heating to the contents of the process tube 102 during the thermal cycling step of the amplification experiment. When the process tube 102 is placed in the heating bore 402, the heating bore 402 may surround the body 218 of the process tube only at a location below the down-sloped portion 216 of the protrusion 212.

The above description discloses various methods and systems of embodiments disclosed herein. The embodiments disclosed herein may be modifications of the methods and materials, and modifications of the manufacturing methods and apparatus. Such modifications will become apparent to those skilled in the art from a consideration of the design of this disclosure or from a practice of the invention disclosed herein. Therefore, it is not intended that the embodiments disclosed herein be limited to the specific embodiments disclosed herein, but that the disclosure cover all modifications and alternatives falling within the true scope and spirit of the invention.

Example 1

This example illustrates a particular process for preparing a carrier tray 300 with process tubes 102 to be provided to an end user.

1. 12 process tube strips were manufactured, the 12 process tube strips including eight connected process tubes constructed of polypropylene.

2. A carrier tray was made of polycarbonate with 96 ports in an 8x12 array.

3.12 process tube strips were placed in a carrying tray.

4. The process tubes of the process tube strip are secured in the ports of the load-bearing tray by applying a force to the top ring of the process tubes.

5. Each process tube in the carrier tray is filled with the same specific liquid reagent.

6. The carrier tray is heated to dry the reagents in the process tube.

7. The process tube is hot stamped with a particular color to indicate the experiment for which the process tube is to be used.

8. The carrier tray is stacked and packaged by other carrier trays with the same or different reagents and shipped to the end user.

9. The end user may use the entire carrier tray unchanged, or may reduce the number of carrier trays filled and refill the carrier tray or trays with a mix of separate process tube strips or tubes of various reagent types.

Example 2

This example describes test steps and test results to determine the force for securing the process tube strip 100 in the port 306 of the load-bearing tray 300 and the force for subsequently removing the process tube strip 100 from the port 306.

An Amtek AccuForce Cadet load cell (0-5 pounds) was used to measure the force used to secure and remove process tube 102 in port 306.

Test procedure

1. A strip of tubing is placed in a row of carrying trays. (not yet fixed in the load tray)

2. The meter is turned on.

3. The meter is zeroed by the meter in the vertical position.

4. And (5) clearing the meter.

5. Each tube was slowly pressed down in the strip starting in row "a" until all tubes snapped into place, with the meter at a small angle of 2-3 degrees from vertical on each tube.

6. The force value and column number on the meter are recorded as the interpolated value.

7. The clear button is pressed to clear the memory.

8. The tubes of the second strip are placed in a second column. And (5) repeating the steps 5-7.

9. Steps 5-7 are repeated for the remaining strips 3-12.

10. The carrier tray is inverted and started with the first strip and the tube is slowly pressed out of the carriers starting at row "a".

11. The force and column numbers are recorded as the removal values.

12. The clear button is pressed to clear the memory.

13. Steps 10, 11 and 12 are repeated for the remaining process tube strips.

14. The 12 process tube strips were rearranged in the carrier tray and steps 3-13 were repeated.

Results

The force results of the tests are provided in table 1. Table 1 shows the forces required to insert and secure all of the process tubes 102 of the process tube strip 100 into the load-bearing tray 300. As shown, the average insertion force to secure process tube strip 100 in load-bearing tray 300 is 1.18 lbf and the average removal force is 0.60 lbf.

Table 1 process tube insertion and removal test

Claims

1. A system, comprising:

a load-bearing tray comprising a base and a rack, the rack comprising a plurality of oblong ports through a top of the rack, each oblong port of the plurality of oblong ports comprising a length diameter greater than a width diameter, and each oblong port of the plurality of oblong ports having an inner wall; and

a process tube configured to fit securely within one of the plurality of oval ports of the load-bearing tray, the process tube comprising:

a raised annular ridge extending laterally from the process tube, the raised annular ridge comprising an upper surface, a lower surface, and an outer surface;

a top ring extending vertically upward from an upper surface of the annular ridge and defining an opening to the process tube;

an annular protrusion extending laterally from an exterior of the process tube at a location on the process tube below the annular ridge, the protrusion having an apex, an up-slope and a down-slope, wherein an angle of the up-slope on the protrusion is steeper than an angle of the down-slope on the protrusion, wherein a cross-section of the annular protrusion at the apex is circular and a diameter of the cross-section of the annular protrusion is greater than a width dimension of the elliptical port;

a neck between the raised annular ridge and the protrusion, wherein the neck is circular in cross-section and has a diameter that is less than the width dimension of the elliptical port;

a body below the protrusion; and

a base defining a bottom of the process tube;

wherein, when the process tube is securely fitted within one of the plurality of elliptical ports, a lower surface of the annular ridge rests on the stent, the neck is received within an inner wall of the elliptical port, and the annular protrusion is positioned below the stent.

2. The system of claim 1, wherein the upturned portion of the protrusion contacts a bottom edge of the inner wall of the port when the process tube is securely fit within the oval port.

3. The system of claim 1, wherein a gap exists between a neck of the process tube and an inner wall of the port when the process tube is securely fit within the elliptical port.

4. The system of claim 3, wherein the gap allows the process tube to tilt in the oval port of the load-bearing tray when the process tube is securely fit within the oval port.

5. The system of claim 1, wherein the process tube further comprises a flat extension extending laterally from the annular ridge, the extension providing a surface on which the process tube is marked.

6. The system of claim 1, wherein the process tube is one of a plurality of process tubes connected together as a process tube strip.

7. The system of claim 1, wherein as the process tube is inserted into the oval port, the process tube experiences maximum tension and is maximally flexed as the apex slides through an inner wall of the oval port of the load-bearing tray, and, when the apex breaks through a bottom edge of the oval port, the tension on the process tube is released and the process tube securely snaps into place.

8. The system of claim 7, wherein as the apex slides through the inner wall of the elliptical port, the process tube bends such that the protrusion is elongated in a length dimension of the elliptical port and compressed in a width dimension of the elliptical port.

9. The system of claim 7, wherein the force required to insert the process tube into the elliptical port is between 0.7 pounds and 1.7 pounds.

10. The system of claim 1, further comprising: a heater assembly positionable below the rack and comprising a plurality of heating wells, each heating well comprising an inner wall and a well bottom, wherein the process tube is received within one of the plurality of heating wells such that the body of the process tube contacts the inner wall of the heating well and forms a gap between the base of the process tube and the well bottom of the heating well, the gap configured to prevent bottoming of the process tube in the heating well.

11. The system of claim 9, wherein the heated bore surrounds the body of the process tube at a location directly below a down-slope of the protrusion.

12. The system of claim 9, wherein the inner wall of the heating bore is conical and the body of the process tube is conical.

13. The system of claim 9, wherein the diameter of the neck is less than the length and width diameters of the port such that the process tube can be adjusted within the elliptical port to fit precisely and securely into the heating bore.

14. A system, comprising:

a carrier tray comprising a plurality of oblong ports therethrough, each port comprising a top edge, a bottom edge, an inner wall, and a length diameter greater than a width diameter; and

a process tube configured to be removably snapped into one of the plurality of oval ports of the carrier tray, the process tube comprising a securing region external to the tube, the securing region comprising an annular ridge, an annular protrusion, and a neck between the ridge and the protrusion, wherein the protrusion comprises an apex, an up-slope from the apex to the neck, and a down-slope from the apex to the body, wherein the angle of the up-slope on the protrusion is steeper than the angle of the down-slope on the protrusion, wherein the diameter of the neck is less than the length diameter and width dimensions of the port, wherein the diameter of the protrusion at the apex is greater than the width dimension of the port, wherein the cross-section of the process tube is circular, and wherein, when the process tube is removably snapped into the oval port, a gap is formed between the neck and the oval port, a bottom surface of the ridge rests on a top surface of the load tray, and an upper slope of the protrusion contacts a bottom edge of the port.

15. The system of claim 14, wherein the gap is configured to allow the process tube to move within the elliptical port.

16. The system of claim 14, wherein a diameter of the protrusion at an apex of the process tube is configured to decrease as the process tube is snapped into the elliptical port of the load-bearing tray.

17. The system of claim 14, wherein a cross-section of the process tube is configured to elongate into the gap when the protrusion is positioned within the elliptical port of the carrying tray as the process tube is snapped into the elliptical port.

18. The system of claim 14, further comprising: a heater assembly comprising a plurality of heating wells, each heating well comprising an inner wall and a well bottom, wherein the process tube is received within one of the plurality of heating wells such that the body of the process tube contacts the inner wall of the heating well and forms a gap between the base of the process tube and the well bottom of the heating well, the gap configured to prevent bottoming of the process tube in the heating well.

19. The system of claim 14, wherein the heated bore surrounds the body of the process tube at a location directly below a down-slope of the protrusion.

20. The system of claim 14, wherein the inner wall of the heating bore is conical and the body of the process tube is conical.

21. The system of claim 14, wherein the diameter of the neck is less than the length and width diameters of the port such that the process tube can be adjusted within the elliptical port to fit precisely and securely into the heating bore.