Test card with well shelf

文档序号：1570437 发布日期：2020-01-24 浏览：29次中文

阅读说明：本技术 具有阱搁板的测试卡 (Test card with well shelf ) 是由诺亚·门罗雷蒙德·奥贝尔布莱恩·利文斯顿帕特里克·艾伦·耶比克罗丝·米尔德于 2017-12-22 设计创作，主要内容包括：本发明提供一种测试卡、制造测试卡的方法以及用于制造该测试卡的模具。测试卡可包括主体和阱。该主体可包括第一表面和与第一表面相对的第二表面。该阱可以限定从第一表面延伸到第二表面并且配置成在其中接收样品的开口。阱还可包括延伸到开口中的搁板,使得开口在搁板和第二表面之间比在搁板和第一表面之间更窄。(The invention provides a test card, a method for manufacturing the test card and a die for manufacturing the test card. The test card may include a body and a well. The body may include a first surface and a second surface opposite the first surface. The well may define an opening extending from the first surface to the second surface and configured to receive a sample therein. The trap may further comprise a shelf extending into the opening such that the opening is narrower between the shelf and the second surface than between the shelf and the first surface.)

1. A test card, comprising:

a body comprising a first surface and a second surface opposite the first surface;

at least one well defining an opening extending from the first surface to the second surface and configured to receive a sample therein; wherein the at least one well comprises:

a shelf extending into the opening such that the opening is narrower between the shelf and the second surface than between the shelf and the first surface.

2. The test card of claim 1, wherein a first distance between the shelf and the first surface is greater than a distance between the shelf and the second surface.

3. The test card of claim 1, wherein the shelf extends into the opening by 0.035mm to 0.05 mm.

4. The test card of claim 1, wherein the at least one well defines a wall bounding an opening and extending between a first surface and a second surface of the test card, wherein a first portion of the wall extends from the shelf to the first surface and a second portion of the wall extends from the shelf to the second surface, and wherein the shelf protrudes from the wall at a junction of the first portion and the second portion.

5. The test card of claim 4, wherein the shelf defines a shelf surface substantially parallel to the first surface or the second surface, and wherein the shelf surface is disposed at a junction of the first portion of the wall and the second portion of the wall.

6. The test card of claim 5, wherein the shelf surface defines a radial width of 0.035mm to 0.05mm relative to a longitudinal axis of the at least one well.

7. The test card of claim 1, wherein the opening has a cross-sectional area in a plane parallel to the first surface or the second surface that is greater between the shelf and the first surface than between the shelf and the second surface.

8. The test card of claim 7, wherein the cross-sectional area of the opening in a plane parallel to the first or second surface is greater between the shelf and the first surface than between the shelf and the second surface at all axial positions.

9. The test card of claim 1, wherein the shelf extends circumferentially around an opening in the at least one well.

10. The test card of claim 1, wherein the at least one well comprises a plurality of wells.

11. The test card of claim 10, wherein said at least one well comprises 104 wells.

12. A method of manufacturing a test card comprising a body comprising a first surface and a second surface opposite the first surface and at least one well defining an opening extending from the first surface to the second surface and configured to receive a sample therein; wherein the at least one well comprises a shelf that extends into the opening such that the opening is narrower between the shelf and the second surface than between the shelf and the first surface; the method comprises the following steps:

aligning a first template with a second template, wherein the first template includes a first pin having a first shape corresponding to a portion of the at least one well extending from the shelf to the first surface, wherein the second template includes a second pin having a second shape corresponding to a portion of the at least one well extending from the shelf to the second surface, wherein the first pin is narrower than the second pin; and is

A test plate is molded between the first and second mold plates.

13. The method of claim 12 wherein the shelf is formed at the intersection of the first and second templates.

14. The method of claim 12, wherein the at least one well comprises a plurality of wells.

15. The method of claim 14, wherein the at least one well comprises 104 wells.

16. A mold configured to form a test card, the test card comprising a body comprising a first surface and a second surface opposite the first surface, and at least one well defining an opening extending from the first surface to the second surface and configured to receive a sample therein; wherein the at least one well comprises a shelf that extends into the opening such that the opening is narrower between the shelf and the second surface than between the shelf and the first surface; the mold comprises:

a first template defining a first pin having a first shape corresponding to a portion of the at least one well extending from the shelf to the first surface;

a second template defining a second pin having a second shape corresponding to a portion of the at least one well extending from the shelf to the second surface; and is

Wherein the first pin is narrower than the second pin.

17. The mold of claim 16, wherein the first pin is taller than the second pin.

18. The mold of claim 16, wherein the distal end of the first pin is 0.07mm to 0.1mm narrower than the distal end of the second pin.

19. The mold of claim 16, wherein the at least one well comprises a plurality of wells.

20. The mold of claim 19, wherein the at least one well comprises 104 wells.

Background

Sample test cards are used to study biological samples quickly and accurately. Typically, test cards are used in conjunction with spectroscopy or other automated analysis machines. An example of a test card system is

Microorganism identification and antibacterial drug sensitive test card and corresponding

A machine.

The test card contains reagents and receives patient samples in a series of small wells formed in rows and columns in the card and typically sealed on both sides with tape or other sealing film. The test card is filled with patient sample material through fine hydraulic passages formed in the card.

The inventors have discovered several improved aspects of existing test cards and their corresponding manufacturing techniques. In particular, the inventors have found that at least 5% to 20% of the wells contain bubbles during filling, which increase the error rate of the test machine and cause the test card system to produce inaccurate results. These bubbles are found to be caused, inter alia, by the hydrophobic nature of the chemical constituents and the size and internal configuration of the trap, where the bubbles are formed by a combination of physical and chemical properties. In some cases, the inventors have found that existing molding techniques can lead to the formation of bubbles. For example, a particular orientation of the parting line from the mold section may cause the trap to trap air in the protrusion formed by the parting line.

Applicants have identified some other improved aspects related to conventional test cards and other related systems. Many of these identified problems have been addressed through application of effort, originality, and innovation, through the development of solutions included in embodiments of the present invention, many examples of which are described in detail herein.

Disclosure of Invention

Test cards and related methods of use and manufacture, and corresponding molds for manufacturing test cards are provided herein.

In one embodiment, a test card is provided that may include a body including a first surface and a second surface opposite the first surface. The test card may include a well defining an opening extending from the first surface to the second surface and configured to receive a sample therein. The well may comprise a shelf extending into the opening such that the opening is narrower between the shelf and the second surface than between the shelf and the first surface.

In some embodiments, the first distance between the shelf and the first surface may be greater than the distance between the shelf and the second surface. The shelf may extend into the opening by 0.035mm to 0.05 mm.

In some embodiments, the well may define a wall surrounding the opening and extending between the first surface and the second surface of the card. A first portion of the wall may extend from the shelf to the first surface, and a second portion of the wall may extend from the shelf to the second surface. The shelf may protrude from the wall at the junction of the first and second portions. In some embodiments, the shelf may define a shelf surface substantially parallel to the first surface or the second surface, and the shelf surface may be disposed at a junction of the first portion of the wall and the second portion of the wall. For example, the shelf surface may define a radial width of 0.035mm to 0.05mm relative to the longitudinal axis of the well.

In some embodiments, the cross-sectional area of the opening in a plane parallel to the first or second surface is greater between the shelf and the first surface than between the shelf and the second surface. In some embodiments, the cross-sectional area of the opening in a plane parallel to the first or second surface is greater between the shelf and the first surface than between the shelf and the second surface at all axial positions.

In some embodiments, the shelf may extend circumferentially around the opening in the well.

In another example embodiment, a method of manufacturing a test card may be provided. The test card may include a body including a first surface and a second surface opposite the first surface, and a well defining an opening extending from the first surface to the second surface and configured to receive a sample therein. The trap may comprise a shelf extending into the opening such that the opening is narrower between the shelf and the second surface than between the shelf and the first surface. The method may include aligning the first template with the second template. The first template may include a first pin having a first shape corresponding to a portion of the well extending from the shelf to the first surface. The second template may include a second pin having a second shape corresponding to a portion of the well extending from the shelf to the second surface. The first pin may be narrower than the second pin. The method may further include molding a test plate between the first mold plate and the second mold plate.

In some embodiments of the method, a shelf may be created at an intersection of the first template and the second template.

In yet another embodiment, a mold configured to form a test card is provided. The test card may include a body including a first surface and a second surface opposite the first surface, and a well defining an opening extending from the first surface to the second surface and configured to receive a sample therein. The trap may comprise a shelf extending into the opening such that the opening is narrower between the shelf and the second surface than between the shelf and the first surface. The mold may include a first template defining a first pin having a first shape corresponding to a portion of the well extending from the shelf to the first surface, and a second template defining a second pin having a second shape corresponding to a portion of the well extending from the shelf to the second surface. The first pin may be narrower than the second pin

In some embodiments of the mold, the first pin may be taller than the second pin.

In some further embodiments, the distal end of the first pin may be 0.07mm to 0.1mm narrower than the distal end of the second pin.

Drawings

Having thus described the invention in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein:

FIG. 1 illustrates a front view of a test card according to some embodiments discussed herein;

FIG. 2 illustrates a perspective view of a test card well having shelves according to some embodiments discussed herein;

FIG. 2A shows a stereogram of the test card of FIG. 2;

FIG. 3 illustrates another perspective view of a test card well having shelves according to some embodiments discussed herein;

FIG. 3A shows a stereogram of the test card of FIG. 3;

fig. 4 illustrates a perspective view of another configuration of shelves in a well according to some embodiments discussed herein;

FIG. 5 illustrates a cross-sectional view of a test card well having shelves according to some embodiments discussed herein;

FIG. 6 illustrates a template for a test card according to some embodiments discussed herein;

FIG. 6A shows a stereogram of the template of FIG. 6;

7A-7E illustrate various views of a trap according to some embodiments discussed herein; and

FIG. 8 is a front perspective view of a test card including 104 of the test card wells of FIGS. 2-3, according to some embodiments discussed herein;

FIG. 9 is a rear perspective view of a test card including the test card well of FIGS. 2-3;

FIG. 10 is a front view of a test card including the test card well of FIGS. 2-3;

FIG. 11 is a rear view of a test card including the test card well of FIGS. 2-3;

FIG. 12 is a right side elevational view of a test card including the test card well of FIGS. 2-3;

FIG. 13 is a left side elevational view of a test card including the test card well of FIGS. 2-3;

FIG. 14 is a top view of a test card including the test card well of FIGS. 2-3;

FIG. 15 is a bottom view of a test card including the test card well of FIGS. 2-3;

FIG. 16 is a detailed view of a test card including the test card well of FIGS. 2-3 shown in FIG. 8;

FIG. 17 is a detailed view of a test card including the test card well of FIGS. 2-3 shown in FIG. 9;

FIG. 18 is a cross-section of a portion taken along line 18-18 in FIG. 16;

FIG. 19 is a cross-section of a portion taken along line 19-19 in FIG. 16;

FIG. 20 is a cross-section of a portion taken along line 20-20 in FIG. 16;

FIG. 21 is a cross-section of a portion taken along line 21-21 in FIG. 16;

FIG. 22 is a front perspective view of a test card including the 104 test card wells of FIGS. 2-3, according to some embodiments discussed herein;

FIG. 23 is a rear perspective view of a test card including the test card well of FIGS. 2-3;

FIG. 24 is a front view of a test card including the test card well of FIGS. 2-3;

FIG. 25 is a rear view of a test card including the test card well of FIGS. 2-3;

FIG. 26 is a right side elevational view of a test card including the test card well of FIGS. 2-3;

FIG. 27 is a left side elevational view of a test card including the test card well of FIGS. 2-3;

FIG. 28 is a top view of a test card including the test card well of FIGS. 2-3;

FIG. 29 is a bottom view of a test card including the test card well of FIGS. 2-3;

FIG. 30 is a detailed view of what is shown in FIG. 22;

FIG. 31 is a detailed view shown in FIG. 23;

FIG. 32 is a cross-section taken along line 32-32 of FIG. 30;

FIG. 33 is a cross-section taken along line 33-33 of FIG. 30;

FIG. 34 is a cross-section taken along line 34-34 of FIG. 30;

FIG. 35 is a cross-section taken along line 35-35 of FIG. 30;

FIG. 36 is a front perspective view of a test card including the 104 test card wells of FIGS. 2-3, according to some embodiments discussed herein;

FIG. 37 is a rear perspective view of a test card including the test card well of FIGS. 2-3;

FIG. 38 is a front view of a test card including the test card well of FIGS. 2-3;

FIG. 39 is a rear view of a test card including the test card well of FIGS. 2-3;

FIG. 40 is a right side elevational view of a test card including the test card well of FIGS. 2-3;

FIG. 41 is a left side elevational view of a test card including the test card well of FIGS. 2-3;

FIG. 42 is a top view of a test card including the test card well of FIGS. 2-3;

FIG. 43 is a bottom plan view of a test card including the test card well of FIGS. 2-3 f;

FIG. 44 is a detailed view of a portion shown in FIG. 36;

FIG. 45 is a detailed view of a portion shown in FIG. 37;

FIG. 46 is a cross-section of a portion taken along line 46-46 in FIG. 44;

FIG. 47 is a cross-section of a portion taken along line 47-47 of FIG. 44;

FIG. 48 is a cross-section of a portion taken along line 48-48 in FIG. 44; and

fig. 49 is a cross-section of a portion taken along line 49-49 in fig. 44.

Detailed Description

Some embodiments of the present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout.

By mixing

The card is placed into a vacuum chamber to fill the wells of the sample test card discussed herein. Both sides of the card are covered with scotch tape and a small suction tube or catheter is attached to the side of the card, and then a vacuum is drawn from the card through the suction tube in the tube containing the liquid sample. The vacuum is then released and liquid is pushed into the wells through the suction tube, filling each well through a channel leading to each well on the card. The microorganisms in the sample may then be allowed to grow or undergo a reaction, typically over a period of up to several hours, although this time varies with the bacteria or other substances being analysed and the type of sample used. Each well contains dry chemicals that have been placed into the card during the filling and drying process. Exemplary instruments for reading test cards and culture carousels for holding cards are further described in U.S. patent nos. 5762873, 5888455, 5965090, 6024921, 6086824, 6136270, 6156565, and 7601300, the contents of which are incorporated herein by reference in their entirety. For example, in U.S. patent nos. 5609828, 5746980, 5869005, 5932177, 5951952, USD 414272; example test cards are further described in U.S. patent publication nos. US2012/0141325a1 and US2012/0088263a1, the contents of each of which are incorporated herein by reference in their entirety.

Test cards can be used to hold a large number of samples for testing and analysis. The specialized machine may fully or partially automate sample preparation, incubation, and analysis within the test card. When filled with a sample, conventional test cards may form bubbles in the wells, which may degrade the quality of the data obtained. These bubbles, which may be caused by the chemistry of the sample and the physical shape of the trap, can combine to trap the cavitation air within the trap.

The sample test card as described herein may have a generally rectangular shape with standard dimensions of about 90mm to 95mm wide, about 55mm to 60mm high, and about 4mm to 5mm thick. In one embodiment, the sample test cards of the present disclosure are about 90mm wide, about 56mm high, and about 4mm thick.

The test cards described herein may include 80 to 140 individual sample wells, or about 96 to 126 individual sample wells, each sample well receiving a test sample, e.g., a biological sample extracted from a patient's blood, other fluids, tissue, or other material, for spectroscopic or other automated analysis. In other embodiments, the sample test card may include 80, 88, 96, 104, 108, 112, 120, 126, 135, or 140 individual sample wells. In a particular embodiment, the sample test card includes 96 individual sample wells. In another specific embodiment, the sample test card includes 104 individual sample wells. In yet another embodiment, the sample test card contains 112 individual sample wells. The sample wells are typically arranged in a series of horizontal rows and vertical columns, and may comprise about 8 to 10 rows and about 10 to 16 columns of wells.

The sample wells may be present in various shapes and sizes. For example, in some embodiments, the well 204 may be circular. In some embodiments, the well 204 may be substantially circular. In some embodiments, the well 204 may be rectangular. In some embodiments, the well 204 may be substantially rectangular. In some embodiments, the well 204 may be rectangular with curved corners (e.g., 0.5mm radius of curvature as shown in the embodiment of fig. 7A). In some embodiments, the well 204 may be diamond shaped. In some embodiments, the wells 204 may be substantially diamond shaped. In some embodiments, the well 204 may be elliptical. In some embodiments, the well 204 may be substantially elliptical.

In some embodiments, the wells 204 may define a long dimension and a short dimension in the plane of the first surface. In the embodiment shown in FIG. 7A, the long dimension is 2.550mm and the short dimension is 1.750 mm. In some embodiments, the long dimension may be 1mm, 1.25mm, 1.5mm, 1.75mm, 2mm, 2.25mm, 2.5mm 2.75mm, 3mm, 3.25mm, 3.5mm, 3.75mm, 4mm, 4.25mm, 4.5mm, 4.75mm, 5mm, 5.25mm, 5.5mm, 5.75mm, 6mm, 6.25mm, 6.5mm, 6.75mm, 7mm, 7.25mm, 7.5mm, 7.75mm, 8mm, 8.25mm, 8.5mm, 8.75mm, 9mm, 9.25mm, 9.5mm, 9.75mm, or 10 mm. In some embodiments, the minor dimension may be 1mm, 1.25mm, 1.5mm, 1.75mm, 2mm, 2.25mm, 2.5mm, 2.75mm, 3mm, 3.25mm, 3.5mm, 3.75mm, 4mm, 4.25mm, 4.5mm, 4.75mm, 5mm, 5.25mm, 5.5mm, 5.75mm, 6mm, 6.25mm, 6.5mm, 6.75mm, 7mm, 7.25mm, 7.5mm, 7.75mm, 8mm, 8.25mm, 8.5mm, 8.75mm, 9mm, 9.25mm, 9.5mm, 9.75mm, or 10 mm.

In some embodiments, the well 204 may define a thickness extending between the first surface and the second surface. In the embodiment shown in fig. 7C, the thickness is 3.2 mm. In some embodiments, the thickness can be 1mm, 1.25mm, 1.5mm, 1.75mm, 2mm, 2.25mm, 2.5mm, 2.75mm, 3mm, 3.25mm, 3.5mm, 3.75mm, 4mm, 4.25mm, 4.5mm, 4.75mm, 5mm, 5.25mm, 5.5mm, 5.75mm, 6mm, 6.25mm, 6.5mm, 6.75mm, 7mm, 7.25mm, 7.5mm, 7.75mm, 8mm, 8.25mm, 8.5mm, 8.75mm, 9mm, 9.25mm, 9.5mm, 9.75mm, or 10 mm.

The biological sample may be a direct sample from the patient, or a patient sample that is extracted, diluted, suspended, or otherwise processed in solution or otherwise. The sample test cards of the present invention are typically used in a lateral orientation.

The test card may be made of polystyrene, polyester, or any other suitable plastic or other material. The test cards may be tempered with a softening material during manufacture to reduce the rigidity of the crystal and the resulting tendency to crack or chip. For example, the test card may be made of a blend of polystyrene (about 90% or more) and an additive of butyl rubber to make the card somewhat more flexible and resistant to damage. In some embodiments, the test card may also be doped with a coloring agent, such as titanium oxide, to produce a white color when desired.

The test cards described herein may be used to identify and/or count any number of microorganisms, such as bacteria and/or other biological agents. As is known in the art, many bacteria, after incubation, can be adapted for automated spectroscopic analysis, fluorescence analysis, and the like. The transmission and absorption of light is affected by the turbidity, density and calorimetric properties of the sample. The fluorescence reaction can be performed alone or in combination with spectroscopy or other measurements. If fluorescence data is collected, it is preferable to use a coloring agent in the test card because the opaque card reduces or eliminates scattering of the fluorescent radiation throughout the card, as may occur with translucent materials. Other types of detection and analysis can be performed on the test card, including testing the susceptibility of microorganisms to different types of antibiotics, at different concentrations, making the test card versatile.

Referring to FIG. 1, a front view of an embodiment of a test card 202 having a plurality of sample wells 204 is shown. Test card 202 may have a first or front surface 206 and a second or back surface opposite the front surface 206 (as shown in fig. 5, 7B, and 7C), a first or front side edge 210, a second or back side edge 212, a top edge 214, and a bottom edge 216. As shown in fig. 1, test card 202 may include 96 individual sample wells arranged in 12 columns of 1 column of 8 sample wells 204. As the test fluid (i.e., patient sample or other solution) enters the introduction port, it collects in the introduction reservoir 222 and travels along the dispensing channel 230 away from the introduction reservoir. Distribution channel 230 comprises a relatively long channel that weaves through front surface 206 of test card 202 in columns of sample wells 204. As shown, the distribution channels 230 first extend horizontally across the top of a first column of sample wells 204 and then extend (or descend) (i.e., descending branches 232) vertically down between parallel groups or columns of sample wells 204 (each column including eight sample wells 204) along the front surface 206 of the test card 204. At the bottom of the first descending branch 232, the distribution channel 230 comprises a transverse branch 234 which traverses in a horizontal manner throughThe surface of the card 202. Distribution channels 230 then extend (or rise) vertically upward (i.e., rising branches 233) along front surface 206 of test card 202 between columns of sample wells 204 of the second group. At the top of the second set of columns of sample wells, distribution channel 230 includes another lateral branch 234 that traverses across the surface of the card in a horizontal manner to the top of the third set of columns of sample wells and then extends vertically downward or descends downward (i.e., descending branch 232) between the columns of sample wells 204. This pattern of alternating descending and ascending branches 232, 233 of distribution channels interconnected with lateral channel branches 234 continues across front surface 206 of test card 202, thereby allowing distribution channels 230 to be circuitous between all vertically aligned columns of sample wells on test card 202. In one embodiment, first distribution channel 230 may include a channel having a width of about 0.5mm and a depth of about 0.5mm (i.e., about 0.25 mm)²Cross-section of (a) of (b) fluid flow channels.

The fill channel 236 may be a relatively short channel (which may be kinked) that extends from the dispensing channel 230 to the sample wells 204, serving as a connection, and thereby filling the individual sample wells 204 of the test card 202. In one embodiment, fill channel 236 may include a width of about 0.2 to about 0.4mm and a depth of about 0.3 to about 0.5mm (i.e., about 0.06 to 0.2 mm)²Cross-section of (a) of (b) fluid flow channels. In another embodiment, fill channel 234 has a width of about 0.3mm and a depth of about 0.4mm (i.e., about 0.12 mm)²Cross-section of (a). In addition to the shelves described in detail below, the test card may also include a bubble trap 250 and connected channel 252 to receive any bubbles that are trapped within the well by the shelves. The test card 202 of this design concept may also include a series of sensor stop holes 260, a barcode or other data indicia (not shown), tapered ramp edges 270, and/or lower and upper rails 280, 282, the lower and upper rails 280, 282 optionally having associated leading edges 284 or trailing cutoffs 286.

Referring to fig. 2-3, the depicted embodiment includes a shelf 300 that extends into an opening 310 of the well 204. The opening 310 of the well 204 may extend from the first or front surface 206 to the second or back surface 207 of the card 202 (as shown in fig. 5, 7B, and 7C). The opening 310 of the well 204 may be defined by a wall 320 extending from the first surface 206 to the second surface 207. Wall 320 may include a first portion 322 defined between shelf 300 and first surface 206, and a second portion 324 defined between shelf 300 and second surface 207 (as shown in fig. 5, 7B, and 7C), such that shelf 300 forms a connection between the first and second portions of the wall. The test card 202 may include any form of supply conduit 290 and bubble trap 250.

Referring to fig. 4, another embodiment of the well 204 shown in fig. 3 is described. In the embodiment of fig. 4, the shelf 300 is formed only at a portion of the wall 320 below the supply conduit 290, wherein the remaining area of the wall between the first portion 322 and the second portion 324 is substantially flat. Shelf 300 may additionally include the same characteristics, dimensions, and features of shelves discussed herein. For example, the shelf 300 shown in fig. 4 may include the same cross-section as shown in fig. 5 and any of fig. 7B-7C, although only at the portion of the wall 320 below the supply conduit 290, the first portion 322 above the shelf of the wall is wider than the second portion 324 below the shelf of the wall. As described in the embodiments discussed herein, at all axial positions (e.g., along axis a shown in fig. 5), the opening 310 may be narrower in the plane of the second portion 324 than at the plane of the first portion 322.

With continued reference to fig. 4, the depicted shelf 300 may include rounded edges that engage the walls 320 as shown. In some embodiments, the shelf 300 may be disposed only below (e.g., directly aligned with) the supply conduit 290 in the direction of axis a. In some embodiments, the shelf 300 may include a constant width in the portion directly below the supply conduit 290 and may be curved or tapered to be flush with the walls 320 on either side of the supply conduit. In some embodiments, the shelf 300 may be disposed on one surface of the wall 320 of the well 204 (e.g., in embodiments having a rectangular or substantially rectangular shape, the shelf may be disposed on one of the four sides of the well).

Referring to FIG. 5, a cross-sectional view of a well 204 in a simplified test card 202 is shown. The well 204 includes an opening 310 defined by a wall 320, the wall 320 having a first portion 322 and a second portion 324 as described above. In some embodiments, the trap 204 may include a shelf 300 extending into an opening 310. Shelf 300 may define a shelf surface 330 that protrudes toward the center of the opening. When moved in the longitudinal direction a, the shelf 300 may extend substantially laterally (e.g., the shelf surface 330 may be defined in a plane perpendicular to the longitudinal axis a of the opening 310 and parallel to the first surface 206 or the second surface 207) to change the interior cross-section of the well 204. In such embodiments, a vector perpendicular to shelf surface 330 may be oriented in longitudinal direction a.

When taken with respect to a plane perpendicular to the longitudinal axis a (e.g., a plane parallel to the first surface 206 or the second surface 207), the shelf 300 may cause the second portion 324 of the wall 320 to have a smaller cross-sectional area than the first portion 322 of the wall. In other words, opening 310 is narrower in portion 324 below shelf 300 than in portion 322 above the shelf. In use, the narrower portion 324 may be positioned gravitationally below the wider portion 322 of the wall 320 and the opening 310 to prevent bubbles from catching on the wall. In such embodiments, bubbles can be released from the trap 204 and trapped in the bubble trap 250 (as shown in fig. 1-4, 7A, 7D, and 7E). In some embodiments, the cross-sectional area and/or diameter of the wall 304 may substantially decrease when moving downward (e.g., moving from the first surface 206 to the second surface 207 along the longitudinal axis a). The opening 310, which widens only when the bubble floats from near the second surface 207 to the first surface 206, is maintained to prevent any pinch points that retain the bubble within the trap 204, and the shelf 300 described herein facilitates and causes the bubble to release.

As used herein, the term "substantially" or "approximately" means that the attendant dimensions need not be achieved with mathematical precision, but rather that the specified dimensions are within standard error within manufacturing tolerances and physical limits, as understood by those of ordinary skill in the art. For example, the edges of the wells may be referred to as "about 90 degrees" despite the limited molding and pressing techniques that require slightly rounded edges. Similarly, opening 310 may not substantially widen when proceeding downward in longitudinal direction a from first surface 206 toward second surface 207; however, this does not preclude the rounded edges from being slightly bent inward within manufacturing limits.

In some embodiments, the shelf 300 may be positioned at any vertical location within the well 204 (e.g., at any point along the longitudinal axis a). In some embodiments, the shelf 300 may be positioned below a mid-point of the well 204 (e.g., closer to the second surface 207 than the first surface 206). In some further embodiments, the shelves 300 may be positioned at any increment (e.g., 1/8, 1/4, 1/3, 3/8, 1/2, 5/8, 2/3, 3/4, 7/8, or any sub-increment thereof) along the longitudinal direction of the well 204.

Shelf 300 may protrude into opening 310 sufficiently to prevent bubbles from adhering to wall 320. In some embodiments, shelf 300 may extend into well 204 (e.g., dimension B, in a direction perpendicular to longitudinal axis a) with a radial width of 0.035mm (0.0014 inches). In some embodiments, the shelf may extend into the well 204 (e.g., dimension B, in a direction perpendicular to the longitudinal axis a) with a radial width of 0.035mm (0.0014 inches) or more. In some embodiments, the shelf 300 may extend into the well 204 (e.g., dimension B, in a direction perpendicular to the longitudinal axis a) with a radial width of 0.05mm (0.0020 inches). In some embodiments, the shelf 300 may extend into the well 204 (e.g., dimension B, in a direction perpendicular to the longitudinal axis a) with a radial width of 0.05mm (0.0020 inches) or greater. In some embodiments, the shelf 300 may extend into the well 204 (e.g., dimension B, in a direction perpendicular to the longitudinal axis a) with a radial width of 0.05mm (0.0020 inches) or less. In some embodiments, shelf 300 may extend into well 204 (e.g., dimension B, in a direction perpendicular to longitudinal axis a) in a radial direction of 0.035mm (0.0014 inches) to 0.05mm (0.0020 inches).

In the embodiments detailed herein, the width of the opening 310 at the first portion 322 of the wall 320 may be different from the width of the opening at the second portion 324 of the wall, as the case may be, determined by the combined width of the shelves on both sides of the well. For example, in embodiments of shelf 300 having a width of 0.035mm (0.0014 inches), shelf 300 extends completely circumferentially around well 204, and for each cross-section extending between the first and second surfaces (e.g., each axis perpendicular to longitudinal axis a), second portion 324 directly below shelf 300 is 0.07mm (0.0028 inches) narrower than first portion 322 directly above shelf 300. Similarly, in embodiments of shelf 300 having a width of 0.05mm (0.0020 inches), shelf 300 extends completely circumferentially around well 204, and for each cross-section (e.g., each axis perpendicular to longitudinal axis a) extending between the first and second surfaces, second portion 324 directly below shelf 300 is 0.1mm (0.0040 inches) narrower than first portion 322 directly above shelf 300, so that, for example, in embodiments having a radial width of 0.035 to 0.05mm, the width of opening 310 may differ by 0.07 to 0.1mm above and below the shelf. This region may similarly be determined by the dimensions of the wells detailed herein. In embodiments having shelves 300 on only a portion of the wall (e.g., as shown in fig. 4), the width may only differ by a factor of 1 from the radial width detailed herein.

In some embodiments, for a given angular position relative to longitudinal axis a, the extension of shelf 300 may be measured as the difference in radii above and below shelf 300. In some embodiments, the wells 204 may be circular, and in some embodiments, the wells 204 may be non-circular (e.g., substantially rectangular or oval). In some embodiments, shelf 300 may extend uniformly into opening 310 about a circumferential direction (e.g., a circumferential direction about longitudinal axis a) such that a difference in radius between first portion 322 and second portion 324 of wall 320 is constant. In some embodiments, shelf 300 may be non-uniform, and the radius between first portion 322 and second portion 324 of wall 320 may vary with angular position.

In some embodiments, shelf 300 may extend into opening 310 only at selected portions of well 204. For example, in some embodiments, the shelf 300 may be positioned directly below the supply conduit 290. In some embodiments, the shelf 300 may be positioned across the trap 204 from the supply conduit 290. In such embodiments, the wall 310 may have a substantially constant radius in the longitudinal direction a without any shelves elsewhere. In some embodiments, shelf 300 may extend circumferentially around the entire opening 310.

Referring to FIG. 6, a template 400 for manufacturing any of the test cards 202 described herein is shown. The template 400 may include a first or second surface 406 (as shown in fig. 5, 7B, and 7C) corresponding to the first surface 206 or the second surface 207 (e.g., depending on which half of the reference mold). The template 400 may also include a plurality of pins 410 that are shaped opposite a portion of the opening 310. For example, in the embodiment shown in fig. 6, a second template is shown representing the second surface, and the top template includes substantially identical pins, although with additional channels of different widths, as shown in fig. 1-5 and 7A-7E.

During manufacturing, two templates 400 (e.g., a first template and a second template) may align surface 406 with surface 406, with the ends of pins 410 abutting each other. The pins 410 of each template 400 may be sized differently to form a shelf 300 (as shown in fig. 2-5 and 7A-7E). In particular, the pins may vary depending on the exact shape of the desired shelf surface 330 size (including each of the possible sizes discussed above). For example, in embodiments where the shelf surface extends 0.035mm to 0.05mm in the opening 330, the radius of the first pin of the first template may be 0.035mm to 0.05mm wider than the second pin of the second template. When the template 400 is applied to a test card material, the shelf 300 is thus formed at the parting line between the mold halves such that the shelf surface 330 is parallel to the ends of the pins of the template. In some embodiments, test card 202 may be formed by injection molding between two plates, by stamping a pliable material between two plates, or by any other manufacturing technique.

Thus, during manufacturing, the test card 202 may be created by aligning the first template with the second template. The first template may include first pins having a first shape corresponding to a portion of the wells 204 extending from the shelf 300 to the first surface 206. Similarly, the second template may include a second pin having a second shape corresponding to a portion of the well extending from the shelf to the second surface. The first pins may be narrower than the second pins, having the same dimensions between the pins as the shelf 300 described above. Once aligned, the method may include molding the test card 202 between the first template and the second, old template.

Figures 7A-7E illustrate various views of a trap according to some embodiments discussed herein. The dimensions depicted in fig. 7A-7E are in millimeters, angles are in degrees, and fig. 7A-7E are drawn to scale. Fig. 7A shows a top plan view of the first surface of the card showing the trap 204 and the bubble trap 250. Figure 7B illustrates a cross-sectional view of the trap 204 of figure 7A taken along the axis D1. As shown in fig. 7B, the shelf 300 is defined in a wall 320 of the well 204, with a first portion 322 extending from the shelf to the first surface and a second portion 324 extending from the shelf to the second surface.

Figure 7C shows a cross-sectional view of the trap 204 of figure 7A taken along the axis D2. In the illustrated embodiment, the first portion 322 of the wall 320 is inclined outwardly at about 3 degrees relative to a direction beginning at the shelf 300 and ending at the first surface. In some embodiments, the first portion may be inclined at 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 degrees. With continued reference to fig. 7C, second portion 324 of the wall may not be angled, or may be angled outward at about 0.5 degrees relative to a direction beginning with shelf 300 and ending at the second surface. In some embodiments, the inclination of the first portion 322 aids in the release of the bubbles. In some embodiments, the sloping of the walls 320 facilitates releasing the card from the mold as detailed herein. In embodiments having sloped wall portions, at each longitudinal and radial position of opening 310, second portion 324 may be narrower (e.g., narrower in distance through the opening) than any portion of first portion 322. In embodiments having sloped wall portions, the second portion 324 may be equal to the first portion 322 or become wider than the first portion 322 (e.g., equal or wider distance through the opening) as the second portion approaches the second surface. In each of the above embodiments, the shelf 300 may protrude outward such that the opening 310 is wider proximate the first portion 322 of the shelf 300 than proximate the second portion 344 of the shelf, regardless of the inclination.

With continued reference to fig. 7C, the card may be approximately 3.2mm (0.126 inch) thick. In some embodiments, as discussed above, shelf 300 may be disposed at a midpoint of the thickness (e.g., at a midpoint between the first and second surfaces). In the illustrated embodiment, the shelf 300 is located 1mm (0.039 inches) from the second surface and 2.2mm (0.087 inches) from the first surface, which is 31.25% of the thickness of the second surface. In some embodiments, the shelf 300 may be disposed one-third from the thickness of the second surface and two-thirds from the thickness of the first surface. In some further embodiments, the shelves 300 may be positioned in any increment (e.g., 1/8, 1/4, 1/3, 3/8, 1/2, 5/8, 2/3, 3/4, 7/8, or any sub-increment thereof) along the longitudinal direction of the wells 204.

Referring to FIG. 7D, an enlarged top view of region D3 of FIG. 7A is shown. The bubble trap 7D may include dimensions and orientations depicted with respect to the well 204 and the channel 252. Referring to FIG. 7E, a cross-sectional view of the bubble trap 250 taken along axis D4 in FIG. 7D is shown. As shown in fig. 7D-7E, the walls of the bubble trap 250 may be inclined outwardly, e.g., 3 degrees, relative to the direction toward the first surface. The bubble trap 250 may terminate within the card and may stop near the second surface.

Many modifications and other embodiments of the inventions set forth herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the embodiments of the invention are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

The claims (modification according to treaty clause 19)