Diagnostic cartridges having flexible seals

Abstract

Disclosed are cartridges and modules that may be utilized in diagnostic systems and methods. The cartridge includes a flexible seal that caps the cartridge. The flexible seal has an opening for a pipette tip, and the flexible seal is configured to create a sealed environment when a pipette tip is positioned in the opening of the flexible seal and when the pipette tip is moved in the X-axis, Y-axis, and Z-axis.

Claims

1. A cartridge for processing a sample, the cartridge comprising: (a) a base; (b) a sample well port; (c) an analysis chamber disposed in the base ; (d) multiple wells disposed in the base, wherein the sample well port is fluidly connected to a first well of the multiple wells of the cartridge; (e) a flexible seal having an opening for a pipette tip, the flexible seal covering and sealing the multiple wells and not covering or sealing the sample well port and the analysis chamber; and (f) a pipette tip comprising a microbial filter positioned in the opening of the flexible seal such that the multiple wells under the flexible seal are closed to the environment.

2. The cartridge of claim 1, wherein the flexible seal permits movement of the pipette tip in an x-axis, y-axis, and z-axis.

3. The cartridge of claim 1, wherein the pipette tip is permanently installed and fastened to the flexible seal.

4. The cartridge of claim 1, further comprising at least one reagent located in at least one well of the multiple wells.

5. The cartridge of claim 1, further comprising a sample well cap.

6. The cartridge of claim 1, further comprising a perforable seal disposed between the flexible seal and the base, wherein the perforable seal is perforable via a pipette tip.

7. The cartridge of claim 1 further comprising a middle frame that surrounds the flexible seal.

8. The cartridge of claim 7, further comprising a top frame that is positioned on top of the flexible seal and within the middle frame, wherein the flexible seal is positioned between the top frame and the base.

9. The cartridge of claim 1, wherein the flexible seal comprises a thermoplastic elastomer.

10. The cartridge of claim 9, wherein the thermoplastic elastomer is selected from the group consisting of styrenic block copolymers, polyolefin blends, elastomeric alloys, thermoplastic polyurethanes, thermoplastic copolyester, and thermoplastic polyamides.

11. The cartridge of claim 1, wherein the flexible seal comprises silicone.

12. The cartridge of claim 1, wherein the opening is a first opening and the pipette tip is a first pipette tip, further comprising a second opening in the flexible seal, and a second pipette tip positioned in the second opening.

13. The cartridge of claim 12, further comprising a third opening in the flexible seal, and a third pipette tip positioned in the third opening.

14. The cartridge of claim 6, wherein the perforable seal is a foil seal.

15. A cartridge for processing a sample, the cartridge comprising: (a) a base; (b) a sample well port; (c) an analysis chamber disposed in the base; (d) multiple wells disposed in the base, wherein the sample well port is fluidly connected to a first well of the multiple wells of the cartridge; (e) a flexible seal covering and sealing the multiple wells and not covering or sealing the sample well port and the analysis chamber; and (f) a first pipette tip comprising a microbial filter positioned in a first opening in the flexible seal and a second pipette tip comprising a microbial filter positioned in a second opening of the flexible seal such that the multiple wells under the flexible seal are closed to the environment, wherein the flexible seal permits movement of the first pipette tip and the second pipette tip in an x-axis, y-axis, and z-axis.

16. The cartridge of claim 15, further comprising a sample well cap.

17. The cartridge of claim 15, further comprising a perforable seal disposed between the flexible seal and the base, wherein the perforable seal is perforable via the first pipette tip or the second pipette tip.

18. The cartridge of claim 15, further comprising a middle frame that surrounds the flexible seal.

19. The cartridge of claim 15, wherein the flexible seal comprises silicone.

20. The cartridge of claim 15, further comprising a third opening in the flexible seal, and a third pipette tip positioned in the third opening.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 provides an exploded, perspective view of one embodiment of a device as contemplated herein.

(2) FIG. 2 provides an assembled, perspective view of one embodiment of a device as contemplated herein.

(3) FIG. 3 provides an exploded, perspective view of one embodiment of a device as contemplated herein.

(4) FIG. 4 provides a cross-sectional, perspective view of one embodiment of a pipette tip positioned in a flexible seal as contemplated herein.

(5) FIG, 5 illustrates perspective views of molds and boots (i.e., flexible seals) hat may be formed using the illustrated molds.

(6) FIG. 6 illustrates a method of making a flexible seal as contemplated herein.

(7) FIG. 7 illustrates additional embodiments of modules comprising a flexible seal as contemplated herein.

(8) FIG. 8 provides a perspective view of one embodiment of a boot/flexible seal as contemplated herein.

(9) FIG. 9 provides a perspective view of one embodiments of a cartridge comprising the boot/flexible seal of FIG. 8.

(10) FIG. 10 provides a cross-section view of the cartridge of FIG. 9 comprising the boot/flexible seal of FIG. 8.

DETAILED DESCRIPTION

(11) The aforementioned devices may be described by the following definitions and figures.

(12) Unless otherwise noted, the terms used herein are to be understood according to conventional usage by those of ordinary skill in the relevant art. In addition to the definitions of terms provided below, it is to be understood that as used in the specification, embodiments, and in the claims, “a”, “an”, or “the” can mean one or more, depending upon the context in which it is used. For example, “a module” should be interpreted, to mean “one or more modules,” depending upon the context in which it is used.

(13) As used herein, “about”, “approximately” “substantially,” and “significantly” will be understood by persons of ordinary skill in the art and will vary to some extent on the context in which they are used. there are uses of the term which are not clear to persons of ordinary skill in the art given the context in which it is used, “about” and “approximately” will mean plus or minus ≦10% of the particular term and “substantially” and “significantly” will mean plus or minus >10% of the particular term, unless defined, as otherwise herein.

(14) As used herein, the terms “include” and “including” have the same meaning as the terms “comprise” and “comprising.” For example, “a method that includes a step” should be interpreted to mean “a method that comprises a step.” The terms “comprise” and “comprising” should be interpreted as being “open” transitional terms that permit the inclusion of additional components further to those components recited in the claims. The terms “consist” and “consisting of” should be interpreted as being “closed” transitional terms that do not permit the inclusion of additional components other than the components recited in the claims. The term “consisting essentially of” should be interpreted to be partially closed and permitting the inclusion only of additional components that do not fundamentally alter the nature of the claimed subject matter.

(15) The presently disclosed cartridges and modules may be utilized in diagnostic systems and methods. The cartridges and modules include a flexible seal that caps and seals the cartridges or modules. The flexible seal has an opening or aperture wherein a pipette tip may he positioned. The flexible seal is configured to create a sealed environment when a pipette is positioned in the opening of the flexible seal. As such, the disclosed cartridges and modules may be utilized to prevent vaporization or spills of samples that are dispensed into the cartridges or modules. The “flexible seals” disclosed herein may otherwise he referred to as “shift boots” or “flexible bellows.” The flexible seal permits movement of the pipette tip in the X-axis, Y-axis, and Z-axis (e.g., via manipulation by an XYZ robot), all while created a closed environment. The disclosed cartridges and modules typically are disposable after a single use.

(16) Referring now to the figures, FIG. 1 provides an exploded, perspective view of one embodiment of a device as contemplated herein. As illustrated in FIG. 1. the device is a cartridge 2 that includes a base 3 with multiple wells (or tubes) 4 that contain reagents and/or that may be used to perform combine reagents and/or to perform reactions. In particular, the cartridge includes wells (or tubes) for performing PCR (4X) 6 and a hybridization chamber 8. The cartridge 2 of FIG. 1 also includes a perforable foil seal 10 for sealing the tops of the wells (or tubes) 4 and a hybridization chamber cover 12 for covering the hybridization chamber 8 and an analysis chamber 10. The cartridge 2 also includes a sample well 14 for containing a sample, a sample well port. 16 for introducing a sample, and a sample well cap 18 for covering the sample well port 16 and closing the sample well 14 to the environment. The cartridge of FIG. 1 also includes a middle frame 20 that sits On top of the foil seal 10 and the sample port 16 is located within the middle frame 16. The cartridge 2 also includes a flexible seal/shift boot 22 placed within the middle frame 20, As illustrated, the flexible seal or shift boot 2 includes two (2X) large pipette tips 24 and one small pipette tip 26 but may include any number of large pipette tips and/or small pipette tips. A top cover/frame 28 is placed on top of the flex seal/shift boot.

(17) FIG. 2 provides an assembled, perspective view of one embodiment of a cartridge 2 as contemplated herein and similar to the cartridge of FIG. 1. As illustrated, the flex seal/shift 22 boot of the cartridge 2 of FIG. 2 includes two (3X) large pipette tips 24 and one small pipette tip 26.

(18) FIG. 3 provides an exploded, perspective view of one embodiment of a device as contemplated herein. As illustrated in FIG. 3, the device is a module 30 that includes a multi-well chamber 32 a flexible seal 34, and a frame 36 surrounding the flexible seal 34. A pipette tip 38 is positioned in the flexible seal 34 such that the multi-well chamber 32 under the flexible seal 34 is closed to the environment. The flexible seal 34 permits movement of the pipette tip 38 in the X-axis, Y-axis, and Z-axis such that the pipette tip 38 can contact and transfer the contents of the wells of the multi-well chamber (e.g., to an adjacent well), all while maintain a sealed environment under the flexible seal 34.

(19) FIG. 4 provides a cross-sectional, perspective view of the pipette tip 38 as positioned in the flexible seal 34 of FIG. 3. As illustrated in FIG. 4, the pipette tip 38 includes a microbial filter 40. As illustrated in the cross-sectional, perspective view of FIG. 4, the flexible seal 34 is configured to include a peak 42 located between two valleys 44a, 44b. The peak 42 includes an opening 46 for inserting the pipette tip 38. The configuration of the flexible seal 34 permits movement of the pipette tip 38 in the X-axis, Y-axis, and Z-axis (see illustrative directional arrows), all while maintaining a scaled environment under the flexible seal 34. For example, the configuration of the flexible seal 34 permits movement of the pipette tip 38 in the X-axis and Z-axis directions via expansion and/or compression of the respective valleys 44a, 44b in the corresponding X-axis or Z-axis direction. As illustrated, in FIG. 4, the pipette tip may be moved in the Z-axis direction via expansion of the valley 44aand via compression of the valley 44b. The configuration of the flexible seal 34 also permits movement of the pipette tip 38 in the Y-axis direction via expansion and/or compression of the peak 42 in the corresponding Y-axis direction.

(20) FIG. 5 illustrates perspective views of molds 48a, 48b as well as boots (i.e., flexible seals) 50a, 50b that may be formed using the illustrated molds.

(21) FIG. 6A, B, and C illustrate a method of making a boot or flexible seal 50b of FIG. 5 using the mold 48b of FIG. 5. A. Mold 48b is utilized to form a boot or flexible seal 50b. B. The boot or flexible seal 50b is removed from the mold 48b. C. The material 52 at the tip of the flexible seal 50b is removed (e.g. snipped off) creating an opening or aperture 4 in the flexible seal 50b in which a pipette tip may be inserted or positioned.

(22) FIG. 7 provides additional embodiments of flexible seals 34a, 34b, and a module 30 comprising a flexible seal 34b as contemplated herein. As illustrated in FIG. 7, the flexible seals 34a, 34b include one or more grooves 56a, 56b for positioning a pipette tip 38 in the flexible seal via one or more corresponding ridges 58 on the pipette tip 38.

(23) FIG. 8 illustrates another embodiment of a boot/flexible seal 58 as contemplated herein. FIG. 9 illustrates the boot or flexible seal 58 of FIG. 8 as positioned in a cartridge 60 with pipette tips 62a, 62b, 62c positioned in the boot/flexible seal 58.

(24) FIG. 10 provides a cross-sectional view of the cartridge 60 of FIG. 9. As illustrated in the cross-sectional view of FIG. 10, the boot/flexible seal 58 is configured to include interior valleys 64a, 64h, 64c, having openings 66a, 66b, 66c, into which the pipette tips 62 are inserted. Also as illustrated in the cross-sectional view of FIG. 10, adjacent to the interior valleys are peaks (e.g. 68a, 68a′) and exterior valleys (e.g., 70a, 70a′). The configuration of the boot/flexible seal 58 thusly permits movement of the pipette tip 38 in the X-axis, Y-axis, and Z-axis via compression/expansion of the respective valleys and/or peak (see illustrative directional arrows), all while maintaining a sealed environment under the flexible seal 34.

(25) In the foregoing description, it will be readily apparent to one skilled in the art that varying substitutions and modifications may be made to the invention disclosed herein without departing from the scope and spirit of the invention. The invention illustratively described herein suitably may be practiced in the absence of any element or elements, limitation or limitations which is not specifically disclosed herein, The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention. Thus, it should be understood that although the present invention has been illustrated by specific embodiments and optional features, modification and/or variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention.