Systems and methods for integrated consumables for analyte testing including premixing devices

Abstract

A system for processing a sample includes a unit body, a snap-on cover having a capillary, a lysis container, a test element and a sliding actuator.

Description

Background Art

[0001] In many cases, doctors, consumers, and medical professionals want to test for multiple analytes. Although laboratory tests are easily accessible to users, such tests require the user to send in a sample and the results are often not ready quickly. Therefore, there is a need for point-of-care (POC) testing systems. Some of the biggest factors affecting the sales and use of POC testing systems are the convenience, disposability, and ease of use provided by the various systems. Therefore, there is a great need for systems that provide such factors. Summary of the invention

[0002] In one embodiment, a system for processing samples includes a unit body. The unit body includes a snap cover, which has a capillary. The unit body includes a container for accommodating a mixed reagent for a sample, the container including a bottom seal and a top seal. The unit body includes a test element. The unit body includes a first puncture element for piercing the top seal to allow the capillary to enter the container. The unit body includes a second puncture element for piercing the bottom seal, and the bottom seal is positioned so that when pierced, the bottom seal releases the contents of the container onto the test element. In an alternative, the snap cover is attached to the unit body via a hinge, and the snap cover can rotate around the hinge so that the capillary enters the hole in the unit body, and the capillary is the first puncture element. In another alternative, when the snap cover enters the hole, the snap cover snaps in place and is held in place, thereby sealing the capillary in the inside of the unit body. Alternatively, when the snap cover enters the hole, the capillary pierces the top seal of the container. In another alternative, when the sliding actuator is slid, the inclined surface portion of the sliding actuator forces the bottom seal of the container to enter into the capillary, thereby piercing the bottom seal, thus, the capillary is the second puncture element. Alternatively, when the sliding actuator is slid, the sliding actuator forces the bottom seal of the container to enter into the second puncture element. In another alternative, the second puncture element is a projection on a part of the main body. In another alternative, the second puncture element is located on the tip of the test element. In another alternative, the test element is slid into the bottom seal to pierce it. Alternatively, the system also includes a protrusion that can be pushed, which is directed on the opposite side of the device, and on this opposite side, the snap cover is interfaced with the unitary body, and the protrusion can be actuated into the bottom seal, wherein, the protrusion can be pushed is the second puncture element.

[0003] In one embodiment, a method for processing a sample includes providing an integrated consumable test system. The test system includes a unitary body. The unitary body includes a container for containing a mixed reagent for the sample, the container including a bottom seal and a top seal. The unitary body includes a test element. The unitary body includes a first puncture element for piercing the top seal to allow a capillary to enter the container. The unitary body includes a second puncture element for piercing the bottom seal, the bottom seal being positioned so that when pierced, the bottom seal releases the contents of the container onto the test element. The method also includes capturing the sample in the capillary. The method also includes piercing the top seal with the first puncture element. The method also includes mixing the sample and the mixed reagent. The method also includes piercing the bottom seal with the second puncture element. The method also includes allowing the mixed sample and the mixed reagent to flow to the test element.

[0004] In one embodiment, a system for processing samples comprises a unitary body. The unitary body comprises a snap cover, which has a capillary. The unitary body comprises a lysis container. The unitary body comprises a test element and a sliding actuator. In an alternative, the snap cover is attached to the unitary body via a hinge, and the snap cover can rotate around the hinge so that the capillary enters the hole in the unitary body. In another alternative, when the snap cover enters the hole, the snap cover snaps in place and is held in place, thereby sealing the capillary in the inside of the unitary body. Alternatively, when the snap cover enters the hole, the capillary pierces the first sealing member of the lysis container. Alternatively, when the sliding actuator is slid, the inclined surface portion of the sliding actuator forces the second sealing member of the lysis container to enter the capillary, thereby piercing the second sealing member. Alternatively, the lysis container comprises a lysis solution. In another alternative, the capillary is configured to receive a blood sample and deliver the blood sample to the cracking container when the snap cap enters the hole and the capillary pierces the first seal. Alternatively, when the second seal is pierced, a mixture of blood sample and lysate is delivered to the test element. Alternatively, the test element is an electrochemical test strip. In another alternative, the test element is a composite membrane sensor. Alternatively, the system also includes a meter, which engages with the unitary body and is electrically connected to the test element and is configured to determine the level of an analyte. Alternatively, the analyte is Hb A1C. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] Figure 1 An exploded view of one embodiment of an integrated consumable for analyte testing including a premixing apparatus (ICA) is shown;

[0006] Figure 2 Shows Figure 1 Another exploded view of the ICA;

[0007] Figure 3 Shown before inserting the snap cover and sliding the slide actuator Figure 1 Cross-sectional view of ICA;

[0008] Figure 4 Shown after inserting the snap cover and sliding the slide actuator Figure 1 Cross-sectional view of ICA;

[0009] Figure 5A shows a cross-sectional view of an embodiment of an ICA;

[0010] Figure 5B shows a cross-sectional view of an embodiment of an ICA;

[0011] Figure 6 An image showing a meter that may interface with the electrode ends of a test strip of an ICA;

[0012] Figure 7 A prototype for metering a capillary and a snap-on cap prior to engagement with the seal of a container containing a lysate is shown;

[0013] Figure 8 is a prototype for metering a capillary tube and a snap-on cap prior to engagement with a seal of a container containing a lysate, wherein the capillary tube has a sample thereon;

[0014] Fig. 9 shows an example of how a capillary tube pierces a seal of a container according to an embodiment of an ICA;

[0015] Fig.10 Another embodiment of a test strip for ICA is shown;

[0016] Fig.11 showing the flow area of ​​the test strip of claim 10;

[0017] Fig.12 An embodiment of ICA is shown;

[0018] Fig.13 and Fig.14 Shows Fig.12 Cross-sectional view of ICA;

[0019] Fig.15 Shows Fig.12 The memory in the ICA; and

[0020] Fig.16 and Fig.17 Shows Fig.12 Detail of the cover of the ICA. DETAILED DESCRIPTION

[0021] Certain terms are used herein for convenience only and are not to be construed as limiting embodiments of systems and methods of integrated consumables for analyte testing, including premixing apparatus (ICA). In many embodiments, the device tests for A1C. In previous A1C POC testing systems, a three-piece system was used. The system included (1) a discrete microcapillary device that temporarily captures a blood sample and then transfers it to a discrete disposable (2) lysis fluid container and dispenser. The blood and lysis fluid will be homogenized and then the lysis fluid container will dispense the contents onto a (3) lateral flow assay sensor. In many embodiments of the ICA, these components are modified and combined so that the resulting ICA performs tasks similar to the three separate components and enables an A1C POC device.

[0022] In many embodiments, to achieve this, all the functions of discrete components and other functions need to be combined into one device. Microfluidics is a design scheme generally referred to as miniaturization, which allows efficient fluid transfer and combination. Blood capture, metering, transfer, on-strip fluid heating, fluid filling detection, chemical composition homogenization, lysis storage, fluid electronic gating, and electronic chemical analysis have been combined on one device.

[0023] Previously, these steps were performed using separate disposable components. By integrating into one unit, material packaging, inventory size, consumer instructions and costs are significantly reduced. Benefits include:

[0024] 1) Improved reliability for consumers; fewer parts lead to fewer process defects

[0025] 2) Reduced inventory requirements and shortened manufacturing time

[0026] 3) Reduced product costs

[0027] 4) Reduced shipping packaging and transportation costs.

[0028] 5.) High chemical precision level.

[0029] Figure 1An exploded view of an embodiment of an ICA 100 is shown. The ICA 100 includes a housing portion 110 that is typically made of plastic or a variety of similar materials (PET, TPE, etc.). The housing portion 110 is attached to a snap cover 120 via a living hinge 125. In an alternative, other interconnecting hinges / systems may be used in addition to the living hinge 125. In many embodiments, the living hinge 125 and the snap cover 120 and the housing portion 110 may be made into a single piece of material. This would be very economical. In most configurations, the snap cover 120 must pivot so that it can engage the hole 130 in the housing portion 110. The snap cover 120 also includes a metering capillary 140. The metering capillary is designed to have a capillary portion that will retain a certain volume of blood when in contact with blood, such as in the case of a finger prick. Multiple volumes may be configured to be retained in the metering capillary 140. In some embodiments, the metering capillary 140 may include a sharp tip for lance, but as shown, a separate lancet is required to pierce a finger or other part of the user's body. Located within the housing portion 110 is a floating lysis container 145, which is moved from a first position to a second position using a sliding actuator 150 interfaced with the housing portion 110. The composite membrane sensor 160 is a test strip that is used to test the analyte of interest. In many cases, this is an electrochemical test strip, but other types of test strips, such as colorimetric and fluorescence, may also be used. The composite membrane sensor 160 includes an electrode end 165 (or wire) that can be inserted into and read by the meter. The sliding actuator 150 includes a locking track 161 that slides to form an interference fit lock with a locking pawl 162 in the housing portion 110.

[0030] Figure 2 Another exploded view of the ICA 100 is shown. In this view, the locking track 161 and the detent 162 are more clearly visible as well as the electrode 165 of the composite membrane sensor 160.

[0031] Figure 3A cross-sectional view of the ICA 100 before inserting the snap cover 120 and sliding the sliding actuator 150 is shown. In this view, the overall arrangement of the mixing and dosing system can be seen. It is important to note that the floating lysis container 145 has two seals 310, 320. These seals are located inside the floating lysis container 145, which has a buffer and lysis solution for lysing red blood cells to release the analyte of interest. In many cases, this is hemoglobin A1C. In this state, the ICA 100 can be used to contact a blood sample and allow the metering capillary 140 to obtain a sample with a desired size, which in many cases is 5 microliters. Many other volumes are also possible based on the multiple possible designs of the ICA 100. Also visible in this view is a groove 330 on the snap cover 120, which cooperates with a protrusion 340 on the housing 110 so that the snap cover 120 is locked in place when the snap cover 120 is rotated 180 degrees around the living hinge 125. The cross-sectional view also shows the sliding actuator 150 and the ramp 350 of the sliding actuator 150. In many embodiments, an end arrow piercing protrusion is included instead of the ramp 350. In this case, when the sliding actuator 150 slides, the piercing arrow at the end of the device pierces the bottom side of the floating lysis container, thereby releasing the sample.

[0032] Figure 4 A cross-sectional view of the ICA 100 after inserting the snap cover 120 and sliding the sliding actuator 150 is shown. Here, the process becomes clear. After obtaining the sample on the metering capillary 140, the snap cover 120 is rotated 180 degrees to penetrate the seal 310. At this time, the sample is delivered to the cracking area 410 where the cracking mixture is located. In many cases, the system is mixed by stirring. Note that since the cracking container 145 can float downward in the device, the seal 320 has not been penetrated at this time. However, the next ramp 350 is slid into the appropriate position, thereby pushing the cracking container 145 upward toward the metering capillary 140 to release the cracked or mixed sample onto the composite membrane sensor 160. Then, the sample can flow through multiple channels and be read by the electrode, and the electrical signal can be transmitted to the instrument via the electrode wire 165.

[0033] Although the system is described with respect to lysate, a variety of solutions may be positioned in a floating lysis container. In many embodiments, the system includes a cover having a protrusion. The protrusion has a capillary region that can receive a sample from a lancet or a body fluid source. The body fluid source can be a drop of blood gathered on a finger. The body fluid source can come from a metered lancet. The protrusion is designed to pierce the floating container (in other embodiments, it is shown as a floating lysis container). This can be achieved by a living hinge or other hinge that connects the cap to the container body. Other methods are also possible, including a screwing system whereby the cap is screwed downward so that the protrusion pierces the floating container. A variety of mixtures may be included in the floating container, including but not limited to reagents that cause a reaction, reagents that cause a color change, and reagents that lyse the sample. Subsequently, the bottom of the floating container is pierced. This can be performed via an inclined plane that slides the module so that the protrusion of the cap pierces the bottom. Alternatively, the device can slide into the puncture feature or have a protrusion that can be pushed into the floating container from the opposite side.

[0034] Figure 5A A cross-sectional view of an embodiment of an ICA is shown. The ICA 500 includes a cap 510 having a protrusion 520 that can receive a sample in its capillary interior and be rotated about a hinge 525 to penetrate a seal 530 on a container bounded by a seal 530 and a seal 540. In a second position, the protrusion 520 can further penetrate the seal 540 and release the sample onto a test strip located on a base 570. The device includes a spacer 550 to separate the seal 540 from the test strip. In addition, the device includes a housing 560 that seals the interior area of ​​the device. Figure 5B A cross-sectional view of another embodiment is also shown. In this embodiment, instead of advancing the cap 510 twice to penetrate both seals, the bottom protrusion can be pushed from the other side according to the arrows shown to penetrate the bottom seal 540. In both cases, when the cap 510 interfaces with the rest of the body by rotation, it forms a seal to prevent liquid leakage. This can be achieved by a friction fit of a snap-fit ​​type system, and a flange or gasket can be included to assist in the seal.

[0035] Figure 6 An image of a meter that may interface with the electrode ends of a test strip of an ICA is shown. Figure 7 A prototype is shown for metering a capillary and a snap-on cap prior to engagement with the seal of a container containing a lysis solution. Figure 7 is a prototype for metering a capillary tube with a sample on it and a snap-on cap prior to engagement with the closure of a container containing a lysate. Fig. 9 An example of how a capillary according to an embodiment of the ICA can pierce a seal of a container is shown.

[0036] Fig.10 Another embodiment of a test strip (particularly a substrate component) for ICA is shown. The test strip 1000 is specifically designed to include a puncture end 1010. The strip also includes a stop 1020 to prevent the strip from advancing too far. In this embodiment, the puncture end 1010 is designed to pierce a reservoir containing a reactant or solvent (or some other substance used to interact with the sample). In addition, in this view, electrode areas 1030, 1040 are shown. In many embodiments, these are interdigitated electrodes, but other configurations are also possible. Wire 1050 interacts with the meter to power the strip to detect the analyte of interest. In an alternative, the strip may still include a puncture end 1010, but may also be an optical strip. Electrode 1060 provides a heating element that can heat the sample by powering the electrode. In addition, in Fig.11 At the finger 1140 shown in FIG. 1 , two wires located at 1070 provide electrical energy to electrically activate the electronic gate located at that area.

[0037] Fig.11 Shown is placed Fig.10 The device is provided with a flow path etched pattern on a substrate component. In addition, a cover not shown is placed on the substrate. Likewise, the device includes a puncture point 1010 aligned with the puncture point 1010 on the substrate. The strip also includes a stopper 1020 to prevent the strip from advancing too far. Typically, the channel of the device relies on capillary-type flow action and includes vents 1130, 1160 in the cover placed on the spacer. The device includes a digestion finger 1110 and a digestion channel 1120 where the sample can be heated so that digestion can occur. In alternative embodiments, other chemical processes can occur in the channel. The AlC finger 1140 leads to an electrode area 1040 where electrochemical testing may occur. The A1C channel 1150 leads to an area located above the electrode area 1040. In addition, included is a channel that does not require digestion, namely a channel 1170 above the electrode 1030. The channel 1170 includes a vent 1160 in the cover. In many embodiments, the channel is a hemoglobin channel.

[0038] Fig.12A cross-sectional view of one embodiment of an ICA 1200 is shown. In this embodiment, a reservoir 1210 for reacting with a sample is mounted in the ICA 1200. The sample in the piercing tip 1230 of the cover 1220 can be rotated into the reservoir 1210, and the cover 1220 snaps into the body of the ICA 1200 so that the device is sealed. In this way, the sample can be mixed in the matching reservoir 1210 / cover 1220. Subsequently, the strip 1000 can be pushed into the reservoir 1210 so as to pierce the other side of the reservoir 1210 and release the mixed sample. In many embodiments, the sides of the reservoir 1210 are sealed with aluminum foil, although alternatives are possible.

[0039] Fig.13 Another cutaway frame-type view of the ICA 1200 is shown. In this view, the test strip 1000 has not yet been advanced into the reservoir 1210. Fig.14 , the test strip 1000 has been advanced into the reservoir 1210 so that the sample can flow onto the strip.

[0040] Fig.15 Shows Fig.12 Here, the top and bottom of the reservoir 1210 are sealed with aluminum foil 1510, 1520. Alternative sealing techniques are possible.

[0041] Fig.16 and Fig.17 Shows Fig.12 Detail of the cover of the ICA. As shown, the cover 1220 includes a puncture tip 1230. In addition, the capillary region 1610 holds the sample. Fig.17 As shown in FIG, lip 1710 provides an interface with ICA 1200 in a snap-fit ​​type arrangement. Other sealing arrangements are possible.

[0042] In many embodiments similar to the ICA 1200, the device is designed with a cap or cover that penetrates one side of a reservoir and delivers the sample to the reservoir. Since the cap seals to the device when penetrating the ICA, a mixing region is formed in which the sample can be safely and easily mixed. In many embodiments, the sample is located in a capillary tube that terminates with a puncture end. Subsequently, a test element with a puncture end can be slid into the other side of the reservoir to release the mixed sample so that it can be tested.

[0043] In many embodiments, the capillary obtains a blood sample of a certain size. The metering capillary can be designed to have a capacity of 5 μl. It has a capacity that can be changed for other chemical components and other sizes. In many embodiments, there is an A1C buffer and a lysate in the lysis container. In many embodiments, by folding the quantitatively supplied blood sample, the metering capillary, the sample is applied to the lysate, so that the movable hinged cap rotates 180°, thereby piercing the first aluminum foil surface in the floating lysis container. First push the floating lysis container downward. The blood sample and the lysate are mixed to a completely homogeneous state. Time or stirring acceleration can be used. The actuator is then used by sliding the actuator to the "closed" state, thereby lifting the biosensor strip to a second position, so that the tip of the metering capillary pierces the second aluminum foil surface, thereby quantitatively supplying the lysed blood sample solution to the bifurcated measurement channel of the strip. Then, the mixture flows and becomes part of the electrochemical assay or the antibody / antigen in the sandwich assay or some other type of assay. In many embodiments, it is electrochemical. The consumables are inserted into the analyzer where the partial functional steps are sequenced.

[0044] In summary, with respect to the description herein, many specific details, such as examples of components and / or methods, are provided to provide a thorough teaching and understanding of embodiments of the present invention. However, those skilled in the relevant art will recognize that embodiments may be practiced without one or more of the specific details, or with other devices, systems, components, methods, components, materials, parts, etc. In other cases, well-known structures, materials, or operations are not specifically shown or described in detail to avoid obscuring various aspects of embodiments of the present invention.

[0045] Likewise, embodiments may be implemented in a variety of forms, and based on the disclosure and teachings provided herein, those skilled in the art will understand other ways and / or methods of implementing equivalent solutions. Throughout the patent specification, references to "one embodiment," "an embodiment," or "a specific embodiment" refer to specific features, structures, or characteristics described in conjunction with the embodiment being included in at least one embodiment, and not necessarily in all embodiments. Therefore, the phrases "in one embodiment," "in one embodiment," or "in a specific embodiment" appearing in multiple locations throughout the patent specification do not necessarily refer to the same embodiment.

[0046] In addition, the specific features, structures or characteristics of any specific embodiment may be combined with one or more other embodiments in any applicable manner. It will be understood that, based on the teachings herein, other variations and modifications of the embodiments described and shown herein are possible and will be considered part of the spirit and scope of the present invention.

[0047] It will also be understood that one or more of the elements depicted in the figures / views may also be implemented in a more separate or integrated manner, or even removed in some cases or rendered operable in other ways in certain circumstances, as may be useful depending on the particular application.

[0048] In addition, unless otherwise specifically noted, any signal arrows in the accompanying drawings / views should be considered as exemplary only and not limiting. In addition, unless otherwise specified, the term "or" used herein is generally intended to mean "and / or". In the case where the term is expected to exhibit separation or combination capabilities, the combination of components or steps will also be considered to be noted.

[0049] As used in the specification herein and throughout the claims that follow, “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Also, as used in the specification herein and throughout the claims that follow, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0050] The foregoing description of the illustrated embodiments included in the embodiments described in the Abstract and Summary and Overview paragraphs is not intended to be exhaustive or to limit the disclosed systems, devices, methods, compositions of materials, or other disclosed subject matter to the precise forms disclosed herein. Although specific embodiments and examples of disclosed systems, devices, methods, compositions of materials, or other disclosed subject matter are described herein for illustrative purposes only, multiple equivalent modifications may be made within the spirit and scope of disclosed systems, devices, methods, compositions of materials, or other disclosed subject matter, as will be recognized and understood by those skilled in the relevant art. As shown, these modifications may be made according to the foregoing description made to the illustrated embodiments, and these modifications will be included within the true spirit and scope of the disclosure provided herein.

Claims

1. A system for processing a sample, comprising: Unit body, including A snap cover, wherein the snap cover has a capillary; Shell part; a container located in the housing portion and containing a mixed reagent for the sample, the container including a bottom seal and a top seal, the container being able to float up and down in the housing portion between a first position and a second position; Test components; a first piercing element for piercing the top seal to allow the capillary tube to enter the container; a second piercing element for piercing the bottom seal, the bottom seal being positioned such that when pierced, the bottom seal releases the contents of the container onto the test element, the top seal being pierced when the container is in the first position, and the bottom seal being pierced when the container is in the second position; as well as A sliding actuator, wherein when the sliding actuator slides along a first direction, the sliding actuator can force the container to float from the first position to the second position, so that the bottom seal is pierced by the second piercing element along a second direction, and the second direction is perpendicular to the first direction.

2. The system of claim 1, wherein: The snap-on cover is attached to the unitary body via a hinge, the snap-on cover can be rotated around the hinge so that the capillary tube enters the hole in the unitary body, and the capillary tube is the first piercing element.

3. The system of claim 2, wherein: When the snap-on cover enters the aperture, the snap-on cover snaps into place and is held in place, thereby sealing the capillary tube within the interior of the unitary body.

4. The system of claim 3, wherein: When the snap cap enters the aperture, the capillary tube pierces the top seal of the container.

5. The system of claim 4, wherein: When the sliding actuator slides, the inclined surface portion of the sliding actuator forces the bottom seal of the container into the capillary tube, thereby piercing the bottom seal, whereby the capillary tube is the second piercing element.

6. The system of claim 1, wherein: The second piercing element is a protrusion located on a portion of the body.

7. The system of claim 4, wherein: The second puncture element is located on the tip of the test element.

8. The system of claim 7, wherein: The test element is slid into the bottom seal to pierce the bottom seal.

9. The system of claim 4, wherein: The system further includes a pushable protrusion oriented on an opposite side of the device where the snap cover interfaces with the unitary body, the pushable protrusion being actuatable into the bottom seal, wherein the pushable protrusion is the second piercing element.

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