HK1173221B - Test sensor cartridges and sensor-dispensing instruments - Google Patents
Test sensor cartridges and sensor-dispensing instruments Download PDFInfo
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- HK1173221B HK1173221B HK13100513.3A HK13100513A HK1173221B HK 1173221 B HK1173221 B HK 1173221B HK 13100513 A HK13100513 A HK 13100513A HK 1173221 B HK1173221 B HK 1173221B
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Description
The present application is a divisional application of an invention patent application entitled "test sensor cartridge and sensor dispensing instrument", having an international application date of 2006, 1/13, an international application number of PCT/US2006/001617, and a national application number of 200680005567.1.
Technical Field
The present invention relates generally to cartridges and sensor-dispensing instruments, and more particularly to cartridges having a plurality of test sensors, for example, for analyzing blood glucose or other analytes contained therein.
Background
The quantification of analytes in body fluids is of great importance in the diagnosis and maintenance of certain physiological abnormalities. For example, lactate, cholesterol, bilirubin should be monitored in certain individuals. In particular, the detection of glucose levels in body fluids is important to diabetic individuals who must frequently check the glucose levels in their body fluids in order to regulate the glucose intake in their diets. Although the remainder of the description will refer to the determination of glucose, it will be appreciated that the invention may also be used to determine other analytes by selection of appropriate enzymes.
The results of this test are used to determine whether insulin or other medication needs to be administered. In a blood glucose testing system, a sensor is used to detect a blood sample.
The test sensor includes a biological detection or reagent material that will react with blood glucose. The testing end of the sensor is intended to be placed in a fluid to be tested, such as blood that accumulates on a person's finger after a finger puncture. Fluid is drawn into a capillary channel by capillary action that extends from the testing end to the reagent material in the sensor so that a sufficient amount of fluid to be tested is drawn into the sensor. The fluid then chemically reacts with the reagent material in the sensor, resulting in an electrical signal representative of the glucose level in the fluid to be tested being supplied to a contact area located near the rear or contact end of the sensor.
Such test sensors are typically very sensitive to ambient humidity. One way to reduce or eliminate the effects of ambient humidity is to have each sensor individually packaged with a desiccant. The disadvantage of this method is the need to open the strip before each use. It is therefore desirable to have a cartridge that contains a plurality of test sensors that does not require the strips to be opened prior to use. Also, for convenience and ease of use, it is desirable to have a simple mechanism to feed test sensors one at a time for testing by a user. This makes it easy for normal users to use and is particularly important for users with some physical limitations. It is also desirable to reliably seal the test sensors within the cartridge.
Disclosure of Invention
According to one embodiment, the cartridge is adapted for use with a sensor-dispensing instrument. The cartridge includes a housing, a plurality of test sensors, a mechanical mechanism, and a pusher assembly. The housing defines at least one opening therethrough. A plurality of test sensors are stacked in the housing. The plurality of test sensors is for assisting in testing at least one analyte. The mechanical mechanism is configured to urge the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The pusher assembly is for pushing one of the plurality of test sensors out of the cartridge. The pusher assembly includes a ferromagnetic material or a magnet.
According to one embodiment, a sensor-dispensing instrument includes a cartridge, an instrument housing, a cover, and a slider. The cartridge includes a cartridge housing, a plurality of test sensors, a mechanical mechanism, and a pusher assembly. The cartridge housing forms at least one cartridge opening therethrough. The plurality of test sensors are stacked in a cartridge housing. The plurality of test sensors is for assisting in testing at least one analyte. The mechanical mechanism is configured to urge the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The pusher assembly is for pushing one of the plurality of test sensors out of the cartridge. The pusher assembly includes a ferromagnetic material or a magnet. The instrument housing forms a dispensing outlet and is adapted to receive a cartridge. The lid is movable between a closed position and an open position such that the lid seals at least one of the dispensing outlet and the cartridge opening when in the closed position. The slider comprises a ferromagnetic material or a magnet. The slider is for magnetically coupling with a pusher assembly of the cartridge. The slider is adapted to slide from a first position to a second position. During movement of the slider from the first position to the second position, the pusher assembly contacts one of the plurality of test sensors and pushes it at least partially through the dispensing opening. At least the pusher assembly or slider includes a magnet.
According to one embodiment, the lid mechanism is used in a cartridge or sensor-dispensing instrument that includes a plurality of test sensors therein to assist in determining the concentration of at least one analyte. The cover mechanism includes a cover and a plurality of retainer tabs. The lid is adapted to slide between a closed position and an open position such that the lid seals the opening when in the closed position. The plurality of retainer tabs help maintain pressure on the lid when forming the seal.
According to another embodiment, a cartridge includes a housing, a plurality of test sensors, a mechanical mechanism, a test-sensor extractor, and a lid. The housing defines at least one opening therethrough. A plurality of test sensors are stacked in the housing. The plurality of test sensors is for assisting in testing at least one analyte. The mechanical mechanism is configured to urge the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The test-sensor extractor is adapted to move between a first position and a second position. The lid is mechanically connected to the test-sensor extractor. The lid is movable between a closed position and an open position such that the lid seals the opening in the closed position. During movement of the lid from the closed position to the open position, the test-sensor extractor moves from the first position to the second position and extracts one of the plurality of test sensors at least partially through the opening.
According to another embodiment, a cartridge includes a housing, a plurality of test sensors, a first mechanical mechanism, a second mechanical mechanism, a test-sensor extractor, and a lid. The housing defines at least one opening therethrough. A plurality of test sensors are stacked in the housing. The plurality of test sensors is for assisting in testing at least one analyte. The first mechanical mechanism is for urging the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The second mechanical mechanism is configured to urge the plurality of test sensors in a second direction. The second direction is arranged substantially perpendicular to the first direction. The test-sensor extractor may be moved between the first position and the second position by a second mechanical mechanism. The lid is movable between a closed position and an open position such that the lid seals the opening in the closed position. During movement of the lid from the closed position to the open position, the test-sensor extractor moves from the first position to the second position and extracts one of the plurality of test sensors at least partially through the opening.
According to another embodiment, a cartridge includes a housing, a plurality of test sensors, a first mechanical mechanism, a lid, and a pusher assembly. The housing defines at least one opening therethrough. The plurality of test sensors are stacked in the housing at an angle. The plurality of test sensors is for assisting in testing at least one analyte. The first mechanical mechanism is for urging the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The lid is movable between a closed position and an open position such that the lid seals the opening in the closed position. The pusher assembly is connected to the lid. The pusher assembly is movable between a first position and a second position. During movement of the lid from the closed position to the open position, the pusher assembly moves from the first position to the second position and extracts one of the plurality of test sensors at least partially through the opening.
According to yet another embodiment, a cartridge includes a housing, a plurality of test sensors, a mechanical mechanism, and a lid. The housing defines at least one opening therethrough. The plurality of test sensors are stacked in the housing at an angle. The plurality of test sensors is for assisting in testing at least one analyte. The mechanical mechanism is configured to urge the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The lid is movable between a closed position and an open position. The lid seals the opening in the closed position. The lid in the open position allows the plurality of test sensors to be manually withdrawn from the cartridge one at a time.
According to yet another embodiment, a cartridge includes a housing, a plurality of test sensors, a mechanical mechanism, and a lid. The housing defines at least one opening therethrough. A plurality of test sensors are stacked in the housing. The plurality of test sensors is for assisting in testing at least one analyte. The plurality of test sensors includes at least one sensor electrical contact. The mechanical mechanism is configured to urge the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The lid is movable between a closed position and an open position such that the lid seals the opening in the closed position. The cover includes at least one cover electrical contact. The at least one electrical contact contacts the at least one sensor contact of one of the plurality of test sensors during movement of the cover from the closed position to the open position. The lid draws one of the plurality of test sensors at least partially through the opening during movement of the lid from the open position to the closed position.
According to yet another embodiment, a cartridge includes a housing, a plurality of test sensors, a mechanical mechanism, and a rotatable drum. The housing has an interior portion. A plurality of test sensors are stacked in the housing. The plurality of test sensors is for assisting in testing at least one analyte. The mechanical mechanism is configured to urge the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The rotatable drum includes at least one groove formed therein. The drum is connected to the housing interior portion. The at least one recess is adapted to receive exactly one test sensor. The plurality of test sensors are extracted from the interior of the cartridge one at a time during movement of the drum from the first position to the second position.
According to yet another embodiment, a cartridge adapted for use with a sensor-dispensing instrument includes a housing, a plurality of test sensors, a mechanical mechanism, and a test-sensor extractor. The housing defines at least two openings therethrough. A plurality of test sensors are stacked in the housing. The plurality of test sensors is for assisting in testing at least one analyte. The mechanical mechanism is configured to urge the plurality of test sensors in a first direction. The test-sensor extractor is for transporting and extracting the plurality of test sensors, one at a time, in a second direction at least partially through one of the at least two openings. The test-sensor extractor has a first portion and a second portion. The first and second portions are connected by at least one hinge. The second direction and the first direction are substantially perpendicular to each other.
According to one embodiment, a sensor-dispensing instrument includes a cartridge, an instrument housing, an ejector mechanism, and at least one deflector. The cartridge includes a cartridge housing, a plurality of test sensors, a mechanical mechanism, and a test-sensor extractor. The cartridge housing forms at least two openings therethrough. A plurality of test sensors are stacked in the housing. The plurality of test sensors is for assisting in testing at least one analyte. The mechanical mechanism is configured to urge the plurality of test sensors in a first direction. The test-sensor extractor is for transporting and extracting the plurality of test sensors, one at a time, in a second direction at least partially through one of the at least two openings. The test-sensor extractor has a first portion and a second portion. The first and second portions are connected by at least one hinge. The second direction and the first direction are substantially perpendicular to each other. The instrument housing forms a dispensing outlet and is adapted to receive the cartridge. An ejector mechanism is adapted to extend through at least one of the openings and into contact with the test-sensor extractor. The at least one deflector is adapted to contact and deflect the first portion of the test-sensor extractor and assist in extracting the plurality of test sensors one at a time at least partially through the dispensing outlet.
According to yet another embodiment, a cartridge adapted for use with a sensor-dispensing instrument includes a housing, a base, a plurality of test sensors, and an external spring mechanism. The housing defines at least one opening therethrough. The base is adapted to sealingly engage the housing in the first position. A plurality of test sensors are stacked in the housing. The plurality of test sensors is for assisting in testing at least one analyte. An external spring mechanism is mounted to the housing and the base for assisting in sealing engagement of the housing and the base. In the first position, the housing and the base are in sealing engagement, and in the second position, the housing and the base are separated.
According to yet another embodiment, a sensor-dispensing instrument includes a cartridge, an instrument housing, and an ejector mechanism. The cartridge includes a cartridge housing, a base, a plurality of test sensors, and an external spring mechanism. The cartridge housing forms at least one opening therethrough. The base is adapted to sealingly engage the housing in the first position. A plurality of test sensors are stacked in the housing. The plurality of test sensors is for assisting in testing at least one analyte. An external spring mechanism is mounted on the cartridge housing and the base for assisting in sealing engagement of the cartridge housing and the base. The instrument housing forms a dispensing outlet and is adapted to receive the cartridge. The ejector mechanism is adapted to move and be interposed between the cartridge housing and the base to separate the cartridge housing and the base. An ejector mechanism is used to transport and extract the plurality of test sensors, one at a time, in the second direction, at least partially from the cartridge. The second direction is substantially perpendicular to the first direction. In the first position, the cartridge housing and the base are in sealing engagement, and in the second position, the cartridge housing and the base are separated.
According to another embodiment, a cartridge includes a housing, a plurality of test sensors, a mechanical mechanism, and a sliding pusher lid assembly. The housing defines at least one opening therethrough. A plurality of test sensors are stacked in the housing. The plurality of test sensors is for assisting in testing at least one analyte. The mechanical mechanism is configured to urge the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The sliding pusher lid assembly includes a flexible pusher tab. The flexible pusher tab is adapted to contact one of the plurality of test sensors and push the test sensor from the housing at least partially through the opening. The flexible pusher tab extends generally outwardly and generally downwardly from the remainder of the sliding pusher lid assembly. In the closed position, the sliding pusher lid assembly is used to help seal the cartridge.
According to another embodiment, a sensor-dispensing instrument is used to determine a concentration of an analyte and includes a cartridge and an instrument housing. The cartridge includes a cartridge housing, a plurality of test sensors, a mechanical mechanism, and a sliding pusher lid assembly. The cartridge housing forms at least one cartridge opening therethrough. A plurality of test sensors are stacked in the cartridge housing. The plurality of test sensors is for assisting in testing at least one analyte. The mechanical mechanism is configured to urge the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge. The sliding pusher lid assembly is movable between a first position and a second position. The sliding pusher lid assembly is used to help seal the sensor-dispensing instrument in the second position. The sliding pusher assembly includes a flexible pusher tab. The flexible pusher tab extends generally outwardly and generally downwardly from the remainder of the sliding pusher lid assembly. The instrument housing forms a dispensing outlet and is adapted to receive a cartridge. A flexible pusher tab is used to push one of the plurality of test sensors from the cartridge at least partially through the dispensing outlet.
Drawings
Fig. 1 is a front view of a cartridge according to one embodiment of the present invention.
FIG. 2 is a front view of the sensor-dispensing instrument of one embodiment, without the cartridge.
Fig. 3a is a front view of the sensor-dispensing instrument of fig. 2, with the cartridge of fig. 1 in a closed position.
Fig. 3b is a side view of the sensor-dispensing instrument of fig. 3 a.
Fig. 3c is a front view of the sensor-dispensing instrument of fig. 2 and the cartridge of fig. 1 in an open position with the sensor extending therethrough.
Fig. 3d is a side view of the sensor-dispensing instrument of fig. 3 c.
Fig. 4a is a side view of another embodiment of a cartridge or sensor-dispensing instrument with the lid in a closed position.
Fig. 4b is a side view of the cartridge or sensor-dispensing instrument of fig. 4a with the lid in an open position.
Fig. 4c is a cross-sectional view taken generally along line 4c-4c of fig. 4 a.
Fig. 4d is a side view of a further embodiment of a lid and retainer tab in an open position.
Fig. 4e is a side view of the lid and retainer tab of fig. 4d in a closed position.
Fig. 5a is a side view of a cartridge in a closed position according to another embodiment.
Fig. 5b is a side view of the cartridge of fig. 5a in an open position.
Fig. 5c is a front view of the cartridge of fig. 5 b.
Fig. 5d is a side view of a cartridge in a closed position according to yet another embodiment.
Fig. 5e is a front view of a cartridge in a closed position according to another embodiment.
Fig. 5f is a front view of the cartridge of fig. 5e in an open position.
Fig. 6a is a front view of a cartridge in a closed position according to yet another embodiment.
Fig. 6b is a front view of the cartridge of fig. 6a in an open position.
Fig. 6c is a side view of the cartridge of fig. 6 b.
Fig. 7a is a front view of a lid in a closed position according to yet another embodiment.
Fig. 7b is a front view of the lid of fig. 7a in an open position.
Fig. 8a is a front view of a cartridge in a closed position according to one embodiment.
Fig. 8b is a front view of the cartridge of fig. 8a in an open position.
Fig. 9a is a front view of a cartridge in a closed position according to yet another embodiment.
Fig. 9b is a front view of the cartridge of fig. 9a in an open position.
Fig. 9c is a front view of a cartridge in a closed position according to another embodiment.
Fig. 9d is a front view of the cartridge of fig. 9c in an open position.
Fig. 10a is a front view of a cartridge in a closed position according to yet another embodiment.
Fig. 10b is a front view of the cartridge of fig. 10a in an open position.
Fig. 11a is an exploded front perspective view of a cartridge of another embodiment.
Fig. 11b is a side view of the cartridge of fig. 11a in a closed position.
FIG. 11c is a perspective view of the cassette of FIG. 11a with the lid in the closed position.
Fig. 11d is an enlarged front view of the lid and cartridge of fig. 11 c.
Fig. 11e, f are perspective views of the cassette of fig. 11a with the lid in open and closed positions, respectively.
Fig. 11g is an enlarged view of the cap and test sensor of fig. 11 f.
Fig. 12a is a front perspective view of a cassette of yet another embodiment.
Fig. 12b is a side view of the cartridge of fig. 12 a.
Fig. 13a is a front perspective view of a cassette of another embodiment.
Fig. 13b is a front perspective view of the cartridge of fig. 13a (without a plurality of test sensors) and an ejector mechanism of another embodiment.
Fig. 13c is a front perspective view of the test-sensor extractor of fig. 13b with a test sensor therein.
Fig. 13d is a perspective view of a sensor-dispensing instrument having the cartridge of fig. 13a and the ejector mechanism of fig. 13 b.
Fig. 13e, f show the ejector mechanism in contact with the test-sensor extractor of fig. 13 c.
Fig. 14a is a front perspective view of the cartridge in a closed position and an ejector mechanism of another embodiment.
Fig. 14b is a front perspective view of the cartridge of fig. 14a and the ejector mechanism of fig. 14a in an open position.
Fig. 14c is a perspective view of the ejector mechanism and test sensor of fig. 14 b.
Fig. 14d is a perspective view of another embodiment of a sensor-dispensing instrument having the cartridge and ejector mechanism of fig. 14 a.
Fig. 15a is a front view of a cartridge in a closed position according to another embodiment of the present invention.
Fig. 15b is a partial top perspective view of the cartridge of fig. 15a in an open position with the test sensors removed.
Fig. 15c is a cross-sectional view taken generally along line 15c-15c of fig. 15 b.
Fig. 16a is an enlarged front view of a partial cartridge with a flexible pusher tab according to another embodiment of the present invention.
Fig. 16b is an enlarged top view of the partial cartridge of fig. 16 a.
Fig. 16c is an enlarged front view of a partial cartridge with a flexible pusher tab according to yet another embodiment of the present invention.
Fig. 17a-c are enlarged front views of a partial cartridge with a flexible pusher tab using a guide mechanism according to one embodiment of the present invention.
Fig. 18a-c are enlarged front views of a partial cartridge with a flexible pusher tab using a guide mechanism according to another embodiment of the present invention.
Fig. 19a-c are enlarged front views of a partial cartridge with a flexible pusher tab according to yet another embodiment of the present invention.
Fig. 20a-c are partial front views of another embodiment sensor-dispensing instrument using the cartridge of fig. 15 a.
Figure 21 is a side view of another embodiment of a cap assembly.
FIG. 22 is a side view of a pusher grip with a locking mechanism, under an embodiment.
Fig. 23 is a top view of the pusher grip of fig. 22.
Detailed Description
The present invention relates to cartridges housing a plurality of test sensors and to sensor-dispensing instruments using cartridges. The plurality of test sensors is used to determine a concentration of an analyte. Analytes that can be measured using the present invention include glucose, lipids (e.g., cholesterol, triglycerides, LDL, and HDL), microalbumin, hemoglobin A1C, fructose, lactic acid, or bilirubin. However, the present invention is not limited to these specific analytes. It is contemplated that the concentration of other analytes may be determined. The analyte may be, for example, in whole blood samples, serum samples, plasma samples, other body fluids such as ISF (interstitial fluid) and urine, and non-body fluids.
Referring to the drawings, the cartridge 10 of FIG. 1 is suitable for use in a sensor-dispensing instrument. The cartridge 10 of fig. 1 includes a housing 12, a plurality of test sensors 14, a mechanical mechanism 16, and a pusher assembly 18. The cartridge 10 is adapted to be disposed of after the plurality of test sensors 14 have been used. When cartridge 10 is used in a sensor-dispensing instrument, the used cartridge may be replaced with a second identical cartridge that includes a plurality of unused test sensors.
Referring to fig. 1, the cartridge 12 defines at least one opening 20 therethrough. The opening 20 is sized to allow the plurality of test sensors 14 to pass through, one at a time, and ultimately exit the cartridge 10. In addition, the pusher assembly 18 may be operable to partially protrude at least a portion thereof through the opening 20. Specifically, the plurality of test sensors 14 exit the cartridge 10 through the opening 20 one at a time. Preferably, the cartridge includes only one opening to reduce or eliminate additional exposure of the plurality of test sensors 14 to air.
The housing 12 may be made from a variety of materials,but are typically made of a polymeric material. Some examples of polymeric materials that may be used to form housing 12 include polycarbonate, ABS, nylon, polystyrene, polypropylene, or combinations thereof. Other additives may be added when forming the housing, e.g. for lubricationOr glass for providing strength. Other additives are contemplated. Polycarbonate is preferred for reasons including its durability and its ability to prevent or inhibit the ingress of air, particularly moisture, into the housing 12.
The housing 12 may be formed by methods known to those skilled in the art, including injection molding methods. Other methods, such as molding, are contemplated.
As shown in fig. 1, a plurality of test sensors 14 are stacked in the housing 12. The plurality of test sensors are in contact with a test sensor support that helps to evenly feed the test sensors, which is particularly important for thinner and more flexible test sensors. The plurality of test sensors 14 is adapted to assist in testing at least one analyte. As noted above, one analyte that may be tested for is, for example, glucose from a whole blood sample. The test sensor 14 is typically an electrochemical sensor or an optical sensor. It is contemplated that another sensor that aids in testing at least one analyte may be used in the present invention.
In one embodiment, the plurality of test sensors includes a suitably selected enzyme to react with a suitable analyte to be tested. An enzyme that can be used to react with glucose is glucose oxidase. The use of other enzymes, such as glucose dehydrogenase, is also contemplated. An example of a test sensor 14 is described in U.S. patent No.6531040 assigned to Bayer corporation. It is contemplated that other test sensors may be used in the cartridge 10.
The number of multiple test sensors 14 may vary from that shown in fig. 1 to accommodate the needs of different users and the physical storage requirements of the test sensors. Typically, the cartridge contains from about 10 to about 100 stacks of test sensors, and particularly from about 25 to about 40 stacks of test sensors. Because of the limited storage and useful life of test sensors, it is contemplated that a user who does not perform the test often may desire a cartridge with fewer test sensors as opposed to a user who performs the test more often.
To urge the stacked test sensors 14 upward (in the direction of arrow a in fig. 1), a mechanical mechanism 16 is used according to one embodiment. The mechanical mechanism 16 helps position one of the plurality of test sensors for eventual ejection from the cartridge 10 through the opening 20. The mechanical mechanism is any device capable of exerting a pushing force on the stacked test sensors 14 to position one of the plurality of test sensors for ejection. For example, the mechanical mechanism 16 shown in FIG. 1 is a spring. Various springs may be used as the mechanical mechanism to urge the stacked test sensors 14 in the direction of arrow a in fig. 1. For example, the spring may be a compression spring or a torsion spring. Springs are preferred because of their simplicity and ease of use. It is contemplated that a plurality of springs may be used to urge the stacked test sensors in the direction of arrow a.
Additionally, the mechanical mechanism 16 may be a pawl pusher. When such an embodiment is used, the pawl pusher automatically engages the stacked test sensors upwardly (i.e., in the direction of arrow a in fig. 1). Preferably, a detent pusher is required to extend the length of the cartridge interior so that all of the test sensors will be used end-on. It is contemplated that the pawl pusher may be used in combination with one or more springs.
To help guide the mechanical mechanism 16 upward (in the direction of arrow a in fig. 1), the housing 12 may be formed with a plurality of prongs or extensions 25. The optional nib or extension 25 helps guide the mechanical mechanism 16 in the direction of arrow a, making it easier for the plurality of test sensors to move in that direction. Such prongs may mate with corresponding guide structures in the housing. For example, the prongs and guide structure may be in a tongue and groove relationship.
The cartridge 10 includes a pusher assembly 18, the pusher assembly 18 for pushing one of the plurality of test sensors 14 from the cartridge. As shown in fig. 1, the pusher assembly 18 is loaded into the cartridge 10. The pusher assembly 18 includes a ferromagnetic material or a magnet. As will be described in detail below, the pusher assembly is adapted to magnetically couple with a slider of the sensor-dispensing instrument when one of the plurality of test sensors 14 is pushed from the cartridge through the opening 20. At least one of the slider and the pusher assembly 18 includes a magnet. For example, the slider and pusher assembly 18 may include a magnet. It is contemplated that the slider may include a magnet and the pusher assembly 18 may include a ferromagnetic material. It is also contemplated that the slider may comprise a ferromagnetic material and the pusher assembly 18 comprises a magnet.
Examples of ferromagnetic materials that may be used to form the pusher assembly 18 include, but are not limited to: iron, nickel, cobalt, or combinations thereof. Ferromagnetic materials have a high magnetic permeability and increase tensile strength. One example of a magnet is an electromagnet.
To assist in sealing the cartridge against the dispensing outlet of a sensor-dispensing instrument (e.g., sensor-dispensing instrument 100 of fig. 2), the cartridge 10 can include a sealing port 22. Preferably, the sealing port 22 surrounds the opening 20 of the cartridge 10. According to one embodiment, the sealing port 22 is a hollow stationary tube made of a polymeric material. Preferably, the material forming the sealing port 22 is made of a material that is softer than the surface of the sensor-dispensing instrument with which it is in contact, such as the inner surface 102a of the housing 102, fig. 2. For example, the inner surface 102a may be made of stainless steel. It is contemplated that the sealing ports may have different shapes and may be made of other materials.
It is contemplated that the seal may be on the sensor-dispensing instrument rather than on the cartridge. In this embodiment, the seal may be on an inner surface 102a of the housing 102 (fig. 2) of the sensor-dispensing instrument 100. The inner surface 102a is in contact with an outer surface of the cartridge 10 when the cartridge is disposed in the sensor-dispensing instrument 100.
The sensor-dispensing instrument 100 may include a detection mechanism that detects whether the lid is in the closed position. For example, the sensor-dispensing instrument 100 may include a detection mechanism, such as a contact switch, that alerts the user when the cap is not in the closed position. The warning may be provided to the user by an audible signal. This is particularly advantageous when the lid in the closed position provides a primary source of protection against exposure of the test sensor to ambient moisture.
To help protect the reagents in the test sensor 14, suitable packaging materials and/or desiccant materials may be used. The cartridge 10 is typically packaged in a material that prevents or inhibits air and moisture from entering the interior of the housing 12 that contains the test sensors 14. One type of removable packaging that may be used to enclose the box 10 is aluminum foil. Other types of removable packaging are contemplated. It is contemplated that desiccant material may be added to the interior of the removable package to help maintain the proper humidity level therein. When the reagent in the test sensor is not sensitive to humidity, it is substantially unnecessary or not necessary to include a large amount of desiccant (when present). The removable packaging with or without desiccant material helps to increase the shelf life of the test sensors. The removable packaging will be removed prior to the cartridge 10 being placed in the sensor-dispensing instrument.
It is contemplated that the cartridge 10 may be first disposed in a polymeric container, such as a bottle or other type of container. The container may be formed similar to the cartridge and have a suitable seal to prevent or inhibit air or moisture from entering the container interior. The container may include a lid that is mounted on the remainder of the container by a living hinge. It is contemplated that a desiccant may also be added to the container. The container with or without the desiccant material helps to increase the shelf life of the test sensor. The cartridge 10 is removed from the container prior to placement in the sensor-dispensing instrument.
As shown in FIG. 1, a desiccant material 26 is preferably added to the cartridge 10 to help maintain a suitable humidity level within the interior of the housing 12 containing the plurality of test sensors 14. In particular, some moisture may enter the interior of the housing 12 as the sensor is pushed out of the cartridge, but this moisture is preferably absorbed by the desiccant in order to prevent degradation of the reagents in the test sensor. By maintaining the appropriate humidity level, the reagent material in the test sensor is protected.
The amount of desiccant material 26 (plus any additional desiccant including any external packaging) should be sufficient to achieve a suitable shelf life (the time interval before any of the plurality of test sensors is used). More specifically, shelf life generally refers to the time interval before the cartridge 10 is removed from the packaging material (when in use). The amount of desiccant material 26 will also be sufficient to achieve a suitable service life (time interval after first using one of the plurality of test sensors). More specifically, the useful life generally refers to the time interval after the cartridge 10 is removed from the packaging material (when in use).
Examples of desiccants that may be contained in the disposable container, in a removable package closing the disposable container, or in a container containing a cartridge include commercially available desiccants. The desiccant can be in a variety of shapes including pellets, tablets, granules or paper. For example, the desiccant may be molecular sieve balls or thick desiccant paper. The desiccant may be disposed within the interior of the housing 12, such as the desiccant material 26 as shown. The desiccant may be molded into the interior surface of the housing 12 of the cartridge to absorb moisture within the cartridge. One non-limiting example of a desiccant material is available from Multisorb of buffalo, New York, in the shape of, for example, molecular sieve beads.
It is contemplated that the desiccant may not be used with a test sensor that is not sensitive to humidity. The amount of desiccant used (when used) depends on the degree of sensitivity of the test sensor to humidity and the appropriate lifetime and shelf life time.
Referring to fig. 2 and 3, a sensor-dispensing instrument 100 is shown according to one embodiment. The sensor-dispensing instrument is used to determine the concentration of an analyte. Analytes that can be measured using the present invention include glucose, lipids (e.g., cholesterol, triglycerides, LDL, and HDL), microalbumin, hemoglobin A1C, fructose, lactic acid, or bilirubin. However, the present invention is not limited to these specific analytes. It is contemplated that the concentration of other analytes may be determined. The analyte may be, for example, in whole blood samples, serum samples, plasma samples, other body fluids such as ISF (interstitial fluid) and urine, and non-body fluids.
The sensor-dispensing instrument 100 includes a cartridge 10 (not shown in fig. 2), an instrument housing 102, a slider 104, and a cover 130. As shown in fig. 3a, 3c, the instrument housing 102 is for receiving the cartridge 10 of fig. 1. Preferably, the cartridge 10 will be removed from and loaded into the instrument housing 102 of the sensor-dispensing instrument 100 in a simple and easy manner. The instrument housing 102 may be designed to load the cartridge through its bottom, side, or top.
Other cartridges are contemplated. Depending on the selected cartridge, the instrument housing interior may be redesigned to correspond to the selected cartridge. The instrument housing 102 also defines a dispensing outlet 106, the dispensing outlet 106 sized to dispense the test sensors 14 one at a time.
The slider 104 comprises a ferromagnetic material or a magnet. As shown in fig. 2, 3a, 3b, the slider 104 includes a portion 104a that is a ferromagnetic material or magnet. However, it is contemplated that the slider may be constructed entirely of ferromagnetic material or a magnet.
The slider 104 is adapted to magnetically couple with the pusher assembly 18 of the cartridge 10. As described above, at least one of the slider and the pusher assembly includes a magnet. For example, the slider 104 and the pusher assembly 18 may include magnets. It is contemplated that the slider 104 may include a magnet and the pusher assembly 18 may include a ferromagnetic material. It is also contemplated that the slider 104 may comprise a ferromagnetic material and the pusher assembly 18 comprises a magnet. Examples of ferromagnetic materials that can be used to form the slider 104 include, but are not limited to: iron, nickel, cobalt, or combinations thereof. Ferromagnetic materials have a high magnetic permeability and increase tensile strength.
Referring to fig. 3a, the slider 104 is shown in a first position. By continuing to manually move the slider 104 in the direction of arrow B in fig. 3a, the slider 104 is moved to the second position (see fig. 3 c). The slider 104 in fig. 3c is positioned closer to the dispensing outlet 106 than the slider 104 of fig. 3 a.
The pusher assembly 18 is adapted to move one of the plurality of test sensors 14, such as the test sensor 14a shown in fig. 3c, 3d, from the cartridge 10 at least partially through the dispensing outlet 106. When the slider 104 is in the first position (fig. 3a, 3b), the pusher assembly 18 (which pusher assembly 18 is also in its first position in fig. 3a) is positioned so that the plurality of test sensors 14 can move in the direction of arrow a. After the test sensor 14a in fig. 3a contacts the portion 18b of the pusher assembly 18, the plurality of test sensors 14 will be prevented from moving in the direction of arrow a. When the slider 104 is moved in the direction of arrow B (see fig. 3c), the pusher assembly 18 is also moved in the direction of arrow B. As shown in fig. 3a, 3c, the portion 18b of the pusher assembly 18 contacts the test sensor 14a and passes it at least partially through the dispensing outlet 106.
To assist in moving one of the plurality of test sensors 14 at least partially through the dispensing outlet 106, the lid 130 is movable between a closed position (fig. 3a, 3b) and an open position (fig. 3c, 3 d). In the closed position of fig. 3a, 3b, the lid 130 seals the dispensing outlet 106. In the open position of fig. 3c, 3d, the cover 130 is moved such that the test sensor 14a can exit through the dispensing opening 106. When in the open position, the cover 130 is located within the recess 132 of fig. 3a, 3b and has a portion 130a extending from the recess 132. The lid 130 is moved between an open position and a closed position by a hinge 134. It is contemplated that other mechanisms may be used to move the lid between the open and closed positions.
The lid 130 is manually movable between an open position (fig. 3a, 3b) and a closed position (fig. 3c, 3 d). The lid 130 is also automatically movable between an open position (fig. 3a, 3b) and a closed position (fig. 3c, 3 d). For example, the cover may have a linkage between the slider 104 and the cover 130 that automatically moves the cover 130 by movement of the slider 104.
To enhance the seal, it is preferred that the lid 130 be slightly more flexible than the perimeter of the dispensing outlet 106. The cover 130 may be made of a material including a polymer material. Some examples of polymeric materials that may be used to form housing 12 include polycarbonate, ABS, nylon, polyethylene, polystyrene, polypropylene, or combinations thereof.
The cap 130 of fig. 2 and 3 is shown as being generally circular. It is also contemplated, however, that the cover may have a different shape than that shown in fig. 2 and 3. The sensor-dispensing instrument may be formed with a different cover than the cover 130 shown in fig. 2 and 3.
To help improve the seal, the sensor-dispensing instrument may include a sealing mechanism, such as a sealing ridge, disposed generally around the perimeter of the dispensing opening. Alternatively or additionally, the lid may have a corresponding sealing ridge that substantially surrounds the periphery of the dispensing opening when the lid is in the closed position. The seal generally around the periphery of the dispensing outlet and/or on the lid may be a variety of different seals, for example: (a) a raised seal that seals against a flat surface; (b) a rib and groove structure; or (c) two substantially flat surfaces. It is contemplated that other sealing techniques may be used to prevent or inhibit moisture from reaching the test sensor.
According to another embodiment, the cartridge may include a sealing mechanism, such as a sealing ridge, disposed generally around the perimeter of the opening. Alternatively or additionally, the lid may have a corresponding sealing ridge that substantially surrounds the periphery of the dispensing opening when the lid is in the closed position. The seal generally around the perimeter of the opening and/or on the lid may be a variety of different seals, such as: (a) a raised seal that seals against a flat surface; (b) a rib and groove structure; or (c) two substantially flat surfaces. It is contemplated that other sealing techniques may be used to prevent or inhibit moisture from reaching the test sensors in the cartridge.
In the embodiment of fig. 1-3, the cover is shown as a component of the sensor-dispensing instrument. In an alternative embodiment, the sealing lid may be a component of the cartridge, wherein a seal is formed to the cartridge inside the sensor-dispensing instrument. Having a lid on the cartridge would eliminate the need to seal the cartridge to the instrument (e.g., the sealing port 22 and the inner surface 102a of the housing 102 shown in fig. 1 and 2).
Fig. 4a, 4b illustrate a sensor-dispensing instrument or cartridge 140 that includes opposing sidewalls 142, 144 and a lid 150. In particular, the cover 150 may be used with a sensor-dispensing instrument or cartridge. The cover 150 is adapted to slide between a closed position (fig. 4a) and an open position (fig. 4 b).
To assist in manually sliding the lid 150 between the open and closed positions, the lid 150 includes a handle or thumb grip 152. In fig. 4a, 4b, the handle 152 is substantially rectangular in shape. However, the handle may also be shaped differently than shown in fig. 4a, 4 b.
It is also contemplated that the cover 150 may be automatically moved between the open and closed positions. For example, the user may initiate movement of the cover 150 by pressing a button. Alternatively, the lid may be coupled to the pusher assembly or the test-sensor extractor such that movement of the pusher assembly or the test-sensor extractor will move the lid. For example, a cam mechanism may connect the lid to the pusher assembly or the test-sensor extractor. For example, when the slider 104 moves from the first position (fig. 3a) to the second position (fig. 3c), the cover moves from the open position to the closed position. The same mechanism may also close the cover when the slider 104 is moved from the second position to the first position. To assist in closing the lid, a spring mechanism may be used.
To assist in sliding the lid 150 between the open and closed positions, the sensor-dispensing instrument or cartridge 140 further includes at least one retainer tab. For example, in fig. 4a-c, retainer tabs 154a, b limit the sliding of the lid 150 between the closed position (fig. 4a) and the open position (4 a). To maintain the positive pressure, retainer tabs 154a, b may be made of a flexible material. To improve the sealing of the lid, the thickness of the lid (D1 in fig. 4 c) may be slightly greater than distance D2 when retainer tabs 154a, b are in the rest position (i.e., when the lid is not exerting any pressure on the retainer tabs). In this embodiment, the cover and the retainer tab form an interference fit. The retainer tabs may be injection molded when forming the cartridge or the sensor-dispensing instrument.
In the closed position (fig. 4a), the lid 150 covers the dispensing outlet 156, and in the open position (fig. 4b), the lid 150 does not cover the dispensing outlet 156. The cover 150 may be made of a similar material as the cover 130.
The cover 150 of fig. 4a, 4b is shown as being generally rectangular in shape. It is however contemplated that the cover may have a different shape than that shown in figures 4a, 4 b.
To help provide an improved seal, the sensor-dispensing instrument or cartridge 140 of fig. 4a, 4b may include a seal 158 disposed generally around the perimeter of the dispensing opening 156, the seal 158 working with the lid 150. The lid is balanced between making it easy to slide between the open and closed positions and still maintaining sufficient downward pressure to form a high quality seal. Having a lower coefficient of friction makes it easier for the lid to move between the open and closed positions. It is contemplated that other sealing techniques may be used to provide a seal between the cap and the dispensing opening, such as an O-ring or compressible gasket.
According to a further embodiment, the at least one retainer tab may be angled. Referring to fig. 4d, 4e, the cover 190 is for use in conjunction with an angled retainer tab 192 a. As shown in fig. 4d, 4e, retainer tab 192a forms at least one detent (detents 194a, 194b) to help indicate complete closure to the user. The detents 194a, 194b correspond with respective notches 196a, 196b formed in the cover 190. However, the cover 190 does not have to work with at least one retainer tab with detents (as shown in fig. 4d, 4 e). The sensor-dispensing instrument or cartridge may also include a seal 198, the seal 198 working in conjunction with the cover 190 to help prevent or inhibit moisture from reaching the plurality of test sensors. Additional seals are contemplated, including seals on the cover 190.
According to another embodiment, the cartridge 210 of fig. 5a-c includes a housing 212, a plurality of test sensors 214, a mechanical mechanism 216, a test-sensor extractor 218, and a lid 230. The cartridge 210 is adapted to be disposable after all of the test sensors 214 have been used.
Referring to fig. 5b, 5c, housing 212 defines at least one opening 220 therethrough. The opening 220 is sized to allow the plurality of test sensors 214 to pass through, one at a time, and eventually exit the cartridge 210. Specifically, the plurality of test sensors 214 exit the cartridge 210 through the opening 220 one at a time. Housing 212 may be formed from the same materials and methods as described above in connection with housing 12.
As shown in fig. 5c, a plurality of test sensors 214 are stacked in the housing 212. The plurality of test sensors 214 is used to assist in testing at least one analyte. As described above. One analyte that may be tested is, for example, glucose from a whole blood sample. The test sensor 214 may be the same as described above in connection with the plurality of test sensors 14.
To urge the stacked test sensors 214 generally upward (in the direction of arrow D in fig. 5c), a mechanical mechanism 216 is used according to one embodiment. The mechanical mechanism 216 helps position one of the plurality of test sensors 214 for eventual ejection from the cartridge 210 through the opening 220. The mechanical mechanism 216 may be a spring or other device as described above in connection with mechanical mechanism 16.
The cartridge 210 also includes a test-sensor extractor 218, the test-sensor extractor 218 being adapted to move between a first position (fig. 5a) and a second position (fig. 5 b). The lid 230 is connected to the test-sensor extractor 218 by, for example, a mechanical linkage. For example, in fig. 5c, the cap 230 is connected to the test-sensor extractor 218 by a linkage 224. It is contemplated that the cap may be mounted on the test-sensor extractor by other mechanisms, such as a cam mechanism.
Movement of the lid 230 from the closed position (fig. 5a) to the open position (fig. 5b) causes the test-sensor extractor 218 to move from the first position to the second position and extract the test sensor 214a at least partially through the opening 220. Fig. 5c shows the cover 230 in an open position, wherein the test sensor 214a has partially passed through the opening 220. When the lid 230 is in the closed position (fig. 5a), the lid seals the opening 220. According to one method, the lid 230 is manually moved between the open and closed positions. To assist in manually moving the lid 230, the lid 230 may include a handle or push tab 236 that makes it easier for a user to grasp the lid 230 and move the lid 230 in the direction of arrow E, as shown in FIG. 5 c. The path of arrow E is generally horizontal, but the cover 230 is raised slightly vertically, as shown in fig. 5c, to enable the test sensor 214a to be removed through the opening 220. It is contemplated that the cover 230 may be moved in an automated manner.
To assist in withdrawing one of the plurality of test sensors 214 at least partially through the opening 220, the cartridge 210 includes a ramp 246 (see fig. 5 c). The ramp 246 helps guide the test sensors 214 one at a time at least partially through the opening 220. The test sensor 214 may then be fully extracted manually by the user. After the test sensor 214a has been extracted, the lid 230 is returned to the closed position (fig. 5a), and the test-sensor extractor is returned to the first position (fig. 5a) in preparation for extracting the next one of the plurality of test sensors 214.
The cover 230 works in conjunction with at least one retainer tab (retainer tabs 228a, 228b) in a similar manner as described above in conjunction with retainer tabs 154a, 154 b. It is contemplated that other covers may be used with the test-sensor extractor 218 to extract a plurality of test sensors one at a time at least partially through the opening.
To help provide clearance for the linkage 224 shown in fig. 5c, the cover may form at least one recess. For example, as shown in fig. 5b, the cover 230 forms a plurality of recesses 238a, 238 b. It is contemplated that multiple recesses may be formed in different locations of the cover. For example, according to one embodiment, the cartridge 250 of fig. 5d includes a lid 252. The cover 252 defines a plurality of recesses 254a, b. The cover 252 having a plurality of recesses 254a, 254b is generally "I" shaped. The cartridge 250 of fig. 5d functions in a similar manner as the cartridge 210 of fig. 5 a.
Referring to fig. 5a-c, the cartridge 210 may also include a sealing mechanism, such as a sealing ridge 240, disposed generally around the perimeter of the opening 220. Similar to the seal ridge 158 described above, the seal ridge 240 helps maintain a desired seal with the lid 230. The lid 230 of fig. 5a, 5b further comprises a corresponding sealing ridge 242, which sealing ridge 242 may be formed instead of the sealing ridge 240 or in addition to the sealing ridge 240 also forming the sealing ridge 242. The sealing ridge 242 helps form a seal generally around the perimeter of the opening 220 when the lid 230 is in the closed position.
To help protect the reagents in the test sensor 214, suitable packaging materials and/or desiccant materials may be used. The cartridge 210 is typically packaged in a material that prevents or inhibits air from entering the interior of the housing 212 containing the test sensors 214, as described above in connection with the cartridge 10. Alternatively, a desiccant material may be added to the cartridge 210, as described above in connection with the cartridge 10.
According to another embodiment, the cartridge 260 of fig. 5e, 5f includes a housing 262, a plurality of test sensors 264, a mechanical mechanism 266, a test-sensor extractor 268, and a lid 280. The cartridge 260 is disposable after all of the test sensors 264 have been used.
Referring to fig. 5e, 5f, the housing 262 defines at least one opening 270 therethrough. The opening 270 is sized to allow the plurality of test sensors 264 to pass through, one at a time, and eventually exit the cartridge 260. Specifically, the plurality of test sensors 264 exit the cartridge 260 one at a time through the opening 270. The housing 262 may be formed from the same materials and methods as described above in connection with housing 12.
As shown in fig. 5e, f, a plurality of test sensors 264 are stacked in the housing 262. The plurality of test sensors 264 are used to assist in testing at least one analyte. As described above. One analyte that may be tested is, for example, glucose from a whole blood sample. The test sensors 264 may be the same as described above in connection with the plurality of test sensors 14.
To urge the stacked test sensors 264 generally upward (in the direction of arrow F in fig. 5e, F), a mechanical mechanism 266 is used according to one embodiment. The mechanical mechanism 266 assists in positioning one of the plurality of test sensors 264 for eventual ejection from the cartridge 260 through the opening 270. The mechanical mechanism 266 may be a spring or other device as described above in connection with mechanical mechanism 16.
The cartridge 260 also includes a test-sensor extractor 268, the test-sensor extractor 268 for movement between a first position (fig. 5e) and a second position (fig. 5 f). The cap 280 is coupled to the test-sensor extractor 268 by, for example, a mechanical linkage. For example, the cap 280 is coupled to the test-sensor extractor 268 by a linkage 274. It is contemplated that the cap may be mounted on the test-sensor extractor by other mechanisms, such as a cam mechanism.
Movement of the lid 280 from the closed position (fig. 5e) to the open position (fig. 5f) causes the test-sensor extractor 268 to move from the first position to the second position and extract the test sensor 264a at least partially through the opening 270. Fig. 5f shows the lid 280 in an open position, wherein the test sensor 264a has partially passed through the opening 270. When the lid 280 is in the closed position (fig. 5e), the lid seals the opening 270. According to one method, the lid 280 is manually moved between the open and closed positions. To assist in manually moving the cap 280, the cap 280 may include a handle or push tab 286 that makes it easier for a user to grasp the cap 280 and move the cap 280 in the direction of arrow G, as shown in fig. 5 f. The path of arrow G is substantially horizontal and substantially perpendicular to the direction of arrow F in fig. 5e, F. It is contemplated that the cover 280 may be moved in an automated manner.
The test sensors 264 may be fully extracted manually by the user. After the test sensor 264a has been extracted, the lid 280 is returned to the closed position (fig. 5e) and the test-sensor extractor is returned to the first position (fig. 5f) in preparation for extracting the next one of the plurality of test sensors 264.
The lid 280 of fig. 5e, f also includes a seal 292, which seal 292 helps form a seal generally around the perimeter of the opening 270 when the lid 280 is in the closed position. It is contemplated that the seal may substantially surround the perimeter of the opening 270. The seal may be formed in addition to the seal 292 or may replace the seal 292.
To help protect the reagents in the test sensors 264, suitable packaging materials and/or desiccant materials may be used. The cartridge 260 is typically packaged in a material that prevents or inhibits air from entering the interior of the housing 262 that contains the test sensors 264, as described above in connection with cartridge 10. Additionally, as described above in connection with the cartridge 10, a desiccant material 276 may be added to the cartridge 260.
According to yet another embodiment, the cartridge 310 of fig. 6a-c includes a housing 312, a plurality of test sensors 314, a first mechanical mechanism 316, a second mechanical mechanism 342, a test-sensor extractor 318, and a lid 330. The cartridge 310 is adapted to be disposable after all of the test sensors 314 have been used.
Referring to fig. 6b, the housing 312 defines at least one opening 320 therethrough. The opening 320 is sized to allow the plurality of test sensors 314 to pass through, one at a time, and eventually exit the cartridge 310. Specifically, the plurality of test sensors 314 exit the cartridge 310 through the opening 320 one at a time. Housing 312 may be formed from the same materials and methods as described above in connection with housing 12.
As shown in fig. 6a, b, a plurality of test sensors 314 are stacked in a housing 312. The plurality of test sensors 314 is used to assist in testing at least one analyte, as described above with respect to test sensors 14. To urge the stacked test sensors 314 in a first direction (in the direction of arrow F in fig. 6a, b), a first mechanical mechanism 316 is used according to one embodiment. The first mechanical mechanism 316 assists in positioning one of the plurality of test sensors 314 for eventual ejection from the cartridge 310 through the opening 320. The first mechanical mechanism 316 may be a spring or other device as described above in connection with mechanical mechanism 16. To help guide the mechanical mechanism 316 upward (in the direction of arrow F in fig. 6a, 6b), the housing 312 may be formed with a plurality of prongs or extensions 325.
The cartridge 310 also includes a test-sensor extractor 318, the test-sensor extractor 318 being adapted to move between a first position (fig. 6a) and a second position (fig. 6 b). The movement of the test-sensor extractor 318 is controlled by the lid 330 and the second mechanical mechanism 342. The second mechanical mechanism 342 is configured to urge the plurality of test sensors 314 in a second direction (the direction of arrow G in fig. 6a, 6 b). The second direction (arrow G direction) is substantially perpendicular to the first direction (arrow F direction). The second mechanical mechanism 342 may be a spring or other device as described above in connection with mechanical mechanism 16.
The lid 330 moves generally downward (in the direction of arrow H) from the closed position (fig. 6a) to the open position (fig. 6 b). This movement of the lid 330 moves the test-sensor extractor 318 from the first position to the second position, the test-sensor extractor 318 extracting one of the plurality of test sensors 314 at least partially through the opening 320. Specifically, when the lid 330 is moved to the open position, the second mechanical mechanism 342 exerts pressure on the test-sensor extractor 318 in the direction of the opening 320 (in the direction of arrow G). The test-sensor extractor 318 then contacts the test sensor 314a and causes the test sensor to move in the direction of the opening 320. In this manner, the test-sensor extractor 318 is moved from the first position (fig. 6a) to the second position (fig. 6b) by the second mechanical mechanism 342. According to one method, the lid 330 is manually moved between the open and closed positions. According to another method, the lid 330 is automatically moved between the open and closed positions by, for example, pressing a button. One example of an automated method would include removing the plurality of test sensors entirely using a motorized mechanism.
According to one embodiment, the test-sensor extractor 318 has a generally horizontal portion 318a and an angled or sloped portion 318 b. When the cover 330 is in the open position, the angled portion 318b extends from the cartridge 310.
When the lid 330 is returned to the closed position, the lid 330 releasably engages the angled portion 318b of the test-sensor extractor 318 and pushes the angled portion 318b back into the cartridge 310. After the test sensor 314a has been extracted, the lid 330 is returned to the closed position (fig. 6a) and the test-sensor extractor 318 is returned to the first position (fig. 6a) in preparation for extracting the next one of the plurality of test sensors. Once the test-sensor extractor 318 returns to its initial position, the next test sensor is loaded into the test-sensor extractor 318 by the first mechanical mechanism 316 (e.g., a spring). When the lid 330 is in the closed position (fig. 6a), the lid 330 seals the opening 320.
According to another embodiment, the test-sensor extractor may be formed in a shape different from that shown in fig. 6 a-c. For example, the test-sensor extractor can include a generally horizontal portion and a second portion that extends from the cartridge when the lid is in the open position. The second portion may be formed such that the lid engages with the second portion and pushes it back into the cartridge.
The cover 330 of fig. 6a-6c works in conjunction with at least one retainer tab (retainer tabs 328a, 328b), as described above in connection with retainer tabs 154, 154 b. Referring also to fig. 6a-6c, the cartridge 310 may further include a sealing mechanism, such as a sealing ridge 340, disposed generally around the perimeter of the opening 320. The sealing ridge 340 helps maintain a desired seal with the lid 330 and functions in the same manner as the sealing ridge 158 described above. It is also contemplated that the sealing mechanism may be disposed on the lid itself.
To help protect the reagents within the test sensor 314, suitable packaging materials and/or desiccant materials may be used. The cartridge 310 is typically encased in a material that prevents or inhibits air from entering the interior of the housing 312 containing the test sensors 314, as described above in connection with cartridge 10. Additionally, as described above in connection with cartridge 10, a desiccant material 326 may be added to the cartridge 310.
It is contemplated that other covers may be used with the aforementioned cartridge and sensor-dispensing instrument. For example, according to another embodiment, a cover 370 may be used, as shown in fig. 7a, 7 b. The cover 370 includes a first end 372 and a second end 374. The lid 370 is movable between a closed position (fig. 7a) and an open position (fig. 7b) by a hinge 376 at the first end 372, such that the lid 370 seals the opening in the closed position. The cover 370 includes a projection 378 at or near the second end 374. The projection 378 extends generally downward into the interior of the cassette. The projection 378 may form at least one detent 380 to assist in locking the cartridge.
One example of a cassette that may be used with the lid 370 is shown in fig. 8a, 8 b. The cartridge 410 of fig. 8a, 8b includes a housing 412, a plurality of test sensors 414, a first mechanical mechanism 416, and a second mechanical mechanism 442, and their functions are the same as those of the same components described above in connection with fig. 6a-6 c. The cartridge also includes a test-sensor extractor 418, the test-sensor extractor 418 including a first portion 418a and a second portion 418 b. In the open position, a user can grasp the test sensor 414a and manually remove it from the cartridge 410. When the lid 370 is moved to the closed position (fig. 8a), the protrusion 378 of the lid 370 contacts the second portion 418b and pushes the test-sensor extractor 418 back into the cartridge 410. The lid may be opened and closed using an automatic method, which may be initiated, for example, by a user pressing a button. One example of an automated method may include removing the plurality of test sensors entirely using a motorized mechanism.
According to another embodiment, the cartridge 510 of fig. 9a, 9b includes a housing 512, a plurality of test sensors 514, a mechanical mechanism 516, a pusher assembly 518, and a lid 530. The cartridge 510 is adapted to be disposable after all of the test sensors 514 have been used.
Referring to fig. 9b, the housing 512 defines at least one opening 520 therethrough, the opening 520 enabling the plurality of test sensors 514 to pass one at a time and eventually exit the cartridge 510. Housing 512 may be formed from the same materials and methods as described above in connection with housing 12.
As shown in fig. 9a and 9b, a plurality of test sensors 514 are stacked in an inclined manner in the housing 512. The plurality of test sensors 514 is used to assist in testing at least one analyte, as described above with respect to test sensors 14. To urge the stacked test sensors 514 in a first direction (in the direction of arrow I in fig. 9a, 9b), a mechanical mechanism 516 is used according to one embodiment. A stop mechanism 536 may be included in the cartridge 510 to help prevent or inhibit the extraction of multiple test sensors at one time. The mechanical mechanism 516 helps position one of the plurality of test sensors 514 for eventual ejection from the cartridge 510 through the opening 520. The mechanical mechanism 516 may be a spring or other device as described above in connection with mechanical mechanism 16.
The cartridge 510 also includes a pusher assembly 518, the pusher assembly 518 for movement between a first position (fig. 9a) and a second position (fig. 9 b). The movement of the pusher assembly 518 is coupled to the cover 530 and is controlled by the cover 530. The pusher assembly 518 may be mounted on a cover 530 by a cam mechanism 528. It is also contemplated that the pusher assembly may be connected to the lid by other mechanisms, such as a linkage.
Movement of the lid 530 from the closed position (fig. 9a) to the open position (fig. 9b) moves the pusher assembly 518 from the first position to the second position, which results in the extraction of one of the plurality of test sensors 514 at least partially through the opening 520. Specifically, when the cover 530 is moved to the open position, the pusher assembly 518 contacts the test sensor 514a and moves the test sensor 514a (in the direction of arrow J) at least partially through the opening 520. According to one method, the lid 530 is manually moved between the open and closed positions. It is contemplated that the cover 530 may be moved in an automated manner, such as by a user pressing a button to initiate the movement. One example of an automated method may include removing the plurality of test sensors entirely using a motorized mechanism. The lid 530 may be moved between an open position and a closed position by a hinge 534. After the test sensor 514a is at least partially extracted through the opening 520, the test sensor 514a may again be completely extracted manually by the user.
When the cover 530 is returned to the closed position, the cover 530 returns the pusher assembly 518 into the cartridge 510. After the test sensor 514a has been extracted, the lid 530 is returned to the closed position (fig. 9a) and the pusher assembly 518 is returned to the first position (fig. 9a) in preparation for extracting the next one of the plurality of test sensors 514. Once the pusher assembly 518 returns to its initial position, the next test sensor is loaded into the pusher assembly 518 by a mechanical mechanism 516 (e.g., a spring). To help properly guide and position the next test sensor, multiple rails 548a, 548b may be used. When the lid 530 is in the closed position (fig. 9a), the lid 530 seals the opening 520.
The cartridge 510 may also include a sealing port disposed generally around the perimeter of the opening 520. The sealing port helps maintain a proper seal with the cap 530 and functions in the same manner as the sealing port 22 described above.
To help protect the reagents in the test sensor 514, suitable packaging materials and/or desiccant materials may be used. The cartridge 510 is typically packaged in a material that prevents or inhibits air from entering the interior of the housing 512 containing the test sensors 514, as described above in connection with cartridge 10. Additionally, as described above in connection with cartridge 10, desiccant material 526 may be added to cartridge 510.
According to an alternative embodiment, the cartridge 540 of fig. 9c, 9d may use a second mechanical mechanism, such as the second mechanical mechanism 542 of fig. 6 a-c. In this embodiment, the second mechanical mechanism is used to urge the plurality of test sensors 514 in a second direction (in the direction of arrow J in fig. 9c, 9 d). The second mechanical mechanism 542 may be a spring or other device as described above in connection with mechanical mechanism 16. When the lid 530 is moved from the closed position to the open position, the second mechanical mechanism will push one of the plurality of test sensors 514 from the cartridge 540. When the lid 530 is moved from the open position to the closed position, the lid 530 pushes the second mechanical mechanism 542 back to its retracted position (fig. 9 c).
According to another embodiment, the cartridge 560 of fig. 10a, 10b includes a housing 562, a plurality of test sensors 564, a mechanical mechanism 566, and a lid 570. The cartridge 560 is adapted to be disposable after all of the test sensors 564 have been used.
Referring to fig. 10b, the housing 562 forms at least one through opening 572, which opening 572 enables the plurality of test sensors 564 to pass one at a time and eventually exit the cartridge 560. The housing 562 may be formed from the same materials and methods as described above in connection with the housing 12.
As shown in fig. 10a, 10b, a plurality of test sensors 564 are stacked in the housing 562 on an inclined basis. The plurality of test sensors 564 is used to assist in testing at least one analyte, as described above with respect to the test sensors 14. To urge the stacked test sensors 564 in a first direction (in the direction of arrow K in fig. 10a, 10b), a mechanical mechanism 566 is used according to one embodiment. The mechanical mechanism 566 helps position one of the plurality of test sensors 564 for eventual ejection from the cartridge 560 through the opening 572. The mechanical mechanism 566 may be a spring or other device as described above in connection with mechanical mechanism 16.
Movement of the lid 570 from the closed position (fig. 10a) to the open position (fig. 10b) enables a user to manually extract the test sensor 564a through the opening 572. The lid 570 may be moved between an open position and a closed position by a hinge 574. It is contemplated that other covers may be used for cassette 560. For example, according to additional embodiments, the cartridge 560 may replace the lid 570 with, for example, the lid 150 of fig. 4a, 4b or the lid 370 of fig. 7a, 7 b.
After the test sensor 564a has been extracted, the next test sensor is moved in the direction of arrow K by a mechanical mechanism 566 (e.g., a spring). To help properly guide and position the next test sensor, multiple tracks 568a, 568b may be used. When the lid 570 is in the closed position, the lid 570 seals the opening 572.
Cartridge 560 may also include a sealing mechanism, such as a sealing port, disposed generally around the perimeter of opening 572. The sealing port helps maintain a proper seal between the lid 570 and the opening 572 and functions in the same manner as the sealing port 22 described above. A sealing mechanism may be located on the lid 570 to form a suitable seal between the lid 570 and the opening 572.
To help protect the reagents in the test sensor 574, suitable packaging materials and/or desiccant materials can be used. The cartridge 560 is typically packaged in a material that prevents or inhibits air from entering the interior of the housing 562 that contains the test sensors 564, as described above in connection with the cartridge 10. Alternatively, a desiccant material may be added to the cartridge 560 as described above in connection with cartridge 10.
According to another embodiment, the cartridge 610 of fig. 11a-g includes a housing 612, a plurality of test sensors 614, a plurality of mechanical mechanisms 616a, 616b, and a lid 630. The housing 612 forms at least one through opening 620. Housing 612 may be formed from the same materials and methods as described above in connection with housing 12.
As shown in fig. 11a, for example, a plurality of test sensors 614 are stacked in a housing 612. The plurality of test sensors 614 is used to assist in testing at least one analyte, as described above with respect to test sensors 14. In addition, as shown in FIG. 11a, each test sensor 614 also includes a plurality of sensor electrical contacts 632 a-c.
To urge the stacked test sensors 614 in a first direction (in the direction of arrow L in fig. 11 a), a plurality of mechanical mechanisms 616a, 616b are used according to one embodiment. The plurality of mechanical mechanisms 616a, 616b help position one of the plurality of test sensors 614 for eventual ejection from the cartridge 610 through the opening 620. The plurality of mechanical mechanisms 616a, 616b may be springs or other devices as described above in connection with mechanical mechanism 16. It is contemplated that only one mechanical mechanism may be used to push the stacked test sensors in the cartridge 610. To help guide the mechanical mechanisms 616a, 616b upward (in the direction of arrow L in fig. 11 a), the housing 612 may be formed with at least one prong or extension 625.
The movement of the cover 630 from the closed position (fig. 11c, 11d) to the open position (fig. 11e) and back to the closed position (fig. 11f) draws one of the plurality of test sensors 614 at least partially through the opening 620. FIG. 11d illustrates the cover 630 and the plurality of test sensors 614 of FIG. 11c in greater detail. According to one method, the lid 630 is manually moved between the open and closed positions.
According to another approach, the cover 630 may be automatically moved between the open and closed positions by, for example, pressing a button. One example of an automated method may include using a motorized mechanism to move the cover to remove the plurality of test sensors entirely.
The cover 630 includes at least one electrical contact. As shown, for example, in fig. 11a, the cover 630 includes a plurality of cover electrical contacts 634 a-c. After the cover 630 is moved in the direction of arrow M from the closed position (fig. 11c) to the open position (fig. 11e), at least one of the plurality of cover electrical contacts is in contact with at least one sensor electrical contact. More specifically, the plurality of cover electrical contacts 634a-c are in contact with respective ones of the plurality of sensor electrical contacts 632 a-c. The lid 630 is moved in the direction of arrow N from the open position (fig. 11e) to the closed position (fig. 11 f). During movement of the lid 630 in the direction of arrow N, the test sensor 614a is at least partially withdrawn from the cartridge 610. Fig. 11g shows the lid 630 and test strip 614a of fig. 11f in a closed position in more detail. The cover 630 may be configured to include an additional step to accommodate a second step (when present) on one of the plurality of test sensors 614.
To assist in moving the cover 630 and sealing the cover 630, a plurality of retainer tabs 636a, 636b may be formed on the cartridge 610, as shown in fig. 11 b. Specifically, the plurality of retainer tabs 636a, 636b apply downward pressure to the lid 630, which helps to enhance the sealing of the lid 630 with the rest of the cartridge 610. The cartridge 610 may also include a plurality of seals 640a, 640b, such as shown in fig. 11 d. Additionally, the case may include at least one detent and corresponding notch that help provide an indication to a user that the lid 630 is in the closed position.
To help protect the reagents in the test sensors 614, suitable packaging materials and/or desiccant materials may be used. The cartridge 610 is typically packaged in a material that prevents or inhibits air from entering the interior of the housing 612 containing the test sensors 614, as described above in connection with cartridge 10. Additionally, desiccant material 626 may be added to the cartridge 610 as described above in connection with the cartridge 10.
According to yet another embodiment, the cartridge 710 of fig. 12 includes a housing 712, a plurality of test sensors 714, a mechanical mechanism 716, and a rotatable drum 726. The housing 712 has an interior portion 712 a. The housing 712 may be formed of the same materials and methods as described above in connection with housing 12.
As shown in fig. 12, a plurality of test sensors 714 are stacked in a housing 712. The plurality of test sensors 714 is used to assist in testing at least one analyte, as described above with respect to the test sensors 14.
To urge the stacked test sensors 714 in a first direction (in the direction of arrow O in fig. 12), a mechanical mechanism 716 is used according to one embodiment. The mechanical mechanism 716, in conjunction with the rotatable drum 726, helps position one of the plurality of test sensors 714 for eventual ejection from the cartridge 710. The mechanical mechanism 716 may be a spring or other device as described above in connection with mechanical mechanism 16. It is contemplated that at least two mechanical mechanisms may be used to push the stacked test sensors in the cartridge 710. To help guide the mechanical mechanism 716 in the direction of arrow O in fig. 12, the housing 712 may be formed with a plurality of prongs or extensions.
To assist in extracting the plurality of test sensors 714 from the cartridge 710, at least one groove 728 is formed in the rotatable drum 726. A rotatable drum 726 is connected with the inner portion 712a of the housing 712. The rotatable drum 726 may be connected with the inner portion 712a by a push-fit attachment. It is contemplated that the rotatable drum may be connected to the inner portion by other techniques (e.g., spring loading). In a preferred embodiment, the rotatable drum 726 is in sealing engagement with the inner portion 712 a. For example, a portion of the inner portion 712a may include a seal that engages the drum 726. In this embodiment, the opposing surfaces 726a, 726b of the drum 726 are in sealing engagement with the interior portion 712 a. In another embodiment, the opposing surfaces 726a, 726b may include respective seals that engage with respective portions of the inner portion 712 a.
The at least one recess 728 is configured to receive exactly one test sensor, such as the test sensor 714a of fig. 12. During movement of the rotatable drum 726 from the first position to the second position, the plurality of test sensors 714 are extracted from the cartridge 710 one at a time. To help rotate the drum 726, a wheel 732 may be included on the cartridge 710, as shown in fig. 12. One example of a wheel that may be used is a twist wheel. It is contemplated that other types of mechanisms may be used to rotate the drum, such as a gear assembly that may be coupled to a sliding mechanism, or an electric or spring driven motor and gear box.
The cartridge 710 may further include an ejector mechanism for at least partially extracting the plurality of test sensors 714, one at a time, from the at least one groove formed in the drum 726 in the direction of arrow P. Fig. 12 shows the test sensor 714a partially removed from the cartridge 710.
To help protect the reagents in the test sensor 714, suitable packaging materials and/or desiccant materials may be used. The cartridge 710 is typically packaged in a material that prevents or inhibits air from entering the interior of the housing 712 containing the test sensors 714, as described above in connection with the cartridge 10. Alternatively, a desiccant material may be added to the cartridge 710, as described above in connection with the cartridge 10.
According to yet another embodiment, the cartridge 760 of fig. 13a includes a housing 762, a plurality of test sensors 764, a mechanical mechanism 766, and a test-sensor extractor 768. The housing 762 defines at least two openings 762a, b therethrough. The housing 762 may be formed from the same materials and methods as described above in connection with the housing 12.
As shown in fig. 13a, a plurality of test sensors 764 are stacked in housing 762. The plurality of test sensors 764 is used to assist in testing at least one analyte, as described above for test sensors 14.
To urge the stacked test sensors 764 in a first direction (in the direction of arrow P in fig. 13a), a mechanical mechanism 766 is used according to one embodiment. The mechanical mechanism 766 helps position one of the plurality of test sensors 764 for eventual ejection from the cartridge 760 in conjunction with an ejector mechanism, which will be described later. The mechanical mechanism 766 may be a spring or other device as described above in connection with the mechanical mechanism 16. It is contemplated that at least two mechanical mechanisms may be used to push against the stacked test sensors 764 in the cartridge 760.
The test-sensor extractor 768 is operative to carry and extract the plurality of test sensors 764, one at a time, in a second direction (the direction of arrow Q) at least partially through the opening 762 a. To more clearly illustrate the test-sensor extractor 768 in the cartridge 760, a number of test sensors are omitted from figure 13b, except for the test sensor 764 a. In addition, fig. 13c also shows a test-sensor extractor 768.
As shown in fig. 13b, 13c, the test-sensor extractor 768 has a first portion 768a and a second portion 768 b. Referring to fig. 13c, the thickness H7 of the first portion 768a is generally less than the thickness of one of the plurality of test sensors 764, while the thickness H8 of the second portion 768b is generally greater than the thickness of one of the plurality of test sensors 764. Referring to fig. 13a, 13b, the test-sensor extractor 768 moves the test sensor from the cartridge 760 in the direction of arrow Q. The first portion 768a and the second portion 768b are connected by at least one hinge. The test-sensor extractor 768 includes a plurality of hinges 770a, b. The second direction (the direction of arrow Q in fig. 13a, 13 b) and the first direction (the direction of arrow P in fig. 13a, 13 b) are substantially perpendicular to each other. Sealing of the openings 762a, b may be achieved in the cartridge 760 by a generally snug fit (snug fit) between the inner wall of the housing 762 and the test-sensor extractor 768.
The cartridge 760 is suitable for use with a sensor-dispensing instrument. According to one embodiment, the sensor-dispensing instrument 750 of fig. 13d includes a cartridge 760, a housing 752, an ejector mechanism 754, and at least one deflector (deflectors 756a, b). The housing 752 forms a dispensing outlet 758 and is adapted to receive the cartridge 760.
The ejector mechanism 754 is adapted to extend through at least one opening 762b (see fig. 13a) and into contact with the test-sensor extractor 768. In fig. 13e, 13f, the ejector mechanism 754 is shown in contact with the test-sensor extractor 768. As the ejector mechanism 754 continues to push the test-sensor extractor 768 (along with one of the plurality of test sensors 764 a) in the direction of arrow Q (see fig. 13b, 13d), the second portion 768b contacts the deflectors 756a, b (see fig. 13 f).
The deflectors 756a, b are adapted to contact and deflect the second portion 768b of the test-sensor extractor 768 and assist in extracting the plurality of test sensors 764, one at a time, at least partially through the dispensing opening 758 (see fig. 13 d). When the second portion 768b is in contact with the deflectors 756a, b, the second portion 768b is guided downwardly by the hinges 770a, b as shown in fig. 13 f. However, the test sensor 764 continues to advance in the direction of arrow Q.
According to one approach, the ejector mechanism 754 may be released from its initial position (fig. 13d), for example, by actuating a button of a motor. The ejector mechanism 754 may be spring loaded to assist in returning to its original position. Alternatively, the ejector mechanism 754 may be activated, for example, by moving a slider in the direction of arrow Q, which is mechanically coupled to the ejector mechanism.
According to another embodiment, the cartridge 910 of fig. 14a, 14b includes a housing 912, a base 913, a plurality of test sensors 914, an internal mechanical mechanism 916, and an external spring mechanism 936. The housing 912 forms at least one through opening 920. The housing 912 may be formed from the same materials and methods as described above in connection with the housing 12. The base 913 is adapted to sealingly engage the housing 912 in the first position (fig. 14 a).
As shown in fig. 14a, a plurality of test sensors 914 are stacked in a housing 912. The plurality of test sensors 914 is used to facilitate testing for at least one analyte, as described above with respect to test sensors 14.
To urge the stacked test sensors 914 in a first direction (in the direction of arrow S in fig. 14a), an internal mechanical mechanism 916 is used according to one embodiment. The internal mechanical mechanism 916 helps position one of the plurality of test sensors 914 for eventual ejection from the cartridge 910 in conjunction with an ejector mechanism to be described later. The internal mechanical mechanism 916 may be a spring or other device as described above in connection with mechanical mechanism 16. It is contemplated that at least two mechanical mechanisms may be used to push against the stacked test sensors 914 in the cartridge 910.
According to one embodiment, the exterior spring mechanism 936 is mounted on the housing 912 and the base 913 and is used to facilitate sealing engagement of the housing 912 and the base 913. In the first position (fig. 14a), the housing 912 and the base 913 are in sealing engagement. However, in the second position (fig. 14b), the housing 912 and the base 913 are spaced apart by the ejector mechanism 904.
As shown in fig. 14a, the exterior spring mechanism 936 includes a plurality of springs 938, a slidable holder 940, and a plurality of shafts 942 (only shafts 942a-c are shown in fig. 14a, 14 b). The exterior spring mechanism 936 maintains the housing 912 sealed to the base 913. In particular, the exterior spring mechanism 936 includes four springs (only springs 938a-c are shown in fig. 14a, 14b) that are mounted such that the housing 912 remains sealed to the base 913. It is contemplated that more or fewer springs may be used to maintain the sealing relationship between the housing 912 and the base 913. For example, the external spring mechanism may comprise two springs. The slidable holder 940 is mounted on the housing 912 and slides along the shafts 942a, b.
The cartridge 910 is suitable for use in a sensor-dispensing instrument. According to one embodiment, the cartridge 910 is used with a sensor-dispensing instrument 900. The sensor-dispensing instrument 900 includes a housing 902 and an ejector mechanism 904. The housing 902 forms a dispensing outlet 906 and is adapted to receive a cartridge 910.
The ejector mechanism 904 is adapted to be moved and inserted between the housing 912 and the base 913 (see fig. 14a, b). Referring to fig. 14c, the thickness J1 of 904 is generally less than the thickness of one of the plurality of test sensors 914, while the thickness J2 of 904 is generally greater than the thickness of one of the plurality of test sensors 914, but less than the thickness of two of the test sensors. Specifically, the ejector mechanism 904 moves in the direction of arrow R, contacts the housing 912 and forces the housing 912 upward (against the force of the plurality of springs 938), and at least partially withdraws the test sensor 914a from the dispensing outlet 906 of the cartridge 910. When the housing 912 is raised upward (in the direction of arrow T in fig. 14 d), the plurality of test sensors 914 remain in contact with the base 913 due to the force of the mechanical mechanism 916. To assist in moving the housing 912 in the direction of arrow T, an end 912a of the housing 912 and at least one end 904a, b of the ejector mechanism 904 may be chamfered.
When the electrochemical sensor is used in a sensor-dispensing instrument, one of the test sensors will be properly positioned relative to the electrical contacts. It is contemplated that the electrical contacts include a plurality of contacts positioned to correspond to the test sensors. The front end of the sensor then receives, for example, a drop of blood to be tested, so that the blood is analyzed by means of the electrical contacts. The analysis results may then be displayed on a display (e.g., a liquid crystal display of the sensor-dispensing instrument). It is contemplated that other types of sensors may be used, such as optical sensors.
The testing end of the sensor is adapted to be placed in contact with a fluid sample to be tested, such as a whole blood sample. The whole blood sample may be produced by a cutting device, such as a lancet. The entire blood sample may be obtained by a lancet, which may be separate from the sensor-dispensing instrument, or may be integrated into the sensor-dispensing instrument. The cutting device may obtain blood by e.g. pricking a finger of a person.
According to one method, a whole blood sample can be prepared for testing by (a) advancing a test sensor to a position for receiving the whole blood sample; (b) generating a whole blood sample; and (c) contacting the test sensor with the whole blood sample, wherein blood is drawn into the sensor substantially by capillary action.
Sensors are typically provided with a capillary channel that extends from a front or testing end of the sensor to a biological detection or reagent material disposed within the sensor. When the testing end of the sensor is placed in a fluid (e.g., blood that accumulates on a person's finger after a finger puncture), a portion of the fluid is drawn into the capillary channel by capillary action. The fluid then chemically reacts with the reagent material within the sensor, providing an electrical signal indicative of the blood glucose level in the blood to be tested, and is subsequently transmitted to the electrical assembly.
After the test is completed, the test sensor may be removed from the sensor-dispensing instrument by a variety of methods. In one embodiment, the sensor-dispensing instrument may include an ejection mechanism that ejects used test sensors from the sensor-dispensing instrument. In this embodiment, the test sensor is forcibly released. In another embodiment, the test sensor is ejected by releasing the grip of the test sensor, causing the test sensor to be discarded from the sensor-dispensing instrument by gravity. In yet another embodiment, the test sensor may also be manually removed from the sensor-dispensing instrument.
According to another embodiment, the cartridge 810 of fig. 15a, b includes a housing 812, a plurality of test sensors 814, a mechanical mechanism 816, a test sensor support 817, and a sliding pusher lid assembly 818. The cartridge 810 may be adapted to be disposable after all of the test sensors 814 have been used.
Referring to fig. 15b, the housing 812 forms at least one through opening 820. The opening 820 is sized to allow the plurality of test sensors 814 to pass through, one at a time, and eventually exit the cartridge 810. The housing 812 also forms a slot 827 (as shown in FIG. 15b) in its top portion, the slot 827 facilitating movement of the lid assembly 818. The housing 812 may be formed from the same materials and methods as described above in connection with the housing 12.
As shown in fig. 15a, a plurality of test sensors 814 are stacked in a housing 812. For clarity, the plurality of test sensors 814, the mechanical mechanism 816, and the test sensor support 817 are not shown in phantom in fig. 15 a. The plurality of test sensors 814 is used to assist in testing at least one analyte, as described above with respect to test sensors 14. To urge the stacked test sensors 814 in a first direction (in the direction of arrow U in fig. 15a, 15b), a mechanical mechanism 816 is used according to one embodiment. The mechanical mechanism 816 helps position one of the plurality of test sensors 814 for eventual ejection from the cartridge 810 through the opening 820. The mechanical mechanism 816 may be a spring or other device as described above in connection with mechanical mechanism 16. The test sensor support 817 helps to evenly feed the test sensors, which is particularly important for thinner and more flexible test sensors. To help guide the mechanical mechanism 816 upward (in the direction of arrow U in fig. 15a, 15b), the housing 812 may be formed with a plurality of prongs or extensions.
The lid assembly 818 of the cartridge 810 is adapted to move between an open position (fig. 15b) and a closed position (fig. 15 a). Specifically, the lid assembly 818 slides between an open position and a closed position. The cover assembly 818 extends through a slot 827 formed in the housing 812. The slot 827 helps guide the lid assembly 818 as it slides between the open and closed positions. The lid assembly 818 includes a flexible pusher tab 819.
The flexible pusher tab 819 is adapted to contact the plurality of test sensors 814 and push the test sensors one at a time from the housing 812 at least partially through the opening 820. The flexible pusher tab 819 extends in a generally downward and generally outward direction from the remainder of the lid assembly 818 (as shown with reference to fig. 15a, b). The plurality of test sensors 814 are pushed, one at a time, in the direction of arrow V, at least partially through the opening 820. The flexible pusher tab 819 is generally located at or near one end of the lid assembly. By having a flexible pusher tab 819 at or near the end, the user can push the test sensor 814 from the opening 820 and, in one embodiment, jump over the seal 840 in one motion. Seal 840 is shown extending from housing 812. It is contemplated that it may be formed separately from or integral with the housing 812. In another embodiment, a seal may be located on the lid assembly 818 to seal with the housing 812.
The flexible pusher tab may be made of a polymeric material. For example, the flexible pusher tab may be made of a polymeric material, such as polycarbonate, ABS, nylon, polyethylene, polystyrene, polypropylene, or combinations thereof. The flexible pusher tab may be molded with the remainder of the sliding pusher lid assembly.
In another embodiment, the flexible pusher tab may be spring loaded to the remainder of the sliding pusher lid assembly. For example, referring to fig. 21, the pusher cap assembly 1018 includes a flexible pusher tab 1019, the flexible pusher tab 1019 being flexible in a direction generally indicated by arrow Z in fig. 21. The flexible pusher tab 1019 is connected to the remainder 1018a of the pusher lid assembly 1018 by flexible supports 1022. The flexible pusher tab 1019 may be made of, for example, a metal or a polymeric material. The flexible support 1022 is made of a flexible material. Non-limiting examples of flexible materials that may be used to form the flexible support include metallic or polymeric materials. The flexible support 1022 may be inserted into an opening formed in the remainder 1018a of the pusher lid assembly or may be molded into the remainder 1018a of the pusher lid assembly.
According to one method, the lid assembly 818 is manually moved between the open position (FIG. 15b) and the closed position (FIG. 15 a). To assist in manually grasping the lid assembly 818 and sliding the lid assembly 818 between the open and closed positions, in one embodiment, the lid assembly 818 includes a pusher grip 821. The lid assembly 818 of fig. 15a-c includes a flexible pusher tab 819, a pusher grip portion 821 and a pusher base 823. As shown in FIG. 15c, the lid assembly 818 is generally "I" shaped in cross-section. It is contemplated that the cross-sectional shape of the lid assembly 818 may be different than that shown in FIG. 15 c.
The pusher grip of the lid assembly may also include a locking or latching mechanism to more securely maintain the seal. For example, referring to fig. 22 and 23, the pusher handle 1021 includes a flexible tab 1025 and a locking or latch mechanism 1030. As shown in fig. 22, the flexible tab 1025 is adapted to move in a generally downward direction (in the direction of arrow a in fig. 22). Specifically, the flexible tab 1025 is pushed in a generally downward direction (in the direction of arrow a) a sufficient distance to unlock and disengage the lid assembly. After unlocking, the cover assembly is moved from the closed position to the open position, as shown by the direction of arrow B in fig. 23. As shown in fig. 23, the pusher grip 1021 also includes a raised surface 1032 to assist the user in gripping the pusher grip 1021 during movement between the open and closed positions.
According to another approach, the lid assembly 818 may be automatically moved between the open and closed positions by, for example, pressing a button. One example of an automated method may include having the plurality of test sensors 814 removed entirely using a motorized mechanism.
To assist in removing the plurality of test sensors 814 one at a time, the cartridge may include a reference surface 842 for contacting the plurality of test sensors 814 and providing a surface for the plurality of test sensors 814 to rest against. The reference surface 842 provides a stop that holds the plurality of test sensors 814 in a position for removal from the cartridge 810. A slot 844 is formed in the reference surface 842, which slot 844 allows for access to the entire length of the topmost test sensor of the stacked test sensors (as shown in fig. 15 b). Another example of a reference surface is shown in fig. 16b (reference numeral 843). A flexible pusher tab 819 extends through the slot 844 to contact and push the topside test sensor (as shown in fig. 15 b). The slot 844 is wide enough at least one end thereof to provide an exit for the topmost test sensor to be pushed at least partially through the opening 820.
The length of the flexible pusher tab 819 that extends down into the cartridge is typically greater than the thickness of the reference surface 842 plus the gap between the bottom of the lid assembly 818 and the top of the reference surface, but not greater than the thickness of the reference surface 842 plus the thickness of one of the test sensors 814. The position of the flexible pusher tab may be referenced to the reference surface to minimize mechanical tolerance requirements. By maintaining these dimensions, the lid assembly 818 (and more specifically, the flexible pusher tab 819) will only move one test sensor at a time.
After the test sensor 814a is pushed from the cartridge 810, the next test sensor is loaded into position by a mechanical mechanism 816 (e.g., a spring). When the lid assembly 818 is in the closed position (fig. 15a), the lid assembly 818 properly seals the opening 820. Although it is preferred to seal the opening 820 to prevent or inhibit contamination by foreign matter (e.g., dust and liquid), the seal 820 does not have to be hermetically or moisture sealed due to the seal 840. For example, referring to fig. 15a, c, the cartridge 810 includes a seal 840 to help prevent or inhibit moisture from entering the housing 812. In the cartridge 810, a seal 840 is disposed generally around the perimeter of the opening. The seal 840 helps maintain a proper seal with the lid assembly 818. Preferably, the seal 840 extends completely around the lid assembly 818 when the lid assembly is in the closed position. Because the pusher tab 819 is flexible, the pusher tab 819 clears the seal 840 as the lid assembly 818 is moved between the open and closed positions. The position of the pusher tab 819 relative to the pusher base 823 helps to push the test sensor farther through the skipped opening 820 in one motion. It is also contemplated that the sealing mechanism may be located on the cap assembly itself.
To assist in sliding the lid assembly 818 between the open and closed positions, at least one retainer tab may be used. For example, in fig. 15c, the retainer tabs 829a, b limit the sliding movement of the lid assembly between the closed and open positions. To maintain positive pressure, the retainer tabs 829a, b may be made of a flexible material. Retainer tabs 829a, b function in a similar manner as described above for retainer tabs 154a, b of fig. 4.
To increase the downward sealing force on the lid assembly 818 in the sealed or closed position and to help indicate to the user that the lid assembly is in the closed position, the cartridge 810 may include at least one detent 839, as shown in fig. 15 a. Specifically, the plurality of detents 839 of FIG. 15a work with corresponding bumps 837 formed in the lid assembly 818.
To help protect the reagents in the test sensor 814, suitable packaging materials and/or desiccant materials may be used. The cartridge 810 is typically packaged in a material that prevents or inhibits air from entering the interior of the housing 812 containing the test sensors 814, as described above in connection with the cartridge 10. Alternatively, a desiccant material 826 (fig. 15a) may be added to the cartridge 810 as described above in connection with the cartridge 10. To help bring the desiccant material 826 into contact with the test sensor, an opening 841 may be formed in the interior structure of the housing 812.
It is contemplated that the flexible pusher tab may have different designs for assisting in pushing the test sensor 814. For example, in fig. 16a, b, the flexible pusher tab 852 forms a notch 854 at one end thereof. A groove 858 is formed in each test sensor 856. During movement of the flexible pusher tab 852, the notch 854 engages at least a portion of the notch 858 and facilitates pushing the plurality of test sensors 856 one at a time. To help prevent or inhibit the plurality of test sensors from being pushed by the flexible pusher tab 852, the thickness T8 of the notch 854 is preferably less than the thickness T6 of the test sensors 856. When the test sensor does not have a notch (e.g., an optical sensor), or when it is desired to push out the notch (electrode) end of the electrochemical sensor first, the thickness T8 of the notch 854 is preferably less than the thickness T7 of the test sensor 856.
The test sensor 856 should be sufficiently rigid such that the test sensor 856 does not bend and jam when the flexible pusher tab 852 contacts the test sensor. The stiffness or hardness of the test sensor is determined by factors such as the material used to form the test sensor and the thickness of the test sensor (e.g., the thicknesses T6 and T7 of the test sensor 856a of fig. 16 a). When the thickness of the test sensor varies, it is preferable to have the harder end (typically the thicker end) of the test sensor enter first through the opening.
The amount of force provided by the flexible pusher tab 852 must be sufficient to push one of the plurality of test sensors at least partially through the opening while the amount of force will not cause (a) significant bending of the test sensor or (b) grabbing of the plurality of test sensors. When the test sensor is bent or a plurality of test sensors are caught, the possibility of generation of jamming increases.
When the flexible pusher tab 852 is moved in the direction of arrow W (fig. 16a), the reference surface 843 provides a surface that pushes against the test sensor 856 as described above in connection with reference surface 842 of fig. 15a, 15 b. The side reference surfaces 846 also help guide the test sensors through the openings 849 in the cartridge. The distance D2 of the opening 849 should be greater than the thickness T7 of the test sensor 856. However, it is preferred that the distance D2 of the opening 849 be no greater than twice the thickness T7 in order to prevent or inhibit multiple test sensors from exiting the opening 849 simultaneously. The side reference surface 846 also helps prevent or inhibit multiple test sensors from exiting simultaneously by being positioned such that the resulting opening only allows one test sensor 856 to be pushed out at a time. It is contemplated that the reference surfaces 843 and 846 may be of different lengths, shapes, or may be discontinuous. The side reference surface 847 helps guide the test sensors 856 into the proper position for pick-up by the pusher tab 852.
The flexible pusher tab 852 may engage a test sensor surface other than that shown in fig. 16a, 16 b. For example, in fig. 16c, the flexible pusher tab 852 is shown engaging the surfaces 856b, 856 c. Thus, in this embodiment, the flexible pusher tab 852 moves one of the plurality of test sensors 856 by pushing on a thicker portion thereof. The flexible pusher tab 852 allows the plurality of test sensors 856 to pass through the opening 849 one at a time in the direction of arrow W. The side reference surfaces 859 function in a similar manner to the reference surfaces 846 described above in connection with fig. 16a, 16 b. It is contemplated that the reference surfaces 843 and 859 may have different lengths, shapes, or may be discontinuous.
According to another embodiment, the cartridge may further include a guide mechanism to assist in positioning the flexible pusher tab assembly and to facilitate removal of the plurality of test sensors one at a time. The flexible pusher tab assembly 860 of fig. 17a-c includes a flexible pusher tab 862 and a guide mechanism. One example of a guide mechanism is a cam mechanism. The cartridge includes a cam mechanism that includes a reference surface 861 and a corresponding surface 862a on the pusher tab 862. In this way, the cam mechanism works in conjunction with the pusher tab 862. The flexible pusher tab 862 has a notch 864 formed therein. As shown in fig. 17a, the notch 864 is first engaged with the generally vertical surface 856d of the test sensor 856 a. As the test sensor 856a of fig. 17a is moved in the direction of arrow W, the notch 864 continues to engage the generally vertical surface 856d, as shown in fig. 17 b.
As shown in fig. 17c, the reference surface 861 forces the flexible pusher tab 862 in the following manner to move in a generally downward direction (in the direction of arrow Z in fig. 17 c) and then back in the direction of arrow W. At this point, the notch 864 is engaged with the generally vertical surface 856d and the generally horizontal surface 856 e. In this way, by using a cam mechanism, the flexible pusher tab 862 contacts and pushes a larger surface area (compare fig. 17c to fig. 17a, b), which reduces the likelihood of contact with the plurality of test sensors 856. The flexible pusher tab 862 pushes the test sensors 856 one at a time through the opening 869.
The exact position of the pusher tab relative to the test sensors may be controlled by various combinations of reference surfaces on the pusher tab and the cartridge. For example, referring to fig. 18a-c, the pusher tab assembly 870 includes a flexible pusher tab 872 and a guide mechanism. The movement of the flexible pusher tab 872 is controlled by a guide mechanism that includes a track 877 in the cartridge and a corresponding pin or reference surface 876 on the pusher tab 872. The track 877 on the cartridge is generally aligned with the reference surface 843 and maintains the vertical position of the pusher tab 872 relative to the test sensors by engaging the pin 876 on the pusher tab, so long as the flexible pusher tab is long enough and has sufficient spring force to engage the alignment cam. With a flexible pusher tab having this feature, the tolerances of the entire assembly can be relaxed without compromising the reliability of the pusher tab with only one sensor removed for a stroke.
As shown in fig. 18a-c, the flexible pusher tab 872 also contacts different surfaces of the test sensors during their exit from the cartridge than, for example, those shown in fig. 17 a-c. For example, the flexible pusher tab 872 of fig. 18a-c is shown in contact with the test sensor 856 a. The flexible pusher tab 872 forms a notch or cavity 874 therein and also includes a surface-contacting extension 875. As shown in fig. 18a, b, the surface-contacting extension 875 contacts the substantially vertical surface 856d of the test sensor 856 a. As the flexible pusher tab 872 moves in the direction of arrow W, the surface-contacting extension 875 continues to contact the surface 856d, as shown in fig. 18 a. The guide mechanism formed by the track 877 and corresponding pin 876 continues to move the flexible pusher tab 872 in the direction of arrow W and in the downward direction (direction of arrow Z in fig. 18 b).
When the flexible pusher tab 872 is moved in a downward direction, the surface-contacting extension 875 extends downward and contacts the bottom surface 856f of the test sensor 856 a. When the surface-contacting extension 875 extends between the two test sensors 856a, 856g, a space 873 is formed between the two test sensors 856a, 856 g. While remaining pushing on the test sensor 856a, the surface-contacting extension 875 continues to engage the bottom surface 856f such that the test sensor 856a does not abut any other test sensor 856. At the same time, the groove 874 is in contact with the generally vertical surface 856 d. The notch 874 serves to more reliably capture the test sensor during the removal process. By having the flexible pusher tab 872 contact the bottom surface 856f of the test sensors 856a, it will help prevent or inhibit the plurality of test sensors from exiting the opening 879.
According to yet another embodiment, the flexible pusher tab 882 of fig. 19a-c is shown in contact with one of the plurality of test sensors 856. Flexible pusher tab 882 has a recess 884 formed therein and also includes a bottom surface contact extension 882 a. As shown in fig. 19b, the surface-contacting extension 882a contacts the bottom surface 856f of the test sensor 856 a. As the flexible pusher tab 882 moves by pushing on the surface 856a in the direction of arrow W, the surface-contacting extension 882a continues to contact the bottom surface 856f, as shown in fig. 19 b.
When the surface-engaging portion 882a contacts the test sensors 856a, the surface-engaging portion 882b urges the remaining ones of the plurality of test sensors 856 in a generally downward direction (in the direction of arrow Y in fig. 19 b). When the surface-contacting extension 882a extends between the two test sensors 856a, g, a space 888 is first formed between the test sensors 856a, g. As the test sensor 856a continues to be pushed in the direction of arrow W, the surface-contacting extension 882a continues to engage the bottom surface 856f such that the test sensor 856a does not abut any of the remaining test sensors 856. As shown in fig. 19b, 19c, when the surface-engaging portion 882b contacts the generally vertical surface 856h of the test sensor 856g, the space 888 increases in size, which results in the formation of a space 890. The notch 884 contacts the generally vertical surface 856d throughout the movement of the flexible pusher tab 882. By having the flexible pusher tab 882 contact the bottom surface 856f of the test sensors 856a, it will help prevent or inhibit multiple test sensors from exiting the opening 889 or the top sensor from "falling off" during forward travel.
Referring to fig. 20a-c, a sensor-dispensing instrument 830 of one embodiment is shown. The sensor-dispensing instrument is used to determine the concentration of an analyte. Analytes that can be measured using the present invention include glucose, lipids (e.g., cholesterol, triglycerides, LDL, and HDL), microalbumin, hemoglobin A1C, fructose, lactic acid, and bilirubin. However, the present invention is not limited to these specific analytes. It is contemplated that the concentration of other analytes may be determined. The analyte may be, for example, in whole blood samples, serum samples, plasma samples, other body fluids such as ISF (interstitial fluid) and urine, and non-body fluids.
The sensor-dispensing instrument 830 includes a cartridge 810 (described above in connection with fig. 15 a-c) and an instrument housing 802. As shown in fig. 20a-c, the instrument housing 802 is adapted to receive the cartridge 810 of fig. 15 a-c. Preferably, the cartridge 810 is removed from and loaded into the instrument housing 802 of the sensor-dispensing instrument 830 in a simple and easy manner.
It is contemplated that other cartridges may be used in the sensor-dispensing instrument, such as cartridges having a sliding pusher lid assembly with various flexible pusher tabs 852, 866, 870, and 880, as described above in connection with fig. 16-19. Depending on the cartridge selected, the interior of the instrument housing may be redesigned to correspond to the selected cartridge. The instrument housing 802 also forms a dispensing outlet 806, the dispensing outlet 806 being sized to dispense either the test sensors 814 or the test sensors 856 one at a time. The instrument housing 802 also forms a cavity 832, the cavity 832 receiving at least a portion of the sliding lid assembly 818 when the sliding lid assembly 818 is in the open position. Cavity 832 also helps guide the sliding pusher assembly between the first and second positions.
Referring to fig. 20a, the instrument 830 is shown with the sliding lid assembly 818 in the open position. When the sliding lid assembly 818 is moved in the direction of arrow W, the flexible tab pusher 819 contacts the test sensor 814a and pushes the test sensor 814a in the same direction, as shown in fig. 20 b. The test sensor 814a is pushed at least partially into the dispensing outlet 806 and then removed. The sliding lid assembly 818 is again placed in the closed position as shown in FIG. 20 c. In the closed position, the sliding lid assembly 818 covers the top of the cartridge 810. Optionally, the sliding lid assembly 818 works in conjunction with the seal 840 to prevent or inhibit moisture from entering the interior of the cartridge 810. By being flexible, the flexible tab pusher 819 may extend at least slightly into the dispensing outlet 806, which causes the seal 840 to form a seal with the remainder of the sliding lid assembly 818, thereby preventing or inhibiting moisture from entering the interior of the cartridge 810.
According to another embodiment, the sliding lid assembly may be part of the sensor-dispensing instrument rather than part of the disposable cartridge. In this embodiment, the lid is retracted slightly further in the direction of arrow W in FIGS. 16-19 to clear the pusher tab and the remainder of the lid assembly over the opening for removal of the used cartridge and replacement thereof with a new cartridge. The instrument may make electrical contact with the cartridge in order to read calibration information of the cartridge. In addition, a contact switch in the instrument or inside the cartridge may be used to enable the electronic meter to detect the position of the lid. This also prompts the user through the electronic device to perform or complete the particular action required for the test. For example, the instrument may emit an audible signal (e.g., beep) when the lid is not fully moved to the closed position. A humidity sensor in the cartridge may be used to detect exposure to excessive moisture.
While it is desirable that the cartridge of the present invention fit into an instrument and dispense the sensors into the appropriate locations for measurement, the cartridge design can be provided as a separate standard test sensor container (i.e., a vial for automated dispensing of strips for manual loading into the instrument).
Alternative embodiment A
A cartridge for a sensor-dispensing instrument, the cartridge comprising:
a housing defining at least one opening therethrough;
a plurality of test sensors stacked in the housing, the plurality of test sensors for assisting in testing at least one analyte;
a mechanical mechanism for urging the plurality of test sensors in a first direction, one of the plurality of test sensors being positioned for removal from the cartridge; and
a pusher assembly for pushing one of the plurality of test sensors from the cartridge, the pusher assembly comprising a ferromagnetic material or a magnet.
Alternative embodiment B
The cartridge of alternate embodiment a wherein the mechanical mechanism is a spring.
Alternative embodiment C
The cartridge of alternate embodiment a wherein the housing defines exactly one opening.
Alternative embodiment D
In the cartridge of alternate embodiment a, the analyte is glucose.
Alternative embodiment E
The cartridge of alternate embodiment a further including a desiccant.
Alternative embodiment F
The cartridge of alternate embodiment a wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment G
The cartridge of alternate embodiment a wherein the plurality of sensors are optical sensors.
Alternative embodiment H
The cartridge of alternate embodiment a wherein the pusher assembly includes a magnet.
Alternative embodiment I
The cartridge of alternate embodiment a wherein the pusher assembly includes a ferromagnetic material.
Alternative embodiment J
The cartridge of alternate embodiment I wherein the ferromagnetic material is iron, nickel, cobalt or combinations thereof.
Alternative embodiment K
The cartridge of alternate embodiment a further including a sealing port surrounding the at least one opening.
Alternative embodiment L
The cartridge of alternate embodiment a further including a lid movable between a closed position and an open position such that the lid seals the at least one opening in the closed position.
Alternative embodiment M
The cartridge of alternate embodiment L wherein the lid is adapted to slide between an open position and a closed position.
Alternative embodiment N
The cartridge of alternate embodiment M further including at least one retainer tab to assist in maintaining pressure on the lid when forming the seal.
Alternative embodiment O
The sensor-dispensing instrument comprises:
a cartridge comprising a cartridge housing forming at least one cartridge opening therethrough, a plurality of test sensors stacked in the housing, the plurality of test sensors for assisting in testing at least one analyte, a mechanical mechanism for urging the plurality of test sensors in a first direction, one of the plurality of test sensors positioned for extraction from the cartridge, and a pusher assembly for urging one of the plurality of test sensors out of the cartridge, the pusher assembly comprising a ferromagnetic material or a magnet;
an instrument housing forming a dispensing outlet and for receiving a cartridge;
a lid movable between a closed position and an open position such that the lid seals at least one of the dispensing outlet and the cartridge opening when in the closed position; and
a slider comprising a ferromagnetic material or a magnet, the slider for magnetically coupling with the pusher assembly of the cartridge, the slider for sliding from a first position to a second position;
wherein during movement of the slider from the first position to the second position, the pusher assembly contacts one of the plurality of test sensors and pushes it at least partially through the dispensing opening;
at least the pusher assembly or slider includes a magnet.
Alternative embodiment P
The sensor-dispensing instrument of alternate embodiment O wherein the mechanical mechanism is a spring.
Alternative embodiment Q
The sensor-dispensing instrument of alternate embodiment O wherein the analyte is glucose.
Alternative embodiment R
The sensor-dispensing instrument of alternate embodiment O wherein the cartridge further includes a desiccant.
Alternative embodiment S
The sensor-dispensing instrument of alternate embodiment O wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment T
The sensor-dispensing instrument of alternate embodiment O wherein the plurality of sensors are optical sensors.
Alternative embodiment U
The sensor-dispensing instrument of alternate embodiment O wherein the pusher assembly and the slider include magnets.
Alternative embodiment V
The sensor-dispensing instrument of alternate embodiment O wherein the pusher assembly includes a ferromagnetic material and the slider includes a magnet.
Alternative embodiment W
The sensor-dispensing instrument of alternate embodiment O wherein the pusher assembly includes a magnet and the slider includes a ferromagnetic material.
Alternative embodiment X
The sensor-dispensing instrument of alternate embodiment O wherein the magnet is an electromagnet.
Alternative embodiment Y
The sensor-dispensing instrument of alternate embodiment O wherein the lid is movable between the open position and the closed position by a hinge.
Alternative embodiment Z
The sensor-dispensing instrument of alternate embodiment Y wherein the slider contacts the lid and moves the lid from the closed position to the open position during movement of the slider from the first position to the second position.
Alternative embodiment A1
The sensor-dispensing instrument of alternate embodiment O wherein the cover is generally circular.
Alternative embodiment B1
The sensor-dispensing instrument of alternate embodiment O wherein the cover is generally rectangular in shape.
Alternative embodiment C1
The sensor-dispensing instrument of alternate embodiment O wherein the cover is adapted to slide between an open position and a closed position.
Alternative embodiment D1
The sensor-dispensing instrument of alternate embodiment C1 further comprising at least one retainer tab to maintain pressure on the lid when the seal is formed.
Alternative embodiment E1
The sensor-dispensing instrument of alternate embodiment D1 wherein the at least one retainer tab includes at least one detent.
Alternative embodiment F1
The sensor-dispensing instrument of alternate embodiment C1 wherein the cover is adapted to be manually slid between the open and closed positions.
Alternative embodiment G1
The sensor-dispensing instrument of alternate embodiment C1 wherein the cover is adapted to automatically slide between the open and closed positions.
Alternative embodiment H1
The sensor-dispensing instrument of alternate embodiment O further including a seal disposed generally about a periphery of the dispensing opening.
Alternative embodiment I1
The sensor-dispensing instrument of alternate embodiment O wherein the cover includes a first end and a second end, the cover being movable between the closed position and the open position by a hinge located adjacent the first end such that the cover seals the opening in the closed position, the cover including a projection located adjacent the second end, the projection extending generally downwardly into the interior of the cartridge.
Alternative embodiment J1
The sensor-dispensing instrument of alternate embodiment I1 wherein the projection forms at least one detent to assist in further sealing the cartridge.
Alternative embodiment K1
The sensor-dispensing instrument of alternate embodiment O wherein the cover seals the dispensing outlet in the closed position.
Alternative embodiment L1
The sensor-dispensing instrument of alternate embodiment O wherein the lid seals the cartridge opening in the closed position.
Alternative embodiment M1
A lid mechanism for use in a cartridge or sensor-dispensing instrument that includes a plurality of test sensors to assist in determining a concentration of at least one analyte, the lid mechanism comprising:
a lid for sliding between a closed position and an open position such that the lid seals the opening when in the closed position; and
a plurality of retainer tabs for assisting in maintaining pressure on the lid when forming the seal.
Alternative embodiment N1
The lid mechanism of alternate embodiment M1 wherein the lid is generally rectangular in shape.
Alternative embodiment O1
The lid mechanism of alternate embodiment M1 wherein at least one of the plurality of retainer tabs includes at least one detent.
Alternative embodiment P1
The lid mechanism of alternate embodiment O1 wherein the perimeter of the lid defines at least one notch that corresponds to the at least one detent.
Alternative embodiment Q1
The lid mechanism of alternate embodiment M1 wherein the plurality of retainer tabs are substantially flexible.
Alternative embodiment R1
The lid mechanism of alternate embodiment M1 wherein the plurality of retainer tabs are injection molded when forming the cartridge or the sensor-dispensing instrument.
Alternative embodiment S1
A cartridge comprising:
a housing defining at least one opening therethrough;
a plurality of test sensors stacked in the housing, the plurality of test sensors for assisting in testing at least one analyte;
a mechanical mechanism for urging the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge;
a test-sensor extractor for movement between a first position and a second position; and
a lid mechanically coupled to the test-sensor extractor, the lid being movable between a closed position and an open position such that the lid seals the opening in the closed position;
wherein during movement of the lid from the closed position to the open position, the test-sensor extractor moves from the first position to the second position and extracts one of the plurality of test sensors at least partially through the opening.
Alternative embodiment T1
The cartridge of alternate embodiment S1, wherein the lid is manually movable between the open position and the closed position.
Alternative embodiment U1
The cartridge of alternate embodiment S1 further comprising a ramp positioned to assist in withdrawing one of the plurality of test sensors at least partially through the opening.
Alternative embodiment V1
The cartridge of alternate embodiment S1, wherein the plurality of test sensors are stacked in an inclined manner.
Alternative embodiment W1
The cartridge of alternate embodiment S1 wherein the lid further includes a seal.
Alternative embodiment X1
The cartridge of alternate embodiment S1 wherein the lid defines at least one recess.
Alternative embodiment Y1
The cartridge of alternate embodiment S1, wherein the lid is mechanically coupled by a flexible linkage.
Alternative embodiment Z1
The carton of alternate embodiment Y1 wherein the lids are mechanically connected by links hinged to the lids.
Alternative embodiment A2
The cartridge of alternate embodiment Y1, wherein the lid is mechanically coupled by a linkage hinged to the test-sensor extractor.
Alternative embodiment B2
The cartridge of alternate embodiment S1, wherein the test-sensor extractor is substantially parallel to the opening.
Alternative embodiment C2
The cartridge of alternate embodiment S1, wherein the mechanical mechanism is a spring.
Alternative embodiment D2
The cartridge of alternate embodiment S1 wherein the housing defines exactly one opening.
Alternative embodiment E2
The cartridge of alternate embodiment S1, wherein the analyte is glucose.
Alternative embodiment F2
The cartridge of alternate embodiment S1 further comprising a desiccant.
Alternative embodiment G2
The cartridge of alternate embodiment S1 wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment H2
The cartridge of alternate embodiment S1 wherein the plurality of sensors are optical sensors.
Alternative embodiment I2
A cartridge comprising:
a housing defining at least one opening therethrough;
a plurality of test sensors stacked in the housing, the plurality of test sensors for assisting in testing at least one analyte;
a first mechanical mechanism for urging the plurality of test sensors in a first direction. One of the plurality of test sensors is positioned for extraction from the cartridge;
a second mechanical mechanism for urging the plurality of test sensors in a second direction. The second direction is arranged substantially perpendicular to the first direction;
a test-sensor extractor movable between a first position and a second position by a second mechanical mechanism; and
a lid movable between a closed position and an open position such that the lid seals the opening in the closed position;
wherein during movement of the lid from the closed position to the open position, the test-sensor extractor moves from the first position to the second position and extracts one of the plurality of test sensors at least partially through the opening.
Alternative embodiment J2
The cartridge of alternate embodiment I2 wherein the first mechanical mechanism is a spring and the second mechanical mechanism is a spring.
Alternative embodiment K2
The cartridge of alternate embodiment I2, wherein the test-sensor extractor has a generally horizontal portion and an angled portion, the angled portion extending from the cartridge when the lid is in the open position.
Alternative embodiment L2
The cartridge of alternate embodiment I2, wherein the test-sensor extractor has a generally horizontal portion and a second portion that extends from the cartridge when the lid is in the open position.
Alternative embodiment M2
The carton of alternate embodiment I2 wherein the lid includes a first end and a second end, the lid being movable between a closed position and an open position by a hinge located proximate the first end such that the lid seals the opening in the closed position, the lid including a projection located proximate the second end, the projection extending generally downwardly into the carton interior.
Alternative embodiment N2
The cartridge of alternate embodiment M2 wherein the projection forms at least one detent to assist in locking the cartridge.
Alternative embodiment O2
The cartridge of alternate embodiment I2 wherein the housing defines exactly one opening.
Alternative embodiment P2
The cartridge of alternate embodiment I2, wherein the analyte is glucose.
Alternative embodiment Q2
The cartridge of alternate embodiment I2 further comprising a desiccant.
Alternative embodiment R2
The cartridge of alternate embodiment I2 wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment S2
The cartridge of alternate embodiment I2 wherein the plurality of sensors are optical sensors.
Alternative embodiment T2
A cartridge comprising:
a housing defining at least one opening therethrough;
a plurality of test sensors stacked obliquely in the housing, the plurality of test sensors for assisting in testing at least one analyte;
a first mechanical mechanism for pushing the plurality of test sensors in a first direction, one of the plurality of test sensors being positioned for extraction from the cartridge;
a lid movable between a closed position and an open position such that the lid seals the opening in the closed position; and
a pusher assembly connected to the lid, the pusher assembly being movable between a first position and a second position;
during movement of the lid from the closed position to the open position, the pusher assembly moves from the first position to the second position and extracts one of the plurality of test sensors at least partially through the opening.
Alternative embodiment U2
The cartridge of alternate embodiment T2 wherein the pusher assembly is connected to the lid by a cam mechanism.
Alternative embodiment V2
The carton of alternate embodiment T2 wherein the lid is movable between the first position and the second position by a hinge.
Alternative embodiment W2
The cartridge of alternate embodiment T2 further comprising at least one track to help guide the plurality of test sensors.
Alternative embodiment X2
The cartridge of alternate embodiment T2 further comprising a second mechanical mechanism for urging the plurality of test sensors in a second direction, the second direction being oriented substantially perpendicular to the first direction.
Alternative embodiment Y2
The cartridge of alternate embodiment T2 further including a stop member for helping to prevent or inhibit the extraction of multiple test sensors at a time.
Alternative embodiment Z2
The cartridge of alternate embodiment T2 wherein the first mechanical mechanism is a spring.
Alternative embodiment A3
The cartridge of alternate embodiment T2 wherein the housing defines exactly one opening.
Alternative embodiment B3
The cartridge of alternate embodiment T2 wherein the analyte is glucose.
Alternative embodiment C3
The cartridge of alternate embodiment T2 further comprising a desiccant.
Alternative embodiment D3
The cartridge of alternate embodiment T2 wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment E3
The cartridge of alternate embodiment T2 wherein the plurality of sensors are optical sensors.
Alternative embodiment F3
The cartridge of alternate embodiment T2 further comprising a sealing port surrounding the at least one opening.
Alternative embodiment G3
A cartridge comprising:
a housing defining at least one opening therethrough;
a plurality of test sensors stacked obliquely in the housing, the plurality of test sensors for assisting in testing at least one analyte;
a mechanical mechanism for pushing the plurality of test sensors in a first direction, one of the plurality of test sensors positioned for extraction from the cartridge; and
a lid movable between a closed position and an open position, the lid sealing the opening in the closed position;
wherein the lid in the open position allows the plurality of test sensors to be manually withdrawn from the cartridge one at a time.
Alternative embodiment H3
The cartridge of alternate embodiment G3 wherein the mechanical mechanism is a spring.
Alternative embodiment I3
The cartridge of alternate embodiment G3 wherein the housing defines exactly one opening.
Alternative embodiment J3
The cartridge of alternate embodiment G3 wherein the analyte is glucose.
Alternative embodiment K3
The cartridge of alternate embodiment G3 further comprising a desiccant.
Alternative embodiment L3
The cartridge of alternate embodiment G3 wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment M3
The cartridge of alternate embodiment G3 wherein the plurality of sensors are optical sensors.
Alternative embodiment N3
The cartridge of alternate embodiment G3 further comprising a sealing port surrounding the at least one opening.
Alternative embodiment O3
A cartridge comprising:
a housing defining at least one opening therethrough;
a plurality of test sensors stacked in the housing, the plurality of test sensors for assisting in testing at least one analyte, the plurality of test sensors including at least one sensor electrical contact;
a mechanical mechanism for pushing the plurality of test sensors in a first direction, one of the plurality of test sensors positioned for extraction from the cartridge; and
a lid movable between a closed position and an open position such that the lid seals the opening in the closed position, the lid including at least one lid electrical contact;
wherein the at least one electrical contact contacts the at least one sensor contact of one of the plurality of test sensors during movement of the lid from the closed position to the open position;
the lid draws one of the plurality of test sensors at least partially through the opening during movement of the lid from the open position to the closed position.
Alternative embodiment P3
The cartridge of alternate embodiment O3 wherein the cover includes a plurality of electrical contacts and each test sensor includes a plurality of sensor contacts.
Alternative embodiment Q3
The cartridge of alternate embodiment O3 further comprising a plurality of retainer tabs for helping to seal the cartridge.
Alternative embodiment R3
The cartridge of alternate embodiment O3 further comprising a desiccant.
Alternative embodiment S3
The cartridge of alternate embodiment O3 wherein the mechanical mechanism is a spring.
Alternative embodiment T3
The cartridge of alternate embodiment O3 wherein the housing defines exactly one opening.
Alternative embodiment U3
The cartridge of alternate embodiment O3 wherein the analyte is glucose.
Alternative embodiment V3
A cartridge comprising:
a housing having an interior portion;
a plurality of test sensors stacked in the housing, the plurality of test sensors for assisting in testing at least one analyte;
a mechanical mechanism for pushing the plurality of test sensors in a first direction, one of the plurality of test sensors positioned for extraction from the cartridge; and
a rotatable drum including at least one recess formed therein, the drum being connected to the housing interior portion, the at least one recess for receiving exactly one test sensor;
wherein the plurality of test sensors are extracted from the interior of the cartridge one at a time during movement of the drum from the first position to the second position.
Alternative embodiment W3
The cartridge of alternate embodiment V3 further comprising an ejector mechanism for at least partially removing one test sensor from the at least one groove in the drum.
Alternative embodiment X3
The cartridge of alternate embodiment V3 wherein the drum is connected to the interior portion of the housing by a push fit attachment, the drum being in sealing engagement with a portion of the interior of the housing.
Alternative embodiment Y3
The cartridge of alternate embodiment V3 wherein the drum is connected to the interior portion of the housing by a spring load and the drum and a portion of the interior of the housing are in sealing engagement.
Alternative embodiment Z3
The cartridge of alternate embodiment V3 further comprising a wheel coupled to the drum and configured to assist in rotating the drum.
Alternative embodiment A4
The cartridge of alternate embodiment Z3 wherein the wheels are twist wheels.
Alternative embodiment B4
The cartridge of alternate embodiment V3 wherein the mechanical mechanism is a spring.
Alternative embodiment C4
The cartridge of alternate embodiment V3 wherein the analyte is glucose.
Alternative embodiment D4
The cartridge of alternate embodiment V3 further comprising a desiccant.
Alternative embodiment E4
The cartridge of alternate embodiment V3 wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment F4
The cartridge of alternate embodiment V3 wherein the plurality of sensors are optical sensors.
Alternative embodiment G4
A cartridge adapted for use with a sensor-dispensing instrument, the cartridge comprising:
a housing defining at least two openings therethrough;
a plurality of test sensors stacked in the housing, the plurality of test sensors for assisting in testing at least one analyte;
a mechanical mechanism for urging the plurality of test sensors in a first direction; and
a test-sensor extractor for carrying and extracting the plurality of test sensors, one at a time, in a second direction at least partially through one of the at least two openings, the test-sensor extractor having a first portion and a second portion, the first and second portions being connected by at least one hinge, the second direction and the first direction being substantially perpendicular to each other.
Alternative embodiment H4
The cartridge of alternate embodiment G4 further comprising at least two seals covering the at least two openings when in the closed position.
Alternative embodiment I4
The carton of alternate embodiment G4 wherein the first and second portions are connected by at least two hinges.
Alternative embodiment J4
The cartridge of alternate embodiment G4 wherein the mechanical mechanism is a spring.
Alternative embodiment K4
The cartridge of alternate embodiment G4 wherein the analyte is glucose.
Alternative embodiment L4
The cartridge of alternate embodiment G4 further comprising a desiccant.
Alternative embodiment M4
The cartridge of alternate embodiment G4 wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment N4
The cartridge of alternate embodiment G4 wherein the plurality of sensors are optical sensors.
Alternative embodiment O4
A sensor-dispensing instrument comprising:
a cartridge comprising a cartridge housing forming at least two openings therethrough, a plurality of test sensors stacked in the housing, the plurality of test sensors for facilitating testing of at least one analyte, a mechanical mechanism for urging the plurality of test sensors in a first direction, and a test-sensor extractor for transporting and extracting the plurality of test sensors in a second direction, one at a time, at least partially through one of the at least two openings, the test-sensor extractor having a first portion and a second portion, the first and second portions connected by at least one hinge, the second and first directions being generally perpendicular to each other;
an instrument housing forming a dispensing outlet and for receiving a cartridge;
an ejector mechanism for extending through at least one of the openings and contacting the test-sensor extractor; and
at least one deflector for contacting and deflecting the first portion of the test-sensor extractor and assisting in extracting the plurality of test sensors one at a time at least partially through the dispensing outlet.
Alternative embodiment P4
The sensor-dispensing instrument of alternate embodiment O4 wherein the at least one deflector is exactly two deflectors.
Alternative embodiment Q4
The sensor-dispensing instrument of alternate embodiment P4 wherein the test sensor is adapted to draw between two deflectors.
Alternative embodiment R4
The sensor-dispensing instrument of alternate embodiment O4 wherein the ejector mechanism is spring loaded.
Alternative embodiment S4
The sensor-dispensing instrument of alternate embodiment O4 wherein the mechanical mechanism is a spring.
Alternative embodiment T4
The sensor-dispensing instrument of alternate embodiment O4 wherein the analyte is glucose.
Alternative embodiment U4
The sensor-dispensing instrument of alternate embodiment O4 further including a desiccant.
Alternative embodiment V4
The sensor-dispensing instrument of alternate embodiment O4 wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment W4
The sensor-dispensing instrument of alternate embodiment O4 wherein the plurality of sensors are optical sensors.
Alternative embodiment X4
A cartridge adapted for use with a sensor-dispensing instrument, the cartridge comprising:
a housing defining at least one opening therethrough;
a base for sealing engagement with the housing in a first position;
a plurality of test sensors stacked in the housing, the plurality of test sensors for assisting in testing at least one analyte; and
an external spring mechanism mounted on the housing and the base for assisting in sealing engagement of the housing and the base;
wherein in the first position the housing and base are in sealing engagement and in the second position the housing and base are separated.
Alternative embodiment Y4
The cartridge of alternate embodiment X4 wherein at least one end of the housing is chamfered.
Alternative embodiment Z4
The cartridge of alternate embodiment X4 wherein the external spring mechanism includes at least two springs.
Alternative embodiment A5
The cartridge of alternate embodiment Z4 wherein the external spring mechanism includes at least four springs.
Alternative embodiment B5
The cartridge of alternate embodiment X4 further comprising an internal mechanical mechanism for urging the plurality of test sensors in a first direction.
Alternative embodiment C5
The cartridge of alternate embodiment B5 wherein the internal mechanical mechanism is a spring.
Alternative embodiment D5
The cartridge of alternate embodiment X4 wherein the housing defines exactly one opening.
Alternative embodiment E5
The cartridge of alternate embodiment X4 wherein the analyte is glucose
Alternative embodiment F5
The cartridge of alternate embodiment X4 further comprising a desiccant.
Alternative embodiment G5
The cartridge of alternate embodiment X4 wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment H5
The cartridge of alternate embodiment X4 wherein the plurality of sensors are optical sensors.
Alternative embodiment I5
A sensor-dispensing instrument comprising:
a cartridge comprising a cartridge housing forming at least one opening therethrough, a base for sealing engagement with the housing in a first position, a plurality of test sensors stacked in the housing for assisting in testing at least one analyte, and an external spring mechanism mounted on the cartridge housing and the base for assisting in sealing engagement of the cartridge housing and the base;
an instrument housing forming a dispensing outlet and for receiving the cartridge; and
an ejector mechanism for moving and inserting between the cartridge housing and the base to separate the cartridge housing and the base, the ejector mechanism for transporting and extracting the plurality of test sensors, one at a time, at least partially from the cartridge, in a second direction, the second direction being substantially perpendicular to the first direction;
wherein in the first position the cartridge housing and the base are in sealing engagement and in the second position the cartridge housing and the base are separated.
Alternative embodiment J5
The sensor-dispensing instrument of alternate embodiment I5 wherein the ejector mechanism is beveled.
Alternative embodiment K5
The sensor-dispensing instrument of alternate embodiment I5 wherein at least one end of the cartridge housing is chamfered.
Alternative embodiment L5
The sensor-dispensing instrument of alternate embodiment I5 wherein the external spring mechanism includes at least two springs.
Alternative embodiment M5
The sensor-dispensing instrument of alternate embodiment L5 wherein the external spring mechanism includes at least four springs.
Alternative embodiment N5
The sensor-dispensing instrument of alternate embodiment I5 further comprising an internal mechanical mechanism for urging the plurality of test sensors in the first direction.
Alternative embodiment O5
The sensor-dispensing instrument of alternate embodiment N5 wherein the internal mechanical mechanism is a spring.
Alternative embodiment P5
The sensor-dispensing instrument of alternate embodiment I5 wherein the cartridge housing defines exactly one opening.
Alternative embodiment Q5
The sensor-dispensing instrument of alternate embodiment I5 wherein the analyte is glucose.
Alternative embodiment R5
The sensor-dispensing instrument of alternate embodiment I5 further comprising a desiccant.
Alternative embodiment S5
The sensor-dispensing instrument of alternate embodiment I5 wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment T5
The sensor-dispensing instrument of alternate embodiment I5 wherein the plurality of sensors are optical sensors.
Alternative embodiment U5
A cartridge comprising:
a housing defining at least one opening therethrough;
a plurality of test sensors stacked in the housing, the plurality of test sensors for assisting in testing at least one analyte;
a mechanical mechanism for pushing the plurality of test sensors in a first direction, one of the plurality of test sensors positioned for extraction from the cartridge; and
a sliding pusher lid assembly including a flexible pusher tab for contacting one of the plurality of test sensors and pushing the test sensor from the housing at least partially through the opening, the flexible pusher tab extending generally outwardly and generally downwardly from a remainder of the sliding pusher lid assembly;
wherein in the closed position, the sliding pusher lid assembly is used to help seal the cartridge.
Alternative embodiment V5
The cartridge of alternate embodiment U5 wherein the sliding pusher assembly further includes a pusher grip to assist a user in grasping the pusher lid assembly and sliding it.
Alternative embodiment W5
The cartridge of alternate embodiment U5 further including a reference surface for contacting the plurality of test sensors one at a time and assisting in removing the plurality of test sensors one at a time.
Alternative embodiment X5
The cartridge of alternate embodiment U5 wherein the flexible pusher tab comprises polycarbonate, ABS, nylon, polyethylene, polystyrene, polypropylene, or combinations thereof.
Alternative embodiment Y5
The cartridge of alternate embodiment U5 wherein each of the test sensors defines a second notch and the flexible pusher tab defines a first notch at one end thereof to facilitate engagement with the second notch and removal of the plurality of test sensors one at a time.
Alternative embodiment Z5
The cartridge of alternate embodiment U5 further including a guide mechanism to assist in positioning the flexible pusher tab and to facilitate removal of the plurality of test sensors one at a time.
Alternative embodiment A6
The cartridge of alternate embodiment Z5 wherein the guide mechanism is a cam mechanism.
Alternative embodiment B6
The cartridge of alternate embodiment U5 wherein the sliding pusher lid assembly is adapted to engage the bottom surface of one of the plurality of test sensors when pushing on the one of the plurality of test sensors such that the one of the plurality of test sensors does not contact any of the remaining test sensors.
Alternative embodiment C6
The cartridge of alternate embodiment U5 wherein the sliding pusher lid assembly further comprises detents to help indicate to a user that the sliding pusher lid assembly is in the closed position.
Alternative embodiment D6
The cartridge of alternate embodiment U5 wherein the mechanical mechanism is a spring.
Alternative embodiment E6
The cartridge of alternate embodiment U5 wherein the housing defines exactly one opening.
Alternative embodiment F6
The cartridge of alternate embodiment U5 wherein the analyte is glucose.
Alternative embodiment G6
The cartridge of alternate embodiment U5 wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment H6
The cartridge of alternate embodiment U5 wherein the plurality of sensors are optical sensors.
Alternative embodiment I6
The cartridge of alternate embodiment U5 wherein the flexible pusher tab is adapted to clear the seal when the sliding pusher lid assembly is moved to the open position.
Alternative embodiment J6
The cartridge of alternate embodiment U5 wherein the flexible pusher tab is mounted to the sliding pusher lid assembly by a flexible support.
Alternative embodiment K6
The cartridge of alternate embodiment U5 wherein the flexible support comprises a metal or polymeric material.
Alternative embodiment L6
The cartridge of alternate embodiment U5 wherein the sliding pusher lid assembly includes a locking mechanism and a flexible tab for unlocking and disengaging the sliding pusher lid assembly.
Alternative embodiment M6
A sensor-dispensing instrument for determining a concentration of an analyte, the sensor-dispensing instrument comprising:
a cartridge comprising a cartridge housing forming at least one cartridge opening therethrough, a plurality of test sensors stacked in the cartridge housing for assisting in testing at least one analyte, a mechanical mechanism for urging the plurality of test sensors in a first direction, one of the plurality of test sensors positioned for extraction from the cartridge, a sliding pusher lid assembly movable between a first position and a second position, the sliding pusher lid assembly for assisting in sealing the sensor-dispensing instrument in the second position, the sliding pusher assembly comprising a flexible pusher tab extending generally outwardly and generally downwardly from a remainder of the sliding pusher lid assembly; and
an instrument housing forming a dispensing outlet and for receiving a cartridge;
wherein the flexible pusher tab is to push one of the plurality of test sensors from the cartridge at least partially through the dispensing outlet.
Alternative embodiment N6
The sensor-dispensing instrument of alternate embodiment M6 wherein the instrument housing further comprises a cavity for at least partially receiving the sliding pusher lid assembly when the sliding pusher assembly is in the first position.
Alternative embodiment O6
The sensor-dispensing instrument of alternate embodiment M6 wherein the sliding pusher lid assembly in the second position is adapted to help seal the cartridge opening and the dispensing outlet.
Alternative embodiment P6
The sensor-dispensing instrument of alternate embodiment M6 wherein the sliding pusher lid assembly further comprises a pusher grip to assist a user in grasping and sliding the sliding pusher assembly.
Alternative embodiment Q6
The sensor-dispensing instrument of alternate embodiment M6 wherein the cartridge further comprises a reference surface for contacting the plurality of test sensors one at a time and assisting in extracting the plurality of test sensors one at a time.
Alternative embodiment R6
The sensor-dispensing instrument of alternate embodiment M6 wherein the flexible pusher tab comprises polycarbonate, ABS, nylon, polyethylene, polystyrene, polypropylene, or combinations thereof.
Alternative embodiment S6
The sensor-dispensing instrument of alternate embodiment M6 wherein each of the plurality of test sensors defines a second notch and the flexible pusher tab defines a first notch at one end thereof to facilitate engagement with the second notch and removal of the plurality of test sensors one at a time.
Alternative embodiment T6
The sensor-dispensing instrument of alternate embodiment M6 wherein the cartridge further comprises a guide mechanism to aid in positioning the flexible pusher tab and to facilitate removal of the plurality of test sensors one at a time
Alternative embodiment U6
The sensor-dispensing instrument of alternate embodiment T6 wherein the guide mechanism is a cam mechanism.
Alternative embodiment V6
The sensor-dispensing instrument of alternate embodiment M6 wherein the sliding pusher lid assembly is adapted to engage the bottom surface of one of the plurality of test sensors when pushing on the one of the plurality of test sensors such that the one of the plurality of test sensors does not contact any of the remaining test sensors.
Alternative embodiment W6
The sensor-dispensing instrument of alternate embodiment M6 wherein the sliding pusher lid assembly further comprises a detent to help indicate to the user that the sliding pusher lid assembly is in the closed position.
Alternative embodiment X6
The sensor-dispensing instrument of alternate embodiment M6 wherein the mechanical mechanism is a spring.
Alternative embodiment Y6
The sensor-dispensing instrument of alternate embodiment M6 wherein the analyte is glucose.
Alternative embodiment Z6
The sensor-dispensing instrument of alternate embodiment M6 wherein the plurality of sensors are electrochemical sensors.
Alternative embodiment A7
The sensor-dispensing instrument of alternate embodiment M6 wherein the plurality of sensors are optical sensors.
Alternative embodiment B7
The sensor-dispensing instrument of alternate embodiment M6 wherein the flexible pusher tab is adapted to clear the seal when the sliding pusher lid assembly is moved to the open position.
Alternative embodiment C7
The sensor-dispensing instrument of alternate embodiment M6 wherein the flexible pusher tab is mounted to the sliding pusher lid assembly by a flexible support.
Alternative embodiment D7
The sensor-dispensing instrument of alternate embodiment C7 wherein the flexible support comprises a metal or polymeric material.
Alternative embodiment E7
The sensor-dispensing instrument of alternate embodiment M6 wherein the sliding pusher lid assembly includes a locking mechanism and a flexible tab for unlocking and disengaging the sliding pusher lid assembly.
While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. For example, the sensor-dispensing instrument may be used to test fluids other than blood glucose. In fact, the sensor-dispensing instrument may be used for any type of chemical fluid analyte that can be analyzed by a reagent material. The invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
Claims (15)
1. A cartridge, comprising:
a housing defining an opening therethrough;
a plurality of test sensors stacked in the housing, the plurality of test sensors for assisting in testing at least one analyte;
a mechanical mechanism for urging the plurality of test sensors in a first direction so that one of the plurality of test sensors is positioned for extraction from the cartridge;
a test-sensor extractor for movement between a first position and a second position; and
a lid mechanically coupled to the test-sensor extractor, the lid being movable between a closed position and an open position such that the lid seals the opening when in the closed position;
wherein movement of the test-sensor extractor from the first position to the second position moves the lid from the closed position to the open position and extracts one of the plurality of test sensors at least partially through the opening.
2. The cartridge of claim 1, wherein: the lid is manually movable between the open and closed positions.
3. The cartridge of claim 1, further comprising: a ramp positioned to assist in withdrawing one of the plurality of test sensors at least partially through the opening.
4. The cartridge of claim 1, wherein: the plurality of test sensors are stacked in an inclined manner.
5. The cartridge of claim 1, wherein: the lid also includes a seal.
6. The cartridge of claim 1, wherein: the cover forms at least one notch to help provide clearance for a mechanical linkage between the cover and the test-sensor extractor.
7. The cartridge of claim 1, wherein: the covers are mechanically connected by flexible linkages.
8. The cartridge of claim 1, wherein: the plurality of test sensors includes electrochemical sensors and/or optical sensors.
9. A cartridge, the cartridge comprising:
a housing defining an opening therethrough;
a plurality of test sensors stacked in the housing, the plurality of test sensors for assisting in testing at least one analyte;
a sealing mechanism for sealing the opening when in a sealing position;
a test-sensor extractor coupled to the sealing mechanism for movement between a first position and a second position;
wherein movement of the test-sensor extractor from the first position to the second position moves the sealing mechanism from the sealed position to the unsealed position and causes one of the plurality of test sensors to pass at least partially through the opening.
10. The cartridge of claim 9, wherein: each of the plurality of test sensors has a length, a width, and a height, the length of the plurality of test sensors being greater than the width and the height, the opening having dimensions substantially corresponding to the width and the height of the test sensors such that one of the test sensors is traversed at a time.
11. A cartridge, comprising:
a housing defining at least one opening therethrough;
a plurality of test sensors stacked obliquely in the housing, the plurality of test sensors for assisting in testing at least one analyte;
a first mechanical mechanism for urging the plurality of test sensors in a first direction to position one of the plurality of test sensors for extraction from the cartridge;
a lid movable between a closed position and an open position such that the lid seals the opening when in the closed position; and
a pusher assembly connected to the lid, the pusher assembly being movable between a first position and a second position;
wherein movement of the pusher assembly from the first position to the second position moves the lid from the closed position to the open position and draws one of the plurality of test sensors at least partially through the opening.
12. The cartridge of claim 11, wherein: the pusher assembly is connected to the lid by a cam mechanism.
13. The cartridge of claim 11, wherein: the lid is movable between a first position and a second position by a hinge.
14. The cartridge of claim 11, further comprising: a second mechanical mechanism for urging the plurality of test sensors in a second direction, the second direction being oriented substantially perpendicular to the first direction.
15. The cartridge of claim 1, further comprising: a stop member to help prevent or inhibit extraction of more than one of the plurality of test sensors at a time.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US64380105P | 2005-01-14 | 2005-01-14 | |
| US60/643,801 | 2005-01-14 | ||
| US68412905P | 2005-05-24 | 2005-05-24 | |
| US60/684,129 | 2005-05-24 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HK1173221A1 HK1173221A1 (en) | 2013-05-10 |
| HK1173221B true HK1173221B (en) | 2015-12-24 |
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