US20120330188A1 - Cocking and Advancing Mechanism for Analyte Testing Device - Google Patents

Abstract

An analyte testing device includes an analyte sensor, a lancet, and a mechanism with an actuator that operates to independently expose the analyte sensor and advance the lancet into position for use. The analyte sensor is preferably included in an analyte sensor cartridge that houses a plurality of sensors. Similarly, the lancet is preferably included in a lancet cartridge that houses a plurality of lancets. The actuator can be a lever configured to expose the analyte sensor and advance the lancet into position with a single motion (e.g., pulling the lever). The actuator also preferably operates to cock a hammer in preparation for lancing a body member to draw a blood sample. The mechanism can be a linkage coupled with the actuator and configured to engage the analyte sensor and lancet.

Description

• This application is a continuation-in-part of U.S. patent application Ser. Nos. 13/187,360 and 13/187,397 both filed Jul. 20, 2011 which are continuation-in-parts of U.S. patent application Ser. No. 13/165,621 filed Jun. 21, 2011, which are incorporated herein by reference in their entirety.
FIELD OF THE INVENTION
• The field of the invention is analyte testing devices.
BACKGROUND
• Analyte testing devices play a critical roll in modern diagnosis and management of health-related issues. For example, a sample of human blood, urine, and/or saliva can be tested for glucose, fructosamine, hematocrit, hemoglobin blood oxygen saturation, lactates, iron, pH, cholesterol, liver enzymes (AST, ALT, alkaline phosphatase/GGT, LDH, bilirubin, etc), hormones, and other compounds.
• For many diabetic patients, monitoring glucose levels and administering appropriate insulin dosages is a daily activity that requires a significant amount of time and mental energy. Current glucose meters and lancing devices often involve multiple devices, components, and supplies, and require numerous steps to monitor glucose levels. For example, conventional glucose monitoring systems may require numerous steps involving reading a test strip, readying a lancet, using the lancet, putting blood on the test strip and inserting the strip into the glucose meter, reading data from a meter, recording the data in a journal and remembering to bring the journal to the next doctor visit, and then putting away the strip and lancet packages, disposing of loose components, and storing the glucose meter. Thus, there is a need to reduce steps and simplify devices and supplies for monitoring analytes. Other needs include a compact analyte testing device and hands-free disposal of test strips.
• Several known prior art references are directed at simplifying the devices and processes for monitoring analytes. Significantly, however, the prior art systems each appear to address only a subset of the convenience issues. U.S. Pat. No. 6,472,220 to Simons, for example, discloses an integrated lancing device and glucose meter. The device holds a cassette that stores a plurality of lancets and test strips. Each lancet is paired with a test strip into a single integrated unit, thus simplifying the number of separate supply components. Unfortunately, the test strip-lancet unit contemplated in Simons prevents the user from using lancets independently of the test strips.
• Simons, and all other extrinsic materials discussed herein, are incorporated by reference in their entirety. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
• U.S. Pat. No. 7,192,405 to DeNuzzio also provides an integrated lancet-test strip unit, similar to Simons. DeNuzzio suffers from the same drawbacks as Simons.
• U.S. Pat. No. 7,582,063 to Wurster discloses a glucose meter that includes a plurality of analyte sensors and a plurality of lancets on the same carrier. Each time a new blood test is performed, the carrier is rotated into position, which simultaneously exposes an analyte sensor, advances a lancet for use, and cocks a spring to operate the pre-positioned lancet. Since the analyte sensors and lancets are rotated together on the same carrier, exposing of an analyte sensor is not independent of advancing a lancet. That can be a disadvantage to a user who might want to use more than one sensor for a given stick (or for example where two different readings are desired), or might need to use two or more lancets to secure an adequate sample for a single sensor.
• Wurster is also designed such that during use, the operative sensor is immediately adjacent (indeed surrounds) the operative lancet tip. That design could be viewed as being inherently problematic because the sensor will tend to sense components in the first amount of blood that is drawn. To avoid that problem it would be more desirable to expose the analyte sensor at a position at least several millimeters away from where the lancet is projected from the housing.
• U.S. Pat. No. 4,794,926 to Munsch discloses a lancing device that holds a cartridge with a plurality of lancets. Rotating the cartridge in the lancing device simultaneously loads the next lancet into position for ejection while “cocking” the lancet for ejection. However, Munsch fails to integrate the lancing device with a glucose meter, and also fails to partially expose a test strip when the lancet cartridge is rotated.
• U.S. Pat. Nos. 7,922,971, 6,997,343, 7,211,096, and 6616616 are other examples of known references that attempt to simplify methods and devices for monitoring glucose levels.
• The POGO™ System by Intuity Medical, Inc. (see http://www.presspogo.com/pogo/system/) is a commercially available glucose and lancing device that is designed to simplify glucose monitoring. While the POGO™ System reduces the steps and components required, and is an improvement over many other systems, the POGO system fails to provide a separate lancet cartridge and test strip cartridge. As such, the user cannot use lancets independently of test strips.
• It has yet to be appreciated that an analyte testing device can house a plurality of analyte sensors and a plurality of lancets, where a single operation of an actuator can expose an analyte sensor while advancing a lancet for projection for use, where the sensors are exposed at a distance of at least several millimeters from where the lancets are projected, and/or where the sensors and lancets can be operated independently from each other.
SUMMARY OF THE INVENTION
• The inventive subject matter provides apparatus, systems, and methods in which an analyte testing device can house a plurality of analyte sensors and a plurality of lancets, where a single operation of an actuator can eject an analyte sensor while advancing a lancet for projection for use.
• In some aspects of preferred embodiments, the analyte sensor is included in an analyte sensor cartridge. The cartridge preferably holds a plurality of analyte sensors. In other aspects of preferred embodiments, each analyte sensor is disposed in a test unit (e.g., a test strip).
• In yet other aspects of some preferred embodiments, the lancet is included in a lancet cartridge. The lancet cartridge preferably holds a plurality of lancets.
• In other aspects of preferred embodiments, the actuator comprises a manually operated lever. In some embodiments, the mechanism is entirely manually operated. In other embodiments, the mechanism is operated at least in part by a motor.
• In some aspects of preferred embodiments, the mechanism includes a hammer, and the actuator operates to cock the hammer. For example, the hammer can be spring loaded and then released to eject a lancet for drawing a blood sample.
• In yet other aspects of preferred embodiments, the mechanism has a linkage that exposes the analyte sensor, advances the lancet for use, and cocks the hammer, all in a single motion of the actuator. In some embodiments, the single motion comprises pulling a lever. In some embodiments the mechanism includes a first link that exposes the analyte sensor, and a second link, different from the first link, that advances the advancing the lancet. Exposing of the analyte sensor is preferably done independently relative to advancing the lancet. For example, the mechanism can include a disengagement control that is capable of disengaging the actuator from either exposing the analyze sensor or advancing the lancet.
• In some aspects of preferred embodiments, the sensors are ejected at a distance of at least several millimeters from where the lancets are projected. In other aspects, the sensors and lancets can be operated independently from each other. For example, the sensors and lancets are each stored in a separate cartridge and the cartridges couple with the analyte testing device independently of one another.
• Various objects, features, aspects, and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.
BRIEF DESCRIPTION OF THE DRAWING
• FIG. 1 is a top perspective view of one embodiment of an analyte testing device.
• FIG. 2 is the device ofFIG. 1, wherein an analyte sensor of a test unit has been exposed.
• FIG. 3 is a bottom perspective view of the device ofFIG. 1.
• FIG. 4 is a back perspective view the device ofFIG. 1.
• FIG. 5 is a perspective views of one embodiment of a lancet cartridge.
• FIG. 6 is a side view of the lancet cartridge ofFIG. 5.
• FIG. 7 is a side view of the lancet cartridge ofFIG. 5.
• FIG. 8 is a perspective view of one embodiment of an analyte sensor cartridge.
• FIG. 9 is a side view of the analyte sensor cartridge ofFIG. 8.
• FIG. 10 is a perspective view of one embodiment of a test unit that has an analyte sensor.
• FIG. 11 shows one embodiment of a linkage mechanism of the device ofFIG. 1 engaged with the lancet cartridge ofFIG. 5. The linkage mechanism is shown at four different stages of use: (i) rest position; (ii) lever pulled; (iii) lever released (cocked and ready); and (iv) button pressed to project hammer.
• FIG. 12 is a side view of the device ofFIG. 1, showing the inner components of the device in a rest position.
• FIG. 13 is a side view of the device ofFIG. 1, showing the inner components of the device as a lever is being pulled.
• FIG. 14 is a side view of the device ofFIG. 1, showing the inner compartments of the device after a lever has been pulled and a hammer has been spring-loaded.
• FIG. 15 is a side view of an analyte device with a motor.
• FIG. 16 is a side of an analyte device with a first and second disengagement control.
• FIG. 17 is a schematic of one embodiment of a method of using the device ofFIG. 1.
DETAILED DESCRIPTION
• The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
• FIG. 1 shows ananalyte testing device100. Thehousing105 ofdevice100 has afirst compartment110 and asecond compartment120, for storing a lancet cartridge115 (seeFIGS. 5-7) and an analyte sensor cartridge125 (seeFIGS. 8-9).Device100 also has anelectronics compartment130 for housing conversion electronics137 (seeFIG. 12).Conversion electronics137 are communicatively coupled to an analyte sensor126 (seeFIGS. 8 and 10) withincartridge125.Conversion electronics137 is configured to convert a signal fromanalyte sensor126 into readable data (e.g., glucose levels).
• Device100 has anactuator140 comprising a lever.Actuator140 is configured to (i) ready a lancing device (e.g., cock a hammer, seeFIGS. 11 and 14), (ii) expose an analyte sensor (seeFIGS. 2 and 14), and (iii) advance a lancet cartridge for use (seeFIGS. 11 and 13).Device100 also has atest unit ejector160, which advantageously allows for hands-free disposal of a used test strip.
• The housing ofdevice100 can be made of plastic, metal, composite, or any other material with structural and mechanical properties suitable for housing a lancet cartridge, test strip cartridge, electronics, and a linkage mechanism.Device100 is preferably compact, with a height no more than 50 mm, a width no more than 17 mm, and a length no more than 100 mm. In especially preferred embodiments, the height is no more than 40 mm, a width is no more than 12 mm, and a length is no more than 75 mm. In some preferred embodiments, the housing ofdevice100 comprises an outer protective shell made of molded plastic and an inner desiccant liner to minimize exposure to moisture.
• Unless the context dictates the contrary, all ranges set forth herein should be interpreted as being inclusive of their endpoints, and open-ended ranges should be interpreted to include commercially practical values. Similarly, all lists of values should be considered as inclusive of intermediate values unless the context indicates the contrary.
• FIG. 2 showsdevice100 afteractuator140 has been cocked. The cocking ofactuator140 has caused atest unit127 to be partially ejected fromslot133, thus exposing analyte sensor126 (seeFIGS. 8 and 10). Onceactuator140 has been cocked, a lancing device withindevice100 can be projected by pressingbutton150, causing one of a plurality of lancets117 (seeFIGS. 5 and 6) to exit from hole113 (seeFIG. 3).Hole113 and slot133 are separated by a substantial distance (more than 5 mm), thus allowing a user to bleed out an initial amount of blood before applying a blood sample to an analyte sensor. The operation ofdevice100 will become more apparent from a discussion ofFIGS. 11-14.
• FIG. 4 shows a back perspective view ofdevice100. A door on the backside ofdevice100 has been opened to revealcompartment110. Alancet cartridge115 is disposed withincompartment110.Device100 has a spring-loadedreturn slider690, which is configured to retract a lancet back intocartridge115 after the lancet has been partially ejected for drawing a blood sample.
• FIGS. 5-7 show different views of alancet cartridge115.Cartridge115 holds a plurality oflancets117. Aslot116 is disposed on a side ofcartridge115, so that a hammer186 (seeFIGS. 11-14) of a lancing device withindevice100 can contact one of the plurality oflancets117, thus causing the lancet to partially exitcartridge115 viaslot118. The lancet is retracted byreturn slider690 of device100 (seeFIG. 4).Cartridge115 also has a moldedbump138 that provides friction to the plurality oflancets117 and helps to maintain each lancet stationary when not being fired.
• Cartridge115 can include any appropriate number of lancets, preferably between 15 and 25 lancets, more preferably between 18 and 22 lancets, and most preferably 20 lancets. The lancets are preferably sterilized and sealed prior to use.
• FIGS. 8 and 9 show different views of aanalyte sensor cartridge125.Cartridge125 holds a plurality of test units127 (e.g., test strips).Cartridge125 haselectrical contacts128 for communicatively coupling the analyte sensors to theconversion electronics137. Alternatively,contacts128 could be eliminated andelectronics137 could directly interface withcontacts129 of test unit127 (seeFIG. 10) via an open aperture incartridge125.Cartridge125 also has aslot129athat couples with a test unit lateral ejection mechanism ofdevice100. When actuator140 is cocked, the advance mechanism entersslot129aand pushes a portion oftest unit127aout ofslot129b, thus exposinganalyte sensor126 for use.
• Cartridge125 can include any appropriate number of test strips, preferably between 15 and 25 test strips, more preferably between 18 and 22 test strips, and most preferably 20 test strips.
• Cartridge125 also has a spring-load base131 configured to push the plurality oftest strips127 upward, thus repositioning a new test strip into place aftertest strip127ais removed fromcartridge125.
• FIG. 10 shows atest unit127ahaving ananalyte sensor126. Analyte sensors are well known and generally comprise an absorbent material with an analyte-binding reactant. Whiletest unit127ais configured as a test “strip”, those of skill in the art will appreciate that other shapes and configurations (e.g., capsules, disks) can be used consistently with the inventive subject matter.Analyte sensor126 is configured to generate a signal that is sent toelectrical contacts129.Electrical contacts129 are communicatively coupled withelectrical contacts128 ofcartridge125 and allows the signal generated byanalyte sensor126 to reach theconversion electronics137 for analysis. Alternatively,electrical contacts129 could directly interface withconversion electronics137 via an open aperture oncartridge125.
• FIG. 11 shows alinkage mechanism180 ofdevice100 coupled withlancet cartridge115.FIG. 11 provides a summary of the four progressive stages for usinglinkage180 andlancet cartridge115 as a lancing device: (i) initial resting position; (ii) cocking ofactuator140; (iii) cocked and ready position; and (iv) releasing and projecting a lancet. At the final stage, a finger or other body part can be placed overhole113 in order to prick the body part and draw a blood sample. These four stages will now be explained in more detail.
• FIG. 12 is a side view ofdevice100 showing various internal components ofdevice100, such as:electronics137,linkage mechanism180,cartridge115, andcartridge125.FIG. 12shows device100 at a resting position (i.e., beforeactuator140 has been cocked).Hammer186 is in an un-cocked position.
• FIG. 13 shows the internal components ofdevice100 asactuator140 is being cocked. The cocking ofactuator140 has causedlink182 to raise up and compressspring181. At the same time,hammer186 has been raised vialink183. In addition, the left end oflink182 has been raised over the top oflink187 such that link182 is maintained in an inclined position andspring181 is maintained in a compressed position (i.e.,hammer186 has been “cocked” or “readied”). At the same time, link183 is driven to the left, pushingtest strip127aout of slot133 (seeFIG. 1). In addition, link184 has been advanced to the left, causingcartridge115 to advance left and into position. In preferred embodiments, link183 couples withcartridge115 such that whencartridge115 has been completely advanced to the left, link183 allows the last lancet ofcartridge115 to remain in a usable (i.e., projectable) position. For example, link183 could release (e.g., de-couple) fromcartridge115 during subsequent cocking ofactuator140. In this manner,linkage mechanism180 allows a lancet to be available for use, even aftercartridge115 has been advanced through each of the plurality oflancets117.
• In this manner,actuator140 andlinkage mechanism180 are configured to (i) cock a lancing device (e.g.,lift hammer186, link182, and spring181) (ii) partially expose an analyte sensor on a test unit; and (iii) advance a lancet cartridge into position, all in a single motion (e.g., pulling up actuator140). It is also contemplated that an analyte testing device could have a linkage mechanism that is configured to accomplish the three steps above using two or more motions (e.g., pulling a lever, then pushing a lever).
• FIG. 14 shows the position oflinkage180 afteractuator140 has been cocked. Onceactuator140 has been cocked,button150 can be pressed to release link187 from underlink182, thus causingspring181 to pushlink182 and hammer186 downward to project a lancet fromcartridge115.
• One of skill in the art will appreciate that configurations oflinkage mechanism180 other than that shown in the drawings can be used consistently with the inventive subject matter taught herein. In some alternative embodiments,linkage mechanism180 is controlled and/or actuated by electrical drivers rather than pure mechanical means. For example, pullingactuator140 could send an electrical signal toconversion electronics137, which then operates a motor, or multiple motors, in order to perform any combination of: (i) cocking a lancing device, (ii) partially exposing a test strip for use, and (iii) advancing a lancet cartridge into position. In yet other embodiments, the lancing system is designed such that a cocking step is not required.
• FIG. 15 shows ananalyte testing device500 that has anactuator540 and amotor550.Actuator540 comprises a button that sends a signal tomotor550.Motor550 operates to drivelinkage mechanism180 upon receiving a signal.Motor550 andactuator540 is one embodiment of an analyte testing device that is not purely mechanism.
• FIG. 16 shows ananalyte testing device600 that has afirst disengagement control610 and asecond disengagement control620.Control610 operates to disengage link182 fromlink183, thus disengagingcartridge125 fromlinkage mechanism180.Control620 operates to disengage link184 fromcartridge115. In this manner,cartridges115 and125 can be disengaged fromlinkage mechanism180, and thus can be used independently of one another.
• FIG. 17 shows a method of usingdevice100, comprising: inserting a lancet cartridge into the device; inserting a test strip cartridge into the device; operating an actuator on the device, which operates a mechanism that (i) readies a lancing device, (ii) advances the lancet cartridge, and (iii) exposes an analyte sensor of a test unit; deploying the lancing device in order to prick a body part and draw a blood sample; and exposing the analyte sensor to the blood sample. The method ofFIG. 15 can optionally include the steps of: reading an output of the device; ejecting and disposing of the test unit; replacing the lancet cartridge with a refill lancet cartridge; and replacing the analyte sensor cartridge with a refill analyte sensor cartridge.
• The first two and last two steps are displayed in round boxes and with dotted lines to indicate that these steps need not be repeated at every cycle of usage of the device. For example, in embodiments having twenty lancets and test strips per cartridge, the steps of inserting/removing cartridges need only be performed every twentieth cycle of use.
• As used herein, and unless the context dictates otherwise, the term “coupled to” is intended to include both direct coupling (in which two elements that are coupled to each other contact each other) and indirect coupling (in which at least one additional element is located between the two elements). Therefore, the terms “coupled to” and “coupled with” are used synonymously.
• It should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the scope of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refers to at least one of something selected from the group consisting of A, B, C . . . and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc.

Claims (18)

1. An analyte testing device, comprising:

a housing that houses an analyte sensor and a lancet; and

an actuator that functions through a mechanism to (a) eject the analyte sensor at a first position of the housing, and (b) advance the lancet for projection from a second position of the housing.

2. The device ofclaim 1, wherein the analyte sensor is included in an analyte sensor cartridge.

3. The device ofclaim 1, wherein the analyte sensor is disposed in a test strip.

4. The device ofclaim 1, wherein the lancet is included in a lancet cartridge.

5. The device ofclaim 2, wherein the lancet is included in a lancet cartridge.

6. The device ofclaim 1, wherein the actuator comprises a manually operated lever.

7. The device ofclaim 1, wherein the mechanism is entirely manually operated.

8. The device ofclaim 1, wherein the mechanism is operated at least in part by a motor.

9. The device ofclaim 1, wherein the mechanism further comprises a hammer, and wherein the actuator cocks the hammer.

10. The device ofclaim 9, wherein the hammer is spring loaded.

11. The device ofclaim 9, wherein the mechanism has a linkage that exposes the analyte sensor, advances the lancet for use, and cocks the hammer in a single motion.

12. The device ofclaim 11, wherein the single motion comprises operating a lever.

13. The device ofclaim 12, further comprising a motor configured to operate the lever.

14. The device ofclaim 12, wherein the lever comprises a manually-operated lever.

15. The device ofclaim 1, wherein the mechanism has a first link that exposes the analyte sensor, and a different, second link that advances the lancet, such that exposing of the analyte sensor can be independently operated relative to advancing the lancet.

16. The device ofclaim 1, wherein the mechanism has a disengagement control that disengages operation of the actuator from exposing of the analyze sensor.

17. The device ofclaim 1, wherein the mechanism has a disengagement control that disengages operation of the actuator from advancement of the lancet.

18. The device ofclaim 1, wherein the first and second positions are separated by at least 5 mm.

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