Patent Application
20120330119
The field of the invention is analyte testing devices.
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 levels, fructosamine, hematocrit, hemoglobin blood oxygen saturation, lactates, iron, pH, cholesterol, liver enzymes (AST, ALT, alkaline phosphatase/GGT, LDH, bilirubin, etc), hormones, and other chemicals.
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 houses a carrier of test strips and a carrier of lancets. The carriers must be rotated into position each time a new blood test is performed. Wurster fails to provide a device that advances the next lancet into position, cocks a lancing device, and partially exposes a test strip for use, all with a single motion. Furthermore, the two carriers are joined together, thus preventing the lancets from being used independently of the test strips.
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 conventional 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 lancet cartridge and a separate test strip cartridge. Furthermore, it has yet to be appreciated that an analyte testing device can be configured to advance a lancet cartridge, cock a lancing device, and expose a test strip, all in a single motion.
Thus, there is still a need for an integrated analyte testing device that reduces the components and steps required for monitoring analyte levels.
The inventive subject matter provides apparatus, systems and methods in which an analyte testing device has a housing that removeably holds a lancet cartridge and a test strip cartridge. Each of the lancet and test strip cartridges holds a plurality of lancets and test strips, respectively. The testing device also has an conversion electronics, which receives a signal from the test trip and converts the signal into readable data.
In one aspect of preferred embodiments, the testing device has an actuator configured to (i) cock a lancing device, (ii) expose individual ones of the plurality of test strips for use; and (iii) advance the lancet cartridge. Preferably, the actuator accomplishes all of these steps in a single action, i.e., with a single motion by the user.
In another aspect of preferred embodiments, the testing device has a disengaging mechanism configured to disengage the second cartridge from the actuator. In this manner, the individual test strips can be used independently of the lancets. Optionally, a second disengaging mechanism can be included to disengage the first cartridge from the actuator.
In yet other aspects of preferred embodiments, the testing device further includes a wireless transmitter for transmitting data to an external device. The testing device can also include a processor programmed to time-stamp data, keep track of supplies ordered and used, supplies remaining in a personal inventory (e.g., home closet), automatically re-order supplies, evaluate data, and send notifications as a function of the data.
From a method perspective, the testing device can be used by: (1) inserting a lancet cartridge into the device; (2) inserting a test strip cartridge into the device; (3) cocking a lever on the device, which operates a mechanism that (a) cocks a lancing device, (b) exposes a test strip, and (c) advances the lancet cartridge; (4) deploying the lancing device in order to prick a body part and draw a blood sample; and (5) contacting the test strip to the blood sample.
Preferred methods further include reading an output of the device; ejecting and disposing of the test strip; replacing the lancet cartridge with a refill lancet cartridge; and replacing the test strip cartridge with a refill test strip cartridge.
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.
a and 4b are perspective and side views, respectively, of one embodiment of a lancet cartridge.
a and 5b are perspective and side views, respectively, of one embodiment of a test strip cartridge.
a and 15b show one embodiment of an analyte testing device with a no-contact test strip ejecting mechanism.
a and 16b show perspective views of one embodiment of an analyte testing device with a wheel for adjusting lancet puncture depth and window for displaying depth setting.
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.
Device 100 has an actuator 140 configured to (i) cock a lancing device (see
The housing of device 100 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. Device 100 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 of device 100 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.
Conversion electronics 137 preferably includes a facility for transmitting data and information out of the housing and to an external storage device (e.g., docking station, laptop, smart phone). It is contemplated that the data can be transmitted using a wireless protocol, and can even transmit data using two or more wireless protocols. Wired protocols and methods are also contemplated.
It is also contemplated that conversion electronics 137 can include a processor programmed to correlate individual instances of data and information derived from the data with time stamps. The processor can also be programmed to correlate individual instances of data with user-entered information such as voice recordings or text. In addition, the processor can be programmed to make an evaluation of the data and information, and send a notification to different recipients as a function of the evaluation. Yet still, the processor can be programmed to keep track of inventory of lancets and test strips, both within and outside the device, and re-order supplies as needed.
In other aspects of preferred embodiments, conversion electronics 137 includes a processor programmed to store voice recordings of diary information selected from the group consisting of supplies used or ordered, food eaten, exercise, medication taken, and estimated calories burned. The processor is also preferably programmed to prompt a user to use the device according to a pre-selected time and/or pre-selected time interval. Alternatively, electronics 137 can be equipped with an accelerometer or pedometer for measuring and calculating distance traveled and calories burned.
Conversion electronics 137 can also include a pedometer and/or accelerometer for calculating a distance traveled and calories burned. In such embodiments, electronics 137 preferably includes a processor for time-stamping the distances traveled and calories burned, and correlating this data with analyte test data.
a and 4b show different views of a lancet cartridge 115. Cartridge 115 holds a plurality of lancets 117. A slot 116 is disposed on a side of cartridge 115, so that a hammer 186 (see
Cartridge 115 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.
a and 5b show different views of a test strip cartridge 125. Cartridge 125 holds a plurality of test strips 127. Cartridge 125 has electrical contacts 128 for communicatively coupling the test strips 127 to the conversion electronics 137. Alternatively, contacts 128 could be eliminated and electronics 137 could directly interface with contacts 129 of test strip 127 (see
Cartridge 125 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.
Cartridge 125 preferably includes test strips configured to test for different analytes. For example, some test strips may test for glucose while other test strips test for fructosamine. Furthermore, cartridge 125 can have at least one test strip capable of testing for two analytes simultaneously, either by including two analyte-binding chemicals/reactants within one absorbing material or by including two different analyte sensors on one test strip. In addition, cartridge 125 preferably includes at least one calibration test strip for verifying the calibration of conversion electronics 137. In one embodiment, the calibration test strip is an analyte sensor that has a known amount of glucose.
Cartridge 125 also has a spring-load base 131 configured to push the plurality of test strips 127 upward, thus repositioning a new test strip into place after test strip 127a is removed from cartridge 125.
One of skill in the art will appreciate that configurations of linkage mechanism 180 other that shown in the drawings can be used consistently with the inventive subject matter taught herein. In some alternative embodiments, linkage mechanism 180 is controlled and/or actuated by electrical drivers rather than pure mechanical means. For example, pulling actuator 140 could send an electrical signal to conversion electronics 137, 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.
Device 200 also has a first work light 220 positioned to illuminate a test strip that has been partially pushed out from device 200, and a second work light 230 positioned to illuminate a lancet hole 213. First and second work lights 220 and 230 are useful for using device 200 in poor lighting conditions.
Conversion electronics within device 200 additionally includes a Personal Emergency Response System (PERS), including a PERS button 240. Button 240 is configured to (i) contact a third party, (ii) identify the user of device 200, and (iii) provide a user's health data to the third-party. Examples of third parties can include spouse, relative, friend, home nurse, doctor, health care worker, ambulance operator, police operator, or any other person that can provide health care assistance. The Personal Emergency Response System is also preferably configured to automatically contact a third party as a function of the user's health data. For example, when the user is a diabetic patient, PERS can be configured to contact a third party when the user's glucose test results are below a predetermined threshold. PERS can also be configured to notify the third party of an urgency level (e.g., low, moderate, high, critical, etc), and can determine who to contact based on the urgency level.
a shows an analyte testing device 500, with a test strip 127a and a test strip ejector 560.
a and 16b show an alternate analyte testing device 600. Unlike device 100, device 600 has a wheel 670 for adjusting a lancet penetration depth. A lancet within lancet cartridge 715 exits device 600 via hole 613 according to an adjustable depth determined by the setting of wheel 670. Device 600 also has a window 675 for indicating the current lancet penetration depth setting. Spring-loaded return slider 690 is configured to retract the lancet back into cartridge 715.
The method of
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.
