Patent Application
20100051455
The present invention relates to biosensor test strip cards, such as are used in monitoring blood glucose.
As the number of patients suffering from diabetes and similar medical conditions increases, self-monitoring of blood glucose wherein the patient monitors his or her blood glucose levels has become a common practice. The purpose of monitoring the blood-glucose level is to determine the concentration level and then to take corrective action, based upon whether the level is too high or too low, to bring the level back within a normal range. The failure to take corrective action can have serious medical implications. Glucose monitoring is a fact of everyday life for diabetic individuals, and the accuracy of such monitoring can literally mean the difference between life and death. Failure to test blood glucose levels accurately and on a regular basis can result in serious diabetes-related complications, including cardiovascular disease, kidney disease, nerve damage and blindness.
People with diabetes who intensively manage their blood sugar experience long-lasting benefits. The Diabetes Control and Complications Trial (DCCT) was a clinical study conducted from 1983 to 1993 by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The DCCT compared intensive to conventional treatments. Patients on intensive treatment kept glucose levels as close to normal as possible with at least three insulin injections a day or an insulin pump, and frequent self-monitoring of blood glucose. Intensive treatment aimed to keep hemoglobin A1c (HbA1c), which reflects average blood glucose over a 2- to 3-month period, as close to normal as possible. Conventional treatment consisted of one or two insulin injections a day with once-a-day urine or blood glucose testing. The results of the DCCT study showed that keeping blood glucose levels as close to normal as possible slows the onset and progression of eye, kidney, and nerve diseases caused by diabetes. In fact, it demonstrated that any sustained lowering of blood glucose helps, even if the person has a history of poor control.
A number of glucose meters are currently available that permit an individual to test the glucose level in a small sample of blood. Many of the meter designs currently available make use of a disposable test strip which in combination with the meter measures the amount of glucose in the blood sample electrochemically. Lot-to-lot variation during the manufacture of disposable test strips requires that the user calibrate the system for each batch of strips. Given the ramifications of accurate monitoring, improvements in the apparatus and/or procedures to meter blood glucose are desired.
One embodiment of the present invention is a biosensor test strip card comprising a substantially credit card sized sheet including a plurality of detachable biosensor test strips. It also includes a plurality of recloseable covers. Each cover is attached to a corresponding test strip and overlaps a reagent test portion of the strip.
In one refinement there is a surround area extending around at least a portion of a perimeter of the sheet. The plurality of test strips are also detachably connected to the surround area.
In another refinement the surround area is U-shaped.
In another refinement the surround area encloses the sheet and the plurality of test strips are detachably connected to the surround area by a plurality of spaced apart contact points.
In another refinement there is a data storage device key positioned in a portion of the surround area.
In another refinement the data storage device is a ROM key is separable from the surround area of the card. The ROM key includes meter calibration information relating to the plurality of test strips.
In another refinement there is a BIT activated key in the surround area at a different position than the data storage device.
In another refinement the surround area defines at least one internal rectangular space, and the plurality of test strips are a two dimensional array within the rectangular space.
In another refinement the plurality of test strips are a two dimensional array of electrochemical biosensor test strips.
In another embodiment of the present invention there is an analyte test strip card including a sheet having a plurality of biosensor test strips. Each strip is detachably connected to adjacent strips. Each strip also has at least a portion of an edge detachably connected to a retaining platform extending around at least a portion of a perimeter of the sheet.
In one refinement the platform is U-shaped.
In another refinement the platform includes a ROM key.
In another refinement the card is one of a plurality of cards stacked atop one another, and the stack of cards is enclosed within an air tight shrink seal.
In another refinement each of the plurality of strips has a corresponding recloseable cover overlapping a reagent portion of the strip.
In another refinement the card is substantially the size of a credit card.
In another refinement the plurality of strips are a two dimensional array of electrochemical biosensor test strips for measuring blood glucose.
In another refinement the card is in combination with a blood glucose meter having a back face, wherein the card is a blood glucose test strip card having a size permitting retention by the back face of the meter
In another embodiment of the present invention there is an analyte test strip card including a substantially flat sheet having a two dimensional array of electrochemical biosensor test strips. The sheet includes means for separating each of the plurality of electrochemical test strips.
In one refinement there are a plurality of recloseable covers. Each cover is attached to a corresponding test strip and overlaps a reagent test portion of the strip.
In another refinement a border zone extends around at least a portion of a perimeter of the sheet. The plurality of test strips are detachably connected to the border zone.
In another refinement the card is substantially credit card sized.
In another refinement a border zone extends around at least a portion of a perimeter of the sheet. The plurality of test strips are detachably connected to the border zone, and include a ROM key positioned in a portion of the border zone. The ROM key includes information relating to the plurality of test strips.
In another refinement the card is in combination with a blood glucose meter having a back face, wherein the card is a blood glucose test strip card having a size permitting retention by the back face of the meter.
In another embodiment of the present invention there is an analyte test strip card including a plurality of biosensor test strips. Each test strip has a reagent portion and a recloseable cover that overlaps the reagent portion. The strips are in a two dimensional array and are at least partially retained within a substantially credit card sized platform. Each strip in at least one row of strips is connected to adjacent strips by a first means for separating adjacent strips and is connected to the platform by a second means for separating strips from the platform.
In one refinement the second means for separating the strips from the platform are spaced contact points joining the strips to the platform.
In another refinement the card further includes a data storage device and a BIT activated key, each key positioned in a different portion of the platform.
For purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
Satisfying the preferences of individual diabetics with respect to management of their bG levels is important to aid compliance with treatment protocols. Discrete and easy to use products for diabetics make managing their bG levels easier and more convenient. A person with diabetes needs to have with them all items necessary to test their Blood Glucose levels. This occurs at various times while the diabetic is out and busy during the day. The diabetic wants to have bG meter test strips with them, but also wants to keep them easy to carry and discrete.
Test strips have storage requirements and come in varying storage apparatus, but most typically come in round or oval containers that are about one inch in diameter by two inches long. Other storage apparatus includes test strips in circle shaped disks (Ascensia Breeze [Bayer]) that are loaded into the meter all together. Additionally, test strips are also available individually (Medisense Pen Meter), typically individually foil wrapped test strips (e.g. Medisense Companion [Abbott]). Carrying the bG test strips individually is difficult due to strip storage requirements. At least some diabetics would prefer an easy way to carry bG meter test strips that are easy to hide, meet storage requirements and can be used individually. The existing approach has been to provide strips within the meter and/or to make use of strip packaging that is added to the meter while testing.
Various embodiments of the present invention enable packaging or cartridge footprints distinctly different than traditional oval vials, such as a substantially flat or flat storage apparatus. Refinements of such embodiments of a test strip card might further include other features as preferred. Examples of such refinements include, but are not limited to, embodiments having a data storage device (including, but not limited to, a ROM key) and/or a BIT activated feature key that provide the meter user with more functionality and information. Other refinements include using the count on the cards to drive a diabetic's testing behaviors and match the recommendations of their healthcare provider. If a patient is to test every hour, then a 12 count card might be a way of matching their day's testing needs. If a child is to test 4 times a day, then the patient or parent might use a 16 count card as a way to track the testing frequency. This might also be used as a means for doctors to track patient usage via prescriptions that identify a card count and number of cards similar to current pills. It is contemplated as within the scope of the invention that the packaging could be an individual card of strips or, alternatively, cards sold in stacks like playing cards to accommodate various strip counts. Similarly, it is further contemplated that single cards or multiple cards could be packaged in an air tight ‘shrink’ seal for safe shelf life.
Various embodiments of the present invention include providing multiple biosensor test strips in a sheet. The test strips are detachable from neighboring test strips. The test strips are also detachable from other fixation point(s), as when the card includes a retaining platform that borders a portion, or the entirety, of the external perimeter of the sheet. Detachability of each individual test strip from neighboring strips and/or any border area is preferably implemented via perforations or other means for separating or tearing with little to no damage to the strips. Examples of such means for separating or tearing include, but are not limited to, perforations, scoring, indentations, grooves, slots, channels, creases, and other rupturable links between the test strips. Such means for separating preferably permit a prepared separation of each strip to aid in consistent removal with little to no damage to the strips. Furthermore, such means for separating might be spaced contact points that only require a bend to ‘snap’ the needed strip from the rest of the strips (and/or from any surrounding perimeter of the border zone of a retaining platform if present). Thus, the perforations used might be similar to that used in store savings or coupon cards, or a credit card with smaller break-off key fob card attached.
The sheet, or combination of sheet and retaining platform, is preferably, but not necessarily, approximately the size (and/or shape) of a standard credit card as, for example, defined by ISO 7810 and ISO 7813 (that define the size as 85.60 mm×53.98 mm×0.76 mm thick with 3.18 mm radius corners). Rounded corners may or may not be present as preferred. Packaging several strips within a card whose size is comparable to a credit card permits the user to store as with credit cards in personal items (wallet, purse, pockets), and to use without drawing attention to oneself because of current storage size, shape and ease of access. It will be understood that it is contemplated as within the scope of the invention that the sheet, or combination of sheet and retaining platform might be sized and shaped other than credit card sized. An example of the same is discussed below with respect to
The individual test strips in the sheet preferably, but not necessarily, have a recloseable protective ‘film’ or cover. The cover preserves the testing end of the strip prior to use, and then may also be used to cover the used test strip for disposal. Putting this protective ‘film’ back over the testing end after a sample has been tested aids in a more sanitary disposal of the used test strip. Furthermore, it should be understood that the protective ‘film’ covering does not need to be separated from the test strip when removed for using the reagent test portion, and is instead preferably recloseable. Such a protective cover is disclosed in, for example, U.S. Pat. No. 7,063,774 B2 to Bhullar et al. entitled “Recloseable Biosensor” that is assigned to the assignee of the present invention and is incorporated herein by reference. The protective ‘film’ used to cover the end or other portion of the strip that receives blood for testing will be secured to the test strip. It will have the ability to be ‘peeled’ back to expose the test area and preferably also have the ability to be put back or re-applied over the tested area covering the used end with the blood sample prior to disposal. Similarly, examples of biosensors (and/or methods for manufacturing the same) for use in the present invention include, but are not limited to, U.S. Pat. No. 5,413,690 to Kost et al. entitled “Potentiometric Biosensor And The Method Of Its Use”; U.S. Pat. No. 5,762,770 to Pritchard et al. entitled “Electrochemical Biosensor Test Strip”; U.S. Pat. No. 6,645,359 to Bhullar et al. entitled “Biosensor”; U.S. Pat. No. 6,662,439 to Bhullar entitled “Laser Defined Features For Patterned Laminates And Electrodes”; and U.S. Pat. No. 7,073,246 to Bhullar et al. entitled “Method Of Making A Biosensor”; all assigned to the assignee of the present invention, and all incorporated herein by reference.
It should be understood that it is contemplated as within the scope of the invention that the sheet of test strips might further include a retaining platform. Such a platform might provide a ‘surround’ area or border zone that retains some or all strips until each strip is detached as, for example, being ‘snapped’ out. The surround area can be, for example, a “U” shape, allowing one end to be the start for removing test strips and protection for all strips not yet removed. For example, in one application the surround area might define the overall size to replicate a credit card size and/or shape (or, as previously mentioned, possess a size and shape tailored to mate with an analyte meter, such as a blood glucose meter). This allows the shape to be consistent even with the last strips (after detachment and removal of many of the strips), with some or all of the strips remaining protected and less likely to be lost. Alternatively, the ‘surround’ might define one or more (two being an example) polygon space(s), particularly a rectangle. Each such space receiving within it a sheet of test strips and the strips being detachably connected to the surround area as well as to neighboring strips.
It should further be understood that it is contemplated as within the scope of the invention that the border zone or ‘surround’ area can be used for advertisement, barcode, data storage device, BIT activated feature set key device, company logos and/or other product information. Such data storage device and/or BIT activated key might be detached via the previously described snap off mechanism, or may be connected to the card via a connection that permits reconnection to the border zone of the card.
The data storage device can be used, for example, to calibrate the meter with respect to any lot to lot variation of the test strips of the card while still attached to the card. Alternatively, the data storage device might be removed from the card for insertion and retention within the meter. In one refinement, each test strip card includes a ROM key, even when several test strip cards are bundled together. In yet another alternative, a single data storage device is included with the lead card for a ‘pack’ of cards. In yet another alternative, a data storage device might be separate from a single card or a ‘pack’ of cards. Each of these different possibilities allow for multiple count packaging, thus permitting a combination of cards ‘bundled’ for sale and customer needs. The data storage device might also include information relating to the test strips other than meter calibration information, such as information calibrating the number of test strips associated with a card or ‘pack’ of cards. The data storage device might be, for example, some type of ROM key, some other type of integrated circuit memory chip, a three dimensional or two dimensional bar code, or a swipable magnetic strip, or even an RFID chip. Examples of a ROM key data storage device and types of data stored thereon include those disclosed in U.S. Pat. No. 5,053,199 to Keiser et al. entitled “Electronically Readable Information Carrier” and U.S. Pat. No. 5,366,609 to White et al. entitled “Biosensor Meter With Pluggable Memory Key”, both assigned to the assignee of the present invention, and both incorporated herein by reference.
The BIT activated feature set key can provide the means for several options of information, demonstrations and/or interactive programs to be run on the meter device. As an example, the Accu-Check Advantage 3 meter from Roche Diagnostics Corporation, an affiliate of the assignee of the prevent application, had a bit activated feature set ‘ROM key’ type of chip that could be used with the meter. In one or more embodiments of the present invention a BIT activated feature set key could be used for tutorials, owner's and/or user's manuals for the meter, other reference information and interactive games to be displayed and run on the meter. All of these and more options might be programmed into the BIT activated feature set chip and used on the bG meter. Thus, the test strip cards could have short movies, games or instructional items or videos, and the bG meter would receive the key and display or show the same on the meter ‘screen.’
Discrete carrying of test strips in, for example, a ‘credit card’ standardized shape provides a solution for diabetics that want a substantially flat or flat method of storage that fits compartments they already have available to them. That is to say, storage in multiple types of personal carry along items (e.g.: wallet, purse, pockets). At least some of the embodiments of the invention described herein are also easy for the diabetic consumer due to the ‘break-off’, or ‘snap-out’ method of removing individual test strips. Such connects the common consumer to familiar concepts that are already present in the consumer's world outside of medical evaluation, such as store cards and discount cards that often include a bar code, or other encoded transaction cards or tags.
It will be understood that that biosensor test strips other than electrochemical test strips are contemplated as within the scope of the invention, such as, for example, optical test strips. It will further be understood that the test strips are not limited to use in testing blood glucose, and that testing of other analytes is contemplated as within the scope of the invention.
All of the above and other aspects will now be discussed further below with respect to specific examples illustrated in the figures.
While meters have grown smaller and easier to carry, the diabetic still needs to carry a container of strips that is approximately one inch in diameter by about two inches long, or carry strips individually that may have unique storage needs. Thus, various embodiments of the present invention have the test strips in a sheet. The sheet and/or associated retaining platform are preferably, but not necessarily, about the size of a credit card for ease of carrying and storage discretely. Each test strip is removable for individual use.
With reference to
The count of the card illustrated in
With reference to
With reference to
With reference to
With reference to
ROM keys sold with existing products are typically a ‘chip’ that is ‘pressed’ or added to a plastic holder that accommodates the mating ‘slot’ on the meter. In embodiments of the present invention, however, a separate plastic holder is not required. For example, in one embodiment the data storage device could be manufactured utilizing critical traces contained with laser etched configurations that burn away contacts as on a detachable strip and then ‘heat stack’, ‘sonic weld’ or ‘bond’ the chip circuit board to the retaining platform so that the data storage device is attached like a detachable test strip. With reference to
With reference to
With reference to
With reference to
The card 900 preferably has a height and a width approximately that of a credit card. Each test strip 905 has dimensions corresponding to existing test strips (ACCU-CHECK® Performa strips) manufactured by Roche Diagnostics Operations Inc., the assignee of the present application, having a thickness 907 of approximately 7 mm and a standard length 917 of about 38 mm. As illustrated in
The card 900 has a two dimensional array of 7 mm wide strips 905 in a vertical layout. A two dimensional array of 9 mm strips having a shortened length in a similar vertical layout yields eight rows of two strips resulting in a sixteen count card. Such a card is illustrated in
With reference to
The card 1000 preferably has a height and a width approximately that of a credit card. Each test strip 1005 has dimensions corresponding to a shortened length version of existing test strips (ACCU-CHECK® Performa strips) manufactured by Roche Diagnostics Operations Inc., the assignee of the present application, having a thickness of approximately 7 mm. The card 1000 is laid out as eight rows with two strips in each row, the count of the card illustrated in
With references to
Test strip card 1100 has a plurality of electrochemical biosensor test strips 1105 in a two dimensional array. In this embodiment the card 1100 includes a surround area 1142 at only one end of the card 1100. The card 1100 includes means for separating 1140 adjacent test strips 1105 from one another as well as means for separating 1140 test strips 1105 from the surround area 1142. The means for separating 1140 are preferably perforations in the edges of adjacent test strips that are only joined at connecting points 1140. Each test strip extends between a first end 1110 and a second end 1120. Each test strip 1105 has a reagent test portion (not illustrated in
The card 1100 preferably has a height and a width approximately that of a credit card. Each test strip 1105 has dimensions corresponding to a shortened or standard length version of existing test strips (ACCU-CHECK® Performa strips) manufactured by Roche Diagnostics Operations Inc., the assignee of the present application, having a thickness of approximately 7 mm. The card 1100 is laid out as eight rows with two strips in each row, the count of the card illustrated in
With reference to
The card 1200 preferably has a height and a width approximately that of a credit card. Each test strip 1205 preferably has dimensions corresponding to a shortened length version of existing test strips (ACCU-CHECK® Performa strips) manufactured by Roche Diagnostics Operations Inc., the assignee of the present application, having a thickness of approximately 7 mm. The card 1200 is laid out as eight rows with two strips in each row, the count of the card illustrated in
Instead of being patterned after the size of a credit card, the test strip card could be patterned after the size of the analyte meter. In various embodiments the test strip card might be sized and shaped to be carried, concealed and/or retained on the back of the analyte meter. It will be understood that the meter might be configured to retain multiple test strip cards, or even a shrink wrapped pack of test strip cards. In one embodiment the analyte meter is a blood glucose meter, however meters for other analytes are contemplated as within the scope of the invention.
With reference to
With reference to
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the spirit of the inventions are desired to be protected. It should be understood that while the use of words such as preferable, preferably, preferred or more preferred utilized in the description above indicate that the feature so described may be more desirable, it nonetheless may not be necessary and embodiments lacking the same may be contemplated as within the scope of the invention, the scope being defined by the claims that follow. In reading the claims, it is intended that when words such as “a,” “an,” “at least one,” or “at least one portion” are used there is no intention to limit the claim to only one item unless specifically stated to the contrary in the claim. When the language “at least a portion” and/or “a portion” is used the item can include a portion and/or the entire item unless specifically stated to the contrary.
