HK1129552B - Lancet integrated test element tape dispenser - Google Patents

Description

Lancet-integrated test element tape dispenser

Technical Field

The present invention relates generally to body fluid sampling devices, and more particularly, but not exclusively, to a lancet integrated test element unit dispenser configured to reduce the risk of unit damage prior to use.

Background

The acquisition and testing of bodily fluids is beneficial for many purposes and is of increasing importance for use in, for example, medical diagnosis and treatment of diabetes, as well as other diverse applications. In medical applications, it is desirable that a laboratory operator can routinely, quickly and repeatably perform tests outside of a laboratory facility, quickly arrive at results, and read the resulting test information. The tests may be performed on different body fluids and for some applications are particularly relevant for the testing of blood and/or interstitial fluid. Performing home testing is difficult for many patients, particularly patients with limited hand dexterity, such as elderly or diabetic patients. For example, diabetics sometimes experience numbness or tingling in their extremities, such as their hands, making self-testing very difficult due to their inability to accurately position a test strip to collect a blood sample. In addition, wounds of diabetics heal more slowly and it is therefore desirable to make incisions less invasive.

In recent years, lancet integrated test strips or elements have been developed that are integrated with a lancet or other lancing device to form a single disposable unit. While these integrated units have somewhat simplified the collection and testing of fluid samples, there are a number of problems that need to be addressed before commercial use. One problem relates to keeping the lancet sterile prior to use in order to reduce the risk of infection. Another problem relates to the handling of used units after use. Once used, the integrated unit becomes a biohazard and needs to be disposed of in a safe manner. Many different types of systems have been proposed for dispensing test strips, lancets or some combination thereof, but most of these systems have significant drawbacks, particularly when used in conjunction with an integrated unit.

In one typical configuration, a single test strip is stacked within the cartridge. The test strips are typically dispensed individually, either manually or via a slide mechanism. Automated handling of test strips is rather complicated due to the individual dispensing of test strips. The slide mechanism can jam during dispensing, damaging the test strip. Typically, after use, the test strips must be manually disposed of via a separate waste container.

Individual test strips or elements have been formed and/or joined together to form a strip of test strips. In one configuration, the tape is folded within the cartridge and individual test elements are manually dispensed by pulling on the tape. However, in the age of smaller fluid sample sizes where the size of the test strip becomes smaller and smaller, manual supply and handling of the strip is not practical due to the size of the test strips involved. Such a manual feeding structure cannot be used for automatic feeding of the strip and automatic handling of the used part of the strip, which usually requires a modern system. To overcome this problem, automatic supply systems such as roll-to-roll cartridges have been developed.

The structure of such reel-to-reel cartridges of test strips is similar to conventional tape cartridges, overcoming many of the test strip handling and storage problems that have previously occurred in test strip cartridge structures. However, it has been found that reel-to-reel cartridges also suffer from a number of significant drawbacks, particularly electrochemical test strips, lancet integrated test strips, and other disposable items that contain easily damaged components. For example, if the electrochemical test strip is tightly wound around a spool within the cartridge, the electrodes within the test strip may bend or break, creating a short circuit, a disconnection condition, or otherwise damaging the electrodes, thereby rendering the test strip unusable. Similarly, if tightly wound around a reel, the lancet within the integrated unit can bend or otherwise become damaged, which in turn can cause injury to the user or otherwise fail to successfully puncture the skin. To overcome this problem, the strip or integrated unit of test strips is loosely wound around a reel. However, the loosely wound strip makes the cartridge larger than necessary and/or reduces the number of tests that can be performed before a new cartridge needs to be reloaded. Even when the tape begins to wind in a loose manner, the tape may become tightly wound as the tape is dispensed, thereby damaging the tape. In addition, the reel-to-reel cartridge configuration tends to operate in reverse, resulting in reintroduction of the used test strip into the sterile supply compartment.

Therefore, there is a need for further contributions in this area.

Disclosure of Invention

One aspect relates to a lancet integrated test strip that includes a plurality of lancet integrated test cells. The lancet integrated test units each include a lancet configured to form an incision in tissue and a test element configured to analyze body fluid from the incision in the tissue. The cartridge includes a supply compartment configured to store an unused portion of the tape. The tape is folded within the supply compartment to limit damage to the lancet integrated test unit.

Another aspect relates to a strip that includes a plurality of test elements configured to analyze bodily fluid. The cartridge includes a supply compartment configured to store an unused portion of the tape. The unused portion of the strip is folded in the supply compartment. The cartridge also includes a waste compartment configured to store a used portion of the tape. An indexing mechanism is configured to index the tape between the supply compartment and the waste compartment.

Another aspect relates to a strip that includes a plurality of test elements configured to analyze bodily fluid. The cartridge includes a supply compartment configured to store an unused portion of the tape. The unused portion of the strip is folded in the supply compartment. The cartridge also includes a waste compartment configured to store a used portion of the tape. The used portion of the strip is folded within the waste compartment.

Another aspect relates to a technique in which a plurality of test elements configured to analyze bodily fluids are assembled on a sterility sheet. A plurality of piercing members configured to pierce tissue are enclosed within the sterility sheet. Each piercing member is associated with one of the test elements so as to form a strip of integrated sampling elements.

Other forms, objects, features, aspects, advantages, and embodiments of the present invention will become apparent from the detailed description and the accompanying drawings set forth herein.

Drawings

FIG. 1 is an exploded view of a lancet integrated test element tape according to one embodiment;

FIG. 2 is a bottom view of a cartridge containing the test element strip of FIG. 1;

FIG. 3 is a partial cross-sectional view of the cassette of FIG. 2;

FIG. 4 is a front view of a meter connected to the cartridge of FIG. 2;

FIG. 5 is a first front view showing electrodes for a lancet integrated test element tape according to another embodiment;

FIG. 6 is a second front view of the test element strip of FIG. 5 once assembled;

FIG. 7 is a front view of a lancet integrated test element tape according to another embodiment;

FIG. 8 is a cross-sectional view of a cassette according to yet another embodiment;

FIG. 9 is a front view of a lancet integrated test element according to another embodiment;

FIG. 10 is a cross-sectional view of a cassette according to yet another embodiment;

FIG. 11 is a front view of a test element strip according to another embodiment;

FIG. 12 is a front view of a lancet element tape configured for use with the test element tape of FIG. 11;

FIG. 13 is a cross-sectional view of a cassette according to another embodiment;

FIG. 14 is a front view of a test element strip according to another embodiment;

FIG. 15 is a front view of a lancet element tape configured for use with the test element tape of FIG. 14;

FIG. 16 is a cross-sectional view of a cassette according to yet another embodiment.

Detailed Description

For the 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. Various embodiments of the invention are described in detail; although those of ordinary skill in the art will appreciate that certain features that are not relevant to the present invention are not shown for the sake of brevity. It should be noted that directional terms such as "upward," "downward," "top," and "bottom" are used herein for the convenience of the reader only to aid the reader in understanding the described embodiments, and it is not intended that the use of such directional terms in any way limit the described, illustrated, and/or claimed features to a particular direction or orientation.

As mentioned above, prior art cartridge or cassette constructions suffer from a number of drawbacks. If tightly wound around a supply reel of a reel-to-reel cartridge or other cartridge type, for example, the lancet tape, test strip, and/or lancet integrated test element (LIT) unit can be damaged. To overcome these and other problems, the LIT tape according to one embodiment is stored in a folded fashion within a supply compartment. By storing in a folded manner, the tension applied to the tape during indexing is typically applied to only a few LIT units, which in turn reduces the chance of the LIT units being damaged. To further reduce the chance of damage to the LIT units, a feed mechanism may be used to automatically feed the tape between the supply and waste compartments of the cartridge. The supply mechanism allows the LIT units to be properly positioned for lancing and sample collection without any user manipulation.

The LIT tape 19 according to one embodiment will be described initially with reference to FIG. 1. Referring to fig. 1, the tape 19 includes a plurality of LIT devices or units 20. For information that may be had about the individual cells 20, reference may be made to U.S. patent application No.11/070502, filed 3/2/2005, which is incorporated herein by reference in its entirety. Each unit 20 includes a lancet assembly or incision forming member 22 for forming an incision in tissue, a sterility sheet 24 for keeping the lancet assembly 22 sterile and connecting the units 20 together, and a test strip 26 for obtaining body fluid from the incision. In the illustrated embodiment, the incision forming member 22 will be described with reference to a lancet. It should be noted that the lancet 22 can include other means for perforating, cutting, piercing and/or otherwise rupturing tissue, such as a needle and blade. The lancet 22 and test strip or element 26 are generally flat in the illustrated embodiment, such that the lancet integrated test strip 20 has a generally flat appearance. Although the common term "test strip" is used to aid the reader in understanding the embodiments described below, it should be noted that the test element or other biosensors described herein should not be limited to those elements shaped in the form of a strip, but rather the test element may be shaped differently. Being flat, the plurality of cells 20 can be folded in a compact manner within the cartridge, allowing the plurality of cells 20 to be used without the need for separate loading and/or handling of the used cells 20. In addition, the generally flat shape allows the LIT tape 19 to be manufactured in a continuous process, wherein multiple layers of constituent materials may be layered to form a continuous strip of cells 20. It should be noted that the LIT tape 19 and/or the LIT units 20 can have different overall shapes in other embodiments.

As shown in FIG. 1, the lancet assembly 22 has a holder or guide member 28 that guides a piercing member or lancet 30 during lancing. The lancet 30 is slidably retained within a guide slot or opening 30 defined in the holder 28. The guide slot 31 guides the movement of the lancet 30 during extension and retraction during lancing. In the illustrated embodiment, the lancet 30 and the holder 28 are separate components that are not directly connected to each other. Unless, in other embodiments, the lancet 30 and the holder 28 can be connected to each other. For example, the lancet assembly 22 can have breakable tabs that connect the lancet 30 to the holder 28 so that the lancet 30 can be held in place during manufacture and prior to lancing, thereby reducing the risk of injury. During lancing, the tabs are damaged such that the lancet 30 extends from the lancet integrated test strip 20. In another example, a spring for retracting the lancet 30 couples the holder 28 to the lancet 30.

As shown, the end stops 32 of the holder 28 extend inwardly at the elongated opening 34 of the guide slot 31 to limit the movement of the lancet 30, thereby retaining the lancet 30 within the guide slot 31. The lancet 20 has a body portion 35 with one or more stop edges 36 that are wider than the elongated opening 34. When the lancet 30 is fully extended, the stop edge 36 of the lancet 30 will contact the end stop 32 and thus limit the travel of the lancet 30. However, in other embodiments, the firing mechanism used to fire the lancet 30 limits the travel of the lancet 30. A neck portion 37 of the lancet 30, which is slightly smaller than the size of the elongated opening 34, extends from the body portion 35 of the lancet 30. The constriction 37 is received between the end stops 32 during extension of the lancet 30 so that the end stops 32 limit unwanted rotation of the lancet 30 during puncturing of tissue, the lancet 30 having a blade portion or tip 38 configured to cut tissue extending from the constriction 37. In the illustrated embodiment, the lancet defines an engagement notch 39 for connecting the lancet 30 to the firing mechanism. In one form, the lancet assembly 22 is at least partially made of medical grade stainless steel, but it should be understood that the lancet assembly 22 can be made of other materials, such as ceramics and/or plastics. Additionally, it is contemplated that the guide member 28 and lancet 30 can be made of different materials and/or manufactured separately. In one embodiment, the guide member 28 and lancet 30 are formed by a photolithographic technique in which a sheet of metal is lithographically printed to form the guide member 28 and lancet 30, and in another embodiment, the lancet assembly 22 is manufactured via stamping. The lancet assembly 22 can be manufactured in other embodiments via other techniques as will be appreciated by those of ordinary skill in the art.

Referring to FIG. 1, after the lancet assembly 22 is formed, the lancet assembly 22 can then be loaded into the sterility sheet 24. As will be appreciated below, the lancet assembly 22 can be packaged within the sterility sheet 24 before, during, or after the lancet assembly 22 is sterilized. In the illustrated embodiment, the sterility sheet 24 is a sheet of metal foil, and in another embodiment, the sterility sheet 24 is made of plastic. It should be understood that the sterility sheet 24 can be made of other types of materials. During manufacture, the sterility sheet 24 is folded into two flaps 40 with a crease or fold 42 between the two flaps, as shown in FIG. 1. After folding, the lancet assembly 22 is clamped between the two flaps 40 such that the crease 42 closes the slot opening 34 of the guide slot 31 in the lancet assembly 22. The flaps 40 are secured to opposite (flat) sides of the lancet assembly 22 such that the lancet 30 is sealed within the guide slot 31 with the slot opening 34 closed by the crease 42. In one form, an adhesive is used to secure the sterility sheet to the guide member 28. Adhesive is applied to the guide member 28 around the guide slot 31 but not to the lancet 30 so that the lancet 30 can slide within the guide slot 31. Although in the illustrated embodiment, adhesive is used and the edges of the flaps 40 are not sealed together, it is contemplated that in other embodiments the edges of the sterility sheet 24 can be sealed together to form a pouch that encloses the entire lancet assembly 22. In yet another embodiment, instead of folding the sterility sheet 24, two sterility sheets 24 are joined together and the lancet assembly 22 is sandwiched between the two sterility sheets 24.

As shown, the integrated lancing test strip 20 in one embodiment is formed in a continuous process. In a continuous process, the sterility sheet 24 is a continuous strip of tape or ribbon that is unwound from a roll and wrapped around the lancet assembly 22, as is unwound from a roll. The lancet assembly 22 is sealed between the flaps 40 of the sterility sheet 24, and the test element 26 is attached to the sheet 24 in the manner described. The sterility sheet 24 is joined together adjacent the LIT units 20 to form a continuous LIT tape 19. Between the individual units 20, the sterility sheet 24 has creases or lines of weakness 43 that allow the tape 19 to be folded in a folding fan for storage. The fold lines 43 may also be configured to allow the individual units 20 to be disengaged from each other. The sterility sheet 24 can be weakened at the fold line 43 in any manner known to those of ordinary skill in the art. For example, the sheet 24 may be scored or thinned at the fold line 43, and it is contemplated that the fold line 43 may be continuous or discontinuous. The fold line 43 can be formed before or after the lancet assembly 22 is covered by the sterility sheet 24. It is contemplated that the fold line 43 may be optional in other embodiments such that the strap 19 is folded naturally in a folding fan or other manner.

Once joined together, the lancet assembly 22 and sterility sheet 24 form a lancet package or assembly 44. As described above, the lancet assembly 22 can be sterilized before or after being enclosed in the sterility sheet 24. The lancet assembly 22 can be sterilized via any sterilization technique known to those of ordinary skill in the art, such as via chemical and/or assisted sterilization techniques. It should be understood that all or a portion of the lancet assembly 22 can be sterilized. If desired, for example, only the lancet 30 and the guide slot 31 can be sterilized. In another embodiment, the lancet assembly 22 is sterilized after the lancet assembly 22 is packaged in the lancet package 44. In one form, the radiation sterilization technique is used once the lancet 30 is closed by the sterility sheet 24. With the lancet package 44, sterilization of the lancet assembly 33 can be performed without exposing the test strip 26 to the adverse effects of lancet sterilization. Thus, a particular batch of calibration data can be formed before the lancet package 44 is attached to the test strip.

In the illustrated embodiment, the test strip 26 is an electrochemical type test strip. In one particular form, the test strip 26 includes any ACCU-CHEKA variant of the brand test strip (roche diagnostics GmbH), but it is envisaged that other types of test elements may be used. For example, the test strip 26 may include an optical type test strip in other embodiments, or may otherwise analyze the fluid sample. At one end, the test strip 26, in the illustrated embodiment, includes a connection portion 46 having electrical contacts 47 that communicate the sample reading to the meter. Opposite the connecting portion 46, the test strip 26 has a capillary channel 48 with an opening configured to draw a body fluid sample from the incision formed by the lancet 30 via capillary action. It should be understood that the test strip 26 within the capillary channel 48 includes an analysis region that includes electrodes such as a working electrode, a counter electrode, and a reference electrode, as well as reagents for analyzing the fluid sample. In one form, the connection portion 46 is connected to a meter and sample readings from the electrodes of the analysis area are transferred to the meter via electrical contacts.

As briefly described above, the sterilized lancet package 44 is attached to the test strip 26 to form the lancet integrated test strip unit 20. As described above, the lancet package 44 is attached at the end of the test strip 26 proximate the capillary opening 49 of the capillary channel 48. In particular, the guide slot opening 34 of the lancet assembly 22 and the capillary opening 49 of the test strip 26 are positioned adjacent to one another in a side-by-side relationship such that the capillary channel opening 49 is positioned adjacent to collect body fluid when the lancet 30 forms an incision. The test strip 26 is attached to the exterior of the sterility sheet 24 enclosing the lancet member 22 to complete the integrated test strip 20. One form of the test strip 26 is attached to the lancet package 44 via an adhesive, but it should be understood that the test strip 26 and lancet package 44 can be attached in other ways. In one form, the lancet package 44 is attached to the test strip 26 such that the end edges of the two are aligned with each other. However, in other embodiments, the edges of the lancet package 44 and the test strip 26 can be offset from one another. For example, the edge of the lancet package 44, represented in the illustrated embodiment by crease 42, is slightly recessed from the edge of the test strip 26 at the capillary opening 49. By recessing the lancet package 44, fluid flow to the capillary channel opening 49 is enhanced. In another example, the sterility sheet 24 is positioned such that the crease 42 extends past the edge of the test strip 26. With this example, all or a portion of the sterility sheet 24 can be hydrophilic or hydrophobic to direct fluid flow toward the capillary channel 48. In one particular form, the sterility sheet 24 extends from the test strip 26 such that the sterility sheet 24 serves as a flexible absorbent structure that draws fluid into the capillary channel 48.

In order to draw body fluid toward the capillary channel opening 49 and away from the lancet 30, the test strip 26 has a fluid directing notch facing the lancet package 44 in the illustrated embodiment. To enhance the flow of fluid toward the capillary passage openings 49, the sterility sheet 24 can be treated and/or made hydrophobic. Because the sterility sheet 24 is hydrophobic, the sterility sheet can scrape or wipe body fluid off the lancet 30 as the lancet 30 retracts into the guide slot 31. It is contemplated that the scraping action of the sterility sheet 24 increases the amount of body fluid available for sampling and makes the lancet 30 cleaner for disposal. As described above, because the lancet 30 is sealed within the lancet package 44, the risk of cross-contamination of the lancet 30 and the test strip 26 is reduced.

In FIG. 1, the test strip 26 also defines a relief slot 51, the blade tip of the cam arm extending when engaging the lancet 30 during loading and firing. Additionally, the relief slots 51 may be used to vent air from the capillary channel 48 as fluid is collected. The length of the relief slot 51 is approximately the length of the lancing stroke of the firing mechanism used to actuate the lancet 30. When the lancet package 44 is attached to the test strip 26, the engagement notch 39 on the lancet 30 aligns with the relief slot 51 in the test strip 26. As described in more detail in US patent application No.11/070502 filed on 3/2/2005, which is incorporated herein by reference, the blade tip of the cam arm for the firing mechanism extends through the engagement notch 39 of the lancet 30 and into the relief slot 51. At this point, the blade tip pierces the sterility sheet 24. During lancing, the cam arm extends and retracts the lancet 30 relative to the test strip 26 via the blade. As the lancet 30 extends, the tip 38 of the lancet 30 pierces the sterility sheet 24 at the crease 42. In one form, the sterility sheet 24 at the crease 42 is weakened to facilitate penetration by the lancet 30, but in other forms the crease 42 is not weakened. Once the lancet 30 is retracted into the guide slot 31, the two flaps 40 of the sterility sheet 24 can hold the lancet 30 inside via friction. By engaging the lancet 30 in this manner, the risk of accidental lancing by the integrated lancet test strip 22 is reduced because it is more difficult to manually and/or accidentally actuate the lancet 30. It should be understood that the lancet assembly 22 can incorporate other structures for engaging the lancet 30. For example, the engagement notch 39 in the lancet 30 can be replaced by a tab or handle. It is also contemplated that the lancet can be fired via non-mechanical and/or non-contact techniques without the need for puncturing of the sterility sheet 24. As one example, the lancet 30 is magnetized in another embodiment and is magnetically excited via a voice coil driver or other magnetic driver. Because the lancet 30 is enclosed within the sterility sheet 24 before and after lancing, the risk of contamination is reduced, and the risk of accidental injury is likewise reduced.

A cartridge or magazine 60 containing test element strips 19 is shown in FIGS. 2 and 3. FIG. 2 shows a top view of the cartridge 60 and FIG. 3 shows a partial cross-sectional view of the cartridge 60. As shown, the cartridge 60 includes a supply compartment 62 for storing the LIT units 20 and a waste compartment 64 for storing the used units 20. As described above, the LI T cells 20 on the tape 19 are folded in the form of a folding fan along the fold line 43 within the supply compartment 62. As described above, the LIT and test strips can be damaged when wound around a spool within the cartridge. For example, when tightly wound around a reel in a reel-to-reel cartridge, the lancet within the LIT can bend, or the electrodes, capillary channel, and/or chemicals within the test strip can be damaged. To avoid damage, the tape is typically wound in a loose manner within the roll-to-roll cassette, which tends to waste space. Even if loosely wound, the lancet and/or test strip can bend or otherwise become damaged. As the tape is indexed within the spool-to-spool cassette, the tape around the supply spool may become taut, which in turn may damage components of the tape.

In contrast, the tape 19 of fig. 3 is folded along the fold line 43 within the supply compartment, which in turn eliminates various problems. When folded, the strip 19 in one form may have a crease at the fold line 43 or in other forms no crease. The individual LIT units 20 remain substantially flat or straight as the tape 19 is folded along fold line 43, reducing the risk of damage. Furthermore, when the tape 19 is folded, the LIT units 20 can be stacked closely within the supply compartment 62 without damaging the LIT units 20. In addition, the tape 20 can be indexed without causing significant damage to the LIT units within the folded supply tape 19, since the pulling force for indexing is typically applied to only a few LIT units 20 to be used. In the illustrated embodiment, the tape 19 is folded in alternating folding fans, but it should be understood that the tape 19 may be folded in other ways. For example, the tape 19 may be folded in an accordion fashion, and/or in another embodiment, the tape 19 includes blank portions between the fold lines 43 that do not include the LIT units 20.

Between the supply compartment 62 and the waste compartment 64, the cartridge 60 has a sampling portion 66 where the LIT units 20 sample bodily fluids and a stabilizing arm 68 that stabilizes the connection between the compartments 62, 64. In other embodiments, the sampling portion 66 and/or the stabilizing arm 68 are optional or may be eliminated. As described above, the sampling portion 66 and the stabilizing arm 68 define a meter cavity 70 that receives at least a portion of a meter. In one embodiment, a firing cam arm of the meter that is configured to engage the engagement notch 39 of the lancet 30 during lancing extends within the meter cavity. In the illustrated embodiment, the sampling portion 66 is normally closed to facilitate maintaining sterility of the cartridge 60, but the sampling portion 66 also incorporates a plurality of openings for engaging the LIT units 20 during sampling. Referring to FIG. 2, the sampling portion 66 near the top of the cartridge 60 and facing the meter once engaged has a contact opening 72 where the contacts of the meter engage the contacts 47 on the LIT unit 20. At the bottom of the cartridge 60, which contacts and faces the tissue during fluid acquisition, the sampling portion 66 of the cartridge 60 has a sample opening 74 through which the lancet 30 extends during lancing, and the test strip 26 collects fluid during sampling. Near the sample opening 74, the cartridge and/or meter may incorporate multiple surfaces (or mechanisms) configured to transfer fluid and/or direct fluid flow. Facing the meter opening 70, the sampling portion 66 of the cartridge 60 has a lancet engaging cavity 76, and the firing arm of the meter can engage the engagement notch 39 in the lancet 30 via the cavity 76. It is contemplated that sampling portion 66 may be otherwise configured or may be eliminated altogether. For example, the tape 19 may be exposed to the external environment while positioned within the sampling portion 66. In another example, the compartments 62, 64 are not directly connected together so that the tape 19 passes through the meter in a manner similar to a film projector.

Referring to fig. 2 and 3, the waste compartment 64 includes a take-up reel that winds the used portion of the tape 19. As shown, the spool defines an engagement socket 80 in which the meter engages and rotates the spool 78. It should be understood that in other embodiments, the spools may be engaged in other manners. Due to the reel 78, the units 20 on the tape 19 can be advanced from the storage compartment 62 to the sampling position, and once used, the used LIT units 20 are stored in the waste compartment 64. Once the LIT units 20 are used, the tape 19 can be wound tightly around the spool 78 without fear of being damaged. Bending of the LIT units 20 will generally damage the units 20, thereby preventing the LIT units 20 from being used again accidentally. Furthermore, the bend in the tape 19 reduces the chance of reinsertion of used tape into the supply compartment 62, which may contaminate the supply compartment 62. To further reduce the risk of encirclement, the cassette 60 includes a ratchet mechanism 82. As shown in fig. 3, the ratchet mechanism 82 includes a pawl 84 that engages a gear 85. The pawl 84 may be biased by a spring or other biasing means. With this configuration, the ratchet mechanism 82 only rotates the spool 78 in one direction, so that the tape 19 can only run within the waste compartment 64. It should be understood that other types of ratchet mechanisms may be used. The waste compartment 64 also incorporates a guide mandrel 86 that guides the tape 19 into the waste compartment 64. To reduce the risk of contamination, the inlets of the compartments 62, 64 include seals 88 that seal against opposite sides of the tape 19. In selected embodiments, the supply compartment 62 includes a desiccant that reduces the humidity within the supply compartment 62.

FIG. 4 shows a body fluid sampling system 90 in which the cartridge 60 is connected to a meter 92. The cartridge 60 can be connected to the meter 92 in any of various ways as would be appreciated by one of ordinary skill in the art, such as via a snap-fit connection and/or via a bayonet-type connection. It is contemplated that in other embodiments the cartridge 60 and meter 92 may be integrated together to form a single unit. Alternatively, the cassette 60 and meter 92 may be completely separate, but may communicate remotely via a wireless connection or other remote connection. As described above, the meter 92 includes a display 94 for displaying test results and other information. The meter 92 also includes one or more input buttons 96 for inputting information into the meter 92 and a firing button 98 for firing the lancet 30 within the LIT unit 20. The meter 92 can include a variety of firing mechanisms for firing the lancet 30 as understood by those of ordinary skill in the art, such as a spring-loaded firing mechanism, a voice coil driver, and/or an electric motor. It should be understood that in other embodiments the meter 92 may alternatively or additionally incorporate other types of input and/or output devices, such as speakers, lights, keyboards, and microphones. Further, the meter 92 may be configured to connect to other devices, such as a computer, via a wired or wireless connection.

To index the tape in the cartridge 60, the meter includes an indexing mechanism 100 that engages the socket 80 in the spool 78 in the cartridge 60. In the illustrated embodiment, the indexing mechanism 100 includes a rotatable handle 102 that rotates a drive shaft 104, which in turn engages the socket 80 in the spool 78. The user indexes the tape 19 in the cassette 60 by manually rotating the handle 102, but in other embodiments a motor may be used to automatically index the tape 19. The indexing mechanism 100 may also incorporate a ratchet-type mechanism to prevent the indexing mechanism 100 from operating backwards, thereby reducing the chance of reintroducing contaminated portions of the tape 19 into the supply compartment 62 of the cassette 60. In another embodiment, the indexing mechanism 100 operates in a camera-like manner, wherein the firing button can only be actuated when the LIT units 20 are properly positioned over the sampling openings 74 in the cartridge 60. The indexing mechanism 100 is used to move the used LIT units 20 into the waste compartment 64 when the lancet 30 is fired.

Referring to FIG. 4, the meter 92 includes contact engagement members 106 that align with the contact openings 72 in the cartridge 60. The contact engagement member 106 has contacts 108 that engage the contacts 47 on the LIT units 20 when positioned over the sample openings 74 in the cartridge 60 for collecting fluid. In one form, the contacts 108 of the meter 92 are leaf spring type contacts, but the contacts 108 in other embodiments may have different shapes.

To use the meter 92, the user rotates the indexing handle 102 so that the tape 19 in the cartridge 60 moves the unused LIT units 20 into position over the sample opening 74 of the cartridge 60, and once moved into position, the contacts 108 of the meter 92 engage the contacts 47 of the unused LIT units 20. The tape 19 may be indexed before or after the user places the meter system 90 against the skin or other tissue to be punctured. To reduce the risk of contamination or infection, the user typically indexes after testing so that used/contaminated LIT units are stored in the waste compartment 64. Once the system 90 is placed against (or near) the incision site, the user presses the firing button 98, causing the lancet 30 (FIG. 1) to enter the tissue and then retract to form an incision in the tissue. Body fluid, such as blood and/or interstitial fluid, flows from the newly formed incision and is drawn into the capillary opening 49 of the capillary channel 48 via capillary action. Electronics within meter 92 analyze the fluid sample within capillary passage 48. As described above, the electrodes within the channel 48 of the LIT unit 20 are connected to the meter 92 via the contacts 47. In the illustrated embodiment, the fluid sample is analyzed electrochemically, e.g., via amperometric, volumetric, and/or potentiometric techniques, but it should be understood that the fluid may be analyzed via other techniques, e.g., optically. The individual units 20 and/or cartridges 60 may incorporate machine-readable codes, such as bar codes, EEPROMS, resistance identification, and the like, to calibrate the meter 92 and/or provide additional information. The results from the analysis are displayed on a display 94 of the meter 92, or output in some other manner. Once the sample is analyzed, the user may index the tape 19 via the indexing mechanism 100 so that the used units 20 are collected within the waste compartment 64. Once all or substantially all of the cells 20 have been used, the user can dispose of the cartridge 60 and replace the cartridge 60 with a new one.

A strip 110 of integrated test elements according to another embodiment will now be described with reference to fig. 5 and 6. The test element strip 110 shown has features in common with the described embodiments, which for the sake of clarity and conciseness will not be described in more detail below, but reference may be made to the previous description. In the illustrated embodiment, the sterility sheet 24 serves as the basis for forming the other portions of the test element (strip) 11. Referring to FIG. 5, one or more electrodes 112 having contacts 47 are formed on the sterility sheet 24. The electrodes 112 may include electrodes of the type known to those of ordinary skill in the art, such as a working electrode, a counter electrode, and/or a reference electrode. It should be understood that the strip 110 may include more or fewer electrodes than shown in the figures. Further, it is contemplated that one of the electrodes 112 can be formed on the sterility sheet 24 while the other electrodes 112 are formed on other layers of the test element 111. As shown, the analyzing end of the electrodes 112 (and sterility sheet 24) is covered with a reagent 114 for analyzing the fluid sample. It should be understood that the reagent 114 includes chemicals for analyzing the fluid, such as enzymes, mediators, and the like. It is contemplated that the reagent 114 can be applied to the sterility sheet 24 before or after the electrodes 112 are formed on the sterility sheet 24. Moreover, in other embodiments, the reagent 114 may be applied on other layers of the strip 110.

Referring to FIG. 6, each LI T unit 116 includes a spacing component 118 that partially defines the capillary channel 48 and a vent component 120 that forms a vent slot 112 for venting air from the capillary channel 48. A cover layer or sheet 124 covers the capillary channel 48 in such a way that the channel opening 49 is capable of collecting a fluid sample. Similar to the previous embodiment, the lancet 22 is enclosed within the sterility sheet 24 by folding the flaps 40 of the sheet 24 along fold lines 42 and sealing the flaps 40 together. In FIG. 6, one of the LIT units 116 is shown with the tip 38 of the lancet 22 in an extended state to show how the tip 38 extends to pierce the sterility sheet 24, but it should be understood that the tip 38 is typically retracted into the sheet 24 prior to use. Similar to the previous embodiment, the strip 110 is folded along fold line 43 to package the strip into the supply compartment of the cassette. As noted above, the strip at the fold line 43 in one embodiment may be scored, perforated, or otherwise shaped to enhance folding, but in other embodiments the fold line 43 may be free of other portions than the strip 110 and may be marked only where the strip 110 is folded.

The strip 110 may be manufactured and sterilized via a variety of techniques. It will be appreciated that the lancet 22 can be sterilized using a variety of sterilization techniques. In addition, the lancet 22 can be sterilized, such as via radiation sterilization techniques, before or after being enclosed in the sterility sheet 24. Certain sterilization techniques are disadvantageous for the chemistry of the reagents. A variety of manufacturing techniques may be used to overcome this problem. In one embodiment, the lancet 22 is sterilized and enclosed within the sterility sheet 24 before the electrodes 112, reagents 114, and other components of the LIT units 116 are applied to the sterility sheet 24. This technique reduces the chance that the chemistry of the reagent 114 will be affected by the sterilization of the lancet 22. In another embodiment, some or all of the components of the LIT units 116 that are not affected by sterilization of the lancet 22 are attached before sterilization of the lancet 22. For example, in one technique, the electrodes 112 are formed on the sterility sheet 24 before the lancet 22 is sterilized and sealed to the sterility sheet 24. Using other techniques, the electrodes 112, spacers 118, and vent member 120 are attached to the sterility sheet 24 prior to sterilization and sealing of the lancet 22. After sterilization, reagent 114 is deposited within capillary channel 48 on or near electrode 112, and cover sheet 124 is then applied over capillary channel 48. In yet another embodiment, all of the components of the test element, including the reagent 114, are assembled on the sterility sheet 24. The lancet needles 22 are then sterilized and enclosed within the sterility sheet 24 (or vice versa). To compensate for the effects of sterilization, after the assembled unit 116 is sterilized, a batch positive reading is taken to calibrate the meter prior to testing.

Test element strips 126 and individual LIT units 128 according to another embodiment are described with reference to FIGS. 7 and 8. The strap 126 of fig. 7 is similar in construction to and shares many of the same elements as the strap 110 shown in fig. 5 and 6, and the strap 126 of fig. 7 is manufactured in a manner similar to that of fig. 5 and 6. For example, the tape includes electrodes 112 formed on the sterility sheet 24, reagents 114 for analyzing the fluid sample, and the lancet 22 encased within the sterility sheet 24. In the embodiment of fig. 7, however, the individual cells 128 are not separate and distinct, but rather are formed from a continuous layer of material. As shown, the tape 126 has a spacer layer 130 that partially defines the capillary channels 48 for each LIT unit 128 and a vent layer 132 that forms a vent slot 134 for venting air from the capillary channels 48. A cover layer or sheet 136 covers the capillary channel 48 in such a way that the channel opening 49 is able to collect a fluid sample via capillary action. As shown, the fold lines 43 are formed on different layers between the individual cells 128. The sterility sheet 24 also includes a conveyor aperture 138 for indexing the tape 126. In the illustrated embodiment, the conveyor aperture 138 is formed along one edge of the strip 126, but it should be understood that the conveyor aperture 138 may be positioned elsewhere, formed in other layers of the strip 126, and/or include a plurality of conveyor aperture arrangements. Moreover, it is contemplated that the strips 126 may be indexed in other manners. To orient and align the LIT units 128, alignment notches 140 are die cut (or otherwise formed) along the edges of the ribbon 126 to form alignment members 142 that act like alignment pins during folding and/or unfolding of the ribbon 126.

A cartridge 144 containing a test element strip 126 is shown in FIG. 8. As shown, the cartridge 144 includes a supply compartment 146 that stores an unused portion of the tape 126 and a waste compartment 148 that stores a used portion of the tape 126. Between the compartments 146, 148, the cartridge 144 has a sampling portion 150 in which the LIT units 128 collect and analyze fluid samples. Each compartment 146, 148 has an access opening 152 facing the sampling portion 150 and sealed by the seal 88. Sampling portion 150 has a sample opening 74 through which lancet 22 pierces tissue, and unit 128 draws fluid into sample chamber 148. In the illustrated embodiment, the sampling portion 150 includes a guide 154 for guiding the tape 126 and an indexing or feed mechanism 156 configured to engage the transporter aperture 138 for indexing the tape 126. In the illustrated embodiment, the supply mechanism 156 comprises a carrier supply mechanism, but the supply mechanism 156 may comprise other forms of supply or indexing mechanisms. The feed mechanism 156 includes an engagement socket 80 wherein the meter engages and moves the feed mechanism 156. In the illustrated embodiment, the supply mechanism 156 includes a conveyor gear. It will be appreciated that the tape 126 may be guided and indexed in other ways. For example, in addition to the cassette 144, the meter in other embodiments may incorporate the guide roller 154 into the feed mechanism 156. In further examples, a conveyor belt or other type of indexing structure may be used in place of the conveyor gear. It is contemplated that the feed mechanism 156 may incorporate a ratchet or other similar type mechanism to prevent reverse operation of the feed mechanism 156. In addition, the supply mechanism 156 may incorporate contacts for the meter and engage the contacts 47 on the strip 126.

In the cartridge 144 of FIG. 8, the tape 126 is stored in a folded manner within the supply compartment 146 and the waste compartment 148, with both compartments 146, 148 oriented in a longitudinal manner. The cassette 144 has a generally compact configuration as the tape 126 is folded within the two compartments 146, 148. During indexing, the supply mechanism 156 pulls on the tape 126 to unwind the tape 126 within the supply compartment 146. Within the waste compartment 148, the strap 126 folds along fold line 43 in a manner similar to a retractable wall or folding closet door. Along both edges of the tape 126, the waste compartment 148 has a guide channel 158 that receives the alignment member 142 of the tape 126. As the tape 126 advances through the supply mechanism 156, the guide channel 158 orients the tape 126 as the tape 126 folds. Within the sampling portion 150 of the cartridge 144, the alignment member 142 may also be used to detect and/or orient each cell 128 over the sampling opening 74. In addition to or as an alternative to the alignment member 142, it is contemplated that the tip 38 of the lancet 22 can remain slightly extended from the tape 126 such that the lancet 22 can be received within the guide channel 158 of the waste compartment 148 to align and/or guide the movement of the tape 126. In the illustrated embodiment, the guide channel 158 is funnel-shaped, but the guide channel 158 may have a different shape in other embodiments. It is contemplated that both compartments 146, 148 may have guide channels 158 located on a single wall of the compartment or on two opposing walls (or even more). Alternatively or additionally, one or more guide channels 158 may extend through the sampling portion 150 of the cartridge 144 to guide the movement of the tape 126.

A variation of the strap 126 of fig. 7 is represented by strap 160 in fig. 9. It can be seen that the strap 160 of fig. 9 has the same components as the strap 126 of fig. 7, and is constructed in a similar manner. As described above, the test element tape 160 of FIG. 9 includes the lancet 22, the sterility sheet 24, the capillary channel 48 with the opening 49, the electrodes 112 with the contacts 47, the spacer layer 130, the venting layer 132 forming the venting slot 134, the cover layer 136, and the conveyor holes 138. For clarity and conciseness, only the significant differences are described below. Referring to fig. 9, the test element strip 160 has an alignment notch 140 formed along only one edge of the strip 160 to form an alignment member 142. Alignment members 142 are formed adjacent to the fold lines for every other cell 162. It is contemplated that alignment members 142 may be formed elsewhere on strip 160.

FIG. 10 shows a cartridge 164 configured to store and dispense the tape 160. In the embodiment of FIG. 10, the supply 166 and waste 168 compartments are oriented in a side-by-side fashion to give the cartridge 164 a compact, U-shaped configuration. In addition, the cartridge may be shaped differently in other embodiments. For example, in other embodiments the cartridge can have a Z-shaped configuration or a circular shape. In a circular shaped cartridge, the supply and waste compartments may be separated by a fixed or sliding wall, such that the size of the compartments varies with tape use; i.e. the supply compartment shrinks and the waste compartment grows as the tape is indexed to the waste compartment. Referring to the embodiment of fig. 10, the strip 160 is stored in a folded manner within the supply 166 and waste 168 compartments. The compartments 166, 168 each have an access opening 152 with a seal 88 to reduce the risk of contamination.

The sampling portion 170 extends between the supply compartment 166 and the waste compartment 168. In one form, the sampling portion 170 is integrated into the cartridge 164, and in other forms, the sampling portion 170 is separate from the cartridge 164 (e.g., incorporated into the meter and/or elsewhere). In the illustrated embodiment, the sampling portion 170 includes a guide 154 for guiding the tape 160, a sample opening 74 for the mechanism 156 and collection of a fluid sample therein. The sampling portion 170 may be open to the outside environment, partially open to the outside environment, or completely closed off from the outside environment. The carrier supply mechanism 156 indexes the strip 160 by engaging the carrier aperture 138 in the manner described. It should be understood that the tape may be indexed in other ways, and the supply mechanism 156 may be positioned elsewhere, such as in one of the compartments 166, 168 or on the meter. To guide the tape 160 as the tape 160 is unfolded and folded, the compartments 166, 168 in the illustrated embodiment include one or more guide surfaces 172 configured to guide the alignment members 142 on the tape 160. It will be appreciated that the strip 160 may be otherwise unguided and guided during folding and unfolding of the strip 160.

A strap system according to a further embodiment is described with reference to fig. 11 and 12. In the illustrated embodiment, the system includes a test element tape 174 (FIG. 11) and a lancing member or lancet tape 176 (FIG. 12), the test element tape 174 and lancet tape 176 being initially separated from each other until after sterilization to avoid sterilization of the lancet tape 176 from adversely affecting the chemistry of the test element tape 174, which could affect calibration. With the tapes 174, 176 separated, the problem of cross-contamination between the lancet and test element is reduced.

Referring to FIG. 11, test element strip 174 includes a plurality of test elements 178 bonded together on sheet 24 to form a continuous strip. Similar to the previous embodiments, each test element 178 includes an electrode 112 having a contact 47, at least one capillary channel 48 having a sample opening 49, and a reagent 114. As described above, successive layers on the strip 174 form different components of the test element 178, such as the spacer layer 130, the vent layer 132 forming the vent slot 134, the cover layer 136, and the conveyor holes 138. Between each element 178, the strip 174 has a fold line 43 along which the test element strip 174 is folded.

Referring to FIG. 12, the lancet tape 176 includes a plurality of incision forming members 22 that are wrapped in the sterility sheet 24. In the illustrated embodiment, the incision forming member 22 includes a lancet, but it should be understood that other forms of incision forming devices can be used. One form of the incision forming member 22 is sandwiched between the folded flaps 40 of the sterility sheet 24. However, in one form, the incision forming member 22 can be covered in other ways. To fold the lancet tape 176, a fold line 43 is defined between each lancet element 182. The lancet tape 176 of FIG. 12 has a series of carrier openings 138 for indexing purposes, but the lancet tape 176 can be indexed in other ways, such as via a reel mechanism of the type shown in FIG. 3, which makes the carrier openings 138 optional.

The straps 174, 176 may be folded in a variety of ways for storage purposes. Fig. 13 shows one way in which the strips 174, 176 may be folded. Referring to fig. 11, 12 and 13, the test element tape 174 and lancet tape 176 are joined to one another at fold line 43, as indicated by reference numeral 184, to form a LIT tape 186. In other embodiments, the test elements 174 and lancet 176 tapes can be joined together at other intervals, such as every third or fourth fold line 43. Further, within a single LIT tape 186, such spacing between bond lines 184 can vary. In one embodiment, the tapes 174, 176 are joined together in a face-to-face manner, with the test elements 178 generally facing the lancet tape 176, and in another embodiment, with the test elements 178 facing away from the lancet tape 176. In one form, the width of the lancet tape 176 is short when the test elements 178 face the test tape 176, so that the contacts 47 on the test element tape 174 remain exposed for contacting the meter.

FIG. 13 shows a cross-sectional view of a cartridge 188 housing a LIT tape 186. Similar to the previous embodiments, the cartridge 188 includes a supply compartment 190 and a waste compartment 192 in which unused and used portions of the LIT tape 186 are stored, respectively. In addition, the cartridge 188 includes a fluid sample sampling portion 194 in which fluid samples are collected and analyzed. The sampling portion 194 includes a supply mechanism 156 for supplying the LIT tape 186, one or more guides 154 that guide the LIT tape 186, and the sample opening 74 through which the sample is drawn.

In the supply compartment 190, the test elements 178 and lancet elements 182 are packaged in a stacked manner. In other words, the test elements 178 within the test element strip 174 are stacked upon one another. This results in the folded areas of the test elements 174 and lancet 176 tapes being positioned in a side-by-side manner. As the supply mechanism 156 indexes the LIT strip 186, the LIT strip 186 unfolds in an accordion fashion. Once the LIT tape reaches the sampling portion 194, the LIT tape 186 is tensioned against the guides 154 so that the test elements 174 and the lancet 176 tape are clamped together. Thus, the test elements 178 and lancet elements 182 are brought together to at least temporarily form the LIT units 196. In the illustrated embodiment, the opposing guides 154 squeeze the strips 174, 176 together, but in other embodiments, other mechanisms may be used to press the strips 174, 176 together. Once indexed over the sampling opening 74, the lancet unit 182 of the LIT unit 196 can be used to form an incision from which a fluid sample is drawn and analyzed via the test elements 178 of the LIT unit 196.

Subsequently, the now used LIT units 196 are indexed to the waste compartments 192. Within the waste compartment 192, the test element 174 and lancet element 176 strips are deployed in an accordion fashion until the LIT strip 186 is folded within the supply compartment 190 in a stack-like manner. With this configuration, the tightness of the LIT tape 186 is enhanced such that the length of the supply 190 and waste 192 compartments can be shortened. Furthermore, because the test elements 178 and lancet elements 182 remain generally apart prior to use and are in full contact just prior to use, the risk of cross-contamination of the test elements 178 and lancet elements 182 prior to use is reduced.

A variation of the test element body tape 198 and lancet tape 200 that can be used in the cartridge 188 of FIG. 13, as well as other types of cartridges, is shown in FIGS. 14 and 15. As can be seen, the test element strip 198 of FIG. 14 has test elements 178 disposed on every other portion of the sterility sheet 24 such that the test elements 178 have blank or covered portions 202 between the fold lines 43. Similarly, the lancet tape 200 of FIG. 15 has cover portions 202 between the lancet elements 182. In the illustrated embodiment, only a single cover portion 202 is located between the test 178 and lancet 182 elements, but in other embodiments more than one cover portion 202 can be located between the elements 178, 182. The spacing of the cover portions 202 may vary within the strip and/or from strip to strip. In addition, the test 198 and lancet 200 tapes can have different spacings of the cover portions 202. The cover portion 202 of the sterility sheet 24 is folded over the test 178 and lancet 182 elements to protect and maintain the sterility of the elements 178 and 182. As the tapes 198, 200 are deployed, the cover portions 202 peel away from the test elements 178 and lancet elements 182, thereby exposing the test elements 178 and lancet elements 182 for testing purposes. For the cartridge 188 of FIG. 13, the test 198 and lancet 200 tapes can be connected at the bonding location 184 or at other locations. In other embodiments, as shown in FIG. 16, the test 198 and lancet 200 tapes can be disconnected before, during, and/or after collection of the fluid sample.

FIG. 16 shows a LIT cartridge 204 according to another embodiment. In the illustrated embodiment, the cartridge 204 has a supply compartment 206 and a waste compartment 208 that separately store the test element tape 174 and the lancet tape 176. Because the strips 174, 176 are separated, sterilization and correction can be simplified and the risk of cross-contamination is reduced. In other embodiments, the straps 174, 176 may be connected together for storage before or after use. It should be understood that the cartridge 204 can accommodate a variety of tapes, such as the test element tape 184 of FIG. 14 and/or the lancet tape 200 of FIG. 15. Between the supply compartment 206 and the waste compartment 208, the cartridge 204 has a sampling portion 210 in which a fluid sample is obtained and/or analyzed. In one embodiment, the sampling portion 210 includes one or more tape guides 154, one or more supply mechanisms 156, and a sampling opening 74 for sampling fluid. In the illustrated embodiment, the sampling portion 210 includes two pairs of guides 154 that position the strips 174, 176 adjacent to or in contact with each other to temporarily form a LIT unit 212 for sampling and analyzing a fluid sample. In one form, the strips 174, 176 are pressed against one another so that the test element 178 is able to collect fluid from the incision formed by the lancet element 182. In other forms, the strips 174, 176 may be spaced slightly apart, but also close to each other so that the test element 178 is able to collect fluid. It should be understood that the sampling portion 210 may be configured differently in other embodiments. For example, the guide 154 may be optional in other embodiments, and/or other types of supply mechanisms 156 may be used. The waste compartment 208 in the illustrated embodiment includes a separating member 214 separating the strips 174, 176, although the separating member 214 may be optional in other embodiments.

From the above description, it should be understood that the LIT units and meters can be used to sample and analyze body fluids from different body parts, such as fingers, and alternative sites, such as the forearm. Furthermore, LIT units can be used to analyze various types of bodily fluids, such as interstitial fluid and blood. The bodily fluid sample may be collected from the fluid flowing onto the tissue surface, or may be drawn directly from beneath the tissue surface. It should also be understood that the features of the cartridge can be adjusted for use with other types of meters than those shown in the figures. Rather, the meter shown can be used in conjunction with other types of cartridges. The cartridge and/or tape may include machine-readable code that can provide a wide variety of information, such as lot code and calibration information. For example, the cartridge may include a machine-readable code, such as a bar code, Radio Frequency Identification (RFID) tag, magnetic code, electronic memory chip, and/or identification resistor.

It is contemplated that the compartments within the cartridge may be integrated together to form a single unit, or separated. Additionally, the waste and supply compartments of other embodiments may incorporate springs or other biasing members to bias the strips. Further, the supply compartment may comprise a desiccant for stabilizing the humidity of the supply compartment.

For the strip of the described embodiment, it is contemplated that the leading portion may be incorporated into the strip. It should also be noted that the strips may be folded and/or oriented in other ways than as shown in the accompanying figures. Additionally, in other embodiments, the LIT units can be constructed in ways other than that shown in the figures. For example, the lancet can be stationary or fixed relative to the test element. In another example, the lancet is retracted via a rotational motion, rather than a linear motion, and/or the lancet extends at an angle relative to the opening of the capillary channel. It is contemplated that selected features from different embodiments may be combined in any number of other combinations. For example, the waste compartment spool shown in FIG. 2 may be incorporated into the other illustrated embodiments to index the tape. Furthermore, the selected feature may be applicable to other strips for collecting and/or analyzing a bodily fluid sample, such as a lancet strip or a test strip.

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 embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected. All publications, patents, or patent applications cited in this specification are herein incorporated by reference as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.

Claims (13)

1. A bodily fluid sampling device comprising:

a lancet integrated test tape comprising a plurality of lancet integrated test units, each of the lancet integrated test units comprising:

a lancet configured to form an incision in tissue; and

a test element configured to analyze bodily fluid from an incision in tissue; and

a cartridge including a supply compartment configured to store an unused portion of the lancet integrated test tape, the lancet integrated test tape folded within the supply compartment so as to limit damage to the lancet integrated test unit;

the body fluid sampling device further comprises:

a supply mechanism for supplying the lancet integrated test tape;

wherein the lancet integrated test tape comprises a fold line between each lancet integrated test unit;

wherein the lancet and the test element are joined together at alternating fold lines to fold the lancet integrated test tape in an accordion fashion, wherein the lancet and the test element are folded away from each other within the supply compartment; and

wherein the lancet integrated test tape is configured to be deployed during indexing in such a manner that the lancet and test element are clamped together to form a lancet integrated test unit.

2. The body fluid sampling device of claim 1, wherein the cartridge comprises a waste compartment in which the used portion of the lancet integrated test tape is stored.

3. The body fluid sampling device of claim 2, wherein the waste compartment comprises a spool around which the used portion of the lancet integrated test tape is wound.

4. The body fluid sampling device of claim 2, wherein the used portion of the lancet integrated test tape is stored in a folded manner in the waste compartment.

5. The body fluid sampling device of claim 1, wherein the supply mechanism comprises a spool configured to rotate so as to wind the lancet integrated test tape around the spool.

6. The body fluid sampling device of claim 1,

the lancet integrated test strip has a conveyor opening; and

the supply mechanism includes a conveyor mechanism that engages a conveyor opening in the integrated lancing test strip.

7. The body fluid sampling device of claim 1, further comprising a meter coupled to the cartridge to provide an analysis result from the test element.

8. The body fluid sampling device of claim 1,

the lancets are incorporated into a lancet tape; and

the test elements are incorporated into a test element strip, wherein the test elements and lancets are brought together to at least temporarily form a lancet-integrated test element unit.

9. The body fluid sampling device of claim 8, wherein the lancet tape and the test element tape are separately folded and stored within the cartridge.

10. The body fluid sampling device of claim 1,

the cassette includes a guide channel; and

the lancet integrated test tape includes one or more alignment members received within the guide channel to guide the lancet integrated test tape within the cartridge.

11. The body fluid sampling device of claim 10, wherein the alignment member is defined by a notch formed in the lancet integrated test strip.

12. The body fluid sampling device of claim 1,

the lancet integrated test tape includes a cover portion between the lancet integrated test units that protects the lancet and the test element prior to use; and

the cover portion is configured to be peeled away to expose the lancet and the test element.

13. The body fluid sampling device of claim 2, comprising:

an indexing mechanism configured to index the tape between the supply compartment and the waste compartment.