HK1169584B - Tape transport lance sampler - Google Patents

Description

Tape transport lancet sampler

Technical Field

The present invention relates generally to a transfer system for an integrated sampling device, and more particularly, but not exclusively, to a system in which a sterile cap is automatically removed from a lancet-sampler, and techniques for manufacturing the same.

Background

The acquisition and testing of bodily fluids is useful for many purposes and is becoming increasingly important for the use of medical diagnostics and therapy, such as for diabetes, as well as for other various applications. In the medical field, there is a need to enable operators to routinely, quickly, and reproducibly perform tests outside of a laboratory setting, as well as rapid results and reading of the resulting test information. Tests may be performed on various bodily fluids for certain applications, particularly tests involving blood and/or interstitial fluid. For many patients, especially for patients with limited manual dexterity, such as the elderly or diabetics, it may be difficult to perform home-based tests. For example, diabetics can sometimes experience numbness or tingling in their four limbs, such as their hands, which can make self-testing difficult because they cannot accurately position the test strip to collect a blood sample. In addition, wounds in diabetics tend to heal more slowly and therefore require less invasive incisions to be made.

More recently, lancets have been developed that integrate test strips, wherein the test strips are integrated with the lancet or other piercing means, thereby forming a single disposable unit. While these integrated units have somewhat simplified the collection and testing of fluid samples, there are still many problems that need to be solved before a commercial unit can be implemented. One problem relates to maintaining the sterility of the lancet, thereby minimizing the risk of infection. Indeed, conventional plastic or syringe-type caps for maintaining the sterility of typical lancets cannot be incorporated with lancet integrated test strips for several reasons. For a typical syringe type cap, the cap encloses the lancet and is removed by pulling or twisting the cap off the lancet. As noted previously, diabetics as well as the elderly may experience hand dexterity problems. Thus, it can be difficult, or even practically impossible, to manually remove the cap from the lancet without destroying or damaging such an integrated device. A commercially practical system for automatically removing caps has not been developed to date.

Integrated systems have been proposed that utilize a closed needle, which is manufactured by conventional needle aspiration techniques. However, these conventional aspiration techniques for needles can be quite expensive. Other systems have been proposed for manufacturing closed needles using semiconductor manufacturing processes in which layers of semiconductor material are layered to form closed needles. However, manufacturing closed needles in this manner can be expensive and is not suitable for high volume production. Other integrated disposable devices have been proposed to date which utilize an improved version of a conventional lancet for lancing the skin.

Making the lancet and needle smaller or thinner, thereby creating a less traumatic or less invasive incision, is a trend, which in turn makes self-monitoring less painful and promotes recovery of the incision. However, due to their thinner nature, lancets are more prone to bending or other damage, especially when the protective cap is removed. Furthermore, the pulling or twisting action during removal of the cap can damage the test strip, such as delicate electrodes in electrochemical-type test strips, or even cause the lancet to detach from the test strip.

Other difficulties arise when using thinner lancets in integrated disposable devices to reduce pain. Some integrated disposable designs have an open capillary channel or groove formed in the lancet for drawing body fluid from the incision to the test area or chamber by capillary action. These open capillary groove integrated disposable devices suffer from a number of difficulties in drawing fluid by capillary action when the lancet is thin. As it has long been appreciated, capillary action occurs when the adhesion of a liquid, such as a body fluid, to the walls of a capillary channel is stronger than the cohesion between the liquid molecules. The adhesion of the liquid to the walls of the capillary channel causes the edges of the liquid to move upwards in the channel, while surface tension acts to keep the surface of the liquid intact, so that not only the edges move upwards, but the entire liquid surface is pulled upwards in the channel. However, by the open capillary groove design, one of the capillary channel walls is eliminated, thereby reducing the overall contact area between the capillary channel wall and the body fluid surface. This reduction in the contact area between the capillary channel and the body fluid reduces the capillary force applied to the fluid. To compensate, disposable devices that incorporate open capillary channels typically require the capillary channel to be deep so that the opposing channel sidewalls provide sufficient contact area with the meniscus to draw the body fluid. However, when the thickness of the lancet is reduced to reduce the pain associated with lancing, the groove becomes too shallow to draw body fluid by capillary action.

Integrated disposable designs have been proposed that enclose the entire unit within a protective package. However, these designs require sterilization of the entire disposable unit at the same time, which results in a number of difficulties. Unfortunately, sterilization techniques (e.g., radiation) used with lancets can negatively impact the chemical performance of the test strip. Therefore, the accuracy of the test strip is greatly limited if left uncompensated. To compensate for variations that occur during sterilization, samples may be taken from the sterilized lot, so that an adjustment or calibration value may be calculated for the lot. Furthermore, certain desirable sterilization techniques for lancets are not practical when the lancet and test strip are combined, because these techniques have a tendency to damage or even destroy components on the test strip. In addition, undesirable cross-contamination between the lancet and the test strip can occur when sealed in the same protective package. For example, components of the test strip (e.g., chemical components, biological components, adhesives, etc.) can migrate from the package to the lancet, which can compromise the sterility of the lancet.

Thus, there is a need for further improvements in this area of technology.

Disclosure of Invention

One aspect relates to a tape assembly including a lancet and a carrier tape. The lancet includes a lancet tip configured to lance tissue. A protective cover covers at least a portion of the lancet tip. The tape is coupled to the lancet and the protective cover. The tape has a slack section between the lancet and the protective cover for allowing the protective cover to be removed from the lancet tip when the tape is pulled.

Another aspect relates to a technique for assembling the belt assembly. The lancet is provided with a portion of the lancet covered by a protective cover. Forming a relaxed area of the belt. The lancet and the protective cover are attached to the tape, and the slack area is positioned between the locations where the lancet and the protective cover are attached to the tape.

Another aspect relates to a technique for automatically removing a protective cover from a lancet. The tape assembly includes a tape and a lancet, and the protective cover covers at least a portion of the lancet. The lancet and the protective cover are attached to the tape, and the slack section of the tape is positioned between the locations where the lancet and protective cover are attached to the tape. The protective cover is pulled away from the lancet by applying tension to the tape.

Yet another aspect relates to a body fluid sampling device that automatically aligns a test pad with a sample collection port. The device includes a lancet configured to cut an incision in tissue. The lancet defines a capillary groove configured to draw body fluid from the incision by capillary action, and the sample transfer opening is configured to collect the body fluid from the capillary groove. A carrier tape is coupled to the lancet. The carrier tape includes a test pad configured to analyze bodily fluids. The carrier tape is folded around the test pad and the test pad is positioned in alignment with the sample transfer opening when the tape is unfolded.

Another aspect relates to a lancet-sampler comprising a lancet. The lancet has a body and a lancet tip extending from the body, the tip configured to cut an incision in tissue. The lancet has opposing first and second sides. The lancet defines a slot in the first side that extends from the lancet tip to the body. A cover covers at least a portion of the groove on the first side to define an enclosed capillary channel configured to draw body fluid by capillary action. The slot has at least one segment that extends completely through the lancet from the first side to the second side.

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

Drawings

Fig. 1 is a perspective view of a lancet according to one embodiment.

Fig. 2 is a perspective view of a lancet strip from which the fig. 1 lancet is formed.

Fig. 3 is a top view of the fig. 2 lancet strip.

Fig. 4 is a perspective view of a lancet-sampler incorporating the lancet of fig. 1.

Fig. 5 is a perspective view of the lancet-sampler of fig. 4 with the protective cover covering one end of the lancet-sampler.

Fig. 6 is a perspective view of a lancet-sampler label that incorporates the lancet-sampler of fig. 4.

FIG. 7 is a perspective view of a carrier tape to which the FIG. 6 lancet-sampler label is attached.

Fig. 8 is a perspective view of the carrier tape of fig. 7 during folding.

Fig. 9 is an exploded view of a tape assembly that includes the fig. 6 lancet-sampler and the fig. 7 carrier tape.

Fig. 10 is a perspective view of the fig. 9 belt assembly.

Fig. 11 is a first perspective view of the fig. 9 tape assembly as the fig. 7 carrier tape is unfolded.

Fig. 12 is a second perspective view of the fig. 9 tape assembly when the fig. 7 carrier tape is fully unfolded.

Fig. 13 is an enlarged view of the fig. 9 tape assembly when the fig. 7 carrier tape is fully unfolded.

Fig. 14 is a top view of the fig. 4 lancet-sampler when filled with a body fluid.

Fig. 15 is a perspective view of a lancet-sampler according to another embodiment.

Fig. 16 is a perspective view of the fig. 15 lancet-sampler with one end covered by a protective cover.

Fig. 17 is a cross-sectional view of the fig. 15 lancet-sampler taken along line 17-17 in fig. 15.

FIG. 18 is a cross-sectional view of the FIG. 17 lancet-sampler as it transfers fluid to a test pad on the tape.

FIG. 19 is a perspective view of a lancet-sampler tape according to yet another embodiment, the tape being configured to electrochemically analyze a fluid sample.

Fig. 20 is a perspective view of a cassette according to one embodiment in which a carrier tape can be stored.

Fig. 21 is a perspective view of the cartridge of fig. 20 with a portion of the housing removed.

Fig. 22A and 22B are perspective views of the carrier tape in the cassette of fig. 20, which illustrate one technique for removing the protective cover from the lancet-sampler.

Fig. 23 is a perspective view of a cassette containing a carrier tape according to another embodiment.

Fig. 24A, 24B, and 24C are perspective views of the cassette of fig. 23 with a portion of its cassette housing removed, which illustrate a technique for flipping the lancets in a trailing first orientation.

Fig. 25 is a front perspective view of a meter into which the cartridge of fig. 23 can be loaded.

FIG. 26 is a rear perspective view of the FIG. 25 meter.

Fig. 27A is an enlarged perspective view of the fig. 25 meter.

FIG. 27B is an enlarged view of the clutch of the lancing unit engaged with the priming gear in the FIG. 25 meter.

Fig. 27C is an enlarged view of the clutch disengaged from the start gear in the meter of fig. 25.

Fig. 28 is an enlarged view of a portion of the fig. 25 meter with the lancet fired from the meter.

29A, 29B, 29C, 29D, 29E and 29F are perspective views of the meter of FIG. 25 during lancing and sampling.

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. Although many embodiments of the invention are shown in detail, it will be apparent to those skilled in the relevant art that some features that are not relevant to the invention may not be shown for the sake of clarity. It should be noted that directional terms, such as "upper," "lower," "top," "bottom," "clockwise," and "counterclockwise," are used herein solely for the convenience of the reader to assist the reader in understanding the illustrated embodiments, and the use of such directional terms is not intended to limit the described, illustrated, and/or claimed features to a particular direction or orientation in any way.

The present invention relates generally to a tape of an integrated lancet test element (LIT) and/or a semi-integrated disposable device, and a technique for manufacturing the LIT and/or semi-integrated disposable device. Specifically, the tape includes a plurality of flat lancets. Each lancet includes a fully etched and/or half etched capillary channel connected to the sample transfer opening, and an actuator engagement keyhole for actuating the lancet. The capillary channel and the sample transfer opening are covered by a continuous roll-to-roll process with a hydrophilic heat sealable foil. Closing the capillary channel allows the lancet-sampler to draw fluid by capillary action, especially when the lancet is thin. Individual lancets are then punched from the tape. The tip of the lancet is heat laminated between the foils to form a removable protective cover. Two adhesive tapes are attached to opposite ends of the lancet, and the lancet assembly is sterilized. A reagent label or test pad configured to analyze a fluid sample is placed in a main cassette or carrier tape. The cassette tape is folded over the test pad in a fan fold fashion and the tape is secured to the test pad by a peelable adhesive to form an air tight package. In this package, a micro-desiccant bead may be affixed adjacent to the test pad. Two adhesive strips are attached to two opposing flaps or areas between the fold lines. During dispensing, the carrier tape is pulled to unfold the package. When the tape is unwound, the protective cover is automatically pulled from the lancet tip. When fully deployed, the test pad automatically aligns with the sample transfer opening. The lancet is then actuated to lance the skin and fluid is drawn through a channel in the lancet onto the test pad. Alignment of the test pad with the sample transfer opening can occur before or after the lancet cuts the skin and collects fluid. In other embodiments, the sample transfer port is optional, such that fluid transfer occurs directly from the capillary channel.

With this system, the difficulties associated with manual removal of the protective cap are eliminated, as the system provides a unique technique for automatically removing the cap. Because the lancet can be sterilized separately from the test pad, many of the difficulties associated with sterilization are reduced. Furthermore, because the lancet and test pad are exposed just prior to use, the risk of cross-contamination between the lancet and test pad is reduced. As will be appreciated from the discussion below, the system also helps to alleviate many other problems. Although the present invention will be discussed with reference to collecting blood from the skin, it should be recognized that other types of bodily fluids, such as interstitial fluid, may be analyzed from a variety of types of tissues in addition to the skin.

FIG. 1 shows a perspective view of a lancet 30 used in a LIT, according to one embodiment. The lancet 30 in one form is made of surgical grade stainless steel, but it is to be understood that the lancet 30 can be made of other materials suitable for lancets. In one particular form, the lancet 30 is made of 76 μm thick Precipitation Hardened (PH) 17-7 stainless steel. As can be seen, the lancet 30 includes a lancet tip 32 that extends from a lancet body or base 34. The lancet tip 32 is configured to cut an incision in tissue. In the illustrated embodiment, the lancet tip 32 has a triangular cutting edge, but it should be appreciated that in other embodiments, the tip 32 can be shaped differently. The profile of the lancet 30 in fig. 1 is generally flat, which in turn simplifies packaging of the LIT. However, it is contemplated that in other embodiments the lancet 30 need not be flat.

The lancet 30 has a capillary groove 36 extending from the lancet tip 32 to the lancet base 34, the capillary groove 36 serving to transfer the body fluid sample from the incision to a sample transfer opening or pooling area 38 in the lancet 30. In the illustrated embodiment, the capillary groove 36 extends partially through the lancet 30, and the sample transfer opening 38 extends completely through the lancet 30. Instead of being partially etched through the lancet 30, the capillary groove 36 can in other embodiments be a fully etched capillary channel that passes completely through the lancet 30. As a side note, the terms "etched," "partially etched," and "fully etched" are used to facilitate the reader's understanding of the concepts being discussed, and it should be understood that the use of these terms in no way limits how the different slots, openings, and other features are formed. Although these features may be etched, it should be recognized that other techniques may also be utilized to form these features, such as stamping, cutting, and die cutting, to name a few. The lancet 30 is 76 μm thick in one embodiment, and the partially etched section of the capillary groove 36 has a width of about 250 μm and a depth of about 40 μm, although it should be appreciated that the dimensions can vary in other embodiments. The sample transfer port 38 is generally wider than the capillary groove 36 so as to collect fluid from the capillary groove 36 for deposition onto the test pad. In the depicted embodiment, the sample transfer opening 38 has a rectangular or oval shape, but in other embodiments the sample transfer opening 38 may be shaped differently or eliminated altogether.

Between the capillary groove 36 and the sample transfer opening 38, the lancet 30 has a fully etched section 39 that has substantially the same width as the capillary groove 36, but the section 39 is fully etched as is the sample transfer opening 38. If fluid from the capillary groove 36 is transferred directly to the wider, fully etched sample transfer opening 38, fluid flow may sometimes stop because the fluid tends to have a higher affinity for the smaller capillary channel, which in this case is the capillary groove 36. The fully etched region 39, which precedes the sample transfer port 38, provides a gradual transition that allows the momentum of the body fluid to carry the fluid to the sample transfer port 38. Opposite the capillary groove 36, the sample transfer opening 38 has a vent groove 40, the vent groove 40 for venting air when the sample transfer opening 38 is filled with fluid. In the illustrated embodiment, the sample transfer opening 38 is wider than the vent slot 40, but it is contemplated that the vent slot 40 may have the same or a wider width than the sample transfer opening 38 in other embodiments. Further, vent slot 40 may be eliminated in other embodiments so that portions of capillary groove 36 not covered and/or sample transfer opening 38 may vent air. In the base 34, the lancet 30 has an actuator engagement opening or keyhole 42 to which an actuator of the lancing mechanism can engage in order to fire the lancet 30. In the depicted embodiment, the actuator engagement aperture 42 includes a rectangular central portion and an opposing circular aperture. As should be appreciated, in other embodiments, the actuator engagement aperture 42 may be shaped differently.

Turning to fig. 2 and 3, one form of the lancet 30 is manufactured by a continuous roll-to-roll process in which various features of the lancet 30 are formed from a continuous lancet strip 44. The openings 38, 42 and capillary groove 36 may be formed, for example, by photolithography, die cutting, and/or stamping techniques, to name a few. In one particular example, the capillary groove 36 is formed via photolithographic techniques by etching only partially into the lancet 30. As should be appreciated, other types of manufacturing processes can be used to form the lancet 30. In the illustrated embodiment, the lancet strip 44 includes a retractor opening 46, the retractor opening 46 being used to guide the lancet strip 44 during manufacture, but in other embodiments, the retractor opening 46 can be optional.

As previously mentioned, it is desirable to make the lancet 30 as thin as possible to minimize the pain associated with lancing. However, it has been found that when the thickness of the lancet 30 is reduced, the available depth of the opposing walls of the capillary channel 36 is likewise reduced. This reduced wall depth of the capillary channel 36 in turn reduces the capillary affinity of the channel 36 to such an extent that the capillary channel 36 will not be able to consistently draw fluid in sufficient quantities for testing purposes, or indeed any fluid, onto the sample transfer port 38.

Contrary to conventional wisdom that teaches the use of lancets with open capillary channels, the capillary groove or channel 36 of the lancet 30 is closed in the illustrated embodiment. To enhance capillary action in thinner lancets, the cover foil 48 is used to close the capillary groove 36, thereby increasing the contact area of the meniscus of body fluid with the capillary groove 36. After the capillary groove 36 and sample transfer opening 38 are formed, the lancet strip 44 is laminated with a cover foil 48 to create an enclosed capillary channel 50. Laminating the cover foil 48 on the lancet 30 provides a simple technique for forming an enclosed capillary channel. In one embodiment, the cover foil 48 is heat sealed to the lancet strip 44, but in other embodiments the cover foil 48 can be secured in other ways, such as by room temperature adhesive. In one form, the cover foil 48 is hydrophilic by being coated with a layer of hydrophilic material. However, it should be understood that the cover foil 48 may be made hydrophilic in other ways, and all or a portion of the cover foil 48 may be hydrophilic. In one form, the cover foil 48 is hydrophilic prior to attaching the cover foil 48 to the lancet 30. In another form, a hydrophilic material is deposited on an area of the cover foil 48 that covers the capillary groove 36. Surfactants typically used to render materials hydrophilic tend to be lubricious. The slippery nature of the surfactant can make it very difficult to attach the cover foil 48 to the lancet 30, for example, with an adhesive. To address this attachment problem, in one embodiment, the cover foil 48 is not covered with a surfactant prior to attaching the foil 48 to the lancet 30. Instead, once the cover foil 48 is attached, a solution of alcohol and surfactant is poured, sprayed and/or otherwise drawn into the now enclosed capillary channel 50. The solution is then dried to leave the surfactant in the enclosed capillary channel 50. In one particular form, the cover foil 48 is a hydrophilic heat sealable 12 μm thick polyethylene terephthalate (PET) foil. In selected embodiments, all or a portion of the cover foil 48 may be transparent and/or translucent to enable detection of the sufficiency of fluid filling.

As can be seen, most of the capillary groove 36 and the sample transfer opening 38 are covered by a cover foil 48 to form an enclosed capillary channel 50. However, a portion of the capillary groove 36 remains exposed at the lancet tip 32 so that the capillary channel 50 can collect the fluid sample. In a similar manner, a portion of the vent slot 40 is vented to the external environment to allow air to vent from the capillary passage 50. It has been found that the enclosed capillary channel 50 tends to be more robust than open capillary channel systems, as compared to open capillary channel designs. In theory, the capillary action for drawing the fluid sample may be enhanced by enclosing the capillary channel 50. Furthermore, the closed capillary channel 50 tends to reduce fluid waste as compared to open capillary channel designs that allow fluid to escape, which in turn reduces the amount of body fluid required for fluid collection. However, it should be recognized that selected features from the systems described herein may be adapted to other systems having open capillary channel designs.

Referring to fig. 4, after the cover foil 48 is laminated to the strip 44, the lancet 30 can be punched from the strip 44 to form the lancet-sampler 52. In one form, the lancet-sampler 52 is punched from the strip 44 using a high speed rotating male/female die system. However, it should be appreciated that the lancet-sampler 52 can be removed from the strip 44 in other manners.

Referring to fig. 5, all or part of the lancet tip 32 is sandwiched between protective foils or films 54, and the foils or films 54 are laminated together to form a protective tip or protective cover 56 for protecting against damage and for maintaining the sterility of the lancet 30. In one form, the protective foils 54 are heat laminated together to form the protective cover 56, but it will be appreciated that the protective foils 54 may be laminated together in other ways, such as with an adhesive. As will be explained in more detail below, the protective cap is configured to automatically pull off the lancet tip 32 prior to use. In one embodiment, the protective foil 54 is a Polyethylene (PE) or PET foil, although it is contemplated that other materials may be used. It should also be appreciated that the protective cover 56 can be formed prior to punching the lancet-sampler 52 from the strip 44. For example, the lancet 30 can be bent or cut from the strip and the protective foil 54 applied before the lancet-sampler 52 is punched from the strip 44.

Once the protective cover 56 covers the lancet tip 32, the tape connectors 58 are secured to opposite ends of the lancet-sampler 52 to create a lancet-sampler label 60, as shown in FIG. 6. The tape connector 58 is used to secure the lancet-sampler 52 to a carrier or cassette tape. In the illustrated embodiment, the connector tapes 58 are adhesive tapes, and in one particular form, the connector tapes 58 comprise PET adhesive tape. One of the connector tapes 58 is secured to the protective cover 56 and the other connector tape 58 is secured to the base 34 of the lancet 30. As shown in FIG. 6, the connector tapes 58 are secured to the top side of the lancet-sampler 52, but it should be understood that the connector tapes 58 can be secured in other locations. For example, one of the connector tapes 58 can be secured to the top side of the lancet-sampler 52, while the other connector tape 58 can be secured to the bottom side of the lancet-sampler 52. In another example, the connector tapes 58 can be attached along the edges of the lancet-sampler 52. As should be appreciated, one or more of the connector tapes 58 can be made integral with the lancet-sampler 52, or the connector tapes 58 can be eliminated. For example, one of the connector straps 58 may be integrally formed with the protective cover 56. Once assembled, the lancet-sampler label 60 can be sterilized. In one form, the lancet-sampler label 60 is sterilized using an inline electron beam (e-beam) sterilization process. However, the lancet 30 can be sterilized in other manners, such as by gamma radiation or ultraviolet sterilization techniques. Further, it should be appreciated that the lancet 30 can also be sterilized at various assembly stages before the connector tape 58 is attached to the lancet-sampler 52.

As noted above, the connector tapes 58 are used to secure the lancet-sampler label 60 to the cassette tapes. By being disposed on the tape, multiple lancet-samplers 52 can be used in a cassette or other type of device that can perform multiple tests before needing to be discarded. However, it is contemplated that features of the system may be incorporated into a single use meter. Fig. 7 shows a carrier or cassette tape 62 on which one or more lancet-sampler labels 60 are secured according to one embodiment. As shown, one or more reagent labels or test pads 64 for analyzing the fluid sample are applied to the tape 62. In one embodiment, the tape 62 is a 5mm wide by 0.012mm thick PET cassette tape, but it is contemplated that in other embodiments, the carrier tape 62 can have different dimensions and be made of other materials. For example, in another form, the tape 62 is 23 μm thick. The test pad 64 incorporates chemicals and/or sensors for analyzing the fluid sample. In one form, the test pad 64 is configured for electrochemical analysis of a fluid sample. The test pad 64 may include, for example, electrodes (e.g., working, counter, and reference electrodes) and chemicals (e.g., catalysts and enzymes) for electrochemically analyzing the fluid sample. A fluid sample may be analyzed using a number of electrochemical techniques, such as amperometric, potentiometric, and coulometric techniques, to name a few. In other forms, the test pad 64 may have chemistry for optically analyzing the fluid sample, such as by reflection and/or transmission techniques. As should be appreciated, the test pad 64 may be configured to analyze the fluid sample in other ways.

To facilitate automatic removal of the protective cover 56, the tape 62 has a slackened or slack section that provides enough slack so that the protective cover 56 can clear the lancet tip 32 when tension is applied to the tape 62. The loose section of the tape 62 also provides sufficient slack so that the lancet 30 can be fired to form an incision. Prior to attaching the lancet-sampler label 60, the tape 62 is folded over the test pad 64 in a fan-fold fashion (180), as shown in FIG. 8. The folded section of tape 62 forms a packet 66 that protects the test pad 64 and provides slack that allows the cap 56 to be pulled from the lancet 30. In one embodiment, the package 66 is sealed with a vapor-tight adhesive and a micro-desiccant bead is secured adjacent to the test pad 64 to control the humidity level in the package 66. In another embodiment, the package 66 is not formed, but rather the tape 62 is folded loosely in a manner to create a loose loop or loose area of tape 62 around the test pad 64. In this embodiment, the cassette containing the tape 62 contains desiccant and has a seal to maintain the humidity level of the test pads 64. As should be appreciated, the system may be adapted for use in non-integrated systems. For example, in yet another form, the tape 62 does not include the test pad 64, rather, the lancet 30 is used only to form an incision (and does not collect and analyze a fluid sample). In this case, the tape 62 does not have the wrapper 66. Instead, the tape 62 has a slack area between where the tape is attached to the protective cover 56 and the lancet 30, thereby facilitating removal of the protective cover 56.

Returning to the embodiment of fig. 8, a pair of fingers 68 of a folding mechanism 70 is used to fold the tape 62. As can be seen, the fingers 68 of the folding mechanism 70 engage opposite sides of the tape 62 and the mechanism 70 is rotated in a counterclockwise manner, as indicated by arrow 72 in fig. 8, to fold the tape 62 to form the package 66. The fingers 68 form a first crease or fold 74 and a second crease or fold 76, and an intermediate tape carrying area 78 with the test pad 64. As will be discussed in detail below, the distance between the first fold 74 and the test pad 64 is selected such that, once unfolded, the test pad 64 is aligned with the sample transfer opening 38 in the lancet 30. This allows the test pad 64 to be positioned to directly absorb the fluid sample in the sample transfer opening 38. The intermediate region 78 of the strip test pad 64 is folded over the strip 62 and sealed to form the package 66. Once the strip 62 is folded, the fingers 68 are temporarily pulled away from the strip 62 as the strip 62 is indexed, and then the fingers 68 are reapplied to the strip 62 to fold the next package 66. As should be appreciated, the folding mechanism 70 allows the tape 62 to be folded in a continuous process, which in turn simplifies manufacturing. However, it should be understood that the tape 62 may be folded in other ways in other embodiments, such as manually or using a different type of folding mechanism.

Referring to fig. 9 and 10, the lancet-sampler label 60 is attached to the tape 62 by the connector tape 58 such that the lancet-sampler label 60 spans the first fold 74 to form a tape assembly 80. The lancet-sampler label 60 can be secured to the tape 62 in a variety of ways, such as by bonding, welding, and/or adhesive. Specifically, the connector tape 58 secured to the base 34 of the lancet 30 is attached to a first section 82 of the tape 62, the first section 82 being upstream of the first fold 74, and the connector tape 58 secured to the protective cover 56 is attached to a second section 84 of the tape 62, the second section 84 being downstream of the intermediate section 78 and the second fold 76. Because the lancet-sampler label 60 is attached to the tape 62 after sterilization, the harmful effects of sterilization on the test pad 64 are avoided. This in turn avoids the need to recalibrate the tape assembly 80.

In one embodiment, once assembled, the tape assembly 80 is housed in a cassette. For example, the Tape assembly 80 may be stored in a cassette as shown and described in U.S. patent application No.11/326,422 entitled "Lancet Integrated Test Element Tape Dispenser" (attorney docket No. 7404-. In one form, the unused sections of the tape assembly 80 are stored in a stacked manner in the supply portion of the cassette, thereby reducing the chance of bending of the lancets 30, which can cause damage to the lancets 30. After use, the used section of the tape assembly 80 can be wrapped around a spool within the waste portion of the cassette because damage to the lancet 30 after use is not a concern. The cartridge may include a desiccant if desired and be sealed to maintain a low humidity level in the cartridge to preserve the test pads and other components. It is contemplated that the belt assembly 80 may be stored in other ways. By way of non-limiting example, the tape assembly 80 may be stored in cassettes, pucks, cylinders, and cassettes, to name a few.

As alluded to above, the tape assembly 80 is configured to automatically remove the protective cover 56 from the tip 32 of the lancet 30. Referring again to fig. 10, the lancet-sampler label 60 is coupled to the first 82 and second 84 tape sections with the packet 66 located between the two sections. Prior to use of the lancet-sampler 52, such as when the lancet-sampler 52 is initially indexed out of the supply portion of the cassette, tension is applied to the second section 84 of the tape 62, as indicated by the arrow 86 in FIG. 10. In one embodiment, tension is applied by a reel, and the used area of tape 62 is wound onto the reel after use. In another embodiment, tension is applied by a traction mechanism that is used to guide the tape 62. It should be appreciated that the belt 62 may be tensioned in other ways. The first region 82 of the belt 62 is held fixed in place by a clamp or brake mechanism 88 when tension is applied. The brake mechanism 88 includes opposing brake pads 90, the brake pads 90 being clamped to the band 62 to hold the first region 82 in place. As should be appreciated, the first region 82 of the band may be held in place in other ways. For example, a reel or pulling mechanism may be used to hold the first region 82 in place. It is contemplated that in other embodiments, tension may be applied to the belt 62 in other manners. For example, the first section 82 of the tape 62 may be pulled while the second section 84 is secured in place. In yet another example, the regions 82, 84 of the belt 62 are pulled in opposite directions simultaneously.

Turning to fig. 11, when tension is applied in the direction 86, the protective cover 56 is pulled from the lancet 30, thereby exposing the lancet tip 32. After the protective cover 56 is removed, the lancet 30 can then be used to form an incision in tissue. Once the protective cover 56 is removed or at some later time, the brake mechanism 88 releases the tape 62 so that the tape 62 can be indexed. To form the incision, the firing mechanism engages the actuator engagement opening 42 so that the lancet 30 can be fired toward the tissue. As should be appreciated, the lancet 30 can be fired by a variety of lancing mechanisms, such as spring-driven lancing mechanisms, electromechanical lancing mechanisms, and the like. For example, a firing mechanism such as that described and shown in U.S. patent application No.10/737,660 filed on 16/12/2003, which is incorporated herein by reference in its entirety, can be used to fire the lancet 30.

As shown in fig. 11, during or after the protective cover 56 is pulled from the lancet 30, the folded portions that form the packet 66 are peeled away from each other, the packet 66 containing the test pad 64. In one form, the peelable adhesive in the package 66 is released, thereby opening the package 66. In contrast to previous systems, the packet 66 is designed to keep the test pad 64 protected immediately prior to use, which in turn reduces the chance of cross-contamination between the lancet 30 and the test pad 64. As previously noted, the package 66 may be sealed in other ways, such as welded shut, or not sealed at all. In these other embodiments, the folded portions of the packet 66 may be separated in other ways. For example, in other embodiments, the packet 66 may include a weakened area or a line of disruption that breaks upon application of tension, thereby allowing the packet 66 to unfold. The free loop of tape 62 formed by the unfolded packet 66 provides freedom of movement for actuating the lancet 30 to form an incision. The cut may occur before or after the package 66 is fully unfolded.

Once the package 66 is fully unfolded, the test pad 64 in fig. 12 and 13 is aligned directly beneath the sample transfer opening 38 such that the test pad 64 is able to directly receive the fluid sample from the sample transfer opening 38. It is envisioned that in other embodiments, the package need not be completely unfolded until the test pad 64 is aligned with the sample transfer opening 38.

The transfer of the fluid sample from the lancet 30 to the test pad 64 can occur in several ways. In one approach, the lancet 30 first collects a fluid sample and then moves over the test pad 64 as the packet 66 is fully unfolded. For example, an incision is made and fluid is collected before the package 66 is fully unfolded. Specifically, with the packet 66 only partially unfolded, the lancet 30 cuts through the skin or other tissue in a manner such as that shown in fig. 11. Fluid collection can occur while the tip 32 of the lancet 30 is still positioned in the tissue (subcutaneous), or a fluid sample can be collected onto the surface of the tissue. After the sample is drawn into the sample transfer opening 38, the packet 66 is fully unfolded, thereby bringing the test pad 64 into contact with the fluid sample in the sample transfer opening 38. The fluid is then transferred to the test pad 64 and subsequently analyzed. In another approach, the packet 66 is completely unfolded before fluid collection occurs. For example, in one embodiment, the packet 66 is fully unfolded and the test pad 64 is positioned under the sample transfer opening 38 and the capillary groove 36 is used to collect the fluid sample before the lancet 30 forms the incision. It is contemplated that the transfer of the fluid sample may occur in other ways.

As previously mentioned, the fluid sample may be collected subcutaneously or on the surface of a tissue. With respect to collecting fluid on the surface of tissue, a number of techniques may be used to collect a sample. For example, after the incision is made, the lancet-sampler 52 is temporarily withdrawn from the tissue and, once a predetermined time has elapsed and/or fluid is detected on the surface of the tissue, the lancet-sampler 52 is reapplied to the incision in order to collect a fluid sample through the capillary channel 50. The lancet-sampler 52 may be positioned using an electromechanical positioning System, such as that disclosed in U.S. patent application No.10/737,660 entitled "Blood Acquisition Suspension System" (attorney docket No. 7404-549), filed 12/16/2003, which is incorporated herein by reference. The electromechanical positioning mechanism slowly moves the lancet-sampler 52 toward the tissue until a fill sensor in the lancet-sampler 52 detects that a sufficient amount of fluid has been collected.

Fig. 14 shows an example of a fluid sample that has been collected using the lancet-sampler 52. As can be seen, fluid from the lancet tip is drawn up the capillary groove 36 and into the sample transfer opening 38. As noted previously, the cover foil 48 over the capillary groove 36 tends to enhance fluid collection. Once the fluid reaches the sample transfer opening 38, the fluid can be immediately transferred to the test pad 64, or the lancet 30 can be moved so that the fluid can be transferred to the test pad 64. In one embodiment, the body fluid volume required for analysis is 100 nanoliters (nL) and the test time is approximately 1-2 seconds. However, it is contemplated that other sample volumes may be used in other embodiments and that the test time may be different. Once the fluid sample is analyzed, the section of tape 62 containing the now-used lancet-sampler 52 is wound around a waste spool in the cassette for later disposal. It should be appreciated that the used lancet-sampler 52 can be disposed of in other ways.

A lancet-sampler 92 according to another embodiment will now be described with reference to fig. 15, 16, and 17. As can be seen, the lancet-sampler 92 in fig. 15 shares several of the same features as the lancet-sampler 52 previously described with reference to fig. 4. Similar to the previous embodiments, the lancet-sampler 92 includes a lancet 30 with a lancet tip 32 extending from a lancet body 34, a capillary groove 36, a vent slot 40, a cover foil 48, and a protective cap 56. For clarity and brevity, the commonly shared features will not be discussed at length below, but reference is made to the previous discussion of these features.

To protect the cap foil 48 when the protective cap 56 is pulled away from the lancet tip 32, the protective cap 56 has a break line 94, and the break line 94 is scored, thinner, and/or otherwise weakened, thereby disengaging the protective cap 56 from the lancet 30 at the break line 94. As should be appreciated, the fracture line 94 may be formed in a number of ways, such as by mechanically scoring the protective cap 56, or scoring with a laser, to name a few.

In the illustrated embodiment, the lancet-sampler 92 does not have a sample transfer opening 38, but rather uses the capillary groove 36 to deposit the sampled body fluid directly onto the test pad 64 of the tape 62. As shown in FIG. 15, the capillary groove 36 is etched completely through the lancet 30 along the entire length of the capillary groove 36. That is, the capillary groove 36 opens on both sides of the lancet 30. By being completely etched, the capillary groove 36 maximizes the available volume for transporting body fluid, which is particularly beneficial for thin lancets. In addition, a fully etched capillary groove 36 tends to simplify manufacturing, as it eliminates the need to tightly control the required depth tolerances to form a partially etched capillary groove 36. It is envisioned, however, that in other embodiments, the capillary groove 36 may have a partially etched region. To form the enclosed capillary channel 50, the lancet 30 is sandwiched between a pair of cover foils 48, as shown in FIG. 17. In another variation, the capillary groove 36 is completely etched, but only one side of the capillary channel 50 is covered with a cover foil 48, such as shown in fig. 18, thereby forming an open capillary channel structure along the entire length of the capillary channel 50. In still other embodiments, the capillary channel 50 may have an open area as well as other areas that are closed. Referring to fig. 15, at the distal end of the lancet tip 32, the capillary groove 36 is uncovered or exposed so that the capillary groove 36 can collect body fluid from the incision, and the opposite end of the capillary groove 36 is exposed to form a vent groove 40.

Referring to fig. 18, the area of the capillary groove 36 on the side of the lancet 30 facing the test pad 64 is likewise not covered by the cover foil 48 so that the capillary groove 36 can deposit body fluid onto the test pad 64. Once the lancet-sampler 92 is positioned on the test pad 64, the lancet-sampler 92 and the carrier tape 62 (test pad 64) form a fluid transfer gap 96. The fluid transfer gap 96 has a higher affinity for body fluid than the capillary groove 36 because the fluid transfer gap 96 is smaller than the capillary groove 36. Due to the higher affinity, the body fluid is transferred to the fluid transfer gap 96, causing the body fluid to spread under the lancet-sampler 92 and over the test pad 64. As can be seen, the body fluid 98 in the fluid transfer gap 96 is able to cover a wider area than the capillary groove 36. It is contemplated that the lancet-sampler 92 and/or the carrier tape 62 can include hydrophobic and/or hydrophilic portions to direct fluid flow.

Fig. 19 shows an electrochemical version of a lancet-sampler 100 according to yet another embodiment. The lancet-sampler 100 of FIG. 19 shares several features in common with the previous embodiments, such as the lancet 30, the capillary groove 36, and the test tape 62. For clarity and brevity, the commonly shared features will not be discussed at length below, but reference is made to the previous discussion. The lancet-sampler 100 includes a reagent or test layer 102 that carries chemicals, such as enzymes and catalysts, for electrochemically analyzing the fluid sample. A reagent layer 102 is disposed on the carrier tape 62 and covers one or more electrodes 104. The electrodes 104 may include working, counter and reference electrodes, as well as other types of electrodes, such as electrodes for detecting fill sufficiency. The electrodes 104 are disposed on the carrier tape 62. All or a portion of these electrodes may be disposed on the same or opposite side of carrier tape 62 as reagent layer 102. In the embodiment shown, the electrodes 104 and reagent layer are disposed on the same side.

A lancet-sampler cassette 106 for storing and indexing the cassette tape 62 according to one embodiment will now be described with reference to fig. 20 and 21. The cassette 106 includes a housing 108, the housing 108 having opposing housing panels 110 and a storage wall 112, the storage wall 112 defining a storage compartment 114 for storing unused areas of the tape 62. In fig. 20 and 21, the perimeter wall surrounding the cassette 106 has been removed between the opposing panels 110 so that the internal workings of the cassette 106 can be easily viewed. It should be appreciated that the cassette 106 may include one or more peripheral wall regions to protect and/or maintain the sterility of the tape 62.

A spool 116 extends between the opposing housing panels 110 and is rotatably coupled to the housing panels 110. The spool 116 is used to move the tape 62, and the tape 62 is wound on the spool 116 once used. As can be seen, the spool 116 has a sprocket opening 118, the sprocket opening 118 being configured to receive a sprocket for rotating the spool 116. A first guide pin or roller 120 and a second guide pin or roller 122 for guiding the tape 62 in the cassette 106 are rotatably coupled to the housing 108. In the illustrated embodiment, the cassette 106 has two guide pins 120, 122, but in other embodiments, the cassette 106 can include more or fewer guide pins than shown, e.g., no guide pins. Referring to fig. 21, a first pin 120 and a second pin 122 are located at one end of the cassette 106 and form a triangular pattern with the spool 116. It should be appreciated that the pins 120, 122 and spool 116 may be oriented in other ways. Between the first guide pin 120 and the second guide pin 122, the tape 62 has a collection section 124 where a fluid sample is obtained with the lancet-sampler 52 and analyzed. At the acquisition area 124, the opposing panel 110 of the housing 108 has one or more sensor openings 126 in which the sensor reader of the meter is received to read the test pads 64 on the tape 62. It is contemplated that in other embodiments, the sensor opening 126 may be omitted when the sensor reader is positioned at other locations along the cassette 106. Depending on the analytical technique used, the sensor reader may comprise, for example, a light sensor or electrical contacts.

Inside the storage compartment 114, the tape 62 is folded in a fan-fold fashion. Referring to fig. 21, the tape 62 is folded with blank sections between each lancet-sampler 52 so that the lancet-samplers 52 face in the same direction. In the illustrated embodiment, the lancet-sampler 52 is oriented in a tail first configuration with the lancet tip 32 extending in a direction opposite to the direction in which the tape 62 moves during indexing. In other words, the tail or lancet body 34 of the lancet-sampler 52 is the front end when the lancet-sampler 52 is moved. With this tail first orientation, the risk of the lancet 30 piercing the tape 62 when the lancet-sampler 52 is wrapped around the spool 116 is reduced. Similarly, when the tape 62 is wound onto the spool 116 in a tail-first orientation, the risk of jamming the spool 116 is reduced. However, it is contemplated that in other embodiments, the lancet-sampler 52 can be oriented in other manners, such as by advancing the head or lancing tip, and the tape 62 can be folded in other manners. For example, the tape 62 can omit blank areas and have a lancet-sampler on each folded portion. The storage compartment 114 may also include a desiccant 128 to reduce harmful humidity in the storage compartment 114. The storage wall 112 includes a dividing wall region 130, the dividing wall region 130 separating the storage compartment 114 from the portion of the cassette 106 containing the spool 116. As will be explained below, the divider wall section 130 assists in pulling the protective cover from the lancet tip 32.

Turning to fig. 22A and 22B, the divider wall region 130 has slots 132 through which the tape 62 passes. On one side of the slot 132, the divider wall region 130 has an engagement block or portion 134 that is biased toward the belt 62 by a spring 136. In one form, the engagement block 134 is made of a resilient material such that the engagement block 134 can act as a seal to prevent contamination of the storage compartment 114. In the illustrated embodiment, the spring 136 is a leaf spring. However, it should be appreciated that the spring 136 may comprise other types of springs, such as coil springs, and/or other resilient devices. For example, in another embodiment, the divider wall region 130 is made of an elastic material in place of the spring 136. The gap height of the slots 132 is large enough to allow the tape 62 to pass through, but the gap height of the slots 132 is small enough so that the engagement block 134 can engage the protective cover 56 to pull the protective cover 56 from the lancet tip 32.

Referring to fig. 22A, as the spool 116 indexes the tape in an indexing direction 138, the lancet-sampler 52 passes through the slot 132. Once the protective cover 56 reaches the engagement block 134, the cover 56 engages the engagement block 134 because the protective cover 56 is too thick to easily pass through the slot 132. As the spool 116 continues to pull the tape 62 in the indexing direction 138, the protective cover 56 is pulled from the lancet tip 32 (FIG. 22B). Once the protective cover 56 is pulled from the lancet 30, the spool 116 continues to pull the tape 62 with sufficient force such that the engagement block 134 deflects and/or deforms to allow the protective cover 56 to pass through the slot 132. The lancet-sampler 52 is then positioned at the acquisition section 124 of the cassette 106, as shown in FIG. 21. The spool 116 slackens the tape 62, which in turn allows the lancet 30 to be fired to cut an incision. After lancing, the spool 116 takes up the slack and places the lancet 30 on the test pad 64 such that the collected fluid sample is deposited on the test pad 64. Through the sensor opening 126, the meter is able to analyze the sample on the test pad 64. Once the test is completed, the spool 116 is rotated, thereby winding the now-used lancet-sampler 52 around the spool 116. With the tail first orientation of the lancet 30 on the tape 62, the risk of the lancet tip 32 cutting and/or breaking the tape 62 is reduced. Next, the unused lancet-samplers 52 in the storage compartment 114 are indexed in a similar manner.

A lancet-sampler cassette or cartridge 140 according to yet another embodiment will now be discussed beginning with reference to fig. 23. The cassette 140 includes a housing 142 with opposing housing walls 144 and a peripheral wall 146 that defines a storage compartment 148 for storing unused areas of the tape 62 folded in a fan-fold fashion, as shown in fig. 24A. Similar to the previously described embodiments, the cassette 140 has a spool 116 for moving the tape 62, and a guide pin 120 for guiding the tape 62 in the cassette 140. In the vicinity of the spool 116, the storage compartment 148 has a curved wall region 150, the curved wall region 150 conforming to the shape of the tape 62 when wound on the spool 116. The desiccant 128 is disposed inside the storage compartment 148 to reduce the humidity inside the storage compartment 148. As can be seen, the storage compartment 148 has an exit 152 where the tape 62 exits the storage compartment 148. At the outlet 152, the cassette 140 has a seal 154 to maintain the humidity level within the storage compartment 148 and reduce the chance of contamination in the storage compartment 148. The housing 142 also has one or more sensor openings 156 in which a sensor reader of a meter is received to read the test pads 64 on the tape 62.

Referring to fig. 24A, the outlet 152, guide pin 120 and spool 116 are oriented in a triangular relationship with one another such that the tape extends at an acute angle to the guide pin 120. At the guide pin 120, the cassette 140 has an end or flip wall member 158 that defines a lancet opening 160 through which the lancets 30 pass during lancing. As shown, the lancet opening 160 is aligned with the guide pin 120. Between the end wall 158 and the outlet 152, the cassette 140 has an actuator opening 162 where the firing mechanism, i.e., the actuation mechanism, of the meter engages the lancet 30 of the lancet-sampler 52.

In the illustrated embodiment, the lancet-samplers 52 are aligned on the tape 62 in a face or lancet tip forward orientation in which the lancet tip 32 of the lancet 30 extends toward the spool 116 on the tape 62. With the tip first orientation of the lancet 30, the removal of the protective cover 56 from the lancet tip 32 is simplified, and similarly, the actuation of the lancet 30 is simplified. However, as previously mentioned, the tip-first orientation may create difficulties when the tape 62 is wound on the spool 116. For example, the lancet 30 can cut or even break the tape 62, and the spool 116 can become jammed by the lancet 30. To address these problems, the cassette in FIG. 24A stores and dispenses the lancet-samplers 52 in a tip first orientation, and then flips the lancets 30 on the tape 62 into a tail first orientation before wrapping the used section of tape 62 onto the spool 116.

In one embodiment, after the lancet-sampler 52 exits the storage compartment 148, the firing mechanism engages the actuator engagement hole 42 in the lancet 30 to hold the lancet 30 in place. The meter and/or cassette 140 includes a clutch that allows the carrier tape 62 to move only in the indexing direction 138. The firing mechanism is then used to pull the lancet 30 in a direction opposite the indexing direction, thereby pulling the protective cover 56 from the lancet 30. It should be appreciated that the protective cover 56 may be removed in other ways. For example, in another embodiment the spool 116 rotates when the firing mechanism holds the lancet 30 in order to pull the protective cover 56 from the lancet 30. Once the protective cover 56 is removed, as shown in fig. 24A, the lancet 30 is fired and a fluid sample is collected with the lancet-sampler 52 for analysis. After the lancet-sampler 52 is used, the spool 116 indexes the tape 62. Referring to FIG. 24B, when the tape 62 is indexed, the lancet 30 extends from the tape 62 because the tape 62 is bent at an acute angle about the guide pin 120. Referring to fig. 24C, as the spool 116 continues to index the tape 62, the lancet 30 hits the wall of the lancet opening 160 in the flip member 158, which in turn causes the lancet 30 to be oriented in a tail first orientation. With the lancet 30 flipped to a tail first orientation, the lancet 30 and tape 62 can be safely wrapped around the spool 116 as the spool 116 rotates. It should be appreciated that in other embodiments, lancing, fluid sampling, and/or analysis can occur after the lancet 30 is flipped. For example, in one embodiment, the lancet 30 lances the tissue when the lancet 30 is flipped (fig. 24B), and then the fluid sample is analyzed with the lancet 30 in a tail first orientation.

A meter 164 into which the cartridge 140 can be loaded is shown in fig. 25 and 26. In fig. 25 and 26, various electrical systems, such as circuit boards and wires, and other components have been removed so that the main system of the meter 164 can be easily viewed. In the illustrated embodiment, the meter 164 includes a housing 166 in which other components of the meter 164 are housed. The meter 164 further includes a power source 168, an indexing mechanism 170 configured to index the cassette 140, a firing mechanism 172 configured to fire the lancet 30, and a sensor system 174 configured to analyze the collected fluid sample. The housing 166, shown in phantom in fig. 25 and 26, has a rectangular shape, but in other embodiments the housing 166 may be formed in a different shape. The power supply 168 is used to drive various systems within the meter 164, such as a steering mechanism 170, a firing mechanism 172, and a sensor system 174. The power source 168 in the illustrated embodiment includes a battery, but it should be understood that other types of power sources may be used, such as an electrical outlet or a fuel cell. As shown, the sensor system 174 is received within the sensor opening 156 of the cassette 140. In the illustrated embodiment, the sensor system 174 includes a light sensor, but it should be appreciated that the sensor system 174 may be configured to analyze the fluid sample in other manners, such as by electrochemical analysis. When electrochemically analyzing the fluid, the sensor system 174 can, for example, include contacts that are configured to electrically couple to the contacts 104 of the electrochemical version of the lancet-sampler 100, and/or can include a transceiver that wirelessly communicates with the lancet-sampler 100.

The indexing mechanism 170 in the meter 164 includes an indexing motor 176, which motor 176 in the illustrated example is a reversible electric motor with a drive worm 178. The indexing motor 176 is driven by the power supply 168. It should also be understood that other types of motors may be used. The drive worm 178 rotates an intermediate gear 180, which intermediate gear 180 in turn rotates a main drive gear 182. The main drive gear 182 includes a sprocket that is received in the sprocket opening 118 of the spool 116. When the indexing motor 176 rotates the drive worm gear 178, the intermediate gear 180 and the main drive gear 182 rotate, which in turn rotates the spool 116, thereby indexing the tape 62. It is contemplated that guide mechanism 170 may be configured differently in other embodiments.

Referring to fig. 25 and 26, the firing mechanism 172 includes a firing or drive motor 184, a carriage 186, a lancing or actuator unit 188 carried on the carriage 186, a transfer member 190 for transferring force from the lancing unit 188, a guide 192 secured to the housing 166, and an actuation arm or member 194, the actuation member 194 being configured to actuate the lancet 30. In the illustrated embodiment, the drive motor 184 is a reversible electric motor 184, but in other embodiments, the drive motor 184 may include other types of motors, such as a pneumatic motor and/or a non-reversible motor. When the drive motor 184 is only capable of providing an output in one direction (i.e., a non-reversible motor), the firing mechanism 172 may incorporate a transmission capable of changing the output. The drive motor 184 has a worm gear 196 engaged with an intermediate priming gear 198, the intermediate priming gear 198 being arranged to prime or start (cock) the lancing unit 188. As shown, the priming gear 198 is rotationally coupled to a guide shaft or rod 199, the guide rod 199 being coupled at both ends to the housing 166.

Referring to FIG. 26, the lancing unit 188 is slidably coupled to the guide shaft 199. In the illustrated embodiment, the lancing unit 188 is mechanically driven, and in particular, the lancing unit 188 includes a torque barrel type firing mechanism, such asSOFTCLIX or MULTICLIX brand device drivers (Roche Diagnostics, Indianapolis, Indiana). For a detailed example of some types of lancing elements 188, see Lange et al, U.S. Pat. No. Re.35,803 and Kuhr et al, 6,419,661, which are incorporated herein by reference in their entirety. It should be appreciated that other types of firing mechanisms may also be used. By way of non-limiting example, in other embodiments, the lancing unit 188 can include other types of mechanical drivers, electromechanical types of drivers, electric types of drivers, pneumatic drivers, or some combination thereof.

Facing the priming gear 198, the lancing unit 188 has a clutch 200, the clutch 200 being disposed in engagement with the priming gear 198, as shown in fig. 27A. The clutch 200 can only rotate in one direction to activate the lancing unit 188. Fig. 27B shows an enlarged view of the priming gear 198 and clutch 200 when engaged. As can be seen, the clutch 200 has clutch fingers 202, which fingers 202 engage clutch teeth 204 on the priming gear 198. The clutch fingers 202 on the clutch 200 are generally resilient and extend in a radially inward direction toward the guide shaft 199. Turning to fig. 27A and 27B, the clutch fingers 202 and the clutch teeth 204 each have respective engagement surfaces 206 extending in generally orthogonal directions, and acute angled disengagement surfaces 208. When the drive motor 184 rotates the priming gear 198 in a clockwise direction 210 (fig. 27B), the engagement surfaces 206 of the priming gear 198 and the clutch 200 engage, such that the priming gear 198 rotates the clutch 200. When the clutch 200 is also rotated in the clockwise direction 210, the winding of the spring within the lancing unit 188 activates the lancing unit 188. Inside the lancing unit 188, the clutch has a second set of one or more fingers 211 (FIG. 27A), which fingers 211 engage notches in the lancing unit 188 such that the clutch 200 can only rotate in the direction of winding the spring within the lancing unit 188 to prime the lancing unit 188. Referring to fig. 27C, when the drive motor 184 rotates the priming gear 198 in the counterclockwise direction 212, the disengaging surfaces 208 typically slide past each other due to the resilient nature of the clutch fingers 202 so that the priming gear 198 does not rotate the clutch 200. While the clutch 200 is disengaged from the priming gear 198, the second set of fingers 211 of the clutch 200 located inside the lancing unit 188 prevent the spring inside the lancing unit 188 from unwinding, thereby leaving the lancing unit 188 in a primed state.

Returning to fig. 26 and 27A, the carriage 186 holding the lancing unit 188 is operably coupled to the priming gear 198 by a carriage actuation member or screw 214. The carriage actuation screw 214 includes a gear head 216 at one end, the head 216 engaging the priming gear 198. Opposite the gear head 216, the carriage actuation screw 214 has a threaded end 218 that is configured to threadably engage an internally threaded collar 220 on the carriage 186. Between the gear head 216 and the threaded end 218, the carriage actuation screw 214 has an unthreaded area 222. During firing of the lancing unit 188, the threaded collar 220 of the carriage 186 is positioned along the unthreaded section 222 of the carriage actuation screw 214. When the drive motor 184 rotates the priming gear 198 in a clockwise direction 210 to prime the lancing unit 188, the carriage actuation screw 214 rotates in a counterclockwise direction 212. As the carriage actuation screw 214 rotates in the counterclockwise direction 212, the threaded collar 220 remains on the unthreaded section 222 and disengages the threaded end 218. The carriage 186 remains stationary while the threaded collar 220 of the carriage 186 remains disengaged from the threaded end 218.

At the end of the shaft 199 in FIG. 26, the meter 164 includes an optional button 223. In one embodiment, the button 223 is adjustable relative to the shaft 199 so that the penetration depth of the lancet 30 can be adjusted. In another embodiment, the button 223 is used to fire the lancet 30. Specifically, in one embodiment, the button 223 includes a hollow tube slidably disposed about the shaft 199 and extending to the lancing unit 188. When the button 223 is pushed, the hollow tube releases the spring inside the lancing unit 188 such that the extension shaft 225 extends from the lancing unit 188. In other embodiments, the hollow tube of the button 223 is not disposed about the shaft 199, rather, the hollow tube serves as a portion of the shaft 199. It will be appreciated that firing may be initiated manually by pressing button 223, or automatically in some other manner. Also, in other embodiments, the button 223 may be optional, and the button 223 may also be placed in a location other than that shown in the figures. Further, the lancing unit 188 can be fired in other manners.

After priming the lancing unit 188 and initiating lancing by pressing the button 223 or in some other manner, in one embodiment, the drive motor 184 is reversed and the priming gear 198 is rotated in the counterclockwise direction 212. In another embodiment, the firing mechanism 172 does not require pushing the button 223 or some other input device to reverse the output of the drive motor 184. For example, after the priming gear 198 has been rotated a predetermined number of times, the drive motor 184 is reversed. Upon reversal of the drive motor 184, the carriage actuation screw 214 rotates in the clockwise direction 210 and thus engages the threaded collar 220 of the carriage 186 with the threaded end 218 of the carriage actuation screw 214. As the carriage actuation screw 214 continues to rotate in the clockwise direction 210, the threaded end 218 causes the carriage 186 along with the lancing unit 188 to move in the extension direction away from the priming gear 198, as indicated by arrow 224 in FIG. 27A. Finally, as the carriage 186 continues to move the lancing unit 188 in the direction 224, the clutch 200 on the lancing unit 188 disengages the priming gear 198 (fig. 27C).

As shown in FIG. 27A, opposite the clutch 200, the lancing unit 188 is coupled to a transmission member 190, and the transmission member 190 transmits the movement of the carriage 186 and the firing movement from the extension shaft 225 of the lancing unit 188 to the actuation member 194. Returning to FIG. 25, the transmission member 190 is housed within the interior of the guide member 192, and the actuation member 194 is similarly housed within the interior of the transmission member 190. With reference to FIG. 27A, the actuator member 194 in the illustrated embodiment has a pair of guide pins 226 extending from opposite sides of the actuator member 194, but it should be appreciated that the actuator member 194 may have more or fewer guide pins 226. The guide pins 226 pass through respective transmission slots 228 in the actuator member 194 and into guide slots 230 in the guide member 192. The guide member 192 is fixed to the housing 166 such that the guide member 192 does not move relative to the housing 166. With reference to fig. 27A and 28, the actuation member 194 has an engagement blade 232, the engagement blade 232 being configured to engage the keyhole 42 in the lancet 30.

As shown in fig. 27A, the guide slot 230 in the guide member 192 is generally L-shaped and the transmission slot 228 in the actuator member 194 is angled or angled. The L-shaped guide slot 230 has a first region 234 and a second region 236 extending orthogonally to each other. In other embodiments, the slots 228, 230 may be shaped differently depending on the desired path of movement for the actuation member 194. When the transmission member 190 slides relative to the guide member 192, such as during firing of the lancing unit 188, and/or when the carriage 186 moves, the transmission slot 228 causes the guide pin 226 to move along the L-shaped path of the guide slot 230. As the guide pins 226 of the actuator part 194 move within the first section 234 of the L-shaped guide slot 230, the engagement blade 232 of the actuator part 194 moves into engagement with the keyhole 42 of the lancet 30. Once the guide pin 226 reaches the corner of the L-shaped guide slot 230, the transmission slot 228 in the moving transmission member 190 pushes the guide pin 226 along the second section 236 of the L-shaped guide slot 230 in the direction 224. This, in turn, causes the lancet 30 to extend from the lancing cap 238 of the meter 164 in order to lance tissue and/or collect fluid from the incision.

One technique for obtaining and analyzing a fluid sample using the cartridge 140 and the meter 164 will be described initially with reference to fig. 29A. To prime the lancing unit 188, the drive motor 184 rotates the priming gear 198 in a clockwise direction 210, which in turn rotates the clutch 200 of the lancing unit 188. During priming of the lancing unit 188, the carriage 186 holds the lancing unit 188 stationary because the carriage actuation screw 214 rotates in the counterclockwise direction 212 such that the threaded collar 220 of the carriage 186 remains on the unthreaded section 222, disengaging the threaded end 218 of the screw 214. As previously mentioned, the indexing motor 176 is used to index the tape 62 in the cassette 140 so that the lancet-sampler 52 is properly positioned to engage the engagement blade 232 of the actuation member 194. In one example, the indexing motor 176 indexes the tape 62 after the lancing unit 188 is activated, but it should be appreciated that the tape 62 can be indexed before, during, or after the lancing unit 188 is activated. During indexing of the tape 62, the protective cover 56 over the lancet tip 32 of the lancet 30 can be removed in a similar manner as described above with respect to the cassette 140. The firing mechanism 172 can be activated before or after the lancing cap 238 is placed on the skin or other tissue.

Turning to FIG. 29B, once the clutch 200 is rotated sufficiently to activate the lancing unit 188, the firing mechanism 172 can be fired. Firing may be initiated by the user, either manually (fig. 26) by, for example, pressing a button 223 or automatically by the meter 164. In one embodiment, firing of the lancing unit 188 begins after the actuator blade 232 engages the lancet 30, and in another embodiment, firing of the lancing unit 188 occurs before the actuator blade 232 engages the lancet 30. Upon priming the lancing unit 188, the drive motor 184 is reversed such that the priming gear 198 rotates in the counterclockwise direction 212. As a result, the carriage actuation screw 214 rotates in the clockwise direction 210, which in turn causes the threaded collar 220 of the carriage 186 to engage the threaded end 218 of the screw 214. Once the collar 220 is engaged with the threaded end 218, the carriage 186 moves away from the priming gear 198, as indicated by directional arrow 224. The lancing unit 188 slides along the guide shaft 199 together with the carriage 186, and the clutch 200 of the lancing unit 188 disengages the priming gear 198. Although the clutch 200 is disengaged from the priming gear 198, the lancing unit 188 remains primed because the second set of fingers 211 (FIG. 27A) only allow the clutch 200 to rotate in the priming direction, thereby preventing unwinding of the torsion spring inside the lancing unit 188. As the carriage 186 moves in the direction 224, the transport member 190 also moves in the same direction. In one embodiment, the lancing unit 188 is not fired as the carriage 186 moves such that the movement of the carriage 186 is the sole source of power for moving the transport component 190. In an alternative embodiment, which launches the lancing unit 188 while the carriage 186 is moved, movement of both the carriage 186 and the extension of the extension shaft 225 moves the transport member 190. Movement of the transmission member 190 and its transmission slot 228 in direction 224 causes the guide pin 226 to move along the first region 234 of the L-shaped guide slot 230. This in turn pushes the actuator blade 232 of the actuator member 194 into the keyhole 42 of the lancet 30, thereby engaging the lancet 30 to the firing mechanism 172. The actuator blade 232 may also be configured to pierce a membrane if the keyhole 42 is covered by a protective cover or membrane.

Referring to fig. 29C, after the actuation blade 232 of the firing mechanism 172 engages the lancet, the drive motor 184 stops driving the carriage 136 in direction 224. At this point, the firing mechanism 172 is ready to fire the lancet 30. Once ready, the lancing unit 188 is fired such that the extension shaft 225 extends from the lancing unit 188 in direction 224. As noted above, the lancing unit 188 can be fired automatically by the meter 164 or manually by pressing the button 223 and/or have some other type of user interface for an input device. As mentioned above, in other embodiments, the lancing unit 188 can be fired while the carriage 186 is moving in the direction 224. Returning to the illustrated embodiment, after the firing mechanism 172 engages the lancet 30 and the user presses the button 223, the lancing unit 188 extends the extension shaft 225. As the telescoping shaft 225 moves, the transmission slot 228 in the moving transmission member 190 causes the guide pin 226 of the actuator arm 194 to slide in the second section 236 of the guide slot 230. Thus, the actuator arm 194 extends or fires the lancet 30 such that the lancet tip 32 cuts an incision in tissue.

After cutting the incision, the lancing unit 188 is configured to retract the extension shaft 225 in a retraction direction as indicated by arrow 240 in FIG. 29D. This in turn causes the guide pin 226 to move in the retracting direction 240, which causes the lancet 30 to withdraw from the incision. Removing the lancet 30 from the incision tends to reduce pain and potentially enhance bleeding from the incision because the lancet tip 32 does not block the incision. The lancet 30 can then be reapplied such that the lancet tip 32 is immersed in the droplet of tissue body fluid, thereby drawing the fluid sample into the lancet-sampler 52. Referring to fig. 29E, to reapply the lancet tip 32 to the drop of fluid, the drive motor 184 rotates the carriage actuation screw 214 in the clockwise direction 210, thereby moving the carriage 186 in the extension direction 224. As the carriage 186 moves, the actuator arm 194 moves with the lancet 30 in the direction 224 toward the incision.

Referring to fig. 29F, once the sample is collected, the drive motor 184 is reversed to rotate the carriage actuation screw 214 in the counterclockwise direction 240. This causes the carriage 186 to retract in the direction 240, which in turn causes the lancet 30 to withdraw from the tissue. As the drive motor 184 continues to retract the carriage 186, the guide pin 226 of the actuator arm 194 moves into the first section 234 of the guide slot 230, which in turn disengages the actuator blade 232 from the keyhole 42 in the lancet 30. The sensor 174 in the meter 164 can be used to analyze the fluid sample before, during, or after the actuator arm 194 disengages from the lancet 30. After the firing mechanism 172 disengages from the lancet 30, the tape 62 can be indexed in the manner described above so that the now-used lancet-sampler 52 can be flipped over and wrapped around the spool 116 of the cassette 140 while the unused lancet-sampler 52 is positioned to engage the actuator arm 194 of the firing mechanism 172. The drive motor 184 continues to retract the carriage 186 until the collar 220 disengages the threaded end 218 at the unthreaded section 222 of the carriage screw 214. At about the same time, the clutch 200 of the lancing unit 188 reengages the priming gear 198, allowing the drive motor 184 to prime the lancing unit 188 again. Subsequent lancets 30 can then be fired and the fluid analyzed in the same manner as described above. It should be appreciated that in other embodiments, the meter may be set in a different manner.

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, and 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 (11)

1. A body fluid sampling device comprising:

a lancet configured to cut an incision in tissue; and

a carrier tape coupled to the lancets, the carrier tape comprising a test pad configured to analyze the bodily fluid, the tape folded around the test pad, wherein the test pad is positioned to align with the lancets when the tape is unfolded.

2. The device of claim 1, wherein the lancet defines a capillary groove configured to draw body fluid from the incision by capillary action.

3. The apparatus of claim 2,

the lancet has a sample transfer opening configured to collect body fluid from the capillary groove; and is

The test pad is positioned in alignment with the sample transfer opening when the tape is unwound.

4. The device of claim 2, further comprising a hydrophilic cover covering at least a portion of the capillary groove to form an enclosed capillary channel.

5. The device of claim 1, wherein the strips folded around the test pad are sealed together to form an air-impermeable package.

6. The device of claim 5, wherein the package is sealed with a peelable adhesive to allow the tape surrounding the test pad to be peeled away.

7. The device of claim 1, further comprising a protective cover covering at least a portion of the lancet, the protective cover being attached to the tape at a location that is configured to pull the protective cover away from the lancet when the tape is pulled.

8. A method, comprising:

providing a tape assembly comprising a tape with a fold region that forms a protective wrap around a test pad and a lancet attached to the tape; and

pulling the protective packaging open;

the method further comprises the following steps:

aligning the test pad with the lancet when the protective package is pulled open.

9. The method of claim 8, further comprising:

after the aligning, transferring a fluid sample from the lancet to the test pad.

10. The method of claim 9,

the lancet comprises a capillary groove; and is

Transferring the fluid sample includes drawing the fluid sample from the capillary groove onto the test pad.

11. The method of claim 8, further comprising:

directing a second folded area of the tape to a fluid collection location, the second folded area forming a second protective wrap around a second test pad; and

pulling the second protective packaging apart to expose the second test pad.