Body fluid lancing, acquiring, and testing cartridge design

A lancet wheel having a rim with a plurality of lancets extending radially inward from the rim is dropped in a circular frame having a plurality of spokes forming a plurality of chambers for facilitating drop-in assembly of the modular lancet wheel with the frame. A test ring having a plurality of test sections is assembled on the frame such that one test section is located adjacent each lancet to form an integrated cartridge. Each lancet includes a lancet tip defining a capillary groove sized to collect a body fluid sample from the incision via capillary action. The lancet tip exits the chamber to form the incision in skin, the capillary groove collects the body fluid sample, the lancet tip retracts into the chamber, and a portion of the lancet contacts the test section to transfer the sample from the capillary groove to the test section to analyze the sample.

BACKGROUND

The present invention generally relates to an integrated disposable cartridge and more specifically, but not exclusively, concerns a cartridge manufactured in a cost-effective manner. Moreover, the integrated disposable includes a unique technique of transferring a fluid sample from a lancet to a test section.

The acquisition and testing of body fluids is useful for many purposes and continues to grow in importance for use in medical diagnosis and treatment, such as for diabetes, and in other diverse applications. In the medical field, it is desirable for lay operators to perform tests routinely, quickly, and reproducibly outside of a laboratory setting, with rapid results and a readout of the resulting test information. Testing can be performed on various body fluids and, for certain applications, is particularly related to the testing of blood and/or interstitial fluid. Performing home-based testing can be difficult for many patients, especially for patients with limited hand dexterity, such as the elderly or diabetics. For example, diabetics can sometimes experience numbness or tingling in their extremities, such as their hands, which can make self-testing difficult because they are unable to accurately position a test strip to collect the blood sample. In addition, wounds for diabetics tend to heal more slowly, and as a result, there is a desire to make incisions less invasive.

Recently, lancet integrated test strips or elements have been developed in which a test strip is integrated with a lancet or other piercing means so as to form a single disposable unit. While these integrated units have somewhat simplified the collection and testing of fluid samples, there are still a number of issues that need to be resolved before a commercial unit can be implemented. A few concerns for a multiple disposable unit include manufacturing the unit simply and inexpensively and positioning individual lancets and test strips in the commercial unit without damage to either the test strip or the lancet. Typically, a plurality of lancets and a plurality of test strips are each individually positioned in sealed compartments in a commercial unit. This process can be time consuming, expensive, and difficult to manufacture. Moreover, there is a possibility some of the lancets and/or test strips can be damaged while being positioned in the commercial unit.

Another concern of multiple disposable units disposed in a commercial unit is sterility of the lancets both initially and to maintain the sterility of the lancets until lancing the skin or tissue. As should be appreciated, sterilizing the lancets separately from the test sections eases the manufacturing process of a commercial unit. For example, the chemistry on the test sections is not disturbed by the separate sterilization of the lancets. After the lancets and test sections are assembled together, it is important to maintain the sterility of the lancets until lancing the skin or tissue to ensure an accurate testing event.

Yet another concern of multiple disposable units disposed in a commercial unit is the alignment of the lancet and test strip. Properly aligning the lancet and test strip ensures an accurate transfer of a body fluid sample from the lancet to the test strip. Moreover the proper alignment of the lancet and test strip reduces waste of the body fluid sample by accurately transferring the sample from the lancet to the test strip.

Another concern of users of multiple disposable units is the preference for smaller body fluid sample sizes that are used for testing, preferably a volume less than 1 microliter. Typically, a small body fluid sample requires a small penetration depth by the lancet which reduces the amount of pain for the user during lancing. Further, it is desirable that there is minimal or very little waste of body fluid from the lancet that is transferred to the test strip. Unnecessary waste of body fluid during the transfer of the body fluid from the lancet to the test strip can result in inaccurate test results or the need for larger body fluid samples to yield an accurate test result. There is a need for a multiple disposable unit that reduces the amount of pain for the user during lancing by using a lancet having a small penetration depth. Moreover there is a need for a multiple disposable unit that also efficiently transfers the small body fluid sample from the lancet to the test strip to eliminate any waste of body fluid.

A precise lancing profile for a lancet in an integrated disposable cartridge ensures an appropriate amount of a body fluid sample is collected during lancing the skin or tissue. A precise lancing profile for a lancet also ensures that an appropriate number of capillaries are cut during lancing the skin or tissue. For example, if too few capillaries are cut then the body fluid sample may not be large enough to yield accurate test results. If too many capillaries are cut then an overly large body fluid sample is collected and the user may experience a greater amount of pain than was necessary to obtain an adequate body fluid sample. Various configurations of the lancet and lancet entry have been used to attempt to solve these concerns. One configuration is a substantially straight lancet with a straight entry. One concern with a straight lancet having a straight entry is the deep penetration depth of the lancet which results in many capillaries being cut and a greater amount of pain for the user. Another configuration is a curved lancet with a rotational entry which can also result in an overly large wound and fluid sample and unnecessary pain for the user.

Thus, there is a need for improvement in this field.

SUMMARY

One aspect concerns an integrated cartridge assembled by dropping or placing the components into a frame. The integrated cartridge includes a test ring having a continuous strip of chemistry such that the test ring is sectionable into a plurality of test sections when the test ring is positioned in the frame. The integrated cartridge also includes a lancet wheel having a lancet rim with a plurality of lancets extending radially inward from the lancet rim. Each of the lancets has a leg portion, a contact portion to contact the test section and to deposit a body fluid sample on the test section, and a lancet tip extending substantially transverse to the leg portion. The integrated cartridge includes a frame having an egg crate shape with a plurality of chambers to facilitate drop-in assembly of the lancet wheel and the test ring onto the frame and to section the test ring into the plurality of test sections such that each of the lancets is positioned next to one test section in the frame.

Another aspect concerns a method of assembling an integrated disposable cartridge. The method includes assembling an integrated disposable cartridge by dropping a lancet wheel onto a frame. The lancet wheel has a rim with a plurality of radially inwardly extending lancets and the frame has a plurality of spoke defining a plurality of chambers. Each of the lancets is positioned in one of the chambers.

Another aspect concerns a method of automatically collecting a body fluid sample with a lancet and transferring the body fluid sample to a test strip. An integrated disposable cartridge includes a frame, a lancet wheel having a plurality of lancets extending radially inward from a rim, and a test ring having a plurality of test sections, wherein the plurality of lancets contact the plurality of test sections. Next, an incision in tissue is formed with one of the lancets by rotating the lancet away from the plurality of test sections. A body fluid sample is collected with a capillary groove on the lancet, and the lancet is withdrawn from the incision in tissue by rotating the lancet towards the plurality of test sections. The body fluid sample in the capillary groove on the lancet is transferred to one of the test sections by contacting the test section with the lancet to release the body fluid sample.

Yet another aspect concerns a microsampler wheel. The microsampler wheel includes a base, a plurality of lancets, and a plurality of ribs. The plurality of ribs and the plurality of lancets extend radially outward from the base, and the plurality of ribs and the plurality of lancets alternate with each other. Each of the lancets includes a curved lancet tip configured to form an incision in skin. Each of the lancets is also configured to rotate about the base such that the curvature of the rotation of the lancet is similar to the curvature of the lancet tip. Each of the plurality of ribs is positioned as a reference plane for determination of the penetration depth of the lancet tip.

Further forms, objects, features, aspects, benefits, advantages, and embodiments will become apparent from a detailed description and drawings provided herewith.

DESCRIPTION OF SELECTED EMBODIMENTS

Any directional references in this detailed description with respect to the Figures, such as up or down, or top or bottom, are intended for convenience of description, and by itself does not limit the present invention or any of its components to any particular positional or spatial orientation.

One embodiment concerns a unique integrated disposable cartridge or disc as well as a technique for inexpensively manufacturing the cartridge or disc, which is by virtue of the design. The unique cartridge utilizes a unique “drop-in” or “modular” design that allows a plurality of lancets on a lancet wheel to be aligned in sample chambers of a disc-shaped frame. This unique drop-in design eliminates the need for individual alignment and placement of the plurality of lancets. A test ring is also positioned on the frame such that the sample chambers form a plurality of test elements on the test ring. As should be appreciated, the lancet wheel, frame, and test ring are manufactured separately and assembled to form an integrated disposable cartridge. In one form, the lancet wheel, frame, and test ring are sterilized after assembly of the cartridge. In another form, the lancet wheel, frame, and test ring are sterilized individually. One or more sealing foils or sheets positioned on the exterior of the cartridge maintain the sterility of the lancets and humidity of the test elements prior to lancing the skin or tissue. The cartridge protects other persons from unintended contact of used lancets after lancing the skin or other tissue. The cartridge includes individual, separate chambers to maintain the humidity of the chemistry on each of the test elements prior to lancing the skin or tissue. The unique shape of the lancets and the placement of the test elements on the frame enable automatic transfer of a body fluid sample from the capillary of the lancet to a test element immediately after a lancing and sampling cycle has occurred. The automatic transfer of the body fluid sample enables a “one step” operation of lancing, sampling, and testing of the body fluid sample. Moreover, the lancet is configured to collect a small volume of body fluid, such as less than 0.1 microliter, and transfer this small volume to the test section for analysis without considerable loss of fluid. As should be appreciated, the one step operation and small size of the cartridge and associated meter provides for on-the-go convenience for users.

A second embodiment also concerns a unique integrated disposable cartridge or disc as well as a technique for inexpensively manufacturing the cartridge or disc. The cartridge in this embodiment utilizes a unique lancet wheel design that includes a plurality of microneedles or lancets that alternate with a plurality of ribs. The cartridge includes a test element disc that has a plurality of test elements positioned next to the plurality of lancets. The lancet wheel and the test element disc are manufactured separately and assembled together to form the cartridge. Together the lancet wheel and the test element disc define a plurality of individual lancing and test events. The lancets have a unique built-in spring shape and the lancet tip forms a slight circular path during lancing. The unique shape of the lancets provides that the lancets spring back or return to their original pre-incision position after lancing the skin or tissue. Moreover, each of the plurality of lancets includes a curved lancet tip corresponding to the curvature of the circular path traced by the lancet tip during the bending and retraction during a lancing cycle of the lancet. The curved shape of the lancet matching a curved trajectory path mimics the straight line motion typical in most common lancing systems. A drive mechanism that forces the lancet tip to follow a curved path during penetration and retraction follows the natural bending or flexing of the lancet arm's radius length and enhances simplicity of design and manufacture of the disposable. As should be appreciated, the return of the contaminated lancet to the pre-incision or un-flexed position protects other persons from accidentally contaminating themselves with a used lancet. Each of the lancet tips includes a micro-capillary sized to collect a body fluid sample via capillary action. The capillary is positioned on the front or rear face of the lancet tip, and the capillary can extend various lengths from the lancet tip along the lancet. The plurality of test elements is positioned next to the capillaries on the lancets such that as the lancet tip returns to its pre-incision position, the body fluid sample in the capillary is transferred from the capillary to the test element.

A cartridge20according to one embodiment is illustrated inFIGS. 1 and 2. The cartridge20is configured to lance skin to form an incision, collect a body fluid sample from the incision, analyze the body fluid sample, and be indexed for a subsequent lancing. The cartridge20forms a sterile environment for a plurality of lancets and a plurality of test elements, and the cartridge20maintains the low humidity of the chemistry independently for each of the plurality of test elements prior to lancing the skin or tissue. The individual elements or modular components of the cartridge20are manufactured separately and assembled into the final form. For example, in one embodiment, the cartridge20includes twenty-five or more lancing and testing modules by assembling five or six components to form cartridge20. Moreover, there is no user input required to transfer the body fluid sample from the lancet to the test strip as the cartridge20performs this task automatically after an incision in skin is formed. The cartridge20also stores the used lancets and test elements after lancing and testing to prevent meter contamination and/or cross contamination between the individual lancets and test elements contained in the cartridge20. As shown, the cartridge20is in the shape of a disc or circle that enables indexing by rotation of the cartridge20and minimizes the size of cartridge20when it is stored in a meter. It should be appreciated that the cartridge20can have a different overall shape in other embodiments. For example, the cartridge20can be oval, square, or rectangular, to name a few shapes.

The cartridge20includes a lancet wheel22with a plurality of lancets24for lancing the skin and collecting the body fluid sample and a test ring26having a continuous test area that is divided into a plurality of test sections28for analyzing the body fluid sample when the test ring26is assembled to a frame30. The cartridge20also includes a frame30that defines a plurality of chambers or compartments32for storing the individual lancets24in a sterile manner. As described in more detail below, the cartridge20can include a breachable sterility sheet40to seal the individual lancets24. The plurality of chambers32aligns each of the test sections28with an individual lancet24. The frame30is similar to an egg crate design that allows for quick assembly of the lancet wheel22with the frame30with drop-in or modular design of the lancet wheel22into the plurality of compartments32. The frame30also defines a plurality of openings34sized to receive a driver36. Each of the chambers32aligns with one of the openings34on the frame30. The driver36is sized and configured to extend through one of the openings34and into the corresponding one of the chambers32to engage and move the lancet24to form an incision in skin. The driver36can be semi or fully automatic in function, and the driver36can be part of an indexing and/or actuation system as described below. The driver36includes a sharp or pointed end to pierce through a second sterility sheet40placed over the openings34, as described below. The cartridge20includes a first sterility sheet38positioned to cover and seal one side of the plurality of chambers32of frame30. The cartridge20also includes a second breachable sterility sheet40positioned to cover and seal the plurality of openings34of the frame30. The test ring26is configured to cover and seal the remaining side of the plurality of chambers32of frame30. The combination of the first sterility sheet38, the second sterility sheet40, and the test ring26over the plurality of chambers32and the plurality of openings34maintains the sterility of the plurality of lancets24and controls the humidity to which the plurality of test sections28are subjected. Example materials for the first sterility sheet38and the second sterility sheet40include plastic, metal, paper, and/or other materials. In one embodiment, the first sterility sheet38and the second sterility sheet40are each made of aluminum-coated polyethylene terephthalate having a thickness of less than 12 micrometers. Furthermore, in this embodiment, the test ring26is made of polyethylene-coated polyethylene terephthalate having a thickness of less than 125 micrometers. As should be appreciated, the first sterility sheet38, the second sterility sheet40, and the test ring26can be made of other materials.

As illustrated inFIGS. 3,4,5, and6, the lancet wheel22includes a lancet rim23with the plurality of lancets24extending radially inwardly from the lancet rim23. In other words, the plurality of lancets24extend from the lancet rim23towards the center of the lancet wheel22.

Each of the lancets24has a flexible leg portion42, a contact portion44, and a lancet tip46. The leg portion42is substantially straight; however, in another form, the leg portion42may be curved or bent or otherwise designed to provide a spring-like link. The leg portion42extends from the lancet rim23to the contact portion44. The contact portion44forms a first angle θ between the leg portion42and the lancet tip46as shown inFIG. 6. In one embodiment, the first angle θ is approximately a 90 degree angle. In other embodiments, the first angle θ may be another angle between 0 and 270 degrees. The lancet24is configured such that the contact portion44is positioned to contact one test section28. The leg portion42forms a second angle β with the edge of a wall50of the frame30, as described in more detail below. As shown inFIG. 6, the second angle β is an acute angle.

The lancet tip46defines a capillary groove48sized to draw a body fluid sample via capillary action and to collect the body fluid sample. In one embodiment, the capillary groove48is coated with a hydrophilic material to enhance the capillary action of the groove48. The capillary groove48may be located on either the front side or the back side of the lancet tip46. The capillary groove48may be an open, closed, or combination open and closed capillary in which to draw the body fluid sample. Typically, the capillary groove48is located on the inside face of the lancet tip46and is an open capillary. As should be appreciated, an open capillary is easier to manufacture because the open capillary can be easily formed. For example, the open capillary can be formed by etching the surface of the lancet tip46and removing material to create the open capillary. Moreover, an open capillary groove collects body fluid that is drawn from beneath the skin surface below the incision. The capillary groove48extends from the lancet tip46into the contact portion44such that as the contact portion44contacts the test section28, the body fluid sample contained in the capillary groove48is released by fluid contact onto the test section28. The capillary grooves48in the plurality of lancets24may be manufactured by stamping, etching, carving, or combinations thereof including other techniques.

The lancet wheel22having the plurality of lancets24can be manufactured from a single piece of material, such as metal, plastic, or combinations thereof including other materials. In one embodiment, the lancet wheel22is formed by etching, stamping, or laser cutting a metal plate and removing portions of the metal plate to expose the plurality of lancets24. The capillary grooves48are formed by etching, laser cutting, or forming the plurality of lancet tips46to expose the capillary grooves48either simultaneously with the formation of the plurality of lancets24or subsequent to the formation of the lancets24. Each of the plurality of lancets24is bent at the contact portion44to form the first angle θ and each of the plurality of lancets24is bent at the rim23to form the second angle β. Each of the plurality of lancets24radiates from the rim23to the center of the lancet wheel22. In another embodiment, the lancet wheel22can be manufactured by attaching the plurality of lancets24to the rim23. It should be appreciated in other embodiments, the lancet wheel22is formed by other manufacturing techniques.

As mentioned previously and illustrated inFIG. 1, the test ring26includes the plurality of test sections28for testing body or biological fluids, such as blood, interstitial fluid, as well as other fluids, from the incision. The test section28for the embodiment ofFIGS. 1 and 2will be described with reference to an optical test strip, but it should be recognized that the test section28can analyze body fluid samples in other manners, such as via amperometry, coulometry, or reflectance photometry, to name a few techniques. As should be recognized, the optical test strip can be analyzed via a charge-coupled device (CCD) and/or color-capture device, and a histogram reader can be used to display the test results.

In the illustrated embodiment, the plurality of test sections28is in the form of a continuous strip or ring of chemistry mounted on or applied to a film. InFIG. 1, the test ring26includes index lines29printed on it to distinguish the individual test sections28; however, in other embodiments the index lines29are optional. Each of the test sections28is located in one of the chambers32and positioned adjacent to and/or in contact with the contact portion44of one of the lancets24. Friction or rubbing between the contact portion44of the lancets24and the test sections28prior to a lancing and testing event can damage the chemistry on the test sections28and affect the analysis of the body fluid sample. In this embodiment, the plurality of test sections28include a thin, soluble layer to protect the chemistry on the plurality of test sections28and to prevent testing errors from the friction or rubbing of the contact portion44of the lancet24with the chemistry on the plurality of test sections28prior to a lancing and testing event. This thin, soluble layer does not interfere with the chemistry or affect the analysis results of the body fluid sample during a lancing and testing event. In another embodiment, each of the test sections28does not contact the contact portion44; instead a breakable tab49is positioned between the lancet24and the test section28to elevate the contact portion44away from the test section28. The breakable tab49remains in position until the driver36engages the leg portion42of the lancet24. The test ring26is configured to cover and seal one side of the frame30and the corresponding side of the plurality of chambers32. In one embodiment, the test ring26includes a chemistry lot coding in a bar code or radio frequency identification (RFID) chip to store information on the calibration for the chemistry lot in a convenient format for the plurality of test sections28.

As illustrated inFIGS. 1,2, and7, the frame30includes a plurality of spokes or walls50configured to define the plurality of chambers32in which each of the chambers32is sized to house one of the lancets24. The plurality of walls50segregate the plurality of lancets24and maintain the sterility of the plurality of lancets24. Moreover, since the lancets24return to their original pre-incision forming position in the chambers32, the plurality of walls50prevent contamination of sterile lancets24by preventing contact between used and unused (sterile) lancets. The frame30is circular in shape, and each of the chambers32is a trapezoidal or wedge-like shape. In one form, the frame30is approximately 38 millimeters diameter, 3-5 millimeters height, and includes twenty-five chambers to store twenty-five of the lancets24and twenty-five of the test sections28. In other forms, the frame30and the chambers32may be shaped differently. For example, the frame30and/or the chambers32can have a rectangular, oval, and/or triangular shape.

As illustrated inFIGS. 2 and 7, the frame30also includes a plurality of internal gears52located near the center of the frame30. Each of the internal gears52is positioned near one of the chambers32. The placement of the gears52next to the chambers32enables a spindle or other engagement mechanism to engage the gears52and rotate the frame30to position a subsequent chamber32and corresponding opening34in line with the driver36. The gears52may be positioned at other locations on the frame30, and the gears52may be configured differently to engage other rotational mechanisms in other embodiments. Each of the plurality of internal gears52is triangular in shape; however, in other embodiments the plurality of internal gears52may be shaped differently. For example, the plurality of internal gears52can have a circular, rectangular, and/or oval shape. In another example, the plurality of internal gears52index the cartridge20to provide only one way in which to insert the cartridge20into a meter66, as discussed below.

The frame30also includes a frame rim53on the exterior, and a hub54on the interior, as illustrated inFIGS. 2 and 7. The frame rim53defines the plurality of openings34such that each of the openings34corresponds with one of the chambers32. Each of the openings34is circular in shape; however, in other embodiments the openings34may be shaped differently. For example, each of the openings34can have an oval, elliptical, and/or rectangular shape, to name a few shapes. In another example, each of the openings34is open to the bottom of the frame30to provide for easier molding of the frame30. Moreover, each of the openings34is sized to receive the driver36. The hub54is circular in shape for mounting the frame30onto a spindle or other rotatable mechanism. The hub54can be shaped differently in other embodiments.

In one embodiment, the frame30is constructed from desiccant-filled plastic which is injection molded into a disc shaped frame. In other embodiments, the frame30can be made from other materials such as metal, wood, ceramic, plastic, other materials, and/or composites thereof. In another embodiment, the frame30includes a separate desiccant wedge or desiccant granules added to each of the chambers32. Moreover, the frame30can be constructed from other techniques such as attaching the plurality of walls50and the plurality of internal gears52to the hub54by gluing, welding, or some other mechanism for attachment. In one form, frame30is sterilized using an inline electron beam (e-beam) sterilization process. The frame30can be sterilized in other manners, such as via gamma radiation or ultraviolet sterilization techniques. Moreover, frame30can also be sterilized at any one of the various assembly stages.

As illustrated inFIGS. 8,9, and10, the cartridge20is loaded into a meter66. The meter66can be configured to display the analysis results of the body fluid sample. The meter66includes an actuation mechanism60. In one embodiment, the actuation mechanism60engages and moves the driver36to engage one of the lancets24. In another embodiment, the actuation mechanism60indexes the frame30to position the driver36adjacent the opening34of an unused lancet24. As should be appreciated, in one embodiment, the actuation mechanism60engages and moves the driver36and the actuation mechanism60also indexes the frame30. The meter66is not shown in its entirety, but it should be appreciated the meter66covers and encloses the cartridge20, the driver36, and the actuation mechanism60. The meter66can be various shapes such as rectangular, triangular, circular, and/or oval, to name a few shapes. The meter66can be made of various materials, such as plastic, metal, and/or other materials.

In the embodiment illustrated inFIG. 10, the meter66includes a lancing cap62that is placed against the incision during lancing. The lancing cap62defines an incision location opening64. As should be appreciated, the user places the appropriate body part that is to be lanced over the incision location opening64and the lancing tip46passes through the incision location opening64to form an incision in the user. The lancing cap62forms a tapered circular shape but can be shaped differently in other embodiments. For example, the lancing cap62can be pyramidal, U-shaped, ovoidal, circular, or some other shape. The incision location opening64is also circular in shape but can be shaped differently in other embodiments. The lancing cap62can be made of various materials, such as plastic, metal, and/or other materials. In one embodiment, the lancing cap62is configured to adjust the penetration depth of the lancing tip46. In one example, the lancing cap62is threaded into the meter66. The threaded engagement allows the lancing cap62to move relative to the meter66in order to control the penetration depth of the lancing tip46.

In another embodiment, the lancing cap62is configured to detect a force required by the user to initiate lancing. The lancing cap62can also control the skin deflection thru the lancing cap62to a known variation or depth. Further, the lancing depth can be controlled by the amount of travel of the driver36to engage the lancet24in which the range of motion of the driver36is set by the user. Additionally, the driver36may move in a linear radial motion, a rotational motion with an eccentric shape, or a tipping motion to lift up and down the flexible leg portion42.

To use the cartridge20, a user positions a body part to be lanced, most likely a finger, over the incision location opening64. The driver36is actuated to pierce through the second sterility sheet40, pass through the corresponding opening34, and enter the chamber32. The driver36continues moving into the chamber32, and the driver36engages the leg portion42of the active lancet24. As the driver36engages the leg portion42, the driver36applies a force to the leg portion42to move the lancet tip46in a direction orthogonal to the frame30. As the lancet tip46moves, the lancet tip46pierces through the first sterility sheet38and continues into the skin of the user that has been placed over the incision location opening64. In one embodiment, as the lancet tip46forms an incision, the body fluid sample from the incision travels along the capillary groove48via capillary action towards the contact portion44and the capillary groove48collects the body fluid sample from the incision while the lancet tip46is in the skin of the user. After the driver36reaches its maximum extension position, the driver36stops and reverses its path of movement. As the driver36reverses its path of movement, the force applied to the leg portion42is reduced and the lancet tip46withdraws from the incision. In another embodiment, the capillary groove48collects the body fluid sample while the lancet tip46returns to its original position in the chamber32, as described next. As the driver36continues to reverse its direction of travel, the motion may be slowed down to allow enough time for the lancet tip46to fill the capillary groove48before the lancet tip46returns to its original position in the chamber32. Due to the resilient nature of each lancet24, the lancet tip46springs back to its original position in the chamber32on its own. In one embodiment, if the first incision formed by the lancet tip46is too shallow in depth to provide an adequate amount of body fluid sample for the test section28to yield accurate test results, then the lancet tip46can form a second incision in skin as described above before the actuation mechanism60rotates the frame30. In its final resting position, the contact portion44of the active lancet24contacts the test section28and the body fluid sample is released from the capillary groove48onto the test section28by preferential capillarity between the contact portion44of the lancet24and the chemistry on the test section28. The lancet24remains in its final resting position with the contact portion44resting against the test section28. For the next test, the actuation mechanism60rotates the frame30via internal gears52or another index mechanism. The actuation mechanism60retracts the driver36and rotates the frame30so as to align the next corresponding opening34and the next unused or sterile lancet24with the driver36.

A cartridge120according to one embodiment is illustrated inFIGS. 11,12,13,14,15,16,17,18, and19. The cartridge120is similar to cartridge20; therefore for the sake of brevity features from the cartridge120that are similar to the cartridge20will not be discussed. Similar to cartridge20, cartridge120includes a first sterility sheet138positioned to cover and seal one side of a plurality of chambers132of frame130. However, cartridge120includes a second sterility sheet140positioned to cover and seal a plurality of openings134and the other side of the plurality of chambers132. In another form, a test ring126and the second sterility sheet140are configured to cover and seal the same side of the plurality of chambers132. In one embodiment, the second sterility sheet140is made of aluminum foil having a thickness of 25 micrometers and the second sterility sheet140is heat sealed over a frame130to seal each of chambers132separately.

Lancet wheel122is similar to lancet wheel22. Similar to lancet wheel22, lancet wheel122includes a lancet rim123with a plurality of lancets124extending radially inward from the lancet rim123. Similar to lancet wheel22, each of the lancets124includes a flexible leg portion142, a contact portion144, and a lancet tip146. However, the contact portion144of each of the lancets124is curved and sized to rest on a cover barrier156when the lancet124is at rest. Further the contact portion144fits in a window157of the cover barrier156when the lancet is actuated, as described below. The spring force of flexible leg portion142applies a force to the cover barrier156to press the cover barrier156against a test section128until the lancet124is actuated by a driver136. Each of lancets124also defines a slot147sized to receive a driver136, as described in more detail below. Similar to lancet tip46, lancet tip146defines a capillary groove148.

Test ring126is similar to test ring26; however, the plurality of test sections128is in the form of a continuous ring of chemistry mounted on or applied to a film. In one form, the chemistry coating is applied to a film made of polyethylene terephthalate having a thickness of 250 micrometers. The test ring126is attached to the second sterility sheet140. As illustrated inFIGS. 13 and 14, a plurality of cover barriers156defining a plurality of windows157are positioned on the test ring126under the contact portion144of the plurality of lancets124. The plurality of cover barriers156protect and cover the chemistry on the test ring126by eliminating contact between the test ring126and the lancet124prior to actuation of the lancet124. Moreover, each cover barrier156is configured to cover one test section128as defined by the plurality of index lines129. As the lancet124is actuated by the driver136, the driver136slides through the slot147of the lancet124and engages the cover barrier156to push the cover barrier156across the test section128thereby positioning the window157over frame window161(described below) and the test section128. The driver136also pushes the cover barrier156under a corresponding wedge159made of desiccant material, in the illustrated embodiment. Lancet124forms an incision in skin and collects a body fluid sample similarly to lancet24, as described above. After the lancet124forms an incision and collects a body fluid sample, the contact portion144contacts the test section128through the window157and frame window161(described below) and deposits the body fluid sample onto the test section128.

In the illustrated embodiment, the cartridge120includes a plurality of wedges159made of a desiccant material. Each of the wedges159is positioned in each chamber132of the frame130adjacent the lancet tip146.

Frame130is similar to the frame30. Frame130includes a plurality of walls150that define a plurality of chambers132. Frame130includes an upper rim153that defines a plurality of openings134. Each of the openings134is connected with a corresponding chamber132. As should be appreciated, since each of the openings134are connected with one of the chambers132, manufacturing of frame130is simplified. In the illustrated embodiment, each of the openings134has a semi-circular shape; however, in other embodiments the openings134are shaped differently. The frame130also includes a lower rim155defining a plurality of frame windows161for allowing contact between the contact portion144of the lancet124and the test section128in which a body fluid sample from the contact portion144is transferred to the test section128through the window157and the frame window161. In the illustrated embodiment, the lower rim155is substantially flat. In other embodiments, the lower rim155is curved.

In this embodiment, the frame130is made of polypropylene and constructed by injection molding techniques. In other embodiments, the frame130is made of other material and other techniques as described above.

The frame130also includes a plurality of internal gears152similar to internal gears52. The frame130also includes a hub154on the interior or center of the frame130. Hub154is similar to hub54.

As mentioned previously, a second embodiment of an integrated disposable cartridge or disc includes a microsampler wheel200and a test ring or plurality of test sections210. As should be appreciated, the lancets on the microsampler wheel200and the plurality of test sections210are oriented in an alternative manner, as described below. One embodiment of a microsampler wheel200is illustrated inFIGS. 20 and 21. The microsampler wheel200lances skin to form an incision and collects the body fluid sample from the incision. The body fluid sample is transferred from the microsampler wheel200to one of the plurality of test sections210where the body fluid sample is analyzed.

The microsampler wheel200includes a plurality of ribs202alternating with a plurality of microneedles or lancets204. The microsampler wheel200also includes a base206from which the plurality of ribs202and the plurality of lancets204extend from and a first cylinder208configured to drive each of the plurality of lancets204to form an incision in skin.

Each of the ribs202serves as a guide or a reference plane for an adjacent lancet204to determine the depth of penetration of a lancet tip226, as described below. Each of the plurality of ribs202is a trapezoidal shape; however, in other embodiments, each of the ribs202may be shaped differently, such as polygonal or oval, to name a few. Furthermore, each of the plurality of ribs202is substantially flat, which beneficially enables the microsampler wheel200to form an overall compact shape. Moreover, each of the ribs202serves as a reference plane or surface from which the depth of penetration of the corresponding lancet tip226can be determined.

Each of the lancets204includes a leg portion220that extends from the base206towards a first leg member222. The first leg member222spans between the leg portion220and a second leg member224of each of the lancets204. The second leg member224spans between the first leg member222and a lancet tip226of each of the lancets204. As shown inFIG. 21, the leg portion220extends from the base206and forms a first angle α with the base206. First angle α is an acute angle. The leg portion220is substantially straight. The first leg member222forms a second angle δ with the leg portion220. The second angle δ is an obtuse angle, as illustrated. The first leg member222is substantially straight. The second leg member224forms a third angle γ with the lancet tip226. The third angle γ is an obtuse angle. The second leg member224is substantially straight. In another embodiment, the first leg member222and/or the second leg member224are curved.

As shown inFIG. 21, the lancet tip226is curved. The curvature of lancet tip226corresponds to the radius of the circular path that the lancet204follows during actuation and retraction of the lancet204. Moreover, the curvature of the lancet tip226corresponds with the curvature of the movement of the lancet204as the lancet tip226forms an incision in a user's skin and thereafter withdraws from the user's skin. In another embodiment, the lancet tip226is straight.

Each of the lancets204also includes a capillary groove228sized to draw body fluid from an incision or skin surface via capillary action. In one embodiment, the capillary groove228includes a hydrophilic coating to draw the body fluid along the capillary groove228towards the second leg member224. The capillary groove228extends from the lancet tip226to the second leg member224as shown inFIGS. 22 and 23. In some embodiments, the capillary groove228extends from the lancet tip226to the second leg member224and into the first leg member222. As illustrated inFIGS. 22 and 23, the capillary groove228is positioned on the front side of the lancet tip226. In other embodiments, the capillary groove228may be positioned on the front side or the rear side of the lancet tip226corresponding to the placement of the test section210. The front side of the lancet tip226corresponds to the face of the lancet204that is furthest away from the base206. The back side of the lancet tip226corresponds to the face of the lancet tip226that is closest to the base206.

As shown inFIG. 23, the capillary groove228forms an open sampling channel to collect a body fluid sample via capillary action. In another embodiment, the capillary groove228is enclosed. As should be appreciated, when compared to a closed capillary or channel, an open capillary groove228has the advantage that the lancet204can be produced more easily in an etching process. Other examples of forming the capillary groove228in the lancet204include a sharp point, a laser beam, or other forms or mechanisms of removing material from the lancet204to create the open capillary groove228. Any technique of forming the capillary groove228results in automatic body fluid sampling when the lancet tip226is positioned in skin. Additionally, an open capillary as compared to a closed capillary more easily collects the body fluid sample that may be on the skin surface surrounding the incision.

As illustrated inFIG. 20, the base206is circular in shape. The base206may be shaped differently in other embodiments, such as, rectangular, oval, or square. As described below, the ribs202, the lancets204, and the base206may be formed from one piece of material. In other forms, the ribs202and/or the lancets204may be manufactured separately and then attached to the base206. In one embodiment, the wheel200is loaded into a meter configured to display the analysis results. Further, in this embodiment, the wheel200is stationary and the base206is attached to a housing of the meter such that the housing or exterior of the meter rotates about the wheel200to expose an unused lancet204. However, in another embodiment, the base206rotates about its center to expose an unused lancet204in the housing.

As illustrated inFIGS. 20 and 21, the first cylinder208is located adjacent the leg portion220of the lancet204. The first cylinder208is substantially circular in shape and rolls or rotates along the leg portion220of the lancet204towards the lancet tip226in one embodiment, or in another embodiment the first cylinder208slides along the surface of the leg portion220towards the lancet tip226. As should be appreciated, the first cylinder208applies a force to the leg portion220to move the lancet204in a direction away from the first cylinder208. The movement of the lancet204from the force of the first cylinder208causes the lancet tip226to follow a circular path to form an incision in a user as described previously. At the end of the movement or range of motion of the first cylinder208, the first cylinder208reverses its direction and moves toward the base206. In other embodiments, actuation of the lancet204occurs by other forms, such as a driver, a spring, or another mechanical or electrical mechanism. These other forms of actuation of the lancets204will also force the curved lancet tip226to follow a circular movement. The lancing profile of the lancet tip226can be traced by correlating the distance the first cylinder208travels along the leg portion220, the diameter of first cylinder208, and the geometry of the lancet204.

After the incision has been formed by the lancet tip226, the lancet tip226is removed from the skin of the user by springing back to its original pre-incision forming position and contacting one of the test sections210to transfer the body fluid sample to the test section210. As the first cylinder208reverses its direction and moves toward the base206, the curvature of the lancet tip226ensures that as the lancet tip226withdraws from the incision, the lancet tip226will follow the same circular path that it formed during the incision. No additional actuator is necessary to withdraw the lancet tip226from the incision; rather the resilient nature of the lancet204causes the lancet tip226to spring back to its original position referenced by the ribs202as the first cylinder208returns to its original position. Moreover, as the lancet204springs back to its original pre-incision forming position, the body fluid sample contained in the capillary groove228is transferred to the test section210as the second leg member224or the lancet tip226contacts the test section210, as described below. The lancet204in its original position will ensure that a subsequent user is not accidentally stuck by the contaminated lancet tip226.

In the embodiment illustrated inFIG. 21, a second cylinder212is positioned adjacent or near the first cylinder208to act as a stop mechanism for the first cylinder208during actuation of the first cylinder208. In the illustrated embodiment, the second cylinder212is substantially circular in shape with a flat surface230positioned to contact the leg portion220. In other embodiments, the second cylinder212may be another shape. For example, the second cylinder can be a rectangular, triangular, or oval, to name a few shapes. The second cylinder212forms a stop for the first cylinder208to limit the movement of the first cylinder208and the lancet204. In another embodiment, the second cylinder212contacts the leg portion220during actuation of the lancet204and retraction of the lancet tip226from the incision. For example, during actuation, the second cylinder212applies a force to the leg portion220as the first cylinder208also applies a force to the leg portion220. In this embodiment, the engagement between the second cylinder212and the leg portion220ensures that the lancet tip226is drawn slowly out of the incision formed in the user's skin. Second cylinder212controls the velocity of the lancet tip226during removal of the lancet tip226from the incision and movement of the lancet tip226to its original position. The combination of the first cylinder208and the second cylinder212ensures that particular prescribed lancing and velocity profiles will be followed by the lancet tip226. The combination of the first cylinder208and the second cylinder212, in one embodiment, ensures that the lancet tip226forms the incision rapidly and the lancet tip226is withdrawn slowly from the incision. In another embodiment, the first cylinder208controls the velocity of the lancet tip226without the second cylinder212.

In one embodiment, the microsampler wheel200is formed from a single piece of material by stamping a metal plate to form the plurality of ribs202and the plurality of microneedles or lancets204and removing any excess material. In another embodiment, the microsampler wheel200is formed from etching and bending a metal plate to form the plurality of ribs202and the plurality of microneedles or lancets204. In other embodiments, the microsampler wheel200may be formed by attaching the plurality of ribs202and the plurality of lancets204to the base206. The microsampler wheel200may be made of metal, such as stainless steel, titanium, or nickel; plastic; and/or other materials.

The plurality of test sections210is similar to the test sections28described above; therefore for the sake of brevity the details are not repeated. The plurality of test sections210are positioned near the plurality of lancets204such that one test section210is positioned near each capillary groove228. The plurality of test sections210may be positioned near the second leg member224as shown inFIG. 22, the front of the lancet tip226as shown inFIG. 24, or the rear of the lancet tip226as shown inFIG. 26.

Reference will now be made to the various configurations of the lancet204and the test section210. As shown inFIG. 22, the test section210is positioned near the second leg member224to analyze the body fluid sample. In this embodiment, the capillary groove228is positioned on the front side of the lancet204as illustrated inFIG. 23. To form an incision, the first cylinder208rotates along the leg portion220and applies a force to the leg portion220to rotate the lancet204about the edge of the base206. In the embodiment illustrated inFIG. 22, the second cylinder212applies a force to the leg portion220to assist the first cylinder208to rotate the leg portion220about the edge of the base206. As should be appreciated, the second cylinder212is optional. While the leg portion220rotates about the edge of the base206, the lancet tip226follows a circular path to form an incision in a user. The capillary groove228collects a body fluid sample as the lancet tip226forms the incision. The body fluid sample in the capillary groove228first flows in the lancet tip226in a direction substantially parallel to the incision in skin. In this embodiment, the body fluid sample continues to flow into capillary228in the second leg member224. As the body fluid sample flows into the second leg member224, the direction of flow changes by the third angle γ. In one form, the third angle γ is approximately 90 degrees; therefore the flow of the body fluid sample changes direction by about 90 degrees from the lancet tip226to the second leg member224. The first cylinder208and the second cylinder212reverse their directions such that the force is removed from the leg portion220and the lancet tip226withdraws from the skin. As the first cylinder208and the second cylinder212reverse their directions, the lancet204springs or moves past the original pre-incision forming position of the lancet204such that the second leg member224touches the test section210. While the second leg member224contacts the test section210, the body fluid sample is transferred from the capillary groove228to the test section210. In this embodiment, the capillary groove228extends into the second leg member224a corresponding distance such that as the second leg member224contacts the test section210, the body fluid sample in the capillary groove228is transferred to the test section210. The test section210analyzes the body fluid sample.

As illustrated inFIGS. 24 and 25, the capillary groove228is positioned on the front side of the lancet tip226and likewise the test section210is positioned near the front side of the lancet tip226. The first cylinder208, second cylinder212, and the lancet204are similar to the embodiment described with reference toFIGS. 22 and 23, unless described differently herein. The lancet tip226is actuated to form an incision in skin, and the capillary groove228collects a body fluid sample from the incision. In this embodiment, the body fluid sample flows in the capillary groove228in a direction substantially parallel to the incision in skin. After the lancet tip226is withdrawn from the incision in skin, the lancet204moves to its original pre-incision forming position and the lancet tip226contacts the test section210. As the lancet tip226contacts the test section210, the body fluid sample from the capillary groove228is deposited onto the test section210.

In another embodiment, illustrated inFIGS. 26 and 27, the capillary groove228is located on the rear side or back side of the lancet tip226. As illustrated, the lancet tip226can include a second capillary groove229that extends from the capillary groove228on the rear side of the lancet tip226through the lancet tip226to the front side of the lancet tip226. With the additional capillary groove229, the test section210can be either positioned adjacent the rear side or adjacent the front side of the lancet tip226. The first cylinder208, second cylinder212, and the lancet204are similar to the embodiment described with reference toFIGS. 22 and 23, unless described differently herein. The lancet tip226forms an incision in skin and the capillary groove228collects a body fluid sample from the incision. In this embodiment, the body fluid sample flows in the capillary groove228in a direction substantially parallel to the incision in skin. In one embodiment, as the lancet tip226returns to its original pre-incision forming position, the rear side of the lancet tip226contacts the test section210positioned adjacent the rear side of the lancet tip226and the body fluid sample in the capillary groove228is deposited onto the test section210. As should be appreciated, the presence of capillary groove229ensures the body fluid sample will be deposited onto the test section210whether the capillary groove228is located on the front or rear side of the lancet tip226and the test section210is positioned adjacent either the rear side or front side of the lancet tip226.

A third embodiment also concerns an integrated disposable cartridge or disc similar to the second embodiment above. The cartridge in the third embodiment also utilizes a unique lancet wheel design that includes a plurality of microneedles or lancets that alternate with a plurality of ribs. The lancets in this embodiment are similar to the lancets in the previously described embodiments. The lancets and the plurality of ribs are attached to a base in an alternating manner and configured in an initial pre-incision forming position. The lancets and the plurality of ribs are configured to rotate about the base. A first drive mechanism forces the lancet tip to rotate about the base during penetration and retraction as the first drive mechanism presses against the lancet and the one or more ribs adjacent the lancet. A second drive mechanism forces one or more of the ribs next to the lancet to contact skin near the incision location as the ribs rotate about the base and thereby form a reference plane from which the penetration depth of a lancet is measured relative to the adjacent one or more ribs. The position of the one or more ribs relative to the lancet allows the user to adjust the penetration depth of the lancet independent of the actuation and movement of the lancet. For example, the actuation and movement of the lancet is determined by pressing the first drive mechanism against the one or more ribs and the lancet while the penetration depth is determined by pressing the second drive mechanism against the one or more ribs. The penetration depth of the lancet is easily adjusted as the orientation of the one or more ribs changes as determined by the second drive mechanism. Moreover, the unique and elegant shape of the second drive mechanism enables the one or more ribs to express additional bodily fluid to the skin as the second drive mechanism presses against and releases the one or more ribs to create a pumping action of the ribs against skin.

A microsampler wheel300according to another embodiment is illustrated inFIGS. 28,29,30,31, and32. The microsampler wheel300is similar to microsampler wheel200; therefore for the sake of brevity features from the microsampler wheel200that are similar to the microsampler wheel300will not be discussed. Similar to microsampler wheel200, microsampler wheel300includes a plurality of ribs302alternating with a plurality of lancets304. Also similar to the microsampler wheel200, the microsampler wheel300includes a base306from which the plurality of ribs302and the plurality of lancets304extend from. Each of the plurality of ribs302includes a first end330attached to the base306and a second end332configured to contact skin S of a user. In this embodiment, prior to actuation of a particular lancet304, the pair of ribs302adjacent to that lancet are substantially parallel to a leg portion320of the lancet304. The microsampler wheel300also includes a first cylinder308and a second cylinder312. First cylinder308is configured similar to first cylinder208. Second cylinder312includes a pair of cylinders or rollers positioned such that each roller contacts an individual rib302. The rollers of second cylinder312straddle one lancet304between them such that the individual rollers of second cylinder312are positioned to avoid contact with the lancet304. In this embodiment, each of the individual rollers of second cylinder312includes a curved portion314and a substantially flat portion316. In other embodiments, the second cylinder312may be another shape. Although not shown, in some embodiments, microsampler wheel300also includes a plurality of test sections as previously described.

As illustrated inFIG. 28, a lancet tip326of one of the lancets304is positioned adjacent to or in contact with skin S of a user. In the illustrated embodiment, an expression ring400is positioned on a finger tip; however, in other embodiments expression ring400is not required for microsampler wheel300to form an incision, express a bodily fluid sample, and collect a bodily fluid sample. Moreover, the microsampler wheel300is configured for use on other body parts of a user in addition to a finger, in other words the microsampler wheel300is configured for alternate site testing. In this initial start position, substantially flat portion316of second cylinder312contacts the pair of ribs302. In this embodiment, the pair of ribs302are substantially parallel to the leg portion320of the lancet304positioned between them. In other embodiments, the pair of ribs302can be positioned either above or below the lancet304.

As illustrated inFIG. 29, second cylinder312is rotated such that the curved portion314of second cylinder312contacts and presses the second end332of each of the pair of ribs302against skin S of the user. The orientation of the curved portion314with the ribs302facilitates rotation of second cylinder312to thereby adjust the orientation of the ribs302during lancing, expressing, and sampling. The initial contact between the pair of ribs302and the skin S of the user is a skin reference position from which penetration depth of the lancet tip326can be measured. In some embodiments, the second cylinder312is rotated to further press the pair of ribs302against skin S of the user to express bodily fluid to the incision site. In other embodiments, the second cylinder312is rotated back and forth to cause a pumping action of the pair of ribs302against skin S of the user to further facilitate expression of the body fluid to the incision site.

As shown inFIG. 30, the lancet304is actuated to form an incision in skin. The first cylinder308is pressed against the pair of ribs302and the leg portion320of the lancet304to rotate the lancet304about the base306and force the lancet tip326into skin S of the user. The penetration depth of the lancet tip326is determined by the geometry of the lancet304, the orientation of the pair of ribs302against the skin S of a user, and the distance the first cylinder308travels along the pair of ribs302and/or until the first cylinder308contacts the second cylinder312. In this form, as the first cylinder308rolls along the pair of ribs302and the leg portion320, the lancet tip326rotates about the base306to form an incision in skin S. As the first cylinder308contacts the second cylinder312, penetration of the lancet tip326in skin S is stopped. In another embodiment, the first cylinder308rolls along only the leg portion320of the lancet304to rotate the lancet304about the base306and force the lancet tip326into skin S of the user. In yet another embodiment, the first cylinder308is configured to press against or roll along the pair of ribs302adjacent the leg portion320. In any embodiment, the lancet tip326follows a circular path to form an incision in skin S of the user as the lancet304is rotated about the base306.

As shown inFIG. 31, the lancet304collects the bodily fluid sample similarly as lancet204described above. However, the second end332of each of the pair of ribs302is pressed against the skin S. As mentioned previously, in another embodiment, the second cylinder312is rotated back and forth to cause a pumping action of the pair of ribs302against skin S of the user. This pumping action facilitates expression of the body fluid to the incision site and sampling of the body fluid in the lancet304.

The first cylinder308starts to move or roll back from the second cylinder312to its initial start position as shown inFIG. 32. As the first cylinder304returns to its original position, the lancet304rotates about the base306and springs back to its pre-incision forming position. Since second cylinder312is configured from two rollers or members separated a distance, the lancet304springs back and travels through the gap formed between the two rollers or members. As mentioned previously and described above, the lancet304contacts a test section to transfer the body fluid sample to the test section similarly to lancet204. The second cylinder312is rotated such that the curved portion314disengages from the pair of ribs302, and the pair of ribs302rotates about the base306towards their initial pre-incision forming position. Although not illustrated, the second cylinder312will continue to rotate to its original pre-incision forming position until the substantially flat portion316contacts the pair of ribs302.

A cartridge420according to one embodiment is illustrated inFIGS. 33,34,35,36,37,38,39, and40. As should be recognized from these figures, cartridge420shares a number of features in common with cartridge20illustrated inFIGS. 1,2,3,4,5,6, and7. Therefore for the sake of brevity, common features from the cartridge420and the cartridge20will not be discussed. Cartridge420has a test ring frame480; however, cartridge20does not have a test ring frame. Like cartridge20, cartridge420has a test ring426; however, test ring426is mounted to test ring frame480as described in more detail below. Also like cartridge20, cartridge420includes a lancet wheel422positioned in a lancet frame430. However, lancet wheel422and lancet frame430are slightly different than lancet wheel22and frame30, respectively. In one embodiment, cartridge20includes twenty-five lancets24, twenty-five test sections28, and twenty-five chambers32. Comparatively, in one embodiment, cartridge420includes fifty lancets424, fifty test sections428, and fifty chambers432in which cartridge420has an approximately 20% larger diameter than cartridge20.

The manner in which cartridge420transfers a body fluid sample from a lancet424to a test section428is different than cartridge20. As explained below, cartridge420includes a lancet424having a lancet tip446that forms an incision in tissue, collects a body fluid sample from the incision in capillary groove448, and transfers the body fluid sample to a test section428as the lancet tip446contacts the test section428. In other words, the lancet tip446transfers the body fluid sample to the test section428. As should be appreciated, the body fluid sample is not required to fill the entire capillary groove448of the lancet424to have a sufficiently sized sample from which to test. Moreover, since the body fluid sample is not required to fill the entire capillary groove448a higher testing success rate is achieved and a smaller sized body fluid sample is needed to test with. As described previously, cartridge20includes a lancet24having a lancet tip46that forms an incision, the body fluid sample is collected in capillary groove48, and as the lancet returns to its original position the contact portion44contacts the test section28to transfer the body fluid sample to the test section28. In this configuration, the contact portion44or tail of the lancet24transfers the body fluid sample to the test section28.

Similar to cartridge20, cartridge420includes a first sterility sheet438as shown inFIG. 33. When cartridge420is assembled, first sterility sheet438is positioned to cover and seal one side of a plurality of tester openings482of test ring frame480. As mentioned above, cartridge420includes a test ring frame480. Test ring frame480includes a plurality of tester openings482. Each of the tester openings482is sized to receive a lancet tip446. Test ring frame480also includes a plurality of windows484and a plurality of frame walls485wherein each of windows484is positioned between a pair of frame walls485. Each of the internal windows484is positioned between a pair of lancet walls434of lancet frame430when the test ring frame480and lancet frame430are assembled. The placement of the windows484next to test sections428enables an optical device or other device positioned in the center of the cartridge420to view a corresponding test section428through one of windows484. In one embodiment, an engagement mechanism can engage one of the frame walls485and rotate the cartridge420to position a subsequent chamber432of lancet frame430and corresponding tester opening482in line with a driver436. Each of the plurality of internal windows484is rectangular in shape; however, the windows484may be configured differently in other embodiments. The plurality of internal windows484and plurality of frame walls485are positioned to receive a test ring426.

Test ring426includes a plurality of index lines429that define a plurality of test sections428as illustrated inFIG. 34. The test ring426is attached to the plurality of internal windows484and plurality of frame walls485of the test ring frame480such that each of the index lines429is in line with each of the lancet walls434. Moreover, each of test sections428is positioned in one of the chambers432of the lancet frame430such that the corresponding window484is aligned with one of a plurality of lancets424.

As shown inFIGS. 33 and 37, lancet wheel422includes a lancet rim423with a plurality of lancets424extending radially inward from the lancet rim423. Each of the lancets424includes a flexible leg portion442, a contact portion444, and a lancet tip446. The contact portion444of each of the lancets424is curved and sized to rest on one of a plurality of ledges492of the lancet frame430when the lancet424is at rest. Additionally, in this resting position, the lancet tip446does not contact the test section428. Further the lancet tip446fits in the tester opening482when the lancet424is actuated, as described below. Each of lancets424also defines a slot447sized to receive a pointed end438of a driver436, as described in more detail below. Lancet tip446defines a capillary groove448. Moreover, after the lancet424has been actuated and is in a final position, the lancet tip446rests against the test section428such that a body fluid sample is transferred from the capillary groove448to the test section428.

Lancet frame430inFIGS. 33,35, and36is configured a little different than frame30illustrated inFIGS. 1 and 2. Lancet frame430inFIG. 33includes a plurality of walls434that define a plurality of chambers432. Lancet frame430includes a rim436that is sized to receive the plurality of frame walls485to position the test ring frame480on the lancet frame430. The lancet frame430also includes a plurality of ledges492. Each of the ledges492is sized to receive the contact portion444of the lancet424. One of the ledges492is positioned in each of the plurality of chambers432. In the illustrated embodiment, each of the plurality of ledges492is substantially flat. A plurality of openings494are positioned between the plurality of walls434and the plurality of ledges492. Each of the openings494is sized to receive a driver436. As illustrated inFIGS. 37,38,39, and40, driver436includes a sharp or pointed end438to pierce through second sterility sheet440placed over the openings494, as described below. Pointed end438enters slot447of lancet424to actuate the lancet424, as described below.

As shown inFIG. 33, cartridge420includes a second sterility sheet440positioned to cover and seal the plurality of chambers432of the lancet frame430. First sterility sheet438, test ring426, and second sterility sheet440are configured to cover and seal the plurality of tester openings482, the plurality of chambers432, and the plurality of internal windows484to form an air-tight cartridge420. Similarly, first sterility sheet38, test ring26, and sterility sheet40of cartridge20are configured to form an air-tight cartridge20.

To use cartridge420, a user positions a body part to be lanced, most likely a finger, over a currently active one of the plurality of tester openings482. The driver436is actuated to pierce through the second sterility sheet440, pass through the corresponding opening494, and enter the chamber432. The driver436continues moving into the chamber432, and the pointed end438of the driver436engages the slot447of the active lancet424. As the driver436engages the slot447, the driver436applies a force to the leg portion442to move the lancet tip446in a direction orthogonal to the frame430. As the lancet tip446moves, the lancet tip446pierces through the first sterility sheet438and continues into the skin of the user that has been placed over the active tester opening482. In one embodiment, as the lancet tip446forms an incision, the body fluid sample from the incision travels along the capillary groove448via capillary action towards the contact portion444and the capillary groove448collects the body fluid sample from the incision while the lancet tip446is in the skin of the user. In one embodiment, an adequate sample size of body fluid is approximately 90 nanoliters.

After the driver436reaches its maximum extension position, the driver436stops and reverses its path of movement. As the driver436reverses its path of movement, the force applied to the leg portion442is reduced and the lancet tip446withdraws from the incision. Due to the resilient nature of each lancet424, the lancet tip446springs back to its original position in the chamber432on its own. In this final position, the lancet tip446of the active lancet424contacts the test section428and the body fluid sample is released from the capillary groove448onto the test section428by preferential capillarity between the lancet tip446of the lancet424and the chemistry on the test section428. The lancet424remains in its final resting position with the contact portion444resting against the ledge492. For the next test, an actuation mechanism retracts the driver436and rotates the test ring frame480so as to align the next corresponding tester opening482and the next unused or sterile lancet424with the driver436.

A lancet frame530, a lancet wheel522, and a test ring526according to another embodiment are illustrated inFIGS. 41,42,43, and44. As should be recognized from these figures, the lancet frame530shares a number of features in common with lancet frame430illustrated inFIGS. 33,35, and36. Therefore for the sake of brevity features from the lancet frame530that are similar to the lancet frame430will not be discussed. Unlike lancet frame430, lancet frame530has a plurality of ledges592that are configured to retain a lancet in a flexed position prior to actuation. Due to the resiliency of the lancet and the configuration of each of the ledges592, after the lancet is released from its corresponding ledge592, it springs back to its original unflexed configuration and the lancet is lifted to form an incision. In other words, the tension imposed on the lancet from the ledge592is released. After the lancet forms an incision and the lancet returns to its corresponding ledge592, the lancet tip contacts a test section528and transfers a body fluid sample to the test section528. The transfer of a body fluid sample from the lancet tip to a test section as compared to the transfer of a body fluid sample from a contact portion of a lancet to a test section requires less travel distance for the body fluid sample before the body fluid sample is transferred to a test section. A transfer of the body fluid sample from the lancet tip as compared to other portions of the lancet results in higher success rates for lancing and testing events. In some clinical trials of this embodiment and the embodiments shown inFIGS. 33,34,35,36,37,38, and39, the success rate for lancet tip transfer of a bodily fluid sample to a test section was greater than 93%. In some embodiments, the total testing time including forming an incision, collecting a bodily fluid sample, and analyzing the bodily fluid sample is less than 1 second.

Lancet frame530includes a plurality of walls534that define a plurality of chambers532. Lancet frame530also includes a plurality of ledges592. Each of the ledges592is sized to receive the contact portion544of the lancet524. One of the ledges592is positioned in each of the plurality of chambers532. In the illustrated embodiment, the plurality of ledges592is substantially rectangular. Each of the ledges592also contains a notch593configured to receive the lancet tip546, as explained in more detail below. A plurality of openings594are positioned between the plurality of walls534and the plurality of ledges592. Each of the openings594is sized to receive a driver.

A lancet wheel522is positioned in the lancet frame530as shown inFIG. 41. Lancet wheel522shares a number of features in common with lancet wheel422illustrated inFIGS. 33 and 37. Therefore for the sake of brevity, common features from the lancet wheel522and lancet wheel422will not be discussed.

Test ring526is illustrated inFIG. 41. Test ring526shares a number of features in common with test ring426illustrated inFIGS. 33 and 37. Therefore for the sake of brevity common features from the test ring526and the test ring426will not be discussed. Test ring526includes a plurality of test sections528. Test ring526is positioned on the lancet frame530such that each of the test sections528is positioned between a pair of walls534of the lancet frame530.

In an initial position, the lancet tip546is positioned in the notch593such that the contact portion544rests against the ledge592to restrain the lancet524from movement until a driver engages the lancet524to release the lancet tip546from the notch593. In this initial position, each of the ledges592extends towards the lancet rim523to bend the contact portion544towards flexible leg portion542. As the lancet524moves from the initial position to an incision forming position, the contact portion544passes over both the notch593and the ledge592and the lancet tip546moves in a direction orthogonal to the lancet frame530. After the contact portion544passes over the ledge592, the contact portion544springs back to its original configuration due to the resilient nature of each lancet524. As the lancet tip546moves, the lancet tip546pierces the skin of the user that has been placed over the corresponding chamber532. In one embodiment, as the lancet tip546forms an incision, the body fluid sample from the incision travels along the capillary groove548via capillary action towards the contact portion544and the capillary groove548collects the body fluid sample from the incision while the lancet tip546is in the skin of the user. After a driver or other mechanism reaches its final extension position, the driver stops and reverses its path of movement. As the driver reverses its path of movement, the force applied to the leg portion542is reduced and the lancet tip546withdraws from the incision. In its final position, the contact portion544of the active lancet524rests against the ledge592and the bodily fluid sample is transferred from the capillary groove548to the corresponding test section528.

A lancet frame630, a lancet wheel622, and a test ring626according to another embodiment are illustrated inFIGS. 45,46, and47. As should be recognized from these features, lancet frame630shares a number of features in common with lancet frame430illustrated inFIGS. 33,35, and36. Therefore for the sake of brevity, common features from lancet frame630and lancet frame430will not be discussed. As described below, lancet frame630includes a plurality of slats692that are configured to restrain the plurality of lancets624such that the plurality of lancets624do not contact the plurality of test sections628prior to actuation. Beneficially, the plurality of slats692are configured to force the lancet tip646to contact a test section and transfer a body fluid sample to the test section after the lancet tip646has collected a body fluid sample. As mentioned above, the transfer of body fluid from the lancet tip requires less blood travel distance than compared to the transfer of body fluid from the contact section or any other section of the lancet. Also beneficially, the plurality of slats692restrains the contaminated lancets624after a testing event.

Lancet frame630includes a plurality of walls634that define a plurality of chambers632as shown inFIGS. 45,46, and47. The lancet frame630also includes a plurality of slats692. A pair of the slats692is positioned in each of the plurality of chambers632. Each of the slats692is attached to one of the walls634. Between each of the pairs of slats692is a slat opening694. The pair of slats692is sized and positioned on the walls634to receive the lancet tip646of the lancet624in the slat opening694when the lancet624is in an initial position. The pair of slats692is also sized and positioned to restrain the lancet624when the lancet624is in its final position. After the lancet624has been actuated and rests in a final position, the pair of slats692restrains the pair of tabs645between the pair of slats692and the lancet frame630. In the illustrated embodiment, each of the plurality of slats692is substantially rectangular. Each of the plurality of slats692forms an angle θ with each of the walls634. Angle θ is an acute angle.

A lancet wheel622is positioned in the lancet frame630as shown inFIG. 45. Lancet wheel622includes a number of features in common with lancet wheel422as shown inFIGS. 33,37, and38; therefore for the sake of brevity common features from the lancet wheel622and the lancet wheel422will not be discussed. Lancet wheel622includes a lancet rim623with a plurality of lancets624extending radially inward from the lancet rim623. Each of the lancets624includes a flexible leg portion642, a contact portion644, and a lancet tip646. The contact portion644of each of the lancets624includes a pair of tabs645sized to rest on the pair of slats692of the lancet frame630when the lancet624is in an initial position. After the lancet624has been actuated and rests in its final position, the pair of slats692restrains the pair of tabs645between the pair of slats692and the lancet frame630. Each of lancets624also defines a slot647sized to receive a pointed end of a driver. In one embodiment, lancet tip646defines a capillary groove (not illustrated).

Test ring626shares a number of common features with test ring526illustrated inFIGS. 41,42, and44; therefore for the sake of brevity common features from the test ring626and the test ring526will not be discussed. Test ring626includes a plurality of test sections628. Test ring626is positioned on the lancet frame630such that each of the test sections628is positioned between a pair of walls634of the lancet frame630.

In an initial position, the lancet tip646is positioned in the slat opening694such that the pair of tabs645rest against the pair of slats692to restrain the lancet624from movement until a driver engages the lancet624to move the lancet624and release the pair of tabs645from the pair of slats692. Additionally, in the initial position, the resiliency of the lancet624causes the contact portion644to bend as the pair of tabs645push against the slats692. As the driver moves the lancet624from the initial position to an incision forming position, the contact portion644passes over the pair of slats692and the compressive force on the contact portion644is released. Due to the resilient nature of each lancet624, the lancet tip646springs to an uncompressed configuration. The lancet tip646moves in a direction orthogonal to the lancet frame630when the lancet624moves from the initial position to the incision forming position. As the lancet tip646moves, the lancet tip646pierces the skin of the user that has been placed over the corresponding chamber632. In one embodiment, as the lancet tip646forms an incision, the body fluid sample from the incision travels along a capillary groove via capillary action towards the contact portion644and the capillary groove collects the body fluid sample from the incision while the lancet tip646is in the skin of the user. After a driver or other mechanism reaches its final extension position, the driver stops and reverses its path of movement. As the driver reverses its path of movement, the force applied to the leg portion642is reduced and the lancet tip646withdraws from the incision. Since the lancet624has returned to an uncompressed configuration, the pair of tabs645slide behind the pair of slats692to restrain the lancet624in a final position and allow the lancet tip646to engage the test section628. In its final position, the lancet624rests against the test section628and the bodily fluid sample is transferred from the capillary groove or the lancet tip646to the corresponding test section628.

FIGS. 48A and 48Bare schematic representations of one technique of restraining a lancet prior to actuation such that the lancet does not contact the test section. As illustrated inFIG. 48A, the lancet rests against a notch in a frame such that the position of the frame results in a compressive force in the lancet. After the lancet is actuated, the lancet is released from the notch and returns to an uncompressed state. The lancet then forms an incision and collects a body fluid sample in the lancet tip. As shown inFIG. 48B, the lancet tip in an uncompressed state touches a test section to transfer the body fluid sample from the lancet to the test section. The position of the test section allows the uncompressed lancet to engage the test section and transfer the body fluid sample to it. Beneficially, the lancet does not contact the test section unless the lancet is transferring a body fluid sample to the test section therefore the test chemistry remains intact. Resiliency of the lancet allows it to return to an uncompressed state after it is released from the notch therefore no additional mechanisms are required to cause the lancet to return to an uncompressed state and transfer a body fluid sample to the test section.

FIGS. 49A and 49Bare schematic representations of another technique of restraining a lancet prior to actuation such that the lancet does not contact the test section. Beneficially, the test chemistry on the test section remains intact and untouched. As shown inFIG. 49A, the lancet rests against a ledge such that the position of the ledge results in a compressive force in the lancet. After the lancet is actuated, the lancet is released from the ledge and returns to an uncompressed state. The lancet then forms an incision and collects a body fluid sample in the lancet tip. As shown inFIG. 49B, the lancet tip in an uncompressed state touches a test section to transfer the body fluid sample from the lancet to the test section. Beneficially no other mechanisms are required to cause the lancet to return to an uncompressed state and transfer a body fluid sample to the test section. The position of the test section allows the uncompressed lancet to engage the test section and transfer the body fluid sample to it.

FIGS. 50A and 50Bare schematic representations of yet another technique of restraining a lancet prior to actuation such that the lancet does not contact the test section therefore the test chemistry on the test section remains intact and untouched. In a first position shown inFIG. 50A, a first band restrains a lancet such that the position of the band results in a compressive force in the lancet and the lancet is flexed or bent. Next, the lancet is actuated and the lancet pierces through the first band to form an incision in skin and collect a body fluid sample. During actuation the lancet returns to its uncompressed shape. As shown inFIG. 50B, after collecting the body fluid sample the lancet tip contacts a second band that includes a test section as the lancet returns to the first position. The body fluid sample in the lancet tip is transferred from the lancet tip to the test section on the second band.

FIGS. 51A and 51Bare schematic representations of yet another technique of restraining a lancet prior to actuation such that the lancet does not contact the test section therefore the test chemistry on the test section remains intact and untouched. As shown inFIG. 51A, the lancet tip rests in a cover made of a soft material such that the position of the cover results in a compressive force in the lancet. After the lancet is actuated, the lancet is driven through the soft cover and returns to an uncompressed state. After the lancet is driven through the cover, the cover then slides down a portion of the lancet as the lancet tip forms an incision and collects a body fluid sample. As shown inFIG. 51B, the lancet has returned to its original position and the lancet tip touches a test section to transfer the body fluid sample from the lancet to the test section. Beneficially no other mechanisms are required to cause the resilient lancet to return to an uncompressed state and transfer a body fluid sample to the test section. The position of the test section allows the uncompressed lancet to engage the test section and transfer the body fluid sample to it.

FIGS. 52A and 52Bare schematic representations of one technique of restraining a lancet prior to actuation such that the lancet does not contact the test section therefore the test chemistry on the test section remains intact and untouched. As shown inFIG. 52A, the lancet includes a tab that rides along a track such that the position of the track causes the lancet to bend or compress. After the lancet is actuated, the tab is driven along the track until the tab clears the track thereby releasing the compressive force on the lancet and the lancet returns to an uncompressed state. After the tab has cleared the track, the lancet tip forms an incision and collects a body fluid sample. As shown inFIG. 52B, the lancet tip touches a test section to transfer the body fluid sample from the lancet to the test section as the lancet returns to its original position. Beneficially no other mechanisms are required to cause the resilient lancet to return to an uncompressed state and transfer a body fluid sample to the test section. The position of the test section allows the uncompressed lancet to engage the test section and transfer the body fluid sample to it.

FIGS. 53A and 53Bare schematic representations of another technique of restraining a lancet prior to actuation such that the lancet does not contact the test section therefore the test chemistry on the test section remains intact and untouched. As shown inFIG. 53A, the lancet is in a bent configuration resting against a bottom layer of a lancet frame. In one form, the bottom layer is a sterility sheet. The bottom layer of the lancet frame is configured such that the driver breaks through it. After forming an incision and collecting a body fluid sample, the lancet falls through the bottom layer of the lancet frame, and the lancet then touches a test section to transfer the body fluid sample from the lancet to the test section.

A portable meter system1000according to one embodiment is illustrated inFIGS. 54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69, and70. Although the portable meter system1000will be described with reference to portable blood glucose testing, it should be appreciated that the meter system1000can be adapted to test a wide variety of biological fluids and fluid properties. Looking atFIGS. 54 and 55, the meter system1000includes a housing1002that houses the lancet frame130, lancet wheel122, and test ring126. Schematically only lancet frame130is shown in the meter system100for clarity although the meter system1000will be described with reference to the lancet wheel122and test ring126. Although the portable meter system1000will be described with reference to lancet frame130, lancet wheel122, and test ring126, it should be appreciated that the meter system1000can be adapted to the above listed cartridges and/or lancet frames, lancet wheels, and test rings.

The housing1002includes a front cover1004, a door1006, and a base1008as illustrated inFIGS. 54 and 55. The front cover1004has a display1012for displaying test results as well as other information. It should be appreciated that the meter system1000can include other output devices, like a speaker, for example. Display1012is positioned such that the user can readily view the display1012when the meter system1000is gripped in the hand of the user. The door1006includes a pressure cup1014sized to receive a fingertip of a user. The pressure cup1014is made from an elastic-type supported plastic material to allow for movement of the pressure cup1014to transfer force from finger pressure of the user to release arm1020in the meter system1000to fire the lancet124, as described in more detail below. The pressure cup1014is positioned over the lancet frame130, lancet wheel122, and the test ring126to advance the lancet frame130, lancet wheel122, and the test ring126for each lancing event. The pressure cup1014defines an opening1015in which the lancet124exits to form an incision in skin. The back surface of the pressure cup1014has a pair of trigger contact tabs1016positioned to engage a pair of tabs1021of release arm1020to actuate the lancet124, as described in more detail below. In one embodiment, the door1006is hingedly attached to the base1008to allow access to the interior of the meter system1000. As such, a used lancet frame130, lancet wheel122, and test ring126can be replaced with a clean or new lancet frame, lancet wheel, and test ring. In other embodiments, the door1006can be attached to base1008by another mechanism.

The portable meter system1000includes a release arm1020. Release arm1020has a pair of tabs1021configured to contact the pair of trigger contact tabs1016. Release arm1020includes a trigger1062positioned to engage a latch and thereby release spring motor1050. The portable meter system1000also includes a first gear1022, a second gear1024, and a third gear1026that interact with each other to rotate the lancet frame130, lancet wheel122, and the test ring126to advance the lancet frame130, lancet wheel122, and the test ring126for each lancing event. Gear1026is mounted to a platform1028in which the lancet frame130, lancet wheel122, and the test ring126have also been attached. First gear1022is driven by fourth gear1024, as described in more detail below. Due to the interaction of gears1022,1024, and1026, the rotational movement of gear1022causes gears1024and1026to rotate.

The portable meter system1000has a lower printed circuit board1030and an upper printed circuit board1032that are powered by a battery1034as illustrated inFIGS. 64 and 65. The upper printed circuit board1032is connected to the display1012. The upper printed circuit board1032includes an edge connector1036. The lower printed circuit board1030includes an edge connector socket or slot1038. Edge connector socket1038is typically a female electrical connector for use with a male electrical connector such as edge connector1036. When assembled, edge connector1036mates with edge connector socket1038to connect upper printed circuit board1032to lower printed circuit board1030.

The portable meter system1000includes a motor1040that drives a fourth gear1042. A priming gear1044connects with the fourth gear1042and a fifth gear1046. The placement of the fourth gear1042, priming gear1044, and fifth gear1046enables the motor1040to have at least two functions depending on the rotational direction of the gears1042,1044, and1046. If the fourth gear1042has a clockwise rotation by motor1040, then the lancet frame130, lancet wheel122, and test ring126will be rotated for the next lancing, sampling, and testing event, as described in more detail below. If the fourth gear1042has a counterclockwise rotation by motor1040, then the spring motor1050is primed to drive the crank shaft1070and after triggering, cause a lancing, sampling, and testing event, as described in more detail below.

As illustrated inFIGS. 60,61, and62, the portable meter system1000includes a force spring1060. The portable meter system1000also includes a crank shaft1070that is connected to a crank arm1072. The crank shaft1070has a dampener stop tab1200, as illustrated inFIG. 66. The crank arm1072is pivotally connected to a tip up link1074. The tip up link1074is connected to driver136that engages lancet124. The portable meter system1000includes a one-way clutch1080that extends through fifth gear1046and a worm drive1090. The portable meter system1000has a first bearing cap1092and a second bearing cap1094. Second bearing cap1094has a hard stop1096.

As illustrated inFIG. 63, the portable meter system1000includes a frame1100. Frame1100supports motor1040, crank shaft1070, tip up link1074, one-way clutch1080, and worm drive1090. In particular, tip up link1074is pivotally mounted to frame1100. Frame1100is positioned next to the lower printed circuit board1030.

FIGS. 67,68, and69illustrate actuation of the lancet124by the portable meter system1000. Crank shaft1070, crank arm1072, tip up link1074, driver136, and lancet124are in an initial position as shown inFIG. 67. InFIG. 67, crank arm1072is in a 0 degree position or a pre-incision forming position. A user places a finger against the opening1015and presses the pressure cup1014towards the base1008. The pressure cup1014is configured to allow movement of the pressure cup1014to transfer force from the finger pressure to actuate the lancet124as follows. Pressure cup1014presses against the release arm1020to transfer the force from the pair of trigger contact tabs1016to the pair of tabs1021to move release arm1020towards the base1008. As release arm1020moves, trigger1062engages a latch and releases spring motor1050to drive the crank shaft1070and crank arm1072.

As shown inFIG. 68, the crank shaft1070rotates crank arm1072in a counterclockwise direction approximately 90 degrees from the initial position of the crank arm1072. Crank arm1072correspondingly rotates or pivots tip up link1074in a clockwise direction. Crank arm1072is now at a 90 degree position or an incision forming position. As tip up link1074rotates, driver136also rotates in a clockwise direction to rotate the lancet tip146through the opening1015to form an incision in skin and collect a body fluid sample. The lancet tip146is lifted into a finger of a user in a few milliseconds. In one embodiment, the lancet tip146could be lifted into a finger in about three to five milliseconds. The movement of the crank shaft1070results in a “fast-in” position wherein the lancet124forms an incision in tissue quickly as compared to the withdrawal of the lancet124as described next.

As shown inFIG. 69, the crank shaft1070continues to rotate crank arm1072in a counterclockwise direction approximately 180 degrees from the incision forming position of the crank arm1072. Dampener stop tab1200engages the frame1100to slowly return the lancet124to its final position wherein the lancet tip146contacts a test section124. This results in a “slow-out” position wherein the lancet124returns to its final position slowly as compared to the lancet forming an incision. In one embodiment, the time required for the lancet tip146to form an incision is ten to one hundred times faster than the time required for the lancet tip146to return to its final position. Crank arm1072is now at a 270 degree position from the initial position of crank arm1072. At this position, the body fluid sample is transferred from the lancet tip146to a corresponding one of the plurality of test sections128. Tip up link1074is rotated in a counterclockwise direction to lower the driver136below the lancet frame130to clear the lancet frame130for rotation to an unused lancet124and a subsequent testing event.

The crank shaft1070continues to rotate crank arm1072in a counterclockwise direction approximately 90 degrees from the body fluid transferring position to the initial position for a subsequent lancing, sampling, and testing event.

A portable meter system2000according to one embodiment is illustrated inFIGS. 71,72,73,74,75,76,77,78,79,80,81,82,83,84, and85. Common features from portable meter system2000and portable meter system1000illustrated inFIGS. 54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69, and70will not be discussed for the sake of brevity. Looking atFIGS. 71 and 73, the meter system2000includes a housing2002that houses the lancet frame130, lancet wheel122, and test ring126. Schematically only lancet frame130is shown in the meter system2000for clarity although the meter system2000will be described with reference to the lancet wheel122and test ring126. Although the portable meter system2000will be described with reference to lancet frame130, lancet wheel122, and test ring126, the meter system2000can be adapted to the above listed cartridges and/or lancet frames, lancet wheels, and test rings. Meter system2000includes an electronic triggering system and a penetration depth control adjustment system whereas meter system100does not include these features.

The housing2002includes a front cover2004, a door2006, and a base2008as illustrated inFIG. 71. The front cover2004has a display2012for displaying test results as well as other information. It should be appreciated that the meter system2000can include other output devices, like a speaker, for example. The door2006includes an opening2015positioned over the lancet frame130, lancet wheel122, and test ring126. Upon actuation, lancet tip146exits opening2015to form an incision in skin. Meter system2000does not include a pressure cup in which to trigger a lancing, sampling, and testing event. Instead meter system2000includes an electric force sensor (not shown) that senses or detects the presence of a finger or other body part positioned over the opening2015. After the finger force is detected on the opening2015, a motor2040starts again and fires the lancet124to complete a lancing, sampling, and testing event, as described in more detail below.

Portable meter system2000includes a wheel2001for adjusting the penetration depth of each of the plurality of lancets124for a lancing event. Wheel2001is rotated to adjust the penetration depth of the active one of lancets124to either a shallow depth setting or a deep depth setting as described in more detail below. Initially, wheel2001is mounted on a first end of a shaft2200such that one of the lancets124is in a shallow depth setting as shown inFIG. 73. Mounted along a midpoint of shaft2200is a first lever2202that defines a first slot2204as illustrated inFIG. 72. Mounted on an opposite end of shaft2200is a second lever2212that is similar to first lever2202. Second lever2212defines a second slot2214. A first end of a first pin2206is configured to fit in first slot2204and a second end of pin2206is configured to fit in the second slot2214. The first pin2206rides along or slides in the first slot2204and the second slot2214as the first lever2202and the second lever2212are rotated corresponding to rotation of wheel2001from a shallow depth setting to a deep depth setting. The middle portion of first pin2206is configured to fit through a first opening2232defined in an intermediate arm2230. The first lever2202and the second lever2212work together or as a pair to control the position of first pin2206which sets the depth setting to either “shallow” or “deep” penetration.

As shown inFIG. 74, intermediate arm2230includes an upper half2236that defines the first opening2232. Intermediate arm2230also includes a lower half2238that includes a second pin2082that fits in and slides in a slot2080of tip up link2074as described below.

A tip up link2074is mounted on the shaft2200. Tip up link2074is attached to the driver136that engages each of the lancets124. Tip up link2074defines a slot2080that is configured to receive the second pin2082of the intermediate arm2230.

Meter system2000also has a different actuation system than portable meter system1000. Meter system2000includes a crank shaft2070that is similar to crank shaft2070. Crank shaft2070includes a disk2250with a stopper2252that is configured to contact a crank arm2072in the final position of a used lancet as illustrated inFIGS. 75 and 78. The crank arm2072is similar to the crank arm1072however a first end of crank arm2072is rotatably mounted on the disk2250. A second end of the crank arm2072is pivotably attached to the intermediate arm2230. The crank shaft2070has a dampener stop tab2200, as illustrated inFIG. 80. The second pin2082of intermediate arm2230slides in slot2080of the tip up link2074to cause the tip up link2074and corresponding driver136to rotate. The interaction of crank shaft2070, crank arm2072, intermediate arm2230, and tip up link2074will be described in more detail below.

Meter system2000has a priming gear2044that connects with a fourth gear2042and a fifth gear2046as shown inFIG. 73. Fourth gear2042, priming gear2044, and fifth gear2046are similar to fourth gear1042, priming gear1044, and fifth gear1046of meter system1000.

Meter system2000includes an electronic triggering system as shown inFIGS. 82,83,84, and85. A trigger cam2280having a catch2282is mounted to priming gear2044. A catch-release pivot shaft2047rides inside the catch2282. The catch-release pivot shaft2047has a guide or follower pin2284. The follower pin2284travels along a cam groove2286in gear2044.

The portable meter system2000includes a motor2040that drives the fourth gear2042. Similar to motor1040, motor2040has at least two functions depending on the rotational direction of the gears2042,2044, and2046. When motor2040is turned “on”, motor2040winds ¾ of a revolution and then motor2040stops. When the finger force is detected on the opening2015, the motor2040starts again and fires the lancet124.

Meter system2000can also be adjusted for either a shallow penetration depth setting or a deep penetration depth setting of a lancet124as described next. As shown inFIG. 73, the pin2206positioned in the first slot2204, the first opening2232, and the second slot2214(not illustrated) is in an initial position of a shallow penetration depth setting. If a deep penetration depth of an active one of the lancets124is desired as shown inFIG. 76, then wheel2001is rotated which causes the attached shaft2200to rotate and the first lever2202and second lever2212(not illustrated) to pivot which in turn causes the pin2206in the first slot2204, the first opening2232, and the second slot2214(not illustrated) to move down or towards the crank arm2072. After the wheel2001is rotated to a deep penetration depth setting, the pin2206is positioned to cause the tip up link2074and driver136to rotate a greater distance and thereby force the active one of the lancets124to move a greater distance and form a deeper incision.

FIGS. 73,74, and75illustrate actuation of the active one of lancets124by the portable meter system2000with the meter system2000in a shallow penetration depth setting with first pin2206positioned at the top of first opening2232of intermediate arm2230. Crank shaft2070, crank arm2072, intermediate arm2230, tip up link2074, driver136, and lancet124are in an initial position as shown inFIG. 73. InFIG. 73, crank arm2072is in a 0 degree position or a pre-incision forming position. A user turns “on” motor2040to cause motor2040to wind three-fourths of a revolution and then stop. A user places a finger against the opening2015. The electric sensor senses the finger force and the motor2040starts again. The spring2050is wound one revolution from the interaction of the motor2040, fourth gear2042, and priming gear2044. Catch-release pivot shaft2047is then activated to release spring motor2050to drive the crank shaft2070and crank arm2072.

As shown inFIG. 74, the crank shaft2070rotates crank arm2072in a counterclockwise direction approximately 90 degrees from the initial position of the crank arm2072. Crank arm2072correspondingly rotates or pivots intermediate arm2230and tip up link2074in a clockwise direction. The second pin2082of intermediate arm2230is in the top position of slot2080of the tip up link2074to cause the tip up link2074and corresponding driver136to rotate the driver136towards the opening2015. Crank arm2072is now at a 90 degree position or an incision forming position. As tip up link2074rotates, driver136also rotates in a clockwise direction to rotate the lancet tip146through the opening2015to form an incision in skin and collect a body fluid sample. The lancet tip146is lifted into a finger of a user in a few milliseconds. In one embodiment, the lancet tip146could be lifted into a finger in about three to five milliseconds. The movement of the crank shaft2070results in a “fast-in” position similar to the crank shaft1070of meter system1000.

As shown inFIG. 75, the crank shaft2070continues to rotate crank arm2072in a counterclockwise direction approximately 180 degrees from the incision forming position of the crank arm2072. Stopper2252contacts the crank arm2072and dampener stop tab2200engages a frame2100(not illustrated) to slowly return the lancet124to its final position wherein the lancet124contacts a test section124. This results in a “slow-out” position similar to meter system1000. In one embodiment, the time required for the lancet tip146to form an incision is twice as fast as the time required for the lancet tip146to return to its final position. Crank arm2072is now at a 270 degree position from the initial position of crank arm2072. At this final position, the body fluid sample is transferred from the lancet tip146to a corresponding one of the plurality of test sections128. As shown inFIG. 75, the second pin2082of intermediate arm2230is in the bottom of slot2080of the tip up link2074to cause the tip up link2074and corresponding driver136to rotate the driver136below the lancet frame130such that the driver136has cleared the lancet frame130for rotation of the lancet frame130to an unused lancet124and a subsequent testing event.

The crank shaft2070reverses its direction to rotate crank arm2072in a clockwise direction approximately 270 degrees from the body fluid transferring position to the initial position for a subsequent lancing, sampling, and testing event.

FIGS. 76,77, and78illustrate actuation of the lancet124by the portable meter system2000with the meter system2000in a deep penetration depth setting. The wheel2001is rotated to lower the first pin2206to the bottom of first opening2232of intermediate arm2230and force the tip up link2074and driver136to rotate further than the shallow depth setting to cause a deeper penetration depth of the active one of the lancets124. Crank shaft2070, crank arm2072, intermediate arm2230, tip up link2074, driver136, and lancet124operate as described previously with respect toFIGS. 73,74, and75.