Abstract: A lancet housing assembly comprising multiple lancets for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is provided. The lancet housing assembly includes a housing structure comprising multiple lancet compartments. At least one of the lancet compartments comprises an outer facing side and an inner facing side. An opening is located at the outer facing side that is arranged and configured to align with a lancet port of the medical diagnostic device. A floor extends between the outer facing side and the inner facing side. A reagent material is located on the floor and within the lancet compartment. A lancet structure is located in the at least one lancet compartment. The lancet structure comprises a skin penetrating end and a blood transport portion adjacent the skin penetrating end. The skin penetrating end, when extended through the opening, is shaped and sized to penetrate the patient's skin at the skin site to provide an amount of blood.

Abstract: A method of adjusting a skin penetrating depth of a lancet structure of a portable handheld medical diagnostic device is provided. The method includes providing an elongated lancet structure having a skin piercing end and a blood transport portion adjacent the skin piercing end. The skin piercing end when displaced makes an incision at the skin site to produce an amount of bodily fluid from the skin site and in which the blood transport portion transports the amount of bodily fluid away from the skin site for use by the measurement system in making the physiological measurement. An adjustable linkage is adjusted that is connected to a drive member such that movement of the adjustable linkage moves the drive member toward and away from the lancet port to adjust a skin penetrating depth of the lancet structure.

Abstract: A bodily fluid sampling device includes a piercing device and a sensor enclosed in a housing. A cassette, which contains test media, is positioned proximal to the sensor so that the sensor is able to analyze a bodily fluid sample collected on the test media. The cassette includes a supply portion from which unused test media is supplied and a storage portion in which contaminated test media is stored after exposure to the bodily fluid. The cassette is adapted to collect a series of bodily fluid samples without requiring disposal of the test media.

Abstract: A pump drive and a method thereof to dispense a liquid drug from a container having a plunger piston are disclosed. The pump drive provides a unidirectional clutch provided about a rotational axis which supports centrally a wheel. The clutch has an inner race operably connected to the plunger piston, wherein the clutch is configured to rotate both the inner race about the axis in unison with rotation of the wheel in only a first direction to advance the plunger piston, and to let the wheel rotate relative to the inner race about the axis in a second direction opposite to the first direction without advancing the piston plunger. The drive in one embodiment includes at least one shape memory alloy wire which when excited rotates the wheel in the first rotational direction to advance the piston plunger and dispense the liquid drug from the container.

Abstract: Adjustment mechanisms are used in conjunction with integrated lancet test strips to adjust the position of the drive system, engagement system, or the drive coupling in a fixed stroke lancing system to thereby adjust the penetration depth of the lancet. In a variable drive stroke lancing system, the lancet penetration depth is adjusted by changing the stroke length of a drive system. The stroke length of a drive system is adjusted by rotating a cam or sliding a cam in a cam type drive system. In either the fixed or the variable drive stroke lancing system, the test strip and/or guidance foil of the integrated lancet test strip is immobilized while the lancet is actuated.

Abstract: A lancet integrated test element (LIT) includes an incision forming member that has a cutting end configured to form an incision in tissue. A test element is attached to the incision forming member to test fluid from the incision. The test element has a sampling end with a sample opening through which the fluid is collected. The test element is bendable from a first state where the cutting end of the incision forming member is retracted from the sampling end of the test element to a second state where at least a portion of the cutting extends past the sampling end of the test element to form the incision in the tissue.

Abstract: A device is constructed so as to define a capillary channel that draws a body fluid form a proximal portion of the capillary channel toward a distal portion. A counterbore defining a “ledge” not substantially normal to the center line of channel causes the meniscus of body fluid to be “biased” into a non-radially-symmetric shape. In one example, the bias draws the body fluid toward a testing element that is set into a groove in the main body of the device. In another example, hydrophilic and/or hydrophobic regions are created on or in device to produce the biasing effect. In certain configurations, device requires less blood to be drawn into the capillary channel for a successful test than if the biasing effect were not created.

Abstract: A self-powered lancing drive system and lancing technique uses permanent magnets to initially store the potential energy that is converted to kinetic energy for extending a lancet during lancing. This self-powered lancing drive system is a pure permanent magnet drive that is highly reliable under numerous operating conditions. Permanent magnets can produce stronger magnetic fields at smaller sizes as compared to electromagnets. In one form, the lancing system has a drive permanent magnet that is kept fixed or stationary while the lancet magnet travels along the firing path. With the drive magnet being stationary, the lancet experiences fewer fluctuations in the magnetic field. The lancet vibrates less and is driven straighter into the tissue. In another form, a retraction magnet is positioned at the end of the firing path of the lancet, near the tissue, to enhance retraction of the lancet.

Abstract: A device is constructed so as to define a capillary channel that draws a body fluid form a proximal portion of the capillary channel toward a distal portion. A counterbore defining a “ledge” not substantially normal to the center line of channel causes the meniscus of body fluid to be “biased” into a non-radially-symmetric shape. In one example, the bias draws the body fluid toward a testing element that is set into a groove in the main body of the device. In another example, hydrophilic and/or hydrophobic regions are created on or in device to produce the biasing effect. In certain configurations, device requires less blood to be drawn into the capillary channel for a successful test than if the biasing effect were not created.

Abstract: An integrated disposable includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing at least a portion of a lancet to maintain the sterility of the lancet. The lancet packet and the sterility sheet, in particular, allow the lancet to be sterilized separately from the test strip. The lancet in one form is incorporated into a lancet tape that is sterilized in a continuous, reel-to-reel sterilization process. The lancet tape in one form is sterilized using an electron beam sterilization process. With electron beam sterilization, sterilization is enhanced by irradiating both sides of the tape with electron beams. Sterilization can adversely affect chemical reagents in the test strip. To alleviate this chemistry degradation issue, the lancet packet is attached to the test strip after the lancet is sterilized.

Abstract: A lancet-sampler system is configured to automatically remove a protective cover from a lancet and automatically unpack a test pad just prior to use. This minimizes the risk of injury and reduces the chance of cross-contamination between the lancet and the test pad. The lancet defines a capillary groove for drawing body fluid from the incision via capillary action and a sample transfer opening for collecting the fluid from the groove. A carrier tape is coupled to the lancet. The carrier tape includes a test pad for analyzing the fluid. The tape is folded around the test pad to form an airtight package. The test pad is located at a position to align with the sample transfer opening when the tape is unfolded. The protective cover covers a portion of the lancet, and when the tape is pulled, the protective cover is automatically pulled from the lancet.

Abstract: A bodily fluid sampling device is operable to lance with a precise depth and express fluid from both fingertip and alternate sites. In one form, the device is operable to adjust the penetration depth of the lancet into the skin. The bodily fluid sampling device includes a lancet adapted to form an incision in skin. A skin contacting member has an orifice through which the lancet extends when lancing the skin. The orifice has a first opening size that is sized to flatten the skin around the lancet during lancing. The orifice has a second opening size that is larger than the first opening size after the incision is formed to express fluid from the incision.

Abstract: A lancet-sampler system is configured to automatically remove a protective cover from a lancet and automatically unpack a test pad just prior to use. This minimizes the risk of injury and reduces the chance of cross-contamination between the lancet and the test pad. The lancet defines a capillary groove for drawing body fluid from the incision via capillary action and a sample transfer opening for collecting the fluid from the groove. A carrier tape is coupled to the lancet. The carrier tape includes a test pad for analyzing the fluid. The tape is folded around the test pad to form an airtight package. The test pad is located at a position to align with the sample transfer opening when the tape is unfolded. The protective cover covers a portion of the lancet, and when the tape is pulled, the protective cover is automatically pulled from the lancet.

Abstract: A system comprising disposable medical devices and a packaging strip comprising a plurality of chambers containing the disposable medical devices. The strip is folded along breadthwise running fold lines to form a series of loops, each loop comprising opposing sections. The opposing sections of at least some of these loops are sealed to each other thus forming chambers between said sections. A cartridge contains such a packaging strip.

Abstract: An integrated lancing test strip includes a pair of blade members that each have a lancing tip that are configured to lance skin. A pair of spacer members connect the blade members together such that the blade members define an internal capillary. A test strip is positioned along the internal capillary, and the test strip is configured to test analyte levels in the bodily fluid. During use, the lancing tips form one or more incisions in the skin. The fluid from the incisions is drawn via capillary action through the internal capillary and onto the test strip.

Abstract: An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. In one form, a firing mechanism has a blade that punctures and slits the sterility sheet during the firing cycle to reduce the chance of cross contamination between the lancet and the test strip prior to use. This allows an operator to load and subsequently remove an unused integrated lancing test strip without compromising the sterility of the lancet. The lancet includes an engagement opening in which the blade of the firing mechanism engages the lancet. The engagement opening is configured to reduce the chance of the blade becoming dull.

Abstract: A bodily fluid sampling device is operable to lance with a precise depth and express fluid from both fingertip and alternate sites. In one form, the device is operable to adjust the penetration depth of the lancet into the skin. The bodily fluid sampling device includes a lancet adapted to form an incision in skin. A skin contacting member has an orifice through which the lancet extends when lancing the skin. The orifice has a first opening size that is sized to flatten the skin around the lancet during lancing. The orifice has a second opening size that is larger than the first opening size after the incision is formed to express fluid from the incision.

Abstract: A body fluid sampling device includes a firing mechanism that is configured to be automatically cocked and fired. In one form, the device includes an electric motor that is operable to cock the firing mechanism and fire an integrated lancet/sampling device to form an incision in skin. Subsequent to formation of the incision, the integrated lancet device is temporarily removed from the skin to promote bleeding from the incision. After a specified period of time, the integrated lancet device is then repositioned against the skin in order to collect a fluid sample.

Abstract: A test magazine with two film strips (12, 14), which are joined to one another in a sandwich-like manner, can be wound up, and between which holding cells (16) for test elements are kept free. The test magazine also comprises a multitude of test elements (18, 20) each having a puncturing unit (18) for inserting into body tissue and a test unit (20) for being subjected to body fluid. To this end, the puncturing units (18) and test units (20) are placed in separate holding cells (16) whereby separating them from one another.

Abstract: A supply of lancets for a multi-use lancing device are carried by a tape and sequentially brought from a storage position to an activating position by advancing the tape around a bend. The lancets are non-circular in cross-section along their longitudinal lengths, and in their activating position they extend from the tape such that their sharp tips are available for lancing tissue. The carrying tape can be arranged in reel-to-reel format in a housing having a lancing opening. The lancets can be integral with the tape and activated to move the lancet through the lancing opening by moving the tape along its tape path or by translating a dedicated service loop of the tape. The lancets can also be independent from the tape and activated through the lancing opening by a separate lancing actuator. A test media can be included on the carrying tape and the housing can contain a sensor to yield an integrated lancing and testing device.