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 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: The system (2) includes a catheter drive unit (22) and a catheter (24) extending therefrom movably mounted to a catheter drive sled (26). The catheter drive unit rotates and translates the catheter core (34) within the catheter sheath (36). The sled has a serrated, conical drive unit interface (82), with a bag-piercing tip (86) mateable with a translator drive output (92) so that a sterile drape (112) enclosing the catheter drive unit is automatically pierced when the catheter drive unit is mounted to the sled. A control unit (6) is spaced apart from the catheter drive unit and provides power and commands to the catheter drive unit and receives information and data from the catheter drive unit. The rotator and translator drive motors (54, 90) are operated from both the control unit and the catheter drive unit. Both the control unit and catheter drive unit have translation displacement displays (10, 30).

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 bodily fluid sampling device comprising a lancet which can be advanced against a skin-piercing site to produce a droplet of bodily fluid. A transport medium is positioned sufficiently close to the lancing medium to retain a droplet of bodily fluid therebetween by capillary action. One of the two mediums has hydrophobic material on its surface and the other hydrophilic. Various mechanisms are provided for relatively displacing the lancing and transport medium to move the droplet of bodily fluid away from the skin-piercing end. Furthermore, multiple lancet assemblies may be provided in a barrel or disk configuration and indexed to the displacing mechanisms for sampling a skin site.

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: A bodily fluid sampling device comprising a lancet which can be advanced against a skin-piercing site to produce a droplet of bodily fluid. A transport medium is positioned sufficiently close to the lancing medium to retain a droplet of bodily fluid therebetween by capillary action. One of the two mediums has hydrophobic material on its surface and the other hydrophilic. Various mechanisms are provided for relatively displacing the lancing and transport medium to move the droplet of bodily fluid away from the skin-piercing end. Furthermore, multiple lancet assemblies may be provided in a barrel or disk configuration and indexed to the displacing mechanisms for sampling a skin site.

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: 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: A bodily fluid sampling device comprising a lancet which can be advanced against a skin-piercing site to produce a droplet of bodily fluid. A transport medium is positioned sufficiently close to the lancing medium to retain a droplet of bodily fluid therebetween by capillary action. One of the two mediums has hydrophobic material on its surface and the other hydrophilic. Various mechanisms are provided for relatively displacing the lancing and transport medium to move the droplet of bodily fluid away from the skin-piercing end.

Abstract: A drug delivery pump which uses a piezoelectric drive system to advance a small syringe piston to deliver a liquid drug and a method thereof are disclosed. The present invention has a cost and size advantage compared to traditional pumps and is a very compact and potentially disposable pump device design.

Abstract: A drug delivery pump which uses a piezoelectric drive system to advance a small syringe piston to deliver a liquid drug and a method thereof are disclosed. The present invention has a cost and size advantage compared to traditional pumps and is a very compact and potentially disposable pump device design.

Abstract: The invention refers to a sample fluid testing device for analyzing a sample fluid, comprising a test media tape (1) comprising a tape (2) and a plurality of test media portions (3), each test media portion (3) containing a sensor field (7) for producing electrical signals, when the sample fluid is applied and at least two electrodes (4), the at least two electrodes (4) being positioned in the sensor field (7) and being electrically connected to at least two contact fields (5). The sample fluid testing device contains at least one roller with a surface (17), which contains at least one contact zone (14), the at least one roller (12, 13) being in rolling engagement with the test media tape (1) with its surface (17) in order to successively electrically contact the test media portions (3) via at least one contact field (5) with the at least one contact zone (14), the at least one contact zone (14) on the at least one roller (12, 13) being electrically connected to a meter for measuring the electrical signals.

Abstract: A lancet enclosed in a sterility sheet forms a lancet packet to maintain the sterility of the lancet and prevent the lancet from unintentionally piercing the sterility sheet prior to lancet actuation. In one form, the lancet is immobilized by hot tack welding a portion of the sterility sheet to the lancet. Alternatively, portions of the sterility sheet are hot tack welded together through an opening in the lancet to limit movement of the lancet.

Abstract: A bodily fluid sampling device includes a flexible test strip, a lancet, and a deflection mechanism. The test strip is biased to be positioned over the incision site formed by the lancet. The deflection mechanism positions the test strip away from the incision site during lancing so as to allow the lancet to have clear access to the incision site. Due to the flexible nature of the test strip, after lancing the incision, the test strip returns to the original position so as to collect fluid from the incision.

Abstract: Systems and methods for the sampling of bodily fluid from an incision in the skin include test strips which are positioned adjacent to the skin and which include features to inhibit the passage of the bodily fluid between the skin and the underside of the test strip. One system utilizes a sealing member located on the bottom surface of the test strip and positioned to provide a fluid tight seal with the skin. A second system includes a recessed surface aligned with the inlet opening of the test strip to preclude contact of the bodily fluid directly with the bottom surface of the test strip. A third system involves the use of a hydrophobic surface on the underside of the test strip to inhibit wicking of the bodily fluid along the test strip. The present invention further encompasses the combination of the foregoing sampling systems with each other, and with incising, expressing and/or testing systems and methods, particularly in a single, integrated device.

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 supply of test strips for bodily fluid sampling are provided on a tape such that advancing the tape serves to advance the test strips. One end of the test strips are attached to the tape, and their free end is allowed to extend away from the tape for use. This extension facilitates dosing and reduces the chances for contamination. Prior to use the test strips are maintained in a sealed container and/or under a removable covering to preserve their integrity and improve shelf life.

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.