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: 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 expression device for a lancing device of the type that directs a skin-lancing medium against a skin site to make an incision for testing bodily fluids. The expression device has a pair of skin-engaging tabs curved and oriented to make the skin taut adjacent a lancet used with the device. This increases the incision width and enhances the quantity of blood removed for subsequent testing.

Abstract: An integrated bodily fluid sampling device is used to sample a bodily fluid from an incision in skin. The device includes a lancet for forming the incision in the skin. A housing is coupled to the lancet. The housing defines at least in part a capillary channel with an opening. The capillary channel is sized to draw the bodily fluid from the incision via capillary action. A test strip is positioned along the capillary channel for analyzing the fluid. In one form, a flexible sheet extends from the housing proximal the opening of the capillary channel for drawing the bodily fluid into the opening of the capillary channel. In another form, the lancet is slidably received inside the channel. During lancing, the lancet extends from the housing to form the incision. Fluid from the incision is drawn into the channel and is deposited on the test strip for analysis.

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: Web processing apparatus (30, 300) is provided for high speed, extremely accurate die cutting or lamination operations. Processing station (32, 300) includes a Vacuum hold down plate (32, 308) which receives and holds an image bearing incremental segment of the web. In feed and out feed tension on the web is released while a segment of the web is held by the hold down plate. The hold down plate with a segment of the web thereon is selectively shifted about X, Y and ? axis as required to bring the image on the web segment into alignment with a web processing component at the processing station.

Abstract: A sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user's skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Abstract: An integrated bodily fluid sampling device is used to sample a bodily fluid from an incision in skin. The device includes a lancet for forming the incision in the skin. A housing is coupled to the lancet. The housing defines at least in part a capillary channel with an opening. The capillary channel is sized to draw the bodily fluid from the incision via capillary action. A test strip is positioned along the capillary channel for analyzing the fluid. In one form, a flexible sheet extends from the housing proximal the opening of the capillary channel for drawing the bodily fluid into the opening of the capillary channel. In another form, the lancet is slidably received inside the channel. During lancing, the lancet extends from the housing to form the incision. Fluid from the incision is drawn into the channel and is deposited on the test strip for analysis.

Abstract: A body fluid sampling device with an incision forming member travels longitudinally within a capillary member with a capillary tube tip to maintain the incision open when the body fluid sampling device is presented into the skin. The body fluid sampling device both creates the incision and obtains the bodily fluid sample without having to be adjusted or removed from the skin.

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: A multi-use assay system accurately docks a removable test strip supporting a reagent-analyte reaction with an optics system including an LED, photodetector, and lenses or light pipes for directing light to and from the test strip. Docking is achieved using alignment fixturing, whereby an optics block holder is relied upon to align the test strip and test pad with the various optical components. Signals from the photodetector indicative of test strip reaction progress are provided to a processor for measuring the analyte.

Abstract: A sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user's skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Abstract: High speed, extremely accurate web or sheet-fed segment die cutting or lamination apparatus (30, 300) has a processing station (32, 300), which receives a sheet or web segment, and is provided with a vacuum hold-down plate (142, 306) for holding initially fed segments (38). The plate is shiftable as necessary along orthogonal X-Y axes in the plane of the segment (38), and/or is rotatable about a &thgr; axis transverse to the segment plane. Plate movement is effected by a series of aligned, translatable eccentric drive units (178-182, 346-350). Segments (38) carry positioning fiducials (44) that are compared with fixed reference indicia (250, 252) in the station (32, 300). The comparison data is used by a controller (254) to generate the plate movement information used in simultaneous operation of the associated plate drive units (178-182, 346-350).

Abstract: Systems and methods for the expression of bodily fluid from an incision in the skin include devices which bear against the skin in a manner to retain the fluid adjacent the incision site and urge the fluid inwardly toward the incision. One system utilizes a constricting member which engages the skin at initial, outer positions, and moves to draw the skin into an inner position forming a bulged, pinch of skin containing the incision site. The constricting member comprises flexible or non-flexible components, and is formed as a single, continuous member or as a plurality of discrete elements. A second system includes a bi-stable expression member including a skin-engaging portion having a first, outwardly bulged condition, and a second, inverted condition the skin is drawn into and retained within the member. The exterior surface of the expression member is optionally configured or treated to enhance the grasping of the skin.

Abstract: A multi-use assay system accurately docks a removable test strip supporting a reagent-analyte reaction with an optics system including an LED, photodetector, and lenses or light pipes for directing light to and from the test strip. Docking is achieved using alignment fixturing, whereby an optics block holder is relied upon to align the test strip and test pad with the various optical components. Signals from the photodetector indicative of test strip reaction progress are provided to a processor for measuring the analyte.

Abstract: Web or sheet-fed segment processing apparatus (30, 300) is provided for high speed, extremely accurate operations such as die cutting or lamination. The apparatus (30, 300) includes a processing station (32, 300) adapted to receive a segment (38) forming a part of a continuous web (100, 102) or as a discrete sheet. The station (32, 300) includes a vacuum hold-down plate (142, 306) for holding initially fed segments (38); the hold-down plate (32, 308) is shiftable as necessary along orthogonal X-Y axes in the plane of the segment (38), and/or &thgr; rotation about a rotational axis transverse to the segment plane, such movement being effected by a series of aligned, translatable eccentric drive units (178-182, 346-350) coupled with plate (142, 306). Preferably, the segments (38) carry positioning fiducials (44) and which are compared with fixed reference indicia (250, 252) in the station (32, 300).

Abstract: Web or sheet-fed segment processing apparatus (30, 300) is provided for high speed, extremely accurate operations such as die cutting or lamination. The apparatus (30, 300) includes a processing station (32, 300) adapted to receive a segment (38) forming a part of a continuous web (100, 102) or as a discrete sheet. The station (32, 300) includes a vacuum hold-down plate (142, 306) for holding initially fed segments (38); the hold-down plate (32,308) is shiftable as necessary along orthogonal X-Y axes in the plane of the segment (38), and/or &thgr; rotation about a rotational axis transverse to the segment plane, such movement being effected by a series of aligned, translatable eccentric drive units (178-182,346-350) coupled with plate (142,306). Preferably, the segments (38) carry positioning fiducials (44) and which are compared with fixed reference indicia (250, 252) in the station (32, 300).

Abstract: A sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user's skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Abstract: A multi-use assay system accurately docks a removable test strip supporting a reagent-analyte reaction with an optics system including an LED, photodetector, and lenses or light pipes for directing light to and from the test strip. Docking is achieved using alignment fixturing, whereby an optics block holder is relied upon to align the test strip and test pad with the various optical components. Signals from the photodetector indicative of test strip reaction progress are provided to a processor for measuring the analyte.

Abstract: A monitoring system which collects patient physiological date is designed specifically for communication with a communication module which facilitates data transfer from the monitoring system to a remote site. The communication module has data input mechanisms to facilitate setting parameters of the monitoring system and/or the communication module. The communication module is provided with a modem member which is used to communicate with the remote site and an optional data exchange module which is designed to communicate the same information with a local computer system. The remote site may be a bulletin board system or internet site where the monitoring information can be stored by the patient using the monitoring system by patient identification or name and include monitoring readings, time and date stamp, conditions such as meal times, exercise times and therapy amounts and their associated date and time.