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. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.

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 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. In the lancets' 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.

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 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. In the lancets' 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.

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.

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.

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 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.

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.

Abstract: A drug reservoir loading and unloading mechanism for drug delivery device using unidirectional rotated lead screw and method thereof are disclosed. The drug reservoir loading/unloading mechanism allows exchanging the drug reservoir quickly with very few steps and with more safety. The invention neither requires rewinding of the drive system either automatically or manually while replacing the drug reservoir nor requires an additional adapter to secure the drug reservoir.

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. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.

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. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.

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: Web processing method and 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 ? axes as required to bring the image on the web segment into alignment with a web processing component at the processing station.

Abstract: A drug reservoir loading and unloading mechanism for drug delivery device using unidirectional rotated lead screw and method thereof are disclosed. The drug reservoir loading/unloading mechanism allows exchanging the drug reservoir quickly with very few steps and with more safety. The invention neither requires rewinding of the drive system either automatically or manually while replacing the drug reservoir nor requires an additional adapter to secure the drug reservoir.

Abstract: A body fluid sampling device is used to sample a bodily fluid from an incision in skin. The device includes a housing that defines a sample cavity with one open end that contacts skin. The device also includes a lancing mechanism that forms an incision in the skin. A vacuum mechanism is used to create a vacuum inside the sample cavity to express fluid from the incision site. To release the vacuum, a valve is connected with the sample cavity to exchange atmospheric air and further works to minimize fluid splatter. The fluid sample can then be tested or analyzed as desired.

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. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.