Abstract: A medical device that includes a plurality of strut members forming a plurality of generally diamond-shaped openings, the plurality of strut member being configured to form an annular shaped structure with the generally diamond-shaped openings extending generally longitudinally relative to a longitudinal axis of the medical device. A plurality of tissue engaging portions are associated with the plurality of struts, with each tissue engaging portion extending towards the longitudinal axis in a deployed configuration.

Abstract: Apparatus and methods for medicament delivery. The apparatus may include, and the methods may involve, a delivery device for delivering a target amount of the medicament from a distal end of the device. The device may include a rod for moving a plunger that discharges the medicament from the distal end. The device may avoid or reduce deformation of the plunger during the discharge. The plunger motion may be stopped by detent that interacts with the rod. The apparatus and the methods may provide an operator indication of progress of stages of operation. The device may feature triggers corresponding to stages of medicament displacement from the device, such as pre-delivery stages, including priming.

Abstract: A lancet housing assembly 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 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 and having a reagent material. A lancet structure having a skin penetrating end and a blood transport portion adjacent the skin penetrating end is located in housing assembly. The blood transport portion is arranged and configured receive the amount of blood from the skin penetrating end and to carry the amount of blood away from the skin site and to the reagent material.

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: 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. The sterility sheet gives the integrated strip a low profile, which is attractive for packaging multiple integrated strips in cassettes, drums, magazines or the like. In one form, the integrated strip is loaded in a meter that includes an adjustment mechanism that adjusts the position of the test strip relative to the skin being sampled. This allows the user to adjust the position of the test strip so as to not apply excessive pressure against skin, which could hamper bleeding from the incision in the skin.

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 disposable device for analyzing body fluid especially for blood sugar tests includes a container which can be inserted into a measuring apparatus, a sampling member provided in the container to pierce skin of a body part and sample body fluid, and a test member for receiving body fluid obtained by the skin-piercing. In one form, the test member is fixed in a retaining chamber of the container, and the sampling member is configured in the same retaining chamber such that it is separated at a distance from the test member in an initial state and is in contact with the test member to transfer body fluid in a transfer state after the skin-piercing.

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: 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. The sterility sheet gives the integrated strip a low profile, which is attractive for packaging multiple integrated strips in cassettes, drums, magazines or the like. In one form, the integrated strip is loaded in a meter that includes an adjustment mechanism that adjusts the position of the test strip relative to the skin being sampled. This allows the user to adjust the position of the test strip so as to not apply excessive pressure against skin, which could hamper bleeding from the incision in the skin.

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 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.

Abstract: A method of assembling 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 disclosed. The method includes forming a plurality of lancet structures in a lancet sheet. The lancet sheet has a removable ledge for releasing the lancet structures. The removable ledge of the lancet sheet is flexed for releasing the lancet structures from the removable ledge.

Abstract: A lancet structure for making an incision at a skin site and transporting an amount of blood from the incision away from the skin site and methods of utilizing and making such a lancet structure are disclosed. The lancet structure may comprise an elongated body having a first surface and a second surface, a skin penetrating end for making the incision, a through bore extending from the first surface to the second surface, and a blood transport portion extending from the skin penetrating end to the through bore along the first surface. The blood transport portion is configured to transport the amount of blood away from the skin site via a capillary force to the through bore, and the through bore is configured to transport the blood to the second surface.

Abstract: A lancet housing assembly 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 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 and having a reagent material. A lancet structure having a skin penetrating end and a blood transport portion adjacent the skin penetrating end is located in housing assembly. The blood transport portion is arranged and configured receive the amount of blood from the skin penetrating end and to carry the amount of blood away from the skin site and to the reagent material.

Abstract: A closure system and methods of use are provided for use in sealing an opening in a body tissue, such as a vascular puncture site. A method of closing the opening in the body tissue can be performed with the closure system having a closure clip. The method can include positioning the closure clip in a first closure clip position adjacent to the opening in the body tissue such that a plurality of spikes of the closure clip are inserted into the tissue at a location outward from a central axis of the opening. Subsequently, the closure clip can be positioned in a second closure clip position such that the plurality of spikes are pulled inward toward the central axis of the opening so as to pull the tissue between the opening and each of the spikes together and close the opening.

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 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: Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid. In one embodiment, the collection zone includes a plurality of holes, e.g., 3 or more holes, or 50 to 100 holes. The hole size may be small, e.g., having a diameter of 0.01 to 0.5 mm. The holes may or may not extend through the lancet. In some embodiments, the holes have a depth of 50 to 500 ?m. In other embodiments, the collection zone is porous, or is a roughened area. The collection zone can take up a very small volume of body fluid, e.g., 3 to 10 nL, in a very short time period, e.g., less than 0.5 seconds. In other embodiments, the device further comprises a fluid receiving means spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially.

Abstract: A method that includes locating an opening in tissue by advancing a member through the opening in tissue and following locating the opening, deploying a medical device to aid with sealing the opening. The medical device includes a plurality of strut members forming a plurality of generally diamond-shaped openings, the plurality of strut member being configured to form an annular shaped structure with the generally diamond-shaped openings extending generally longitudinally relative to a longitudinal axis of the medical device. The medical device further includes a plurality of tissue engaging portions associated with the plurality of struts, each tissue engaging portion being disposed between adjacently positioned generally diamond-shaped openings.