Abstract:
A process for manufacturing packaged lancets, comprising the steps: providing a tape comprising a plurality of lancets comprising a lancet tip and a lancet body, enveloping at least the lancet tip with at least one foil, whereby the at least one foil build a first and a second portion that overlap at least partly, sealing the at least one foil with a laser beam at least at the edges of the first and second portion of the overlapping parts.
Abstract:
Analysis system for determining an analyte in a body fluid, comprising a reusable analysis instrument (2) and a magazine (3) having a plurality of flat, disposable, integrated sample acquisition and analyzing elements, each comprising a puncturing element (23) and an analyzing element (20) and have two major surfaces. The analysis instrument (2) comprises a drive, by which the puncture movement of the puncturing element (23) is driven, to move it on a movement path in the puncturing direction during a propulsion phase and opposite to the puncturing direction after reaching a reversal point of the puncture movement during a retraction phase, a coupling unit (7), which is adapted for coupling an integrated sample acquisition and analyzing element to the drive, a measuring and evaluation unit (8) for measuring a measurement variable characteristic for determining an analyte and for deriving a desired analysis result, and a holder for receiving the magazine (3). The magazine (3) comprises a housing having a plurality of elongate chambers located neighboring one another. The chamber (9) are separated by two side walls (10) running in the longitudinal direction of the chambers (9), and have a height and length greater than the distance of two neighboring side walls (10). The chambers (9) have major sides (11 ) delimited by the side walls (10) and two long and two short minor sides (12, 13) extending between the side walls (10). The chamber (9) contain an integrated sample acquisition and analyzing element, whose puncturing element has a coupling structure (29) and is movable on the movement path of the puncture movement in the puncturing direction. The chambers (9) have an exit opening (14) on one of their minor sides (12, 13) for allowing at least partial exiting out of the chamber of the puncturing element (23) moved on the movement path. The coupling unit (7) has a coupling element (35). The chambers (9) of the magazine (3) are accessible for the coupling element (35) on one of their long minor sides (12) such that the coupling element (35) can be coupled to the coupling structure (29) of the puncturing element (23) in a formfitting way, when the puncturing element (23) is positioned in the chamber (9) of the magazine (3) and the magazine (3) is located in the holder.
Abstract:
In a device for analyzing body fluids, comprising a piercing element (14) that can be pierced into a body part (22) along a piercing axis (48), the element having a collection volume (44) for collecting of body fluid (52) obtained by means of a puncture, and a receiving element (16) that is configured for verifying the substances of the body fluid (52), wherein the body fluid (52) from the collection volume (44) can be applied to the receiving element, according to the invention the piercing element (14) and the receiving element (16) are disposed in the piercing axis (48) displaceably relative to each other such that the receiving element (16) immerse in the collection volume (44) in the piercing direction during a transfer phase following the puncture.
Abstract:
Instrument for producing a sample of body liquid for analysis by piercing the skin with a lancing element (12) having a skin piercing tip. The instrument (11) has a housing (13) and a lancing drive (14) for driving a lancing element (12) connected thereto in a puncturing movement. A pressure ring (1) surrounds a skin contact opening (4) and is adapted for pressing against the skin such that the skin (3) bulges into the opening (4) for promoting expression of body fluid. The skin contact opening (4) has an opening area corresponding to a circle with a diameter of at least 3 mm and at most 8 mm, and the instrument comprises a pressing force control device (37) for controlling the pressing force between the pressure ring (1) and the skin (3) at the time of triggering the puncturing movement, to be at least 3 N and at most 8 N.
Abstract:
Instrument for producing a sample of body liquid for analysis by piercing the skin with a lancing element (12) having a skin piercing tip. The instrument (11 ) has a housing (13) and a lancing drive (14) for driving a lancing element (12) connected thereto in a puncturing movement. A pressure ring (1 ) surrounds a skin contact opening (4) and is adapted for pressing against the skin such that the skin (3) bulges into the opening (4) for promoting expression of body fluid. The skin contact opening (4) has an opening area corresponding to a circle with a diameter of at least 3 mm and at most 8 mm, and the instrument comprises a pressing force control device (37) for controlling the pressing force between the pressure ring (1 ) and the skin (3) at the time of triggering the puncturing movement, to be at least 3 N and at most 8 N.
Abstract:
The invention relates to an analytical system for determining an analyte in a body fluid, comprising a disposable integrated sample collection and analytical element which includes a lancing element (7) having a tip (15) for lancing the skin of a body part and a flat test strip (6) having a sample receiving zone (10) into which a body fluid sample is transferred to carry out an analysis. The system further comprises a reusable analytical device (2) including a coupling unit adapted to couple an integrated sample collection and analytical element to a drive driving the lancing movement of the lancing element (7). The lancing element is moved on a lancing path in the direction of lancing during an advance phase and, once it has reached a point of return of the lancing movement, it is moved counter to the direction of lancing during a return phase. The measurement and evaluation unit (36) is used to measure a measurement variable which is characteristic for determining the analyte and for determining a desired result of analysis based on said measurement. The sample receiving zone (10) of the test strip (6) is arranged on one of its flat faces (9) that configures a sample contact side (11). The lancing element (7) is arranged in parallel to the test strip (6) and can be moved during at least part of the lancing path relative to the test strip (6) on a movement path. The lancing element (7) is arranged adjacent to the sample contact side (11) of the test strip (6). It has a capillary channel (17) with a sample inlet (23) through which the body fluid can enter the capillary channel (17) after lancing, and a sample outlet (24) through which the body fluid can escape from the capillary channel (17). The movement of the lancing element (7) includes a sample transfer position in which the sample outlet (24) is adjacent to the sample receiving zone (10) of the test strip (6) in such a manner that the body fluid can be transferred from the capillary channel (17) through the sample outlet (24) to the sample receiving zone (10).
Abstract:
The invention relates to a medical contrivance which comprises a lancet (2) having a proximal (5) and a distal end, said lancet (2) comprising a lancet base (4) and a lancet tip (3) on the proximal end (5) thereof. The lancet (2) is at least partially enclosed by a packaging.
Abstract:
The invention relates to a microsampler piercing system for removing a sample of bodily fluid from a body part. Said system comprises: a sampling unit with a piercing element and a piercing device with a drive, which is used to displace a sampling unit along a displacement path, in order to allow the piercing element to penetrate and be withdrawn from the skin of the body part by means of a piercing and retraction displacement; an adjusting device for adjusting the piercing depth of the wound that is to be pierced; and a control unit for controlling the piercing and retraction displacement with the following sequential displacement phases: a propulsion phase (V), in which the piercing element (5) penetrates the skin to a defined pierced depth (dm); a withdrawal phase (R1), in which the piercing element (5) is partially withdrawn over a withdrawal distance (?d), slowing down towards the end of the withdrawal phase (R1) so that it is lodged in the skin at a defined pierced remainder depth (dr); and a collection phase (S), in which the piercing element remains lodged in the skin and the sampling unit takes a sample of bodily fluid. The adjusting device is configured in such a way that the defined pierced depth can be adjusted independently of the defined pierced remainder depth that is defined by temporal means , in relation to the collection phase.
Abstract:
The invention relates to a piercing system for removing bodily fluid from the skin of a human or animal. Said system comprises a disposable piercing unit (1), which contains a needle element (6) for puncturing the skin, a piercing device (2), which encompasses a piercing drive (4), said drive propelling a piercing displacement of the piercing unit (1), which is coupled to the piercing drive (4) by means of a coupling mechanism (3), a predefined value of the piercing depth being guaranteed using a piercing depth reference element (10), which comprises a skin contact surface (11) and the predefined value of the piercing depth being determined by the distance in the piercing direction between the skin contact surface (11) and the position of the needle tip at the inversion point of the piercing displacement. The piercing depth reference element (10) is connected to the needle element (6) and coupled to the drive in such a way that it is displaced together with the needle element (1) during at least one part of the propulsion phase and has a defined longitudinal position in the piercing direction in relation to the needle element (6), at least at the inverse point of the piercing displacement.
Abstract:
An actuator for driving a test element is proposed. The test element comprises a lancet for perforating a skin portion of a living organism. The actuator comprises an engaging part for engaging and driving the test element to perform a lancing motion. The actuator further comprises a lancing actuator and a lancing spring, wherein the lancing actuator is adapted for biasing the lancing spring by executing a forward movement and thereby exerting a biasing force on the engaging part. The actuator further comprises a latch element, wherein the latch element is a force-sensitive latch element, wherein the latch element is adapted for exerting a retention force holding back the engaging part, The retention force counteracts the biasing force. The latch element is adapted for releasing the engaging part when the biasing force exerted by the lancing actuator exceeds the retention force exerted by the latch element, thereby allowing for the test element to perform the lancing motion.