Instruments and system for producing a sample of a body fluid and for analysis thereof

Abstract

An instrument for producing a sample of body fluid for analysis by piercing the skin with a lancing element having a piercing tip is disclosed. The instrument can comprise a housing and a lancing drive for driving a lancing element connected thereto in a puncturing movement. A pressure ring can surround a skin contact opening and can be adapted for pressing against the skin such that the skin can bulge into the skin contact opening for promoting expression of body fluid. The skin contact opening can have a circular opening with a diameter of at least about 3 mm and at most about 8 mm. The instrument can comprise a pressing force control device for controlling the pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, to be at least about 3 N and at most about 8 N.

1 . An instrument for producing a body fluid sample for analysis by piercing skin with a lancing element having a piercing tip, the instrument comprising:
 a housing;   a lancing drive within the housing for driving a lancing element connected thereto in a puncturing movement in which the lancing element moves, after triggering the puncturing movement, in a puncture direction until it reaches a point of maximum displacement and in a reverse direction after it has reached the point of maximum displacement;   a pressure ring surrounding a skin contact opening and adapted for pressing against the skin such that the skin bulges into the skin contact opening for promoting expression of body fluid, wherein the skin contact opening has a circular opening with a diameter of at least about 3 mm and at most about 8 mm; and   a pressing force control device for controlling a pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, wherein the pressing force ranges between about 3 N and at the most about 8 N.   
     
     
         2 . The instrument according to  claim 1 , wherein the skin contact opening has a circular opening with a diameter of at least about 4 mm and at most about 7 mm. 
     
     
         3 . The instrument according to  claim 1 , wherein the skin contact opening has a circular opening with a diameter of at least about 5 mm and at most about 6.5 mm. 
     
     
         4 . The instrument according to  claim 1 , wherein the skin contact opening has a circular opening with a diameter of at least about 5.5 mm and at most about 6 mm. 
     
     
         5 . The instrument according to  claim 1 , wherein the pressing force ranges between at least about 4 N and at most about 7 N. 
     
     
         6 . The instrument according to  claim 1 , wherein the pressing force ranges between at least about 5 N and at most about 6 N. 
     
     
         7 . The instrument according to  claim 1 , further comprising,
 a holding device for holding an analysis element in the housing such that the body fluid sample produced by piercing the skin can be transported thereto for analysis.   
     
     
         8 . An instrument for producing a body fluid sample by piercing skin and for analyzing the body fluid sample comprising a lancing element having a piercing tip, a sample collection device for collecting an amount of body fluid sample required for analysis and a disposable analysis element, wherein the instrument further comprises:
 a housing;   a lancing drive within the housing connected to a lancing element and for driving the lancing element connected thereto in a puncturing movement in which the lancing element moves, after triggering the puncturing movement, in a puncture direction until it reaches a point of maximum displacement and in a reverse direction after it has reached the point of maximum displacement;   a pressure ring surrounding a skin contact opening and adapted for being pressed against the skin such that the skin bulges into the skin contact opening for promoting expression of body fluid; and   a holding device for holding the disposable analysis element in the housing such that the body fluid sample is transported thereto from the sample collection device for analysis;   wherein a minimum interaction time period required for lancing and sampling a sufficient amount of body fluid sample for analysis is at most about 3 seconds.   
     
     
         9 . The instrument according to  claim 8 , wherein the minimum interaction time period is not more than about 2 seconds. 
     
     
         10 . The instrument according to  claim 8 , wherein the minimum interaction time period is not more than about 1 second. 
     
     
         11 . The instrument according to  claim 8 , further comprising,
 a minimum interaction time controlling device for controlling the minimum interaction time maintained by a user of the instrument.   
     
     
         12 . The instrument according to  claim 11 , wherein the minimum interaction time controlling device comprises,
 a signal generating device adapted to generate an audible, tactile or visible signal for the user at the beginning of the minimum interaction time period and at the end of the minimum interaction time period.   
     
     
         13 . The instrument according  claim 8 , further comprising,
 a pressing force control device for controlling the pressing force between the pressure ring and the skin.   
     
     
         14 . The instrument according to  claim 13 , wherein the pressing force control device maintains a minimum pressing force of at least about 3 N between the pressure ring and the skin during the measurement interaction time period. 
     
     
         15 . The instrument according to  claim 13 , wherein the pressing force control device maintains a minimum pressing force of at least about 4 N between the pressure ring and the skin during the measurement interaction time period. 
     
     
         16 . The instrument according to  claim 13 , wherein the pressing force control device maintains a minimum pressing force of at least about 5 N between the pressure ring and the skin during the measurement interaction time period. 
     
     
         17 . The instrument according to  claim 13 , wherein the pressing force control device maintains a maximum pressing force of at most about 10 N between the pressure ring and the skin during the measurement interaction time period. 
     
     
         18 . The instrument according to  claim 13 , wherein the pressing force control device maintains a maximum pressing force of at most about 8 N between the pressure ring and the skin during the measurement interaction time period. 
     
     
         19 . The instrument according to  claim 13 , wherein the pressing force control device maintains a maximum pressing force of at most about 7 N between the pressure ring and the skin, during the measurement interaction time period. 
     
     
         20 . The instrument according to  claim 13 ; wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−0.5 N. 
     
     
         21 . The instrument according to  claim 13 , wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−0.3 N. 
     
     
         22 . The instrument according to  claim 13 , wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−0.2 N. 
     
     
         23 . The instrument according  claim 13 , wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−15%. 
     
     
         24 . The instrument according  claim 13 , wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−10%. 
     
     
         25 . The instrument according  claim 13 , wherein the pressing force control device maintains a maximum variation range of the pressing force between the pressure ring and the skin during the measurement interaction time period of not more than about +/−5%. 
     
     
         26 . The instrument according to  claim 13 , wherein the pressing force control device comprises a spring device arranged such that one end of the spring device acts against the pressure ring and the other end of the spring device acts against the housing. 
     
     
         27 . The instrument according to  claim 26 , wherein the lancet drive is connected with the pressure ring in a defined spatial configuration, such that the distance between the point of maximum displacement of the lancet movement and the pressure ring is independent from the compression status of the spring device and from the axial movement position of the pressure ring. 
     
     
         28 . The instrument according to any one of  claims 26 , further comprising,
 a pressure ring movement limiting arrangement, by which the maximum displacement of the pressure ring possible by pressing with a finger or other body part is limited within a spring-loaded movement range of the pressure ring.   
     
     
         29 . The instrument according to  claim 28 , wherein the pressure ring movement limiting arrangement comprises a contact surface in the vicinity of the pressure ring arranged such that a body part pressed against the pressure ring and thereby moving the pressure ring, abuts against the contact surface. 
     
     
         30 . The instrument according to  claim 26 , wherein the spring device is pre-tensioned such that its force acting on the pressure ring varies by not more than about 20% within the spring-loaded movement range of the pressure ring. 
     
     
         31 . The instrument according to  claim 26 , wherein the spring device is pre-tensioned such that its force acting on the pressure ring varies by not more than about 10%, within the spring-loaded movement range of the pressure ring. 
     
     
         32 . The instrument according to  claim 8  has no user-setable penetration depth adjustment. 
     
     
         33 . The instrument according to  claim 8 , further comprising, a device for automatically triggering of the puncturing movement. 
     
     
         34 . The instrument according to  claim 33 , further comprising,
 a delay timing device for controlling a delay time between the point of time at which a defined minimum pressure force is applied and the triggering of the puncturing movement.   
     
     
         35 . The instrument according to  claim 8 , wherein the pressure ring has a mean width of at least about 0.5 mm and at most about 3.5 mm. 
     
     
         36 . The instrument according to  claim 8 , wherein the pressure ring has a mean width of at least about 0.7 mm and at most about 2.5 mm. 
     
     
         37 . The instrument according to  claim 8 , wherein the pressure ring has a mean width of at least about 0.8 mm and at most about 1 mm. 
     
     
         38 . A lancing system for producing a body fluid sample analysis by piercing the skin, the system comprising:
 a reusable hand-held-instrument comprising,
 a housing, 
 a lancing drive within the housing connected to a lancing element and for driving a lancing element connected thereto in a puncturing movement in which the lancing element moves, after triggering the puncturing movement, in a puncture direction until it reaches a point of maximum displacement and in a reverse direction after it has reached the point of maximum displacement, 
 a pressure ring surrounding a skin contact opening and adapted for being pressed against the skin such that the skin bulges into the skin contact opening for promoting expression of body fluid, and 
 a holding device for holding an analysis element in the housing such that a body fluid sample is transported thereto from the sample collection device for analysis; and 
   a lancing element interchangeably connected to the drive of the instrument.   
     
     
         39 . The lancing system according to  claim 36 , wherein the lancing element is a part of an integral lancing and analysis element. 
     
     
         40 . The lancing system according to  claim 36 , wherein the lancing element is a direct sampler having a capillary channel for transporting the body fluid produced by piercing the skin by capillary flow to a sample collection zone thereof. 
     
     
         41 . The lancing system according to  claim 36 , further comprising,
 a fluid communication device such that body fluid sample can be transferred from a sample collection zone of the lancing element to the analysis element for analysis.   
     
     
         42 . The lancing system according to  claim 39 , wherein the fluid communication device is switchable between a first configuration where no fluid communication is provided and a second position wherein fluid communication is provided.