Lancing device and method of sample collection

Abstract

A lancing device and method for self-collecting a sample of body fluid by penetrating a body tissue at a sampling site. The invention includes a housing geometry configured for ease of use at different sampling sites on the body, even by persons having reduced dexterity and/or poor vision. Depth of penetration is selectively controlled by adjusting the stroke range of a spring-driven lancet carrier. A pressure applicator is included for stimulating flow of the body fluid. A transparent portion permits observation of the sampling site.

1 . A lancing device for use with a lancet to penetrate tissue and facilitate collection of a sample of a body fluid, said lancing device comprising:
 (a) a housing;   (b) a lancet carrier translationally mounted to said housing for carrying a lancet along a stroke traversing an extended position wherein a tissue penetrating portion of the lancet extends a distance outwardly of said housing, said lancet carrier comprising a limit member; and   (c) a thumbwheel rotationally mounted to said housing, and comprising an eccentric contact surface forming a selectively movable stop for contacting said limit member to limit the stroke of the lancet carrier in the direction of the extended position.   
   
   
       2 . The lancing device of  claim 1 , further comprising indicia on said thumbwheel for indicating the distance the tissue penetrating portion of the lancet extends outwardly of said housing in said extended position. 
   
   
       3 . The lancing device of  claim 1 , further comprising indexing means for incrementing rotation of said thumbwheel relative to said housing through a plurality of discrete positions. 
   
   
       4 . The lancing device of  claim 3 , wherein said indexing means comprises an arcuate series of detents formed in said housing and at least one cooperating projection formed on said thumbwheel. 
   
   
       5 . The lancing device of  claim 1 , further comprising a pressure applicator, said pressure applicator comprising a forward panel of said housing defining an opening therethrough, and a raised lip surrounding at least a portion of said opening. 
   
   
       6 . The lancing device of  claim 1 , wherein said housing comprises a releasable endcap, and wherein at least a portion of said endcap is transparent. 
   
   
       7 . The lancing device of  claim 1 , wherein said lancet carrier comprises a first gripping jaw, a second gripping jaw positioned in opposition to said first gripping jaw, biasing means for biasing said first and second gripping jaws from an open position for receiving and releasing a lancet towards a closed position for gripping a lancet, a first release arm extending from said first gripping jaw, and a second release arm extending from said second gripping jaw. 
   
   
       8 . The lancing device of  claim 1 , wherein said housing is generally symmetric about perpendicular first and second planes of symmetry, has an aspect ratio of no more than 4:1, and has a transverse ratio of at least 3:2. 
   
   
       9 . A lancing device for use with a lancet to penetrate tissue and facilitate collection of a sample of a body fluid, said lancing device comprising:
 (a) a housing;   (b) a lancet carrier mounted to said housing for releasably engaging a lancet, said lancet carrier comprising:
 (i) a first gripping jaw; 
 (ii) a second gripping jaw positioned in opposition to said first gripping jaw to define a lancet-receiving channel between said first and second gripping jaws, said first and second gripping jaws being movable between a closed position for gripping a lancet and an open position for receiving and releasing a lancet; 
 (iii) biasing means for biasing said first and second gripping jaws toward said closed position; and 
 (iv) a first release arm connected to said first gripping jaw and a second release arm connected to said second gripping jaw, whereby application of force to said first and second release arms moves said first and second gripping jaws toward said open position. 
   
   
   
       10 . The lancing device of  claim 9 , wherein said first and second gripping jaws comprise opposed portions of an integrally-formed split cylinder joined about a common hinge point. 
   
   
       11 . A lancing device for use with a lancet to penetrate tissue and facilitate collection of a sample of a body fluid, said lancing device comprising:
 (a) a housing having a forward end and a transparent portion adjacent said forward end;   (b) a lancet carrier mounted to said housing for carrying a lancet between a retracted position within said housing and an extended position wherein a tissue penetrating portion of the lancet extends a distance beyond the forward end of said housing; and   (c) a pressure applicator adjacent said forward end of said housing.   
   
   
       12 . The lancing device of  claim 11 , wherein said transparent portion comprises a releasable endcap. 
   
   
       13 . The lancing device of  claim 11 , wherein said pressure applicator comprises a forward panel of said housing defining an opening therethrough, and a raised lip surrounding at least a portion of said opening, wherein said opening is viewable through said transparent portion. 
   
   
       14 . A lancing device for use with a lancet to penetrate tissue and facilitate collection of a sample of a body fluid, said lancing device comprising a housing having an overall length, an overall width, and an overall thickness, said overall length being no more than about four times said overall width, and said overall width being at least about one and one-half times said overall thickness, wherein said housing is generally symmetric about perpendicular first and second planes of symmetry, and wherein a trigger button is arranged approximately midway along a front face of said housing. 
   
   
       15 . The lancing device of  claim 14 , further comprising engaging means for releasably engaging a lancet and driving means for driving the lancet toward an extended position wherein a tissue penetrating portion of the lancet extends a distance beyond a forward end of said housing. 
   
   
       16 . The lancing device of  claim 15 , further comprising a cocking mechanism for shifting the engaging means from a retracted position to a cocked position. 
   
   
       17 . The lancing device of  claim 16 , further comprising a triggering mechanism for releasing the engaging means from the cocked position to drive the lancet toward the extended position. 
   
   
       18 . The lancing device of  claim 15 , further comprising stroke control means for controlling the distance the tissue penetrating portion of the lancet extends beyond said forward end of said housing in its extended position. 
   
   
       19 . The lancing device of  claim 18 , wherein said stroke control means comprises a selectively movable stop and a limit member, whereby contact between said stop and said limit member defines the extended position. 
   
   
       20 . The lancing device of  claim 14 , comprising a forward panel defining an opening therethrough, and further comprising a raised lip projecting from said forward panel and surrounding at least a portion of said opening. 
   
   
       21 - 30 . (canceled)