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 - 30 . (Canceled)  
     
     
         31 . A lancing device for use with a lancet to penetrate tissue and facilitate collection of a sample of a body fluid, the lancing device comprising: 
 (a) a housing having front and back housing shells;    (b) a lancet carrier mounted with the housing for releasably carrying a lancet having a tissue penetrating portion from a retracted to position to an extended position;    (c) a transparent plastic end cap removably and releasably attachable to the housing, the end cap comprising; 
 (i) an opening for allowing passage of the tissue penetrating portion of the lancet through the cap, the opening having a diameter less than a diameter of the lancet yet greater than a diameter of the tissue penetrating portion; and  
 (ii) a pressure applicator surrounding the opening;  
   (d) a cocking actuator operably connected to the lancet carrier; and    (e) a trigger button operably connected to the lancet carrier and to the cocking actuator, the trigger button positioned on the lancing device between the cocking actuator and the transparent end cap.    
     
     
         32 . The lancing device according to  claim 31  further comprising stroke control means for controlling the distance the tissue penetrating portion of the lancet extends beyond the opening in the end cap when the lancet carrier is moved to the extended position, the stroke control means comprising indexing means to provide tactile feedback.  
     
     
         33 . The lancing device according to  claim 32 , wherein the stroke control means has at least five positions.  
     
     
         34 . The lancing device according to  claim 31 , wherein the pressure applicator comprises a raised lip around at least a portion of the opening.  
     
     
         35 . The lancing device according to  claim 34 , wherein the raised lip is an annular ring.  
     
     
         36 . The lancing device according to  claim 34 , wherein the raised lip is adjacent the opening.  
     
     
         37 . The lancing device according to  claim 34 , wherein the raised lip projects 1 mm to 3 mm.  
     
     
         38 . The lancing device according to  claim 31 , wherein the pressure applicator comprises a forward-facing annular land surrounding the opening.  
     
     
         39 . The lancing device according to  claim 38 , wherein the forward-facing annular land is about 2 mm across.  
     
     
         40 . The lancing device according to  claim 31 , wherein the opening has a diameter of 4 mm to 8 mm.  
     
     
         41 . A method of collecting a body fluid sample, the method comprising: 
 (a) positioning a lancing device on a desired sample site, the lancing device comprising: 
 (i) a housing having front and back housing shells;  
 (ii) a lancet carrier mounted with the housing for releasably carrying a lancet having a tissue penetrating portion from a retracted to position to an extended position;  
 (iii) a transparent plastic end cap removably and releasably attachable to the housing, the end cap comprising; 
 (A) an opening for allowing passage of the tissue penetrating portion of the lancet through the cap, the opening having a diameter less than a diameter of the lancet yet greater than a diameter of the tissue penetrating portion; and  
 (B) a pressure applicator surrounding the opening;  
 
 (iv) a cocking actuator operably connected to the lancet carrier; and  
 (v) a trigger button operably connected to the lancet carrier and to the cocking actuator, the trigger button positioned on the lancing device between the cocking actuator and the transparent end cap;  
   (b) actuating the cocking actuator;    (c) pressing the pressure applicator against the sample site;    (d) pressing the trigger button to release the lancet so that the tissue penetrating portion penetrates the sample site; and    (e) monitoring the sample site through the transparent end cap.    
     
     
         42 . (Canceled)  
     
     
         43 . The method according to  claim 41 , wherein the step of pressing the pressure applicator against the sample site comprises: 
 (a) applying compressive pressure to the sample site.    
     
     
         44 . The method according to  claim 43 , wherein the step of applying compressive pressure to the sample site comprises: 
 (a) applying steady compressive pressure to the sample site.    
     
     
         45 . The method according to  claim 43 , wherein the step of applying compressive pressure to the sample site comprises: 
 (a) applying varying compressive pressure to the sample site.