Body fluid sampling device - sampling site interface

Abstract

An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes: a housing, the housing comprising a first opening; a skin interface member disposed in the first opening, the skin interface member comprising an inner member having a second opening, and an outer member at least partially surrounding the inner member and attached to the first opening; and at least one skin-penetration member configured and arranged to project within the second opening. Arrangements having alternatively constructed skin interface members are also described.

1 - 48 . (canceled) 
     
     
         49 . An arrangement to assist in obtaining a body fluid sample from a sampling site of a user, the arrangement comprising:
 a housing; and   a plate releasably mountable to the housing, the plate comprising a skin interface member attached thereto, the skin interface member comprising an inner member having an opening configured to receive the sampling site of a user, and an outer member at least partially surrounding the inner member, wherein the outer member is coplanar with the plate and is configured to flex more than the inner member upon application of force to the skin interface member.   
     
     
         50 . The arrangement of  claim 49 , wherein the inner member has a first hardness and the outer member has a second hardness that is less than the first hardness. 
     
     
         51 . The arrangement of  claim 49 , wherein the inner member and the outer member are integral. 
     
     
         52 . The arrangement of  claim 49 , wherein the outer member is formed from an elastomer, a silicone rubber, or a soft plastic and the inner member is formed from a metal, an elastomer, or a ceramic. 
     
     
         53 . The arrangement of  claim 49 , wherein the skin interface member comprises a punching or cutting mechanism. 
     
     
         54 . The arrangement of  claim 53 , wherein the punching or cutting mechanism comprises a downwardly projecting member. 
     
     
         55 . The arrangement of  claim 49  further comprising a cartridge configured to be received in the housing, wherein the cartridge comprises at least one skin-penetration member. 
     
     
         56 . The arrangement of  claim 55 , wherein the cartridge further comprises at least one analyte quantification member. 
     
     
         57 . The arrangement of  claim 56 , wherein the cartridge comprises a plurality of skin-penetration members, a plurality of actuators, and a plurality of analyte quantification members operatively arranged such that multiple tests can be performed using the arrangement without replacing the cartridge. 
     
     
         58 . The arrangement of  claim 55 , wherein the cartridge comprises an outer surface, and wherein the skin interface member is configured to form a seal with the outer surface of the cartridge upon being pressed against skin of the user. 
     
     
         59 . An arrangement to assist in obtaining a body fluid sample from a sampling site of a user, the arrangement comprising:
 a housing; and   a plate releasably mountable to the housing, the plate comprising a skin interface member coupled thereto, the skin interface member comprising an inner member having an opening, and an outer member at least partially surrounding the inner member, wherein a perimeter portion of the outer member is affixed to the plate, the outer member is substantially flat, and the outer member is configured to flex more than the inner member upon application of force to the skin interface member.   
     
     
         60 . The arrangement of  claim 59 , wherein the inner member has a first hardness and the outer member has a second hardness that is less than the first hardness. 
     
     
         61 . The arrangement of  claim 59 , wherein the inner member and the outer member are integral. 
     
     
         62 . The arrangement of  claim 59 , wherein the outer member is formed from an elastomer, a silicone rubber, or a soft plastic and the inner member is formed from a metal, an elastomer, or a ceramic. 
     
     
         63 . The arrangement of  claim 59 , wherein the skin interface member comprises a punching or cutting mechanism. 
     
     
         64 . The arrangement of  claim 63 , wherein the punching or cutting mechanism comprises a downwardly projecting member. 
     
     
         65 . The arrangement of  claim 59  further comprising a cartridge configured to be received in the housing, wherein the cartridge comprises at least one skin-penetration member. 
     
     
         66 . The arrangement of  claim 65 , wherein the cartridge further comprises at least one analyte quantification member. 
     
     
         67 . The arrangement of  claim 66 , wherein the cartridge comprises a plurality of skin-penetration members, a plurality of actuators, and a plurality of analyte quantification members operatively arranged such that multiple tests can be performed using the arrangement without replacing the cartridge. 
     
     
         68 . The arrangement of  claim 65 , wherein the cartridge comprises an outer surface, and wherein the skin interface member is configured to form a seal with the outer surface of the cartridge upon being pressed against skin of the user. 
     
     
         69 . An arrangement to assist in obtaining a body fluid sample from a sampling site of a user, the arrangement comprising:
 a housing;   a plate releasably mountable thereto, wherein the plate is fixed relative to the housing when mounted thereon; and   a skin interface member coupled to the plate, the skin interface member comprising an inner member having an opening configured to receive the sampling site, and an outer member at least partially surrounding the inner member, wherein the outer member is configured to flex more than the inner member upon application of force to the skin interface member.   
     
     
         70 . The arrangement of  claim 69 , wherein the inner member has a first hardness and the outer member has a second hardness that is less than the first hardness. 
     
     
         71 . The arrangement of  claim 69 , wherein the inner member and the outer member are integral. 
     
     
         72 . The arrangement of  claim 69 , wherein the outer member is formed from an elastomer, a silicone rubber, or a soft plastic and the inner member is formed from a metal, an elastomer, or a ceramic. 
     
     
         73 . The arrangement of  claim 69 , wherein the skin interface member comprises a punching or cutting mechanism. 
     
     
         74 . The arrangement of  claim 73 , wherein the punching or cutting mechanism comprises a downwardly projecting member. 
     
     
         75 . The arrangement of  claim 69  further comprising a cartridge configured to be received in the housing, wherein the cartridge comprises at least one skin-penetration member. 
     
     
         76 . The arrangement of  claim 75 , wherein the cartridge further comprises at least one analyte quantification member. 
     
     
         77 . The arrangement of  claim 76 , wherein the cartridge comprises a plurality of skin-penetration members, a plurality of actuators, and a plurality of analyte quantification members operatively arranged such that multiple tests can be performed using the arrangement without replacing the cartridge. 
     
     
         78 . The arrangement of  claim 75 , wherein the cartridge comprises an outer surface, and wherein the skin interface member is configured to form a seal with the outer surface of the cartridge upon being pressed against skin of the user.