US2020155052A1PendingUtilityA1

Multi-site body fluid sampling and analysis cartridge

70
Assignee: INTUITY MEDICAL INCPriority: Sep 30, 2005Filed: Sep 11, 2019Published: May 21, 2020
Est. expirySep 30, 2025(expired)· nominal 20-yr term from priority
A61B 2560/0462A61B 5/157A61B 5/6824A61B 5/150946A61B 5/6828A61B 5/150083A61B 5/155A61B 5/15161A61B 5/15151A61B 5/15186G01N 21/0303A61B 5/150022A61B 5/681A61B 5/150229A61B 5/15121A61B 5/1427A61B 5/150969A61B 5/15163A61B 5/150076A61B 5/150954A61B 5/150396A61B 5/150984A61B 2560/0443A61B 5/150389A61B 5/15148A61B 5/150167A61B 5/1468A61B 5/150412A61B 5/1486A61B 5/15111A61B 5/14546A61B 5/150068A61B 5/15123A61B 5/15113A61B 5/150343A61B 5/1411A61B 5/150099A61B 5/15117A61B 5/14532G01N 27/416A61B 5/15146A61B 5/151G01N 21/77G01N 1/14
70
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Claims

Abstract

An arrangement includes a housing, a plurality of sampling and analysis sites contained within the housing, each of the sampling and analysis sites having a skin-penetration member having a first end configured to pierce the skin, and an inner lumen in communication with the first end, an actuator operatively associated with the skin-penetration member, and an analyte quantification member in fluid communication with the inner lumen of the skin-penetration member. Integrated devices including such arrangements are also described.

Claims

exact text as granted — not AI-modified
1 - 40 : (canceled) 
     
     
         41 : An arrangement comprising:
 a cartridge, wherein the cartridge comprises:
 a frame comprising a plurality of openings; and 
 a plurality of sampling and analysis sites contained within the cartridge, each sampling and analysis site aligned with an opening of the plurality of openings in the frame and comprising a skin-penetration member, an actuator, and an analyte quantification member; and 
   a triggering mechanism advanceable through each opening to actuate the corresponding sampling and analysis site to drive the skin-penetration member into skin.   
     
     
         42 : The arrangement of  claim 41 , wherein each of the sampling and analysis sites further comprises a hub coupled to the skin-penetration member. 
     
     
         43 : The arrangement of  claim 42 , wherein the actuator is coupled to the hub. 
     
     
         44 : The arrangement of  claim 43 , wherein the triggering mechanism is advanceable through the corresponding opening to contact the hub to actuate the corresponding sampling and analysis site. 
     
     
         45 : The arrangement of  claim 42 , wherein the hub comprises a locking feature. 
     
     
         46 : The arrangement of  claim 45 , wherein the locking feature comprises one of a projection and a groove. 
     
     
         47 : The arrangement of claim  1 , wherein the triggering mechanism is advanceable through the opening to contact the corresponding actuator. 
     
     
         48 : The arrangement of  claim 41 , wherein the actuator comprises a spring. 
     
     
         49 : The arrangement of  claim 48 , wherein the spring is a torsional spring configured to move the skin-penetration member in an arcuate path. 
     
     
         50 : The arrangement of  claim 41 , wherein each of the plurality of openings is sealed. 
     
     
         51 : The arrangement of  claim 41 , wherein the cartridge further comprises a seal and wherein the seal comprises a solid flexible membrane, an apertured membrane in combination with a secondary seal, or a pierceable membrane. 
     
     
         52 : The arrangement of  claim 51 , wherein the seal is configured to maintain sealing after passage of the triggering mechanism therethrough. 
     
     
         53 : The arrangement of  claim 41 , wherein the cartridge is disposable. 
     
     
         54 : The arrangement of  claim 41 , wherein the skin-penetration member comprises a lumen therethrough. 
     
     
         55 : The arrangement of  claim 41 , wherein each of the sampling and analysis sites are in a pre-cocked position prior to actuation. 
     
     
         56 : An integrated body fluid sampling and analysis device comprising the arrangement of  claim 41 . 
     
     
         57 : A method of operating a body fluid sampling device comprising:
 providing a body fluid sampling device comprising a cartridge and a triggering mechanism, wherein the cartridge comprises:
 a frame comprising a plurality of openings; and 
 a plurality of sampling and analysis sites contained within the cartridge, each sampling and analysis site aligned with an opening of the plurality of openings in the frame and comprising a skin-penetration member, an actuator, and an analyte quantification member; and 
   advancing a portion of the triggering mechanism through one of the plurality of openings, wherein advancing a portion of the triggering mechanism through the opening actuates the corresponding sampling and analysis site.   
     
     
         58 : The method of  claim 57 , wherein actuating the corresponding sampling and analysis site comprises releasing the corresponding sampling and analysis site and allowing the corresponding actuator to move the corresponding skin-penetration member toward skin of a user. 
     
     
         59 : The method of  claim 58 , wherein the actuator moves the corresponding skin-penetration member in an arcuate path toward the skin of the user. 
     
     
         60 : The method of  claim 57 , wherein releasing the corresponding sampling and analysis site comprises applying a force to the hub with the triggering mechanism. 
     
     
         61 : The method of  claim 60 , wherein applying a force to the hub disengages a locking feature on the hub. 
     
     
         62 : The method of  claim 57 , wherein advancing a portion of the triggering mechanism through one of the plurality of openings further comprises advancing the portion of the triggering mechanism through each of the plurality of openings. 
     
     
         63 : The method of  claim 57 , wherein each of the plurality of sampling and analysis sites is in a pre-cocked position prior to actuation.

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