MULTI-SITE BODY FLUID SAMPLING AND ANALYSIS CARTRIDGE
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.
1 - 40 . (canceled)
41 . An arrangement comprising:
a cartridge, wherein the cartridge comprises:
a frame comprising a plurality of chambers and a corresponding plurality of openings; and
a plurality of sampling and analysis sites, each sampling and analysis site contained within a respective chamber of the plurality of chambers and aligned with a respective opening of the plurality of openings, each sampling and analysis site comprising a skin-penetration member, an actuator, and an analyte quantification member; and
a triggering mechanism advanceable through each opening to actuate a respective sampling and analysis site to drive the respective 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 opening to contact the hub to actuate the respective 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 41 , wherein the actuator comprises a spring.
48 . The arrangement of claim 47 , wherein the spring is a torsional spring configured to move the skin-penetration member in an arcuate path.
49 . The arrangement of claim 41 , wherein each of the plurality of openings is sealed.
50 . 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.
51 . The arrangement of claim 50 wherein the seal is configured to maintain sealing after passage of the triggering mechanism therethrough.
52 . The arrangement of claim 41 , wherein the cartridge is disposable.
53 . The arrangement of claim 41 , wherein the skin-penetration member comprises a lumen therethrough.
54 . The arrangement of claim 41 , wherein each of the sampling and analysis sites is in a pre-cocked position prior to actuation.
55 . The arrangement of claim 41 , wherein each of the analyte quantification members is an assay pad.
56 . The arrangement of claim 44 , wherein, when the respective sampling and analysis site is actuated, the skin-penetration member and the analyte quantification member move together.
57 . An integrated body fluid sampling and analysis device comprising the arrangement of claim 41 .
58 . 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 chambers and a corresponding plurality of openings; and
a plurality of sampling and analysis sites, each sampling and analysis site contained within a respective chamber of the plurality of chambers and aligned with a respective opening of the plurality of openings, each sampling and analysis site comprising a skin-penetration member, an actuator, and an analyte quantification member; and
advancing a portion of the triggering mechanism through one of the openings of the plurality of openings, wherein advancing a portion of the triggering mechanism through the opening actuates a respective sampling and analysis site.
59 . The method of claim 58 , wherein actuating the sampling and analysis site comprises releasing the respective sampling and analysis site and allowing the actuator to move the skin-penetration member toward skin of a user.
60 . The method of claim 59 , wherein the actuator moves the skin-penetration member in an arcuate path toward the skin of the user.
61 . The method of claim 59 , wherein each sampling and analysis site further comprises a hub coupled to the skin-penetration member, and wherein releasing the respective sampling and analysis site comprises applying a force to the hub with the triggering mechanism.
62 . The method of claim 61 , wherein applying a force to the hub disengages a locking feature on the hub.
63 . The method of claim 58 , 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.
64 . The method of claim 58 , wherein each of the plurality of sampling and analysis sites is in a pre-cocked position prior to actuation.
65 . The method of claim 59 , wherein, when the actuator moves the skin-penetration member, the analyte quantification member of the respective sampling and analysis site moves with the skin-penetration member.
66 . The method of claim 58 , wherein each analyte quantification member is an assay pad.