Packaged medical device with a deployable dermal tissue...

Surgery – Diagnostic testing – Liquid collection

Reexamination Certificate

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Details

C600S583000, C600S573000, C606S181000

Reexamination Certificate

active

10640296

ABSTRACT:
A packaged medical device includes upper and lower flexible sheets, a lance body and a test strip. The lance body includes upper and lower surfaces, an opening that extends between the upper and lower surfaces and a dermal tissue penetration member that projects into the lance body opening. The test strip has an opening therethrough and is attached to the lance body lower surface such that the dermal tissue penetration member is operatively aligned with the test strip opening. The upper flexible sheet is attached to the lance body upper surface and covers the lance body opening, while the lower flexible sheet is detachably attached to the test strip and covers the test strip opening. The upper flexible sheet, lance body and test strip are configured such that, when the lower flexible sheet has been detached to uncover the test strip opening, the upper flexible sheet, lance body and test strip can be bent to deploy the dermal tissue penetration member from the lance body opening. A kit includes the packaged medical device described above and a deployment device for detaching the lower flexible sheet and bending the upper flexible sheet, lance body and test strip to deploy the dermal tissue penetration member. A method for deploying a dermal tissue penetration member of a packed medical device includes providing the packaged medical device described above, detaching the lower flexible sheet to uncover the test strip opening and bending the upper flexible sheet, lance body and test strip to deploy the dermal tissue penetration member.

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Allen, John J. et al., “Integrated Lance and Strip for Analyte Measurement”, U.S. Appl. No. 10/460,030, filed Jun. 11, 2003.
Allen, John J. et al., “Method of Analyte Measurement Using Integrated Lance and Strip”, U.S. Appl. No. 10/460,106, filed Jun. 11, 2003.

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