Packaged medical device with a deployable dermal tissue penetration member

• US 7,223,248 B2
• Filed: 08/13/2003
• Issued: 05/29/2007
• Est. Priority Date: 08/13/2003
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Allen, John, Erickson, Brian
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): Nguyen; H. Q.
• Application Number:
  US10/640,296
• Publication Number:
  US 20050036909A1
• Time in Patent Office: 1,385 Days
• Field of Search: 600/573, 600/576, 600/583, 600/584, 606/181, 606/182
• US Class Current: 600/584
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150709 semi-automatically removed, i.e. before puncturing the protection is removed by a mechanism initiated by a deliberate action by the user, such as pressing a button
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 50/3001 for sharps

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.

Claims

1. A packaged medical device comprising:

an upper flexible sheet;

a lance body that includes;

a lance body upper surface;

a lance body lower surface;

a lance body opening extending from the lance body upper surface to the lance body lower surface; and

a dermal tissue penetration member projecting into the lance body opening;

a test strip with a test strip opening therethrough; and

a lower flexible sheet,

wherein;

the upper flexible sheet is attached to the lance body upper surface covering the lance body opening;

the test strip is attached to the lance body lower surface such that the dermal tissue penetration member is operatively aligned with the test strip opening;

the lower flexible sheet is detachably attached to the test strip covering the test strip opening; and

the upper flexible sheet, lance body and test strip are configured such that, when the lower flexible sheet has been at least partially detached from the test strip, thereby uncovering the test strip opening, the upper flexible sheet, lance body and test strip can be bent such that a bent portion of the upper flexible sheet, lance body, and test strip moves away from the packaged medical device as the packaged medical device remains essentially stationary, thereby deploying the dermal tissue penetration member from the lance body opening.

2. The packaged medical device of claim 1, wherein the test strip is an electrochemical test strip.

3. The packaged medical device of claim 1, wherein the test strip is a colorimetric test strip.

4. The packaged medical device of claim 1, wherein the test strip is a glucose measurement test strip.

5. The packaged medical device of claim 1, wherein the upper flexible sheet, lance body and test strip can be bent through an arc in the range of approximately 90 degrees to approximately 100 degrees to deploy the dermal tissue penetration member.

6. The packaged medical device of claim 1, wherein the packaged medical device is formed using lamination techniques.

7. The packaged medical device of claim 1, wherein the test strip includes at least one electrode contact and the upper flexible sheet is attached to the lance body upper surface and the test strip is attached to the lance body lower surface such that the at least one electrode contact extends beyond the lance body and the upper flexible sheet.

8. A kit comprising:

a packaged medical device that includes;

an upper flexible sheet;

a lance body that includes;

a lance body upper surface;

a lance body lower surface;

a lance body opening extending from the lance body upper surface to the lance body lower surface; and

a dermal tissue penetration member projecting into the lance body opening;

a test strip with a test strip opening therethrough; and

a lower flexible sheet,

wherein;

the upper flexible sheet is attached to the lance body upper surface covering the lance body opening;

the test strip is attached to the lance body lower surface such that the dermal tissue penetration member is operatively aligned with the test strip opening;

the lower flexible sheet is detachable attached to the test strip covering the test strip opening; and

the upper flexible sheet, lance body, and test strip are configured such that, when the lower flexible sheet has been at least partially detached from the test strip, thereby uncovering 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; and

a deploying device configured for at least partially detaching the lower flexible sheet from the test strip and bending of the upper flexible sheet, lance body and test strip such that a bent portion of the upper flexible sheet, lance body and test strip moves away from the packaged medical device as the packaged medical device remains essentially stationary, thereby deploying the dermal tissue penetration member from the lance body opening.

9. The kit of claim 8, wherein the deploying device includes:

a stripping block for at least partially detaching the lower flexible sheet from the test strip; and

a folding block for bending the upper flexible sheet, lance body and test strip to deploy the dermal tissue penetration member.

10. The kit of claim 8, wherein the test strip is an electrochemical test strip.

11. The kit of claim 8, wherein the test strip is a colorimetric test strip.

12. The kit if claim 8, wherein the test strip is a glucose measurement test strip.

13. The kit of claim 8, wherein the packaged medical device is a laminated packaged medical device.