Split tip expression device

• US 20050197666A1
• Filed: 03/05/2004
• Published: 09/08/2005
• Est. Priority Date: 03/05/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Raney, Charles C.
• Granted Patent: US 7,377,903 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15121 comprising piezos
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

An expression device for a lancing device of the type that directs a skin-lancing medium against a skin site to make an incision for testing bodily fluids. The expression device has a pair of skin-engaging tabs curved and oriented to make the skin taut adjacent a lancet used with the device. This increases the incision width and enhances the quantity of blood removed for subsequent testing.

Claims

1. Apparatus for sampling bodily fluid, said apparatus comprising

a housing,

a skin-lancing device mounted in said housing for directing a skin-lancing medium against a skin surface to form an incision therein, and then remove the skin-lancing medium from the incision,

a device mounted in said housing and having a plurality of skin-engaging elements oriented to urge the skin taut adjacent the incision site on said skin to at least open the incision

2. Apparatus as claimed in claim 1 wherein the plurality of skin-engaging elements on the device act to express bodily fluid after incision.

3. Apparatus as claimed in claim 1 wherein the plurality of skin-engaging elements holds the skin taut before incision.

4. Apparatus as claimed in claim 1 wherein said device has a pair of skin-engaging elements.

5. Apparatus as claimed in claim 4 wherein said elements comprise flexible tabs each extending from a base.

6. Apparatus as claimed in claim 5 wherein the tabs adjacent to the skin-engaging elements have a geometry extending outwardly from said incision.

7. Apparatus as claimed in claim 6 wherein said tabs have friction enhancing surfaces on their tips for engaging the skin.

8. Apparatus as claimed in claim 7 wherein said base is removable from said housing.

9. Apparatus as claimed in claim 8 further comprising clips mounted on said housing and having slots into which said base extends, said base having a slot surrounding the site for said lancing medium to permit sideways removal from said base.

10. Apparatus as claimed in claim 5 wherein said pair of skin-engaging elements are opposed from one another and have line contact with the skin, said lancing medium being a blade-like lancet extending parallel to said opposed line contacts.

11. Apparatus as claimed in claim 10 wherein said lancing medium further comprises a capillary passage adjacent said blade-like lancet to carry bodily fluid from said incision.

12. Apparatus as claimed in claim 4 wherein said tips extend beyond the lancing medium in its condition prior to lancing said skin.

13. Apparatus as claimed in claim 1 further comprising a removable cap over said skin-lancing mechanism and said expression device.

14. A method of sampling bodily fluid from an incision in a skin site, said method comprising:

making an incision, and

stretching the skin taut at said site to at least open the incision.

15. a method as claimed in claim 14 further comprising the further step of stretching the skin taut prior to making an incision

16. a method as claimed in claim 15 comprising the further step of expressing bodily fluid from the incision.

17. apparatus for sampling bodily fluid, said apparatus comprising:

a housing,

a skin-lancing device mounted in said housing for directing a skin-lancing medium against a skin surface to form an incision therein, and then remove the skin-lancing medium from the incision, and

means mounted in said housing and having a plurality of skin-engaging elements for urging the skin taut adjacent the incision to at least open the incision.

18. apparatus as claimed in claim 17 wherein said means for urging the skin taut additionally urges the skin taut prior to making an incision.