Device for sampling blood

• US 7,775,991 B2
• Filed: 08/31/2005
• Issued: 08/17/2010
• Est. Priority Date: 08/31/2005
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Leuschner, Udo, Strehl, Michael, Cohen, David S., Feaster, Shawn R., Kaylor, Rosann M.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US11/217,091
• Publication Number:
  US 20070049959A1
• Time in Patent Office: 1,812 Days
• Field of Search: 600/181, 600/583, 600/584, 606/181, 606/182, 606/184
• US Class Current: 600/584
• 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 5/150358 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150541 Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A blood sampling device includes a lancet having a skin piercing member disposed at an end thereof. The lancet is slidable within and releasably engaged with an elongated lancet guide that remains stationary with use of the device. A shell is axially movable relative to the lancet guide between a rest position and an actuate position, with the lancet being spring loaded within the lancet guide by movement of the shell from the rest position to the actuate position.

Claims

1. A blood sampling device, comprising:

a lancet having a first end and a second end opposite the first end, and a skin piercing member disposed at said first end;

an elongated lancet guide, said lancet disposed with said first and second ends within said lancet guide and axially movable relative to said lancet guide;

a shell, said lancet guide disposed at least partially within said shell with a first longitudinal end of said lancet guide extending from said shell and placed against a user'"'"'s skin in operation of said sampling device, said shell axially movable relative to said lancet guide from a rest position to an actuate position;

a bias element disposed between said second end of said lancet and a stop on said shell;

a releasable catch configured on said lancet guide, said catch extending radially into said lancet guide and engaged with said lancet between said first and second ends of said lancet in a rest position of said lancet such that said lancet does not move relative to said lancet guide in said rest position, and a release member configured on said shell so as to directly contact and release said catch in said actuate position of shell;

wherein in use of said blood sampling device, forced movement of said shell relative to said lancet guide loads said bias element against said lancet until said release member directly contacts and releases said catch at said actuate position of said shell such that said lancet is propelled by said bias element through said lancet guide;

wherein said lancet guide is an open-ended longitudinally extending member, said bias element extending through a second longitudinal end of said lancet guide and disposed against said lancet;

wherein said lancet guide comprises a recessed skin engagement area defined between said first longitudinal end of said lancet guide and a plate member that is spaced axially from said first longitudinal end of said lancet guide, said plate member comprising an opening through which said skin piercing member extends into said skin engagement area in the actuate position of said lancet guide; and

wherein said shell defines an outer housing, said blood sampling device further comprising a blood testing device configured with said housing.

2. The blood sampling device as in claim 1, wherein said shell comprises guide tracks along said lancet guide.

3. The blood sampling device as in claim 1, wherein said catch comprises a cantilevered clip engaged within a recess in said lancet.

4. The blood sampling device as in claim 3, wherein said clip comprises an angled engagement surface, and said release member comprises a wedge surface that engages said angled engagement surface on said clip to move said clip out of said recess in said lancet.

5. The blood sampling device as in claim 1, further comprising a safety cap attached to said first longitudinal end of said lancet guide.

6. The blood sampling device as in claim 1, wherein said bias element comprises a spring having an end attached to said lancet.

7. The blood sampling device as in claim 6, wherein said spring comprises a length and spring constant such that said piercing member is withdrawn back into said lancet guide after actuation with said shell at said actuate position.

8. The blood sampling device as in claim 1, wherein the blood testing device is contained within an elongated portion of said outer housing.

9. The blood sampling device as in claim 1, wherein said blood testing device comprises a lateral flow assay strip.

10. The blood sampling device as in claim 1, wherein said blood testing device is separate from and attachable to said outer housing.

11. The blood sampling device as in claim 1, wherein said bias element comprises a single spring configured to overextend in the actuate position and retract to an equilibrium position within the lancet guide a sufficient distance so that the skin piercing member is withdrawn from said opening in said plate member.