Blood sampling device with diaphragm actuated lancet

• US 7,001,344 B2
• Filed: 06/12/2002
• Issued: 02/21/2006
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Freeman, Dominique M., Drbal, Vladimir
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/173,236
• Publication Number:
  US 20030088191A1
• Time in Patent Office: 1,350 Days
• Field of Search: 600/573, 600/309, 600574-584, 606180-182, 606/171, 206/569, 604/115, 604/22
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150221 Valves
• 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 5/150503 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150832 by topography of the surface, e.g. Braille, embossed printing
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

A device and method to obtain a blood sample in a sealed configuration. The device includes a sampling assembly having a driver, a lancet, and a blood reservoir, and a pad having a proximal side and a distal side. The proximal side of the pad conforms to the shape of a skin area, and the distal side is attached to the sampling assembly. The pad and the sampling assembly are configured to provide a sealed configuration around the skin area for transferring blood from the skin area to the blood reservoir.

Claims

1. A blood sampling device, comprising:

a sampling assembly including a driver, a lancet, and a blood reservoir, said lancet having a proximal end and a distal end; and

a pad having a proximal side and a distal side, said proximal side conforming to the shape of a skin area, and said distal side attached to the sampling assembly, said pad and said sampling assembly configured to provide a sealed configuration around the skin area for transferring blood from the skin area to said reservoir;

wherein the driver is electromagnetically actuated to move the lancet from a first position to a second position to pierce the skin area;

wherein the driver includes a diaphragm coupled to the lancet, said diaphragm to drive said lancet.

2. The blood sampling device of claim 1, wherein said pad includes relatively soft durometer type material.

3. The blood sampling device of claim 2, wherein said material includes silicone rubber.

4. The blood sampling device of claim 1, wherein said diaphragm is formed with an elastomer of harder durometer type material than said pad.

5. The blood sampling device of claim 1, wherein said diaphragm is formed with an elastomer of less permeability than said pad.

6. The blood sampling device of claim 1, wherein said diaphragm compresses and flexes toward the skin area when said diaphragm is actuated and said lancet is protracted out.

7. The blood sampling device of claim 1, wherein said diaphragm creates suction upon retraction of said lancet.

8. The blood sampling device of claim 1, wherein said blood reservoir is enclosed by said diaphragm and said sampling assembly.

9. The blood sampling device of claim 8, further comprising:

an opening on a surface of said sampling assembly, said opening configured to provide a conduit for the blood sample into the reservoir.

10. The blood sampling device of claim 9, wherein said surface of said sampling assembly is coupled to the distal side of said pad.

11. The blood sampling device of claim 9, wherein said proximal end of the lancet is approximately perpendicular to said surface of the sampling assembly, and is concentric with said opening.

12. The blood sampling device of claim 9, further comprising:

a first valve coupled to said opening, said first valve to regulate inflow of the blood sample into said reservoir.

13. The blood sampling device of claim 12, wherein said lancet passes through said first valve to hold said first valve open prior to piercing the skin area.

14. The blood sampling device of claim 12, wherein said first valve includes a duckbill check valve.

15. The blood sampling device of claim 8, further comprising:

a second valve to enable outflow of the blood sample from said reservoir.

16. The blood sampling device of claim 9, further comprising:

a sensor disposed on the surface of said sampling assembly, said sensor configured to detect when said proximal side of said pad conforms to the shape of said skin area.

17. A device, comprising:

a blood sampling assembly having a surface with an opening, said sampling assembly including;

a lancet having a proximal end and a distal end, said proximal end configured with respect to said surface of said sampling assembly to pierce a finger tip;

a driver coupled to the distal end of said lancet to drive the lancet from a first position to a second position to pierce skin, wherein the driver is electromagnetically actuated;

a blood reservoir enclosed by said driver and said sampling assembly;

a first valve fitted to said opening, said first valve kept open by said lancet prior to piercing said finger tip, said first valve to control transfer of blood from said finger tip into said blood reservoir; and

a finger pad disposed between said finger tip and said sampling assembly, said finger pad configured to enable transfer of blood from said finger tip to said blood reservoir in a sealed configuration, wherein a proximal side of the finger pad conforms to the shape of a skin area, and a distal side attached to the sampling assembly;

wherein retracting the lancet from the second position back into the blood sampling assembly creates negative pressure that draws blood into the blood reservoir;

wherein said driver includes a diaphragm volumetrically dimensioned to contain at a fully retracted position a blood sample volume appropriate for blood analysis.

18. The device of claim 17, wherein said first valve is closed by withdrawal of said lancet from the first valve upon completion of lancing operation to allow only a singe use of said sampling assembly.

19. The device of claim 17, further comprising:

a blood outflow conduit to enable outflow of the blood from said reservoir for analysis.

20. The device of claim 19, further comprising:

a second valve coupled between said reservoir and said blood outflow conduit to regulate the outflow of the blood.

21. A method, comprising:

positioning a skin area to be lanced on a pad;

applying a force on said skin area to allow the pad to conform to the shape of said skin area, and to configure said skin area in a scaled configuration;

lancing said skin area through said pad using a lancet driven by a driver that is electromagnetically actuated; and

drawing a blood sample from said lanced skin area through said pad to collect the blood sample without substantially exposing the blood sample to ambient air;

wherein said lancing includes actuating and compressing a diaphragm to drive the lancet into said skin area.

22. The method of claim 21, further comprising:

providing a reservoir to store the collected blood sample.

23. The method of claim 22, wherein said suctioning includes allowing a lancet to keep a first valve open to provide an inflow conduit for the blood sample flowing into said reservoir.

24. The method of claim 23, wherein said suctioning includes retracting the lancet beyond said first valve such that said first valve is closed once appropriate volume of the blood sample has been collected in said reservoir.

25. The method of claim 24, wherein said suctioning includes depressing a diaphragm to create a negative pressure.

26. The method of claim 21, further comprising:

dispensing said collected blood sample through a second valve for blood analysis.

27. A computer readable medium containing executable instructions which when executed in a processing system, performs lancing operation and obtains a blood sample from a finger tip in a sealed configuration, said executable instructions comprising:

sensing to confirm that a sealed configuration around a skin area has been formed to transfer blood from the skin area into a blood reservoir without exposing the blood to ambient air;

lancing said skin area within the sealed configuration using a lancet driven by a driver that is electromagnetically actuated; and

transferring the blood sample from said lanced skin area in the sealed configuration;

wherein said lancing includes actuating a diaphragm to drive a lancet.

28. The medium of claim 27, wherein said sensing includes detecting to confirm that a pad coupled to said skin area conforms to the shape of said skin area.

29. The medium of claim 27, wherein said sensing includes detecting to confirm that a pad forms a seal around an opening in said blood reservoir.

30. A method, comprising:

positioning a skin area to be lanced on a pad;

applying a force on said skin area to allow the pad to conform to the shape of said skin area, and to configure said skin area in a sealed configuration;

lancing said skin area through said pad using a lancet driven by a driver that is electromagnetically actuated; and

drawing a blood sample from said lanced skin area through said pad to collect the blood sample without substantially exposing the blood sample to ambient air;

providing a reservoir to store the collected blood sample;

wherein said suctioning includes allowing a lancet to keep a first valve open to provide an inflow conduit for the blood sample flowing into said reservoir;

wherein said suctioning includes retracting the lancet beyond said first valve such that said first valve is closed once appropriate volume of the blood sample has been collected in said reservoir;

wherein said suctioning includes depressing a diaphragm to create a negative pressure.