Extraction and transportation of blood for analysis

• US 6,132,449 A
• Filed: 03/08/1999
• Issued: 10/17/2000
• Est. Priority Date: 03/08/1999
• Status: Expired due to Fees

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Agilent Technologies, Inc.
• Inventors: Greenstein, Michael, Lum, Paul, Freeman, Dominique M., Verdonk, Edward D., Leonard, Leslie A., Keely-Templin, Catherine
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/264,597
• Time in Patent Office: 589 Days
• Field of Search: 606/181, 606/182, 606/183, 606/170, 128/765, 128/763
• US Class Current: 606/181
• 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 5/150099 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 5/150106 Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

A device for sampling blood from the skin of a patient by puncture. The device includes one or more lancets for lancing the skin and a fluid-conducting plate unit for transporting blood from the lancing wound. The plate unit has one or more channels for conducting fluid to one or more target locations. Preferably there is a first channel for conducting away a first portion of fluid that contains more of a fluid that is emitted initially (initial fluid) from the puncture wound and a second channel for conducting a second portion of fluid that contains less of the initial fluid from the puncture wound. Blood is drawn into the channels by capillary force. The device can be used to lance the skin and obtain a representative sample of blood with relatively simple procedures.

Claims

1. A device for sampling blood from the skin of a patient, the device comprising:

(a) fluid-conducting plate unit having one or more openings for facing against the skin of a patient, through which openings one or more lancets can pass to puncture the skin to result in a puncture wound, the plate unit having channels each for conducting fluid from the puncture wound; and

(b) one or more lancets positioned near the plate unit associated therewith for passing through the one or more openings to puncture the skin when pressed into the skin;

wherein the plate unit comprises a first channel for conducting away a first portion of the fluid and a second channel for conducting a second portion of the fluid.

2. A device according to claim 1, wherein the first channel and the second have channel one or both of a difference in size and a difference in position relative to the bleeding wounds such that the first channel conducts a fluid that contains more of a fluid that is emitted initially (initial fluid) from the puncture wound and a second channel conducts a second portion of fluid that contains less of the initial fluid.

3. A device according to claim 1, wherein the plate unit further comprises a chamber into which liquid can enter from the one or more openings on the plate unit, the first channel and the second channel being in fluid communication with the chamber.

4. A device according to claim 1, wherein each channel has an entrance portion each having an average diameter, the entrance portion of the second channel having an average diameter larger than the average diameter of the entrance portion of the first channel such that capillary force draws fluid at a faster volume flow rate into the first channel than in the second channel.

5. A device according to claim 1, wherein the plate unit further comprises a chamber into which blood can enter from the one or more openings on the plate unit, the first channel and the second channel being connected for fluid communication with the chamber.

6. A device according to claim 1, wherein the second channel has a one way valve and a pump to pump fluid away from the puncture wound.

7. A device according to claim 1, wherein the first channel is a passageway in a sponge structure.

8. A device according to claim 1, wherein the first channel is a passageway in a sponge structure, wherein the sponge structure is connected towards the end portion of the second channel such that the initial fluid that passes through the second channel will be soaked up by the sponge structure, and wherein the second channel has a distal end opening for analysis of liquid sample conducted through the second channel.

9. A device according to claim 1, further comprising a detector at the end of the second channel for detecting property of blood conducted through the second channel.

10. A device according to claim 1, further comprising a detector at the end of the second channel for detecting property of the fluid conducted through the second channel, the detector including electronics and a display for processing data of the detected property, the device being of a hand-held size.

11. A device for sampling blood from the skin of a patient, the device comprising:

(a) fluid-conducting plate unit having one or more openings for facing against the skin of a patient, through which openings one or more lancets can pass to puncture the skin to result in a puncture wound, the plate unit having multiple channels each for conducting fluid from the puncture wound; and

(b) one or more lancets positioned near the plate unit associated therewith for passing through the one or more openings to puncture the skin when pressed into the skin;

wherein the plate unit'"'"'s openings against the skin are surrounded by a resilient flexible lip that applies a radially outward force to the skin when the lip is pressed against the skin.

12. A device according to claim 11, wherein the lip comprises a polymeric material enabling the lip to deform when it is pressed against the skin.

13. A device for sampling blood from the skin of a patient, the device comprising:

(a) fluid-conducting plate unit having one or more openings for facing against the skin of a patient, through which openings one or more lancets can pass to puncture the skin to result in a puncture wound, the plate unit having multiple channels each for conducting fluid from the puncture wound; and

(b) a plurality of lancets positioned near the plate unit associated therewith for passing through the one or more openings to puncture the skin when pressed into the skin;

wherein each of the lancets is at less than a distance DD from another of the lancets, the distance DD being chosen to be about the discriminatable distance between distinct pain perception points in the patient, such that the patient would perceive a single puncture when two lancets at less than distance DD apart puncture the skin.

14. A device for sampling blood from the skin of a patient, the device comprising:

(a) fluid-conducting plate unit having one or more openings for facing against the skin of a patient, through which openings one or more lancets can pass to puncture the skin to result in a puncture wound, the plate unit having one of more channels each for conducting fluid from the puncture wound; and

(b) one or more lancets positioned near the plate unit associated therewith for passing through the one or more openings to puncture the skin when pressed into the skin;

the device additionally comprising a plurality of lancets and wherein the plate unit has a plurality of openings each for allowing a lancet to pass through to puncture the skin.

15. A device according to claim 14, wherein the openings are each about the size of a lancet to allow the lancet to pass through.

16. A device for sampling blood from the skin of a patient, the device comprising:

(a) fluid-conducting plate unit having one or more openings for facing against the skin of a patient, through which openings one or more lancets can pass to puncture the skin to result in a puncture wound, the plate unit having multiple channels each for conducting fluid from the puncture wound; and

(b) a plurality of lancets positioned near the plate unit associated therewith for passing through the one or more openings to puncture the skin when pressed into the skin;

the device further comprising a top from which the one or more lancets are anchored such that pressing the top causes the one or more lancets to press against the skin.

17. A device according to claim 16, wherein the top has a resilient member contacting the plate unit, the resilient member is compressed when the top is pressed to drive the one or more lancets into the skin and springs back to its original shape to pull the lancets from the skin after the pressure on the top is released.

18. A device for sampling blood from the skin of a patient, the device comprising:

(a) fluid-conducting plate unit having one or more openings for facing against the skin of a patient, through which openings one or more lancets can pass to puncture the skin to result in a puncture wound, the plate unit having one or more channels each for conducting fluid from the puncture wound; and

(b) a plurality of lancets positioned near the plate unit associated therewith for passing through the one or more opening to puncture the skin when pressed into the skin;

wherein at least one of the one or more channels has a flaring portion to inhibit a bubble from entering into the channel.

19. A device for puncturing the skin of a patient to sample blood, comprising:

(a) fluid-conducting plate unit having one or more openings for facing against the skin being punctured, the plate unit having a first channel for conducting away a first portion of fluid that contains more of a fluid that is emitted initially (initial fluid) from the skin after puncture and a second channel for conducting a second portion of fluid containing less of the initial fluid; and

(b) a plurality of lancets positioned near the plate unit, the lancets each passing through one of the one or more openings on the plate unit and puncturing the skin when pressed against the skin to yield blood.

20. A device according to claim 19, further comprising a housing associated with the plate unit for housing the plate unit and the lancets, the housing having a detector for detecting a property of the second portion of fluid.

21. A device for puncturing the skin of a patient to sample blood, comprising:

(a) fluid-conducting plate unit having one or more openings for facing against the skin being punctured, through which openings a plurality of lancets can pass to puncture the skin to yield blood, the plate unit having two or more channels each for conducting a portion of fluid from the puncture wound; and

(b) one or more lancets positioned near the plate unit associated therewith for passing through the one or more openings to puncture the skin when pressed into the skin;

wherein the plate unit comprises a first channel for conducting away a first portion of the fluid and a second channel for conducting a second portion of the fluid.