Extraction and transportation of blood for analysis

• US 6,364,890 B1
• Filed: 07/12/2000
• Issued: 04/02/2002
• Est. Priority Date: 03/08/1999
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Agilent Technologies, Inc.
• Inventors: Greenstein, Michael, Freeman, Dominique M., Leonard, Leslie A., Keely-Templin, Catherine, Lum, Paul, Verdonk, Edward D.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/614,318
• Time in Patent Office: 629 Days
• Field of Search: 606/181, 606/182, 606/183, 606/170, 606/1, 128/898
• 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 method of making a lancet device for puncturing the skin of a patient, comprising:

(a) on a plate unit, forming one or more openings for facing against the skin being punctured such that one or more lancets can pass therethrough to puncture the skin to result in bleeding, forming one or more channels for conducting fluid from the skin after puncture; and

(b) positioning one or more lancets near the plate unit such that the one or more lancets can pass through the one or more openings on the plate unit to puncture the skin when pressed against the skin to result in a puncture wound,

the method further comprising forming on the plate unit a first channel for conducting a first portion of fluid that contains more of a fluid that is emitted initially from the skin after puncture (initial fluid) and a second channel for conducting a second portion of fluid that contains less of the initial fluid, the first channel and the second channel being in fluid communication with each other either directly or through another passageway.

2. A method according to claim 1, wherein the first channel and the second channel are connected to a common channel such that blood from the skin passes through the common channel to the first channel and fills it before filling the second channel.

3. A method of making a lancet device for puncturing the skin of a patient, comprising:

(a) on a plate unit, forming one or more openings for facing against the skin being punctured such that one or more lancets can pass therethrough to puncture the skin to result in bleeding, forming one or more channels for conducting fluid from the skin after puncture; and

(b) positioning one or more lancets near the plate unit such that the one or more lancets can pass through the one or more openings on the plate unit to puncture the skin when pressed against the skin to result in a puncture wound,

the method further comprising positioning a plurality of lancets near the plate unit such that the lancets can pass through the one or more openings on the plate unit to puncture the skin when pressed against the skin to result in a bleeding puncture wound.

4. A method of making a lancet device for puncturing the skin of a patient, comprising:

(a) on a plate unit, forming one or more openings for facing against the skin being punctured such that one or more lancets can pass therethrough to puncture the skin to result in bleeding, forming one or more channels for conducting fluid from the skin after puncture; and

(b) positioning one or more lancets near the plate unit such that the one or more lancets can pass through the one or more openings on the plate unit to puncture the skin when pressed against the skin to result in a puncture wound,

the method further comprising forming a chamber to receive blood from the openings and wherein the first channel and the second channel are connected to the chamber to conduct blood therefrom.

5. A method of making a lancet device for puncturing the skin of a patient, comprising:

(a) on a plate unit, forming one or more openings for facing against the skin being punctured such that one or more lancets can pass therethrough to puncture the skin to result in bleeding, forming one or more channels for conducting fluid from the skin after puncture; and

(b) positioning one or more lancets near the plate unit such that the one or more lancets can pass through the one or more openings on the plate unit to puncture the skin when pressed against the skin to result in a puncture wound,

the method further comprising forming a resilient flexible lip that surrounds the openings, the lip applies a radially outward force to the skin when the lip is pressed against the skin.

6. A method of making a lancet device for puncturing the skin of a patient, comprising:

(a) on a plate unit, forming one or more openings for facing against the skin being punctured such that one or more lancets can pass therethrough to puncture the skin to result in bleeding, forming one or more channels for conducting fluid from the skin after puncture; and

(b) positioning one or more lancets near the plate unit such that the one or more lancets can pass through the one or more openings on the plate unit to puncture the skin when pressed against the skin to result in a puncture wound,

the method further comprising forming a plurality of openings on the plate unit to admit blood and positioning a plurality of lancets near the plurality of openings each for allowing a lancet to pass through to puncture the skin, the lip surrounding the plurality of openings.

7. A method of using a lancet device to sample blood from the skin of a patient, comprising:

(a) applying a plate unit with one or more openings against the skin being sampled;

(b) driving one or more lancets through the one or more openings against the skin to result in a bleeding wound and allowing blood to pass from the bleeding wound through the one or more openings into the plate unit; and

(c) conducting away a portion of fluid that is emitted from the bleeding wound through one or more channels in the plate unit,

the method further comprising conducting away a first portion of fluid that contains more of a fluid that is emitted initially (initial fluid) from the bleeding wound and a second channel for conducting a second portion of fluid containing less of the initial fluid using capillary force in the plate unit, the first channel and the second channel being in fluid communication with each other either directly or through a passageway.

8. A method according to claim 7, wherein blood passes from the openings of the plate unit to a passageway to fill the first channel first and then fill the second channel.

9. A method according to claim 7, further comprising using a detector at the end of the second channel for detecting property of the blood conducted through the second channel, the detector including electronics and a display for processing data of the detected property, the device having a hand-held size.

10. A method according to claim 7, further comprising receiving blood from the one or more openings into a chamber and conducting blood from the chamber to the channel.

11. A method according to claim 7, wherein the one or more lancets are anchored to a top and the method comprises pressing the top toward the skin to press the lancets to puncture the skin.

12. A method according to claim 7, comprising using openings about the size of the lancets to allow each lancet to pass through a different opening.

13. A method of using a lancet device to sample blood from the skin of a patient, comprising:

(a) applying a plate unit with one or more openings against the skin being sampled;

(b) driving one or more lancets through the one or more openings against the skin to result in a bleeding wound and allowing blood to pass from the bleeding wound through the one or more openings into the plate unit; and

(c) conducting away a portion of fluid that is emitted from the bleeding wound through one or more channels in the plate unit,

the method further comprising driving a plurality of lancets through the one or more openings to result in the bleeding wound.

14. A method of using a lancet device to sample blood from the skin of a patient, comprising:

(a) applying a plate unit with one or more openings against the skin being sampled;

(b) driving one or more lancets through the one or more openings against the skin to result in a bleeding wound and allowing blood to pass from the bleeding wound through the one or more openings into the plate unit; and

(c) conducting away a portion of fluid that is emitted from the bleeding wound through one or more channels in the plate unit,

the method further comprising applying a radially outward force to the skin to increase the tautness of the skin around the openings by applying a resilient flexible lip on the skin surrounding the openings.

15. A method of using a lancet device to sample blood from the skin of a patient, comprising:

(a) applying a plate unit with one or more openings against the skin being sampled;

(b) driving one or more lancets through the one or more openings against the skin to result in a bleeding wound and allowing blood to pass from the bleeding wound through the one or more openings into the plate unit; and

(c) conducting away a portion of fluid that is emitted from the bleeding wound through one or more channels in the plate unit,

the method further comprising applying a radially outward force to the skin to increase the tautness of the skin around the openings by applying a resilient flexible lip on the skin surrounding the openings and applying a plurality of lancets through a plurality of openings on the plate unit to lance the skin, the lip surrounding the plurality of openings.