Physiological fluid extraction with rapid analysis

• US 6,375,627 B1
• Filed: 03/02/2000
• Issued: 04/23/2002
• Est. Priority Date: 03/02/2000
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Agilent Technologies, Inc.
• Inventors: Freeman, Dominique, Mauze, Ganapati R., Lum, Paul
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/517,711
• Time in Patent Office: 782 Days
• Field of Search: 600/309, 600/316, 600/341, 600/365, 600/576, 600/583, 600/584, 606/181, 422/99, 204/403, 204/409, 436/68, 436/164
• US Class Current: 600/584
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• 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 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use

Abstract

A device for sampling and analyzing a physiological fluid from the skin of a patient by puncture. The device includes a body and sensors. The body has a needle with a point for puncturing a physiological tissue and a channel in the body for conducting the physiological fluid away from the point. The sensors are located in the body and are accessible to the physiological fluid conducting along the channel for physiological fluid analysis. The device can be used to lance the skin and obtain a representative sample of the physiological fluid, with relatively simple procedures and quick analysis to minimize the exposure of the physiological fluid sample to air.

Claims

1. A device for analyzing a physiological fluid from a physiological tissue comprising:

(a) a body, including a needle with a point for puncturing a physiological tissue and a channel in the body for conducting a physiological fluid extracted from the physiological tissue proximally from the point;

(b) sensors in the body, wherein the sensors are proximate the point of the needle and accessible to the physiological fluid conducting along the channel for analyzing the physiological fluid; and

(c) interrogation elements corresponding to the sensors in the body for obtaining information from the sensors, said interrogation elements in communication with an analyzer.

2. A device according to claim 1 further comprising a shell having the interrogation elements.

3. A device according to claim 2 wherein the needle has a cross section that includes straight sides.

4. A device according to claim 2 wherein the body is detachable from the shell to be replaced with a new body.

5. A device according to claim 2 wherein one or more of the sensors each have a recess in the channel, said recesses containing chemicals that interact with specific constituents of the physiological fluid for sensing characteristics thereof.

6. A device according to claim 2 wherein at least one of the sensors has no fluid communication with any space external to the body except through the channel and contains a chemical that reacts with a constituent of the physiological fluid.

7. A device according to claim 2 wherein the body has two halves, at least one of which has a groove such that the two halves can be coupled for the groove on a half in conjunction with the other half to form the channel.

8. A device according to claim 2 wherein the body is slidable on the shell for positioning the sensors in the body to be proximate to the interrogation elements for obtaining information from the sensors.

9. A device according to claim 8 further comprising a suction source connected to the channel for facilitating conduction of the physiological fluid from the point to the sensors.

10. A device according to claim 2 further comprising a chemical that reacts with an analyte in the physiological fluid in one of the sensors.

11. A device according to claim 2 wherein the body has a portion that has a planar surface through which light can penetrate to interrogate the physiological fluid in at least one of the sensors.

12. A device according to claim 2 wherein at least one of the interrogation elements includes electrical contact to contact an electrical conductor on the body to conduct electrical signals from the sensor corresponding to the interrogation element.

13. A device according to claim 2 wherein the body has a layer of material on its outer surface extending substantially from the point of the needle to an end in the body away from the point.

14. A method for analyzing a physiological fluid from a physiological tissue, comprising:

(a) puncturing the physiological tissue with a lancing unit having a needle with a sharp point and a channel leading from the sharp point to a portion of the lancing unit distant from the sharp point, said needle comprising sensors adjacent said channel wherein said sensors are in communication with interrogation elements in communication with an analyzer;

(b) conducting a physiological fluid from the physiological tissue from the sharp point up the channel past said sensors; and

(c) directly analyzing the physiological fluid while the physiological fluid is in the channel employing said interrogation elements in communication with said analyzer.

15. A method according to claim 14 further comprising analyzing the physiological fluid with sensors having chemicals that changes a characteristic in the presence of a constituent in the physiological fluid.

16. A method according to claim 14 further comprising moving the lancing unit after the physiological fluid has conducted up the channel to locate the sensors near to interrogation elements in a shell surrounding the lancing unit to provide information on the physiological fluid to the shell from the sensors.

17. A method according to claim 16 further comprising optically interrogating the sensors at the interrogation elements.

18. A method according to claim 16 further comprising receiving electrical signals from at least one of the sensors by one of the interrogation elements.

19. A method according to claim 16 further comprising installing a lancing unit into the shell such that the lancing unit is removable therefrom after use.

20. A method according to claim 16 further comprising sliding the lancing unit on the shell distally towards the physiological tissue to puncture the physiological tissue and sliding the lancing unit on the shell proximally from the physiological tissue to position the sensors near to the interrogation elements.

21. A method for analyzing a physiological fluid from a physiological tissue, comprising:

(a) installing a lancing unit into a shell such that it is removable therefrom after use, the lancing unit having a channel through a needle to a sharp point and having sensors positioned along the channel, the shell having interrogation elements corresponding to the sensors and a distal portion encircling the sharp point after installation, the interrogation elements being in direct communication with an analyzer;

(b) positioning the distal portion of the shell on the physiological tissue;

(c) sliding the lancing unit to extend the needle, pushing the sharp point from the shell to puncture the physiological tissue;

(d) conducting a physiological fluid from the physiological tissue from the sharp point up the channel;

(e) analyzing the physiological fluid at the sensors in the channel; and

(f) sliding the lancing unit relative to the shell to retract the sharp point into the shell and position the sensors proximate to the interrogation elements to communicate information from the sensors to the interrogation elements and from the interrogation elements to the analyzer.

22. A method of making a device for analyzing a physiological fluid, comprising:

(a) forming a lancing unit with a channel extending from a portion of the lancing unit through a needle to a sharp point;

(b) immobilizing chemicals that interact with one or more constituents of the physiological fluid at one or more sensors along the channel;

(c) forming a shell in which the lancing unit can slide, the shell having interrogation elements corresponding to the sensors to which information from the sensors can be communicated thereto when the lancing unit is in the shell at a retracted state; and

(d) installing the lancing unit in the shell wherein said interrogation elements are in communication with an analyzer.