Easy-to-use multi-use body fluid specimen collection and analyte sensing assembly

• US 7,862,519 B1
• Filed: 06/16/2003
• Issued: 01/04/2011
• Est. Priority Date: 05/21/2003
• Status: Expired due to Fees

• Current Assignee: Konamite Limited
• Original Assignee: Isense Corporation
• Inventors: Sass, Richard G., Ward, W. Kenneth
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SMITH, FANGEMONIQUE A
• Application Number:
  US10/463,848
• Time in Patent Office: 2,759 Days
• Field of Search: 600/583, 600/584, 600/573, 600/576, 600/578, 600/181, 600/575, 600/345, 600/347, 600/182, 600/365, 600/316, 600/547
• US Class Current: 600/583
• 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 5/150435 Specific design of proximal end
• 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 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A multiple use analyte sensing assembly that includes a long, thin conductor. A plurality of sensing sites are spaced along the conductor and each sensing site includes a membrane system adapted to create a current when placed into contact with body fluid containing the analyte. The assembly also includes a housing, having an aperture, an uptake spool and a payout spool, the conductor being wrapped about the payout spool before the sensing assembly is used. A sensor positioning actuator turns the uptake spool to move each sensing site, in sequence, to the housing aperture and then to the uptake spool. The assembly also includes a skin broaching assembly, having a multiplicity of lancets and a lancet positioning actuator adapted to move each lancet to the aperture. In addition, a lancet use actuator is adapted to move each lancet at least partially through the aperture and then back again.

Claims

1. A multiple use analyte sensing assembly, comprising:

(a) a long, thin electrical conductor;

(b) a plurality of sensing sites spaced along said electrical conductor, each said sensing site including a membrane system adapted to create a current in conjunction with said electrical conductor when each said sensing site is placed into contact with body fluid containing an analyte;

(c) a housing, having a housing aperture;

(d) an uptake spool and a payout spool, located within said housing, said electrical conductor being wrapped about said payout spool and threaded to said uptake spool prior to said sensing assembly being used;

(e) a sensor positioning actuator for turning said uptake spool so that each said sensing site is moved, in sequence, to said housing aperture and to said uptake spool; and

(f) a skin broaching assembly, having;

(i) a multiple lancet holding mechanism;

(ii) a multiplicity of lancets held by said multiple lancet holding mechanism;

(iii) a lancet positioning actuator adapted to move, in sequence, each lancet to a position coincident to said housing aperture; and

(iv) a lancet use actuator adapted to move a lancet that is positioned coincident to said housing aperture, at least partially through said housing aperture and then back again.

2. The multiple use analyte sensing assembly of claim 1, wherein said membrane system is a single membrane system that is continuous along said electrical conductor.

3. The multiple use analyte sensing assembly of claim 1, wherein said electrical conductor is covered with insulation, and wherein said insulation is absent in a plurality of regions, said plurality of regions being the locations of said sensing sites where said membrane system has been applied.

4. The multiple use analyte sensing assembly of claim 1, wherein said membrane system is covered by an absorbent layer.

5. The multiple use analyte sensing assembly of claim 4, wherein tight bands are interspersed about said absorbent layer between sensing sites to prevent blood entering a first sensing site of said plurality of sensing sites from a second sensing site of said plurality of sensing sites.

27. The multiple use analyte sensing assembly of claim 1, wherein said membrane system comprises an interferent excluding membrane, an enzyme membrane, and a permselective membrane.

6. A method of taking a sequence of blood analyte measurements, comprising:

(a) providing an analyte sensing assembly, including;

(i) a lengthwise electrical conductor; and

(ii) a first measurement site and a second measurement site located along said lengthwise electrical conductor, each said measurement site including a membrane assembly adapted to create an electrical current flowing out of said lengthwise electrical conductor in the presence of an analyte when a voltage is placed on said lengthwise electrical conductor relative to ground;

(b) forming a first analyte measurement by placing a voltage on said lengthwise electrical conductor, exposing said first measurement site to body fluid, and measuring electrical current in said lengthwise electrical conductor; and

(c) subsequent to forming said first analyte measurement, forming a second analyte measurement by placing a voltage on said lengthwise electrical conductor, exposing said second measurement site to body fluid and measuring electrical current in said lengthwise electrical conductor.

7. The method of claim 6, wherein said analyte sensing assembly includes further measurement sites, in addition to said first measurement site and said second measurement site.

8. The method of claim 6, wherein said analyte sensing assembly includes a reference electrode for each measurement site.

9. The method of claim 6 wherein said body fluid comes from a patient having skin, and wherein said body fluid rests on said skin during forming of said first analyte measurement and said second analyte measurement and wherein said skin of said patient serves as a reference electrode.

10. The method of claim 6 wherein said membrane assembly includes more than one type of membrane.

11. The method of claim 6 wherein said first measurement site is positionally associated with a body fluid retention element at the time said first measurement is formed and said second measurement site is positionally associated with said body fluid retention element at the time said second measurement is formed.

12. The method of claim 11 wherein said body fluid retention element is a cavity traversed by said first and second measurement sites.

13. The method of claim 11 wherein said body fluid retention element comprises absorbent material.

14. The method of claim 6 wherein said lengthwise electrical conductor is a wire.

15. The method of claim 6 wherein said membrane assembly is present only at said measurement sites.

16. The method of claim 6 wherein said lengthwise electrical conductor is coated by said membrane assembly at said measurement sites as well as between said measurement sites.

28. The method of claim 6, wherein said membrane assembly comprises an interferent excluding membrane, an enzyme membrane, and a permselective membrane.

17. An analyte sensing assembly, including:

(a) a lengthwise electrical conductor having an outer surface; and

(b) a first measurement site and a second measurement site located along the outer surface of said lengthwise electrical conductor, each said measurement site including a membrane assembly adapted to create, in the presence of an analyte, an electrical current flowing out of said lengthwise electrical conductor when a voltage has been placed on said lengthwise electrical conductor relative to ground.

18. The assembly of claim 17, wherein said analyte sensing assembly includes further measurement sites, in addition to said first measurement site and said second measurement site.

19. The assembly of claim 17, wherein said analyte sensing assembly includes a reference electrode for each measurement site.

20. The assembly of claim 17 wherein said membrane assembly includes more than one membrane.

21. The assembly of claim 17 wherein said first measurement site is positionally associated with a body fluid retention element at the time said first measurement is formed and said second measurement site is positionally associated with said body fluid retention element at the time said second measurement is formed.

22. The assembly of claim 21 wherein said body fluid retention element is a cavity traversed by said first and second measurement sites.

23. The assembly of claim 21 wherein said body fluid retention element comprises absorbent material.

24. The assembly of claim 17 wherein said lengthwise electrical conductor is a wire.

25. The assembly of claim 17 wherein said membrane assembly only exists at said measurement sites.

26. The assembly of claim 17 wherein said lengthwise electrical conductor is coated by said membrane assembly at said measurement sites and between said measurement sites.

29. The assembly of claim 17, wherein said membrane assembly comprises an interferent excluding membrane, an enzyme membrane, and a permselective membrane.

30. The assembly of claim 17, wherein said lengthwise electrical conductor is circular in cross-section.

31. The assembly of claim 17, wherein said first measurement site and said second measurement site are separated from each other by insulation.

32. The assembly of claim 17, wherein said first measurement site and said second measurement site are separated from each other by a constrictive band.

33. The assembly of claim 17, wherein said first and second measurement sites encircle the lengthwise electrical conductor.