IP Library Granted Patent US 7,569,393
Granted Patent B2
US 7,569,393 · App. 10/185,201 · Granted Aug 4, 2009

Analytical test cartridge; and, methods

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Quick Facts
Patent No.
US 7,569,393
App. No.
10/185,201
Granted
Aug 4, 2009
Kind
B2
Abstract

An analytical test cartridge is provided. The analytical test cartridge can be used for medical analyses of liquid samples removed from a patient, for example blood. The analytical test cartridge is configured to provide for titration experiments. An example of a titration experiment that can be performed with the arrangement, is titration of heparin with protamine. Methods of assembly and use are provided.

Claims (53)

1. A sample analysis cartridge comprising:

(a) a liquid sample inlet;

(b) a main flow channel in fluid flow communication with the inlet;

(c) a titration cell arrangement including: at least two titration spins located off of and in fluid flow communication with the main flow channel; and, a titration cell in each spur separated from the main flow channel;

(d) a titration sensor arrangement including a sensor positioned in each titration cell in the titration cell arrangement; and

(e) a titration agent positioned in each titration cell of the titration cell arrangement, with a different amount of titration agent in at least two of the titration cells.

2. A sample analysis cartridge according to claim 1 including:

(a) an electrical conductor arrangement positioned to provide operational electrical communication from the sensor arrangement to an analytical measurement device, when the cartridge is operably connected to the analytical measurement device.

3. A sample analysis cartridge according to claim 1 including:

(a) a secondary flow channel providing fluid flow communication between the main flow channel and the titration cell arrangement.

4. A sample analysis cartridge according to claim 1 wherein:

(a) the titration cell arrangement includes at least four titration spurs, each of which includes a titration cell; and

(b) a different amount of titration agent is positioned in at least four of the titration cells.

5. A sample analysis cartridge according to claim 1 including:

(a) a spur waste changer;

(i) each titration spur being configured for fluid flow communication from the main flow channel, eventually through a selected titration cell and to the spur waste chamber.

6. A sample analysis cartridge according to claim 1 wherein:

(a) each titration spur is a capillary spur.

7. A sample analysis cartridge according to claim 1 wherein:

(a) a selected set of titration cells, including more than one of said titration cells, comprises a selected analyte titration set of titration cells;

(i) each cell in the selected analyte titration set of titration cells includes a titrating agent for a selected analyte; and

(ii) an amount of titrating agent for the selected analyte in selected ones of the capillary spurs in the selected analyte titration set, differs adequately to generate a selected analyte titration calculation based upon operation of said electrochemical sensor arrangement.

8. A sample analysis cartridge according to claim 7 wherein:

(a) the titrating agent for the selected analyte is a titrating agent for heparin.

9. A sample analysis cartridge according to claim 8 wherein:

(a) the titrating agent is protamine.

10. A sample analysis cartridge according to claim 9 wherein;

(a) each capillary spur of the selected analyte titration set defines a titration cell volume within 5% of a selected titration cell volume.

11. A sample analysis cartridge according to claim 1 comprising:

(a) a base structure defining a cartridge perimeter area of no mare than 100 sq. cm.

12. A sample analysis cartridge according to claim 11 having:

(a) a total sample volume in the main flow channel and the titration spurs of no more than 100 microliters.

13. A sample analysis cartridge according to claim 12 having:

(a) a titration cell volume, of each titration cell, of no more than 2.5 μl.

14. A sample analysis cartridge according to claim 12 including:

(a) a single reference electrode, for all sensor located in the titration cells; the single reference electrode being positioned in the main flow channel.

15. A sample analysis cartridge according to claim 14 including:

(a) at least one analytical sensor electrode positioned in the main flow channel.

16. A sample analysis cartridge according to claim 12 including:

(a) a main flow channel waste reservoir;

(i) said main flow conduit being positioned in fluid flow communication between said liquid sample injection port and said main channel waste reservoir.

17. A method of defining an analyte presence in a liquid sample; said method including steps of:

(a) directing a liquid sample into a plurality of spurs located off of and in fluid flow communication with a single main flow channel, each spur leading to one or more of a plurality of titration cells containing sensors;

(b) titrating at least one of a selected analyte and a selected reagent in the liquid sample to a different degree in selected ones of the plurality of cells; and

(c) calculating an amount of an analyte in the liquid sample based on a titration analysis determined by the step of titrating.

18. A method according to claim 17 wherein:

(a) said step of titrating comprises titrating heparin in a blood sample.

19. A method according to claim 17 wherein:

(a) said step of directing comprises directing a liquid sample into an analytical sample cartridge having a total perimeter area of no more than 100 sq. cm.

20. A method according to claim 19 wherein:

(a) said step of calculating comprises calculating on a basis of titration measurements taken in at least six different cells at different amounts of titration.

21. A method according to claim 17 wherein:

(a) said step of titrating comprises titrating heparin, in blood, with protamine.

Assignments (25)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 2, 2017
From: LIFEHEALTH, LLC
To: DSI ASSIGNMENTS LLC, SOLELY IN ITS CAPACITY AS ASSIGNEE FOR THE BENEFIT OF CREDITORS OF LIFEHEALTH, LLC
Reel/Frame 043759/0368 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CORRECT ASSIGNEE NAME PREVIOUSLY RECORDED ON REEL 042829 FRAME 0071. ASSIGNOR(S) HEREBY CONFIRMS THE LIFEHEALTH, LLC IS TRUE ASSIGNEE. Recorded Sep 25, 2017
From: LIFEHEALTH, LLC
To: LIFEHEALTH, LLC
Reel/Frame 043983/0898 →
CORRECTIVE ASSIGNMENT TO CORRECT THE POSTAL CODE OF RECEIVING PARTY AND PCT NUMBER US1999014696 PREVIOUSLY RECORDED ON REEL 043595 FRAME 0554. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Sep 20, 2017
From: DSI ASSIGNMENTS LLC
To: EASYDX, INC.
Reel/Frame 043929/0162 →
RELEASE OF SECURITY INTEREST Recorded Sep 14, 2017
From: SIMCAH PARTNERS L.P.
To: LIFEHEALTH, LLC; THE MICHAEL SINSHEIMER REVOCABLE TRUST U/A DATED 04/09/15
Reel/Frame 043747/0496 →
RELEASE OF SECURITY INTEREST Recorded Sep 14, 2017
From: PETERSON, MARK
To: LIFEHEALTH, LLC
Reel/Frame 043865/0861 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 14, 2017
From: DSI ASSIGNMENTS LLC
To: EASYDX, INC.
Reel/Frame 043595/0554 →
RELEASE OF SECURITY INTEREST Recorded Sep 14, 2017
From: MICHAEL N. SINSHEIMER REVOCABLE TRUST U/A DATED 04/09/15
To: LIFEHEALTH, LLC
Reel/Frame 043747/0483 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT APPL. NO. 13/843,452 PREVIOUSLY RECORDED AT REEL: 040842 FRAME: 0847. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jun 29, 2017
From: LIFEHEALTH, LLC
To: SIMCAH PARTNERS, L.P.
Reel/Frame 043051/0413 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT APPL. NO. 13/843,452 PREVIOUSLY RECORDED AT REEL: 040842 FRAME: 0303. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Jun 29, 2017
From: LIFEHEALTH, LLC
To: THE MICHAEL N. SINSHEIMER REVOCABLE TRUST U/A DATED 04/09/15
Reel/Frame 043042/0686 →
CORRECTIVE ASSIGNMENT TO CORRECT THE APPLICATION NUMBER 13843452. PREVIOUSLY RECORDED AT REEL: 040843 FRAME: 0325. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT . Recorded Jun 29, 2017
From: THE MICHAEL N. SINSHEIMER REVOCABLE TRUST U/A DATED 04/09/15
To: SIMCAH PARTNERS, L.P.
Reel/Frame 043042/0737 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT APPL. NO. 13/843,452 PREVIOUSLY RECORDED AT REEL: 040842 FRAME: 0594. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY AGREEMENT. Recorded Jun 29, 2017
From: LIFEHEALTH, LLC
To: PETERSON, MARK
Reel/Frame 043050/0060 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 27, 2017
From: LIFEHEALTH, LLC
To: INSTRUMENTATION LABORATORY COMPANY
Reel/Frame 042829/0071 →
RELEASE OF SECURITY INTEREST Recorded Jan 27, 2017
From: BLACKROCK CAPITAL INVESTMENT CORPORATION
To: ACCRIVA DIANOGSTIC, INC.; ACCUMETRICS, INC.
Reel/Frame 041519/0240 →
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY NAME PREVIOUSLY RECORDED AT REEL: 040843 FRAME: 0325. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Jan 11, 2017
From: THE MICHAEL N. SINSHEIMER REVOCABLE TRUST U/A
To: SIMCAH PARTNERS, L.P.
Reel/Frame 041328/0753 →
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY NAME PREVIOUSLY RECORDED AT REEL: 040842 FRAME: 0847. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Jan 11, 2017
From: LIFEHEALTH, LLC
To: SIMCAH PARTNERS, L.P.
Reel/Frame 041329/0164 →
SECURITY INTEREST Recorded Jan 4, 2017
From: LIFEHEALTH, LLC
To: THE MICHAEL N. SINSHEIMER REVOCABLE TRUST U/A DATED 04/09/2015
Reel/Frame 040842/0303 →
SECURITY INTEREST Recorded Jan 4, 2017
From: LIFEHEALTH, LLC
To: PETERSON, MARK
Reel/Frame 040842/0594 →
SECURITY INTEREST Recorded Jan 4, 2017
From: LIFEHEALTH, LLC
To: SIMCA PARTNERS, L.P.
Reel/Frame 040842/0847 →
SECURITY INTEREST Recorded Jan 4, 2017
From: THE MICHAEL N. SINSHEIMER REVOCABLE TRUST U/A DATED 04/09/2015
To: SIMCA PARTNERS, L.P.
Reel/Frame 040843/0325 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 5, 2014
From: INTERNATIONAL TECHNIDYNE CORPORATION
To: LIFEHEALTH, LLC
Reel/Frame 033465/0629 →
SECURITY AGREEMENT Recorded Jan 30, 2014
From: INTERNATIONAL TECHNIDYNE CORPORATION
To: BLACKROCK KELSO CAPITAL CORPORATION
Reel/Frame 032137/0798 →
RELEASE OF SECURITY INTEREST Recorded Jan 23, 2014
From: COMERICA BANK
To: INTERNATIONAL TECHNIDYNE CORPORATION
Reel/Frame 032123/0787 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Apr 5, 2011
From: INTERNATIONAL TECHNIDYNE CORPORATION
To: COMERICA BANK
Reel/Frame 026079/0301 →
INTELLECTUAL PROPERTY ASSIGNMENT Recorded Jan 16, 2004
From: DIAMETRICS MEDICAL, INC.
To: INTERNATIONAL TECHNIDYNE CORPORATION
Reel/Frame 014261/0885 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 28, 2002
From: VAN SIN, KEE
To: DIAMETRICS MEDICAL, INC.
Reel/Frame 013063/0768 →