Diagnostic devices and apparatus for the controlled movement of reagents ...

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(12) United States Patent

Buechler

(io) Patent No.: (45) Date of Patent:

US 7,824,611 B2 Nov. 2, 2010

(54) DIAGNOSTIC DEVICES AND APPARATUS FOR THE CONTROLLED MOVEMENT OF REAGENTS WITHOUT MEMBRANES

(75) Inventor: Kenneth F. Buechler, San Diego, CA (US)

(73) Assignee: Biosite, Inc., Waltham, MA (US)

( * ) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 298 days.

(21) Appl.No.: 10/697,351

(22) Filed: Oct. 29, 2003

(65) Prior Publication Data

US 2004/0077103 Al Apr. 22, 2004

Related U.S. Application Data

(60) Continuation of application No. 09/613,650, filed on Jul. 11, 2000, now Pat. No. 7,524,456, which is a continuation-in-part of application No. 08/828,041, filed on Mar. 27,1997, now Pat. No. 6,156,270, which is a continuation-in-part of application No. 08/447, 895, filed on May 23, 1995, now Pat. No. 6,019,944, whichis a division of application No. 08/065,528, filed on May 19, 1993, now abandoned, which is a continuation-in-part of application No. 07/887,526, filed on May 21, 1992, now Pat. No. 5,458,852, said application No. 09/613,650 is a continuation-in-part of application^. 08/810,569, filed on Mar. 3, 1997, now Pat. No. 6,143,576, which is a continuation-in-part of application No. 08/447,981, filed on May 23, 1995, now Pat. No. 5,885,527, which is a division of application No. 08/065,528, said application No. 09/613, 650 is a continuation-in-part of application No. 08/902,775, filed on Jul. 30,1997, now Pat. No. 6,271, 040, which is a continuation-in-part of application No. 08/828,041, said application No. 08/828,041 is a division of application No. 08/065,528.

(52) U.S. CI 422/58; 422/61; 436/164;

436/177; 436/518

(58) Field of Classification Search 422/56,

422/58, 61, 164, 177, 518 See application file for complete search history.

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(Continued)

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(Continued)

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(Continued)

Primary Examiner—Lyle A Alexander

(74) Attorney, Agent, or Firm—Wilson Sonsini Goodrich &

Rosati

The assay devices, assay systems and device components of this invention comprise at least two opposing surfaces disposed a capillary distance apart, at least one of which is capable of immobilizing at least one target ligand or a conjugate in an amount related to the presence or amount of target ligand in the sample from a fluid sample in a zone for controlled fluid movement to, through or away the zone. The inventive device components may be incorporated into conventional assay devices with membranes or may be used in the inventive membrane-less devices herein described and claimed. These components include flow control elements, measurement elements, time gates, elements for the elimination of pipetting steps, and generally, elements for the controlled flow, timing, delivery, incubation, separation, washing and other steps of the assay process.

3 Claims, 17 Drawing Sheets

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