« AnteriorContinuar »
(12) United States Patent ao) Patent No.: us 6,974,701 B2
Bouboulis (45) Date of Patent: Dec. 13,2005
(54) ERYTHROCYTE SEDIMENTATION RATE
(ESR) TEST MEASUREMENT INSTRUMENT
OF UNITARY DESIGN AND METHOD OF
USING THE SAME
(75) Inventor: Denis A. Bouboulis, Darien, CT (US)
(73) Assignee: Hemovations, LLC, Greenwich, CT (US)
( * ) Notice: Subject to any disclaimer, the term ol this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days.
(21) Appl. No.: 10/395,860
(22) Filed: Mar. 21, 2003
(65) Prior Publication Data
US 2004/0185570 Al Sep. 23, 2004
(51) Int. CI.7 G01N 33/86
(52) U.S. CI 436/70; 436/63; 422/73;
(58) Field of Search 436/63, 70, 174,
436/180; 422/61, 73, 99, 100, 102, 103,
104, 939-940, 946; 435/2
(56) References Cited
U.S. PATENT DOCUMENTS
Web-based publication entitled "Erythrocyte Sedimentation
Rate (ESR)" by Gregory C. Gardner, M.D., University ol
Washington School ol Medicine, http://uscme.org/courses,
Jul. 1, 1999, pp. 1-4.
Web-based publication entitled "Ask A Doctor" by MDAd-
l.html, Sep. 12, 1999, pp. 1-2.
Web-based product brochure for the MICROTEST 1EC Electronic Calibration, ALIFAX S.P.A., www.alilax.com, 1 page.
Web-based product brochure for the Analyslnstrument AB Sedimatic 10 by Analyslnstrument AB, www.analysinstrument.com, Apr. 26, 2000, pp. 1-2.
Web-based publication entitled "Erythrocyte Sedimentation Rate Apparatus" by Guest Medical, www.guest-medical.co.uk/HTMLesr.htm, pp. 1-5.
Web-based product brochures for the ESR-10, ESR-100, ESR-8, ESR-Auto Plus, and ESR-Chex, by Streck Laboratories, Inc., www.streck.com, 2001, pp. 1-4. Web-based product brochures for the Sed-Chek® 2, SediplastTM, and Sedimat® 15, by PolyMedCo, Inc., http://
www.polymedco.com/sedcheck 2.html, pp. 1-5.
Web-based product brochures for the SEDI-RATETM
Autozero Westergren ESR System and SEDIGRENTM
Autozero Westergren ESR System, by Globe Scientific Inc.,
www.globescientific.com, 1997, pp. 1-3.
Product brochure for the Sedisure-Rapid Sedimentation
Rate Control, by Quantimetrix Corp., Redondo Beach, CA,
May 2001, pp. 1-2.
Scientific publication entitled "Reference and Selected Pro-
cedure for the Erythrocyte Sedimentation Rate (ESR) Test;
Approved Standard—Fourth Edition" by Koepke et al.,
NCCLS, Wayne, PA, vol. 20, No. 27, 2000, pp. 1-4.
* cited by examiner
Primary Examiner—Maureen M. Wallenhorst
(74) Attorney, Agent, or Firm—-Thomas J. Perkowski, Esq.,
An erythrocyte sedimentation rate (ESR) measurement instrument having a Blood Collection Configuration and an ESR Measurement Configuration. The ESR measurement instrument includes a sedimentation measurement tube having an hollow interior volume containing a predetermined quantity of blood sample diluting agent therewithin and being air/fluid sealed with respect to the ambient environment; and a blood collection tube having a hollow interior volume containing a predetermined quantity of anti
coagulant and being vacuum-sealed with respect to the ambient environment, and physically coupled to the airsealed sedimentation measurement tube, by at least a portion of the sedimentation measurement tube being inserted within a portion of the hollow interior volume of the blood collection tube. The sedimentation measurement tube and the blood collection tube are maintained stationarily fixed relative to each other as a unitary assembly having a syringe-like form factor when the ESR measurement instrument is arranged in the Blood Collection Configuration. During this configuration, a needle-supporting connector can be connected to the blood collection tube and a sample of whole blood from a patient vacuum-drawn and injected into the blood collection tube. After the sample of anticoagulated blood has been collected in the blood collection tube and the needle-supporting connector is disconnected therefrom, the air/fluid seal of the sedimentation measurement tube can be broken and then the sedimentation measurement tube can be manually plunged into and to the bottom of the hollow interior volume of said blood collection tube, using a single-handed operation to rearrange the ESR measurement instrument into the ESR Measurement Configuration. The anti-coagulated sample of blood fills up a substantially portion of the sedimentation measurement tube and mixes with the blood sample diluting agent to enable the blood plasma/erythrocyte cell (P/E) interface level within the sedimentation measurement tube to settle downwards toward the blood collection tube during a predetermined time period when said ESR measurement instrument is oriented in a gravity vertical position. By virtue of the present invention, the erythrocyte sedimentation rate (ESR) of the collected blood sample can be measured by determining how far the P/E interface level has moved against graduation markings formed along the length of the sedimentation measurement tube during the predetermined time period.
15 Claims, 59 Drawing Sheets