Patents by Inventor David A. Heavner
David A. Heavner has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).
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Patent number: 11035783Abstract: A method to normalize at least one of a population of subordinate clinical diagnostic analyzer to a master clinical diagnostic analyzer such that an assay result from a subordinate clinical diagnostic analyzer can be converted to the equivalent result of the master clinical diagnostic analyzer by using a simple multiplicative factor when the assay executed on each analyzer uses a common fluorescently labeled dye. Also a method to re-normalize a subordinate clinical diagnostic analyzer assay result to a master clinical diagnostic analyzer assay result by using a simple multiplicative factor when the assay executed on the subordinate clinical diagnostic analyzer uses a different fluorescently labeled dye than the assay executed on the master clinical diagnostic analyzer.Type: GrantFiled: February 6, 2018Date of Patent: June 15, 2021Assignee: ORTHO-CLINICAL DIAGNOSTICS, INC.Inventor: David A. Heavner
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Patent number: 10656151Abstract: A lateral flow diagnostic assay device is defined by a substrate having a top surface that further includes a sample addition zone for receiving a sample, a transport and reaction zone, and a wicking zone. Each of the sample addition zone, reaction and transport zone and wicking zone are disposed on the top surface of the substrate and fluidically interconnected by means that permit lateral capillary flow along at least one fluid flow path from the sample addition zone to the wicking zone. The assay device further includes a capillary vent disposed in relation to the wicking zone, the capillary vent having an overall length and cross sectional area that creates a backpressure so as to control the flow rate of a sample applied to the assay device.Type: GrantFiled: January 27, 2017Date of Patent: May 19, 2020Assignee: ORTHO-CLINICAL DIAGNOSTICS, INC.Inventor: David A. Heavner
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Patent number: 10509031Abstract: A method for providing quality control on a lateral flow assay device or for triggering a process-related step, the device including a substrate having at least one sample receiving area, at least one reagent zone downstream and in fluid communication with the at least one sample receiving area, at least one detection zone downstream and in fluid communication with the at least one reagent zone and at least one wicking zone downstream of the at least one detection zone, each fluidly interconnected therewith along at least one fluid flow path. The detection material provided in the at least one reagent zone produces a detectable signal that can be tracked and monitored prior to the completion of at least one test being performed on the lateral flow assay device.Type: GrantFiled: September 23, 2016Date of Patent: December 17, 2019Assignee: Ortho-Clinical Diagnostics, Inc.Inventors: Zhong Ding, James E. Robinson, David A. Tomasso, David A. Heavner
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Patent number: 10073091Abstract: A lateral flow assay device includes a substrate having a top surface, as well as a sample receiving area disposed upon the top surface. At least one fluid flow path extends along the substrate from the sample receiving area, wherein the sample receiving area can be placed in contact with a peripheral reservoir formed at a sample addition area to draw sample therefrom in a controlled manner. The device can further include a reagent area that is designed to promote uniform dissolution of a deposited detection material by a sample moved through the device along the fluid flow path as well, as a flow channel configure to promote mixing of sample and reagent and an absorbing or wicking zone configured to affect various flow characteristics.Type: GrantFiled: August 6, 2015Date of Patent: September 11, 2018Assignee: Ortho-Clinical Diagnostics, Inc.Inventors: Zhong Ding, Philip C. Hosmier, Edward R. Scalice, Daniel P. Salotto, David A. Heavner
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Publication number: 20180231458Abstract: A method to normalize at least one of a population of subordinate clinical diagnostic analyzer to a master clinical diagnostic analyzer such that an assay result from a subordinate clinical diagnostic analyzer can be converted to the equivalent result of the master clinical diagnostic analyzer by using a simple multiplicative factor when the assay executed on each analyzer uses a common fluorescently labeled dye. Also a method to re-normalize a subordinate clinical diagnostic analyzer assay result to a master clinical diagnostic analyzer assay result by using a simple multiplicative factor when the assay executed on the subordinate clinical diagnostic analyzer uses a different fluorescently labeled dye than the assay executed on the master clinical diagnostic analyzer.Type: ApplicationFiled: February 6, 2018Publication date: August 16, 2018Inventor: David A. Heavner
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Publication number: 20170276600Abstract: A method to normalize at least one of a population of subordinate clinical diagnostic analyzer to a master clinical diagnostic analyzer such that an assay result from a subordinate clinical diagnostic analyzer can be converted to the equivalent result of the master clinical diagnostic analyzer by using a simple multiplicative factor when the assay executed on each analyzer uses a common fluorescently labeled dye. Also a method to re-normalize a subordinate clinical diagnostic analyzer assay result to a master clinical diagnostic analyzer assay result by using a simple multiplicative factor when the assay executed on the subordinate clinical diagnostic analyzer uses a different fluorescently labeled dye than the assay executed on the master clinical diagnostic analyzer.Type: ApplicationFiled: September 17, 2015Publication date: September 28, 2017Inventor: David A. Heavner
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Publication number: 20170219576Abstract: A lateral flow diagnostic assay device is defined by a substrate having a top surface that further includes a sample addition zone for receiving a sample, a transport and reaction zone, and a wicking zone. Each of the sample addition zone, reaction and transport zone and wicking zone are disposed on the top surface of the substrate and fluidically interconnected by means that permit lateral capillary flow along at least one fluid flow path from the sample addition zone to the wicking zone. The assay device further includes a capillary vent disposed in relation to the wicking zone, the capillary vent having an overall length and cross sectional area that creates a backpressure so as to control the flow rate of a sample applied to the assay device.Type: ApplicationFiled: January 27, 2017Publication date: August 3, 2017Inventor: David A. Heavner
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Publication number: 20170010262Abstract: A method for providing quality control on a lateral flow assay device or for triggering a process-related step, the device including a substrate having at least one sample receiving area, at least one reagent zone downstream and in fluid communication with the at least one sample receiving area, at least one detection zone downstream and in fluid communication with the at least one reagent zone and at least one wicking zone downstream of the at least one detection zone, each fluidly interconnected therewith along at least one fluid flow path. The detection material provided in the at least one reagent zone produces a detectable signal that can be tracked and monitored prior to the completion of at least one test being performed on the lateral flow assay device.Type: ApplicationFiled: September 23, 2016Publication date: January 12, 2017Inventors: Zhong Ding, James E. Robinson, David A. Tomasso, David A. Heavner
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Patent number: 9470678Abstract: A method for providing quality control on a lateral flow assay device or for triggering a process-related step, the device including a substrate having at least one sample receiving area, at least one reagent zone downstream and in fluid communication with the at least one sample receiving area, at least one detection zone downstream and in fluid communication with the at least one reagent zone and at least one wicking zone downstream of the at least one detection zone, each fluidly interconnected therewith along at least one fluid flow path. The detection material provided in the at least one reagent zone produces a detectable signal that can be tracked and monitored prior to the completion of at least one test being performed on the lateral flow assay device.Type: GrantFiled: November 15, 2013Date of Patent: October 18, 2016Assignee: Ortho-Clinical Diagnostics, Inc.Inventors: Zhong Ding, James E. Robinson, David A. Tomasso, David A. Heavner
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Publication number: 20160041163Abstract: A lateral flow assay device includes a substrate having a top surface, as well as a sample receiving area disposed upon the top surface. At least one fluid flow path extends along the substrate from the sample receiving area, wherein the sample receiving area can be placed in contact with a peripheral reservoir formed at a sample addition area to draw sample therefrom in a controlled manner. The device can further include a reagent area that is designed to promote uniform dissolution of a deposited detection material by a sample moved through the device along the fluid flow path as well, as a flow channel configure to promote mixing of sample and reagent and an absorbing or wicking zone configured to affect various flow characteristics.Type: ApplicationFiled: August 6, 2015Publication date: February 11, 2016Inventors: Zhong Ding, Philip C. Hosmier, Edward R. Scalice, Daniel P. Salotto, David A. Heavner
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Publication number: 20160018394Abstract: An assay device for determining the concentration of multiple analytes or controls, where the device is capable of determining the presence or concentration of at least six analytes or controls includes: a fluid flow path; a liquid sample addition zone; a reagent zone downstream and in fluid communication with the sample addition zone containing one or more reagents; multiple detection zones in fluid communication with the reagent zone. The fluid flow path, which extends through the detection zones, has a length capable of having at least six detection zones linearly spaced at least a sufficient distance apart in order to discriminate each signal peak from its adjacent signal peak. The device further includes a wicking zone in fluid communication with the detection zones having a capacity to receive liquid sample flowing from the detection zone.Type: ApplicationFiled: July 17, 2014Publication date: January 21, 2016Inventors: Susan Danielson, James D. Kanaley, Zhong Ding, Philip C. Hosimer, James W. Hassett, Timothy C. Warren, David A. Heavner
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Publication number: 20150153338Abstract: An assay device includes: a liquid sample zone; a reagent zone downstream and in fluid communication with the sample addition zone containing a reagent material; a detection zone in fluid communication with the reagent zone. The detection zone has a substrate and projections which extend substantially vertically from the substrate, wherein the projections have a height, cross-section and a distance between one another that defines a capillary space between the projections capable of generating capillary flow parallel to the substrate surface. The device is capable of creating a reagent plume in the detection zone that includes liquid sample and dissolved reagent, where the width of the reagent plume extends substantially across the width of the detection zone, The device further includes a wicking zone in fluid communication with the detection zone having a capacity to receive liquid sample flowing from the detection zone.Type: ApplicationFiled: December 22, 2014Publication date: June 4, 2015Inventors: Philip C. Hosimer, Zhong Ding, David A. Heavner, Edward R. Scalice, Susan Danielson, James D. Kanaley, David A. Tomasso, Timothy C. Warren
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Publication number: 20140206098Abstract: An assay device includes: a liquid sample zone; a reagent zone downstream and in fluid communication with the sample addition zone containing a reagent material; a detection zone in fluid communication with the reagent zone. The detection zone has a substrate and projections which extend substantially vertically from the substrate, wherein the projections have a height, cross-section and a distance between one another that defines a capillary space between the projections capable of generating capillary flow parallel to the substrate surface. The device is capable of creating a reagent plume in the detection zone that includes liquid sample and dissolved reagent, where the width of the reagent plume extends substantially across the width of the detection zone, The device further includes a wicking zone in fluid communication with the detection zone having a capacity to receive liquid sample flowing from the detection zone.Type: ApplicationFiled: January 18, 2013Publication date: July 24, 2014Applicant: Ortho-Clinical Diagnostics, Inc.Inventors: Philip C. Hosimer, Zhong Ding, David A. Heavner, Edward R. Scalice, Susan Danielson, James D. Kanaley, David A. Tomasso, Timothy C. Warren
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Publication number: 20140141527Abstract: A method for providing quality control on a lateral flow assay device or for triggering a process-related step, the device including a substrate having at least one sample receiving area, at least one reagent zone downstream and in fluid communication with the at least one sample receiving area, at least one detection zone downstream and in fluid communication with the at least one reagent zone and at least one wicking zone downstream of the at least one detection zone, each fluidly interconnected therewith along at least one fluid flow path. The detection material provided in the at least one reagent zone produces a detectable signal that can be tracked and monitored prior to the completion of at least one test being performed on the lateral flow assay device.Type: ApplicationFiled: November 15, 2013Publication date: May 22, 2014Applicant: Ortho-Clinical Diagnostics, Inc.Inventors: Zhong Ding, James E. Robinson, David A. Tomasso, David A. Heavner
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Patent number: 8323585Abstract: A fluid aspirating/dispensing member includes a sample cavity for sample acquisition and a sealable cavity that, once sealed, permits the separation of particles from the remainder of a fluid sample within the sample cavity after centrifugation or other separation means. The fluid aspirating/dispensing members, either individually or as part of an array, increase the efficiency of sample processing before analysis by a clinical analyzer.Type: GrantFiled: July 5, 2012Date of Patent: December 4, 2012Assignee: Ortho-Clinical Diagnostics, Inc.Inventor: David A. Heavner
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Publication number: 20120276654Abstract: A fluid aspirating/dispensing member includes a sample cavity for sample acquisition and a sealable cavity that, once sealed, permits the separation of particles from the remainder of a fluid sample within the sample cavity after centrifugation or other separation means. The fluid aspirating/dispensing members, either individually or as part of an array, increase the efficiency of sample processing before analysis by a clinical analyzer.Type: ApplicationFiled: July 5, 2012Publication date: November 1, 2012Applicant: Ortho-Clinical Diagnostics, Inc.Inventor: David A. Heavner
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Publication number: 20100015690Abstract: A fluid aspirating/dispensing member includes a sample cavity for sample acquisition and a sealable cavity that, once sealed, permits the separation of particles from the remainder of a fluid sample within the sample cavity after centrifugation or other separation means. The fluid aspirating/dispensing members, either individually or as part of an array, increase the efficiency of sample processing before analysis by a clinical analyzer.Type: ApplicationFiled: July 16, 2008Publication date: January 21, 2010Applicant: Ortho-Clinical Diagnostics, Inc.Inventor: David A. Heavner
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Publication number: 20050185177Abstract: A method for measuring the presence or concentration of an analyte in a sample by spectrophotometry: providing an open top cuvette having a sample with an analyte to be measured; providing a light source and a detector for detecting emitted light; taking at least two measurements that includes: (i) directing at least two beams of light from the light source to different locations on the cuvette; (ii) passing the at least two beams through the cuvette at their respective locations and through the sample to be measured; and (iii) measuring at least two respective emitted light beams with the detector; and comparing the at least two emitted light beams to determine if: all the emitted light beams should be disregarded; one or more of the emitted light beams should be disregarded; or the sample absorbances should be averaged. In a preferred embodiment, the method includes taking at least three measurements.Type: ApplicationFiled: January 31, 2005Publication date: August 25, 2005Inventors: Donald Moran, Michael LaCourt, Davis Freeman, Merrit Jacobs, David Heavner
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Patent number: 5330716Abstract: A pusher blade and its housing are described, in which the blade has a stiff front end for engaging slide-type test elements, and a flexible body portion and back end. The housing forces the blade to curve through an angle, preferably about 90.degree. C., to minimize the extension in one direction the blade would have if it were entirely rigid.The housing can provide for separate stacks of elements in separate environments to be engaged by the blade, since sealing means are provided for preventing substantial intermixing of the environments when the blade is activated.Type: GrantFiled: September 28, 1990Date of Patent: July 19, 1994Assignee: Eastman Kodak CompanyInventors: James D. Shaw, Martin F. Muszak, David A. Heavner