US 11,980,352 B2
Nasal irrigation diagnostic assembly
Keith Rubin, Ft. Lauderdale, FL (US); Ken Solovay, Weston, FL (US); James Layer, Cooper City, FL (US); Alfred A. Desimone, Ft. Lauderdale, FL (US); and Bin Yan, Miami, FL (US)
Assigned to PREVA, LLC, Weston, FL (US)
Filed by Preva, LLC, Weston, FL (US)
Filed on Aug. 15, 2022, as Appl. No. 17/888,396.
Application 17/888,396 is a continuation of application No. 16/796,545, filed on Feb. 20, 2020, abandoned.
Application 16/796,545 is a continuation in part of application No. 16/688,654, filed on Nov. 19, 2019, granted, now 11,179,513, issued on Nov. 23, 2021.
Application 16/688,654 is a continuation of application No. 15/604,205, filed on May 24, 2017, abandoned.
Application 15/604,205 is a continuation in part of application No. 15/299,792, filed on Oct. 21, 2016, abandoned.
Application 16/688,654 is a continuation in part of application No. 15/257,409, filed on Sep. 6, 2016, granted, now 10,478,547, issued on Nov. 19, 2019.
Application 15/257,409 is a continuation in part of application No. 13/664,034, filed on Oct. 30, 2012, granted, now 9,433,724, issued on Sep. 6, 2016.
Claims priority of provisional application 62/244,362, filed on Oct. 21, 2015.
Prior Publication US 2023/0032349 A1, Feb. 2, 2023
Int. Cl. A61B 10/00 (2006.01); A61B 5/00 (2006.01); A61B 5/145 (2006.01); A61B 5/1468 (2006.01); A61M 3/02 (2006.01); G01N 33/487 (2006.01); G01N 33/543 (2006.01); G01N 33/558 (2006.01); G01N 33/569 (2006.01)
CPC A61B 10/0045 (2013.01) [A61B 5/145 (2013.01); A61B 5/14507 (2013.01); A61B 5/1468 (2013.01); A61B 5/6819 (2013.01); A61M 3/02 (2013.01); A61M 3/0212 (2014.02); G01N 33/4875 (2013.01); G01N 33/54353 (2013.01); G01N 33/558 (2013.01); G01N 33/569 (2013.01); G01N 33/56911 (2013.01); A61M 2210/0618 (2013.01); G01N 2333/235 (2013.01); G01N 2469/10 (2013.01)] 7 Claims
OG exemplary drawing
 
1. A nasal irrigation diagnostic assembly comprising:
an irrigation device including a housing having a first chamber section structured to removably contain irrigating fluid therein and a second chamber section,
an applicator connected to said housing and dimensioned and configured to be inserted in the nasal cavity,
said applicator comprising a first passage and a second passage, said first passage at least partially defining a flow path of irrigating fluid from said first chamber section into the nasal cavity, said second passage at least partially defining a path of travel of a drained waste solution from the nasal cavity into said second chamber section,
said second chamber section further defining a fluid collection portion disposed and structured to retain a biological sample in the form of waste solution, from the nasal cavity, resulting from irrigation,
said fluid collection portion disposed and structured to retain a biological sample, in the form of waste solution from the nasal cavity resulting from irrigation,
a detection member, structured to determine the existence of at least one analyte biological sample of the waste solution, disposed in an operative position on said irrigation device in exposed relation to the biological sample,
said detection member comprising a plurality of zones individually structured to analyze the biological sample upon engagement of said detection member with the biological sample,
said plurality of zones include at least a reaction zone and a detection zone relatively disposed in successive fluid engagement with the waste solution and the biological sample,
said reaction zone and said detection zone respectively include reagents cooperatively formulated and reactive to detect the existence of the at least one analyte, comprising a pathogen/pathogen specific protein, in the biological sample of the waste solution,
said reaction zone including an analyte specific antibody-chromophore conjugate soluble in the waste solution; said analyte specific antibody-chromophore conjugate is configured to bind with the at least one analyte,
said detection zone includes a first immobilized antibody configured to bind with and immobilize the at least one analyte,
said plurality of zones further comprises a control zone, said control zone configured to provide an indication of valid operation of at least said detection member, said detection member further comprising a sample pad disposed in fluid communicating relation to said plurality of zones,
said operative position comprising at least said sample pad disposed within said fluid collection, in direct engagement with the waste solution from the nasal cavity collected within the fluid collection portion, and
said detection member comprises a paper-based material having a porous construction structured to facilitate capillary flow of the waste solution from the sample pad to each of the plurality of zones.