Cartridge-based detection system

A cartridge-based detection system (100) to prepare an injected sample to be investigated for determination of microbial pathogen content or another analyte of interest using a detector, wherein the system (100) comprises:

• (a) a syringe (140) having a needle (145);
• (b) a field-safe cartridge (110), wherein a syringe port (120) is disposed on the cartridge and a syringe channel (125) is disposed in the cartridge (110) between a septum (130) and the syringe port (120) and fluidly connected to the syringe port (120), wherein a first collar (127) is disposed in the syringe channel (125) adjacent to the syringe port (120), wherein a second collar (128) is disposed in the syringe channel (125) proximal to the first collar (127), wherein the first collar (127) and the second collar (128) each comprise a diameter smaller than a diameter of the syringe channel (125) for sealing against a syringe body (141) upon insertion of the syringe (140), wherein a syringe channel volume is greater than a volume of the syringe (140) for safely containing an unintentional discharge from the syringe (140) before piercing the septum (130);
• (c) a plurality of reagent chambers (160) disposed in the cartridge (110) comprising a first anterior reagent chamber (161), a first posterior reagent chamber (162), a plurality of additional sequentially mated anterior reagent chambers (161) and opposing posterior reagent chambers (162), and a final anterior reagent chamber (163), wherein the first anterior reagent chamber (161) is adjacent to the septum (130);
• and
• (d) a rotating cylindrical dial (170) having a dial channel (175) disposed therethrough, wherein the dial (170) facilitates a sequential introduction of various fluids contained in the reagent chambers (160) into the sample to be investigated through the dial channel (175), wherein the dial (170) is centrally disposed in the cartridge (110), wherein the dial (170) comprises a dial top surface (171), a dial bottom surface (172), and a cylindrical dial side wall (173), wherein the dial (170) extends through the cartridge (110) to engage an inside wall of the cartridge bottom surface (116), wherein the dial (170) comprises a dial thickness (174) from the dial top surface (171) to the dial bottom surface (172) about equal to the cartridge thickness (117), wherein the dial channel (175) is disposed through the dial (170) from a first location on the dial side wall (173) to a second location on an opposing side of the dial side wall (173), wherein a dual window region of interrogation (180) is centrally disposed in the dial (170), wherein the dual window region of interrogation (180) is transparent, wherein the dial channel (175) is disposed between a top window (181) and a bottom window (182) of the dual window region of interrogation (180), wherein a cross-section of the dial channel (175) is greater at the first location on the dial side wall (173) and the second location on the dial side wall (173) than the cross-section of the dial channel (175) between the top window (181) and the bottom window (182) of the region of interrogation (180), wherein a cross-sectional area of the dial channel (175) reduces towards the region of interrogation (180) and increases towards the dial side wall (173) to create bubbles upon agitation of the sample to be investigated, wherein when the dial (170) is rotated into a position, each mated anterior reagent chamber (161) and posterior reagent chamber (162) are fluidly connected via the dial channel (175),

A method for preparing an injected sample to be investigated for determination of a microbial pathogen or another analyte of interest using a detector, wherein the method comprises:

• (a) obtaining a disposable cartridge-based detection system (100) to prepare an injected sample to be investigated for determination of the presence of microbial pathogens or other analytes of interest using a detector, wherein the system (100) comprises a syringe (140) having a needle (145);
• a field-safe, hollow cartridge (110) having a cartridge anterior end (111), a cartridge posterior end (112), a cartridge first side (113), a cartridge second side (114), a cartridge top surface (115), and a cartridge bottom surface (116), wherein the cartridge (110) comprises a cartridge thickness (117) between the cartridge top surface (115) and the cartridge bottom surface (116);
• wherein a syringe port (120) is disposed on the cartridge posterior end (112) proximal to the cartridge first side (113), wherein a cylindrical syringe channel (125) is disposed in the cartridge (110) between a septum (130) and the syringe port (120) and fluidly connected to the syringe port (120), wherein an elastomeric first collar (127) is disposed in the syringe channel (125) adjacent to the syringe port (120), wherein an elastomeric second collar (128) is disposed in the syringe channel (125) proximal to the first collar (127), wherein the first collar (127) and the second collar (128) each comprise a diameter smaller than a diameter of the syringe channel (125) for sealing against a syringe body (141) upon insertion of the syringe (140), wherein a syringe channel volume is greater than a volume of the syringe (140) for safely containing an unintentional discharge from the syringe (140) before piercing the septum (130), wherein a tapered syringe lock (129) is disposed on a syringe channel side wall (126) for locking a fully inserted syringe (140) into position, wherein a locking tab (150) is slidably disposed in a locking tab channel (155), wherein the locking tab channel (155) comprising a locking tab channel anterior side (156) and a locking tab channel posterior side (157) is disposed on the cartridge posterior end (112), wherein a first locking tab stop (151) is disposed on the locking tab channel posterior side (157) adjacent to the syringe port (120) to hold the locking tab into a first, open position, wherein a second locking tab stop (152) is disposed on the locking tab channel posterior side (157) at a distance equal to a locking tab length from an opposite syringe channel side wall (126) to hold the locking tab into a second, closed position, wherein a tensioning projection (153) is disposed on the locking tab channel anterior side (156) between the first locking tab stop (151) and the second locking tab stop (152) to provide tension on the locking tab (150) in the first position or the second position;
• a plurality of reagent chambers (160) disposed in the cartridge (110) comprising a first anterior reagent chamber (161), a first posterior reagent chamber (162), a plurality of additional sequentially mated anterior reagent chambers (161) and opposing posterior reagent chambers (162), and a final anterior reagent chamber (163), wherein the first anterior reagent chamber (161) is adjacent to the septum (130);
• and a rotating cylindrical dial (170) having a dial channel (175) disposed therethrough, wherein the dial (170) facilitates a sequential introduction of various fluids contained in the reagent chambers (160) into the sample to be investigated through the dial channel (175), wherein the dial (170) is centrally disposed in the cartridge (110), wherein the dial (170) comprises a dial top surface (171), a dial bottom surface (172), and a cylindrical dial side wall (173), wherein the dial (170) extends through the cartridge (110) to engage an inside wall of the cartridge bottom surface (116), wherein the dial (170) comprises a dial thickness (174) from the dial top surface (171) to the dial bottom surface (172) about equal to the cartridge thickness (117), wherein the dial channel (175) is disposed through the dial (170) from a first location on the dial side wall (173) to a second location on an opposing side of the dial side wall (173), wherein a dual window region of interrogation (180) is centrally disposed in the dial (170), wherein the dual window region of interrogation (180) is transparent, wherein the dial channel (175) is disposed between a top window (181) and a bottom window (182) of the dual window region of interrogation (180), wherein a cross-section of the dial channel (175) is greater at the first location on the dial side wall (173) and the second location on the dial side wall (173) than the cross-section of the dial channel (175) between the top window (181) and the bottom window (182) of the region of interrogation (180), wherein a cross-sectional area of the dial channel (175) reduces towards the region of interrogation (180) and increases towards the dial side wall (173) to create bubbles upon agitation of the sample to be investigated, wherein when the dial (170) is rotated into a position, each mated anterior reagent chamber (161) and posterior reagent chamber (162) are fluidly connected via the dial channel (175), wherein the dial (170) comprises a first dial indentation (185) and a second dial indentation (185) adapted to receive a finger or a thumb of a user inserted therein for manually rotating the dial (170), wherein the dial (170) comprises a ratchet mechanism (190) having a grooved track (191) disposed on a cartridge inside surface and a mated spring-biased pin (192) for following the grooved track (191), wherein for placement of the dial (170) to a first position, the dial (170) is rotated in a clockwise manner wherein the dial (170) encounters a first front stop, wherein the dial channel (175) is fluidly connected to and in alignment with the first anterior reagent chamber (161) and the first posterior reagent chamber (162), wherein for placement of the dial (170) in a next position, the dial (170) is rotated in a counter clockwise manner to release the dial (170) from the first front stop wherein the dial (170) encounters a first back stop, wherein the dial is rotated in a clockwise manner wherein the dial (170) encounters a next front stop, wherein the dial channel (175) is fluidly connected to and in alignment with the next anterior reagent chamber (161) and the next posterior reagent chamber (162), wherein for placement of the dial (170) in a final position, the dial (170) is rotated in a counter clockwise manner to release the dial (170) from the next front stop wherein the dial (170) encounters a final back stop, wherein the dial is rotated in a clockwise manner wherein the dial (170) encounters a final front stop, wherein the dial channel (175) is fluidly connected to and in alignment with the final anterior reagent chamber (161), wherein upon reaching the final position, the dial (170) is prevented from rotation to a prior position;
• wherein each chamber comprises a reagent disposed therein;
• (b) drawing a sample to be investigated into the syringe (140);
• (c) inserting the syringe (140) into the syringe channel (125), wherein the syringe body (141) slides through the first collar (127) and the second collar (128), wherein the first collar (127) and the second collar (128) hold the syringe (140) into the syringe channel (125), wherein the syringe needle (145) pierces the septum (130), wherein a syringe back edge slides past the syringe lock (129) until the syringe lock (129) snaps over the syringe back edge affixing it into position;
• (d) activating the syringe (140) dispensing the sample to be investigated into the first anterior reagent chamber (161);
• (e) depressing the locking tab (150) toward the cartridge (110) to release it from the first locking tab stop (151), wherein the locking tab (150) is slidably moved to the second position to cover the syringe (140) and the syringe channel (125) to block the syringe (140) from removal, wherein the second locking tab stop (152) prevents the locking tab (150) from sliding back to the first position via tension from the tensioning projection (153)
• (f) moving the dial (170) to a first position, wherein the device is shaken or rocked to flush the fluid across the region of interrogation (180) between the first anterior reagent chamber (161) and the first posterior reagent chamber (162), wherein upon agitating, bubbles are formed and passed through the dial channel (175), causing the microbial pathogens and/or other analytes of interest to be transported in close proximity to inside surfaces of the region of interrogation (180) due to bubble flow through the dial channel (175), wherein the microbial pathogens and/or other analytes of interest are retained against the inside surfaces of the region of interrogation (180) of the dial channel (175);
• (g) moving the dial (170) to a next, sequential position, wherein the device is shaken, then rocked to flush the fluid across the region of interrogation (180) between the next anterior reagent chamber (161) and the next posterior reagent chamber (162), wherein upon shaking or rocking, bubbles are formed and passed through the dial channel (175), causing the microbial pathogens and/or other analytes of interest to be transported in close proximity to inside surfaces of the region of interrogation (180) via creation of a thin film on the inside surfaces due to bubble flow through the dial channel (175), wherein the microbial pathogens and/or other analytes of interest are retained against the inside surfaces of the region of interrogation (180) of the dial channel (175);
• (h) repeating the prior process until the dial (170) is moved into a final position, wherein the sample to be investigated is sealed into the final anterior reagent chamber (163) and the dial (170) is locked into position and prevented from rotation to a prior position;
• and
• (i) analyzing the targeted analyte through the region of interrogation (180) using visual indication, magnifying equipment, illuminating equipment, or other electromagnetic equipment;
• wherein the disposable cartridge-based detection system (100) prepares an injected sample to be investigated for determination of a microbial pathogen and/or another analyte of interest using a detector.