Point-of-care testing cartridge with sliding cap
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
B01L-003/00
G01N-035/00
출원번호
16854201
(2020-04-21)
등록번호
11161109
(2021-11-02)
발명자
/ 주소
Samsoondar, James
출원인 / 주소
INVIDX CORP.
대리인 / 주소
J.A. Lindeman & Co. PLLC
인용정보
피인용 횟수 :
0인용 특허 :
0
초록▼
A joint point-of-care testing (POCT) analyzer, and a system comprising an analyzer and a cartridge, for measuring one or more analyte quantities per unit volume of blood and one or more formed element quantities per unit volume of blood, is described. Examples of formed elements of blood are red blo
A joint point-of-care testing (POCT) analyzer, and a system comprising an analyzer and a cartridge, for measuring one or more analyte quantities per unit volume of blood and one or more formed element quantities per unit volume of blood, is described. Examples of formed elements of blood are red blood cells and white blood cells, and cell counts are determined by imaging using a two-dimensional multi-channel detector. Examples of analytes are hemoglobin and bilirubin, and hemoglobin and bilirubin concentrations are determined by spectroscopy using a one-dimensional multi-channel detector. Other examples of analytes are electrolytes, and electrolyte concentrations may be determined using biosensors incorporated in the cartridges.
대표청구항▼
1. A cartridge for measuring one or more properties of a blood sample, the cartridge comprising: a cartridge body; the cartridge body comprising an upper surface and a lower surface, the upper surface defining a sample storage well, and an optical chamber in fluid communication with the sample stora
1. A cartridge for measuring one or more properties of a blood sample, the cartridge comprising: a cartridge body; the cartridge body comprising an upper surface and a lower surface, the upper surface defining a sample storage well, and an optical chamber in fluid communication with the sample storage well;the sample storage well comprising a top portion for receiving the blood sample and a bottom portion, the bottom portion for releasing at least a portion of the blood sample into the optical chamber, or for receiving a liquid stored within the cartridge or from a system when the cartridge is in fluid communication with the system, the liquid for mixing with the blood sample to produce an altered blood sample and releasing at least a portion of the altered blood sample into the optical chamber;the optical chamber comprising at least one of an upper optical window and a lower optical window, the optical chamber for facilitating interrogation of the blood sample, or the altered blood sample by electromagnetic radiation;a post-optical chamber conduit for receiving excess blood or excess altered blood from the optical chamber;a flat surface located on the upper surface of the cartridge body, the flat surface of the cartridge body surrounding the top portion of the sample storage well;one or more tracks that slidingly attach a sliding cap to the cartridge body, the sliding cap having a top side and an underside, wherein the underside of the sliding cap comprises a cap flat surface, the cap flat surface faces, and slides along, the upper surface, the sliding cap slidable from a first position to a second position;in the first position the sample storage well is configured to receive the blood sample; andin the second position at least a portion the flat surface of the cartridge body mates with at least a portion of the cap flat surface and the sliding cap is positioned over the sample storage well; the cartridge further comprising at least one vent defined by a surface in the cap, or the at least one vent defined by a surface in the post-optical chamber conduit; and the cartridge comprising a means for moving the blood sample or the altered blood sample out of the sample storage well and into the optical chamber. 2. The cartridge of claim 1, wherein the means for moving the blood sample or the altered blood sample comprises: an air bladder disposed in the cartridge body, the air bladder in fluid communication with the sample storage well, the optical chamber and the post-optical chamber conduit, oran analyzer pump attachable to the cartridge body and in fluid communication with the sample storage well, the optical chamber and the post-optical chamber conduit. 3. The cartridge of claim 2, wherein: the at least one vent is defined by the surface of the post-optical chamber conduit, andthe flat surface of the cartridge body comprises an air bladder communication port or an associated analyzer pump communication port, and when the sliding cap is positioned over the sample storage well, a closed air passage is formed,the closed air passage operatively connecting the air bladder communication port, or the associated analyzer pump communication port to the sample storage well so that pressurized air from the air bladder, or the associated analyzer pump, is transferable to the sample storage well,wherein the closed air passage is facilitated by a groove set into the upper surface of the cartridge body and aligned with the cap flat surface when the sliding cap is in the second position,a recess set into the underside of the cap, ora combination thereof, whereby when the air bladder is squeezed, or the associated analyzer pump is activated, some, or all, of the blood sample is urged from the sample storage well towards the optical chamber, and air within the optical chamber is purged through the at least one vent. 4. The cartridge of claim 1, wherein the vent is defined by a surface in the cap, and the cartridge further comprises a cartridge exit duct operatively connected to the optical chamber, the cartridge exit duct attachable to an analyzer pump so that when the cartridge body is operatively connected to the analyzer pump, negative pressure from the analyzer pump is transferable through the exit duct and the optical chamber to the bottom portion of the sample storage well. 5. A system for measuring one or more properties of a blood sample, the system comprising a cartridge of claim 1 and an analyzer, the analyzer comprising: a receptor for receiving the cartridge;at least one source of interrogating electromagnetic radiation (EMR) for interrogating at least some of the blood sample when the blood sample is positioned within the optical chamber, or for interrogating at least some of the altered blood sample when the altered blood sample is positioned within the optical chamber;at least one of:a one-dimensional multi-channel detector for receiving EMR emerging from one of the blood sample in the optical chamber or the altered blood sample in the optical chamber, via an EMR dispersing element, the EMR dispersing element for providing wavelength-specific EMR and the one-dimensional multi-channel detector for generating wavelength-specific electrical signals, ora two-dimensional multi-channel detector for receiving EMR emerging from one of the blood sample in the optical chamber or the blood sample in the optical chamber, and generating detector-specific electrical signals;one or more analog to digital converter for receiving one or more of the wavelength-specific electrical signals for generating wavelength-specific digital information, or the detector-specific electrical signals for generating detector-specific digital information; andone or more processors for controlling the analyzer and transforming at least one of the wavelength-specific digital information and the detector-specific digital information into the one or more properties of the blood sample. 6. The system of claim 5, wherein the system comprises the one-dimensional multi-channel detector and the two-dimensional multi-channel detector. 7. The system of claim 5, wherein the means for moving the blood sample or the altered blood sample comprises: an air bladder disposed in the cartridge body, the air bladder in fluid communication with the optical chamber and the sample storage well, oran analyzer pump attachable to the cartridge body and in fluid communication with the optical chamber and the sample storage well. 8. The cartridge of claim 1, wherein the cartridge further comprises means for mitigating blood flow out of the bottom portion of the sample storage well when blood is received in the sample storage well through the top portion. 9. A cartridge for measuring one or more properties of a blood sample, the cartridge comprising: a cartridge body;the cartridge body comprising an upper surface and a lower surface, the upper surface defining a sample storage well, the sample storage well comprising a top portion for receiving the blood sample, and a bottom portion for receiving a liquid for mixing with the blood sample to produce an altered blood sample;an optical chamber in fluid communication with the sample storage well, the optical chamber comprising at least one of an upper optical window and a lower optical window, the optical chamber for facilitating sample interrogation by electromagnetic radiation;a flat surface located on the upper surface of the cartridge body, the flat surface of the cartridge body surrounding the top portion of the sample storage well;a hollow sliding cap, slidably attached to the upper surface, the hollow sliding cap comprising an upper cap wall, a lower cap wall, side walls connecting the upper cap wall with the lower cap wall, the upper cap wall, the lower cap wall and the side walls defining a cap mixing cavity, the upper cap wall defining a cap vent for releasing pressure in the cap mixing cavity, the lower cap wall comprising a lower cap flat surface, the lower cap wall defining a cap inlet leading into the cap mixing cavity, the lower flat cap surface faces and slides along the upper surface, the hollow sliding cap movable from a first position to a second position;in the first position the sample storage well is configured to receive the blood sample;in the second position at least a portion of the flat surface of the cartridge body mates with at least a portion of the lower cap flat surface, and at least a section of the top portion of the sample storage well and at least a section of the cap inlet are brought into alignment so that the sample storage well is in fluid communication with the cap mixing cavity; and the cartridge comprising a means for moving the blood sample and the liquid into the cap mixing cavity, and for moving the altered blood sample into the optical chamber. 10. The cartridge of claim 9, wherein the cartridge body further comprises one of: one or more tracks that slidingly attach the hollow sliding cap to the cartridge body, the one or more tracks for sliding the hollow sliding cap from the first position to the second position, anda pivot that slidingly attaches the hollow sliding cap to the cartridge body, the pivot for rotatably sliding the hollow sliding cap from the first position to the second position. 11. The cartridge of claim 9, wherein the cartridge body further comprises: a directional valve stem moveable from a first position to a second position wherein, in the first position, the blood sample and the liquid are not in fluid communication, in the second position, a fluid communication between the blood sample and liquid is established; anda means for moving the valve stem from the first position to the second position. 12. The cartridge of claim 11 wherein, when the cartridge is inserted into an analyzer, the means for moving the valve stem from the first position to the second position is provided by the analyzer. 13. The cartridge of claim 12, wherein the cartridge body further comprises: a sealed blister containing the liquid,a means for rupturing the sealed blister to produce a ruptured blister,a liquid holding conduit in communication with the sample storage well when the valve is in the second position, the liquid holding conduit for temporarily holding a metered volume of the liquid after the liquid is released from the ruptured blister. 14. The cartridge of claim 12, wherein the cartridge body further comprises, a flappable valve element for preventing backflow of the liquid from the liquid holding conduit into the ruptured blister. 15. The cartridge of claim 9, wherein the post-optical chamber conduit comprises one or more reagents, the one or more reagents for mixing with the blood sample when present to produce an altered blood sample, and a means for drawing the altered blood sample into the optical chamber for altered blood sample interrogation. 16. A system for measuring one or more properties of a blood sample, the system comprising the cartridge of claim 9 and an analyzer, the analyzer comprising: a receptor for receiving the cartridge;at least one source of interrogating electromagnetic radiation (EMR) for interrogating at least some of the altered blood when the altered blood is positioned within the optical chamber;at least one of:a one-dimensional multi-channel detector for receiving EMR emerging from the altered blood sample in the optical chamber via an EMR dispersing element, the EMR dispersing element for providing wavelength-specific EMR, and the one-dimensional multi-channel detector for generating wavelength-specific electrical signals, ora two-dimensional multi-channel detector for receiving EMR emerging from the altered blood sample in the optical chamber, and generating detector-specific electrical signals;one or more analog to digital converter for receiving one or more of the wavelength-specific electrical signals for generating wavelength-specific digital information and the detector-specific electrical signals for generating detector-specific digital information; andone or more processors for controlling the analyzer and transforming at least one of the wavelength-specific digital information and the detector-specific digital information into the one or more properties of a blood sample. 17. The system of claim 16, wherein system comprises the one-dimensional multi-channel detector and the two-dimensional multi-channel detector. 18. The system of claim 16, wherein the means for moving the blood sample and the liquid into the cap mixing cavity, and for moving the altered blood sample into the optical chamber comprises: an air bladder disposed in the cartridge body, the air bladder in fluid communication with the optical chamber and the sample storage well, oran analyzer pump attachable to the cartridge body and in fluid communication with the optical chamber and the sample storage well. 19. The system of claim 16, wherein the cartridge comprises the liquid in a sealed blister, or the cartridge is in fluid communication with the analyzer and the analyzer comprises the liquid in an analyzer liquid pouch. 20. The cartridge of claim 9, wherein the means for moving the blood sample and the liquid, and for moving the altered blood sample comprises: an air bladder disposed in the cartridge body, the air bladder in fluid communication with the optical chamber and the sample storage well, oran analyzer pump attachable to the cartridge body and in fluid communication with the optical chamber and the sample storage well. 21. A cartridge for measuring one or more properties of a blood sample, the cartridge comprising: a cartridge body comprising an upper surface and a lower surface, the upper surface defining a sample storage well, and one or more detection chambers in fluid communication with the sample storage well;the sample storage well comprising a top portion for receiving the blood sample and a bottom portion, the bottom portion for releasing at least a portion of the blood sample into the one or more detection chambers;a detection chamber exit conduit for receiving excess blood from the one or more detection chambers;a flat surface located on the upper surface of the cartridge body, the flat surface of the cartridge body surrounding the top portion of the sample storage well;one or more tracks that slidingly attach a sliding cap to the cartridge body, the sliding cap having a top side and an underside, wherein the underside of the sliding cap comprises a cap flat surface, the cap flat surface faces, and slides along, the upper surface, the sliding cap slidable from a first position to a second position;in the first position the sample storage well is configured to receive the blood sample; andin the second position at least a portion of the flat surface of the cartridge body mates with at least a portion of the cap flat surface and the sliding cap is positioned over the sample storage well; the cartridge further comprising at least one vent defined by a surface in the cap, or the at least one vent defined by a surface in the detection chamber exit conduit; and the cartridge comprising a means for moving the blood sample out of the sample storage well and into the one or more detection chambers. 22. The cartridge of claim 21, wherein the means for moving the blood sample comprises: an air bladder disposed in the cartridge body, the air bladder in fluid communication with the sample storage well, the one or more detection chambers and the detection chamber exit conduit, oran analyzer pump attachable to the cartridge body and in fluid communication with the sample storage well, the one or more detection chambers and the detection chamber exit conduit. 23. The cartridge of claim 21, wherein the one or more detection chambers comprises an optical chamber having at least one of an upper optical window and a lower optical window, the optical chamber for facilitating interrogation of the blood sample by electromagnetic radiation. 24. The cartridge of claim 21, wherein the one or more detection chambers comprises an electrochemical sensor chamber having at least one of an amperometric sensor, a conductivity sensor and a potentiometric sensor. 25. The cartridge of claim 21, wherein the one or more detection chambers comprises an optical chamber having at least one of an upper optical window and a lower optical window, the optical chamber for facilitating interrogation of the blood sample by electromagnetic radiation, and an electrochemical sensor chamber having at least one of an amperometric sensor, a conductivity sensor and a potentiometric sensor, and wherein the optical chamber is disposed between the sample storage well and the electrochemical sensor chamber, whereby the electrochemical sensor chamber receives blood flowing out of the optical chamber. 26. The cartridge of claim 25, further comprising means for calibrating at least one of the electrochemical sensors. 27. The cartridge of claim 21, wherein the one or more tracks is a female track having a first height defined as a height along a first portion of the track, wherein the first portion of the track is a portion of the track occupied by the cap when the cap is in the first position, anda second height defined as a height along a second portion of the track, wherein the second portion of the track is a portion of the track occupied by the cap when the cap is in the second position, whereinthe first height and the second height are sufficiently high to facilitate movement of the cap along the track, and wherein the second height is sufficiently smaller than the first height in order to provide an airtight seal between the cap and the cartridge when the cap is in the second position. 28. The cartridge of claim 21, wherein cartridge further comprises one or more reagents and means for mixing the blood sample and one or more reagents. 29. The claim of cartridge 21, wherein the cartridge further comprises means for mitigating blood flow out of the bottom portion of the sample storage well when blood is received in the sample storage well through the top portion.
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