It is claimed:
1. An assay device for measuring serum cholesterol associated with high-density lipoproteins (HDL) in a blood fluid sample containing lipoproteins other than HDLs, the device comprising:
a sample distribution array;
a HDL test pad in which HDL concentration can be assayed; and
a reagent pad containing a binding reagent effective to selectively bind and remove non-HDLs from the fluid sample;
wherein said HDL test pad and said reagent pad are joined.
2. The device of claim 1, wherein said HDL test pad and said reagent pad are joined by a heat formed bond.
3. The device of claim 1, wherein said HDL test pad and said reagent pad are joined by an acrylic acid copolymer adhesive bond.
4. The device of claim 3, wherein said acrylic acid copolymer is ethylene acrylic acid copolymer.
5. The device of claim 1, wherein at least one of said HDL test pad or said reagent pad is composed of a polysulfone layer.
6. The device of claim 1, further comprising a sieving pad effective to remove cellular components from the blood fluid sample prior to the sample contacting said sample distribution array.
7. The device of claim 1, further comprising a cassette body for containing said sieving pad, said cassette body comprising a well for containing said blood fluid sample and in fluid communication with said sieving pad.
8. The device of claim 7, further comprising a reaction bar comprising mounting means effective to attach said reaction bar to said cassette body.
9. The device of claim 1, wherein said reagent comprises a binding polyanionic reagent.
10. The device of claim 9, wherein said binding polyanionic reagent includes a sulfonated polysaccharide.
11. The device of claim 1, wherein said HDL test pad contains reagents which produce a detectable change in the presence of HDL cholesterol.
12. The device of claim 11, wherein said change can be detected optically.
13. The device of claim 1, wherein said HDL test pad comprises a biosensor.
14. The device of claim 13, wherein said biosensor is effective to electrochemically measure production of oxygen or hydrogen peroxide.
15. A method of preparing a device suitable for measuring serum cholesterol comprising:
providing a reagent pad and an HDL test pad formed of an asymmetric polysulfone membrane having a small pore side and an open pore side;
orienting the reagent pad with the HDL test pad such that the small pore side of the reagent pad contacts the open pore side of the HDL test pad;
heating to adhere said HDL test pad and said reagent pad; and
applying (i) HDL test reagents to said HDL test pad, and (ii) a reagent effective to selectively bind and remove non-HDLs from a fluid sample to said reagent pad to form said device.
16. The method of claim 15, wherein said heating is at a temperature above 165 C.
17. A method of preparing a device suitable for measuring serum cholesterol comprising:
coating a reagent pad with an acrylic acid copolymer;
applying (i) HDL test reagents to said HDL test pad, and (ii) a reagent effective to selectively bind and remove non-HDLs from a fluid sample to said reagent pad;
heating to adhere said HDL test pad and said reagent pad to form said device.
18. The method of claim 17, wherein said acrylic acid copolymer is ethylene acrylic acid copolymer.
19. The method of claim 18, wherein the ethylene acrylic acid copolymer is about 4.0% to about 10.0% emulsion.
20. The method of claim 17, further comprising the step of drying said reagent pad after said coating step.
21. The method of claim 17, wherein each of said HDL test pad and reagent pad have a small pore side and an open pore side; further comprising the step of orienting the HDL test pad and the reagent pad such that the small pore side of the reagent pad faces the open pore side of the HDL test pad.
22. The method of claim 17, wherein said heating step comprises applying a temperature of between 75 and 90 C.
23. A method of measuring serum cholesterol associated with high-density lipoproteins (HDL) in a blood fluid sample containing lipoproteins other than HDLs, comprising:
contacting the sample with a laminate comprising (i) an HDL test pad having a detectable indicator of HDL cholesterol, (ii) a reagent pad containing a reagent effective to selectively bind and remove non-HDLs from the fluid sample;
wherein said blood fluid sample passes through said laminate by capillary action andor gravity through said laminate to permit measurement of HDL concentration.
24. The method of claim 23, wherein contact between said sieving pad and said sample distribution pad is broken when a desired amount of sample has been transferred.
25. The method of claim 23, wherein said reagent comprises a sulfonated polysaccharide.
26. The method of claim 23, wherein at least one of said HDL test pad or said reagent pad comprises a porous polymeric membrane.
27. The method of claim 23, wherein said reagent pad comprises multiple stacked layers, at least one of which contains a reagent effective to bind non-HDLs.
28. The method of claim 23, wherein said measurement of HDL concentration is via optical detection.
29. The method of claim 23, wherein said HDL test pad comprises a biosensor.
30. The method of claim 29, wherein said biosensor is effective to electrochemically measure production of oxygen or hydrogen peroxide.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A wearable Continuous Renal Replacement Therapy (CRRT) device comprising:
a dialyzer;
a blood circuit configured to move blood from a patient through said dialyzer and back to said patient;
a dialysate circuit configured to circulate dialysate through said dialyzer and to refresh said dialysate;
a microcontroller configured to control the movement of blood and dialysate through said blood circuit and said dialysate circuit respectfully;
a dual-channel pulsatile pump, controlled by the microcontroller, the dual-channel pulsatile pump comprising a single motor, a first pump channel in the blood circuit and a second pump channel in the dialysate circuit, the dual-channel pulsatile pump adapted to be powered by a battery;
a covering substantially covering said wearable CRRT device;
means for enabling a patient to wear said wearable CRRT device attached to said covering;
a moisture sensor, inside said covering for sensing moisture, said moisture sensor providing a moisture signal that indicates moisture presence on the inside the covering, to said microcontroller.
2. The wearable CRRT device of claim 1, adapted to operate between 5 watts and 10 watts of power.
3. The wearable CRRT device of claim 1, adapted to electrically connect to and hold a rechargeable battery, said rechargeable battery adapted to provide at least 5 hours of continuous power to said wearable CRRT device.
4. The wearable CRRT device of claim 1, wherein said dialysate circuit is configured to circulate and refresh said dialysate for at least 24 hours without requiring said dialysate to be replaced.
5. The wearable CRRT device of claim 1, further comprising at least one filter in said dialysate circuit for refreshing said dialysate.
6. The wearable CRRT device of claim 5, further comprising a dialysate sensor for sensing a physical attribute of said dialysate, said physical attribute being indicative of whether at least one filter has decreased efficiency.
7. The wearable CRRT device of claim 6, wherein said dialysate sensor senses for at least one of pH and ammonia.
8. The wearable CRRT device of claim 1, wherein said dialyzer comprises less than about 0.5 meters of dialyzing surface area.
9. The wearable CRRT device of claim 1, wherein said microcontroller is configured to monitor a plurality of sensing circuits and to determine if an alarm condition exists, the microcontroller being further configured to set an alarm condition wherein the patient is informed of the alarm condition.
10. The wearable CRRT device of claim 9, wherein said microcontroller is configured to turn off predetermined parts of said wearable CRRT device in the event of the alarm condition.
11. The wearable CRRT device of claim 1, wherein said dialysate circuit comprises at least one filter cartridge that is removable and replaceable by the patient.
12. The wearable CRRT device of claim 1, further comprising a micropump connected to add dialysate additives to said dialysate circuit, said micropump adapted to add an additive at a rate of 0.1 ml to 400 ml per hour.
13. The wearable CRRT device of claim 1, further comprising:
a fluid valve connected to said dialysate circuit for extracting fluid from said dialysate circuit; and
a bladder, in fluid connection with said fluid valve, said microcontroller configured to control said fluid valve, said microcontroller adapted to receive a signal from said bladder indicative of the fullness of said bladder.
14. The wearable CRRT device of claim 1 further comprising a gas valve for removing bubbles or gas from said dialysate circuit.
15. A wearable Continuous Renal Replacement Therapy (CRRT) device comprising:
a dialyzer;
a dual-channel pulsatile pump, the dual channel pulsatile pump comprises a single motor, a first pump channel for blood, and a second pump channel for dialysate, the dual-channel pulsatile pump adapted to accept power from a battery source;
a blood circuit comprising the first pump channel and the dialyzer, the blood circuit being configured to carry blood from a patient, through the first pump channel, through the dialyzer, and back to the patient;
a filter section configured to recycle the dialysate for continued use;
a dialysate circuit comprising the second pump channel, the dialyzer and a dialysate filter, the dialysate circuit being configured to circulate dialysate through the second pump channel, through the dialyzer, through the dialysate filter and back to the second pump channel;
a microcontroller configured to monitor and control the movement of blood and dialysate through the blood circuit and the dialysate circuit respectively;
a covering substantially covering the blood circuit and the dialysate circuit;
a moisture sensor inside the covering, the moisture sensor provides a moisture signal to the microcontroller that is indicative of the humidity or a liquid being present on the inside of the covering of the wearable CRRT device; and
means for enabling a patient to wear the entire CRRT device.