Automated blood sampler and analyzer
First Claim
1. A system for automatically sampling blood from a patient, the system comprising:
- an intravenous blood access catheter;
a tube set connected to the catheter forming a single passageway for transporting and dispensing blood samples from a patient to the end of the passageway at a point of measurement, which is in sensing communication with an external blood parameter sensor;
a clamp-on air-bubble sensor and an occlusion sensor externally attached to the tube set;
two 3-way pinch valves spaced apart and externally atached to the tube set and a single peristaltic pump externally attached to the tube set between said pinch valves;
a rinse solution in fluid communication with both said pinch valves; and
a controller operatively connected to the peristaltic pump and said pinch valves;
wherein the controller is configured to operate the peristaltic pump in forward and reverse mode, in forward mode, when the catheter is inserted in a patient'"'"'s bodily fluid vessel, the peristaltic pump draws blood from the patient to the point of measurement, once the external sensor measures the blood analyte, the controller controls the pinch valves, releasing rinse solution, rinsing said passageway;
after which the controller controls the pinch valves and operates the pump in reverse mode, re-infusing blood back into said patient.
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Accused Products
Abstract
An automated blood sampler integratable with a glucose monitor comprises a catheter connected to a tube-set forming a single blood passageway; a clamp-on air-bubble sensor and a occlusion sensor externally attached to the tube set; a single peristaltic pump and two 3-way pinch valves attached to the tube set and control fluid flow. The sampler draws blood from a stationary patient, samples the blood for analytical measurement of blood parameters; after which the passageway is rinsed, the blood re-infused, and slow saline infusion prevents vein collapse. The cycle repeats at user or predefined intervals. In another preferred embodiment, blood is not re-infused, and only one 3-way pinch valve is used.
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Citations
25 Claims
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1. A system for automatically sampling blood from a patient, the system comprising:
- an intravenous blood access catheter;
a tube set connected to the catheter forming a single passageway for transporting and dispensing blood samples from a patient to the end of the passageway at a point of measurement, which is in sensing communication with an external blood parameter sensor;
a clamp-on air-bubble sensor and an occlusion sensor externally attached to the tube set;
two 3-way pinch valves spaced apart and externally atached to the tube set and a single peristaltic pump externally attached to the tube set between said pinch valves;
a rinse solution in fluid communication with both said pinch valves; and
a controller operatively connected to the peristaltic pump and said pinch valves;wherein the controller is configured to operate the peristaltic pump in forward and reverse mode, in forward mode, when the catheter is inserted in a patient'"'"'s bodily fluid vessel, the peristaltic pump draws blood from the patient to the point of measurement, once the external sensor measures the blood analyte, the controller controls the pinch valves, releasing rinse solution, rinsing said passageway;
after which the controller controls the pinch valves and operates the pump in reverse mode, re-infusing blood back into said patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
- an intravenous blood access catheter;
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15. A system for automatically sampling blood from a patient, the system comprising:
- an intravenous blood access catheter;
a tube set connected to the catheter forming a single passageway for transporting and dispensing blood samples from a patient to the end of the passageway at a point of measurement, which is in sensing communication with an external blood parameter sensor, a clamp-on air-bubble sensor and an occlusion sensor externally attached to the tube set;
an in-line dilution sensor inserted in the passageway near the point of measurement;
two 3-way pinch valves spaced apart and externally attached to the tube set and a single peristaltic pump externally attached to the tube set between said pinch valves;
a rinse sulution in fluid communication with both said pinch valves; and
a controller operatively connected to the peristaltic pump and said pinch valves;wherein the controller is configured to operate the peristaltic pump in forward and reverse mode, in forward mode, when the catheter is inserted in a patient'"'"'s vein, the peristaltic pump draws blood from the patient to the point of measurement, once the external sensor measures the blood analyte, the controller controls the pinch valves, releasing rinse solution, rinsing said passageway;
after which the controller controls the pinch valves and operates the pump in reverse mode, re-infusing blood back into said patient;
the system is integrated with a glucose monitor in a closed loop with feedback control, the glucose monitor comprising, a test strip based glucose meter, a plurality of test strips, and means, for presenting a test strip in sensing communication with a blood sample at the point of measurement, and for ejecting a test strip after measurement; and
the system includes a waste reservoir for collecting dispensed fluids and ejected test strips. - View Dependent Claims (16, 17, 18, 19)
- an intravenous blood access catheter;
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20. A method far automatically sampling at least one parameter of blood from a patient, wherein the system with feedback control is integrated with a test strip based glucose monitor having a glucose meter, a plurality of test strips and means for presenting test strips in sensing communication with a blood sample, using said system comprising:
- an intravenous blood access catheter, a tube set connected to the catheter forming a single passageway for transporting and dispensing blood samples from a patient to the end of the passageway at a point of measurement, which is in sensing communication with an external blood parameter sensor;
a clamp-on air-bubble sensor and an occlusion sensor externally attached to the tube set;
two three-way pinch valves spaced apart and externally attached to the tube set and a single peristaltic pump externally attached to the tube set between said pinch valves;
a rinse solution in fluid communication with both said pinch valves; and
a controller operatively connected to the peristaltic pump and said pinch valves, the method comprising the steps of;a, before connecting the catheter to the tube set prime the tube set by rinsing the tube set with saline to remove all it bubbles; b, via an aseptic detachable connection connect the tube set to the catheter; c, when the catheter is inserted in a patient'"'"'s vein, use the controller to operate the peristaltic pump in forward mode to draw blood from the patient to the point of measurement until the blood is undiluted; d, use the controller to operate the peristaltic pump in reverse mode to pull back in the passageway any hanging blood droplet to prevent untimely suction of a blood sample by the test strip, thereby preventing said meter from giving an error message tiggered by a premature blood sample dispensed on the one of said test strips; e, activate the means for presenting test strips in sensing communication with a blood sample to present one of said test strips for measuring a blood sample; f, use the controller to operate the peristaltic pump in forward mode to dispense a blood sample onto one of said test strips presented using the automatic strip feeder; g, use the meter to perforin the measurement; h, discard the strip in the waste reservoir; i, transmit the measured value to a display monitor through the communication protocol; j, use the controller to open one of said pinch valves to release saline to clear the passageway of blood; k, use the controller to operate the peristaltic pump in reverse mode to re-infuse the unused blood back into the patient; l, use the controller to reduce the speed of the pump to slowly infuse saline into the vein to keep vein open before next measurement; m, repeat above steps at a predefined or user defined frequency of measurement.
- an intravenous blood access catheter, a tube set connected to the catheter forming a single passageway for transporting and dispensing blood samples from a patient to the end of the passageway at a point of measurement, which is in sensing communication with an external blood parameter sensor;
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21. A system for automatically sampling blood from a patient, such that blood reinfusion is not required, the system comprising:
- an intrvenous blood access catheter, a tube-set connected to the catheter forming a single passageway for transporting and dispensing blood samples from a patient to the end of a passageway at a point of measurement, the blood pssageway being heparin coated and in sensing communication with an external blood parameter sensor;
a clamp-on air-bubble sensor and an occlusion sensor externally attached to the tube set;
a single three-way pinch valve and a single peristaltic pump externally attached to the tube set;
a rinse solution; and
a controller operatively connected to the peristaltic pump and the pinch valve;
the controller is configured to first operate the pump and valve to draw blood from the patient, dispensing a blood sample to the point of measuement;
then to operate the pump and valve to rinse said blood passageway to the waste. - View Dependent Claims (22, 23, 24)
- an intrvenous blood access catheter, a tube-set connected to the catheter forming a single passageway for transporting and dispensing blood samples from a patient to the end of a passageway at a point of measurement, the blood pssageway being heparin coated and in sensing communication with an external blood parameter sensor;
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25. A system for automatically sampling blood from a patient, the system comprising:
- an intravenous blood access catheter;
a tube set connected to the catheter forming a single passageway for transporting and dispensing blood samples from a patient to the end of the passageway at a point of measurement, which is in sensing communication with an external blood parameter sensor;
a clamp-on air-bubble sensor and an occlusion sensor externally attached to the tube set;
two 3-way pinch valves spaced apart and externally attached to the tube set and a single peristaltic pump externally attached to the tube set between said pinch valves;
a rinse solution in fluid communication with both said pinch valves; and
a controller operatively connected to the peristaltic pump and said pinch valves;the catheter is connected to the tube set via a specially designed luer connection, wherein the catheter comprises a patient end and a spaced apart end having a hub attached thereto;
the luer connection has a first end, a barbed end spaced apart a distance L, and a cylindrical core having an inside diameter D, which is tapered at the point of transition to the barbed end;
the luer first end is inserted inside the catheter hub;
L and D are sized to eliminate the dead volume normally present when blood enters said catheter hub;an aseptic quick release connection attached to the tube set proximal to the luer connection, comprising a female port with a self sealing diaphragm, a male connector with a non-coring needle, and a leak proof negligible dead volume Design; the catheter is a small gage catheter having a size of 22 ga, and the tube set comprises micro tubing having a size of 0.5 mm ID; the length of tubing of the tube set ranges from 30 cm to 120 cm; the flow rate of the peristaltic pump ranges from 100 μ
L/min to 1000 μ
L/min;wherein the controller is configured to operate the peristaltic pump in forward and reverse mode, in forward mode, when the catheter is inserted in a patient'"'"'s bodily fluid vessel, the peristaltic pump draws blood from the patient to the point of measurement, once the external sensor measures the blood analyte, the controller controls the pinch valves, releasing rinse solution, rinsing said passageway;
after which the controller controls the pinch valves and operates the pump in reverse mode, re-infusing blood back into said patient;the bodily fluid vessel is a vein;
the rinse solution is saline;
after the blood is fully re-infused, the pump reduces speed to slowly infuse the patient with saline just enough to keep the vein open, preventing blood clotting;
during this time the system is in standby or therapeutic infusion mode until the next predefined or user actuated measurement;the blood parameter is blood glucose, and the blood parameter sensor is a blood glucose sensor;
the system includes a dextrose reservoir, an insulin reservoir, and a fluid selector manifold, for choosing the release of either saline, dextrose, or insulin;
wherein the manifold defaults to saline but will release dextrose, if the glucose reading is low, or release insulin, if the glucose reading is high;the pinch valves are actuated using a motor selected from the group consisting of, solenoid motors and piezoelectric motors; and
the system regulates the blood glucose using feedback control in a closed loop;an anticoagulant, heparin of low-molecular weight variety, is added to the saline.
- an intravenous blood access catheter;
Specification