DETERMINATION OF BLOOD PUMP SYSTEM PERFORMANCE AND SAMPLE DILUTION USING A PROPERTY OF FLUID BEING TRANSPORTED

• US 20120065482A1
• Filed: 07/29/2011
• Published: 03/15/2012
• Est. Priority Date: 04/08/2005
• Status: Abandoned Application

• Current Assignee: Dan Welsh, Dave Mcmahon, Dave Tobler, Donald W. Landry, James H. Macemon, John O'Mahony, Mark Ries Robinson, Mike Borrello, Richard P. Thompson, Russell Abbink, Shonn Hendee, Stephen Vanslyke, Steve Bernard, Victor Gerald Grafe, William R. Patterson
• Original Assignee: Dan Welsh, Dave Mcmahon, Dave Tobler, Donald W. Landry, James H. Macemon, John O'Mahony, Mark Ries Robinson, Mike Borrello, Richard P. Thompson, Russell Abbink, Shonn Hendee, Stephen Vanslyke, Steve Bernard, Victor Gerald Grafe, William R. Patterson
• Inventors: Robinson, Mark Ries, Borrello, Mike, Thompson, Richard P., Vanslyke, Stephen, Hendee, Shonn, Welsh, Dan, Bernard, Steve, O'Mahony, John, McMahon, Dave, Tobler, Dave, Patterson, William R., Landry, Donald W., Macemon, James H., Abbink, Russell, Grafe, Victor Gerald
• Application Number:
  US13/193,602
• Publication Number:
  US 20120065482A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2039/0009 Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation

Abstract

The present invention provides methods and apparatuses related to measurement of analytes, including measurements of analytes in samples withdrawn from a patient.

Claims

1. A method of measuring an analyte in a patient, comprising:

(a) removing a sample of blood from the patient; and

(b) measuring the analyte in the sample.

2. A method as in claim 1, comprising

(a) removing a sample of blood from the patient;

(b) transporting the sample of blood in a sterile manner to an analyte measurement system;

(c) measuring the analyte parameter in the transported sample using the analyte measurement system;

(d) transporting at least a portion of the measured blood to the patient in a sterile manner and infusing the portion into the patient;

(e) transporting a maintenance substance to the analyte measurement system without infusing a substantial amount of the maintenance substance into the patient;

(f) transporting at least a portion of the maintenance substance from the analyte measurement system to a waste channel.

3. A method as in claim 1, comprising:

(a) Measuring the value of the analyte at a plurality of times, with each pair of successive measurements separated by a time interval;

(b) Wherein the time intervals are not all the same duration;

(c) And wherein at least one time interval is determined from at least one patient condition, or at least one environmental condition, or a combination thereof.

5. A method as in claim 1, comprising comparing an indicator characteristic of blood from the patient determined at a first time with the indicator characteristic of the blood determined at a second time, and evaluating the comparison against a metric.

6. A method as in claim 1, further comprising calibrating an automated analyte measurement system by passing calibration fluid having at least two different analyte concentrations by an analyte sensor while infusing substantially none of at least one of such calibration fluids into the patient.

7. A method as in claim 1, further comprising controlling a level of blood glucose in a patient using an extracorporeal blood circuit, and comprising:

(a) withdrawing blood from a vascular system in the patient to the extracorporeal circuit;

(b) removing ultrafiltrate from the withdrawn blood in the circuit and passing the ultrafiltrate through an ultrafiltration passage;

(c) determining a level of glucose present in the blood using a glucose sensor monitoring ultrafiltrate flowing through an ultrafiltration passage;

(d) infusing insulin into the vascular system to control the blood glucose, wherein a rate of insulin infused is based on the determined level of glucose;

(e) introducing a calibration solution into the ultrafiltrate passage; and

(f) calibrating the glucose sensor based on a measurement made by the sensor of the calibration solution flowing through the ultrafiltrate passage.

9. A method as in claim 1, comprising:

(a) Placing a blood access system in fluid communication with the circulatory patient, wherein the blood access system comprises at least one pressure sensor, at least one analye sensor, and at least one pump;

(b) Using the pressure sensor to determine the frequency response of the blood access system at a first time before step c;

(c) Operating the pump to withdraw blood from the patient to the analyte sensor;

(d) Operating the analyte sensor to determine the presence, concentration, or both of an analyte in the withdrawn blood;

(e) Using the pressure sensor to determine the frequency response of the blood access system at a second time after step c;

(f) Determining if a bubble is present in the blood access system by comparing the frequency response determined at the first time with the frequency response determined at the second time.

10. A method as in claim 1, further comprising determining the quality of a biological sample procured for ex vivo analysis, by:

(a) measuring a parameter of the biological sample at two or more distinct times;

(b) analyzing the measurements to determine a relationship between the two or more measurements;

(c) determining whether the relationship within predetermined limits.

15. An apparatus as in claim 1, comprising:

(a) A fluid access system, configured to withdraw a sample of a bodily fluid from a patient;

(b) An analyte measurement system, configured to measure the value of an analyte in a sample withdrawn from the patient by the fluid access system;

(c) A controller, configured to respond to a patient condition, an environment condition, or a combination thereof, and to cause the fluid access system to withdraw a sample for measurement by the analyte measurement system

4. A method of withdrawing a blood sample from a withdrawal catheter port, wherein an infusate is infused through an infusion catheter port, comprising:

(a) determining patient conditions related to blood flow or pressure that are likely to lead to contamination of the withdrawn blood sample with the infusate, wherein the withdrawal port is distal from the heart relative to the infusion port;

(b) withdrawing a sample from the withdrawal port under withdrawal conditions determined in part from the patient conditions.

8. A method of determining the presence of a bubble in a blood access system comprising at least one pressure detector, comprising:

(a) Using the pressure detector to determine a first frequency response of the system at a first time;

(b) Using the pressure detector to determine a second frequency response of the system at a second time;

(c) Determining if a bubble is present in the system by comparing the first and second frequency responses.

11. An apparatus that measures an analyte in a patient, comprising a subsystem configured to remove a sample of blood or other fluid from the patient, and a subsystem configured to measure the analyte in the sample.

12. An apparatus as in claim 11, comprising:

(a) An analyte measurement system;

(b) A fluidics system, configured to remove blood from a body, transport a portion of the removed blood to the analyte measurement system for measurement, infuse a portion of the blood measured by the analyte measurement system back into the patient, flow a maintenance substance to the analyte measurement system without infusing a substantial amount of the maintenance substance into the patient, and flow at least a portion of the maintenance substance from the analyte measurement system to a waste channel.

13. An apparatus as in claim 11, comprising:

(a) A blood removal element, configured to communicate blood with the circulatory system of a patient;

(b) A first fluid transport apparatus, in fluid communication with the blood removal element;

(c) A second fluid transport apparatus, in fluid communication with the blood removal element and the first fluid transport apparatus;

(d) An analyte sensor, in fluid communication with the first fluid transport apparatus;

(e) A fluid management system, in fluid communication with the first and second fluid transport apparatuses and configured to control fluid flow in the first and second fluid transport apparatuses.

14. An apparatus as in claim 11, comprising:

(a) a blood removal element, configured to communicate blood with the circulatory system of a patient;

(b) a first fluid transport apparatus, in fluid communication with the blood removal element;

(c) a second fluid transport apparatus, in fluid communication with the blood removal element and the first fluid transport apparatus;

(d) an analyte sensor, in bidirectional fluid communication with at least one of the first fluid transport apparatus and second fluid transport apparatus;

(e) a first fluid pump, mounted with the first fluid transport apparatus such that the first fluid pump can draw fluid into and push fluid out of the first fluid transport apparatus;

(f) a second fluid pump, in fluid communication with the second fluid transport apparatus;

(g) a maintenance fluid reservoir, in fluid communication with the first fluid pump and configured to supply a maintenance fluid to the first fluid pump;

(h) a waste system, in fluid communication with the second fluid pump.

16. An apparatus as in claim 11, comprising:

(a) A patient interface device, capable of interfacing with the circulatory system of a patient;

(b) An analyte sensor having first and second ports, with the first port in fluid communication with the patient interface device;

(c) A flow generation and reservoir system having first and second ports, with the first port in fluid communication with second port of the analyte sensor; and

(d) A first fluid source, mounted such that it can be placed in fluid communication with the second port of the flow generation and storage system, wherein the first fluid source provides a first fluid having a first predetermined analyte concentration.

17. An apparatus as in claim 11, comprising:

(a) A patient interface device, capable of interfacing with the circulatory system of a patient;

(b) An analyte sensor having first and second ports, with the first port in fluid communication with the patient interface device;

(c) A flow generation and reservoir system having first and second ports, with the first port in fluid communication with second port of the analyte sensor;

(d) A first fluid source, mounted such that it can be placed in fluid communication with the second port of the flow generation and reservoir system, wherein the first fluid source provides a first fluid having a first predetermined analyte concentration; and

(e) A second fluid source, mounted such that it can be placed in fluid communication with the second port of the analyte sensor, wherein the second fluid source provides a second fluid having a second predetermined analyte concentration, where the second predetermined analyte concentration is different than the first predetermined analyte concentration.

18. An apparatus as in claim 11, comprising:

(a) A patient interface device capable of interfacing with the circulatory system of a patient;

(b) An analyte sensor having first and second ports, with the first port in fluid communication with the patient interface device;

(c) A flow generation device having first and second ports, with the first port in fluid communication with second port of the analyte sensor;

(d) A waste channel in fluid communication with the second port of the flow generation device through a first flow control device that allows fluid flow from the flow generation device to the waste channel but substantially prevents fluid from the waste channel to the flow generation device;

(e) A first fluid source, mounted such that it can be placed in fluid communication with the second port of the flow generation device through a second flow control device that allows fluid flow from the first fluid source to the flow generation device but substantially prevents fluid from the flow generation device to the first fluid source, wherein the first fluid source provides a first fluid having a first predetermined analyte concentration.

19. An apparatus as in claim 11, comprising:

(a) An arterial catheter, configured to be placed in fluid communication with an artery of a patient;

(b) A blood pressure monitoring subsystem mounted with the arterial catheter such that the blood pressure monitoring subsystem can determine the pressure of blood in the artery; and

(c) An analyte measuring subsystem mounted with the arterial catheter such that the analyte measuring subsystem can determine the presence, concentration, or both of one or more analytes in blood withdrawn from the artery.

20. An apparatus as in claim 11, comprising:

(a) an analyte measurement system, configured to measure the level of an analyte in a patient'"'"'s blood, or an indicator thereof;

(b) an infusion recommendation system, configured to recommend medication infusion parameters based on information comprising the measured blood analyte level;

(c) an infusion control system, configured to infuse a medication into the patient;

(d) an authorization system configured to allow a clinician to authorize an infusion of the medication into the patent by the infusion control system based on a recommendation to the of infusion parameters by the infusion recommendation system.

21. An indwelling fiber optic probe, comprising at least one optical fiber having a proximal end and a distal end, wherein illumination light from a near-infrared light source is coupled into the proximal end and directed to the distal end of the fiber and wherein the distal end is inserted into a patient tissue and wherein light from the tissue is collected by the distal end of the at least one optical fiber and returned to the proximal end of the fiber as collected light.