Urinalysis for the early detection of and recovery from worsening heart failure

• US 7,606,617 B2
• Filed: 01/31/2006
• Issued: 10/20/2009
• Est. Priority Date: 01/31/2006
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Wariar, Ramesh
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US11/343,441
• Publication Number:
  US 20070179389A1
• Time in Patent Office: 1,358 Days
• Field of Search: 607 17- 18, 607/60, 600/300, 600/301, 600/481, 600529-538, 600500-508, 436/155, 705/4
• US Class Current: 607/17
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/208 adapted to determine urine quantity, e.g. flow, volume
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: G01N 2800/325 Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system and method of detecting decompensation of heart failure for a patient includes urinalysis to determine the change in physical and/or chemical composition of a patient'"'"'s urine over time. The change in chemical and/or physical composition of the patient'"'"'s urine is used to infer the onset of decompensation. Optionally, the inference is verified with other data, such as with baseline transthoracic impedance data, patient weight data, and/or blood composition data.

Claims

1. A system for early detection of decompensation of heart failure, the system comprising:

a first interface configured to receive urinalysis data that indicates whether decompensation of heart failure is present or impending, and to send the urinalysis data to a computer via a network;

a second interface configured to receive data from a cardiac rhythm management device, the data from the cardiac rhythm management device capable of indicating whether decompensation of heart failure is present or impending, and to send the data from the device to the computer;

a set of instructions stored in the computer, which when executed causes the computer to access the urinalysis data and the data from the cardiac rhythm management device, and based at least in part upon both the accessed urinalysis data and the data from cardiac rhythm management device, to detect and indicate decompensation of heart failure.

2. The system of claim 1, further comprising:

a third interface configured to receive weight data, and to send the weight data to the computer.

3. The system of claim 2, wherein the set of instructions, when executed, further causes the computer to access the weight data, and to detect an impending decompensation of heart failure based at least in part upon the accessed data.

4. The system of claim 3, further comprising:

a fourth interface configured to receive blood constituent concentration data, and to send the blood constituent concentration data to the computer.

5. The system of claim 4, wherein the set of instructions, when executed, further causes the computer to access the blood constituent concentration data, and to detect an impending decompensation of heart failure based at least in part upon the accessed data.

6. The system of claim 1, further comprising:

a collection volume configured to hold a urine sample;

a transmitter configured to propagate a signal through the urine sample; and

a detector configured to receive the propagated signal, and to send a second signal standing in known relation to the received propagated signal to a processor in data communication with a memory storing a set of instructions, which when executed causes the processor to construct urinalysis data based upon the second signal, and to send the urinalysis data to the first interface.

7. The system of claim 6, wherein the urinalysis data comprises conductivity, specific gravity, color, or refractive index of the urine sample.

8. The system. of claim 6, wherein the propagated signal is an electromagnetic signal.

9. The system of claim 6, wherein the propagated signal is an acoustic signal.

10. The system of claim 1, further comprising:

a collection volume configured to hold a urine sample;

a strip having at least one chemically treated portion, the at least one portion being configured to contact the urine sample, and to change state in proportion to a concentration level of a constituent within the urine sample; and

a detector configured to observe the state of the at least one portion, and to send a signal standing in known relation to the observed state to a processor in data communication with a memory storing a set of instructions, which when executed causes the processor to construct urinalysis data based upon the signal, and to send the urinalysis data to the first interface.

11. The system of claim 10, wherein the state comprises color of the at least one chemically treated portion.

12. The system of claim 10, wherein the urinalysis data comprises information regarding a concentration level of a given constituent in the urine sample.

13. A method of early detection of decompensation of heart failure in a patient, comprising:

comparing a urinalysis measurement with a first boundary to determine if the urinalysis measurement is abnormal for the patient, wherein the urinalysis measurement provides data that indicates whether decompensation of heart failure is present or impending;

comparing a measurement made by a cardiac rhythm management device with a second boundary to determine if the device measurement is abnormal for the patient wherein the urinalysis measurement provides data capable of indicating whether decompensation of heart failure is present or impending; and

determining and indicating whether decompensation of heart failure is imminent for the patient on the basis of at least both of the comparisons.

14. The method of claim 13, wherein the urinalysis measurement comprises conductivity, specific gravity, color, or refractive index of a urine sample.

15. The method of claim 13, wherein the urinalysis measurement comprises information regarding a concentration level of a given constituent in the urine sample.

16. The method of claim 15, wherein the constituent is protein, albumin, microalbumin, uric acid, urea, creatinine, sodium, leukocyte estrase, nitrites, bilirubin, ketones, glucose, or heart failure medication.

17. The method of claim 16, wherein the urinalysis measurement comprises a ratio of urine sodium to urine creatinine.

18. The method of claim 15, further comprising:

measuring a blood concentration level of the given constituent;

measuring a urine production rate; and

determining a clearance rate of the given constituent on the basis of the measurements.

19. The method of claim 13, further comprising:

comparing a weight measurement with a third boundary to determine if the weight is abnormal for the patient; and

determining whether decompensation of heart failure is imminent for the patient on the further basis of the weight comparison.

20. The method of claim 13, wherein the measurement made by a cardiac rhythm management device is a transthoracic impedance measurement.

21. A computerized method of early detection of decompensation of heart failure in a patient, comprising:

accessing a set of urinalysis data, each datum within the data set describing a particular characteristic of the patient'"'"'s urine at differing points in time, wherein the urinalysis data indicates whether decompensation of heart failure is present or impending;

determining a boundary from the accessed urinalysis data set;

comparing a data point describing the particular characteristic of the patient'"'"'s urine with the boundary; and

detecting and indicating impending decompensation of heart failure for the patient, based at least in part upon the comparison.

22. The method of claim 21, the act of determining the boundary comprises:

determining the mean of the urinalysis data set; and

adding a quantity to the mean to arrive at the boundary.

23. The method of claim 22, wherein the quantity is a value standing in known relation to the standard deviation of the urinalysis data set.

24. The method of claim 21, wherein the act of determining the boundary comprises:

finding a first value greater than a given percentage of the data within the urinalysis data set; and

setting the boundary to a second quantity standing in known relation to the first quantity.

25. A computerized method of early detection of decompensation of heart failure in a patient, comprising:

accessing a plurality of sets of urinalysis data, wherein the urinalysis data indicates whether decompensation of heart failure is present or impending, and wherein for a given one of the urinalysis data sets, each datum therein describes a particular characteristic of the patient'"'"'s urine at a differing points in time, and wherein each of the urinalysis data sets corresponds to a different characteristic of the patient'"'"'s urine;

determining a plurality of boundaries, each of the boundaries corresponding to a given one of the plurality of urinalysis data sets;

comparing each of a plurality of data points describing characteristics of the patient'"'"'s urine with a corresponding one of the plurality of boundaries; and

detecting and indicating impending decompensation of heart failure for the patient, based at least in part upon the comparisons.

26. The method of claim 25, wherein the act of detecting and indicating impending decompensation of heart failure comprises:

detecting and indicating impending decompensation of heart failure upon the occurrence of any of the data points falling outside of their respective boundaries.

27. The method of claim 25, wherein the act of detecting and indicating impending decompensation of heart failure comprises:

counting the number of data points falling outside of their respective boundaries; and

detecting and indicating impending decompensation of heart failure if the counted number exceeds a threshold.

28. The method of claim 25, wherein the act of detecting and indicating impending decompensation of heart failure comprises:

assigning a weight to each of the boundaries;

tallying a weighted count of the number of data points falling outside of their respective boundaries; and

detecting and indicating impending decompensation of heart failure if the weighted count exceeds a threshold.

29. The method of claim 25, wherein the act of detecting and indicating impending decompensation of heart failure comprises:

identifying a subset of boundaries;

detecting and indicating impending decompensation of heart failure if one of the data points corresponding to one of the subset of boundaries falls outside of its respective boundary.

30. The method of claim 25, wherein the data points are obtained by a device at a location remote from a computer executing the computerized method.

31. The method of claim 30, wherein the remote location comprises the patient'"'"'s home.

32. A system for early detection of decompensation of heart failure, the system comprising:

a means for obtaining urinalysis data that indicates whether decompensation of heart failure is present or impending; and

a means for detecting and indicating impending decompensation of heart failure, based upon the urinalysis data.