Device and method of monitoring a patient

• US 20090054741A1
• Filed: 03/24/2006
• Published: 02/26/2009
• Est. Priority Date: 03/29/2005
• Status: Abandoned Application

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Inventors: McAleer, Jerry
• Application Number:
  US11/887,139
• Publication Number:
  US 20090054741A1
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G01N 2800/325 Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/53 Immunoassay; Biospecific binding assay; Materials therefor
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A device for remote management of patients suffering or likely to suffer from heart failure that can measure the amplitude and frequency changes of one or more biomarkers. The device aids in predicting the need for medical intervention in such patients. The device may further aid in monitoring the efficacy and safety of treatment in such patients.

Claims

1. A device for predicting heart failure comprising a detector configured to monitor concentration excursions, in samples taken from a patient at regular intervals, a level of a first biomarker selected from the group consisting of:

a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention.

2. The device of claim 1, further comprising detecting the frequency of concentration excursions from average concentrations of the first biomarker.

3. The device of claim 1, further comprising a display configured to provide an output to the patient.

4. The device of claim 1, wherein the detector is configured to monitor concentration excursions of the level of a second biomarker.

5. The device of claim 1, wherein the detector is configured to monitor concentration excursions of the level of a third biomarker.

6. The device of claim 4, wherein the second biomarker is selected from the group consisting of:

a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention.

7. The device of claim 5, wherein the third biomarker is selected from the group consisting of:

a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention.

8. The device of claim 1, wherein the first biomarker includes a marker of plaque instability.

9. The device of claim 6, wherein the first biomarker includes a marker of inflammation and the second biomarker is a marker of plaque instability.

10. The device of claim 7, wherein the first biomarker includes a marker of inflammation, the second biomarker is a marker of plaque instability, and the third biomarker is a marker of plaque rupture.

11. The device of claim 1, wherein the marker of inflammation includes E-selectin, P-selectin, intracellular adhesion molecule-1, vascular cell adhesion molecule-1, Nourin-1, interleukin-1β

, interleukin-6, interleukin-8, interleukin-10, tumor necrosis factor-alpha, hs-CRP, myeloperoxidase, neutrophils, or white blood cell count.

12. The device of claim 1, wherein the marker of plaque instability includes oxidized-LDL.

13. The device of claim 1, wherein the marker of thrombus formation includes (fe) thromboxane.

14. The device of claim 1, wherein the marker of plaque rupture includes malondialdehyde-modified LDL (MDA-LDL).

15. The device of claim 1, wherein the marker of myocardial apoptosis or injury includes cardiac troponin I, troponin T, myoglobin, creatine kinase or creatine kinase MB (CK MB), urotensin, or urotensin-related peptide.

16. The device of claim 1, wherein the marker of myocardial ischemia includes ischemia-modified albumin, oxygen-regulated peptide (ORP150), free fatty acid, Nourin-1, urotensin, or urotensin-related peptide.

17. The device of claim 1, wherein the marker of anemia includes hemoglobin or hematocrit.

18. The device of claim 1, wherein the marker of renal function includes creatinine or Cystatin C.

19. The device of claim 1, wherein the marker of electrolyte balance includes Na⁺ or K⁺.

20. The device of claim 1, wherein the marker of sodium retention includes uroguanylin.

21. The device of claim 1, further comprising a probe for measuring a vital sign of the patient.

22. The device of claim 21, wherein the probe is capable of measuring a weight, a heart rate, variability of heart rate, a breathing rate, a blood pressure, a temperature, a blood oxygen saturation, or an electrocardiogram of the patient.

23. The device of claim 1, further comprising a memory capable of storing the results of regular measurements of the level of the first biomarker.

24. The device of claim 23, wherein the device is configured to compare the result of a measurement of the level of the first biomarker to stored results from previous measurements.

25. The device of claim 24, wherein the memory is further capable of storing a threshold value of the level of the first biomarker.

26. The device of claim 25, wherein the device is configured to compare the result of a measurement of the level of the first biomarker to the threshold value and to previous measurements.

27. The device of claim 26, wherein the device is configured to instruct the patient to contact his physician when the device detects concentration excursions in the levels of the first biomarker.

28. The device of claim 26, wherein the device is configured to instruct the patient to alter a treatment plan when the device detects concentration excursions in the levels of the first biomarker occurring at high frequency.

29. The device of claim 26, wherein the device is configured to further instruct the patient to obtain a measurement of a second biomarker and/or third biomarker.

30. The device of claim 1, further comprising a display for displaying the results of the measurement, a patient query, or a patient instruction.

31. The device of claim 30, further comprising an input device for supplying a response to a patient query.

32. The device of claim 30, wherein the device is configured to provide a personalized patient instruction in response to the results of the measurement.

33. The device of claim 1, further comprising a communication port configured to transmit a result of a measurement to a recipient.

34. The device of claim 33, wherein the communication port is further configured to receive information from the recipient.

35. A method of monitoring a patient for heart failure comprising measuring and detecting concentration excursions, in samples taken from a patient at regular intervals, the levels of a first biomarker selected from the group consisting of:

a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention.

36. The method of claim 35, further comprising providing an output to the patient.

37. The method of claim 35, further comprising comparing the measured level of the first biomarker to a threshold value and to previous measurements.

38. The method of claim 35, further comprising instructing the patient to obtain a measurement of a second biomarker and/or a third biomarker when rapid concentration excursions are detected in the levels of the first biomarker.

39. The method of claim 35, further comprising measuring and detecting concentration excursions in a sample taken from a patient, a level of a second biomarker selected from the group consisting of:

a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention.

40. The method of claim 39, further comprising measuring and detecting concentration excursions in a sample taken from a patient, a level of a third biomarker selected from the group consisting of:

a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention.

41. The method of claim 35, further comprising determining whether the patient is suffering from one or more symptoms associated with heart failure.

42. The method of claim 35, further comprising measuring a weight, a heart rate, variability of heart rate, a breathing rate, a blood pressure, a temperature, a blood oxygen saturation, or an electrocardiogram of the patient.

43. A health care kit comprising:

a test cartridge including a sample port and a first assay, wherein the first assay recognizes a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention; and

a device including a detector configured to measure and to monitor concentration excursions of a level of the biomarker recognized by the assay.

44. The kit of claim 43, wherein the device is configured to provide an output to a patient.

45. The kit of claim 43, wherein the first assay includes an antibody that recognizes a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention.

46. The kit of claim 43, further comprising a second test cartridge including a sample port and a second assay, wherein the second assay recognizes a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention.

47. The kit of claim 46, wherein the second assay includes an antibody that recognizes a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention.

48. The kit of claim 46, further comprising a third test cartridge including a sample port and a third assay, wherein the second assay recognizes a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention.

49. The kit of claim 48, wherein the third assay includes an antibody that recognizes a marker of inflammation, a marker of plaque stability, a marker of thrombus formation, a marker of plaque rupture, a marker of myocardial ischemia, a marker of myocardial apoptosis or injury, a marker of left ventricular volume overload or myocardial stretch, a marker of anemia, a marker of renal function, a marker of electrolyte balance, and a marker of sodium retention.

50. The kit of claim 43, wherein the test cartridge includes a second assay, the second assay being different from the first assay.