Monitoring method and apparatus

• US 20050137481A1
• Filed: 12/17/2004
• Published: 06/23/2005
• Est. Priority Date: 12/18/2003
• Status: Active Grant

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Reay, Marika, Sheard, Paul
• Granted Patent: US 8,129,191 B2
• Time in Patent Office: Days
• US Class Current: 600/508
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: G01N 2333/58 Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
• CPC Class Codes: G01N 2800/32 Cardiovascular disorders
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

A device for remote management of patients suffering from heart failure and hypertension can measure one or more biomarker. The device aids in monitoring the efficacy and safety of treatment in such patients.

Claims

1. A device for monitoring cardiac health comprising a detector configured to measure, in a sample taken from a patient, a level of a first biomarker selected from the group consisting of:

a marker of left ventricular volume overload or myocardial stretch, a marker of myocardial apoptosis or injury, a marker of myocardial ischemia, a marker of inflammation, 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 a display configured to provide an output to the patient.

3. The device of claim 1, wherein the detector is configured to measure a level of a second biomarker.

4. The device of claim 3, wherein the second biomarker is selected from the group consisting of:

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

5. The device of claim 1, wherein the first biomarker includes a natriuretic peptide.

6. The device of claim 4, wherein the first biomarker is a marker of left ventricular volume overload or myocardial stretch and includes a natriuretic peptide, and the second biomarker is a marker of left ventricular volume overload or myocardial stretch and includes a second natriuretic peptide.

7. The device of claim 4, wherein the first biomarker includes a natriuretic peptide and the second biomarker is a marker of renal function.

8. The device of claim 1, wherein the marker of myocardial apoptosis or injury includes a troponin, a urotensin, or a urotensin-related peptide.

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

10. 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-1 β

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

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

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

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

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

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

16. The device of claim 15, 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.

17. The device of claim 1, further comprising a memory capable of storing the results of a measurement of the level of the first biomarker.

18. The device of claim 17, wherein the device is configured to compare the result of a measurement of the level of the first biomarker to a stored result.

19. The device of claim 18, wherein the memory is further capable of storing a threshold value of the level of the first biomarker.

20. The device of claim 19, wherein the device is configured to compare the result of a measurement of the level of the first biomarker to the threshold value.

21. The device of claim 20, wherein the first biomarker includes a natriuretic peptide.

22. The device of claim 21, wherein the device is configured to instruct the patient to alter a treatment plan when the level of the first biomarker exceeds the threshold value.

23. The device of claim 22, wherein the device is configured to further instruct the patient to obtain a measurement of a marker of renal function when the level of the first biomarker exceeds the threshold value.

24. The device of claim 22, wherein the device is configured to measure a marker of renal function when the level of the first biomarker exceeds the threshold value.

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

26. The device of claim 25, further comprising an input device for supplying a response to a patient query.

27. The device of claim 25, wherein the device is configured to provide a personalized patient instruction in response to the results of the measurement.

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

29. The device of claim 28, wherein the communication port is further configured to receive information from the recipient.

30. A method of monitoring a patient comprising measuring in a sample taken from a patient, a level of a first biomarker selected from the group consisting of:

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

31. The method of claim 30, further comprising providing an output to the patient.

32. The method of claim 30, wherein the first biomarker includes a natriuretic peptide.

33. The method of claim 32, further comprising comparing the measured level of the first biomarker to a threshold value.

34. The method of claim 33, further comprising instructing the patient to obtain a measurement of a marker of renal function when the level of the first biomarker exceeds the threshold value.

35. The method of claim 33, further comprising measuring a marker of renal function when the level of the first biomarker exceeds the threshold value.

36. The method of claim 30, further comprising measuring in a sample taken from a patient, a level of a second biomarker selected from the group consisting of:

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

37. The method of claim 36, wherein the first biomarker is a marker of left ventricular volume overload or myocardial stretch and includes a natriuretic peptide, and the second biomarker is a marker of renal function.

38. The method of claim 30, further comprising recording the measured level of the first biomarker.

39. The method of claim 36, further comprising measuring the level of the first biomarker at a later time, and comparing the recorded measured level to the later measured level.

40. The method of claim 30, further comprising determining whether the patient is suffering from one or more symptoms associated with heart failure.

41. The method of claim 30, 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.

42. A health care kit comprising:

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

a device including a detector configured to measure a level of the biomarker recognized by the assay.

43. The kit of claim 42, wherein the device is configure to provide an output to a patient.

44. The kit of claim 42, wherein the first assay includes an antibody that recognizes a marker of left ventricular volume overload or myocardial stretch, a marker of myocardial apoptosis or injury, a marker of myocardial ischemia, a marker of inflammation, a marker of anemia, or a marker of sodium retention.

45. The kit of claim 44, wherein the antibody recognizes a natriuretic peptide.

46. The kit of claim 42, further comprising a second test cartridge including a sample port and a second assay, wherein the second assay recognizes a marker of left ventricular volume overload or myocardial stretch, a marker of myocardial apoptosis or injury, a marker of myocardial ischemia, a marker of inflammation, a marker of anemia, a marker of renal function, a marker of electrolyte balance, or a marker of sodium retention.

47. The kit of claim 46, wherein the second assay includes an antibody that recognizes a marker of left ventricular volume overload or myocardial stretch, a marker of myocardial apoptosis or injury, a marker of myocardial ischemia, a marker of inflammation, a marker of anemia, or a marker of sodium retention.

48. The kit of claim 47, wherein the first assay includes an antibody that recognizes a natriuretic peptide.

49. The kit of claim 46, wherein the second assay includes an antibody that recognizes a second natriuretic peptide.

50. The kit of claim 44, wherein the second assay recognizes a marker of renal function.