CONTINUOUS CARDIAC MARKER SENSOR SYSTEM

• US 20090299155A1
• Filed: 01/29/2009
• Published: 12/03/2009
• Est. Priority Date: 01/30/2008
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Boock, Robert, Yang, Richard C., Matsubara, Bradley Shigeto
• Application Number:
  US12/362,194
• Publication Number:
  US 20090299155A1
• Time in Patent Office: Days
• US Class Current: 600/301
• 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: 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 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• 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

Abstract

The present invention relates generally to systems and methods for continuous measurement of a cardiac marker in vivo. In some embodiments, the system includes a continuous sensor and a communication device. The continuous sensor is configured to continuously measure a concentration of a cardiac marker in vivo and to provide a signal associated therewith. The communication device includes a processor module configured to process the signal to obtain cardiac information, wherein the communication device is configured to output the cardiac information.

Claims

1. A system for continuously detecting a cardiac marker, comprising:

a continuous sensor configured to continuously, continually, and/or intermittently measure a concentration of a cardiac marker in vivo and provide a signal associated therewith; and

a communication device comprising a processor module configured to process the signal to obtain cardiac information, wherein the communication device is configured to output the cardiac information.

2. The system of claim 1, wherein the cardiac marker is selected from the group consisting of creatine kinase MB, cardiac troponin T, cardiac troponin I, troponin C, aspartate transaminase, lactate dehydrogenase, myoglobin, alanine transaminase, alkaline phosphatase, albumin, ischemia-modified albumin, myeloperoxidase, glycogen phosphorylase isoenzyme BB, brain natriuretic peptide, N-terminal pro-natriuretic peptide, monocyte chemo attractive protein, gamma glutamyl transpeptidase, high sensitive C-reactive protein, heart type fatty acid binding protein, P-selectin, soluble CD40 ligand, glycoprotein IIb/IIIa, prothrombin fragment 1.2, D-dimer, thrombin-antithrombin II, beta-thromboglobulin, platelet factor 4, platelet/endothelial cell adhesion molecule 1, soluble fibrin, glycogen phosphorylase-BB, thrombus precursor protein, interleukin-1 receptor family/ST2, interleukin 6, interleukin 18, placental growth factor, pregnancy-associated plasma protein A, glutathione peroxidase, plasma thioredoxin, Cystatin C, serum deoxyribonuclease I, ATP/ADP, total bilirubin, direct bilirubin, potassium, calcium, and combinations thereof.

3. The system of claim 1, wherein the cardiac information is selected from the group consisting of a cardiac marker concentration, a change in cardiac marker concentration, an acceleration of cardiac marker concentration change, an area under the curve of a plot of time versus cardiac marker concentration, and combinations thereof.

4. The system of claim 1, wherein the communication device is configured to provide one or more alarms indicative of cardiac health.

5. The system of claim 4, wherein the processor module is configured to trigger the alarm when the cardiac marker concentration meets a criterion.

6. The system of claim 1, wherein the processor module is configured to provide a cardiac status.

7. The system of claim 6, wherein the cardiac status comprises a level of cardiac status.

8. The system of claim 6, wherein the processor module is configured to predict a cardiac status.

9. The system of claim 6, wherein the cardiac status is selected from the group consisting of improving cardiac health, declining cardiac health, stable cardiac health, ischemic heart disease, pericarditis, endocarditis, myocarditis, congestive cardiac failure, cardiogenic shock, acute coronary syndrome, alcoholic cardiomyopathy, coronary artery disease, congenital heart disease, ischemic cardiomyopathy, hypertensive cardiomyopathy, valvular cardiomyopathy, inflammatory cardiomyopathy, cardiomyopathy secondary to a systemic metabolic disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, noncompaction cardiomyopathy, congestive heart failure, valvular heart disease, hypertensive heart disease, and combinations thereof.

10. The system of claim 6, wherein the processor module is configured to predict a cardiac event.

11. The system of claim 10, wherein the cardiac event is selected from the group consisting of myocardial infarction, myocardial ischemic attack, unstable angina, acute coronary syndrome, myocardial rupture, endocarditis, pericarditis, cardiogenic shock, and combinations thereof.

12. The system of claim 1, further comprising a vascular access device configured for insertion into at least one of a circulatory system of the host and an extracorporeal blood circulation device.

13. The system of claim 1, wherein the sensor is further configured to continuously, continually, and/or intermittently measure a second substance in vivo and to provide a signal associated therewith.

14. The system of claim 13, wherein the second substance is selected from the group consisting of glucose, potassium, calcium, oxygen, carbon dioxide, and liver enzymes.

15. The system of claim 1, wherein the communication device is configured to receive and process data from a secondary medical device.

16. The system of claim 15, wherein the secondary medical device is selected from the group consisting of an electrocardiograph, an oxygen monitor, a fluid delivery device, a pacing device, leads, a mechanical ventilator, an extracorporeal membrane oxygenator, a cardiac output monitor, a blood pressure monitor, a central venous pressure monitor, a pulmonary capillary wedge pressure monitor, an intra-aortic balloon pump, an end-tidal carbon dioxide monitor, an intra-cranial pressure monitor, a Doppler monitor, a thermometer, a hemodynamic monitor, a patient monitor, and combinations thereof.

17. The system of claim 15, wherein the communication device is configured to display data from the secondary medical device.

18. The system of claim 1, wherein the communication device is configured to transmit instructions to a secondary medical device.

19. The system of claim 18, wherein the secondary medical device displays the cardiac information.

20. The system of claim 1, wherein the communication device comprises a user interface configured to display the cardiac information.

21. The system of claim 20, wherein the user interface is remote.

22. The system of claim 20, wherein the user interface is configured to provide an alarm.

23. The system of claim 1, wherein the communication device comprises a component of a secondary medical device.

24. The system of claim 23, wherein the secondary medical device is selected from the group consisting of an electrocardiograph, an oxygen monitor, a fluid delivery device, a pacing device, leads, a mechanical ventilator, an extracorporeal membrane oxygenator, a cardiac output monitor, a blood pressure monitor, a central venous pressure monitor, a pulmonary capillary wedge pressure monitor, an intra-aortic balloon pump, an end-tidal carbon dioxide monitor, an intra-cranial pressure monitor, a Doppler monitor, a thermometer, a hemodynamic monitor, a patient monitor, and combinations thereof.

25. The system of claim 1, wherein the system is configured to calibrate the signal using at least one reference data point.

26. The system of claim 25, wherein the system is configured to calibrate the signal using at least one reference point for each of two or more cardiac markers.

27. A method for determining cardiac health of a host, comprising:

using a sensor to continuously, continually, and/or intermittently detect a concentration of a cardiac marker in vivo;

providing a signal associated with the concentration of the cardiac marker;

processing the signal to obtain cardiac information; and

outputting the cardiac information.

28. The method of claim 27, wherein the cardiac marker is selected from the group consisting of creatine kinase MB, cardiac troponin T, cardiac troponin I, troponin C, aspartate transaminase, lactate dehydrogenase, myoglobin, alanine transaminase, alkaline phosphatase, albumin, ischemia-modified albumin, myeloperoxidase, glycogen phosphorylase isoenzyme BB, brain natriuretic peptide, N-terminal pro-natriuretic peptide, monocyte chemo attractive protein, gamma glutamyl transpeptidase, high sensitive C-reactive protein, heart type fatty acid binding protein, P-selectin, soluble CD40 ligand, glycoprotein IIb/IIIa, prothrombin fragment 1.2, D-dimer, thrombin-antithrombin II, beta-thromboglobulin, platelet factor 4, platelet/endothelial cell adhesion molecule 1, soluble fibrin, glycogen phosphorylase-BB, thrombus precursor protein, interleukin-1 receptor family/ST2, interleukin 6, interleukin 18, placental growth factor, pregnancy-associated plasma protein A, glutathione peroxidase, plasma thioredoxin, Cystatin C, serum deoxyribonuclease I, ATP/ADP, total bilirubin, direct bilirubin, potassium, calcium, and combinations thereof.

29. The method of claim 27, wherein the processing step comprises providing a cardiac status.

30. The method of claim 29, wherein the cardiac status comprises a level of cardiac status.

31. The method of claim 29, wherein the processing step comprises predicting a future cardiac status.

32. The method of claim 27, wherein the processing step comprises predicting a cardiac event.

33. The method of claim 27, wherein the outputting step comprises displaying the cardiac information.

34. The method of claim 27, wherein the outputting step comprises providing one or more alarms.

35. The method of claim 27, further comprising the step of calibrating the signal.