ELECTRONIC DEVICE AND SYSTEM FOR DETECTING REJECTION IN TRANSPLANT RECIPIENTS

• US 20100016684A1
• Filed: 01/17/2008
• Published: 01/21/2010
• Est. Priority Date: 01/18/2007
• Status: Active Grant

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Czer, Lawrence S.C.
• Granted Patent: US 8,523,780 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant

Abstract

The current invention relates to an implantable device, system, method, and computer readable medium comprising computer executable components for detection of rejection of a cardiac allograft. Acute rejection and chronic rejection are the leading cause of death in heart transplant recipients post transplant. The current invention seeks to address this problem by providing methods, devices, systems and computer readable media comprising computer executable components to monitor the efficacy of immunosuppressant therapy and evaluate the degree of rejection in a cardiac allograft. To provide this functionality, an implantable device comprises sensors which measure physiologic parameters at specified intervals after the transplant procedure. These measured parameters are subsequently compared with baseline parameter data to detect rejection of the cardiac allograft.

Claims

1. A method for detecting cardiac allograft rejection in a subject that has received a cardiac allograft, comprising:

determining baseline data regarding the subject and the cardiac allograft;

measuring at least one parameter of the cardiac allograft during a measurement interval;

determining at least one average parameter value for the at least one parameter during the measurement interval; and

comparing the at least one average parameter value with the baseline data to detect the presence of a cardiac allograft rejection,

wherein the at least one parameter is selected from the group consisting of electrical activity generated by the cardiac allograft, at least one voltage generated by the cardiac allograft, rate of change of the at least one voltage generated by the cardiac allograft, impedance within the chest, body temperature and combinations thereof.

2. The method of claim 1, further comprising providing an implantable device for detecting rejection of the cardiac allograft in the subject, comprising:

a plurality of sensors to measure the at least one parameter;

a processor in electronic communication with the plurality of sensors, the processor configured to receive at least one measured parameter;

a memory component to store the baseline data, data corresponding to the at least one measured parameter and/or data corresponding to the at least one average parameter value; and

a power supply component to provide electricity to components of the implantable device.

3. The method of claim 1, further comprising determining a presence of a statistically significant deviation from the baseline data, whereby the presence of the statistically significant deviation is indicative of an acute or a chronic rejection episode.

4. The method of claim 1, further comprising annotating the at least one average parameter value if the at least one parameter value differs by more than one standard deviation from the baseline data.

5. The method of claim 1, further comprising annotating the at least one average parameter value if the at least one parameter value differs by more than two standard deviations from the baseline data.

6. The method of claim 1, wherein collecting the data used to determine the baseline data begins about five days after a cardiac allograft transplant procedure.

7. The method of claim 1, wherein determining the baseline data comprises collecting data for about thirty minutes a day for a period of about one week and determining the average values of the data.

8. The method of claim 1, wherein the measurement interval is selected from the group consisting of about 50, 100, 200, 300, 400, 500, and 1000 contraction cycles of the cardiac allograft.

9. The method of claim 8, wherein the measurement interval is about one hundred contraction cycles of the cardiac allograft.

10. The method of claim 1, wherein the measurement interval is selected from the group consisting of about 0.5, 1, 2, 3, 4, 5, 10, 15, 20, 30, 45, and 60 minutes.

11. The method of claim 1, wherein the at least one parameter is impedance within the chest and is used to calculate cardiac output, lung water content or both.

12. An implantable device for detecting cardiac allograft rejection in a subject that has received a cardiac allograft, comprising:

a plurality of sensors to measure at least one parameter;

a processor in electronic communication with the plurality of sensors, the processor configured to receive at least one measured parameter;

a memory component to store baseline data, data corresponding to the at least one measured parameter and/or data corresponding to at least one average parameter value;

a power supply component to provide electricity to components of the implantable device; and

a housing to encapsulate components of the implantable device,

wherein the at least one parameter is selected from the group consisting of electrical activity generated by the cardiac allograft, at least one voltage generated by the cardiac allograft, rate of change of the at least one voltage generated by the cardiac allograft, impedance within the chest, body temperature and combinations thereof.

13. The implantable device of claim 12, further comprising a transmitting component to transmit the data corresponding to the at least one measured parameter to an external device.

14. The implantable device of claim 12, wherein at least one sensor measures the body temperature and is selected from the group consisting of a thermocouple, a thermistor, a resistance thermometer and combinations thereof.

15. The implantable device of claim 12, wherein the processor is further configured to determine the at least one average parameter value for the at least one parameter during a measurement interval.

16. The implantable device of claim 15, wherein the measurement interval is selected from the group consisting of about 50, 100, 200, 300, 400, 500, and 1000 contraction cycles of the cardiac allograft.

17. The implantable device of claim 16, wherein the measurement interval is about one hundred contraction cycles of the cardiac allograft.

18. The implantable device of claim 15, wherein the measurement interval is selected from the group consisting of about 0.5, 1, 2, 3, 4, 5, 10, 15, 20, 30, 45, and 60 minutes.

19. An external device adapted to communicate with an implantable device for detecting cardiac allograft rejection, the implantable device comprising:

a plurality of sensors to measure at least one parameter;

a processor in electronic communication with the plurality of sensors, the processor configured to receive at least one measured parameter; and

a memory component to store baseline data, data corresponding to the at least one measured parameter and/or data corresponding to at least one average parameter value,

wherein the at least one parameter is selected from the group consisting of electrical activity generated by the cardiac allograft, at least one voltage generated by the cardiac allograft, rate of change of the at least one voltage generated by the cardiac allograft, impedance within the chest, body temperature and combinations thereof.

20. The external device of claim 19, further adapted to receive and analyze the at least one average parameter value to determine a presence of a statistically significant deviation from baseline data, whereby the presence of the statistically significant deviation is indicative of an acute or chronic rejection episode.

21. The external device of claim 19, further adapted to receive information regarding the presence of a statistically significant deviation from the baseline data that is indicative of an acute or chronic rejection episode.

22. The external device of claim 19, further adapted to provide an alert regarding the rejection of the cardiac allograft.

23. A system for detecting cardiac allograft rejection in a subject that received a cardiac allograft, comprising:

an implantable device for detecting cardiac allograft rejection, comprising;

a plurality of sensors to measure at least one parameter,

a processor in electronic communication with the plurality of sensors, the processor configured to receive at least one measured parameter,

a memory component to store baseline data, data corresponding to at least one measured parameter and/or data corresponding to at least one average parameter value,

a power supply component to provide electricity to components of the implantable device, and

a housing to encapsulate components of the implantable device,

wherein the at least one parameter is selected from the group consisting of electrical activity generated by the cardiac allograft, at least one voltage generated by the cardiac allograft, rate of change of the at least one voltage generated by the cardiac allograft, impedance within the chest, body temperature and combinations thereof; and

an external device adapted to communicate with the implantable device.

24. The system of claim 23, wherein the at least one sensor measures the body temperature and is selected from the group consisting of a thermocouple, a thermistor, a resistance thermometer and combinations thereof.

25. The system of claim 23, wherein the processor is further configured to determine at least one average parameter value for the at least one parameter during a measurement interval.

26. The system of claim 25, wherein the measurement interval is selected from the group consisting of about 50, 100, 200, 300, 400, 500, and 1000 contraction cycles of the cardiac allograft.

27. The system of claim 26, wherein the measurement interval is about one hundred contraction cycles of the cardiac allograft.

28. The system of claim 25, wherein the measurement interval is selected from the group consisting of about 0.5, 1, 2, 3, 4, 5, 10, 15, 20, 30, 45, and 60 minutes.

29. The system of claim 23, wherein the external device is further adapted to receive and analyze the at least one average parameter value to determine a presence of a statistically significant deviation from baseline data, whereby the presence of the statistically significant deviation is indicative of an acute or chronic rejection episode.

30. The system of claim 23, wherein the external device is further adapted to receive information regarding the presence of a statistically significant deviation from the baseline data that is indicative of an acute or chronic rejection episode.

31. The system of claim 23, wherein the external device is further adapted to provide an alert regarding the rejection of the cardiac allograft.

32. A computer readable medium to detect cardiac allograft rejection in a subject that has received a cardiac allograft, comprising computer executable components for:

determining baseline data regarding the subject and the cardiac allograft;

measuring at least one parameter of the cardiac allograft during a measurement interval;

determining at least one average parameter value for the at least one parameter during the measurement interval; and

comparing the at least one average parameter value with the baseline data to detect the presence of a cardiac allograft rejection,

wherein the at least one parameter is selected from the group consisting of electrical activity generated by the cardiac allograft, at least one voltage generated by the cardiac allograft, rate of change of the at least one voltage generated by the cardiac allograft, impedance within the chest, body temperature and combinations thereof.

33. The computer readable medium of claim 32, further comprising a computer executable component for determining a presence of a statistically significant deviation from the baseline data, whereby the presence of the statistically significant deviation is indicative of an acute or a chronic rejection episode.

34. The computer readable medium of claim 32, further comprising a computer executable component for annotating the at least one average parameter value if the at least one parameter value differs by more than one standard deviation from the baseline data.

35. The computer readable medium of claim 32, further comprising a computer executable component for annotating the at least one average parameter value if the at least one parameter value differs by more than two standard deviations from the baseline data.

36. The computer readable medium of claim 32, wherein the measurement interval is selected from the group consisting of about 50, 100, 200, 300, 400, 500, and 1000 contraction cycles of the cardiac allograft.

37. The computer readable medium of claim 36, wherein the measurement interval is about one hundred contraction cycles of the cardiac allograft.

38. The method of claim 32, wherein the measurement interval is selected from the group consisting of about 0.5, 1, 2, 3, 4, 5, 10, 15, 20, 30, 45, and 60 minutes.

39. The computer readable medium of claim 32, further comprising a computer executable component for calculating cardiac output, lung water content or both.