Systems for monitoring and applying electrical currents in an organ perfusion system

• US 9,457,179 B2
• Filed: 07/06/2007
• Issued: 10/04/2016
• Est. Priority Date: 03/20/2007
• Status: Active Grant

• Current Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Original Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Inventors: Lambert, Vincent II, Hassanein, Waleed, Elbetanony, Ahmed, Bringham, Richard, Havener, Robert, Ochs, Burt
• Primary Examiner(s): Bowers, Nathan
• Assistant Examiner(s): EDWARDS, LYDIA E
• Application Number:
  US11/822,495
• Publication Number:
  US 20080234768A1
• Time in Patent Office: 3,378 Days
• Field of Search: 435/284.1, 435/286.5, 435/286.6, 435/307.1, 600/36, 623/915, 623/916, 623/921, 623/922
• US Class Current: 1/1
• CPC Class Codes: A01N 1/0247 for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
• CPC Class Codes: A01N 1/0294 Electromagnetic, i.e. using electromagnetic radiation or electromagnetic fields
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0488 Details about the lead
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence

Abstract

Electrode systems have been developed for use in perfusion systems to measure the electrical activity of an explanted heart and to provide defibrillation energy as necessary. The perfusion systems maintain the heart in a beating state at, or near, normal physiological conditions; circulating oxygenated, nutrient enriched perfusion fluid to the heart at or near physiological temperature, pressure and flow rate. These systems include a pair of electrodes that are placed epicardially on the right atrium and left ventricle of the explanted heart, as well as an electrode placed in the aortic blood path.

Claims

1. An organ care system for maintaining an explanted heart at a near physiologic condition using perfusion fluid and which allows for sending electrical signals to and from the explanted heart, the system comprising:

a heater assembly configured to heat the perfusion fluid;

a first electrode placed in an aortic bloodstream conduit and connected to the organ care system for receiving signals from the explanted heart;

a second electrode connected to the organ care system for receiving signals from the explanted heart and sending signals thereto;

a third electrode connected to the organ care system for sending signals to the explanted heart; and

a controller that;

receives a signal from at least one of the first and second electrodes and determines whether to provide pacing signals to maintain the explanted heart based on the signal received from the at least one of the first and second electrodes, and

controls the heater assembly to maintain the heart at a temperature between 26° and

37°

C. using the perfusion fluid,

wherein at least one of the second and third electrode is in a sterile environment.

2. The organ care system of claim 1, wherein each of the second electrode and third electrode is configured to be placed on the explanted heart.

3. The organ care system of claim 1, wherein at least a portion of at least one of the second electrode and third electrode is covered with silicone.

4. The organ care system of claim 1, wherein the signals are at least one of ECG signals, defibrillation signals, and pacing signals.

5. The organ care system of claim 1, wherein the sterile environment further comprises a housing which encloses the explanted heart and into which a conduit delivers perfusion fluid which passes through the explanted heart.

6. The organ care system of claim 5, wherein the housing further comprises a pad, wherein the pad is configured to receive an explanted heart so that when the explanted heart is beating at a normal physiologic rate it is maintained in a stable position within the housing.

7. The organ care system of claim 6, wherein at least one of the second electrode and the third electrode is held in place against the pad by the weight of the heart.

8. The organ care system of claim 1 wherein the first one of the electrodes further comprises:

an electrically conductive pin placed within a bloodpath of an organ care system;

a wire for electrically coupling the electrode to the organ care system;

wherein the wire and the pin are physically and electrically connected by a conductive epoxy.

9. The organ care system of claim 1,

wherein the first electrode is configured to receive ECG signals from the explanted heart;

and wherein the system further comprises

a right atrial electrode connected to the organ care system for epicardial placement on the explanted heart; and

wherein the right atrial electrode is configured to receive ECG signal from the explanted heart.

10. The system of claim 1, wherein the controller

controls the heater assembly to maintain the heart at a temperature between 32°

and 37°

C.

11. An organ care system for maintaining an explanted heart at a near physiologic condition using perfusion fluid, the system comprising:

a heater assembly configured to heat the perfusion fluid;

a first electrode connected to the organ care system for receiving signals from an explanted heart,

wherein the first electrode is placed in the aortic bloodstream of the explanted heart;

a second electrode connected to the organ care system for receiving signals from the explanted heart and sending signals thereto,

wherein the second electrode is configured to be placed on the explanted heart adjacent the right atria;

a third electrode connected to the organ care system for sending signal to the explanted heart,

wherein the third electrode is configured to be placed epicardially on the explanted heart adjacent the left ventricle when the explanted heart is maintained at a near physiologic condition; and

a controller that;

receives a signal from at least one of the first and second electrodes and determines whether to provide pacing signals to maintain the explanted heart based on the signal received from the at least one of the first and second electrodes, and

controls the heater assembly to maintain the heart at a temperature between 26° and

37°

C. using the perfusion fluid.

12. The organ care system of claim 11, wherein at least a portion of the second and third electrode is covered with silicone.

13. The organ care system of claim 11, wherein the system further comprises a pad, wherein the pad is configured to receive the explanted heart so that the explanted heart is maintained in a stable position within the housing.

14. The organ care system of claim 13, wherein at least one of the second electrode and the third electrode is held in place against the pad by the weight of the heart.

15. The organ care system of claim 11, wherein an electrical circuit is completed between the first electrode and the second electrode utilizing as a conductor at least one of a perfusion fluid and the heart.

16. The system of claim 11, wherein the controller

controls the heater assembly to maintain the heart at a temperature between 32°

and 37°

C.

17. An apparatus for maintaining an explanted heart at a near physiologic condition using perfusion fluid, the apparatus comprising:

a heater assembly configured to heat the perfusion fluid;

a first electrode placed in the aortic bloodstream of an explanted heart,

wherein the first electrode is comprised of at least one of stainless steel and polycarbonate;

a second electrode for epicardial placement on the explanted heart;

a third electrode for epicardial placement on the explanted heart;

a controller that;

receives a signal from at least one of the first, second and third electrodes, and determines whether to provide pacing signals to maintain the explanted heart based on the signal received from the at least one of the first, second and third electrodes, and

controls the heater assembly to maintain the heart at a temperature between 26° and

37°

C. using the perfusion fluid;

wherein at least one of the second electrode and third electrode is comprised of stainless steel,

wherein at least a portion of at least one of the second electrode and third electrode is covered by silicone; and

wherein at least one of the first electrode, second electrode and third electrode is configured to send and receive signals to the explanted heart while the heart is at a near physiologic condition.

18. The apparatus of claim 17, wherein at least one of the second and third electrode is held in place against a pad by the weight of the explanted organ heart so that the explanted heart is maintained in a stable position within the housing.

19. The apparatus of claim 18, wherein the pad is at least partially comprised of silicone, and

wherein at least one of the second and third electrode is at least partially held in place by friction.

20. The apparatus of claim 17, wherein the first electrode further comprises silicone.

21. The system of claim 17, wherein the controller

controls the heater assembly to maintain the heart at a temperature between 32°

and 37°

C.

22. An organ care system for maintaining an explanted organ at a near physiologic condition, the system comprising:

a silicone pad defining an aperture and being configured to be in contact with the explanted organ;

a chamber configured to hold the explanted organ;

a heater assembly configured to heat perfusion fluid;

a first electrode disposed in an aortic bloodstream conduit coupled to the chamber that receives electrical signals from the explanted organ;

a second electrode disposed in the chamber and that contacts the explanted organ through the aperture in the silicone pad when the explanted organ is placed in the chamber;

a controller that;

receives a signal from at least one of the first and second electrodes and to determines whether to provide pacing signals to maintain the explanted heart based on the signal received from the at least one of the first and second electrodes, and

controls the heater assembly to maintain the explanted organ at a temperature between 26° and

37°

C. using the perfusion fluid.

23. The organ care system of claim 22, wherein the second electrode is configured to send and receive signals to an explanted heart.

24. The organ care system of claim 23, wherein the second electrode is at least partially held in place against the explanted organ by the weight of the explanted organ.

25. The organ care system of claim 22, wherein the second electrode is at least partially held in place on the silicone pad by friction.

26. The system of claim 22, wherein the controller controls the heater assembly to maintain the explanted organ at a temperature between 32°

and 37°

C.

27. An organ care system for maintaining an explanted heart at a near physiologic condition using perfusion fluid, the system comprising:

a heater assembly configured to heat perfusion fluid;

an aortic electrode connected to the organ care system placed in an aortic bloodpath of an explanted heart, wherein the aortic electrode is configured to receive electrocardiogram (ECG) signals from the explanted heart;

a right atrial electrode connected to the organ care system for epicardial placement on the explanted heart, wherein the right atrial electrode is configured to receive ECG signal from the explanted heart, and wherein the right atrial electrode is configured to send to the explanted heart at least one of defibrillation energy and pacing signals;

a left ventricle electrode connected to the organ care system for epicardial placement on the explanted heart, wherein the left ventricle electrode is configured to send to the explanted heart at least one of defibrillation energy and pacing signals; and

a controller that;

receives a signal from at least one of aortic and right atrial electrodes and determines whether to provide pacing signals to maintain the explanted heart based on the signal received from the at least one of the aortic and right atrial electrodes, and

controls the heater assembly to maintain the heart at a temperature between 26° and

37°

C. using the perfusion fluid.

28. The organ care system of claim 27, wherein the ECG signals received by the aortic electrode and the right atrial electrode are received by a circuit at least partially comprised of the aortic electrode, the right atrial electrode, a perfusion fluid and the explanted heart.

29. The system of claim 27, wherein the controller controls the heater assembly to maintain the heart at a temperature between 32°

and 37°

C.

30. An organ care system for maintaining an explanted heart at a near physiologic condition using perfusion fluid, the system comprising:

a circuit for receiving electrocardiogram (ECG) signals from the explanted heart, wherein the circuit comprises;

a first electrode placed in the aortic bloodpath of the explanted heart;

a second electrode configured to be placed epicardially on the explanted heart;

a perfusion fluid configured to perfuse the explanted heart; and

a heater assembly configured to heat perfusion fluid;

a controller that;

measures the ECG signals from the explanted heart, and determines whether to provide pacing signals to maintain the explanted heart based on at least the measured ECG signal, and

controls the heater assembly to maintain the heart at a temperature between 26° and

37°

C. using the perfusion fluid.

31. The system of claim 30, wherein the controller controls the heater assembly to maintain the heart at a temperature between 32°

and 37°

C.

32. A method for measuring electrocardiogram (ECG) signals in an organ care system for maintaining an explanted heart at a near physiologic condition, the method comprising:

maintaining the heart at a temperature between 26° and

37°

C.;

placing a first electrode in the aortic bloodpath of the explanted heart;

placing a second electrode epicardially on the explanted heart;

measuring ECG signals produced by the explanted heart using a circuit comprising at least the first and second electrodes, a perfusion fluid, and the explanted heart;

receiving signals from the circuit; and

determining whether pacing signals to maintain the heart are required.

33. A method for sending and receiving signals in an organ care system for maintaining an explanted heart at a near physiologic condition, the method comprising:

maintaining the heart at a temperature between 26° and

37°

C.;

providing a perfusion fluid to the explanted heart;

providing a defibrillation source;

placing at least a first electrode in the aortic bloodpath of the explanted heart;

placing a second electrode epicardially;

placing a third electrode epicardially;

forming a second circuit comprising the second electrode, the third electrode and the defibrillation source;

receiving electrocardiogram (ECG) signals from a first circuit comprising the first electrode, the second electrode, and the perfusion fluid, wherein the ECG signals are measured from the explanted heart; and

sending at least one of a defibrillation signal and a pacing signal to a second circuit comprising the second electrode, the third electrode, and the defibrillation source, to maintain the heart.