Method of timing pulsatile flow of normothermic perfusate to the heart

• US 7,651,835 B2
• Filed: 10/07/2005
• Issued: 01/26/2010
• Est. Priority Date: 10/07/2004
• Status: Active Grant

• Current Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Original Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Inventors: Hassanein, Waleed, Newell, Scott, Taylor, Ronald, Goff, Larry, Bringham, Richard, Fishman, Robert, Cecere, Giovanni, Ochs, Burt, Havner, Robert, Algamil, Hossam, Bishop, Thomas, Menn, Dmitri, Kyi, Stanley, Khayal, Tamer
• Primary Examiner(s): Saucier; Sandra E
• Application Number:
  US11/246,905
• Publication Number:
  US 20070190636A1
• Time in Patent Office: 1,572 Days
• Field of Search: None
• US Class Current: 435/1.2
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0226 Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
• CPC Class Codes: A01N 1/0242 Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
• CPC Class Codes: A01N 1/0247 for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts

Abstract

The invention provides, in various embodiments, systems, devices and methods relating to ex-vivo organ care. In certain embodiments, the invention relates to maintaining an organ ex-vivo at near-physiologic conditions.

Claims

1. A method of preserving a heart ex vivo comprising,

placing a heart in a protective chamber of a portable organ care system,

delivering a perfusion fluid to the heart in a pulsatile flow with a pump, the perfusion fluid being at a temperature of between about 25°

C. and about 37°

C., and at a volume of between about 200 ml/min and about 5 L/min,

measuring with a sensor one or more physiologic characteristics of the heart while it is beating, and

operating the pump in response to the one or more physiologic characteristics wherein said step of operating the pump includes timing the pulsatile flow so the perfusion fluid enters the heart when the heart is in a diastolic state.

2. The method of claim 1, wherein the one or more physiologic characteristics include an electrical characteristic.

3. The method of claim 1, wherein the one or more physiologic characteristics include a pressure characteristic.

4. The method of claim 1, wherein the perfusion fluid is blood product based.

5. The method of claim 1, wherein the perfusion fluid is synthetic blood substitute based.

6. The method of claim 1 wherein the pump is a pulsatile pump.

7. The method of claim 1, wherein the one or more physiologic characteristics include a rate at which the heart is beating, and said operating the pump includes adjusting the rate of the pulsatile pump in response to the rate at which the heart is beating in which said adjusting has the perfusion fluid enter the heart when the heart is in a diastolic state.

8. The method of claim 1, wherein the one or more physiologic characteristics include a rate at which the heart is beating, and said operating the pump includes adjusting the stroke volume of the pulsatile pump in response to the rate at which the heart is beating in which said adjusting has the perfusion fluid enter the heart when the heart is in a diastolic state.

9. The method of claim 1, wherein the diastolic state is a diastolic state of a ventricle of the heart.

10. The method of claim 9, wherein the ventricle is the a left ventricle.

11. The method of claim 1, wherein the diastolic state is a diastolic state of an atrium of the heart.

12. The method of claim 1, wherein said operating the pump includes altering the shape of a waveform in response to the one or more physiologic characteristics of the heart, in which said altering has the perfusion fluid enter the heart when the heart is in a diastolic state and said waveform is representative of a rate and stroke volume at which a pump operates.

13. The method of claim 1, wherein the operating the pump includes altering a flow volume in response to the physiologic characteristics of the heart, in which said altering has the perfusion fluid enter the heart when the heart is in a diastolic state and said flow volume is flow volume of fluid per unit time at which the pump operates.

14. The method of claim 1, wherein the one or more physiologic characteristics include an r-wave from the heart and said operating the pump includes operating the pump in response to the r-wave, in which the said operating has the perfusion fluid enter the heart when the heart is in a diastolic state.

15. The method of claim 1, wherein the one or more physiologic characteristics include an r-wave from the heart and said operating the pump includes a user selectable pumping delay.

16. The method of claim 1 comprising flowing the perfusion fluid through a channel formed between two heated plates of a perfusion fluid heater to maintain the perfusion fluid at a temperature of between about 32°

C. and about 37°

C.

17. The method of claim 16 comprising monitoring the temperature of the perfusion fluid as it enters the channel.

18. The method of claim 16 comprising monitoring the temperature of the perfusion fluid as it exits the channel.

19. The method of claim 16 comprising monitoring temperature of the perfusion fluid heater.

20. The method of claim 1 wherein the pump includes a pump driver that pumps the perfusion fluid to the heart and the pump driver is isolated from the perfusion fluid.

21. The method of claim 1, wherein said step of delivering a perfusion fluid includes

delivering the perfusion fluid to the coronary sinus of the heart via retrograde perfusion of an aorta of the heart,

providing a flow of the perfusion fluid away from the heart via a right ventricle of the heart, and

providing a pulsatile flow of between about 200 ml/min and about 400 ml/min of the perfusion fluid to the heart, the perfusion fluid being at a temperature of between about 25°

C. and about 37°

C.

22. The method of claim 21 comprising maintaining the pumping the perfusion fluid, the providing a flow of perfusion away, and the providing the flow volume for greater than about 2 hours while maintaining the heart in suitable condition for transplantation.

23. The method of claim 1, wherein the operating the pump includes a timed delay between applying a pump force to the perfusion fluid and the diastolic state of the heart.