Surgery – Blood drawn and replaced or treated and returned to body
Reexamination Certificate
1999-05-06
2003-01-21
Sykes, Angela D. (Department: 3762)
Surgery
Blood drawn and replaced or treated and returned to body
C604S006110, C604S006160, C604S008000, C604S009000, C604S019000, C604S096010, C604S101010
Reexamination Certificate
active
06508777
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to circulatory support systems and cardiopulmonary bypass systems. More particularly, it relates to a circulatory support system and method of use for isolating organ systems for separate closed loop perfusion.
BACKGROUND OF THE INVENTION
Circulatory support systems are used in many different medical settings to supplement or to replace the pumping function of a patient's heart. Applications of circulatory support systems and methods include, inter alia, augmenting cardiac output in patients with a failing heart, resuscitating victims of severe trauma or injury, and supporting a patient's circulatory functions during surgery.
One particular type of circulatory support system, known as a cardiopulmonary bypass (CPB) system, is used to temporarily replace the functions of the heart and the lungs by supplying a flow of oxygenated blood to the patient's circulatory system. The CPB system drains deoxygenated blood from the patient's venous system, passes it through a blood oxygenator, and pumps the oxygenated blood back into the patient's arterial system. CPB systems may be configured for direct cannulation of the inferior and superior vena cava or the right atrium and the aorta, or they may be configured for peripheral cannulation through the femoral vein or jugular vein and the femoral artery. The cardiopulmonary bypass system allows the patient's heart to be temporarily stopped, for example by cardioplegic arrest, hypothermic arrest or fibrillation, for performing a variety of cardiothoracic surgical procedures.
Previous CPB systems have generally been configured to provide a single circulatory loop for supplying the entire body with oxygenated blood from a single CPB pump. Thus, all organ systems of the body receive oxygenated blood at the same pressure and temperature and with the same blood composition. This single-loop configuration has significant limitations in many medical circumstances. It has been found, for instance, that the optimal perfusion temperature for organ preservation during prolonged circulatory support is different for different organs of the body. Likewise, different chemical compositions of the blood are beneficial for preservation of different organ systems. For optimal preservation of all the organ systems within the body, it would be desirable to be able to selectively perfuse different organ systems with different perfusates, which have been optimized for each of the organ systems.
U.S. Pat. Nos. 5,308,320, 5,383,854, 5,820,593 and 5,879,316 by Peter Safar, S. William Stezoski and Miroslav Klain, describe a cardiopulmonary bypass system capable of segmenting a patient's aorta and for selectively perfusing the different segments of the aorta with perfusates of different temperatures or chemical compositions. Other U.S. patents that address the concept of selective aortic perfusion include commonly owned, copending patent applications; 08/909,293, filed Aug. 11, 1997; 08/909,380, filed Aug. 11, 1997, and 09/152,589 filed Aug. 11, 1998 by Safar et al.; and U.S. Pat. No. 5,738,649 and commonly owned copending patent application 09/060,412 filed Apr. 14, 1998 by John A. Macoviak; and U.S. Pat. Nos. 5,827,237 and 5,833,671 by John A. Macoviak and Michael Ross and commonly owned copending patent application 08/665,635, filed Jun. 17, 1996; filed Jun. 18, 1996, by John A. Macoviak and Michael Ross; and 60/067,945, filed Dec. 8, 1997, by Bresnahan et al. These patent applications and all other patents referred to herein are hereby incorporated by reference in their entirety. The balloon catheter of Safar et al. may be introduced into the patient's aorta from a peripheral entry point, such as the femoral artery or the subclavian artery, or it may be introduced by a direct puncture in the patient's aorta during open chest surgery.
The previously described system, however, does not isolate the segments of the circulatory system from one another on the venous side of the circulatory system because the blood from each of the segments mingles together. Thus, any organ preserving temperature gradients, chemicals or therapeutic agents introduced into one of the segments will eventually mix with and be diluted into the entire systemic blood supply. In many circumstances it would be desirable to at least partially segment blood flow on the venous side of the circulatory system. For example, when administering anesthesia to a patient during surgery, it may be desirable to limit the flow of the anesthetic to the cerebral circulation only and to avoid dilution of the anesthetic in the systemic blood supply, and even to recirculate the anesthetic to the cerebral circulation. As another example, when administering a therapeutic agent that is very costly or which has systemic, central or specific organ toxicity or other undesirable effects, it may be desirable to limit the flow of the therapeutic agent to the target organs as much as possible without it entering the systemic blood supply such as gene therapy, viral vectors protein plasmids and angiogenic genes. As a third example, when performing segmented selective perfusion combined with hypothermic organ preservation, it would be desirable to isolate the segments of the circulatory system on the venous side to allow more precise and efficient temperature control within each circulatory loop. It would be desirable, therefore, to provide a circulatory support system or cardiopulmonary bypass system that allows segmentation of the circulatory system on the venous side, as well as on the arterial side, for isolated closed loop circulatory support of separate organ systems. Such a closed loop circulatory support system may be used to supply the entire body; with blood or other fluids through a plurality of isolated circulatory loops when the heart is not pumping. Alternatively, the closed loop circulatory support system may be used to create a single circulatory loop for supplying a single segment or organ system of the body with blood or other fluids while the beating heart supplies blood to the remainder of the body.
A plethora of known and newly discovered organ preserving chemicals and therapeutic agents are suitable for use with the circulatory support system of the present invention. Among these are natural and artificial blood substitutes or oxygen carriers, such as free hemoglobin, PERFLUBRON, and perfluorocarbons, and hemoglobin modifiers, such as RSR-13 (Allos Therapeutics), that increase oxygen delivery from blood to tissues. Also among these are neuroprotective agents, which have been the subject of intensive research in recent years. Promising neuroprotective agents include Na
+
blockers, glutamate inhibitors, nitric oxide inhibitors and radical scavengers. A thorough treatment of this subject can be found in the book
Neuroprotective Agents
, published by the New York Academy of Sciences. Possible therapeutic agents include, inter alia, thrombolytic agents, such as tPA, streptokinase and urokinase as well as gene therapy including angiogenic genes.
SUMMARY OF THE INVENTION
The circulatory support system of the present invention generally includes one or more venous cannulae for draining blood from the venous side of the patient's circulatory system, one or more arterial cannulae for perfusing the arterial side of the patient's circulatory system, and one or more blood circulation pumps connected between the venous cannulae and the arterial cannulae. The arterial cannulae and the venous cannulae of the circulatory support system may take one of several possible configurations. The circulatory support system is configured to segment a patient's circulatory system into one or more isolated circulatory loops. The circulatory loops may be isolated from one another and/or from the remainder of the patient's circulatory system on the venous side, as well as on the arterial side, for isolated closed loop circulatory support of separate organ systems. The circulatory support system of the p
Baker Steve
Leary James J.
Macoviak John
Samson Wilfred J.
Cardeon Corporation
Deak Leslie R.
Fulwider Patton Lee & Utecht
Sykes Angela D.
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