Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-12-26
2002-11-05
Hayes, Michael J. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S102030, C604S917000
Reexamination Certificate
active
06475186
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a portable and modular cardiopulmonary bypass apparatus and more particularly it relates to a portable apparatus that can be used to effectively treat patients in suspected terminal states or clinical death. The invention also includes an associated aortic balloon catheter and an associated method.
2. Background of the Invention
The development of external cardiopulmonary-cerebral resuscitation (CPCR) was initiated by one of the co-inventors herein, Dr. Peter Safar. This breakthrough revolutionized the then embryonic field of critical care medicine by allowing anyone anywhere to initiate life-saving procedures. Since its introduction, it has been taught worldwide and used innumerable times on victims of cardiac arrest. It is standard procedure worldwide in treating victims of heart arrest, asphyxiation or other lethal emergencies.
There are, however, limits to the application of standard CPCR because sternal compression cannot reliably produce enough blood flow to maintain viability of vital organs. Moreover, prolonged life support (PLS) after restoration of a heartbeat has its limits without the availability of artificial circulation and oxygenation.
This need led to the development of emergency cardiopulmonary bypass (CPB). CPB permits the control of flow, pressure, temperature and oxygenation of the blood. See Safar et al., “Cardiopulmonary Bypass for Emergency Resuscitation after Prolonged Cardiac Arrest”, American Journal Of Emergency Medicine, 2:348, 1984.
It is known that periods of no-blood flow to the brain can seriously affect brain function. Therefore, the key element in resuscitation is to start life-saving procedures as quickly as possible after onset of cardiac arrest. This invention relates to an aortic balloon catheter and an associated method for use in cardiopulmonary bypass operations that can be used to effectively treat patients undergoing various cardiopulmonary procedures.
Another advantage of CPB over CPCR is that CPB can be used in association with other techniques to prevent or correct derangements encountered in terminal states and clinical death such as rapid blood loss, blood gas derangements, temperature extremes and intoxication. CPB can be used in association with methods to purify blood and to provide hemoadsorption, plasma and blood cell apheresis. Other procedures that can be used in association with CPB are heating or cooling the blood and total body blood washout and blood replacement. Therefore, any CPB apparatus should be adapted to accommodate modules to accomplish these procedures.
Therefore, there is a need for an aortic balloon catheter which is adapted for use in establishing cardiopulmonary bypass of patients for the purpose of assisting medical personnel in performing various medical procedures on such patients who may be experiencing any or all of the above-described derangements. Further, such a balloon catheter should facilitate application of the procedures described below for perfusing and withdrawing fluids respectively to and from such patients.
SUMMARY OF THE INVENTION
The aortic balloon catheter of the present invention meets the above-mentioned needs. The catheter includes an elongated tube device formed with a first lumen sized to communicate blood between an aortic lumen of a patient and a location external to the aortic lumen. Mounted on the tube device is an inflatable balloon sized to, when fully inflated, sealingly engage the walls of the aortic lumen of an adult human to thereby block blood flow past the balloon. The associated method of using the aortic balloon catheter includes introducing the catheter into the aortic lumen, positioning the first lumen and the balloon, inflating the balloon and withdrawing and perfusing fluids through the first lumen.
It is an object of the invention to provide an apparatus for CPB which is portable such that it can be used at the scene of an accident or of a patient having cardiac arrest or other life-threatening emergency.
It is a further object of the invention to provide an apparatus that provides life saving CPB at the earliest possible time either inside or outside a hospital.
It is a further object of the invention to provide a portable CPB apparatus that can be adapted to contain several blood conditioning modules.
It is a further object of the invention to provide an aortic balloon catheter module associated with the CPB apparatus to provide differential perfusion of selective regions of a patient's body.
It is a further object of the invention to provide a massive blood infusor module to supplement or replace a patient's blood.
It is a further object of the invention to provide a blood heat exchanger to control the temperature of a patient's blood.
These and other objects of the invention will be more fully understood from the following description of the invention with reference to the drawings appended to this application.
REFERENCES:
patent: 627465 (1899-06-01), Allen
Klain Miroslav
Safar Peter
Stezoski S. William
Fulwider Patton Lee & Utecht LLP
Hayes Michael J.
Lewis Michelle
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