Temporary heart-assist system

Surgery – Cardiac augmentation – Aortic balloon pumping

Reexamination Certificate

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C623S003260, C623S003280

Reexamination Certificate

active

06669624

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to methods and devices for mechanically assisting the failing heart. More specifically, it relates to balloon catheters and bypass pumps.
BACKGROUND OF THE INVENTION
Many types of cardiac assist devices have been developed over the past 40 years. The general types of devices can be characterized as short-term (hours to days), bridge-to-transplantation, bridge-to-recovery, and permanent or long-term. The goal of these devices is to mechanically support the failing heart by increasing systemic perfusion, and/or reducing the workload of the failing heart, thus creating the most favorable environment for cardiac recovery.
Short-term devices are used on patients whose hearts have sustained a serious injury but can recover if adequately supported. The most commonly used short-term device is the intra-aortic balloon pump (“IABP”). Indications for employment of the IABP include cardiogenic shock or severe heart failure secondary to acute myocardial infarction or following open-heart surgery, unstable angina resistant to drug therapy, and refractory ventricular irritability after myocardial infarction. The following patents disclose intra-aortic balloon pumps. The full disclosures of these patents are all incorporated herein by this reference:
6,290,641
Intra-aortic balloon pump having improved automated electro-
cardiogram based intra-aortic balloon deflation timing
6,245,008
Fast response intra-aortic balloon pump
6,241,706
Fast response intra-aortic balloon pump
6,238,382
Intra-aortic balloon catheter having a tapered Y-fitting
6,210,319
Intra-aortic balloon pump condensation prevention system
6,191,111
Method and device for enhancing of biobypass by increasing
the coronary blood flow
5,817,001
Method and apparatus for driving an intra-aortic balloon pump
The following patents disclose intra-aortic balloons. The full disclosures of these patents are all incorporated herein by this reference:
6,213,975
Intra-aortic balloon catheter having an ultra-thin stretch blow
molded balloon membrane
6,149,578
Piston-action intra-aortic coronary assist device
6,024,693
Intra-aortic balloon catheter
5,935,501
Method for making a packaging sheath for intra-aortic balloon
catheters
5,928,132
Closed chest intra-aortic balloon based ventricular assist
device
5,913,814
Method and apparatus for deflation of an intra-aortic balloon
5,865,721
Intra-aortic balloon catheters
5,817,001
Method and apparatus for driving an intra-aortic balloon pump
5,772,631
Procedure for alleviating arterial obstruction
5,759,175
Intra-aortic balloon catheter
5,718,861
Method of forming intra-aortic balloon catheters
5,697,906
Intra-aortic balloon catheter
5,683,347
Balloon catheter
5,618,270
Transthoracic aortic sleeve
5,599,329
Multi purpose perfusion cannula
5,524,757
Packaging sheaths for intra-aortic balloon catheters
5,460,607
Balloon catheter
5,456,665
Intra-aortic balloon catheter
RE34,993
Method of inserting a lab device into the body
5,413,549
Devices and methods for efficient intra-aortic balloon
pumping
5,330,451
Multi purpose perfusion cannula
5,230,692
Intra-aortic balloon pump
5,158,529
Pumping device for operating an intra-aortic balloon
5,120,299
Intra-aortic balloon assembly with hemostasis device
4,994,018
Intra-aortic balloon assembly
4,901,707
Prepackaged intra-aortic balloon assembly with holder, and
method of using same
4,897,077
Method of inserting an IAB device into the body
4,827,906
Apparatus and method for activating a pump in response to
optical signals from a pacemaker
4,809,681
Electrocardiographic measurement method for controlling an
intra-aortic balloon pump
4,804,358
Coronary perfusion pump
4,733,652
Intra-aortic balloon
4,697,573
Percutaneous intra-aortic balloon and method for using same
4,644,936
Percutaneous intra-aortic balloon and method for using same
4,576,142
Percutaneous intra-aortic balloon and method for using same
4,552,127
Percutaneous intra-aortic balloon having an EKG electrode
and a twisting stylet for coupling the EKG electrode to
monitoring and/or pacing instrumentation external to the body
4,531,512
Wrapping system for intra-aortic balloon utilizing a wrapping
envelope
4,522,195
Apparatus for left heart assist
4,522,194
Method and an apparatus for intra-aortic balloon monitoring
and leak detection
4,515,587
IAB having apparatus for assuring proper balloon inflation
and deflation
4,473,067
Introducer assembly for intra-aortic balloons and the like
incorporating a sliding, blood-tight seal
4,467,790
Percutaneous balloon
4,444,186
Envelope wrapping system for intra-aortic balloon
4,422,447
Percutaneous balloon
4,407,271
Apparatus for left heart assist
4,402,307
Balloon catheter with rotatable energy storing support member
4,362,150
Percutaneous intra-aortic balloon apparatus
4,346,698
Balloon catheter with rotatable support
4,327,709
Apparatus and method for the percutaneous introduction of
intra-aortic balloons into the human body
4,311,133
Intra-aortic balloon
4,287,892
Cannula for intra-aortic balloon devices and the like
4,276,874
Elongatable balloon catheter
4,261,339
Balloon catheter with rotatable support
4,122,858
Adapter for intra-aortic balloons and the like
4,080,958
Apparatus for aiding and improving the blood flow in patients
3,985,123
Method and means for monitoring cardiac output
Aortic occlusion balloons are known in the prior art. Such aortic balloons are non co-pulsating with the heartbeat and are not employed with an aortic bypass pump. The following patents disclose aortic occlusion balloons. The full disclosures of these patents are all incorporated herein by this reference:
6,254,563
Perfusion shunt apparatus and method
6,248,086
Method for cannulating a patient's aortic arch and occluding
the patients ascending aortic arch
5,413,558
Selective aortic perfusion system for use during CPR
5,216,032
Selective aortic arch perfusion using perfluorochemical and
alpha-adrenergic agonist to treat cardiac arrest
5,195,942
Cardiac arrest treatment
4,697,574
Pump for assistance in circulation
4,531,936
Device and method for the selective delivery of drugs to the
myocardium
The basic components of the intra-aortic balloon pump (“IABP”) are a catheter tipped with a long balloon and a pump console that shuttles helium gas through the catheter to inflate and deflate the balloon synchronously with the heart beat. The balloon is inserted into an artery and guided to a position in the descending thoracic aorta just distal to the left subclavian artery. The pump control console contains signal processing, drive, timing, and control mechanisms for appropriate inflation and deflation. During cardiac systole ventricular contraction and ejection, the IABP is rapidly deflated, reducing the workload and oxygen demands of the heart by decreasing the resistance to blood flow from the ventricle. During cardiac diastole ventricular relaxation and filling, the IABP is rapidly inflated counter-pulsation increasing aortic and coronary perfusion pressures. Timing of the inflation-deflation cycle is based on the electrocardiogram and arterial blood pressure waveform.
When heart failure is severe, the IABP cannot provide adequate circulatory support because it cannot replace cardiac function. The treatment of severe heart failure requires the use of cardiac-bypass blood pumps. These devices are more invasive than the IABP and employ direct cannulation of the ventricle or atrium. Implantation and removal of the cardiac cannulas may further injure the heart and be associated with bleeding complications. It is estimated that nearly 100,000 patients worldwide underwent short-term mechanical circulatory support during 2000. The following patents disclose cardiac bypass pumps. The full
6,238,334
Method and apparatus for assisting a heart to pump blood
6,149,683
Power system for an implantable heart pump
6,099,460
Electromagnetic heart-assist technique and apparatus
6,015,434
Artificial heart pump
5,588,812
Implantable electric axial-flow blood pump
5,443,503
Artificial heart pump
5,344,443
Heart pump
5,263,979
Artificial hear

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