Surgery – Cardiac augmentation
Reexamination Certificate
1999-10-25
2001-07-10
Getzow, Scott M. (Department: 3737)
Surgery
Cardiac augmentation
C128S898000
Reexamination Certificate
active
06258021
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a method for improving cardiac function. More particularly, this invention relates to an intrapericardial assist procedure. The invention is useful in assisting a patient's heart in its pumping function, even where there is congestive heart failure. This invention also relates to a method for assisting a patient's heart in its pumping function.
BACKGROUND OF THE INVENTION
When a patient's heart stops, for example, in the operating room, cardiopulmonary resuscitation (CPR) is required. In that procedure the chest is violently pounded at the region of the sternum to compress the chest and thereby compress the heart between the sternum and the spine. This compression forces blood out of the ventricles through the one-way valves of the heart. When the pressure on the heart is released, the heart expands and blood is sucked into the heart.
For all its violence, CPR is a delicate procedure in that it must be performed correctly in order to have the desired result of starting the stopped heart. A problem with CPR is that, whether or not it is performed correctly, CPR invariably results in cracked ribs, a fractured sternum and destroyed costo-chondral (cartilage) junctions. Thus even if a patient survives CPR, he is usually injured.
Another serious cardiac condition arises in people who have experienced heart attacks. In such persons, a portion of the heart muscle is frequently destroyed by the attack. Although nerves passing through the damaged heart tissue are not destroyed to the point of ceasing function, the operation of the nerves may be significantly impaired. Conduction of nerve impulses may be delayed. This delay in signal transmission over the impaired nerves results in a delay in heart muscle contraction in those parts of the heart controlled by the impaired nerves. This condition is observed as a “bundle branch block” in an electrocariogram.
Reviving a patent after cardiac arrest is made more difficult when the patient suffers from congestive heart failure. Congestive heart failure occurs, inter alia, where there has been a heart attack or an infection. In either case, the pumping action of the heart is impaired. In another malfunction, left ventricular hypertrophy, the myocardium of the left ventricle becomes thickened to the point of interfering with effective heart contraction. Hypertrophy of the left ventricular muscle arises from a sticky heart valve or aortic stenosis. The increase in left ventricular pressure resulting from increased resistance to blood flow out of the left ventricle gradually induces an increase in the size of the myocardium about the left ventricle. This left ventricular hypertrophy is a dangerous condition, particularly where the individual suffers from coronary artery disease. The larger heart muscle requires greater blood flow and is therefore more sensitive to even temporary reductions in that flow. Such a reduction in blood flow occurs, for example, when the afflicted individual exercises.
A surgical procedure for treating congestive heart failure, developed by a doctor in Brazil, involves removing a triangular portion of a patient's heart. In this operation, approximately one-third of the patient's left ventricular muscle is removed. The result is that the smaller heart pumps more efficiently. This technique of course requires open heart surgery, with its attendant expense and extended convalescence.
OBJECTS OF THE INVENTION
An object of the present invention is to provide a method and/or an associated device for assisting cardiac function.
A more particular object of the present invention is to provide such a method and/or device which is less traumatic than conventional manual heart resusitation techniques.
Another particular object of the present invention is to provide such a method and/or device wherein the device is implanted into the intrapericardial space.
A further object of the present invention is to provide such a method and/or device which can compensate for or take into account congestive heart failure.
Another object of the present invention is to provide such a method and/or device which is of simple construction.
A further, more particular, object of the present invention is to provide such a method and/or device which is implemented at least partially automatically.
These and other objects of the present invention will be apparent from the drawings and detailed descriptions herein.
SUMMARY OF THE INVENTION
The present invention is directed to a surgical method for assisting cardiac function and utilizes a balloon which is initially in a collapsed configuration. Pursuant to the present invention, the balloon together with another preferably implantable device is inserted into a patient inside the pericardium. More particularly, the balloon is positioned in the intrapericardial space. The secondary device is employed to close off the lower end portions of the patient's ventricles, the balloon being used to contract or compress the remaining portion of the patient's heart to squeeze blood from the reduced-size ventricles.
The secondary device may operate in compression to contract the lower portion of the patient's heart. In that case, the secondary device is also inserted at least partially into the pericardium and positioned about the lower portion of the patient's heart. Specific forms of the secondary device are an anciliary balloon and a pronged or fingered element. Alternatively, the secondary device may operate by tension. In that case, the secondary device may be deployed intravenously. A catheter is inserted into a ventricle and a wire ejected from the catheter. The wire is pushed into the myocardium and tension is placed on the wire to pull generally opposing walls of the heart together, thereby reducing the volume of the ventricles at their lower ends.
Where two balloons are used to carry out the cardiac assist method of the present invention, one of the balloons is disposed about one portion of the patient's heart and the other of the balloons about another portion of the patient's heart. The method further includes differentially inflating the balloons in the intrapericardial space to differentially compress the different portions of the patient's heart. More specifically, one balloon is placed about a lower part of the patient's heart and is inflated and maintained in an inflated configuration, while the other balloon is placed about a higher portion of the patient's heart and periodically or repeatedly inflated and alternately deflated to push blood from the patient's ventricles in pulsatile fashion.
The insertion of the balloons may be implemented in a minimally invasive manner by using a hypodermic type needle. The needle is inserted through a skin surface and into the intrapericardial space, and the balloons are injected in collapsed configurations into the intrapericardial space. It is to be noted, however, that the present method may be utilized in open surgical procedures as well as in minimally invasive procedures.
Where an intrapericardial assist device in accordance with the present invention comprises a pair of balloons connected to one another, the balloons have predetermined sizes and shapes in an expanded configuration so that the balloons are capable of being disposed in a patient's intrapericardial space about the patient's heart. The device further comprises a first pressure source operatively connected to one of the balloons for controllably pressurizing the one of the balloons and a second pressure source operatively connected to the other of the balloons for controllably pressurizing the other of the balloons. Preferably, the balloon which is repeatedly inflated and alternately deflated has a configuration of a cuff in an expanded configuration. The balloon which is positioned about the lower end of the patient's heart may have a substantially cup-shaped configuration conforming to the lower end of the patient's heart. One or more spring elements exem
Coleman Henry D.
Coleman Sudol Sapone P.C.
Getzow Scott M.
Sudol R. Neil
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