Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-01-11
2004-06-15
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S509000, C604S008000, C604S009000, C604S915000
Reexamination Certificate
active
06749598
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to apparatus for treating congestive heart disease by providing increased perfusion to the kidneys, thereby enhancing renal function.
BACKGROUND OF THE INVENTION
It has long been known that cardiac dysfunction induces a series of events that ultimately contribute to congestive heart failure (“CHF”). One such event is a reduction in renal blood flow due to reduced cardiac output. This reduced flow can in turn result in the retention of excess fluid in the patient's body, leading for example, to pulmonary and cardiac edema.
Chapter 62 of
Heart Disease: A Textbook of Cardiovascular Medicine
, (E. Braunwald, ed., 5th ed. 1996), published by Saunders, Philadelphia, Pa., reports that for patients with CHF, the fall in effective renal blood flow is proportional to the reduction in cardiac output. Renal blood flow in normal patients in an age range of 20-80 years averages 600 to 660 ml/min/m
2
, corresponding to about 14 to 20 percent of simultaneously measured cardiac output. Within a wide spectrum of CHF severity, renal blood flow is depressed to an average range of 250 to 450 ml/min/m
2
.
Previously known methods of treating congestive heart failure and deteriorating renal function in patients having CHF principally involve administering drugs, including diuretics that enhance renal function, such as furosemide and thiazide, vasopressors intended to enhance renal blood flow, such as Dopamine, and vasodilators that reduce vasoconstriction of the renal vessels. Many of these drugs, when administered in systemic doses, have undesirable side-effects.
In addition, for patients with severe CHF (e.g., those awaiting heart transplant), mechanical methods, such as hemodialysis or left ventricular assist devices, may be implemented. Mechanical treatments, such as hemodialysis, however, generally have not been used for long-term management of CHF.
Advanced heart failure (“HF”) requires the combination of potent diuretics and severe restriction of salt intake. Poor patient compliance is a major cause of refractoriness to treatment. On the other hand, as renal urine output decreases with reduced renal perfusion, in the event of dehydration, the required diuretic dosages increase.
In view of the foregoing, it would be desirable to provide methods and apparatus for treating and managing CHF without administering high doses of drugs or dehydrating the patient.
It further would be desirable to provide methods and apparatus for treating and managing CHF by improving blood flow to the kidneys, thereby enhancing renal function.
It also would be desirable to provide methods and apparatus for treating and managing CHF that permit the administration of low doses of drugs, in a localized manner, to improve renal function.
It still further would be desirable to provide methods and apparatus for treating and managing CHF using apparatus that may be percutaneously and transluminally implanted in the patient.
SUMMARY OF THE INVENTION
In view of the foregoing, it is an object of the present invention to provide methods and apparatus for treating and managing CHF without administering high doses of drugs or dehydrating the patient.
It is another object of this invention to provide methods and apparatus for treating and managing CHF by improving blood flow to the kidneys, thereby enhancing renal function.
It is also an object of this invention to provide methods and apparatus for treating and managing CHF that permit the administration of low doses of drugs, in a localized manner, to improve renal function.
It further is an object of the present invention to provide methods and apparatus for treating and managing CHF using apparatus that may be percutaneously and transluminally implanted in the patient.
These and other objects of the present invention are accomplished by providing a catheter having an inlet end configured for placement in a source of arterial blood, such as the aorta, the left ventricle or a femoral artery, and an outlet end having at least one conduit configured to be placed in a renal artery. The catheter includes a lumen through which arterial blood passes directly into a renal artery. The conduit may include means for engaging an interior surface of the renal artery to retain the conduit in position, and may comprise an occluder that reduces backflow of blood exiting the conduit into the abdominal aorta. The catheter preferably is configured to permit percutaneous, transluminal implantation.
In accordance with the principles of the present invention, high pressure blood passes through the lumen of the catheter during systole and into the conduit disposed in the renal artery. It is expected that blood passing through the catheter will have a higher pressure and higher flow rate than blood reaching the renal artery via the abdominal aorta. This in turn is expected to improve renal function, without administering systemic doses of drugs to improve renal function or renal blood flow. The enhanced renal blood flow is expected to provide a proportional increase in renal function, thereby reducing fluid retention.
In alternative embodiments, the catheter may include first and second conduits for perfusing both kidneys, a one-way valve disposed in the lumen to prevent backflow of blood in the lumen during diastole or a mechanical pump to further enhance the flow of blood through the lumen. Still other embodiments of the catheter may include a drug infusion reservoir that injects a low dose of a drug, e.g., a diuretic or vasodilator, into blood flowing through the lumen, so that the drug-infused blood passes directly into the kidneys. Still further embodiments may comprise separate catheters to perfuse the left and right kidneys, or may draw arterial blood from a peripheral vessel using an external pump.
Methods of implanting the apparatus of the present invention also are provided.
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Keren Gadi
Shmulewitz Ascher
Flowmedica Inc.
O'Banion John P.
Peacock, III James C.
Thissell Jeremy
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