Enhanced intra-aortic balloon assist device

Details Enhanced intra-aortic balloon assist device Enhanced intra-aortic balloon assist device

1999-07-13

2001-02-20

Schaetzle, Kennedy (Department: 3762)

Surgery

Cardiac augmentation

Aortic balloon pumping

C604S914000, C604S101050

Reexamination Certificate

active

06190304

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to intra-aortic balloon pumps (“IABP”) that act as a left ventricular assist device (“LVAD”). More particularly, the present invention relates to a cooperatively acting dual balloon system wherein one balloon is located inside the aorta and a second balloon is located outside the body, a hollow catheter allowing for blood communication between the second balloon and the aorta.
2. Description of the Prior Art
The intra-aortic balloon pump (“IABP”) is by far the most commonly utilized left ventricular assist device (“LVAD”). This device is used when the patient's cardiac output is not sufficient to maintain an adequate blood pressure for supplying the patient's organs with arterial blood.
The IABP consists of an inflatable balloon attached to a catheter, which is advanced through the patient's femoral artery and into the descending aorta. Inflation and deflation of the balloon is accomplished by an external control unit synchronized with the heart beat. This unit rapidly inflates the balloon during the diastolic or resting phase of the heart cycle, and thus elevates diastolic aortic blood pressure and improves blood flow to the heart, the brain and other tissues. The balloon is rapidly deflated as the heart contracts. This reduces the aortic blood pressure that the heart must overcome to eject blood from the left ventricle. Thus, the IABP is a LVAD that also augments diastolic aortic blood pressure.
However, present IABP devices cannot sustain the circulation if the heart is severely diseased or injured, since ventricular ejection must be sufficient to keep the mean aortic blood pressure above approximately 60 mmHg. When the aortic pressure falls below this value, there is insufficient blood to fill the space around the balloon when it is deflated. In that case the wall of the aorta collapses around the deflated balloon of prior art devices, and the IABP becomes ineffective. Thus, present IABP devices can be used only in less severe cases of left ventricular failure.
The present invention is directed towards improving the usefulness of IABP devices by enhancing the use of a single balloon in the descending aorta with a second, external balloon located outside the body and in direct communication with the blood within the aorta through a hollow catheter tube connecting both balloons. Although several IABP devices have used multiple balloons to enhance circulation, none use an external balloon working cooperatively with the internal balloon. Gabbay (U.S. Pat. No. 4,527,549) discloses the use of a balloon within the ascending aorta and multiple smaller balloons within the aortic arch and descending aorta. Given the difficulty in positioning a balloon within the ascending aorta with a catheter coming up from the descending aorta, the Gabbay device is cumbersome and difficult to operate. More importantly, the Gabbay device has the disadvantage of being positioned in the ascending aorta in order to function, thus increasing the chance of producing emboli that can cause problems such as stroke. Choy et al. (U.S. Pat. No. 4,902,273) discloses a dual balloon device, but which operates by a completely different mode. In the Choy et al. device, one balloon enters the left ventricle of the heart and another balloon enters the right ventricle of the heart. In a diseased heart, which may already be dilated, this would excessively expand the ventricle and may cause rupture or other permanent damage. Positioning the balloons in that invention is also cumbersome, making the device impractical for many applications.
Thus, what is needed is a IABP that has greater pumping capacity, that is simple to use and capable of rapid insertion and operation in an emergency situation, and that is capable of elevating blood pressure within the ascending aorta even if the descending aorta should collapse around the internal pumping balloon. The present invention is directed towards such a device.
SUMMARY OF THE INVENTION
One object of the present invention is to provide a means and method for enhancing heart function when the blood pressure within the aorta is insufficient to prevent the collapse of the descending aorta around the intra-aortic balloon.
Another object of the present invention is to enhance the blood flow to the heart, brain, and other tissues under the conditions of poor heart function.
Another object of the present invention is to provide a means for enhancing the pumping and sucking effect of an IABP within the aorta by using a simple, unitary device that is self contained and easy to use.
Yet another object of the present invention is to provide a means of enhancing the perfusion of other arteries such as the renal arteries and the aortic arch arteries.
Yet another object of the present invention is to provide a dual balloon IABP that acts cooperatively through a continuous unit, the size of which can be varied to adapt to the size of the patient or the desired amount of pumping.
These objects are achieved in the present invention by an intra-aortic circulatory enhancing apparatus for use in human patients to improve blood flow to other arteries continuous with the aorta of the patient. The apparatus comprises an internal inflation means located within the aorta of the patient and an external inflation means located outside of the patient. The internal inflation means can be an internal balloon coupled to a hollow extent which is operatively coupled to a blood communication means. The blood communication means can be a first hollow catheter tube in one embodiment. The external inflation means can be an external balloon coupled to a hollow extent running through the center of the balloon and continuous with a second hollow catheter tube. The blood communication means is coupled to the internal and external inflation means, allowing blood within the aorta to communicate with the secondary inflation means. Further, a pressurization means for pressurizing and depressurizing the internal and external balloons is provided. The pressurization control means is a lumen in one embodiment of the invention, the lumen associated with the balloons and extending from the balloons to be coupled to an external control unit. When operating, the balloons pump simultaneously, then draw or suck blood simultaneously, thus helping to generate blood flow. The balloons pressurize and depressurize simultaneously, thus acting cooperatively to enhance the blood-pumping action of a diseased human heart and enhance blood flow to the heart, brain, and other tissues.
Additional objects, features and advantages will be apparent in the written description which follows.


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Niccolò Marchionni, MD, et al., “Effective Arterial Elastance and the Hemodynamic Effects of Intraaortic Balloon Counterpulsation in Patients with Coronary Heart Disease”, American Heart Journal, May 1998, pp. 855-861.
Jackie Davidson, MS, et al., “Intra-Aortic Balloon Pump: Indications and Complications”, Journal of the National Medical Association, vol. 90, No. 3, pp. 137-140.
David F. Torchiana, MD, et al., “Intraaortic Balloon Pumping For Cardiac Support: Trends In Practice And Outcome, 1968 to 1995”, The Journal of Thoracic and Cardiovascular Surgery, vol. 113, No. 4, pp. 758-769.
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