Surgery – Instruments – Internal pressure applicator
Reexamination Certificate
2000-08-18
2003-11-25
Casler, Brian L. (Department: 3763)
Surgery
Instruments
Internal pressure applicator
C606S151000, C623S023700, C128S898000
Reexamination Certificate
active
06652555
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a membrane structure applied to or across the ostium of an atrial appendage to prevent a thrombus from leaving the atrial appendage.
2. Description of the Related Art
There are a number of heart diseases (e.g., coronary artery disease, mitral valve disease) that have various adverse effects on the heart. An adverse effect of certain cardiac diseases, such as mitral valve disease, is atrial (or auricular) fibrillation. Atrial fibrillation may result in pooling of blood in the left atrial appendage. Blood pooling may also be spontaneous. When blood pools in the atrial appendage, blood clots can form and accumulate therein, build upon themselves, and propagate out from the atrial appendage into the atrium. These blood clots can then enter the systemic or pulmonary circulations and cause serious problems if they migrate from the atrial appendage and become free in the blood stream and embolize distally into the arterial system. Similar problems also occur when a blood clot extending from an atrial appendage into an atrium breaks off and enters the blood supply. Since blood from the left atrium and ventricle supply the heart and brain, blood clots from the atrial appendages can obstruct blood flow therein causing heart attacks, strokes or other organ ischemia. It is therefore necessary to find a means of preventing blood clots from forming in the atrial appendages and to prevent these blood clots, once formed, from leaving the atrial appendages to the heart, lungs, brain or other circulations of the patient which can cause heart attacks or strokes or other organ ischemia.
U.S. Pat. No. 5,865,791 relates to the reduction of regions of blood stasis and ultimately thrombus formation in such regions, particularly in the atrial appendages of patients with atrial fibrillation. More specifically, the '791 patent relates to procedures and devices for affixing the atrial appendages in an orientation that prevents subsequent formation of thrombus. In the '791 patent, the appendage is removed from the atrium by pulling on it and by putting a loop around it to form a sack of the atrial appendage and then cutting it off from the rest of the heart.
U.S. Pat. No. 5,306,234 relates to a method for surgically closing the passage between the atrium and the atrial appendage or severing the atrial appendage.
Other methods of treatment include surgically removing the atrial appendages to prevent blood stasis in the atrial appendages.
SUMMARY OF THE INVENTION
The invention provides a membrane that substantially prevents blood clots formed in the atrial appendages from exiting therefrom. Such clots may cause heart attacks, strokes and other embolic events if allowed to leave the atrial appendage and enter the bloodstream. The membrane is permanently positioned across the ostium of the atrial appendage by direct securement means to the ostium or the atrial wall adjacent the ostium.
The membrane effectively isolates blood clots inside the left atrial appendage from leaving and entering the atrium. It may be larger than the ostium of the appendage, and extend over an area larger than the ostium. The membrane may be percutaneously delivered to the ostium of the atrial appendage by a catheter and then may be expanded for positioning across or over the ostium.
According to one embodiment, the membrane is impermeable to blood flow. This membrane inhibits thrombus in the left atrial appendage from exiting and entering the bloodstream. The membrane also prevents blood from flowing into or out of the left atrial appendage.
According to another embodiment, the membrane itself is permeable to permit blood flow across the membrane. By allowing the such blood flow across the membrane, the permeable structure minimizes any pressure gradient between the atrial appendage and the atrium in a controlled manner. Moreover, the permeable membrane acts as a filter in allowing blood to flow across, but substantially inhibits the passage of thrombus therethrough.
The permeable filtering membrane may eventually become infiltrated with cells. The permeable filtering membrane allows such tissue growth which may begin along the outer periphery of the structure. Such tissue growth minimizes uncontrolled leakage about the periphery of the filtering membrane and may assist in attachment of the filtering membrane across the ostium to tissue surrounding the ostium. The filtering membrane may be coated or covered with an anticoagulant or other compounds, such as, for example, heparin, or it may be treated to prevent thrombus from forming on the filtering membrane surface, to extend its patency or until it is infiltrated with cells and/or develops an endothelial covering.
There are many means for securing the membrane in position across the ostium of the atrial appendage. Direct securement means for the membrane may be provided by a biocompatible adhesive applied between the membrane and the ostium or the atrial wall. In this manner, the membrane can be adhered directly to the tissue. In another embodiment, direct securement is made by the use of staples, clips, sutures, wires, barbs, prongs or other methods of fixation which pass through the tissue of the ostium or atrial wall. In yet another embodiment, direct securement is achieved by the use of structure connected to the membrane which extends through the ostium and into the interior of the atrial appendage and engages the interior of the atrial appendage, wherein the interior wall of the atrial appendage may also include any portion of the ostium extending within the atrial appendage. The direct securement means may provide a self-centering feature for the membrane about the appendage ostium.
OBJECTS OF THE INVENTION
It is an object of the invention to provide a membrane between the atrium and atrial appendage to prevent blood clots from flowing therebetween.
It is an object of the invention to provide a membrane which is permanently implanted between the atrium and the atrial appendage by direct securement to the ostium or the atrial wall adjacent the ostium.
It is an object of the invention to provide a membrane between the atrium and the atrial appendage which is impermeable to blood flow or the passage of thrombus.
It is an object of the invention to provide a filtering membrane between the atrium and atrial appendage to allow blood flow across the filter, e.g., to reduce any hemodynamic pressure differential therebetween.
It is an object of the invention to prevent blood clots from forming in the atrial appendage.
It is an object of the invention to position across the ostium of the atrial appendage a non-thrombogenic, biocompatible surface that prevents blood clots from forming.
It is an object of the invention to provide a permeable filtering membrane surface which may eventually become lined with endothelial or endocardial cells.
It is an object of the invention to isolate the atrial appendage from the atrium proper with respect to the passage of thrombus with a filtering membrane, while allowing communication through which blood may flow.
It is an object of the invention to minimally invasively prevent blood clots from forming in the atrial appendages and escaping therefrom.
It is an object of the invention to prevent thrombus by use of heparin, other antithrombogenic substances, or other compounds on or eluted from the membrane.
It is an object of the invention to ensure the membrane is centered across or over the ostium of the atrial appendage.
It is an object of the invention to accurately place the membrane across or over the ostium of the atrial appendage.
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Borillo Thomas E.
Hauser Robert G.
Holmes David
Schwartz Robert
Sutton Gregg S.
Atritech, Inc.
Casler Brian L.
Chasan Michael J.
Fish & Neave
Jackson Robert R.
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