Surgery – Miscellaneous – Methods
Reexamination Certificate
2002-03-08
2004-02-24
Philogene, Pedro (Department: 3732)
Surgery
Miscellaneous
Methods
C606S108000, C606S194000
Reexamination Certificate
active
06694983
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the delivery of a stent or conduit and other devices into the myocardium of a patient, and more particularly, to a stent or conduit delivery system to provide a bypass through the myocardium from the left ventricle into a coronary artery.
2. Description of the Related Art
Coronary arteries as well as other vessels frequently become clogged with plaque that at the very least impairs the efficiency of the heart's pumping action and can lead to heart attack and death. One conventional treatment for clogged coronary or other arteries is a bypass operation wherein one or more venous segments are inserted between the aorta and the coronary artery. The inserted venous segments or transplants act as a bypass of the clogged portion of the coronary artery and thus provide for a free or unobstructed flow of blood to the heart.
Such coronary artery bypass surgery, however, is expensive, time-consuming and traumatic to the patient. Hospital stays subsequent to the surgery and convalescence are prolonged.
A new coronary artery bypass technique is disclosed in U.S. Pat. No. 5,429,144. That technique utilizes a stent made of a biocompatible material and comprises steps of moving the stent in a collapsed configuration through a blood vessel of a patient's vascular system to the patient's heart, inserting the stent in the patient's myocardium, and upon disposition of the stent in the myocardium, expanding the stent from the collapsed configuration to a substantially tubular expanded configuration so that a blood flow path is formed at least partially through the myocardium.
One problem with tile coronary artery bypass method providing a stent through the myocardium of the heart is how to get the stent into the myocardium. U.S. Pat. No. 5,429,144 describes a percutaneous approach wherein the stent is brought to the myocardium through the patient's vasculature on the distal end of a catheter, and advanced into the myocardium over a guidewire. One particular challenge is how to make an angled bend in the guidewire to puncture through the wall of the vessel and into the myocardium. This challenge is exacerbated when it is desired to penetrate the guidewire through the myocardium at an obtuse angle relative to the direction that the guidewire is advanced through the vasculature.
Another problem with this approach is that catheters delivering the guidewire, stent or other devices to be provided into the myocardium are conventionally guided to the puncture point through the blockage in the coronary artery. However, when the blockage is too large, a delivery catheter cannot access the desired insertion site.
In addition, it is often difficult to advance devices into the myocardium because of the traction and force necessary to push through the myocardium. This problem arises not only for delivery of the stent, but also for the delivery of dilation catheters used to expand the cross-section of the passageway through the myocardium, and other devices.
Accordingly, what is needed is a method and apparatus for delivering guidewires, stents and other devices into the myocardium. In particular, what is needed is a delivery system that can deliver these devices at an angled bend for transverse insertion into the myocardium. Moreover, what is needed is a delivery method and apparatus for advancing a delivery catheter to a puncture site in a coronary vessel when the blockage in the vessel is too large to permit passage of a catheter therethrough. What is also needed is a method and apparatus for advancement of a stent, dilation catheter or other device into and through the myocardium.
SUMMARY OF THE INVENTION
Briefly stated, the present invention addresses the above needs by providing various methods and apparatuses for delivering stents or conduits and other devices into the heart wall or myocardium of a patient. One preferred stent delivery system provides access to the insertion site in the myocardium by advancing a delivery catheter through a blockage in a coronary artery, or around the blockage through a coronary vein or through a channel or tunnel formed around the blockage. In one embodiment, once the distal end of the delivery catheter is adjacent the myocardium, an angled bend is created in the catheter by actuating expandable steering guides mounted to the catheter which cooperate with the walls of the blood vessel to cause the catheter to turn. Then, a guidewire is advanced through the delivery catheter and into the myocardium. In another embodiment, a tip-deflecting pull wire extends from the distal end of the delivery catheter which may be actuated to turn towards and then inserted into the myocardium. In another embodiment, an exit port facing the insertion site is provided within the catheter or a balloon mounted on the catheter so that a guide ire may be directed through a lumen and out the exit port into the myocardium. Once the guidewire punctures into the myocardium, the guidewire is anchored using barbs, balloons or other actuatable members to secure the guidewire to the myocardium. Subsequently, using a push-pull mechanism, stents and other medical devices can be advanced over the guidewire into the myocardium.
In one aspect of the present invention, a guidewire is delivered into the patient such that the proximal end of the guidewire extends out of the patient, while the distal end of the guidewire is positioned adjacent the heart wall. The distal end of the guidewire is inserted into the heart wall, and the guidewire is then anchored to the heart wall. An introducer catheter carrying a medical device is advanced over the guidewire to deliver the device into the heart wall.
In another aspect of the present invention, a method for delivering a conduit into a heart wall to bypass a blockage formed in a coronary artery is provided. A channel is created from a position proximal to the blockage in the coronary artery to a position distal to the blockage in the coronary artery. A guidewire is advanced through the channel until a distal end of the guidewire is adjacent the heart wall. The guidewire is inserted into the heart wall, and a conduit is advanced over the guidewire into the heart wall.
In another aspect of the present invention, a bypass around a blockage in a blood vessel is formed by delivering a guidewire along a pathway from a location in the blood vessel proximal to the blockage to a location in the blood vessel distal to the blockage. A channel is created along the pathway formed by the guidewire. This pathway may preferably be created either through the heart wall or through the pericardial space. The channel may be dilated and shunted along the pathway defined by the guidewire.
In another aspect of the present invention, a method is provided for creating a bypass around a blockage in a coronary artery, adjacent a heart wall. A needle is inserted into a patient into the heart wall, the needle having a lumen extending therethrough. The needle is advanced through the heart wall and into the coronary artery distal to the blockage. A guidewire is advanced through the lumen in the needle, the guidewire once advanced extending through the coronary artery proximal to the blockage, through the heart wall, and into the coronary artery distal to the blockage. The needle is removed from the patient while leaving the guidewire in place. A shunt is advanced over the guidewire, the shunt once advanced having a distal end in the coronary artery distal to the blockage.
In another aspect of the present invention, a method is provided for creating a bypass through the heart wall of a patient to bypass a blockage formed in a coronary artery. A first tunnel is created through the heart wall having a proximal end and a distal end. The proximal end of the tunnel opens into the coronary artery proximal to the blockage. The distal end of the tunnel is positioned within the heart wall. A second tunnel is created through the heart wall, the second tunnel having a first branch extending from the
Pompili Vincent
Wilk Peter J.
Wolf Scott J.
Finnegan Henderson Farabow Garrett & Dunner LLP
Percardia Inc.
Philogene Pedro
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