JP2003500121A - Ventricular wall conduction catheter for artificial conduit - Google Patents

Abstract

(57) SUMMARY Various methods and devices for delivering a stent or conduit into the myocardium are described herein. One preferred stent delivery system accesses an insertion point in the myocardium by advancing a delivery catheter through or around an occlusion in an artery, or through a tunnel formed around the occlusion. . In one embodiment, the catheter is curved by manipulating the inflatable steering guide and rotating the catheter in cooperation with the vessel wall. The guidewire is then advanced through the delivery catheter into the myocardium. In another embodiment, a distal deflection puller wire extends from the delivery catheter and the catheter is rotated toward the myocardium and inserted into the myocardium. In yet another embodiment, an exit port is provided in the catheter facing the insertion point or on a balloon attached to the catheter such that the guidewire exits the exit port through the lumen and enters the myocardium. . The guidewire is locked into the myocardium using barbs, balloons and the like. Subsequently, a medical device, such as a stent, is advanced over the guidewire and into the myocardium using a push-pull mechanism.

Description

Detailed Description of the Invention

TECHNICAL FIELD OF THE INVENTION The present invention relates to the delivery of stents, conduits or other devices to the myocardium of a patient, and more particularly to a stent or conduit delivery system that provides a bypass through the myocardium from the left ventricle into the coronary arteries. Regarding

Description of the Prior Art Coronary arteries and other blood vessels are often clogged by plaque, which at least interferes with the efficiency of the heart's pumping and can lead to heart attack and death. One conventional method for treating arterial occlusions, such as a blocked coronary artery, is bypass surgery in which one or more venous segments are inserted between the aorta and the coronary artery. The inserted vein or graft acts as a bypass for the occlusion of the coronary arteries, providing free, unobstructed blood flow to the heart.

However, such coronary artery bypass surgery is expensive, time consuming, and traumatic to the patient. Being kept in the hospital after surgery, the recovery is prolonged.

US Pat. No. 5,429,144 discloses a new coronary artery bypass technique. This technique uses a stent made of a biocompatible material that moves a collapsed-shaped stent through the blood vessels of the patient's vasculature to the patient's heart and inserts the stent into the patient's myocardium. Upon reaching the myocardium, the steps of expanding the stent from a collapsed state to a substantially tubular expanded state and forming a blood flow path at least partially through the myocardium are performed.

One problem with coronary artery bypass grafting through the myocardium of the heart is how to place the stent into the myocardium. US Pat. No. 5,429,14
No. 4 describes a percutaneous approach in which a stent is attached to the end of a catheter and carried through the patient's vasculature to the myocardium where it is guided over a guide wire and advanced into the myocardium. To do. One particular problem is how to form an angled bend in the guidewire to break through the vessel wall and into the myocardium. This problem is compounded when it is desired to pierce the myocardium at an obtuse angle with respect to the direction in which the guidewire travels through the vasculature.

[0006] Another problem with this approach is that catheters that deliver guidewires, stents or other devices to be delivered into the myocardium have traditionally passed through occlusions in the coronary arteries to the point where they were punctured. Is to be guided like. But,
If the blockage is too large, the delivery catheter will not be able to access the desired insertion location.

Moreover, it is often difficult to advance the device through the myocardium because of the force required to push it through the myocardium. This problem occurs not only with delivery of the stent, but also with delivery of dilatation catheters and other devices used to expand the cross-section of the passage through the myocardium.

Accordingly, there is a need for methods and devices for delivering guidewires, stents, and other devices into the myocardium. What is particularly needed is a delivery system that allows these devices to be laterally inserted into the myocardium at a predetermined angle. Further, there is a need for methods and devices for advancing a catheter to a perforation site in a coronary vessel when the occlusion in the vessel is too large to fit through the catheter. There is also a need for methods and devices for advancing stents, dilatation catheters, and other devices within or through the myocardium.

SUMMARY OF THE INVENTION Briefly stated, the present invention achieves the above-identified objects by providing various methods and devices for delivering stents, conduits or other devices into the heart wall or myocardium of a patient. Is. One preferred stent delivery system provides access to the insertion site in the myocardium by advancing a catheter through or circumventing a coronary artery, or through a channel or tunnel formed through a coronary vein or circumventing an occlusion. It will be possible. In one embodiment, when the distal end of the delivery catheter is adjacent to the myocardium, manipulation of an inflatable steering guide attached to the catheter causes the catheter to bend at a predetermined angle, which causes the catheter to bend against the vessel wall. The catheter rotates in cooperation. The guide wire is then advanced through the delivery catheter and into the myocardium. In another embodiment, a distal deflection puller wire extends from the distal end of the delivery catheter and is manipulated to direct the wire towards the myocardium and then into it. In yet another embodiment, an exit port facing the insertion site is provided in the catheter or balloon attached to the catheter and a guide wire is inserted through the lumen and out the exit port into the myocardium. Once the guidewire has pierced the myocardium, the guidewire is locked and secured to the myocardium using barbs, balloons or other steerable members. Subsequently, the push-pull mechanism is used to advance the stent or other medical device over the guidewire and into the myocardium.

According to one aspect of the invention, the delivery system inserts a conduit at least partially into the heart wall between the heart chamber and the blood vessel. The delivery system includes a guidewire having a proximal end and a distal end. A rotating mechanism is used to rotate the distal end of the guide wire towards the heart wall. A locking mechanism on the guidewire locks the guidewire to the heart wall. Guidewires are used to deliver conduits to the heart wall.

According to another aspect of the invention, the guidewire has a proximal end extending outside the patient's body,
It is delivered to the patient such that the distal end is positioned adjacent to the heart wall. The distal end of this guidewire is inserted into the heart wall and then the guidewire is locked to the heart wall.
An introducer catheter carrying a medical device is advanced over the guide wire and delivered into the heart wall.

According to another aspect of the invention, there is provided a method of delivering a conduit into a heart wall to bypass an occlusion formed in a coronary artery. A channel is formed from a position on the proximal side of the occlusion in the coronary artery to a position on the distal side of the occlusion in the coronary artery. The guidewire is advanced through the channel until its end is adjacent the heart wall. The guidewire is inserted into the heart wall and the conduit is advanced over the guidewire into the heart wall.

In accordance with another aspect of the invention, intravascular delivery is accomplished by delivering a guidewire along a passageway from a location within the blood vessel proximal to the occlusion to a location within the blood vessel distal to the occlusion. A bypass is formed that goes around the closed portion. A channel is created along the passage formed by this guide wire. This passage is preferably formed through the heart wall or through the pericardial space. This channel is inflated,
Form a shunt along the path defined by the guide wire.

According to another aspect of the invention, there is provided a method of orbiting an occlusion within a coronary artery to form a bypass adjacent to a heart wall. A needle having a lumen is inserted into the heart wall of the patient. The needle advances through the heart wall and into the coronary artery distal to the occlusion. A guide wire is advanced through the lumen of the needle, the guide wire extending through the coronary artery proximal to the occlusion, through the heart wall, and into the coronary artery distal to the occlusion. The needle is removed from the patient, leaving the guidewire in place. A shunt has advanced over the guidewire, and the advanced shunt has an end in the coronary artery distal to the occlusion.

According to another aspect of the invention, there is provided a method of creating a bypass through a heart wall of a patient to bypass an occlusion formed in a coronary artery. A first tunnel having a proximal end and a distal end is formed through the heart wall. The proximal end of this tunnel opens into the coronary artery on the proximal side of the occlusion. The end of the tunnel is located in the heart wall. A second tunnel is formed through the heart wall, the second tunnel having a first branch extending from the end of the first tunnel and opening into the coronary artery at a position distal to the occlusion. The second branch of the second tunnel extends from the end of the first channel and opens into the heart chamber. A conduit is installed in the second tunnel and provides a passage therethrough.

According to another aspect of the invention, a delivery catheter is provided. The delivery catheter comprises an elongated tubular body having a proximal end and a distal end and a lumen extending through the catheter. A first steering member is attached to the end of the tubular body, and a second steering member is attached to the end of the tubular body on the end side of the locking member.

According to another aspect of the invention, there is provided a method of rotating the distal end of a catheter within a body lumen. The catheter comprises an elongated tubular body having a proximal end and a distal end. The locking member attached to the proximal end is manipulated to secure the catheter to the body lumen. A steering member is attached to the distal end of the guide wire at a position distal to the locking member. When the steering member is manipulated, it cooperates with the body lumen to rotate the distal end of the catheter.

According to another aspect of the invention, a method is provided for delivering a medical device to a delivery site within a patient. The method includes providing a delivery catheter having a proximal end and a distal end and a lumen extending through and into the lumen of the patient's body. This delivery catheter is fixed in the lumen of the human body. The distal end of the catheter is rotated by manipulating a steering member attached to the distal end of the catheter that is pushing against the wall of the body lumen. The medical device advances through the lumen of the delivery catheter and exits the distal end.

According to another aspect of the invention, there is provided a method of delivering a conduit into a heart wall of a patient. A delivery catheter having a proximal end and a distal end and a lumen extending through the catheter into the patient's vasculature is advanced until the distal end is adjacent the heart wall. A puller wire extending from the distal end of the delivery catheter is manipulated to rotate the puller wire toward the heart wall. The puller wire travels from the end of the delivery catheter into the heart wall. A conduit is delivered over the puller wire to the heart wall.

According to another aspect of the invention, a method of delivering a conduit to a heart wall of a patient is provided. A delivery catheter having a proximal end and a distal end and a lumen extending from the proximal end to a lateral port proximate the distal end is advanced through the patient's vasculature until the lateral port faces the heart wall. . A guide wire having a proximal end and a distal end is inserted into the lumen. The distal end of the guidewire travels through the lumen and exits the side port.
The guide wire enters the heart wall over which the conduit is fed into the heart wall.

According to another aspect of the invention, there is provided a method of delivering a conduit to a heart wall of a patient. A delivery catheter having a proximal end and a distal end is advanced within the patient's vasculature until the distal end abuts the heart wall. A locking member attached to the distal end of the catheter expands to secure the delivery catheter within the vasculature. A guidewire having a proximal end and a distal end is inserted through the lumen of the inflated locking member extending from the proximal end of the locking member to the lateral port facing the heart wall, the distal end of the guidewire being extended through the lateral port. Issued to. The guidewire is advanced into the heart wall over which the conduit is advanced into the heart wall.

According to another aspect of the invention, a delivery catheter is provided. The catheter comprises an elongated body having a proximal end and a distal end. An inflatable member is attached to the distal end of the tubular body, the inflatable member having a proximal end, a distal end, and an outer surface. A guide lumen extends from the proximal end of the balloon to a side port on the outer surface of the inflatable member to guide the medical device through the guide lumen.

According to another aspect of the invention, there is provided a delivery catheter having an elongate body having a proximal end and a distal end defining a generally longitudinal axis therebetween. A guidewire lumen having a proximal end and a distal end extends at least partially between the proximal end and the distal end of the elongated body. The exit port at the end of the guidewire lumen forms a curvature of between about 0 and 180 degrees relative to the longitudinal axis of the elongate body and directs the guidewire out of the lumen. In one embodiment, the outlet port is a lateral port formed proximally to the distal end of the elongated body. In another embodiment, the exit port is provided at the distal end of the elongate body and comprises a narrowed passage between the guidewire lumen and the exit port.

According to another aspect of the invention, a method of treating an aneurysm is provided. A catheter having a proximal end and a distal end is advanced to the location of the aneurysm. An inflatable member attached to the distal end of the catheter is activated to substantially wrap the aneurysm. An embolic element is inserted into the aneurysm.

According to another aspect of the invention, an assembly is provided for delivering a medical device to a heart wall of a patient. The assembly includes an insertion tube having a proximal end and a distal end and a delivery channel extending through the insertion tube. A tubular member is provided having a proximal end and a distal end and a lumen extending through the tubular member, the tubular member having a distal end portion,
The distal end portion has an internal spring force that biases the distal end portion into an arc when no external force is applied to straighten the distal end portion. The tubular member is longitudinally slidable within the delivery channel. The distal end portion is held at the distal end of the channel and is maintained in a relatively straight line shape, and is maintained outside the channel in an alternating manner. The guide wire is slidable longitudinally within the lumen of the tubular member.

According to another aspect of the invention, there is provided a method of delivering a guidewire at a predetermined angle to a desired insertion site within the body. The method includes delivering an insertion tube into a patient's vasculature, the insertion tube having a delivery channel extending therethrough,
Once delivered, the proximal end is positioned outside the patient's body and the distal end is positioned adjacent the desired insertion site. A delivery catheter is delivered through the delivery channel, the delivery catheter having a guidewire lumen extending therethrough. When the delivery catheter is delivered, the proximal end is positioned outside the patient's body and the distal end is positioned within the delivery channel. The distal end of the delivery catheter projects from the delivery channel at the end of the insertion tube. The protrusion of the delivery catheter from the delivery channel causes the distal end of the delivery catheter to rotate toward the insertion site. The guidewire is advanced to the insertion site through the guidewire lumen.

According to another aspect of the invention, there is provided a method of delivering a guidewire into the heart wall. A guidewire is inserted into the lumen of the delivery catheter and has a proximal section and a distal section. The distal section of the guidewire is folded back over the proximal section within the lumen of the delivery catheter. The delivery catheter is delivered into the patient's body, and when the delivery catheter is delivered, the proximal end is positioned outside the patient's body and the distal end is positioned adjacent the desired insertion site in the myocardium. The distal section of the guidewire projects from the distal end of the lumen of the delivery catheter. The guidewire is pulled proximally such that its distal section pierces the heart wall at an obtuse angle with respect to the direction in which the guidewire projects from the distal end of the lumen of the delivery catheter.

According to another aspect of the invention, there is provided a method of delivering a guidewire to an insertion site within the body. A delivery catheter having a proximal end, a distal end, and a lumen extending therethrough is advanced into the body. The distal end of the advanced delivery catheter is positioned adjacent the insertion site. The distal end of the delivery catheter is turned towards the insertion site. A guidewire is advanced through the lumen of the tucking catheter, proximal to distal. The guide wire exits the distal end and is guided to the insertion site through a narrowed passage formed in the lumen.

According to another aspect of the invention, there is provided a method for delivering a medical device into tissue of a patient's body. The method includes inserting a guidewire having a proximal end and a distal end into a myocardium from a coronary vessel. The guidewire is anchored in body tissue and the medical device is pushed over the guidewire and into body tissue. The proximal end of the guide wire is correspondingly pulled proximally, while the medical device is pushed distally to facilitate entry of the medical device into human tissue.

According to another aspect of the invention, there is provided a delivery system that directs a therapeutic agent at least partially toward the heart wall. The delivery system includes a guide wire having a proximal end and a distal end, a means for rotating the distal end of the guide wire toward the heart wall, a means for locking the guide wire to the heart wall, a guide wire for receiving the catheter, and A therapeutic agent-bearing catheter having a lumen extending therethrough for advancement into the heart wall.

According to another aspect of the invention, there is provided a method of delivering a conduit into a patient's heart to bypass an occlusion formed in a coronary artery. This method advances a catheter having a proximal end and a distal end and a lumen extending at least partially therethrough through a patient's coronary artery from the proximal end to the distal opening until the distal opening passes through the occlusion. Including the step of The catheter is turned so that the distal opening faces the heart wall.
A wire having a proximal end and a distal end projects through the distal opening such that the distal end pierces the heart wall. The wire ends are locked to the heart wall. An inflation catheter carrying an inflation balloon at its distal end is fed over the wire until the balloon is within the heart wall. The inflation balloon is inflated to form an opening in the heart wall. The inflation balloon is then deflated and the inflation catheter removed from the wire. A conduit introducer catheter carrying a conduit at its distal end is delivered over the wire until the conduit is positioned within the opening in the heart wall. This conduit develops within the opening in the myocardium.

According to another aspect of the invention, there is provided a method of delivering a therapeutic agent to the heart wall of a patient. A tubular wire having a lumen therethrough is fed into the patient. When the wire is delivered, its proximal end extends outside the patient's body and its distal end is positioned adjacent to the heart wall. Means are provided for rotating the distal end of the wire towards the heart wall. Next, the end of the wire is inserted into the heart wall. The therapeutic agent is delivered to the heart wall through the lumen of the wire.

Preferred Embodiments of the Invention The preferred embodiment described below delivers a stent or conduit to the myocardium,
1 illustrates a method and device for creating a passageway between a left ventricle and a coronary artery.
However, these embodiments may also be used to deliver stents, conduits, and other medical devices into other tissues and ducts of the body, particularly those devices at an angle to the axis of blood flow. Please note that it can also be used. Furthermore,
The delivery methods and devices described herein are also suitable for application of stents, conduits or other devices, or drug delivery that partially penetrates the myocardium.

The principles of the present invention are not limited to left ventricular conduits, but also include conduits for the passage of body fluids from any space within a patient's body, including mammals, to other spaces within the patient's body. Furthermore,
The flow of this fluid through the conduit is not limited to a particular flow direction and may be antegrade or retrograde to normal fluid flow. Moreover, the conduits communicate between a body space and a blood vessel, or from one blood vessel to another blood vessel (eg, an artery to a vein or vice versa). Further, the conduit may be provided in a single body space to allow fluid to flow from one part of the space to another. For example, the conduit can be used to create a bypass within a single blood vessel and allow blood to flow from the base of an occluded coronary artery to a portion of the same coronary artery near its distal end.

Further, the conduits and associated means are preferably capable of passing through various intermediate destinations and are not limited to any particular flow sequence. A preferred embodiment is disclosed that includes a direct transmyocardial flow technique that leads from the left ventricle through the myocardium to the coronary arteries. The term "transmyocardium" should not be construed in a narrow sense with respect to the conduits through which fluid is suitably flowed, as are other fluid flows that do not pass through the myocardium and heart. With respect to the walls of the heart (and more specifically the “heart wall”), preferred conduits and associated means are those that pass through all these walls, including pericardium, epicardium, myocardium, endocardium, septum, etc. Allows fluid flow, but is not limited to these walls.

The bypasses obtained by the preferred embodiments and methods associated therewith are not limited to complete bypasses of body fluid flow, but also include partial bypasses that are preferred to supplement normal body blood flow. Further, the obstruction to be bypassed may be partial or complete, so the term "bypass" or "occlusion" is not limited to complete bypass or complete occlusion, and Such as partially bypassing or partially occluding.

The preferred conduits and associated methods disclosed herein can also provide full or partial passages through body tissue. In this regard, conduits include stents, shunts, etc. that provide passages and openings for body fluids such as blood. Thus, although many preferred embodiments describe stents and shunts, it should be appreciated that other types of conduits could be used as well. Furthermore, the conduit need not have a stent or device attached, only tunnels or openings formed in the patient's tissue.

The conduits of the present invention preferably include both integral or one-piece conduits and those in which multiple parts are joined to form a continuous conduit. The conduits of the present invention can be deployed in a variety of ways consistent with sound medical practices, including transvascular or surgical delivery techniques, including minimal dissection techniques as described below. For example, various preferred embodiments of delivery rods and associated methods may be used. In one embodiment, the delivery rod is in the form of a solid trocar. It is rigid or semi-rigid and is capable of piercing the patient's tissue, thereby forming wholly or partly a conduit for the purpose of fluid communication. In another preferred embodiment, the delivery rod is hollow and forms the conduit itself (eg, the conduit is preferably self-implanting or self-inserting),
Alternatively, it has a conduit mounted on this rod (eg, the feed rod is preferably withdrawn leaving the installed conduit). In this way, the preferred conduit device and its installation method should be determined by the appropriate patient's instructions through sound medical practice.

As shown in FIGS. 1A and 1B, the heart wall or myocardium M of the patient's heart PH.
A coronary artery bypass is created by placing the stent 10 in YO. The stent 10 extends from the left ventricle LV of the heart PH to a location downstream of the occluded portion BL of the blocked coronary artery CA to form a shunt 12. The stent 10 is preferably made of a biocompatible material such as stainless steel or nitinol, but titanium,
Other materials such as titanium alloys, nickel alloys, cobalt alloys and biocompatible polymers can also be used. In one embodiment, the stent has a one-way valve 14,
It allows blood to flow from the left ventricle LV towards the coronary CA. The contraction pressure of the heart muscle during contraction elastically deforms the stent 10, but keeps the stent open and allows blood to pass from the patient's left ventricle LV into the coronary artery CA. During diastole, blood pumped through the shunt 12 into the coronary arteries is prevented by the one-way valve 14 from returning to the left ventricle LV. Further details are disclosed in US Pat. No. 5,429,144. In accordance with the preferred embodiment described herein, various types of conduits and stents and medical devices and methods of delivery thereof are also used.

FIG. 2 illustrates another application where it is desirable to place a stent in the myocardium MYO of a patient. In this application, the stent 10 is provided partially invading the myocardium MYO from the left ventricle LV. The stent 10 guides blood directly from the left ventricle LV to the myocardium MYO, and supplies blood to the muscles of the oxygen-deficient heart.
Further details are disclosed in the above-mentioned US Pat. No. 5,429,144. Other applications for inserting a stent into the myocardium and partially or completely penetrating the myocardium for access from either side of the coronary artery or the left ventricle are contemplated by the present invention.

In order to achieve some or all of the objects of the present invention, and in particular to create a myocardial passage between the left ventricle LV and the coronary artery CA for placement of a stent, the necessary equipment is provided. There is a need for a delivery system that can be directed to and inserted into. As described in more detail below, a suitable delivery system provides (1) access to the insertion site adjacent the myocardium, and (2) an angled bend for lateral insertion of the device into the myocardium. And (3) direct the device into the myocardium to create the myocardial passage.

I. Access to the Myocardium The delivery system described herein may include, for example, one or more catheters or guidewires shown in FIG. 1A that are percutaneously inserted into the patient's body through the femoral artery and advanced through the aorta AO into the vascular system. Is equipped with. It should be appreciated that a percutaneous approach is not required to achieve many of the objects of the present invention, and thus an approach such as a thoracotomy may also be used. Furthermore, access to the treatment site using a saphenous vein graft (SVG) is also conceivable.

As shown in FIG. 3A, an exemplary delivery catheter or guidewire 20 that has been percutaneously advanced, eg, through the femoral artery, is advanced through the occlusion BL in the coronary artery CA. . The distal end 22 of this catheter is the myocardium MY
It is fed through the occlusion so that it is positioned adjacent to the desired insertion point in O. FIG. 3B shows an alternative access method whereby the catheter 20 is delivered through the left ventricle LV to a position adjacent the myocardium.

4A and 4B show another access route used when the occlusion in the coronary artery is too large for the catheter to pass through. In this embodiment, delivery catheter 20 enters the body, preferably through an access point in the femoral vein (not shown). This catheter travels intravenously to reach the vena cava VC and enters the right atrium RA, as shown in FIG. 4A. Next, the catheter 20 is placed in the coronary sinus C.
Head to S and then reach the coronary vein CV, which runs alongside the coronary artery CA.

As shown in FIG. 4B, the delivery catheter 20 separates the coronary vein CV and the coronary artery CA after the distal end 22 of the catheter 20 has passed the occlusion BL in the adjacent coronary vein. It is inserted through the existing blood vessel wall VW. Manipulation of the catheter 20 between the coronary vein CV and the coronary artery CA is performed using the catheter rotation method and device described in detail below or any other suitable method. As described in detail below, the delivery catheter is rotated toward myocardium MYO for insertion into the myocardium or for directing a guidewire therethrough. Access to the insertion point is to steer the delivery catheter through the coronary artery CA to reach a point near the occlusion and to catheterize the catheter in the coronary vein to bypass the occlusion, as shown in FIG. 4B. By re-inserting the catheter into the coronary artery through the coronary vein at a position past the occlusion.

Another way to access the myocardium MYO when the obstruction BL is too large for the catheter to pass through is to create a channel around the obstruction. Figure 5
As shown in FIG. 2, the coronary artery CA to the myocardium MYO
A tunnel 24 is created inside. The tunnel is made using radiation, lasers, surgical drills, and other suitable methods for making tunnels. This tunnel 2
4 extends to the lower side of the occlusion portion BL, and at a point on the distal side of the occlusion portion BL, the coronary CA
Connected with. As shown in FIG. 6, the delivery catheter 20 penetrates the coronary artery CA, advances into the tunnel 24, passes through the blockage BL, and is coronary CA.
Return to inside. It will be appreciated that other methods of circling the occlusion and redirecting the delivery catheter may also be used, for example by inserting the catheter into the pericardial space outside the coronary arteries, as described below. I want to. Further, as will be described below, a shunt is provided to keep the tunnel 24 open with a stent,
It is also possible to provide a bypass around the occlusion.

The tunnel 24 shown in FIG. 6 is described as providing access to the myocardial insertion point for bypassing the coronary arteries, but this tunneling technique is for removal of the occlusion BL. It should be recognized that it is also useful. In particular, in the conventional method of excising a closed portion, the closed portion can be accessed from only one side.
However, by adopting the tunnel forming method shown in FIG.
It is possible to perform processing not only from the base end side of L but also from the end side thereof.

7A-7G, a preferred guidewire method of forming a channel through the myocardium is shown. As shown in FIG. 7A, in this method, the delivery catheter 200 is delivered near the blockage BL on the proximal side of the coronary artery CA. The delivery catheter 200 has a proximal end 202 (not shown), a distal end 204, and a lumen 206 (not shown) extending through the catheter 200. The distal end 204 of the delivery catheter 200 is directed toward the myocardium MYO using any of the methods described below or any other suitable method. Next, as shown in FIG. 7B, the guide wire 208 is inserted into the delivery catheter 2
It exits into the myocardium through a lumen 206 at the distal end 204 of 00. This guide wire 20
As shown in FIG. 7C, 8 is set in advance so that the guide wire is bent to the lower side of the occlusion portion BL, is exposed outside the myocardium MYO, and is inserted into the coronary artery CA on the distal side of the occlusion portion. Formed of a shape memory alloy having a curved shape.

The myocardium MYO is then preferably inflated along the passage formed by the guidewire 208 in the myocardium. In FIG. 7D, the myocardium is inflated by inserting the catheter 210 over the guide wire 208, and the catheter 21
0 shows a state in which a passage that penetrates the myocardium is efficiently formed. It should be appreciated that other methods of passage dilation, including balloon, radiation, and laser, can also be used. Once inflated, a myocardial passage 212 is formed from the proximal side to the distal side of the occlusion, as shown in FIG. 7E.

The myocardial passage 212 enables access to the coronary arteries on the distal side of the blockage BL. FIG. 7F also shows that this passage 212 receives the shunt 220 to keep the passage open. As shown in FIG. 7F, preferably shunt 220.
Is delivered through delivery catheter 200 and over a guide wire 208. As shown in FIG. 7G, the shunt 220 includes a proximal end 222 and a distal end 2.
24 and an inner lumen 226 (not shown) passing through the shunt 220. Figure 7
As shown in G, in one embodiment, when the shunt is delivered, the proximal end 22
Both 2 and terminal 224 project into the coronary artery CA. This facilitates guiding a stent or other medical device through the shunt 220. This is because these devices delivered through the coronary arteries do not have to be forced into the myocardium MYO. Further, the lumen 2 connecting the proximal end 222 to the distal end 224.
26 also serves as a blood passage providing a bypass around the obstruction BL.

8A to 8F show another method of orbiting the occlusion BL to form a bypass or access channel through the pericardial space PS. FIG. 8A shows an occlusion within the coronary artery CA adjacent to the myocardium MYO. The delivery catheter 200 described above is advanced to a point on the proximal end side of the occlusion in the coronary artery CA. As shown in FIG. 8A, the distal end 204 of catheter 200 is bent towards the anterior wall AW of the coronary artery. A guide wire 208 extending through the lumen 206 (not shown) of the delivery catheter 200 exits the distal end 204 of the catheter 200 and advances through the anterior wall.

As shown in FIGS. 8B and 8C, guidewire 208 is steered around occlusion BL and through pericardial space PS. Guidewire 208 comprises a small endoscope that assists in maneuvering through pericardial space PS. A guide wire 208 made of a shape memory alloy is used for the rotation of the guide wire around the occlusion portion, and the guide wire 208 is given a preset curved shape so that the guide wire 208 is guided to the coronary artery CA on the distal side of the occlusion portion. It is done by putting it back inside. The guide wire can also be rotated by using forceps to move the guide wire in the pericardial space.

As shown in FIG. 8D, the guide wire 208 re-enters the coronary artery CA distal to the occlusion BL. The shunt 220 shown in FIG. 8E then penetrates the coronary artery proximal to the occlusion BL and is fed over the guidewire into the pericardial space PS and into the coronary artery distal to the occlusion. Return. Once delivered, the shunt 220 has a proximal end 222 and a distal end 224 that project into the flow path of the coronary artery, as shown in FIG. 8F. A lumen 226 (not shown) extends between the ends to coronary artery C
It provides an access channel that feeds the device to a point distal to the occlusion in A. This lumen 226 also serves as a blood flow conduit and provides a bypass around the occlusion.

9A-9E show another embodiment for delivering a shunt to form a bypass or access channel that circulates around the obstruction BL. As shown in FIG. 9A, the needle 228 pierces the anterior wall AW of the coronary artery CA from the pericardial space PS. This needle has a lower wall LW that faces the myocardium MYO when the needle 228 is advanced.
Through the myocardium MYO to advance below the occlusion portion BL, and is curved again to come out of the myocardium MYO and penetrate the lower wall LW. The needle 228 then preferably pierces the anterior wall AW into the pericardial space PS as shown in Figure 9B. This needle 228 is preferably hollow, as shown in FIG.
As shown in C, the guidewire 208 can be passed after the needle is removed. Next, as shown in FIG. 9D, the proximal end 222 of the shunt enters the pericardial space PS on the proximal side of the occlusion and the distal end 224 of the shunt on the pericardial space PS on the distal side of the occlusion.
Shunt 220 is advanced over guidewire 208 until it enters. Shunt 2
20 may be in a collapsed shape and is inserted through a delivery tube on a guide wire or other methods known to those of ordinary skill in the art. FIG. 9E
The guidewire 208 is removed, and the proximal and distal ends 222 and 224 of the shunt are moved into the coronary artery CA, respectively, to complete the blood flow conduit around the occlusion BL, as shown in FIG. The openings formed in the anterior wall due to shunt breakthrough are preferably closed by sutures 229 or other closure means.

10A-10E show a similar technique for forming a conduit around an occlusion, but as shown in FIG. 10B, the needle 228 has its distal end again in the pericardial space PS. The difference is that it is advanced to the extent that it stays in the coronary artery rather than entering. Then, after the guide wire 208 has been inserted and the needle removed (FIG. 10C).
), The shunt 220 is advanced so that its distal end 224 is located within the coronary artery CA. As shown in FIG. 10E, only the proximal end 222 needs to be moved from the pericardial space PS into the coronary artery CA, preferably the artery is closed with suture 229.

11A-11F illustrate a method and device for direct shunting from the left ventricle into the coronary arteries. As shown in FIG. 11A, the needle 228 is inserted into the myocardium MYO adjacent to the coronary artery CA at a position near the proximal end side of the occlusion portion BL in the coronary artery CA. As shown in FIG. 11B, the needle 228 is directed toward the coronary artery CA as the needle enters the left ventricle LV and then the myocardium MYO as the needle advances through the myocardium MYO. It is desirable to be curved. 11B, the needle 228 enters the coronary artery CA, pierces the anterior wall and enters the pericardial space PS. In another embodiment shown in FIG. 11C, needle 228 is advanced so that it remains within coronary artery CA.

The needle 228 is preferably hollow so that the guide wire 208 can pass through it. This guide wire 208 after the needle 228 has been removed is shown in FIG. 11D. 11D illustrates an embodiment in which the needle 208 does not pierce the anterior wall AW, the guide wire 208 penetrates the anterior wall through the needle of FIG. 11C and pericardial space PS.
It should be appreciated that it may be provided within. As shown in FIG. 11E, a push rod, delivery catheter, or other method known to those of skill in the art is used to open proximal end 222 into left ventricle LV and distal end 224 into coronary artery CA. , Shunt 220 is fed over the guidewire as shown in FIG. 11F. When the guide wire 208 is removed, the shunt 220 provides a conduit from the left ventricle to the coronary artery CA. The shunt is preferably angled so as to form a downstream blood flow out of the conduit and into the coronary artery CA.

In another embodiment, the myocardium MYO is located from a point proximal to the occlusion in the coronary artery.
A tunnel is formed through the left ventricle. As shown in FIG. 12, in which the blockage BL substantially closes the coronary artery CA, there is a first tunnel 26 extending from the proximal end side of the blockage BL into the myocardium MYO below the blockage BL. Has been formed.
The tunnel 26 has a proximal end 2 that is open to the coronary artery CA on the proximal end side of the blockage portion BL.
8 and an end 30 inside the myocardium MYO below the occlusion BL. A second tunnel 32 extends from the end 30 of the first tunnel, the first branch 34 of which is the obstruction B.
It opens a channel beyond the L position to reach the coronary artery CA. The second branch 36 of the second tunnel 32 extends downwardly from the distal end 30 and opens into the left ventricle LV.
As shown in FIG. 12, a substantially Y-shaped passage is formed through the myocardium MYO and bypasses the occlusion BL.

As shown in FIG. 13, after the Y-shaped passage in the myocardium MYO is formed,
Within the second tunnel 32, one or more stents 10 are provided that extend between the left ventricle LV and the coronary artery CA. The stent 10 opens a myocardial passage that provides a bypass that bypasses the occlusion BL. Positioning the stent 10 within the tunnel 32 advances the guidewire through the first tunnel 26 and the second tunnel 3
Preferably, this is done by entering each bifurcation 34 and 36 of the two and then advancing the stent over the guidewire as described below. After placement of the stent, the tunnel 26 between the coronary artery CA and the stent 14 is at least at its distal end 30.
At the proximal end 28 and preferably at the proximal end 28 as well. The tunnel is closed by inserting a closing means 38 such as a plug, or by sealing the tunnel by stitching or other method. Other suitable closure means include occlusion coils, balloons, adhesives such as cyanoacrylates, GELFO
Examples include plugs sold under the product name of AM. As another example, the tunnel is closed by the natural contraction of openings 28 and 30 over time.

Although the previous examples describe how to create channels through the myocardium or pericardial space, other passageways exit the blood vessel proximal to the occlusion and re-enter the blood vessel distal to the occlusion. It should be recognized that channels can also be formed by. For the embodiments described above, the passage may be expanded using the methods described below prior to delivering the stent over the guidewire. In addition, guidewire 208 may be anchored to the myocardium as described below.

II. Delivery Catheter Once the desired insertion site is accessible, the appropriate delivery system is delivered to that site. The preferred embodiment described below relates to a delivery system for inserting a stent or other medical device into the myocardium at an angle to the axis of blood flow. This insertion angle is adjusted between 0 and 180 degrees depending on the desired application. Further, while the delivery systems described below relate to the insertion of the device into the myocardium, these systems deliver the medical device at an angle into and through other body lumens and tissues. You can also

A. Dual Balloon Delivery System In one embodiment, the stent delivery system comprises a catheter that creates a predetermined curve for insertion of the device into the myocardium MYO. FIG. 14 shows the delivery catheter 40 advanced across the occlusion BL into the coronary artery CA. The catheter 40 is a tubular body 42 having a lumen 44 (not shown) extending from a proximal end 46 (not shown) to a distal end 48. Catheter 40 is preferably formed of a flexible biocompatible material such as polymer, stainless steel, nitinol or the like.

Attached near the distal end 48 of the catheter 40 are two steering guides, which are inflatable members such as balloons 50, 52. As shown in FIG. 14, a steering member, such as balloon 52, is positioned distal to a locking member, such as balloon 50, such that steering balloon 52 is positioned near or at the distal end 48 of catheter 40. It is desirable to be done. Balloons 50 and 52 are, respectively, such that locking balloon 50 is mounted opposite lower wall LW adjacent myocardium MYO and steering balloon 52 is mounted opposite front wall UW opposite said lower wall LW. Preferably, it is mounted on both sides of the tubular body 42 of the catheter. In another example, the locking balloon 50 may be mounted concentrically around the tubular body 42 so that it expands and presses against both the upper and lower walls. It should be appreciated that filters, posts and other inflatable members may be used as locking and / or steering members.

As shown in FIG. 14, balloons 50 and 52 remain uninflated while catheter 40 is advanced to a position that should be adjacent myocardium MYO. As shown in FIG. 15, when the distal end 48 of the catheter 40 is positioned adjacent the desired insertion site into the myocardium MYO, the balloons 50 and 52 are inflated. Upon inflation, balloons 50 and 52 cooperate with the vessel wall to bend the distal end of the catheter. Specifically, in the intermediate state, the locking balloon 50 inflates and presses against the inferior side wall LW of the coronary artery CA, while the steering balloon 50 presses against the anterior wall UW.

As shown in FIG. 16, the locking balloon 50 is shown in the coronary artery CA as a tubular body 42.
Acts to fix. When the balloon 50 is inflated, the catheter 40 is displaced in the opposite direction to the inferior wall LW, which causes the catheter to occupy a better position for transverse insertion of the distal end 48 into the myocardium MYO. When the steering balloon 52 is further inflated, the tubular body 32 is resisted by the front wall UW against the balloon.
Its distal end 48 curves downward and faces toward the inferior wall LW and the myocardium MYO. 16
It also shows the effect of inflation of the two balloons on the upper and lower walls of the coronary artery CA. When balloons 50 and 52 are fully inflated, the forces exerted on lower wall LW and front wall UW, respectively, cause the walls to move at least slightly in the direction of balloon inflation. In particular,
The lower sidewall LW tends to curve distally of the balloon 50 toward the distal end 48 of the delivery catheter 40, helping to bend the catheter.

When the balloons 50, 52 are fully inflated due to the rotational action of the catheter 40 caused by the inflation of the balloons 50 and 52 and the curvature of the inferior sidewall LW towards the distal end 48, the distal end 48 of the catheter 30 is coronal. It is positioned at an angle substantially perpendicular to the inferior wall LW of the artery CA and the myocardium MYO. Catheter 40 serves as a guide for delivering the device used to create the myocardial passageway from this location.
For example, as shown in FIG. 16 and described in detail below, piercing wire or guide wire 100 is advanced through lumen 44 of tubular body 42 and catheter 4
It goes out from the end 48 of 0, penetrates the lower wall LW, and enters the myocardium MYO.

The two balloon delivery system described above also has the advantage of being able to rotate the catheter 40 at an angle greater than 90 degrees with respect to the direction of blood flow through the coronary artery CA. Thus, as shown in FIG. 17, the balloons 50 and 52 can be inflated to orient the distal end 48 of the catheter 40 toward the myocardium at a posterior angle.

B. Wire Traction Actuator FIG. 18 shows another embodiment for vertically delivering the device into the myocardium MYO of the patient's heart. Catheter 54 is shown extending through occlusion BL and through coronary artery CA. Catheter 54 comprises an elongate tubular body 56 having a lumen 58 (not shown) extending from a proximal end 60 (not shown) to a distal end 62. A distal bent piercing wire or puller wire 64 projects from the distal end 62 of the catheter 54. The wire 64 is manipulated at the proximal end (not shown) and can be bent to form an angle close to 90 degrees with respect to the catheter 54. It should be appreciated that the wire 64 can also be manipulated to form angles less than 90 degrees or greater than 90 degrees. End 6 of wire 64
6 is rotated so as to be adjacent to the myocardium MYO. This shape is locked and the wire 64 is pushed through the coronary artery CA and pierces the wall of the myocardium MYO. The medical device is advanced over the wire into the myocardium while holding the wire 64 in place, as described in more detail below.

C. Side Port In another embodiment, the delivery catheter comprises a side port for exiting the piercing wire. As shown in FIGS. 19A and 20A, delivery catheter 70 includes an elongated tubular body 72 having a proximal end 76 (not shown), a distal end 78, and an at least partially penetrating lumen 74 (not shown). I have it. The distal end 78 is preferably fitted with an inflatable locking member, such as an inflatable balloon 80, which inflates to maintain the position of the catheter 70 within the artery. Preferably, balloon 80 is a perfusion type balloon having channels 86 to allow blood flow through the artery during the procedure. In another example, a filter or other device that allows blood flow through the artery upon locking of catheter 70 may be used. Perfusion is through the lumen of tubular body 72. A distal opening or side port outlet 82 is provided through the wall of the tubular body 72 near the distal end of the catheter extending from the lumen 74. The side port outlet 82 may be provided on the proximal side of the balloon 80 as in FIG. 19A, or may be provided on the distal side of the balloon 80 as in FIG. 20A. The catheter 70 is fed into the vascular system until the side port outlet 82 passes the position of the blockage BL. Prior to inflation of the balloon, catheter 70 is rotated about its longitudinal axis so that opening 82 faces the myocardium.

FIGS. 19B and 20B show a guidewire 1 passing through the lumen 74 of the catheter 70.
Shows the passage for 00. In FIG. 19B, the guidewire 100 extends through the lumen 74 towards the distal end 78 of the catheter. At the proximal end side of the balloon 80, the lumen 74
Faces downward to the side port exit 82. Thus, before the guidewire 100 reaches the proximal end of the balloon 80, the guidewire 100 exits the lateral port 82 towards the lower wall LW of the coronary artery CA. A second lumen 84 is also provided in the catheter 70 for delivering inflation fluid to the balloon 80.

FIG. 20B is substantially the same structure except that lumen 74 extends through balloon 80 such that side port outlet 82 is distal of balloon 80. . Accordingly, guidewire 100 extends through lumen 74,
Exit the side port outlet 82 toward the lower wall LW. As in the case of FIG. 19B,
A second lumen 84 is provided through the tubular body 72 to provide inflation fluid into the balloon 80.

As shown in FIG. 21A, in another embodiment, side port 82 is provided on the outer surface of balloon 80. The balloon 80 is inflated after the catheter 70 has been fed to a position past the blockage BL. As shown in the cross-sectional view of FIG. 21B, balloon 80 includes a perfusion channel 86 extending from the proximal end of balloon 80 to allow blood to flow through the blood vessel. Lumen 7 that extends into the balloon 80 and bends down to the side port outlet 82
4 is provided through the catheter 70. The catheter 70 is a balloon 80
It also has a lumen 84 for inflating. Guidewire 100 is advanced through lumen 74 and exits lateral port outlet 82 and into myocardium MYO.

21C and 21D show yet another embodiment of a delivery catheter having a side port outlet. The catheter 70 includes a proximal end 76 (not shown) to a distal end 7
It comprises an elongated tubular body 72 having a lumen 74 extending up to eight. This lumen 74
Are in fluid communication with the balloon 80 to inflate the balloon. When inflated, the balloon 80 has a perfusion lumen 86 through which blood can flow. When the balloon 80 is inflated, it also has a guide lumen 88 extending from its proximal end to the lower wall LW. The guide wire 100 is then inserted into this guide lumen 88 and the side port outlet 82
Exit into the myocardium MYO.

As shown in FIGS. 19A-21D, the side port outlet 82 is shown to exit the guidewire 100 at an angle of approximately 90 degrees, while the side port outlet 82 is shown.
Please note that the guidewire 100 can be exited at angles smaller or larger than 90 degrees. This is done by rotating the guidewire in the lumen 74 near the outlet 82 and orienting it in the desired direction. The desired angled lumen 74 is shown in FIG. 20C. More specifically, the guidewire 100 exits at an obtuse angle with respect to the insertion direction of the catheter 70 due to the passageway formed by the lumen 74 at the side boat exit 82. Turning the lumen 74 of FIGS. 19B and 21B and the lumen 88 of FIG. 21D to different angles causes the guidewire 100 to exit the side port 82 at any angle in the range of approximately 0 degrees to 180 degrees. I want to be recognized.

The delivery catheters shown and described in FIGS. 21A-21D are useful not only for placing stents in the myocardium, but also for treating aneurysms. Aneurysms are often treated by introducing embolic elements to fill the aneurysm. When the aneurysm substantially opens into the blood vessel, it becomes difficult to retain and fill the embolic element within the aneurysm. FIG. 22A shows how the delivery catheter 70 described with respect to FIGS. 21C and 21D can be used to solve this problem. A catheter 70 carrying an inflatable balloon 80 is advanced through a blood vessel 90 having an aneurysm 92 such that the balloon 80 is adjacent to the aneurysm 92. The balloon 80 is inflated to substantially wrap around the aneurysm. Wire 94 or other embolic element is advanced through guiding lumen 88 of balloon 80 and out of side port 82. The wire 94 fills the aneurysm 92 and is retained within the aneurysm by the balloon 80 wrapping the aneurysm and preventing the wire 94 from entering the blood vessel. Wires 94 and other embolic elements may be delivered through lumen 74, as shown with respect to the embodiment of Figure 21B. After the aneurysm 92 has been filled with the wire 94, the wire 94 is severed, the balloon 80 is deflated, and the catheter 70 is deflated.
Is removed from the blood vessel.

FIG. 22B shows another embodiment of the balloon 80 described above for treating an aneurysm 92. The balloon 80 is mounted on a catheter 70 having an inflation lumen (not shown) for inflating the balloon. When the balloon is inflated as shown, the perfusion lumen 86 extends through the balloon 80, allowing blood to flow from the proximal side to the distal side of the balloon. A guide lumen 88 extends from the proximal end of the balloon to the side of the balloon facing the aneurysm and terminates at outlet port 82. The guide lumen 88 is funnel-shaped or tapered and has an opening 81 at the proximal end of the balloon that is larger than the opening of the side port outlet 82. This facilitates the wire 94 through the balloon 80 and into the aneurysm 92. Since blood also flows into the aneurysm through the guiding lumen 88, the balloon 80 is provided with an outflow lumen 83 to provide fluid communication between the aneurysm and the distal end of the balloon, allowing blood to aneurysm 92. It is possible to drain from.

It should be appreciated that insertion of the embolic element need not be through the balloon 80. For example, a wire or other embolic element may be fed into the aneurysm using another catheter while the balloon 80 is wrapped around the aneurysm. In one embodiment, a wire-delivering catheter is inserted into the aneurysm prior to inflating the aforementioned balloon 80. The balloon is then inflated and the wire exiting the catheter is used to fill the aneurysm. It should be appreciated that devices other than balloons may be used to wrap the aneurysm as the embolic element is delivered to the aneurysm.

D. Rotational Guide of Delivery Catheter FIGS. 23-24C illustrate another method for delivering a guidewire into the myocardium at a predetermined angle. As shown in FIG. 23, the delivery catheter 300 is
A proximal end 304, a distal end 306, and a lumen 308 extending through the catheter 300.
And a tubular member having. The distal portion 310 is spring biased or remembered to be arcuate, eg, substantially U-shaped. The tubular member 302 is
The proximal end 304 is provided with a flange or other grip 312 to facilitate the use of the device described in detail below.

As shown in FIGS. 24A-24C, the tubular member 302 is insertable through the delivery channel 314 of the insertion tube or catheter 316. Tubular member 3
02 is slidable in the channel 314 in the longitudinal direction. Thus, the distal portion 310 of the tubular member 302 remains relatively straight in the distal section of the channel 314 as the tube 316 is inserted and removed from the patient. Upon reaching the desired insertion location at the distal end of the insertion tube 316, the tubular member 302 will continue until a portion of the distal portion 310 exits the channel and is bent by the force of an internal spring incorporated into the tubular member 302. Travel distally through channel 314.

As shown in FIGS. 24A-24C, the distal portion 310 of the tubular member 302.
The degree of bending of the is controlled by controlling the degree of protrusion of the distal portion 310 from the channel 314. The greater the extent to which the tubular member 302 is pushed distally, the greater the angle a1 between the distal end 306 of the tubular member 302 and the longitudinal axis of the channel 314. In this way, this angle a1 is adjusted to an arbitrary value from approximately 0 degrees to 180 degrees.

As shown in FIG. 25A, in order to deliver delivery catheter 300 to a position adjacent the myocardium, insertion tube 316 may be inserted into any of the methods described above until its distal end 318 is adjacent the target insertion site. It is advanced percutaneously using Figure 25B
The delivery catheter 300 is projected from the distal end 318 until the desired angle to the myocardium MYO is obtained, as shown in FIG. As shown in FIG. 25C, a guidewire 100 is then inserted into the myocardium MYO at the desired angle through the lumen of the delivery catheter.

E. Inverse Guidewire FIGS. 26A-26C show another method for delivering a guidewire into the myocardium at a backward angle. As shown in FIG. 26A, delivery tube 400 is advanced within coronary artery CA adjacent to myocardium MYO using any of the methods previously described. Guidewire 100 is delivered through delivery tube lumen 404 toward delivery tube distal end 402. Preferably, the guidewire is folded so that the distal section 116 is folded back over the proximal section 114 before inserting the guidewire 100 into the lumen 404. Bent portion 118 of guide wire 100
The length from to the distal portion 104 is preferably chosen to be greater than the length the guidewire is inserted into the myocardium MYO. The guidewire positioned inside the lumen 404 of the distal end 402 of the delivery tube 400 is rotated so that the distal section 116 is closest to the myocardium MYO.

In one embodiment, guidewire 100 is made of a shape memory alloy material such as Nitinol. In this example, the shape of the folded guidewire is set by a memory-imparting heat treatment, as known to those skilled in the art. More specifically, the fold angle is set prior to inserting the guidewire into lumen 404 to correspond to the desired angle of insertion of the guidewire into the myocardium with respect to the axis of the delivery tube.
Then, when the guidewire 100 is inserted into the lumen 404, the fold angle is reduced to allow insertion, but not to the extent of permanent deformation of the guidewire.

As shown in FIG. 26B, the guidewire 100 has a distal section 11
6 projects from the distal end 402 of the delivery tube 400 so that it completely exits the lumen 404. When exiting the lumen 404, the distal section 116 remains in the proximal section 11.
It is still maintained in the folded state with respect to 4, but the folding angle preferably returns to the set original shape. After the distal section 116 exits the lumen 404, the guidewire is withdrawn proximally, as shown in FIG. 26C.
The distal end 104 of the guide wire is pierced into the myocardium MYO at the desired insertion point. The guide wire 100 is pulled back proximally until the distal end 104 breaks through the myocardium MYO and enters the left ventricle LV. After placement of the guidewire 100, the stent is delivered into the myocardium as described below.

F. Inverse Catheter FIG. 27 illustrates another embodiment for delivering a guidewire into the myocardium at a backward angle. In this embodiment, the delivery catheter 500 is a myocardium MY.
It is advanced to the insertion site adjacent to O and rotated towards the myocardium using any of the methods described above. The delivery catheter is specially configured to have an inner tapered lumen 506 toward the distal end 504. In other words, the wall of the catheter 500 increases in thickness towards the distal end 504, providing a narrowed passage 508. The guide wire 100 is the proximal end 50 of the delivery catheter.
2 (not shown), inserted through lumen 506, guided through narrowed passageway 508, exiting distal end 504 in the desired direction toward the insertion site. FIG. 27
As shown in FIG. 5, the distal rotation of the delivery catheter and the narrowed passage 50
In combination with the provision of 6, the guidewire 100 preferably exits the delivery catheter at a backward angle and enters the myocardium.

III. Locking Guidewires The embodiments described above are primarily aimed at delivering the guidewire 100 into the myocardium of a patient. As described in more detail below, this guidewire 100 is used to deliver a medical device into the myocardium of a patient. However, it should be appreciated that many of the embodiments described above may be used in connection with other methods of forming a passageway through the myocardium. For example, the delivery catheter as described above,
Used to deliver a surgical drill or other tissue penetrating device protruding from its distal end. This approach is useful, for example, in forming a tunnel through the myocardium as described above. Details are disclosed in US Pat. No. 5,429,144.

As shown in FIG. 28, a piercing device, such as guidewire 100, is directed into myocardium 100 using any of the suitable methods described above. Guide wire 10
0 has a proximal end 102 (not shown) remaining outside the patient's body and a distal end 104 inserted through the delivery catheter as previously described. In one embodiment, where the delivery catheter is placed through the coronary artery, the guidewire is advanced until the guidewire distal end 104 enters the left ventricle. In another example, where it is desirable to only partially implant a stent or other device into the myocardium, the guidewire 1
00 does not have to extend all the way to the left ventricle. Guidewire 100 does not have to extend all the way to the left ventricle. End 1 of guide wire 100
04 is preferably made of a radiopaque material that is visible to the physician by available methods such as fluoroscopy.

The distal end of guidewire 100 is preferably shaped so that it may be easily advanced but difficult to pull back through tissue. As shown in FIG. 28, the distal end 104 of one embodiment comprises one or more barbs 106 of the “barrel with multiple overhangs” type protruding from the distal end. These barbs allow the guidewire to be pierced distally into the myocardium, but require a large force to withdraw guidewire 100 proximally from the myocardium, thus providing effective locking.

FIG. 29A shows another embodiment in which guidewire 100 carries an inflatable member, such as balloon 110, at its distal end. The use of this inflatable member reduces damage to the myocardium during subsequent withdrawal of the wire 100.
As shown in FIG. 29B, when the balloon 110 reaches the left ventricle LV, the balloon 110 is inflated. The balloon is then pulled back proximally with respect to the ventricle wall to secure the guidewire 100 in place.

As another example, FIGS. 30A-30C show an inflatable guidewire 100 extending through the myocardium MYO, which locks the guidewire within the myocardium MYO. FIG. 30A shows the guide wire 100 penetrating the myocardium MYO.
Guidewire 100 includes an inflatable device 112 at distal end 104, which is actuated by operator manipulation of the proximal end of the guidewire external to the patient. The operation of this device is carried out by using a shape memory material such as Nitinol and heating this material above the transformation temperature. As another example, the guidewire may be mechanically manipulated to assume the desired shape. FIG. 30B shows guidewire 100 with distal end 104 manipulated to partially open device 112 into a lockable configuration. Figure 30
C shows the inflatable device 112 fully open and locking the guidewire 100 to the artery wall. Other types of locking and inflatable members can be used to secure the guidewire 100.

FIG. 31 shows a customized guidewire 100 having a threaded end 110. Specifically, the distal end 104 of the guidewire 100 is threaded to aid in piercing the myocardium.

Once the guide wire 100 is locked in place, the delivery catheter can be removed without moving the guide wire inserted into the myocardium. A catheter or other medical device used to form the passageway and deliver the stent is then placed in the myocardium while the guidewire 100 is locked in place. As another example, the delivery catheter remains within the vessel and other catheters or medical devices are advanced over the guidewire through the delivery catheter. In addition, an inflatable member, such as a balloon, is provided on the delivery catheter or guidewire 100 to lock the catheter or guidewire to the vessel wall and more securely deploy the medical device into the myocardium.

IV. Delivery on the Guidewire The device can be delivered to the myocardium to form a myocardial passage by locking the guidewire 100 into or against the myocardium MYO. In particular, locking the guidewire 100 facilitates insertion of a wire-coated catheter, such as an introducer catheter, into the myocardium using the push-pull mechanism. If it is desired to advance the catheter over guidewire 100, guidewire 100 is pulled proximally by an operator from outside the body. The guide wire 100 is prevented from coming out of the myocardium MYO by the locking member which is a balloon, barb, or other member at the end of the guide wire. On the other hand, the delivery catheter and other wire covering devices are pushed into the myocardium MYO by the traction force of the locking member toward the catheter. The locking member helps place the wire-coated catheter within the myocardium by preventing the catheter from protruding beyond the position of the locking member.

As shown in FIG. 32, in order to form a myocardial passage, an inflation balloon 1
A catheter 120 having a guide wire 1 as shown in FIG.
00 is advanced into the myocardium MYO. Locked balloon 110 acts as a barrier to the advancement of balloon 122 and then expands within myocardium MYO to open the myocardial passage. The balloon 122 is then deflated and the catheter 120 is removed. This process is sequentially repeated with a large dilatation balloon to form the desired sized passage.

After the maximum dilatation balloon is inflated, the catheter 120 is withdrawn and the stent introducer catheter 130 is advanced over the wire 100, as shown in FIG. The catheter 130 includes a stent 1 carried by a balloon 132.
34 has an inflation balloon 132 attached to its distal end for deployment. When the balloon 132 is positioned inside the myocardium MYO, the balloon 132 is inflated, as shown in FIG. 35, to resist the compressive forces of the heart muscles and the stent 13.
Helps the first expansion of 4. When the stent 134 occupies the desired position, the balloon 1
32 deflate, catheter 130 and wire 100 withdrawn, stent 134
Are left in place to form a coronary bypass between the ventricle LV and the artery CA.

It should be appreciated that the stent 134 can be delivered in other ways. It should be appreciated that the guidewire lock could be used in other applications, such as feeding the shunt between two points in the human body as described above.

V. Drug Delivery The aforementioned guidewire delivered to the myocardium MYO can also be used to deliver the drug to the myocardium. As shown in FIG. 36, the guide wire 14
The 0 is partially inserted into the myocardium using any of the methods described above. Guidewire 140 has a lumen 148 extending from proximal end 144 (not shown) to distal end 146.
And a tubular body 142 having The guidewire is bent using the rotation method described above to position the distal end of the guidewire for drug delivery in the myocardium at the desired location. Drug delivery fluid 150 is ejected from the distal end 146 into the myocardium.
The guide wire 140 shown in FIG. 36 is not locked to the myocardium MYO, but the locking means described above may be provided. Further, the guidewire 140 includes a plurality of ports 152 near the distal end 146 along the tubular body 142.

The embodiments illustrated and described above are merely illustrative of particular preferred embodiments of the present invention. Those skilled in the art can make other changes and modifications to the embodiments shown here without departing from the spirit and scope of the present invention defined in the claims.

[Brief description of drawings]

FIG. 1A is a cross-sectional view of a human heart, showing a stent placed in the myocardium of the heart to form a bypass shunt between the left ventricle and the coronary arteries.

FIG. 1B   FIG. 1B is an enlarged view of the shunt of FIG. 1A.

FIG. 2 is a schematic partial cross-sectional view of a human heart, showing a stent partially invading the myocardium from the left ventricle.

FIG. 3A is a schematic partial cross-section of a coronary artery adjacent to the left ventricle, showing a delivery catheter being advanced through an occlusion of the coronary artery.

FIG. 3B is a schematic partial cross-section of a coronary artery adjacent to the left ventricle showing the delivery catheter being advanced into the left ventricle.

FIG. 4A   FIG. 6 is a schematic side view of a venous access route through a patient's heart.

4B is a schematic partial cross-sectional view of the venous access route of FIG. 4A between a coronary vein and a coronary artery, showing the delivery catheter being advanced through the coronary vein and into the coronary artery.

FIG. 5 is a schematic partial cross-sectional view of a coronary artery adjacent to the left ventricle showing a tunnel formed to bypass an occlusion in the coronary artery through the myocardium.

FIG. 6 is a schematic partial cross-sectional view of a coronary artery adjacent to the left ventricle, showing a delivery catheter being advanced through a tunnel formed through the myocardium.

FIG. 7A is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a guidewire method of forming a bypass or access channel through the myocardium around the occlusion.

FIG. 7B is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a guidewire method of forming a bypass or access channel through the myocardium around the occlusion.

FIG. 7C is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a guidewire method of forming a bypass or access channel through the myocardium around the occlusion.

FIG. 7D is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a guidewire method of forming a bypass or access channel through the myocardium around the occlusion.

FIG. 7E is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a guidewire method of forming a bypass or access channel through the myocardium around the occlusion.

FIG. 7F is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a guidewire method of forming a bypass or access channel through the myocardium around the occlusion.

FIG. 7G is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a guidewire method of forming a bypass or access channel through the myocardium around the occlusion.

FIG. 8A is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a method of forming a bypass or access channel in the pericardial space around the occlusion.

FIG. 8B is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a method of forming a bypass or access channel in the pericardial space around the occlusion.

FIG. 8C is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a method of forming a bypass or access channel in the pericardial space around the occlusion.

FIG. 8D is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a method of forming a bypass or access channel in the pericardial space around the occlusion.

FIG. 8E is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a method of forming a bypass or access channel in the pericardial space around the occlusion.

FIG. 8F is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing a method of forming a bypass or access channel in the pericardial space around the occlusion.

FIG. 9A is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing another method of forming a bypass or access channel around the occlusion.

FIG. 9B is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing another method of forming a bypass or access channel around the occlusion.

FIG. 9C is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing another method of forming a bypass or access channel around the occlusion.

FIG. 9D is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing another method of forming a bypass or access channel around the occlusion.

FIG. 9E is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing another method of forming a bypass or access channel around the occlusion.

FIG. 10A is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing another method of forming a bypass or access channel around the occlusion.

FIG. 10B is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing another method of forming a bypass or access channel around the occlusion.

FIG. 10C is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing another method of forming a bypass or access channel around the occlusion.

FIG. 10D is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing another method of forming a bypass or access channel around the occlusion.

FIG. 10E is a schematic partial cross-sectional view of a coronary artery with an occlusion therein, showing another method of forming a bypass or access channel around the occlusion.

FIG. 11A is a schematic partial cross-sectional view of a coronary artery adjacent to the left ventricle showing the guidewire method of forming the left ventricular conduit.

FIG. 11B is a schematic partial cross-sectional view of the coronary artery adjacent to the left ventricle showing the guidewire method of forming the left ventricular conduit.

FIG. 11C is a schematic partial cross-sectional view of a coronary artery adjacent to the left ventricle showing the guidewire method of forming the left ventricular conduit.

FIG. 11D is a schematic partial cross-sectional view of a coronary artery adjacent to the left ventricle showing the guidewire method of forming the left ventricular conduit.

FIG. 11E is a schematic partial cross-sectional view of a coronary artery adjacent to the left ventricle showing the guidewire method of forming the left ventricular conduit.

FIG. 11F is a schematic partial cross-sectional view of a coronary artery adjacent to the left ventricle showing the guidewire method of forming the left ventricular conduit.

FIG. 12 is a schematic partial cross-sectional view of a coronary artery adjacent to the left ventricle showing a Y-shaped tunnel formed through the myocardium to bypass an occlusion in the coronary artery.

13 is a partial cross-sectional view of the Y-shaped tunnel of FIG. 12, showing the stent provided therein.

FIG. 14 is a side view of a delivery catheter carrying two uninflated steering balloons within an occluded coronary artery, with the artery shown in partial cross-section.

FIG. 15 is a side view of the delivery catheter of FIG. 14, showing the two balloons starting to inflate.

16 is a side view of the delivery catheter of FIG. 14, showing the two balloons fully inflated and the guidewire protruding from the distal end of the delivery catheter.

FIG. 17 is a side view of the delivery catheter of FIG. 14 with the two balloons fully inflated and the guidewire protruding from the distal end of the delivery catheter at a backward angle.

FIG. 18 is a side view of a delivery catheter with a blunt distal wire within an occluded coronary artery, with the artery shown in partial cross-section.

FIG. 19A is a side view of a delivery catheter within an occluded coronary artery having a lateral port near the base of an inflatable balloon, with the artery shown in partial cross-section.

19B is a cross-sectional view of the delivery catheter of FIG. 19A showing a guide wire therethrough.

FIG. 20A is a side view of a delivery catheter within an occluded coronary artery having a lateral port near the end of an inflatable balloon, the artery shown in partial cross-section.

20B is a cross-sectional view of the delivery catheter of FIG. 20A showing a guidewire therethrough.

FIG. 20C is a cross-sectional view of a delivery catheter having side ports for delivering the guidewire at a backward angle.

FIG. 21A is a side view of a delivery catheter within an occluded coronary artery having a side port on an inflatable balloon, with the artery shown in partial cross-section.

21B is a cross-sectional view of the delivery catheter of FIG. 21A showing a guide wire extending through a balloon.

FIG. 21C is a side view of another embodiment of a delivery catheter within an occluded coronary artery having a side port on an inflatable balloon, with the artery shown in partial cross-section.

21D is a cross-sectional view of the delivery catheter of FIG. 21C showing a guide wire extending through the balloon.

FIG. 22A is a side view of a delivery catheter having a side port on an inflatable balloon used to treat an aneurysm in a blood vessel, with the blood vessel partially shown in cross-section.

FIG. 22B is a partial cross-sectional view of a delivery catheter having a side port on an inflatable balloon used to treat an aneurysm in a blood vessel, with the blood vessel shown in partial cross-section.

FIG. 23   FIG. 9 is a side view of a delivery catheter having a curved end.

FIG. 24A is a partial side view of the device of FIG. 23 showing the delivery catheter escaping from the end of the channel.

FIG. 24B is a partial side view of the device of FIG. 23 showing the delivery catheter escaping from the distal end of the channel.

FIG. 24C is a partial side view of the device of FIG. 23 showing the delivery catheter escaping from the end of the channel.

FIG. 25A is a side view of the delivery of the device of FIG. 23 in a coronary artery adjacent to the myocardium, with the artery and myocardium shown in partial cross-section.

FIG. 25B is a side view of the delivery of the device of FIG. 23 within the coronary artery adjacent to the myocardium, with the artery and myocardium shown in partial cross-section.

FIG. 25C is a side view of the delivery of the device of FIG. 23 in a coronary artery adjacent to the myocardium, with the artery and myocardium shown in partial cross-section.

FIG. 26A is a schematic partial cross-sectional view of a coronary artery adjacent to the left ventricle showing the folded guidewire being delivered into the myocardium.

FIG. 26B is a schematic partial cross-sectional view of a coronary artery adjacent to the left ventricle, showing a folded guidewire being delivered into the myocardium.

FIG. 26C is a schematic partial cross-sectional view of the coronary artery adjacent to the left ventricle showing the folded guidewire being delivered into the myocardium.

FIG. 27 is a schematic partial cross-sectional view of the coronary artery adjacent to the left ventricle, showing the guide wire being delivered at a backward angle through the delivery catheter.

FIG. 28 is a side view of a locking guidewire extending through the myocardium, the myocardium shown in partial cross-section.

FIG. 29A is a side view of a guidewire carrying an inflatable balloon distal through the myocardium, the myocardium shown in partial cross-section.

29B is a side view of the guidewire of FIG. 29A showing the balloon inflated to lock the guidewire to the myocardium.

FIG. 30A is a side view of another embodiment of a guidewire anchored to the inner wall of the myocardium, the myocardium shown partially in cross-section.

FIG. 30B is a side view of another embodiment of a guidewire anchored to the inner wall of the myocardium, the myocardium shown in partial cross-section.

FIG. 30C is a side view of another embodiment of a guidewire anchored to the inner wall of the myocardium, the myocardium shown in partial cross-section.

FIG. 31   FIG. 6 is a perspective view of a guide wire having a threaded end.

FIG. 32 is a side view of an inflatable catheter in a coronary artery over a guide wire extending into the myocardium, with the artery and myocardium shown in partial cross-section.

FIG. 33   FIG. 33 is a side view of the inflatable catheter of FIG. 32 traveling through the myocardium.

FIG. 34 is a side view of an intracoronary stenting catheter that is advanced over a guidewire that extends into the myocardium, with the artery and myocardium shown in partial cross-section.

FIG. 35   FIG. 35 is a side view of the stent introduction catheter of FIG. 34 that advances into the myocardium.

FIG. 36 is a side view of the drug delivery wire advanced into the myocardium through the coronary artery,
The arteries and myocardium are shown in partial cross section.

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE), OA (BF, BJ , CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, K E, LS, MW, SD, SL, SZ, UG, ZW), E A (AM, AZ, BY, KG, KZ, MD, RU, TJ , TM), AE, AL, AM, AT, AU, AZ, BA , BB, BG, BR, BY, CA, CH, CN, CR, CU, CZ, DE, DK, DM, EE, ES, FI, G B, GD, GE, GH, GM, HR, HU, ID, IL , IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, M G, MK, MN, MW, MX, NO, NZ, PL, PT , RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, UA, UG, US, UZ, V N, YU, ZA, ZW (72) Inventor Furnish, Simon Em.             United States, Kentucky 40204,             Louisville, Longest Avenue 2429 (72) Inventor Wolf, Scott Jay.             Minnesota 55405, Minnese, United States             Apolis, Irvine Avenue South               2501 (72) Inventor Wilk, Peter Jay.             United States, New York 10023,             New York, West End Aveni             185 (72) Inventor Phelps, David Wy.             United States, Kentucky 40223,             Louisville, Shady Lane 904 (72) Inventor Pompili, Vincent             United States, Indiana 46032,             Carmel, Quail Point Drive               14360 F term (reference) 4C060 MM25                 4C167 AA05 AA07 AA28 AA41 BB02                       BB04 BB07 BB26 BB28 BB52                       CC09 CC19 DD01 DD08 HH08 [Continued summary] Go over the ear and enter the myocardium.

Claims (40)

[Claims] 1. A delivery system for at least partially inserting a conduit into a heart wall between a heart chamber and a blood vessel, the guidewire having a proximal end and a distal end; And a locking mechanism on the guide wire for locking the guide wire to the heart wall, the guide wire being used to deliver the conduit to the heart wall. Delivery system. 2. The delivery system according to claim 1, wherein the rotation mechanism comprises a delivery catheter having a lumen for receiving the guide wire. 3. The delivery catheter comprises an elongated tubular body having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, and a first tubular body attached to the distal end of the tubular body. The delivery system according to claim 2, comprising one steering member and a second steering member attached to the distal end of the tubular body at a position distal to the first steering member. 4. The first steering member is an inflatable locking member, and when the first steering member is actuated, the wall of the lumen of the human body is pressed to fix the catheter to the lumen. The delivery system according to claim 3, comprising. 5. The method of claim 3, wherein the second steering member is an inflatable locking member and when actuated, the second steering member cooperates with a wall of a body lumen to rotate the distal end of the catheter. Delivery system. 6. The delivery system of claim 3, wherein the first steering member and the second steering member are inflatable balloons. 7. The first steering member is attached to one side of the tubular body,
4. The delivery system of claim 3, wherein the second steering member is mounted on the opposite side of the tubular body. 8. The delivery catheter comprises: an elongate body having a proximal end and a distal end; an inflatable member having a proximal end, a distal end and an outer surface attached to the distal end of the tubular body; 3. The delivery system of claim 2 including a guide lumen extending from the proximal end of the flexible member to a side port on the outer surface of the inflatable member for threading a guide wire. 9. The delivery system of claim 8, wherein the guide lumen extends through the elongated body from the side port to a proximal end of the elongated body. 10. The delivery system of claim 8, wherein the guide lumen is separate from the elongated body. 11. The inflatable member is an inflatable balloon.
Delivery system described in. 12. The delivery system of claim 8, further comprising a perfusion channel extending through the expandable member to allow blood to flow through the perfusion channel. 13. An elongate body, the delivery catheter having a proximal end and a distal end defining a generally longitudinal axis between the proximal end and the distal end, and at least a portion of the elongate body between the proximal end and the distal end. A guide wire lumen extending generally and having a proximal end and a distal end, and about 0 degrees to the longitudinal axis of the elongate body to guide the guide wire from within the guide wire lumen. An exit port provided at the end of the guidewire lumen to provide a 180 degree range of curvature.
Delivery system described in. 14. The delivery system of claim 13, wherein the outlet port is a lateral port formed proximally distal of the elongated body. 15. The delivery system of claim 13, further comprising an inflatable member attached proximally to the distal end of the elongated body. 16. The delivery system of claim 13, further comprising a narrowed passageway between the guidewire lumen and the outlet port. 17. The rotating mechanism comprises: a proximal end, a distal end, an insertion channel having a delivery channel extending between the proximal end and the distal end, a proximal end, a distal end, and the proximal end. A tubular member having a lumen extending between the distal end and the distal end, the tubular member having a distal end portion, the distal end portion being acted upon by a force to straighten the distal end portion from the outside. If not, the tubular member is longitudinally slidable within the delivery channel and has an internal spring force that biases the distal portion into an arc. At a distal end of the tubular member and relatively straight and out of the channel and alternately maintained in the arc shape, wherein the guidewire is longitudinally slidable within the lumen of the tubular member. The delivery system according to Item 1. 18. The delivery system of claim 1, wherein the locking mechanism is an inflatable balloon. 19. The delivery system according to claim 1, wherein the locking mechanism is provided at a distal end of the guide wire. 20. A proximal end, a distal end, an elongated tubular body having a lumen extending between the proximal end and the distal end, and a first steering member attached to the distal end of the tubular body. A delivery catheter having a second steering member attached to the distal end of the tubular body at a position distal to the distal end of the stop member. 21. The first maneuvering member is an inflatable locking member which, when actuated, pushes against a wall of the lumen of the body to secure the catheter within the lumen. 21. The catheter of claim 20 having different dimensions. 22. The method of claim 4, wherein the second steering member is an inflatable member and when actuated, the second steering member cooperates with a wall of the lumen of the body to rotate the distal end of the catheter. Catheter. 23. The catheter of claim 5, wherein the second steering member is capable of rotating the distal end of the catheter greater than 90 degrees. 24. The catheter of claim 20, wherein the locking member and steering member are inflatable balloons. 25. The catheter of claim 20, wherein the locking member is mounted on one side of the tubular body and the steering member is mounted on the opposite side of the tube body. 26. An elongate body having a proximal end and a distal end; an inflatable member having a proximal end, a distal end and an outer surface attached to the distal end of the tubular body; and the inflatable member for passing a medical device. A delivery catheter having a guide lumen extending from a proximal end of the member to an outer surface of the inflatable member. 27. The delivery catheter of claim 26, wherein the guide lumen extends through the elongated body from the side port to a proximal end of the elongated body. 28. The guide lumen is separate from the elongated body.
The delivery catheter described in. 29. The delivery catheter of claim 26, wherein the guide lumen is curved to about 90 degrees. 30. The inflatable member is an inflatable balloon.
The delivery catheter according to item 6. 31. The delivery catheter of claim 26, further comprising a perfusion channel that allows blood flow. 32. The delivery catheter of claim 12, wherein the perfusion channel extends through the expandable member. 33. An elongated body having a proximal end and a distal end defining a generally longitudinal axis between the proximal end and the distal end; extending at least partially between the proximal end and the distal end of the elongated body; A guide wire lumen having a proximal end and a distal end, and a distal end of the guide wire lumen forming a curvature between about 0 degrees and 180 degrees relative to a longitudinal axis of the elongate body. A delivery catheter having an exit port for guiding a guide wire exiting the lumen. 34. The delivery catheter of claim 33, wherein the outlet port is a side port formed proximally to the distal end of the elongated body. 35. The delivery catheter of claim 14, further comprising an inflatable member mounted proximal to the side outlet port. 36. The delivery catheter of claim 14, further comprising an inflatable member mounted distally of the side outlet port. 37. The guidewire lumen extends from a proximal end of the elongate body to a distal end and the exit port is provided at a distal end of the elongate body.
The delivery catheter described in. 38. The delivery catheter of claim 33, further comprising a narrowed passage between the guidewire lumen and the exit port. 39. An elongated tubular body having a proximal end, a distal end, and a lumen extending at least partially between the proximal end and the distal end; and a guidewire inserted into body tissue at a predetermined angle. A catheter provided near the distal end of the tubular body for 40. An assembly for delivering a medical device within a wall of a patient's heart, the insertion tube having a proximal end, a distal end, and a delivery channel extending between the proximal end and the distal end. A tubular member having a proximal end, a distal end, and an inner lumen extending between the proximal end and the distal end, the tubular member having a distal end portion, the distal end portion being external to the distal end, The tubular member has an internal spring force that biases the distal portion into an arc when the force tending to straighten the portion is not exerted, and the tubular member slides longitudinally within the delivery channel. A tubular member that is moveable, the distal portion being retained at the distal end of the channel and relatively straight, the tubular member exiting the channel and being maintained in the arcuate shape alternately; With a guide wire that can slide in the longitudinal direction Is equipped with
An assembly for delivering a medical device within the wall of a patient's heart.