Designs for left ventricular conduit

Information

  • Patent Grant
  • 6290728
  • Patent Number
    6,290,728
  • Date Filed
    Wednesday, August 4, 1999
    24 years ago
  • Date Issued
    Tuesday, September 18, 2001
    22 years ago
Abstract
A conduit is provided to provide a bypass around a blockage in the coronary artery. The conduit is adapted to be positioned in the myocardium or heart wall to provide a passage for blood to flow between a chamber of the heart such as the left ventricle and the coronary artery, distal to the blockage. The stent is self-expanding or uses a balloon to expand the stent in the heart wall. Various attachment means are provided to anchor the stent and prevent its migration.
Description




FIELD OF THE INVENTION




The present invention relates to an apparatus for bypassing a blocked blood vessel segment, and, more particularly, to a conduit or stent positioned between the coronary artery or other blocked vessel and a chamber of the heart, such as the left ventricle of the heart, to bypass a blocked segment of the coronary artery or other blood vessel.




BACKGROUND OF THE INVENTION




Coronary artery disease is a major problem in the U.S. and throughout the world. Coronary arteries as well as other blood vessels frequently become clogged with plaque, which at the very least impairs the efficiency of the heart's pumping action, and can lead to heart attack and death. In some cases, these arteries can be unblocked through noninvasive techniques such as balloon angioplasty. In more difficult cases, a bypass of the blocked vessel is necessary.




In a bypass operation, one or more venous segments are inserted between the aorta and the coronary artery. The inserted venous segments or transplants act as a bypass of the blocked portion of the coronary artery and thus provide for a free or unobstructed flow of blood to the heart. More than 500,000 bypass procedures are performed in the U.S. every year.




Such coronary artery bypass surgery, however, is a very intrusive procedure that is expensive, time-consuming and traumatic to the patient. The operation requires an incision through the patient's sternum (stemotomy), and that the patient be placed on a bypass pump so that the heart can be operated on while not beating. A vein graft is harvested from the patient's leg, another highly invasive procedure, and a delicate surgical procedure is required to piece the bypass graft to the coronary artery (anastomosis). Hospital stays subsequent to the surgery and convalescence are prolonged.




As mentioned above, another conventional treatment is percutaneous transluminal coronary angioplasty (PTCA) or other types of angioplasty. However, such vascular treatments are not always indicated due to the type or location of the blockage, or due to the risk of emboli.




Thus, there is a need for an improved bypass system which is less traumatic to the patient.




SUMMARY OF THE INVENTION




The preferred embodiments of the present invention address the need in the previous technology by providing a bypass system that avoids the sternotomy and other intrusive procedures normally associated with coronary bypass surgery. These embodiments also free the surgeon from the multiple anastomoses necessary in the current process.




The preferred device provides a shunt for diverting blood directly from a chamber in the heart, such as the left ventricle, to the coronary artery, distal to the blockage, therefore bypassing the blocked portion of the vessel. The shunt comprises a stent or conduit adapted to be positioned in the heart wall or myocardium between the left ventricle and the coronary artery that allows for the direct passage of blood therethrough. As used herein, the terms “stent” and “conduit” are interchangeable, and refer to a device that allows for the passage of blood therethrough. The terms “myocardium” and “heart wall” are also used interchangeably. In addition, although the left ventricle is referred to throughout the description, it should be understood that the conduit described herein can be used to provide a passageway for the flow of blood from any heart chamber, not only the left ventricle.




The stent device is delivered either externally or internally through the coronary artery to a position distal to the blockage. At that position, the coronary artery, the myocardium and the wall of the left ventricle are pierced to provide a channel completely through from the coronary artery to the left ventricle of the heart. The stent is then positioned in the channel to provide a permanent passage for blood to flow between the left ventricle of the heart and the coronary artery, distal to the blockage. The stent is sized so that one open end is positioned within the coronary artery, while the other open end is positioned in the left ventricle. The hollow lumen of the stent provides a passage for the flow of blood.




The stent can be self-expandable or expanded by means of a balloon or similar device, and can be provided with various means to anchor it in position within the myocardium, such as expandable legs, hooks, barbs, collars, suture holes and the like. The stent can be formed from a plurality of rings, which can be connected to provide stability. The stent can include a valve in its interior, and can also be used to deliver drugs or other pharmaceutical compounds directly into the myocardium and the coronary circulation.











BRIEF DESCRIPTION OF THE DRAWINGS





FIG. 1A

is a cross-sectional view of a human heart, aorta and coronary artery.





FIG. 1B

is a side view of one embodiment of an expandable stent and the balloon catheter used for stent delivery.





FIG. 2

is a side view of the stent of

FIG. 1B

mounted on the distal end of the catheter for delivery into the myocardium, with the coronary artery and myocardium shown cut-away.





FIG. 3

is a side view of the distal end of the stent/catheter assembly of

FIG. 1B

positioned in the myocardium, with the coronary artery and myocardium shown cut-away.





FIG. 4

is a cross-sectional side view of the stent of

FIG. 1B

positioned within the myocardium after removal of the catheter used for delivery.





FIG. 5

is a side view of another embodiment of the stent and the catheter used for stent delivery.





FIG. 6

is a cross-sectional side view of the catheter and puncture device used to introduce the self-expanding stent of

FIG. 5

into the myocardium.





FIG. 7

is a cross-sectional side view of the stent/catheter assembly of

FIG. 5

positioned in the myocardium.





FIG. 8

is a side view of the self-expanding stent of

FIG. 5

positioned within the myocardium after removal of the catheter and puncture device, with the coronary artery and myocardium shown cut-away.





FIG. 9

is a perspective view of another embodiment of the stent having expandable legs, showing the stent mounted on the distal end of the introducer catheter.





FIG. 10

is a perspective view of the stent of

FIG. 9

, showing the distal end of the introducer catheter pushed forward to allow the legs of the stent to expand.





FIG. 11

is a perspective view of the stent of

FIG. 9

, showing the legs of the stent in an expanded position.





FIG. 12

is a side view of another embodiment of the stent positioned within the myocardium, with the coronary artery and myocardium shown cut-away.





FIG. 13

is a side view of a biodegradable stent positioned within the myocardium, with the coronary artery and myocardium shown cut-away.





FIG. 14

is a side view of a catheter and puncture device used to introduce a bulkhead stent into the myocardium, with the coronary artery and myocardium shown cut-away.





FIG. 15

is a side view of the stent/catheter assembly of

FIG. 14

positioned in the myocardium, with the coronary artery and myocardium shown cutaway.





FIGS. 16-19

are progressive side views of the stent/catheter assembly of

FIG. 14

, showing the bulkhead stent being deployed into the myocardium.





FIGS. 20 and 21

are enlarged views of

FIGS. 18 and 19

, respectively, showing the bulkhead stent being deployed into the myocardium.





FIG. 22

is a perspective view of a ring of a bulkhead stent in a loaded configuration





FIG. 23

is a perspective view of a ring of a bulkhead stent in an inserted configuration.





FIG. 24

is a perspective view of a bulkhead stent within a delivery catheter, showing the rings of the bulkhead stent being inserted.





FIG. 25

is a perspective view of a bulkhead stent, with the rings of the stent in loaded and inserted configurations.





FIG. 26

is a perspective view of an inserter device used to insert a bulkhead stent.





FIG. 27A

is a schematic, cross-sectional view of the human heart, showing a catheter used to form a channel through the myocardium and into the left ventricle inserted into the coronary artery.





FIG. 27B

is an enlarged view of the distal end of the catheter and the channel through the myocardium in FIG.


27


A.





FIG. 28

is a schematic, cross-sectional view of a stent delivery catheter positioned inside the channel formed in the myocardium.





FIG. 29

is a schematic, partial cross-sectional view of a self-expanding spring stent being positioned in the channel formed in the myocardium.





FIG. 30

is a schematic, partial cross-sectional view of the self-expanding stent deployed within the myocardium.





FIG. 31

is a perspective view of another embodiment of a stent having retention members which maintain the position of the stent.











DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT




As is well known, the coronary artery branches off the aorta and is positioned along the external surface of the heart wall. The anatomy of the human heart is illustrated in FIG.


1


A. Oxygenated blood flows from the heart PH to the aorta AO, on to the rest of the body, some of the blood flowing into the coronary artery CA. In some individuals, plaque builds up within the coronary artery CA, blocking the free flow of blood and causing complications ranging from mild angina to heart attack and death.




In order to restore the flow of oxygenated blood through the coronary artery, one embodiment of the present invention provides for the shunting of blood directly from the heart to a site in the coronary artery that is distal to the blockage. A channel is formed through the wall of the coronary artery and the myocardium and into the left ventricle of the heart that lies beneath the coronary artery. A stent or conduit is positioned in the passage to keep it open, and allow for the flow of oxygenated blood directly from the heart into the coronary artery. Again, it should be understood that while the insertion of the conduit in the myocardium between the left ventricle and the coronary artery is described in detail below, this is merely exemplary and use of the conduit between other chambers of the heart and the coronary artery, and between blood vessels is also contemplated.




The principles of the present invention are not limited to left ventricular conduits, and include conduits for communicating bodily fluids from any space within a patient to another space within a patient, including any mammal. Furthermore, such fluid communication through the conduits is not limited to any particular direction of flow and can be antegrade or retrograde with respect to the normal flow of fluid. Moreover, the conduits may communicate between a bodily space and a vessel or from one vessel to another vessel (such as an artery to a vein or vice versa). Moreover, the conduits can reside in a single bodily space so as to communicate fluids from one portion of the space to another. For example, the conduits can be used to achieve a bypass within a single vessel, such as communicating blood from a proximal portion of an occluded coronary artery to a more distal portion of that same coronary artery.




In addition, the conduits and related methods can preferably traverse various intermediate destinations and are not limited to any particular flow sequence. For example, in one preferred embodiment of the present invention, the conduit communicates from the left ventricle, through the myocardium, into the pericardial space, and then into the coronary artery. However, other preferred embodiments are disclosed, including direct transmyocardial communication from a left ventricle, through the myocardium and into the coronary artery. Thus, as emphasized above, the term “transmyocardial” should not be narrowly construed in connection with the preferred fluid communication conduits, and other non-myocardial and even noncardiac fluid communication are preferred as well. With respect to the walls of the heart (and more specifically the term “heart wall”), the preferred conduits and related methods are capable of fluid communication through all such walls including, without limitation, the pericardium, epicardium, myocardium, endocardium, septum, etc.




The bypass which is achieved with certain preferred embodiments and related methods is not limited to a complete bypass of bodily fluid flow, but can also include a partial bypass which advantageously supplements the normal bodily blood flow. Moreover, the occlusions which are bypassed may be of a partial or complete nature, and therefore the terminology “bypass” or “occlusion” should not be construed to be limited to a complete bypass or a complete occlusion but can include partial bypass and partial occlusion as described.




The preferred conduits and related methods disclosed herein can also provide complete passages or partial passages through bodily tissues. In this regard, the conduits can comprise stents, shunts, or the like, and therefore provide a passageway or opening for bodily fluid such as blood. Moreover, the conduits are not necessarily stented or lined with a device but can comprise mere tunnels or openings formed in the tissues of the patient.




The conduits of the present invention preferably comprise both integral or one-piece conduits as well as plural sections joined together to form a continuous conduit. The present conduits can be deployed in a variety of methods consistent with sound medical practice including vascular or surgical deliveries, including minimally invasive techniques. For example, various preferred embodiments of delivery rods and associated methods may be used. In one embodiment, the delivery rod is solid and trocar-like. It may be rigid or semi-rigid and capable of penetrating the tissues of the patient and thereby form the conduit, in whole or in part, for purposes of fluid communication. In other preferred embodiments, the delivery rods may be hollow so as to form the conduits themselves (e.g., the conduits are preferably self-implanting or self-inserting) or have a conduit mounted thereon (e.g., the delivery rod is preferably withdrawn leaving the conduit installed). Thus, the preferred conduit device and method for installation is preferably determined by appropriate patient indications in accordance with sound medical practices.




In some individuals, aortic insufficiency or peripheral venous insufficiency occurs. Aortic insufficiency is the leakage of blood through the aortic valve, resulting in a backflow of blood into the left ventricle. The heart compensates for the backflow of blood by pumping harder, resulting in hypertrophy (thickening of the heart muscle) and dilation of the left ventricle wall. Left untreated, heart failure can result. In venous insufficiency, the heart valves are unable to prevent the backflow of blood. This too can result in heart failure. Accordingly, one embodiment of the invention provides for the use of a conduit placed within the heart wall to improve the flow of oxygenated blood through the body.




A first embodiment of the present invention is illustrated in FIG.


1


B. This embodiment is a balloon-expanded stent


10


. The stent


10


is introduced as described below, using a high-pressure balloon catheter


12


to deploy the stent


10


once it is properly positioned in the myocardium MYO (FIG.


2


). When the stent


10


is positioned inside the myocardial wall MYO, the balloon


14


is inflated to expand the stent


10


and open the conduit from the left ventricle LV into the coronary artery CA. The stent


10


can include attachment mechanisms not limited to hooks, barbs, flanges, large collars, suture holes and/or other means to ensure a seal is created between the coronary artery CA and the wall of the myocardium MYO and to prevent the threat of stent


10


migration. When the attachment of the stent


10


is completed, the remaining catheter assembly


12


is removed, leaving the stent


10


in place. Upon deflating the balloon


14


, the stent


10


will remain open. Because of the shape of this stent


10


, a dumbbell shaped balloon


14


is preferably used to ensure proper expansion, as described below.





FIGS. 1B through 4

illustrate the introduction of the balloon-expanded stent


10


into the myocardial wall MYO.

FIG. 1B

illustrates the stent


10


mounted over the balloon


14


on the distal end of the stent introducer catheter


12


.

FIG. 2

illustrates the stent introducer catheter


12


following the path created by a puncture wire


16


extending past the distal end-of the introducer catheter


12


, and used to access the left ventricle LV through the coronary artery CA and myocardium MYO. Further details regarding conduits and conduit delivery systems are described in copending patent applications entitled DELIVERY METHODS FOR LEFT VENTRICULAR CONDUIT Ser. No. 09/368,868, LEFT VENTRICULAR CONDUIT WITH BLOOD VESSEL GRAFT, VALVE DESIGNS FOR LEFT VENTRICULAR CONDUIT Ser. No. 09/368,393, LEFT VENTRICULAR CONDUITS TO CORONARY ARTERIES AND METHODS FOR CORONARY BYPASS Ser. No. 09/534,038, and BLOOD FLOW CONDUIT DELIVERY SYSTEM AND METHOD OF USE Ser. No. 09/368,644, all filed on the same day as the present application, and U.S. Pat. Nos. 5,429,144 and 5,662,124, the disclosures of which are all hereby incorporated by reference in their entirety.





FIG. 3

illustrates the non-expanded stent


10


positioned inside the myocardial wall MYO prior to inflation of the balloon


14


.

FIG. 4

illustrates an expanded stent


10


in position, with the introducer catheter


12


removed. Because of the way the attachment mechanisms


18


expand on this stent


10


, a dumbbell shaped balloon


14


is preferably used to flare out the ends of the stent


10


. These flared edges


18


maintain the stent


10


in its proper position in the heart wall MYO and provide a seal between the coronary artery CA and the outer heart wall MYO.




The second embodiment of the stent or conduit incorporates a self-expanding stent


20


, illustrated in

FIGS. 5-8

. The stent


20


, having a retaining sheath


26


to hold it in a non-expanded configuration, is introduced into the wall of the myocardium MYO as follows. The stent delivery catheter


22


is advanced over a puncture mechanism


24


and into the wall of the myocardium MYO as described above. When the stent


20


is properly seated in the myocardial wall MYO, its retaining sheath


26


is withdrawn, allowing the stent


20


to expand and open a conduit from the ventricle LV to the coronary artery CA. This stent


20


also includes attachment mechanisms not limited to hooks, barbs, flanges, large collars, suture holes and/or other means to ensure a seal is created between the artery CA and the wall of the myocardium MYO, and to prevent the threat of stent


20


migration. When the positioning is completed, the remaining catheter assembly


22


is removed, leaving the stent


20


in place.




The self-expanding stent


20


mounted on the distal end of the stent introducer catheter


22


is illustrated in FIG.


5


.

FIG. 6

illustrates the stent introducer


22


following the path created by a puncture wire


24


used to form the passage between the coronary artery CA and the left ventricle LV.

FIG. 7

illustrates a non-expanded stent


20


located in position on the stent introducer catheter


22


with the introducer catheter


22


in position in the heart wall MYO.

FIG. 8

illustrates the self-expanding stent


20


in position, with the introducing catheter


22


removed. Flared edges


28


on the stent


20


maintain its proper position in the heart wall MYO and provide a seal between the coronary vessel CA and outer surface of the heart MYO.




For the stent designs described above, additional anchoring methods may be desired to maintain the stent's proper position and/or create a leak-free seal in the coronary artery. Suitable attachment mechanisms include a set of barbs located on the stent body or flares and a collar on the coronary side to help seal and prevent blood from exiting the gap between the vessel and outer heart wall. The stent can also be anchored in place by applying sutures. The stent can include holes at either end to facilitate the placement of these anchoring sutures. A suture gun can be used to apply multiple sutures at the same time. In addition, the stents can be lined, if desired, with materials such as polymers, for example polytetrafluoroethylene (PTFE), silicone or GORTEX, to provide for the ease of blood flow therethrough.




A third embodiment of the stent design, illustrated in

FIGS. 9-11

, incorporates attachment flanges or “legs”


30


that expand after introduction into the myocardium to hold the stent


34


in place. The puncture instrument


32


and stent


34


are mated together and are advanced into the myocardial wall as a single unit. The puncture instrument's distal end


36


is shaped in a “nose-cone” configuration, which is responsible for containing the legs


30


of the stent


34


while it is being introduced into the wall of the myocardium. When the stent


34


is in the proper position in the myocardial wall, the nose cone


36


is pushed forward, releasing the attachment legs


30


of the stent


34


. The internal diameter (ID) of the stent


34


is large enough to allow the nose cone


36


to pass back through. The stent


34


is then released from the catheter


38


and the catheter


38


is removed.





FIG. 9

illustrates the stent


34


mounted on the introducer catheter


38


. The expanding legs


30


of the stent


34


are held in place by the nose cone


36


on the distal end of the catheter


38


that acts as a dilator. The catheter assembly


38


is advanced over a puncture wire if desired, into proper position in the myocardium, and the nose cone


36


is pushed forward allowing the legs


30


to expand as shown in FIG.


10


. The nosecone/puncture assembly


32


,


36


is then withdrawn through the lumen of the stent


34


. When the nose-cone/puncture assembly


32


,


36


is removed, the stent


34


can be pushed off the introducer catheter


38


and remains in the myocardium in the position shown in FIG.


11


.

FIG. 11

also illustrates a sealing collar


44


that may be used in the interface between the coronary artery and the outer wall of the heart to prevent hemorrhaging around the stent


34


and to hold the stent


34


in place. Sutures can be used to ensure that the stent is maintained in its proper position and prevent migration.





FIG. 12

illustrates a further embodiment of the present invention, a “bulkhead” stent


50


. This stent


50


consists of a plurality of rings, which are placed in the myocardium MYO. The rings


50


form a passage through which blood flows from a chamber in the heart, such as the left ventricle LV, directly into the coronary artery CA. The stent


50


is preferably formed of biocompatible material such as a metal or polymer. A gun or other suitable device can be used to implant the stent


50


in the myocardium MYO.




If desired, the separate units or rings of the stent


50


can be connected via a wire, suture thread, or similar means. The wire is threaded through the holes


51


located in each ring. Connecting the rings of the stent


50


in this manner serves to make the stent


50


more stable and to prevent the migration of the individual units. If desired, a valve (not shown) can be incorporated into the stent


50


to help prevent the backflow of blood into the left ventricle LV. Additional details regarding valve designs are disclosed in the above referenced copending applications entitled LEFT VENTRICULAR CONDUIT WITH BLOOD VESSEL GRAFT, VALVE DESIGNS FOR LEFT VENTRICULAR CONDUIT Ser. No. 09/368,868 and LEFT VENTRICULAR CONDUITS TO CORONARY ARTERIES AND METHODS FOR CORONARY BYPASS Ser. No. 09/534,038, filed on the same day as the present application, all of which are incorporated by reference in their entirety.




If desired, the stent or conduit of the present invention can be formed of biodegradable or bioabsorbable materials and/or used to deliver drugs directly into the myocardium and the coronary circulation. Such a stent


52


is illustrated in FIG.


13


. The biodegradable stent


52


can extend only partially through the myocardium MYO as illustrated in

FIG. 13

, but can also extend entirely through from the left ventricle LV to the coronary artery CA. Once positioned in the myocardium MYO, the stent


52


degrades, dissolves or is absorbed over time to release drugs, genes, angiogenesis or growth factors, or other pharmaceutical compounds directly into the heart muscle MYO and the coronary artery CA, as shown by the arrows in FIG.


13


. Bioabsorbable materials include, but are not limited to, polymers of the linear aliphatic polyester and glycolide families, such as polylactide and polyglycolide. Further details are described in the above-referenced application entitled LEFT VENTRICULAR CONDUITS TO CORONARY ARTERIES AND METHODS FOR CORONARY BYPASS Ser. No. 09/534,038, filed on the same date as the present application.




Turning now to

FIGS. 14-26

, there is illustrated in greater detail one preferred method and apparatus for providing a bulkhead stent


50


, as shown in

FIG. 12

, into the myocardium MYO. As shown in

FIG. 14

, a stent delivery catheter


60


is advanced over a puncture wire


62


and into the wall of the myocardium MYO as described above. The stent delivery catheter


60


follows the path created by the puncture wire


62


used to form the passage between the coronary artery CA and the left ventricle LV.

FIG. 15

illustrates a bulkhead stent


50


still located in position inside the stent delivery catheter


60


with the catheter


60


in position in the heart wall MYO.

FIGS. 16-19

show one embodiment for deploying the bulkhead stent


50


into the myocardium MYO. As the delivery catheter


60


is retracted proximally from the myocardium MYO, the rings comprising the bulkhead stent


50


are deployed into the myocardium MYO.

FIGS. 20 and 21

are enlarged views of

FIGS. 18 and 19

, showing the rings of the bulkhead stent


50


positioned within the myocardium MYO to form the passageway therethrough.





FIGS. 22-25

illustrate more particularly the structure and deployment of the rings comprising the bulkhead stent


50


. As shown in

FIG. 24

, the bulkhead stent comprises a plurality of rings


64


that are initially loaded into the delivery catheter


60


. While inside the lumen of the catheter


60


, each ring


64


has a loaded configuration


64


A, shown in

FIGS. 22 and 25

. After ejectment from the catheter


60


, the ring


64


assumes an inserted configuration


64


B, shown in

FIGS. 23 and 25

. Preferably, the inserted configuration of ring


64


B includes a plurality of flanges


66


around the circumference of each ring


64


, thereby providing a securement mechanism to anchor each ring


64


to the myocardium MYO. Each ring


64


transforms from its loaded configuration


64


A to its inserted configuration


64


B by virtue of being released from the catheter


60


. Specifically, the catheter


60


acts as a restraint on each ring


64


to keep it in its loaded configuration


64


A. Then, once the ring


64


is released from the catheter


60


, the flanges


66


provided along the circumference of each ring


64


are allowed to extend outward to provide the securement mechanism.





FIG. 26

illustrates an inserter device or handle


68


that may be used in deploying the bulkhead stent


50


into the myocardium. The inserter handle


68


preferably comprises a gun


70


with a trigger


72


, and a wire


74


extending from a nozzle


76


. The rings


64


(not shown) of the bulkhead stent


50


are preferably loaded onto the wire


74


, and may be deployed into the myocardium preferably one at a time by pressing the trigger


72


.





FIGS. 27-30

illustrate another embodiment of the present invention. Here, a self-expanding spring or screw stent


140


is delivered into the myocardium MYO. As illustrated in

FIG. 27A

, a channel


142


through the wall of the myocardium MYO is first created, as described above, using a device


144


delivered through the aorta AO and coronary artery CA. The channel


142


travels from the coronary artery CA through the myocardium MYO and into the left ventricle LV as shown in FIG.


27


B. The distal end of the stent delivery catheter


146


bearing the stent


140


is then positioned within the channel


142


, as shown in FIG.


28


. Preferably, the position of the distal end of the delivery catheter


146


is checked radiographically, to ensure proper positioning. Next, as illustrated in

FIG. 29

, the self-expanding spring stent


140


is delivered into the channel


142


wall of the myocardium MYO. The stent


140


is cut such that it does not extend past the myocardium MYO and into either the left ventricle LV or the coronary artery CA. Again, the proper positioning and length of the stent


140


is preferably checked radiographically and any necessary adjustments made before the delivery catheter


146


is removed, as shown in FIG.


30


.





FIG. 31

illustrates another embodiment of the stent


200


having retention members


202


. The hollow stent body


204


is held in place in the heart wall by one or more retention members


202


which are deployed after the stent


200


is properly positioned, as described above.

FIG. 31

shows the retention members


202


in their deployed position. A flange


206


acts to seal the opening in the coronary artery, while the retention members


202


reside in the myocardium, helping to anchor the stent


200


in place.




It should be appreciated that the stents described above, and particularly the bulkhead stent, are useful in other applications in addition to stenting the myocardium. For example, these stents may also serve as other types of coronary stents, arterial or venous stents, as well as billiary and esophageal stents.




The present vascular shunt provides significant improvements in the present treatment of blockages in the coronary artery. Although the invention has been described in its preferred embodiments in connection with the particular figures, it is not intended that this description should be limited in any way.



Claims
  • 1. A bypass conduit for use in a wall of a heart, comprising:a hollow conduit having an interior and an exterior and adapted to be positioned in the heart wall between the coronary artery and a chamber in the heart, wherein the conduit has an attachment mechanism on at least one end adapted to anchor the conduit in place.
  • 2. The device of claim 1, wherein the conduit is self-expandable.
  • 3. The device of claim 1, wherein the conduit is expanded using an inflatable balloon.
  • 4. The device of claim 1, wherein the chamber is the left ventricle.
  • 5. The device of claim 1, wherein the attachment mechanism is selected from the group consisting of hooks, barbs, flanges, collars, suture holes, and expandable legs.
  • 6. A bypass conduit for use in a wall of a heart, comprising:a hollow conduit having a plurality of circular rings, an interior, and an exterior and adapted to be positioned in the heart wall between the coronary artery and a chamber in the heart, wherein the conduit has an attachment mechanism on at least one end adapted to anchor the conduit in place.
  • 7. The device of claim 6, wherein the rings are reversibly connected to one another.
  • 8. The device of claim 1, wherein the conduit is biodegradable.
  • 9. The device of claim 1, wherein the conduit is bioabsorbable.
  • 10. The device of claim 9, wherein the conduit is used to deliver pharmaceutical compounds directly into the heart wall.
  • 11. The device of claim 1, wherein the attachment mechanism is adapted to anchor the conduit in the heart wall.
  • 12. The device of claim 1, wherein the attachment mechanism is adapted to anchor the conduit in the coronary artery.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Applications Ser. Nos. 60/099,767, filed Sep. 10, 1998, and Ser. No. 60/104,397, filed Oct. 15, 1998.

US Referenced Citations (99)
Number Name Date Kind
4503568 Madras Mar 1985
4733665 Palmaz Mar 1988
4769029 Patel Sep 1988
4995857 Arnold Feb 1991
5035702 Taheri Jul 1991
5135467 Citron Aug 1992
5258008 Wilk Nov 1993
5287861 Wilk Feb 1994
5330486 Wilk Jul 1994
5344426 Lau et al. Sep 1994
5384541 Kirsch et al. Jan 1995
5409019 Wilk Apr 1995
5423744 Samuels Jun 1995
5429144 Wilk Jul 1995
5443497 Venbrux Aug 1995
5456712 Maginot Oct 1995
5456714 Owen Oct 1995
5470320 Tifenbrun et al. Nov 1995
5527337 Stack et al. Jun 1996
5554119 Harrison et al. Sep 1996
5578075 Dayton Nov 1996
5593434 Williams Jan 1997
5609626 Quijano et al. Mar 1997
5618299 Khorsavi et al. Apr 1997
5655548 Nelson et al. Aug 1997
5662124 Wilk Sep 1997
5755682 Knudson May 1998
5758663 Wilk et al. Jun 1998
5797933 Snow et al. Aug 1998
5810836 Hussein et al. Sep 1998
5824038 Wall Oct 1998
5824071 Nelson et al. Oct 1998
5830222 Makower Nov 1998
5843163 Wall Dec 1998
5851232 Lois Dec 1998
5855597 Javaraman Jan 1999
5865723 Love Feb 1999
5876419 Carpenter et al. Mar 1999
5878751 Hussein et al. Mar 1999
5908028 Wilk Jun 1999
5908029 Knudson et al. Jun 1999
5935119 Guy et al. Aug 1999
5935161 Robinson et al. Aug 1999
5935162 Dang Aug 1999
5944019 Knudson et al. Aug 1999
5961548 Shmulewitz Oct 1999
5968093 Kranz Oct 1999
5971993 Hussein et al. Oct 1999
5976159 Bolduc et al. Nov 1999
5976169 Imran Nov 1999
5976181 Whelan et al. Nov 1999
5976182 Cox Nov 1999
5976192 McIntyre et al. Nov 1999
5976650 Campbell et al. Nov 1999
5979455 Maginot Nov 1999
5980548 Evans et al. Nov 1999
5980551 Summers et al. Nov 1999
5980552 Pinchasik et al. Nov 1999
5980553 Gray et al. Nov 1999
5980566 Alt et al. Nov 1999
5984955 Wisselink Nov 1999
5984956 Tweden et al. Nov 1999
5984963 Ryan et al. Nov 1999
5984965 Knapp et al. Nov 1999
5989207 Hughes Nov 1999
5989287 Yang et al. Nov 1999
5993481 Marcade et al. Nov 1999
5993482 Chuter Nov 1999
5997563 Kretzers Dec 1999
5997573 Quijano et al. Dec 1999
6001123 Lau Dec 1999
6004261 Sinofsky et al. Dec 1999
6004347 McNamara et al. Dec 1999
6004348 Banas et al. Dec 1999
6007575 Samuels Dec 1999
6007576 McClellan Dec 1999
6010530 Goicoechea Jan 2000
6017365 Von Oepen Jan 2000
6026814 LaFontaine et al. Feb 2000
6029672 Vanney et al. Feb 2000
6035856 LaFontaine et al. Mar 2000
6045565 Ellis et al. Apr 2000
6053911 Ryan et al. Apr 2000
6053924 Hussein et al. Apr 2000
6053942 Eno et al. Apr 2000
6067988 Mueller May 2000
6068638 Makower May 2000
6071292 Makower et al. Jun 2000
6076529 Vanney et al. Jun 2000
6080163 Hussein et al. Jun 2000
6093166 Knudson et al. Jul 2000
6102941 Tweden et al. Aug 2000
6113630 Vanney et al. Sep 2000
6123682 Knudson et al. Sep 2000
6126649 Van Tassel et al. Oct 2000
6139541 Vanney et al. Oct 2000
6152141 Stevens et al. Nov 2000
6159225 Makower Dec 2000
6162245 Jayaraman Dec 2000
Foreign Referenced Citations (74)
Number Date Country
0 732 088 Sep 1996 EP
0 824 903 Feb 1998 EP
0 876 803 Nov 1998 EP
0 903 123 Mar 1999 EP
0 904 745 Mar 1999 EP
0 955 019 Nov 1999 EP
0 955 017 Nov 1999 EP
0 962 194 Dec 1999 EP
2 316 322 Feb 1998 GB
9416629 Aug 1994 WO
9713463 Apr 1997 WO
9727897 Aug 1997 WO
9727898 Aug 1997 WO
9727896 Aug 1997 WO
9727893 Aug 1997 WO
9732551 Sep 1997 WO
9743961 Nov 1997 WO
9741916 Nov 1997 WO
9802099 Jan 1998 WO
9806356 Feb 1998 WO
9808456 Mar 1998 WO
9810714 Mar 1998 WO
9816161 Apr 1998 WO
9819607 May 1998 WO
9844869 Oct 1998 WO
9846115 Oct 1998 WO
9846119 Oct 1998 WO
9849964 Nov 1998 WO
9857591 Dec 1998 WO
9855027 Dec 1998 WO
9853759 Dec 1998 WO
9908624 Feb 1999 WO
9917683 Apr 1999 WO
9921490 May 1999 WO
9925273 May 1999 WO
9922655 May 1999 WO
9921510 May 1999 WO
9936001 Jul 1999 WO
9936000 Jul 1999 WO
9937218 Jul 1999 WO
9932051 Jul 1999 WO
9938459 Aug 1999 WO
9940868 Aug 1999 WO
9947071 Sep 1999 WO
9948545 Sep 1999 WO
9948427 Sep 1999 WO
9949910 Oct 1999 WO
9951162 Oct 1999 WO
9949793 Oct 1999 WO
9953863 Oct 1999 WO
9962430 Dec 1999 WO
9960941 Dec 1999 WO
0009195 Feb 2000 WO
0012029 Mar 2000 WO
0010623 Mar 2000 WO
0015275 Mar 2000 WO
0015149 Mar 2000 WO
0015148 Mar 2000 WO
0015147 Mar 2000 WO
0015146 Mar 2000 WO
0018326 Apr 2000 WO
0018331 Apr 2000 WO
0021463 Apr 2000 WO
0021436 Apr 2000 WO
0021461 Apr 2000 WO
0018325 Apr 2000 WO
0024449 May 2000 WO
0033725 Jun 2000 WO
0041633 Jul 2000 WO
0041632 Jul 2000 WO
0045711 Aug 2000 WO
0056387 Sep 2000 WO
0066035 Nov 2000 WO
9713471 Nov 2000 WO
Non-Patent Literature Citations (11)
Entry
Gardner, M.D. et al., “An Experimental Anatomic Study of Indirect Myocardial Revascularization”, Journal of Surgical Research, May 1971, vol. 11, No. 5, pp. 243-247.
Palmaz et al., “Expandable Intrahepatic Portacaval Shunt Stents: Early Experience in the Dog”, AJR, vol. 145, pp. 821-825.
Palmaz et al., “Expandable Intrahepatic Portacaval Shunt Stents in Dogs with Chronic Portal Hypertension, ” AJR, vol. 147, pp. 1251-1254.
Richter, M.D. et al., “Transjugular Intrahepatic Portacaval Stent Shunt: Preliminary Clinical Results,” Radiology, 1990, vol. 174, No. 3, pp. 1027-1030.
Zemel, M.D. et al., “Percutaneous Transjugular Portosystemic Shunt,” JAMA, 1991, vol. 266, No. 3, pp. 390-393.
Massimo, M.D. et al., “Myocardial Revascularization by a New Method of Carrying Blood Directly from the Left Ventricular Cavity into the Coronary Circulation,” Journal of Thoracic Surgeons, Aug. 1997, vol. 34, No. 2, pp. 257-264.
Lary, M.D. et al., “Myocardial Revascularization Experiments Using the Epicardium,” Archives of Surgery, Jan. 1969, vol. 98, No. 1, pp. 69-72.
Munro, M.D. et al., “The possibility of myocardial revascularization by creation of a left ventriculocoronary artery fistula,” Journal of Thoracic and Cardiovascular Surgery, Jul. 1969, vol. 58, No. 1, pp. 25-32.
Kuzela, M.D. et al., “Experimental evaluation fo direct transventricular revascularization,” The Journal of Thoracic and Cardiovascular Surgery, Jun. 1969, vol. 57, No. 6, pp. 770-773.
Anabtawi, M.D. et al., “Experimental evaluation of myocardial tunnelization as a method of myocardial revascularization,” The Journal of Thoracic and Cardiovascular Surgery, Nov. 1969, vol. 58, No. 5, pp. 638-646.
Tweden et al., “Ventriculocoronary Artery Bypass (VCAB), a Novel Approach to Myocardial Revascularization,” #2000-4653, Feb. 2000.
Provisional Applications (2)
Number Date Country
60/099767 Sep 1998 US
60/104397 Oct 1998 US