Surgery – Miscellaneous – Methods
Reexamination Certificate
1998-01-20
2001-06-26
Isabella, David J. (Department: 3738)
Surgery
Miscellaneous
Methods
Reexamination Certificate
active
06250305
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention pertains to an implant for passing blood flow directly between a chamber of the heart and a coronary vessel. More particularly, this invention pertains to a flexible transmyocardial implant.
2. Description of the Prior Art
Commonly assigned and co-pending U.S. patent application Ser. No. 08/882,397 filed Jun. 25, 1997, entitled “Method and Apparatus for Performing Coronary Bypass Surgery”, and filed in the name of inventors Mark B. Knudson and William L. Giese, now U.S. Pat. No. 5,944,019 teaches an implant for defining a blood flow conduit directly from a chamber of the heart to a lumen of a coronary vessel. An embodiment disclosed in the aforementioned application teaches an L-shaped implant in the form of a rigid conduit having one leg sized to be received within a lumen of a coronary artery and a second leg sized to pass through the myocardium and extend into the left ventricle of the heart. As disclosed in the above-referenced application, the conduit is rigid and remains open for blood flow to pass through the conduit during both systole and diastole. The conduit penetrates into the left ventricle in order to prevent tissue growth and occlusions over an opening of the conduit.
Commonly assigned and co-pending U.S. patent application Ser. No. 08/944,313 filed Oct. 6, 1997, entitled “Transmyocardial Implant”, and filed in the name of inventors Katherine S. Tweden, Guy P. Vanney and Thomas L. Odland, now U.S. Pat. No. 5,984,950 teaches an implant such as that shown in the aforementioned '397 application with an enhanced fixation structure. The enhanced fixation structure includes a fabric surrounding at least a portion of the conduit to facilitate tissue growth on the exterior of the implant.
Implants such as those shown in the aforementioned applications include a portion to be placed within a coronary vessel and a portion to be placed within the myocardium. The implants disclosed in the above-mentioned applications are rigid structures. Being rigid, the implants are restricted in use. For example, an occluded site may not be positioned on the heart in close proximity to a heart chamber containing oxygenated blood. To access such a site with a rigid, titanium implant, a very long implant must be used. A long implant results in a long pathway in which blood will be in contact with the material of the implant. With non-biological materials, such as titanium, a long residence time of blood against such materials increases the probability of thrombus. The risk can be reduced with anti-thrombotic coatings. Moreover, a rigid implant can be difficult to place while achieving desired alignment of the implant with the vessel. A flexible implant will enhance placement of the implant. Unfortunately, flexible materials tend to be non-biostable and trombogenic and may collapse due to contraction of the heart during systole.
SUMMARY OF THE INVENTION
According to a preferred embodiment of the present invention, a transmyocardial implant is disclosed for establishing a blood flow path through a myocardium between a heart chamber and a lumen of a coronary vessel residing on an exterior of the heart. The implant includes a hollow conduit adapted to be inserted into and retained within the heart wall of a heart chamber containing oxygenated blood. The conduit is in blood-flow communication with blood contained within the chamber. A natural blood vessel graft is secured to the conduit for blood from the chamber to flow into the graft. The graft is secured to the coronary vessel in blood flow communication with a lumen of the coronary vessel. The conduit and graft define a blood flow path between the heart chamber and the vessel.
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Heartstent Corporation
Isabella David J.
Merchant & Gould P.C.
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