Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent combined with surgical delivery system
Reexamination Certificate
1998-11-17
2001-04-03
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent combined with surgical delivery system
Reexamination Certificate
active
06210430
ABSTRACT:
FIELD OF INVENTION
The present invention relates generally to the field of vascular surgery and, more specifically, to a branching device for blood vessels, especially for bypass operations on the coronary vessels.
BACKGROUND
An increased flow resistance in the various coronary vessels can jeopardise the oxygen supply to the cardiac muscle. In some cases an expansion of vascular stenosis is possible. If the flow of blood in a vessel is completely or practically completely blocked, the only thing to be done is to bypass the blocked portion to prevent an irreparable injury from arising. Such a bypass operation is usually effected by connecting a new vessel after the blocked point and connecting it to another blood vessel, for instance the aorta, which may give a sufficient flow of blood to the blood vessel after the blocked point.
In practice, such a bypass operation requires the use of a heart-lung machine, i.e. that the heart be temporarily stopped since the bypass operation when connecting, for instance, the two vessels involved requires the heart to be immovable. In consequence of the connecting technique employed and the use of the heart-lung machine, the operation will be relatively time-consuming and not completely without risk.
When larger vessels are involved, it is known from e.g. U.S. Pat. No. 5,456,712 to provide a branch by blocking the vessel by means of balloons on each side of the intended branch point, whereupon an incision is made in the blocked portion of the blood vessel. Then an expanded end of a vascular prosthesis is inserted through the incision and a stent is inserted through the one blocking balloon to a position inside the incision, where finally the stent is expanded by means of a further balloon positioned inside the stent. For completely safe fixing of the expanded end to the area around the incision in the vessel, some sort of suture is used, primarily for connecting the expanded end of the vascular prosthesis with the blood vessel around the incision therein.
The prior-art technique implies that a blocking can be made on each side of the intended branch point, and that the stent can be inserted via the diseased vessel involved and through one of the blocking balloons. In practice, also a fixing of the expanded end of the vascular prosthesis relative to the vessel involved by means of some sort of suture is required.
The technique according to U.S. Pat. No. 5,456,712 is thus not suited for use in thin vessels, such as the coronary vessels, or in other positions where the described blocking by means of a balloon from the inside of the vessel is not possible.
SUMMARY OF INVENTION
The object of the present invention is to provide a simple and reliable bypass of the coronary vessels without necessitating temporary internal blockings, preferably in a manner which can make it possible that the heart-lung machine need not be used, i.e. it should be possible to perform the bypass operation with the heart beating. Most preferably, it should be possible to carry out the operation by applying endoscopy.
According to the invention, this object is achieved by a branching device having a sleeve, which is radially extensible and has an opening in its circumferential surface, and a collar which consists of a fluid-tight material and is fixed to the sleeve before the branching device is used and which has on the one hand a shoulder portion extending at least around the opening in the circumferential surface of the sleeve and, on the other hand, a neck portion integral with the shoulder portion and projecting radially from the opening in the circumferential surface of the sleeve.
The opening in the circumferential surface of the sleeve is preferably arranged unsymmetrically relative to the ends of the sleeve. This confers an advantage since the necessary longitudinal incision in the blocked vessel need not be made longer than the distance from the neck portion to the nearest end of the sleeve, while the sleeve of the branching device can be retained safely in the vessel thanks to the sleeve obtaining a long part (seen from the neck portion), which must thus first be inserted into the opening in the vessel.
After the insertion of the sleeve into the vessel in a reciprocating movement, the short part of the sleeve is positioned completely beyond the opening in the vessel, while the long part of the sleeve covers the main part of the opening in the vessel and besides can extend beyond this a distance of essentially the same length as the short part of the sleeve. Once the sleeve is correctly positioned in the vessel, its position is to be fixed. This is possible according to the invention thanks to the sleeve being radially extensible and retaining its extended shape, i.e. the shape of the sleeve is permanently deformable. This results in an expansion of the vessel, which then clamps the sleeve in place and also clamps the shoulder portion of the collar against the sleeve.
REFERENCES:
patent: 5304220 (1994-04-01), Maginot
patent: 5443497 (1995-08-01), Venbrux
patent: 5456712 (1995-10-01), Maginot
patent: 5571167 (1996-11-01), Maginot
patent: 5643340 (1997-07-01), Nunokawa
patent: 5755778 (1998-05-01), Kleshinski
patent: 5893886 (1999-04-01), Zegdi et al.
patent: 5925254 (1999-07-01), Taylor et al.
patent: 6068654 (2000-05-01), Berg et al.
patent: 8806865 (1988-09-01), None
Browdy and Neimark
Isabella David J.
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