Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
1999-07-06
2001-02-13
Buiz, Michael (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
C606S152000
Reexamination Certificate
active
06187020
ABSTRACT:
The present invention concerns a connecting device for anastomosis of a tubular prosthesis to a tubular conduit in which a lateral or terminal opening has been formed, the prosthesis including, at a connecting end, a turned-back portion forming an annular layer whose free edge is adapted to be pressed onto the immediate vicinity of the rim of the opening in the tubular conduit.
It also concerns a device for fitting fasteners for anastomosis of a tubular prosthesis to a tubular conduit in which a lateral or terminal opening has been formed, the device including, at a connecting end, a turned-back portion forming an annular layer whose free edge is adapted to be pressed onto the immediate vicinity of the rim of the opening in the tubular conduit.
It finally concerns an implant comprising a tubular prosthesis, in particular a vascular prosthesis, and a device for fitting a set of fasteners.
The vascular prostheses routinely used at present are made by weaving or knitting fibers. They constitute substantially cylindrical conduits adapted to bypass or to be substituted for portions of diseased tubular conduits.
Anastomosis of a vascular prosthesis consists in causing it to communicate with a blood vessel, for example a vein or an artery. In particular, it consists in butt-jointing the prosthesis and the vessel.
An unhealthy portion of a vessel is replaced by termino-terminal anastomosis; in other words the prosthesis is axially aligned with the healthy part of the vessel, replacing a diseased portion that has been removed.
A bypass entails termino-lateral anastomosis; in other words the mouth of the prosthesis is connected laterally to the vessel, in which a lateral opening has previously been formed for this purpose.
In a first kind of anastomosis the prosthesis is sewn to the vessel using a suture. In this case, the vascular prosthesis and the blood vessel are sewn edge to edge.
In a second kind of anastomosis, the prosthesis has at the connection end an outwardly turned-back portion forming an annular layer whose free edge is adapted to be pressed onto the immediate vicinity of the rim of the opening formed in the blood vessel. In this case, the anastomosis of the vascular prosthesis to the blood vessel is effected by fitting a system of fasteners, also known as “clips”, in order to clamp the annular layer to the rim of the opening in the blood vessel to attach it thereto.
To ensure a satisfactory connection, it is necessary to fit fasteners approximately every 4 mm around the rim of the opening. Each fastener is fitted individually, making the operation a lengthy one, which can be harmful to the health of the patient because circulation through the blood vessel must be interrupted while the prosthesis is being fitted.
French patent application FR-A-2 751 867 filed in the name of the Association René Leriche describes anastomosis of a vascular prosthesis to a blood vessel using the above method.
It is very difficult to fit each of the fasteners in succession without having to increase the size of the incision by the method described in the above document. Also, this technique is very time-consuming when used in the coele-surgery field.
SUMMARY OF THE INVENTION
The aim of the invention is to provide means for fast anastomosis between a tubular prosthesis, for example a vascular prosthesis, and a tubular organic conduit, for example a blood vessel, in particular in a limited operating field.
To this end, the invention consists in a connecting device for anastomosis of a tubular prosthesis to a tubular conduit in which a lateral or terminal opening has been formed, the prosthesis having, at a connecting end, a turned-back portion forming an annular layer whose free edge is adapted to be applied to the immediate vicinity of the rim of the opening in the tubular conduit. The connecting device includes a set of fasteners each adapted to press the annular layer onto the rim of the opening, and an annular support around which the fasteners are distributed.
In particular embodiments, the connecting device includes one or more of the following features:
said annular support is in one piece with the fasteners;
said annular support is removable to enable the set of fasteners to be separated;
said fasteners, which form clamps, include two jaws and each jaw is elastically deformable between a rest position in which the fastener is closed, the two jaws being in contact, and an open position enabling it to be fitted, in which the two jaws are spread apart;
in the closed position, the fasteners lie substantially along a generatrix of the annular support; and
in the closed position, the fasteners are substantially radial relative to the annular support.
The invention also consists in a device for fitting fasteners for anastomosis of a tubular prosthesis to a tubular conduit in which a lateral or terminal opening has been formed, the prosthesis having, at a connecting end, a turned-back portion forming an annular layer whose free edge is adapted to be pressed onto the immediate vicinity of the rim of the opening in the tubular conduit. The device comprises a connecting device as defined above and means for releasably holding the set of fasteners in the open position.
In particular embodiments, the device includes one or more of the following features:
the an immobililizing mechanism releasable retaining mechechanism include, for each fastener, an immobilizing mechanism for immobilizing a first jaw relative to the annular support and a temporary immobilization mechanism for temporarily immobilizing the second jaw relative to the first jaw;
the temporary immobilizing mechanism includes a rigid outer ring for retaining the ends of the second jaws of each fastener;
the temporary immobilizing mechanism includes fragile ties providing the connection between the second jaws and the annular support;
the temporary immobilizing mechanism includes an inner sleeve for retaining the ends of the second jaws of each fastener, which sleeve slides relative to the annular support;
device includes a tubular support carrying the annular support at one end, which tubular support delimits a passage for receiving the tubular prosthesis, and the releasable retaining mechanism includes a remote releasing mechanism for remotely releasing the temporary immobilizing mechanism, which remote releasing mechanism is movable relative to the tubular support member;
the lengths of the tubular support member and the remote releasing mechanism are sufficient to enable them to be actuated manually from outside the body, the support and the remote releasing mechanism passing through an incision in the body;
the remote releasing mechanism includes a sleeve carrying the rigid outer ring at one end, which sleeve slides relative to the tubular support member to move said rigid ring away from the second jaws of each fastener;
the remote releasing mechanism includes at least one cutting member at the end of a sleeve which is movable relative to the tubular support member, the or each cutting member being adapted to cooperate with the fragile ties; and
the remote releasing mechanism includes a sleeve extending the inner sleeve, which sleeve slides relative to the tubular support member to move the inner sleeve away from the second jaws of each fastener.
The invention equally consists in an implant including a tubular prosthesis, in particular a vascular prosthesis, having at a connecting end a turned-back portion forming an annular layer whose free edge is adapted to be pressed onto the immediate vicinity of the rim of the opening in a tubular conduit to which the tubular prosthesis is to be anastomized and a fastener-fitting device as defined above.
REFERENCES:
patent: 3974835 (1976-08-01), Hardy, Jr.
patent: 5250058 (1993-10-01), Miller et al.
patent: 5366462 (1994-11-01), Kaster et al.
patent: 5486187 (1994-11-01), Schenck
patent: 5695504 (1997-12-01), Gifford, III et al.
patent: 195 42 733 (1997-07-01), None
patent: 0 820 724 (1998-01-01), None
Gerardin Jean-Paul
Perouse Eric
Zegdi Rachid
Buiz Michael
Laboratoire Perouse Implant
Ngo Lien
Wenderoth , Lind & Ponack, L.L.P.
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