Surgery – Instruments – Internal pressure applicator
Reexamination Certificate
2001-07-31
2004-03-09
Milano, Michael J. (Department: 3731)
Surgery
Instruments
Internal pressure applicator
C623S001110
Reexamination Certificate
active
06702833
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to a prosthesis tube connection between two arteries, or arterial regions, inside the human body having a flexible, blood-impermeable prosthesis tube of a suitable length whose ends can be introduced into the arteries to be connected and can be connected thereto in a blood-tight manner.
Known prosthesis tube connections substantially consist only of a prosthesis tube made of a primarily impermeable standard prosthesis material. To connect the prosthesis tube to the artery to be connected, e.g. the Aorta abdominales, or the pelvic artery, the artery must be cut open at the connection point and connected to the prosthesis tube consisting of plastic by a manual suture. However, the production of this suture is only possible taking a considerable time and with a considerable risk of error, in particular when using minimally invasive operation techniques. While it has already been attempted to produce the sutures using suitable apparatuses, this is problematic with respect to both the amount of space required and to the operational safety.
A prosthesis tube connection is already known from WO 97/43961 in which a shoulder piece provided with a tube support is fastened to an expandable metal grid provided with an elongate slot, with the prosthesis tube being connectable to the tube support via an adapter consisting of moving parts.
A T-shaped flange connector is k now n from WO 98/19629 which consists of a foldable metal grid and a jacket. The transverse beam of the T-shaped connector is introduced into the artery through an orifice in the folded state and then expanded by a tool. The web of the T-shaped connector then extends from the orifice in the artery so that the base of the T can be connected to the aorta.
FR-27 58 254 discloses a prosthesis tube which is provided with a tubular section at the end and in whose end regions expandable means can be introduced or be arranged from the start.
WO 98/19607 describes the connection of a blood line having an expandable connection segment of plastic by a suture. The connection segment has a non-folded central region at which the suture is provided. Only the end regions, which are excluded from the connection to the blood tube, can be inflated.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a simply designed and simply positionable artificial prosthesis tube connection of the kind initially mentioned with which the implantation of the vessel prosthesis is possible without the time delay caused by the application of the suture, whereby the operation times can be considerably shortened and the risk of a suture breaking and of a bursting open of the connection between the blood vessel and the vessel prosthesis should be banished.
The idea of the invention is therefore to be seen in that, for example, a tubular metal grid known for the widening of arteries, which optionally has an inner lining and/or jacket and which is also known as a stent, is directly connected in a blood-tight manner to a standard prosthesis tube which branches off in T-shaped manner. The folded metal grid having an inner lining and/or jacket and having only a limited length can be introduced into an artery provided with the orifice without problem with the prosthesis tube bent onto the folded metal grid and can then be fixed in place by clamping, in particular by means of self-expansion or balloon expansion, without a suture having to be produced for this purpose. The metal grid having an inner lining and/or jacket must be so long that the two end regions can clearly protrude over the end of the artery incision and ensure the clamping inside the artery. After the operation has been carried out, the incision then grows together again as far as possible, whereby the mounting of the metal grid inside the artery is further improved. Advantageously, special components such as adapters or branches are omitted, whereby a particularly simple design is achieved by only the one end of the prosthesis tube being attached, in particular sutured, directly to an expandable stent. A particular advantage of the direct connection of metal grid and prosthesis tube lies in the fact that the prosthesis tube can be bent onto the folded metal grid, whereby the introduction of the metal grid into the artery through the incision can be carried out without problem.
In addition to the fast and safe application of the prosthesis in an artery, the risk of infection is also reduced by the embodiment in accordance with the invention.
According to another aspect of the invention, an initially folded-up or compressed metal grid can be expanded so far after the introduction into the artery that it is seated securely and fixedly inside the artery.
Other features of the invention improve the flexibility of the tube, or of the jacket, provide an oval orifice which favors the flow of blood from the inside of the metal grid into the tube, and enhance the connection of the tube to the metal grid, or to the inner lining and/or to the jacket.
A particularly stable arrangement is achieved by an embodiment of the invention in which the orifices normally present in the metal grid are also used to lead the blood into the tube without it being necessary to produce an additional orifice in the metal grid.
Another variant of the invention lies in identical lengths of the upstream part, of the downstream part and of the connection point. The length of each of these three elements should be approximately 1.7 cm. The optimum measurements depend on the diameter of the metal grid, the diameter of the metal grid orifice and the diameter of the prosthesis tube.
It is a feature of the invention that the inner lining and/or jacket, including the balloon, of the metal grid can be introduced into the inside of the artery through the orifice therein without problem and can then be expanded to the diameter required for the secure fit inside the artery by inflating the balloon.
According to another aspect of the invention, the metal grid having an inner lining and/or jacket can be brought into the final working position automatically or can be supported by an introduced balloon by pulling the tear line which is guided outwardly through the orifice.
The angle at which the end region of the tube facing the metal grid is arranged relative to the meal grid is preferably in the range between 30° to 60° so that as a result of the oblique connection of the end region of the tube, the folding of the same to the metal grid is favored and so its introduction into the artery simplified.
REFERENCES:
patent: 3648704 (1972-03-01), Jackson
patent: 5304220 (1994-04-01), Maginot
patent: 5755682 (1998-05-01), Knudson
patent: 5755778 (1998-05-01), Kleshinski
patent: 5919225 (1999-07-01), Lau et al.
patent: 5972017 (1999-10-01), Berg et al.
patent: 5976178 (1999-11-01), Goldsteen et al.
patent: 6019788 (2000-02-01), Butters et al.
patent: WO 97/12643 (1997-04-01), None
patent: WO 97/43961 (1997-11-01), None
patent: WO 98/19607 (1998-05-01), None
patent: WO 98/19629 (1998-05-01), None
Gussmann Andreas
Metz Dietrich
Metz Helga Emma
Metz Katharina
Metz Ludwig
Baxter Jessica R
Metz Dietrich
Metz Helga Emma
Metz Katharina
Milano Michael J.
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