Surgery – Instruments – Electrical application
Reexamination Certificate
1998-05-29
2001-05-15
Peffley, Michael (Department: 3739)
Surgery
Instruments
Electrical application
C606S040000, C606S213000, C606S108000
Reexamination Certificate
active
06231573
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a device intended to treat lesions of the wall of blood vessels, in particular false aneurysms, by means of coagulation.
A classic cause of formation of false aneurysms is the puncture of a blood vessel. Following such a puncture, the wall of a vessel may be damaged and a pocket containing blood may form outside the vessel. Such a pocket is referred to in surgery as a “false aneurysm”, by analogy with an aneurysm which results from deterioration of the walls of a vessel. In addition, the use of anticoagulants (common in the case of surgical interventions) favours the formation of false aneurysms.
BACKGROUND OF THE INVENTION
A known method for eliminating the pocket of a false aneurysm consists in pushing the pocket back by applying pressure from outside or by closing the channel supplying the pocket by controlled compression. Such a method can only be applied if the pocket is easily accessible, for example when the false aneurysm forms on a side of the vessel facing the patient's skin, or when the pressure is painful or ineffective.
Another known treatment method is to bring about the coagulation of the blood contained in the pocket, the consequence of which is necrosis of the said pocket.
The necrosed tissues are then eliminated naturally by the immune system, leaving only a very slight scar on the wall of the vessel.
Direct injection of coagulants is unfortunately ineffective and often contraindicated; this is because these products risk being entrained in large part by the blood stream, which is particularly harmful in the case of persons undergoing treatment.
A method with a more localized effect consists in inserting a filament made of totally inert biocompatible material which can be left in place without causing a detrimental reaction in the pocket, so as to form a ball therein.
However, this is a delicate operation; for the intervention to be effective, it may be necessary to introduce several meters of filament. The time needed to obtain sufficient coagulation is typically from one to two hours.
If the filament is to be recovered, the operation must then be repeated or must purely and simply be interrupted for a not inconsiderable period of time, which involves a substantial medical infrastructure.
If the filament is left in place, it may interfere with the proper conduct of subsequent operations performed on the same site or near this site, a fact which can be particularly inconvenient in the case of chronic diseases.
BRIEF SUMMARY OF THE INVENTION
The aim of the invention is to develop a device with which it is possible to treat false aneurysms by coagulation in a very short time compatible with the operating periods, and which is easy to maneuver and is reliable.
To this end, the subject of the invention is a device for provoking coagulation of a false aneurysm, which device comprises an introducer with valve and with removable needle, a filament which is able to be introduced as a ball into a pocket of a vascular lesion (where it will temporarily dwell) by folding up on itself therein, and a means of introduction which is able to introduce the said filament into the pocket through this introducer.
According to a first preferred embodiment, the filament is held via its proximal end in such a way that it can be withdrawn from the pocket after a defined time.
The filament is advantageously made up of a plurality of portions joined to one another via pliable zones.
The filament is preferably hollow and is bored longitudinally with a plurality of orifices through which it is possible locally to instill a coagulant into the pocket. p The filament can comprise a wire made of shape-memory metal treated in such a way that it has a substantially rectilinear shape at ambient temperature and a substantially rolled-up shape at the temperature of the body.
The filament advantageously comprises a core which is covered with an interlacing made of a thrombogenic material (for example, a braid).
In another embodiment, the filament is able to send an electric current sufficient to provoke electrocoagulation.
According to another advantageous embodiment, the filament comprises a core co-braided with a bundle of wires made of a thrombogenic material.
The material of the interlacing is chosen advantageously from between natural silk and Dacron®.
In another embodiment, the filament is made of bioabsorbable material with at thrombogenic effect.
The material of the filament has, for example, a minimum absorption period of 20 minutes.
In a preferred manner, the means for introducing the filament comprises an envelope which can be torn longitudinally and in which the filament is accommodated.
The means for introducing the wire can also comprise a guide along which the filament is applied in a detachable manner or a rod with an end in the form of an elastically deformable loop which is able to introduce the filament into the pocket by way of a reciprocating movement.
The filament is preferably radiopaque.
Using the device according to the invention, it is possible to reduce the time needed for coagulation to a few minutes, which means that it is possible to perform an operation practically without interruption, which benefits both the practitioner and the patient.
The length of the filament is considerably shorter in relation to the empirical method described above, a fact which reduces the time needed for the introduction and diminishes the risks associated with the operation.
Since the filament has an entirely localized effect in the pocket of the aneurysm, it is no longer necessary to inject coagulants in liquid form, and so there is no longer a risk of these products disseminating through the body.
Trials have shown that treatment using the device according to the invention is reliable since the false aneurysm thus coagulated presents a very low risk of relysis after withdrawal or elimination of the wire at the end of a predetermined time.
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Amor Max
Henry Michel
Medicorp S.A.
Peffley Michael
Roylance Abrams Berdo & Goodman L.L.P.
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