Surgery – Instruments – Means for inserting or removing conduit within body
Reexamination Certificate
1998-05-05
2001-06-05
Dawson, Glenn K. (Department: 3761)
Surgery
Instruments
Means for inserting or removing conduit within body
C623S001110, C623S001230
Reexamination Certificate
active
06241738
ABSTRACT:
The present invention relates to a capturing device to be introduced into a tubular biological conduit of the human or animal body, in order to capture a tubular article situated in this conduit, comprising
a support sheath having a first axial cavity,
pusher means accommodated inside the support sheath and capable of sliding in the said first axial cavity,
first control means permitting a relative displacement between the pusher means and the support sheath, and
flexible gripping means which are borne by the pusher means and are displaced between a position outside the support sheath, in which position they are spread apart from one another, and a position inside the support sheath, in which position they are drawn together, the gripping means having a distal end curved outwards.
For some time now it has been necessary to have available a capturing device permitting extraction, by the intraluminal route, of endoprostheses situated in a tubular biological conduit of the human or animal body. Tubular biological conduit is to be understood as meaning all the vessels of the human or animal body, for example the blood vessels, the lymphatic ducts, the urinary canals, the bile ducts, the airways, such as the bronchi, the oesophagus, and similar parts. Tubular article is to be understood as meaning any article of cylindrical shape placed inside these tubular biological conduits, in particular for supporting, replacing or dilating a diseased wall. This article is generally in intimate contact with the inner wall of these tubular conduits. Such articles can be, in particular, endoprostheses, metal stents, which may or may not be coated with a synthetic covering, channel dilators, and similar elements.
Devices of the type cited at the outset are already known (see U.S. Pat. 5,098,440). The device specified in the said patent is, however, designed with gripping loops which are to be inserted between the stent to be captured and the wall of the vessel in which it is situated. In practice, however, it is extremely difficult to effect this insertion, because the tubular articles introduced into the vessels are designed in such a way as to exert a radial dilation on the vessels in which they are situated. Moreover, many endoprostheses are nowadays coated with a covering which is very favourable to the growth of cells. Thus, a few days after the endoprosthesis has been deployed, the cells of the walls of the vessel are already developing in the coating of the endoprosthesis. From this point onwards, the insertion of metal loops between the endoprosthesis and the vessel becomes difficult, if not impossible. Another capturing device which is of a similar type and functions in this same way is described in EP-A-0518839.
Mention may also be made of the capturing devices from the company COOK PACEMAKER CORPORATION, United States of America, which are made up of a support sheath and of a wire sliding inside the latter. The distal end of the wire is provided in the manner of a lasso which can be drawn tight when the object to be captured is caught. This same company markets a “Deflecting Wire” device where the wire sliding inside the support sheath forms a loop which is not closed at its fastening end, or else a device of the “Dotter Basket” type in which the capturing end is formed by 3 or 4 wires joined at their distal end. When these wires emerge from the support sheath, they form a sort of closed basket which is made up of helically disposed wires (see advertising brochure from the company COOK PACEMAKER CORPORATION of 1992; CLYDE W. et al, Cardiac Pacemaker Electrodes: Improved Methods of Extraction, Radiology 1994, 193: 739-742). For similar devices, see also U.S. Pat. No. 4,471,777, WO-93/15671, U.S. Pat. No. 0,461,159,4, and DE-A-3542667.
A capturing device called the Boren-McKinney Retriever Set is also known, which has a twin recovery wire. These flexible wires are curved inwards at their distal end and they spread apart from one another in an axial plane when they are situated outside the support sheath (CLYDE W. et al, op. cit.). Such capturing devices with several wires which are curved inwards are also known and are intended to recover small objects situated in cavities of large dimension, whether by laparoscopy (U.S. Pat. No. 4,174,715) or by endoscopy (U.S. Pat. No. 4,655,219). These devices act in the manner of grapnels.
Consequently, none of these capturing devices permits gripping of tubular articles, such as endoprostheses, which have been incorrectly deployed in tubular cavities, such as blood vessels, passages of the gastrointestinal system or urinary system, or other similar sites.
It may in fact happen, for example when deploying an endoprosthesis in a vessel, that the endoprosthesis is positioned imperfectly, and in particular at a site where, for example, it partially or completely occludes the mouth of another vessel. In this case, it is necessary either to displace the endoprosthesis, by gripping it and sliding it to the correct position, or to recover the endoprosthesis and replace it. None of the devices mentioned above is capable of performing such an operation.
Appliances for removing an elongate structure implanted in biological tissue are also known. These appliances are relatively complex systems and entirely complementary to the object to be recovered, whether this be a cardiac pacemaker or a cardiac conductor inserted in a wall of the heart, for example (see U.S. Pat. Nos. 4,943,289, 4,988,347, 5,011,482 and 5,013,310).
Mention may also be made of a device which is intended for supporting a vessel and is provided with three hooks at its end (U.S. Pat. No. 5,053,041). During a surgical intervention, this device is used to keep open the end of the vessel to be grafted, especially during the suturing operation. It is not intended for introduction by the intraluminal route and for capturing an object.
Finally, devices which can be implanted in the blood vessels are known. These devices are formed, for example, by 2 bundles of metal wires joined to each other by a ring, from which they extend radially in an umbrella configuration, on both sides. These devices are deployed on a permanent basis at a given site in order to filter the blood and prevent the passage of blood clots towards the heart. Thus, they are not in any way intended for capturing an object, and still less for recovering an endoprosthesis (see U.S. Pat. No. 3,868,956).
The problems specified hereinabove are solved by means of a device as described at the outset, in which the gripping means comprise fastening elements which are disposed peripherally on a pusher in such a way as to extend forwards, inside the support sheath, and to spread apart radially from one another outside the support sheath, and which fastening elements are each provided at their distal end with a hook which is curved radially outwards, which hooks, when the fastening elements are situated inside the tubular article and are brought into the said position outside the support sheath, are capable of entering into a position of fastening to an inner surface of the tubular article, and which, when the fastening elements are situated in the abovementioned fastening position and are brought towards the said position inside the support sheath, radially compress the tubular article and, if appropriate, elongate it longitudinally. This device has the advantage that the operating surgeon does not lose time suitably orienting the fastening elements radially with respect to the object which is to be gripped. If the aim is to capture an object of the endoprosthesis type, for example a vascular endoprosthesis, the fastening elements, each advantageously equipped with a hook curved radially outwards, enter into engagement with the inner wall of the endoprosthesis. Radial traction can then be exerted on the latter, which traction detaches it from the vessel wall and permits its recovery.
According to an advantageous embodiment, the fastening elements are thin flexible wires which, at one end, are fixed to a distal end of the pusher and are elastic
Dawson Glenn K.
Dereume Jean-Pierre G. E.
Scully Scott Murphy & Presser
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