Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
2000-01-24
2002-07-09
McDermott, Corrine (Department: 3738)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C623S001230, C623S001110
Reexamination Certificate
active
06416522
ABSTRACT:
The invention relates to an implantation device for treating damaged or diseased tissue in the region of the inner walls of hollow organs, and in particular to an implantation device for treating a dissection in body vessels, with a catheter and at least one fastening means connected with said catheter, whereby the catheter has a long-stretching hollow body which is open at least at its front end when employed as intended, and in which each fastening means is received with axial mobility when the implantation device is inserted in the vessel of the body.
Such an implantation device is known from EP-A-466 518 even though said device is not intended for treating vessels of the body.
Said known implantation device is a device for implanting an artificial blood vessel, which is implanted by means of a catheter in the correct position and expanded in the site of implantation. For this purpose, the artificial blood vessel is received during the implantation in a constricting covering, which is removed after the implantation. The artificial blood vessel is provided with spring elements which, in turn have barbs that get hooked up in the site of implantation, and in this way maintain the artificial blood vessel elastically in its desired position, expanding it to some extent as desired. Owing to the fact that the elastic fastening means are connected with the artificial blood vessel and, to that extent, in each case indirectly also with the catheter, exact positioning of the fastening means as deemed desirable, for example for treating dissections, but also in connection with other applications, is not possible. In connection with the object of EP-A-466 518, the fastening means are rather connected with the artificial blood vessel in a fixed manner. Therefore, it is not possible with said known implantation device to implant the fastening means as such.
A method and a device for securing a graft in the lumen of a body vessel are known from U.S. Pat. Ser. No. 4,872,874.The known device comprises a catheter with an expandable balloon segment at its distal end. The balloon segment is provided with a U-shaped annular groove, in which staples as securing means are distributed over the circumference and receivable with legs connected with each other via a bridge in such a way that the free ends of the legs point outwardly. By means of said device, a graft first introduced in a body vessel can be secured on vascular walls by positioning the balloon segment with the annular groove receiving the securing means, said balloon segment being inserted in the vessel in its expanded condition and being provided with securing means, within the proximity of one end of the graft, and by subsequently inflating the balloon segment. In this process, the radially protruding legs of the staples have to pierce the graft and penetrate the vascular wall in order to keep the graft attached to the vascular wall after the balloon segment has been deflated.
However, it has been found that the legs of the staples serving as securing means easily assume a slanted position when the balloon segment is expanded, or only inadequately penetrate the vascular wall. This can be assumed to be attributable to the fact that the depth of the annular groove serving for receiving the securing means becomes progressively smaller, causing the securing means to lose their guidance. As a result thereof, the graft is only inadequately tacked to the vascular wall, and, furthermore, damage may be caused to the vascular wall.
In the known device, the balloon segment of the catheter is considerably widened radially even when it is in its unexpanded condition, so that this implantation device can be employed on with larger body vessels.
Accordingly, the invention is based on the problem of creating an improved implantation device of the type and for the purpose specified above. Such device permits strictly local treatments of damaged or diseased tissue of the inner walls of hollow organs while reducing at the same time the stress to which the tissue is subjected to in such treatments.
Said problem is solved in that the implantation device as defined in the introductory part of claim
1
comprises a catheter with a long-stretched hollow body, which is open at least at its front end when used as intended, and in which one or a plurality of securing means are received with axial mobility. The application of such a catheter requires only a small cross section for its insertion. Such a catheter is, therefore, suitable also for vessels with a small lumen. After the catheter has been placed in its correct position, the securing means received therein is expelled from the catheter and implanted in the vascular wall.
The implantation device thus comprises a catheter in which one or several securing means are received when it is introduced in the body vessel. Following placement of the catheter in its appropriate position within the region of the site of the diseased tissue, for example on a dissecate, said securing means are advanced from the catheter and implanted in the vascular wall. In case of a dissecate, the treatment is carried out in a simple fashion in that the dissecate is tacked to the vascular wall with the help of the securing means. The implantation device as defined by the invention therefore assures that the treatment of the dissecate is precisely “on target”. The tissue is stressed only within the immediate proximity of the securing means and the stress to which the tissue of the organ is subjected to is consequently reduced to a minimum. With larger dissecates, the application of several securing means is recommended, which have to be implanted spaced from each other.
The possibilities available for employing the implantation device as defined by the invention extend far beyond the treatment of vascular diseases and may comprise also, for example the treatment of detachments of the retina, by reliably and permanently connecting the latter with the choroid with the help of securing means. As opposed to currently applied coagulation therapies, which only permit a prophylactic treatment of endangered regions, the treatment with the help of the implantation device as defined by the invention also permits reattachment by tacking on areas of the retina that have become detached.
Treatment possibilities are expanded in that means for receiving and positioning a protective cover for the affected tissue are arranged on the catheter. It is possible with the help of the protective cover to treat also large areas of the tissue regions, where the use of only securing means is inadequate or not possible. Covering the bag-like dilatation of the vessel with such a protective cover is recommended especially for the treatment of aneurisms, whereby the protective cover is tacked within the marginal region of the aneurism with securing means in the healthy tissue. As opposed to the conventional treatment with stents, the lumen of the vessel is not narrowed down and the risk of a stenosis due to formation of a neointima is largely reduced.
The type of protective covering to be used depends in this connection on the application in a given case. A useful protective covering is, for example a piece of textile or tissue adapted to the damaged area of the tissue. The fabric may consist of a stable or flexible material depending on the application. The use of a biodegradable material is recommendable for many applications. In particular, the use of the body's own tissue or of a transplant is possible as well.
The present implantation device also permits tacking grafts to the inner wall of a body vessel. A supporting stent structure can be entirely omitted in this way. As opposed to conventional treatments with stents, the lumen of the body vessel is not noticeably reduced.
A nail adapted to the thickness of the wall of the hollow organ is a securing means that is adequate in many cases. The shaft of such a nail is inserted in the vascular wall. However, staples with two or more legs can be used as well depending on to which extent the affected region o
Barrett Thomas C.
Collard & Roe P.C.
McDermott Corrine
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