Surgery – Instruments – Means for inserting or removing conduit within body
Reexamination Certificate
2000-08-18
2002-04-02
Truong, Kevin (Department: 3731)
Surgery
Instruments
Means for inserting or removing conduit within body
C606S198000
Reexamination Certificate
active
06364887
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to the subject matter disclosed in international application PCT/EP99/01073 of Feb. 19, 1999, the entire specification of which is incorporated herein by reference.
The invention relates to a device for inserting a tubular implant into a vessel.
Surgical treatment of abdominal or also thoracic aortic aneurysms is usually performed by a large abdominal or thorax incision, with the aneurysmatic vessel portion being clamped out, resected and replaced by a suitable prosthetic section with a manual suture.
Operating methods are also known wherein endoluminally a tubular implant is introduced into a vessel and fixed there, for example, with the aid of barbs (U.S. Pat. No. 5,527,355 A). Such endoluminal techniques are much less stressful than conventional surgical operations, but increased risks are also involved. There is the danger that the tubular implants inserted will shift within the vessel, and, in addition, leakages may occur in the area of the proximal and distal attachments of the tubular implants in the vessel.
The object of the invention is to so design a device for inserting a tubular implant in a vessel that after insertion into the vessel, a tubular implant can be easily and safely fixed on the vessel and sealed off in relation to the vessel with this device.
SUMMARY OF THE INVENTION
This object is accomplished in accordance with the invention by a device for inserting a tubular implant into a vessel, which is characterized by an introducing head having an advancing handle and being insertable into the implant, radially outwardly movable spreading elements being arranged on the circumference of the introducing head, and by a locking member mounted for displacement on the introducing head and being displaceable via a transmission member between a rest position in which the spreading elements are radially retracted, and a spread position in which the spreading elements protrude radially outwards.
By means of such a device, a tubular implant can be pushed onto the introducing head and together with the latter introduced into a vessel. Once the insertion position is reached, the spreading elements can be driven into the spread position by displacement of the locking member mounted on the introducing head. They thereby not only press the implant surrounding the introducing head radially outwardly against the inner wall of the vessel, but also widen out vessel and implant in the area of contact so that a space is created between the introducing head, on the one hand, and the implant and the vessel wall, on the other hand. This space can be used by the operator to fix the implant on the vessel wall from the outside, for example, by performing a circumferential suture or by introducing suitable connecting elements. It is also essential that the two layers of the implant and the vessel wall lying surface-to-surface against each other be tensioned by the extended spreading elements. These spreading elements thus act as abutments so that the two layers to be joined together can be joined by the surgeon in this area lifted off the introducing head, without there being any danger of the layers shifting or deviating during the operation. Provision is made in a preferred embodiment for the introducing head to comprise a releasable holding device for the implant. It is thereby ensured that upon inserting the introducing head and the implant pulled over the latter, the implant is permanently held on the introducing head, but after the implant has been fixed on the vessel, the introducing head can be withdrawn from the operating site without taking the implant along with it by releasing the holding device.
In particular, provision may be made for the holding device to be a flexible bandage, in particular in the form of a thread, which is placed around the implant and holds the implant under tension against the introducing head, with the tension of the bandage being reducible.
Herein it is advantageous for the ends of the bandage to be guided for free displacement along the introducing instrument and along the handle, and, in particular, for them to be guided through the introducing head. The operator is then able to tension the free ends of the bandage at the place at which the device exits from the vessel in order to close the holding device, or to leave the free ends loose in order to release the holding device.
The free ends can, of course, also be connected to an actuating member which, for example, is mounted for displacement along the device.
Herein it is expedient for the introducing head to comprise a recess on its outer surface in the area of the bandage.
This enables the bandage to be fixed along the introducing head, and, in addition, it can thereby be achieved that the bandage does not protrude radially outwardly or only slightly over the circumference of the introducing head.
In particular, this recess can be in the form of a circumferential groove.
The introducing head is preferably in the form of a circular-cylindrical body. It is expedient for the introducing head to be atraumatically rounded-off at its front end opposite the advancing handle, for example, the introducing head may have an approximately spherical-cap-like shape.
The advancing handle can be constructed in the fashion of a catheter, in particular, it can be in the form of a flexible tube which transmits pushing forces.
The spreading elements can be of different design. For example, they can be flexible filler bodies which are expanded outwardly by being filled up with a gas or a liquid, or they can be mechanically extendable spreading elements which, for example, can be transferred from the rest position to the spread position and vice versa via a gear mechanism.
Provision is made in accordance with a preferred embodiment for the spreading elements to be spring elements which are spread radially outwards in the relaxed position.
Herein it is expedient for the spring elements to consist of a superelastic alloy, i.e., of an alloy from the group of the so-called memory alloys which exhibit an extremely elastic deformability, for example, these can be NiTi alloys.
It is advantageous for the spring elements to be arranged in radially outwardly open recesses of the introducing head and to protrude from these recesses in the relaxed state. Thus, in the rest position, these spring elements are driven into the introducing head and do not obstruct insertion of the introducing head and the implant held on the latter into the vessel.
Further provision may be made for the locking member in the rest position to close the recesses on their outer side and thereby push the spring elements into the recesses.
It is particularly advantageous for the locking member to be a tube which is longitudinally displaceable with respect to the introducing head and which closes the recesses in the one position, but releases the recesses in the other position.
Provision may be made for the locking member in the rest position to form a steady continuation of the outer surface of the introducing head so that the tube simultaneously forms a supporting surface for the tubular implant drawn onto the introducing head.
In a preferred embodiment, the spring elements are spring tongues fixed at one side on the introducing head parallel to the longitudinal direction of the introducing head and protruding radially outwardly with their free end in the relaxed state.
These may be thickened and rounded-off atraumatically at their free end in order to prevent damage to the implant and/or the vessel wall.
It is expedient for several such spring elements to be distributed along the circumference of the introducing head so that the tubular implant and the surrounding vessel wall are uniformly expanded in all directions. This enables the surgeon to fix the implant on the vessel along the entire circumference in the same way.
REFERENCES:
patent: 4592341 (1986-06-01), Omagari et al.
patent: 4681110 (1987-07-01), Wiktor
patent: 5411507 (1995-05-01), Heckele
patent: 5443477 (1995-08-01), Marin et al.
p
Dworschak Manfred
Lutze Theodor
Stallforth Harald
Weik Thomas
Aesculap AG & Co. KG
Lipsitz Barry R.
McAllister Douglas M.
Truong Kevin
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