Prosthesis for connecting an anatomical duct

According to the invention, the tubular prosthesis for connecting an anatomical duct includes at least two individual tubular elements and a sealed mechanical element for connecting said separate elements to each other.

The present invention relates to a prosthesis for connecting an anatomical duct.

Although it is particularly suitable for connecting two portions of the same anatomical duct (for example, a blood vessel), the prosthesis according to the present invention can also be used to connect an anatomical duct to an organ or to an artificial device (for example a cardiac prosthesis or a ventricular assist device).

Moreover, it is known that some diseases or medical disorders require the removal of a portion of a blood vessel (for example an artery or a vein) for replacement by a vascular prosthesis. This type of prosthesis comprises, for example, a monolithic tubular body forming an anatomical duct over its entire length, generally cylindrical in form.

For implanting a vascular prosthesis of the above-mentioned type it is also known that surgical teams must cut the diseased portion of the vessel and then suture each of the free portions of the vessel thus out to an end of the monolithic vascular prosthesis.

However, because some vessels are difficult to access and/or because suturing a prosthesis to a vessel is difficult to perform, surgeons are obliged to cut the vascular prosthesis in two in order to facilitate the suturing of the ends of said prosthesis to the vessel to be treated. Once this has been performed, surgeons suture the two free ends of the prosthesis to each other.

In other words, this type of vascular prosthesis requires a supplementary suture zone (the zone defined between the two out ends of the prosthesis), which increases the time needed to implant the prosthesis and the haemodynamic risks (for example, stasis, haemorrhaging through the suture stitches made, etc.).

Drawbacks of this type are also observed when connecting a blood vessel to a cardiac prosthesis by means of a monolithic vascular prosthesis of the above-mentioned type.

The object of the present invention is to overcome these drawbacks.

Therefore, according to the invention, the tubular prosthesis for connecting an anatomical duct, which comprises at least two individual tubular elements and mechanical means for connecting said individual elements to each other,

is notable in that the mechanical connecting means are sealed and comprise:two annulus-shaped joining parts, each of them being fixed to the free end of an individual tubular element;at least one seal (for example, taking the form of a preformed compressible mechanical seal or alternatively GRF (gelatine-resorcinol-formaldehyde) surgical glue applied to one of the two joining parts and designed to be inserted between the two joining parts around the opening formed by the tubular prosthesis; anda first and a second fixing ring each traversed by an individual tubular element and designed to cooperate with each other to hold together, one against the other, the two joining parts between which the seal is compressed.

Therefore, owing to the invention, it is no longer necessary to out the prosthesis, as it consists of at least two individual tubular elements, which ensures a clean and regular cutting zone. In addition, the mechanical connecting means fitted on the prosthesis allow the two free ends of the individual elements to be joined together quickly and easily without carrying out additional suturing. Consequently, the haemodynamic risks are substantially reduced and the work of the surgeons is made significantly easier.

In addition, the first and second fixing rings hold the joining parts firmly against each other and compress the seal between said rings, which helps guarantee the seal along the tubular prosthesis (in particular at the junction of the two parts). Bodily fluid (for example blood when the anatomical duct is a blood vessel) flowing into the prosthesis is also prevented from coming into contact with materials other than that of the individual tubular elements (which are preferably made of a biocompatible material, such as a woven polyester).

In an embodiment according to the invention:the first fixing ring comprises an inner flange on which one of the annuluses is designed to be firmly pressed;the second fixing ring comprises a projecting annular collar at the end of which the other annulus is positively connected; andthe projecting collar is suitable for being inserted inside the first ring in order to put the two annuluses in contact with each other.

In addition, according to this embodiment:the first fixing ring may comprise internal radial projections; andthe second fixing ring may comprise recesses made in the side wall of the projecting collar and which are suitable for receiving the corresponding radial projections of the first ring.

Moreover, each of the radial projections may be in the form of a stud and each of the recesses may comprise:an axial notch for the insertion of a radial projection; anda locking incline extending over a particular, angular sector, the entrance of which is formed by the associated axial notch.

In particular, the locking incline may be helical and end in a locking notch, which allows the seal to be compressed in a predetermined manner and held in the locked position.

Furthermore, the radial projections and the corresponding recesses, preferably three in number, can be distributed at equal angles in order to maintain a uniform compression of the seal over its length.

In a variant embodiment according to the invention, the inner side wall of the first ring has threading suitable for cooperating with corresponding threading made in the outer side wall of the fixing collar. In addition, the first ring, mounted rotating freely around the corresponding individual tubular element is independent of the annulus associated therewith.

Moreover, the prosthesis advantageously comprises auxiliary fixing means for holding said annuluses securely against each other.

In particular, these auxiliary fixing means may comprise at least one fixing eyelet positively connected to the first fixing ring, and at least one corresponding fixing orifice made in the side wall of the second fixing ring, the fixing eyelet and the fixing orifice being suitable for being connected to each other, for example by a suture thread.

Moreover, it will be noted that, depending on the shape of the anatomical duct, the prosthesis may have a generally cylindrical, conical, bifurcated (if the anatomical duct is itself bifurcated) or other shape.

As mentioned above, the prosthesis according to the present invention can be used just as well for connecting two portions of the same anatomical duct (for example a blood vessel) as for connecting an anatomical duct to an organ or to an artificial device (for example an artificial heart).

For reasons of clarity and conciseness, the prosthesis according to the invention will be described below in relation more particularly to blood vessels.

The tubular prosthesis1according to the present invention and illustrated inFIGS. 1 and 2, comprises two individual tubular elements2, for example made of woven polyester, each defining an internal opening3.

The individual cylindrical tubular elements2are designed to be sutured by a surgeon at one of their ends5R to a portion P of an anatomical duct C to be treated.

The outer surface S of each of the individual tubular elements2is annulate so as to be flexible and provide better engagement in the corresponding portion P of the anatomical duct C.

The prosthesis1also comprises sealed mechanical means4for connecting the respective free ends5L of the two individual tubular elements2(the free ends5L being those that are not sutured to the portions P).

As shown inFIGS. 3 to 8, the mechanical connection means4comprise:two annulus-shaped joining parts6which are fixed respectively to a free end5L of an individual tubular element2. Each tubular element2can be fixed to an annulus6by gluing and/or by suturing7its free end5L thereto (it being possible for the suture to be made leak-proof during the manufacturing process of the prosthesis1). In particular, each tubular element2passes through the internal opening of the corresponding annulus6in order to cover, with its free end5L, at least a portion of the outer surface6E (i.e. that turned towards the other tubular element2) thereof.an annular seal8which is positively connected with the outer surface6E of the annulus6and which is positioned in the vicinity of the opening3. The seal8is designed to be compressed by the two annuluses6when the corresponding two individual tubular elements2are connected to each other; andmechanical means9for holding the annuluses6against each other while compressing the seal8between them in order to seal the length of the tubular prosthesis1.

The holding means9comprise a first9A and a second9B fixing ring which are designed to cooperate with each other and which are each traversed by the associated tubular element2.

In this example, the first ring9A comprises an inner flange10on which a corresponding annulus6can be firmly pressed. It also comprises projections11in the form of a stud which extend radially towards the inside of the ring9A.

The second ring9B comprises a projecting annular collar12at the end of which the other annulus6is positively connected. Advantageously, the ring9B, the collar12and the associated annulus6can be formed as one and the same part.

The projecting collar12is suitable for being inserted, with adjustment, inside the first ring9A. In this way, the annulus6, which is positively connected with the projecting collar12, is pressed firmly against the seal8carried by the annulus6of the ring9B.

Furthermore, the collar12comprises recesses13which are made in the side wall thereof and which are suitable for receiving the corresponding radial projections11.

Each recess13comprises:an axial notch13A oriented outwards and suitable for receiving one of the studs11; anda locking incline13B extending over a specified angular sector, the entrance of which consists of an associated axial notch13A.

In particular, each locking incline13B may be helical so as to end in a locking notch13C, which allows the seal to be compressed in a pre-determined manner when the corresponding stud11has reached the locking notch130while immobilising the two rings9A and9B relative to each other in a locked position.

In the example described, the first ring9A comprises three studs11and consequently the collar12comprises three associated recesses13to receive the corresponding studs11.

The studs11and the corresponding recesses13are advantageously distributed at equal angles to maintain uniform compression along the seal8.

In addition, to further secure the immobilisation of the two rings relative to each other, the prosthesis1comprises auxiliary fixing means14.

In the example described, the auxiliary fixing means14are in the form of fixing eyelets14A positively connected with the first fixing ring9A, to which fixing orifices14B made in the side wall of the second fixing ring9B, open at the bottom, are respectively associated.

To immobilise the two rings9A and9B relative to each other in the locked position, suture thread15(seeFIG. 2) for example may be used, in order to connect each eyelet14A to the corresponding fixing orifice14B to ensure that the rings9A and9B do not rotate relative to each other.

Each eyelet14A is mounted on the first ring9A in a longitudinal extension of a stud11. Furthermore, each fixing orifice14B is made in a longitudinal extension of a locking notch13C.

Therefore, when the studs11engage with the notch13C of the recesses13, the eyelets14A are aligned longitudinally with the corresponding fixing orifices14B (see in particularFIG. 2).

Moreover, it goes without saying that the present invention is not limited to the embodiment of the mechanical connection means described above.