WO1998031302A1 - Device for vascular bypass - Google Patents

Abstract

The invention concerns a vascular prosthesis for a bypass, in particular for an aortic anastomosis, characterised in that it comprises a tubular section (20) adapted for being introduced in the aorta (A) via a lateral incision (I) formed therein and a bifurcated branch conduit (30) laterally connected on the section (20) to emerge through the incision.

Description

VASCULAR BRIDGE DEVICE

The present invention relates to the field of vascular surgery.

More specifically, the present invention relates to the field of vascular bypass surgery, in particular bypass surgery of the aorta.

The conventional techniques for carrying out aorto-bifemoral bypasses consist in performing either an end-to-side aortic anastomosis as illustrated in FIGS. 1A and 1B, or an end-to-end aortic anastomosis as illustrated in FIGS. 2A and 2B. These aortic anastomoses consist of attaching a bifurcated prosthesis P bypassing the aorta A.

For a termino-lateral aortic anastomosis, the common upper trunk P1 of the prosthesis P is connected laterally to the aorta A, opposite an incision formed in it, then the lower bifurcated branches P2, P3 are connected to the femoral arteries AF1, AF2, opposite lateral incisions formed in the latter (see Figures 1A and 1B).

^• For an end-to-end aortic anastomosis, aorta A is sectioned, the common trunk P1 of prosthesis P is connected axially to the upper part of aorta A _; the lower portion of the aorta A is closed and the bifurcated lower branches P2, P3 of the prosthesis P are connected to the femoral arteries AF1, AF2 compared ^to lateral incisions formed in the latter (see Figures 2A and 2B).

These various connections are made using sutures or staples shown diagrammatically under the reference S in FIGS. 1 and 2.

Although very delicate to carry out these interventions are carried out quite frequently these days in the open air.

However, to date, practitioners have not succeeded in carrying out such aortic anastomosis operations under laparoscopy, nor in general most vascular operations.

So while laparoscopy has made great progress (notably reduction of scars, pain, administered accompanying products, hospitalization time and post-operative complications) in many surgical fields, in particular gynecology and digestive surgery, until now specialists have not been able to provide vascular operated patients with these advantages.

The present invention now aims to improve the known means for vascular bypass, in particular to allow a complete operation under laparoscopy.

This object is achieved according to the present invention thanks to a vascular prosthesis comprising

- a tubular section adapted to be introduced into the aorta via a lateral incision, and

- a bifurcated branch connected laterally on the section to emerge through the incision.

According to another advantageous characteristic of the invention, the device further comprises at least one expandable support member (generally called a stent) adapted to urge the open upper end of the tubular section of the prosthesis against the internal wall of the aorta.

The lower end of said tubular section can be closed.

However, this lower end of said tubular section can be open, in which case a second expandable support member is provided to urge the open lower end of the tubular section of the prosthesis against the internal wall of the aorta.

Other features and advantages of the present invention will appear on reading the detailed description which follows, and with reference to the appended drawings, given by way of nonlimiting example and in which:

FIGS. 1A and 1B previously described schematically illustrate a termino-lateral aortic anastomosis,

FIGS. 2A and 2B previously described schematically illustrate an end-to-end aortic anastomosis, FIG. 3 represents a schematic perspective view of a vascular prosthesis according to the present invention for an aortic anastomosis,

FIG. 4 schematically illustrates a step of lateral aortic incision, FIG. 5 schematically illustrates the insertion of the upper tubular section of the prosthesis according to the present invention into an aorta,

FIG. 6 schematically represents the prosthesis according to the present invention introduced by its upper tubular section into the aorta,

FIG. 7 represents a schematic view in longitudinal section of the upper prosthesis section in accordance with the present invention introduced into an aorta,

FIG. 8 represents the step of introducing an expandable support member into the prosthesis,

FIG. 9 represents the positioning of this expandable support member facing the upper end of the tubular section of the prosthesis,

FIG. 10 schematically represents said expandable support member, in the expanded state in order to urge the open upper end of the tubular section of the prosthesis against the internal wall of the aorta,

FIG. 11 represents a variant of prosthesis according to the invention, and

- Figure 12 illustrates the attachment of the tubular section of the prosthesis using two expandable support members.

Schematically shown in Figure 3 a vascular prosthesis for an aortic anastomosis according to the present invention.

This prosthesis 10 comprises an upper tubular section 20 provided with a bifurcated bypass 30.

The entire prosthesis 10 is made of a material preferably having a certain flexibility or elasticity, in particular to allow the upper section 20 to be adapted to the internal dimension of the receiving aorta A.

Very preferably, the prosthesis 10 is thus made of expanded polytetrafluoroethylene.

The upper tubular section 20 has a section at rest substantially complementary to the section of the receiving aorta A.

Preferably the diameter of the upper section 20 is between 8 and 10 mm. Preferably the length of the upper section 20 is between 10 and 20 mm.

The bifurcated bypass 30 has the general shape of a fork comprising an upper common trunk 32 connected laterally to the upper section 20 and two lower branches 34, 36. The upper trunk 32 is connected to the section 20 substantially at mid-height thereof. this.

The lower ends of the branches 34, 36 are open in order to be connected, in a conventional manner per se, by sutures or staples on the respective femoral arteries AF1, AF2. The upper end 22 of the section 20 is open.

Depending on the application envisaged, the lower end 24 of the upper section 20 can be open or closed.

The surgeon uses a prosthesis comprising a lower end 24 open when it is desired to maintain circulation throughout the aorta. On the other hand, the surgeon uses an upper section having its end 24 closed when the state of the aorta A requires an interruption in circulation below the bypass performed by the prosthesis.

The implications for the laying technique will be described later.

By way of nonlimiting examples, the length of the bifurcated branch 30 is preferably between 3 and 5 cm while its mean diameter is between 12 and 15 mm, preferably being of the order of 14 mm. To implant a vascular prosthesis 10 in accordance with the present invention, an incision I is first made in the recipient vessel to be bypassed, preferably aorta A (see FIG. 4).

Then the tubular section 20 of the prosthesis 10 is introduced into the incision I so that the tubular section 20 is disposed coaxially inside the receptor vessel A, the bifurcated shunt 32 emerging outside the vessel A through the incision I (see Figures 5, 6 and 7).

Then as illustrated in FIG. 8, an expandable support member 40 is introduced into the prosthesis 10 by one of the branches 34, 36 and positioned opposite the upper end 22 of the tubular section 20, as illustrated in FIG. 9, then expanded as illustrated in FIG. 10 to urge this upper end 22 of the section 20 against the internal wall of the aorta A. Once the expansion of the member 40 produced or guarantees sealing between the external surface of the section 20 and the internal wall of the aorta A.

Thus if the lower end 24 of the section 20 is closed, all of the flow coming from the aorta A is diverted towards the bifurcated diversion 30. In the case where, on the contrary, the lower end 24 of the section 20 is open to allow a flow towards the lower section of the aorta A, a second expandable support member 50 similar to the member 40 is introduced into the prosthesis 10 by one of the branches 34, 36, positioned opposite the lower end 24 of the section 20 and expanded to urge the lower end 24 of the section 20 of the prosthesis 10 against the internal wall of the aorta A and thus ensure sealing, as illustrated in FIG. 12.

The open ends of the branches 34, 36 are then connected to the femoral arteries AF1 and AF2, by sutures or staples, according to the conventional technique. Of course, all of the above operations are carried out after temporary closure of the aorta A above the incision I using conventional forceps, as is well known to those skilled in the art.

The expandable support members 40, generally called Stent, are well known to those skilled in the art. These elements are most often formed of a metallic tubular member in the form of a grid. Likewise, their techniques of introduction, guidance and expansion are well known to those skilled in the art. The dilation of these organs can call upon either a plastic or elastic memory in which case generally these organs are dilated by balloon inflation, or even a thermal memory in which case the dilation of these organs is carried out either by the application of a control heat flow, either automatically by body temperature. Insofar as these expandable support members 40 are well known to those skilled in the art, they will not be described in detail below.

By way of nonlimiting examples, those skilled in the art may refer to the following documents which describe such expandable support members: EP-A-0221570, EP-A-0335341, EP-A-0364787, EP-A- 0606165.

Of course, the vascular prosthesis 10 in accordance with the present invention can be used during open operations. However, it will be noted that the present invention offers the enormous advantage of allowing all of the aortic bypass operations to be carried out by laparoscopy.

Of course the present invention is not limited to the particular embodiment which has just been described but extends to any variant in accordance with its spirit.

Thus for example the expandable support member 40 used to apply the upper end of the prosthesis against the internal wall of the aorta A can be an integral part of the section 20. The same is true for the expandable support member used in the case if necessary to stress the lower end 24 of the section 20.

Furthermore, the present invention is not limited to aortic anastomoses but can be used for other types of vascular operations.

Furthermore the prosthesis 10 according to the present invention is not limited to the particular embodiment illustrated in Figures 3 to 10 attached. Where appropriate, this prosthesis 10 may include additional bifurcations, for example for associated restorations such as hypogastric restorations, such as the bifurcation illustrated under the reference 60 in FIG. 11.

Claims

1. Vascular prosthesis for bypass, in particular for an aortic anastomosis, characterized in that it comprises a tubular section (20) adapted to be introduced into the aorta (A) via a lateral incision (I) formed therein and a bifurcated bypass (30) laterally connected to the section (20) to emerge through the incision. 2. Prosthesis according to claim 1, characterized in that there is further provided an expandable support member (40) adapted to urge the upper end (22) of the tubular section (20) against the internal wall of the aorta (AT). 3. Prosthesis according to one of claims 1 or 2, characterized in that there is further provided an expandable support member (50) adapted to urge the lower end (24) of the tubular section (20) against the wall internal of the aorta (A). 4. Prosthesis according to one of claims 2 or 3, characterized in that the expandable support member (40, 50) is an integral part of the prosthesis (10). 5. Prosthesis according to one of claims 1 or 2, characterized in that the lower end (24) of the tubular section (20) is closed. 6. Prosthesis according to one of claims 1 to 5, characterized in that it is made of expanded polytetrafluoroethylene. 7. Prosthesis according to one of claims 1 to 6, characterized in that the bifurcated bypass (30) is connected to the tubular section (20) substantially at mid-length thereof. 8. Prosthesis according to one of claims 1 to 7, characterized in that the tubular section (20) has a diameter between 8 and 10 mm. 9. Prosthesis according to one of claims 1 to 8, characterized in that the tubular section (20) has a length between 10 and 20 mm. 10. Prosthesis according to one of claims 1 to 9, characterized in that the bifurcated bypass (30) has a length between 3 and 5 cm. 11. Prosthesis according to one of claims 1 to 10, characterized in that the bifurcated bypass (30) has a diameter between 12 and 15 mm. 12. Prosthesis according to one of claims 1 to 11, characterized in that it comprises at least one additional bifurcation for example for a hypogastric restoration.