FR2887432A1 - MINI-INVASIVE SYSTEM FOR THE COMMUNICATION OF TWO BODY CONDUITS - Google Patents

Abstract

According to the invention, this system comprises: - two catheters intended to be engaged in the conduits or body structures (100) to be treated, the distal end portions (1) of which are bent so that the distal openings of these parts distal ends (1) can be brought into proximity to one another; - circular magnets (5) connected to said distal end portions (1), which can attract each other and stick to each other. other coaxially through the tissues delimiting the conduits or body structures (100) to be treated; - a means (6) for piercing the tissues delimiting the conduits or body structures to be treated, which can be engaged and slid inside the body; at least one of the catheters; a guide wire (6) which can be engaged and slid inside the catheters; and a connection system of the two conduits or body structures (100) which can be engaged and slid into the catheter. catheter interior ers.

Description

The present invention relates to a minimally invasive system for

  communication of two conduits or body structures.

  It is necessary in some cases to put two conduits or body structures in communication, including two veins, two arteries, or an artery and a vein, to treat circulatory insufficiency.

  Existing systems for carrying out such communication have the drawbacks of being relatively invasive and, in general, of not giving complete satisfaction.

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

  For this purpose, the system it concerns comprises: - two catheters, one of which is intended to be engaged in one of the conduits or body structures to be treated and the other is intended to be engaged in the other of these conduits or body structures to be treated, the distal end portions of these catheters, i.e. those intended to be engaged in said conduits or body structures, being bent or being able to be bent so that the distal openings of these distal end portions may be brought into proximity with one another when the non-curved portions of the catheters extend more or less parallel to each other; circular magnets connected to said distal end portions, coaxially with them and flush with said openings of the distal end portions, these magnets being able to attract each other and to coax each other coaxially through tissues defining the conduits or body structures to be treated; tissue piercing means delimiting the conduits or body structures to be treated which can be engaged and slid inside at least one of the catheters; - A guide wire, which can be engaged and slid inside the catheters, and - a connection system of the two conduits or body structures, which can be engaged and slid inside the catheters.

  One of the catheters is engaged and slid into one of the conduits or body structures until its distal end is at the site of communication to be created and the other catheter is engaged and slid into the another body conduit, also until its distal end is at the communication site to be created.

  The distal ends of the two catheters are then approximated, and optionally oriented, by manipulating a catheter, or both, from their proximal ends, so as to cause the two magnets to draw through the walls of two conduits or structures. bodily and then to cling, this connection bringing the walls of two conduits or body structures in contact with each other.

  The piercing means is then engaged and slid into one of the catheters and is then pierced through the walls of the two conduits or body structures and is then slid into the other catheter.

  The guidewire, if it does not itself constitute this piercing means, is then engaged and slid into the catheters and then removed.

  The connection system is then engaged and slid on the guide wire to the level of the walls of the two conduits or body structures and is put in place to carry out the maintenance of these two conduits in this state of communication.

  The piercing means may be the guidewire itself, a radio frequency probe, or any other suitable mechanical means.

  The system may also include means for expanding the communication created between the two conduits or body structures, including an inflatable balloon, the enlargement means being engageable and slidable on the guidewire.

  Preferably, the connection system comprises at least one expandable "stent" type armature, which can, in the non-deployed state, be engaged on either side of the walls of the two ducts or structures and then be deployed in such a way as to ensure placing the conduits or structures in communication and / or maintaining this communication.

  The armature may be expandable by means of the balloon, or may be self-expanding, especially of a shape memory material such as a titanium-nickel alloy.

  An armature may be in the form of double flanges connected by a narrowed central portion, the central portion being intended to extend at the walls of two ducts or structures, and each collar bearing against the wall of one of the ducts or structures, on the side of the interior of this conduit or this structure.

  Another reinforcement may also be tubular, may be dimensioned so as to be able to extend on both sides of the communication, and may or may not comprise, on the whole of its surface or on only a part of this surface, a wall of waterproof cover.

  This cover wall serves to exclusively guide the flow of a body fluid from one conduit or structure to the other conduit or structure. The absence of this wall on the portion of the frame engaged in a body duct or a body structure allows the preservation of a circulation of a body fluid in this conduit or structure, beyond the communication zone. with the other conduit or structure, in addition to the communication created towards this other conduit or structure by means of the armature.

  The system may also comprise a single deployable reinforcement combining a flange identical to that described above and a tubular portion, coated or not. This frame combines a tubular portion placed in one of the ducts and a flange bearing against the wall of the second duct just at the level of the communication. The latter is thus intended to maintain the tubular portion in connection with the other conduit.

  The connection system may comprise a connection device comprising a catheter including a sleeve for holding a deployable armature in the non-deployment position and a balloon allowing or promoting the deployment of this armature.

  Said distal end portions of the catheters may be formed in said curved shape.

  These distal end portions may also be flexible, in which case the system includes mandrels having said curved shape, which may be slidably engaged in the catheters. The catheters are then engaged in the conduits or body structures to be treated with the mandrels introduced into them, so that they have said curved shape.

  After bonding the magnets, the mandrels are removed, which frees said distal end portions of this curved shape and thus facilitates both the detachment of the magnets and the removal of the catheters.

  The magnets can be fixed on the catheters; they can also be separable from them and are then intended to be implanted and to maintain the junction of the zones of the walls of the conduits or body structures connected to one another.

  The magnets may be permanent magnets or electromagnets.

  The invention will be better understood, and other features and advantages thereof will become apparent, with reference to the attached schematic drawing, showing, by way of non-limiting example, several possible embodiments of the minimally invasive system that it concerned.

  Figure 1 is a perspective view of a distal end portion of a catheter that includes; Figure 2 is a side view of this distal end portion; Figure 3 is a view of two body conduits to be communicated with each other, in each of which is engaged a catheter having a distal end portion as shown in Figures 1 and 2; Figures 4 to 8 are views similar to Figure 3, during different successive stages of the realization of the communication of the two body conduits; and FIGS. 9 to 11 are communication views of two body ducts made in different ways.

  FIGS. 1 and 2 show the distal end portion 1 of a catheter forming part of a minimally invasive system for communicating two body passages 100 visible in FIGS. 3 to 8.

  The minimally invasive system comprises two identical catheters, one of which is intended to be engaged in one of the body conduits 100 and the other is intended to be engaged in the other of these body conduits 100.

  Each catheter has a length such that it can be introduced, through its distal end portion 1, into one of the body conduits 100 and can be slid into this conduit to the communication site to be created, while having its proximal end protruding outside the patient.

  As shown in FIGS. 1 and 2, the distal end portion 1 of each catheter has a bent distal end portion 2, such that the distal opening 3 of the catheter normally extends in a plane substantially parallel to the longitudinal direction of the catheter. the non-curved portion 4 of the catheter.

  Each catheter may be made of a common synthetic material, such that it has sufficient longitudinal rigidity to allow its engagement and sliding in a body duct 100 but that it has a certain flexibility in the transverse direction, allowing a degree of deformation elastic.

  On its distal end, the distal end portion 1 comprises a circular permanent magnet 5, fixed coaxially at this end, flush with the opening 3. The magnets 5 of the two catheters can attract each other and stick together. one another coaxially through the tissues defining the body conduits 100.

  The minimally invasive system also comprises a guide wire 6, visible in FIGS. 4 to 8. It is a sufficiently rigid wire or wire in the longitudinal direction to be able to be inserted and slid into the light of the one then the other catheters, and sufficiently elastically flexible in the transverse direction to be curved as shown in Figures 4 to 7.

  The minimally invasive system further comprises a connecting device 7 including a catheter 8, a sheath 9, a stentable expandable armature 10 and an inflatable balloon 11.

  The catheter 8 can be engaged and slid on the guide wire 6 as shown in FIG. 6. During this engagement, the sheath 9 covers the armature 10, itself placed above the balloon 11, and holds this armature 10 in the folded state. The catheter 8 further comprises a distal cone 12, promoting its engagement in one of the body conduits 100 and allowing the engagement of its distal portion comprising the balloon 11 and the armature 10 through the tissue delimiting the body conduits 100.

  The armature 10 has, in the expanded state, a double-collar shape connected by a tubular central part. As shown in Figure 8, the central portion of the armature 10 is, after establishment of this armature, intended to extend at the walls of two ducts 100, and each collar is intended to bear against the wall of one of the ducts 100, on the inside side of this duct.

  The balloon 11 can be inflated after removal of the sheath 9, while it is engaged through the tissue delimiting the body conduits 100. It thus forms a means of widening the holes created in the tissues of the two body conduits 100 by the wire 6, and allows and / or promotes the deployment of the frame 10. If the latter is tubular and identical structure over its entire length, the balloon 11 has a shape adapted to the shape to be given to this frame 10, the deployed state of it. On the other hand, if the armature 10 is provided at its center with a rigid part preventing its deployment beyond a certain diameter, during the inflation of the balloon 11, the deployment will be symmetrical up to the maximum diameter of the center, then, beyond this diameter, the continued inflation of the balloon 11 will lead to the expansion of the ends in a plane perpendicular to the axis of the balloon 11 giving its final shape to the frame 10 with a flange at both ends and a central tubular portion of smaller diameter.

  In practice, one of the catheters is engaged and is slid into one of the body conduits 100 until its distal end is at the site of the communication to be created, and the other catheter is engaged and is slid into the other bodily conduit, also until its distal end is at the site of communication (see Figure 3). In certain situations, a catheter or both is engaged and slid on a guide wire previously set up to the level of the communication to be created. The positioning of the catheter can thus be facilitated in the event of communication to be created in an area difficult to access.

  The distal ends of the two catheters are then brought together, and possibly oriented, so as to cause the two magnets 5 to attract each other through the walls of two body conduits 100 and then to bunch up, this connection bringing the walls of two ducts. 100 in contact with each other (see Figure 4).

  The guide wire 6 is then engaged and slid into one of the catheters and then is caused to pierce the walls of two body conduits 100 and is then slid into the other catheter, as shown in FIG. 4.

  A pull is then made on the catheters so as to take off the magnets 5 and then the catheters are removed, as shown in FIG. 5. The flexibility of the catheters at their distal end portions 1 promotes this detachment and then the sliding of the catheters. on the guide wire 6.

  The connecting device 7 is then engaged and slid on the guide wire 6 (see FIG. 6) until the balloon 11 and the armature 10 are engaged through the walls of the two body conduits 100, on the other of these walls, as it appears in Figure 7.

  The sheath 9 is then removed and the balloon 11 is inflated so as to allow the deployment of the armature 10 and / or to perform this deployment. The flanges of the frame 10 then bear against the walls of the ducts 100 and thus maintain the maintenance of these two ducts in this state of communication.

  The balloon 11 is then deflated, then the connecting device 7 and the guide wire 6 are removed (see Figure 8).

  FIGS. 9 to 11 show that the system may comprise, in replacement of the armature 10, a tubular reinforcement 20.

  In the case of FIG. 9, this armature 20 is covered over its entire surface with a fluid-tight cover wall 21 flowing in the body conduits 100. The armature 20 is applied to the walls of the two ducts 100 so that its wall 21 serves to exclusively guide the flow of a body fluid from a conduit 100 to the other conduit 100.

  In the case of Figure 10, the tubular reinforcement 20 is covered by the cover wall 21 only on its portion engaged in one of the conduits 100; its portion engaged in the other conduit 100 is devoid of this wall 21 so that only the mesh structure of this armature 20 is present in this other conduit. The absence of the wall 21 on this second portion of the frame 20 allows the preservation of a body fluid flow in the conduit 100, beyond the communication zone with the other conduit, in addition to the communication created towards this other leads by means of the armature 20.

  In the case of FIG. 11, the tubular reinforcement 20, coated by a wall 21, has a flange 22 at one end, similar to the collar of the armature 10 and functioning in the same way to put the two ducts into communication. 100 and to maintain this communication. The tubular portion of the armature 20 is engaged in one of the ducts 100, is applied to the wall of this duct 100.

  The wall 21 also serves to exclusively guide the flow of a body fluid from a conduit 100 to the other conduit 100. The collar 22, the only portion of the armature 20 engaged in the other conduit 100, is placed at the level of the communication between the two body conduits 100, and is applied to the wall of the second duct 100. The body fluid flowing in the second duct 100 is therefore not disturbed by the presence of a mesh as in the figure 10.

  As will be seen from the foregoing, the invention provides a system for placing two body passages, in particular two veins, two arteries, or an artery and a vein, in communication with one another for treating circulatory insufficiency, the main advantages of which are to be truly miniinvasive and, in general, to give complete satisfaction.

  It goes without saying that the invention is not limited to the embodiment described above by way of example but that it encompasses all the variants covered by the claims ciannexées.

Claims (9)

  A minimally invasive system for communicating two conduits or body structures (100), characterized in that it comprises: two catheters, one of which is intended to be engaged in one of the conduits or body structures (100) to be treated and the other is intended to be engaged in the other of these conduits or body structures (100) to be treated, the distal end portions (1) of these catheters, that is to say those intended to be engaged in said body conduits or structures (100), being bent or curvatable so that the distal apertures (3) of said distal end portions (1) can be brought into close proximity to each other when the non-curved portions of the catheters extend more or less parallel to each other; circular magnets (5) connected to and coaxially with said distal end portions (1) and flush with said openings (3) of the distal end portions (1), which magnets (5) can attract mutually and coax each other coaxially through tissues defining the conduits or body structures (100) to be treated; tissue piercing means (6) defining the conduits or body structures to be treated which can be engaged and slid inside at least one of the catheters; - a guide wire (6), engageable and slidable within the catheters, and - a system (7, 10, 20) for connecting the two conduits or body structures (100), which can be engaged and slid to inside the catheters.   2 System according to claim 1, characterized in that it includes a communication expansion means created between the two conduits or body structures (100), including an inflatable balloon (11), the enlargement means can be engaged and slid on the guide wire (6).   3 System according to claim 1 or claim 2, characterized in that the connection system (7, 10, 20) comprises at least one expandable armature (10, 20) of the "stent" type, which can, in the non-state deployed, be engaged on both sides of the walls of the two ducts (100) and can be deployed to ensure the communication of conduits or structures (100) and / or the maintenance of this communication.   4 System according to claim 3, characterized in that a frame is in the form of double flanges connected by a narrowed central portion, the central portion being intended to extend at the walls of two ducts or structures, and each collar taking bearing against the wall of one of the ducts or structures, the side of the interior of this conduit or this structure.     System according to claim 3, characterized in that a reinforcement is tubular, is dimensioned so as to be able to extend on both sides of the communication, and comprises, or not, on the whole of its surface or on a only part of this surface, a waterproof cover wall.   6 System according to claim 3, characterized in that an armature (20) is composed on the one hand of a tubular portion dimensioned so as to be able to extend in one of the ducts or structures (100) and on the other hand a flange (22) bearing against the wall of the other conduit or structure (100), on the interior side of this conduit or structure, and now the tubular portion in connection with the other leads.   7 System according to one of claims 3 to 6, characterized in that the connection system (7, 10, 20) comprises a connection device (7) comprising a catheter including a sheath (9) for holding a frame deployable (10) in non-deployment position and a balloon (11) allowing or promoting the deployment of this frame (10).   System according to one of claims 1 to 7, characterized in that said distal end portions (1) of the catheters are formed in said curved shape.   System according to one of claims 1 to 7, characterized in that said distal end portions of the catheters are flexible and in that the system comprises mandrels having said curved shape, which can be slidably engaged in the catheters.     System according to one of claims 1 to 9, characterized in that the magnets (5) are fixed on the catheters.   11. System according to one of claims 1 to 9, characterized in that the magnets are separable from the catheters and are intended to be implanted and to maintain the junction of the zones of the walls of the conduits or body structures connected to one another. other.