# Patent

## Title
Endoprosthesis for vascular bifurcation

## Abstract

An apparatus for treating an area of bifurcation where a principal body conduit separates into at least two secondary conduits comprises a radially expandable first stent body. The first stent body has a substantially conical shape and a first end having a greater diameter than a second end when fully expanded. The first stent body is preferably shaped to be independent of any other stent bodies, and is free of any means for connecting to any other stent bodies when fully expanded.

## Background
This application is a continuation of International Application No. PCT/EP2002/012509, filed Nov. 8, 2002, which is incorporated by reference herein.


BACKGROUND OF THE INVENTION
The present invention relates to an apparatus and kit for the treatment of bodily conduits in the area of a bifurcation, that is to say in the area where a principal conduit separates into two secondary conduits. It also relates to equipment for positioning this apparatus.
The apparatus and kit of the invention can be used for the treatment of vascular bifurcations, in particular the carotid, femoral, iliac, popliteal, renal or coronary bifurcations, or nonvascular bifurcations, such as tracheal or biliary bifurcations, for example between the common bile and cystic ducts, or in the area of the bifurcation of the principal bile tract.
The treatment can consist in re-establishing the appropriate diameter of the bifurcation, in cases of arteriosclerosis or internal cell proliferation, in rectifying a localized or non-localized dissection in the wall of the conduit, or, in cases of aneurysm, in recreating a bifurcation of normal diameter, while eliminating the aneurysmal pouch.
DESCRIPTION OF THE PRIOR ART
It is known to treat narrowing of a rectilinear blood vessel by means of a radially expandable tubular apparatus, commonly referred to as a stent. This apparatus is introduced in the unexpanded state into the internal lumen of the vessel, in particular by the percutaneous route, as far as the area of narrowing. Once in place, it is expanded in such a way as to support the vessel wall and thus re-establish the appropriate cross section of the vessel.
The apparatus can be made of a non-elastic material, and in this case is expanded by means of an inflatable balloon on which it is engaged, or can be self-expanding, that is to say made of an elastic material, expanding spontaneously when withdrawn from a sheath which is holding it in the contracted state.
U.S. Pat. Nos. 4,733,665 and 4,886,062 are illustrative of existing apparatuses and of corresponding positioning techniques.
A conventional stent is not entirely suitable for the treatment of a narrowing situated in the area of a bifurcation, since its engagement both in the principal conduit and in one of the secondary conduits can cause immediate or delayed occlusion of the other secondary conduit.
It is known to reinforce a vascular bifurcation by means of a apparatus comprising two elements, each formed by helical winding of a metal filament. One of the two elements has two parts of diameter corresponding respectively to the diameter of the principal vessel and to the diameter of one of the secondary vessels, and is intended to be engaged on the one hand in this principal vessel and, on the other hand, in this secondary vessel. The other element has a diameter corresponding to the diameter of the other secondary vessel and is coupled to the first element, after the latter has been put into place, by engaging one or more of its turns in the turns of the first element.
This equipment permits reinforcement of the bifurcation but appears unsuitable for treating a vascular narrowing or an occlusive lesion, in view of its structure and of the low possibility of radial expansion of its two constituent elements.
Moreover, the shape of the first element does not correspond to the shape of a bifurcation, which has a widened transitional zone between the end of the principal vessel and the ends of the secondary vessels. Thus, this equipment does not make it possible to fully support this wall or to treat a dissection in the area of this wall. In addition, the separate positioning of these two elements seems relatively difficult.
U.S. Pat. No. 5,683,449 to Marcade (Marcade) discloses a bifurcated graft formed from a series of individual components that are intraluminally delivered apart from one another and then assembled to form a fully supported structure. The system includes a base member and one or more grafts connected thereto. Marcade's system requires overlapping connection of its components in order to achieve a fully supported structure and to lock the components to one another, thereby assuring a secure assembly and minimizing the possibility of leakage. Marcade discloses further that systems and methods that do not employ such an overlapping system are prone to acute and chronic failure whereby the graft could become displaced or collapsed.
U.S. Pat. No. 6,068,655 to Seguin et al. (the 655 Patent) discloses a apparatus having a first segment that is conical in shape, at least one secondary segment, and a flexible link between segments. The flexible link enables the adjustment of segments relative to each other, but maintains them in connection with one another, limiting their independent positioning.
SUMMARY OF THE INVENTION
Prior art apparatuses are not sufficient for treating areas of vascular bifurcation because they require a connection, either direct or indirect, between multiple apparatus segments. This connection forces segments to be aligned relative to one another, as opposed to being aligned according to the shape and curvature of bifurcated vessels to be treated. This decreases the flexibility of the apparatus. In addition, segments connected so as to be directly adjacent or overlapping further decrease the flexibility of the apparatus. Such apparatuses are problematic, for example, for treating a bifurcated secondary conduit that has an axis perpendicular to the axis of the primary conduit.
The present invention aims to overcome various of these disadvantages by making available apparatus with which it is possible to treat a pathological condition in the area of a bifurcation, by fully supporting the vascular wall and by being relatively simple to position.
The apparatus to which the invention relates comprises a conical segment shaped to conform to the shape of the bifurcation in the area of a widened transitional zone. The conical segment is shaped to conform to the increasing cross section of the principal conduit at an area of and facing the vascular bifurcation.
In embodiments, the distal end of the stent may expand to a diameter that is at least about 105% of the diameter of the proximal end of the stent. In embodiments, the distal end of the stent may expand to a diameter that is at least about 110% of the diameter of the proximal end of the stent.
In embodiments, the apparatus comprises only a body (i.e., segment) which has, in a predetermined expanded state, a truncated shape, corresponding to the shape of the bifurcation in the area of the widened transitional zone which separates the principal conduit from the secondary conduits. In this way, only a single stent is required to treat a vascular bifurcation, thereby eliminating the need for the surgical insertion, positioning and coordination of multiple stent segments.
In embodiments, the apparatus comprises:

    
    
        at least one radially expandable segment which has, in a predetermined expanded state, a cross section substantially greater than the cross section of one of the secondary conduits; and
        a segment which has, in a predetermined expanded state, a truncated shape, corresponding to the shape of the bifurcation in the area of the widened transitional zone which separates the principal conduit from the secondary conduits.
    
    


In these embodiments, the segments do not overlap one another, and are not linked together and preferably include no means for being linked together. In this way, optimal positioning of stent segments can be achieved independently from one another. For the purposes of this application, an “unlinked segment” is defined as an independent segment that is neither directly nor indirectly connected to any other surgical apparatus, such as additional stents or segments, when the independent segment is in its predetermined, fully expanded state.
For the sake of simplification, the segment which has, in the expanded state, a cross section substantially greater than the cross section of one of the secondary conduits will be referred to hereinafter as the “secondary segment,” while the segment which has, in the expanded state, a truncated shape will be referred to hereinafter as the “truncated segment.”
In embodiments, the conical stent body may be packaged with a packaging element in a kit for treating an area of vascular bifurcation. In embodiments, the kit may include only the conical stent body and packaging element. Alternatively, the kit may further include at least one secondary stent body.
The secondary segment is intended to be introduced into the secondary conduit in the contracted state and to bear, in the expanded state, against the wall of this conduit. This expansion not only makes it possible to treat a narrowing or a dissection situated in the area of this conduit, but also to ensure perfect immobilization of the apparatus in the conduit.
In this position of the apparatus, the truncated segment bears against the wall of the conduit delimiting the widened transitional zone of the bifurcation, which it is able to support fully. A narrowing or a dissection occurring at this site can thus be treated by means of this apparatus, with uniform support of the vascular wall, and thus without risk of this wall being damaged.
The two non-overlapping, unlinked segments orient themselves suitably independently from each other upon their expansion.
In embodiments, at least the truncated segment is covered by a wall which gives it impermeability in a radial direction.
This wall makes it possible to trap, between it and the wall of the conduit, particles which may originate from the lesion being treated, such as arteriosclerotic particles or cellular agglomerates, and thus to avoid the migration of these particles in the body.
Moreover, the apparatus can permit treatment of an aneurysm by guiding the liquid through the bifurcation and thereby preventing stressing of the wall forming the aneurysm.
The segments can be made from tubes of material of a different diameter, with the tube for the truncated segment having a larger diameter than the tube for the secondary segment. The tubes may be comprised of the same material. The use of tubes of different diameters results in the truncated segment having a larger radial force, especially at larger diameters.
Alternatively, the segments can be made from a single tube with different patterns of cuts to result in different shapes and sizes.
The apparatus can comprise several secondary segments, placed one after the other, to ensure supplementary support of the wall of the secondary conduit. To this same end, the apparatus can comprise, on that side of the truncated segment directed toward the principal conduit, at least one radially expandable segment having, in the expanded state, a cross section which is substantially greater than the cross section of the principal conduit.
According to embodiments of the invention, apparatus segments have a meshwork structure, the meshes being elongated in the longitudinal direction of the apparatus, and each one having a substantially hexagonal shape; the meshes of the truncated segment have a width which increases progressively in the longitudinal sense of the apparatus, in the direction of the end of this segment having the greatest cross section in the expanded state.
This increase in the width of the meshes is the result of an increase in the length of the edges of the meshes disposed longitudinally and/or an increase in the angle formed between two facing edges of the same mesh.
In addition, the truncated segment can have an axis not coincident with the longitudinal axis of the secondary segment, but oblique in relation to this axis, in order to be adapted optimally to the anatomy of the bifurcation which is to be treated.
The apparatus can be made of a metal with shape memory. This metal is preferably the nickel/titanium alloy known by the name NITINOL.
The equipment for positioning the apparatus comprises means for permitting the expansion of this apparatus when the latter is in place. These means can comprise a removable sheath in which the apparatus is placed in the contracted state, when this apparatus is made of an elastic material, or a support core comprising an inflatable balloon on which the apparatus is placed, when this apparatus is made of a non-elastic material.
In either case, this equipment comprises, according to the invention, means with which it is possible to identify, through the body of the patient, the longitudinal location of the truncated segment, so that the latter can be correctly positioned in the area of the widened zone of the bifurcation.
In the case where the expansion of this same segment is not uniform in relation to the axis of the apparatus, the equipment additionally comprises means with which it is possible to identify, through the body of the patient, the angular orientation of the apparatus in relation to the bifurcation, so that that part of this segment having the greatest expansion can be placed in a suitable manner in relation to the bifurcation.



BRIEF DESCRIPTION OF THE DRAWINGS
To ensure that it is fully understood, the invention is again described hereinbelow with reference to the attached diagrammatic drawings which show, by way of non-limiting example, embodiments of the apparatuses to which the invention relates.
FIG. 1 is a side view thereof, according to a first embodiment;
FIG. 2 is a perspective view of apparatuses of the invention in a state of radial contraction, and, in partial cutaway, of the equipment allowing it to be positioned;
FIG. 3 is a longitudinal sectional view of a bifurcation to be treated;
FIGS. 4 to 6 are views of this bifurcation similar to FIG. 3, during three successive stages of positioning of apparatuses of the invention;
FIG. 7 is a view, similar to FIG. 3, of a bifurcation presenting an aneurysm, in which apparatuses of the invention are placed, and
FIG. 8 is a side view of apparatuses according to a second embodiment.



DESCRIPTION OF EMBODIMENTS
FIG. 1 shows expandable apparatus 1 permitting the treatment of bodily conduits in the area of a bifurcation, that is to say, as is shown in FIG. 3, in the area where a principal conduit 2 separates into two secondary conduits 3.
In embodiments, the apparatus 1 comprises a conical segment having a proximal end 5 and a distal end 6, and at least one secondary segment(s) having a proximal end 7 and a distal end 8, each of meshwork structure, which are non-overlapping and unlinked as illustrated at 9. The apparatus 1 may optionally include a third segment 200, as well. In some embodiments, the third segment 200 has, in an expanded state, a substantially cylindrical shape and a cross section substantially greater than a cross section of a secondary conduit 3.
The meshes 10 of these segments are elongated in the longitudinal direction of the apparatus 1 and have in each case a substantially hexagonal shape.
The proximal end 5 of the conical segment has a tubular shape and has a diameter which is substantially greater than the diameter of the principal conduit 2.
The distal end 6 of the conical segment has meshes 10 whose width increases progressively, compared to that of the meshes of the proximal end 5, on the one hand in the longitudinal sense of the apparatus 1, in the direction of the end of the distal end 6 situated opposite the proximal end 5.
A transverse increase in the width of the meshes 10 may result from an increase in the length of the edges 10a of the meshes 10 disposed longitudinally, as well as an increase in the angle formed between two facing edges 10a. 
This conical segment thus has a truncated shape with an axis which is oblique in relation to the longitudinal axis of the apparatus 1. This shape corresponds to the shape of the bifurcation in the area of the widened transitional zone 11 which separates the end of the principal conduit 2 from the ends of the secondary conduits 3.
In various alternate embodiments, the conical segment may continuously taper from the proximal end to the distal end, or the tapering may vary as appropriate.
The proximal end 7 and distal end 8 of the secondary segment have an identical diameter, which is substantially greater than the diameter of one of the secondary conduits 3.
The apparatus 1 may be made by appropriate cutting of a sheet of nickel/titanium alloy known by the name NITINOL, then folding the resulting blank into a circle and welding the parts of this blank which come into proximity with each other.
This alloy is malleable at a temperature of the order of 10□C. but can recover its neutral shape at a temperature substantially corresponding to that of the human body.
FIG. 2 shows the apparatus 1 in a state of radial contraction, obtained by cooling its constituent material. During this contraction, the edges 10a pivot in relation to the transverse edges 10b of the meshes 10, in such a way that the meshes 10 have, in this state of contraction, a substantially rectangular shape.
By virtue of this contraction, the segments 5 a cross section which is smaller than that of the conduits 2 and 3, and they can be introduced into these, as will be described hereinafter.
The apparatus 1 is engaged on a central support core 15, and is then contracted radially on the latter. This core 15 comprises an axial abutment such as a shoulder (not visible in FIG. 2) which has a diameter smaller than that of the apparatus 1 when this apparatus is expanded, but greater than the diameter of this apparatus 1 when the latter is contracted. This abutment consequently permits the axial immobilization of the apparatus 1 on the core 15 when the latter is contracted.
A sheath 16 is then engaged on the apparatus 1 in order to hold it in its contracted state. This sheath 16 may include, e.g., four radiopaque markers 20, 21, 22, 23 impressed on it, containing, for example, a barium compound. Three markers 20, 21, 22 have an annular 5 shape and extend round the whole periphery of the sheath 16. They are situated, respectively, in the area of the free ends of the segments. The fourth marker 23 is situated at substantially the halfway point of the generatrix of the segment 6. It has a diamond shape and a small thickness.
The core 15 has a longitudinal axial hole permitting its engagement on a guide wire 25 (FIGS. 4 to 6). This wire 25 can be engaged, by the percutaneous route, in the conduit 2, by way of the zone 11, and then in one of the conduits 3, through which it can slide, and comprises a cone 26 of synthetic material, situated in front of the assembly consisting of core 15, apparatus 1 and sheath 16.
The bifurcation 30 shown in FIG. 3 has excrescences 31 which create a narrowing in cross section, which impedes the flow of the liquid circulating in the conduits 2 and 3. In the case of a vascular bifurcation, these excrescences may be due, for example, to arteriosclerosis or cellular growth.
The apparatus 1 permits treatment of this bifurcation by re-establishing the appropriate diameter of the conduits 2, 3 and of the widened zone 11.
As appropriate, depending on whether reinforcement is needed in the secondary conduits, the conical segment may be used alone in the widened area of bifurcation, or it may be used in conjunction with one or more secondary segments.
In practice, as can be seen in FIG. 4, the assembly consisting of core 15, apparatus 1 and sheath 16 may be engaged on the wire 25 as far as the cone 26. By means of its sliding action, this wire 25 permits the engagement and then the guiding of this assembly in the conduit 2, the zone 11 and then the conduit 3. The cone 26 facilitates the sliding of the assembly and reduces the risk of trauma.
The marker 22 makes it possible to visualize, with the aid of a suitable radiography apparatus, the position of the conical segment, and thus to visualize the location of the conical segment so that it can be correctly positioned in relation to the widened zone 11.
With the markers 20 and 21 it is possible to ensure that the segments are correctly positioned in the principal conduit 2 and the secondary conduit 3.
The marker 23 is, for its part, visible in a plan view or an edge view, depending on whether it is oriented perpendicular or parallel to the radius of the radiography apparatus. It thus makes it possible to identify the angular orientation of the apparatus 1 in relation to the bifurcation 30, so that the part of the conical segment having the greatest expansion can be placed in an appropriate manner in relation to the zone 11.
The sheath 16, which has a length such that it opens out beyond the opening having permitted introduction of the assembly, is then progressively withdrawn, as is shown in FIGS. 5 and 6, in order to permit the complete expansion of the apparatus 1. The latter is reheated by the body temperature, and this permits its expansion, or it may expand by simple spring force without temperature effects. After complete expansion of the apparatus 1, the core 15 and the wire 25 are withdrawn.
FIG. 7 shows that the apparatus 1 can also be used to treat an aneurysm 40. At least a portion of the conical segment is covered by a polyester film 41, impermeable to the liquid circulating in the conduits, which film, for example, is sewn onto them. The apparatus then guides this liquid through the bifurcation 30 and consequently prevents stressing of the wall forming the aneurysm 40.
FIG. 8 shows a apparatus 100 according to the invention, having segments 105, 106, 107, 108, with a structure similar to that of the segments 5 to 8 in the apparatus shown in FIG. 1.
In the apparatus 100, individual segments include six omega-shaped bridges 190. The curved central part 190a of these bridges 190 has a multidirectional elasticity permitting the appropriate longitudinal orientation of the various segments in relation to one another.
The advantage of these bridges 190 is that they provide individual segments, and thus the apparatus, with longitudinal continuity, which facilitates the passage of said apparatus into a highly curved zone and which eliminates the need to reduce this curvature, which is always dangerous in the cases of arteriosclerosis, so as to permit the passage of the apparatus.
The invention thus provides apparatuses permitting the treatment of a pathological condition in the area of a bifurcation 30. These apparatuses have the many advantages indicated above, in particular those of ensuring a perfect support of the vessel wall and of being relatively simple to position.
It goes without saying that the invention is not limited to the embodiments described hereinabove by way of example, but instead embraces all the variant embodiments.
Thus, the apparatuses 1 and 100 can comprise a single, conical segment, or a conical segment and one or several secondary segments placed one after the other, in order to ensure supplementary support and, if need be, to increase the hold of the apparatus in the bifurcation 30.
The core 15 could comprise an inflatable balloon, either to effect the expansion of the apparatus 1, in the case where the latter is made of a nonelastic material, or to ensure the total expansion of a self-expanding apparatus 1 after the latter has been put into place.
The markers 20 to 23 could be impressed on the core 15 or directly on the apparatus 1.
The conical segment could have an axis coincident with the longitudinal axis of the apparatus, and not oblique in relation to this axis, if such is rendered necessary by the anatomy of the bifurcation which is to be treated.
In addition, the secondary segment could itself have, in the expanded state, a widened shape corresponding to the shape of the widened connecting zone via which, in certain bifurcations, the secondary conduits 3 are connected to the widened transition zone 11. The secondary segment would thus have a shape corresponding to the shape of this widened connecting zone, and would ensure perfect support thereof.
The bridges 190 could be greater or smaller in number than six, and they could have a shape other than an omega shape, permitting their multidirectional elasticity, and in particular a V shape or W shape.
As discussed above, the conical stent body may be packaged with a packaging element 202 in a kit for treating an area of vascular bifurcation. In embodiments, the kit may also include only the conical stent body and packaging element 202. Alternatively, the kit may further include at least one secondary stent body.
The stent system described may be adapted as mentioned above to treat any of a number of bifurcations within a human patient. For example, bifurcations of both the left and right coronary arteries, the bifurcation of the circumflex artery, the carotid, femoral, iliac, popliteal, renal or coronary bifurcations. Alternatively this apparatus may be used for nonvascular bifurcations, such as tracheal or biliary bifurcations, for example between the common bile and cystic ducts, or in the area of the bifurcation of the principal bile tract.

## Claims

1. An apparatus for treating an area of bifurcation where a principal body conduit separates into at least two secondary conduits and wherein the principal conduit increases in cross section to the junction with the multiple conduits, said apparatus comprising:
a radially expandable first stent body configured to be engaged in the primary conduit in the area of bifurcation, said first stent body having, in a predetermined fully expanded state, a substantially conical shape and a first, downstream end having a diameter at least 105% of the diameter of a second, upstream end, and a cross section substantially greater than a cross section of one of the secondary conduits;
the first stent body being shaped to conform to the increasing cross section of the principal conduit, in the area of a widened transitional zone of the bifurcation that separates the principal conduit from the secondary conduits, in the direction of at least one secondary conduit,
said first stent body having a plurality of struts that extend in a longitudinal direction from the first stent body, wherein struts at the first, downstream end have a greater length than struts at the second, upstream end,
said first, downstream end configured to be positioned downstream with respect to said second, upstream end and configured to open out in the direction of said secondary conduits upon expansion, and
said second, upstream end configured to be positioned upstream with respect to said bifurcation,
the first, downstream end being substantially conical and the second, upstream end being substantially cylindrical, the diameter of the second, upstream end substantially greater than the diameter of the principal conduit,
the first stent body being shaped to be independent of any other stent bodies, and free of any means for connecting to any other stent bodies, when the first stent body is in a predetermined fully expanded state.

2. The apparatus of claim 1, further comprising at least one radially expandable second stent body having, in a predetermined fully expanded state, a substantially cylindrical shape, said second stent body being configured to be engaged in a said secondary conduit; the cross section of the at least one second stent body, in the predetermined expanded state, being less than the cross section of the first and second ends of the first stent body when the first stent body is in its predetermined expanded state.

3. The apparatus of claim 2, the first stent body being configured to be engaged in the principal conduit only, and the at least one second stent body being configured to be engaged in one secondary conduit only.

4. The apparatus of claim 2, said first and second stent bodies being made from first and second tubes of material, respectively, the first tube having a larger diameter than the second tube.

5. The apparatus of claim 4, said tubes being made of the same material.

6. The apparatus of claim 2, further comprising a plurality of radially expandable second stent bodies capable of being placed one after the other in a said secondary conduit and having, in the predetermined expanded state, a cross section that is substantially greater than the cross section of that secondary conduit.

7. The apparatus of claim 2, said first and second stent bodies having a meshwork structure formed of meshes elongated in a longitudinal direction of the apparatus, each mesh having a substantially hexagonal shape, wherein the meshes of said first stent body have a width which increases progressively in the longitudinal direction of the apparatus with the meshes toward the first end of the first stent body having the greatest cross section in the expanded state.

8. The apparatus of claim 2, further comprising at least one radially expandable third segment having, in an expanded state, a substantially cylindrical shape and a cross section that is substantially greater than the cross section of the secondary conduit.

9. The apparatus of claim 1, the diameter of the first stent body continuously decreasing from the first end to the second end thereof.

10. A kit for treating an area of vascular bifurcation where a principal conduit separates into at least two secondary conduits and wherein the principal conduit increases in cross section to the junction with the multiple conduits, said kit comprising:
a packaging element, and
a radially expandable first stent body configured to be engaged in the primary conduit in the area of bifurcation where a principal conduit separates into at least two secondary conduits and wherein the principal conduit increases in cross section to the junction with the multiple conduits;
the first stent body having, in a predetermined fully expanded state, a substantially conical shape and a first, downstream end having a diameter at least 105% of the diameter of a second, upstream end, and a cross section substantially greater than a cross section of one of the secondary conduits, the first stent body being shaped to conform to the increasing cross section of the principal conduit, in the area of a widened transitional zone of the bifurcation that separates the principal conduit from the secondary conduits, in the direction of at least one secondary conduit,
said first stent body having a plurality of struts that extend in a longitudinal direction from the first stent body, wherein struts at the first, downstream end have a greater length than struts at the second, upstream end,
said first, downstream end configured to be positioned downstream with respect to said second, upstream end and configured to open out in the direction of said secondary conduits upon expansion, and
said second, upstream end configured to be positioned upstream with respect to said bifurcation,
the first, downstream end being substantially conical and the second, upstream end being substantially cylindrical, the diameter of the second, upstream end substantially greater than the diameter of the principal conduit,
the first stent body being shaped to be independent of any other stent bodies, and free of any means for connecting to any other stent bodies, when the first stent body is in a predetermined fully expanded state.

11. The kit of claim 10, said kit consisting only of said packaging element and said first stent body.

12. The kit of claim 10, further comprising at least one radially expandable second stent body having, in a predetermined fully expanded state, a substantially cylindrical shape, said second stent body being configured to be engaged in a said secondary conduit;
the cross section of the at least one second stent body, in the predetermined expanded state, being less than the cross section of the first and second ends of the first stent body when the first stent body is in its predetermined expanded state.