Patent Description:
Aneurysms or ulcers of the descending thoracic aorta or aortic arch can be treated by insertion of a stent graft into an appropriate position. Owing to the curvature of the aorta, it is desirable to try and create conformance of the stent graft with the curve of the aorta.

One known stent graft for doing so includes a proximal alignment stent and a sealing stent distal of the alignment stent. The sealing stent has a suture attached to it for creating better conformance with the curve of the aorta.

<CIT> discloses an assembly of stent grafts with diameter reducing ties. <CIT> discloses a stent graft and introducer assembly.

Aspects of the present invention seek to provide an approved stent graft and/or stent graft delivery system.

According to an aspect of the invention, there is provided a stent graft, including:.

According to an aspect of the disclosure, there is provided a stent graft, including:.

It will be appreciated that 'pass circumferentially around' does not necessarily mean passing circumferentially around the entire circumference. In some embodiments, the loop element is configured to pass circumferentially around only a part of the circumference of the graft body and/or distal end of the sealing stent.

In some embodiments, the loop element is configured to have a release wire pass through the loop externally to the graft body.

In embodiments, the diameter reducing loop arrangement is configured to pass around the entire circumference of the graft body and/or distal end of the sealing stent.

In some embodiments, the first end of the loop element is attached to the distal end of the sealing stent.

In some embodiments, the loop element is a first loop element and the diameter reducing loop arrangement includes a second loop element, the second loop element including a first end, a second end, and a strand section from the first end to the second end, the first end being attached at the distal end of the sealing stent, for example to the distal end of the sealing stent, the second loop element being configured to pass circumferentially around the distal end of the sealing stent in the opposite direction to the first loop element and have the first loop element pass through a loop at the second end of the second loop element.

In some embodiments, the first ends of the first and second loop elements are attached to adjacent struts of the sealing stent.

In some embodiments, the first and second loop elements are configured to pass around the distal end of the sealing stent and overlap every distal apex of the sealing stent.

In some embodiments, each of the first and second loop elements has a length in the region of from <NUM>% to <NUM>% of an expanded diameter of the graft body.

In some embodiments, the sealing stent is completely overlapped by the graft body.

In some embodiments, every loop element of the diameter reducing loop arrangement contributes to an overall loop arrangement length, the overall loop arrangement length being in the region of from <NUM>% to <NUM>% of an expanded diameter of the graft body.

In some embodiments, the strand section of the first and/or second loop element is part of a strand which loops back on itself to form the respective loop.

In some embodiments, the first and/or second loop element includes a second strand section from the respective second end to the respective first end.

In some embodiments, the first and/or second strand section of the first and/or second loop element is attached to the sealing stent and/or graft body at a plurality of locations around the circumference of the graft body.

In some embodiments, the first and/or second strand section of the first and/or second loop element is attached to the sealing stent and/or graft body at distal apices of the sealing stent.

In some embodiments, the first and/or second strand section of the first and/or second loop element is attached to the graft body at a plurality of locations around the circumference of the graft body by penetrating the graft material at each of the plurality of locations.

In some embodiments, each of the first and/or second loop elements is attached to the graft body and/or sealing stent only at the distal end of the sealing stent.

In some embodiments, the diameter reducing loop arrangement is configured to be actuated by a single release wire.

In some embodiments, the diameter reducing loop arrangement is configured to be held in a constricting configuration by attachment to a release wire only at a single circumferential location.

In some embodiments, the stent graft includes a distal-most stent and at least one intermediate stent between the sealing stent and the distal-most stent; wherein every intermediate stent is free of diameter reducing ties.

In one embodiment, the loop element is a first loop element and the diameter reducing loop arrangement includes a second loop element, the second loop element including a first end, a second end, and a strand section from the first end to the second end, the first end being attached to the distal end of the sealing stent, the second loop element being configured to pass circumferentially around the distal end of the sealing stent in the opposite direction to the first loop element and have the first loop element pass through a loop at the second end of the second loop element;.

According to an aspect of the invention, there is provided a stent graft delivery system, including:.

The stent graft delivery system can include a pre-curved cannula on which the stent graft is retained, wherein the release wire extends within a passageway in a tubing along the cannula, passes out of the passageway in the tubing through a first aperture, passes through the loop at the second end of the first loop element, and passes through a second aperture back into the passageway of the tubing, wherein the release wire is external to the tubing on the outside of the curve of the pre-curved cannula.

The tubing is preferably around the cannula such that the passageway in the tubing is in between the tubing and the cannula. However, it is not excluded that the tubing could be the cannula itself and that the passageway could be the lumen of the cannula.

According to an aspect of the disclosure, there is provided a method of deploying a stent graft from the stent graft delivery system of the aspect above, including:.

In some embodiments including first and second loop elements, each of the first and second loop elements is configured to pass circumferentially around part of the circumference of the graft body and/or distal end of the sealing stent when constricting the distal apices of the sealing stent.

Embodiments of the invention can provide an enlarged and modified (as compared to prior art devices) diameter reducing tie suture to generate conformance in the aortic arch in wider spectra of different anatomies. This can decrease the amount of cases where the proximal sealing stent tilts inwards if used in extreme cases.

Embodiments of the invention can reduce tilting because the diameter reducing loop arrangement is not dependent on the position of a cannula. In particular, in embodiments of the invention, the constriction is provided by a circumferential arrangement rather than by radial ties to an inner cannula.

Embodiments of the present invention are described below, by way of example only, with reference to the accompanying drawings, in which:.

In this description, when referring to a delivery system, the term distal is used to refer to an end of a component which in use is furthest from the surgeon during the medical procedure, including within a patient. The term proximal is used to refer to an end of a component closest to the surgeon and in practice in or adjacent an external manipulation part of the delivery system.

On the other hand, when referring to a stent graft, the term proximal refers to a location which in use is closest to the patient's heart, in the case of a vascular implant, and the term distal refers to a location furthest from the patient's heart.

One problem which has been identified by the inventors is that, in some instances of implanting a stent graft into the aorta, especially if the stent graft is used in extreme cases, the proximal sealing stent can be caused to tilt inwards or proximally. As described below, embodiments of the present invention are able to reduce such tilting using a diameter reducing loop arrangement as described. In particular, as described below, embodiments of the invention are able to generate a cone shape for the proximal sealing stent in a manner which is less dependent on the position of the cannula, allowing the proximal sealing stent to deploy in a more angular position, leading to a better conformance in the aortic curve. The diameter reducing loop arrangement described below can reduce proximal tilt of the sealing stent particularly in straight aorta sections.

Referring to the Figures, <FIG> shows a part of a stent graft <NUM>. The stent graft <NUM> includes a cylindrical graft body <NUM> having a proximal end <NUM> and a distal end <NUM> (the distal end is shown in <FIG>). The graft body in this embodiment is constructed of a woven polyester fabric, but other suitable materials can be used in other embodiments.

Stent graft <NUM> includes a sealing stent <NUM> at the proximal end of the graft body <NUM> attached to the graft body <NUM> and completely overlapped by the graft body <NUM>. It is noted that the term 'overlap' is not intended to imply a relative radial position; an element can be overlapped on the radially internal or external side, or on a combination of radial internal and external. In the embodiment shown in the figures, the sealing stent is an internal stent and is externally overlapped by the graft body <NUM>. However, in other embodiments, the sealing stent can be an external stent and can be internally overlapped by the graft body <NUM>.

The sealing stent includes proximal apices <NUM> at a proximal end thereof <NUM> and distal apices <NUM> at a distal end thereof (labelled in <FIG>).

In the embodiment shown in the figures the sealing stent <NUM> comprises barbs in a conventional manner to improve fixation, although this is not necessary in every embodiment. In this embodiment the barbs protrude through the graft body because the sealing strut is internal.

In the embodiment shown in the figures, the stent graft also includes an alignment stent <NUM> at the proximal end of the graft body <NUM>. The alignment stent <NUM> is not completely overlapped by the graft body <NUM>, but extends proximally of the graft body <NUM>, providing a partially exposed or bare stent. In this embodiment, the alignment stent is attached to the graft body <NUM> only at its distal apices. In this embodiment, the proximal apices of the alignment stent have a greater radius of curvature than the distal apices.

It is noted that it is not necessary to have an alignment stent in every embodiment. Also, it is not necessary for the sealing stent to be completely overlapped by the graft body <NUM> in all embodiments; however, at least a majority of the sealing stent is overlapped by the graft body <NUM>.

The stent graft <NUM> includes a distal-most stent <NUM> (shown in <FIG>) which is completely overlapped by the graft body <NUM>, or of which at least a majority is overlapped by the graft body <NUM>.

The stent graft also includes a plurality of intermediate stents <NUM> attached to the graft body <NUM> between the sealing stent <NUM> and the distal most stent <NUM> such that the graft body is fully stented to provide stability and expansile force to open the lumen of the graft body during deployment. The intermediate stents <NUM> are spaced from each other and from the sealing and distal-most stents longitudinally along the length of the graft body <NUM>. In the embodiment shown in the figures, the distal-most stent and the intermediate stents are external stents. However, in other embodiments they can be internal stents, or some can be internal and some can be external.

As can be seen, all of the stents extend around the circumference of the stent graft in a zig-zag configuration, alternating between proximal and distal apices with each proximal apex connected to each of its neighbouring distal apices by a generally straight portion.

In this embodiment the stents are self-expanding nitinol stents and the attachment is by being sewn to the graft body with braided polyester and monofilament polypropylene suture. However, other materials and forms of attachment can be used in other embodiments. In some embodiments, the stents can be balloon expandable.

In the embodiment shown in the figures, the stent graft <NUM> is not tapered. However, in other embodiments it can be tapered. In tapered embodiments, the proximal end <NUM> has a first diameter and the distal end <NUM> has a second diameter which is less than the first diameter. In tapered embodiments, the stent graft preferably includes a proximal section with the first diameter, a distal section with the second diameter, and a tapered section between the proximal and distal sections, meaning that the stent graft is tapered for only part of its length. Note of course that these diameters for the stent graft refer to an expanded configuration.

Typical (expanded) diameters for the stent graft <NUM> in non-tapered embodiments, or for the first diameter in tapered embodiments, are in the range of <NUM> to <NUM>. However, other diameters can be used in other embodiments in dependence on the patient and the procedure.

The dimensions, materials, configuration, and deployment procedure for the graft body <NUM> and stents attached thereto can, except where otherwise indicated, be as for the Zenith Alpha Thoracic Proximal Grafts, available from Cook®, for example those with product numbers ZTA-P-XX-YY or ZTA-PT-XX-YY. Examples of Zenith Alpha Thoracic Proximal Grafts can be seen in <FIG> which shows proximal and distal components for different types of Zenith Alpha Thoracic Endovascular Grafts. <FIG> shows an example of the implantation of a Zenith Alpha Thoracic Graft.

In the embodiment of <FIG>, radiopaque markers, in this embodiment gold markers, are placed on stent apices at the proximal and distal aspects of the graft margins denoting the edge of the graft material, to assist with deployment accuracy, although this is not necessary in every embodiment.

The stent graft <NUM> includes a diameter reducing loop arrangement <NUM> to reduce the diameter around the distal end of the sealing stent <NUM> to lead to an angled position or conical configuration of the sealing stent. The diameter reducing loop arrangement <NUM> comprises a first loop element <NUM> and a second loop element <NUM>. The first loop element <NUM> includes a first end <NUM> and a second end <NUM>. The first loop element <NUM> includes a strand section from the first end <NUM> to the second end <NUM>. The first loop element <NUM> includes a loop at the second end <NUM>. In the embodiment shown in the figures, the first loop element consists of a single strand which passes from the first end <NUM> to the second end <NUM> where it loops back on itself to the first end <NUM>, thereby forming a loop at the second end <NUM>. In this way, the first loop element <NUM> includes a first strand section from the first end <NUM> to the second end <NUM> of the first loop element <NUM> and a second strand section from the second end <NUM> to the first end <NUM> of the first loop element <NUM>. However, in other embodiments, the first loop element can include a loop at the second end <NUM> without the strand section necessarily being part of a single strand which loops all the way back to the first end <NUM>. For example, the strand can be tied to itself at a point between the first and second ends <NUM>, <NUM>, for example by the second strand section extended from the second end <NUM> and being tied to the first strand section between the first and second ends <NUM>, <NUM> of the first loop element <NUM>.

The first end <NUM> of the first loop element is attached at the distal end of the sealing stent <NUM>, in this embodiment to the distal end of the sealing stent <NUM>, although in other embodiments it can be attached to the graft body. In the embodiment shown in the figures, the first end <NUM> of the first loop element <NUM> is tied to the sealing stent <NUM> with a knot at a first distal apex of the sealing stent <NUM>. Furthermore, in the embodiment shown in the figures, owing to the fact that the strand of the first loop element loops all the way back to the first end <NUM>, both ends of the strand are tied to the sealing stent <NUM> at the first distal apex of the sealing stent <NUM>. In particular, the first end <NUM> of the first loop element <NUM>, and therefore both ends of the strand of the first loop element <NUM>, are tied to a strut or leg of the sealing stent at the first distal apex.

The second loop element <NUM> includes a first end <NUM> and a second end <NUM>. The second loop element <NUM> is similar to the first loop element <NUM> already described.

The second loop element <NUM> is attached at the distal end of the sealing stent, in this embodiment to the distal end of the sealing stent in the same manner as described above for the first loop element <NUM>, although, as for the first loop element <NUM>, in other embodiments the first end of the second loop element <NUM> can be attached to the graft body. In the embodiment shown in the figures the second loop element <NUM> is attached at the first distal apex, which is the same apex to which the first end <NUM> of the first loop element <NUM> is attached. In other embodiments, it is possible for the first ends <NUM>, <NUM> of the first and second loop elements <NUM>, <NUM> to be attached at different apices, but this would provide less effective diameter restriction.

In the embodiment shown in the figures, the first ends <NUM>, <NUM> of the first and second loop elements <NUM>, <NUM> are attached to directly adjacent struts at the first distal apex of the sealing stent <NUM>. In other words, each is attached to the same stent leg, but on each side of the apex. This can be seen in <FIG>.

The first and second loop elements <NUM>, <NUM>, in particular the first and second strand sections thereof, are configured to pass or be wrapped circumferentially around the distal end of the sealing stent <NUM> in opposite directions from the respective first ends <NUM>, <NUM> such that the second ends <NUM>, <NUM> of the first and second loop elements <NUM>, <NUM> can meet in a constricting configuration. The constricting configuration can restrict the diameter of the distal end of the sealing stent. As described below, the second ends <NUM>, <NUM> can be retained by a release wire in the constricting configuration to maintain a constricted diameter at the distal end of the sealing stent. In the embodiment shown in the figures, the first and second loop elements <NUM>, <NUM>, in particular the strand sections thereof, are between them configured to pass around the entire circumference of the graft body <NUM> at the distal end of the sealing stent <NUM> in the constricting configuration. Each of the first and second loop elements <NUM>, <NUM> is configured to pass circumferentially around a part of the circumference of the graft body <NUM> at the distal end of the sealing stent <NUM> in the constricting configuration.

In the embodiment shown in the figures, the first and second loop elements <NUM>, <NUM>, in particular the strand sections thereof, pass circumferentially around the distal end of the sealing stent <NUM> in opposite directions, and overlap each distal apex of the sealing stent <NUM> which they pass such that between them they overlap every distal apex of the sealing stent.

The size of the loop elements determine the size of the diameter reduction of the distal end of the barbed sealing stent <NUM> in the constricting configuration and the angle of the conical shape created. The lengths of the loop elements <NUM>, <NUM> may vary depending on the (expanded) diameter of the stent graft <NUM> (which may vary for example from a diameter of <NUM> to a diameter of <NUM> as discussed above). For a stent graft with a (expanded) diameter of <NUM>, each of the loop elements <NUM>, <NUM> typically has a length of about <NUM>. Some other options are given in Table <NUM> below.

As can be seen, in preferred embodiments, each of the first and second loop elements has a length in the region of from <NUM>% to <NUM>% of the expanded diameter of the graft body, more preferably in the region of from <NUM>% to <NUM>% of the expanded diameter of the graft body. Furthermore, in preferred embodiments, an overall loop arrangement length (to which every loop element of the diameter reducing loop arrangement contributes and which is the combined length of the loop elements in these embodiments) is in the region of from <NUM>% to <NUM>% of the expanded diameter of the graft body, more preferably in the region of from <NUM>% to <NUM>% of the expanded diameter of the graft body. These dimensions are able to provide an advantageous angle to the conical shape created for the sealing stent. Indeed, the overall loop arrangement length can be selected so as to provide a desired angle to the sealing stent when it is held in a conical or frustoconical shape.

Although Table <NUM> is based on the assumption that the first and second loop elements are the same length as each other, the skilled person will appreciate that they do not need to be the same length. For example, it is possible to increase the length of one of the loop elements and reduce the length of the other, such that they are not the same length as each other, but such that they retain the same combined length dimension for example as given in Table <NUM>.

The skilled person will appreciate that the values above are lengths for the loop elements rather than for the strands forming the loop elements; the strands forming the loop elements are likely to be significantly longer than the values above if laid out in a straight line without loops.

In the embodiment shown in the figures, the first and second loop elements <NUM>, <NUM> pass circumferentially around the distal end of the sealing stent <NUM> in opposite directions, and the strand sections thereof are attached to the graft body and/or the sealing stent <NUM> at each respective distal apex of the sealing stent <NUM> which they pass. In other words, at every distal apex of the sealing stent <NUM>, the sealing stent <NUM> and/or the graft body <NUM> is attached to one or other of the first and second loop elements <NUM>, <NUM>. In the embodiment shown in the figures, the strand sections of the loop elements are attached to the graft body at each distal apex of the sealing stent <NUM> which they pass by penetrating the graft material at each of those apices.

The attachment of the strand sections of the first and second loop elements to the graft body and/or the sealing stent <NUM> at each distal apex of the sealing stent <NUM> which they pass can serve to control the loop elements to prevent them sliding off the distal end of the sealing stent and to make sure the loop elements do not get caught in a barb or knot when released. This can be seen in <FIG> and <FIG>. Furthermore, as can be seen in <FIG>, as a result of their attachment to the graft body at the distal apices of the sealing stent, the loop elements can only slide in the direction around the graft and not along the length of the graft.

In the embodiment shown in the figures, each of the first and second loop elements <NUM>, <NUM> passes a set of distal apices of the sealing stent <NUM> and is attached to the graft body <NUM> at each of the distal apices of the respective set by the loop element, in particular the strand sections thereof, weaving through the graft material at each of those distal apices. In the embodiment shown in the figures, at each of the distal apices of the respective set, the first and second strand sections of the respective loop element <NUM>, <NUM> penetrate the graft body <NUM> and pass from external of the graft body <NUM> to internal of the graft body <NUM>, pass around one of the struts of the sealing stent <NUM> at the distal apex and then pass from internal of the graft body <NUM> to external of the graft body <NUM>. In other words, the stand sections of the loop elements <NUM>, <NUM> pass radially internally of the graft body <NUM> around one of the two struts at each distal apex of the respective set of distal apices of the sealing stent <NUM> but otherwise passes circumferentially around the graft body <NUM> externally to the graft body <NUM>. Nevertheless, it is possible in other embodiments for the loop elements <NUM>, <NUM> to be attached to the sealing stent and/or the graft body <NUM> in a different manner.

As can be seen, in the embodiment shown in the figures, each of the first and second loop elements <NUM>, <NUM> is attached to the graft body and/or sealing stent only at the distal end of the sealing stent.

Of course, in embodiments in which the second strand section does not pass all the way back to the first end of the respective loop element, it may be only the first strand section which passes circumferentially around the distal end of the sealing stent and is attached to the graft body and/or sealing stent at each distal apex of the sealing stent which it passes.

In some embodiments, it is possible to obtain some of the advantages of the attachment of the loop elements at the distal apices by the loop elements being attached at just a subset of the distal apices, although it is preferred that the loop elements are attached at every distal apex as described. Furthermore, in some embodiments it is possible for the loop elements to be substantially unattached to the graft body or sealing stent except at their first ends. However, this is not preferred for the reasons discussed. Furthermore, although in the embodiment shown in the figures the first and second strand sections of each loop element are attached to the graft body and/or the sealing stent at each distal apex of the sealing stent which they pass, in other embodiments just one or other of the strand sections can be so attached. Furthermore, it is not excluded that the first and/or second strand section of the first and/or second loop element can be attached to the sealing stent and/or graft body at a plurality of locations around the circumference of the graft body other than at distal apices of the sealing stent. However, attachment at distal apices is preferable for efficient constriction of the distal end of the sealing stent.

In the constricting configuration, the first and second loop elements <NUM>, <NUM> together extend around the entire circumference of the graft body <NUM> and distal end of the sealing stent <NUM> and the first loop element passes through the loop at the second end <NUM> of the second loop element, allowing for a release wire to pass through the loop at the second end of the first loop element <NUM> to hold the first and second loop elements <NUM>, <NUM> in the constricting configuration. Owing to the location of the first and second loop elements <NUM>, <NUM> around the distal end of the sealing stent, the diameter reducing loop arrangement <NUM> is configured to constrict the distal apices of the sealing stent and cause the sealing stent to adopt a substantially conical or frustro conical shape. This conical or frustro conical shape allows the proximal sealing stent to deploy in a more angular position, which leads to a better conformance to the aortic curve.

In the embodiment shown in the figures the first and second loop elements <NUM>, <NUM> are made from thread which is green braided PTFE impregnated polyester fibre suture. Other materials can be used in other embodiments; however, the first and second loop elements are preferably each provided by a suture and most preferably by a single strand thereof.

In the embodiment shown in the figures, every intermediate stent is free of diameter reducing ties. However, in other embodiments, one or more intermediate stents may have diameter reducing ties.

The distal-most stent may optionally have a conventional retention arrangement configured to be released in a conventional manner. However, this is not critical and details are therefore not described herein.

The stent graft delivery system includes the stent graft and a first release wire <NUM> (shown for example in <FIG>). The first release wire <NUM> passes through the loop at the second end of the first loop element <NUM> (as shown for example in <FIG>). As can be seen, the first release wire <NUM> passes through the loop at the second end of the first loop element <NUM> externally to the graft body <NUM>. As a result, both the loop elements <NUM>, <NUM> are attached to the first release wire <NUM> and each other. They are held by the first release wire in the constricting configuration which pulls the distal apices of the sealing stent radially inwardly and holds the sealing stent in a substantially conical or frustoconical shape, in particular a proximally facing conical or frustoconical shape. The diameter reducing loop arrangement <NUM> can be released from the constricting configuration by pulling the first release wire <NUM>, which releases the first and second loop elements from each other and allows their respective second ends <NUM>,<NUM> to separate. As a result, the loop elements no longer constrict the diameter of the distal end of the sealing stent <NUM>, which is consequently free to expand.

It is to be noted that in the embodiment shown in the figures, only a single release wire <NUM> passes through the loop at the second end <NUM> of the first loop element <NUM>, meaning that the diameter reducing loop arrangement <NUM> is configured to be actuated by a single release wire. However, in other embodiments, more than one release wire can be used. Nevertheless, it is preferred that the diameter reducing loop arrangement is configured to be held in a constricting configuration by attachment to one or more release wires only at a single circumferential location, to minimise dependence on the position of the cannula.

It is also noted that the first release wire <NUM> passes through the loop at the second end <NUM> of the first loop element <NUM> but not the loop at the second end <NUM> of the second loop element <NUM>. In other embodiments, it can pass through the loops at the second ends <NUM>, <NUM> of both the first and second loop elements <NUM>, <NUM>.

In the embodiment shown in the figures, the delivery system includes a delivery cannula <NUM> including a nose cone <NUM> at its distal end. In this embodiment, the delivery cannula is compatible with a <NUM> inch wire guide, although other sizes and configurations are possible in other embodiments. The delivery cannula is typically pre-curved in a known manner in order to align appropriately with the aorta at the desired deployment location. The delivery cannula in the embodiment shown in the figures is UAT.

The first release wire <NUM> passes from a release mechanism at the proximal end of the delivery system, through a passageway in between a tubing around the cannula <NUM> and the outside of the cannula <NUM> itself. The release mechanism can be any of a variety of configurations provided that it can be actuated to pull the first release wire; in some embodiments it may not be necessary if the first release wire can be pulled directly. The tubing around the delivery cannula <NUM> includes first and second apertures <NUM>, <NUM>. The stent graft <NUM> is arranged on the cannula <NUM> such that the diameter reducing loop arrangement is distal of the first aperture <NUM> and proximal of the second aperture <NUM>. The first release wire <NUM> passes out of the passageway of the tubing through the first aperture <NUM>, penetrates the graft body <NUM> near the distal end of the sealing stent, passes through the loop at the second end <NUM> of the first loop element <NUM> external to the graft body <NUM>, goes back through the graft body <NUM> and through the second aperture <NUM> into the passageway in the tubing around the cannula <NUM>. As can be seen in <FIG>, the first release wire <NUM> penetrates the graft material before and after a distal apex of the sealing stent <NUM>. The first release wire <NUM> is then temporarily secured within the tubing around the cannula <NUM> or in the nose cone <NUM> until it is released by operation of the release mechanism. In this embodiment, the first release wire is external to the tubing around the cannula <NUM> on the outside of the curve of the pre-curved cannula as shown in <FIG>.

As can be seen from <FIG>, in the embodiment shown in the figures proximal apices of the alignment stent <NUM> are constrained in a delivery configuration by a proximal constraining mechanism. In the embodiment shown in the figures, the proximal constraining mechanism is provided by the first <NUM>, as well as second and third release wires constraining the proximal apices of the alignment stent by each emerging through an aperture in the tubing around the cannula <NUM>, looping over a subset of the proximal apices of the alignment stent <NUM>, and entering a further aperture in the tubing around the cannula <NUM> whereby to constrain the respective subset of the proximal apices to the cannula <NUM>. The subsets constrained by the first, second and third release wires together include all of the proximal apices of the alignment stent such that all of the proximal apices of the alignment stent <NUM> are constrained. At the proximal end of the delivery system, the first <NUM>, second and third release wires are attached to the release mechanism which may be actuated to retract the first, second and third release wires and thereby release the proximal apices of the alignment stent as well as the diameter reducing loop arrangement. In the embodiment shown in the figures, the release mechanism is configured to retract the first, second and third release wires together; however, in other embodiments it may be possible to retract them separately. Furthermore, other constraining mechanisms for the alignment stent can be used in other embodiments.

As described above, in the embodiment shown in the figures, the first release wire <NUM> to which the diameter constricting loop arrangement is attached also partially constrains the proximal apices of the alignment stent. However, this is not necessary in every embodiment. In other embodiments, the diameter reducing arrangement <NUM> may be actuated by a release wire separate from those used to release the proximal apices of the alignment stent and that separate release wire may be actuated by a separate release mechanism.

The delivery system and stent graft described can be used to create proximal conformance and sealing of the stent graft in the aortic arch during thoracic endovascular aortic repair (TEVAR) procedures. For example, the stent graft can be used to treat patients with aneurysms, ulcers or dissections of the descending thoracic aorta or aortic arch.

The graft length is preferably selected to cover the aneurysm, ulcer or dissection as measured along the greater curve of the aneurysm, ulcer or dissection, plus a minimum of <NUM> of seal zone on the proximal and distal ends.

During introduction, the stent graft is covered by a sheath (not shown) in a known manner. This can for example be a Flexor® Introducer Sheath, which resists kinking and is hydrophilic coated to enhance trackability in the iliac arteries and thoracic aorta, with a Captor® Hemostatic Valve which can be loosened or tightened for the introduction and/or removal of ancillary devices into and out of the sheath. In this embodiment, the introducer sheath is <NUM> Fr with an outer diameter of <NUM>, although different dimensions may be used in other embodiments. The delivery cannula <NUM> is advanced to the deployment site in a known manner, for example by tracking over a wire guide, such as a stiff <NUM> inch, <NUM>/<NUM> LESDC wire guide. The pre-curve of the cannula serves to align the cannula with the vessel with the first release wire external to the tubing around the cannula on the outside of the curve. Once the stent graft <NUM> is at the desired deployment site, the sheath is retracted in a conventional manner allowing the stent graft <NUM> to partially expand, leaving the proximal end of the stent graft <NUM> in the configuration shown in <FIG>. As can be seen in <FIG>, the proximal apices of the alignment stent <NUM> remain constrained against the cannula <NUM> and the distal end of the sealing stent <NUM> remains constricted by the diameter constricting loop arrangement <NUM>. As a result, the sealing stent has a conical or frustoconical shape, which is maintained by attachment of the loop elements <NUM>, <NUM> to the first release wire <NUM> externally to the graft body <NUM>. As a result, the diameter constraining loop arrangement <NUM> is not dependent on the position of the cannula <NUM>.

Once the surgeon is satisfied that the stent graft is in the correct position, he or she may retract the release wires. When the release wires are retracted, they are retracted from the proximal apices of the alignment stent, which are thereby allowed to expand. As the first release wire <NUM> is retracted proximally of the diameter reducing loop arrangement <NUM>, it is retracted from the loop at the second end <NUM> of the first loop element <NUM>. This releases the first and second loop elements from each other and the first loop element <NUM> is able to slide out of the loop at the second end <NUM> of the second loop element <NUM> and the second ends <NUM>,<NUM> of the first and second loop elements <NUM>, <NUM> are thereby allowed to separate. As a result, the loop elements no longer constrict the diameter of the distal end of the sealing stent, and the distal apices of the sealing stent can expand into contact with the vessel wall.

The conical shape of the sealing stent before full deployment, and the independence of the loop arrangement from the position of the cannula <NUM>, means that the proximal sealing stent can deploy in a more angular position which leads to better conformance of the aortic curve and can reduce proximal tilt of the sealing stent for example in straight aorta sections. This can be seen from <FIG>. This can allow the stent graft to be used in wider spectra of different anatomies as the proximal sealing stent is less likely to tilt inwards even if used in extreme cases.

If appropriate for the patient, the stent graft described herein can be used as a proximal component of a modular stent graft together with a distal component, or it can be used independently. The distal component can be for example a Zenith Alpha Thoracic Distal Graft from Cook®. However, other types of distal extensions can of course be used, in particular for example if a dissection is being treated.

In some embodiments, the stent graft can be provided with one or more scallops, fenestrations, internal branches and/or external branches.

Although the embodiment shown in the figures includes first and second loop elements <NUM>, <NUM>, in some embodiments it is possible to use any number of loop elements in the diameter reducing loop arrangement, provided that the diameter reducing loop arrangement is configured to constrict distal apices of the sealing stent to cause the sealing stent adopt a substantially conical or frustro conical shape.

Claim 1:
A stent graft (<NUM>), including:
a graft body (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>);
a sealing stent (<NUM>) at the proximal end (<NUM>) of the graft body (<NUM>), a majority of the sealing stent (<NUM>) being overlapped by the graft body (<NUM>), the sealing stent (<NUM>) including proximal apices (<NUM>) at a proximal end thereof and distal apices (<NUM>) at a distal end thereof;
a diameter reducing loop arrangement (<NUM>) including a loop element (<NUM>), the loop element (<NUM>) including a first end (<NUM>), a second end (<NUM>), and a strand section from the first end (<NUM>) to the second end (<NUM>), the first end (<NUM>) being attached at the distal end of the sealing stent (<NUM>), the loop element (<NUM>) being configured to pass circumferentially around the distal end of the sealing stent (<NUM>) and have a release wire (<NUM>) pass through a loop at the second end (<NUM>), the diameter reducing loop arrangement (<NUM>) being configured to constrict the distal apices (<NUM>) of the sealing stent (<NUM>) and cause the sealing stent (<NUM>) to adopt a substantially conical or frustoconical shape.