Patent Description:
Aneurysms, dissections, penetrating ulcers, intramural hematomas and/or transections may occur in blood vessels, and most typically occur in the aorta and peripheral arteries. The diseased region of the aorta may extend into areas having vessel bifurcations or segments of the aorta from which smaller "branch" arteries extend.

The diseased region of the aorta can be bypassed by use of a stent-graft placed inside the vessel spanning the diseased portion of the aorta, to seal off the diseased portion from further exposure to blood flowing through the aorta.

The use of stent-grafts to internally bypass the diseased portion of the aorta is not without challenges. In particular, care must be taken so that critical branch arteries are not covered or occluded by the stent-graft yet the stent-graft must seal against the aorta wall and provide a flow conduit for blood to flow past the diseased portion.

<CIT> and <CIT> describe a modular aortic arch prosthetic assembly and method of use thereof.

The techniques of this disclosure generally relate to a modular stent device configured to be deployed via supra aortic access through the brachiocephalic artery. The modular stent device is a base or anchor component to which additional modular stent devices can be attached to exclude diseased areas of the aorta while at the same time allowing perfusion of the left common carotid artery and the left subclavian artery.

The invention as defined in claim <NUM> provides an assembly including a first modular stent device. The first modular stent device includes a main body, a bypass gate extending distally from a distal end of the main body, and an artery leg extending distally from the distal end of the main body. The artery leg has a greater radial force than a radial force of the bypass gate. The main body has a first longitudinal axis, the bypass gate has a second longitudinal axis, and the artery leg has a third longitudinal axis, the first, second, and third longitudinal axes are parallel with one another when the first modular stent device is in a relaxed configuration. A second modular stent device is configured to be coupled inside the bypass gate.

In another aspect, the present disclosure provides an assembly including the first modular stent device and a stent-graft prosthesis configured to be coupled inside the bypass gate. In one embodiment, the stent-graft prosthesis includes a main body and a coupling extending radially from the main body of the stent-graft prosthesis.

In yet another aspect, the present disclosure provides an assembly including the first modular stent device and a double gate bifurcated device configured to be coupled inside the bypass gate.

As an overview and in accordance with one embodiment, referring to <FIG>, a modular stent device <NUM> is deployed via supra aortic access through the brachiocephalic artery BCA. Modular stent device <NUM> is a base or anchor component to which additional modular stent devices can be attached to exclude diseased areas of the aorta <NUM> while at the same time allowing perfusion of the left common carotid artery LCC and the left subclavian artery LCA.

Now in more detail, <FIG> is a side plan view of a first modular stent device <NUM> in accordance with one embodiment. <FIG> is a perspective view of modular stent device <NUM> of <FIG> in accordance with one embodiment.

Referring now to <FIG> together, modular stent device <NUM>, sometimes called a prosthesis or aortic arch prosthesis, includes a main body <NUM>, a bypass gate <NUM> and an artery leg <NUM>, sometimes called a brachiocephalic artery (BCA) leg/limb <NUM>.

In accordance with this embodiment, main body <NUM> includes a main body proximal opening <NUM> at a proximal end <NUM> of main body <NUM>. A distal end <NUM> of main body <NUM> is coupled to a proximal end <NUM> of bypass gate <NUM> and a proximal end <NUM> of artery leg <NUM>.

Bypass gate <NUM> includes a bypass gate distal opening <NUM> at a distal end <NUM> of bypass gate <NUM>. Artery leg <NUM> includes a leg distal opening <NUM> at a distal end <NUM> of artery leg <NUM>. Openings <NUM>, <NUM> are sometime called distal first and second openings <NUM>, <NUM>, respectively.

As used herein, the proximal end of a prosthesis such as modular stent device <NUM> is the end closest to the heart via the path of blood flow whereas the distal end is the end furthest away from the heart during deployment. In contrast and of note, the distal end of the catheter is usually identified to the end that is farthest from the operator/handle while the proximal end of the catheter is the end nearest the operator/handle.

For purposes of clarity of discussion, as used herein, the distal end of the catheter is the end that is farthest from the operator (the end furthest from the handle) while the distal end of modular stent device <NUM> is the end nearest the operator (the end nearest the handle), i.e., the distal end of the catheter and the proximal end of modular stent device <NUM> are the ends furthest from the handle while the proximal end of the catheter and the distal end of modular stent device <NUM> are the ends nearest the handle. However, those of skill in the art will understand that depending upon the access location, modular stent device <NUM> and the delivery system descriptions may be consistent or opposite in actual usage.

Main body <NUM> includes graft material <NUM> and one or more circumferential stents <NUM> coupled to graft material <NUM>. Graft material <NUM> may be any suitable graft material, for example and not limited to, woven polyester, DACRON® material, expanded polytetrafluoroethylene, polyurethane, silicone, electro spun materials, or other suitable materials.

Circumferential stents <NUM> may be coupled to graft material <NUM> using stitching or other means. In the embodiment shown in <FIG>, circumferential stents <NUM> are coupled to an outside surface of graft material <NUM>. However, circumferential stents <NUM> may alternatively be coupled to an inside surface of graft material <NUM>.

Although shown with a particular number of circumferential stents <NUM>, in light of this disclosure, those of skill in the art will understand that main body <NUM> may include a greater or smaller number of stents <NUM>, e.g., depending upon the desired length of main body <NUM> and/or the intended application thereof.

Circumferential stents <NUM> may be any stent material or configuration. As shown, circumferential stents <NUM>, e.g., self-expanding members, are preferably made from a shape memory material, such as nickel-titanium alloy (nitinol), and are formed into a zig-zag configuration. The configuration of circumferential stents <NUM> is merely exemplary, and circumferential stents <NUM> may have any suitable configuration, including but not limiting to a continuous or non-continuous helical configuration. In another embodiment, circumferential stents <NUM> are balloon expandable stents.

The circumferential stent 128A of the circumferential stents <NUM> which is disposed at proximal end <NUM> is referred to herein as the proximal-most stent 128A. In the embodiment of <FIG>, proximal-most stent 128A extends only to the edge of graft material <NUM> in a closed-web configuration as shown. However, in another embodiment, proximal-most stent 128A extends proximally past the edge of graft material <NUM> in an open-web or uncovered configuration.

Further, main body <NUM> includes a longitudinal axis LA1. A lumen <NUM> is defined by graft material <NUM>, and generally by main body <NUM>. Lumen <NUM> extends generally parallel to longitudinal axis LA1 and between proximal opening <NUM> and distal end <NUM> of main body <NUM>. Graft material <NUM> is cylindrical having a substantially uniform diameter in this embodiment. However, in other embodiments, graft material <NUM> varies in diameter.

Bypass gate <NUM> includes graft material <NUM> and one or more circumferential stents <NUM> coupled to graft material <NUM>. Graft material <NUM> may be any suitable graft material, for example and not limited to, woven polyester, DACRON® material, expanded polytetrafluoroethylene, polyurethane, silicone, electro spun materials, or other suitable materials.

Although shown with a particular number of circumferential stents <NUM>, in light of this disclosure, those of skill in the art will understand that bypass gate <NUM> may include a greater or smaller number of stents <NUM>, e.g., depending upon the desired length of bypass gate <NUM> and/or the intended application thereof.

Further, bypass gate <NUM> includes a longitudinal axis LA2. A lumen <NUM> is defined by graft material <NUM>, and generally by bypass gate <NUM>. Lumen <NUM> extends generally parallel to longitudinal axis LA2 and between proximal end <NUM> and distal opening <NUM> of bypass gate <NUM>. Graft material <NUM> is cylindrical having a substantially uniform diameter in this embodiment. However, in other embodiments, graft material <NUM> varies in diameter.

Artery leg <NUM> includes graft material <NUM> and one or more circumferential stents <NUM> coupled to graft material <NUM>. Graft material <NUM> may be any suitable graft material, for example and not limited to, woven polyester, DACRON® material, expanded polytetrafluoroethylene, polyurethane, silicone, electro spun materials, or other suitable materials.

Although shown with a particular number of circumferential stents <NUM>, in light of this disclosure, those of skill in the art will understand that artery leg <NUM> may include a greater or smaller number of stents <NUM>, e.g., depending upon the desired length of artery leg <NUM> and/or the intended application thereof.

Further, artery leg <NUM> includes a longitudinal axis LA3. A lumen <NUM> is defined by graft material <NUM>, and generally by artery leg <NUM>. Lumen <NUM> extends generally parallel to longitudinal axis LA3 and between proximal end <NUM> and distal opening <NUM> of artery leg <NUM>. Graft material <NUM> is cylindrical having a substantially uniform diameter in this embodiment. However, in other embodiments, graft material <NUM> varies in diameter.

Generally, main body <NUM> is bifurcated at distal end <NUM> into bypass gate <NUM> and artery leg <NUM>. More particularly, lumen <NUM> of main body <NUM> is bifurcated into lumen <NUM> of bypass gate <NUM> and lumen <NUM> of artery leg <NUM>.

In one embodiment, graft materials <NUM>, <NUM>, <NUM> may be the same graft material, e.g., may be a single piece of graft material cut and sewn. However, in other embodiments, one or more of graft materials <NUM>, <NUM>, <NUM> may be different that the others of graft materials <NUM>, <NUM>, <NUM>, e.g., different graft materials are cut and sewn together. In the relaxed configuration of modular stent device <NUM> as illustrated in <FIG>, longitudinal axes LA1, LA2, and LA3 are parallel with one another such that bypass gate <NUM> and artery leg <NUM> extend distally from main body <NUM>.

Main body <NUM> has a first diameter D1, bypass gate <NUM> has a second diameter D2, and artery leg <NUM> has a third diameter D3. In accordance with this embodiment, first diameter D1 is greater than second diameter D2. Further, second diameter D2 is greater than third diameter D3. In accordance with this embodiment, first diameter D1 is greater than second diameter D2 combined with third diameter D3 (D1>D2+D3) such that bypass gate <NUM> and artery leg <NUM> are located within an imaginary cylinder defined by graft material <NUM> of main body <NUM> extended in the distal direction. The parallel design mimics anatomical blood vessel bifurcations to limit flow disruptions.

In one embodiment, first diameter D1 is greater than second diameter D2 combined with third diameter D3 (D1>D2+D3) at distal end <NUM> and proximal ends <NUM>, <NUM>, sometimes called the transition region. However, main body <NUM>, bypass gate <NUM> and/or artery leg <NUM>, flare or taper away from the transition region in accordance with another embodiment, so D1>D2+D3 at the transition region but is not necessarily correct in regions away from the transition region. Flaring is indicated by the dashed lines in <FIG>.

Stated another way, the transition region from main body <NUM> to artery leg <NUM> and bypass gate <NUM> does not exceed first diameter D1 of main body <NUM>. This insures artery leg <NUM> and bypass gate <NUM> don't crush each other or negatively impact flow in any way. By avoiding having artery leg <NUM> and bypass gate <NUM> extend out wider than main body <NUM>, a good seal of stents <NUM> of main body <NUM> against the aorta is insured and type I endoleaks are minimized or avoided.

In accordance with one embodiment, the transition region between main body <NUM> and artery leg <NUM> and bypass gate <NUM> is fully supported by one or more supporting stents, e.g., stents <NUM>, <NUM>, <NUM>, to prevent kinking in angled anatomy. Absent the supporting stents, modular stent device <NUM> may be predispose to kinking in type III arches or gothic arches.

Main body <NUM> has a first length L1 in a direction parallel to the longitudinal axis LA1, bypass gate <NUM> has a second length L2 in a direction parallel to the longitudinal axis LA2, and artery leg <NUM> has a third length L3 in a direction parallel to the longitudinal axis LA3. In accordance with this embodiment, third length L3 is greater than second length L2 such that distal opening <NUM> the artery leg <NUM> is distal to distal opening <NUM> of bypass gate <NUM>. Generally, artery leg <NUM> is longer than bypass gate <NUM>.

In one embodiment, first diameter D1 ranges from <NUM> to <NUM>. In another embodiment, first diameter D1 is smaller for a second device to treat the left common carotid or left subclavian artery and first diameter D1 is as small as <NUM> for transections. In one particular embodiment, first diameter D1 is in the range of <NUM> to <NUM>.

In one embodiment, second diameter D2 is any one of a number of values to accommodate a minimum diameter of artery leg <NUM> and the various possible diameters D1 of main body <NUM>. In one embodiment, second diameter D2 of bypass gate <NUM> is maximized by subtracting the third diameter D3 of artery leg <NUM> from first diameter D1 of main body <NUM>. For the brachiocephalic artery, also known as the innominate artery, the minimum diameter of artery leg <NUM> is suitably around <NUM> to <NUM>. Accordingly, when first diameter D1 is <NUM>, second diameter D2 of bypass gate <NUM> is <NUM>. However, second diameter D2 is as large as <NUM> in another embodiment. Suitably, second diameter D2 is in the approximate range of <NUM> to <NUM>.

Third diameter D3 is the diameter for the innominate artery, the left subclavian, and/or the left common carotid in one embodiment. The innominate artery ranges in size from approximately <NUM> up to <NUM>. The left subclavian artery size range is closer to <NUM> to <NUM> and the left common carotid artery is in the <NUM> to <NUM> range. Accordingly, third diameter D3 is suitably in the approximate range of <NUM> to <NUM> and in one particular embodiment is in the approximate range of <NUM> to <NUM>.

In one embodiment, landing is targeted in the middle of the ascending aorta. The distance between the sinotubular junction STJ and innominate artery ranges in size from <NUM>-<NUM> so first length L1 is suitably in the range of around <NUM> to <NUM>. However, to extend coverage all the way to the sinotubular junction STJ, in one embodiment, first length L1 can vary. Suitably, first length L1 is in the approximate range of <NUM> to <NUM>. Alternatively, a proximal cuff is used as discussed further below.

Second length L2 is suitably sufficient for providing adequate overlap in an environment with significant respiratory and cardiac induced motion. It is also suitable to space bypass gate <NUM> so that bypass gate <NUM> does not inadvertently open inside of a target branch. In one embodiment, second length L2 is suitably in the approximate range of <NUM> to <NUM> and in one particular embodiment is in the range of <NUM> to <NUM>. In one embodiment, the minimum overlap is shortened by providing some mechanism for anchoring of the device.

Third length L3 is suitably in the approximate range of <NUM> to <NUM> in one embodiment and is in the range of <NUM> to180mm in one particular embodiment. In one embodiment, artery leg <NUM> is extended with additional devices.

Although fixed diameters D1, D2, and D3 are illustrated and discussed, in one embodiment, main body <NUM>, bypass gate <NUM> and/or artery leg <NUM> are non-uniform in diameter. For example, main body <NUM> flares or tapers at proximal end <NUM>. Similarly, bypass gate <NUM> and/or artery leg <NUM> flare or taper at distal ends <NUM>, <NUM>, respectively. For example, bypass gate <NUM> and/or artery leg <NUM> flare or taper at distal ends <NUM>, <NUM> to enhance sealing.

Artery leg <NUM> is configured to exert a higher radial force than the radial force of bypass gate <NUM>. As used herein, "radial force" includes both a radial force exerted during expansion/deployment as well as a chronic radial force continuously exerted after implantation such that a scaffold has a predetermined compliance or resistance as the surrounding native anatomy, e.g., the aorta, expands and contracts during the cardiac cycle. The radial force of bypass gate <NUM> is configured to be lower than that of artery leg <NUM> to avoid collapse of artery leg <NUM> when bypass gate <NUM> is deployed against and adjacent thereof and thus maintain perfusion of the brachiocephalic artery as discussed further below.

To configure bypass gate <NUM> and artery leg <NUM> with differing relative radial forces, circumferential stents <NUM> of artery leg <NUM> be constructed with relatively thicker and/or shorter segments of material than circumferential stents <NUM> of bypass gate <NUM>. Shorter and/or thicker circumferential stents <NUM> have less flexibility but greater radial force to ensure that circumferential stents <NUM> of bypass gate <NUM> do not collapse lumen <NUM> of artery leg <NUM>. Other variations or modification of circumferential stents <NUM>, <NUM> may be used to achieve relative radial forces in other embodiments.

Modular stent device <NUM> further includes radiopaque markers <NUM>, <NUM>, <NUM>. In accordance with this embodiment, radiopaque marker <NUM> is shaped as a <FIG> marker, i.e., in the shape of the number <NUM>. Radiopaque marker <NUM> is sewn into graft material <NUM> in line with artery leg <NUM>. Under fluoroscopy, radiopaque marker <NUM> is rotated so that it is seen on the edge on the outer curvature of the aortic arch in one embodiment so that artery leg <NUM> is accurately and reproducibly deployed on the outer curve of the aorta.

Radiopaque maker <NUM> is sewn in the transition region where main body <NUM> meets bypass gate <NUM> and artery leg <NUM> to indicate the desired extent of overlap. Radiopaque marker <NUM>, e.g., a coil marker, is sewn into bypass gate <NUM> to aid in cannulation of bypass gate <NUM>.

<FIG> is a cross-sectional view of a vessel assembly <NUM> including modular stent device <NUM> of <FIG> during deployment in accordance with one embodiment. Referring to <FIG> and <FIG> together, the thoracic aorta <NUM> has numerous arterial branches. The arch AA of the aorta <NUM> has three major branches extending therefrom, all of which usually arise from the convex upper surface of the arch AA. The brachiocephalic artery BCA originates anterior to the trachea. The brachiocephalic artery BCA divides into two branches, the right subclavian artery RSA (which supplies blood to the right arm) and the right common carotid artery RCC (which supplies blood to the right side of the head and neck). The left common carotid artery LCC artery arises from the arch AA of the aorta <NUM> just to the left of the origin of the brachiocephalic artery BCA. The left common carotid artery LCC supplies blood to the left side of the head and neck. The third branch arising from the aortic arch AA, the left subclavian artery LSA, originates behind and just to the left of the origin of the left common carotid artery LCC and supplies blood to the left arm.

However, a significant proportion of the population has only two great branch vessels coming off the aortic arch AA while others have four great branch vessels coming of the aortic arch AA. Accordingly, although a particular anatomical geometry of the aortic arch AA is illustrated and discussed, in light of this disclosure, those of skill in the art will understand that the geometry of the aortic arch AA has anatomical variations and that the various structures as disclosed herein would be modified accordingly.

Aneurysms, dissections, penetrating ulcers, intramural hematomas and/or transections, generally referred to as a diseased region of the aorta <NUM>, may occur in the aorta arch AA and the peripheral arteries BCA, LCC, LSA. For example, thoracic aortic aneurysms include aneurysms present in the ascending thoracic aorta, the aortic arch AA, and one or more of the branch arteries BCA, LCC, LSA that emanate therefrom. Thoracic aortic aneurysms also include aneurysms present in the descending thoracic aorta and branch arteries that emanate therefrom. Accordingly, the aorta <NUM> as illustrated in <FIG> has a diseased region similar to any one of those discussed above which will be bypassed and excluded using modular stent device <NUM> as discussed below.

As illustrated in <FIG>, a guide wire <NUM> is introduced via supra aortic access, e.g. through the right subclavian artery RSA, and advanced into the ascending aorta <NUM>. A delivery system <NUM> including modular stent device <NUM> is introduced via supra aortic access, e.g. through the right subclavian artery RSA, and is advanced into the ascending aorta <NUM> over guidewire <NUM>. Delivery system <NUM> is positioned at the desired location such that the position of modular stent device <NUM> is in the ascending aorta near the aortic valve AV.

In accordance with this embodiment, delivery system <NUM> includes a tip capture mechanism <NUM> and a delivery sheath <NUM>. Delivery sheath <NUM> maintains modular stent device <NUM> in a collapsed configuration during delivery to the desired location within the aorta <NUM>. Tip capture mechanism <NUM> captures proximal end <NUM> of main body <NUM>, e.g., proximal circumferential stent 128A, and keeps proximal end <NUM> in a collapsed configuration until released as discussed further below. Tip capture mechanism <NUM> controls proximal deployment accuracy in a highly mobile environment with large amounts of fluid flow, e.g., in the ascending aorta.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of modular stent device <NUM> in accordance with one embodiment. Referring to <FIG> together, delivery sheath <NUM> is withdrawn to expose main body <NUM>, bypass gate <NUM>, and the proximal most portion of artery leg <NUM>. This deploys main body <NUM> and bypass gate <NUM> which self-expand into the aorta <NUM>. Bypass gate <NUM> is opened thus insuring perfusion to distal territories, e.g., including the aorta <NUM>, the left common carotid LCC, and the left subclavian artery LCA. Radiopaque marker <NUM> aids in positioning of modular stent device <NUM> during deployment.

The design of bypass gate <NUM> limits wind socking of modular stent device <NUM> during deployment. More particularly, the relatively large diameter D2 of bypass gate <NUM> readily allows blood flow through bypass gate <NUM> thus minimizing undesirable motion of modular stent device <NUM> during deployment.

To allow adjustment of the position of modular stent device <NUM>, proximal end <NUM> of main body <NUM> remains captured within tip capture mechanism <NUM> and the distal portion of artery leg <NUM> remains collapsed and captured within delivery sheath <NUM>. Modular stent device <NUM> is moved, e.g., proximally or distally and/or rotated, if necessary, until positioned at the desired location. The closed web tip capture system of tip capture mechanism <NUM> insures accurate deployment at the sinotubular junction STJ to maximize the proximal seal of modular stent device <NUM> in the aorta <NUM>.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of modular stent device <NUM> in accordance with one embodiment. Referring to <FIG> and <FIG> together, delivery sheath <NUM> is completely withdrawn to expose the entirety of artery leg <NUM>. This deploys artery leg <NUM> which expands into the brachiocephalic artery BCA. Further, proximal end <NUM> of main body <NUM> is released from tip capture mechanism <NUM> and thus expands into aorta <NUM>. Generally, this completes deployment of modular stent device <NUM>.

As artery leg <NUM> has a greater radial force than bypass gate <NUM>, artery leg <NUM> remains un-collapsed and opened. Accordingly, blood flow through artery leg <NUM> and perfusion of the brachiocephalic artery BCA and preservation of blood flow to cerebral territories including the brain is insured. This avoids stroke, or other medical complications from occlusion of the brachiocephalic artery BCA.

Perfusion of the brachiocephalic artery BCA is immediate and dependable. More particularly, artery leg <NUM> is released within brachiocephalic artery BCA and accordingly is necessarily located therein. Artery leg <NUM> is located within brachiocephalic artery BCA regardless of the radial orientation or longitudinal (axial) placement of modular stent device <NUM> within the aorta <NUM>. By avoiding the requirement of precise radial orientation and longitudinal placement of modular stent device <NUM>, the complexity of the procedure of deploying modular stent device <NUM> is reduced thus insuring the most possible favorable outcome.

If there is any collapse between artery leg <NUM> and bypass gate <NUM>, the collapse is in bypass gate <NUM>. However, bypass gate <NUM> has a sufficiently large diameter D2 such that any collapse of bypass gate <NUM> is partial and blood flow through bypass gate <NUM> and the aorta <NUM> is maintained.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of a second modular stent device 100A in accordance with one embodiment. Referring now to <FIG>, second modular stent device 100A is the same or similar to modular stent device <NUM>, the discussion of which is applicable to the second modular stent device 100A.

In accordance with this embodiment, second modular stent device 100A is deployed in a reverse, sometimes called mirrored, arrangement as compared to modular stent device <NUM>. More particularly, an artery leg 106A of modular stent device 100A is deployed within the left subclavian artery LSA via supra aortic access through the left subclavian artery LSA. A bypass gate 104A of modular stent device 100A is located within aorta <NUM> and arranged to face and point towards bypass gate <NUM> of modular stent device <NUM>. A main body 102A of modular stent device 100A is located within the descending aorta <NUM>. Modular stent device 100A is deployed in a manner similar to deployment of modular stent device <NUM> as described in relation to <FIG> and only the significant differences are discussed below.

In accordance with this embodiment, blood flow enters modular stent device 100A through bypass gate 104A, and exits through main body 102A and artery leg 106A. Accordingly, blood flow through artery leg 106A and perfusion of the left subclavian artery LSA is insured.

As discussed above, the proximal end of a prosthesis such as modular stent device 100A is the end closest to the heart via the path of blood flow whereas the distal end is the end furthest away from the heart during deployment. Accordingly, due to the reverse deployment of modular stent device 100A as compared to modular stent device <NUM>, the naming of certain features is reversed in modular stent device 100A as compared to modular stent device <NUM>. More particularly, proximal opening <NUM>, proximal end <NUM>, distal end <NUM>, proximal end <NUM>, distal opening <NUM>, distal end <NUM> of modular stent device <NUM> are called distal opening 108A, distal end 110A, proximal end 112A, distal end 114A, proximal opening 118A, proximal end 120A of modular stent device 100A, respectively.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a final stage during deployment of a tube graft <NUM> into modular stent devices <NUM>, 100A in accordance with one embodiment. Referring to <FIG>, tube graft <NUM> is deployed within and spans bypass gates <NUM>, 104A.

Tube graft <NUM> includes graft material <NUM> and one or more circumferential stents <NUM>. Graft material <NUM> includes any one of the graft materials as discussed above in relation to graft materials <NUM>, <NUM>, <NUM>. In addition, circumferential stents <NUM> are similar to or identical to any one of circumferential stents <NUM>, <NUM>, <NUM> as discussed above.

Upon completion of deployment of tube graft <NUM>, blood flows from bypass gate <NUM> through tube graft <NUM> and to bypass gate 104A. In this manner, any overlapped diseased regions of the aorta <NUM> are excluded.

In accordance with this embodiment, tube graft <NUM> overlaps, excludes and thus occludes the left common carotid artery LCC. In accordance with this embodiment, a bypass <NUM> provides perfusion to the left common carotid artery LCC. Illustratively, bypass <NUM> provides perfusion of the left common carotid artery LCC from the left subclavian artery LSA. Bypass <NUM> is surgically inserted during the same procedure as deployment of modular stent device 100A and tube graft <NUM>. However, in another embodiment, bypass <NUM> is surgically inserted prior to deployment of modular stent device 100A and tube graft <NUM>, e.g., to simplify the procedure.

Further, as illustrated in <FIG>, optionally, a proximal cuff <NUM> is coupled to main body <NUM> of modular stent device <NUM> and extend proximately therefrom. For example, proximal cuff <NUM> is deployed in the event that proximal end <NUM> of main body <NUM> is deployed distally from the aortic valve AV to extend between the desired deployment location and proximal end <NUM> of main body <NUM>. Proximal cuff <NUM> is optional and in one embodiment is not deployed or used.

Proximal cuff <NUM> includes graft material <NUM> and one or more circumferential stents <NUM>. Graft material <NUM> includes any one of the graft materials as discussed above in relation to graft materials <NUM>, <NUM>, <NUM>. In addition, circumferential stents <NUM> are similar to or identical to anyone of circumferential stents <NUM>, <NUM>, <NUM> as discussed above.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of second modular stent device 100A in accordance with another embodiment. <FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a final stage during deployment of tube graft <NUM> into modular stent devices <NUM>, 100A in accordance with one embodiment. <FIG> and <FIG> are similar to <FIG> and <FIG> and only the significant differences are discussed below.

Referring now to <FIG> and <FIG>, artery leg 106A of modular stent device 100A is deployed within the left common carotid artery LCC via supra aortic access through the left common carotid artery LCC. Accordingly, blood flow through artery leg 106A and perfusion of the left common carotid artery LCC is insured.

In accordance with this embodiment, tube graft <NUM> and/or modular stent device 100A overlaps, excludes and thus occludes the left subclavian artery LSA. In accordance with this embodiment, bypass <NUM> provides perfusion to the left subclavian artery LSA. Illustratively, bypass <NUM> provides perfusion of the left subclavian artery LSA from the left common carotid artery LCC.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of second modular stent device 100B in accordance with another embodiment. Second modular stent device 100B is the same or similar to modular stent device <NUM>, the discussion of which is applicable to the second modular stent device 100B.

In accordance with this embodiment, an artery leg 106B of modular stent device 100B is deployed within the left subclavian artery LSA via supra aortic access through the left subclavian artery LSA. A bypass gate 104B of modular stent device 100B is located within aorta <NUM> and arranged to point away and distally from modular stent device <NUM>. A main body 102B of modular stent device 100B is located within bypass gate <NUM> of modular stent device <NUM>.

In accordance with this embodiment, blood flow enters modular stent device 100B through main gate 102B, and exits through bypass gate 104B and artery leg 106B. Accordingly, blood flow through artery leg 106B and perfusion of the left subclavian artery LSA is insured. In this manner, any overlapped diseased regions of the aorta <NUM> are excluded.

In accordance with this embodiment, modular stent device 100B overlaps, excludes and thus occludes the left common carotid artery LCC. In accordance with this embodiment, bypass <NUM> provides perfusion to the left common carotid artery LCC. Illustratively, bypass <NUM> provides perfusion of the left common carotid artery LCC from the left subclavian artery LSA.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a final stage during deployment of a tube graft <NUM> into modular stent device 100B in accordance with one embodiment. Referring to <FIG>, tube graft <NUM> is deployed into bypass gate 104B and into aorta <NUM> and is attached thereto.

Tube graft <NUM> includes graft material <NUM> and one or more circumferential stents <NUM>. Graft material <NUM> includes any one of the graft materials as discussed above in relation to graft materials <NUM>, <NUM>, <NUM>. In addition, circumferential stents <NUM> are similar to or identical to anyone of circumferential stents <NUM>, <NUM>, <NUM> as discussed above.

Further, as illustrated in <FIG>, optionally, proximal cuff <NUM> is coupled to main body <NUM> of modular stent device <NUM> and extend proximately therefrom.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of second modular stent device 100B in accordance with another embodiment. <FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a final stage during deployment of tube graft <NUM> into modular stent device 100B in accordance with one embodiment. <FIG> and <FIG> are similar to <FIG> and <FIG> and only the significant differences are discussed below.

Referring now to <FIG> and <FIG>, artery leg 106B of modular stent device 100B is deployed within the left common carotid artery LCC via supra aortic access through the left common carotid artery LCC. Accordingly, blood flow through artery leg 106B and perfusion of the left common carotid artery LCC is insured.

In accordance with this embodiment, tube graft <NUM> and/or modular stent device 100B overlaps, excludes and thus occludes the left subclavian artery LSA. In accordance with this embodiment, bypass <NUM> provides perfusion to the left subclavian artery LSA. Illustratively, bypass <NUM> provides perfusion of the left subclavian artery LSA from the left common carotid artery LCC.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of a distal aortic stent-graft prosthesis <NUM>, sometimes called a second modular stent device <NUM>, in accordance with another embodiment. Distal aortic stent-graft prosthesis <NUM> includes a main body <NUM> and a coupling <NUM> extending radially from main body <NUM>.

Main body <NUM> is generally cylindrically shaped but can vary in diameter in other embodiments. A proximal end <NUM> of main body <NUM> of distal aortic stent-graft prosthesis <NUM> is deployed within bypass gate <NUM> of modular stent device <NUM> via femoral access. Main body <NUM> extends distally from bypass gate <NUM> and a distal end <NUM> of main body <NUM> is deployed within the descending aorta <NUM>. Generally, main body <NUM> defines a lumen extending therethrough.

Main body <NUM> is deployed such that coupling <NUM> is aligned with the left subclavian artery LSA. Coupling <NUM> corresponds with an opening in the main body <NUM>. Coupling <NUM> is generally frustoconically shaped and includes a base <NUM> and a top <NUM>. A circumference of base <NUM> is greater than a circumference of top <NUM>. Coupling <NUM> defines a lumen in fluid communication with the lumen of main body <NUM>.

Accordingly, blood flow exiting bypass gate <NUM> of modular stent device <NUM> enters proximal end <NUM> of main body <NUM>. Blood flows through the lumen of main body <NUM> and exits distal end <NUM> and into the aorta <NUM>.

Further, blood flow from the lumen of main body <NUM> flows through coupling <NUM> and into the left subclavian artery LSA. More particularly, blood flows enter into base <NUM> of coupling <NUM>, through the lumen of coupling <NUM>, and exits top <NUM> of coupling <NUM> into the left subclavian artery LSA.

Main body <NUM> includes graft material <NUM> and one or more circumferential stents <NUM>. Graft material <NUM> includes any one of the graft materials as discussed above in relation to graft materials <NUM>, <NUM>, <NUM>. In addition, circumferential stents <NUM> are similar to or identical to anyone of circumferential stents <NUM>, <NUM>, <NUM> as discussed above.

Coupling <NUM> includes graft material <NUM> and one or more circumferential stents <NUM>. Graft material <NUM> includes any one of the graft materials as discussed above in relation to graft materials <NUM>, <NUM>, <NUM>. In addition, circumferential stents <NUM> are similar to or identical to anyone of circumferential stents <NUM>, <NUM>, <NUM> as discussed above.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of a bridging stent graft <NUM> in accordance with one embodiment. Referring to <FIG> and <FIG> together, bridging stent graft <NUM> is deployed within coupling <NUM> and within the left subclavian artery LSA. More particularly, bridging stent graft <NUM> is anchored within coupling <NUM> and the left subclavian artery LSA. Bridging stent graft <NUM> is deployed via supra aortic access through the left subclavian artery LSA or alternatively through femoral access.

Bridging stent graft <NUM> includes graft material <NUM> and one or more circumferential stents <NUM>. Graft material <NUM> includes any one of the graft materials as discussed above in relation to graft materials <NUM>, <NUM>, <NUM>. In addition, circumferential stents <NUM> are similar to or identical to anyone of circumferential stents <NUM>, <NUM>, <NUM> as discussed above.

Upon deployment of bridging stent graft <NUM>, blood flow into coupling <NUM> is bridged and passed into the left subclavian artery LSA through bridging stent graft <NUM>.

In accordance with this embodiment, main body <NUM> overlaps, excludes and thus occludes the left common carotid artery LCC. In accordance with this embodiment, bypass <NUM> provides perfusion to the left common carotid artery LCC. Illustratively, bypass <NUM> provides perfusion of the left common carotid artery LCC from the left subclavian artery LSA.

Further, as illustrated in <FIG>, optionally, proximal cuff <NUM> can be coupled to main body <NUM> of modular stent device <NUM> and extend proximately therefrom.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of a distal aortic stent-graft prosthesis 1400A, sometimes called a second modular stent device 1400A, in accordance with another embodiment. <FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of bridging stent graft <NUM> in accordance with one embodiment. <FIG> and <FIG> are similar to <FIG> and <FIG> and only the significant differences are discussed below.

In accordance with this embodiment, the positioning of coupling <NUM> upon main body <NUM> in aortic stent-graft prosthesis 1400A is different (more proximal) than the position of coupling <NUM> upon main body <NUM> in aortic stent-graft prosthesis <NUM> of <FIG> and <FIG>.

Main body <NUM> is deployed such that coupling <NUM> is aligned with the left common carotid artery LCC in accordance with this embodiment.

Accordingly, blood flow from the lumen of main body <NUM> flows through coupling <NUM> and into the left common carotid artery LCC. More particularly, blood flows enter into base <NUM> of coupling <NUM>, through the lumen of coupling <NUM>, and exits top <NUM> of coupling <NUM> into the left common carotid artery LCC.

Paying particular attention now to <FIG>, bridging stent graft <NUM> is deployed within coupling <NUM> and within the left common carotid artery LCC. More particularly, bridging stent graft <NUM> is anchored within coupling <NUM> and the left common carotid artery LCC. Bridging stent graft <NUM> is deployed via supra aortic access through the left common carotid artery LCC or alternatively through femoral access. Upon deployment of bridging stent graft <NUM>, blood flow into coupling <NUM> is bridged and passed into the left common carotid artery LCC through bridging stent graft <NUM>.

In accordance with this embodiment, main body <NUM> overlaps, excludes and thus occludes the left subclavian artery LSA. In accordance with this embodiment, bypass <NUM> provides perfusion to the left subclavian artery LSA. Illustratively, bypass <NUM> provides perfusion of the left subclavian artery LSA from the left common carotid artery LCC.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of double gate bifurcated device <NUM>, sometimes called a second modular stent device, in accordance with another embodiment. In accordance with this embodiment, double gate bifurcated device <NUM> includes a main body <NUM>, a bypass gate <NUM>, a first arterial gate <NUM>, and a second arterial gate <NUM>.

In accordance with one embodiment, main body <NUM> is deployed within bypass gate <NUM> of modular stent device <NUM>. For example, double gate bifurcated device <NUM> is deployed via supra-aortic access, e.g., from the left subclavian artery LSA (left arm access).

A distal opening <NUM> of first arterial gate <NUM> is proximal of the left common carotid artery LCC and a distal opening <NUM> of second arterial gate <NUM> is proximal of the left subclavian artery LSA. Bypass gate <NUM> is deployed within the aorta <NUM>. Double gate bifurcated device <NUM> includes graft material(s) and stent(s) such as those discussed above.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of bridging stent grafts <NUM>, <NUM> in accordance with one embodiment. Referring to <FIG> and <FIG> together, bridging stent grafts <NUM>, <NUM> are deployed within first arterial gate <NUM> and second arterial gate <NUM> and within the left common carotid artery LCC and the left subclavian artery LSA, respectively. More particularly, bridging stent graft <NUM> is anchored within first arterial gate <NUM> and the left common carotid artery LCC. Bridging stent graft <NUM> is anchored within second arterial gate <NUM> and the left subclavian artery LSA. Bridging stent grafts <NUM>, <NUM> are deployed via supra aortic access through the left common carotid artery LCC and the left subclavian artery LSA, respectively.

Bridging stent graft grafts <NUM>, <NUM> includes graft materials <NUM>, <NUM> and one or more circumferential stents <NUM>, <NUM>, respectively. Graft materials <NUM> and/or <NUM> include any one of the graft materials as discussed above in relation to graft materials <NUM>, <NUM>, <NUM>. In addition, circumferential stents <NUM> and/or <NUM> are similar to or identical to anyone of circumferential stents <NUM>, <NUM>, <NUM> as discussed above.

Upon deployment of bridging stent graft grafts <NUM>, <NUM>, blood flow into first arterial gate <NUM> and second arterial gate <NUM> is bridged and passed into the left common carotid artery LCC and the left subclavian artery LSA through bridging stent grafts <NUM>, <NUM>, respectively.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a final stage during deployment of a tube graft <NUM> into double gate bifurcated device <NUM> in accordance with one embodiment. Referring to <FIG>, tube graft <NUM> is deployed into bypass gate <NUM> and into aorta <NUM> and is attached thereto.

<FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of a double gate bifurcated device 1800A, sometimes called a second modular stent device, in accordance with another embodiment. <FIG> is a cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of bridging stent grafts <NUM>, <NUM> in accordance with one embodiment. <FIG> and <FIG> are similar to <FIG> and <FIG> and only the significant differences are discussed below.

In accordance with this embodiment, double gate bifurcated device 1800A includes main body <NUM>, a bypass gate 1804A, first arterial gate <NUM>, and second arterial gate <NUM>. Bypass gate 1804A of double gate bifurcated device 1800A is longer than bypass gate <NUM> of double gate bifurcated device <NUM> eliminating the need of tube graft <NUM> (see <FIG>).

Claim 1:
An assembly comprising:
a first modular stent device (<NUM>) comprising:
a main body (<NUM>) including graft material (<NUM>) and one or more circumferential stents (<NUM>) coupled to graft material (<NUM>);
a bypass gate (<NUM>) including graft material (<NUM>) and one or more circumferential stents (<NUM>) coupled to graft material (<NUM>), the bypass gate extending distally from a distal end of the main body (<NUM>); and
an artery leg (<NUM>) including graft material (<NUM>) and one or more circumferential stents (<NUM>) coupled to graft material (<NUM>), the artery leg (<NUM>) extending distally from the distal end of the main body (<NUM>),
wherein the artery leg (<NUM>) has a greater radial force than a radial force of the bypass gate (<NUM>),
wherein the main body (<NUM>) has a first longitudinal axis (LA1), the bypass gate (<NUM>) has a second longitudinal axis (LA2), and the artery leg (<NUM>) has a third longitudinal axis (LA3), the first, second, and third longitudinal axes are parallel with one another when the first modular stent device (<NUM>) is in a relaxed configuration; and
a second modular stent device (100A, <NUM>, <NUM>) configured to be coupled inside the bypass gate (<NUM>).