Patent Application
20080097578
Common reference numerals are used throughout the drawings and detailed description to indicate like elements.
In accordance with one example, referring to
More particularly,
Main graft 102 includes a cylindrical graft material 108 having a lower, e.g., first, opening 110 at a lower, e.g., first, end 112. Main graft 102 further includes an upper, e.g., second, opening 114 at an upper, e.g., second, end 116. Main graft 102 defines a lumen 117 extending through main graft 102 from lower opening 110 to upper opening 114.
To facilitate sealing of main graft 102 with the main vessel, main graft 102 further includes a lower, e.g., first, stent ring 118 and an upper, e.g., second, stent ring 120 at lower and upper ends 112, 116, respectively. In one embodiment, stent rings 118, 120 are self-expanding.
Stent rings 118, 120 are optional. In one example, a main graft similar to main graft 102 is formed with either stent ring 118 or stent ring 120, but not both. In another example, a main graft similar to main graft 102 is formed without either of stent rings 118, 120. It yet another example, a main graft similar to main graft 102 is formed with more than two stent rings or other resilient self-expanding structure.
Protruding radially outward from a collateral opening 121 in the cylindrical surface of graft material 108 of main graft 102 is a main graft branch limb 122. In various examples, main graft branch limb 122 is a graft, a stent, or a stent-graft.
Collateral opening 121 and thus main graft branch limb 122 are located not right at the ends, but inward from the ends at a distance from lower and upper ends 112, 116. Main graft branch limb 122 includes a lumen 124 extending through main graft branch limb 122. Lumen 124 is in fluid communication with lumen 117 of graft material 108. As discussed further below in reference to
Lower extender cuff 104, sometimes called a thoracic extender cuff, includes a cylindrical graft material 128 having a lower, e.g., first, opening 130 at a lower, e.g., first, end 132. Lower extender cuff 104 further includes an upper, e.g., second, opening 134 at an upper, e.g., second, end 136. Lower extender cuff 104 defines a lumen 137 extending through lower extender cuff 104 from lower opening 130 to upper opening 134.
To facilitate sealing of graft material 128 of lower extender cuff 104 with the main vessel and/or main graft 102, lower extender cuff 104 further includes a lower, e.g., first, stent ring 138 and an upper, e.g., second, stent ring 140 at lower and upper ends 132, 136, respectively. In one embodiment, stent rings 138, 140 are self-expanding.
Stent rings 138,140 are optional. In one example, an extender cuff similar to lower extender cuff 104 is formed with either stent ring 138 or stent ring 140, but not both. In another example, an extender cuff similar to lower extender cuff 104, e.g., extender cuff 106, is formed without either of stent rings 138, 140. It yet another example, an extender cuff similar to lower extender cuff 104 is formed with more than two stent rings or other resilient self-expanding structure.
Protruding radially outward from a collateral opening 141 in the cylindrical surface of graft material 128 of lower extender cuff 104 is an extender cuff branch limb 142. In various examples, extender cuff branch limb 142 is a graft, a stent, or a stent-graft.
Collateral opening 141 and thus extender cuff branch limb 142 are located between and at a distance from lower and upper ends 132, 136. Extender cuff branch limb 142 includes a lumen 144 extending through extender cuff branch limb 142. Lumen 144 is in fluid communication with lumen 137 of graft material 128. As discussed further below in reference to
Lower extender cuff 104 further includes a cutout 146 formed at lower end 132. Cutout 146 is sometimes called a 3-sided window, opening, or scallop of graft material 128.
Cutout 146 is defined by a U-shaped edge 148 of graft material 128. A first end 150 of edge 148 is at lower end 132. Edge 148 extends longitudinally back from first end 150 to an apex 152 (the furthest point or line longitudinally back from the edge) and then back toward a second end 154 of edge 148. Second end 154 of edge 148 is also at lower end 132. Although a particular shape for cutout 146 is described, in other examples, cutout 146 is formed in another shape such as a square, rectangle, triangle, curve or other shape.
Cutout 146 has an area defined by edge 148 that is equivalent to the portion of graft material that is absent (in comparison to an element expected conventional geometric end shape that the end would take if the graft material were not absent) to form cutout 146. If the end was configured in a regular geometric shape or pattern such as a square end or and oblique end or a rapid sinusoidal wave pattern. Then the cutout area is the area missing from a normative end geometry or pattern. As discussed in greater detail below, the area of cutout 146 is greater than the area of collateral opening 121 in main graft 102. This allows lower extender cuff 104 to be rotated and/or moved longitudinally (telescoped (have a varying degree of overlap with the adjacent piece)) relative to main graft 102 without blocking collateral opening 121. Stated another way, this allows lower extender cuff 104 to be positioned so that extender cuff branch limb 142 can be positioned in a branch vessel while having a longitudinal length overlapping internally (or externally) the adjacent main body end and the longitudinal position of the collateral opening 121 without obstructing collateral opening 121. The extender cuff can be rotated and/or telescoped relative to main graft 102 while keeping an overlap between collateral opening 121 and cutout 146.
Upper extender cuff 106 is similar to lower extender cuff 104 and only the significant differences between upper extender cuff 106 and lower extender cuff 104 are discussed. More particularly, upper extender cuff 106 includes a cylindrical graft material 128A, a lower opening 130A, a lower end 132A, an upper opening 134A, an upper end 136A, a lumen 137A, a collateral opening 141A, a cutout 146A, an edge 148A, an end 150A, an apex 152A, and an end 154A similar to cylindrical graft material 128, lower opening 130, lower end 132, upper opening 134, upper end 136, lumen 137, collateral opening 141, cutout 146, edge 148, end 150, apex 152, and end 154 of lower extender cuff 104, respectively.
As discussed in greater detail below, the area of cutout 146A in upper extender cuff 106 is greater than the area of collateral opening 141 in lower extender cuff 104. This allows upper extender cuff 106 to be rotated and/or telescoped relative to lower extender cuff 104 without blocking collateral opening 141. Stated another way, this allows upper extender cuff 106 to be rotated and/or telescoped relative to lower extender cuff 104 while keeping an overlap between collateral opening 141 and cutout 146A.
Although modular graft assembly 100 is set forth above as including both lower extender cuff 104 and upper extender cuff 106, in another example, a modular graft assembly similar to modular graft assembly 100 includes only lower extender cuff 104 or upper extender cuff 106, but not both. In another example, a modular graft assembly similar to modular graft assembly 100 includes two or more lower extender cuffs 104, two or more upper extender cuffs 106, or other combinations of lower extender cuff 104 and upper extender cuff 106.
As discussed above, the area of cutout 146 is greater than the area of collateral opening 121. More particularly, the width of cutout 146 is greater than the width of collateral opening 121. This allows lower extender cuff 104 to be rotated relative to main graft 102 while still maintaining an overlap between cutout 146 and collateral opening 121. In this manner, flexibility in the rotational placement of collateral opening 141/extender cuff branch limb 142 relative to collateral opening 121/main graft branch limb 122 is provided. Stated another way, the rotational position of collateral opening 141/extender cuff branch limb 142 relative to collateral opening 121/main graft branch limb 122 is set by rotation of lower extender cuff 104 relative to main graft 102.
Further, the length of cutout 146 is greater than the length of collateral opening 121. This allows lower extender cuff 104 to be longitudinally moved, sometimes called telescoped, relative to main graft 102 while still maintaining an overlap between cutout 146 and collateral opening 121. In this manner, flexibility in the longitudinal placement of collateral opening 141/extender cuff branch limb 142 relative to collateral opening 121/main graft branch limb 122 is provided. Stated another way, the longitudinal position of collateral opening 141/extender cuff branch limb 142 relative to collateral opening 121/main graft branch limb 122 is set by telescoping of lower extender cuff 104 relative to main graft 102.
Similarly, lower end 132A of upper extender cuff 106 is inserted into upper opening 134 of lower extender cuff 104. More generally, upper extender cuff 106 is inserted into lower extender cuff 104 such that cutout 146A is aligned with and overlaps collateral opening 141 in lower extender cuff 104.
As discussed above, the area of cutout 146A is greater than the area of collateral opening 141. More particularly, the width of cutout 146A is greater than the width of collateral opening 141. This allows upper extender cuff 106 to be rotated relative to lower extender cuff 104 while still maintaining an overlap between cutout 146A and collateral opening 141. In this manner, flexibility in the rotational placement of collateral opening 141A of upper extender cuff 106 relative to collateral opening 141/extender cuff branch limb 142 of lower extender cuff 104 is provided.
Further, the length of cutout 146A is greater than the length of collateral opening 141. This allows upper extender cuff 106 to be longitudinally moved, sometimes called telescoped, relative to lower extender cuff 104 while still maintaining an overlap between cutout 146A and collateral opening 141. In this manner, flexibility in the longitudinal placement of collateral opening 141A of upper extender cuff 106 relative to collateral opening 141/extender cuff branch limb 142 of lower extender cuff 104 is provided.
In another example, instead of inserting lower extender cuff 104 into main graft 102, main graft 102 is inserted into lower extender cuff 104 such that cutout 146 is aligned with and overlaps collateral opening 121 in main graft 102. In yet another example, instead of inserting upper extender cuff 106 into lower extender cuff 104, lower extender cuff 104 is inserted into upper extender cuff 106 such that cutout 146A is aligned with and overlaps collateral opening 141 in lower extender cuff 104.
Further, graft material 128 of lower extender cuff 104 includes a middle sealing portion 156. Middle sealing portion 156 is a cylindrical surface longitudinally located between cutout 146 and collateral opening 141.
Further, graft material 108 of main graft 102 includes an end sealing portion 126 at upper end 116. End sealing portion 126 is a cylindrical surface located at upper end 116.
As shown in
Similarly, graft material 128A of upper extender cuff 106 includes a middle sealing portion 156A. Middle sealing portion 156A is a cylindrical surface longitudinally located between cutout 146A and collateral opening 141A.
Further, graft material 128 of lower extender cuff 104 includes an end sealing portion 158 at upper end 136. End sealing portion 158 is a cylindrical surface located at upper end 136.
As shown in
Accordingly, lumens 117, 137, 137A of main graft 102, lower extender cuff 104, upper extender cuff 106, respectively, collectively form a single lumen 202 longitudinally extending through modular graft assembly 100. Upper opening 134A of upper extender cuff 106 forms an upper lumen opening for lumen 202 and lower opening 110 of main graft 102 forms a lower lumen opening for lumen 202. Further, collateral openings 121, 141, 141A of main graft 102, lower extender cuff 104, upper extender cuff 106, respectively, are in fluid communication with lumen 202.
Specifically, collateral opening 121 of main graft 102 is in fluid communication with lumen 202 through cutout 146 of lower extender cuff 104. Accordingly, collateral opening 121 forms a first collateral opening in the cylindrical surface 204 of modular graft assembly 100 collectively created by graft material 108, graft material 128, and graft material 128A of main graft 102, lower extender cuff 104, upper extender cuff 106, respectively.
Similarly, collateral opening 141 of lower extender cuff 104 is in fluid communication with lumen 202 through cutout 146A of upper extender cuff 106. Accordingly, collateral opening 141 forms a second collateral opening in cylindrical surface 204 of modular graft assembly 100.
Finally, collateral opening 141A of upper extender cuff 106 is in directing fluid communication with lumen 202. Collateral opening 141A of upper extender cuff 106 forms a third collateral opening in cylindrical surface 204 of modular graft assembly 100.
Referring now to
Branching off main vessel 302 are three branch vessels 304, 306, 308, e.g., the subclavian, the common carotid, and the brachiocephalic trunk.
Collateral opening 121 of main graft 102 is aligned with branch vessel 304. Further, main graft branch limb 122 of main graft 102 extends into branch vessel 304. Accordingly, collateral flow from lumen 202 of modular graft assembly 100 to branch vessel 304 is provided through collateral opening 121 and main graft branch limb 122. Illustratively, main graft branch limb 122 stents branch vessel 304.
Similarly, collateral opening 141 of lower extender cuff 104 is aligned with branch vessel 306. Further, extender cuff branch limb 142 of lower extender cuff 104 extends into branch vessel 306. Accordingly, collateral flow from lumen 202 of modular graft assembly 100 to branch vessel 306 is provided through collateral opening 141 and extender cuff branch limb 142. Illustratively, extender cuff branch limb 142 stents branch vessel 306.
Finally, collateral opening 141A of upper extender cuff 106 is aligned with branch vessel 308. Accordingly, collateral flow from lumen 202 of modular graft assembly 100 to branch vessel 308 is provided through collateral opening 141A.
Further, as described above, by rotating and/or telescoping main graft 102, lower extender cuff 104, and upper extender cuff 106 relative to the one previously placed during the deployment process, variations in the radial and longitudinal positions of branch vessels 304, 306, 308 are readily accommodated by modular graft assembly 100. Accordingly, aneurysm 304 is excluded while at the same time collateral flow to branch vessels 304, 306, 308 is provided. Further, custom fabrication of a graft assembly to accommodate the vessel structure of a particular patient and the associated costs are avoided.
A method of assembling a modular graft assembly includes: frictionally connecting a first extender cuff with a main graft comprising a collateral opening, wherein a cutout of the first extender cuff is aligned with and overlaps the collateral opening of the main graft, the first extender cuff includes a collateral opening, the cutout having a greater area than the collateral opening of the main graft. The method can further include rotating the first extender cuff relative to the main graft to set the rotational position of the collateral opening of the first extender cuff relative to the collateral opening of the main graft. The method can further include telescoping the first extender cuff relative to the main graft to set the longitudinal position of the collateral opening of the first extender cuff relative to the collateral opening of the main graft. The method may further include frictionally connecting a second extender cuff with the first extender cuff, wherein a cutout of the second extender cuff is aligned with and overlaps the collateral opening of the first extender cuff, the second extender cuff comprising a collateral opening, the cutout of the second extender cuff having a greater area than the collateral opening of the first extender cuff.
A further method according to the present invention includes the steps of placing a main graft including an integral branch graft extension in a main vessel at an intersection of the main vessel with a first branch vessel, where the integral branch graft extension is deployed in the first branch vessel and provides fluid communication from said main graft into the branch vessel, and positioning and deploying a branch extender cuff branch with integral branch graft, the branch graft extending into a second branch vessel, the cuff branch having a generally cylindrical main body with a scalloped lower edge to overlap an upper portion of said main graft and surround an opening of said main integral branch graft with the scallop opening positioned in the area of the opening of the integral branch graft to maintain patency for branch flow while providing a seal with said longitudinal portion of said main graft. A further step where a second cuff branch provides and extesion and seal for a immediately adjacent third vessel branching from the main vessel. The cuff branch have openings which provide an opening for the passage of blood to the adjacent branch. The main cuff having the side branch opening may include integral branch graft or stent graft extensions providing an adequate landing zone for sealing into the adjacent branch vessels.
This disclosure provides exemplary embodiments. The scope is not limited by these exemplary embodiments. Numerous variations, whether explicitly provided for by the specification or implied by the specification or not, such as variations in structure, dimension, type of material and manufacturing process may be implemented by one of skill in the art in view of this disclosure.
