Support ring and aortic prosthesis
Patent Information
- Application Number
- ES2022738200T
- Authority / Receiving Office
- ES · ES
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-06-14
- Filing Date
- 2022-06-13
- Publication Date
- 2026-09-15
- Estimated Expiration
- 2042-06-13
Smart Images
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Abstract
Description
Support ring and aortic prosthesis Background Aortic pathologies, including aortic aneurysms, are often treated with open surgical reconstruction or, alternatively, with endovascular repair, a minimally invasive option. However, to optimize the success of endovascular repair, it is essential to assess the patient's anatomy. In the case of an arterial aneurysm, or more specifically, a thoracic or abdominal aortic aneurysm, a well-fitting prosthesis spanning both the proximal and distal ends of the aneurysm ensures exclusion of the aneurysm sac by properly anchoring the prosthesis to the aorta, thereby minimizing endoleaks and prosthesis movement within the aorta. In some cases, the aneurysm encompasses a branching blood vessel, and consequently, a branching prosthesis (also referred to herein as a "bridging-covered endoprosthesis" or "bridging prosthesis") must be implanted in a fenestration in a specially designed main tubular prosthesis. In such assemblies, maintaining a watertight seal between the fenestration of the prosthesis and the branching prosthesis extending through it into a branching blood vessel is especially critical. Blood leakage at the junction where the branching prosthesis passes through the fenestration can have serious and even fatal consequences. However, to ensure a secure fit between the base of the branch prosthesis and the main tubular prosthesis at the fenestration, the branch prosthesis must often extend into an inner portion defined by the main tubular prosthesis. However, placing the branch prosthesis into an inner portion of the main tubular prosthesis can damage the proximal end of the bridging endoprosthesis, which, in turn, can significantly interfere with the blood flow path through the main tubular prosthesis and with blood flow from the main tubular prosthesis to and through the branch prosthesis. Furthermore, in some cases, the fenestration of a main tubular prosthesis is reinforced, often with wire between the branch prosthesis and a perimeter of the fenestration.However, wear between the main tubular prosthesis and the branching prosthesis can be aggravated by the presence of any metallic component, resulting in a loss of integrity of the tissue components of the main tubular prosthesis and the branching prosthesis that divide the metallic support surrounding the fenestration and the metallic endoprostheses of the branching prosthesis. This loss of integrity of the tissue components can cause a failure of the seal between the main tubular prosthesis and the branching prosthesis, resulting in leaks and ultimately further complications, injury, or death. Therefore, there is a need for endovascular repair devices and methods to treat aortic pathologies, such as aortic aneurysms, that overcome or minimize the problems mentioned above. US2012 / 0035714A1 describes a covered endoprosthesis having a reinforcing ring and marker. WO 2018 / 156850 describes a covered endoprosthesis with a fenestration lock. CN100562297C describes fenestrated covered endoprostheses. Summary The invention is defined by the appended claims. This disclosure relates to a support ring for an aortic prosthesis, an aortic prosthesis including a support ring, and a method for forming a support ring for an aortic prosthesis. This disclosure also relates to a graft cuff assembly and methods for its manufacture and use. The invention is useful for treating and repairing aortic vascular damage, such as vascular damage associated with aortic dissections and aneurysms, and damage to regions of the aorta that have arterial branches supplying blood to vital organs and tissues, such as thoracic aortic aneurysms, abdominal aortic aneurysms, and thoracoabdominal aortic aneurysms, and more specifically, juxtarenal aortic aneurysms and short-necked abdominal aortic aneurysms employing fenestrated endovascular aortic repair. A support ring for an aortic prosthesis includes a helical coil having a first helical coil end and a second helical coil end, the helical coil defining a lumen and extending in an arc, wherein the first helical coil end and the second helical coil end are in an opposite relationship to each other, defining a space between the first helical coil end and the second helical coil end and outside the lumen. A wire extends across the lumen and has a first wire end and a second wire end, the wire passing through the space between the first helical coil end and the second helical coil end along at least a length of wire between the first wire end and the second wire end, and wherein the first wire end and the second wire end are fixed to each other. This invention has many advantages. For example, the support ring can be manufactured by routing a wire through the light of a helical coil, where the wire forms at least one complete loop passing through a space between opposite ends of the helical coil along a length of wire distinct from a first wire end and a second wire end that are fixed together. By passing through the space between the first and second ends of the helical coil along at least a length between the first and second wire ends where they are secured together, the wire, in combination with the helical coil, effectively forms a pulley system that reduces the force required to secure the first wire end to the second wire end against the outward radial force applied to the support ring.By reducing the force required to secure the first wire end to the second wire end, the first and second wire ends can be secured together by a mechanism that is easier and quicker to implement, such as crimping relatively soft metal around the first and second wire ends, than would be necessary without winding the wire into at least one additional loop beyond the overlap of the first and second wire ends at the point where they are joined. Failure to properly secure the support ring against radial expansion can cause leakage at the fenestration between the fenestration and the branch prosthesis, which can lead to failure of the prosthesis assembly and, consequently, serious injury or death.Furthermore, the grouping of the wire within a helical coil avoids having to temporarily group the wire during the assembly of an aortic prosthesis, for example, by tying the grouped wire at several points around its periphery, which further simplifies manufacturing and improves quality control during the assembly of the aortic prosthesis prior to implantation. Furthermore, the graft cuff assembly of the invention includes a support ring attached to a graft cuff component on a graft cuff wall of the graft cuff component closer to a proximal end of the graft cuff than to a distal end of the graft cuff, thereby enabling the placement of a branched-covered endoprosthesis, for example, within the graft cuff distal to the support ring, or substantially distal to the support ring.Placing a branch-covered endoprosthesis within the graft cuff and securing the distal branch-covered endoprosthesis to the support ring—as would occur through self-expansion or balloon expansion of the endoprostheses supporting the branch-covered endoprosthesis against the graft cuff wall—substantially or completely avoids the tissue attrition that would otherwise occur when the branch-covered endoprosthesis is secured within a support ring fixed to a fenestration defined by a tubular graft component. Furthermore, it is not necessary to fix the support ring to the fenestration of the tubular graft component; it can be fixed to the graft cuff wall, either in conjunction with its attachment to the fenestration of the tubular graft component or independently. Because the support ring is attached to the graft cuff, the support ring in the graft cuff can be manufactured separately, as an assembly, apart from the tubular graft component to which it is ultimately attached. Furthermore, the graft cuff, which has a base that defines a plane intersecting a plane defined by the distal end of the graft cuff, when attached to a tubular graft component, will have a longitudinal axis that forms an acute angle with a longitudinal axis of the tubular graft component to which it is attached. This facilitates cannulation of the graft cuff using a branch-covered stent (also called a "bridge-covered stent") during implantation. Furthermore, the support ring does not have to be in a plane that is parallel to the plane defined by the proximal end of the graft cuff and, therefore, can be, for example, in a plane that is orthogonal to a longitudinal axis of the graft cuff, thus enabling the fabrication of a branching cuff assembly, in which the support ring is optimally positioned with respect to the proximal end of the graft cuff, the tubular graft component, and the covered shunt endoprosthesis to be implanted within the graft cuff component of the branching cuff assembly.Furthermore, by allowing the implantation of a branch-covered endoprosthesis within a branch sleeve assembly of the invention, wherein a proximal end of the branch-covered endoprosthesis is distal to the support ring, the presence of the proximal end of the branch-covered endoprosthesis within the tubular graft component is avoided, thereby preventing damage to the proximal end of the bridging endoprosthesis and obstruction of blood flow from the tubular graft component to the branch-covered endoprosthesis. Brief description of the drawings The foregoing will become clear from the following more detailed description of example embodiments, as illustrated in the accompanying drawings, in which the same reference characters refer to the same parts across the different views. The drawings are not necessarily to scale; rather, the emphasis is on illustrating the embodiments. FIG. 1 is a side view of an embodiment of a wire component of a support ring of the invention, showing a first wire end and a second wire end overlapping each other and a length of wire between the first wire end and the second wire end overlapping the overlapping first wire end and the second wire end. FIG. 2 is a side view of an embodiment of a helical coil component and a wire component of a support ring of the invention for an aortic prosthesis, wherein the wire is wound through a light defined by the helical coil, the helical coil having a first helical coil end and a second helical coil end, the helical coil defining a light and extending in an arc, wherein the wire component spans a distance between the first helical coil end and the second helical coil end along a length of wire between the first wire end and the second wire end. FIG. 2A is a cross-section of the support ring of FIG. 2 taken along line 2A-2A. FIG. 2b is an end view of the support ring shown in FIG. 2. FIG. 2C is a side view of the wire in FIG. 1 showing the length L of the wire between a first end of the wire and the second end of the wire extending between a first end of the helical coil and an opposite second end of the helical coil. FIG. 3 is a side view of an embodiment of the support ring of the invention, wherein there is a connector located at the first wire end and at the second wire end. FIG.4 is a side view of the support ring of FIG.3 after the connector has been crimped to secure the first wire end and the second wire end together, thereby forming the support ring of the invention. FIG. 5 is a detail of the support ring of FIG. 4, where the connector has been crimped at one point to secure the first wire end and the second wire end together. FIG.6 is a detail of the support ring of FIG.4, where the connector has been crimped at two points to secure the first wire end and the second wire end together. FIG. 7 is a side view of an embodiment of an aortic prosthesis of the invention, having a support ring of the invention fixed to the periphery of a fenestration defined by a tubular graft wall of a tubular graft component of the aortic prosthesis. FIG.7A is a detail of the fenestration and support ring of the prosthesis of the invention shown in FIG.7, showing the suture of the support ring to the perimeter of the fenestration defined by the tubular graft wall of the aortic prosthesis of FIG.7. FIG. 8 is a schematic representation of an embodiment of an aortic prosthesis after implantation at an aneurysm site and after insertion of a branching prosthesis through a fenestration defined by a tubular graft wall of the aortic prosthesis, wherein a support ring of the invention seals a junction between the branching prosthesis and the tubular graft wall of the aortic prosthesis at the fenestration defined by the tubular graft wall. FIG. 9 is a side view of a graft sleeve from one embodiment of a branch sleeve assembly. FIG. 10 is a side view of a branch sleeve assembly, wherein a support ring has been fixed to the graft sleeve wall of a graft sleeve depicted in FIG. 9. FIG.11 is a side view of the branch sleeve assembly of FIG.10 after it has been attached to the perimeter of a fenestration of a tubular graft component. FIG.12 is a view of the branch sleeve assembly attached to a tubular graft component, as shown in FIG.11, but viewed along a line of sight parallel to a longitudinal axis of the tubular graft component. FIG.13 is a side view of an embodiment of the invention, wherein a support ring is attached to a graft sleeve, the proximal end of which is attached to the perimeter of a fenestration of a tubular graft, and wherein a branch-covered endoprosthesis is attached to the graft sleeve by means of an interference fit. FIG. 14 is a side view of another embodiment of the invention, wherein a graft sleeve has a support ring attached to an outer surface of the graft sleeve, wherein the graft sleeve is attached to a liner covering a sealing ring in a fenestration of a tubular graft, and a branch-covered endoprosthesis secured to the graft sleeve by an interference fit of the branch-covered endoprosthesis with the graft sleeve. FIG. 15 is a side view of an aortic prosthesis after it has been implanted within a patient's aneurysm site, and after a fenestration defined by a tubular graft component and a branching cuff assembly of the aortic prosthesis has been cannulated, and a branching-covered endoprosthesis has been implanted in the branching cuff assembly, such that the branching-covered endoprosthesis is secured within the branching cuff assembly by an interference fit between the branching cuff assembly and a proximal end of the branching-covered endoprosthesis, and wherein the branching cuff protrudes caudally from a proximal end to a distal end of the graft cuff. FIG. 16 is a lateral view of an aortic prosthesis after implantation within a patient's aneurysm, and after a fenestration defined by a tubular graft component and a branching cuff assembly of the aortic prosthesis has been cannulated, and a branching-covered endoprosthesis has been implanted within the branching cuff assembly, such that the branching-covered endoprosthesis is secured within the branching cuff assembly by an interference fit between the branching cuff assembly and a proximal end of the branching-covered endoprosthesis, and wherein the cuff and graft project cranially from a proximal end to a distal end of the graft cuff.17 is an embodiment of the placement of a branch-covered endoprosthesis implanted at least partially within the tubular graft component and branch sleeve assembly of FIG. 11 and 12, wherein a proximal end of the branch-covered endoprosthesis extends into an inner lumen defined by the tubular graft component. FIG. 18 is a side view of the branch-covered endoprosthesis of FIG. 17 after it has been directed further into the branch cuff assembly, so that a proximal end of the branch-covered endoprosthesis is secured by an interference fit to the graft cuff wall of the graft cuff, and wherein the proximal end of the branch-covered endoprosthesis no longer interferes with the flow path through the tubular graft component or runs the risk of potential damage to the proximal end of the branch-covered endoprosthesis that would obstruct blood flow from the tubular graft component to the branch-covered endoprosthesis implanted within the branch cuff assembly. Detailed description The invention relates generally to a support ring. An aortic prosthesis including the support ring and a method for manufacturing both the aortic prosthesis and the support ring are also described. The aortic prosthesis is useful for treating and repairing vascular damage, such as vascular damage associated with an aortic aneurysm, including regions of the aorta that have arterial branches supplying blood to vital organs and tissues, including perivisceral aortic aneurysms, such as juxtarenal aortic aneurysms and short-necked abdominal aortic aneurysms. A description of example realizations follows. When referring to a covered stent, also referred to herein as a "stent," "covered stent stent," or "vascular stent," to be administered or implanted in a patient, the word "proximal" means the portion of the stent or stent component that is relatively close to the blood source of the patient's heart. "Distal" means the portion of the stent or stent component that is relatively far from the blood source of the patient's heart. "Cranial," as defined herein, means closer, in absolute terms, to the patient's heart, while "caudal," as defined herein, means farther, in absolute terms, from the patient's heart. However, when referring to a delivery system or a component of a delivery system used to administer or implant a prosthesis, the word "proximal," as used herein, means closer to the clinician using the delivery system. When referring to a delivery system or a component of a delivery system, "distal," as used herein, means farther from the clinician using the delivery system. For clarity, the word "next" means "near," as opposed to the meanings attributed to "proximal" or "distal" described above with respect to the prosthesis or delivery system. Figure 1 shows an embodiment of a wire for a support ring of the invention. As shown therein, wire 10 includes the first end of wire 12 and the second end of wire 14. Wire 10 is coiled, causing the first end of wire 12 to overlap the second end of wire 14, and also includes a length L between the first end of wire 12 and the second end of wire 14 that overlaps the first end of wire 12 and the second end of wire 14. In alternative embodiments, wire 10 may include a plurality of lengths between the first end of wire 12 and the second end of wire 14. In various embodiments, wire 10 may include 2, 3, 4, 5, 6, 7, 8, 9, or 10 overlapping lengths L between the first end of wire 12 and the second end of wire 14, as shown in Figure 2C. Wire 10 is made of a suitable material, such as, for example, a shape-memory alloy or stainless steel. In one particular embodiment, wire 10 includes a shape-memory alloy. Examples of suitable shape-memory alloys include at least one of the following: a nickel-titanium alloy, an iron-based alloy, a copper-based alloy, a zinc-based alloy, a gold-based alloy, and a high-temperature shape-memory alloy. In one particular embodiment, the shape-memory alloy is nitinol. Wire 10 may be radiopaque. Furthermore, wire 10 has a suitable gauge, such as a thickness between approximately 0.102 mm (0.004 in.) and approximately 0.152 mm (0.006 in.). Typical thicknesses are 0.102 mm (0.004 inches), 0.127 mm (0.005 inches) and 0.152 mm (0.006 inches) and intermediate thicknesses. Figure 2 shows an embodiment of a support ring of the invention before the first wire end 12 is attached to the second wire end 14. As can be seen in Figure 2, the helical coil 16 includes the first helical coil end 18 and the second helical coil end 20. The helical coil 16 defines the light 22 shown in Figure 2A, which is a cross-section of Figure 2 taken along line 2A-2A. Figure 2B is an end view of the wire 10 and the helical coil 16 shown in Figure 2. The helical coil 16 is made of a suitable material, such as tantalum, gold, platinum, iridium, nitinol, tungsten, and stainless steel. In one embodiment, the helical coil 16 is radiopaque. In another embodiment, the helical coil 16 is made of a shape-memory alloy, such as nitinol. As can be seen in FIG. 2, the first end of helical coil 18 and the second end of helical coil 20 are in an opposite relationship to each other, defining the open space 24 between the first end of helical coil 18 and the second end of helical coil 20, and outside the light 22. As can also be seen in FIG. 2, the length L of wire 10 passes through, or spans, the open space 24 between the first end of helical coil 18 and the second end of helical coil 20 along at least one length L of wire 10 between the first end of wire 12 and the second end of wire 14. It should be understood that, although FIG. 2, as shown, appears to indicate that the wire ends at the first wire end 12 and the second wire end 14 are within the open space 24 between the first end of helical coil 18 and the second end of helical coil 20. The ends of wire 10 may, instead, be within the light 22 between the first end of helical coil 18 and the second end of helical coil 20, or they may extend beyond the open space 24 defined by the first end of helical coil 18 and the second end of helical coil 20. In either case, the length L of wire 10 between the first end of wire 12 and the second end of wire 14 completely crosses, or spans, the open space 24 between the first end of helical coil 18 and the second end of helical coil 20. FIG.Figure 2C shows wire 10 when straightened to illustrate the length L between the first end of wire 12 and the second end of wire 14. As can be seen in FIG. 1 and 2, wire 10 completes two full loops, 11 and 13, as can be observed in FIG. 1, where the first end 12 and the second end 14 overlap. When the two loops 11, 13 of wire 10 are extended through the light 22 defined by the helical coil 16, a portion of wire 10 between the first end 12 and the second end 14 traverses a distance 24 between the first end 18 and the second end 20 of the helical coil 16. The portion of wire 10 between the first end 12 and the second end 14 that traverses the distance 24 between the first end 18 and the second end 20 of the helical coil 16 is the length L. Wire 10 may have more than two loops. For example, wire 10 may have 3, 4, 5, 6, or more loops.The number of lengths L between the first end 12 and the second end 14 depends on the number of wire loops 10 that extend within the light 22 of the helical coil 16. If, for example, the wire 10 includes three loops, then two lengths L of wire would span the distance 24 between the first end 18 and the second end 20 of the helical coil 16. The two lengths L of wire 10 would be equally spaced between the first end 12 and the second end 14 of the wire 10. If there were four loops of wire 10, there would be three lengths L of wire 10 between the first end 12 and the second end 14, and so on. Wire 10 is combined with helical coil 16 by directing the first end of wire 12 or the second end of wire 14 through the first end of helical coil 18 or the second end of helical coil 20 so that it comes out of the other first end of helical coil 18 or second end of helical coil 20 and continuing until that end is redirected through the opposite end of helical coil 16 from where it was first directed, and then directed through the light 22 defined by helical coil 16 until it comes out of the other end of helical coil 16, thereby making wire 10 have a length L between the first end of wire 12 and the second end of wire 14 that spans, or crosses, the open space 24 between the first end of helical coil 18 and the second end of helical coil 20.In various embodiments, the wire 10 can continue to be routed through the light 22 of the helical coil 16 in the same manner until a plurality of lengths L between the first end of wire 12 and the second end of wire 14 span the open space 24 between the first end of helical coil 18 and the second end of helical coil 20. The number of loops or turns of the wire 10 determines the load on the connector 26, which is discussed below, and allows the use of a very small, thin-walled crimp made of radiopaque material, such as tantalum, which can be set in line with the thickness of a radiopaque marker coil. The connector 26 works in conjunction with the thickness of the support ring, the wire 10, which is typically made of NiTi, so that it fits into the helical coil 16 and yet remains able to reopen the assembly when deployed. FIG. 3 is the embodiment of wire 10 and helical coil 16 shown in FIG. 2, after applying connector 26 to the first end of wire 12 and the second end of wire 14 before securing the first end of wire 12 to the second end of wire 14. FIG. 4 is the embodiment shown in FIG. 3 after crimping connector 26 at two places 28, 30, thereby securing the first end of wire 12 to the second end of wire 14 and thus forming support ring 32. FIG. 5 is a detail of an embodiment of the crimp of connector 26 to thereby fix the first end of wire 12 to the second end of wire 14. In the embodiment shown in FIG. 5, connector 26 is crimped at only one location 28. As can be seen in FIG. 5, the length L of wire 10 between the first end of wire 12 and the second end of wire 14 does not pass through connector 26. FIG. 6 is a detail of FIG. 4, where the connector 26 is crimped at two points 28, 30 along its length to fix the first wire end 12 to the second wire end 14. As in FIG. 5, the length L of wire 10 between the first end of wire 12 and the second end of wire 14 does not pass through the connector 26. In any case, and regardless of how the first end of wire 12 and the second end of wire 14 are fixed to each other, the combination of wire 10, the helical coil 16, and the connector 16 constitute embodiments of the support ring 32 of the invention shown, for example, in FIG. 7A. The connector 26 is made of a suitable material, such as tantalum, gold, platinum, iridium, nitinol, and stainless steel. In one embodiment, the connector 26 is radiopaque. FIG. 7 is an embodiment of an aortic prosthesis 34 comprising the tubular graft component 36 and the support ring 32 of the invention. As shown in FIG. 7, the tubular graft component 36 comprises the first end of tubular graft component 38 and the second end of tubular graft component 40, and the tubular graft wall 42 extending between the first end of tubular graft component 38 and the second end of tubular graft component 40. The tubular graft wall 42 defines the fenestration 44 between the first end of tubular graft component 38 and the second end of tubular graft component 40. However, it should be understood that the tubular graft wall 42 may, in other embodiments, define a plurality of fenestrations, such as at least 2, 3, 4, or 5 fenestrations. As shown in FIG.7, the tubular graft component 36 also includes endoprostheses 46 between the first end of tubular graft component 38 and the second end of tubular graft component 40. As shown in FIG. 7, each endoprosthesis 46 includes struts 48 that are attached at opposite ends to define the proximal vertices 50 and the distal vertices 52. The support ring 32, as shown in FIG. 4 and described above, is stitched to the tubular graft wall 42 at the perimeter 54 of the fenestration 44. FIG. 7A is a detail of the support ring 32 at the fenestration 44 of the tubular graft wall 42 shown in FIG. 7. As can be seen in FIG. 7A, in this embodiment, the sutures 56 surround the helical coil 16 and fix the support ring 32 to the tubular graft wall 42 of the tubular graft component 36. The support ring 32 can be fixed, for example, by stitching, to an inner or outer surface of the tubular graft wall 42. Figure 8 is a schematic representation of an embodiment of the aortic prosthesis 34 after implantation at the aneurysm site 58. The branching graft 61 extends through the fenestration 44 and is radially limited by the support ring 32 in the tubular graft wall 42. The branching graft 61 extends from within the tubular graft component 36 and distally from the tubular graft component 36 through the ostium 59 to the arterial branching site 67 at a point distal to the aneurysm site 58. It should be understood that the ostium 59 need not be part of the aneurysm site 58. An advantage of the invention is that the support ring of the invention can be employed at aneurysm sites along a blood circulation path that includes at least one branching blood vessel that is not part of the aneurysm. FIG. 9 shows an embodiment of a graft sleeve from a branch sleeve assembly. As shown therein, graft sleeve 60 includes the proximal end of graft sleeve 62, the distal end of graft sleeve 64, and the wall of graft sleeve 66 that extends between the proximal end of graft sleeve 62 and the distal end of graft sleeve 64. The distal end of graft sleeve 64 has a diameter D', and the proximal end of graft sleeve 62 has a base diameter D''. The base diameter D'' of the proximal end of graft sleeve 62 is greater than D' of the distal end of graft sleeve 64. The proximal end of graft sleeve 62 defines plane A, which intersects plane B defined by the distal end of graft sleeve 64.Although not required, the wall of graft sleeve 66 is tapered, wherein the diameter D of graft sleeve 60 at a point proximal to the distal end of graft sleeve 64 lies in a plane orthogonal to the longitudinal axis 68 of graft sleeve 60 and is greater than the diameter D' of the distal end of graft sleeve 64. In one embodiment, graft sleeve 60 is tapered or fusiform. In a specific embodiment of a tapered shape of graft sleeve 60, a first orthogonal cross-section 69 of graft sleeve 60 has a larger diameter than a second orthogonal cross-section 71 of graft sleeve 60 at a point along the longitudinal axis 68 that is distal to the first orthogonal cross-section 69 of graft sleeve 60. Figure 10 is a side view of one embodiment of the branching cuff assembly 70, which includes the graft cuff 60 of Figure 9 and the support ring 72 attached to the wall of the graft cuff 66 closer to the proximal end of graft cuff 62 than to the distal end of graft cuff 64. The support ring 72 may be on an outer surface of graft cuff 60 or within a lumen defined by graft cuff 60, as shown in Figure 10. The support ring 72 is of a suitable construction, as known in the technique of rings that are fixed to fenestrations defined by tubular grafts used in the repair of aortic aneurysms. In one embodiment, the support ring 72 is an assembly that includes a radiopaque component. Examples of suitable materials for the radiopaque component of support ring 72 include, for example, at least one of gold, platinum, iridium, and tantalum. In another embodiment, shown in FIG. 11, the aortic prosthesis 92 includes a tubular graft component 94 having a first tubular graft component end 96, a second tubular graft component end 98, and a tubular graft wall 100 extending between the first tubular graft component end 96 and the second tubular graft component end 98. The tubular graft wall 100 defines at least one fenestration 102 between the first tubular graft component end 96 and the second tubular graft component end 98, wherein the graft sleeve wall 66 of the branch sleeve assembly 70 is attached to the tubular graft wall 100 around the fenestration 102. As shown in FIG. 11, the branching sleeve assembly 70 is fixed to the tubular graft wall 100 around the fenestration 102 by means of sutures 104 that extend around the fenestration 102 and the proximal end of the graft sleeve 62. In another embodiment, not shown, the support ring 72 is fixed to the tubular graft wall 100 at the fenestration 102, wherein the fenestration 102 is within the arc of the support ring 72, and the support ring 72 is also fixed to the proximal end of the graft sleeve 62. In another embodiment, also not shown, the tubular graft component 64 is a covered endoprosthesis. In one embodiment, the longitudinal axis 101 of the branch sleeve assembly 70 intersects the longitudinal axis 103 of the tubular graft wall 100 at an angle. The angle range can be, for example, between 0° and 180°, such as 30°, 60°, 90°, 120°, or 150°. The embodiment shown in FIGS. 11 and 12 includes the aortic prosthesis 92, which has, as component parts, the tubular graft component 94, the graft sleeve 60, and the support ring 72. In a specific embodiment, the support ring 72 is fixed to the wall of the graft sleeve 66 and includes the helical coil 16 defining the lumen 22, shown in FIG. 2A, and the wire 10, shown in FIGS. 1-6 extending through the lumen 22, and includes a length L of wire 10 passing through the space (not shown) between the first end of helical coil 18 and the second end of helical coil 20, and wherein the first end of wire 12 and the second end of wire 14 are secured to each other, as shown in FIGS. 4-6, and discussed in detail above. One method for forming the aortic prosthesis 92, as shown in FIG. 11, includes the step of forming the tubular graft component 94 having the first end of tubular graft component 96 and the second end of tubular graft component 98. The tubular wall 100 extends between the first end of tubular graft component 96 and the second end of tubular graft component 98, wherein the tubular graft wall 100 defines the fenestration 102, as shown in FIG. 11. The graft cuff 60 is formed with a proximal end of graft cuff 62, a distal end of graft cuff 64, and a graft cuff wall 66 extending between the proximal end of graft cuff 62 and the distal end of graft cuff 64, as shown in FIG. 9 and 10.The proximal end of graft sleeve 62 has a base diameter and the distal end of graft sleeve 64 has a smaller diameter than the base diameter of the proximal end of graft sleeve 62, as described above with reference to FIG. 9, for example, at an acute angle, where the proximal end of graft sleeve 62 defines plane A which intersects plane B defined by the distal end of graft sleeve 64, as also described above with reference to FIG. 9. The support ring 72 is fixed to the wall of graft sleeve 66 closer to the proximal end of graft sleeve 62 than to the distal end of graft sleeve 64, thereby forming the graft sleeve assembly 70, as described above with reference to FIG. 10.The resulting graft sleeve assembly 70 is attached to the tubular graft wall 100 around the fenestration 102, thereby forming the aortic prosthesis 92, as previously depicted in FIG. 11 and 12. In an alternative embodiment, the graft sleeve 60 is fixed to the tubular graft component 100 and around the fenestration 102 by a suitable means, such as suturing or using an adhesive, and the support ring 72 is then fixed to an outer surface of the graft sleeve 60 where the graft sleeve 60 is fixed to the tubular graft component 100, or distal to where the graft sleeve 60 is fixed to the tubular graft component 94, by suitable means, such as suturing. The distal end 64 of the graft sleeve 60 can be positioned cranial or caudal with respect to the proximal end 62 of the graft sleeve 60. Covered endoprostheses can be implanted at a surgical site encompassing an aneurysm, particularly in the perivisceral segment of the aorta, using appropriate methods as known in the art. After implantation, the bridging endoprostheses can be introduced through the fenestration, the fenestration ring, and into a branch of the aorta, such as the renal, superior mesenteric, or celiac arteries. Suitable delivery devices for implanting covered endoprostheses are described, for example, in U.S. patent applications Nos. 63 / 111,357 and 63,153,701, and in U.S. application serial No. 210,381. In one embodiment, the support ring 72 is formed by a method that includes directing the wire 10 through the light 22 defined by the helical coil 16, shown in FIG.1 and 2A-2C, which extends in an arc from the first end of helical coil 18 to the second end of helical coil 20 opposite the first end of helical coil 18, and along the length L of the space defined by the first end of helical coil 18 and the second end of helical coil 20 that is outside the light 22 defined by the helical coil 16, so that wire 10 passes through the length L of the space between the first end of helical coil 18 and the second end of helical coil 20 along at least a length L of wire 10 between the first end of wire 12 and the second end of wire 14, and the first end of wire 12 is fixed to the second end of wire 14, thereby forming the support ring 32, as depicted, for example, above, and as described above, with reference to FIG. 4.In one embodiment, the method further includes the step of attaching the support ring 72, shown in FIG. 11 and 12, to the tubular graft component 94 in the fenestration 102 in the tubular graft wall 100 of the tubular graft component 94, wherein the fenestration 102 is within the arc of the support ring 72, thereby forming another embodiment of the aortic prosthesis 92 of the invention. In another embodiment, shown in FIG. 13, the graft sleeve assembly 140 has a graft sleeve 131, which includes the proximal end of graft sleeve 132, the distal end of graft sleeve 134, and the graft sleeve wall 136 extending between the proximal end of graft sleeve 132 and the distal end of graft sleeve 134. The proximal end of graft sleeve 132 has a base diameter, and the distal end of graft sleeve 134 has a smaller diameter than the base diameter of the proximal end of graft sleeve 132. The proximal end of graft sleeve 132 defines plane A, which intersects plane B defined by the distal end of graft sleeve 134.In one embodiment, the graft sleeve 131 is tapered or tapered, such that the diameter of a first orthogonal cross-section 135 of the graft sleeve 131 is wider than a second orthogonal cross-section 137 of the graft sleeve 131 distal to the first orthogonal cross-section 135. The support ring 138 of the graft sleeve assembly 140 is attached to the wall of the graft sleeve 136 closer to the proximal end of the graft sleeve 132 than to the distal end of the graft sleeve 134, thereby forming the graft sleeve assembly 140. The support ring 138 may be on an outer surface of the graft sleeve 131, as shown, or on an inner surface of the graft sleeve 131. The graft sleeve 131 is attached to the tubular graft component 100 around a fenestration perimeter 102 by suitable means, such as by stitching or adhesive.The branch-covered endoprosthesis 142 is implanted by directing the branch-covered endoprosthesis 142 through the fenestration 102 and into the graft cuff 131 until the distal end 145 of the branch-covered endoprosthesis 142 protrudes from the distal end 134 of the graft cuff 131, and the proximal end 144 of the branch-covered endoprosthesis 142 is secured to the graft cuff 131 by an interference fit with the graft cuff 131, as indicated by the ridge mark 166. In an alternative embodiment, the support ring 138 is fixed directly to the tubular graft component 100 around the perimeter of the fenestration 102 by suitable means, such as sutures. The distal end 134 of the graft sleeve 131 can be positioned cranially or caudally with respect to the proximal end 132 of the graft sleeve 131. In one embodiment, the branch-covered endoprosthesis 142 is flared at the proximal end 144, as shown in FIG. 13. While the proximal end 144 of the branch-covered endoprosthesis 142 always receives blood flowing out of the branch-covered endoprosthesis 142 through the distal end 145, the graft sleeve 131 and the branch-covered endoprosthesis 142 collectively define the longitudinal axis 147 that intersects with the longitudinal axis 149 of the tubular graft component 100 at the angle.The angle can vary from 0° to 180°, meaning that, after implantation, the distal end 145 of the branch-covered endoprosthesis 142 can be positioned cranially or caudally with respect to the proximal end 144 of the branch-covered endoprosthesis 142. Typical angles between 0° and 180° are, for example, 30°, 60°, 90°, 120°, and 150°. In this case, the support ring 138 extends around the graft cuff 131. The branch-covered endoprosthesis 142 is implanted by directing the branch-covered endoprosthesis 142 through the fenestration 102 and into the graft cuff 131 until the branch-covered endoprosthesis 142 extends from the distal end 134 of the graft cuff 131, and the proximal end 144 of the branch-covered endoprosthesis is secured to the graft cuff 131 by an interference fit with the graft cuff 131, as indicated by the ridge mark 166. In another embodiment, shown in FIG. 14, the graft sleeve assembly 130 is attached to the assembly 150, as described in U.S. Patent Serial No. 63 / 210,258. More specifically, the ring 152 extends around the fenestration 154 defined by the tubular graft component 156, and wherein the ring 152 is secured between one side of the tubular graft component 156 of the covered endoprosthesis 158 and the lining 160, and wherein the lining 160 extends through the fenestration 154. As shown in FIG. 14, the ring 152 is optional when the support ring 133 is present. Typically, the support ring 133 is the one shown in FIG. 4 and described above. In another embodiment, ring 152 is the support ring shown in FIG. 4 and described above, and support ring 133 is not present. In yet another embodiment, ring 152 has a different configuration than that shown in FIG. 4.For example, FIG. 4 may be a series of turns of a suitable wire, such as nitinol wire. Alternatively, ring 152 may be a continuous or discontinuous ring of radiopaque markers. In yet another embodiment, ring 152 is a support ring, as described with reference to FIG. 4, and element 133 of FIG. 14 is present but has an alternative configuration, such as a series of turns of a suitable material, such as nitinol, or a continuous or discontinuous ring of radiopaque markers. The graft sleeve assembly 130 is attached by suitable means, such as sewing or adhesive, to a portion of the liner 160 that is external to the tubular graft component 156. The graft sleeve 131 of the graft sleeve assembly 130 is attached to the liner 160 by suitable means, such as sewing or adhesive. The support ring 133 is attached to the proximal end of the graft sleeve 131 by suitable means, such as sewing. Alternatively, in another embodiment, not shown, the graft sleeve 131 can be attached directly to the tubular graft component 156.The branch-covered endoprosthesis 162 is directed through the fenestration 154 and into the graft sleeve 131 of the graft sleeve assembly 130 until the proximal end 164 of the branch-covered endoprosthesis 162 is in interference relationship with the graft sleeve 131, as shown by the rim mark 166. Examples of tubular graft components and methods for their implantation at an aneurysm site are those known in the art, as described in the relevant teachings of all patents, published applications, and references cited herein. Covered endoprostheses can be implanted at a surgical site encompassing an aneurysm, particularly in the perivisceral segment of the aorta, using appropriate methods as known in the art. After implantation, the bridging endoprostheses can be introduced through the fenestration, the fenestration ring, and into a branch of the aorta, such as the renal, superior mesenteric, or celiac arteries. Suitable delivery devices for implanting covered endoprostheses are described, for example, in U.S. patent applications Nos. 63 / 111,357 and 63 / 153,701, and in U.S. serial No. 63 / 210,381. A method for implanting a branched aortic prosthesis, such as the branched aortic prosthesis 106 shown in FIG. 15, at the aneurysm site 114 is also described, wherein the branching cuff assembly 70 includes a graft cuff 60 extending through the ostium 71, which is essentially aligned with the tubular graft component 94, and into the aortic branch 73, and is oriented caudally from the proximal end of graft cuff 72 to the distal end of graft cuff 64. Alternatively, as can be seen in FIG. 16, the branching sleeve assembly 70 can be oriented cranially from the proximal end of graft sleeve 62 to the distal end of graft sleeve 64, where the graft sleeve 60 extends through the ostium 71, which is essentially aligned with the tubular graft component 94, and into the aortic branch 73. In FIG. 15 or FIG. 16, implantation of the branched aortic prosthesis 106 includes directing the aortic prosthesis 92 to an aortic surgical site, where the aortic prosthesis 92 includes the tubular graft component 94, which includes the first end of tubular graft component 96 and a second end of tubular graft component 98, where the tubular graft component includes the tubular graft wall 100, which extends between the first end of the tubular graft component. 96 and the second end of tubular graft component 98.The tubular graft wall 100 defines at least the fenestration 102 between the first end of tubular graft component 96 and the second end of tubular graft component 98. As shown in the progression from FIG. 17 to FIG. 18, the branch-covered endoprosthesis 110 is directed distally through the proximal end of the graft cuff 62 until at least a portion of the proximal end of the branch-covered endoprosthesis 62 is distal to the support ring 72, so that the branch-covered endoprosthesis 110 (also referred to herein as the "bridge-covered endoprosthesis" or "bridge prosthesis") is secured by an interference fit 116 between the proximal end of the branch-covered endoprosthesis 112 and the graft cuff 60, shown in FIG. 18, thereby implanting the branch-covered endoprosthesis 110 at the surgical site 114, as shown in FIG. 15 and 16. In a particular embodiment of the implantation method of the support ring 72 of the invention, the step of fixing the support ring 72 to the tubular graft wall 100 of the tubular graft component 100 in the fenestration 102 is included, as shown in FIG. 11, wherein the fenestration 102 is within the arc of the support ring 72. The graft sleeve 60 can then be fixed to the tubular graft component 100 in the fenestration 102 over the support ring 72 by a suitable means, such as suture or by using adhesive. In an alternative embodiment, the graft sleeve 60 is fixed to the tubular graft component 100 and around the fenestration 102 by a suitable means, such as suturing or using an adhesive, and the support ring 72 is then fixed to an outer surface of the graft sleeve 60 where the graft sleeve 60 is fixed to the tubular graft component 100, or distal to where the graft sleeve 60 is fixed to the tubular graft component 94, by suitable means, such as suturing. The distal end 64 of the graft sleeve 60 can be positioned cranial or caudal with respect to the proximal end 62 of the graft sleeve 60. Covered endoprostheses can be implanted at a surgical site encompassing an aneurysm, particularly in the perivisceral segment of the aorta, using appropriate methods as known in the art. After implantation, the bridging endoprostheses can be introduced through the fenestration, the fenestration ring, and into a branch of the aorta, such as the renal, superior mesenteric, or celiac arteries. Suitable delivery devices for implanting covered endoprostheses are described, for example, in U.S. patent applications Nos. 63 / 111,357 and 63,153,701, and in U.S. application serial No. 210,381. There are relevant lessons in U.S. patents Nos. US 10,987,235, US 11,000,359, US 11,291,572, US 11,278,390, US 11,219,540 and US 11,154,392; in published U.S. patent applications Nos.: US 2019 / 0269498 A1, US 2019 / 0231514 A1, US 2019 / 0231571 A1, US 2019 / 0247178 A1, US 2019 / 0269497 A1, US 2019 / 0282355 A1, US 2019 / 0321207 A1, US 2020 / 352700A1 and US 2021 / 0401602 A1; and in U.S. application serial No.: 17 / 522.251. There are also relevant lessons in the US patent application entitled "Support Ring for Vascular Aortic Repair and Methods of Use", filed on June 13, 2022 by Eduardo Alejandro Garcia, Timothy Lostetter and Eitan Magen.
Claims
1. A support ring for an aortic prosthesis, comprising a) a helical coil (16) having a first helical coil end (18) and a second helical coil end (20), the helical coil defining a lumen (22) and extending in an arc, wherein the first helical coil end (18) and the second helical coil end (20) are in an opposite relationship to each other defining a space that is between the first helical coil end (18) and the second helical coil end (20) and is outside the lumen (22); (b) a wire (10) extending through the light (22) and having a first wire end (12) and a second wire end (14), the wire (10) passing completely through the space between the first helical coil end (18) and the second helical coil end (20) along at least a length of wire between the first wire end (12) and the second wire end (14),wherein the wire (10) completes two or more complete loops (11, 13) and the first wire end (12) and the second wire end (14) overlap, and wherein the first wire end (12) and the second wire end (14) are secured to each other with a crimp connector (26).
2. The support ring of any of the preceding claims, wherein the crimp connector (26) is in the space between the first helical coil end (18) and the second helical coil end (20).
3. The support ring of any of the preceding claims, wherein the crimp connector (26) includes at least one of tantalum, gold, platinum, iridium, nitinol, and stainless steel.
4. The support ring of any of the preceding claims, wherein the helical coil (16) is radiopaque.
5. The support ring of any of the preceding claims, wherein the helical coil (16) includes at least one of the following: tantalum, gold,platinum, iridium, nitinol, tungsten, and stainless steel.
6. The support ring of any of the preceding claims, wherein the wire (10) includes at least one of a shape-memory alloy and stainless steel.
7. The support ring of any one of claims 1 to 5, wherein the wire (10) includes a shape-memory alloy.
8. The support ring of claim 6 or claim 7, wherein the shape-memory alloy includes at least one of a nickel-titanium alloy, an iron-based alloy, a copper-based alloy, a zinc-based alloy, a gold-based alloy, and a high-temperature shape-memory alloy.
9. The support ring of claim 6 or claim 7, wherein the shape-memory alloy includes nitinol.
10. The support ring of any of the preceding claims,wherein the wire (10) completely traverses the space between the first end of the helical coil (18) and the second end of the helical coil (20) in a plurality of lengths between the first wire end (12) and the second wire end (14).
11. The support ring of any of the preceding claims, wherein the wire (10) completely traverses the space between the first end of the helical coil (18) and the second end of the helical coil (20) in two, three, four, five, six, seven, eight, nine or ten lengths along the wire (10).
12. The support ring of any of the preceding claims, further comprising a tubular graft (36) having a first tubular graft end (38), a second tubular graft end (40), and a tubular graft wall (42) extending between the first tubular graft end (38) and the second tubular graft end (40),defining the tubular graft wall (42) by at least one fenestration (44) between the first end of the tubular graft (38) and the second end of the tubular graft (40), wherein the helical coil (16) is fixed to the tubular graft wall (42) at the fenestration (44), and wherein the fenestration (44) is within the arc of the helical coil (16).
13. The support ring of claim 12, wherein the tubular graft (36) is a covered endoprosthesis with a branching graft (61) extending through the fenestration (44) of the covered endoprosthesis.
14. The support ring of claim 13, wherein the radial diameter of the branching graft (61) at the fenestration (44) is restricted.