SUPPORT RING, AORTIC PROSTHESIS AND METHOD OF FORMING
20230063108 · 2023-03-02
Inventors
Cpc classification
A61F2220/0075
HUMAN NECESSITIES
A61F2002/061
HUMAN NECESSITIES
International classification
Abstract
A support ring for an aortic prosthesis includes a helical coil extending in an arc and defining a space between a helical coil first end and helical coil second end in opposing relation to each other. A wire extending through the lumen defined by the helical coil includes a wire first end and a wire second end that are fixed to each other, and a length between the wire first end and the wire second end that traverses the space between helical coil first end and the helical coil second end. A branch sleeve assembly includes a graft sleeve having a proximal end that defines a plane that intersects a plane defined by the distal end of the graft sleeve, and a support ring fixed to the graft sleeve wall that is closer to the proximal end of the graft sleeve than to the graft sleeve distal end.
Claims
1. A support ring for an aortic prosthesis, comprising a) a helical coil having a helical coil first end and a helical coil second end, the helical coil defining a lumen and extending in an arc, wherein the helical coil first end and the helical coil second end are in an opposing relation to each other that defines a space that is between the helical coil first end and the helical coil second end and is outside the lumen; and b) a wire extending through the lumen and having a wire first end and a wire second end, the wire traversing the space between the helical coil first end and the helical coil second end along at least one length of the wire between the wire first end and the wire second end, and wherein the wire first end and the wire second end are secured to each other.
2. The support ring of claim 1, further including a crimped connector at the wire, whereby the wire first end and the wire second end of the wire are secured to each other.
3. The support ring of claim 2, wherein the crimped connector is in the space between the helical coil first end and the helical coil second end.
4. The support of claim 3, wherein, the crimped connector includes at least one of tantalum, gold, platinum, iridium, nitinol, and stainless steel.
5. The support ring of claim 3, wherein the helical coil is radiopaque.
6. The support ring of claim 5, wherein the helical coil includes at least one of tantalum, gold, platinum, iridium, nitinol, tungsten, and stainless steel.
7. The support ring of claim 1, wherein the wire includes at least one of a shape-memory alloy and stainless steel.
8. The support ring of claim 7, wherein the wire includes a shape-memory alloy.
9. The support ring of claim 8, 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.
10. The support ring of claim 9, wherein the shape-memory alloy includes nitinol.
11. The support ring of claim 10, wherein the wire traverses the space between the helical coil first end and the helical coil second end at a plurality of lengths between the wire first end and the wire second end.
12. The support ring of claim 11, wherein the wire traverses the space between the helical coil first end and the helical coil second end at two, three, four, five, six, seven, eight, nine, or ten lengths along the wire.
13. The support ring of claim 12, further including a tubular graft having a tubular graft first end, a tubular graft second end, and a tubular graft wall extending between the tubular graft first end and tubular graft second end, the tubular graft wall defining at least one fenestration between the tubular graft first end and the tubular graft second end, wherein the helical coil is fixed to the tubular graft wall at the fenestration, and wherein the fenestration is within the arc of the helical coil.
14. The support ring of claim 13, wherein the tubular graft is a stent graft.
15. (canceled)
16. (canceled)
17. A branch sleeve assembly for an aortic prosthesis, comprising: a) a graft sleeve having a graft sleeve proximal end, a graft sleeve distal end, and a graft sleeve wall extending between the graft sleeve proximal end and the graft sleeve distal end, the graft sleeve proximal end having a base diameter and the graft sleeve distal end having a diameter less than the base diameter, and wherein the graft sleeve proximal end defines a plane that intersects a plane defined by the graft sleeve distal end; and b) a support ring fixed to the graft sleeve wall that is closer to the proximal end of the graft sleeve than to the graft sleeve distal end.
18-29. (canceled)
30. An aortic prosthesis, comprising: a) a tubular graft component including a tubular graft component first end and a tubular graft component second end, and a tubular graft wall extending between the tubular graft component first end and the tubular graft component second end, the tubular graft wall defining at least one fenestration between the tubular graft component first end and the tubular graft component second end; and b) a support ring at the tubular wall, the support ring including i) a helical coil having a helical coil first end and a helical coil second end, the helical coil defining a lumen and extending in an arc, wherein the helical coil first end and the helical coil second end are in an opposing relation to each other that defines a space between the helical coil first end and the helical coil second end and is outside the lumen, the helical coil being fixed to the tubular wall at the fenestration, wherein the fenestration is within the arc of the helical coil, and ii) a wire extending through the lumen and having a wire first end and a wire second end, the wire traversing the space between the wire first end and the wire second end along at least one length of the wire between the wire first end and the wire second end, and wherein the wire first end and the wire second end are secured to each other.
31. (canceled)
32. (canceled)
33. A method of forming a support ring for an aortic prosthesis, comprising the steps of: a) directing a wire through a lumen defined by a helical coil from a helical coil first end through a helical coil second end that is in opposition to the helical coil first end, and across a space defined by the helical coil first end and the helical coil second end that is outside the lumen, whereby the wire traverses the space between the helical coil first end and the helical coil second end along at least one length of the wire between a wire first end and a wire second end; and b) securing the wire first end to the wire second end, thereby forming the support ring.
34. The method of claim 33, further including the step of fixing the support ring to a tubular graft having a tubular graft first end and a tubular graft second end, and a tubular wall extending between the tubular graft first end and the tubular graft second end, the tubular wall defining a fenestration, and wherein the fenestration is within the arc of the helical coil.
35-39. (canceled)
40. A method for implanting a branched aortic prosthesis, comprising the steps of: a) directing an aortic prosthesis to an aortic surgical site, the aortic prosthesis including, i) a tubular graft component including a tubular graft first end and a tubular graft second end, and a tubular graft wall extending between the tubular graft first end and the tubular graft second end, the tubular graft wall defining at least one fenestration between the tubular graft first end and the tubular graft second end, ii) a graft sleeve having a graft sleeve proximal end, a graft sleeve distal end, and a graft sleeve wall extending between the graft sleeve proximal end and the graft sleeve distal end, the graft sleeve proximal end having a base diameter and the graft sleeve distal end having a diameter less than the base diameter, wherein the graft sleeve proximal end defines a plane that intersects a plane defined by the graft sleeve distal end, and wherein the graft sleeve wall is fixed to the tubular wall around the fenestration, and iii) a support ring fixed to the graft sleeve wall, wherein the support ring is fixed to the graft sleeve wall closer to the graft sleeve proximal end than to the graft sleeve distal end; and b) directing a branch stent graft distally through the graft sleeve until a branch stent graft proximal end is distal to the support ring, whereby the branch stent graft is secured by an interference fit between the branch stent graft distal end and the graft sleeve, thereby implanting the branched stent graft at the surgical site.
41. The method of claim 40, wherein the support ring includes: a) a helical coil having a helical coil first end and a helical coil second end, the helical coil defining a lumen and extending in an arc, wherein the helical coil first end and the helical coil second end are in an opposing relation to each other that defines a space between the helical coil first end and the helical coil second end and is outside the lumen, the helical coil being fixed to the tubular wall at the fenestration, wherein the fenestration is within the arc of the helical coil; and b) a wire extending through the lumen and having a wire first end and a wire second end, the wire traversing the space between the helical coil first end and the helical coil second end along at least one length of the wire between the wire first end and the wire second end, and wherein the wire first end and wire second end are secured to each other.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The foregoing will be apparent from the following more particular description of example embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments.
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DETAILED DESCRIPTION
[0042] The features and other details of the invention, either as steps of the invention or as combinations of parts of an invention, will now be more particularly described and pointed out in the claims. It will be understood that the particular embodiments of the invention are shown by way of illustration and not as to limitations of the invention. The principal features of this invention can be employed in various embodiments without departing from the scope of the invention. It will also be understood that the same number appearing in different drawings represents the same item.
[0043] The invention generally is directed to a support ring and an aortic prosthesis that includes the support ring, and a method of fabricating both the aortic prosthesis and the support ring. The aortic prosthesis is useful in treating and repairing vascular damage, such as vascular damage associated with an aortic aneurysm, including regions of the aorta having arterial branches that supply blood to vital organs and tissues, including perivisceral aortic aneurysms, such as juxtarenal aortic aneurysms and short-neck abdominal aortic aneurysms.
[0044] A description of example embodiments follows.
[0045] When reference is made to a stent graft, also referred to herein as a “prosthesis,” “stent graft prosthesis,” or “vascular prosthesis” to be delivered or implanted in a patient, the word “proximal” means that portion of the prosthesis or component of the prosthesis that is relatively close to the source of blood from the heart of the patient. “Distal” means that portion of the prosthesis or component of the prosthesis that is relatively far from the source of blood flow from the heart of the patient. “Cranial,” as defined herein, means closer, as an absolute measure, to the heart of the patient, while “caudal,” as defined herein, means farther, as an absolute measure, from the heart of the patient.
[0046] When, however, reference is made to a delivery system or component of a delivery system employed to deliver, or implant, a prosthesis, the word “proximal,” as employed herein, means closer to the clinician using the delivery system. When reference is made to a delivery system or component of a delivery system, “distal,” as that term is employed herein, means, further away from the clinician using the delivery system.
[0047] For clarity, the word “proximate” means “close to,” as opposed to the meanings ascribed to “proximal” or “distal” described above with respect to either the prosthesis or delivery system.
[0048] One embodiment of a wire of a support ring of the invention is shown in
[0049] Wire 10 is formed 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 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 can be radiopaque. Further, wire 10 has a suitable gauge, such as a thickness between about 0.004 inches and about 0.006 inches. The typical thickness is 0.004 inches, 0.005 inches, and 0.006 inches and thicknesses in between.
[0050]
[0051] As can be seen in
[0052] Wire 10 is combined with helical coil 16 by directing either of wire first end 12 or wire second end 14 through either of helical coil first end 18 or helical coil second end 20 to emerge from the other of helical coil first end 18 or helical coil second end 20 and continue until that end is redirected through the opposing end of helical coil 16 it was first directed through, and then directed through lumen 22 defined by helical coil 16 until it emerges from the other end helical coil 16, thereby causing wire 10 to have a length L between wire first end 12 and wire second end 14 that traverses, or spans, the open space 24 between helical coil first end 18 and helical coil second end 20. In various embodiments, wire 10 can continue to be directed through lumen 22 of helical coil 16 in the same manner until a plurality of lengths L between wire first end 12 and wire second end 14 span open space 24 between helical coil first end18 and helical coil second end 20. The number of loops, or turns of wire 10 determine the load on connector 26, discussed below, and enables the employment of a very small, thin-wall crimp made of radiopaque material, such as tantalum, which can be tacked in line with the thickness of a radiopaque marker coil. Connector 26 works in combination with the thickness of the support ring, wire 10, which typically is formed of NiTi, so it fits in helical coil 16, and yet is still able to reopen the assembly when deployed.
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[0057] Support ring 32, such as that shown in
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[0059] One embodiment of a graft sleeve of a branch sleeve assembly of the invention is shown in
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[0061] In another embodiment, shown in
[0062] As shown in
[0063] The embodiment of the invention shown in
[0064] In another embodiment, the invention is a method of forming aortic prosthesis 92, such as is shown in FIG.11, that includes the step of forming tubular graft component 94 having tubular graft component first end 96 and tubular graft component second end 98. Tubular wall 100 extends between the tubular graft component first end 96 and the tubular graft component second end 98, wherein the tubular graft wall 100 defines fenestration 102, such as is shown in
[0065] In an alternative embodiment, graft sleeve 60 is fixed to tubular graft component 100 and around fenestration 102 by a suitable means, such as by stitching or by use of an adhesive, and then support ring 72 is fixed to an outside surface of graft sleeve 60 where graft sleeve 60 is fixed to tubular graft component 100, or distal to where graft sleeve 60 is fixed to tubular graft component 94, by suitable means, such as by stitching. Distal end 64 of graft sleeve 60 can be either cranial or caudal to proximal end 62 of graft sleeve 60.
[0066] Stent grafts can be implanted at a surgical site that spans an aneurysm, in particular in the perivisceral segment of the aorta, by suitable methods, such as is known in the art. Following implantation, bridging stents can be delivered through the fenestration, fenestration ring and into a branch of the aorta, such a renal, superior mesenteric or celiac arteries. Suitable delivery devices for implanting stent grafts are described, for example, in U.S. Patent Application Nos. 63/111,357 and 63,153,701, and U.S. Ser. No. 210,381, the relevant teachings of all of which are hereby incorporated by reference in their entirety.
[0067] In one embodiment, support ring 72 is formed by a method including directing wire 10 through lumen 22 defined by helical coil 16, shown in
[0068] In another embodiment, shown in
[0069] In an alternative embodiment, support ring 138 is fixed directly to tubular graft component 100 at a perimeter of fenestration 102 by suitable means, such as by stitching. Distal end 134 of graft sleeve 131 can be either cranial or caudal to proximal end 132 of graft sleeve 131. In an embodiment, branch stent graft 142 is flared at proximal end 144, as shown in
[0070] In this instance, support ring 138 extends around graft sleeve 131. Branch stent graft 142 is implanted by directing branch stent graft 142 through fenestration 102 and into graft sleeve 131 until branch stent graft 142 extends from distal end 134 of graft sleeve 131, and proximal end 144 of branch stent is fixed at graft sleeve 131 by an interference fit with graft sleeve 131, as indicated by ridge mark 166.
[0071] In still another embodiment, shown in
[0072] Graft sleeve assembly 130 is fixed by suitable means, such as by stitching or use of adhesive, to a portion of liner 160 that is external to tubular graft component 156. Graft sleeve 131 of graft sleeve assembly 130 is fixed to liner 160 by suitable means, such as by stitching or by an adhesive. Support ring 133 is fixed to the proximal end of graft sleeve 131 by suitable means, such as by stitching. Alternatively, in another embodiment, not shown, graft sleeve 131 can be fixed directly to tubular graft component 156. Branch stent graft 162 is directed through fenestration 154 and into graft sleeve 131 of graft sleeve assembly 130 until proximal end 164 of branch stent graft 162 is in interfering relation with graft sleeve 131, as shown by ridge mark 166.
[0073] Examples of tubular graft components, and methods of their implantation at an aneurysm site are such as are known in the arts, such as is described in the relevant teachings of all patents, published applications, and references cited herein, all of which are incorporated by reference in their entirety. Stent grafts can be implanted at a surgical site that spans an aneurysm, in particular in the perivisceral segment of the aorta, by suitable methods, such as is known in the art. Following implantation, bridging stents can be delivered through the fenestration, fenestration ring and into a branch of the aorta, such a renal, superior mesenteric or celiac arteries. Suitable delivery devices for implanting stent grafts are described, for example, in U.S. Patent Application Nos. 63/111,357 and 63/153,701, and U.S. Ser. No. 63/210,381, the relevant teachings of all of which are hereby incorporated by reference in their entirety.
[0074] In another embodiment, the invention is a method for implanting a branched aortic prosthesis, such as branched aortic prosthesis 106, shown in
[0075] As shown in the progression from
[0076] In one particular embodiment of the method of implanting support ring 72 of the invention includes the step of fixing support ring 72 to tubular graft wall 100 of tubular graft component 100 at fenestration 102, as shown in
[0077] In an alternative embodiment, graft sleeve 60 is fixed to tubular graft component 100 and around fenestration 102 by a suitable means, such as by stitching or by use of an adhesive, and then support ring 72 is fixed to an outside surface of graft sleeve 60 where graft sleeve 60 is fixed to tubular graft component 100, or distal to where graft sleeve 60 is fixed to tubular graft component 94, by suitable means, such as by stitching. Distal end 64 of graft sleeve 60 can be either cranial or caudal to proximal end 62 of graft sleeve 60.
[0078] In a further embodiment, the invention is a support ring for an aortic prosthesis, comprising (a) a helical coil having a helical coil first end and a helical coil second end, the helical coil defining a lumen and extending in an arc, wherein the helical coil first end and the helical coil second end are in an opposing relation to each other that defines a space that is between the helical coil first end and the helical coil second end and is outside the lumen; and (b) a wire extending through the lumen and having a wire first end and a wire second end, the wire traversing the space between the helical coil first end and the helical coil second end along at least one length of the wire between the wire first end and the wire second end, and wherein the wire first end and the wire second end are secured to each other.
[0079] The support ring of paragraph [0078], further including a crimped connector at the wire, whereby the wire first end and the wire second end of the wire are secured to each other.
[0080] The support ring of paragraph [0079], wherein the crimped connector is in the space between the helical coil first end and the helical coil second end.
[0081] The support of paragraph [0080], wherein, the crimped connector includes at least one of tantalum, gold, platinum, iridium, nitinol, and stainless steel.
[0082] The support ring of paragraph [0080], wherein the helical coil is radiopaque.
[0083] The support ring of paragraph [0082], wherein the helical coil includes at least one of tantalum, gold, platinum, iridium, nitinol, tungsten, and stainless steel.
[0084] The support ring of paragraph [0082], wherein the wire includes at least one of a shape-memory alloy and stainless steel.
[0085] The support ring of paragraph [0084], wherein the wire includes a shape-memory alloy.
[0086] The support ring of paragraph [0085], 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.
[0087] The support ring of paragraph [0086], wherein the shape-memory alloy includes nitinol.
[0088] The support ring of paragraph [0087], wherein the wire traverses the space between the helical coil first end and the helical coil second end at a plurality of lengths between the wire first end and the wire second end.
[0089] The support ring of paragraph [0088], wherein the wire traverses the space between the helical coil first end and the helical coil second end at two, three, four, five, six, seven, eight, nine, or ten lengths along the wire.
[0090] The support ring of paragraph [0088], further including a tubular graft having a tubular graft first end, a tubular graft second end, and a tubular graft wall extending between the tubular graft first end and tubular graft second end, the tubular graft wall defining at least one fenestration between the tubular graft first end and the tubular graft second end, wherein the helical coil is fixed to the tubular graft wall at the fenestration, and wherein the fenestration is within the arc of the helical coil.
[0091] The support ring of paragraph [0090], wherein the tubular graft is a stent graft.
[0092] The support ring of paragraph [0091], further including a branch graft extending through the fenestration of the stent graft.
[0093] The support ring of paragraph [0092], wherein radial diameter of the branch graft at the fenestration is constrained.
[0094] In yet another embodiment, the invention is a branch sleeve assembly for an aortic prosthesis, comprising: (a) a graft sleeve having a graft sleeve proximal end, a graft sleeve distal end, and a graft sleeve wall extending between the graft sleeve proximal end and the graft sleeve distal end, the graft sleeve proximal end having a base diameter and the graft sleeve distal end having a diameter less than the base diameter, and wherein the graft sleeve proximal end defines a plane that intersects a plane defined by the graft sleeve distal end; and (b) a support ring fixed to the graft sleeve wall that is closer to the proximal end of the graft sleeve than to the graft sleeve distal end.
[0095] The branch sleeve assembly of paragraph [0094], wherein the graft sleeve is tapered, wherein a cross-sectional diameter is greater proximal to the graft sleeve distal end than at the graft sleeve distal end.
[0096] The branch sleeve assembly of paragraph [0095], wherein the support ring is an assembly that includes a radiopaque component.
[0097] The branch sleeve assembly of paragraph [0096], wherein the radiopaque component includes at least one of gold, platinum, iridium, and tantalum.
[0098] The branch sleeve assembly of paragraph [0096], wherein the support ring includes: (a) a helical coil having a helical coil first end and a helical coil second end, the helical coil defining a lumen and extending in an arc, wherein the helical coil first end and the helical coil second end are in an opposing relation to each other that defines a space that is between the helical coil first end and the helical coil second end, and is outside the lumen; and (b) a wire extending through the lumen and having a wire first end and a wire second end, the wire traversing the space between the helical coil first end and the helical coil second end along at least one length of the wire between the wire first end and the wire second end, and wherein the wire first end and the wire second end are secured to each other.
[0099] The branch sleeve assembly of paragraph [0098], wherein the helical coil is the radiopaque component.
[0100] The branch sleeve assembly of paragraph [0099], wherein the wire traverses the space between the helical coil first end and the helical coil second end at a plurality of lengths between the wire first end and the wire second end.
[0101] The branch sleeve assembly of paragraph [00100], wherein the wire traverses the space between the helical coil first end and the helical coil second end at two, three, four, five, six, seven, eight, nine, or ten lengths along the wire.
[0102] The branch sleeve assembly of paragraph [00100], further including a tubular graft having a tubular graft first end, a tubular graft second end, and a tubular graft wall extending between the tubular graft first end and tubular graft second end, the tubular graft wall defining at least one fenestration between the tubular graft first end and the tubular graft second end, wherein the graft sleeve wall is fixed to the tubular graft wall around the fenestration.
[0103] The branch sleeve assembly of paragraph [00102], wherein the support ring is fixed to the tubular graft wall at the fenestration, and wherein the fenestration is within the arc of the helical coil.
[0104] The branch sleeve assembly of paragraph [00103], wherein the tubular graft is a stent graft.
[0105] The branch sleeve assembly of paragraph [00104], further including a branch stent graft having a branch stent graft proximal end and a branch stent graft distal end, the branch stent graft extending distally from within the graft sleeve distal end, the branch stent graft being secured to the graft sleeve by an interference fit between the branch stent graft and the graft sleeve.
[0106] The branch sleeve assembly of paragraph [00105], wherein the branch stent proximal end is distal to the support ring.
[0107] In an additional embodiment, the invention is an aortic prosthesis, comprising: (a) a tubular graft component including a tubular graft component first end and a tubular graft component second end, and a tubular graft wall extending between the tubular graft component first end and the tubular graft component second end, the tubular graft wall defining at least one fenestration between the tubular graft component first end and the tubular graft component second end; and (b) a support ring at the tubular wall, the support ring including (i) a helical coil having a helical coil first end and a helical coil second end, the helical coil defining a lumen and extending in an arc, wherein the helical coil first end and the helical coil second end are in an opposing relation to each other that defines a space between the helical coil first end and the helical coil second end and is outside the lumen, the helical coil being fixed to the tubular wall at the fenestration, wherein the fenestration is within the arc of the helical coil, and (ii) a wire extending through the lumen and having a wire first end and a wire second end, the wire traversing the space between the wire first end and the wire second end along at least one length of the wire between the wire first end and the wire second end, and wherein the wire first end and the wire second end are secured to each other.
[0108] In yet another embodiment, the invention is an aortic prosthesis, comprising: (a) a tubular graft component including a tubular graft component first end and a tubular graft component second end, and a tubular graft wall extending between the tubular graft component first end and the tubular graft component second end, the tubular graft wall defining at least one fenestration between the tubular graft component first end and the tubular graft component second end; (b) a graft sleeve having a graft sleeve proximal end, a graft sleeve distal end, and a graft sleeve wall extending between the graft sleeve proximal end and the graft sleeve distal end, the graft sleeve proximal end having a base diameter and the graft sleeve distal end having a diameter less than the base diameter, and wherein the graft sleeve proximal end defines a plane that intersects a plane defined by the graft sleeve distal end, wherein the graft sleeve wall is fixed to the tubular wall around the fenestration; and (c) a support ring fixed to the graft sleeve wall, wherein the support ring is fixed to the graft sleeve wall closer to the graft sleeve proximal end than to the graft sleeve distal end, the support ring including (i) a helical coil having a helical coil first end and a helical coil second end, the helical coil defining a lumen and extending in an arc, wherein the helical coil first end and the helical coil second end are in an opposing relation to each other that defines a space between the helical coil first end and the helical coil second end, and is outside the lumen, the helical coil being fixed to the tubular wall at the fenestration, whereby the fenestration is within the arc of the helical coil, and (ii) a wire extending through the lumen and having a wire first end and a wire second end, the wire traversing the space between the helical coil first end and the helical coil second end along at least one length of the wire between the wire first end and the wire second end, and wherein the wire first end and the wire second end are secured to each other.
[0109] The aortic prosthesis of paragraph [00108], wherein the wire includes nitinol.
[0110] In a further embodiment, the invention is a method of forming a support ring for an aortic prosthesis, comprising the steps of: (a) directing a wire through a lumen defined by a helical coil from a helical coil first end through a helical coil second end that is in opposition to the helical coil first end, and across a space defined by the helical coil first end and the helical coil second end that is outside the lumen, whereby the wire traverses the space between the helical coil first end and the helical coil second end along at least one length of the wire between a wire first end and a wire second end; and (b) securing the wire first end to the wire second end, thereby forming the support ring.
[0111] The method of paragraph [00110], further including the step of fixing the support ring to a tubular graft having a tubular graft first end and a tubular graft second end, and a tubular wall extending between the tubular graft first end and the tubular graft second end, the tubular wall defining a fenestration, and wherein the fenestration is within the arc of the helical coil.
[0112] In still another embodiment, the invention is a method of forming an aortic prosthesis, comprising the steps of: (a) forming a tubular graft having a tubular graft first end and a tubular graft second end, and a tubular graft wall extending between the tubular graft first end and the tubular graft second end, the tubular graft wall defining a fenestration; (b) forming a graft sleeve having a graft sleeve proximal end, a graft sleeve distal end, and a graft sleeve wall extending between the graft sleeve proximal end and the graft sleeve distal end, the graft sleeve proximal end having a base diameter and the graft sleeve distal end having a diameter less than the base diameter, and wherein the graft sleeve proximal end defines a plane that intersects a plane defined by the graft sleeve distal end; (c) fixing a support ring to the graft sleeve wall closer to the graft sleeve proximal end than to the graft sleeve distal end, thereby forming a graft sleeve assembly of the graft sleeve and the support ring; and (d) fixing the graft sleeve assembly to the tubular wall around the fenestration, thereby forming the aortic prosthesis.
[0113] The method of paragraph [00112], further including the step of forming the support ring.
[0114] The method of paragraph [00113], wherein the support ring is formed by the steps of: (a) directing a wire through a lumen defined by a helical coil extending in an arc from a helical coil first end through a helical coil second end in opposition to the helical coil first end, and across a space defined by the helical coil first end and the helical coil second end that is outside the lumen defined by the helical coil, whereby the wire traverses the space between the helical coil first end and the helical coil second end along at least one length of the wire between a wire first end and a wire second end; and (b) securing the wire first end to the wire second end, thereby forming the support ring.
[0115] The method of paragraph [00114], further including the step of fixing the support ring to the tubular graft at the fenestration in the tubular wall, wherein the fenestration is within the arc of the helical coil, thereby forming the aortic prosthesis.
[0116] In another embodiment, the invention is a method of forming an aortic prosthesis, comprising the steps of: (a) forming a tubular graft having a tubular graft first end and a tubular graft second end, and a tubular wall extending between the tubular graft first end and the tubular graft second end, the tubular wall defining at least one fenestration between the tubular graft first end and the tubular graft second end; (b) forming a support ring by (i) directing a wire through a lumen defined by a helical coil from a helical coil first end through a helical coil second end that is in opposition to the helical coil first end, and across a space defined by the helical coil first end and the helical coil second end that is outside the lumen, whereby the wire traverses the space between the helical coil first end and the helical coil second end along at least one length of the wire between a wire first end and a wire second end; and (ii) securing the wire first end to the wire second end, thereby forming the support ring; and (c) fixing the support ring to the tubular graft at the fenestration in the tubular wall, wherein the fenestration is within the arc of the helical coil, thereby forming the aortic prosthesis.
[0117] A further embodiment of the invention is a method for implanting a branched aortic prosthesis, comprising the steps of: (a) directing an aortic prosthesis to an aortic surgical site, the aortic prosthesis including, (i) a tubular graft component including a tubular graft first end and a tubular graft second end, and a tubular graft wall extending between the tubular graft first end and the tubular graft second end, the tubular graft wall defining at least one fenestration between the tubular graft first end and the tubular graft second end, (ii) a graft sleeve having a graft sleeve proximal end, a graft sleeve distal end, and a graft sleeve wall extending between the graft sleeve proximal end and the graft sleeve distal end, the graft sleeve proximal end having a base diameter and the graft sleeve distal end having a diameter less than the base diameter, wherein the graft sleeve proximal end defines a plane that intersects a plane defined by the graft sleeve distal end, and wherein the graft sleeve wall is fixed to the tubular wall around the fenestration, and (iii) a support ring fixed to the graft sleeve wall, wherein the support ring is fixed to the graft sleeve wall closer to the graft sleeve proximal end than to the graft sleeve distal end; and (b) directing a branch stent graft distally through the graft sleeve until a branch stent graft proximal end is distal to the support ring, whereby the branch stent graft is secured by an interference fit between the branch stent graft distal end and the graft sleeve, thereby implanting the branched stent graft at the surgical site.
[0118] The method of paragraph [00117], wherein the support ring includes: (a) a helical coil having a helical coil first end and a helical coil second end, the helical coil defining a lumen and extending in an arc, wherein the helical coil first end and the helical coil second end are in an opposing relation to each other that defines a space between the helical coil first end and the helical coil second end and is outside the lumen, the helical coil being fixed to the tubular wall at the fenestration, wherein the fenestration is within the arc of the helical coil; and (b) a wire extending through the lumen and having a wire first end and a wire second end, the wire traversing the space between the helical coil first end and the helical coil second end along at least one length of the wire between the wire first end and the wire second end, and wherein the wire first end and wire second end are secured to each other.
[0119] Stent grafts can be implanted at a surgical site that spans an aneurysm, in particular in the perivisceral segment of the aorta, by suitable methods, such as is known in the art. Following implantation, bridging stents can be delivered through the fenestration, fenestration ring and into a branch of the aorta, such a renal, superior mesenteric or celiac arteries. Suitable delivery devices for implanting stent grafts are described, for example, in U.S. Patent Application Nos. 63/111,357 and 63,153,701, and U.S. Ser. No. 210,381, the relevant teachings of all of which are hereby incorporated by reference in their entirety.
[0120] The relevant teachings of all patents, published applications and references cited herein are incorporated by reference in their entirety. The relevant teachings of U.S. Pat. Nos. 10,987,235, 11,000,359, 11,291,572, 11,278,390, 11,219,540, and 11,154,392; US Published Patent Application 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 U.S. application Ser. No. 17/522,251, are also incorporated by reference in their entirety. The relevant teachings of United States patent application, titled “Support Ring for Vascular Aortic Repair and Methods of Use,” filed Jun. 13, 2022, by Eduardo Alejandro Garcia, Timothy Lostetter, and Eitan Magen (Attorney Docket No.: BMN-07425) are also incorporated by reference in their entirety.
[0121] While example embodiments have been particularly shown and described, it will be understood by those in the art various changes in form and details may be made therein without departing from the scope of the embodiments encompassed by the appended claims.