Method for aortic branched vessel repair

• US 10,390,930 B2
• Filed: 01/27/2017
• Issued: 08/27/2019
• Est. Priority Date: 11/16/2011
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Arbefeuille, Samuel, Christian, Fletcher, Manguno, Jr., Joseph A., Canning, John C.
• Primary Examiner(s): Rodjom, Katherine M
• Application Number:
  US15/417,467
• Publication Number:
  US 20170135807A1
• Time in Patent Office: 942 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

An aortic graft assembly includes a tubular component that defines a wall aperture having a proximal end that extends perpendicular to a major longitudinal axis of the tubular aortic component, and a tunnel graft connected to the wall of the tubular aortic component and extending from the wall aperture toward a proximal end of the tubular aortic component. The method for delivery of the aortic graft assembly includes delivering the aortic graft assembly through the wall aperture and into interfering relation with the tunnel graft.

Claims

1. A method for implanting a prosthesis, comprising the steps of:

a) delivering an aortic graft assembly that includes a tubular aortic component through an aorta to an aneurysm site of a patient, the tubular aortic component defining a tunnel lumen and having a proximal end and a distal end connected by a wall, the wall defining a wall aperture that is between the proximal end and the distal end, the wall aperture having a proximal end and a distal end, the proximal end of the wall aperture including an first plane extending perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis, the tubular aortic component being radially and releasably constrained by a distal clasp at a distal end of an outer control tube of a delivery device, and releasably attached by a retention component to a proximal clasp at the outer control tube proximal to the proximal clasp, the tubular aortic component further supported by a control catheter of the delivery device extending within the outer control tube, the aortic graft assembly further including a tunnel graft extending from the wall aperture and within the tunnel lumen of the tubular aortic component toward the proximal end of the tubular aortic component, wherein the length of the proximal end of the wall aperture in the first plane is greater than the diameter of the tunnel graft lumen in a second plane extending orthogonally to the major longitudinal axis at a point proximal to the proximal end of the wall aperture;

b) aligning the wall aperture over at least one vessel ostium at the aneurysm site of the patient; and

c) retracting the outer control tube, thereby releasing the tubular aortic component from the distal and proximal clasps, thereby deploying the tubular aortic component at the aneurysm site in the patient.

2. The method of claim 1, wherein at least one supporting wire extends from the outer control tube, the at least one supporting wire extending through a suture loop inside the proximal end of the tubular aortic component to thereby prevent collapse of the proximal end of the tubular aortic component during deployment.

3. The method of claim 2, further including the step of partially retracting an inner sheath from around the tubular aortic component, whereby the at least one supporting wire at least partially restricts longitudinal movement of the proximal end of the tubular aortic component until the proximal end of the tubular aortic component is secure within the aorta, to thereby prevent collapse of the proximal end of the tubular aortic component at an inferior portion of the aorta.

4. The method of claim 3, wherein the control catheter is curved.

5. The method of claim 4, wherein the wall aperture aligns over two vessel ostiums at the aneurysm site of the patient.

6. The method of claim 2, wherein the at least one supporting wire has at least one stop, the at least one stop limiting movement of the retention component along the at least one supporting wire.

7. The method of claim 3, wherein the inner sheath is releasably secured to a distal end within a cavity defined by a proximal end of a nose cone of the delivery device, and the tubular aortic component further includes a clasping stent at the proximal end of the tubular aortic component, wherein the steps of the method further include:

a) partially retracting the inner sheath from around the tubular aortic component to release a distal end of the inner sheath from the nose cone and thereby cause partial deployment of the tubular aortic component;

b) partially retracting the control catheter to thereby release the clasping stent from the distal clasp and the retention component from the proximal clasp;

c) further retracting the control catheter to at least partially retract the nose cone to within the tubular aortic component while retaining the clasping stent on the supporting wires;

d) advancing the tubular aortic component to a final position in the aorta of the patient spanning the aneurysm site;

e) fully retracting the inner sheath from the tubular aortic component; and

f) fully retracting the nose cone and the supporting wires to release the clasping stent from the supporting wires, thereby fully deploying the tubular aortic component within the aorta of the patient at the aneurysm site.

8. The method of claim 7, wherein the inner sheath defines at least one through hole at a proximal end of the inner sheath.

9. The method of claim 1, further including the step of partially retracting an inner sheath from around the tubular aortic component, and wherein the tubular aortic component and the inner sheath each include a radiopaque marker longitudinally aligned along a path of relative movement of the inner sheath and the tubular aortic component during deployment of the tubular aortic component, and spaced apart from each other, whereby the partial retraction of the inner sheath will cause overlap of the radiopaque marker of the tubular aortic component and the inner sheath.

10. The method of claim 9, wherein the radiopaque markers are on superior portions of the inner sheath and the tubular aortic component.

11. The method of claim 10, wherein the radiopaque marker of the tubular aortic component is elongate and substantially aligned with the major longitudinal axis of the inner sheath.

12. The method of claim 1, wherein the tubular aortic component further includes at least one radiopaque marker.

13. The method of claim 12, wherein the radiopaque marker is located on the tubular aortic component facing away from a concavity of a curve defined by the control catheter.

14. The method of claim 1, further including the step of implanting a tubular branch component through at least one branch artery of the aorta of the patient into the wall aperture and the tunnel graft within the tubular aortic component.

15. The method of claim 1, wherein the retention component is a suture loop.

16. The method of claim 1, wherein the retention component is radiopaque.

17. The method of claim 1, wherein the retention component is at least one of a magnet or stent apex.