Stent graft delivery system with constricted sheath and method of use
Inventors
Assignees
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Publication Number
US-12083030-B2
Publication Date
2024-09-10
Expiration Date
Abstract
A delivery system and method for implanting a stent graft includes a flexible sheath that defines loops distributed longitudinally and wherein substantial alignment of the loops along a longitudinal axis of a guidewire catheter radially constrict the flexible sheath. The flexible sheath defines longitudinal edges that at least partially form a seem when the openings are aligned, whereby, upon alignment, the flexible sheath defines at least one fenestration in the luminal configuration of the flexible sheath. A ligature extends through the openings of the flexible sheath and causes the openings to be substantially aligned, thereby constraining the flexible sheath. The ligature is proximally retractable from the openings to thereby release the flexible sheath from a radially constricted configuration.
Core Innovation
The invention provides a stent graft delivery system including a handle, a guidewire catheter, and an outer catheter. A flexible sheath extends between the guidewire catheter and the outer catheter and is longitudinally moveable relative to the guidewire catheter and the outer catheter. The flexible sheath includes openings defined, at least in part, by loops fixed to the flexible sheath.
An arrangement of the openings causes the flexible sheath to have a luminal configuration with a constricted radial diameter. The flexible sheath defines longitudinal edges, where the longitudinal edges partially form a seam when the openings are aligned. At least one of the longitudinal edges is scalloped, so that upon alignment of the openings the flexible sheath defines a sheath fenestration exposing at least a portion of an internal sheath lumen.
A ligature extends through the openings and causes the openings to conform to an arrangement, configuring the flexible sheath to conform to the constricted radial diameter luminal configuration. The ligature is proximally retractable from the openings to thereby release the flexible sheath from the constricted radial diameter. The disclosed arrangement also supports fenestration alignment for branch prostheses and provides a configuration in which the sheath can be rotated or repositioned while partially deployed by partially releasing the ligature.
In additional embodiments, the system integrates a stent graft prosthesis and ties the radial constriction to alignment of the sheath openings, with stent struts fixed along a wall of the stent graft. The disclosed system further includes an apex capture assembly and an apex capture catheter configured to releasably capture and at least partially constrain proximal apices of a bare stent, with release occurring when the apex capture catheter is retracted relative to the distal apex capture component.
Claims Coverage
The partial content identifies one independent claim covering the overall stent graft delivery system, with multiple dependent claims refining structural and functional details. The key inventive features are centered on a flexible sheath whose openings are controlled by a proximally retractable ligature to create a constricted luminal configuration and to expose sheath fenestrations when aligned.
Constricted luminal configuration from aligned sheath openings
A flexible sheath includes openings defined at least in part by loops fixed to the flexible sheath, where an arrangement of the openings causes the flexible sheath to have a luminal configuration having a constricted radial diameter, and the flexible sheath defines longitudinal edges.
Seam and scalloped longitudinal edge forming sheath fenestration
The longitudinal edges partially form a seam when the openings are aligned, and wherein at least one longitudinal edge is scalloped such that upon alignment of the openings the flexible sheath defines a sheath fenestration exposing at least a portion of an internal sheath lumen.
Proximally retractable ligature through openings releases constricted diameter
A ligature extending through the openings causes the openings to conform to the arrangement, thereby configuring the flexible sheath to conform to the constricted radial diameter luminal configuration, the ligature being proximally retractable from the openings to thereby release the flexible sheath from the constricted radial diameter.
Moveable guidewire and fixed outer catheter with longitudinally moveable sheath
A stent graft delivery system includes a guidewire catheter moveable relative to a handle and an outer catheter fixed to and extending distally from the handle about the guidewire catheter, with the flexible sheath extending between the guidewire catheter and the outer catheter and being longitudinally moveable relative to the guidewire catheter and the outer catheter.
Across the identified independent claim, the coverage emphasizes a flexible sheath whose luminal configuration becomes constricted via an opening arrangement, alignment of openings to create longitudinal-edge seam behavior and a scalloped sheath fenestration exposing an internal sheath lumen, and a proximally retractable ligature through the openings that releases the sheath from the constricted radial diameter.
Stated Advantages
Improves accuracy of fenestration/branch prosthesis positioning by enabling rotation/repositioning while partially deployed by only partially releasing the ligature.
Reduces risk of vascular injury or graft distortion.
Documented Applications
Fenestrated endovascular aortic repair (FEVAR), including juxtarenal aortic aneurysm and short-neck abdominal aortic aneurysm, including deployment for arterial branches such as renal/splanchnic supply.
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