Hybrid prosthesis and delivery system
Inventors
DEBUS, Sebastian • Kölbel, Tilo • Nelis, Vincent • Cresswell, Callum
Assignees
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Publication Number
US-11458008-B2
Publication Date
2022-10-04
Expiration Date
Abstract
A hybrid endoprosthetic device comprises a stented tubular part and a branched tubular body connected such that a main lumen of the stented tubular part communicates with a main lumen of the branched tubular body. The branched tubular body has multiple branch lumens for connection with natural vessels of the vasculature, and includes at least one branch lumen for access to facilitate delivery and implantation of the hybrid endoprosthetic device by an endovascular step in a hybrid surgical procedure. The hybrid endoprosthetic device is configured to replace a part of the aorta and common iliac artery. A delivery system for use with the device is also disclosed.
Core Innovation
The invention relates to a hybrid endoprosthetic device and a delivery system in which the device includes a stented tubular part and a branched tubular body. The stented tubular part includes a sleeve defining a lumen and ring stents at the sleeve, and the branched tubular body defines a main lumen in communication with the stented tubular part and includes a plurality of tubular branches extending from the branched tubular body portion, together with an access branch extending from the branched tubular body portion.
The delivery system uses a delivery shaft inserted through the access branch, with a distal tip at the stented tubular part. A removable sheath compactly restrains the stented tubular part, and a stopper defines a stopper throughbore through which the delivery shaft extends and is slidable along the delivery shaft, while a hub at the access branch defines a hub throughbore within which the stopper is secured.
A hemostatic seal is formed within the access branch, such that the removable sheath can be removed to release the stented tubular part from compact restraint while the delivery shaft is retracted from the stented tubular part. The hub/stopper arrangement maintains the hemostatic seal within the access branch during shaft retraction, and an optional hub splitter mechanism can be provided to cause longitudinal splitting when the removable sheath is retracted across the splitter.
Claims Coverage
The document provides two independent claims, one to a hybrid endoprosthetic delivery system and one to a method of implanting the hybrid endoprosthetic device in an aorta of a patient. The independent claims include 1 set of structural inventive features and 1 set of procedural inventive features with a defined sequence for implanting and de-airing via tubular branches.
Hybrid endoprosthetic delivery system with access-branch hemostatic seal during retraction
A hybrid endoprosthetic delivery system including a hybrid endoprosthetic device with a stented tubular part in communication with a branched tubular body, a plurality of tubular branches, and an access branch; and a delivery device with a delivery shaft inserted through the access branch having a distal tip at the stented tubular part, a removable sheath compactly restraining the stented tubular part, a slidable stopper through which the delivery shaft extends, and a hub at the access branch within which the stopper is secured, wherein a hemostatic seal is formed within the access branch and is maintained while the removable sheath is removed and the delivery shaft is retracted from the stented tubular part.
Implantation method with purse-string, access-branch release, and de-airing through tubular branches
A method for implanting a hybrid endoprosthetic device in an aorta of a patient comprising anastomosing a branch of a branched tubular body to a side of a first iliac artery distal to an aneurysm site or a dissection site; closing the branch; forming a purse-string suture in the aorta; directing a stented tubular part through the purse-string suture and proximally into the aorta; retracting a removable sheath through a hub at an access branch to release the stented tubular part from compact restraint; retracting a delivery shaft through a stopper obstructing the access branch within the hub; removing the delivery system shaft, hub, and stopper from the access branch; de-airing the hybrid endoprosthetic device through one of a plurality of tubular branches; and attaching distal ends of the plurality of tubular branches to respective branch arteries.
Across the independent claims, the core inventive aspect is the delivery configuration that uses an access-branch hub and stopper to form and maintain a hemostatic seal while releasing the stented tubular part and retracting the delivery shaft, together with the implantation sequence that includes purse-string introduction, access-branch release, and de-airing through tubular branches.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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