Endo-cameral closure device
Inventors
Rogers, Toby • Sonmez, Merdim • Kocaturk, Ozgur • Lederman, Robert J.
Assignees
US Department of Health and Human Services
Publication Number
US-10603021-B2
Publication Date
2020-03-31
Expiration Date
2036-09-30
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Abstract
Disclosed herein are devices and methods for closing a hole in the wall of a cardiovascular structure from the inside using a self-assembling closure device. The closure device can be delivered to the subject hole from the inside of the cardiovascular chamber using a transcatheter approach. Disclosed techniques involve deploying the closure device from the delivery device such that an endo-cameral portion of the closure device self-expands first to cover the hole from the inside, and then extra-cameral arms of the device are released to self-deploy against the outside of the wall by withdrawal of a retaining element, such as a guidewire, to secure the closure device to the wall.
Core Innovation
Disclosed herein are devices and methods for closing a hole in the wall of a cardiovascular structure or other anatomical structure using a self-assembling closure device. The closure device can be delivered to the subject hole from the inside of the cardiovascular chamber using a transcatheter approach. The closure device is deployed from the delivery device such that an endo-cameral portion self-expands first to cover the hole from the inside, and then extra-cameral arms of the device are released to self-deploy against the outside of the wall by withdrawal of a retaining element, such as a guidewire, to secure the closure device to the wall.
Holes in cardiovascular walls may be created intentionally during procedures or accidentally, and if not closed quickly and safely, can cause serious complications with high morbidity and mortality. Surgical closure requires access to the site of the hole, which may be impossible or cause injury to adjacent structures.
The closure device can be delivered through the cardiovascular system to approach the hole from inside the chamber without requiring access to both faces of the wall. The endo-cameral occlusion member self-expands to conform to the inner surface of the wall, while the extra-cameral arms are retained in a compressed state by the guidewire. Upon retraction of the guidewire, the arms are released to self-expand and pinch the tissue between the inner occlusion member and the outer arms, securing the device and creating a hemostatic seal. The device is resilient and can be deformed for delivery and then return to its natural configuration to seal the hole securely.
Claims Coverage
The patent includes multiple independent claims covering novel closure devices, delivery systems, and methods of closing cardiovascular holes, described primarily in claims 1, 19, 24, and 31. These claims encompass inventive features related to the structure of the closure device, the delivery mechanisms, and the method steps for deployment.
Closure device with endo-cameral occlusion member and dual extra-cameral arms
A closure device comprising an endo-cameral occlusion member made of resiliently deformable material configured to radially self-expand within the cardiovascular structure to seal the hole from the inside, coupled to first and second extra-cameral arms made of mesh material. The arms are retained in a radially compressed delivery configuration by a retaining element (e.g., guidewire) passing through openings in the arms, and are configured to self-expand to engage the outer surface of the wall and secure the device upon removal of the retaining element.
Delivery system for transcatheter deployment with guidewire retention
A delivery device configured to deliver the closure device in a radially compressed state over a guidewire that extends through the central lumen of the occlusion member and through openings in the extra-cameral arms. The guidewire holds the arms compressed during delivery and deployment of the occlusion member, with retraction of the guidewire releasing the arms to self-deploy and secure the device to the wall.
Method of closing a hole from inside the cardiovascular structure using self-expanding closure device
A method involving advancing a delivery device through the patient's anatomy to position a closure device through the hole, retracting a sheath to allow the endo-cameral occlusion member to radially self-expand within the cardiovascular chamber covering the hole, then proximally retracting the retaining element to release extra-cameral arms to curl radially outward and pinch the outer surface of the wall between the arms and the occlusion member to seal the hole.
Closure device with disk-shaped extra-cameral member for sealing holes
A closure device comprising an endo-cameral occlusion member and an extra-cameral mesh member shaped as a disk, both made of resiliently deformable material. The extra-cameral member is held in a radially compressed delivery configuration by retaining elements passing through openings near its perimeter, and self-expands to a disk-shaped configuration after the occlusion member self-expands, thereby pinching the wall to seal the hole upon removal of the retaining element.
The independent claims cover novel closure devices featuring self-expanding endo-cameral occlusion members combined with resilient extra-cameral arms or disk-shaped members retainable by a guidewire or retaining element during delivery and releasable to secure the closure device to the wall. Delivery systems and methods involve transcatheter approaches with guidewire retention and staged deployment facilitating safe and effective closure of cardiovascular holes from the inside or outside of the wall.
Stated Advantages
The closure device can be delivered and deployed from one side of the cardiovascular wall without requiring access to both sides, facilitating less invasive procedures.
The device's self-expanding features and resilient materials enable secure sealing of holes of various sizes, maintaining a pinch force regardless of wall thickness.
Deployment reduces the number of instruments and access sites required, simplifying endovascular procedures.
The closure device can be recaptured and repositioned if initially placed incorrectly, enhancing procedural safety and flexibility.
Documented Applications
Closing holes in walls of cardiovascular structures created intentionally or accidentally during procedures such as transatrial intrapericardial heart valve annuloplasty and atrial appendage ligation.
Sealing access holes formed in structures like the right atrium, right atrial appendage, left ventricle apex, or other cardiac chambers and blood vessels.
Use during transcatheter access procedures where holes are created for treatment delivery, including holes created via surgical, endovascular, or endoscopic instruments.
Closure of holes accessed via various vascular routes such as transfemoral, jugular, axillary, subclavian, or transthoracic approaches.
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