Atrial appendage ligation
Inventors
Rogers, Toby • Ratnayaka, Kaniska • Kocaturk, Ozgur • Lederman, Robert J.
Assignees
US Department of Health and Human Services
Publication Number
US-10575851-B2
Publication Date
2020-03-03
Expiration Date
2034-10-27
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Abstract
This disclosure relates to devices and methods for manipulating, such as with a suction based traction device, a target anatomic structure inside the body and delivering an ligation device around the anatomic structure. In particular examples, the target structure can be an atrial appendage, and the devices and methods are for atrial appendage ligation.
Core Innovation
This disclosure relates to devices and methods for manipulating a target anatomic structure inside the body using a suction based traction device, and delivering a ligation device around the anatomic structure. In particular, the invention focuses on atrial appendage ligation, especially left atrial appendage (LAA) ligation, where the traction device non-traumatically grips the LAA to facilitate placement of a ligation device such as a suture or clip. The traction device and delivery device can be introduced coaxially through a delivery catheter to the pericardial space, where the LAA is grasped and manipulated to enable secure ligation.
The problem addressed is that existing methods for isolating the LAA involve risks such as the need for trans-septal puncture, anticoagulation, and surgical procedures that can cause bleeding, rupture, laceration, or perforation of the atrial appendage. Prior devices require either dry sub-xiphoid access or major surgery and pose a threat of injury causing immediate hemodynamic compromise and often require open surgical repair. This disclosure solves the problem by providing a non-traumatic suction based traction device that distributes negative pressure over a broad segment of the LAA to reduce injury risks during manipulation and ligation.
The disclosed traction devices include one or more independently actuated suction cups or ports that can be deployed in the pericardial space to grasp and apply traction on the LAA or other target structures. Articulating wings with adjustable angles facilitate conformance to anatomical variations to apply atraumatic suction. The traction device can be introduced transvascularly via the right atrial appendage or by a transpericardial approach and used in tandem with a delivery device that applies a ligation device around the LAA base or neck to exclude it and prevent thrombus formation, thereby reducing stroke risk.
Claims Coverage
The patent includes two independent claims: one for a device combining a delivery catheter, suction-based traction device with articulating wings and suckers, and a delivery device for ligation; and one for a method of ligating the left atrial appendage using such a device. These claims cover the structure, functionality, and method of use of the traction and delivery devices for atrial appendage ligation.
Suction based traction device with articulating wings
A traction device extending through a delivery catheter that non-traumatically grasps the left atrial appendage using suction. The device comprises a distal gripper with a tubular neck and two resiliently deformable wings that articulate open and closed about an axis perpendicular to the catheter axis. Each wing and the junction between wings have independent suckers coupled to independent vacuum tubes running through the catheter.
Delivery catheter configured for pericardial space access
A delivery catheter adapted to be directed into the pericardial space adjacent to the left atrial appendage, including trans-atrial appendage delivery through the right atrial appendage.
Adjustable articulation angle between traction device wings
Capability to adjust the articulation angle between the two wings via relative axial motion between the delivery catheter and wings, or by moving a rod or vacuum tube coupled to the wing junction, allowing accommodation of different target structure sizes.
Delivery device for ligation with pre-shaped, articulated shape-memory loop
A delivery device that delivers a ligation device to the left atrial appendage, comprising a pre-shaped, articulated, interrupted shape-memory loop carrying a suture. The device may have hollow or solid loops with separable segments withdrawn to leave only the suture around the appendage.
Method of left atrial appendage ligation using suction-based gripper
A method involving advancing a delivery catheter into the pericardial space, deploying a suction-based gripper with articulating wings and multiple suckers to grip the LAA, manipulating the LAA to facilitate ligation device placement, securing suction for traction, and then delivering and positioning the ligation device around the LAA or its neck/base.
The claims cover an integrated system and method for non-traumatic suction-based traction and ligation of the left atrial appendage via a delivery catheter configured for pericardial access, including adjustable articulation of gripping wings and a method for manipulating and ligating the appendage to prevent thrombus formation.
Stated Advantages
Non-traumatic gripping and manipulation of the left atrial appendage reduces risks of avulsion, injury, or perforation of the fragile LAA wall during ligation procedures.
Suction-based traction redistributes negative pressure over a broad surface, minimizing local force maxima and tissue trauma.
Adjustable articulation of the traction device wings allows accommodation of varied anatomical sizes of the LAA.
The suction-based traction device can detach safely before causing tissue damage if excessive force is applied.
The device enables minimally invasive access and ligation of the LAA from the pericardial space, avoiding major surgical procedures and their associated complications.
Documented Applications
Ligation of the left atrial appendage in patients with atrial fibrillation to exclude the LAA and prevent thrombus formation and subsequent stroke.
Manipulation and ligation of the right atrial appendage using similar devices and methods.
Application of the suction-based traction and delivery devices to intracavitary procedures for extraction of cardiac or pulmonary tumors, embolisms, thrombi, or embolized devices.
Manipulation of other internal anatomic structures within the pericardial or other body spaces using suction-based traction devices.
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