Three-dimensional right atrial appendage curve catheter
Inventors
Lederman, Robert J. • Rogers, Toby • Rafiee, Nasser • Greenbaum, Adam B. • O'Neill, William W.
Assignees
Henry Ford Health System • US Department of Health and Human Services
Publication Number
US-11173278-B2
Publication Date
2021-11-16
Expiration Date
2036-05-09
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Abstract
Disclosed delivery catheters have a three-dimensional curvature that facilitates reaching the RAA from the inferior vena cava, positioning the distal end of the catheter generally parallel to the plane of the pericardial space at the puncture location within the RAA, orienting the puncturing device in a direction that avoids the right coronary artery, aorta, pulmonary artery, and other structures to prevent bystander injury to such structures, and provides sufficient rigidity to puncture through a wall of the RAA into the pericardial space.
Core Innovation
The invention disclosed is a three-dimensional curved transvascular catheter designed to facilitate safe and effective access to the pericardial space from the right atrial appendage (RAA) of the heart. The catheter comprises a proximal segment, a transition segment, and a distal segment with the transition and distal segments forming a clockwise three-dimensional spiral curvature. This specific curvature is configured so that when positioned within a patient, the proximal segment lies within the inferior vena cava, the transition segment extends circularly across the caval-atrial junction to abut the right lateral wall of the right atrium, and the distal segment curves to abut the anterior and superior walls of the right atrium adjacent to the RAA, terminating at a sulcus on the RAA.
This three-dimensional shape orients the distal end of the catheter generally leftward and parallel to the plane of the pericardial space at the puncture location within the RAA. This orientation facilitates guiding a coaxial puncturing device from the catheter's distal end to puncture the sulcus of the RAA into the pericardial space safely. The design specifically minimizes risks of injury to adjacent structures such as the right coronary artery, pulmonary artery, and the aorta by directing the puncturing device away from these critical anatomical features. The catheter also provides sufficient rigidity to enable puncturing the wall of the RAA. Additionally, in some embodiments, the catheter includes or cooperates with an inflatable balloon to separate trabeculations of the RAA to enhance apposition against the sulcus for safer and more controlled puncture.
The problem addressed by this invention arises from the need to access the pericardial space safely for procedures such as left atrial appendage ligation, circumferential tricuspid annuloplasty, or epicardial ablation for rhythm disorders. Prior methods of advancing a catheter through the right atrium into the RAA and puncturing into the pericardial space pose risks including myocardial or coronary laceration due to less optimal catheter orientation and trajectory, leading to potential bystander injuries. The disclosed catheter's three-dimensional spiral curvature and segment-specific shaping provide a means to reduce these risks by optimizing the catheter's path and puncture trajectory within the heart chambers.
Claims Coverage
The patent contains one independent claim detailing a transvascular catheter with several inventive features focusing on catheter shape, curvature, positioning, and function.
Three-dimensional spiral curvature of the catheter
The catheter includes a proximal segment, a transition segment, and a distal segment extending distally, with the transition and distal segments exhibiting a clockwise three-dimensional spiral curvature around a central axis with right-handed chirality, enabling a generally clockwise path when viewed from the proximal segment distally.
Positioning of catheter segments within heart anatomy
The spiral curvature positions the proximal segment within the inferior vena cava, the transition segment across the caval-atrial junction abutting the right lateral wall of the right atrium, and the distal segment curving leftward, forward, and upward through the right atrium to abut anterior and superior walls adjacent to the right atrial appendage, ending at the sulcus of the RAA.
Orientation of the catheter's distal end for safe puncture
The three-dimensional spiral curvature orients the distal end generally leftward and parallel with the pericardium, enabling a coaxial puncturing device to puncture through the sulcus of the RAA into the pericardial space without damaging the pericardium or nearby structures such as the right coronary artery, pulmonary artery, and aorta.
Together, these inventive features describe a catheter with a specific three-dimensional shape and anatomical positioning that allows safe, precise access to the pericardial space via the right atrial appendage with reduced risk of bystander tissue injury.
Stated Advantages
Facilitates reaching the right atrial appendage from the inferior vena cava with improved positioning.
Orients the distal catheter end parallel to the pericardial space, minimizing risk of pericardial damage.
Avoids critical bystander structures such as the right coronary artery, aorta, and pulmonary artery during puncture.
Provides sufficient rigidity to effectively puncture through the wall of the right atrial appendage.
Enables delivering therapeutic devices into the pericardial space with a smoother, safer trajectory.
Documented Applications
Accessing the pericardial space for left atrial appendage ligation.
Performing circumferential tricuspid annuloplasty.
Conducting epicardial ablation for rhythm disorders.
Delivering therapeutic devices through the right atrial appendage into the pericardial space.
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