Devices and methods for treating functional tricuspid valve regurgitation
Inventors
Lederman, Robert J. • Ratnayaka, Kanishka • Rogers, Toby
Assignees
US Department of Health and Human Services
Publication Number
US-9987135-B2
Publication Date
2018-06-05
Expiration Date
2034-03-13
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Abstract
Disclosed here are devices and methods for treating functional tricuspid valve regurgitation and related conditions. Disclosed devices are adapted for applying force to an area of a patient's heart along or near the atrioventricular groove, and can include a tensioning element configured to be delivered by a flexible member guided through a catheter and positioned generally along or near the atrioventricular groove, and a compression member positionable along the tensioning element and over a desired segment of the atrioventricular groove to develop force to be applied to an adjacent area of the heart by selective tensioning of the tensioning element.
Core Innovation
The invention disclosed provides devices and methods for treating functional tricuspid valve regurgitation by applying force along or near the heart's atrioventricular groove. It utilizes a tensioning element, delivered by a flexible member guided through a catheter, positioned generally around the heart near the atrioventricular groove. A compression member is positioned along this tensioning element over a desired segment to develop force applied to an adjacent area of the heart by selectively tensioning the tensioning element.
The devices described include a tensioning element and a compression member that can be delivered through the vasculature via the right atrium or right atrial appendage, or alternatively inserted through transthoracic or subxiphoid/subcostal paths. The compression member may be tubular or grooved to receive the tensioning element, and it includes features such as anti-slip barbs and a shaped profile with bends, arches, or vertices designed to self-orient and apply force efficiently when tensioned.
The problem this invention addresses is that functional tricuspid valve regurgitation results from dilation of the tricuspid valve annulus causing blood regurgitation into the right atrium. Traditional surgical replacement is invasive, risky, and carries serious complications such as thrombosis and infection. Hence, the innovation aims to provide minimally invasive treatment options that avoid organ or component replacement and reduce the risks associated with invasive surgery.
Claims Coverage
The patent claims include two main independent claims directed to a device and methods for applying force to the heart along or near the atrioventricular groove using a tensioning element and compression member.
Device configured for minimally invasive positioning of a force-applying system along the heart's atrioventricular groove
The device comprises a flexible member guided through a catheter to position around the heart near the atrioventricular groove, a capture loop extending from the catheter to snare the flexible member's end and pull it back, a tensioning element delivered by the flexible member around the heart, and a compression member positionable along the tensioning element over a desired segment to develop force on an adjacent area through selective tensioning.
Compression member features to enhance force application and positioning
The compression member can be delivered via catheter through the right atrium or right atrial appendage or via transthoracic paths. It may be tubular or have a groove to receive the tensioning element. It includes anti-slip features, such as protruding barbs, shaped profiles including M-shaped sections, bends, inflection points, straight or vertexed center segments, and end segments shaped to self-orient upon tension application. It can be made of multiple components assembled near the treatment site and be resiliently deformable to change from delivery to final shape.
Protection member for safeguarding vital structures
A protection member is shaped to provide a protected space accommodating blood vessels or vital structures such as the pulmonary artery or left atrium. It receives the tensioning element and distributes force from tensioning to either side of the protected space to reduce deformation of vital structures.
Method of applying force to the heart using the device
The method includes positioning the tensioning element around the heart near the atrioventricular groove, delivering a compression member through the right atrium or right atrial appendage via catheter, positioning the compression member over the desired treatment location, and applying force to this location by tensioning the tensioning element. Imaging guidance is used to ascertain positions of components. Assembly of multiple compression member components and positioning of protection members along the tensioning element are also covered.
The independent claims cover a system combining a flexible member, tensioning element, compression member, and protection member designed for minimally invasive delivery and positioning to apply selective force to the heart along the atrioventricular groove to treat functional tricuspid valve regurgitation and related cardiac conditions, along with corresponding methods for performing such procedures.
Stated Advantages
Provides a minimally invasive approach to treat functional tricuspid valve regurgitation without requiring replacement of heart valves or components.
Reduces the risks and morbidities associated with invasive open heart surgery and cardiopulmonary bypass.
Allows for selective application of force to desired areas of the heart, enhancing leaflet coaptation and retarding annulus dilation.
Incorporates protection members to safeguard vital structures such as coronary arteries from unintended deformation during treatment.
Enables device delivery and deployment through catheters, compatible with various vascular and transthoracic access paths, improving procedural flexibility.
Documented Applications
Treatment of functional tricuspid valve regurgitation by applying extracardiac circumferential tension around the tricuspid valve annulus.
Tricuspid valve annuloplasty by restricting dilation of the valve's free wall to enhance leaflet coaptation.
Providing extracardiac force to compress the right ventricular outflow tract or pulmonary artery trunk as a less invasive alternative to surgical banding, addressing congenital heart disease.
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