Encircling implant delivery systems and methods
Inventors
Rogers, Toby • Lederman, Robert J. • Sonmez, Merdim • Franson, Dominique N. • Kocaturk, Ozgur
Assignees
US Department of Health and Human Services
Publication Number
US-10463495-B2
Publication Date
2019-11-05
Expiration Date
2034-06-03
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Abstract
Delivery devices for delivering encircling implants can include two separate limbs that are held together at a distal articulation by the implant being delivered. The implant can comprise a suture and/or a braided tube. The implant can extend through or over the limbs. The implant and at least a distal portion of the limbs can be compressible into a delivery shape that allows for advancement through the lumen of a delivery catheter. When the distal portion of the limbs move out of the delivery catheter, the limbs and implant can resiliently assume a loop shape that is complementary to a shape of a target around which the encircling implant is to be placed. The limbs are then retracted from along the implant to leave the implant in the desired delivery position. The delivery device can be used to place encircling implants around the heart or other targets, and the implant can be tightened to exert compressive force on the target.
Core Innovation
The invention relates to delivery systems and methods for delivering encircling implants through catheters for placement around anatomical targets, such as the heart or other organs. The delivery systems comprise two limbs held together at a distal articulation by the implant being delivered, which can be a suture or braided tube extending through or over the limbs. Both the implant and the distal portion of the limbs are compressible into a delivery shape suitable for advancement through the lumen of a delivery catheter. Upon exiting the catheter, the limbs and implant resiliently assume a loop shape complementary to the shape of a target structure. The limbs are then retracted to leave the implant positioned appropriately for tightening around the target to exert compressive force.
The disclosed devices may be comprised of resiliently deformable materials, such as shape-memory alloys like nitinol, allowing the limbs to deform into a linear shape during delivery and then form loops when unconstrained outside the catheter. The implant may be a continuous suture or a braided tubular implant with an internal suture for tightening. The delivery limbs articulate at a tip held together by the implant and can slide along or within the implant, enabling precise placement and subsequent retraction without disturbing the implant's position. The devices can accommodate various loop shapes and target anatomies and may include additional compression or protection members placed over the implant.
The problem addressed originates from challenges in minimally invasive, transcatheter procedures for encircling a target structure within the body with a continuous loop that can be remotely tightened to compress the target. Prior art lacks technology effectively enabling the delivery, precise placement, and secure fixation of such loops via catheters in a minimally invasive manner, particularly for complex anatomical structures like the heart.
Claims Coverage
The patent includes two independent system claims and two independent method claims, covering systems and methods for delivering encircling implants via catheter-based delivery devices comprising articulating limbs and flexible implants.
System for delivering an encircling tubular implant with articulating limbs
A system comprising a flexible delivery catheter, a continuous flexible encircling tubular implant, and first and second delivery limbs linked at a distal articulation tip by the implant. The implant extends over the limbs to hold their distal ends together. The distal limb portions are resiliently deformable from a compressed delivery shape to a loop shape sized complementary to a target structure. The tubular implant forms a loop extending from adjacent the catheter along limbs and across the articulation, with the limbs extending within a lumen of the implant during delivery.
Method of delivering an encircling implant via articulating limbs and catheter
A method comprising advancing articulated first and second delivery limbs through a delivery catheter with the limbs and implant compressed. Upon emergence from the catheter distal end, distal limb portions resiliently assume a loop shape causing the encircling implant to form a loop around the target structure while retaining a portion of the limbs within the catheter, followed by optional deployment of protection devices and subsequent tightening of the implant.
The independent claims focus on the unique configuration of flexible delivery limbs linked and held by an encircling implant that transitions between a compressed delivery shape and a loop shape complementary to the target. The claims cover tubular implants with limbs extending inside their lumen, methods of deployment through a catheter, controlled articulation and loop formation, limb retraction leaving the implant in place, and tightening methods to compress target structures.
Stated Advantages
Allows minimally invasive delivery of an encircling implant around complex anatomical targets such as the heart via catheter systems.
Delivers implants in a compressed shape through catheters and deploys them into pre-shaped loops complementary to target anatomy for precise placement.
Enables secure positioning and tensioning of the implant remotely by retracting delivery limbs without disturbing implant placement.
Braided tubular implants prevent tissue damage by distributing pressure and avoid buckling or kinking during tightening.
Compatibility with various anatomical targets and access routes including intravascular, percutaneous, and body cavities.
Documented Applications
Transcatheter mitral valve annuloplasty by encircling the mitral valve to exert compressive remodeling forces for improved valvular function.
Transcatheter tricuspid valve annuloplasty via encircling the heart's atrioventricular groove and placement of protective devices over coronary arteries.
Left atrial appendage ligation by placing an encircling implant around the atrial appendage to exclude it and prevent thrombus formation.
Placement of encircling implants around various anatomical or implantable targets including heart, atrial appendage, cecal appendix, gallbladder, neoplasms, uterus, aneurysms, blood vessels, intraocular lenses, urinary bladder, kidney, prostate, or foreign bodies.
Delivery via percutaneous or intraluminal routes through flexible catheters, including trans-thoracic and sub-xiphoid approaches.
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