Implant-cinching devices and systems
Inventors
Sheps, Tal • Keidar, Yaron • Zipory, Yuval
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-11832784-B2
Publication Date
2023-12-05
Expiration Date
2038-10-08
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Abstract
An annuloplasty implant comprises an elongate member, a plurality of anchors, and a gripper. The elongate member has a proximal end, and a distal portion that includes a distal end. The plurality of anchors are distributed along the elongate member. The elongate member extends proximally from a proximal-most anchor and through the gripper. The gripper comprises a locking element that, in a locked state, inhibits sliding of the elongate member through the gripper. An unlocker, disposed within the gripper, obstructs the locking element from assuming the locked state, and is pullable proximally out of the gripper. The gripper automatically assumes the locked state upon the unlocker being pulled proximally out of the gripper. A tool tensions the distal portion of the elongate member by pulling the elongate member proximally through the gripper while the unlocker obstructs the locking element from assuming the locked state. Other embodiments are also described.
Core Innovation
The invention relates to systems, devices, and methods for cinching, tightening, or tensioning a medical implant, particularly useful in adjusting cardiovascular implants such as annuloplasty devices. The system includes an elongate member that is configured to extend into and through an elastic pouch and a gripper. Stretching the pouch pulls the elongate member through the gripper and into the pouch, causing contraction of the implant body. The gripper can lock to hold the elongate member in place, maintaining the adjusted size.
The problem being solved arises from ischemic heart disease causing valve regurgitation due to dilation of valve annulus regions, which prevents proper leaflet coaptation, leading to cardiac dysfunction. Existing annuloplasty devices adjust the valve annulus shape, but need improvements in adjustability and secure fixation post-implantation. This invention addresses the need for an adjustable, cinchable device that can be tensioned after implantation and maintained in a desired configuration.
Claims Coverage
The patent contains one independent apparatus claim and one independent method claim featuring innovative elements related to an annuloplasty implant system.
Annuloplasty implant with elongate member and gripper
An implant for heart valve repair comprising an elongate member with multiple anchors distributed along its length, passing proximally from the proximal-most anchor through a gripper. The gripper has a locking element that clamps the elongate member to prevent sliding in the locked state.
Unlocker mechanism within the gripper
An unlocker disposed within the gripper which obstructs the locking element from locking and is removable by proximal pulling. The gripper automatically locks upon removal of the unlocker.
Tool for tensioning elongate member
A transluminally advanceable tool configured to tension the distal portion of the elongate member by pulling it proximally through the gripper while the unlocker prevents locking.
Container coupled to the gripper
A container, such as a pouch, coupled to the gripper to confine the proximal portion of the elongate member after tensioning. The container is elastic or comprises a shape memory material and transitions from a stretched to a contracted state to hold the elongate member securely.
Method for implanting and adjusting the implant
Transluminal advancement and anchoring of the implant anchors to the valve annulus, tensioning the elongate member by pulling it through the gripper while the unlocker is in place, followed by removal of the unlocker to lock the gripper and maintain tension.
The independent claims cover an apparatus and method for a transluminally deliverable annuloplasty implant with a unique combination of elongate member, gripper with automatic locking via an unlocker, a tensioning tool, and a container to confine excess elongate member, enabling controlled adjustment and secure fixation of the implant after deployment.
Stated Advantages
Provides controlled, adjustable cinching or tightening of a medical implant after implantation.
Allows secure locking of the elongate member in a desired tensioned state via an automatic locking gripper mechanism.
Incorporates an elastic or shape memory container to confine the excess elongate member tidily within the body, preventing deleterious movement.
Enables transluminal or transcatheter delivery and adjustment of annuloplasty implants, improving minimally invasive treatment of valve regurgitation.
Documented Applications
Adjustment and contraction of annuloplasty implants or implant bodies implanted around heart valve annuli such as mitral or tricuspid valves.
Use in cardiovascular implants requiring tensioning or cinching, including annuloplasty bands, rings, or prosthetic chordae tendineae.
Minimally invasive, transluminal delivery and adjustment of implants for treatment of ischemic heart disease-induced valve regurgitation.
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