Annuloplasty technologies
Inventors
Aviv, Ehud • Reich, Tal • Sheps, Tal • Hariton, Ilia • Brauon, Haim • Kutzik, Meir • KOIFMAN, Alexei • Herman, Yaron
Assignees
Valtech Cardio Ltd • Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-12138164-B2
Publication Date
2024-11-12
Expiration Date
2036-04-21
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Abstract
A method is described for use with a heart of a subject, the heart having a valve and an atrium upstream of the valve. The method includes transluminally advancing multiple tissue anchors to the atrium; and securing an elongate contraction member at least partly around an annulus of the valve by anchoring the tissue anchors to the annulus, such that the tissue anchors are distributed along the elongate contraction member. The method further includes subsequently contracting the annulus by applying tension the elongate contraction member, such that a radiopaque indicator that is disposed within the heart and that is coupled to the contraction member undergoes a conformational change in response to the tension. The conformational change of the radiopaque indicator within the heart is observed, and the tension is adjusted responsively to the observed conformational change. Other embodiments are also described.
Core Innovation
The invention relates to a method and apparatus for repairing atrioventricular valves, specifically targeting ischemic mitral regurgitation caused by dysfunction and displacement of papillary muscles and dilatation of the mitral valve annulus. The invention addresses the challenge posed by dilation of the mitral valve annulus that prevents proper coaptation of valve leaflets, leading to blood regurgitation, increased stroke volume, decreased cardiac output, and ventricular weakening.
The solution involves a multi-component tubular system comprising steerable guiding catheters that facilitate the delivery and anchoring of an implant to the annulus of a cardiac valve. The implant includes a flexible sleeve and an elongate contraction member anchored to the annulus via multiple tissue anchors distributively placed along the contraction member. The system allows for adjustment of the annulus by tensioning the contraction member, with the tension monitored through a radiopaque indicator that undergoes a conformational change in response to tension. This indicator's change is observed and utilized to adjust the tension accordingly.
The implant-delivery tool allows sequential deployment of tissue anchors through the sleeve wall into heart tissue, with the first anchor often having a larger tissue-coupling element for increased anchoring strength. The system supports translation and reorientation of components to position the implant effectively around the valve annulus, enables measurement of forces during implantation to assess anchoring strength, and comprises an adjustment tool for modulating the contractile tension of the implant post-implantation.
Claims Coverage
The independent claims cover inventive features related to methods of implanting and adjusting an annuloplasty device within a heart using tissue anchors, and corresponding apparatus components.
Method for sequential anchoring and tensioning of an elongate contraction member around a valve annulus
Includes transluminal advancement of multiple tissue anchors via a catheter to an atrium, securing an elongate contraction member partly around a valve annulus by anchoring the tissue anchors to the annulus, sequential deployment of anchors, application of tension to contract the annulus, and observation of conformational change in a radiopaque indicator responsive to tension for adjustment.
Steerable multi-component tubular catheter system for implant delivery
Comprises at least two concentrically disposed catheters each with independently steerable distal portions configured for initial advancement to the heart atrium and precise positioning around the valve annulus for implant delivery and anchoring.
Implant with flexible sleeve and adjustable contraction member
Implant includes a sleeve with a tubular lateral wall defining a lumen, an adjustment mechanism, and a contraction member woven or threaded through the sleeve and coupled to the adjustment mechanism for contractile tensioning to reduce sleeve length.
Anchor and anchor driver with tissue-piercing lance
Anchor driver includes a longitudinal shaft, a deployment element reversibly lockable to the anchor head, and a tissue-piercing lance extendable past the distal tip of the anchor to stabilize and penetrate tissue prior to anchor deployment, with automatic unlocking of the deployment element upon lance retraction.
Method and system for force gauging during implant manipulation
Method involves measuring forces applied through an implant-manipulating handle before and after anchoring to determine the net force applied to tissue, facilitated through incorporation of force gauges in the handle and anchor manipulators.
Adjustment device with locking mechanism and intracorporeally decouplable adapter
Adjustment device includes an adjustment mechanism coupled to the implant and a lock inhibiting actuation of the mechanism. The adapter couples to the adjustment device via a fastener and includes an unlocking mechanism actuated percutaneously to cyclically unlock and lock the adjustment mechanism for implant dimension modulation.
The claims collectively cover a comprehensive system and method for transcatheter delivery, anchoring, real-time adjustment, and monitoring of an annuloplasty implant to repair atrioventricular valves, incorporating novel anchor deployment mechanisms, multi-level steering catheter systems, tension-responsive indicators, and force measurement capabilities.
Stated Advantages
Facilitates precise transcatheter delivery and anchoring of an annuloplasty implant to a cardiac valve annulus using steerable catheter systems.
Allows controlled contraction of the valve annulus by tensioning an elongate contraction member distributed with multiple tissue anchors.
Enables accurate monitoring and adjustment of tension using a radiopaque indicator that undergoes conformational changes visible during the procedure.
Provides improved implant positioning and anchoring strength through use of different sized tissue anchors and reversible locking anchor drivers with stabilization lances.
Permits measurement of anchoring forces to ensure implant security and prevent over-tensioning, improving safety and efficacy.
Offers means for repeated percutaneous adjustment of the implant post-implantation using a lockable adjustment mechanism and percutaneously deliverable adapter and tool.
Documented Applications
Repair of ischemic mitral regurgitation by contracting and securing an annuloplasty ring structure to the mitral valve annulus percutaneously via transseptal catheter access.
Transluminal implantation and adjustment of annuloplasty implants around cardiac valves, particularly the mitral valve, using multiple tissue anchors and multi-component steering catheters.
Use of force gauging during implantation to assess anchoring strength of tissue anchors within the heart.
In vivo adjustment of annuloplasty ring tension and monitoring of cardiac valve function using a radiopaque tension indicator.
Interested in licensing this patent?