Location indication system for implant-delivery tool
Inventors
Sheps, Tal • Hammer, Tal • Reich, Tal • Aviv, Ehud • GROSS, AMIR • Herman, Yaron • KOIFMAN, Alexei • Zipory, Yuval
Assignees
Valtech Cardio Ltd • Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-11890190-B2
Publication Date
2024-02-06
Expiration Date
2033-10-23
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Abstract
A catheter, advanced toward an anatomical site, has a proximal end and a steerable distal end. An anchor is advanced through the catheter. An anchor driver drives the anchor out of the catheter's distal end, anchoring the anchor at the site. A first constraining member engages tissue, and inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a first axis between the anchor driver's distal end and a site at which the first constraining member engages the tissue. A second constraining member inhibits, after the anchor has been driven out of the catheter and before the anchoring, movement of at least the anchor driver's distal end, on a second axis. Other embodiments are also described.
Core Innovation
The invention provides a multi-component tubular system comprising a first steerable guiding catheter and a second steerable catheter disposed within the first. The first catheter has a distal portion steerable to a first spatial orientation, and the second catheter, advanced through the first, has a distal portion steerable to a second spatial orientation. The system includes a rotational locking mechanism provided by mutually cooperating first and second couplings on the respective catheters to maintain the spatial orientation of the first catheter while steering the second, enabling controlled steering functionality for implant delivery.
An implant-delivery tool system is provided that facilitates transluminal advancement to a cardiac valve annulus, delivering an annuloplasty ring structure with a flexible sleeve and an adjusting mechanism. The system uses an anchor driver to deploy a plurality of tissue anchors through the sleeve into cardiac tissue, anchoring the implant around the valve annulus. The anchor drivers include mechanisms allowing reversible coupling and controlled rotation to screw the anchors into tissue without twisting or damaging the sleeve.
The system enables fluoroscopically and electrophysiologically-based guidance through use of radiopaque markers on components, looped or longitudinal guides configured to engage cardiac tissue, and electrically conductive tissue anchors connected via the anchor driver to an extracorporeal control unit. This control unit provides real-time positioning information of the tissue anchors inside the heart based on electrical signals received, facilitating precise implantation and anchoring of the annuloplasty ring structure.
Claims Coverage
The patent presents several inventive features across multiple independent claims focused on an implant delivery system, catheter system locking mechanisms, method of electrophysiological guided implantation, and adjustable annuloplasty implant with closure and stiffening elements.
Electrophysiological guidance of implant positioning
A system comprising an implant with a tissue anchor having an electrically conductive distal helical tissue engaging element and coupling head, a multi-component tubular system with catheter and slidable channel, an anchor driver reversibly couplable to the coupling head, first and second electrodes contacting the subject and heart respectively, and a control unit electrically coupled to the electrodes configured to receive electrical signals and provide position information of the second electrode inside the heart.
Electrical coupling of tissue anchor to control unit
The tissue anchor and its coupling head are electrically conductive and coupled to the control unit via the anchor driver, enabling the tissue anchor to act as an electrode for electrophysiological position determination.
Spatial orientation control via rotational locking mechanism
The multi-component tubular system includes a distal locking mechanism comprising first and second couplings at distal portions of coaxial catheters, configured to automatically intracorporeally lock upon given rotational and longitudinal alignment, inhibiting rotation and allowing longitudinal sliding of the second catheter with respect to the first.
Adjustable annuloplasty implant with closure element
An implant structure configured to treat a native atrioventricular valve comprising a sleeve defining a lumen with a proximal opening, a closure element with a flap biased toward a closed state that reduces fluid communication through the lumen when closed, and a longitudinal element slidable within and out of the lumen, wherein positioning of the longitudinal element inside the lumen retains the flap in the open state.
Torque-limiting tool for anchor deployment
A tool for use with an anchor driver, comprising rotatably coupled proximal and distal portions with a variable-resistance mechanism configured to progressively inhibit rotation of the proximal portion with respect to the distal portion based on rotational distance, to prevent over-torquing of tissue anchors during implantation.
The independent claims collectively cover a system for delivering an implant with electrophysiological guidance, a catheter system with controlled rotational locking for steering, an adjustable implant with closure mechanisms, and tools for controlled torque application during implantation, providing a comprehensive framework for the implant-delivery tool and procedure.
Stated Advantages
Controlled relative spatial orientation of coaxial steerable catheters enabling precise steering of an implant delivery tool without disturbing the orientation of outer catheter.
Facilitation of transluminal delivery of an adjustable annuloplasty ring structure, including real-time electrophysiological guidance of anchor positioning within the heart.
Improved implant anchoring by providing mechanical constraints and guiding members that limit undesired movements of the anchor driver and implant relative to tissue.
Optimization of anchor insertion torque to avoid over-tightening and tissue damage using torque-limiting tools and electronic control.
Enhanced anchoring precision through visual fluoroscopic markers and tissue-contact looped or longitudinal guides facilitating accurate placement and deployment of tissue anchors.
Documented Applications
Repair of cardiac valves, particularly delivery and anchoring of annuloplasty ring structures along the annulus of the mitral or tricuspid valves.
Implantation of adjustable annuloplasty implants by transluminal, transseptal, transapical, minimally invasive thoracic, or surgical open-heart approaches.
Guidance of implant delivery using electrophysiological signals and fluoroscopic radiopaque markers.
Use of torque-limiting deployment tools to prevent damage to heart tissue or annuloplasty sleeves during anchor insertion.
Potential application to other cardiac valves and annular muscles elsewhere in the body, such as sphincter muscles in the stomach or urinary tract.
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