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-12274618-B2
Publication Date
2025-04-15
Expiration Date
2033-10-23
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Abstract
A tubular system is configured to transluminally deliver an implant comprising a tissue anchor having a coupling head and a distal helical tissue-engaging element, into a heart of a subject. The tissue anchor is slidable through a channel of the system, the channel being slidable within a catheter. An anchor driver is configured, while coupled to the coupling head of the tissue anchor, to drive the tissue anchor through the system and out the system's distal end, to anchor the tissue-engaging element to tissue of the heart. While a first electrode is in contact with the subject and a second electrode is inside the heart of the subject, a control unit receives an electrophysiological signal from the electrodes, and based on the electrophysiological signal, indicates a position of the second electrode inside the heart. Other embodiments are also described.
Core Innovation
The present invention relates to a multi-component tubular system for transluminal delivery of an implant comprising a tissue anchor into the heart of a subject. The system comprises a catheter and a channel slidable within the catheter. The tissue anchor has a coupling head and a distal helical tissue-engaging element and is slidably disposed through the channel. An anchor driver is configured to reversibly couple to the coupling head and to drive the tissue anchor through the system and out of its distal end, anchoring the element to heart tissue. The system further includes electrodes and a control unit that receives electrophysiological signals from the electrodes to indicate the position of the tissue anchor inside the heart.
The problem being solved is the accurate placement and anchoring of an implant in a desired orientation to the annulus of a cardiac valve via a controlled and steerable delivery system that minimizes distortion and maintains orientation during steering. Additionally, the system addresses the need for electrophysiological guidance for accurate positioning of the implant and the ability to deploy anchors precisely while providing feedback indicating the position and anchoring strength of the tissue anchor.
Claims Coverage
The independent claims cover a tissue anchor delivery system with electrophysiological position indication, implant delivery and anchoring features, steerable multi-catheter systems with locking mechanisms, radiopaque markers for positioning, and torque-limiting tools for anchor deployment.
Tissue anchor delivery system with electrophysiological position indication
- A tubular system comprising a catheter and a channel slidable within it, delivering an implant with a tissue anchor having a helical tissue-engaging element and a coupling head; the anchor driver reversibly couplable to the head drives and anchors the anchor through the heart tissue. The system includes a first electrode contacting the subject, a second electrode inside the heart, and a control unit that receives electrophysiological signals from both electrodes and provides position information via a display.
Control and feedback in the anchoring system
- The control unit can detect anchoring strength by applying a proximal pulling force to the anchor driver. It can provide audio and tactile feedback based on the position of the electrodes. The tissue anchor and its coupling head are electrically conductive and electrically coupled to the control unit, which is also electrically coupled to the electrically-conductive anchor driver acting as second electrode.
Multi-catheter steerable system with locking mechanisms
- A first catheter with steerable distal end and first coupling, and a second catheter with steerable distal end and second coupling, the second catheter being advanceable in any rotational orientation through the first catheter. Upon alignment, the two couplings automatically intracorporeally lock, preventing rotation and allowing controlled steering without substantially disturbing relative orientation. A proximal locking mechanism similarly prevents rotation and longitudinal sliding at the proximal ends.
Use of radiopaque markers and guide elements
- Radiopaque markers are movable with respect to catheter components and implant, enabling fluoroscopic identification of the implant position relative to tissue. Longitudinal guide members and looped guide portions are provided to engage tissue and indicate and guide the position of the implant delivery tube and channel relative to the anatomical site.
Torque-limiting deployment tools
- Tools coupled to the anchor driver comprising variable-resistance mechanisms that progressively inhibit rotation to limit torque delivered to the tissue anchor, with indicators providing visual feedback of torque applied. The tool may comprise clutch mechanisms or shear pins to provide temporary or permanent rotational disengagement upon exceeding a predetermined torque, preventing over-tightening or tissue damage.
Overall, the claims cover a coordinated system comprising a steerable multi-catheter arrangement with locking and orientation control, a tissue anchor delivery system with electrical and electrophysiological position indication and feedback, radiopaque and tactile guide elements, and deployment tools with controlled torque application and safety features to assure precise implant placement and secure anchoring within cardiac tissue.
Stated Advantages
Provides controlled steering and relative spatial orientation of steerable multiple catheters maintaining the spatial orientation of each without essentially distorting the other.
Enables accurate, controlled transluminal delivery of implants and tissue anchors to targeted heart valve annulus regions.
Provides electrophysiological feedback to indicate the position of the implant and the tissue-engaging element inside the heart, facilitating accurate placement.
Facilitates fluoroscopically-identifiable arrangements by using radiopaque markers and guide elements for positioning adjacent to tissue.
Includes torque-limiting tools and feedback mechanisms that prevent over-tightening of tissue anchors, reducing potential tissue damage.
Improves anchoring quality by detecting temporary electrocardiographic abnormalities (e.g., PVCs) during anchor deployment.
Documented Applications
Transluminal repair of a cardiac valve (e.g., mitral or tricuspid) using a steerable implant-delivery system placing an annuloplasty ring structure along the valve annulus.
Electrophysiological guidance of tissue anchor positioning inside the heart based on signals received from electrodes placed external to the subject and at the tissue anchor.
Use of radiopaque markers and guide wires or loops to facilitate fluoroscopic visualization and accurate positioning of implants with respect to heart valve tissue.
Deployment of tissue anchors into heart tissue via a transluminal catheter system for securing valve repair implants.
Adjusting the implant perimeter (e.g., an annuloplasty ring) after implantation using an adjustable mechanism actuated via a guidewire seating and rotational tool.
Torque-controlled deployment of tissue anchors to avoid over-tightening or tissue damage during implant anchoring.
Minimally invasive transseptal or transapical approaches for delivering and implanting valve repair devices using steerable multi-catheter systems.
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