Anchor magazine
Inventors
Zipory, Yuval • KOIFMAN, Alexei • Aviv, Ehud • Reich, Tai
Assignees
Valtech Cardio Ltd • Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-11766263-B2
Publication Date
2023-09-26
Expiration Date
2034-10-21
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Abstract
An anchor-handling device comprises a housing shaped to define a channel having an anchor-storage zone and a proximal opening. An anchor driver comprises an anchor-engaging head, the anchor-engaging head being dimensioned to be advanceable through the proximal opening toward the anchor-storage zone. A tissue anchor is stored in the anchor-storage zone, and comprises a coupling head configured to be locked to the anchor-engaging head. The tissue anchor is movable out of the anchor-storage zone toward the proximal opening in response to a proximally-directed force being applied to the tissue anchor by the anchor driver. The anchor-handling device comprises an element that serves as an indicator of movement of the tissue anchor out of the anchor-storage zone toward the proximal opening, by moving in response to the proximally-directed force such that at least part of the element protrudes out of the housing. Other embodiments are also described.
Core Innovation
The invention provides an anchor-handling device configured to facilitate the handling of one or more tissue anchors. The device comprises a housing defining a channel with an anchor-storage zone and a proximal opening through which an anchor driver with an anchor-engaging head can be advanced toward the anchors. The tissue anchor is stored within the anchor-storage zone and is designed to be movable out of this zone toward the proximal opening only in response to a proximally-directed force applied by the anchor driver that exceeds a predetermined threshold.
This force requirement is achieved by a retaining member within the device that holds the tissue anchor in place until a sufficient force is applied. The retaining member obstructs exit of the tissue anchor and includes an inhibitor that prevents movement of the retaining member except when the applied force surpasses the threshold, thereby preventing inadvertent release of the anchor during handling or transport. The retaining member moves in response to the force, often sliding within a chamber of the housing and protruding partially outside the housing to signal anchor movement.
The anchor-handling device can be integrated into multi-component tubular systems used for transcatheter delivery of implants, facilitating sequential delivery of multiple anchors. It includes features such as rotationally asymmetrical openings to limit orientation of the anchor-engaging head, bases to immobilize the housing and handle, and elements that provide visual or mechanical indication of anchor movement. The device ensures reliable coupling between anchor driver and tissue anchor before release, enhancing safety and operational control.
Claims Coverage
The patent claims include multiple inventive features centered on an anchor-handling device, anchor driver, and tissue anchor system, emphasizing mechanisms for retention, controlled release, indication of anchor movement, and integration with delivery systems.
Anchor-handling device with retention and controlled release
A housing defining a channel with an anchor-storage zone and proximal opening, and a retaining member configured to retain the tissue anchor in the storage zone, allowing release only upon application of a proximally-directed force exceeding a pre-defined threshold.
Protruding element indicating anchor movement
An element that moves in response to the proximally-directed force applied to the tissue anchor such that at least part of the element protrudes out of the housing, thereby providing an indication of movement of the tissue anchor out of the anchor-storage zone.
Inhibitor mechanism preventing sub-threshold movement
An inhibitor, such as an inhibitor tongue or detent, that inhibits the retaining member from moving under sub-threshold force and allows movement only when the proximally-directed force surpasses the threshold, often involving cavities and detent engagement to regulate force resistance and element position.
Rotationally asymmetrical opening for oriented coupling
The proximal opening and anchor-engaging head each have rotationally asymmetrical transverse cross-sections (e.g., elliptical shapes with segments removed), limiting the orientations in which the anchor-engaging head can enter the housing to ensure correct rotational coupling to the tissue anchor without further rotation.
Multi-channel, multi-anchor handling device
The device comprises multiple channels each with respective anchor-storage zones, proximal openings, tissue anchors, retaining members, and movable elements serving as indicators for each anchor's movement.
Flexible shaft anchor driver enabling transcatheter delivery
The anchor driver includes a flexible shaft configured for transluminal advancement into a subject, with a distal anchor-engaging head designed to be advanced through the proximal opening to engage and move the tissue anchor.
Indicator element configured to resist distal return post-removal
The system is configured such that after removal of the tissue anchor, the distally-directed force required to return the protruding part of the element into the housing is more than twice the threshold force, preventing inadvertent reinsertion and serving as an empty-housing indicator.
The claims collectively cover an integrated system of a housing with controlled anchor retention and release mechanisms, visual and mechanical movement indicators, orientation-limited access openings, multi-anchor configurations, and specialized anchor drivers with flexible shafts, providing safe, reliable, and controlled handling and delivery of tissue anchors.
Stated Advantages
Prevents inadvertent movement or exit of tissue anchors during handling or transport by requiring a threshold force to release the anchor.
Provides clear indication of successful coupling and withdrawal of tissue anchors through protruding elements visible or accessible to the operator.
Enhances safety and reliability by testing anchor-driver coupling force before releasing the anchor from the device.
Facilitates sequential delivery of multiple anchors via integration with multi-component tubular systems.
Improves operator handling and control through design features such as rotationally asymmetrical openings, immobilizing bases, and operable adjusters during use.
Documented Applications
Handling and retrieval of multiple tissue anchors for intracorporeal implantation, particularly where the anchors are small (less than 11 mm length and 3 mm width).
Use in combination with multi-component tubular systems for transcatheter delivery of implants to anchor devices, such as annuloplasty devices, to tissue in subjects, e.g., anchoring heart valve annuloplasty sleeves to the mitral valve annulus.
Integration within flexible intravascular delivery systems for transluminal advancement of tissue anchors into patients via catheter-based procedures.
Providing visual and mechanical indications for operators during minimally invasive delivery procedures to confirm anchor coupling and retrieval.
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