Annuloplasty and tissue anchor technologies
Inventors
Kasher, Yuval • Shoham, Tomer • Cohen, Or • Benshahar, Tal
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-11819411-B2
Publication Date
2023-11-21
Expiration Date
2040-10-27
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Abstract
Apparatus comprising a tissue anchor for use with an anchor driver. The anchor comprises a head, and a tissue-engaging element coupled to a proximal end of the head. The tissue-engaging element defines a central longitudinal axis of the anchor, and has a sharpened distal tip, configured to be driven into tissue of a subject. The head comprises a driver interface, configured to be reversibly engaged by the anchor driver, and an eyelet, disposed laterally from the central longitudinal axis, defining an aperture on an aperture plane, the aperture having a length along a long axis of the aperture and a width along a short axis of the aperture, the long axis and the short axis disposed on the aperture plane. The eyelet is mounted such that the aperture plane is slanted at a fixed angle with respect to the central longitudinal axis. Other applications are also described.
Core Innovation
The invention relates to apparatus comprising a tissue anchor usable with an anchor driver, having a tissue-engaging element with a sharpened distal tip to be driven into tissue, and a head coupled at the proximal end that includes a driver interface and an eyelet defining an aperture. The eyelet is disposed laterally from the central longitudinal axis of the anchor, mounted such that the aperture plane is slanted at a fixed angle to the axis, and is revolvable around the axis while maintaining the slanted aperture plane.
The invention solves challenges in annuloplasty and other tissue remodeling procedures, including secure anchoring of implants using tissue anchors that facilitate smooth sliding of a contracting member (wire, line, suture) both when aligned and orthogonal to the anchor, enabling transcatheter delivery and subsequent tensioning without suture use. It addresses improved implant contraction control, implant anchoring visibility under imaging, and controlled deployment through delivery tools configured to maintain anchor and contracting member orientation and movement.
Claims Coverage
The patent includes multiple independent claims focusing on a tissue anchor apparatus with a specific eyelet configuration and related system components.
Slanted and revolvable eyelet aperture
A tissue anchor head includes an eyelet defining an aperture with a length greater than width, disposed laterally and mounted such that the aperture plane is slanted at a fixed angle to the anchor's central axis, and the eyelet is revolvable around the axis while maintaining this fixed angle.
Eyelet shape facilitating multi-axis sliding over a wire
An implant with the anchor and a wire threaded through the eyelet aperture, where the eyelet defines mutually orthogonal slide-axes parallel and perpendicular to the anchor axis, shaped to facilitate smooth sliding of the eyelet over the wire in either alignment.
Tapered eyelet external shape engaging spacers
The eyelet has an external tapered portion tapering away from the aperture along the second slide-axis, enabling the use of tubular spacers with flared ends that snugly fit over the tapered portions between pairs of anchors on the wire, limiting proximity and stabilizing force distribution.
Delivery tool and tube with keyhole channel
A delivery tool including an anchor driver and a percutaneously advanceable tube defining an internal channel with a keyhole-shaped orthogonal cross-section having a major channel for the tissue-engaging element and a minor channel for the eyelet, allowing the anchor and driver to slide through the tube with the eyelet snug in the minor channel.
Facilitated sliding and lateral exit of wire from the delivery tube
The eyelet is shaped to facilitate smooth sliding of the wire through the aperture both when the wire is parallel and orthogonal to the anchor axis; the tube defines a lateral slit adjacent to the minor channel allowing the wire, but not the anchor, to exit laterally proximally from the distal end.
The claims center on the design of a tissue anchor having a head with a slanted, revolvable eyelet shaped to facilitate smooth sliding of a wire or contracting member in multiple orientations, the use of tapered eyelets and matching spacers to stabilize anchors, and a delivery tool with a keyhole-shaped channel allowing controlled advancement of the anchor while accommodating the wire's position and exit path.
Stated Advantages
Eyelets designed for smooth sliding of contracting members both parallel and orthogonal to the anchor enable easy advancement and tensioning during implantation and adjustment.
Fixed-angle slanted eyelet mounted to be revolvable reduces wear on the contracting member and improves durability.
Use of tapered eyelets with flared spacers limits unwanted proximity between anchors and facilitates stable force distribution during contraction.
Delivery tools with keyhole-shaped channels facilitate controlled rotational positioning of anchors and smooth transit through delivery tubes.
Protrusions and radiopaque components on tissue anchors provide visible indicators for successful implantation under imaging.
Documented Applications
Annuloplasty procedures involving tissue remodeling by pulling annular tissue with a contracting wire or line coupled to multiple tissue anchors.
Use in percutaneous, transcatheter delivery and deployment, including through flexible tubes and catheters for minimally invasive tissue anchoring.
Annulus contraction and reshaping to improve coaptation of heart valve leaflets, such as mitral and tricuspid valves.
Docking implants for subsequent prosthetic valve implantation, providing stable annulus engagement and improved prosthetic valve retention.
Systems and tools for determining successful (complete) anchoring in tissue not in line-of-sight via radiopaque protrusions and tissue-indicating devices on delivery tubes.
Contracting-member-covering devices and fastening/locking systems for securing, locking, cutting, and covering excess portions of contracting members after tissue anchor implantation.
Wire uptake assemblies for gripping and controlling apparel wire or contracting members during implantation or adjustment.
Wire assemblies with radiopaque coatings or composite wire constructions for visualization and distance measurement between tissue anchors during implantation.
Interested in licensing this patent?