Adjustable annuloplasty device with alternating peaks and troughs
Inventors
Kutzik, Meir • Brauon, Haim • Levin, Michael • FOGEL, Alon • Hariton, Ilia • Reich, Tal
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-12102533-B2
Publication Date
2024-10-01
Expiration Date
2037-03-31
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Abstract
An implant, disposed within a catheter, comprises a ring, anchors, and adjustment elements. The ring comprises struts arranged in a pattern of alternating peaks and troughs. Each strut has a first end-portion and a second end-portion. Each peak is defined by convergence of adjacent first end-portions disposed at an angle with respect to each other, and each trough is defined by convergence of adjacent second end-portions. Each of the anchors has a longitudinal axis, is coupled to the ring at a respective trough, and is configured to be driven along the longitudinal axis with respect to the trough and into tissue of the heart. Each of the adjustment elements is configured to adjust an angular disposition between a respective pair of the struts. A first adjustment element is coupled to its pair, and a second adjustment element is coupled to its pair distal to the first adjustment element.
Core Innovation
The invention relates to an adjustable annuloplasty device for use in repairing cardiac valves, particularly atrioventricular valves like the mitral valve. The device includes an implant comprising a ring formed by multiple struts arranged in an alternating pattern of peaks and troughs. Each peak is formed by the convergence of adjacent first end-portions of the struts at an angle, while each trough is formed by convergence of adjacent second end-portions.
Anchors are coupled to the ring at the troughs and have longitudinal axes along which they are driven into the heart tissue for anchoring. The anchors are designed to both move along their longitudinal axes relative to the troughs and deflect or pivot with respect to the ring structure to facilitate better anchoring in the tissue. The device also includes adjustment elements coupled to pairs of adjacent struts at the peaks, which adjust the angular disposition between those struts to reshape and reduce the diameter of the valve annulus.
The problem addressed by the invention is the dilation of atrioventricular valve annuli which impairs valve leaflet coaptation and causes regurgitation. Traditional annuloplasty devices may be difficult to deliver percutaneously or minimally invasively, or may lack mechanisms for controlled and adjustable reshaping of the valve annulus once implanted. The invention provides a system allowing percutaneous transluminal delivery, stepwise assembly from subunits if desired, controlled anchoring with adaptable anchor orientation, and adjustment of the valve annulus shape post-deployment.
Additionally, the invention describes techniques to improve delivery and compression of the device, including arrangements of adjustment elements to allow smaller compressed device diameters and to control expansion after deployment. Guide members and articulation bearings facilitate navigation and actuation of adjustment elements located at peaks that may be positioned higher in the atrium. The invention also contemplates methods for intracorporeal assembly of the implant from subunits delivered transfemorally.
Claims Coverage
The claims include two independent claims describing a system with a percutaneously delivered implant for cardiac valve repair comprising a ring with struts, anchors, and adjustment elements, with various specific features in anchoring and adjusting the implant.
Ring with struts arranged in alternating peaks and troughs
The implant includes a ring composed of multiple struts arranged in a pattern of alternating peaks and troughs circumscribing a central axis, where each peak is defined by convergence of adjacent first end-portions disposed at an angle and each trough by convergence of adjacent second end-portions.
Anchors coupled at troughs and configured for axial insertion into heart tissue
A plurality of anchors each having a longitudinal axis coupled to the ring at respective troughs and configured to be driven along their longitudinal axes into the surrounding heart tissue.
Adjustment elements movably coupled to pairs of struts at peaks
Adjustment elements are movably coupled to respective pairs of struts at peaks such that movement of an adjustment element changes the angular disposition between the struts of the pair.
Arrangement of adjustment elements in alternating axial and stepwise patterns
Multiple adjustment elements are arranged at two distinct axial positions around the ring in an alternating pattern or stepwise pattern to optimize implant compression and expansion.
Adjustment elements comprising nuts threadedly coupled to struts
Each adjustment element comprises a nut threadedly coupled to the respective pair of struts, wherein screwing the nut changes the angular disposition between those struts.
Anchors coupled with hinges facilitating deflection relative to ring
The anchors are coupled to the ring at troughs via hinges, such as flexure bearings or fabric strips, which allow the longitudinal axes of anchors to deflect or pivot relative to the ring, improving anchoring adaptability.
Anchor mounts articulatably coupled to struts via hinges
At each trough, an anchor mount is articulatably coupled to adjacent second end-portions of struts via hinges, and anchors are rotatably coupled to these mounts such that rotation moves anchors along their longitudinal axes.
System including catheter for percutaneous delivery and tools for anchor driving and adjustment element actuation
The system includes a catheter configured for percutaneous advancement, an anchor driver configured to move anchors into tissue, and an adjustment tool for rotating adjustment elements to reshape the ring.
The independent claims cover a system for percutaneously delivering an annuloplasty implant with a ring of struts forming peaks and troughs, anchors at troughs capable of axial movement and deflection via hinges, adjustment elements at peaks for angular modification of struts, and arrangements of these elements and tools enabling controlled implantation and reshaping of the valve annulus.
Stated Advantages
Allows percutaneous transluminal delivery and stepwise assembly of the annuloplasty implant, enabling minimally invasive procedures.
Facilitates controlled and adjustable reshaping of the valve annulus after implantation via adjustment elements.
Provides anchors that can both move axially and deflect relative to the ring, improving anchoring by accommodating variable tissue orientations.
Designs adjustment elements arrangement (alternating axial positions or stepwise patterns) to reduce compressed profile of the implant for easier delivery.
Incorporates guide members and articulation bearings to facilitate navigation and actuation of adjustment elements positioned high within the atrium.
Documented Applications
Treatment and repair of dilated atrioventricular heart valves, such as the mitral valve, by reshaping the valve annulus to improve leaflet coaptation and reduce regurgitation.
Percutaneous and minimally invasive implantation of annuloplasty devices for cardiac valve repair.
Intracorporeal assembly of annuloplasty implants from multiple subunits delivered transfemorally.
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