Systems and methods for heart valve repair
Inventors
BAPAT, Vinayak Nilkanth • BAPAT, Shalaka Vinayak
Assignees
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Abstract
The disclosed subject matter relates to a system for transcatheter heart valve repair, including a sheath; at least two clips each comprising: a ventricular jaw, an atrial jaw, and a cable; and a locking mechanism.
Core Innovation
The patent describes a transcatheter heart valve repair system including a sheath defining a lumen and at least two clip assemblies. Each clip assembly includes an elongate member slidably disposed within the sheath lumen, with a first clip and a second clip that are releasably coupled to and selectively detachable from their respective elongate members.
The first clip and the second clip each include a ventricular jaw and an atrial jaw, where the ventricular jaw and the atrial jaw of each clip are each individually deployable to respective positions to approximate different leaflet portions of a heart valve. The system further includes a locking mechanism configured to slide along the first and second elongate members and to couple and lock together the first and second clips.
In the described arrangement, the first and second elongate members are unconnected and extend separately toward the heart valve, enabling the respective first and second clips to be positioned for approximation on separate leaflet portions before the locking mechanism couples and locks the clips together. The disclosure also describes configurations in which multiple clips can be placed sequentially on mitral or tricuspid leaflets, using a V-Clip arrangement that allows adjustable leaflet eversion/inversion degrees.
The jaws and engagement features are described with structural variations such as jaw geometry differences, teeth and cleats, and clasp versus hollow jaw configurations, including optional cloth or pericardial covering. An embodiment is described in which a V-Clip is used to rail-road an artificial chord, and the chord is secured and cut with a single catheter.
Claims Coverage
The partial content includes two independent claims: a system claim and a method claim. Across these independent claims, the inventive features include a transcatheter repair system with a sheath and two separately extendable clip assemblies, individually deployable ventricular and atrial jaws on each clip, and a locking mechanism that slides along elongate members to couple and lock the clips together (system), and a corresponding method of inserting a sheath, separately extending clip assemblies, clipping first and second leaflet portions by individually deploying the jaws, and optionally engaging a locking mechanism to secure the clips (method).
Sheath with lumen and separate elongate members
A system for transcatheter heart valve repair with a sheath defining a lumen, at least two clip assemblies, and first and second elongate members slidably disposed within the lumen and unconnected such that they are extendable out from the lumen toward the heart valve separately from each other.
Individually deployable ventricular and atrial jaws for leaflet approximation
Each clip assembly includes a clip having a ventricular jaw and an atrial jaw, wherein the ventricular jaw and the atrial jaw of each clip are each individually deployable to a respective position for approximation of a respective leaflet portion of the heart valve, with the first clip approximating a first leaflet portion and the second clip approximating a second leaflet portion.
Locking mechanism that slides along elongate members to couple and lock clips
A locking mechanism configured to slide along the first elongate member and the second elongate member and to couple and lock together the first and second clips.
Insert sheath into heart chamber and extend first and second clip assemblies
A method for heart valve repair comprising inserting a sheath into a chamber of a heart of a patient, where the sheath defines a lumen, providing at least two clip assemblies with first and second separately extendable elongate members and clips, and individually extending the first elongate member and first clip and separately extending the second elongate member and second clip from an end of the sheath toward the heart valve.
Clip first and second leaflet portions by individually deploying jaws
Clipping the first leaflet portion with the first clip by individually deploying the ventricular jaw and the atrial jaw such that the first leaflet portion is approximated between the ventricular jaw and the atrial jaw; and clipping the second leaflet portion with the second clip by individually deploying the ventricular jaw and the atrial jaw such that the second leaflet portion is approximated between the ventricular jaw and the atrial jaw.
The independent system claim is centered on a transcatheter repair architecture that combines separately extendable clip assemblies with individually deployable ventricular and atrial jaws on each clip and a locking mechanism that slides along elongate members to couple and lock the clips together. The independent method claim covers inserting the sheath into a heart chamber, separately extending first and second clip assemblies, clipping a first leaflet portion and a second leaflet portion by individually deploying each clip’s ventricular and atrial jaws, and engaging a locking mechanism to secure the clips.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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