Transcatheter heart valve prosthesis assembled inside heart chambers or blood vessels
Inventors
Iyer, Ramji • Anderson, Stephen • Johnson, Samuel Thomas
Assignees
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Publication Number
US-11701223-B2
Publication Date
2023-07-18
Expiration Date
Abstract
Some embodiments described herein include a heart valve replacement system that may be delivered to the targeted heart valve site via a delivery catheter. In some embodiments, the heart valve replacement system can assemble a valve device after the valve device is delivered to the heart. In some embodiments, heart valve replacement system includes two anterior flaps that are separate but overlap each other.
Core Innovation
A transcatheter tricuspid valve replacement system is described in which a non-tubular, helical/open-ended valve device is delivered via a delivery catheter and assembled into a tubular prosthesis after delivery inside the heart. The prosthetic tricuspid valve includes an occluder with valve leaflets arranged to allow flow through a main body from an inlet end to an outlet end, and the valve further includes first and second anterior flaps extending laterally from the outlet end of the main body in a same direction, and a posterior flap extending laterally from the outlet end in an opposite direction.
During implantation in a native tricuspid valve, the first and second anterior flaps extend into a right ventricular outflow tract and the anterior flaps overlap, including overlapping anterior flap portions in the same direction. A pacemaker lead pass-through between separate anterior flaps is described as an option, positioning the lead relative to the flap structures. A posterior flap distal tip is described with an angular conformance, using a distal tip portion with an axis at a non-zero angle, configured to conform with a posterior section of a right ventricular wall behind a posterior leaflet of the native tricuspid valve.
Deployment and assembly are described such that the non-tubular valve device is delivered into the heart and then assembled into a tubular structure upon delivery. The disclosure outlines delivery system configurations using a sheath catheter and nested, slidably disposed catheter lumens, with releasably attached components and removable sutures. It describes a deployment sequencing concept in which the posterior flap is expressed first, followed by the anterior flaps, and then the occluder, while maintaining anchoring and cuff features intended to avoid restricting the right coronary artery.
Claims Coverage
The independent claims cover implanting and treating tricuspid valve regurgitation using a prosthetic tricuspid valve having an occluder with leaflets and three lateral flaps, including first and second anterior flaps in a same direction and a posterior flap in an opposite direction. The inventive features focus on flap geometry and relationships, implantation relationships to the right ventricular outflow tract and native tricuspid valve opening, and positioning of a pre-existing pacemaker lead.
Main body occluder with valve leaflets allowing flow
A main body comprising an occluder having valve leaflets arranged to allow flow through the main body from an inlet end to an outlet end.
Two anterior flaps extend laterally in the same direction
A first anterior flap extending laterally from the outlet end of the main body; and a second anterior flap extending laterally from the outlet end of the main body in a same direction as the first anterior flap.
Opposing posterior flap direction relative to anterior flaps
A posterior flap extending laterally from the outlet end of the main body in an opposite direction as the first and second anterior flaps.
Anterior flap extension into right ventricular outflow tract
Implanting the prosthetic tricuspid valve in the native tricuspid valve such that the first and second anterior flaps each extend into a right ventricular outflow tract of the patient.
Filling and covering portions of native tricuspid valve opening
Implanting the prosthetic tricuspid valve in an opening defined by the native tricuspid valve, wherein a first portion of the opening defined by the native tricuspid valve is filled by the main body and a second portion of the opening defined by the native tricuspid valve is covered by the first and second anterior flaps.
Posterior flap covers a third portion of the opening
A third portion of the opening defined by the native tricuspid valve is covered by the posterior flap.
Pacemaker lead extends between anterior flaps during treatment
Implanting the prosthetic tricuspid valve in the native tricuspid valve such that the pacemaker lead extends between the first and second anterior flaps.
Anterior flap overlap
Portions of the first anterior flap and the second anterior flap overlap each other when the prosthetic tricuspid valve is implanted in the native tricuspid valve.
Anterior flaps wrap around pacemaker lead
First and second anterior flaps wrap around the pacemaker lead.
Non-zero angle posterior flap distal tip conforming to right ventricle wall
A distal tip portion of the posterior flap extends along an axis at a non-zero angle relative to a portion of the posterior flap extending directly from the main body, and the distal tip portion conforms with a posterior section of a right ventricular wall behind a posterior leaflet of the native tricuspid valve.
Across the independent claims, the prosthetic tricuspid valve is implanted so that the anterior flaps extend into the right ventricular outflow tract while the posterior flap extends in an opposite direction. Coverage also defines how portions of the native tricuspid valve opening are filled and covered by the main body, anterior flaps, and posterior flap, and, where present, how a pacemaker lead is positioned between the anterior flaps. Additional relationships include overlap and wrapping of the anterior flaps and a posterior flap distal tip with a non-zero angular axis configured to conform with a right ventricular wall behind a native posterior leaflet.
Stated Advantages
Smaller delivery profile via non-tubular delivery is stated.
Deployment sequencing is described to support flap expression order.
A posterior flap distal tip with angular conformance is described as reducing trauma.
Anchoring and cuff features are described to avoid restricting the right coronary artery.
Documented Applications
Implanting a prosthetic tricuspid valve in a patient to address a native tricuspid valve.
Treating tricuspid valve regurgitation of a native tricuspid valve in a patient having a pre-existing pacemaker lead extending therethrough.
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