Prosthetic heart valves
Inventors
Askegaard, Gunnar Paul • Schneider, Lucas Tradd • Iyer, Ramji
Assignees
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Publication Number
US-11918460-B2
Publication Date
2024-03-05
Expiration Date
Abstract
Prosthetic heart valves may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valve includes structural features that securely anchor the prosthetic heart valve to the anatomy at the site of the native heart valve. Such structural features can provide robust migration resistance. In addition, the prosthetic heart valves can include structural features that improve sealing between the prosthetic valve and native valve anatomy to mitigate paravalvular leakage. In particular implementations, the prosthetic heart valves occupy a small delivery profile, thereby facilitating a smaller delivery catheter system for advancement to the heart. Some delivery catheter systems can include a curved inner catheter to facilitate deployment of the prosthetic heart valve to a native tricuspid valve site via a superior vena cava or inferior vena cava.
Core Innovation
The invention relates to a prosthetic heart valve, including a valve deployment system and a prosthetic tricuspid valve. The prosthetic heart valve includes a frame member with an inflow end portion comprised of first cells and an outflow end portion comprised of second cells, and an occluder extending between the inflow end and outflow end portions with valve leaflets attached to the frame member in an arrangement that allows blood flow through the occluder from the inflow end portion toward the outflow end portion along a central axis and prevents blood flow in the opposite direction along the same central axis.
The prosthetic valve further includes a first anterior flap extending from the outflow end portion in a first direction transverse to the central axis, and a second anterior flap extending from the outflow end portion in the first direction. The first cells are smaller than the second cells, and the anterior flaps define open spaces that are larger than open spaces defined by the first cells and larger than open spaces defined by the second cells. In some embodiments, the valve also includes a posterior flap extending from the outflow end portion in a second direction opposite the first direction, where an open space defined by the posterior flap is larger than open spaces defined by the first cells and larger than open spaces defined by the second cells.
The deployment system is described as nested catheters that support delivery and deployment of a prosthetic heart valve. The system includes an outer sheath catheter defining a first lumen, a middle deflectable catheter slidably disposed in the first lumen and defining a second lumen, and an inner control catheter slidably disposed in the second lumen with one or more control wires that configure the inner control catheter to releasably couple with the prosthetic heart valve.
The inner control catheter includes a distal end portion that elastically transitions to a naturally curved configuration when the inner control catheter converts from being radially constrained to being radially unconstrained, and the naturally curved distal end portion defines an interior angle of less than 135 degrees. The middle deflectable catheter includes a selectively deflectable distal end portion having at least one plane of deflection.
Claims Coverage
The partial content includes three independent claims: a deployment system claim and two prosthetic heart valve claims that share similar core structural relationships. Across these independent claims, the inventive features focus on nested catheter deployment with a naturally curved, elastically transitioning distal end portion and defined interior angle, and on a prosthetic valve frame with inflow/outflow cells of different size plus an occluder configured for one-way flow, together with anterior and posterior flap structures defining comparatively larger open spaces.
Nested catheter deployment with naturally curved elastically transitioning distal end
A prosthetic heart valve deployment system comprising an outer sheath catheter defining a first lumen, a middle deflectable catheter slidably disposed in the first lumen and defining a second lumen with a selectively deflectable distal end portion having at least one plane of deflection, and an inner control catheter slidably disposed in the second lumen including one or more control wires that configure the inner control catheter to releasably couple with a prosthetic heart valve, wherein the inner control catheter includes a distal end portion that elastically transitions to a naturally curved configuration when the inner control catheter converts from being radially constrained to being radially unconstrained, and wherein the distal end portion defines an interior angle of less than 135 degrees when in the naturally curved configuration.
One-way occluder with inflow/outflow cells and anterior flaps defining larger open spaces
A prosthetic heart valve comprising a frame member including an inflow end portion comprised of first cells and an outflow end portion comprised of second cells, an occluder extending between the inflow end and outflow end portions and comprising valve leaflets attached to the frame member that allows blood flow through the occluder from the inflow end portion toward the outflow end portion along a central axis and prevents blood flow in the opposite direction, a first anterior flap extending from the outflow end portion in a first direction transverse to the central axis, and a second anterior flap extending from the outflow end portion in the first direction, wherein the first cells are smaller than the second cells, and wherein the first and second anterior flaps define open spaces that are larger than open spaces defined by the first cells and larger than open spaces defined by the second cells.
One-way occluder with inflow/outflow cells and posterior open-space expansion
A prosthetic heart valve comprising a frame member including an inflow end portion comprised of first cells and an outflow end portion comprised of second cells, an occluder extending between the inflow end and outflow end portions and comprising valve leaflets attached to the frame member that allows blood flow through the occluder from the inflow end portion toward the outflow end portion along a central axis and prevents blood flow in the opposite direction, a first anterior flap extending from the outflow end portion in a first direction transverse to the central axis, a second anterior flap extending from the outflow end portion in the first direction, and a posterior flap extending from the outflow end portion in a second direction opposite of the first direction, wherein the first cells are smaller than the second cells, and wherein an open space defined by the posterior flap is larger than open spaces defined by the first cells and larger than open spaces defined by the second cells.
Overall, the independent claims cover a deployment system with nested catheters where the inner control catheter transitions to a naturally curved configuration with an interior angle of less than 135 degrees, and prosthetic heart valve structures that create one-way blood flow using an occluder with valve leaflets attached to a frame while using smaller inflow cells than outflow cells and using anterior and optionally posterior flaps to define open spaces larger than cell-defined open spaces.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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