Prosthetic heart valve device, delivery system, interventional system and related method
Inventors
CLAPP, CHARLIE • Madrid, Gilbert
Assignees
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Publication Number
US-12226313-B2
Publication Date
2025-02-18
Expiration Date
Abstract
A prosthetic aortic valve device, delivery system, interventional system, and related method are disclosed. The device includes an inner frame having relative compressed and expanded configurations; leaflets connected to the inner frame and cooperating with each other to control opening and closing of the blood flow passage; and a positioning mechanism arranged in a circumferential direction of the inner frame, the positioning mechanism including a fixed end connected to the inner frame and a free end extending towards the inflow end, the positioning mechanism being configured to be switchable among a loaded configuration, a transition configuration, and a released configuration.
Core Innovation
A prosthetic heart valve device is provided in which an inner frame has a meshed cylindrical structure that is radially deformable and has opposite inflow and outflow ends, with an axially-through blood flow passage defined in the interior. Leaflets are connected to the inner frame and cooperate with each other to control opening and closing of the blood flow passage. A positioner is arranged in a circumferential direction of the inner frame and includes a fixed end connected to the inner frame and a free end extending towards the inflow end.
The positioner is switchable among a loaded configuration, a transition configuration, and a released configuration. In the loaded configuration, the inner frame is in the compressed configuration and the fixed end and free end of the positioner contact or are adjacent to the inner frame in a radial direction. In the transition configuration, the inner frame remains in the compressed configuration and the free end extends from a peripheral region to define a first receiving space between the free end and an outer wall of the inner frame for allowing entry of a native leaflet.
In the released configuration, the inner frame is expanded and a second receiving space is defined for clipping the native leaflet. For prosthetic aortic valve devices, the outflow end of the inner frame is flared in the expanded configuration, and a flared angle P4 relative to an axial direction is defined as 0 degrees <P4≤45 degrees. Additional structural refinements define guiding members arranged sequentially in the circumferential direction with each guiding member having a root and a wing aligned with respective leaflets, with the root located between commissure regions corresponding to coaptation portions of adjacent leaflets.
Claims Coverage
The provided claim set includes six independent claims. The claims center on a prosthetic heart valve/aortic valve device having a radially deformable meshed cylindrical inner frame with leaflets and a circumferential positioner switchable among loaded, transition, and released configurations defined by first and second receiving spaces for a native leaflet, with additional angle, guiding-member, frame-bar, and spacing-region limitations.
Switchable circumferential positioner defining receiving spaces with a flared outflow end
A prosthetic aortic valve device comprising a radially deformable meshed cylindrical inner frame with an axially-through blood flow passage and leaflets controlling opening and closing, and a circumferentially arranged positioner having a fixed end connected to the inner frame and a free end extending towards the inflow end, wherein the positioner is switchable among a loaded configuration, a transition configuration with a first receiving space for allowing entry of a native leaflet, and a released configuration with an expanded inner frame and a second receiving space for clipping the native leaflet, and wherein the outflow end is flared in the expanded configuration with flared angle P4 defined as 0 degrees <P4≤45 degrees.
Sequential guiding members with root and wing aligned to leaflets and positioned relative to commissure regions
A prosthetic heart valve device having a radially deformable meshed cylindrical inner frame with an axially-through blood flow passage and leaflets controlling opening and closing, and a circumferentially arranged positioner switchable among a loaded configuration, a transition configuration with a first receiving space for allowing entry of a native leaflet, and a released configuration with a second receiving space for clipping the native leaflet, wherein the positioner comprises guiding members arranged sequentially in the circumferential direction, each guiding member having a connection portion as a root and a portion extending from the root towards the inflow end as a wing, the guiding members being aligned with respective leaflets in the circumferential direction, wherein the inner frame has at least two commissure regions corresponding to coaptation portions of adjacent leaflets, and wherein the root of each guiding member is located between two commissure regions in the circumferential direction.
Wing angle relationship P1>P2 in transition and released configurations
A prosthetic heart valve device with a radially deformable meshed cylindrical inner frame with an axially-through blood flow passage and leaflets controlling opening and closing, and a circumferentially arranged positioner switchable among a loaded configuration, a transition configuration defining a first receiving space for allowing entry of a native leaflet, and a released configuration defining a second receiving space for clipping the native leaflet, wherein the positioner comprises guiding members arranged sequentially in the circumferential direction with each guiding member having a root connected to the inner frame and a wing extending from the root towards the inflow end, the guiding members aligned with respective leaflets, wherein an angle between the wing and an axis of the inner frame in the transition configuration is P1, an angle between the wing and the axis of the inner frame in the released configuration is P2, and P1 is greater than P2.
Root with twisting frame bars bound to the inner frame and connected to the wing
A prosthetic heart valve device with a radially deformable meshed cylindrical inner frame having an axially-through blood flow passage and leaflets controlling opening and closing, and a circumferentially arranged positioner switchable among a loaded configuration, a transition configuration defining a first receiving space for allowing entry of a native leaflet, and a released configuration defining a second receiving space for clipping the native leaflet, wherein the positioner comprises guiding members arranged sequentially with roots and wings aligned with respective leaflets, wherein the root comprises a first frame bar and a second frame bar that can be twisted about their own longitudinal axes relative to the inner frame, and wherein the first frame bar and the second frame bar are bound to the inner frame with one end of each bar spaced apart from the other bar and connected to the wing while the other ends are fixed to the inner frame at the outflow end.
Multi-bar frame structure with root frame bars and a wing extended by third and fourth frame bars, with twisting when switching
A prosthetic heart valve device with a radially deformable meshed cylindrical inner frame defining an axially-through blood flow passage and leaflets controlling opening and closing, and a circumferentially arranged positioner switchable among a loaded configuration, a transition configuration defining a first receiving space for allowing entry of a native leaflet, and a released configuration defining a second receiving space for clipping the native leaflet, wherein the positioner comprises guiding members arranged sequentially with roots and wings, wherein the root comprises a first frame bar and a second frame bar with one end of each bar connected to the wing and the other ends fixed to the inner frame, wherein the wing comprises adjacent the root a third frame bar and a fourth frame bar, the third frame bar being connected with the first frame bar and extending towards the inflow end, the fourth frame bar being connected with the second frame bar and extending towards the inflow end and intersecting with the third frame bar, wherein the first, second, third, and fourth frame bars form a frame structure, and wherein at least one of the four frame bars is configured to be twisted about its own longitudinal axis when the positioner is switched from the transition configuration to the released configuration.
Positioner avoiding a spacing region between commissure regions
A prosthetic heart valve device with a radially deformable meshed cylindrical inner frame having an axially-through blood flow passage and leaflets controlling opening and closing, and a circumferentially arranged positioner switchable among a loaded configuration, a transition configuration defining a first receiving space for allowing entry of a native leaflet, and a released configuration with an expanded inner frame and a second receiving space for clipping the native leaflet, wherein the inner frame has at least two commissure regions corresponding to coaptation portions of adjacent leaflets and provided sequentially in the circumferential direction, a spacing region defined between two adjacent commissure regions in an outer peripheral region of the inner frame, and the positioner avoids the spacing region.
The core claim coverage is directed to a prosthetic heart/aortic valve device that uses a radially deformable meshed cylindrical inner frame with leaflets and a circumferential positioner switchable among loaded, transition, and released configurations. The inventive scope is defined by first and second receiving spaces for a native leaflet, with further claim coverage requiring a flared outflow end defining P4 for aortic devices, and specifying guiding-member geometry and placement relative to commissure regions, including wing/root structures and comparative angle relationships P1>P2, multi-bar frame structures with twisting behavior, and positioner avoidance of a spacing region.
Stated Advantages
Documented Applications
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