Prosthetic valve. delivery apparatus and delivery method
Inventors
Lombardi, Fabien • Biadillah, Youssef • Hefti, Jean-Luc • Mantanus, Luc • Delaloye, Stephane
Assignees
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Publication Number
US-11793636-B2
Publication Date
2023-10-24
Expiration Date
Abstract
A delivery catheter for a prosthetic heart valve, the valve expandable from a collapsed condition for delivery to an expanded condition for implantation, the delivery catheter comprising: a holder for engaging the valve in the collapsed state of the valve, the holder configured such that (i) in response to a radial compression force exerted thereon, the holder has a first shape defining an exposed engagement region for engaging at least a portion of the collapsed prosthetic heart valve for restraining axial displacement of the prosthetic valve in at least one axial direction of the catheter, and (ii) in response to removal of the radial compression force upon expansion of the valve, at least a portion of the holder transitions to a second shape.
Core Innovation
The invention relates to transcatheter prosthetic heart valve delivery using a delivery catheter in which a prosthetic heart valve is expandable from a collapsed condition for delivery to an expanded condition for implantation. A holder engages the valve in the collapsed state and restrains axial displacement of the prosthetic heart valve when the valve is in the collapsed condition around the holder.
The delivery catheter includes a sheath translatable with respect to the holder between a first position and a second position. In the first position, the sheath surrounds at least a first portion of the holder, and in the second position the sheath does not surround the first portion while the sheath translates in a distal direction when moving from the first position to the second position. The catheter further includes an interface member positioned distal of the holder and biased towards a radially expanded condition for bridging a gap between the holder and the sheath when in the second position and/or defining a generally smooth interface surface between the holder and the sheath when in the second position.
In additional configurations, the holder has an engagement region comprising one or more male and/or female engagement regions for mating and/or interlocking engagement with the prosthetic heart valve, and the engagement region and at least one element defining a stop surface are relatively movable with respect to each other. The holder is configured so that, in response to a radial compression force exerted thereon, the holder has a first shape defining the engagement region, and in response to removal of the radial compression force upon expansion of the valve, at least a portion of the holder transitions to a second shape.
The delivery catheter may also include a deployable ramp for shrouding the engagement region and/or permitting axial sliding between the valve and the holder when the ramp is deployed, with transition to a non-deployed state in response to radial compression force applied to the holder and/or the deployable ramp.
Claims Coverage
The document contains three independent claims. The claims define a delivery catheter architecture around a holder, a distally translating sheath, and a biased interface member, with additional independent features regarding a deployable ramp and holder engagement structure including male/female engagement regions and holder shape transition.
Holder for engaging the valve in the collapsed state and restraining axial displacement
The delivery catheter comprises a holder for engaging the valve in the collapsed condition, with an engagement region for engaging at least a portion of the prosthetic heart valve for restraining axial displacement of the prosthetic heart valve in at least one axial direction of the catheter when the valve is in the collapsed condition around the holder.
Sheath translatable relative to the holder between first and second positions
The delivery catheter comprises a sheath translatable with respect to the holder between a first position in which the sheath surrounds at least a first portion of the holder, and a second position in which the sheath does not surround the first portion of the holder and wherein the sheath translates in a distal direction of the delivery catheter when moving from the first position to the second position.
Biased interface member bridging a gap and/or defining a smooth interface surface
The delivery catheter comprises an interface member biased towards a radially expanded condition for bridging a gap between the holder and the sheath when in the second position, and/or defining a generally smooth interface surface between the holder and the sheath when in the second position.
Deployable ramp for shrouding the engagement region and/or permitting axial sliding
The delivery catheter further comprises a deployable ramp for shrouding the engagement region and/or permitting axial sliding between the valve and the holder when the ramp is deployed, the ramp biased to a deployed state, and being transitioned to a non-deployed state in response to a radial compression force applied to the holder and/or the deployable ramp.
Male/female interlocking engagement regions with relatively movable engagement and stop surface elements
The engagement region of the holder comprises one or more male and/or female engagement regions for mating and/or interlocking engagement with the prosthetic heart valve, and the engagement region, and at least one element defining a stop surface associated with the engagement region, are relatively movable with respect to each other.
Holder shape transition in response to radial compression force and removal
The holder is configured such that in response to a radial compression force exerted thereon, the holder has a first shape defining the engagement region for engaging at least a portion of the collapsed prosthetic heart valve for restraining axial displacement of the prosthetic heart valve in at least one axial direction of the catheter, and in response to removal of the radial compression force upon expansion of the valve, at least a portion of the holder transitions to a second shape.
Across the independent claims, the core coverage is a delivery catheter where a holder engages the prosthetic heart valve in a collapsed condition to restrain axial displacement, a sheath translates distally away from the holder, and a biased interface member bridges gaps and/or forms a smooth interface surface in the second position. Additional claims add a deployable ramp transitioned between deployed and non-deployed states in response to radial compression force, and male/female interlocking engagement regions with relatively movable engagement/stop-surface elements and holder first-shape to second-shape transition driven by radial compression and its removal.
Stated Advantages
Documented Applications
No documented applications found
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