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Publication Number
US-11660218-B2
Publication Date
2023-05-30
Expiration Date
Abstract
A delivery device can provide sequential delivery of a plurality of intraluminal devices held in a compressed state on the delivery device. Delivery platforms on the delivery device can hold an intraluminal device in a compressed position and be positioned between pusher bands that may also be radiopaque markers. A post deployment dilation device can be included. The post deployment dilation device can be a plurality of expansion filaments, a bellows, or a balloon. An intravascular device deployment method can include allowing a self-expanding intravascular device to expand, aligning the post deployment dilation device under the intravascular device, and causing the post deployment dilation device to expand radially to push outward on the intravascular device.
Core Innovation
A delivery device is disclosed for deploying a self-expanding intraluminal device into a vessel from an inner shaft. The delivery device includes an outer sheath outward of the inner shaft that is movable relative to the inner shaft, with a pre-deployment position that covers the self-expanding intraluminal device and a delivery position in which the self-expanding intraluminal device is uncovered to release the self-expanding intraluminal device from the delivery device.
After deployment, the delivery device includes a post-deployment dilation device that applies radial force to an inner surface of the self-expanding intraluminal device. The post-deployment dilation device includes a balloon attached to the outer sheath and having a pre-actuated configuration with a pre-deployment diameter and an actuated configuration with a deployment diameter larger than the pre-deployment diameter. One or more inflation lumens contained in the outer sheath are in fluid communication with the balloon, and radiopaque markers include a distal radiopaque marker adjacent a distal end of the balloon and a proximal radiopaque marker adjacent a proximal end of the balloon.
A single helical filament is wrapped around the balloon in a pre-deployment configuration and is retractable into a helical filament lumen of the inner shaft to release the balloon in a deployment configuration in which the balloon is inflated. The post-deployment dilation device is configured to improve at least one of expansion of the self-expanding intraluminal device or seating of the self-expanding intraluminal device in the vessel. In some variations, the helical filament extends out of the helical filament lumen to wrap helically around the balloon and trap the balloon.
Claims Coverage
The partial content provides three independent claims (clm-00001, clm-00009, clm-00011), each covering a delivery device with an inner shaft, a movable outer sheath for uncovering a self-expanding intraluminal device, and a post-deployment balloon dilation mechanism with radiopaque markers and inflation lumens. Across the independent claims, the inventive features are centered on post-deployment balloon dilation using a pre-actuated-to-actuated diameter change and release of the balloon using a helical filament and helical filament lumen.
Movable sheath delivery of self-expanding intraluminal device
An outer sheath outward of an inner shaft and movable with respect to the inner shaft, wherein the outer sheath has a pre-deployment position in which the self-expanding intraluminal device is covered and a delivery position in which the self-expanding intraluminal device is uncovered to release the self-expanding intraluminal device from the delivery device.
Post-deployment balloon dilation applying radial force
A post-deployment dilation device comprising a balloon attached to the outer sheath, the balloon having a pre-actuated configuration with a pre-deployment diameter and an actuated configuration having a deployment diameter larger than the pre-deployment diameter, and wherein the post-deployment dilation device is configured to apply a radial force to an inner surface of the self-expanding intraluminal device after deployment of the self-expanding intraluminal device to improve at least one of expansion of the self-expanding intraluminal device or seating of the self-expanding intraluminal device in the vessel.
Inflation lumens in fluid communication with the balloon
One or more inflation lumens contained in the outer sheath and in fluid communication with the balloon.
Radiopaque marker positioning relative to balloon and sheath
A distal radiopaque marker adjacent a distal end of the balloon, wherein the distal radiopaque marker is spaced from a distal end of the outer sheath, and a proximal radiopaque marker adjacent a proximal end of the balloon.
Single helical filament retracted into a helical filament lumen to release the balloon
The inner shaft includes a helical filament lumen, the single helical filament configured to be retracted into the helical filament lumen to release the balloon of the post-deployment dilation device.
Helical filament wrapper/trapping configuration for balloon release
A helical filament wrapped around the balloon in a pre-deployment configuration and retractable into a helical filament lumen of the inner shaft to release the balloon in a deployment configuration in which the balloon is inflated, including a refinement in which the helical filament extends out of the helical filament lumen to wrap helically around the balloon and trap the balloon.
Across clm-00001, clm-00009, and clm-00011, the independent claims cover a catheter delivery device structure that uses a movable outer sheath to uncover and release a self-expanding intraluminal device, and a post-deployment balloon dilation mechanism that transitions from a pre-actuated to an actuated deployment diameter. The independent claims further require inflation lumens and radiopaque markers, and they define balloon release by a helical filament using a helical filament lumen, with optional wrapping/trapping functionality in the provided refinements.
Stated Advantages
Elimination or reduction of angioplasty balloon exchanges.
Procedural time and/or cost reduction.
Improved expansion and/or seating (apposition) of the self-expanding intraluminal device in the vessel.
Onboard dilation with wide working diameters.
Documented Applications
Deployment of a self-expanding intraluminal device into a vessel with post-deployment dilation to improve expansion or seating.
Alignment using marker-based alignment at a lesion, based on radiopaque markers.
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