Delivery device and method of delivery

Inventors

Longo, Michael

Assignees

Intact Vascular LLC

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Publication Number

US-11304836-B2

Patent

Publication Date

2022-04-19

Expiration Date


Abstract

A delivery device can provide sequential delivery of a plurality of intraluminal devices or tacks held in a compressed state on the delivery device. Delivery platforms on the delivery device can hold a tack in a compressed position and be positioned between annular pusher bands that may also be radiopaque markers. The annular pusher bands can be made of wire or sections of material to increase flexibility while remaining radiopacity. 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. A tack deployment method can include allowing a self-expanding tack to expand, aligning the post deployment dilation device under the tack, and causing the post deployment dilation device to expand radial to push outward on the tack.

Core Innovation

The disclosure relates to an endoluminal delivery device for sequentially deploying multiple compressed tacks and/or intraluminal devices using multiple delivery platforms held between annular pusher bands. The device includes radiopaque alignment features that enable outboard imaging alignment, including radiopaque marker bands on an outer sheath and the tacks, and radiopaque rings for centering and alignment of elements under imaging.

The device provides a post-deployment dilation system that radially expands and seats an already-deployed self-expanding tack. The post-deployment dilation system includes selectable post-dilation expansion elements, including expansion filaments with controllable engagement via distal-fixed or proximal-fixed filament configurations with retractable or extendable actuation, bellows-based expandable frames, and inflatable inner-core balloons with optional helical filament confinement to reduce snagging during balloon retraction and deflation.

For targeted activation from the proximal end, radiopaque rings can center and align the post-dilation element beneath the tack. The described expansion filaments and delivery platform arrangements include polymer covering and configurations including recesses/pockets and radiopaque features integrated with the delivery platform and sheath structure, supporting controlled radial increase and decrease between pre-actuated/pre-deployment and actuated/deployment states.

Claims Coverage

The independent claims (clm-00001, clm-00004, and clm-00005) each define a delivery device that uses circumferential expansion filaments with pre-actuated and actuated positions to receive and control a self-expanding intraluminal device, with annular bands and a controlled proximal actuation member to radially increase and decrease filament diameter. Across the independent claims, the main inventive features are repeated with additional limitations in clm-00004 and material limitation in clm-00005.

Dual annular bands and delivery platform receiving a self-expanding intraluminal device

An inner shaft with a distal annular band fixed to the inner shaft and a proximal annular band fixed to the inner shaft, where the distal annular band and the proximal annular band have a second diameter larger than the first diameter, and a delivery platform between the proximal end of the distal annular band and the distal end of the proximal annular band configured to receive a self-expanding intraluminal device, with an outer sheath around the inner shaft and the delivery platform.

Pre-actuated and actuated expansion filament geometry with bends and longitudinal section

A plurality of expansion filaments circumferentially spaced around the inner shaft, each expansion filament having a pre-actuated position with a pre-deployment diameter and an actuated position with a deployment diameter larger than the pre-deployment diameter, the actuated position including a proximal bend, a distal bend, and a longitudinal section between the proximal bend and the distal bend that is parallel to the longitudinal axis of the inner shaft, wherein the longitudinal section of each expansion filament has a length greater than a length of the self-expanding endoluminal implant.

Polymer covering with expansion filament recesses and proximal actuation member

A polymer covering surrounding the plurality of expansion filaments, and a plurality of expansion filament recesses in the inner shaft where each expansion filament is in one expansion filament recess in the pre-actuated position, and an expansion control member at a proximal end of the delivery device with each expansion filament extending through the inner shaft to the expansion control member, wherein the expansion filaments are configured to be pushed distally to radially increase towards the actuated position and pulled proximally to radially decrease towards the pre-actuated position.

Filament distal placement relative to the delivery platform

In the delivery device, the plurality of expansion filaments is distal to the delivery platform.

Elastic polymer or elastic metal expansion filament material

The plurality of expansion filaments comprises at least one of an elastic polymer or an elastic metal.

Across the independent claims, the inventive concept is a delivery device using a delivery platform for a self-expanding intraluminal device combined with circumferential expansion filaments that transition between pre-actuated and actuated larger-diameter states. The filament transition is defined by specific proximal and distal bends and a longitudinal section longer than the implant length, with polymer covering and filament recesses, and is controlled by an expansion control member that pushes filaments distally to radially increase and pulls them proximally to radially decrease. Additional independent limitations specify distal placement of the filaments relative to the delivery platform and restrict filament materials to at least one of an elastic polymer or an elastic metal.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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