Anchored dilator system and methods for same

Inventors

Sutton, Gregg • Olson, Charles • Ganske, Karl V.

Assignees

Surmodics Inc

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Publication Number

US-11980730-B2

Patent

Publication Date

2024-05-14

Expiration Date


Abstract

An anchored dilator includes a push tube having proximal and distal push tube portions. A dilator tip is coupled with the distal push tube portion and is configured for selectable coupling with a catheter. The dilator tip includes an anchor cuff having a cuff interface. The anchor cuff is configured to transition between a shuttle configuration having a shuttle profile and an anchored configuration having an anchored profile larger than the shuttle profile. A cuff operator assembly is configured to transition the anchor cuff between the anchored and shuttle configurations. The cuff operator assembly includes a cuff operator movably coupled with the dilator tip, and an operator shaft coupled with the cuff operator. The operator shaft extends toward the proximal push tube portion. Actuation of the cuff operator with the operator shaft transitions the anchor cuff between the shuttle configuration and the anchored configuration.

Core Innovation

The anchored dilator system includes a guide catheter having proximal and distal catheter end portions and a catheter lumen extending therebetween. An anchored dilator is received in the catheter lumen, where the anchored dilator includes a dilator tip having an anchor cuff and a push tube coupled with the dilator tip and extending toward the proximal catheter end portion. A cuff operator proximate the dilator tip and an operator shaft coupled with the cuff operator extend from the dilator tip toward the proximal catheter end portion.

The anchor cuff transitions between anchored and shuttle configurations to deploy and withdraw the dilator tip within the catheter lumen. In the anchored configuration, actuation of the cuff operator with the operator shaft deploys the anchor cuff into engagement with the distal catheter end portion, and the anchor cuff has an anchored profile equal to or greater than a lumen profile of the guide catheter. In the shuttle configuration, the anchor cuff is withdrawn and disengaged with the distal catheter end portion, and the anchor cuff has a shuttle profile smaller than a lumen profile of the guide catheter.

The system further includes transition features that conceal catheter edges and provide an anchored dilator transition at the dilator tip and guide catheter interface. The dilator tip and anchor cuff form a unitary composite assembly with the guide catheter when the dilator tip is anchored, and the transition between shuttle and anchored configurations is actuated by a cuff operator assembly including a movable cuff operator and an operator shaft.

Claims Coverage

The document provides three independent claims covering an anchored dilator system, an anchored dilator with selectable catheter coupling, and a method for using an anchored dilator system. Across these independent claims, the main inventive features include the anchor cuff transitioning between shuttle and anchored configurations, profile relationships between cuff and catheter lumen, and actuation of the transition via a cuff operator and operator shaft received in an operator cavity at the dilator tip.

Anchor cuff profile transitioning between shuttle and anchored configurations

The anchor cuff is configured to transition between anchored and shuttle configurations, where actuation deploys the anchor cuff into engagement with the distal catheter end portion with an anchored profile equal to or greater than a lumen profile of the guide catheter, and in the shuttle configuration the anchor cuff is withdrawn and disengaged with the distal catheter end portion with a shuttle profile smaller than a lumen profile of the guide catheter.

Actuation by cuff operator and operator shaft

Actuation of the cuff operator with the operator shaft deploys the anchor cuff into engagement with the distal catheter end portion in the anchored configuration, and the anchor cuff is withdrawn and disengaged in the shuttle configuration.

Operator cavity and cavity surface surrounding the operator cavity

The dilator tip includes a cavity surface surrounding an operator cavity, where the cuff operator is received in the operator cavity and an operator shaft coupled with the cuff operator extends toward the proximal push tube portion.

Movably coupled cuff operator assembly for transitioning the anchor cuff

A cuff operator assembly includes a cuff operator movably coupled with the dilator tip, and the actuation of the cuff operator with the operator shaft transitions the anchor cuff between the shuttle configuration and the anchored configuration.

Anchor cuff engaging an interior surface after shuttle-to-anchored transition

An anchored dilator tip is anchored with an anchor cuff by transitioning the anchor cuff from a shuttle configuration having a shuttle profile smaller than a lumen profile of the catheter to an anchored configuration having an anchored profile larger than the shuttle profile, with the anchored profile equal to or larger than the lumen profile of the catheter, and engaging the anchor cuff in the anchored configuration with the interior surface of the catheter.

Passing dilator tip and deploying anchor cuff through the catheter lumen

Passing a dilator having a dilator tip coupled with a push tube through a catheter lumen, then anchoring the dilator tip includes delivering the anchor cuff toward the distal catheter portion through the catheter lumen while the anchor cuff is in a shuttle configuration.

Overall, the independent claims center on a transitionable anchor cuff with explicit cuff-profile-to-lumen-profile relationships, actuation using a cuff operator and operator shaft, and engagement of the deployed anchor cuff with the catheter interior.

Stated Advantages

Conceals catheter edges.

Reduces trauma/razoring.

Supports delivery without an introducer sheath.

Documented Applications

Anchored dilator system for vascular access/navigation in combination with a guide catheter and vascular delivery and anchoring of a dilator tip using an anchor cuff transition.

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