Upstream Access Bi-Directional Sheath

Description:

Inventors:
Jeffrey P. Carpenter, MD – Professor of Surgery, Cooper University Health Care

Overview

A novel vascular access system designed to provide both antegrade and retrograde vessel access from a single insertion site using a balloon-anchored sheath and steerable U-turn catheter.

Clinical Need

Peripheral artery disease affects more than 12 million Americans and frequently requires complex vascular interventions. Existing unidirectional access systems can be limited by anatomy, may require multiple access sites, and often increase procedural complexity, costs, and complication risk. Long vascular sheaths can also obstruct vessel walls and restrict the length of artery available for treatment.

Solution

The Upstream Access Bi-Directional Sheath addresses these challenges with a balloon-anchored design and a steerable U-turn catheter. This system provides antegrade and retrograde access in a single procedure, reducing the need for additional access points and thus the risk of infection. It uses a balloon-anchor to secure the sheath within the vessel, reducing trauma and increasing treatable artery length. The device also enables precise, 360° wire placement using the steerable catheter with directional indicators. These functionalities serve to streamline procedural workflow.

Technology

The device includes two main components: the Balloon Anchored Sheath and the U-turn catheter. The inflatable balloon securely anchors the sheath to the vessel wall without obstructing blood flow. The short sheath length allows access to more arteries for treatment. The U-Turn Catheter features a curved, steerable tip for precise wire placement in any direction, and it also includes a marker on the hub to guide catheter rotation.

Figure 1. Demonstrates the functionality of the bi-directional sheath. (A) Progression from a basic flush port sheath to a sheath with an integrated inflatable balloon anchor (B) Depth and hub markers that are critical for user guidance, enhancing procedural efficiency (C) Demonstrates the ability of the standard curved tip of the U-turn catheter to adapt its shape for precise maneuverability.

Advantages

Antegrade and retrograde access through a single procedure
Eliminates need for secondary access sites
Reduces procedural risks and infection potential
Balloon anchoring minimizes vessel trauma and sheath migration
Provides access to a greater length of treatable artery
Streamlines procedural workflow by integrating multiple functions into one system