Bi-directional Sheath System for Endovascular Access

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Solution Overview

Problem

Current vascular access methods for endovascular interventions are limited to single-lumen, unidirectional sheaths, which do not allow for simultaneous bi-directional access upstream and downstream from a single access site, increasing the risk of complications due to multiple access sites and procedures.

Innovation Solution

A bi-directional sheath system with an elongated cylindrical body and dual dilators (antegrade and retrograde) that enables access through a single access point, featuring a side lumen, intraluminal balloon assembly, and trapdoor mechanism for controlled fluid release and occlusion, allowing for both antegrade and retrograde access.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a single lumen, unidirectional sheath is used for vascular access, then the device structure is simple, but it cannot provide bi-directional access for simultaneous upstream and downstream interventions

Engineering Contradiction:
Improvebi-directional access capabilityVSAvoidsheath structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The sheath is divided into multiple lumens (first lumen for antegrade access, second lumen for retrograde access) within a single sheath body, allowing independent bidirectional pathways while maintaining overall structural integration. This segmentation enables simultaneous upstream and downstream interventions without requiring multiple separate access sites.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The sheath body serves multiple functions: it provides both antegrade and retrograde vascular access, houses multiple dilators, supports guide wires, and enables imaging and therapeutic interventions in both directions from a single access site. This multi-functionality eliminates the need for separate unidirectional sheaths or multiple access procedures.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If multiple vascular access sites are created to achieve bi-directional access, then bi-directional functionality is achieved, but the risk of complications increases

Engineering Contradiction:
Improvebi-directional access capabilityVSAvoidrisk of complications
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

Multiple access pathways (antegrade and retrograde) are merged into a single sheath structure that enters through one vascular access site. The first and second lumens both originate from the same access point, combining what would traditionally require separate puncture sites into one unified device, thereby reducing procedural risks.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The sheath acts as an intermediary structure that provides controlled access to both upstream and downstream vessels through a single puncture site. Rather than creating multiple direct access points to the vasculature, the sheath mediates all interventions through its multiple lumens, reducing the number of times the vessel wall must be penetrated.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Adaptability or versatility

If multiple separate procedures are performed to achieve bi-directional access, then comprehensive vascular access is achieved, but the procedure time and complexity increase

Engineering Contradiction:
Improvebi-directional access capabilityVSAvoidprocedure time
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

Both antegrade and retrograde access pathways are established simultaneously during the initial sheath insertion, rather than requiring sequential procedures. The dilators and lumens are pre-configured to enable both directions of access from the start, eliminating the need for separate procedural steps to create each access pathway.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20210346659A1Systems and methods for bi-directional endovascular access for diagnostic and therapeutic interventions
Publication Date: 2021.11.11 YALE UNIVERSITY
  • US20210346659A1 patent drawing
  • US20210346659A1 patent drawing
  • US20210346659A1 patent drawing

AI summary

The present invention relates to a sheath system that enables endovascular imaging and treatment of concomitant multiple lesions, both in antegrade and retrograde direction in a blood vessel. Further, the present invention relates to a method for using the sheath system enabling endovascular imaging and treatment of concomitant multiple lesions, both in antegrade and retrograde direction.