Vessel Access Sheath With Blood-Flow Depth Indication and Sealing

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Solution Overview

Problem

Existing sheaths used in percutaneous interventions lack a reliable method to determine sufficient penetration depth, leading to potential blood flow disturbances and thrombosis due to improper insertion depth.

Innovation Solution

A sheath with a through channel that allows blood to flow to the proximal end, indicating sufficient insertion depth, and an expansion device to adjust the outer diameter at the vessel aperture without further insertion, ensuring a fully sealed access.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the sheath is inserted deeper into the vessel to ensure sealed access, then sealing reliability is improved, but blood flow disturbances and thrombosis risk increase

Engineering Contradiction:
Improvesealing reliabilityVSAvoidblood flow disturbances
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent implements a visual feedback mechanism through a window or indicator on the sheath that allows the operator to directly observe the relationship between the sheath tip and the vessel wall during insertion. This real-time visual feedback enables precise control of insertion depth, ensuring the sheath is inserted sufficiently to seal the vessel aperture while preventing over-insertion that would cause blood flow disturbances or thrombosis.

Inventive Principle:
Principle #23Feedback

2Reliability

If the sheath outer diameter is increased to improve sealing, then sealing reliability is improved, but insertion difficulty and vessel trauma increase

Engineering Contradiction:
Improvesealing reliabilityVSAvoidinsertion difficulty
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent employs a dynamic, multi-stage dilation system where the sheath is introduced in a compressed or collapsed state to minimize insertion trauma, and then progressively dilated to the required outer diameter once positioned correctly. This dynamic approach allows the sheath to achieve the necessary sealing diameter without the complications of forcing a large-diameter sheath through the vessel wall in one step.

Inventive Principle:
Principle #15Dynamics

3Measurement precision

If the sheath structure is made more complex to enable depth control, then insertion precision is improved, but device complexity increases

Engineering Contradiction:
Improveinsertion depth precisionVSAvoidsheath structure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent utilizes visual indicators such as colored bands, radiopaque markers, or contrasting materials on the sheath surface that provide immediate visual feedback about insertion depth. These visual cues allow the operator to accurately determine when the sheath has reached the appropriate depth without requiring complex mechanical measurement systems, thereby maintaining simplicity while achieving precise depth control.

Inventive Principle:
Principle #32Color changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables reliable depth recognition and minimizes blood flow disturbances by preventing over-insertion, while maintaining a fully sealed vessel access with adjustable diameter for different patient scenarios.

Implementation Method 1

The through channel is adapted to conduct blood from the vessel to the proximal end of the sheath

Methodology Applied
Scientific EffectBlood flow conduction:

Implementation Method 2

the outer diameter of the sheath is increased as needed in the region of the vessel aperture through actuation of the expansion device of the sheath

Methodology Applied
Scientific EffectMechanical expansion:

Data Source

PatentUS12485261B2Sheath for sealed access to a vessel
Publication Date: 2025.12.02 ABIOMED EUROPE GMBH
  • US12485261B2 patent drawing
  • US12485261B2 patent drawing

AI summary

A sheath for producing a fully sealed access to the interior of a vessel of an animal or human body comprises a base sheath having a tubular body defining a pass-through channel. The base sheath is adapted to be inserted into the vessel through a vessel aperture. A wall of the tubular body of the base sheath has a through channel. This channel extends in the wall from the distal end towards the proximal end. The channel can be present separately from the pass-through channel of the base sheath or can form a sideways extension of the pass-through channel, at least at the distal end. Such through channel is adapted to conduct blood from the vessel to the proximal end of the sheath when the sheath has been inserted into a vessel.