Percutaneous Vessel Closure Tube for Visual Hemostasis Detection

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Solution Overview

Problem

Current percutaneous closure techniques lack visual confirmation of successful hemostasis after vascular procedures, posing risks such as hematoma, airway obstruction, and critical blood loss due to the inability to detect leaks post-sheath removal.

Innovation Solution

A pressure relief device with a tube and visual indicator is used to monitor vessel closure, featuring a distal opening near the arteriotomy and a proximal opening outside the skin, allowing blood to drain and change color upon contact, indicating leaks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If percutaneous closure techniques are used without visual confirmation, then the procedure can be performed quickly and simply, but the ability to detect leaks and confirm hemostasis is lost

Engineering Contradiction:

Improveprocedure speedVSAvoidvisual confirmation of closure

Core Design Contradiction:

ProductivityVSLoss of information

Solution Approach 1:

The patent implements a feedback mechanism by placing a visual indicator at the distal end of the sheath that changes color or becomes visible when blood leaks through the closure site. This provides real-time feedback to the operator about the status of hemostasis, allowing confirmation of successful closure without extending procedure time significantly.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent introduces an intermediary visual indicator element that mediates between the closure site and the operator's observation. This indicator acts as a signal transmitter, converting the invisible blood leak into a visible signal that can be detected from outside the patient's body, thus bridging the information gap.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If manual compression or closure devices are used without pressure relief, then hemostasis can be achieved, but the risk of hematoma and tissue damage increases

Engineering Contradiction:

Improvehemostasis achievementVSAvoidhematoma and tissue damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent segments the pressure management function by providing a dedicated pressure relief pathway separate from the closure mechanism. The sheath maintains compression for hemostasis while a separate lumen or channel allows controlled pressure release, preventing hematoma formation without compromising closure reliability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent implements prior cushioning by designing the sheath with an integrated pressure relief mechanism that prevents excessive pressure buildup before it can cause damage. The relief pathway acts as a safety valve, cushioning against potential hematoma formation while maintaining the primary hemostasis function.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Measurement precision

If fluoroscopy is used to monitor closure, then leak detection is possible, but the procedure becomes more complex and time-consuming

Engineering Contradiction:

Improveleak detection accuracyVSAvoidmonitoring system complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical/radiological fluoroscopy system with a simple optical visual indicator system. Instead of using X-rays and contrast injection to detect leaks, the invention uses a visual indicator that changes appearance when exposed to blood, providing equivalent leak detection accuracy with minimal added complexity.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent utilizes color changes as the detection mechanism. The visual indicator is designed to change color or become visible when contacted by blood, providing a simple optical signal that replaces the need for complex fluoroscopic imaging while maintaining leak detection precision.

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

Provides visual confirmation of hemostasis, reducing the risk of complications by detecting leaks and facilitating timely intervention, thus ensuring effective vessel closure.

Implementation Method 1

The visual indicator can be a thin disc of material configured to change color upon contact with blood from the internal lumen

Methodology Applied

Scientific EffectColor change: Thermochromism

Implementation Method 2

In use, the proximal opening can be positioned external to the patient's skin forming a pressure gradient with the region near the closed arteriotomy

Methodology Applied

Scientific EffectPressure gradient: Pressure Gradient

Data Source

PatentUS12551655B2Detection and pressure relief for percutaneous closure of a vessel

Publication Date: 2026.02.17 BOSTON SCIENTIFIC SCIMED INC

AI summary

A pressure relief device for use in a percutaneous procedure, the device comprising a tube having a distal opening into an internal lumen and a proximal opening from the internal lumen, a length of the tube sized to position the distal opening near a closed arteriotomy in a vessel and the proximal opening remains external to a patient's skin. Related devices, kits, and methods are provided.