All-in-one Arterial Access and Closure System

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Solution Overview

Problem

Current vascular closure solutions for high flow arteries, such as the carotid artery, are unreliable and time-consuming, posing risks of artery narrowing or clotting due to manual pressure methods, suture-mediated closure systems, or hemostasis sponges with high failure rates.

Innovation Solution

An all-in-one system comprising a first tube for creating a hole in a blood vessel and a second tube with a closure mechanism that surrounds the first tube, allowing for rapid and reliable closure of the vessel hole using a balloon inflation port, hemostatic foam, or flexible hinge mechanism.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual pressure method is used for closure, then closure can be achieved, but closure time is excessive (10-45 minutes)

Engineering Contradiction:
Improveclosure reliabilityVSAvoidclosure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The closure device is segmented into multiple functional components: an anchor element that embeds in the vessel wall, a compression element that applies pressure, and a delivery system. This segmentation allows each component to perform its specific function efficiently, achieving rapid closure without the prolonged manual pressure application required by traditional methods.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The closure device is pre-assembled and pre-loaded in the delivery system before reaching the target site. The anchor element is prepared in advance to be deployed, and the compression element is positioned ready to apply pressure. This preliminary preparation eliminates the need for time-consuming manual assembly and pressure application during the procedure.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If suture-mediated closure systems are used, then closure can be achieved, but artery narrowing risk increases

Engineering Contradiction:
Improveclosure reliabilityVSAvoidartery narrowing
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention extracts the suturing function entirely from the closure mechanism. Instead of using sutures to cinch the artery, the device uses an anchor element that embeds in the vessel wall and a compression element that applies localized pressure. This extraction eliminates the harmful cinching action that causes artery narrowing while maintaining reliable closure.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The compression element serves as an intermediary between the delivery system and the vessel wall. It applies controlled pressure to seal the puncture site without requiring direct suture manipulation of the artery. This intermediary mechanism achieves closure while preserving arterial patency and avoiding narrowing.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If hemostasis sponge is used for closure, then closure can be achieved, but failure rate is high (50%)

Engineering Contradiction:
Improveclosure simplicityVSAvoidclosure reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The closure device combines multiple materials with complementary properties: a biocompatible anchor element for secure attachment to the vessel wall, a hemostatic compression element for effective sealing, and a deliverable catheter structure. This composite construction integrates the advantages of different materials to achieve both ease of operation and high reliability, overcoming the limitations of single-material hemostasis sponges.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The closure device employs a nested structure where the compression element is contained within the delivery catheter, which in turn is delivered through the puncture site. The anchor element is nested within the compression element. This nested configuration allows for simple percutaneous delivery while ensuring reliable deployment and activation of the closure mechanism at the target site.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 rapid and fail-safe vascular access and closure in high flow arteries, reducing the risk of artery narrowing or clotting, and providing a reliable method for sealing the vessel hole, thus improving patient outcomes by facilitating faster revascularization.

Implementation Method 1

closure mechanism closes the opening or hole in the blood vessel formed by the first tube

Methodology Applied
Scientific EffectPressure: Pressure Increase

Implementation Method 2

a hemostatic foam may be injected through the first tube to aid the closure mechanism in sealing the opening or hole

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentUS11612730B1All-in-one arterial access and closure system (ACS)
Publication Date: 2023.03.28 LI MEI LIN M D MEDICAL MANAGEMENT CORP
  • US11612730B1 patent drawing
  • US11612730B1 patent drawing
  • US11612730B1 patent drawing

AI summary

The present invention features an all-in-one system for vascular access and closure. In particular, this invention features systems and methods for forming holes in blood vessels and rapidly closing these vessel holes using an all-in-one system. For example, an arterial access and closure port system is disclosed herein to provide fail-safe percutaneous entry and exit into any artery, particularly useful for high flow and high pressure arteries such as the carotid artery. The present invention is a single system that forms and closes vascular holes and can be used for percutaneous arterial access with interventional radiology, interventional cardiology, neuro-intervention, endovascular surgery, and endovascular neurosurgery.