Density Gradient Sealing Plug Radial Expansion Vascular Puncture

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Solution Overview

Problem

Current vascular closure devices face challenges in achieving a stable seal at tissue puncture sites, often resulting in prolonged bleeding and patient discomfort due to manual compression, and difficulties in properly seating the sealing plug, which can lead to incomplete closure.

Innovation Solution

A sealing plug with a density gradient and radial expansion capability, facilitated by slits on its surface, is used in conjunction with an anchor and anchor support, allowing for reliable and reproducible compression and deployment within the tissue tract to ensure effective sealing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If manual compression is applied at the puncture site to stop bleeding from the incision track, then bleeding is stopped, but patient soreness increases and additional time from medical personnel is required

Engineering Contradiction:
ImprovebleedingVSAvoidpatient comfort
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The sealing plug is designed to automatically expand and seal the incision track without requiring manual compression by medical personnel. The plug's self-expanding mechanism through radial force application eliminates the need for harmful manual compression, thereby stopping bleeding while avoiding patient soreness and reducing medical personnel time requirements.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces the manual mechanical compression system with an automated radial expansion mechanism. The sealing plug uses radial forces to expand and seal the track internally, substituting the harmful external manual compression with an internal self-expanding mechanical system that achieves hemostasis without patient discomfort.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Object-affected harmful factors

If manual compression is applied to stop bleeding, then bleeding is controlled, but the time spent by medical personnel increases

Engineering Contradiction:
ImprovebleedingVSAvoidmedical personnel time
Core Design Contradiction:
Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The sealing plug autonomously performs the sealing function through its self-expanding mechanism, eliminating the need for continuous manual compression by medical personnel. This self-service capability stops bleeding automatically while freeing medical personnel from time-consuming compression tasks.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent extracts the time-consuming manual compression step from the closure process by implementing an automated self-expanding sealing plug. The plug independently performs the hemostasis function, removing the harmful time loss for medical personnel while maintaining effective bleeding control.

Inventive Principle:
Principle #2Taking out (Extraction)

3Reliability

If a sealing plug is placed at the tissue puncture site, then the puncture site is sealed, but the incision track often continues to ooze blood from side vessels

Engineering Contradiction:
Improvepuncture site sealingVSAvoidtrack bleeding
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The sealing plug features a density gradient with a less dense intermediate region and denser end regions, creating local quality variations that enable radial expansion. This local density differentiation allows the plug to expand outward and seal side vessels along the incision track, addressing track bleeding while maintaining puncture site sealing reliability.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The sealing plug transitions from a compressed delivery state to an expanded deployed state through radial expansion. This dynamic transformation allows the plug to adapt to the tissue tract dimensions and seal side vessels effectively, preventing track bleeding while maintaining reliable puncture site closure.

Inventive Principle:
Principle #15Dynamics

4Ease of operation

If the sealing plug is compressed longitudinally to facilitate deployment, then the plug can be inserted, but the plug must expand radially to achieve proper sealing

Engineering Contradiction:
ImprovedeploymentVSAvoidsealing effectiveness
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The sealing plug employs a dynamic two-stage transformation: first compressed longitudinally for easy insertion through the delivery device, then expanded radially to achieve proper sealing. This dynamic shape change enables both ease of deployment and reliable sealing effectiveness.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The sealing plug utilizes parameter changes in its physical state, transitioning from a compressed longitudinal configuration during delivery to an expanded radial configuration during sealing. This parameter transformation allows the plug to be easily inserted while maintaining the capability to achieve effective sealing through radial expansion.

Inventive Principle:
Principle #35Parameter 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

The solution provides a stable and reproducible seal at tissue puncture sites, reducing bleeding and patient discomfort, while eliminating the need for manual compression and ensuring proper seating of the sealing plug, thus enhancing the efficiency of vascular procedures.

Implementation Method 1

a plurality of slits formed into an exterior surface of the sealing plug, the plurality of slits configured to facilitate radial expansion of the sealing plug in response to longitudinal compression of the sealing plug

Methodology Applied
Scientific EffectRadial expansion: Poisson's Effect

Data Source

PatentEP3162295B1Puncture closure apparatuses and sealing plugs
Publication Date: 2018.09.12 TERUMO PUERTO RICO L L C
  • EP3162295B1 patent drawingFigure 1~2
  • EP3162295B1 patent drawingFigure 3
  • EP3162295B1 patent drawingFigure 4

AI summary

A sealing plug (240) for use in a puncture closure apparatus, comprising: a first end region (242), a second end region (244), and an intermediate region (246) positioned between the first end region (242) and the second end region (244), wherein the intermediate region (246) comprises a material with a density less than a density of the first end region (242) and a density of the second end region (244).