Non-Invasive Sheath Securement Device for Vascular Access

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Solution Overview

Problem

Existing methods for securing vascular access sheaths during interventional medical procedures are inadequate, as they often result in accidental dislodgement due to the slippery coating, and existing solutions involving adhesives are inconvenient and compromised by blood exposure, which can lead to uncontrolled bleeding and trauma.

Innovation Solution

A non-invasive sheath securement device with a base and retention channels that securely hold the sheath sidearm without obstructing access, using adhesive or mechanical clamping to attach to the patient or drape, minimizing exposure to blood and allowing easy insertion and removal of the sheath.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If adhesive-backed devices are placed over or adjacent to the puncture site to secure the sheath, then sheath stability is improved, but the adhesive is compromised by blood exposure and becomes ineffective

Engineering Contradiction:

Improvesheath stabilityVSAvoidblood exposure to adhesive

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The adhesive is extracted from the puncture site area and placed on a base positioned away from the puncture site. The securement device includes a base with adhesive applied to its distal end, positioning the adhesive away from the puncture site where blood exposure would compromise its effectiveness. The sidearm retention channel remains functional while the adhesive is protected from blood.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The base acts as an intermediary between the adhesive and the puncture site. The adhesive is applied to the base rather than directly near the puncture site, and the base serves as a carrier that positions the adhesive in a location not exposed to blood while still enabling sheath securement through the sidearm retention channel.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Stability of the object's composition

If the sheath is secured tightly to prevent dislodgement, then sheath stability is improved, but access to the hub and sidearm is obstructed

Engineering Contradiction:

Improvesheath stabilityVSAvoidaccess to hub and sidearm

Core Design Contradiction:

Stability of the object's compositionVSEase of operation

Solution Approach 1:

The securement device is segmented into distinct functional zones: a base for positioning, a sidearm retention channel for securement, and an open hub area for access. The sidearm retention channel is positioned on the base such that it secures the sidearm while leaving the hub area completely open and accessible for blood sampling and other procedures.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different regions of the securement device have different properties: the base provides a stable platform, the sidearm retention channel provides localized securement of the sidearm, and the hub area remains open for access. This local differentiation allows simultaneous securement and access without compromise.

Inventive Principle:

Principle #3Local quality

3Stability of the object's composition

If adhesive is placed immediately adjacent to the puncture site for securement, then sheath stability is improved, but the risk of uncontrolled bleeding increases if the adhesive is compromised

Engineering Contradiction:

Improvesheath stabilityVSAvoiduncontrolled bleeding risk

Core Design Contradiction:

Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The adhesive is extracted from the immediate puncture site area and placed on the distal end of the base, which is positioned away from the puncture site. This extraction eliminates the risk that blood exposure to the adhesive would compromise securement and potentially lead to uncontrolled bleeding.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The design anticipates potential adhesive failure due to blood exposure by positioning the adhesive away from the puncture site before any blood exposure can occur. This preventive positioning ensures that even if blood contacts the device, the adhesive remains effective and continues to provide securement, preventing uncontrolled bleeding.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

4Stability of the object's composition

If existing securement devices are used to stabilize the sheath, then sheath stability is improved, but the slippery coating causes accidental dislodgement

Engineering Contradiction:

Improvesheath stabilityVSAvoidslippery coating effect

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The sidearm retention channel utilizes the sidearm itself as the securement mechanism. The sidearm is inserted into the retention channel and secured through friction and mechanical interlocking, without requiring additional adhesives or coatings. The channel's geometry provides inherent securement that is not dependent on the sheath's external coating properties.

Inventive Principle:

Principle #25Self-service

Data Source

PatentUS11285296B1Apparatus for a non-invasive interventional sheath securement device

Publication Date: 2022.03.29 BENZ PHILIP

AI summary

A non-invasive interventional sheath securement device is used by clinicians for removably securing a sidearm of a vascular access sheath for the purpose of preventing the sheath's movement through or out of a puncture site during its deployment in an interventional medical procedure.