Transradial Access Device with Protractor and Transparent Sheath

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Solution Overview

Problem

Current interventional procedures, such as coronary angiography and angioplasty, face challenges with patients having peripheral artery disease, abdominal aortic aneurysm, groin infection, or morbid obesity, due to difficulties in transradial access and a higher risk of vascular complications like groin hematoma, especially with the transfemoral route.

Innovation Solution

A needle access device with a sheath and protractor mechanism that allows visualization of puncture through blood retrieval and automatic retraction of the needle tip to prevent overperforation, featuring a transparent or translucent sheath for visual detection of blood entry and a mechanism for facilitated protraction and retraction of the needle tip.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If transradial access is performed using traditional needle techniques, then vascular access can be obtained, but the risk of overperforation increases due to the smaller size of radial vessels

Engineering Contradiction:

Improvesuccess rate of vascular accessVSAvoidoverperforation risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The needle tip is pre-loaded in a retracted position within the needle hub, and the protractor mechanism is prepared in advance to enable controlled protraction only when needed. This preliminary configuration prevents accidental overperforation while maintaining the ability to achieve proper puncture depth

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The transparent or translucent sheath provides real-time visual feedback by allowing the operator to observe blood flow into the sheath, indicating successful vessel puncture. This feedback mechanism enables the operator to stop needle advancement at the correct depth, preventing overperforation while ensuring reliable vascular access

Inventive Principle:

Principle #23Feedback

2Reliability

If the needle tip is advanced deeply to ensure vessel puncture, then access reliability improves, but the risk of overperforation and vascular complications increases

Engineering Contradiction:

Improvevessel puncture reliabilityVSAvoidvascular complications

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The transparent sheath acts as an intermediary between the needle tip and the operator's vision, allowing indirect observation of blood flow without requiring direct visualization of the needle tip position. This intermediary mechanism enables precise depth control while maintaining puncture reliability

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention replaces traditional mechanical depth-marking systems with an optical visualization system using the transparent sheath. Instead of relying on mechanical stops or depth markings, the operator uses visual feedback from blood flow through the sheath to determine optimal needle depth, reducing the risk of overperforation

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Device complexity

If a traditional opaque needle sheath is used, then the device structure is simple, but visualization of blood flow and puncture detection becomes difficult

Engineering Contradiction:

Improvesheath structure simplicityVSAvoidpuncture detection ease

Core Design Contradiction:

Device complexityVSDifficulty of detecting and measuring

Solution Approach 1:

The sheath material changes from opaque to transparent or translucent, fundamentally altering its optical properties. This change allows light to pass through the sheath, enabling the operator to visually detect blood flow and confirm puncture success without adding complex detection systems

Inventive Principle:

Principle #32Color changes

Solution Approach 2:

The transparent sheath enables self-visualization of the puncture process and blood flow without requiring external assistance or additional detection devices. The sheath itself provides the visualization function, eliminating the need for separate imaging systems or assistants

Inventive Principle:

Principle #25Self-service

4Ease of operation

If the needle tip remains exposed during the procedure, then manipulation flexibility is improved, but the risk of accidental overperforation and hematoma formation increases

Engineering Contradiction:

Improveneedle manipulation flexibilityVSAvoidhematoma risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The needle tip transitions from a static exposed state to a dynamically controllable state through the protractor mechanism. The needle can be protracted when manipulation flexibility is needed and retracted when safety is prioritized, creating a dynamic system that adapts to procedural requirements while minimizing hematoma risk

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS11464543B2Transradial access devices, systems, and methods

Publication Date: 2022.10.11 DTHERAPEUTICS LLC

AI summary

Transradial access devices, systems, and methods. An exemplary device of the present disclosure for providing access to a vessel or other luminal organ and to prevent overperforation of the same including a needle having a needle tip and at least one current element positioned thereon or embedded therein at or near the needle tip, a sheath positioned around at least part of the needle, and a protractor in communication with the needle, whereby engagement of the protractor causes the needle tip to protract from the sheath through the aperture, and whereby release of the protractor causes the needle tip to retract through the aperture into the sheath. Activation of the at least one current element can facilitate vasodilation of the vessel or other luminal organ.