Retractable Needle Protractor for Transradial Access

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Solution Overview

Problem

Current interventional procedures, such as coronary angiography and angioplasty, face challenges with transfemoral access, particularly in patients with peripheral artery disease, abdominal aortic aneurysm, groin infection, or morbid obesity, due to high failure rates and vascular complications like groin hematoma, and the transradial approach is difficult due to smaller vessel sizes leading to overperforation risks.

Innovation Solution

A needle access device with a retractable needle tip and a transparent or translucent sheath that allows visualization of puncture through blood retrieval, featuring a protractor mechanism for controlled protrusion and retraction of the needle tip to prevent overperforation, along with a needle mechanism like a spring for facilitating movement, and optional sensors for automated control.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If transradial access is attempted with smaller needle size to match smaller vessel size, then vascular complications are reduced, but needle control precision deteriorates leading to overperforation risk

Engineering Contradiction:

Improvevascular complicationsVSAvoidneedle control precision

Core Design Contradiction:

Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The needle is designed with dynamic controllability through a protractor mechanism that allows the operator to adjust and control the needle's protrusion distance from the sheath. This dynamic adjustment capability enables precise control of needle penetration depth, preventing overperforation while maintaining safety in small vessels.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The patent replaces traditional mechanical needle control systems with a protractor-based angular measurement and control mechanism. This substitution allows for more precise control of needle insertion angle and depth, improving manufacturing precision and reducing overperforation risk while using smaller needles.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If needle protrusion distance is increased to ensure vessel puncture, then puncture reliability is improved, but overperforation risk increases

Engineering Contradiction:

Improvepuncture reliabilityVSAvoidoverperforation risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The protractor mechanism provides visual feedback through angular measurements that indicate needle protrusion distance. This feedback system allows the operator to monitor and control needle extension in real-time, ensuring sufficient protrusion for reliable puncture while preventing excessive protrusion that would cause overperforation.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent changes the control parameter from fixed needle length to variable angular measurement. By using a protractor scale that measures the angle of needle protrusion, the system allows dynamic adjustment of needle exposure, enabling optimization of protrusion distance for each specific procedure to balance reliability and safety.

Inventive Principle:

Principle #35Parameter changes

3Ease of operation

If transfemoral access route is used for easier vascular access, then ease of operation is improved, but vascular complications increase

Engineering Contradiction:

Improveease of vascular accessVSAvoidgroin hematoma

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a specialized needle-sheath-protractor system as an intermediary between the operator and the small radial artery. This intermediary system provides enhanced control, visualization, and precision for accessing small vessels, making transradial access as easy and safe as transfemoral access by mediating the challenges of working with smaller vessels.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Adaptability or versatility

If needle size is reduced to match small radial artery size, then adaptability to small vessels is improved, but needle strength deteriorates

Engineering Contradiction:

Improveadaptability to small vesselsVSAvoidneedle strength

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

The patent employs a nested structure where a small, strong needle is contained within a protective sheath. The needle can be extended from the sheath when needed while being protected when retracted. This nesting arrangement allows the use of thin, adaptable needles for small vessels while maintaining structural integrity through the sheath protection.

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS10219828B2Devices, systems, and methods for transradial access

Publication Date: 2019.03.05 DTHERAPEUTICS LLC

AI summary

Devices, systems, and methods for transradial access. In at least one embodiment of a device for providing access to a vessel or other luminal organ of the present disclosure, the device comprises a needle having a needle tip, a sheath positioned around at least part of the needle, the sheath defining an aperture at a distal sheath end, and a protractor in communication with the needle, whereby engagement of the protractor causes the needle tip to protract from the sheath, and whereby release of the protractor causes the needle tip to retract into the sheath.