Dilator Centering Device for Sheath Hub Alignment

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Solution Overview

Problem

Current medical instruments, such as sheath assemblies, face issues with instrument integrity during vascular access procedures, leading to potential tissue trauma, contamination, and fluid leakage due to malfunctioning or damaged parts, particularly with rubber valves prone to tearing during dilator insertion.

Innovation Solution

A dilator centering device with a lumen that centers the dilator shaft within the sheath hub, equipped with a releasable locking mechanism and various seal designs like funnel, spiral funnel, or hinged flap seals to prevent damage and leakage, ensuring precise alignment and secure attachment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a dilator is inserted through a sheath hub with rubber valves, then vascular access can be achieved, but the rubber valves are prone to tearing and instrument integrity is compromised

Engineering Contradiction:
Improveinstrument integrityVSAvoidvalve tearing
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A dilator centering device is introduced as an intermediary component between the dilator and the sheath hub. This centering device includes a lumen that guides and centers the dilator shaft, preventing direct contact between the dilator and the rubber valves in the sheath hub, thereby preventing valve tearing while maintaining instrument integrity

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system is divided into separate functional components: the sheath hub with valves, the dilator centering device with lumen, and the dilator. This segmentation allows the dilator to be guided through the centering device without directly interacting with the vulnerable rubber valves, reducing the risk of tearing

Inventive Principle:
Principle #1Segmentation

2Ease of operation

If the dilator shaft is inserted directly into the sheath hub, then the procedure is simple, but precise alignment and centering are difficult to achieve

Engineering Contradiction:
Improveinsertion simplicityVSAvoidshaft centering accuracy
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The dilator centering device serves as a mediator that provides a structured pathway through its lumen. This lumen guides the dilator shaft into precise alignment with the sheath hub center, achieving accurate centering while maintaining operational simplicity through a straightforward insertion motion

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The dilator centering device is pre-assembled with the sheath hub before the dilator insertion. This preliminary assembly ensures that the dilator shaft will be automatically centered as it passes through the pre-positioned lumen, eliminating the need for manual alignment adjustments during insertion

Inventive Principle:
Principle #10Preliminary action

3Stability of the object's composition

If a locking mechanism is added to secure the dilator to the sheath hub, then instrument stability is improved, but device complexity increases

Engineering Contradiction:
Improvedilator-sheath connection stabilityVSAvoidlocking mechanism complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The locking mechanism is designed to be dynamically activated during the insertion process. As the dilator shaft is pushed through the centering device, it automatically engages with the locking mechanism, providing stable connection without requiring complex manual operations or additional components

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The locking mechanism is designed to self-engage and self-lock during the insertion process. The dilator shaft itself activates the locking action as it passes through the centering device, eliminating the need for separate locking operations or complex mechanisms, thereby providing stability with minimal added complexity

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS9566413B2Dilator centering device and assemblies
Publication Date: 2017.02.14 TERUMO MEDICAL CORP
  • US9566413B2 patent drawing
  • US9566413B2 patent drawing
  • US9566413B2 patent drawing

AI summary

The present technology is directed to a dilator centering device and assemblies and methods using same. In particular, a dilator centering device in accordance with the disclosed technology can be used with a sheath hub assembly. In one embodiment, a dilator centering device includes a lumen capable of receiving a dilator shaft and centering a dilator shaft with respect to the sheath hub as the dilator shaft enters the sheath hub. In one embodiment, the dilator centering device can be attached to the sheath hub during manufacturing or it can be attached at the use site. In one embodiment, the dilator centering device can be integrated with and non-removable from the sheath hub. The embodiments disclosed herein are illustrative and do not limit the scope and spirit of the disclosed technology.