Dilating Introducer Structure for Sheathless Vascular Access

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Solution Overview

Problem

Conventional percutaneous introduction of transvascular medical devices requires multiple steps and additional introducer sheaths, which can lead to complications such as air introduction and blood loss, especially with large devices, and increase procedural complexity and cost.

Innovation Solution

A dilating introducer device comprising a conical tube with a clip and suture mechanism that allows for simultaneous dilation and introduction of catheter-based medical devices without an additional introducer sheath, reducing the number of steps and minimizing complications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional percutaneous introduction method is used with multiple steps and additional introducer sheaths, then the medical device can be introduced into the blood vessel, but the procedural complexity increases and the risk of complications (air introduction and blood loss) increases

Engineering Contradiction:

Improveprocedural safetyVSAvoidprocedural complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the introducer sheath and dilator into a single integrated dilating introducer device. The conical tube serves both as the introducer sheath and contains the collapsible dilator within its lumen, eliminating the need for separate devices and reducing procedural steps while maintaining safety

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The dilating introducer device performs multiple functions: it acts as an introducer sheath for device delivery, contains a collapsible dilator for vascular dilation, and provides a sealed pathway throughout the procedure. This multi-functionality reduces the number of separate devices needed and minimizes procedural complexity

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Productivity

If conventional percutaneous introduction method is used with multiple steps and additional introducer sheaths, then the medical device can be introduced into the blood vessel, but the number of devices needed increases and cost increases

Engineering Contradiction:

Improveprocedural efficiencyVSAvoidnumber of devices

Core Design Contradiction:

ProductivityVSQuantity of substance

Solution Approach 1:

The patent merges the introducer sheath and dilator into a single integrated device. The conical tube serves as the introducer while containing the collapsible dilator within its lumen, reducing the total number of devices from multiple separate components to one unified system

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Reliability

If conventional percutaneous introduction method is used with additional introducer sheaths, then the medical device can be introduced into the blood vessel, but the risk of air introduction increases

Engineering Contradiction:

Improveprocedural safetyVSAvoidair introduction risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The dilating introducer device maintains a continuous sealed pathway throughout the procedure. The conical tube serves as both introducer and containment structure, while the collapsible dilator expands within the vessel lumen under controlled conditions, preventing air embolism that could occur with separate sheath changes

Inventive Principle:

Principle #6Universality (Multi-functionality)

4Reliability

If conventional percutaneous introduction method is used with additional introducer sheaths, then the medical device can be introduced into the blood vessel, but the risk of blood loss increases

Engineering Contradiction:

Improveprocedural safetyVSAvoidblood loss

Core Design Contradiction:

ReliabilityVSLoss of substance

Solution Approach 1:

The dilating introducer device maintains a continuous sealed pathway throughout the procedure. The conical tube serves as both introducer and containment structure, while the collapsible dilator expands within the vessel lumen under controlled conditions, preventing uncontrolled blood loss that could occur with separate sheath changes

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS12569338B2Dilating introducer devices and methods for vascular access

Publication Date: 2026.03.10 LAPLACE INTERVENTIONAL INC

AI summary

Devices used to deploy transvascular medical device systems and methods for using such devices are described in this document. For example, this document describes dilating introducer devices used for the percutaneous vascular deployment of catheter-based medical devices such as structural heart medical devices. Such dilating introducer devices can facilitate the percutaneous vascular deployment of catheter-based medical devices without an additional introducer sheath.