Medical Implant Delivery via Thin Guide Wire Navigation

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Solution Overview

Problem

Existing catheter-based systems for delivering cardiac implants into the annulus of heart valves face challenges such as thick catheters that are difficult to maneuver, risk of catheter sticking due to memory properties, and limited time for accurate placement before temperature activation.

Innovation Solution

A medical arrangement using a thin guide wire to guide a hollow tubular implant with loop-shaped structures, where the guide wire is introduced first to navigate through narrow channels and the implant follows, allowing for precise and safe delivery without memory properties, and optional introducers to facilitate navigation and positioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a thick catheter-based system is used to deliver the implant, then the implant can be delivered through the catheter, but the catheter is difficult to maneuver and has limited flexibility in narrow channels

Engineering Contradiction:
Improvecatheter structural strengthVSAvoidcatheter maneuverability
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The delivery system is divided into multiple components: a thin guide wire for navigation, a delivery catheter for implant containment, and a deployment mechanism. This segmentation allows each component to be optimized independently - the guide wire can be extremely thin for easy navigation while the delivery catheter provides structural support when needed.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A thin guide wire is introduced as an intermediary element to facilitate navigation through narrow channels. The guide wire precedes the delivery catheter and implant, creating a pathway that the larger components can follow. This intermediary solves the contradiction by providing a thin, maneuverable element that guides the thicker delivery components.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Stability of the object's composition

If a catheter with memory properties is used, then the catheter can maintain its shape for stable delivery, but it risks sticking to the vessel walls due to temperature activation

Engineering Contradiction:
Improvecatheter shape stabilityVSAvoidcatheter sticking risk
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The delivery catheter is pre-formed with the desired curved shape before introduction. This preliminary shaping allows the catheter to navigate anatomical curves without relying on temperature-dependent memory effects during delivery, eliminating the sticking risk while maintaining shape stability through mechanical pre-forming.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The catheter design transitions from using temperature-dependent memory properties to using mechanically pre-formed shapes. This parameter change eliminates the harmful temperature activation effect while preserving the beneficial shape stability through a different mechanism - physical pre-forming rather than thermal memory.

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If multiple catheters with curve portions are used to reach the target position, then the implant can be delivered to the anatomical target position, but the system complexity increases and delivery time is extended

Engineering Contradiction:
Improveimplant positioning accuracyVSAvoidcatheter system complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The delivery catheter is designed as a multi-functional component that combines navigation, implant containment, and deployment functions. It can be introduced through standard vascular access and navigated to the target position using its pre-formed curves, then serves as the delivery vehicle for the implant. This universality reduces the need for multiple specialized catheters.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The delivery catheter is pre-formed with appropriate curves to match the anatomical pathway to the target position. This preliminary configuration allows it to navigate complex anatomy in a single introduction, eliminating the need for sequential catheter exchanges or multiple curved catheters that would increase system complexity and procedure time.

Inventive Principle:
Principle #10Preliminary action

4Ease of operation

If a thin guide wire is used instead of a thick catheter, then the guide wire can easily navigate narrow channels, but the implant must follow the guide wire which requires precise tracking

Engineering Contradiction:
Improveguide wire navigabilityVSAvoidimplant tracking accuracy
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The thin guide wire serves as an intermediary that creates a stable track or pathway through the narrow channels. The delivery catheter then follows this pre-established track, and the implant follows the delivery catheter. This intermediary approach ensures that each component has a clear, stable path to follow, maintaining tracking accuracy despite the thinness of the guide wire.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The guide wire is introduced first to establish the pathway before the delivery catheter and implant are introduced. This preliminary action creates a stable reference track that subsequent components can follow precisely, ensuring accurate implant positioning despite the guide wire's thin dimensions.

Inventive Principle:
Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables easy, fast, and accurate implant delivery with reduced stress on the anatomical target, minimizing the risk of catheter sticking and allowing for precise adjustment and secure attachment of the implant.

Implementation Method 1

The guide wire is at least partially formed from a shape memory material operable to assume an activated shape and an inactivated shape, wherein in said inactivated shape the guide wire is configured to be delivered in a straightened configuration through said first introducer and in said activated shape the guide wire is configured to take said at least first curved shape within or near the anatomical target position

Methodology Applied
Scientific EffectShape memory material: Shape Memory Alloy

Implementation Method 2

The implant is configured to follow said guide wire and said first curved shape of the guide wire into said anatomical target position

Methodology Applied
Scientific EffectFriction: Friction

Data Source

PatentEP3763328B1A medical arrangement for introducing an object into an anatomical target position
Publication Date: 2024.08.21 HVR CARDIO OY
  • EP3763328B1 patent drawingFigure 1A~2
  • EP3763328B1 patent drawingFigure 3~6
  • EP3763328B1 patent drawingFigure 7~10

AI summary

A medical arrangement (100) for introducing an implant (110) into an anatomical target position (20) comprises a first introducer (101) and a guide wire (103). The guide wire (103) is configured to be introduced before the implant (110) into or towards the anatomical target position (20). The implant (110) is configured to be delivered along the guide wire (103) into the anatomical target position (20). The guide wire (110) is configured to be retracted after the implant (110) has been introduced into said anatomical target position (20) so that said object (110) essentially maintains the shape taken when introduced into said anatomical target position (20).