Medical Device Support Spine for Tortuous Lumen Navigation

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Solution Overview

Problem

Existing medical devices face challenges in maintaining flexibility and structural integrity while traversing tortuous body lumens, particularly due to cuts in the sidewall which reduce strength and increase the risk of breaking, and they often obstruct fluid flow or energy delivery.

Innovation Solution

A medical device with a flexible elongate member and a support spine that is affixed to the distal end within the lumen, providing support to the sidewall and distributing bending stress, while maintaining unobstructed fluid flow and energy delivery capabilities.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If cuts are made in the sidewall to increase flexibility, then the device can navigate tortuous body lumens more easily, but the strength of the sidewall is reduced and the risk of breaking increases

Engineering Contradiction:
ImproveflexibilityVSAvoidsidewall strength
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The sidewall is segmented by introducing cuts at multiple locations around the circumference, creating a segmented structure that allows flexibility while maintaining overall integrity through the uncut portions and support spine

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device uses a composite structure combining the elongate member material with a support spine of different material properties (stiffer, more flexible depending on embodiment), creating a composite that achieves both flexibility and strength

Inventive Principle:
Principle #40Composite materials

2Strength

If a support spine is added to provide structural support, then the device can maintain its shape and reduce breaking risk, but the lumen may be obstructed and fluid flow may be compromised

Engineering Contradiction:
Improvestructural integrityVSAvoidfluid flow
Core Design Contradiction:
StrengthVSQuantity of substance

Solution Approach 1:

The support spine is positioned specifically in the distal portion of the lumen where it provides maximum structural support while minimizing obstruction to fluid flow in the proximal portion, creating local quality variations in the device structure

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The support spine extends proximally from the distal end within the lumen, utilizing the longitudinal dimension to provide support while leaving the proximal lumen unobstructed for fluid flow

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Ease of operation

If the elongate member is made more flexible to traverse tortuous lumens, then navigation is easier, but the device may kink or break more easily during manipulation

Engineering Contradiction:
ImproveflexibilityVSAvoidresistance to kinking and breaking
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The device has varying degrees of flexibility along its length, with the distal portion being more flexible for navigation and the proximal portion being stiffer for manipulation resistance, creating a dynamic flexibility profile

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The support spine is pre-formed with a specific configuration that provides inherent resistance to kinking and breaking before the device is subjected to manipulation forces during use

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20250318869A1Medical device having a support structure
Publication Date: 2025.10.16 BOSTON SCI MEDICAL DEVICE LTD
  • US20250318869A1 patent drawing
  • US20250318869A1 patent drawing
  • US20250318869A1 patent drawing

AI summary

Embodiments of medical devices and methods are disclosed. The medical devices typically comprise a flexible elongate member defining a lumen, and a support spine affixed to the distal end and extending proximally therefrom within the elongate member lumen. In some embodiments, the support spine is pre-shaped such that the support spine biases the distal region of the elongate member to adopt a straight configuration, or the support spine biases at least a portion of the distal region of the elongate member to adopt a curved shape to form a curved portion. Some embodiments include apertures at or near the distal end for enabling fluid communication between the lumen and the outside environment. In some embodiments, the support wire extends proximally from the distal end within a distal portion of the lumen such that a proximal portion of the lumen is substantially unobstructed.