Flexible Tissue Modification Device with Segmented Rungs

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Solution Overview

Problem

Current minimally invasive surgical techniques for spinal stenosis are invasive, cause significant tissue damage, and lead to long-term morbidity due to the need for spinal fusion, which reduces spinal mobility and increases stress on adjacent segments, and existing tools struggle to effectively modify tissues like ligamentum flavum and bone in confined spaces without direct visualization.

Innovation Solution

Development of flexible tissue modification devices with rungs and spacers that are flexibly connected, allowing for precise cutting and tissue collection, which can be used in a guidewire-based system for bimanual tensioning to modify tissues like ligamentum flavum and bone within the spinal foramen, reducing the need for extensive incisions and fusion procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Illumination intensity

If traditional open surgical techniques are used for spinal stenosis, then complete visualization and access to tissue is achieved, but tissue damage increases and recovery time extends

Engineering Contradiction:
ImprovevisualizationVSAvoidtissue damage
Core Design Contradiction:
Illumination intensityVSObject-affected harmful factors

Solution Approach 1:

The surgical system is segmented into separate components: a guidewire for access, a flexible delivery catheter for transport, and a separate tissue modification device with cutting elements. This segmentation allows minimally invasive delivery while maintaining effective tissue modification capability, reducing tissue damage compared to open surgery.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A flexible delivery catheter acts as an intermediary device, allowing the tissue modification device to be delivered through a small puncture site rather than requiring large open incisions. This intermediary enables minimally invasive access while still delivering the full functionality needed for tissue modification.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If small-diameter minimally invasive tools are used in confined spinal spaces, then tissue damage is reduced, but the ability to effectively cut and contour bone and ligamentous tissue is limited

Engineering Contradiction:
Improvetissue damageVSAvoidtissue modification capability
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The tissue modification device incorporates a flexible distal portion with rungs that can dynamically adjust their configuration. The rungs can be positioned to engage with tissue and provide stable cutting surfaces, while the flexible connector allows the device to adapt to curved anatomical structures within the confined spinal space.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device uses a flexible distal portion made of thin-walled tubing that can navigate confined spinal spaces. This flexible construction allows the device to bend and conform to the curved anatomy of the spine while still providing rigid cutting edges through the attached rungs and blades.

Inventive Principle:
Principle #30Flexible shells and thin films

3Manufacturing precision

If rigid cutting tools are used for bone and ligament modification, then cutting precision is improved, but the ability to navigate curved anatomical structures is reduced

Engineering Contradiction:
Improvecutting precisionVSAvoidanatomical adaptability
Core Design Contradiction:
Manufacturing precisionVSAdaptability or versatility

Solution Approach 1:

The device is divided into a rigid proximal portion for stability and control, and a flexible distal portion with segmented rungs for navigating curved anatomy. This segmentation allows each portion to optimize its function: the rigid proximal part provides structural support while the flexible distal part with individual rungs can conform to curved spinal structures.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the device have different mechanical properties tailored to their specific functions. The proximal portion is rigid for stable manipulation and force application, while the distal portion is flexible for navigating curved anatomy. The rungs themselves have localized rigidity at their cutting surfaces while maintaining flexibility in their connections.

Inventive Principle:
Principle #3Local quality

4Adaptability or versatility

If flexible devices are used to navigate curved spinal structures, then anatomical adaptability is improved, but structural stability for precise cutting is reduced

Engineering Contradiction:
Improveanatomical adaptabilityVSAvoidstructural stability
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The device is segmented into a rigid proximal portion that provides structural stability for precise cutting operations, and a flexible distal portion with individual rungs that can adapt to curved anatomical structures. This segmentation allows the stable proximal part to remain steady while the flexible distal part conforms to the anatomy.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device combines materials with different mechanical properties: the proximal portion uses rigid materials for structural stability, while the distal portion uses flexible materials for anatomical adaptability. This composite construction allows both rigidity where needed for cutting stability and flexibility where needed for navigation.

Inventive Principle:
Principle #40Composite materials

Data Source

PatentEP2328489B1Tissue modification devices
Publication Date: 2019.10.09 AMENDIA INC
  • EP2328489B1 patent drawingFigure 1
  • EP2328489B1 patent drawingFigure 2A
  • EP2328489B1 patent drawingFigure 2B~2C

AI summary

Described herein are elongate devices for modifying tissue having a plurality of flexibly connected and rungs or links, and methods of using them, including methods of using them to decompress stenotic spinal tissue. These devices may be included as part of a system for modifying tissue. In general, these devices include a plurality of blades positioned on (or forme from) rungs that are flexibly connected and may be separated by one or more spacers. The rungs are typically wider than they are long (e.g., rectangular). The rungs may be arranged, ladder like, and may be connected by a flexible connector substrate or between two or more cables. Different sized rungs may be used, or rungs with different cutting properties. In some variations the tissue modification devices may have a non-linear axial shape, or may be converted from a first axial shape to a second axial shape.