Cross-linked Material Attachment to Implantable Frames

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Solution Overview

Problem

There is a need for implantable medical devices that attach materials to a frame without using adhesives, requiring a connection that maintains the material in a structured orientation within the dynamic environment of a body vessel, particularly for devices like venous valves where fluid flow directionality is crucial.

Innovation Solution

The use of cross-linkable materials that form cross-link chemical bonds with themselves or other polymers to create a stable attachment to a frame, allowing for movement relative to the frame while maintaining structural integrity, using methods like dehydrothermal treatment or ultraviolet irradiation to cross-link materials such as extracellular matrix materials and polymers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If adhesives are used to attach material to the frame, then the attachment strength is improved, but the biocompatibility and long-term stability are worsened due to adhesive degradation and immune response

Engineering Contradiction:
Improveattachment strengthVSAvoidlong-term stability
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The patent removes adhesives from the attachment system entirely, extracting the harmful element while maintaining the attachment function through an alternative mechanism. The material is attached to the frame without any adhesive layer, eliminating the source of degradation and immune response while preserving structural integrity through direct mechanical and chemical bonding.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the chemical and physical parameters of the material and frame surface to enable direct bonding. By modifying surface properties and using cross-linking chemistry, the material can attach directly to the frame without adhesives, achieving both strong attachment and long-term biocompatibility through parameter optimization rather than adding intermediate substances.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If the material is rigidly fixed to the frame, then the structural stability is improved, but the flexibility and ability to accommodate movement are worsened

Engineering Contradiction:
Improvestructural stabilityVSAvoidflexibility
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The patent creates a dynamic attachment system where the material is cross-linked to the frame but can still undergo controlled movement and deformation. The cross-linking density and distribution are optimized to provide stability while allowing the material to flex and adapt to physiological movements, transforming a static rigid connection into a dynamic adaptive structure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent applies cross-linking with non-uniform density across the material-frame interface. Regions requiring stability have higher cross-link density, while regions requiring flexibility have lower cross-link density. This local variation in attachment strength allows the structure to maintain overall stability while permitting localized movement and adaptation.

Inventive Principle:
Principle #3Local quality

3Duration of action of stationary object

If cross-linking conditions are applied to attach material to the frame, then the attachment durability is improved, but the material flexibility is worsened due to excessive cross-linking

Engineering Contradiction:
Improveattachment durabilityVSAvoidmaterial flexibility
Core Design Contradiction:
Duration of action of stationary objectVSStability of the object's composition

Solution Approach 1:

The patent applies cross-linking to only the necessary regions and to a controlled extent, rather than fully cross-linking the entire material. This partial cross-linking approach provides sufficient attachment durability at the material-frame interface while leaving the bulk material sufficiently uncross-linked to maintain its natural flexibility and mechanical properties.

Inventive Principle:
Principle #16Partial or excessive 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

This solution provides a secure and flexible attachment of materials to medical device frames within body vessels, ensuring effective valve function and fluid flow regulation without the use of adhesives, enhancing the durability and stability of the devices.

Implementation Method 1

a first region of cross-linkable material can be joined to a second region of the cross-linkable material by treating the first region and the second region with conditions that promote the formation of cross-link chemical bonds

Methodology Applied
Scientific EffectCross-link chemical bonds: Chemical Bonding

Implementation Method 2

using methods like dehydrothermal treatment or ultraviolet irradiation to cross-link materials

Methodology Applied
Scientific EffectDehydrothermal treatment: Heat Treatment

Implementation Method 3

using methods like dehydrothermal treatment or ultraviolet irradiation to cross-link materials

Methodology Applied
Scientific EffectUltraviolet irradiation: Photopolymerisation

Data Source

PatentEP1928512B1Attachment of material to an implantable frame by cross-linking
Publication Date: 2012.11.14 COOK MEDICAL TECHNOLOGIES LLC
  • EP1928512B1 patent drawingFigure 1A~2
  • EP1928512B1 patent drawingFigure 3~4
  • EP1928512B1 patent drawingFigure 5~6

AI summary

Medical devices for implantation in a body vessel, and methods of using and making the same, are provided. A medical device includes a frame and a cross-linkable material having at least one cross-linked region and a non cross-linked region, where the cross-linked region maintains the cross-linkable material in connection to the frame. A method of making an implantable medical device includes providing a frame and covering the frame with a cross-linkable material. The method also includes cross-linking at least one region of the cross-linkable material by joining a first region of the cross-linkable material to a second region of the cross- linkable material to form a point of attachment. A method of treating a subject includes the step of implanting the medical device at a point of treatment.