Compliant Biomedical Patch for Dural Defect Sealing

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Solution Overview

Problem

Current dural substitutes for repairing dural defects during neurosurgical procedures are difficult to handle, unreliable, non-compliant, and require suturing, which can lead to leaks and complications, especially in high-pressure areas like the base of the skull.

Innovation Solution

A compliant patch system comprising electro-spun fibers that can be compressed to fit through tissue defects, expand to a planar shape, and biodegrade, with adhesives for secure implantation on both the inner and outer surfaces of the dura mater to prevent leaks and promote tissue ingrowth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If dural substitutes are made from planar materials that require suturing, then they can cover and seal dural defects, but they become difficult to handle and require complex suturing procedures that can lead to leaks and complications

Engineering Contradiction:
Improvesealing reliabilityVSAvoidhandling ease
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent employs a flexible, thin-film dural substitute that can be easily manipulated and positioned. The material's flexibility allows it to conform to the dural defect without requiring rigid suturing, while still providing reliable sealing. This resolves the contradiction by enabling both easy handling and reliable sealing through the inherent properties of the flexible film material.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The patent replaces the mechanical suturing system with an adhesive bonding system. Instead of using needles and threads to secure the dural substitute, the invention uses adhesives applied to the edges or surface of the patch to bond it to the surrounding dura. This substitution eliminates the complexity and potential complications of suturing while maintaining secure attachment and sealing reliability.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If dural substitutes require suturing for secure attachment, then they can remain in place, but the suturing process increases complexity and risk of leaks especially in high-pressure areas

Engineering Contradiction:
Improveattachment reliabilityVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical suturing system with an adhesive bonding system. Instead of using needles and threads to secure the dural substitute, the invention uses adhesives applied to the edges or surface of the patch to bond it to the surrounding dura. This substitution eliminates the complexity and potential complications of suturing while maintaining secure attachment and sealing reliability.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the bonding mechanism from mechanical (sutures) to chemical (adhesives). By utilizing adhesive materials that can bond to both the dural substitute and surrounding tissue, the invention achieves reliable attachment without the need for complex suturing procedures. This parameter change in the attachment method reduces procedural complexity while maintaining or improving attachment reliability.

Inventive Principle:
Principle #35Parameter changes

3Stability of the object's composition

If dural substitutes are made non-compliant for structural stability, then they can maintain shape, but they become difficult to implant through tissue defects and less adaptable to curved surfaces

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

Solution Approach 1:

The patent employs a dynamic dural substitute that transitions from a flexible, implantable state to a stable, structured state after implantation. The material is designed to be compliant during insertion to navigate through tissue defects and conform to curved dural surfaces, then maintains structural stability once positioned. This dynamic behavior resolves the contradiction by providing both adaptability during implantation and stability during function.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent employs a flexible, thin-film dural substitute that can be easily manipulated and positioned. The material's flexibility allows it to conform to the dural defect without requiring rigid suturing, while still providing reliable sealing. This resolves the contradiction by enabling both easy handling and reliable sealing through the inherent properties of the flexible film material.

Inventive Principle:
Principle #30Flexible shells and thin films

4Reliability

If dural substitutes use traditional materials, then they can provide immediate sealing, but they do not promote tissue ingrowth and regeneration of native dura

Engineering Contradiction:
Improvesealing effectivenessVSAvoidtissue integration capability
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent employs composite dural substitute materials that combine sealing properties with tissue-promoting characteristics. The composite structure may include layers or components that provide immediate sealing functionality alongside elements that facilitate tissue ingrowth and regeneration. This resolves the contradiction by integrating both sealing effectiveness and tissue integration capabilities into a single material system.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent utilizes porous dural substitute materials that allow tissue ingrowth through their interconnected pore structures. These porous materials maintain sealing effectiveness while providing pathways for native dural tissue to grow through and integrate with the implant. The porosity enables both immediate sealing and long-term tissue regeneration, resolving the contradiction between sealing effectiveness and tissue integration capability.

Inventive Principle:
Principle #31Porous materials

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

The patch system provides a reliable, easy-to-implement, and effective seal of dural defects with reduced risk of leaks and complications, promoting faster healing and improved patient outcomes by allowing secure adhesion and tissue integration without the need for extensive suturing.

Implementation Method 1

The compliant patch may comprise a first adhesive, the compliant patch may define an outer surface when in the first state, and the first adhesive may be located on the outer surface

Methodology Applied
Scientific EffectAdhesive: Adhesive

Data Source

PatentUS10441403B1Biomedical patch and delivery system
Publication Date: 2019.10.15 SOLVENTUM INTELLECTUAL PROPERTIES CO
  • US10441403B1 patent drawing
  • US10441403B1 patent drawing
  • US10441403B1 patent drawing

AI summary

A multi-laminar repair matrix for repairing a tissue defect may comprise a top patch and a bottom compliant patch. The bottom compliant patch may be compressed and sized to fit through a tissue defect, and expand to a substantially planar state after being implanted to the tissue defect. The top and/or bottom patch may include adhesives. A tool for implanting a patch to a tissue defect may include a shaft, a plurality of arms pivotally connected to the shaft, and a control. The control may be configured to radially expand the plurality of arms upon actuation of the control.