Hernia Mesh Fixation Coil for Balloon Deployment

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Solution Overview

Problem

Current hernia repair techniques face challenges in efficiently deploying and positioning hernia meshes within the abdominal cavity due to difficulties in unrolling, orienting, and fixing the mesh, particularly in minimally invasive procedures, where rapid and secure attachment to deployment means like inflatable balloons is necessary without causing harm or limiting mesh size compatibility.

Innovation Solution

A hernia kit comprising a mesh and a deployment means, such as an inflatable balloon, with a fixating system featuring a coil that reconfigures from a retracted to an unretracted shape to attach securely to the mesh, utilizing a sharpened element for penetration and threading through the mesh, allowing for easy attachment and detachment, and made from materials like nylon or shape memory alloys for mechanical or thermal reconfiguration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If the mesh is manually unrolled and positioned using laparoscopic forceps, then the mesh can be placed in the abdominal cavity, but the procedure time increases significantly due to the complexity of unrolling, orienting, and positioning the mesh

Engineering Contradiction:
Improvemesh deployment speedVSAvoidprocedure time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The mesh is pre-attached to the inflatable balloon in a rolled or folded configuration before surgery. The balloon serves as a pre-prepared deployment device that already has the mesh secured to it, eliminating the need for manual attachment during the procedure.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The inflatable balloon acts as an intermediary device between the surgeon and the mesh. Instead of directly manipulating the mesh with forceps, the surgeon inflates the balloon which then pushes the mesh into position, simplifying the deployment process.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the mesh is attached to an inflatable balloon for deployment, then rapid deployment is achieved, but the fixation method must be strong enough to prevent detachment while allowing easy removal

Engineering Contradiction:
Improvemesh attachment securityVSAvoidattachment and detachment ease
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The fixation system transitions from a static attachment to a dynamic one that can change states. The balloon's inflation and deflation create dynamic forces that secure the mesh during deployment while allowing easy release when deflated, providing both strength and ease of operation.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The attachment security is controlled by changing the inflation parameter of the balloon. When inflated, the balloon provides strong fixation forces; when deflated, the fixation is released. This parameter change allows the same system to provide both strong attachment and easy detachment.

Inventive Principle:
Principle #35Parameter changes

3Extent of automation

If a wire frame made of shape memory alloys is embedded in the prosthetic for automatic deployment, then the mesh deploys automatically when heated, but embedding the wire frame becomes complicated

Engineering Contradiction:
Improveautomatic mesh deploymentVSAvoidwire frame embedding complexity
Core Design Contradiction:
Extent of automationVSDevice complexity

Solution Approach 1:

The complex wire frame embedding process is extracted and replaced with a simpler system. Instead of embedding shape memory alloy wire frames within the mesh structure, the patent uses an external inflatable balloon that provides the deployment force, eliminating the need for complex internal structural modifications.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The inflatable balloon serves as an intermediary that provides the deployment force without being embedded in the mesh. This external mediator simplifies the overall system by replacing the need for complex embedded actuation mechanisms while achieving automatic deployment through balloon inflation.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If the mesh is secured with staples or sutures to underlying tissue, then the mesh is held in place, but this adds to the procedure time and complexity

Engineering Contradiction:
Improvemesh positioning stabilityVSAvoidfixation procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The complex suture or staple fixation process is extracted and replaced with a simpler balloon-based positioning system. The inflated balloon provides temporary stabilization during positioning without requiring attachment to underlying tissue, eliminating the need for additional fixation procedures.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The mesh positioning is accomplished in advance through balloon inflation before any fixation is needed. The balloon provides temporary stabilization that allows proper positioning to be achieved quickly, eliminating or reducing the need for subsequent suture or staple fixation.

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

This solution significantly reduces the time required for mesh deployment and positioning, ensuring secure attachment and compatibility with various mesh sizes, facilitating efficient and minimally invasive hernia repair surgeries while maintaining patient safety and procedural efficiency.

Implementation Method 1

a second portion (200b), comprising a coil (252) having a predetermined retracted shape; said coil is reconfigurable from a plurality of unretracted positions to a plurality of retracted positions and from said plurality of retracted positions to said plurality of unretracted positions

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 2

a third portion (200c) having at least one sharpened element (256), adapted to fully penetrate said mesh (2)

Methodology Applied
Scientific EffectMechanical penetration: Impact Force

Data Source

PatentUS20240090991A1Fixating means between a mesh and mesh deployment means especially useful for hernia repair surgeries and methods thereof
Publication Date: 2024.03.21 DAVOL INC
  • US20240090991A1 patent drawing
  • US20240090991A1 patent drawing
  • US20240090991A1 patent drawing

AI summary

The present invention provides a fixating means adapted for use in hernia repair surgeries in attaching a mesh and mesh deployment means; said fixating means are attached to said mesh deployment means; and fixating means comprising: (a) a first portion coupled to said deployment means; and, (b) a second portion comprising a coil having a predetermined retracted shape; said coil is reconfigurable from a plurality of unretracted positions to a plurality of retracted positions and from said plurality of retracted positions to said plurality of unretracted positions; wherein said attachment between said deployment means and said mesh is obtained by reconfiguration of said coil from at least one of said unretracted positions to at least one of said retracted positions.