Implantable Hernia Prosthesis with Anti-Adhesion Barrier and Tether Fixation

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Solution Overview

Problem

Current laparoscopic hernia repair methods face challenges such as adhesions forming between the mesh patch and abdominal cavity structures, instability of the patch due to stapling into the thin peritoneum, and risk of cutting important anatomical structures during procedures.

Innovation Solution

An implantable prosthesis comprising a biocompatible structure with a rigid reinforcement member, a mesh structure promoting tissue ingrowth, and an anti-adhesion barrier with a collagen coating, designed to be partially flexible and collapsible for stable deployment, with tethers for fixation and a bioactive agent for preventing adhesions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a mesh patch is used for hernia repair in direct contact with abdominal cavity structures, then the defect is covered and reinforced, but adhesions form between the mesh and structures like intestines

Engineering Contradiction:
Improvehernia repair stabilityVSAvoidadhesion formation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The prosthesis is divided into multiple functional layers: an outer biocompatible structure for tissue integration, a rigid reinforcement member for structural support, a mesh structure for defect coverage, and an anti-adhesion barrier layer to prevent adhesions. This segmentation allows each layer to perform its specific function without interfering with others.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The anti-adhesion barrier layer acts as an intermediary between the mesh structure and the abdominal cavity structures. This intermediate layer prevents direct contact and adhesion formation while still allowing the mesh to provide reinforcement and coverage.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If a patch is stapled into the peritoneum for hernia repair, then the patch is secured in place, but the thin unstable peritoneum may tear or the patch may shift position

Engineering Contradiction:
Improvepatch fixation stabilityVSAvoidperitoneum integrity
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The prosthesis uses a flexible biocompatible outer structure that can conform to the abdominal wall anatomy without requiring rigid fixation. The tethers provide anchoring through tissue rather than the fragile peritoneum, distributing mechanical stress across stronger tissue layers.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The traditional mechanical stapling system is replaced with a tether-based anchoring system that uses sutures or tacks to secure the prosthesis to the abdominal wall. This substitution eliminates the need to penetrate and secure to the thin peritoneum, reducing the risk of tearing and displacement.

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

3Ease of operation

If laparoscopic instruments are used to create dissected spaces, then minimally invasive access is achieved, but the dissected space may be in an undesired plane leading to bleeding and obscured surgical field

Engineering Contradiction:
Improveminimally invasive accessVSAvoiddissection plane accuracy
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The prosthesis is designed with pre-formed tethers and anchoring structures that guide the creation of the correct dissected plane during implantation. The tethers can be used to identify and maintain the proper preperitoneal space plane, preventing dissection in incorrect planes that would lead to bleeding.

Inventive Principle:
Principle #10Preliminary action

4Productivity

If the peritoneum is cut away and stapled closed during laparoscopic repair, then the repair is completed, but the procedure is time consuming and risks cutting important anatomic structures

Engineering Contradiction:
Improverepair completionVSAvoidsurgical procedure time
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The prosthesis is designed to be implanted through a minimally invasive approach without requiring the extraction or removal of the peritoneum. The anti-adhesion barrier allows the prosthesis to function without peritoneal closure, eliminating the time-consuming and risky steps of cutting and stapling the peritoneum.

Inventive Principle:
Principle #2Taking out (Extraction)

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 prosthesis provides a stable and effective repair by minimizing adhesions, maintaining structural integrity, and facilitating tissue integration, while reducing the risk of complications during and after surgery.

Implementation Method 1

a stiffness of the rigid reinforcement member is greater than a stiffness of the first and second biocompatible structures

Methodology Applied
Scientific EffectStiffness:

Implementation Method 2

an anti-adhesion barrier positioned on a bottom surface of the second biocompatible structure

Methodology Applied
Scientific EffectAnti-adhesion: Adhesive

Data Source

PatentUS11813154B2Implantable prosthesis for repairing or reinforcing an anatomical defect
Publication Date: 2023.11.14 COVIDIEN LP
  • US11813154B2 patent drawing
  • US11813154B2 patent drawing
  • US11813154B2 patent drawing

AI summary

An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect is provided. The implantable prosthesis includes a first biocompatible structure having a tether attached thereto for maintaining stable deployment of the implantable prosthesis through an abdominal wall; a rigid reinforcement member positioned adjacent a bottom side of the first biocompatible structure, the rigid reinforcement member including an inner circumferential ring, a plurality of spoke elements, a plurality of openings, and a plurality of guide members molded thereon; a mesh structure positioned adjacent a bottom surface of the rigid reinforcement member, the mesh structure overlapping the inner circumferential ring of the rigid reinforcement member; a second biocompatible structure and an anti-adhesion barrier having a collagen coating positioned on a bottom surface of the second biocompatible structure.