Self-anchoring urethral sling with textured implant

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Solution Overview

Problem

Current surgical techniques for sling suspension in treating female urinary incontinence face challenges with synthetic mesh materials, which can cause infections and tissue erosion due to foreign body reactions, while natural materials require sutures and more invasive procedures, necessitating a solution that combines the benefits of both without their drawbacks.

Innovation Solution

A minimally invasive system using a hybrid or natural material sling kit with a textured implant member and introducer needle system that eliminates the need for sutures, providing self-anchoring properties and easy placement, allowing for either upward or downward surgical approaches without specialized equipment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If synthetic mesh material is used for sling support, then the material is strong, easy to sterilize, and inexpensive, but it causes foreign body reactions leading to infections and tissue erosion

Engineering Contradiction:
Improvesling material strengthVSAvoidinfections and tissue erosion
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent applies composite materials by combining synthetic mesh with biological materials (such as collagen or other tissue-derived substances). This creates a hybrid sling that maintains the structural strength and sterilization advantages of synthetic materials while adding biocompatibility and reduced immune response from the biological components, thereby preventing infections and tissue erosion

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent changes the material parameters by treating synthetic mesh with surface modifications or coatings that alter its physical and chemical properties. This includes changing surface roughness, porosity, or chemical composition to reduce foreign body reactions while maintaining the mechanical strength required for sling support function

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If natural tissue material is used for sling support, then biocompatibility is improved, but sutures and more invasive procedures are required

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidsurgical procedure complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

By creating composite slings that integrate natural tissue components with synthetic structural elements, the invention achieves high biocompatibility from the natural materials while the synthetic portion provides self-anchoring capabilities that eliminate the need for sutures, thereby reducing surgical complexity

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent enables the sling material to self-anchor within the tissue through inherent mechanical properties such as friction, interlocking structures, or elastic recovery. This self-service capability eliminates the need for additional suturing steps and complex surgical maneuvers, simplifying the procedure while maintaining biocompatibility

Inventive Principle:
Principle #25Self-service

3Device complexity

If self-anchoring sling is used to eliminate sutures, then surgical procedure is simplified, but the sling must withstand high forces without rupture or tear

Engineering Contradiction:
Improvesurgical procedure complexityVSAvoidsling material strength
Core Design Contradiction:
Device complexityVSStrength

Solution Approach 1:

The composite structure combines synthetic materials with high tensile strength and elastic properties with natural tissue components. This combination ensures the sling can withstand high forces from activities like sneezing while maintaining the simplified self-anchoring design that eliminates sutures

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent employs flexible, thin-film structures with engineered properties that allow the sling to conform to tissue while maintaining strength. These flexible structures distribute mechanical loads effectively, enabling the material to resist rupture under high force while maintaining the simple self-anchoring configuration

Inventive Principle:
Principle #30Flexible shells and thin films

4Force

If textured implant member is used to improve self-anchoring, then friction with tissue is increased, but material surface roughness may cause abrasion

Engineering Contradiction:
Improvefriction force for self-anchoringVSAvoidtissue abrasion
Core Design Contradiction:
ForceVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by creating different surface characteristics in different regions of the implant. The textured areas provide increased friction for self-anchoring where needed, while smooth areas contact the urethra and surrounding tissues to prevent abrasion. This spatial variation in surface properties resolves the contradiction between anchoring force and tissue protection

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The composite material structure allows combining textured synthetic portions for anchoring with smooth biocompatible coatings or natural tissue layers for tissue contact. This multi-layered approach provides high friction where required for fixation while maintaining smooth surfaces that prevent tissue abrasion and erosion

Inventive Principle:
Principle #40Composite 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 system offers a low complication rate, good tissue ingrowth, and improved flexibility, reducing the risk of infections and tissue erosion while minimizing invasive procedures and hospital stay, providing effective support for the urethra with reduced material usage.

Implementation Method 1

the sling be held firmly in place by friction with the patient's tissue

Methodology Applied
Scientific EffectFriction: Friction

Implementation Method 2

good tissue ingrowth

Methodology Applied
Scientific EffectTissue ingrowth:

Data Source

PatentUS8097007B2Self-anchoring sling and introducer system
Publication Date: 2012.01.17 CR BARD INC
  • US8097007B2 patent drawing
  • US8097007B2 patent drawing
  • US8097007B2 patent drawing

AI summary

A system for supporting the urethra using an introducer needle, the ends of which are flattened and which have openings therethrough, a handle having a latch mechanism which engages the opening in the flattened portion of the first end of the introducer needle, an implant, and a connector joining the end of the implant to the flattened portion of one of the ends of the introducer needle. These components are used to draw the implant into position, either through vaginal or abdominal incisions, to form a U-shaped loop beneath the urethra. The ends of the implant are adjusted to provide proper support for the urethra. The implant can have slits that open under applied tensile force.