Resiliently Deflectable Insert for Atraumatic Anal Fistula Implant Delivery

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Solution Overview

Problem

Anal fistulas often require invasive treatments that can compromise fecal continence, and existing methods for implant delivery and site assessment are not atraumatic, risking damage to the implant and surrounding tissue.

Innovation Solution

A treatment system comprising a resiliently deflectable insert with a guide tube for atraumatic implant delivery, featuring a tip portion for coupling with the implant and a body portion that can bend without kinking, along with a guide tube that is more flexible than the insert, to facilitate precise placement and assessment of the implant within the fistula.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional invasive treatments (fistulotomy, seton) are used to treat anal fistulas, then the fistula can be treated, but fecal continence is compromised and tissue damage occurs

Engineering Contradiction:

Improvefistula treatment efficacyVSAvoidtissue damage and fecal incontinence

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a guide tube as an intermediary device that facilitates atraumatic implant delivery. The guide tube protects the delicate implant during insertion and allows precise placement into the fistula tract without direct mechanical engagement between the implant and tissue, thereby maintaining tissue integrity while achieving fistula treatment

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces traditional mechanical invasive techniques (fistulotomy involving cutting, seton involving threading) with a less invasive implant delivery system. The resiliently deflectable insert and guide tube system allows implant placement through a softer, more flexible mechanism that avoids the harsh mechanical forces of traditional surgery

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Ease of operation

If existing implant delivery methods are used, then implant can be placed, but the implant and surrounding tissue are at risk of damage due to traumatic engagement

Engineering Contradiction:

Improveimplant deliveryVSAvoidimplant integrity and tissue integrity

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent employs a resiliently deflectable insert with a flexible body portion that can bend without kinking, and a guide tube that is more flexible than the insert. These flexible components navigate the anatomical pathways smoothly and reduce mechanical stress on the implant and surrounding tissue during delivery

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The guide tube acts as a protective sheath that cushions and protects the delicate implant during the delivery process. The tube prevents direct contact between the implant and potentially damaging elements in the delivery system or surrounding tissue, maintaining implant integrity until precise placement is achieved

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Manufacturing precision

If rigid delivery tools are used for implant placement, then precise placement can be achieved, but tissue manipulation and engagement increase causing trauma

Engineering Contradiction:

Improveimplant placement precisionVSAvoidtissue manipulation and trauma

Core Design Contradiction:

Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The guide tube and resiliently deflectable insert provide a flexible yet controllable delivery system. The flexibility allows the components to conform to anatomical structures while maintaining enough rigidity to enable precise implant placement through controlled manipulation of the delivery system

Inventive Principle:

Principle #30Flexible shells and thin films

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 enables atraumatic implant delivery and effective site assessment, reducing the risk of implant damage and tissue manipulation, thereby improving treatment efficacy and maintaining tissue integrity.

Implementation Method 1

an insert 100 that is resiliently deflectable, the insert extending between a tip portion 110 and a control portion 112, with a body portion 114 located between the tip portion and the control portion

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 2

a guide tube 200 having an internal lumen that is configured to permit passage of the tip portion and the body portion through the guide tube

Methodology Applied

Scientific EffectFriction reduction: Lubrication

Data Source

PatentUS12064099B2Delivery and assessment aids for implants

Publication Date: 2024.08.20 WL GORE & ASSOC INC

AI summary

A treatment system includes an insert that is resiliently deflectable. The tip portion of the insert can be configured to be coupled to the trailing portion of an implant. A guide tube having an internal lumen is configured to permit passage of the tip portion and the body portion of the insert through a guide tube. The guide tube can have a length that is less than that of the insert. Treatment systems include a plurality of inserts, each insert differing from in at least one of length, diameter, and curvature. Treating a patient can include sizing a fistula using an insert.