Fistula Grafts With Expandable Capping Member

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Solution Overview

Problem

Current medical treatments for fistulae, such as anorectal and gastrointestinal fistulae, often result in sphincter muscle damage and incontinence, and existing methods for gastrointestinal fistulae have low success rates for spontaneous closure, necessitating improved solutions for effective treatment.

Innovation Solution

Development of biocompatible fistula grafts with a capping member and an elongate plug member, made from remodelable materials like extracellular matrix, to block primary fistula openings and extend into fistula tracts, potentially using expandable elements and anchoring adaptations for secure placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical treatment of fistulae involves passing a fistula probe through the tract and dividing the overlying tissue (fistulotomy), then the fistula tract is opened and drained, but sphincter muscle is divided causing impaired sphincter control and incontinence

Engineering Contradiction:

Improvefistula treatment effectivenessVSAvoidsphincter muscle damage and incontinence

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The fistula treatment is divided into multiple stages: first placing a seton to drain infection and mature the tract, then later injecting sealant or sclerosant to close the fistula. This segmentation allows the harmful effects to be avoided by not dividing the sphincter in one procedure.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A seton is placed through the fistula tract in advance to drain infection and allow the tract to mature before definitive closure. This preliminary action prepares the tract for subsequent sealant injection while avoiding immediate sphincter division.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If sealant or sclerosant is injected into an unprepared or infected fistula tract, then fistula closure is attempted, but infection flares up and abscess formation occurs

Engineering Contradiction:

Improvefistula closure successVSAvoidinfection flare-up and abscess formation

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The fistula tract is prepared in advance by placing a seton to drain infection and mature the tract before sealant injection. This preliminary drainage and maturation prevents infection flare-up when the sealant is later injected.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The seton acts as a protective measure placed beforehand to drain infection and reduce bacterial load in the tract, cushioning against the risk of infection flare-up that would occur if sealant were injected into an infected tract.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If conventional fistula treatments are used, then some fistulae may close, but success rates are low and additional surgeries are often required

Engineering Contradiction:

Improvefistula closure success rateVSAvoidmultiple procedures and extended treatment time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent uses remodelable materials that change their physical properties over time - initially providing structural support and then gradually being remodeled by host tissue. This parameter change enables durable closure with a single procedure rather than requiring multiple surgeries.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The graft construct combines remodelable extracellular matrix materials with other biocompatible materials to create a composite structure that provides both immediate closure and long-term integration with host tissue, improving success rates.

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 grafts effectively seal fistula openings, reduce the risk of sphincter damage, and promote tissue ingrowth, potentially leading to more successful and durable closure of fistulae with minimal side effects.

Implementation Method 1

The graft body is comprised of a remodelable material, such as a remodelable extracellular matrix material. The remodelable material promotes and/or facilitates the formation of new tissue, and is capable of being broken down and replaced by new tissue

Methodology Applied

Scientific EffectTissue ingrowth:

Data Source

PatentUS11696749B2Fistula grafts and related methods and systems for treating fistulae

Publication Date: 2023.07.11 COOK BIOTECH INC

AI summary

Described are medical graft products, systems, and methods for treating fistulae. Certain products of the invention are configured to have portions residing in and around a primary fistula opening, e.g., one occurring in a wall of the alimentary canal. One such product includes a biocompatible graft body which is configured to block at least the primary opening. The graft body includes a capping member, which is configured to contact portions of the alimentary canal wall adjacent to the primary opening, and an elongate plug member extending from the capping member, which is configured to extend into at least a portion of the fistula. In certain embodiments, a graft body component has the capacity to expand or otherwise change form to provide a suitable capping arrangement. Such a component can include a resilient wire frame, e.g., one that is self-expandable or one that requires at least some manipulation in order to expand.