Stoma Guide Apparatus for Secure Intestinal Attachment

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Solution Overview

Problem

Conventional stoma formation methods in ostomy procedures are prone to complications such as leaks, bleeding, parastomal herniation, necrosis, stenosis, retraction, dermal infection, mucocutaneous separation, and prolapse due to inadequate securement and patency of the intestine to the abdominal wall.

Innovation Solution

A guide apparatus with a flange segment and an insert segment, featuring a plurality of apertures and fasteners, is used to securely attach the end margins of a body vessel to the skin, maintaining patency and minimizing complications by evenly distributing fasteners and allowing for easy removal of the guide.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional suture methods are used to create a stoma, then the procedure is simple to perform, but complications such as leaks, bleeding, necrosis, and mucocutaneous separation occur due to inadequate securement and non-uniform attachment

Engineering Contradiction:

Improvestoma security and patencyVSAvoidattachment mechanism complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The guide apparatus is positioned and secured to the abdominal wall before the actual stoma formation procedure. This preliminary positioning establishes a stable template that ensures uniform fastener distribution and proper alignment, preventing complications from misalignment while maintaining procedural simplicity through pre-planned positioning

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The guide apparatus serves as an intermediary device between the surgeon and the tissue attachment process. It provides a structured framework with pre-defined aperture patterns that mediate the attachment process, ensuring uniform fastener placement and reducing variability in attachment quality without requiring complex surgical techniques

Inventive Principle:

Principle #24Intermediary (Mediator)

2Strength

If multiple fasteners are used to secure the intestine to the skin, then attachment strength improves, but the risk of necrosis and stenosis increases due to excessive tissue compression

Engineering Contradiction:

Improveattachment strengthVSAvoidtissue compression and necrosis risk

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The guide apparatus implements local quality by providing different aperture patterns in different regions. The apertures are strategically positioned to provide adequate fastener density for securement in critical areas while maintaining larger spacing in regions where tissue compression could cause harm. This localized optimization allows strong attachment where needed while preventing necrosis and stenosis in vulnerable areas

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The guide apparatus enables parameter changes in fastener distribution by providing a template with varying aperture sizes and spacing patterns. This allows the surgical system to adjust the density and arrangement of fasteners based on local tissue characteristics, achieving optimal attachment strength while minimizing compression-related complications through spatially varying fastener parameters

Inventive Principle:

Principle #35Parameter changes

3Measurement precision

If the guide apparatus is designed with a rigid structure for stability, then positioning accuracy improves, but the ease of removal and tissue compatibility decreases

Engineering Contradiction:

Improvepositioning accuracyVSAvoidguide removal ease

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The guide apparatus is segmented into multiple functional components that can be independently optimized. The positioning elements maintain rigidity for accurate alignment, while the removal mechanism incorporates flexible or detachable features. This segmentation allows the device to achieve precise positioning during the procedure while enabling easy removal afterward without compromising tissue compatibility

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The guide apparatus incorporates dynamic characteristics that allow it to transition from a stable, rigid positioning state during the procedure to a removable, flexible state afterward. This may include detachable components, flexible mounting mechanisms, or materials that change properties under different conditions, enabling both precise positioning and easy removal while maintaining tissue compatibility

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS10758398B2Apparatus and associated methodologies for creating a stoma

Publication Date: 2020.09.01 COVIDIEN LP

AI summary

A guide apparatus for facilitating formation of a stoma includes a guide having an outer flange segment arranged about a central longitudinal axis and an insert segment. The flange segment is configured for engaging end margins of a body vessel extending through an opening in skin of a subject, and defines a plurality of apertures. The insert segment extends from the outer flange segment along the longitudinal axis. The insert segment is configured for at least partial positioning within the body vessel to maintain the patency of the body vessel. The guide apparatus further includes a plurality of fasteners for insertion within respective apertures of the flange segment of the guide. The fasteners are configured for penetrating the end margins of the body vessel extending through the opening in the skin to attach the end margins to the skin to thereby create a stoma.