Biodegradable Polymeric Bowel Shield for Fascial Closure

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Solution Overview

Problem

Current surgical instruments used in abdominal surgery, such as metal malleable retractors and the Glassman Visceral Retractor, are inadequate in shielding the bowel during fascial closure, leading to increased risks of bowel injury, hernia recurrence, and post-operative complications like bowel obstruction and adhesions, due to their inability to completely protect the viscera and the need for removal before final fascial sutures are tied.

Innovation Solution

Development of biodegradable polymeric compositions that combine flexibility and strength, specifically glycerolate and dihydroxyacetone-based materials, which can be processed into thin wafers to shield the bowel and rapidly degrade within 3-24 hours, eliminating the need for removal and reducing toxicity risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If metal malleable retractors or PVC Glassman Visceral Retainer are used to shield the bowel, then bowel protection during surgery is improved, but the device must be removed before final fascial closure which creates risk of retained instruments and bowel injury

Engineering Contradiction:
Improvebowel protectionVSAvoiddevice removal
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent employs a biodegradable polymer barrier that serves as a temporary protective device during surgery and then automatically degrades within the body, eliminating the need for removal. The barrier is designed to be used once and then naturally break down into safe byproducts, functioning as a disposable medical device that avoids the risks of retained foreign objects.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The biodegradable barrier performs the protective function during surgery and then self-destructs through biological degradation processes. The material autonomously breaks down into metabolizable components without requiring surgical intervention for removal, allowing the device to serve its protective purpose and then automatically exit the system safely.

Inventive Principle:
Principle #25Self-service

2Ease of operation

If the Glassman Visceral Retractor is made thin enough to be removed through small opening, then ease of removal is improved, but the device is not wide enough to prevent bowel from entering surgical field

Engineering Contradiction:
Improvedevice removalVSAvoidshielding area
Core Design Contradiction:
Ease of operationVSArea of stationary object

Solution Approach 1:

The biodegradable barrier can be designed in optimal dimensions for maximum protective coverage without concern for removal difficulty. Since the device automatically degrades and eliminates itself, the design freedom allows for larger shielding area that completely prevents bowel entry into the surgical field, unlike removable devices constrained by extraction requirements.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent changes the fundamental parameter of device permanence from removable to biodegradable, which transforms the design constraints. This parameter change allows the barrier to achieve optimal thickness and area dimensions for protection without the conflicting requirement of ease of removal, as the degradation process naturally handles device exit.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If biodegradable polymeric compositions are used as surgical barrier, then the need for device removal is eliminated and toxicity is reduced, but the material must maintain sufficient strength to block needle puncture

Engineering Contradiction:
Improveno removal neededVSAvoidresistance to needle puncture
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The patent utilizes composite polymeric materials combining biodegradable components with enhanced mechanical properties. The composite structure integrates multiple polymer phases or cross-linked networks that provide both biodegradability and improved strength characteristics, enabling the barrier to resist needle puncture while maintaining its temporary, removable nature through degradation.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent modifies the physical and chemical parameters of biodegradable polymers to achieve optimal balance between strength and degradability. By adjusting molecular weight, cross-linking density, crystallinity, and polymer composition, the material parameters are optimized to provide sufficient puncture resistance during surgery while ensuring complete degradation into safe metabolites afterward.

Inventive Principle:
Principle #35Parameter changes

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 biodegradable polymeric compositions effectively shield the bowel from needle puncture, reduce the risk of post-operative adhesions, and facilitate safe fascial closure by remaining in the body until fully degraded, thereby minimizing complications associated with instrument retention.

Implementation Method 1

The polymeric composition is also advantageously biodegradable and non-toxic, thereby permitting the composition, when used as a shield, to naturally degrade within the body without adverse effect

Methodology Applied
Scientific EffectHydrolysis: Hydrolysis

Implementation Method 2

The polymeric composition contains a glycerolate moiety, carbonate linkages, a polyalkylene oxide moiety, and crosslinked DHA

Methodology Applied
Scientific EffectChemical Bonding: Chemical Bonding

Data Source

PatentUS10660991B2Polymeric DHA-containing biodegradable compositions and surgical barrier devices made thereof
Publication Date: 2020.05.26 CORNELL UNIVERSITY
  • US10660991B2 patent drawing
  • US10660991B2 patent drawing
  • US10660991B2 patent drawing

AI summary

Polymer compositions having the following chemical structure: wherein L1 represents a polymeric linker having the structure shown connecting ethylene oxide oligomers and their use in surgical devices containing the above composition is also described.