Foamable Surgical Composition for Anastomotic Leak Detection
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing surgical methods for detecting leaks in anastomosis of the small bowel and ascending or transverse colon lack reliable testing methods, and require foam formulations that are biocompatible, stable, and easily mixable, while meeting FDA safety standards, with specific properties for effective leak detection.
Innovation Solution
A foamable composition comprising sodium bicarbonate or potassium bicarbonate in aqueous suspension, xanthan gum as a viscosity modifier, and polysorbate 80 as a surfactant, producing a gaseous foam upon contact with an acid activator, with specific rheological properties and stability for leak detection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a foamable composition is used for leak detection in anastomosis, then the ability to detect leaks is improved, but the formulation complexity increases due to multiple constraints (biocompatibility, stability, mixability, FDA approval)
Solution Approach 1:
The patent optimizes specific parameters of the foamable composition including pH (6-7 for bowel procedures), viscosity (using xanthan gum as thickener), foam stability duration (5+ minutes), and biocompatibility (FDA-approved ingredients only). These parameter changes resolve the contradiction by establishing precise formulation specifications that ensure reliable leak detection while maintaining manageable complexity through standardized parameters.
Solution Approach 2:
The foamable composition uses a composite formulation combining multiple biocompatible components: sodium bicarbonate or potassium bicarbonate base, xanthan gum thickener, and polysorbate 80 surfactant. This composite approach enables the foam to simultaneously achieve leak detection capability, structural stability, ease of mixing, and FDA compliance, resolving the formulation complexity issue while maintaining reliability.
2Duration of action of stationary object
If the foam must be stable for extended periods to allow surgical repairs, then the foam stability is improved, but the foam may become too viscous to inject through small gauge needles
Solution Approach 1:
The foamable composition exhibits dynamic rheological properties where the foam structure adapts to different stress conditions. The xanthan gum provides shear-thinning behavior, allowing the composition to remain fluid during injection (low viscosity under shear) then stabilize into a firm foam structure once injected and activated. This dynamic property resolves the contradiction between long-term stability and ease of injection through 16 gauge or smaller needles.
Solution Approach 2:
The patent specifies precise viscosity parameters and foam stability duration (at least 5 minutes) that balance injectability and stability. The formulation parameters are optimized so the liquid composition remains injectable through small gauge needles while the resulting foam maintains structural integrity for the required surgical repair time.
3Productivity
If the foam development is fast to suit time-sensitive surgical environment, then the productivity is improved, but the tissue may over-pressurize before the surgeon can respond
Solution Approach 1:
The foamable composition is designed to produce foam at a controlled rate rather than all at once. The acid-base reaction kinetics are moderated to provide progressive foam development, allowing the surgeon to respond to foam emergence and prevent tissue over-pressurization while still achieving sufficient foam volume for leak detection within the surgical time frame.
Solution Approach 2:
The patent optimizes the reaction kinetics parameters of the acid-base system to achieve moderate foam development speed. This parameter optimization balances productivity (sufficient foam generation for leak detection) with safety (preventing tissue over-pressurization by allowing surgeon response time).
Data Source
AI summary
Provided herein are foamable compositions comprising (1) a base, in aqueous suspension, (2) a viscosity modifier component, and (3) a surfactant component. In preferred embodiments, the foamable composition may further comprise a salt. Additional components that may optionally be present in the formable composition include sugars and sugar alcohols, colorants, antioxidants, preservatives, and other excipients generally known to those skilled in the art. Also provided herein are kits for producing a gaseous foam. Also provided herein are methods for detecting the presence of leaks or defects in anatomical tissue or organ.