Biodegradable Anastomotic Guide Laminate Structure
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Solution Overview
Problem
Intestinal anastomosis procedures face challenges such as stricture, leakage, peritonitis, sepsis, necrosis, and adhesions, which increase complications and prolong surgery time, necessitating a solution to reduce these risks and improve procedural efficiency.
Innovation Solution
Development of anastomotic guides comprising a tubular body with a biocompatible, biodegradable laminate structure and water-soluble adhesive polymer, designed for insertion into the intestine to maintain position and facilitate suturing or stapling, potentially reducing adverse events and surgery time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional anastomosis procedures are performed without specialized guides, then the surgical procedure can be completed with simpler tools, but the risks of stricture, leakage, peritonitis, sepsis, necrosis, and adhesions increase, and surgery time is prolonged
Solution Approach 1:
The anastomotic guide is divided into multiple functional layers including an outer protective layer, an intermediate layer with adhesive polymer, and an inner luminal surface layer. This segmentation allows each layer to perform specific functions such as structural support, tissue adhesion, and luminal maintenance, thereby improving anastomosis reliability while keeping the overall device manageable in complexity
Solution Approach 2:
The anastomotic guide acts as an intermediary device placed between the two bowel ends to be anastomosed. It provides a structured interface that facilitates proper alignment, maintains luminal patency during healing, and reduces direct tissue contact that could lead to adhesions, thereby improving surgical outcomes
2Productivity
If conventional anastomosis methods are used, then fewer specialized materials are needed, but the procedure time is prolonged and patient exposure to anesthesia is extended
Solution Approach 1:
The anastomotic guide is pre-formed with the appropriate size, shape, and layered structure before surgery. The water-soluble adhesive polymer is pre-included in the laminate structure. This preliminary preparation eliminates the need for intraoperative shaping or adhesive application, thereby reducing surgical time and anesthesia duration while maintaining high productivity
Solution Approach 2:
The guide utilizes phase changes of the water-soluble adhesive polymer, which transitions from a solid state during implantation to a dissolved state during degradation. This parameter change allows the guide to be easily inserted in its intact form and then automatically decompose in the aqueous environment of the bowel, reducing the time the device needs to remain in place and facilitating quicker healing
3Duration of action of stationary object
If non-biodegradable materials are used for the anastomotic guide, then the guide can maintain structural integrity longer, but the risk of long-term complications such as obstruction, peritonitis, and adhesions increases
Solution Approach 1:
The guide is designed with time-dependent parameter changes through the use of biodegradable materials. The structural integrity parameters are optimized to maintain support during the critical early healing phase (days to weeks), after which the material gradually degrades and loses structural properties. This controlled parameter change ensures adequate support duration while eliminating long-term complication risks associated with permanent foreign bodies
Solution Approach 2:
The anastomotic guide employs a composite laminate structure combining different biodegradable materials with complementary properties. The outer protective layer provides initial structural strength, the intermediate adhesive layer ensures tissue bonding, and the inner luminal layer maintains patency. This composite approach allows the guide to maintain structural integrity during the healing period while ensuring complete degradation afterward, thereby balancing duration of action with reduction of harmful factors
4Ease of manufacture
If a single-layer structure is used for the anastomotic guide, then the device is simpler to manufacture, but the functional performance in reducing complications is compromised
Solution Approach 1:
The guide is manufactured as a multi-layer laminate structure where each layer is produced separately with specific material properties and then bonded together. This segmentation allows optimization of each layer's manufacturing process while maintaining overall device reliability through the synergistic combination of layers with complementary functions
Solution Approach 2:
The laminate structure combines multiple biodegradable materials with different degradation rates and mechanical properties. The manufacturing process integrates these materials in a controlled sequence, with each layer contributing specific functional characteristics that collectively enhance complication reduction efficacy while remaining feasible to produce
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 guides help in reducing stricture, leakage, and adhesion risks, while easing the anastomosis procedure, potentially leading to improved patient outcomes and reduced complications by maintaining the anastomotic site integrity and facilitating quicker healing.
Implementation Method 1
the layers of the laminate structure being joined by a water soluble adhesive polymer
Implementation Method 2
The guide is made of one or multiple biocompatible and biodegradable polymer(s) or materials
Data Source
AI summary
The present invention is directed to guides for use in anastomotic procedures, and in particular in small intestine anastomosis. An anastomotic guide of the invention preferably comprises a tubular body comprising a wall having an abluminal surface, a luminal surface and two ends; the wall comprising at least one sheet of a biocompatible material in a laminate structure having two or more layers, the layers of the laminate structure being joined by a water soluble adhesive polymer, the tubular body being insertable into the lumen of an organ having a luminal surface so that the abluminal surface of the anastomotic guide contacts the luminal surface of the organ.