Suture Testing System for Static and Dynamic Leak Rate Evaluation
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Solution Overview
Problem
There is a need for surgical systems and methods that provide a watertight closure of arthrotomy and sealed soft tissue closure to prevent wound complications such as infections after total knee replacement surgery, and for testing sutures to select those that minimize complications and promote rapid healing.
Innovation Solution
A system and method for testing the integrity and performance of sutures used in total knee arthroplasty, involving a test bench with a continuous passive motion machine, fluid supply subsystem, and pressure monitoring to evaluate the leak rate and efficacy of suture closures under static and dynamic conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sutures are used to close surgical incisions, then the incisions can be closed effectively, but knots are required which can cause slippage, knot breakage, re-opening of the incision, and infections
Solution Approach 1:
The patent removes the knot element from the suture system by using barbed sutures that create friction and mechanical interlocking through tissue engagement, eliminating the need for knots while maintaining closure reliability
Solution Approach 2:
The suture design changes from a smooth conventional suture to a barbed suture with projecting barbs, fundamentally altering the mechanical interaction with tissue to achieve knotless securement
2Reliability
If conventional sutures with knots are used, then the incisions can be closed, but extra work is required and operating time is lengthened
Solution Approach 1:
By removing the knot-tying step entirely through the use of barbed sutures, the surgical process is simplified, reducing the time and skill required for suture placement while maintaining effective closure
3Productivity
If barbed sutures are used to achieve watertight closure, then operating time is shortened and costs are reduced, but the performance and integrity of the suture closure must be carefully evaluated
Solution Approach 1:
The testing system is divided into distinct functional modules including fluid infusion subsystem, pressure control subsystem, leakage detection subsystem, and data acquisition subsystem, allowing for systematic evaluation of suture performance
Solution Approach 2:
The patent replaces subjective visual inspection with objective electronic sensing and data acquisition systems to measure and quantify suture closure integrity under controlled conditions
4Device complexity
If sutures are tested under static conditions only, then the testing process is simple, but the dynamic performance and leak rate under motion are not evaluated
Solution Approach 1:
The testing system incorporates dynamic motion capabilities to simulate physiological conditions, allowing evaluation of suture performance under both static and dynamic loading conditions to ensure reliability in actual surgical applications
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 system allows for consistent and reliable evaluation of suture performance, ensuring a watertight closure and reducing the risk of surgical site infections by accurately measuring leak rates and pressure integrity, thereby promoting healing and minimizing complications.
Implementation Method 1
a fluid supply subsystem for infusing a fluid into an intracapsular cavity of the knee
Implementation Method 2
a pressure monitoring subsystem for monitoring a pressure level of the fluid
Implementation Method 3
The CPM machine is preferably configured to rotate between a first position in which the CPM machine is upright and located above the test bench and a second position in which the CPM machine is inverted and located below the test bench
Implementation Method 4
rotating the rotatable table and the CPM machine into the inverted configuration... and, after the infusing fluid step, collecting any of the infused fluid that passes through the surgical opening closed by the one or more sutures
Data Source
AI summary
A system for testing sutures includes a test bench having a rotatable table, a framework supporting the test bench and the rotatable table above a surface, and a continuous passive motion (CPM) machine mounted on the rotatable table. The CPM machine is configured to rotate between a first position in which the CPM machine is upright and located above the rotatable table and a second position in which the CPM machine is inverted and located below the rotatable table. The system includes a fluid supply subsystem for directing an infusion fluid toward the CPM machine, a pump for circulating the infusion fluid in the fluid supply subsystem, a heat exchanger for heating the infusion fluid, a fluid collection tray located below the CPM machine and the rotatable table, and a pressure monitoring subsystem for monitoring a pressure level of the infusion fluid.