Sternal Tie Plug Assembly for Bleeding-Resistant Closure
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Solution Overview
Problem
Current sternal wire closure methods cause bleeding from needle holes, sternal malunion, and dehiscence, leading to prolonged operative times, increased surgical complications, and higher patient mortality rates due to the need for re-operation and blood transfusions.
Innovation Solution
A sternal tie assembly with a plug system that includes a needle, suture material, and posterior and anterior plugs to secure the sternum, distributing force over a larger bone surface, reducing bleeding and stabilizing the sternum, using a plug system that includes a needle, suture material, and posterior and anterior plugs to secure the sternum, distributing force over a larger bone surface.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sternal wires are used for closure, then sternal re-approximation is achieved, but bleeding from needle holes occurs and sternal malunion/dehiscence results
Solution Approach 1:
A plug is introduced as an intermediary element between the sternal wire and the bone. The plug fills the needle hole created by the wire, preventing direct contact between the wire and bone that causes erosion and bleeding. This mediator component resolves the harmful effects while maintaining the closure function.
Solution Approach 2:
The closure system is divided into separate functional components: the sternal wire for re-approximation, the plug for hemostasis and bone protection, and the suture material for securing. This segmentation allows each component to perform its specific function optimally without the drawbacks of traditional integrated wire systems.
2Ease of manufacture
If traditional wire closure is used, then simple and inexpensive closure is achieved, but prolonged operative times and increased re-operation are required
Solution Approach 1:
Multiple functions are merged into a single integrated assembly: the sternal wire, plug, and suture material are combined into one unit that can be implanted in a single surgical motion. This eliminates the need for separate steps to place wires, fill needle holes with additional materials, and secure everything, thereby reducing operative time while maintaining simplicity.
3Strength
If sternal wires are tightened to secure the sternum, then closure strength is improved, but excess force on sternal bone causes erosion and non-union
Solution Approach 1:
The plug serves as a protective intermediary between the tightened wire and the sternal bone. It distributes the compressive forces from the wire over a larger surface area of the bone, preventing stress concentration that leads to erosion. The plug absorbs and disperses the mechanical load, protecting the bone while maintaining closure strength.
Solution Approach 2:
The plug provides localized protection at the needle hole site where stress concentration occurs, while allowing the wire to maintain its tightening force elsewhere. This local intervention prevents bone erosion at critical points without compromising the overall closure strength.
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
Reduces blood loss and sternal dehiscence rates, shortens operative times, and improves patient outcomes by stabilizing the sternum, thereby decreasing the need for re-operation and transfusions.
Implementation Method 1
distributing force over a larger bone surface
Implementation Method 2
A sternal tie assembly with a plug system that includes a needle, suture material, and posterior and anterior plugs to secure the sternum
Data Source
Figure 1
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Figure 4
AI summary
A sternal tie assembly having a pair of hook-shaped needles, a length of sternal tie extending from a proximal end of each of the needles, and a pair of posterior plugs, each of the posterior plugs being slidably mounted on the tie and tethered, via suture material, to the proximal end of a respective one of the needles. A method of use of the sternal tie assembly includes creation of a hole or channel in sternum, manubrium, rib, rib cartilage, intercostal muscle, or other tissue, drawing a portion of the tie and the suture material through the channel formed in the tissue by the needle, severing the needle from the tie and suture material, continuing to advance the suture material until a post of each of the posterior plugs is pulled into the respective channel in the tissue, or at least until a head of the plug is disposed against the channel in the tissue, then threading an anterior plug onto each exposed end of the sternal tie, securing the anterior plugs into respective anterior openings in the tissue, then crossing and twisting the sternal tie ends together until the tissue ends are closed together.