Hemostatic Anchorage Device for Pacemaker Implantation
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Solution Overview
Problem
Current anchorage devices for implantable medical devices lack effective solutions for reducing bleeding and infection at surgical sites, leading to increased costs and complications such as surgical site infections (SSIs).
Innovation Solution
A surgical system comprising a substrate coated with a hemostatic agent, specifically collagen and glycerin, which includes a hemostatic agent like tranexamic acid, applied to an anchorage device to prevent bleeding and infection, utilizing a novel coating that forms a conformal, anti-bacterial surface to anchor implantable medical devices like pacemakers or cardioverter-defibrillators.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional anchorage device is used to secure an implantable medical device, then the device can be anchored to surrounding tissue, but bleeding and infection risks remain high at the surgical site
Solution Approach 1:
The patent combines multiple functions into a single anchorage device: mechanical anchoring capability, hemostatic function through tranexamic acid coating, and antibacterial function through gentamicin sulfate coating. This integration allows the device to simultaneously secure the implantable medical device while preventing bleeding and infection at the surgical site.
Solution Approach 2:
The hemostatic and antibacterial coatings are applied to the anchorage device before implantation. The tranexamic acid coating is applied first, followed by the gentamicin sulfate coating, so that both protective functions are already in place when the device is implanted, preventing bleeding and infection proactively rather than reacting to them afterward.
2Object-affected harmful factors
If hemostatic agents are applied topically during surgery, then bleeding can be controlled, but the effect is temporary and requires repeated application
Solution Approach 1:
The hemostatic agent (tranexamic acid) is pre-applied to the anchorage device surface before implantation. This preliminary application ensures that the hemostatic effect is present from the moment of implantation and continues as the device remains in place, providing prolonged protection without requiring repeated intraoperative applications.
Solution Approach 2:
The anchorage device itself serves as the carrier for the hemostatic agent, eliminating the need for separate hemostatic applications. The device's structure provides the platform for drug delivery, and its presence at the surgical site automatically maintains the hemostatic effect throughout the healing period.
3Object-affected harmful factors
If antibiotics are administered systemically to prevent infection, then infection risk can be reduced, but antibiotic resistance develops and side effects increase
Solution Approach 1:
The patent extracts the antibacterial function from systemic antibiotic administration and places it directly at the surgical site through a local coating on the anchorage device. The gentamicin sulfate coating provides targeted infection prevention exactly where needed, eliminating the need for systemic antibiotics and their associated risks of resistance and side effects.
Solution Approach 2:
The anchorage device coating acts as an intermediary between the need for infection prevention and the patient's body. Instead of introducing systemic antibiotics that circulate throughout the body, the gentamicin sulfate coating serves as a localized intermediary that prevents bacterial adhesion and infection only at the surgical site, preserving antibiotic effectiveness.
4Object-affected harmful factors
If a conformal coating is applied to the anchorage device, then hemostatic and antibacterial effects are enhanced, but the manufacturing process becomes more complex
Solution Approach 1:
The patent segments the coating process into two distinct steps: first applying the tranexamic acid hemostatic coating, then applying the gentamicin sulfate antibacterial coating. This segmentation allows each coating to be optimized independently and simplifies the overall manufacturing process compared to attempting to combine both functions in a single coating layer.
Solution Approach 2:
Each coating is applied with specific local quality in mind: the tranexamic acid coating provides hemostatic properties, while the gentamicin sulfate coating provides antibacterial properties. This local quality approach allows each layer to perform its specific function effectively without compromising the other, maintaining manufacturing simplicity while enhancing overall efficacy.
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 effectively reduces bleeding and infection risks by promoting hemostasis and preventing bacterial adhesion, potentially minimizing the use of antibiotics and enhancing healing outcomes.
Implementation Method 1
stop or reduce the flow of blood at a surgical site and/or speed up the blood clotting process
Implementation Method 2
forming a conformal, anti-bacterial surface
Data Source
AI summary
A package for a surgical implant includes a body having a side wall including opposite top and bottom ends. The body includes a bottom wall coupled to the bottom end. The body includes a flange extending outwardly from the top end. Inner surfaces of the walls define a cavity. The top end defines an opening that is in communication with the cavity. An insert extends from the bottom wall such that the insert is positioned in the cavity. A lid is configured to be coupled to the flange such that the lid covers the opening. Devices, kits and systems are disclosed.