Anchorage Device Kit With Separate Hemostatic Agent
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Solution Overview
Problem
Current anchorage devices for implantable medical devices face challenges in managing postoperative bleeding, particularly in Cardiac Implantable Electronic Device (CIED) procedures, where pocket hematomas are common and increase the risk of infection, requiring a large inventory of devices with varying hemostatic agents to accommodate different types of devices and patient sizes.
Innovation Solution
A kit comprising an anchorage device with a mesh substrate coated with a polymer that elutes an active agent, separate from a hemostatic agent, which can be delivered before, during, or after implantation to reduce bleeding and infection, featuring a soluble polymer and active agents like tranexamic acid, collagen, and antibiotics to control bleeding effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If hemostatic agents are incorporated into anchorage devices, then bleeding control is improved, but device complexity and inventory requirements increase
Solution Approach 1:
The patent separates the hemostatic agent from the anchorage device into distinct components. The anchorage device contains only the mesh substrate and polymer without embedded hemostatic agents, while hemostatic agents are provided as separate items that can be applied independently. This segmentation allows each component to be standardized and simplifies inventory management while maintaining effective bleeding control through the combination of components.
Solution Approach 2:
The patent creates a universal anchorage device design that can be used with multiple types of implantable medical devices (pacemakers, ICDs, etc.) without requiring device-specific hemostatic agent combinations. The standardized anchorage device paired with separate hemostatic agent options provides multi-functionality across different surgical scenarios while reducing the need for specialized inventory items for each device type.
2Reliability
If multiple types of hemostatic agents are used for different device types and patient sizes, then treatment effectiveness is improved, but ease of operation decreases
Solution Approach 1:
By segmenting the hemostatic agents into separate, pre-packaged items rather than incorporating them into the anchorage device, the patent allows surgical teams to select and prepare only the specific hemostatic agents needed for each procedure. This eliminates the complexity of managing multiple anchorage device variants with different hemostatic agents while maintaining the ability to provide effective treatment for different device types and patient sizes.
3Reliability
If hemostatic agents are incorporated into the anchorage device, then bleeding control is improved, but manufacturing complexity increases
Solution Approach 1:
The patent divides the product into separately manufacturable components: the anchorage device (mesh substrate and polymer) and the hemostatic agents. This segmentation allows each component to be manufactured independently using optimized processes, avoiding the complexity of incorporating hemostatic agents during anchorage device manufacturing. The separate components can then be assembled or applied during surgery as needed.
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 solution provides predictable and effective control of bleeding, reducing the risk of infection and hematoma formation, allowing for a more streamlined inventory and improved surgical outcomes by delivering the hemostatic agent separately from the anchorage device.
Implementation Method 1
The polymer comprises an active agent that is configured to elute over time
Implementation Method 2
the hemostatic agent prevents or reduces bleeding at a target site
Data Source
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AI summary
A kit includes a mesh substrate and a polymer that is fixed to the mesh substrate. The polymer includes an active agent that is configured to elute over time. The kit further includes a hemostatic agent. The hemostatic agent is separate from the mesh substrate and the polymer. Systems and methods are disclosed.