Implant Anchorage Devices With Polymer-Eluted Hemostasis
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Solution Overview
Problem
Existing anchorage devices for implantable medical devices often result in pocket hematomas, which increase the risk of infection and delay healing, particularly in Cardiac Implantable Electronic Device (CIED) procedures, due to postoperative bleeding and the need for anticoagulant therapy.
Innovation Solution
An anchorage device incorporating a substrate with a hemostatic agent that controls bleeding and includes a polymer to elute over time, providing support to the implantable medical device and reducing blood loss, with optional active pharmaceutical ingredients for additional therapeutic effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If anchorage devices are used to secure implantable medical devices, then device stability is improved, but pocket hematoma formation increases due to postoperative bleeding
Solution Approach 1:
The hemostatic agent is incorporated into the anchorage device before implantation, enabling it to act preemptively on blood vessels at the implantation site. This preliminary action stops bleeding before hematoma can form, resolving the contradiction between achieving stable anchorage and preventing harmful hematoma formation.
Solution Approach 2:
The hemostatic agent serves as an intermediary substance between the anchorage device and the surrounding tissue. It mediates the interaction by controlling blood flow and preventing hematoma formation while allowing the anchorage device to maintain its stabilizing function.
2Reliability
If anticoagulant therapy is used to prevent thromboembolic events, then thromboembolic risk is reduced, but postoperative bleeding and hematoma formation increase
Solution Approach 1:
The hemostatic agent provides localized hemostatic action at the implantation site, creating a zone of controlled bleeding. This local quality allows systemic anticoagulant therapy to continue for thromboembolic prevention while the local area maintains hemostasis, resolving the contradiction between preventing thromboembolism and controlling postoperative bleeding.
Solution Approach 2:
The solution segments the hemostatic function from the systemic anticoagulant therapy. The anchorage device with hemostatic agent handles local hemostasis, while systemic anticoagulants handle thromboembolic prevention, allowing both functions to coexist without contradiction.
3Stability of the object's composition
If hematomas form after device implantation, then device anchorage is achieved, but infection risk increases by 7.7 times
Solution Approach 1:
The hemostatic agent acts preliminarily to prevent hematoma formation before the device is fully implanted and before infection can occur. By stopping bleeding in advance, it eliminates the medium (hematoma) that would otherwise facilitate bacterial growth, resolving the contradiction between achieving anchorage and preventing infection.
Solution Approach 2:
The invention converts the harmful effect of bleeding into a beneficial outcome. By using the bleeding itself as a trigger for the hemostatic agent activation, the system transforms the harmful blood loss into a controlled process that actually protects against infection by preventing hematoma formation.
4Ease of operation
If hematomas require re-intervention for draining, then medical attention is provided, but healing process is delayed
Solution Approach 1:
The hemostatic agent performs preliminary hemostatic action during the initial implantation procedure, preventing hematoma formation before it can require drainage. This eliminates the need for subsequent re-interventions and allows the healing process to proceed without interruption, resolving the contradiction between providing medical intervention and minimizing healing time.
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 device effectively controls bleeding for several days, reducing the risk of hematomas and infections, thereby enhancing the healing process and device stability.
Implementation Method 1
a hemostatic agent that is configured to elute over time... stop or reduce the flow of blood at a surgical site and/or speed up the blood clotting process
Implementation Method 2
the polymer includes the hemostatic agent such that the hemostatic agent elutes over time in an area surrounding or adjacent to the anchorage device
Data Source
AI summary
An anchorage device is provided that is configured to surround an implantable medical device. The anchorage device includes a substrate and a hemostatic agent. The substrate includes a first piece and a second piece that is joined with the first piece. The first piece includes the hemostatic agent and the second piece includes an active pharmaceutical ingredient. Kits, systems and methods are disclosed.