Dual Occlusion Plug Vascular Sealing for Reliable Hemostasis
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Solution Overview
Problem
Current vascular closure devices (VCDs) require expertise, have a steep learning curve, and may fail to achieve effective hemostasis, leading to prolonged bleeding or complications such as hematoma formation and pseudoaneurysms, necessitating further interventions.
Innovation Solution
A vascular sealing device with a guidewire and sheath member, featuring dual occlusion plugs that can be deployed inside and outside the blood vessel to apply controlled pressure for hemostasis, using biocompatible and potentially bioabsorbable materials, and incorporating radio-opaque markers for real-time visualization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If Vascular Closure Devices (VCDs) are used to stop bleeding, then hemostasis is achieved, but the device requires proper training and expertise to minimize complications
Solution Approach 1:
The device segments the closure function into two independent plugs: an internal occlusion plug deployed inside the blood vessel and an external occlusion plug deployed outside the blood vessel. This segmentation allows each plug to perform a specific function independently, simplifying the overall operation and reducing the training required while maintaining reliable hemostasis.
Solution Approach 2:
The sheath member acts as an intermediary delivery system that guides both occlusion plugs to their respective deployment locations. The sheath provides a controlled pathway for deploying the plugs, making the device easier to operate while ensuring reliable placement for effective hemostasis.
2Reliability
If VCDs are used to close arterial access sites, then bleeding is stopped, but complications such as hematoma formation and pseudoaneurysms may occur
Solution Approach 1:
By dividing the occlusion function into internal and external plugs, the device distributes the hemostatic action across two separate locations. This reduces the concentration of force and pressure at any single point, thereby minimizing the risk of complications such as hematoma formation and pseudoaneurysm while maintaining effective bleeding control.
Solution Approach 2:
The internal occlusion plug is specifically designed to occlude the vessel lumen from the inside, while the external occlusion plug addresses the external tissue layer. This local differentiation of function ensures that each plug addresses specific aspects of hemostasis, improving reliability while reducing harmful effects on surrounding tissues.
3Reliability
If manual compression is applied to achieve hemostasis, then bleeding is stopped, but prolonged compression times and patient discomfort occur
Solution Approach 1:
The occlusion plugs are pre-formed and ready for deployment, eliminating the need for prolonged manual compression. The plugs can be quickly deployed through the sheath member to achieve immediate hemostasis, significantly reducing the time required compared to traditional manual compression methods while maintaining reliable bleeding control.
4Reliability
If VCDs are used to achieve effective hemostasis, then bleeding is controlled, but inconsistent pressure application occurs
Solution Approach 1:
The occlusion plugs are designed to self-adjust to the vessel wall and surrounding tissues upon deployment. The plugs automatically conform to the anatomical structures they contact, ensuring consistent pressure application without requiring precise manual control from the operator. This self-adjusting mechanism improves both reliability and ease of operation.
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 provides rapid and reliable hemostasis with reduced complications, minimizing the need for specialized training and equipment, and ensuring secure sealing of vascular access points.
Implementation Method 1
The at least one occlusion plug is configured to selectively operate in an inflated configuration and a deflated configuration to apply a controlled pressure to an interior portion of the blood vessel and an exterior portion of the blood vessel at the vascular access point
Data Source
AI summary
The present disclosure relates to a vascular sealing device. The vascular sealing device includes a guidewire, a sheath member, and an occlusion plug. The guidewire is deployable into a blood vessel through a vascular access point of a subject. The sheath member defines a hollow cavity along a length of the sheath member. The hollow cavity allows insertion of the guidewire therein. The sheath member is deployable from the guidewire and is configured to be positioned in a lumen of the blood vessel. The occlusion plug is deployable from the sheath member and positioned at the lumen of the blood vessel. The occlusion plug selectively operates in an inflated configuration and a deflated configuration to apply a controlled pressure to an interior portion of the blood vessel and an exterior portion of the blood vessel at the vascular access point to occlude the vascular access point of the blood vessel.