Vascular Closure Device With Slider-Driven Reference Marker
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Solution Overview
Problem
Conventional vascular closure devices result in significant blood loss during sheath exchange and are complex to use, requiring external balloon placement for occlusion, which may not be feasible in all incision profiles, and traditional manual pressure methods are time-consuming, expensive, and uncomfortable for patients.
Innovation Solution
A vascular closure device with a slider mechanism that deploys a closure element through an introducer sheath, minimizing blood loss by facilitating hemostasis and eliminating the need for external occlusion, featuring a slider that moves to expose a reference marker for complete expansion or pivoting of the closure element within the vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional manual pressure is applied to seal the incision, then hemostasis is achieved, but the patient must remain bedridden for a substantial period and the procedure is time-consuming
Solution Approach 1:
The closure device is divided into multiple functional segments: an introducer sheath for minimal invasive access, a closure element with arms that can be independently deployed, and a deployment mechanism. This segmentation allows the hemostatic function to be achieved through a minimally invasive procedure rather than requiring prolonged bedridden manual compression
Solution Approach 2:
The closure element is designed to deploy automatically or semi-automatically within the vessel, where the arms self-adjust to engage with the vessel wall and achieve hemostasis without requiring continuous external manual pressure. The device performs the hemostatic function itself rather than relying on external compression
2Ease of operation
If an insertion sheath is removed and an introducer sheath is introduced to facilitate closure device insertion, then the closure device can be deployed, but significant blood loss occurs during sheath exchange
Solution Approach 1:
The closure element is pre-loaded within the introducer sheath in a compressed, ready-to-deploy state. The sheath maintains a sealed environment around the puncture site during insertion, and the closure element is deployed immediately upon introduction, preventing blood loss during the exchange process rather than allowing blood loss and then correcting it
Solution Approach 2:
The closure device is nested within the introducer sheath, which itself is introduced through the existing insertion sheath pathway. This nested configuration allows the closure element to be delivered through the same access route without requiring removal of the initial sheath, thereby eliminating the blood loss associated with sheath exchange
3Loss of substance
If a temporary inflated balloon is introduced for occlusion to mitigate blood loss, then blood loss is reduced, but the procedure becomes highly complex and may not be feasible in complex incision profiles
Solution Approach 1:
The complex balloon occlusion step is extracted and eliminated from the procedure. Instead of requiring balloon placement for proximal occlusion, the closure element is designed to achieve hemostasis directly at the puncture site through its deployed arms that engage with the vessel wall, simplifying the overall procedure
Solution Approach 2:
The closure element is pre-positioned within the introducer sheath such that upon deployment, it immediately engages with the vessel wall to prevent blood loss. This preliminary positioning eliminates the need for subsequent balloon occlusion steps that would be required in traditional methods
4Reliability
If conventional vascular closure devices are used, then wound closure is achieved, but the devices provide limited control and flexibility to the operator leading to improper or undesirable closure
Solution Approach 1:
The closure element features dynamic arms that can move and adjust their position independently. The arms are designed to pivot and engage with the vessel wall at optimal angles, providing the operator with control over the deployment process and allowing adaptation to different vessel geometries and incision profiles
Solution Approach 2:
Different portions of the closure element have specialized functions: some arms are designed for engagement with the vessel wall, others for maintaining seal integrity. The closure element can be deployed with varying degrees of expansion depending on the specific clinical situation, providing localized adaptation to the puncture site characteristics
Data Source
AI summary
A vascular closure system is configured to seal an incision in a vessel of the patient's body. The system includes a slider that is moved from an initial position to a deployed position (that is, towards the puncture of the patient body), until the proximal end of the slider exposes a reference marker on an inner tube. This confirms the deployment of the closure element and completely expands or opens or pivots the closure element in the blood vessel.