Extravascular Balloon Hemostasis With a Separable Vessel Closure Layer
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Solution Overview
Problem
Conventional vascular closure devices (VCDs) with intravascular components pose a risk of detachment and embolic events, and manual compression is ineffective and uncomfortable, requiring prolonged patient immobilization.
Innovation Solution
The use of inflatable balloons for extravascular compression, combined with a separable hemostasis layer that remains on the vessel surface after balloon removal, and optional secondary balloons or anchors for intravascular support.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If conventional VCDs with intravascular components are used to achieve rapid hemostasis, then hemostasis speed is improved, but the risk of embolic events increases due to potential detachment of intravascular components
Solution Approach 1:
The patent removes the intravascular component from the VCD design, extracting only the necessary function of applying compression to achieve hemostasis. The extravascular balloon applies compression from outside the vessel, eliminating the risk of intravascular component detachment while maintaining rapid hemostasis capability.
Solution Approach 2:
The patent introduces a hemostasis layer as an intermediary substance between the extravascular balloon and the vessel opening. This layer facilitates effective compression transmission while allowing the balloon to be positioned extravascularly, achieving both rapid hemostasis and safety without intravascular components.
2Device complexity
If manual compression is used to achieve hemostasis, then device complexity is reduced, but hemostasis effectiveness is insufficient and patient mobilization is delayed
Solution Approach 1:
The patent divides the compression function into separate components: an inflatable balloon for applying controlled pressure and a hemostasis layer for maintaining closure. This segmentation allows for more effective and controllable hemostasis compared to simple manual compression, while still avoiding complex intravascular device placement.
3Speed
If intravascular components are used in VCDs to achieve rapid hemostasis, then hemostasis speed is improved, but device reliability decreases due to potential component detachment
Solution Approach 1:
The patent extracts the intravascular component from the VCD system, positioning the balloon extravascularly instead. This eliminates the reliability issue of intravascular component detachment while preserving the rapid hemostasis function through effective external compression.
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
Rapid hemostasis is achieved without leaving intravascular components, reducing the risk of embolic events and allowing early patient mobilization.
Implementation Method 1
the first balloon exerts pressure on the opening to achieve hemostasis
Data Source
AI summary
A system for performing vascular hemostasis comprises a balloon insertable into a tissue track so as to be disposed outside a vessel above an opening formed in the vessel. A hemostasis layer is removably disposed on at least a portion of an outer surface of the balloon. A balloon tube is fluidly coupled to the balloon and configured to selectively inflate or deflate the balloon. The balloon is inflatable above the opening such that the hemostasis layer is disposed on the outer surface of the vessel and closes the opening. The hemostasis layer is separable from the balloon so as to remain disposed on the outer surface of the vessel when the balloon is removed from the tissue track, and continues to close the opening after removal of the balloon.