Expandable Balloon for Temporary Hemostasis and Sealing Material Delivery
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Solution Overview
Problem
Current methods for sealing percutaneous punctures in blood vessels are time-consuming, uncomfortable for patients, and risk hematoma due to incomplete hemostasis and leakage of sealing materials, which can lead to embolism.
Innovation Solution
A device with an expandable member, such as a balloon, is introduced into the puncture site to provide hemostasis by expanding within the vessel and optionally delivering a sealing compound, ensuring effective sealing and minimizing blood flow until the material solidifies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external pressure is applied to seal the puncture, then hemostasis is achieved, but the procedure becomes time-consuming and requires patient immobilization
Solution Approach 1:
The device performs preliminary action by deploying an expandable member (balloon) at the puncture site before removing the introducer sheath. This balloon is inflated to temporarily seal the puncture, preventing blood leakage during the subsequent sealing material delivery process. This preliminary sealing action eliminates the need for prolonged external compression after sheath removal.
Solution Approach 2:
The expandable balloon acts as an intermediary device between the puncture site and the sealing material. It provides temporary mechanical occlusion of the puncture, allowing controlled delivery of sealing material into the vessel while preventing uncontrolled blood leakage into the surrounding tissue. The balloon mediates the transition from open puncture to sealed closure.
2Ease of operation
If the introducer sheath is removed to deliver sealing material, then sealing access is improved, but hematoma risk increases due to uncontrolled bleeding
Solution Approach 1:
The introducer sheath is removed in advance before sealing material delivery, allowing direct access to the puncture site. However, the expandable balloon is deployed first to seal the puncture, creating a controlled environment that prevents hematoma formation during the subsequent sealing material delivery process.
Solution Approach 2:
The expandable balloon serves as a protective intermediary that remains in place after sheath removal. It continuously seals the puncture during sealing material delivery, preventing blood from leaking into surrounding tissue while allowing controlled injection of sealing material into the vessel lumen.
3Reliability
If sealing material is delivered into the puncture, then hemostasis is enhanced, but embolism risk increases from material leakage into the vessel
Solution Approach 1:
The expandable balloon is deployed in advance to create a physical barrier that prevents sealing material from leaking into the vessel lumen. This preliminary protective action counteracts the potential harmful effect of embolism by blocking the migration path of sealing material into the blood flow before the material can cause harm.
Solution Approach 2:
The expandable balloon acts as a protective intermediary barrier between the sealing material and the vessel lumen. It allows controlled delivery of sealing material into the puncture site while preventing uncontrolled leakage into the bloodstream, thus eliminating embolism risk.
4Reliability
If a collagen plug is delivered into the puncture, then sealing is achieved, but the device complexity increases for effective isolation and delivery
Solution Approach 1:
The device is segmented into distinct functional components: an introducer sheath for initial access, an expandable balloon for puncture sealing, and a delivery mechanism for sealing material. This segmentation allows each component to perform its specific function independently, simplifying the overall operation compared to integrated complex systems.
Solution Approach 2:
The expandable balloon is deployed in advance to seal the puncture before sealing material delivery. This preliminary action simplifies the subsequent delivery process by creating a controlled environment, eliminating the need for complex isolation mechanisms that would otherwise be required to prevent blood leakage during material injection.
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 rapidly achieves hemostasis, reduces the risk of hematoma, and allows for efficient sealing of blood vessels, providing a comfortable and effective solution for patients by ensuring the sealing material does not leak into the vessel during application.
Implementation Method 1
A device with an expandable member, such as a balloon, is introduced into the puncture site to provide hemostasis by expanding within the vessel
Implementation Method 2
The hub may include a valve communicating with the interior, and a plunger having a fluid port thereon that is movable into and out of the valve
Implementation Method 3
The plunger may be advanceable into the valve to open the valve and allow fluid to be evacuated from the interior
Implementation Method 4
The plunger may be biased such that when the plunger is released, it automatically withdraws from the valve, allowing the valve to close again to its one-way configuration
Data Source
AI summary
An apparatus for providing hemostasis within a puncture through tissue includes an elongate member having a lumen extending between proximal and distal ends thereof, an expandable member carried on the distal end and a housing on the proximal end, the housing including an interior communicating with the lumen, and further including a valve assembly with a one-way valve allowing access into the housing interior upon application of a pressure differential across the valve, and a movable plunger for overriding and opening the valve.