Inflatable Balloon Vascular Access Device for Hemostatic Closure
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Solution Overview
Problem
Conventional surgical and interventional procedures require invasive methods, including open surgical techniques and cardiopulmonary bypass, which increase morbidity, mortality, and recovery time, and pose challenges in closing large bore vascular access sites effectively.
Innovation Solution
Development of vascular access devices with inflatable balloons that form hemostatic connections within vessels, allowing for minimally invasive procedures without cardiopulmonary bypass and enabling endovascular closure of large bore vascular access sites through smaller peripheral access sites.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional open surgical techniques or thoracoscopic procedures are used for coronary bypass, then access to the heart and vessels is achieved, but morbidity, mortality, and recovery time increase due to invasive procedures and cardiopulmonary bypass requirement
Solution Approach 1:
The patent inverts the traditional approach by performing coronary bypass procedures through peripheral vascular access (radial, brachial, or femoral arteries) rather than direct surgical access to the chest. The procedure is performed retrograde through the vascular system, eliminating the need for sternotomy, thoracoscopy, and cardiopulmonary bypass, thereby significantly reducing invasiveness and improving patient safety
Solution Approach 2:
The patent uses the peripheral arterial system as an intermediary pathway to reach the coronary arteries. Instead of directly accessing the heart, the procedure utilizes the existing vascular network (radial, brachial, or femoral arteries) as a conduit to deliver bypass grafts to the coronary vessels, enabling minimally invasive revascularization
2Ease of operation
If percutaneous access is used for intravascular procedures, then smaller access incisions are made, but closure of large bore vascular access sites (21 French) remains difficult
Solution Approach 1:
The patent segments the closure function into multiple components: an occlusion device with expandable elements (balloon or mesh) that can be deployed within the vessel at the access site, and a delivery system for placing the device. This segmentation allows the closure mechanism to be independently optimized and deployed through the same percutaneous access
Solution Approach 2:
The patent employs a nested structure where the occlusion device is contained within a delivery catheter or sheath. The occlusion device (balloon or mesh cylinder) is collapsed within the delivery system for percutaneous insertion, then expanded at the target access site to achieve closure, enabling the closure function to be delivered through minimal access
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
These devices allow for reduced blood loss, minimized trauma and infection risk, shorter recovery times, and more efficient performance of cardiac procedures like coronary bypass without the need for cardiopulmonary bypass, while effectively sealing larger vascular holes from within the vessel.
Implementation Method 1
an inflatable balloon which, when inflated, forms a hemostatic connection with a wall of the vessel
Data Source
AI summary
Vascular access devices, systems, and methods of their use are provided. In one embodiment, a vascular access device includes a catheter, a balloon, and an inflation lumen. The catheter includes an elongate flexible shaft having a proximal end and a distal end with a primary lumen therethrough. The balloon is disposed about the distal end of the catheter. The inflation lumen is in fluid communication with the balloon and extends toward the proximal end of the shaft of the catheter. The balloon is inflatable into a shape having a first open end, a second open end, a sidewall between the first and second open ends, and a passageway therethrough, which, when the balloon is deployed and inflated within a vessel, permits blood flowing in the vessel to flow through the passageway. The balloon further includes a balloon lumen which is coupled at its first end to the primary lumen of the catheter and which extends to an aperture in the sidewall of the balloon, thereby providing a hemostatic connection and luminal access to a wall of the vessel via the primary lumen of the catheter.