Dual Balloon Puncture Closure Device
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for sealing percutaneous punctures in the body, such as those in blood vessels, are time-consuming, uncomfortable for patients, and can lead to vascular complications due to incomplete hemostasis, often requiring manual compression and risking hematoma formation.
Innovation Solution
A system comprising an occlusion catheter and an anchor catheter with expandable balloons that are deployed to seal the puncture site, allowing for controlled inflation to achieve hemostasis without intravascular impairment, enabling the patient to move and reducing the need for manual compression.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external pressure is applied manually or using sandbags to seal the puncture, then hemostasis is achieved, but the procedure becomes time-consuming and requires prolonged patient immobilization
Solution Approach 1:
The puncture sealing function is segmented into two distinct balloon components: an intravascular balloon positioned within the vessel to occlude the puncture opening, and an extravascular balloon positioned in the tissue tract to seal the puncture pathway. This segmentation allows each balloon to address specific aspects of hemostasis independently, achieving reliable sealing without requiring prolonged external compression.
Solution Approach 2:
The dual-balloon system acts as an intermediary mechanism between the puncture site and the need for external compression. Instead of applying prolonged manual pressure or sandbag weight directly to the puncture site, the balloons provide intermediate sealing forces at both the intravascular and tissue tract levels, achieving hemostasis more quickly and comfortably.
2Reliability
If external pressure is applied manually to seal the puncture, then hemostasis is achieved, but patient comfort deteriorates and immobilization is required
Solution Approach 1:
By segmenting the sealing function into intravascular and extravascular components, the system eliminates the need for uncomfortable prolonged external compression. The intravascular balloon seals the puncture from within the vessel, while the extravascular balloon seals the tissue tract, together providing effective hemostasis without requiring the patient to remain immobilized or tolerate uncomfortable pressure.
Solution Approach 2:
The manual mechanical compression system (hands or sandbags) is replaced with an inflatable balloon system that can be precisely positioned and controlled. The balloons provide consistent sealing force without requiring the patient to maintain any particular position, significantly improving comfort while maintaining hemostasis reliability.
3Device complexity
If a single balloon is used to seal the puncture, then device complexity is reduced, but complete hemostasis cannot be achieved and vascular complications occur
Solution Approach 1:
The sealing function is divided into two segments: the intravascular balloon addresses the puncture opening within the vessel to prevent blood loss, while the extravascular balloon addresses the tissue tract to seal the puncture pathway. This segmentation ensures complete hemostasis by addressing both critical locations, overcoming the limitations of a single-balloon design without excessive complexity.
Solution Approach 2:
The two balloons are delivered through a nested configuration where the extravascular balloon catheter is positioned within the intravascular balloon catheter system. This nested delivery mechanism allows both balloons to be introduced through the same puncture site and deployed in sequence, achieving complete hemostasis while managing device complexity through integrated delivery.
4Reliability
If prolonged balloon inflation is used to achieve hemostasis, then complete sealing is achieved, but intravascular blood flow may be impaired
Solution Approach 1:
The sealing function is segmented between two balloons positioned at different locations: the intravascular balloon is positioned at the puncture site within the vessel to provide immediate sealing, while the extravascular balloon is positioned in the tissue tract to maintain prolonged sealing. This segmentation allows the intravascular balloon to be deflated after initial sealing, removing the source of blood flow impairment while maintaining hemostasis through the extravascular balloon.
Solution Approach 2:
The intravascular balloon provides preliminary sealing action to immediately stop blood flow at the puncture site, allowing time for the extravascular balloon to be properly positioned and inflated. Once the extravascular balloon is in place and providing sustained sealing, the intravascular balloon can be deflated and removed, eliminating the harmful effect on blood flow while maintaining the sealing benefit.
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 system effectively seals punctures, promoting complete hemostasis, reducing patient discomfort, and minimizing the risk of complications, allowing for ambulation and potentially reducing procedure time and costs.
Implementation Method 1
The balloon is expandable from a collapsed state to an expanded state when fluid is introduced into the inflation lumen
Data Source
AI summary
A system is provided for causing hemostasis at a puncture and a puncture tract. The system includes an inner member comprising an expandable member at its distal end and an inflation lumen that extends from inner member proximal end to an interior of the expandable member. The system further includes an outer member comprising a lumen sized and shaped to allow the inner member to slide therein, an occlusion balloon at its distal end, and an inflation lumen that extends from its proximal end to the interior of the occlusion balloon. The expandable member can be inflated by fluid flowing through the inner member inflation lumen so that the expandable member can close a puncture in a subcutaneous vessel of a living being. The occlusion balloon can be inflated by fluid flowing through the outer member inflation lumen so that the occlusion balloon can contact and apply pressure to a puncture tract extending from the skin of the living being to the puncture.