Expandable Tubular Occlusion Device for Vascular Puncture Sealing
Solution Overview
Problem
Current methods for occluding vascular punctures and sealing openings in the body are inefficient, requiring significant time, skill, and risk of complications such as hematoma and embolism, with existing devices being difficult to position and manufacture, and having large cross-sectional profiles that hinder delivery through small sites.
Innovation Solution
A device with an outer elongate tubular body that expands to form wings, featuring a slide tube and guide member to occlude fluid flow, and an optional tether for positioning, allowing for precise occlusion and fluid management through slits and torsional forces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external pressure is applied to the puncture site until clotting and wound sealing occur, then hemostasis is achieved, but the procedure becomes time consuming (up to an hour) and requires patient immobilization
Solution Approach 1:
The device is inserted into the puncture site before the natural clotting process is complete, with the balloon already positioned and ready to be inflated. This preliminary placement allows the sealing mechanism to be activated immediately without waiting for spontaneous clotting to occur, thereby reducing the overall time required to achieve hemostasis.
Solution Approach 2:
The patent replaces the passive mechanical compression method (applying external pressure) with an active inflatable balloon mechanism. The balloon, when inflated, creates controlled pressure against the vessel wall to seal the puncture site, substituting the need for prolonged external manual pressure with a more efficient mechanical sealing system that achieves hemostasis faster.
2Reliability
If a biodegradable plug is delivered through an introducer sheath into a puncture site, then the puncture is sealed, but the plug is difficult to position properly with respect to the vessel
Solution Approach 1:
The patent introduces a guidewire as an intermediary element that is first positioned within the vessel to establish the correct path and target location. The balloon catheter is then advanced over the guidewire, allowing the operator to use the guidewire as a guide for accurate positioning of the balloon at the puncture site, thereby solving the positioning difficulty.
Solution Approach 2:
The guidewire is inserted and positioned beforehand to establish the optimal pathway and target location. This preliminary action provides a reliable reference for subsequently positioning the balloon catheter accurately at the puncture site, ensuring proper alignment before the sealing operation begins.
3Reliability
If percutaneous suturing is used to close an opening, then the opening is sealed, but the device requires significant user skills and is mechanically complex and expensive to manufacture
Solution Approach 1:
The patent extracts the complex suturing mechanism from the closure system and replaces it with a simpler inflatable balloon mechanism. By removing the need for sutures, needles, and complex stitching operations, the device achieves opening closure through a much simpler mechanical inflation process, thereby reducing device complexity and manufacturing costs.
Solution Approach 2:
The patent replaces the complex mechanical suturing system with a simpler inflatable balloon system. Instead of requiring needles, sutures, and complex stitching mechanisms, the closure is achieved through balloon inflation that creates a seal against the vessel wall, significantly simplifying the mechanical system and reducing manufacturing complexity.
4Reliability
If a device with a large cross-sectional profile is used for occlusion, then effective sealing is achieved, but delivery through small sites becomes difficult
Solution Approach 1:
The patent employs a nested structure where the balloon is contained within a catheter shaft, and both are advanced over a guidewire. The balloon remains compressed within the catheter during delivery through small puncture sites, then is inflated only after successful positioning. This nesting allows the device to have a small delivery profile while achieving effective occlusion when deployed.
Solution Approach 2:
The patent uses a dynamic balloon that transitions from a compressed, low-profile state during delivery to an inflated, sealing state at the target location. The balloon can be selectively inflated and deflated, allowing it to adapt its size according to the delivery requirements versus the sealing requirements, thereby overcoming the contradiction between delivery profile and occlusion effectiveness.
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 effectively occludes openings with minimal trauma, reduces procedural time, and minimizes complications by allowing for precise expansion and positioning, enhancing hemostasis and fluid control.
Implementation Method 1
The proximal and distal portions can be configured to expand in response to a torsional force that is applied to the outer elongate tubular body
Implementation Method 2
Both a proximal portion and a distal portion of the outer elongate tubular body can have a plurality of slits formed therein. The slits are configured to allow the proximal and distal portions to expand to form proximal and distal wings
Data Source
AI summary
Devices and methods for occluding or promoting fluid flow through openings are disclosed. In one exemplary embodiment an occlusion device is provided having an expandable outer elongate tubular body, a guide member extending from a distal end of the outer body, and a slide tube disposed within the outer body, the proximal portions of the outer body and the slide tube being fixedly mated. The slide tube is configured to slide distally within the outer tubular body when the tubular body is expanded to form wings. A tether can be included as part of the device and it can be used to assist in positioning and locking a location of the device in an opening. Exemplary methods for delivering devices disclosed herein are also provided.