Tether-Driven Implant Delivery for Venous Occlusion
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Solution Overview
Problem
Current treatments for venous insufficiency, such as varicose veins and chronic venous insufficiency, often require invasive procedures like vein stripping or thermal ablation, which may not effectively address the underlying valve failure and can have limitations in occluding hollow anatomical structures like the great saphenous vein.
Innovation Solution
A method and apparatus for delivering a bioabsorbable implant with a tether system, where the implant is advanced distally within a sheath lumen using a tether mechanism, allowing for occlusion of the vein by forming a fibrotic occlusion through the body's natural foreign body healing response, potentially reducing the need for invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If vein stripping or thermal ablation is used to treat venous insufficiency, then occlusion of the vein can be achieved, but the procedure becomes highly invasive with significant patient morbidity
Solution Approach 1:
A delivery catheter system is introduced as an intermediary to deliver the occlusion implant through a minimally invasive percutaneous approach. The catheter navigates through the venous system to position the implant at the target site without requiring open surgical access, thereby reducing patient morbidity while maintaining occlusion effectiveness
Solution Approach 2:
The patent replaces the mechanical trauma of vein stripping or thermal energy application with a bioabsorbable occlusion implant that achieves vein closure through a controlled foreign body response. The implant mechanically occludes the vein lumen and initiates a biological healing process that results in permanent fibrotic occlusion, substituting invasive mechanical/thermal methods with a less invasive implant-based approach
2Object-affected harmful factors
If a bioabsorbable implant is used to occlude the vein, then the procedure becomes minimally invasive, but the mechanism of occlusion relies on the body's natural healing response which may take time to complete
Solution Approach 1:
The occlusion implant is pre-formed with a specific geometry and material composition designed to immediately occlude the vein lumen upon deployment. The implant is prepared in advance with properties that trigger the foreign body response, initiating the occlusion process at the moment of implantation rather than requiring extended treatment time
Solution Approach 2:
The patent utilizes changes in the physical and chemical parameters of the bioabsorbable implant material to control the occlusion process. The material properties are engineered to degrade at specific rates and trigger inflammatory responses that promote fibrosis, allowing control over the timing and completeness of occlusion while maintaining minimal invasiveness
3Reliability
If an occluding implant is placed in the hollow anatomical structure, then complete occlusion can be achieved, but the implant must be delivered through a complex delivery system
Solution Approach 1:
The occlusion implant is nested within a collapsible delivery catheter that can be compressed to a small profile for percutaneous insertion. The implant is contained within the catheter lumen, allowing the entire assembly to be introduced through a small puncture site. Once positioned, the catheter is expanded or the implant is released to achieve complete occlusion, simplifying the delivery process while maintaining occlusion reliability
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 solution provides a minimally invasive approach to occlude veins, promoting natural fibrotic occlusion and potentially reducing the strain and pressure associated with venous insufficiency, offering a less invasive alternative to existing treatments.
Implementation Method 1
The tether has a first portion that extends from the implant body distally within the sheath portion and around the bearing surface, where the tether changes direction, and extends back proximally, as a second portion, from the bearing surface along and within the sheath portion. The apparatus is configured to move the first tether portion proximally and thereby draw the implant body distally along and within the sheath lumen.
Data Source
AI summary
One embodiment of the apparatus comprises a housing with a sheath portion projecting distally therefrom. The sheath portion has a sheath with a lumen, and a bearing surface in the sheath lumen or aligned with the sheath lumen, and located at or near a distal end of the sheath. The implant is at least partially positioned in the apparatus, and comprises an implant body and a tether connected to the implant body. The tether extends from the implant body distally within the sheath portion and around the bearing surface, where the tether changes direction, and extends back proximally from the bearing surface along and within the sheath portion. The apparatus is configured to move the first tether portion proximally and thereby draw the implant body distally along and within the sheath lumen.