Expandable Stent Graft with Split Sheath for Vascular Repair
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Solution Overview
Problem
Current methods for treating vascular trauma, such as temporary shunts and vessel ligation, are time-consuming, require high skill, and can lead to complications like clot formation and muscle necrosis, often necessitating specialized physician intervention and prolonged patient stabilization.
Innovation Solution
A stent/graft device and method for intraoperative placement in body vessels, comprising an expandable cylindrical stent body with a graft material and connectors, designed to be positioned and secured within the vessel to inhibit migration, allowing for rapid and effective repair of damaged vessel portions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If temporary shunts are used to restore blood flow, then blood flow is restored and blood loss is stopped, but clot formation occurs and requires return to operating room within 36-48 hours
Solution Approach 1:
The patent employs a disposable stent/graft device that is inserted, used once, and then removed. The device is designed as a single-use implant that performs its function of restoring blood flow and preventing clot formation during the critical period, after which it is removed and a permanent graft is placed. This eliminates the need for long-term retention of temporary shunts and reduces the risk of clot formation associated with prolonged shunt placement.
Solution Approach 2:
The patent utilizes expandable stents that change their physical parameters (diameter, volume) from a compressed delivery state to an expanded functional state. The stent transitions from a small profile for insertion through the vessel to a larger expanded state that provides structural support and prevents clot formation, thereby changing the physical parameters to achieve the desired therapeutic effect.
2Reliability
If vessel ligation is performed to treat vascular injury, then vascular injury is treated, but muscle necrosis, loss of muscle function, edema, or compartment syndrome occurs with potential limb loss
Solution Approach 1:
The patent extracts the damaged vessel segment and replaces it with a stent/graft device that restores blood flow without requiring ligation. By removing the need for ligating the vessel, the invention prevents the harmful effects of muscle necrosis, edema, and compartment syndrome that would otherwise result from vessel occlusion, thereby preserving limb function.
Solution Approach 2:
The expandable stent device changes the hemodynamic parameters of the damaged vessel segment by providing structural support that restores and maintains blood flow. This parameter change from a damaged, non-functional state to a restored, flow-positive state eliminates the need for ligation and its associated harmful effects.
3Reliability
If traditional vascular repair methods are used, then vascular trauma is treated, but the process is time-consuming and requires high physician skill
Solution Approach 1:
The stent/graft device is pre-assembled and pre-positioned within a delivery catheter before insertion. This preliminary preparation allows the device to be inserted as a complete unit into the damaged vessel, eliminating the need for time-consuming in-situ assembly and reducing the skill level required during the critical emergency phase.
Solution Approach 2:
The patent introduces a delivery catheter as an intermediary device that facilitates the insertion of the stent/graft. The catheter acts as a mediator between the operator and the stent, allowing for guided placement through the vessel system and simplifying the procedure for emergency physicians by providing a straightforward insertion mechanism.
4Reliability
If specialized physician skills are required for vascular trauma treatment, then treatment effectiveness is improved, but access to specialized physicians is limited and response time is delayed
Solution Approach 1:
The stent/graft device is designed to be self-positioning and self-expanding once introduced into the vessel. The device performs its own function of restoring blood flow and preventing clot formation without requiring complex manipulation or specialized skills during deployment, thereby enabling emergency physicians to perform the procedure effectively and quickly.
Solution Approach 2:
The expandable stent mechanism allows for rapid deployment by changing the device parameters from a compressed insertion state to an expanded functional state. This parameter change can be achieved quickly with simple manipulation, enabling emergency physicians to restore blood flow rapidly without requiring specialized vascular surgery skills.
Data Source
AI summary
An assembly for open surgical repair of a damaged wall portion of a body vessel includes a stent/graft device comprising an elongated stent body and a graft material covering the stent body. The device is expandable from a compressed condition having a diameter less than a diameter of the vessel to an expanded condition at least as great as the diameter of the vessel. A sheath enclosing the device when in the compressed condition includes a sheath body and a pull string for selectively splitting the sheath body to allow expansion of the device. The device and enclosing sheath are sized for insertion through the damaged wall portion into the vessel, wherein the pull string is extendable through the damaged wall portion for splitting the sheath body.