Perfusion Device With Self-Expanding Stent Seal for Aortic Hemorrhage
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Solution Overview
Problem
Current methods for managing hemorrhage from aortic injuries, particularly in military and civilian settings, face challenges in controlling bleeding without occluding the vessel, especially in scenarios where advanced medical equipment and expertise are not readily available, leading to risks of organ failure and ischemia during transport to a medical facility.
Innovation Solution
An implantable perfusion device with an expandable sealing member, such as an inflatable balloon or self-expandable stent, is deployed in the injured aorta to create a blood-impermeable seal while allowing antegrade blood flow, enabling minimization of bleeding and perfusion downstream of the injury, and can be positioned using portable markers or sensors without conventional fluoroscopy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional clamp and sew approach is used to repair aortic pathology, then the injury can be repaired, but distal ischemia and organ failure occur during repair
Solution Approach 1:
The device segments the aorta into proximal and distal sections relative to the injury site. The seal member isolates the injury zone while perfusion ports provide dedicated flow paths to distal vessels, separating the bleeding control function from the perfusion function to prevent distal ischemia during repair.
Solution Approach 2:
The device acts as an intermediary between the injured aorta and the distal vasculature. The seal member temporarily seals the injury while perfusion ports serve as intermediary channels to maintain blood flow to distal organs and vessels, preventing ischemia without requiring immediate surgical repair.
2Object-affected harmful factors
If distal aortic perfusion by left heart bypass is used, then perfusion can be maintained, but device complexity and operational difficulty increase
Solution Approach 1:
The device combines multiple functions into a single implantable structure: the seal member provides bleeding control, the body provides structural support and defines the perfusion pathway, and the perfusion ports provide distal perfusion. This multi-functional design eliminates the need for separate left heart bypass equipment and reduces operational complexity.
Solution Approach 2:
The device utilizes the patient's own blood pressure and circulatory system to drive perfusion through the device. The pressure differential between proximal and distal aorta automatically propels blood through the perfusion ports, eliminating the need for external perfusion pumps or complex life support equipment.
3Measurement precision
If fluoroscopic imaging equipment is used for device positioning, then accurate placement can be achieved, but equipment availability and operational complexity increase
Solution Approach 1:
The device incorporates radiopaque markers that appear bright on fluoroscopic imaging, enabling accurate visualization and positioning. These markers provide high-contrast visual cues that allow operators to precisely locate and deploy the device without requiring complex imaging systems, as the markers are visible on standard fluoroscopy equipment widely available in medical facilities.
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 controls bleeding, allows continuous blood flow to vital organs and extremities, reduces the risk of organ failure and ischemia during transport, and can be easily removed for subsequent surgical repair, addressing the limitations of existing treatments by providing a simple, effective solution for hemorrhage management in austere environments.
Implementation Method 1
The sealing member has a blood-impermeable surface configured to form a seal along an inner surface of the blood vessel adjacent a ruptured portion of the blood vessel when the sealing member is deployed from a radially collapsed state to a radially expanded, deployed state inside the vessel
Data Source
AI summary
A medical assembly includes a perfusion device that has a self-expandable stent. The stent has a proximal end portion and a distal end portion. The proximal end portion tapers from the distal end to a proximal end thereof. A blood-impermeable cover extends at least partially over the distal end portion and the proximal end portion of the stent. The perfusion device further includes an elongated shaft having a proximal end a distal end, wherein the distal end is fixedly secured to the proximal end of the proximal end portion of the stent. The assembly further includes a sheath configured to retain the stent and the cover is a radially collapsed state for insertion into a vessel of a patient, wherein the stent and the cover are expandable from the radially collapsed state to a radially expanded, deployed state within the vessel when deployed from the sheath.