Expandable Membrane Graft for Aneurysm Occlusion and Vessel Patency
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Solution Overview
Problem
Existing medical devices for treating vascular diseases such as aneurysms and atherosclerosis are invasive, cause reocclusion, and have limitations in agent delivery and biocompatibility, leading to uncontrolled release and bulkiness.
Innovation Solution
A system comprising an expandable device with a membrane that radially expands to engage the vessel inner surface, maintaining patency and delivering drugs, while minimizing inflammatory response and necrosis, using materials like Nitinol and polymers for flexibility and biocompatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional open-heart surgery is used to treat coronary artery disease, then complete treatment of diseased segments is achieved, but patient trauma and invasiveness increase significantly
Solution Approach 1:
The treatment is divided into separate steps: first delivering the stentless graft via catheter to the target coronary segment, then performing atherectomy to remove plaque, and finally expanding the graft. This segmentation allows minimally invasive delivery while achieving complete treatment of diseased segments.
Solution Approach 2:
The stentless graft is delivered in a compressed state within a delivery catheter, similar to a nested structure. The graft is inserted through the catheter and then expanded at the target site, allowing minimally invasive delivery of a device that will ultimately provide complete vessel reconstruction.
2Productivity
If balloon angioplasty is used to open occluded arteries, then blood flow is restored, but reocclusion occurs in a significant percentage of patients
Solution Approach 1:
The atherectomy procedure is performed before deploying the stentless graft, removing atheromas and plaque from the vessel wall in advance. This preliminary action addresses the root cause of reocclusion by eliminating the occlusive material that would otherwise lead to restenosis.
Solution Approach 2:
The stentless graft is constructed from biocompatible materials that promote endothelialization and reduce restenosis. The composite structure includes the graft material itself and the removed atheromas that can be used for imaging analysis, providing both therapeutic and diagnostic functions.
3Quantity of substance
If agents are coated onto implant surfaces or mixed in polymeric coatings, then drug delivery is achieved, but uncontrolled release and bulkiness occur
Solution Approach 1:
Instead of coating agents onto the graft surface, the atheromas and plaque are extracted and removed from the vessel. These removed materials can be imaged and analyzed, and the extraction process itself addresses the disease while avoiding the need for additional drug coatings that would cause uncontrolled release.
Solution Approach 2:
The stentless graft acts as an intermediary structure that supports vessel patency without requiring drug coatings. The graft's mechanical presence and the removed atheromas (which can be imaged) serve as the primary therapeutic mechanism, eliminating the need for polymeric drug delivery systems.
4Reliability
If an expandable device with membrane is used to engage vessel inner surface, then vessel patency is maintained and agent delivery is improved, but device complexity increases
Solution Approach 1:
The stentless graft is constructed as a flexible, thin-walled tubular structure without rigid struts or complex frameworks. This flexible shell design allows the graft to conform to the vessel wall while maintaining patency, and simplifies the delivery mechanism compared to traditional stent structures.
Solution Approach 2:
The graft transitions from a compressed delivery state to an expanded functional state through a dynamic expansion process. This dynamic design allows the graft to adapt to vessel movement and physiological changes while maintaining simplicity in its basic tubular structure.
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 occludes aneurysms, remodels vessels, promotes healing, and delivers agents in a controlled manner, reducing reocclusion and inflammation, and maintaining blood flow.
Implementation Method 1
an expandable device configured to radially expand from a first position to a second position
Implementation Method 2
a membrane expandable in response to the expansion of the expandable device
Data Source
AI summary
A system and method are provided for treating an aneurysm or other vessel disease or defect. The present disclosure includes an expandable device for placement in a vessel, where the mechanically expandable device includes a membrane. Also disclosed is a delivery device constructed and arranged to position the expandable device such that the exterior surface of the expandable device engages with the inner surface of the vessel and maintains a fluid pathway through said vessel.