Aortic Arch Embolic Protection with Stabilized Peripheral Sealing
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing embolic protection devices suffer from inefficiencies such as iatrogenic damage to vessels, high profile limiting procedures, insufficient sealing leading to bypassing of embolic particles, and unstable positioning in the aortic arch, which increases the risk of cerebral embolism during endovascular procedures.
Innovation Solution
A catheter device with an embolic protection system featuring a frame and tissue apposition sustaining units, including tethers and stabilization forces, is deployed in the aortic arch to prevent embolic particles from entering side vessels by ensuring stable, sealed positioning and preventing bypassing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If embolic protection devices are positioned in the aortic arch, then cerebral protection is provided, but iatrogenic damage to vessels occurs due to bows or arms extending into side vessels
Solution Approach 1:
The device divides the aortic arch into multiple segments using individual protection elements (bows) that can be independently positioned. Each bow is segmented to cover specific side vessel ostia without extending into the vessel lumens, thus providing localized protection while minimizing harm to individual vessels.
Solution Approach 2:
The protection device applies different structural characteristics to different regions: the bows are positioned to make contact with the aortic arch outer wall at specific locations corresponding to side vessel ostia, while maintaining clearance from the side vessels themselves. This localized positioning provides protection exactly where needed without causing damage to the side vessels.
2Stability of the object's composition
If bows or arms extend into side vessels to provide anchoring, then device stability is improved, but risk of scraping off embolic particles increases
Solution Approach 1:
Instead of extending bows or arms into the side vessels to achieve anchoring, the device inverts the approach by positioning the bows to contact the aortic arch outer wall from the opposite side. This inverted positioning provides anchoring through the aortic wall contact while maintaining clearance from the side vessels, thus preventing particle scraping.
3Adaptability or versatility
If device profile in aortic arch is reduced, then compatibility with endovascular procedures is improved, but sealing effectiveness may be compromised
Solution Approach 1:
The device uses multiple segmented bows rather than a single large structure, allowing each segment to be independently sized and positioned. This segmentation enables a low overall profile that accommodates endovascular procedures while maintaining effective sealing at each individual side vessel ostium through targeted bow positioning.
Solution Approach 2:
The bows are constructed with flexible, thin-walled structures that can conform to the aortic arch geometry and side vessel ostia. This flexibility allows the device to maintain effective sealing contact with the aortic wall while keeping the overall profile low and compatible with passage of endovascular instruments.
4Reliability
If device is positioned to cover side vessel ostia, then embolic protection is provided, but unstable positioning in aortic arch occurs
Solution Approach 1:
The device employs counterbalancing forces through the bow structure design, where the bows extend to contact the aortic arch outer wall at positions that create mechanical counterweight against blood flow forces. This counterweight effect stabilizes the device positioning while maintaining coverage of the side vessel ostia for embolic protection.
Data Source
AI summary
A catheter device is disclosed comprising; an elongate sheath (503) with a lumen and a distal end for positioning at a heart valve (6), an embolic protection device (200) for temporarily positioning in the aortic arch for deflection of embolic debris from the ascending aorta to the descending aorta, said embolic protection device is connectable to a transluminal delivery unit (130) extending proximally from a connection point (131), and having: a frame with a periphery, a blood permeable unit within said periphery for preventing embolic particles from passing therethrough with a blood flow downstream an aortic valve into side vessels of said aortic arch to the brain of a patient, and at least one tissue apposition sustaining unit (300, 350) extending from said catheter, into said aortic arch, and being attached to said embolic protection device at a sustaining point (502), for application of a stabilization force offset to said connection point at said embolic protection device, such as at said periphery, and for providing said stabilization force towards an inner wall of said aortic arch, away from said heart, and in a direction perpendicular to a longitudinal extension of said periphery, when said catheter device is positioned in said aortic arch, such that tissue apposition of said periphery to an inner wall of said aortic arch is supported by said force for improving stability and peripheral sealing. In addition related methods are disclosed.