Systems and methods for the treatment of aneurysms
Inventors
Busold, Rany • Marini, John • Sharma, Upma • Rago, Adam • Mortensen, Jennifer • Lomakin, Joseph • Zugates, Gregory T. • Komatsu, Janet • Groom, III, Jeffrey
Assignees
Medtronic Inc • Medtronic Vascular Inc • Arsenal Medical Inc
Publication Number
US-10052107-B2
Publication Date
2018-08-21
Expiration Date
2032-06-25
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Abstract
Systems and method for treating aneurysms are provided which utilize formulations that form polymer foams in situ. The formulations generally have a buoyancy greater than or less than blood, and either float to the top of the aneurysm and foam from the top down or sink to the bottom and foam from the bottom up.
Core Innovation
The invention provides systems and methods for treating aneurysms using formulations that form polymer foams in situ. The formulations are introduced into the aneurysm sac, where they react with blood to generate a foam that fills the space between an endoprosthesis, such as a stent graft or catheter balloon, and the aneurysm wall. The foam expansion can be tailored to proceed from the top down or from the bottom up, depending on whether the formulation is buoyant or denser than blood, enabling controlled filling of the aneurysm and occlusion of collateral vessels.
The core problem addressed is the difficulty in effectively treating aneurysms, particularly the prevention of endoleaks following endovascular aneurysm repair (EVAR). Current treatments, including pre-formed foams, are limited by issues such as lack of conformity to the aneurysm shape, inability to seal collateral vessels without visualization, and risk of foam migration. Traditional polymers may also cause tissue irritation, lack adequate mechanical properties, or are challenging to deploy in complex anatomical landscapes.
The invention’s core innovation lies in formulating and delivering in situ polymer foams that specifically adapt to the anatomical configuration of the aneurysm and adjacent vessels, providing top-down or bottom-up solid foam expansion. The systems may use catheters with specialized tips, venting mechanisms, and optional shields to ensure precise foam placement, with the foam density modulated to either float or sink within the aneurysm sac as required. This approach enables conformal sealing, effective displacement of blood, and treatment of endoleaks by selectively filling spaces while minimizing the risks associated with pre-formed foams and invasive surgery.
Claims Coverage
There are two independent claims, each covering key inventive features relating to a system for treating aneurysms with in situ forming polymer foams distinguished by unique formulation properties, endoprosthesis, and delivery configuration.
System utilizing in situ forming siloxane polymer foams with tunable density for aneurysm treatment
The system comprises: - An endoprosthesis configured to span an aneurysm. - A formulation adapted to form a polymer foam when exposed to blood, specifically a siloxane formulation that reacts in situ. - The formulation is engineered to have density characteristics: either less than blood (enabling it to float and form foam that expands downward) or greater than blood (enabling it to sink and form foam that expands upward). - The formulation expands no more than 1.3 times the original volume. - The foam forms an expanding mass in the space between the endoprosthesis and the aneurysm wall, enabling both top-down and bottom-up foam formation based on density. - Delivery may involve a catheter with specialized tips, lumens for discharge of foam or inflow of displaced blood, and optional retractable shields.
System for treating abdominal aortic aneurysms using in situ reacting siloxane foam
The system comprises: - An endoprosthesis configured to span an abdominal aortic aneurysm. - A formulation configured to form a polymer foam within the aneurysm, specifically a siloxane formulation that reacts with blood in situ. - The density of the formulation may be less than or greater than blood, allowing for tailored placement within the aneurysm.
The inventive features establish comprehensive systems for treating aneurysms with in situ forming siloxane polymer foams, enabling density-dependent directionality of foam expansion and adaptability to various aneurysm anatomies using endoprosthesis and specialized delivery devices.
Stated Advantages
Allows delivery into closed, fluid-filled lumens or cavities, such as aneurysm sacs, with minimally invasive techniques.
Provides the ability to seal collateral vessels and aneurysm sites from retrograde flow and defects, preventing endoleaks.
Displaces blood or other fluids from a space in a safe, highly-controlled, and repeatable fashion.
Provides anchoring and stabilization of endovascular grafts by conforming to the stent graft and preventing leaks at proximal and distal ends.
Applicable to complex geometries and enables conformal contact with aneurysm walls and associated vessels without the need for visualization.
Documented Applications
Use in endovascular procedures to fill aneurysm spaces and occlude collateral vessels, especially in the treatment and prevention of endoleaks post-EVAR.
Prophylactic treatment of Type II endoleaks.
Treatment of Type I, II, or IV endoleaks as an alternative to open surgical procedures.
Stabilization of stent grafts following intravascular aneurysm repair.
Occlusion of fluid-filled body lumens, including but not limited to vascular embolization and the occlusion of blood vessels supplying tumor tissue or tissue to be resected.
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