In-situ forming foams with outer layer
Inventors
Freyman, Toby • Lomakin, Joseph • Marini, John • Mortensen, Jennifer • Rago, Adam • Busold, Rany • Sharma, Upma • Zugates, Gregory T.
Assignees
Publication Number
US-9883865-B2
Publication Date
2018-02-06
Expiration Date
2030-08-24
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Abstract
Systems, methods and kits relating to in-situ forming polymer foams for the treatment of aneurysms or fluid filled spaces are disclosed. The systems include an insertable medical device and an in-situ forming foam of lava like materials with a fast forming outer skin and a slower hardening interior that is formed from a one-, two- or multi-part formulation. When used to treat an aneurysm, the foam is placed into contact with at least a portion of an exterior surface of the medical device and/or the tissue surface of the aneurysm.
Core Innovation
The invention provides systems, methods, and kits for treating aneurysms or other fluid-filled spaces using in-situ forming polymer foams. The key aspect is delivering a polymer formulation into a space defined by the exterior surface of an insertable medical device, such as a stent-graft, and the tissue surface of the aneurysm, where the formulation reacts in-situ to generate a gas and form a foam structure. This foam consists of a first portion comprising a fast-forming, robust outer skin and an inner portion that hardens more slowly, resulting in a cohesive, conformal fill of the space without requiring knowledge of the specific aneurysm configuration.
The problem being addressed is the limitation of current aneurysm treatments, particularly endovascular aneurysm repair (EVAR), where pre-formed foams or devices may not adequately conform to the complex and variable geometry of the aneurysm sac. This inadequacy can lead to complications such as endoleaks—unwanted blood flow into the aneurysm sac—due to incomplete sealing between the stent-graft and aneurysm wall. Pre-formed foams used previously are difficult to shape in-situ, often requiring multiple implants and failing to fill all spaces or prevent material migration.
The invention distinguishes itself through its use of in-situ forming foams that react upon delivery, filling and conformally contacting the aneurysm walls and any collateral vessels. The outer skin of the foam rapidly forms to encase and control the core material, resisting deformation and migration into unwanted areas. This approach works with one-part, two-part, or multi-part polymer formulations and allows for adaptable delivery systems, such as catheters, to fill complex anatomical spaces efficiently while minimizing risks associated with pre-formed devices.
Claims Coverage
There is one independent claim, covering a method with several inventive features focused on in-situ foam formation for aneurysm treatment.
In situ forming foam delivery within aneurysm space
A method of treating an aneurysm in a patient comprising delivering an in-situ forming foam within an aqueous space defined by an inner wall of the aneurysm and an outer wall of a medical device placed within the aneurysm. The foam contains a polymer that reacts in the space to generate a gas and form a foam structure with a plurality of gas-filled cells encapsulated within a skin.
Foam structure in conformal contact with tissue
The method ensures that the formed foam is in conformal contact with tissue surrounding the space between the inner wall of the aneurysm and the outer wall of the medical device, enhancing sealing and stability.
The inventive features center on the in-situ formation of a gas-generating polymer foam within the aneurysm sac, ensuring conformal contact with adjacent tissue and a robust skin to maintain desired placement and function.
Stated Advantages
The polymers can be deployed into an aneurysm sac without requiring specific knowledge of the aneurysm configuration while nonetheless creating conformal contact within the sac.
The in-situ forming foam minimizes and/or prevents endoleaks, stabilizing pressure within the treated space.
Formation of a robust skin encases the polymer formulation, promoting material cohesion and resisting movement into collateral vessels or outside the targeted area.
The foam's expansion allows it to fill complex and variable spaces efficiently using minimal material.
The foams are biocompatible and may be tailored for biodegradability or biostability, with mechanical properties suitable for supporting tissues and medical devices.
Documented Applications
Treatment of aneurysms, including abdominal aortic aneurysms and aneurysms in locations such as the thoracic aorta, peripheral vasculature, and brain.
Filling or partially filling vessels, cavities, spaces, or chambers within the body, including abdominal, pelvic, and cardiothoracic cavities.
Preventing or limiting movement of bodily fluids, such as controlling hemorrhage and preventing endoleaks after endovascular aneurysm repair.
Use with various insertable medical devices, including stent-grafts, grafts unsupported by stent scaffolds, and inflatable balloons.
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