Delivery catheters for in situ forming foams
Inventors
Freyman, Toby • Mortensen, Jennifer • Groom, II, Jeffrey
Assignees
Publication Number
US-10888639-B2
Publication Date
2021-01-12
Expiration Date
2034-08-29
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Abstract
Delivery catheters for in situ forming foams are provided. The catheters include, in various embodiments, coatings, valves, mixing structures, exit ports and combinations of the same.
Core Innovation
The invention provides delivery catheters for in situ forming foams, featuring a range of improvements such as coatings, valves, mixing structures, and specifically configured exit ports. The delivery systems and methods are designed for the administration of a pre-polymer fluid to a space inside the body where it subsequently solidifies, foams, or becomes immobilized. The foam, upon application, is intended for various clinical purposes, including organ stabilization, hemostasis, and treating endoleaks after endovascular repair of abdominal aortic aneurysms.
The invention addresses the challenge of delivering in situ foaming formulations with high temporal, spatial, and volumetric precision. Conventional methods struggle with achieving precise delivery and often lack the necessary features to ensure homogeneous foam formation. The present systems enable superior mixing, aeration, and formulation delivery, aiming to yield a more uniform and desirable foam product at the target site.
The catheters can incorporate polymer coatings, such as polyvinylalcohol or polyvinylpyrrolidone, on at least part of their surfaces to prevent adherence of the foam to the catheter and facilitate clean withdrawal. Some designs employ one-way valves—optionally duckbill valves—at the distal end to enable controlled release of the formulation. The invention also encompasses catheter tips with non-circular shapes or multiple side exit ports to tailor the discharged foam structure, as well as internal mixing structures to enhance homogeneity for one- or two-part foam systems.
Claims Coverage
There are two independent claims, each introducing major inventive features concerning catheter configuration and foam delivery components.
Catheter system with first and second lumens and exit port for mixing foaming fluids
A system comprising: - A catheter having proximal and distal ends, with an outer catheter wall surrounding a first and second lumen along their entire lengths. - The first lumen extends from the proximal to the distal end; the second lumen is parallel and extends from the proximal end, terminating in at least one exit port separated from the distal end. The exit port fluidly connects the first lumen to the second lumen within the catheter. - First and second fluids are included and configured to form a homogeneous polymeric formulation within the first lumen, and foam when mixed.
Catheter system with mixing structure in first lumen and sealed second lumen having multiple perpendicular exit ports
A system comprising: - A catheter with proximal and distal ends, featuring an outer catheter wall surrounding a first lumen (extending from proximal to distal end) and a second lumen parallel to the first, ending in at least one exit port separated from the distal end. The exit port fluidly connects the first lumen to the second lumen within the catheter. - First and second fluids are included and configured to form a homogeneous polymeric formulation within the catheter, and foam when mixed. - The first lumen includes a mixing structure distally relative to the exit port(s). - The second lumen includes a plurality of exit ports oriented perpendicularly to the long axis of the catheter, with the distal end of the second lumen sealed shut.
In summary, the claims cover catheter systems featuring separate lumens for foam components, internal fluidic connections enabling controlled mixing, and the integration of mixing structures and specialized exit ports for enhancing the formation and quality of in situ foams.
Stated Advantages
Delivers in situ foaming formulations with high temporal, spatial, and/or volumetric precision.
Permits proper foam formation and yields a homogeneous foam product at the target site.
Polymer coatings enable substantially clean and smooth detachment of the catheter from the delivered foam, minimizing trauma and risk of vessel injury.
Valved tips, such as duckbill valves, prevent backflow and allow removal of the catheter without leakage or foam adherence.
Catheter designs with specific exit port configurations (such as non-circular or multiple side ports) help tailor the structure and distribution of foamed material within body spaces.
Internal mixing structures promote homogeneous mixing and improved curing of two-part foaming formulations.
Documented Applications
Stabilizing organs within the body.
Providing hemostasis.
Treating endoleaks following endovascular repair of abdominal aortic aneurysms.
Application of foam to spaces in the body that are filled with fluid.
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