Compressible intravascular embolization particles and related methods and delivery systems
Inventors
Matson, Louis R. • McNamara, Gerald R. • Brandom, Donald K.
Assignees
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Publication Number
US-10448955-B2
Publication Date
2019-10-22
Expiration Date
Abstract
The present invention relates to substantially compressible, spherical porous embolization particles, including methods of making and using the particles. Methods of using the particles include methods of embolization, in which at least one particle can be positioned in a target area of a blood vessel. The particles can also include interior pores that extend to the surface of the particles. Further, the invention relates to embolization delivery systems for the introduction of the particle into the vascular luer.
Core Innovation
A method of embolization uses a substantially spherical particle that includes an interior portion and an exterior surface layer. The interior portion extends from a center of the particle to the exterior surface layer and comprises pores having diameters of 25 microns or more, where at least a portion of the pores are interconnected, and the exterior surface of the particle comprises surface pores having diameters of at least 50 microns.
The particle is defined by a compressibility of from 60% to 95% and by a diameter when hydrated and fully expanded that ranges from 1000 microns to 10000 microns. The diameter when hydrated and fully expanded is greater than an inner diameter of the target area of the blood vessel, and the method occludes blood flow through the blood vessel with the particle.
In related methods, the substantially spherical particle is urged through a catheter in a compressed state and is positioned in a target vascular area. Upon exiting the catheter, the particle expands until an exterior of the particle contacts an inner wall of the target vascular area, exerting pressure on the inner wall as the particle expands to a first expanded state less than the fully expanded state, and occlusion of blood flow is achieved in the target vascular area.
In one arrangement, a first embolization device is positioned in a target vascular area and a second embolization device is positioned in proximity to the first, and blood flow is occluded through the vessel. The first embolization device comprises a first substantially spherical particle with interconnected interior pores, and the second embolization device comprises a second substantially spherical particle having a hydrated and fully expanded diameter of 300 microns to 1200 microns and a compressibility of 6.9% to 34%.
Claims Coverage
The document provides three independent methods that share a common particle architecture defined by compressibility, pore connectivity, and hydrated fully expanded diameter, and that are directed to embolizing by occluding blood flow in a target vascular area using catheter delivery and particle expansion. The coverage also includes positioning, pressure on the inner wall upon expansion, and a second embolization device used in proximity.
Substantially spherical compressible porous embolization particle with interior pores and exterior surface layer
A substantially spherical particle in a target area of a blood vessel, comprising an interior portion and an exterior surface layer where the interior portion comprises interconnected pores of diameters of 25 microns or more, and the exterior surface comprises surface pores of diameters of at least 50 microns; the particle has a compressibility of 60% to 95% and a hydrated and fully expanded diameter of 1000 microns to 10000 microns, where the hydrated and fully expanded diameter is greater than an inner diameter of the target area; occluding blood flow through the blood vessel with the particle.
Catheter urging of compressible porous particle with expansion to contact inner wall and exert pressure
Obtaining at least one substantially spherical particle comprising an interior portion with interior pores and an exterior portion with exterior pores, where at least a portion of the interior pores extend to the exterior pores; the particle has compressibility of 60% to 95% and a hydrated and fully expanded diameter of 1000 microns to 10000 microns; urging the particle through a catheter while in a compressed state; positioning the particle in a target vascular area where upon exiting the catheter the particle expands until an exterior of the particle contacts an inner wall and expands to a first expanded state that is less than the fully expanded state and exerts pressure on the inner wall; and occluding blood flow through the target vascular area.
Proximal dual embolization device arrangement using different compressible porous particles
Positioning a first embolization device in a target vascular area and positioning a second embolization device in proximity to the first; occluding blood flow through the vessel; wherein the first embolization device comprises a first substantially spherical particle comprising interior pores where at least a portion of the interior pores are interconnected and the first particle has compressibility of 60% to 95% and a hydrated and fully expanded diameter of 1000 microns to 10000 microns; and wherein the second embolization device comprises a second substantially spherical particle having a hydrated and fully expanded diameter of 300 microns to 1200 microns and a compressibility of 6.9% to 34%.
Across the independent claims, the inventive coverage centers on porous substantially spherical embolization particles defined by interior interconnected pores and exterior surface pores, specified compressibility, and hydrated fully expanded diameters. Delivery and deployment are defined by urging a compressed particle through a catheter followed by expansion to contact an inner wall and exert pressure to occlude blood flow, and one independent claim combines this with a second embolization device positioned in proximity.
Stated Advantages
Occluding blood flow through a blood vessel or target vascular area with the particle.
Exerting pressure on an inner wall of the target vascular area upon expansion until contact with the inner wall.
Allowing an embolization arrangement with first and second embolization devices positioned in proximity while occluding blood flow.
Documented Applications
Embolization of a target area of a blood vessel in a patient by positioning the particle(s) and occluding blood flow.
Use in embolization involving a first embolization device positioned in a target vascular area and a second embolization device positioned in proximity to the first to occlude blood flow.
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