POROUS INTRAVASCULAR EMBOLIZATION PARTICLES AND RELATED METHODS
The present invention relates to porous embolization devices, methods of making and using the devices as well as methods and devices to hydrate and deliver embolization particle(s).
1 . An embolization particle comprising a substantially spherical crosslinked polymer particle comprising a porous interior having pores that extend to the surface of said particle while the surface pores have a diameter of at least about 1 micron and said particle has a diameter ranging from about 45 microns to about 1400 microns.
2 . An embolization particle comprising a crosslinked PVA polymer that defines a plurality of pores in the interior and on the surface of the particles, wherein said pores have a diameter of greater than about 1 micron and wherein the particle is substantially spherical and has a diameter of about 45 microns or more.
3 . The particle of claim 1 or 2 , wherein the particle has a diameter ranging from about 100 to about 300 microns.
4 . The particle of claim 1 or 2 , wherein the particle has a diameter ranging from about 300 to about 500 microns.
5 . The particle of claim 1 or 2 , wherein the particle has a diameter ranging from about 500 to about 700 microns.
6 . The particle of claim 1 or 2 , wherein the crosslinked polymer comprises crosslinked PVA polymer.
7 . An embolization device comprising a catheter in combination with the embolization particle of any of claims 1 - 6 .
8 . A method of embolization comprising:
positioning the embolization particles of any of claims 1 - 6 in a target region of a blood vessel.
9 . A method of making embolization particles comprising:
mixing a PVA polymer and a porogen to produce a PVA mixture;
adding a substance to cause crosslinking in the PVA mixture;
removing air bubbles from the PVA mixture; and
adding the mixture to a reaction medium and stirring the mixture and medium.
10 . The method of claim 8 , wherein the reaction medium comprises a surfactant and a hydrophobic material.
11 . An embolization kit comprising:
an embolization particle of any of claims 1 through 6 ; and
at least one of a delivery device comprising a connection component and two syringes, wherein said connection component is adapted to fluidly connect with said two syringes, (1) a container of hydration fluid, e.g., saline with or without contrast agent, (2) a hydration pressure reduction apparatus such as the syringe of FIG. 5 or the apparatus of FIG. 6 , which includes two syringes and a 3-way stopcock and (3) instructions for preparation and/or application of the particles to form a kit.
12 . The kit of claim 11 , wherein the connection component is a three-way stopcock.
13 . The kit of claim 11 , wherein the embolization particles are disposed within a vial or a syringe.
14 . A method of hydrating foam embolization particle(s) comprising:
exposing said mixture to reduced pressure, mixing dehydrated foam embolization particles with a hydration solution to form a mixture in a sealed device whereby entrapped gases are removed from the particles.
15 . The method of claim 14 , wherein the sealed device is a syringe.
16 . The method of claim 14 , wherein the sealed device is a vial.
17 . The method of claim 14 , wherein a syringe is used to withdraw gas from the sealed device to reduce the pressure therein.
18 . The method of claim 14 further comprising delivering the hydrated embolization particles to a target region of a blood vessel.
19 . The method of claim 18 , wherein said delivering comprises positioning a delivery device in proximity to a target region of the blood vessel and ejecting the hydrated particle(s) from the delivery device such that the particles are positioned in the target region.