COMPRESSIBLE INTRAVASCULAR EMBOLIZATION PARTICLES AND RELATED METHODS AND DELIVERY SYSTEMS

• US 20130190795A1
• Filed: 12/17/2012
• Published: 07/25/2013
• Est. Priority Date: 01/30/2006
• Status: Active Grant

• Current Assignee: Biosphere Medical Inc. (Merit Medical Systems, Inc.)
• Original Assignee: Biosphere Medical Inc. (Merit Medical Systems, Inc.)
• Inventors: Brandom, Donald K., Matson, Louis R., McNamara, Gerald R.
• Granted Patent: US 10,448,955 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61L 24/0036 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids

Abstract

The present invention relates to substantially compressible, spherical porous embolization particles, including methods of making and using the particles. Further, the invention relates to embolization delivery systems for the introduction of the particle into the vascular luer.

Claims

1. A method of embolization, comprising:

positioning a substantially spherical particle in a target area of a blood vessel of a patient, the particle comprising;

interior pores that extend to the surface of the particle, wherein the particle has a compressibility of from 60% to 95% and a diameter when hydrated and fully expanded that ranges from 1000 microns to 10000 microns.

2. The method of claim 1, further comprising:

obtaining the particle, wherein the particle is in dehydrated form; and

hydrating the particle by adding hydration fluid to the particle prior to positioning the particle in the target area of the blood vessel.

3. The method of claim 2, wherein the hydration fluid is a contrast agent, saline or any combination thereof.

4. The method of claim 1, wherein the particle has a diameter when hydrated and fully expanded that is greater than an inner diameter of the target area of the blood vessel.

5. The method of claim 1, wherein the diameter of the particle ranges from 2000 microns to 4500 microns.

6. The method of claim 1, wherein the interior of the particle comprises pores having diameters that are greater than 10 microns.

7. The method of claim 1, wherein the particle comprises a polyvinyl alcohol (PVA) polymer.

8. The method of claim 1, wherein the particle comprises polyurethane.

9. The method of claim 1, wherein the particle is made by a method comprising:

a) adding porogen to a polyvinyl alcohol (PVA) solution;

b) adding a crosslinking agent and a crosslinking reactant to the mixture of (a);

c) mixing air or other inert gas with the mixture of (b); and

d) placing the mixture of (c) into a mold, and heating.

10. The method of claim 9, wherein the mold is a hollow sphere formed from two halves of a sphere.

11. A method of embolization comprising:

obtaining at least one substantially spherical particle comprising interior pores that extend to the surface of the particle, wherein the particle has a compressibility of from 60% to 95% and a diameter when hydrated and fully expanded that ranges from 1000 microns to 10000 microns;

urging the particle through a catheter, wherein the particle is in a compressed state while in the catheter;

positioning the particle in a target vascular area, wherein the particle expands to an expanded state upon exiting the catheter; and

occluding blood flow through the vessel.

12. The method of claim 11, wherein urging the particle through the catheter comprises contacting the particle with a guidewire.

13. The method of claim 11, wherein urging the particle through the catheter comprises applying fluid pressure to the particle.

14. The method of claim 11, further comprising;

loading the particle into the catheter comprising;

positioning the particle in a luer hub of the catheter;

coupling a syringe containing hydration fluid to the luer hub; and

operating the syringe to urge the particle out of the luer hub and into the catheter.

15. The method of claim 11, further comprising:

loading the particle into the catheter comprising;

positioning the particle in a luer hub of the catheter;

coupling a three-way stopcock to the luer hub, wherein the stopcock is coupled to a first and second syringe, wherein one or both of the syringes initially contain hydration fluid; and

operating the first syringe to urge the particle out of the luer hub and into the catheter.

16. The method of claim 15, wherein urging the particle through the catheter comprises operating the second syringe.

17. The method of claim 11, wherein the particle has a diameter when hydrated and fully expanded that is greater than an inner diameter of the target vascular area.

18. The method of claim 17, wherein the particle in the expanded state is substantially fixed in position in the target vascular area.

19. A method of embolization comprising:

positioning a first embolization device in a target vascular area;

positioning a second embolization device in proximity to the first embolization device; and

occluding blood flow through the vessel,

wherein at least one of the embolization devices comprises a substantially spherical particle comprising interior pores that extend to the surface of the particle, wherein the particle has a compressibility of from 60% to 95% and a diameter when hydrated and fully expanded that ranges from 1000 microns to 10000 microns.

20. The method of claim 19, wherein the diameter of the particle ranges from 2000 microns to 4500 microns.

21. The method of claim 19, wherein the interior of the particle comprises pores having diameters that are greater than 10 microns.

22. The method of claim 19, wherein the particle comprises a polyvinyl alcohol (PVA) polymer.