EMBOLIZATION PARTICULATES FOR OCCLUDING A BLOOD VESSEL

• US 20180028194A1
• Filed: 03/02/2016
• Published: 02/01/2018
• Est. Priority Date: 03/02/2015
• Status: Active Grant

• Current Assignee: Accurate Medical Therapeutics Ltd.
• Original Assignee: Accurate Medical Therapeutics Ltd.
• Inventors: TAL, Michael Gabriel, MILLER, Eran
• Granted Patent: US 10,456,235 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61K 31/704 attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin digitoxin A61K31/7048
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/1676 having a drug-free core with discrete complete coating layer containing drug adsorbates of liquid drug formulations on inert powders without simultaneous granulation step A61K9/141; with further drug-free outer coating A61K9/5078; drug conjugated to non-active particles A61K47/6921
• CPC Class Codes: A61L 2300/23 Carbohydrates
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/02 containing inorganic materials
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices artificial blood vessels A61L27/507
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 35/00 : Antineoplastic agents

Abstract

Injectable embolization particulates (e.g., particles, microstructures, beads) employed in embolization procedures, for facilitating blood vessel occlusion. Exemplary embolization particulates for occluding a blood vessel include a plurality of embolization beads, each bead having a plurality of outwardly protruding portions, wherein, upon a first one and a second one of the beads accumulating against a boundary of the blood vessel, protruding portions of the first bead are configured to intermesh with protruding portions of the second bead, so as to occlude the blood vessel. Also disclosed are compositions of embolization particulates including a plurality of shaped embolization beads, and methods for embolizing or occluding a blood vessel using embolization particulates or compositions thereof. Embolization particulates have particular shapes for facilitating blood vessel occlusion while preventing or diminishing back flow (reflux) of embolic material, and may be coated or impregnated with therapeutic agents or radioactive isotopes, for increasing desirable therapeutic effects.

Claims

1. Embolization particulates suitable for occluding a blood vessel, the embolization particulates comprising:

a plurality of embolization beads, each of said embolization beads comprises;

a plurality of outwardly protruding portions, wherein, upon a first one and a second one of said embolization beads accumulating against a boundary of the blood vessel, said protruding portions of said first embolization bead are configured to intermesh with said protruding portions of said second embolization bead, so as to occlude the blood vessel.

2. The embolization particulates of claim 1, wherein said embolization beads are configured to resist or/and dissipate forces generated by, or originating from, fluid flow during an embolization procedure.

3. The embolization particulates of claim 1, wherein at least one of said outwardly protruding portions is hydrodynamically shaped to facilitate laminar or/and unhindered flow there around and to diminish impact of incoming fluid flow directed thereto.

4. The embolization particulates claim 1, wherein said embolization beads at least have three outwardly protruding portions.

5. The embolization particulates of claim 1, wherein said embolization beads have a tetrapod-like shape.

6. The embolization particulates of claim 1, having an elongated body extending between a first bead end and a second bead end, and wherein said protruding portions extend from at least one of said first bead end and second bead end.

7. The embolization particulates of claim 6, having four protruding portions, wherein each two protruding portions extend from first bead end and second bead.

8. The embolization particulates of claim 1, wherein at least one of said outwardly protruding portions has a tetrahedron or tetrahedron-like shape.

9. The embolization bead of claim 1, having a density within the range of between about 0.8 and about 1.6 g/cm3.

10. The embolization particulates of claim 1, wherein at least one of said outwardly protruding portions includes at least one concavity;

wherein said at least one concavity is filled with a therapeutic agent.

11. The embolization particulates of claim 1, wherein at least one of said outwardly protruding portions includes at least one hole passing through said outwardly protruding portion;

wherein said at least one hole is filled with a therapeutic agent.

14. The embolization particulates of claim 1, wherein said embolization beads have a maximal diameter in a range of between about 5 microns and about 1,000 microns, wherein said diameter is measured between external surfaces of two opposing protruding portions of one of said embolization beads.

15. The embolization bead of claim 1, having a maximal diameter within the range of 5 microns and 500 microns.

16. The embolization particulates of claim 15, wherein said diameter is in a range of between about 5 microns and about 100 microns.

17. A composition comprising:

embolization particulates according to claim 1, and a pharmaceutically acceptable excipient or carrier.

18. The composition according to claim 17, further comprising a contrasting agent or a therapeutic agent.

19. The composition according to claim 18, wherein said contrasting agent is selected from the group consisting of tantalum, tantalum oxide, and barium sulfate.

20. The composition according to claim 18, wherein said therapeutic agent is a chemotherapeutic agent.

21. A method for embolizing or occluding a blood vessel in a subject, the method comprising:

injecting into the blood vessel a sufficient amount of embolization particulates according to claim 1, or a composition according to claim 17, thereby allowing said embolization beads to aggregate into a chosen aggregated structure prior to or/and during embolization.

22. The method of claim 21, wherein the blood vessel feeds a tumor or an arteriovenous malformation.

12. (canceled)

13. (canceled)

23-27. -27. (canceled)