Embolic compositions and methods

Patent metadata

Field	Value
Publication number	US-11730865-B2
Application number	US-201916409633-A
Country	US
Kind code	B2
Filing date	May 10, 2019
Priority date	May 15, 2018
Publication date	Aug 22, 2023
Grant date	Aug 22, 2023

Abstract

An embolization system and methods for controlling solidification of embolic compositions comprising a first and a second embolic component that react with each other in vivo at a target site to form an embolic material, with the embolic components being dilutable in physiological fluids so that they do not form an embolic composition at a site that is not desired.

First claim

It is claimed:

1. A method of embolization comprising
delivering a first liquid comprising an initiator through a first catheter lumen to a target lumen and delivering a second liquid that comprises a co-initiator through a second catheter lumen to the target lumen, with at least one of the first liquid and the second liquid comprising a water soluble polymer that comprises at least 80% by weight, based on the total weight of the water soluble polymer, of polyethylene glycol having a plurality of functional groups that form radical initiated crosslinks,
wherein the initiator and the co-initiator react with each other to form a radical initiator that initiates a free radical polymerization of the water soluble polymer functional groups to crosslink the water soluble polymer to form an embolization material in the target lumen when the first liquid and the second liquid mix with each other wherein the crosslinked polymer is a hydrogel with a swelling of about 20% or greater.

2. The method of claim 1 wherein a dilution in a range from 100% to 400% v/v dilution of a 1:1 v/v mixture of the first liquid and the second liquid prevents formation of the embolization material for at least 120 seconds as measured by an in vitro gel time test.

3. The method of claim 2 wherein the functional groups comprise an acrylate group and/or a methacrylate group.

4. The method of claim 3 wherein the 1:1 v/v mixture of the first liquid and the second liquid forms the embolization material in no more than 5 seconds as measured by the in vitro gel time test.

5. The method of claim 4 wherein the initiator comprises a peroxide.

6. The method of claim 5 wherein a concentration of the peroxide in the first liquid is from 10 to 3000 parts per million (ppm).

7. The method of claim 6 wherein the co-initiator comprises a reductant.

8. The method of claim 7 wherein the reductant comprises Fe 2 +, Cr 2 +, V 2 +, Ti 3 +, Co2+, or Cu+.

9. The method of claim 8 wherein a concentration of the reductant in the 1:1 v/v mixture of the first liquid and the second liquid is from 0.2 to 200 mM.

10. The method of claim 1 wherein the water soluble polymer comprises a number of vinylic groups in a range from 2 to 16 and wherein a calculated spacing between crosslinks of the hydrogel is from 4000 Daltons to 200,000 Daltons.

11. The method of claim 1 wherein the water soluble polymer further comprises hyaluronic acid, a protein, a peptide, or a polyvinyl alcohol.

12. The method of claim 1 wherein the first liquid and/or second liquid comprises a radiopaque contrast medium.

13. The method of claim 1 wherein the embolization material is a cohesive hydrogel.

14. The method of claim 1 wherein the first catheter lumen is coaxially deployed within the second catheter lumen.

15. The method of claim 14 wherein the first liquid and the second liquid are delivered with the distal tip of the inner catheter distal to a distal tip of the outer catheter.

16. The method of claim 1 wherein the embolization material is formed in a hypervascular tumor, a vascular laceration, a blood vessel, an organ, a tumor, a fibroid, a cell mass, an aneurysm, an aortic aneurysm, abdominal aortic aneurysm, a peripheral aneurysm, for hemostasis, a venous laceration, or a tissue having a pathological condition.

17. The method of claim 15 wherein a distal tip of the first catheter lumen is located distally relative to a distal tip of the second catheter lumen by at least 2 mm.

Assignees

• Incept Llc

Inventors

• Sawhney Amarpreet S
• Claesson Hans
• Lareau Raymond
• Billings Douglas

Classifications

• A61L31/048 Primary

  obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L31/041 takes precedence) · CPC title

• A61B17/12113

  within an aneurysm · CPC title

• A61B17/12186

  liquid materials adapted to be injected · CPC title

• A61B17/12195

  comprising a curable material · CPC title

• A61L24/0031

  Hydrogels or hydrocolloids · CPC title