# US 11,896,234 B2 · Apparatus and method of using in situ solidifying complex coacervates for vascular occlusion

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- Number: US 11,896,234 B2
- Document ID: US11896234B2
- Status: Granted
- Kind: B2
- Application number: 16/964,424
- Filed: 2019-01-25
- Published: 2021-02-18
- Granted: 2024-02-13
- Earliest claimed: 2018-01-26
- Assignees: Fluidx Medical Technology, LLC
- Applicants: Fluidx Medical Technology, LLC
- Inventors: Shawn Patrick Fojtik; Russell Stewart
- Web page: https://patentgrep.com/patent/US11896234B2

## CPC

- A61B 17/12109: {in a blood vessel}
- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- A61B 17/12031: {complete occlusion}
- A61B 17/12136: {Balloons}
- A61B 17/12181: {formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices}
- A61B 17/12195: {comprising a curable material}
- A61L 24/0015: {Medicaments; Biocides}
- A61L 24/0042: {Materials resorbable by the body}
- A61L 24/046: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds (A61L24/043 takes precedence)}
- A61L 24/108: {Specific proteins or polypeptides not covered by groups A61L24/102 - A61L24/106}
- C08F 220/34: Esters containing nitrogen {, e.g. N,N-dimethylaminoethyl (meth)acrylate}
- C08F 220/56: Acrylamide; Methacrylamide
- C08L 79/02: Polyamines
- A61B 17/00491: {Surgical glue applicators}
- A61B 17/1204: {temporary occlusion}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00893: {pharmaceutically effective}
- A61B 2017/1205: {Introduction devices}
- A61L 2300/254: Enzymes, proenzymes
- A61L 2300/256: Antibodies, e.g. immunoglobulins, vaccines
- A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2430/36: for embolization or occlusion, e.g. vaso-occlusive compositions or devices
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- C08F: MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## Abstract

Described herein are the use of fluid complex coacervates that produce solid adhesives in situ to anchor medical devices such as catheters in a blood vessel. The anchored devices permit the targeted delivery of bioactive agents. The anchored devices can perform as an embolic agent by reducing or preventing blood flow in the vessel. Additionally, the embolic produced from the solid adhesive produced in situ can also include one or more bioactive agents that can be released in a controlled manner.

## Claims

### Claim 1

A method for anchoring a catheter in a blood vessel of a subject, the method comprising (a) inserting into a blood vessel of a subject a catheter; and (b) injecting into the catheter an injectable composition, wherein the injectable composition comprises water and oppositely charged polyelectrolytes and counterions, wherein the concentration of the counterions in the injectable composition is greater than the concentration of ions in the blood vessel, whereupon introduction of the injectable composition into the blood vessel a solid or gel is produced in situ that seals the catheter to an inner wall of the vessel.

### Claim 2 (depends on 1)

The method of claim 1, wherein the catheter comprises a first catheter and a second catheter, wherein the second catheter is extended further into the vessel than the first catheter, wherein the injectable composition is injected into the first catheter, whereupon introduction of the injectable composition into the blood vessel a solid or gel is produced in situ that seals the second catheter to the inner wall of the vessel.

### Claim 3 (depends on 2)

The method of claim 2, wherein the first catheter and second catheter are a co-axial catheter.

### Claim 4 (depends on 2)

The method of claim 2, wherein the second catheter comprises an occlusion balloon catheter.

### Claim 5 (depends on 2)

The method of claim 2, wherein the first catheter and second catheter are sistered to one another.

### Claim 6 (depends on 5)

The method of claim 5, wherein the diameter of the first catheter is greater than the diameter of the second catheter.

### Claim 7 (depends on 6)

The method of claim 6, wherein a tip of the second catheter extends past a tip of the first catheter.

### Claim 8 (depends on 2)

The method of claim 2, wherein the solid or gel completely seals the vessel.

### Claim 9 (depends on 2)

The method of claim 2, wherein the first catheter is removed from the vessel.

### Claim 10 (depends on 2)

The method of claim 2, wherein the second catheter is removed producing a hole that is filled with additional injectable composition to produce an embolus.

### Claim 11 (depends on 1)

The method of claim 1, further comprising injecting a bioactive agent in the second catheter.

### Claim 12 (depends on 1)

The method of claim 1, wherein the catheter comprises a first lumen and a second lumen, and wherein the catheter comprises an outer first aperture from the first lumen, wherein the injectable composition is injected into the first lumen and exits the outer first aperture, whereupon introduction of the injectable composition into the blood vessel a solid or gel is produced in situ that seals the catheter to the inner wall of the vessel.

### Claim 13 (depends on 12)

The method of claim 12, wherein the gel or solid completely seals the vessel.

### Claim 14 (depends on 12)

The method of claim 12, wherein the catheter is removed producing a hole that is filled with additional injectable composition to produce an embolus.

### Claim 15 (depends on 12)

The method of claim 12, further comprising injecting a bioactive agent in the second lumen of the catheter.

### Claim 16 (depends on 1)

The method of claim 1, wherein the injectable composition further comprises one or more bioactive agents.

### Claim 17 (depends on 16)

The method of claim 16, wherein the bioactive agent comprises a nucleic acid, an antibiotic, a pain reliever, an anti-inflammatory agent, an immune modulator, a growth factor, an enzyme inhibitor, a hormone, a mediator, a messenger molecule, a cell signaling molecule, a receptor agonist, an oncolytic, a chemotherapy agent, a receptor antagonist, an antibody fragment, a monoclonal antibody, an anti-angiogenic agent, or any combination thereof.

### Claim 18 (depends on 1)

The method of claim 1, wherein the injectable composition further comprises a radiographic contrast agent or a fluoroscopic contrast agent.

### Claim 19 (depends on 1)

The method of claim 1, wherein the anchored catheter reduces or inhibits blood flow to a tumor, an aneurysm, a varicose vein, or a vascular malformation.

### Claim 20 (depends on 1)

The method of claim 1, wherein the subject has a tumor.