# US 12,758,688 B2 · Medical devices including therapeutic coatings for local delivery of a direct anticoagulant

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- Number: US 12,758,688 B2
- Document ID: US12758688B2
- Status: Granted
- Kind: B2
- Application number: 18/632,758
- Filed: 2024-04-11
- Published: 2024-10-17
- Granted: 2026-10-13
- Earliest claimed: 2023-04-12
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Thomas John Herbst; Edward Kopesky; Steven L. Kangas; Hongxia Zeng; Aaron Cooper Foss
- Web page: https://patentgrep.com/patent/US12758688B2

## CPC

- A61L 33/0041: {characterised by the choice of an antithrombatic agent other than heparin (heparinoïd A61L33/08; polypeptides A61L33/12)}
- A61L 29/085: {Macromolecular materials}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61L 31/10: Macromolecular materials
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61L 2300/204: with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
- A61L 2300/216: with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2300/42: Anti-thrombotic agents, anticoagulants, anti-platelet agents
- A61L 2300/61: containing two or more active agents in different layers
- A61L 2300/622: Microcapsules
- A61L 2300/802: Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
- A61L 2420/02: Methods for coating medical devices
- A61L 2420/08: Coatings comprising two or more layers
- 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)

## Abstract

A medical device may be coated with a therapeutic composition that includes a direct oral anticoagulant. An illustrative drug coating composition may comprise an excipient including polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), or poly(vinylidene fluoride)-co-hexafluoropropylene (PVDF-HFP) and a direct oral anticoagulant (DOAC). The illustrative drug coating may be applied to an outer surface of a medical device.

## Claims

### Claim 1

A method for manufacturing a drug coating composition, the method comprising:
dissolving polylactic acid (PLA) or poly(lactic-co-glycolic acid) (PLGA) and rivaroxaban in a mixture of dichloromethane and dimethylformamide to form a first solution;
adding the first solution to aqueous poly (vinyl acid) PVA while mixing to form a bead solution;
filtering the bead solution to collect a plurality of microspheres; and
drying the plurality of microspheres.

### Claim 2 (depends on 1)

The method of claim 1, wherein the PLA or PLGA and rivaroxaban are dissolved at a ratio of in the range of about 85 to 95 weight percent PLA or PLGA to about 5 to about 15 weight percent rivaroxaban.

### Claim 3 (depends on 1)

The method of claim 1, wherein the mixture of dichloromethane and dimethylformamide is about 75 weight percent dichloromethane and about 25 weight percent dimethylformamide.

### Claim 4 (depends on 1)

The method of claim 1, wherein the aqueous PVA is about 2% PVA.

### Claim 5 (depends on 1)

The method of claim 1, further comprising adding the bead solution to a 0.1% solution of aqueous PVA and mixing for a first period of time.

### Claim 6 (depends on 1)

The method of claim 1, wherein drying the plurality of microspheres includes drying the microspheres under vacuum at room temperature for a second period of time.