# US 12,178,942 B2 · Method for manufacturing stent for drug release, including flexible nanostructured film connected in three dimensions, and stent for drug release prepared thereby

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- Number: US 12,178,942 B2
- Document ID: US12178942B2
- Status: Granted
- Kind: B2
- Application number: 17/336,321
- Filed: 2021-06-02
- Published: 2021-12-23
- Granted: 2024-12-31
- Earliest claimed: 2020-06-17
- Assignees: Korea Institute of Science and Technology
- Applicants: Korea Institute of Science and Technology
- Inventors: Joonseok Lee; Eunyoung Jeon
- Web page: https://patentgrep.com/patent/US12178942B2

## CPC

- A61L 31/088: {Other specific inorganic materials not covered by A61L31/084 or A61L31/086}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2300/606: Coatings
- A61L 2300/802: Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
- A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
- A61L 2420/02: Methods for coating medical devices
- 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

Provided are a method of manufacturing a stent for drug release that may be coated with a drug by forming a 3D nanostructured film on the surface of a stent and a stent for drug release manufactured thereby, more particularly, a method of manufacturing a stent for drug release including: (a) preparing a stent, (b) forming a 3D nanostructured film on a surface of the stent; and (c) surface-treating the 3D nanostructured film, and a stent for drug release manufactured thereby.

## Claims

### Claim 1

A method of manufacturing a stent for drug release, the method comprising:
(a) preparing a stent;
(b) forming a three-dimensional (3D) nanostructured film on a surface of the stent, wherein step (b) comprises (b1) adding an ionic surfactant and an auxiliary spacer to a reactor in which the stent is immersed, and stirring and heating a mixture, (b2) adding a ceramic precursor solution to the reactor, and stirring and heating the mixture, and (b3) removing residual substances by washing the stent; and
(c) surface-treating the 3D nanostructured film,
wherein the ionic surfactant is a cationic surfactant or an anionic surfactant,
wherein when the cationic surfactant is present, the auxiliary spacer comprises at least one selected from the group consisting of sodium salicylate, sodium benzoate, sodium cinnamate, salicylic acid, benzoic acid, cinnamic acid, sodium methoxybenzoate, methoxybenzoic acid, sodium vinylbenzoate, vinylbenzoic acid, and sodium p-toluenesulfonate.

### Claim 2 (depends on 1)

The method of claim 1, wherein the auxiliary spacer has an ion opposite to that of the ionic surfactant.

### Claim 3 (depends on 1)

The method of claim 1, wherein in the step (b1),
the ionic surfactant and the auxiliary spacer are self-assembled to form a micelle structure on the surface of the stent.

### Claim 4 (depends on 1)

The method of claim 1, wherein in the step (b2),
the ceramic precursor is laminated on the surface of the stent.

### Claim 5 (depends on 1)

The method of claim 1, wherein the stent is formed of at least one material selected from the group consisting of an alloy, a biodegradable polymer, and a nondegradable polymer.

### Claim 6 (depends on 5)

The method of claim 5, wherein the alloy comprises at least one selected from the group consisting of stainless steel, a cobalt-chromium alloy, a nickel-titanium alloy, and a platinum-chromium alloy, the biodegradable polymer comprises at least one selected from the group consisting of polylacticacid (PLA), polyglycolide (PGA), polycaprolactone (PCL), polyethyleneglycol (PEG), and polylactic-co-glycolicacid (PLGA), and the nondegradable polymer comprises at least one selected from the group consisting of polytetrafluoroethylene (PTFE), polyvinylalcohol (PVA), polyurethane (PU), and polyethylene terephthalate (PET).

### Claim 7 (depends on 1)

The method of claim 1, wherein the ceramic precursor solution is a silica precursor solution or a metal oxide precursor solution.

### Claim 8 (depends on 7)

The method of claim 7, wherein the silica precursor solution comprises at least one selected from the group consisting of tetraethyl orthosilicate (TEOS), tetrapropyl orthosilicate (TPOS), tetrabutyl orthosilicate (TBOS), tetramethyl orthosilicate (TMOS), tetramethoxyvinylsilane (TMVS), tetrakis(2-hydroxyethyl) orthosilicate (THEOS), and sodium metasilicate.

### Claim 9 (depends on 1)

The method of claim 1, wherein the step (b2) is performed in a temperature range of 40° C. to 95° C.

### Claim 10 (depends on 1)

The method of claim 1, wherein the cationic surfactant comprises at least one selected from the group consisting of cetyltrimethylammonium chloride (CTAC), cetyltrimethylammonium bromide (CTAB), dodecyltrimethylammonium bromide (DTAB), and tetradecyltrimethylammonium bromide (TTAB).

### Claim 11 (depends on 1)

The method of claim 1, wherein the step (c) comprises:
(c1) adding a surface treatment compound to the reactor in which the stent having the 3D nanostructured film is immersed, and stirring and heating a mixture; and
(c2) removing residual substances by washing the stent.

### Claim 12 (depends on 11)

The method of claim 11, wherein the surface treatment compound is a silane coupling agent.

### Claim 13 (depends on 1)

The method of claim 1, further comprising (d) coating a drug on the surface of the 3D nanostructured film after the step (c).

### Claim 14 (depends on 13)

The method of claim 13, wherein the coating is performed by at least one method selected from the group consisting of dip coating, spin coating, ultrasonic spray coating, electrospray coating, and vapor deposition coating.

### Claim 15 (depends on 1)

The method of claim 1, wherein the anionic surfactant comprises sodium dodecyl sulphate (SDS) or sodium dodecyl benzene sulfonate (SDBS).
