# US 9,040,111 B2 · Method of making a stent

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- Number: US 9,040,111 B2
- Document ID: US9040111B2
- Status: Granted
- Kind: B2
- Application number: 13/729,630
- Filed: 2012-12-28
- Published: 2013-05-09
- Granted: 2015-05-26
- Earliest claimed: 2010-03-03
- Assignees: Japan Stent Technology Co., Ltd.; Tokai University Educational System; Toyo Advanced Technologies Co., Ltd.; Hiroo Iwata
- Applicants: Japan Stent Technology Co., Ltd.; Tokai University Educational System; Toyo Advanced Technologies Co., Ltd.; Hiroo Iwata
- Inventors: Ikuo Omura; Zhen Yu Jin; Shuzo Yamashita; Hiroo Iwata; Akira Mochizuki
- Web page: https://patentgrep.com/patent/US9040111B2

## CPC

- A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07)
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)}
- A61L 31/10: Macromolecular materials
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 9/14: Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
- A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F 2002/91541: {Adjacent bands are arranged out of phase}
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61L 33/0041: {characterised by the choice of an antithrombatic agent other than heparin (heparinoïd A61L33/08; polypeptides A61L33/12)}
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2300/608: having two or more layers
- A61L 2420/08: Coatings comprising two or more layers
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A method of making a stent, including preparing a solution containing a composition, the composition comprising a biodegradable polymer and a vascular intimal hyperplasia inhibitor of a kind, including argatroban, which does not inhibit proliferation of endothelial cells, the weight compositional ratio of the polymer to the vascular intimal hyperplasia inhibitor being within the range of 8:2 to 3:7, the composition dissolved in a solvent selected from the group consisting of a mixture of a lower alkyl ketone and methanol, a mixture of a lower alkyl ester and methanol or a mixture of a lower halogenated hydrocarbon and methanol; coating at least an outer surface of a stent body of a cylindrical configuration having outer and inner surfaces with a diamond-like thin film coated on the surfaces; and after the coating, removing the solvent to complete a first coated layer.

## Claims

### Claim 1

A method of making a stent, comprising:
preparing a solution containing a first composition,
the first composition comprising a biodegradable polymer and a vascular intimal hyperplasia inhibitor, which does not inhibit proliferation of endothelial cells, the weight compositional ratio of the polymer to the vascular intimal hyperplasia inhibitor being within the range of 8:2 to 3:7,
the composition dissolved in a solvent selected from the group consisting of a mixture of a lower alkyl ketone and methanol, a mixture of a lower alkyl ester and methanol, and a mixture of a lower halogenated hydrocarbon and methanol;
coating at least an outer surface of a stent body of a cylindrical configuration having outer and inner surfaces with a diamond-like thin film coated on the surfaces; and
after the coating, removing the solvent to complete a first coated layer,
wherein the inhibitor is micro-dispersed in crystal state in the polymer.

### Claim 2

A method of making a stent, comprising:
preparing a solution containing a first composition,
the first composition comprising a biodegradable polymer and a vascular intimal hyperplasia inhibitor, which does not inhibit proliferation of endothelial cells, the weight compositional ratio of the polymer to the vascular intimal hyperplasia inhibitor being within the range of 8:2 to 3:7, and
the composition dissolved in a solvent selected from the group consisting of a mixture of a lower alkyl ketone and methanol, a mixture of a lower alkyl ester and methanol, and a mixture of a lower halogenated hydrocarbon and methanol;
coating at least an outer surface of a stent body of a cylindrical configuration having outer and inner surfaces without a diamond-like thin film coated on the surfaces; and
after the coating, removing the solvent to complete a first coated layer, wherein the inhibitor is micro-dispersed in crystal state in the polymer.

### Claim 3 (depends on 1)

The method of making a stent according to claim 1, wherein the vascular intimal hyperplasia inhibitor is selected from the group consisting of argatroban, ximelagatran, melagatran, dabigatran and dabigatran etexilate.

### Claim 4 (depends on 1)

The method of making a stent according to claim 1, wherein the stent body is made of a material selected from the group consisting of a metallic material a ceramic material and a high molecular polymer material, and the diamond like thin film is coated on the surface of the stent body.

### Claim 5 (depends on 1)

The method of making a stent according to claim 1, wherein a second coated layer is prepared of a biodegradable polymer alone or a second composition comprising a biodegradable polymer and a drug, the weight compositional ratio of the drug being less than 20% by weight of the composition over the first coated layer after the first coated layer is formed.

### Claim 6 (depends on 2)

The method of making a stent according to claim 2, wherein the vascular intimal hyperplasia inhibitor is selected from the group consisting of argatroban, ximelagatran, melagatran, dabigatran and dabigatran etexilate.

### Claim 7 (depends on 1)

The method of making a stent according to claim 1, wherein the stent body is made of a material selected from the group consisting of a metallic material, a ceramic material and a high molecular polymer material, and the diamond like thin film is not coated on the surface of the stent body.

### Claim 8 (depends on 1)

The method of making a stent according to claim 1, wherein a second coated layer is prepared of a biodegradable polymer alone or a second composition comprising a biodegradable polymer and a drug, the weight compositional ratio of the drug being less than 20% by weight of the composition over the first coated layer after the first coated layer is formed.
