Stent and manufacturing method of stent

Patent metadata

Field	Value
Publication number	US-2016206451-A1
Application number	US-201615071710-A
Country	US
Kind code	A1
Filing date	Mar 16, 2016
Priority date	Sep 27, 2013
Publication date	Jul 21, 2016
Grant date	—

Abstract

A stent and a manufacturing method of a stent are disclosed in which a drug is satisfactorily and uniformly effective by preventing the drug from being peeled off or separated due to the stress concentration and/or the distortion resulting from the expanding deformation of the stent. The stent has an annular body configured to include a waved strut having a bending portion and multiple main strut portions. Then, only an outer surface of the main strut portions and a side surface of an end portion of the main strut portions adjacent to the bending portion are coated with the drug except the bending portion.

First claim

What is claimed is:

1 . A stent comprising:
an annular body that is configured to include a waved strut having a bending portion and multiple main strut portions, wherein only an outer surface of the main strut portion and a side surface of an end portion of the main strut portion adjacent to the bending portion are coated with a drug.

2 . The stent according to claim 1 ,
wherein the drug is loaded by a polymer so as to configure a coating layer.

3 . The stent according to claim 2 ,
wherein a side surface of both end portions of the main strut portion is coated with the drug.

4 . The stent according to claim 2 ,
wherein a thickness of the drug coating layer in the end portion of the main strut portion gradually decreases toward the bending portion.

5 . The stent according to claim 2 ,
wherein the polymer is a biodegradable polymer.

6 . The stent according to claim 5 ,
wherein the biodegradable polymer is polylactic acid, polyglycolic acid, or a copolymer of lactic acid and glycolic acid.

7 . The stent according to claim 2 ,
wherein the annular body is arrayed at multiple locations along an axial direction of the stent, wherein the strut further has a link portion for integrating the adjacent annular bodies with each other, and wherein an outer surface of the main strut portion and a side surface of an end portion of the main strut portion adjacent to the bending portion are coated with the drug, and wherein the link portion and the bending portion are not coated with the drug.

8 . The stent according to claim 1 ,
wherein a primer coating layer is arranged between the outer surface of the strut and the drug coating layer.

9 . A manufacturing method of a stent that has an annular body configured to include a waved strut having a bending portion and multiple main strut portions, the method comprising:
a drug coating process of coating the stent with a drug, wherein in the drug coating process, only an outer surface of the main strut portion and a side surface of an end portion of the main strut portion adjacent to the bending portion are coated with the drug.

10 . The manufacturing method of a stent according to claim 9 ,
wherein in the drug coating process, the stent is coated with the drug by discharging a coating solution through a nozzle unit while the nozzle unit communicating with a container for storing the coating solution obtained by dissolving the drug and a polymer into a solvent is moved along the strut.

11 . The manufacturing method of a stent according to claim 10 ,
wherein one end portion and the other end portion of the bending portion are respectively adjacent to an end portion of a first main strut portion and an end portion of a second main strut portion of the strut, wherein in the drug coating process, the coating solution is continuously supplied to the nozzle unit, and wherein if the nozzle unit reaches the end portion of the first main strut portion, the nozzle unit moves to the end portion of the second main strut portion without passing through the bending portion, and thereafter the nozzle unit moves toward the other end portion of the second main strut portion.

12 . The manufacturing method of a stent according to claim 11 ,
wherein in the drug coating process, a coating solution supplied to the nozzle unit while the nozzle unit moves from the end portion of the first main strut portion to the end portion of the second main strut portion is held in a distal end of the nozzle unit, and wherein when the nozzle unit reaches the end portion of the second main strut portion, the coating solution held in the distal end of the nozzle unit flows down from the outer surface to the side surface of the end portion of the second main strut portion so as to coat the side surface of the end portion of the second main strut portion with the drug.

13 . The manufacturing method of a stent according to claim 12 ,
wherein in the drug coating process, the amount of the coating solution held in the distal end of the nozzle unit is controlled by adjusting a period of time during which the nozzle unit moves from the end portion of the first main strut portion to the end portion of the second main strut portion.

14 . The manufacturing method of a stent according to claim 12 ,
wherein in the drug coating process, moving directions of the nozzle unit are alternately and repeatedly reversed so as to increase a thickness of the drug coating layer by recoating the drug coating layer with the drug.

15 . The manufacturing method of a stent according to claim 14 ,
wherein the side surface of both end portions of the main strut portion is coated with the drug.

16 . The manufacturing method of a stent according to claim 14 ,
wherein the thickness of the drug coating layer in the end portion of the main strut portion gradually decreases toward the bending portion.

17 . The manufacturing method of a stent according to claim 16 ,
wherein in the drug coating process, when the moving directions of the nozzle unit are alternately and repeatedly reversed, a position of the nozzle unit when moving from the end portion of the first main strut portion to the end portion of the second main strut portion is changed so that the thickness of the drug coating layer gradually decreases toward the bending portion.

18 . The manufacturing method of a stent according to claim 9 ,
wherein the annular body is arrayed at multiple locations along an axial direction of the stent, wherein the strut further has a link portion for integrating the adjacent annular bodies with each other, and wherein in the drug coating process, the stent is coated with the drug except the link portion.

19 . The manufacturing method of a stent according to claim 9 ,
wherein in the drug coating process, before the stent is coated with the drug, the outer surface of the strut is coated with a primer.

Assignees

• Terumo Corp

Inventors

• Maruyama Kazuhiro

Classifications

• A61L2420/02

  Methods for coating medical devices · CPC title

• A61L2420/06

  Coatings containing a mixture of two or more compounds · CPC title

• B05D1/26

  performed by applying the liquid or other fluent material from an outlet device in contact with, or almost in contact with, the surface · CPC title

• A61F2240/001

  Designing or manufacturing processes · CPC title

• A61F2250/0067

  Means for introducing or releasing pharmaceutical products into the body · CPC title