Stent for angioplasty and associated production process

• US 20030195613A1
• Filed: 05/07/2003
• Published: 10/16/2003
• Est. Priority Date: 12/30/1996
• Status: Active Grant

• Current Assignee: CID S.p.A (Alvimedica ApS)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Vallana, Franco, Curcio, Maria, Rolando, Giovanni
• Granted Patent: US 7,607,208 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: 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; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2250/0025 differing in roughness
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2310/00574 Coating or prosthesis-covering structure made of carbon, e.g. of pyrocarbon
• CPC Class Codes: A61F 2310/0058 Coating made of diamond or of diamond-like carbon DLC
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/084 Carbon; Graphite
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/025 Carbon; Graphite
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling
• CPC Class Codes: Y10T 29/49995 Shaping one-piece blank by removing material

Abstract

A stent has surface sculpturing, preferably on its outer surface only, having, for example, microspheres, having the function of increasing the actual geometric surface area of the stent, of creating undercuts and roughness to encourage the application of coatings of active or activatable agents, as well as of improving the attachment of the stent to the blood vessel wall.

Claims

1. A method of making a medicated stent comprising:

providing a tubular body portion having an inner surface and an outer surface and defining a stent thickness therebetween;

laser cutting a plurality of apertures in the tubular body portion extending from the outer surface to the inner surface, the apertures being positioned such that the tubular body portion is expandable from a radially-contracted position to a radially-expanded position;

laser cutting a plurality of incisions in the outer surface of the tubular body portion, the incisions being defined at least in part by first and second side walls and a bottom surface between the side walls, a radial distance between the outer surface of the tubular body portion and the bottom surface of the incisions comprising an incision depth, the incision depth being less than the stent thickness;

coating the tubular body of the stent with a biocompatible carbon material; and

after the coating step, applying an outer coating in the plurality of incisions, the outer coating including an active agent.

2. The method of claim 1 wherein the step of laser cutting the apertures is performed before the step of laser cutting the incisions.

3. The method of claim 1 wherein the step of laser cutting the incisions is performed before the step of laser cutting the apertures.

4. The method of claim 1 wherein the active agent is an antithrombogenic agent.

5. A method of making a medicated stent comprising:

providing a tubular body portion having an inner surface and an outer surface and defining a stent thickness therebetween;

laser cutting a plurality of apertures in the tubular body portion extending from the outer surface to the inner surface, the apertures being positioned such that the tubular body portion is expandable from a radially-contracted position to a radially-expanded position;

laser cutting a plurality of incisions in the outer surface of the tubular body portion, the incisions being defined at least in part by first and second side walls and a bottom surface between the side walls, a radial distance between the outer surface of the tubular body portion and the bottom surface of the incisions comprising an incision depth, the incision depth being less than the stent thickness; and

coating the outer surface of the tubular body portion such that the coating is deposited in the plurality of incisions, the coating being the outermost layer of the medicated stent, the coating comprising an active agent.

6. A method of making a medicated stent for deployment at a treatment site in a vessel of a human body comprising:

providing a tubular body portion having an inner surface and an outer surface and defining a stent thickness therebetween;

laser cutting a plurality of apertures in the tubular body portion extending from the outer surface to the inner surface, the apertures being positioned such that the tubular body portion is expandable from a radially-contracted position to a radially-expanded position;

laser cutting a plurality of incisions in the outer surface of the tubular body portion, the incisions being defined at least in part by first and second side walls and a bottom surface between the side walls, a radial distance between the outer surface of the tubular body portion and the bottom surface of the incisions comprising an incision depth, the incision depth being less than the stent thickness; and

depositing an active agent in the plurality of incisions in a manner that results in direct contact between the active agent and the walls of the vessel when the medicated stent is deployed at the treatment site in the vessel.

7. A method of making a medicated stent for deployment at a treatment site in a vessel of a human body comprising:

providing a tubular body portion having an inner surface and an outer surface and defining a stent thickness therebetween;

laser cutting a plurality of apertures in the tubular body portion extending from the outer surface to the inner surface, the apertures being positioned such that the tubular body portion is expandable from a radially-contracted position to a radially-expanded position;

laser cutting a plurality of incisions in the outer surface of the tubular body portion, the incisions being defined at least in part by first and second side walls and a bottom surface between the side walls, a radial distance between the outer surface of the tubular body portion and the bottom surface of the incisions comprising an incision depth, the incision depth being less than the stent thickness; and

depositing a coating including an active agent in the plurality of incisions such that when the medicated stent is deployed at the treatment site in the vessel the coating is in direct contact with a wall of the vessel.

8. A method of making a medicated stent for deployment at a treatment site in a vessel of a human body comprising:

providing a tubular body portion having an inner surface and an outer surface and defining a stent thickness therebetween;

laser cutting a plurality of apertures in the tubular body portion extending from the outer surface to the inner surface, the apertures being positioned such that the tubular body portion is expandable from a radially-contracted position to a radially-expanded position;

laser cutting a plurality of incisions in the outer surface of the tubular body portion, the incisions being defined at least in part by first and second side walls and a bottom surface between the side walls, a radial distance between the outer surface of the tubular body portion and the bottom surface of the incisions comprising an incision depth, the incision depth being less than the stent thickness; and

depositing an active agent in the plurality of incisions, the incisions being a sufficient anchorage site for the active agent that other methods of binding the active agent to the tubular body portion are unnecessary.

9. A method of conveying an active agent to a stenotic site within a vessel in a human body comprising:

providing a stent having a tubular body including a plurality of apertures configured such that the tubular body is expandable from a radially-contracted position to a radially-expanded position, the tubular body forming a mesh-like structure in the radially-expanded position, the tubular body having an inner surface and an outer surface, the outer surface being provided with a plurality of incisions having first and second side walls and a bottom surface between the side walls, a radial distance between the outer surface of the tubular body and the bottom surface of the incisions comprising an incision depth, the incision depth being less that the stent thickness;

coating the outer surface of the tubular body with an active agent so that the active agent is deposited on the outer surface and in the incisions, the incisions being a sufficient anchorage site for the active agent that other methods of binding the active agent to the tubular body are unnecessary;

delivering the stent to the stenotic site within the vessel in its radially-contracted position; and

expanding the stent to its radially-expanded position at the stenotic site such that the active agent on the outer surface of the tubular body is brought into contact with the walls of the vessel.

10. A method of conveying an active agent to a stenotic site within a vessel in a human body comprising:

providing a stent having a tubular body including a plurality of apertures configured such that the tubular body is expandable from a radially-contracted position to a radially-expanded position, the tubular body forming a mesh-like structure in the radially-expanded position, the tubular body having an inner surface and an outer surface, the outer surface being provided with a plurality of incisions having first and second side walls and a bottom surface between the side walls, a radial distance between the outer surface of the tubular body and the bottom surface of the incisions comprising an incision depth, the incision depth being less that the stent thickness;

coating the outer surface of the tubular body with an active agent so that the active agent is deposited on the outer surface and in the incisions;

delivering the stent to the stenotic site within the vessel in its radially-contracted position; and

expanding the stent to its radially-expanded position at the stenotic site such that the active agent on the outer surface of the tubular body is brought into contact with the walls of the vessel.

11. A method of conveying an active agent to a stenotic site within a vessel in a human body comprising:

providing a stent having a tubular body including a plurality of apertures configured such that the tubular body is expandable from a radially-contracted position to a radially-expanded position, the tubular body forming a mesh-like structure in the radially-expanded position, the tubular body having an inner surface and an outer surface, the outer surface being provided with a plurality of incisions having first and second side walls and a bottom surface between the side walls, a radial distance between the outer surface of the tubular body and the bottom surface of the incisions comprising an incision depth, the incision depth being less that the stent thickness;

depositing an active agent in the plurality of incisions;

delivering the stent to the stenotic site within the vessel in its radially-contracted position; and

expanding the stent to its radially-expanded position at the stenotic site such that the active agent in the plurality of incisions is brought into contact with the walls of the vessel.

12. A method of conveying an active agent to a stenotic site within a vessel in a human body comprising:

providing a stent having a tubular body including a plurality of apertures configured such that the tubular body is expandable from a radially-contracted position to a radially-expanded position, the tubular body forming a mesh-like structure in the radially-expanded position, the tubular body having an inner surface and an outer surface, the outer surface being provided with a plurality of incisions having first and second side walls and a bottom surface between the side walls, a radial distance between the outer surface of the tubular body and the bottom surface of the incisions comprising an incision depth, the incision depth being less that the stent thickness;

depositing an active agent in the plurality of incisions, the incisions being a sufficient anchorage site for the active agent that other methods of binding the active agent to the tubular body portion are unnecessary;

delivering the stent to the stenotic site within the vessel in its radially-contracted position; and

expanding the stent to its radially-expanded position at the stenotic site such that the active agent in the plurality of incisions is brought into contact with the walls of the vessel.

13. A stent for conveying an active agent to a stenotic site comprising:

a tubular body including a plurality of apertures configured such that the tubular body is expandable from a radially-contracted position to a radially-expanded position, the tubular body forming a mesh-like structure in the radially-expanded position, the tubular body having an inner surface and an outer surface, the outer surface being provided with a plurality of incisions having first and second side walls and a bottom surface between the side walls, a radial distance between the outer surface of the tubular body and the bottom surface of the incisions comprising an incision depth, the incision depth being less that the stent thickness; and

an active agent deposited on the outer surface of the tubular body and in the incisions, the incisions being a sufficient anchorage site for the active agent that other methods of binding the active agent to the tubular body are unnecessary.

14. A stent for conveying an active agent to a stenotic site in a vessel comprising:

a tubular body including a plurality of apertures configured such that the tubular body is expandable from a radially-contracted position to a radially-expanded position, the tubular body forming a mesh-like structure in the radially-expanded position, the tubular body having an inner surface and an outer surface, the outer surface being provided with a plurality of incisions having first and second side walls and a bottom surface between the side walls, a radial distance between the outer surface of the tubular body and the bottom surface of the incisions comprising an incision depth, the incision depth being less that the stent thickness; and

an outer coating comprising an active agent deposited on the outer surface of the tubular body and in the plurality of incisions, the tubular body being configured such that the outer coating is in contact with the walls of the vessel when the tubular body is in its radially-expanded position.

15. A method of making a medicated stent comprising:

providing a tubular body portion having an exposed surface including an inner surface and an outer surface and defining a stent thickness therebetween;

laser cutting a plurality of apertures in the tubular body portion extending from the outer surface to the inner surface, the apertures being positioned such that the tubular body portion is expandable from a radially-contracted position to a radially-expanded position;

laser cutting a plurality of incisions in the outer surface of the tubular body portion, the incisions being defined at least in part by first and second side surfaces and a bottom surface between the side surfaces, a radial distance between the outer surface of the tubular body portion and the bottom surface of the incisions comprising an incision depth, the incision depth being less than the stent thickness;

coating the exposed surface of the tubular body of the stent with a biocompatible carbon material; and

after the coating step, applying an exposed layer comprising an active agent over at least a portion of the outer surface of the tubular body such that the active agent is deposited within the plurality of incisions.

16. A method of making a medicated stent comprising:

providing a tubular body portion having an inner surface and an outer surface and defining a stent thickness therebetween;

laser cutting a plurality of apertures in the tubular body portion extending from the outer surface to the inner surface, the apertures being positioned such that the tubular body portion is expandable from a radially-contracted position to a radially-expanded position;

forming a plurality of anchorage sites in the outer surface of the tubular body portion; and

depositing within the anchorage sites an active agent such that the active agent is exposed on the outer surface of the tubular body portion.

17. A method of making a medicated stent comprising:

providing a tubular body portion having an inner surface and an outer surface, the outer surface having a first surface area;

laser cutting a plurality of apertures in the tubular body portion extending from the outer surface to the inner surface, the apertures being positioned such that the tubular body portion is expandable from a radially-contracted position to a radially-expanded position;

modifying the outer surface of the tubular body portion, the modified outer surface having a second surface area, the second surface area being greater than the first surface area; and

after the modifying step, applying an exposed outer coating on the modified outer surface of the tubular body portion, the exposed outer coating including an active agent.

18. A method of conveying an active agent to a stenotic site within a vessel in a human body comprising:

providing a stent having a tubular body including a plurality of apertures configured such that the tubular body is expandable from a radially-contracted position to a radially-expanded position, the tubular body forming a mesh-like structure in the radially-expanded position, the tubular body having an inner surface and an outer surface, the outer surface having a surface area;

modifying the outer surface of the tubular body to increase the surface area of the outer surface; and

applying an active agent on the modified outer surface of the tubular body, the modified outer surface area being a sufficient anchorage site for the active agent that other methods of binding the active agent to the tubular body are unnecessary.

19. A method of conveying an active agent to a stenotic site within a vessel in a human body comprising:

providing a stent having a tubular body including a plurality of apertures configured such that the tubular body is expandable from a radially-contracted position to a radially-expanded position, the tubular body forming a mesh-like structure in the radially-expanded position, the tubular body having an inner surface and an outer surface, the outer surface having a surface are;

modifying the outer surface of the tubular body to increase the surface area of the outer surface;

applying an active agent on the modified outer surface of the tubular body;

delivering the stent to the stenotic site within the vessel in its radially-contracted position; and

expanding the stent to its radially-expanded position at the stenotic site such that the active agent on the outer surface of the tubular body is brought into contact with the walls of the vessel.