Biodegradable drug delivery vascular stent

• US 5,551,954 A
• Filed: 10/12/1994
• Issued: 09/03/1996
• Est. Priority Date: 10/04/1991
• Status: Expired due to Term

• Current Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Doyle, Erin S., Buscemi, Paul J., Stejskal, Elizabeth A.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/322,107
• Time in Patent Office: 692 Days
• Field of Search: 600/36, 606/194, 606/195, 673/1, 673/11, 673/12
• US Class Current: 623/1.15
• 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 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A stent includes a main body of a generally tubular shape having an exterior surface, a cambered interior surface, a leading end and a trailing end. The main body has substantially the same thickness at the leading end as at the trailing end. The stent may be made of a biodegradable material having a rate of degradation and including a drug releasable at a rate controlling the rate of degradation of the biodegradable material.

Claims

1. A stent having a generally tubular main body formed from a coiled strip for insertion into a lumen of a vessel of a living being wherein the main body includes an exterior surface for contacting the vessel when the main body is placed in a living being, said coiled strip including a cambered interior surface contacting a fluid passing through the lumen of the vessel, said coiled strip including a substantially flat exterior surface to which said cambered interior surfaces abuts, said cambered interior surface including a leading end facing a direction of flow and a trailing end wherein the leading end is immediately adjacent a wall of the vessel and the trailing end is immediately adjacent the wall of the vessel.

2. The stent of claim 1 wherein a camber of the cambered interior surface has an angle of curvature that is substantially within a range of 10 to 20 degrees.

3. The stent of claim 1 wherein the coiled strip is made of a biodegradable material.

4. The stent of claim 1 wherein the exterior surface includes pores, the pores having a diameter, depth and distribution that are effective to promote growth of cells on the exterior surface.

5. The stent of claim 3 wherein the coiled strip is made of a biodegradable material in a layer.

6. The stent of claim 3 and further including a water soluble coating that overlays the interior surface.

7. The stent of claim 3 wherein the main body has a rate of degradation and further includes a drug that is releasable into the lumen of the vessel at a rate that modifies the rate of degradation of the biodegradable main body.

8. The stent of claim 3 wherein the main body has a rate of degradation and further includes a drug that is releasable into the lumen of the vessel at a rate that is controlled by the rate of degradation of the biodegradable main body.

9. The coiled strip of claim 3 wherein the biodegradable material is treated by application of energy of a magnitude ineffective to cause bonding with living tissue of the lumen while the stent is in the lumen.

10. The coiled strip of claim 9 further comprising a meltable film coating that melts upon application of the energy and that overlays the interior surface.

11. The coiled strip of claim 9 wherein the energy causes an increase in temperature of the biodegradable material above a glass transition temperature of the biodegradable material.

12. A stent having a generally tubular main body formed from a coiled strip for insertion into a lumen of a vessel of a living being wherein the main body includes an exterior surface for contacting the vessel when the main body is placed in a living being and said coiled strip including a cambered interior surface contacting a fluid passing through the lumen of the vessel, said coiled strip including a substantially flat exterior surface to which said cambered interior surfaces abuts, the cambered interior surface including a leading end and a trailing end, the leading end immediately adjacent a wall of the vessel and the trailing end immediately adjacent the wall of the vessel, wherein a camber of the cambered interior surface has an angle of curvature that is substantially within a range of 10 to 20 degrees.

13. The stent of claim 12 wherein the coiled strip is made of biodegradable material.

14. The stent of claim 13 wherein the coiled strip is made of a biodegradable material in a layer.

15. The stent of claim 13 and further including a water soluble coating that overlays the interior surface of the stent.

16. The stent of claim 13 wherein the coiled strip has a rate of degradation and further includes a drug that is releasable into the lumen of the vessel at a rate that modifies the rate of degradation of the biodegradable main body.

17. The stent of claim 13 wherein the coiled strip has a rate of degradation and further includes a drug that is releasable into the lumen of the vessel at a rate that is controlled by the rate of degradation of the biodegradable main body.

18. The stent of claim 13 wherein the biodegradable material is treated by application of energy of a magnitude ineffective to cause bonding with living tissue of the lumen while the stent is in the lumen.

19. The stent of claim 18 wherein the energy causes an increase in temperature of the biodegradable material above a glass transition temperature of the biodegradable material.

20. The stent of claim 18 further comprising a meltable film coating that overlays the interior surface of the tubular main body and that melts upon application of the energy.

21. The stent of claim 12 wherein the exterior surface includes pores, the pores having a diameter, depth and distribution that are effective to promote growth of cells on the exterior surface.