Medical device for delivering biologically active material

• US 20050113903A1
• Filed: 11/11/2004
• Published: 05/26/2005
• Est. Priority Date: 01/31/2002
• Status: Active Grant

• Current Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Barry, James J., Miller, Matthew, Rosenthal, Arthur
• Granted Patent: US 7,445,629 B2
• Time in Patent Office: Days
• US Class Current: 623/1.150
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2250/0014 having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

This invention relates generally to medical devices, such as stents, for delivering a biologically active material to a desired location within the body of a patient. In particular, the invention relates generally to a medical device for delivering a biologically active material to a surface of a body lumen. More particularly, the invention is directed to a medical device comprising two opposing end sections, each having a surface, and a middle portion. The middle portion comprises a plurality of struts and the two opposing end sections comprises non-structural elements. The end sections of the surface either (1) contain a greater amount of a biologically active material per unit length of the surface or (2) have a greater capacity per unit length to contain such material than the middle section of the surface by having a greater surface area per unit length of the surface than the middle section or having a greater affinity for the biologically active material per unit length of the surface than the middle section. The struts and the non-structural elements comprise biologically active materials. The invention is also directed to a method for delivering the biologically active material to the body tissue of a patient by inserting this medical device into the body of the patient. Still further, the invention is directed to a method of treating a body lumen surface by preventing or treating restenosis or hyperplasia, using the system of the invention. Still further, the invention is directed to a stent having a sidewall which comprises a middle section, a first end section and a second end section. The stent also comprises a band comprising a biologically active material. The band is connected to the first end section and/or second end section of the stent.

Claims

1. A medical device comprising a sidewall having a middle section, a first end section and a second end section;

and a first band comprising a first biologically active material, wherein the first band is connected to the first end section.

2. The medical device of claim 1, wherein the first band further comprises a radiopaque material.

3. The medical device of claim 1, wherein the first band comprises a polymeric material.

4. The medical device of claim 1, wherein the sidewall comprises a second biologically active material.

5. The medical device of claim 4, wherein the second biologically active material is coated onto the sidewall.

6. The medical device of claim 4, wherein the first and second biologically active material are the same;

and wherein the amount of the first biologically active material is greater than the amount of the second biologically active material.

7. The medical device of claim 1, wherein the first band is connected to the first end section with an adhesive.

8. The medical device of claim 1, wherein the stent further comprises a second band connected to the second end section.

9. The medical device of claim 8, wherein at least one of the bands comprises a plurality of layers.

10. The medical device of claim 8, wherein at least one of the bands is elastic.

11. The medical device of claim 8, wherein at least one of the bands only partially surrounds the circumference outer surface of one of the end sections.

12. The medical device of claim 8, wherein at least one of the bands has a textured surface.

13. The medical device of claim 8, wherein the first band contains a biological agent at a first amount and the second band contains a biological agent at a second amount;

wherein first and second amounts are not equal.

14. The medical device of claim 1, wherein the first and second end sections each comprise an edge and the first band comprises an inner end;

and wherein the first band is connected to the first end section in a manner such that the first band inner end is adjacent to the first end section edge.

15. The medical device of claim 1, wherein the first end section comprises an outer surface;

and wherein the first band is connected to the first end section in a manner such that the first band covers at most 10%, 20% 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 98% of the outer surface of the first end section.

16. The medical device of claim 1, wherein the first band comprises an inner surface and an outer surface;

and wherein diffusion of a biologically active material is inhibited from the inner surface of the first band.

17. The medical device of claim 1, wherein the first and second end sections each comprise an edge and the first band comprises an outer end;

and wherein the first band is connected to the first end section in a manner such that the first band outer end extends axially beyond the first end section edge end.

18. The medical device of claim 17, wherein at least a portion of the first band outer end extending axially beyond the first end section edge is tapered.

19. The medical device of claim 1, wherein the first band comprises an inner surface and an outer surface;

and wherein the amount of the first biologically active material released from the band outer surface is greater than the amount of the first biologically active material released from the band inner surface.

20. The medical device of claim 1, wherein the first band comprises an inner surface and an outer surface;

and wherein the amount of the first biologically active material released from the band inner surface is greater than the amount of the first biologically active material released from the band outer surface.

21. The medical device of claim 1, wherein the first band further comprises a second biologically active material and wherein the first band comprises an inner surface and an outer surface;

and wherein the first biologically active material is released from the band outer surface and the second biologically active material from the band inner surface.

22. The medical device of claim 1, wherein the middle section of the sidewall comprises a barrier layer.