Directional drug delivery stent and method of use

• US 6,071,305 A
• Filed: 11/24/1997
• Issued: 06/06/2000
• Est. Priority Date: 11/25/1996
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Roorda, Wouter E., Brown, James E.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US08/976,725
• Time in Patent Office: 925 Days
• Field of Search: 623/1, 623/12, 604/891.1, 604/892.1, 606/198, 606/191
• US Class Current: 623/1.43
• 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 2/91 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 33/0005 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: A61L 33/0064 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 33/066 Rubbers
• CPC Class Codes: A61L 33/068 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L33/062 takes precedence
• CPC Class Codes: A61L 33/08 Polysaccharides
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion

Abstract

The invention relates to a directional drug delivery stent which includes an elongated or tubular member having a cavity containing a biologically active agent. In one embodiment, the active agent is diffused from the reservoir directly to the walls of a body lumen, such as a blood vessel, through directional delivery openings arranged on an outer surface of the elongated member. Another variation of the stent includes an osmotic engine assembly for controlling the delivery of the active agent from the reservoir. The drugs which may be applied by the directional delivery stent include, but are not limited to, steroids, anti-inflammatory agents, restenosis preventing drugs, anti-thrombotic drugs, and tissue growth regulating drugs. The invention also relates to a method of using the directional drug delivery stent.

Claims

1. A nonbiodegradable and expandable stent for directionally delivering an active agent, the stent comprising:

a nonbiodegradable tubular member having an exterior surface and an interior surface together defining a tubular member thickness of said tubular member, said tubular member having a recessed active agent receiving portion formed in said exterior surface, said recessed active agent receiving portion having a depth less than said tubular member thickness, said recessed active agent receiving portion containing at least one active agent.

2. The stent according to claim 1, wherein said recessed active agent receiving portion is a helical groove extending around said tubular member.

3. The stent according to claim 1, further comprising a plurality of slots extending through said tubular member thickness, said recessed active agent receiving portion including a plurality of spaced apart groove portions, adjacent ones of said groove portions being separated by one of said slots.

4. The stent according to claim 3, wherein when said stent is expanded said slots expand to increase a distance between adjacent ones of groove portions.

5. The stent according to claim 1, wherein said tubular member is cylindrical.

6. The stent according to claim 1, wherein said active agent is contained in a delivery matrix.

7. An expandable stent for directionally delivering an active agent, the stent comprising:

a nonbiodegradable and tubular member having an exterior surface and an interior surface together defining a tubular member thickness of said tubular member, said tubular member having a groove formed in said exterior surface, said groove having a depth less than said tubular member thickness, said groove containing at least one active agent.

8. The stent according to claim 7, wherein said groove is helical.

9. The stent according to claim 7, further comprising a plurality of slots extending through said tubular member thickness, said groove including a plurality of spaced apart groove portions, adjacent ones of said groove portions being separated by one of said slots.

10. The stent according to claim 9, wherein said slots extend parallel with a longitudinal axis of said tubular member.

11. The stent according to claim 9, wherein said slots are formed with a laser.

12. The stent according to claim 7, wherein said active agent is contained in a delivery matrix.

13. The stent according to claim 7, wherein said tubular member is pipe-shaped.

14. The stent according to claim 7, wherein said active agent is one of steroids, anti-inflammatory agents, restenosis preventing drugs, anti-thrombotic drugs, and tissue growth regulating drugs.

15. The stent according to claim 7, wherein said groove is formed with a laser.

16. An expandable stent for directionally delivering an active agent, the stent comprising:

a nonbiodegradable and tubular member having an exterior surface and an interior surface together defining a tubular member thickness of said tubular member, said exterior surface of said tubular member having recessed means for receiving at least one active agent, said recessed means having a depth less than said tubular member thickness.

17. The stent according to claim 16, wherein said tubular member includes a plurality of openings passing through said tubular member thickness.

18. The stent according to claim 16, wherein said recessed means includes a helical groove formed in said exterior surface.

19. The stent according to claim 16, wherein said recessed means receives said at least one active agent.

20. The stent according to claim 19, wherein said active agent is contained in a delivery matrix.

21. The stent according to claim 19, wherein said recessed means includes a groove that is formed with a laser.