Medical devices comprising drug-loaded capsules for localized drug delivery

• US 20050037050A1
• Filed: 08/11/2003
• Published: 02/17/2005
• Est. Priority Date: 08/11/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Weber, Jan
• Granted Patent: US 7,364,585 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0058 having an electroactive polymer material, e.g. for steering purposes, for control of flexibility, for locking, for opening or closing
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1027 Making of balloon catheters

Abstract

A medical device comprising a plurality of capsules, and a method of administering therapeutic agent to a patient using the same. The capsules further comprise a therapeutic agent and a multilayer polyelectrolyte shell. The medical device is adapted to apply a pressure to the capsules that is greater than or equal to the critical pressure of at least a portion of the capsules, such that therapeutic agent is released from the capsules.

Claims

1. A medical device comprising a plurality of capsules, said capsules comprising a therapeutic agent and a multilayer polyelectrolyte shell, wherein said medical device is adapted to apply a pressure to said capsules that is greater than or equal to the critical pressure of at least a portion of said capsules such that therapeutic agent is released from said capsules.

2. The medical device of claim 1, wherein at least a portion of said capsules comprise two or more therapeutic agents.

3. The medical device of claim 1, wherein at least a first portion of said capsules comprise a first therapeutic agent and wherein at least a second portion of said capsules comprise a second therapeutic agent.

4. The medical device of claim 1, wherein at least a first portion of said capsules comprise a first therapeutic agent and have a first critical pressure, wherein at least a second portion of said capsules comprise a second therapeutic agent and have a second critical pressure, and wherein said second critical pressure is greater than said first critical pressure.

5. The medical device of claim 1, wherein at least a portion of said capsules are disposed at or near the surface of said medical device.

6. The medical device of claim 1, wherein at least a portion of said capsules are attached to the surface of said medical device.

7. The medical device of claim 1, wherein at least a portion of said capsules are provided within a polymer layer at or near the surface of said medical device.

8. The medical device of claim 1, wherein said medical device is a stent

9. The medical device of claim 8, wherein said stent is adapted to apply said pressure in cooperation with an inflatable balloon.

10. The medical device of claim 8, wherein said stent comprises an electroactive polymer actuator.

11. The medical device of claim 8, wherein said stent is selected from a coronary vascular stent, a cerebral stent, a urethral stent, a ureteral stent, a biliary stent, a tracheal stent, a gastrointestinal stent and an esophageal stent.

12. The medical device of claim 1, wherein said medical device is an expandable catheter.

13. The medical device of claim 12, wherein said catheter comprises a balloon.

14. The medical device of claim 12, wherein said catheter comprises an electroactive polymer actuator.

15. The medical device of claim 12, wherein said catheter is a vascular catheter.

16. The medical device of claim 1, wherein said therapeutic agent is selected from the group consisting of an anti-thrombotic agent, an anti-proliferative agent, an anti-inflammatory agent, an anti-migratory agent, an agent affecting extracellular matrix production and organization, an antineoplastic agent, an anti-mitotic agent, an anesthetic agent, an anti-coagulant, a vascular cell growth promoter, a vascular cell growth inhibitor, a cholesterol-lowering agent, a vasodilating agent, and an agent that interferes with endogenous vasoactive mechanisms.

17. A medical procedure comprising:

inserting the medical device of claim 1 into a patient; and

activating said medical device to apply said a pressure to said capsules such that therapeutic agent is released from said capsules.

18. The medical procedure of claim 17, wherein said medical procedure is a vascular procedure.

19. The medical procedure of claim 17, wherein said medical procedure is a stent placement procedure.

20. The medical procedure of claim 17, wherein said medical procedure is a percutaneous transluminal angioplasty procedure.

21. The medical procedure of claim 17, wherein said medical procedure is a percutaneous transluminal coronary angioplasty procedure.

22. The medical procedure of claim 17, wherein said released therapeutic agent is selected from the group consisting of an anti-thrombotic agent, an anti-proliferative agent, an anti-inflammatory agent, an anti-migratory agent, an agent affecting extracellular matrix production and organization, an antineoplastic agent, an anti-mitotic agent, an anesthetic agent, an anti-coagulant, a vascular cell growth promoter, a vascular cell growth inhibitor, a cholesterol-lowering agent, a vasodilating agent, and an agent that interferes with endogenous vasoactive mechanisms.

23. A medical procedure comprising:

inserting the medical device of claim 4 into a patient; and

activating said medical device to apply a pressure to said capsules that is greater than or equal to said first critical pressure and less than said second critical pressure such that said first therapeutic agent is released; and

(d) further activating said medical device to apply a pressure to said capsules that is greater than or equal to said second critical pressure such that said second therapeutic agent is released.