Method and apparatus for loading a beneficial agent into an expandable medical device

• US 20050222676A1
• Filed: 06/25/2004
• Published: 10/06/2005
• Est. Priority Date: 09/22/2003
• Status: Active Grant

• Current Assignee: Microport Cardiovascular LLC
• Original Assignee: Innovational Holdings, LLC
• Inventors: Shanley, John F., Diaz, Stephen Hunter
• Granted Patent: US 7,785,653 B2
• Time in Patent Office: Days
• US Class Current: 623/1.420
• 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 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/63 Crystals
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

The present invention relates to method and apparatus for dispensing a beneficial agent into an expandable medical device. The method includes the step of placing an expandable medical device on a support and dispensing a beneficial agent into a plurality of openings in the medical device with a shield gas for controlling a local environment surrounding the dispenser.

Claims

1. A method for loading a medical device with a beneficial agent, the method comprising:

providing a medical device with a plurality of holes;

dispensing a beneficial agent through a dispenser into the plurality of holes in a dropwise manner; and

controlling a local environment surrounding a dispensing tip of the dispenser to prevent clogging of the dispenser tip by delivering a shield gas adjacent the tip.

2. The method of claim 1, wherein the local environment is controlled by delivering a shield gas comprising a dry gas to an area surrounding a dispensing tip of the dispenser to control a humidity of the gas in the local environment.

3. The method of claim 2, wherein the dry gas is selected from the group consisting of nitrogen, helium, argon, dry air, inert gases, and combinations thereof.

4. The method of claim 1, wherein the shield gas is delivered by providing a liquid source and evaporating the liquid to create the shield gas.

5. The method of claim 1, wherein the shield gas is delivered from an orifice within about 1 inch of the dispensing tip of the dispenser.

6. The method of claim 1, wherein the beneficial agent includes a solvent which absorbs water from the environment.

7. The method of claim 1, wherein the beneficial agent includes a lipophilic drug which crystallizes in the presence of water.

8. The method of claim 7, wherein the drug is a lipophilic drug.

9. The method of claim 1, wherein the beneficial agent includes a biological compound and the shield gas is a reducing atmosphere.

10. The method of claim 1, wherein the shield gas is controlled to maintain a humidity at the dispensing tip below a predetermined humidity.

11. The method of claim 1, further comprising sensing a humidity and controlling an amount of the shield gas delivered depending on the sensed humidity.

12. The method of claim 1, wherein the dispenser is a dropwise dispenser.

13. A system for loading a medical device with a beneficial agent, the system comprising:

a support for a medical device;

a dispenser for dispensing a fluid beneficial agent from a dispensing tip into a plurality of holes in the medical device; and

a shield gas dispenser adjacent the dispensing tip for delivery of a shield gas to create a desired local environment around the dispensing tip.

14. The system of claim 13, further comprising a shield gas supply of a dry gas.

15. The system of claim 14, wherein the dry gas is selected from the group consisting of nitrogen, helium, argon, dry air, inert gases, and combinations thereof.

16. The system of claim 13, wherein the shield gas dispenser includes a liquid source and means for vaporizing the liquid to create the shield gas.

17. The system of claim 13, wherein the shield gas dispenser includes a gas delivery orifice within about 1 inch of the dispensing tip of the dispenser.

18. The system of claim 13, wherein the shield gas dispenser includes a source of non-oxidizing gas.

19. The system of claim 13, further comprising a humidity sensor, wherein the shield gas dispenser is controlled based on a humidity sensed by the humidity sensor.

20. A method of loading a medical device with a beneficial agent, the method comprises the steps of placing an expandable medical device on a support and dispensing a beneficial agent into a plurality of openings in the medical device by a dispenser with a shield gas delivered locally surrounding the dispensed beneficial agent.

21. The method of claim 20, wherein the local environment is controlled by delivering the shield gas and the shield gas comprises a dry gas delivered to an area surrounding a dispensing tip of the dispenser to control a humidity of the gas in the local environment.

22. The method of claim 21, wherein the dry gas is selected from the group consisting of nitrogen, helium, argon, dry air, inert gases, and combinations thereof.