APPARATUS AND METHODS FOR FILLING A DRUG ELUTING MEDICAL DEVICE VIA CAPILLARY ACTION

• US 20170086996A1
• Filed: 12/12/2016
• Published: 03/30/2017
• Est. Priority Date: 04/26/2012
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Pandya, Abby S., Guo, Ya, Peterson, Justin, Mitchell, James, Glucklich, Nate, Berglund, Joseph
• Granted Patent: US 10,463,512 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2240/00 Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Methods and apparatus are disclosed for filling a therapeutic substance or drug within a hollow wire that forms a stent. The stent is placed within a chamber housing a fluid drug formulation. During filling, the chamber is maintained at or near the vapor-liquid equilibrium of the solvent of the fluid drug formulation. To fill the stent, a portion of the stent is placed into contact with the fluid drug formulation until a lumenal space defined by the hollow wire is filled with the fluid drug formulation via capillary action. After filling is complete, the stent is retracted such that the stent is no longer in contact with the fluid drug formulation. The solvent vapor pressure within the chamber is reduced to evaporate a solvent of the fluid drug formulation. A wicking means may control transfer of the fluid drug formulation into the stent.

Claims

1-20. -20. (canceled)

21. :

A method of filling a fluid drug formulation within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a medical device, the method comprising the steps of;

placing the medical device formed from a hollow wire having a plurality of side openings within a chamber that houses a fluid drug formulation and a plurality of beads that are in contact with the fluid drug formulation;

placing a portion of the medical device into contact with the plurality of beads such that at least one of the plurality of side openings is in contact with the plurality of beads; and

maintaining contact between the plurality of beads and the selected portion of the medical device until a lumenal space defined by the hollow wire is filled with the fluid drug formulation via capillary action through the at least one of the plurality of side openings in contact with the plurality of beads.

22. :

The method of claim 21, further comprising the steps of;

retracting the medical device such that the portion of the medical device is no longer in contact with the plurality of beads.

23. :

The method of claim 22, wherein the step of retracting the medical device such that the portion of the medical device is no longer in contact with the plurality of beads removes excess fluid drug formulation from an exterior surface of the hollow wire during the step of retracting the medical device.

24. :

The method of claim 21, wherein the plurality of beads comprises at least one of glass beads, ceramic beads, steel beads, aluminum beads, titanium beads, stainless steel beads or polymeric beads.

25. :

The method of claim 21 further comprising applying a voltage or potential to the plurality of beads causing the plurality of beads to become hydrophilic.

26. :

The method of claim 25, wherein after the

hollow wire is filled with the fluid drug formulation, the method further comprises applying a voltage or potential to the plurality of beads causing the plurality of beads to become hydrophobic.

27. :

The method of claim 21 further comprising vibrating the plurality of beads.

28. :

The method of claim 21 further comprising stirring the plurality of beads.

29. :

A method of filling a fluid drug formulation within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a medical device, the method comprising the steps of;

placing a medical device formed from a hollow wire having a plurality of side openings within a chamber that houses a plurality of beads disposed within a fluid drug formulation, wherein the plurality of beads has first and second layers of beads such that the first layer of beads extends over the second layer of beads and the second layer of beads is submersed in the fluid drug formulation;

placing a portion of the medical device into contact with the second layer of beads such that at least one of the plurality of side openings is in contact with the fluid drug formulation;

maintaining contact between the fluid drug formulation and the portion of the medical device until a lumenal space defined by the hollow wire is filled with the fluid drug formulation via capillary action through the at least one of the plurality of side openings in contact with the fluid drug formulation;

retracting the medical device such that the portion of the medical device is no longer in contact with the fluid drug formulation, and

removing fluid drug formulation from an exterior surface of the hollow wire by further retracting the medical device such that the portion of the medical device which was in contact with the fluid drug formulation passes through the first layer of beads.

30. :

The method of claim 29, further comprising the step of;

increasing the temperature of the fluid drug formulation after the step of maintaining contact between the fluid drug formulation and the portion of the medical device until a lumenal space defined by the hollow wire is filled with the fluid drug formulation via capillary action but prior to the step of retracting the medical device.

31. :

The method of claim 29, further comprising the step of;

covering at least a portion of an exterior surface of the hollow wire with a coating prior to the step of placing an end of the medical device into contact with the fluid drug formulation.

32. :

The method of claim 29, wherein the plurality of beads comprises at least one of glass beads, ceramic beads, steel beads, aluminum beads, titanium beads, stainless steel beads or polymeric beads.

33. :

The method of claim 29 further comprising applying a voltage or potential to the plurality of beads causing the plurality of beads to become hydrophilic.

34. :

The method of claim 29, wherein after the

hollow wire is filled with the fluid drug formulation, the method further comprises applying a voltage or potential to the plurality of beads causing the plurality of beads to become hydrophobic.

35. :

The method of claim 29 further comprising vibrating the plurality of beads.

36. :

The method of claim 29 further comprising stirring the plurality of beads.