Apparatus and methods for loading a drug eluting medical device

• US 8,678,046 B2
• Filed: 09/17/2010
• Issued: 03/25/2014
• Est. Priority Date: 09/20/2009
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Melder, Robert, Wohl, Barry
• Primary Examiner(s): NIESZ, JASON KAROL
• Application Number:
  US12/884,501
• Publication Number:
  US 20120067454A1
• Time in Patent Office: 1,285 Days
• Field of Search: 623/1.42, 623/1.43, 427/2.1, 427/2.25, 427/230, 427/231, 141/2, 141/18, 141/284
• US Class Current: 141/18
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• 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 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• 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 loading a therapeutic substance or drug within a lumenal space of a hollow wire having a plurality of side openings along a length thereof that forms a hollow drug-eluting stent with a plurality of side drug delivery openings. Loading a drug within the lumenal space of the hollow stent includes a drug filling step, in which the drug is mixed with a solvent or dispersion medium. The lumenal space may be filled with the drug solution or suspension in a reverse fill process and/or a forward fill process. After the drug filling step, a solvent or dispersion medium extracting step is performed to extract the solvent or dispersion medium from within the lumenal space such that only the drug remains within the hollow stent. A stent cleaning step may be performed to an exterior surface of the hollow stent.

Claims

1. An apparatus for loading a therapeutic substance within a lumenal space of a hollow wire having a plurality of side openings that forms a hollow stent comprising:

upper and lower segments that mate along longitudinally-extending surfaces to form a cylindrical structure, the cylindrical structure including

a reservoir for containing a drug suspension including the therapeutic substance and a dispersion medium,

a loading compartment for securing at least one hollow structure therein that is to be filled with the therapeutic substance, the loading compartment being positioned downstream of and in fluid communication with the reservoir,

a restraining plate positioned downstream of the loading compartment that allows flow of the dispersion medium therethrough while retaining the therapeutic substance upstream thereof within the hollow structure, and

a sump chamber positioned downstream of the restraining plate that captures and contains the dispersion medium that passes through the restraining plate.

2. The apparatus of claim 1, wherein the hollow structure is a plurality of straight hollow wires and the loading compartment includes a plurality of grooves each of which is configured to hold a respective straight hollow wire to be filled with the therapeutic substance.

3. The apparatus of claim 1, wherein the hollow structure is a hollow stent and the loading compartment is cylindrical and sized to hold the hollow stent.

4. The apparatus of claim 1, wherein the upper and lower segments are equal halves of the cylindrical structure.

5. The apparatus of claim 1, wherein the reservoir is wedge-shaped.

6. The apparatus of claim 1, wherein the restraining plate is formed from sintered glass.

7. The apparatus of claim 1, wherein the loading compartment includes a rubber coating to prevent leaking of the drug suspension.

8. The apparatus of claim 1, further comprising:

at least one screw cap for holding the two segments together in the cylindrical configuration.

9. A method of loading a therapeutic substance within a lumenal space of a hollow wire having a plurality of side openings that forms a hollow stent, the method comprising the steps of:

placing at least one hollow structure within a loading compartment of a loading apparatus;

filling a reservoir of the loading apparatus with a drug suspension including the therapeutic substance and a dispersion medium;

placing the loading apparatus into a centrifuge rotor;

applying a high G centrifugal force to drive the drug suspension into a lumenal space of the hollow structure, whereby the therapeutic substance packs within the lumenal space of the hollow structure as the therapeutic substance is separated from the dispersion medium that passes through a downstream restraining plate of the loading apparatus and is captured within a downstream sump chamber of the loading apparatus; and

removing the hollow structure from the loading apparatus when the lumenal space is substantially full of the therapeutic substance.

10. The method of claim 9, wherein the step of placing at least one hollow structure includes placing a plurality of straight hollow wires within a plurality of grooves formed in the loading compartment.

11. The method of claim 9, wherein the step of placing at least one hollow structure includes placing a hollow stent into the loading compartment, wherein the loading compartment is cylindrically shaped to hold the hollow stent.

12. The method of claim 11, further comprising:

inserting a rod through the hollow stent to secure the stent in place during the filling step.

13. The method of claim 9, wherein the loading apparatus includes upper and lower segments that mate along longitudinally-extending surfaces to form a cylindrical structure and the loading apparatus is closed by sandwiching at least one hollow structure between the upper and lower segments.

14. The method of claim 13, wherein the step of filling the reservoir of the loading apparatus with the drug suspension includes injecting the drug suspension through a rubber diaphragm of a screw cap that holds the upper and lower segments together in the cylindrical configuration.

15. The method of claim 9, wherein the reservoir of the loading apparatus is wedge-shaped.

16. The method of claim 9, wherein the restraining plate of the loading apparatus is formed from sintered glass.

17. The method of claim 9, wherein the loading compartment of the loading apparatus includes a compliant rubber coating to prevent leaking of the drug suspension.

18. The method of claim 9, wherein the drug suspension also includes an excipient to assist in elution of the therapeutic substance, wherein the excipient and therapeutic substance are packed within the hollow structure when the high G centrifugal force is applied.

19. A method of loading a therapeutic substance within a lumenal space of a hollow wire having a plurality of side openings that forms a hollow stent, the method comprising the steps of:

placing at least one hollow structure within a loading compartment of a loading apparatus;

filling a reservoir of the loading apparatus with a drug solution including the therapeutic substance dissolved within a solvent;

placing the loading apparatus into a centrifuge rotor;

applying a high G centrifugal force to drive the drug solution into a lumenal space of the hollow structure, whereby the drug solution fills the lumenal space of the hollow structure; and

removing the hollow structure from the loading apparatus when the lumenal space is substantially full of the drug solution.

20. The method of claim 19, further comprising:

the step of extracting the solvent from the lumenal space of the filled hollow structure while the therapeutic substance remains within the hollow structure such that the hollow structure is thereby loaded with the therapeutic substance, wherein the hollow structure loaded with the therapeutic substance is one of a hollow stent and a hollow wire that is subsequently formed into a hollow stent.