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

• US 20070082120A1
• Filed: 03/02/2005
• Published: 04/12/2007
• Est. Priority Date: 09/07/2001
• Status: Active Grant

• Current Assignee: Microport Cardiovascular LLC
• Original Assignee: Conor Medsystems Incorporated
• Inventors: Park, Kinam, Diaz, Stephen, Shanley, John
• Granted Patent: US 7,658,758 B2
• Time in Patent Office: Days
• US Class Current: 427/2.240
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: B01D 1/18 to obtain dry solids B01D1/24 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 mandrel, the medical device forming a cylindrical device having a plurality of openings and dispensing a beneficial agent into the plurality of openings.

Claims

1. A method of obtaining a quantity of a dry, solid form of an agent of interest comprising:

(a) providing a liquid which comprises an agent of interest dissolved or dispersed in a volatile liquid medium;

(b) depositing a microquantity of the liquid onto a pre-selected site of a substrate; and

(c) drying the microquantity by volatizing the volatile liquid medium to produce a dry, solid form of the agent of interest.

2. The method of claim 1, wherein the volatile liquid medium comprises a solvent for the agent of interest and the liquid of step (a) comprises a solution of the active agent dissolved in the solvent.

3. The method of claim 1, wherein the agent of interest comprises a pharmaceutical agent.

4. The method of claim 3, wherein the pharmaceutical agent comprises a peptide or a protein.

5. The method of claim 1, wherein the volatile liquid medium is non-aqueous.

6. The method of claim 1, wherein the microquantity has a volume between 1 nl and 1 μ

L.

7. The method of claim 1, wherein the microquantity has a volume between 10 nL and 500 nL.

8. The method of claim 7, wherein the microscale reservoir has a volume between 1 nL and 100 μ

L.

9. The method of claim 1, wherein step (b) comprises depositing two or more discrete microquantities onto two or more discrete preselected sites, respectively.

10. The method of claim 9, wherein the discrete preselected sites are provided on a single substrate.

11. The method of claim 9, wherein the single substrate comprises 100 or more discrete preselected sites.

12. The method of claim 9, wherein each of the two or more preselected sites is a microscale reservoir.

13. The method of claim 12, wherein the agent of interest comprises a pharmaceutical agent and the microscale reservoirs are provided in an implantable drug delivery device.

14. The method of claim 9, which is conducted in a continuous process.

15. A pharmaceutical formulation comprising a dry, solid form of a pharmaceutical agent made by the method of claim 3.

16. A medical device comprising microscale reservoirs containing a dry, solid form of a pharmaceutical agent made by the method of claim 3.

17. A method of creating a solid layer of a beneficial agent comprising:

(a) providing a solution comprising the beneficial agent and a solvent;

(b) delivering the solution of step (a) into openings; and

(c) evaporating the solvent to create a solid layer of the beneficial agent.

18. The method of claim 17, wherein the solution of step (a) comprises the beneficial agent dissolved in the solvent.

19. The method of claim 17, wherein the beneficial agent comprises a therapeutic agent or drug.

20. The method of claim 19, wherein the beneficial agent comprises peptides and protein drugs.

21. The method of claim 17, wherein the solution is delivered into the opening having a depth of about 125 to about 140 microns and an area of at least 5×

10<sup>−

6</sup> square inches.

22. The method of claim 17, wherein step (b) comprises loading the beneficial agent into the openings.

23. The method of claim 22, wherein the openings are provided on a tissue supporting device.

24. The method of claim 23, wherein the tissue supporting device comprises a series of openings.

25. The method of claim 22, wherein each of the openings is a reservoir.

26. The method of claim 25, wherein the beneficial agent comprises a therapeutic agent or drug and the reservoirs are provided in a tissue supporting device.

27. A therapeutic agent or drug formulation comprising a solid beneficial agent made by the method of claim 19.

28. A tissue supporting device comprising reservoirs containing a solid beneficial agent made by the method of claim 19.