Devices and methods for controlled delivery from a drug delivery device

• US 20050070883A1
• Filed: 11/21/2001
• Published: 03/31/2005
• Est. Priority Date: 11/29/2000
• Status: Abandoned Application

• Current Assignee: Edward M. Gillis, Felix Theeuwes, James A. Filice, James E. Brown, John Culwell, Peter Wickman, Su IL Yum
• Original Assignee: Edward M. Gillis, Felix Theeuwes, James A. Filice, James E. Brown, John Culwell, Peter Wickman, Su IL Yum
• Inventors: Culwell, John, Brown, James E, Wickman, Peter, Theeuwes, Felix, Yum, Su Il, Gillis, Edward M, Filice, James A
• Application Number:
  US10/433,196
• Publication Number:
  US 20050070883A1
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61M 2205/0294 Piezoelectric materials
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281

Abstract

The invention features a plug for use with a drug delivery device, wherein the plug defines an expansion control channel, which accommodates thermal expansion of a formulation in a reservoir of a drug delivery device, and an exit channel. In one embodiment, the plug comprises an inner plug member and an outer plug member, which members define an expansion control channel to facilitate release of entrapped air and to accommodate thermal expansion of formulation from the sealed drug reservoir. The plug further defines an exit channel, and may optionally further comprise a frit positioned within the flow pathway just prior to the delivery outlet, or both.

Claims

1. A plug defining an inlet, an expansion control channel, and an outlet, wherein during use the inlet, expansion control channel and outlet define a flow path from a reservoir of a drug delivery device, through the plug, and out of the drug delivery device.

2. The plug of claim 1, wherein the plug comprises:

an inner plug member; and

an outer plug member.

3. The plug of claim 2, wherein the outer plug member is adapted to receive the inner plug member.

4. The plug of claim 2, wherein the inner plug member is slidable within the expansion control channel.

5. The plug of claim 2, wherein the expansion control channel is defined by the outer plug member.

6. The plug of claim 2, wherein the expansion control channel is defined by an inner wall of the drug delivery device.

7. The plug of claim 4, wherein during use the inner plug member is slidable to a first position to accommodate thermal expansion of a formulation in the drug delivery device reservoir.

8. The plug of claim 4, wherein the inner plug member is slidable to a second position to provide for fluid communication between the expansion control channel and the outlet.

9. The plug of claim 8, wherein the plug further defines an exit channel positioned between the expansion control channel and the outlet.

10. The plug of claim 2, wherein at least a portion of the expansion control channel is defined by an outer wall of the inner plug member and an inner wall of the outer plug member.

11. The plug of claim 2, wherein the plug further comprises a frit positioned in the flow path prior to the outlet.

12. The plug of claim 1, wherein the plug further defines an exit channel positioned in the flow path between the expansion control channel and the outlet.

13. The plug of claim 12, wherein the exit channel is at least partially filled with an drug formulation-immiscible fluid.

14. The plug of claim 12, wherein the exit channel is defined by a groove in an outer wall of the outer plug member and an inner wall of a reservoir following insertion of the plug into a reservoir of a drug delivery device.

15. The plug of claim 12, wherein the plug further comprises a frit positioned in the flow path between the exit channel and the outlet.

16. The plug of claim 2, wherein the expansion control channel comprises a first channel extending longitudinally through the inner plug member, a second channel extending laterally through the inner plug member, and a third helical channel extending in a spiral fashion along or through the inner plug member.

17. The plug of claim 16, wherein the third helical channel is defined by mating surfaces of an outer wall of the inner plug member and an inner wall of the outer plug member.

29. A drug delivery device comprising:

a reservoir body defining a reservoir for retaining a formulation comprising a drug; and

a plug according to claim 1;

wherein the plug is seated within the reservoir to provide for a flow pathway from the reservoir and out the outlet of the plug.

30. The drug delivery device of claim 29, wherein the drug delivery device is implantable.

31. The drug delivery device of claim 29, wherein the drug is selected from the group consisting of peptides, polypeptides, nucleic acids, and hormones.

32. The drug delivery device of claim 29, wherein the drug delivery device is operably attached to a catheter for delivery of the formulation from the reservoir to a delivery site.

33. A method of delivering a drug to a delivery site, the method comprising:

implanting at least a portion of drug delivery device in a subject, the drug delivery device comprising a plug according to claim 1 and a reservoir body defining a reservoir for retaining a formulation comprising a drug, wherein the plug is seated within the reservoir to provide for a flow pathway from the reservoir and out the outlet of the plug;

delivering the formulation from the reservoir and to a delivery site in a subject.

34. The method of claim 33, wherein the drug delivery device further comprises a catheter operably attached for delivery of the formulation from the reservoir and to the delivery site, wherein at least a distal end of the catheter comprising a drug delivery outlet is implanted in the subject.

35. The method of claim 33, wherein the drug is selected from the group consisting of peptides, polypeptides, nucleic acids, and hormones.

18. A plug comprising,

an inner plug member comprising a first end and a second end and an inner plug member body;

and

an outer plug member adapted to receive the inner plug member;

wherein the plug defines an expansion control channel, the expansion control channel extending from a plug inlet, through the inner plug member body, and to an outlet defined by the outer plug member, and wherein the inlet, expansion control channel, and outlet define a flow path through the plug.

19. The plug of claim 18, wherein the expansion control channel is defined by the outer plug member, and the inner plug member is slidable within the expansion control channel.

20. The plug of claim 19, wherein the inner plug member is slidable to a first position to accommodate thermal expansion of a formulation in the drug delivery device reservoir.

21. The plug of claim 19, wherein the inner plug member is slidable to a second position to provide for fluid communication between the expansion control channel and the outlet.

22. The plug of claim 18, wherein the plug further comprises a frit positioned in the flow path prior to the outlet.

23. The plug of claim 18, wherein the plug further defines an exit channel positioned in the flow path between the expansion control channel and the outlet.

24. The plug of claim 23, wherein the exit channel is defined by a groove in an outer wall of the outer plug member and an inner wall of a reservoir following insertion of the plug into a reservoir of a drug delivery device, and wherein a passage in a wall of the outer plug member provides for fluid communication between the expansion control channel and the exit channel.

25. The plug of claim 23, wherein the exit channel comprises a flowable material immiscible with the formulation to be delivered through the flow path.

26. The plug of claim 23, wherein the plug further comprises a frit positioned in the flow path between the exit channel and the outlet.

27. The plug of claim 18, wherein the expansion control channel comprises a first channel extending longitudinally through the inner plug member, a second channel extending laterally through the inner plug member, and a third helical channel extending in a spiral fashion along or through the inner plug member.

28. The plug of claim 27, wherein the third helical channel is defined by mating surfaces of an outer wall of the inner plug member and an inner wall of the outer plug member.