IMPLANTABLE DRUG DELIVERY DEVICES

• US 20120059349A1
• Filed: 02/17/2010
• Published: 03/08/2012
• Est. Priority Date: 02/17/2009
• Status: Active Grant

• Current Assignee: Kuvio, Inc.
• Original Assignee: PharmaNova, Inc.
• Inventors: Kuo, Youti, Violante, Michael R.
• Granted Patent: US 8,603,051 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61J 1/067 Flexible ampoules, the contents of which are expelled by squeezing
• CPC Class Codes: A61J 1/14 Details; Accessories therefor A61J7/00 takes precedence; openers B65D, B67B7/00
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2039/0238 having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/3515 using magnetic means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• 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

Abstract

The invention relates generally to implantable drug delivery devices. Devices having a single drug chamber configuration, a divided drug chamber configuration and a compact dual-drug configuration are described. The devices have features to prevent clogging of the dispensing catheter and the creation of a local vacuum caused by the dispensing of the drug fluid. Also provided are features of a failsafe refilling process, automatic refill notification, and performance verification process. The divided drug chamber configuration enables frequent or continuous minute doses. A dual-drug chamber configuration uses self-locking refill containers to prevent mismatching between refill containers and drug chambers.

Claims

1. An implantable drug delivery device comprising;

a. housing walls,

b. a first chamber supported by housing walls having an outlet and containing a first fluid,

c. a piston positioned inside said first chamber, being driven in forward and backward motions by a drive means, said piston moving the first fluid toward the outlet when being driven forward by said drive means,

d. a second chamber having a collapsible wall containing a second fluid, said second fluid being separated from the first fluid by said piston, said collapsible wall collapsing as the second fluid moves in with said piston in response to the reduced volume of the first fluid in the first chamber.

2. An implantable drug delivery device of claim 1 comprising

a. housing walls,

b. a first chamber supported by housing walls having an outlet and containing a first fluid,

c. a piston positioned inside said first chamber, being driven in forward and backward motions by a drive means, said piston moving the first fluid toward the outlet when being driven forward by a drive means,

d. a catheter having a base end attached to the outlet and a dispensing end attached with a positive-closing valve, said positive-closing valve being at a closed position when no pumping pressure is exerted by the piston.

6. A process for dispensing drug using the drug delivery device of claim 2 wherein said drive means is controlled by a microprocessor, said microprocessor being programmed to move the piston forward a first distance for dispensing the first fluid and then to move the piston backward a second distance to ensure the closing of the positive-closing valve, said first distance being larger than the second distance by a value corresponding to a specified amount of the first fluid being dispensed.

7. A process for preventing clogging of the dispensing end of an implantable drug delivery device of claim 2 wherein said microprocessor provides repeated motions of opening and closing of the positive-closing valve by moving the piston forward and backward with a specified frequency and a specified amplitude without dispensing the first fluid.

12. An implantable drug delivery device of claim 1 wherein said piston is made of ferrite material and said drive means comprises a permanent magnet positioned at the outlet end of the first chamber and a set of induction coils supported by the housing walls, said induction coils magnetizing the piston to move in forward and backward directions depending on the polarity of the magnetic field induced by the induction coils responding to directions of electrical current imposed on the induction coils.

13. A process for refilling an implantable drug delivery device of claim 1, comprising the steps of:

a. attaching a septum to the outlet, said septum being in flow communication with said first chamber,

b. inserting the needle of a refill container into said septum,

c. retracting the piston away from the outlet by the drive means forcing the positive-closing valve to the closed position and resulting in withdrawal of the refill fluid from the refill vial into the first chamber.

23. An implantable drug delivery device of claim 6, wherein said septum has a plunger that can be pushed by the needle of said refill container to block the flow channel of the outlet.

24. An implantable drug delivery device of claim 6, comprising a contact switch in electrical communication with said drive means, said contact switch being activated by the insertion of the needle of said refill container activating the movement of the piston.

33. An implantable drug delivery device of claim 2 wherein said piston is made of ferrite material and said drive means comprises a permanent magnet positioned at the outlet end of the first chamber and a set of induction coils supported by the housing walls, said induction coils magnetizing the piston to move in forward and backward directions depending on the polarity of the magnetic field induced by the induction coils responding to directions of electrical current imposed on the induction coils.

34. A process for refilling an implantable drug delivery device of claim 2 comprising the steps of:

a. attaching a septum to the outlet, said septum being in flow communication with said first chamber,

b. inserting the needle of a refill container into said septum,

c. retracting the piston away from the outlet by the drive means forcing the positive-closing valve to the closed position and resulting in withdrawal of the refill fluid from the refill vial into the first chamber.

3-5. -5. (canceled)

8-11. -11. (canceled)

14. A refill container for refilling an implantable drug delivery device comprising:

a. a tubular housing with inner wall surface having first opening and second opening, said tubular housing containing a drug fluid,

b. a needle being attached to the second opening, said needle being in flow communication with the drug fluid,

c. a disc situated inside said tubular housing in slidable sealing fit with inner wall surface, said disc not accessible from outside the housing and being only movable following the flow direction toward the needle when the drug fluid is being removed from the housing through the needle, said disc being exposed to ambient pressure through the first opening.

15. A refill container for refilling an implantable drug delivery device comprising:

a. a collapsible pouch containing a drug fluid having flexible film wall fastened to a top plate having an exit opening, said film wall being collapsible when the drug fluid is drawn through the exit opening,

b. a needle being attached to the exit opening of the top plate and being in flow communication with the drug fluid.

16. (canceled)

17. An implantable drug delivery device comprising;

a. housing walls,

b. an internal fluid chamber, containing a first fluid, supported by housing walls and divided into a first compartment and a second compartment by a wall having a one-way valve, the first compartment having an outlet and a piston and the second compartment having a follower which is in communication with the movement of the piston, said one-way valve closing when the piston moves toward the outlet and said one-way valve opening when the piston moves away from the outlet causing the first fluid to flow from the second compartment into the first compartment,

c. an external fluid chamber containing a second fluid supported by housing walls and enclosed partially by a collapsible wall, said second fluid being separated from said first fluid by the piston and the follower, said collapsible wall contracting as the second fluid moves in with said piston in response to the reduced volume of the first fluid in the first chamber,

d. a drive means for imparting forward and backward movements of the piston, said forward movement for moving the first fluid toward the outlet and said backward movement for moving the first fluid away from the outlet causing expansion of the collapsible wall.

18-19. -19. (canceled)

20. An implantable drug delivery device system comprising:

a. a refill container comprising housing walls, a reservoir containing a first fluid and a needle,

b. an internal fluid chamber containing the first fluid, said internal fluid chamber being divided by a wall having a one-way valve into a first compartment having a piston and a second compartment having a follower,

c. a septum attached to said internal chamber for insertion of the needle of said refill container,

d. an outlet having opposing walls forming a flow channel in communication with said first compartment, said opposing walls can be forced to contact each other to block the flow of the first fluid by insertion of the needle of said refill container,

e. a drive means for imparting motion of the piston to draw in the first fluid from said refill container into the internal fluid chamber,

f. a second fluid chamber, containing a second fluid, said second fluid chamber enclosed partially by collapsible walls, said second fluid being separated from said first fluid by the piston and the follower to fill the space left by the movements of the piston and the follower.

21-22. -22. (canceled)

25-26. -26. (canceled)

27. An implantable dual drug delivery device comprising:

a. a first drug chamber containing a first drug fluid and having a first outlet, a septum and a first piston,

b. a first magnet having a first polarity attached to the septum of said first drug chamber,

c. a second drug chamber containing a second drug fluid and having a second outlet, a septum and a second piston,

d. a second magnet having a second polarity attached to the septum of said second drug chamber, the second polarity being opposite to the first magnet polarity,

e. a third chamber, said third chamber containing a third fluid enclosed partially by a collapsible soft layer, said third fluid being separated from the first drug fluid and the second drug fluid by the first piston and the second piston.

28. (canceled)

29. A refill container for refilling an implantable dual drug delivery device comprising:

a. a tubular housing wall containing a drug fluid, said tubular housing having a valve chamber with a top opening end and a reservoir chamber with a bottom enclosed end,

b. a needle attached to the top opening end of the valve chamber,

c. an orifice plate being positioned separating the valve chamber and the reservoir chamber, said orifice plate having an orifice at the center for passing the drug fluid from the reservoir chamber to the valve chamber,

d. a magnet valve having a polarity and being movably attached to the valve chamber, such that said magnet valve blocks the opening of the orifice plate when moved in contact with the orifice plate and allows for the flow from the reservoir chamber to the needle when said magnet valve is moved away from the orifice plate.

30. (canceled)

31. A refill system of an implantable dual drug delivery device comprising:

a. a first refill container containing a first drug fluid having a magnet valve with a first polarity,

b. a second refill container containing a second drug fluid having a magnet valve with a second polarity,

c. a first drug chamber containing a first drug fluid and having an outlet, a septum and a first piston, said septum being attached with a first magnet with first polarity attracting the magnet valve of the first refill container and repelling the second refill container,

d. a second drug chamber containing a second drug fluid and having an outlet, a septum and a second piston, said septum being attached with a second magnet with second polarity attracting the magnet valve of the second refill container, said second polarity being opposite to the first polarity of said first refill container.

32. (canceled)