Implantable drug delivery devices

• US 8,603,051 B2
• Filed: 02/17/2010
• Issued: 12/10/2013
• Est. Priority Date: 02/17/2009
• Status: Active Grant

• Current Assignee: Kuvio, Inc.
• Original Assignee: Kuvio, Inc.
• Inventors: Kuo, Youti, Violante, Michael R.
• Primary Examiner(s): Mendez, Manuel
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US13/201,960
• Publication Number:
  US 20120059349A1
• Time in Patent Office: 1,392 Days
• Field of Search: 604/890.1, 604/891.1, 604/93.01, 60428801-28804
• US Class Current: 604/288.01
• 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 having a flow opening for a filler fluid to pass through,

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

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

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

2. The 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 said 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.

3. An implantable drug delivery device comprising:

a. housing walls,

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

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

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.

4. A process for dispensing a drug fluid using the drug delivery device of claim 3 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 drug fluid being dispensed.

5. A process for preventing clogging of the dispensing end of an implantable drug delivery device of claim 3 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 drug fluid.

6. The implantable drug delivery device of claim 3 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.

7. An implantable drug delivery device comprising:

a. housing walls having a flow opening for a filler fluid to pass through,

b. an internal fluid chamber, containing a drug fluid, supported by said 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 closes when the piston moves toward the outlet and said one-way valve opens when the piston moves away from the outlet causing the drug fluid to flow from the second compartment into the first compartment,

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

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

8. An implantable drug delivery device system comprising:

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

b. a fluid chamber containing said drug fluid and having a piston,

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

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

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

9. The implantable drug delivery device of claim 8 wherein said 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, and said follower moves with the motion of the piston when drawing in said drug fluid from said refill container.

10. The implantable drug delivery device of claim 8, 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 said piston.

11. An implantable dual drug delivery device comprising:

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

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

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