Multiple reservoir implantable drug infusion device and method

• US 8,551,044 B2
• Filed: 03/05/2008
• Issued: 10/08/2013
• Est. Priority Date: 03/05/2008
• Status: Active Grant

• Current Assignee: FLO, LLC
• Original Assignee: Flowonix Medical, Inc.
• Inventors: Burke, Paul F., Buckman, Joshua L., O'Connor, Patrick J.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US12/074,570
• Publication Number:
  US 20090227989A1
• Time in Patent Office: 2,043 Days
• Field of Search: 604/890.1, 604/891.1, 604/131, 604/67
• US Class Current: 604/141
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1486 the bags being substantially completely surrounded by fluid
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407

Abstract

Multiple reservoir implantable valve accumulator pump for the delivery of medication, and method of infusate delivery. The apparatus includes at least first and second infusate reservoirs in a common pressure chamber, each in fluid communication with a metering assembly. The metering assembly includes an accumulator that is preferably a fixed volume accumulator having an inlet and an outlet. A first valve is in fluid communication with the first infusate reservoir and an inlet of the accumulator, and a second valve is in fluid communication with the second infusate reservoir and an inlet of the accumulator. An outlet valve is in fluid communication with the outlet of the accumulator. The accumulator can be filled with infusate from the first and second infusate reservoirs sequentially, can be filled from the first infusate reservoir multiple times consecutively, the second infusate reservoir multiple times consecutively, or any combination or permutation thereof.

Claims

1. An implantable infusion apparatus, comprising:

a housing defining a pressure chamber that contains a fluid having positive vapor pressure at normal body temperature;

a first infusate reservoir defined within said pressure chamber and maintained at a positive pressure by said fluid that is external to said first infusate reservoir;

a second infusate reservoir oppositely disposed to said first infusate reservoir and defined within said pressure chamber and maintained at a positive pressure by said fluid that is external to said second infusate reservoir, wherein said first and second infusate reservoirs are individually expandable to a selected portion respectively of a total available volume of the pressure chamber, the first infusate reservoir expanding in a first direction and the second infusate reservoir expanding in a second direction that is opposite the first direction;

a metering assembly comprising a fixed volume accumulator having an inlet and an outlet, said accumulator comprising a chamber housing a flexible diaphragm that provides a barrier between a gas portion of the chamber and an infusate portion of the chamber;

a first valve in fluid communication with said first infusate reservoir and said inlet of said accumulator;

a second valve in fluid communication with said second infusate reservoir and said inlet of said accumulator;

an outlet valve providing fluid communication through said outlet of said accumulator; and

a control module programmed to actuate said first valve, said second valve, and said outlet valve.

2. The implantable infusion apparatus of claim 1,

wherein said diaphragm is configured to deflect in a first direction when either of said first and second valves is opened while said outlet valve is closed, and configured to deflect in a second direction-when said outlet valve is opened while said first and second inlet valves are closed.

3. The implantable infusion apparatus of claim 2, wherein said accumulator further comprises a spacer, said spacer having an annular groove and a trough in fluid communication with said annular groove and with said inlet and outlet of said accumulator, the diameter of said annular groove being smaller than the length of said trough, said annular groove and trough defining a fluid flow path, wherein said annular groove is the only annular groove in said spacer.

4. The implantable infusion apparatus of claim 1, wherein said accumulator is configured to release an infusate in a series of predetermined volume spikes, the frequency of said spikes being determined by the cycling rate of said first and second valves and said outlet valve.

5. The implantable infusion apparatus of claim 1, wherein said second valve in an open position is configured to direct infusate from said second infusate reservoir into said accumulator with said first valve and said outlet valve in a closed position.

6. The implantable infusion apparatus of claim 1, further comprising:

a first bellow defining the first infusate reservoir, said first bellow positioned within said pressure chamber; and

a second bellow defining the second infusate reservoir, said second bellow positioned within said pressure chamber,

wherein said first and second bellows are oppositely and axially disposed to minimize size of said pressure chamber.

7. The implantable infusion apparatus of claim 1, wherein said first infusate reservoir and said second infusate reservoir is are each independently expandable to fill a total available volume of said pressure chamber.

8. The implantable infusion apparatus of claim 1, wherein said first valve and said second valve are positioned within said housing.

9. The implantable infusion apparatus of claim 1, wherein said accumulator is positioned within said housing.

10. The implantable infusion apparatus of claim 1, further comprising:

a first septum port in fluid communication with said first infusate reservoir and configured to receive a first infusate from a first inserted needle to fill the first infusate reservoir;

a second septum port in fluid communication with said second infusate reservoir and configured to receive a second infusate from a second inserted needle to fill the second infusate reservoir,

wherein the total available volume of said pressure chamber is filled to a selected ratio by the first and second infusate reservoirs by a relative amount of the received first and second infusates.

11. The implantable infusion apparatus of claim 1, wherein said first infusate reservoir contains a first infusate, and

wherein said control module is programmed to introduce said first infusate from said first infusate reservoir into said accumulator by opening said first valve while said second valve and said outlet valve are in a closed position and to empty said accumulator of said first infusate by opening said outlet valve while said first and second valves are closed.

12. The implantable infusion apparatus of claim 11, wherein said second infusate reservoir contains a second infusate, and

wherein said control module is further programmed to introduce said second infusate from said second infusate reservoir into said accumulator by opening said second valve while said first valve and said outlet valve are in a closed position and to empty said accumulator of said second infusate by opening said outlet valve while said first and second valves are closed.

13. The implantable infusion apparatus of claim 12, wherein said control module is further programmed to introduce said first infusate into said accumulator and to empty said first infusate from said accumulator multiple times before said second infusate is introduced into said accumulator.

14. The implantable infusion apparatus of claim 13, wherein said first and second infusate reservoirs are filled respectively with the first and second infusate to a selected ratio corresponding to the multiple times that the first infusate is emptied from the said accumulator by the control module as compared to a single time of the second infusate.