Drug delivery apparatus

• US 9,180,054 B2
• Filed: 01/06/2011
• Issued: 11/10/2015
• Est. Priority Date: 01/29/2004
• Status: Active Grant

• Current Assignee: Charles Stark Draper Laboratory Incorporated, Massachusetts Eye And Ear Infirmary (Foundation of The Massachusetts Eye and EAR Infirmary Incorporated)
• Original Assignee: Charles Stark Draper Laboratory Incorporated, Massachusetts Eye And Ear Infirmary (Foundation of The Massachusetts Eye and EAR Infirmary Incorporated)
• Inventors: Fiering, Jason O., Mescher, Mark J., Kujawa, Sharon G., McKenna, Michael J., Sewell, William F.
• Primary Examiner(s): Price, Nathan R
• Application Number:
  US12/986,067
• Publication Number:
  US 20110295194A1
• Time in Patent Office: 1,769 Days
• Field of Search: 604 27- 45, 604/132, 604/133, 604/152, 6048901-8921
• US Class Current: 1/1
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2210/0662 Ears
• CPC Class Codes: A61M 2210/0668 Middle ear
• 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 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

An implantable drug delivery apparatus for delivering a drug into a bodily fluid in a body cavity of a patient over a period of time includes a variable-volume vessel defining a working chamber for receiving a drug and recirculating a therapeutic fluid. The fluid can contain a bodily fluid, such as, for example, perilymph, and a drug. The device allows for the controlled delivery of the therapeutic fluid to a predetermined location in the bodily cavity of the patient, such as, for example, a cochlea of a human ear.

Claims

1. A drug delivery apparatus for delivering a drug into a bodily fluid in a bodily cavity over a period of time, the apparatus comprising:

a cannula for facilitating fluid flow through a lumen thereof to and from the bodily cavity;

at least one hollow member defining a lumen in fluid communication with the cannula, the at least one hollow member and the cannula being adapted to fill with fluid;

a drug storage element in fluid communication with the at least one hollow member; and

an actuator for driving fluid through the cannula and the at least one hollow member, wherein the actuator is configured to operate non-continuously and to cause the at least one hollow member and the cannula to be emptied at a rate slower than a rate at which the hollow member and cannula fill.

2. The apparatus of claim 1, wherein the at least one hollow member comprises a loop for facilitating a recirculating flow of a fluid therethrough.

3. The apparatus of claim 1, wherein the at least one hollow member comprises a variable volume working chamber.

4. The apparatus of claim 3, wherein the actuator is adapted to temporarily maintain at least one movable wall of the variable volume working chamber in an inward position.

5. The apparatus of claim 4, wherein the at least one movable wall moves inwardly and outwardly at different rates.

6. The apparatus of claim 1, wherein the at least one hollow member comprises a compliant element adapted to act as a fluidic capacitor.

7. The apparatus of claim 1, wherein the at least one hollow member comprises sections of different diameters.

8. The apparatus of claim 1, wherein the at least one hollow member comprises at least one diameter different than a diameter of the cannula.

9. The apparatus of claim 1, wherein the actuator is a pump.

10. The apparatus of claim 1, wherein the actuator is modulated to turn on and off at a frequency lower than an actuator cycle frequency.

11. A method for delivering a drug into a bodily fluid in a bodily cavity over a period of time, the method comprising:

non-continuously operating an actuator to repeatedly;

(a) draw, at a first rate, a first volume of the bodily fluid from the bodily cavity through a lumen of a cannula into at least one hollow member in fluid communication therewith; and

(b) discharge, by an actuator, a fluid comprising a drug and a second volume of the bodily fluid at a second rate different from the first rate from the at least one hollow member and the cannula into the bodily cavity, wherein the first rate is greater than the second rate.

12. The method of claim 11, wherein the at least one hollow member comprises a loop for facilitating a recirculating flow of a fluid therethrough.

13. The method of claim 11, wherein the at least one hollow member comprises a variable volume working chamber.

14. The method of claim 13 further comprising providing a drug to the variable volume working chamber from a drug storage element in fluid communication therewith.

15. The method of claim 13 further comprising temporarily maintaining at least one movable wall of the variable volume working chamber in an inward position.

16. The method of claim 15 further comprising moving the at least one movable wall inwardly and outwardly at different rates.

17. The method of claim 11, wherein the at least one hollow member comprises a compliant element adapted to act as a fluidic capacitor.

18. The method of claim 11, wherein the actuator is a pump.

19. The method of claim 11 further comprising modulating the actuator to activate and deactivate at a frequency lower than an actuator cycle frequency.