Drug delivery apparatus

• US 9,764,121 B2
• Filed: 11/03/2014
• Issued: 09/19/2017
• Est. Priority Date: 02/02/2011
• 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., Pararas, Erin E., Borenstein, Jeffrey T., Sewell, William F., Kujawa, Sharon G., McKenna, Michael J., Kim, Ernest S.
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US14/531,808
• Publication Number:
  US 20150157837A1
• Time in Patent Office: 1,051 Days
• 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 5/14276 specially adapted for implantation

Abstract

An implantable drug delivery apparatus for delivering a drug into a bodily fluid in a bodily cavity of a patient over a period of time includes a drug supply reservoir to supply drug into a delivery channel and an actuator for delivering the drug to a predetermined location in the bodily cavity of the patient, such as, for example, a cochlea of a human ear. The drug is loaded into the delivery channel while producing substantially negligible flow at an outlet of the delivery channel.

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,

a leaky check valve comprising a one-way check valve and a leak path, the leaky check valve disposed within at least one of the cannula or the at least one hollow member and configured to enable a fluid flow through the at least one hollow member and the cannula in a first direction at a first rate and in a second direction opposite to the first direction and at a second rate different than the first rate; and

an actuator for driving fluid through the at least one hollow member and the cannula, the actuator being adapted to operate non-continuously.

2. The apparatus of claim 1, wherein the actuator comprises one of a linear motor, a rotating motor with a cam, a solenoid with a latching mechanism, an electromagnet with a latching mechanism, a solenoid with bistable modes, or an electromagnet with bistable modes.

3. The apparatus of claim 1 further comprising a sensor for measuring properties of an endogenous fluid that enters the apparatus.

4. The apparatus of claim 1, wherein the leaky valve is configured to enable the fluid flow through the one-way check valve and the leak path in the first direction and substantially prevent the fluid flow through the one-way check valve in the second direction.

5. The apparatus of claim 1 further comprising a drug storage element in fluid communication with the at least one hollow member.

6. The apparatus of claim 5, wherein the drug storage element comprises multiple compartments, each compartment being separated from the at least one hollow member by a single-use valve.

7. The apparatus of claim 5, wherein the drug storage element comprises at least one of an erodible solid or a polymer configuration so that drug is continuously and passively released into the fluid.

8. The apparatus of claim 5, wherein the drug storage element is adapted to release multiple compounds, each at separate time intervals, so as to perform treatment according to a chosen therapeutic sequence.

9. The apparatus of claim 1, wherein the apparatus is adapted to be integrated with a cochlear prosthesis for electrically stimulating an auditory system.

10. The apparatus of claim 9, wherein the apparatus is adapted to deliver drugs to the cochlea to treat hearing disorders.

11. The apparatus of claim 9, wherein the apparatus is adapted to reduce side effects of implant surgery.

12. The apparatus of claim 9, wherein the apparatus is adapted to improve performance of the prosthesis.

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

providing a drug delivery apparatus comprising;

a cannula in fluid communication with a bodily cavity;

at least one hollow member coupled to the cannula;

a leaky check valve comprising a one-way check valve and a leak path, the leaky check valve disposed within at least one of the cannula or the at least one hollow member and configured to enable a fluid flow through the at least one hollow member and the cannula in a first direction at a first rate and in a second direction at a second rate different than the first rate; and

an actuator;

activating the actuator to drive a carrier fluid in the first direction through the one-way check valve and the leak path and into the bodily cavity at the first rate; and

withdrawing a second fluid in the second direction through the leak path of the leaky check valve at the second rate.

14. The method of claim 13, where the second rate is slower than the first rate.

15. The method of claim 13, wherein the actuator comprises one of a linear motor, a rotating motor with a cam, a solenoid with a latching mechanism, an electromagnet with a latching mechanism, a solenoid with bistable modes, or an electromagnet with bistable modes.

16. The method of claim 13, further comprising passively releasing a drug into the carrier fluid from an erodible solid or a polymer.

17. The method of claim 13, wherein the second fluid comprises at least one of a drug, the carrier fluid, and an endogenous fluid.

18. The method of claim 13, further comprising activating the actuator non-continuously.

19. The method of claim 13, wherein the drug delivery apparatus further comprises a drug storage element in fluid communication with the at least one hollow member.

20. The method of claim 19, further comprising

loading, from the drug storage element, a drug into the at least one hollow member;

and

driving the drug and the carrier fluid into the bodily cavity.