Micro-droplet delivery device and methods

• US 10,624,781 B2
• Filed: 01/11/2016
• Issued: 04/21/2020
• Est. Priority Date: 01/12/2015
• Status: Active Grant

• Current Assignee: Bausch + Lomb Ireland Ltd. (Bausch Health Cos., Inc.)
• Original Assignee: Kedalion Therapeutics, Inc. (Novartis Ag)
• Inventors: Ivri, Yehuda
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US14/992,975
• Publication Number:
  US 20160199225A1
• Time in Patent Office: 1,562 Days
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: F04B 43/046 with piezoelectric drive

Abstract

Micro-droplet delivery devices and methods are described where the device may comprise a piezoelectric actuator having a piezoelectric chip that is operatively coupled to a drug package under a preloading force. The actuator is configured to generate an acoustic pressure within the drug package to dispense droplets of an agent from an aperture, e.g., to the corneal surface of the eye. The piezoelectric actuator can be coupled or decoupled from the drug package.

Claims

1. A system for emitting a fluid, comprising:

(a) an actuator having a contact portion; and

(b) a drug package comprising;

(i) a fluid reservoir near or at one end of the drug package;

(ii) an elongated conduit extending from the fluid reservoir and terminating in a tip section having a single aperture, wherein the elongated conduit comprises an internal fluid channel in fluid communication with the interior of the fluid reservoir and the aperture;

(iii) an acoustic cavity comprising a cylindrical chamber having an upper circular face sealed by a thin-wall membrane, wherein the acoustic cavity is positioned along the internal fluid channel between the fluid reservoir and the tip section; and

(iv) a fluid ophthalmic drug composition present in the fluid reservoir, acoustic cavity and internal fluid channel,

wherein the drug package is removably separable from the actuator and is also positionable to align thin-wall membrane of the acoustic cavity with the contact portion of the actuator such that displacement induced on the external surface of the thin-wall membrane by the contact portion of the actuator transmits one or more acoustic pulses through the fluid ophthalmic drug composition in the internal fluid channel to eject fluid through the aperture to produce a stream.

2. The system of claim 1 wherein the actuator comprises a piezoelectric chip.

3. The system of claim 2 wherein the piezoelectric chip is configured to have a displacement of 1-5 microns.

4. The system of claim 1 wherein the acoustic cavity further comprises a concave surface opposite the upper surface.

5. The system of claim 4 wherein a distance between the fluid reservoir and the acoustic cavity is about 5-15 mm.

6. The system of claim 4 wherein a distance between the acoustic cavity and aperture is about 30-60 mm.

7. The system of claim 4 further comprising a restriction positioned along the conduit between the acoustic cavity and the fluid reservoir to restrict a propagation of acoustic pressure waves into the fluid reservoir.

8. The system of claim 4 wherein the acoustic cavity has a volume of 30-100 μ

L.

9. The system of claim 1 wherein the fluid reservoir has a volume of about 1000 μ

L.

10. The system of claim 1 wherein the aperture has a diameter of 80-120 micron.

11. The system of claim 1 wherein the actuator is programmed to dispense the fluid through the aperture at a frequency of 10 Hz-30 KHz.

12. The system of claim 1 wherein the fluid is ejected as a stream of micro-droplets.

13. The system of claim 12 wherein the actuator is programmed to eject the fluid in a single drop format to produce a stream of micro-droplets.

14. The system of claim 12 wherein the micro-droplets range in volume from 100 pL to 1000 pL.

15. The system of claim 1 wherein the actuator is programmed to eject the fluid as a stream of micro-droplets at pre-determined time intervals.

16. The system of claim 1 further comprising an eyeglass frame upon which the system is attached.

17. The system according to claim 16 wherein the system is attached to an earpiece of the eyeglass frame.

18. The system according to claim 17 wherein the system is attached to the earpiece in a manner such that the drug package reaches a lens of the eyeglass frame and the tip section is bent sideways such that the aperture is oriented toward the eye.

19. A method of emitting a fluid, comprising:

aligning an actuator having a contact portion with a drug package comprising an aperture at a first end comprising a tip section of the drug package and a fluid reservoir near or at a second end of the drug package, wherein the fluid reservoir contains a volume of a fluid ophthalmic drug composition and the drug package is removably separable from the actuator; and

displacing the contact portion of the actuator on the external surface of the drug package to cause one or more acoustic pulses to be transmitted through the fluid ophthalmic drug composition in the drug package such that fluid is ejected through the aperture as a stream;

wherein the actuator is attached to an earpiece of an eyeglass frame and the drug package reaches a lens of the eyeglass frame and the tip section is bent sideways such that the aperture is oriented toward the eye.

20. The method of claim 19 further comprising removing the drug package from the actuator.

21. The method of claim 19 wherein displacing comprises actuating a piezoelectric chip which displaces the contact portion.

22. The method of claim 21 wherein displacing comprises displacing the contact portion 1-5 microns.