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High modulus polymeric ejector mechanism, ejector device, and methods of use

Inactive Publication Date: 2013-06-13
EYENOVIA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present patent describes an ejector device and method for delivering safe and repeatable dosages of fluids to the eye, skin, mouth, or lungs. The device includes an ejector plate and a high modulus polymeric generator plate with openings that generate a directed stream of droplets with low entrained airflow. The droplets have an average ejected droplet diameter greater than 15 microns and an average initial velocity in the range of 0.5-100 m / s. The device can deliver a volume of fluid in the form of droplets that have high percentage deposition upon application. The technical effects of the invention include improved delivery of fluids with controlled properties, such as viscosity and speed, and reduced airflow, which can lead to reduced ocular discomfort and improved safety during use.

Problems solved by technology

A major challenge in providing such a device is to provide consistent and accurate delivery of suitable doses.
The application of fluids, as in the case of eye drops, has always posed a problem, especially for children and animals who tend to blink or jerk at the critical moment of administration, causing the droplet to land on the eyelid, nose or other part of the face.
Elderly also often lose the hand coordination necessary to get the eye drops into their eyes.
Stroke victims have similar difficulties.
However, in practice, subjects that are prescribed eye medications for home use tend to forget to dose, or dose excessively or cross-dose with other medications.
One of the compliance problems is that, even if the subject is intent on following the treatment regimen, he or she may not be compliant for any number of reasons.
Current eye dropper bottles pose the risk of poking the user in the eye, potentially causing physical damage to the eye, and further, exposing the tip to bacterial contamination due to contact with the eye.
As such, the subject runs the risk of contaminating the medication in the eye drop bottle and subsequently infecting the eye.
Additionally, a large volume of the medication flows out of the eye or is washed away by the tearing reflex.
As a result, this method of administration is also inaccurate and wasteful.
Moreover, the technology does not provide a satisfactory way of controlling the amount of medication that is dispensed, nor does it provide a way of ensuring that the medication that is dispensed actually lands on the eye and remains on the eye.
Eye droppers also provide no way of verifying compliance by a subject.
Even if after a week of use the eye dropper bottle could be checked for the total volume of medication dispensed, e.g., by weighing the bottle, this does not provide a record of day-to-day compliance.
Also, the poor precision with which eye droppers deliver drops to the eye makes it difficult to determine whether the medication is actually delivered into the eye, even though it may have been dispensed.

Method used

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  • High modulus polymeric ejector mechanism, ejector device, and methods of use
  • High modulus polymeric ejector mechanism, ejector device, and methods of use
  • High modulus polymeric ejector mechanism, ejector device, and methods of use

Examples

Experimental program
Comparison scheme
Effect test

example a

Modes of Operation

[0093]Although many arrangements are possible, one implementation uses a piezoelectric-driven ejector mechanism which includes a 6 mm outer diameter, 300 μm thick PEEK generator plate that is bonded to a 20 mm outer diameter, 50 μm thick 304 stainless steel ejector plate annulus. The ejector plate annulus includes a 4 mm diameter central opening which is aligned with the PEEK generator plate, and a 16 mm outer diameter, 8 mm inner diameter piezoelectric actuator is attached directly to the ejector plate. A modulation frequency of approximately 108 kHz to over 140 kHz is applied to the piezoelectric actuator, causing the ejector plate to oscillate. Digital holographic microscopy images are captured to observe oscillation of the high modulus polymeric generator plate. By way of example, with reference to FIG. 5, a frequency scan of the implemented ejection assembly vs. oscillation amplitude was performed to provide for identification of optimal resonant frequency and...

example b

Spray Performance

[0095]Ejector assembly performance may be evaluated over a range of fluid viscosities from low viscosity, e.g., using distilled water (viscosity 1.017 cP), to high viscosity, e.g., using medications such as an ophthalmic emulsion of cyclosporine such as Restasis™ (dynamic viscosity=18.08 cP). By way of example, ejector assembly performance may be evaluated by analyzing fluid mass ejection as a function of actuation frequency.

[0096]The mass ejection profile closely tracks the membrane oscillation amplitude with a maximum mass ejection at ˜110 kHz and maximum oscillation amplitude of ˜2 microns at 110 kHz. Ejection of low viscosity fluids (water) was observed with capillary lengths of both 70 and 120 microns. With reference to FIG. 6, mass ejection vs. frequency for water using a 300 μm thick PEEK generator plate with 70 μm capillary channel length is illustrated, with an onset of maximum amplitude at 108 kHz and a maximum amplitude of 2.3 μm at 110 kHz, which coincid...

example c

Effect of Capillary Length

[0097]In certain implementations of ejector mechanisms of the disclosure, capillary length of the openings of the generator plate may affect spray performance. As illustrated in FIGS. 7A-7B, mass ejection vs. frequency reveals a shift in frequency, to lower frequencies, for water ejected from PEEK membranes having 120 micron long capillary channels. However, for high viscosity fluids such as Restasis™ (dynamic viscosity=18.08 cP), a significant increase in the mass ejection peak (2.5×) for PEEK membranes with 120 micron long capillary channels vs. membranes with 70 micron long capillary channels is observed.

[0098]More particularly, FIG. 7A illustrates ejection of Newtonian fluids (water), while FIG. 7B illustrates ejection of Non-Newtonian fluids (Restasis). FIG. 7A shows that an increase in capillary length leads to an increase in resistance and load on the fluid as it exits the opening. This mass loading effect leads to a shift in the peak ejection freque...

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PUM

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Abstract

An ejector device and method of delivering safe, suitable, and repeatable dosages to a subject for topical, oral, nasal, or pulmonary use is disclosed. The ejector device includes a housing, a reservoir disposed within the housing for receiving a volume of fluid, and an ejector mechanism in fluid communication with the reservoir and configured to eject a stream of droplets, the ejector mechanism comprising an ejector plate coupled to a generator plate and a piezoelectric actuator; the piezoelectric actuator being operable to oscillate the ejector plate, and thereby the generator plate, at a frequency and generate a directed stream of droplets.

Description

RELATED APPLICATIONS[0001]This application claims the benefit of the filing date of U.S. Provisional Application No. 61 / 569,739, filed Dec. 12, 2011, and of U.S. Provisional Application No. 61 / 591,786, filed Jan. 27, 2012, contents of which are herein incorporated by reference in their entireties.BACKGROUND OF THE INVENTION[0002]Using spray devices to administer products in the form of mists or sprays is an area with large potential for safe, easy-to-use products. A major challenge in providing such a device is to provide consistent and accurate delivery of suitable doses.[0003]An important area where spray devices are needed is in delivery of eye medications. The application of fluids, as in the case of eye drops, has always posed a problem, especially for children and animals who tend to blink or jerk at the critical moment of administration, causing the droplet to land on the eyelid, nose or other part of the face. The impact of a large drop or drops of fluid on the eyeball, espe...

Claims

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Application Information

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IPC IPC(8): A61F9/00
CPCA61F9/0008B05B17/0661B05B17/0646B05B17/0607A61F9/0026
Inventor HUNTER, CHARLES ERICGERMINARIO, LOUIS THOMASWILKERSON, JONATHAN RYANLYNCH, IYAMCLEMENTS, J. SIDBROWN, JOSHUA RICHARD
Owner EYENOVIA
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