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EP-4735083-A1 - AEROSOL DELIVERY DEVICE

EP4735083A1EP 4735083 A1EP4735083 A1EP 4735083A1EP-4735083-A1

Abstract

A device includes an elongate handle having a pneumatic port at a first end, a discharge nozzle at a second end, a grasp portion between the discharge nozzle and the second end, and an actuator fluidically coupled to the discharge nozzle. The pneumatic port, the discharge nozzle, and the grasp portion are aligned along a longitudinal axis. The actuator is disposed at a selected radial relative to the longitudinal axis. The discharge nozzle includes a first tube and a second tube. The first tube and the second tube are arranged coaxially and the first tube is coupled to the pneumatic port. The actuator includes a fluid supply. The fluid supply includes a reservoir coupled to a pump. The fluid supply has an output coupled to the second tube.

Inventors

  • OLSEN, TIMOTHY W.
  • NAQWI, AMIR

Assignees

  • EyeMacular Regenaration, Inc.

Dates

Publication Date
20260506
Application Date
20240627

Claims (20)

  1. 1. A device comprising: an elongate handle having a pneumatic port at a first end, and a discharge nozzle at a second end, a grasp portion between the first end and the second end, and an actuator fluidically coupled to the discharge nozzle; the pneumatic port, the discharge nozzle, and the grasp portion are aligned along a longitudinal axis; the actuator is disposed at a selected radial relative to the longitudinal axis; the discharge nozzle includes a first tube and a second tube, the first tube and the second tube arranged coaxially, the first tube coupled to the pneumatic port; and the actuator includes a fluid supply, the fluid supply including a reservoir coupled to a pump, the fluid supply having an output coupled to the second tube.
  2. 2. The device of claim 1 wherein a terminus of a distal end of the first tube differs from a terminus of a distal end of the second tube.
  3. 3. The device of claim 1 wherein an inner diameter of the second tube is greater than an outer diameter of the first tube.
  4. 4. The device of claim 1 wherein the second tube includes a radial orifice fluidly coupling a lumen of the second tube with the fluid supply.
  5. 5. The device of claim 1 wherein a proximal end of the second tube is fluidly coupled with the fluid supply.
  6. 6. The device of claim 1 wherein a proximal end of the second tube includes a leak-proof coupling with an outer diameter of the first tube.
  7. 7. The device of claim 6 wherein the leak-proof coupling includes a crimp.
  8. 8. The device of claim 1 wherein a distal end of the first tube is fixedly aligned in concentric relationship with the second tube.
  9. 9. The device of claim 1 wherein the distal end of the first tube includes a slotted flare.
  10. 10. The device of claim 1 wherein the reservoir includes an elastic bladder.
  11. 11. The device of claim 1 wherein the pump includes a deformable contact pad having an outer surface configured for hand-manipulation and an inner surface configured to engage with the reservoir.
  12. 12. The device of claim 11 wherein the contact pad and the reservoir are penetrable by a syringe needle.
  13. 13. The device of claim 10 wherein the elastic bladder is disposed proximate a first septum.
  14. 14. The device of claim 13 wherein the elastic bladder and the first septum is disposed proximate a second septum.
  15. 15. The device of claim 1 further including a rigid cover configured for fitment with the actuator.
  16. 16. The device of claim 1 wherein the fluid supply includes a syringe.
  17. 17. The device of claim 16 wherein the actuator includes a pivot-mounted lever configured to engage a plunger of the syringe.
  18. 18. The device of claim 17 wherein a discharge port of the syringe is coupled to a lumen of the second tube.
  19. 19. The device of claim 16 further comprising a first septum disposed proximate a plunger of the syringe.
  20. 20. The device of claim 19 further comprising a second septum disposed proximate the first septum.

Description

AEROSOL DELIVERY DEVICE CLAIM OF PRIORITY This patent application claims the benefit of priority of U.S. Provisional Patent Application Serial Number 63/523,954, filed on June 29, 2023 (Attorney Docket No.5383.003PRV), which is hereby incorporated by reference herein in its entirety. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT This invention was made with government support under R41EY030819 awarded by National Eye Institute (NEI) of the National Institutes of Health (NIH). The government has certain rights in the invention. TECHNICAL FIELD This document pertains generally, but not by way of limitation, to a manually-controlled device to provide an aerosolized drug for use in a surgical procedure. BACKGROUND Proliferative vitreoretinopathy (PVR) is a leading cause of recurrent retinal detachment (RD). Currently, PVR is managed surgically with pars plana vitrectomy, removal of surface membranes, and occasional removal or incision of subretinal traction bands. Such treatment protocols sometimes are associated with complications. To address these complications, some have considered other treatment options, including using intravitreal methotrexate (MTx) to improve the outcomes. Treatment using MTx has not been proven effective in clinical studies, in part, because of complications related to drug delivery at the target site. Eyes with retinal detachment typically require a tamponade agent (gas, air, perfluorocarbon gas, or silicone oil). Delivery of MTx (liquid state) while the eye contains any of these tamponade agents results in maldistribution of an injected liquid form of MTx or another drug. Thus, effective technology for suitable treatment using MTx has remained elusive. US 2020-0289768 refers to drug delivery devices and methods for administering substances to a body cavity by heterogenous aerosolization. SUMMARY An example of the present subject matter enables aerosolized nanoparticle drug delivery for treatment of diseases such as PVR. Gas-phase aerosolized drug deliver can provide a more even, reliable, and predictable distribution. One example of a device includes a handle with a manually- operable drug pump and drug reservoir. A discharged drug is atomized by injection at the periphery of a gas flowing in core channel of the nozzle. Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples. This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. FIG. 1 illustrates a view of a system, according to one example. FIG. 2 illustrates a view a device, according to one example. FIG. 3 illustrates a partial cross-section view of a portion of a device, according to one example. FIG. 4A illustrates a cross-section view of a portion of a device, according to one example. FIG. 4B illustrates a view of a portion of a device, according to one example. FIGS. 5 A and 5B illustrate a cross-section view of a portion of a device, according to one example. FIG. 6 illustrates a view of a portion of a device, according to one example. FIG. 7 illustrates a view of a device, according to one example. FIG. 8 illustrates a view of a device, according to one example. FIG. 9 illustrates a flowchart of a method, according to one example. FIG. 10 illustrates a view of a device, according to one example. FIG. 11 illustrates a view of a device, according to one example. DETAILED DESCRIPTION FIG. 1 illustrates a view of a system, according to one example. In this example, gas supply 10 provides a pressurized supply of gas via line 12 A, fitting 13, line 12B, and line 12C. Gas supply 10 provides a supply of gas to maintain an intraocular pressure of eye 14 during a surgical procedure. Fitting 13 can include a valve, a manifold, or ‘tee-junction’ for distribution of the output from gas supply 10. In the example shown, line 12C provides gas to maintain inflation via inflator nozzle 17. Line 12B provides a pneumatic supply to device 100A. Lines 12A, 12B, and 12C can include light weight and flexible tubes. Device 100 A includes a user-operable valve and, using the supplied gas, provides an aerosolized discharge to the eye via a cannula. Output filter 15 provides for removal of gas from eye 14 through the pars plana region via vent 16 and ensures retention of the aerosolized particles wi