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WO2025006673A1 - Aerosol delivery device - Google Patents

Aerosol delivery device Download PDF

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Publication number
WO2025006673A1
WO2025006673A1 PCT/US2024/035712 US2024035712W WO2025006673A1 WO 2025006673 A1 WO2025006673 A1 WO 2025006673A1 US 2024035712 W US2024035712 W US 2024035712W WO 2025006673 A1 WO2025006673 A1 WO 2025006673A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
coupled
fluid supply
actuator
discharge nozzle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/035712
Other languages
French (fr)
Inventor
Timothy W. Olsen
Amir Naqwi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Imacular Regeneration LLC
Original Assignee
Imacular Regeneration LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Imacular Regeneration LLC filed Critical Imacular Regeneration LLC
Publication of WO2025006673A1 publication Critical patent/WO2025006673A1/en
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M13/00Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/006Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
    • A61M11/007Syringe-type or piston-type sprayers or atomisers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/06Sprayers or atomisers specially adapted for therapeutic purposes of the injector type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/04Liquids
    • A61M2202/0468Liquids non-physiological
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0612Eyes

Definitions

  • 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.
  • Proliferative vitreoretinopathy is a leading cause of recurrent retinal detachment (RD).
  • RD retinal detachment
  • 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.
  • MTx intravitreal methotrexate
  • 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.
  • tamponade agent gas, air, perfluorocarbon gas, or silicone oil
  • US 2020-0289768 refers to drug delivery devices and methods for administering substances to a body cavity by heterogenous aerosolization.
  • 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.
  • 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.
  • FIG. 1 illustrates a view of a system, according to one 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.
  • 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 within eye 14.
  • Vent 16 may contain a filter to remove aerosolized drug, but not air from exiting the eye.
  • FIG. 2 illustrates an exploded view of device 100B, according to one example of the present subject matter.
  • Device 100B includes handle 30A, assembly 29, cannula 76, septum assembly 54.
  • Device 100B includes grasp portion 32 configured as a substantially hollow body having an elongate form aligned on longitudinal axis 15.
  • One end of grasp portion 32 includes pneumatic port 34A.
  • Pneumatic port 34A includes a threaded coupler to engage with corresponding coupler 34B affixed to line 12B.
  • the coupling provided by port 34A and coupler 34 is known as a Luer fitting.
  • the coupling provided by port 34A and coupler 34 includes a threaded coupling, a hose-and-barb- coupling or other quick connect fitting.
  • Grasp portion 32 includes actuator coupling 39A disposed at an end opposite that of port 34A. Coupling 39A provides a joint between grasp portion 32 and actuator 38 A.
  • actuator 38A provides a fluid reservoir and a manually-operable fluid pump.
  • the outlet of actuator 38A includes discharge nozzle 18.
  • Discharge nozzle 18 is coupled to cannula 76.
  • cannula 76, discharge nozzle 18, grasp portion 32, and pneumatic port 34A are aligned on axis 15.
  • Actuator 38A receives contact pad 25.
  • Contact pad 25 can include a compliant material such as silicone.
  • Contact pad 25 can be manipulated by a user digit in order to control the discharge of the reservoir contents.
  • Cover 20 can be fitted to engage with portions of the actuator, or other portions of handle 30A, and remain in place. Cover 20 can be fitted or removed without using tools. When in place, cover 20 provides a measure of safety in preventing manipulation of contact pad 25 and inadvertent discharge of reservoir contents. In one example, cover 20 can be translucent and thus, enable viewing of contents in the underlying fluid reservoir.
  • Actuator 38A can include some or all elements shown in assembly 29.
  • actuator 38 A can include contact pad 25, a diaphragm, a bulb-type reservoir, and other components to provide both a fluid reservoir and a fluid pump.
  • cover 20 is omitted.
  • Actuator 38A can be coupled to grasp portion 32 by actuator coupling 39 A.
  • Actuator coupling 39A can include a threaded fitting, a bonded coupling, or an ultrasonically welded coupling.
  • Cannula 76 includes first tube 41 and second tube 42.
  • tubes 41 and 42 are coaxially aligned with first tube 41 nested within second tube 42. In this manner, an outer diameter of first tube 41 is less than an inner diameter of second tube 42.
  • first tube 41 provides an inner cannula and second tube 42 provides an outer cannula.
  • First tube 41 and second tube 42 can be retained in alignment and position by ultrasonic welding, by an adhesive bond, through the active flow of fluid between first tube 41 and second tube 42, or by other manner of fastening.
  • Septum assembly 54 allows for delivering drug to reservoir (bladder) of device 100B.
  • Septum assembly 54 includes first septum 51 and second septum 52 arranged in stacked alignment and retained by cap 53.
  • First septum 51 and second septum 52 can be fabricated of an elastic material such as silicone and allows for needle penetration and self-sealing after needle withdrawal.
  • Septum assembly 54 can include an air gap between first septum 51 and second septum 52.
  • Cap 53 retains the septum assembly relative to the actuator 38 A.
  • Cap 53 can include retention threads or can include a sealing surface to allow bonding to actuator 38 A.
  • cap 53 is attached by a crimp, an interference fit, lugs, or a snap fit.
  • septum assembly 54 includes a single septum component.
  • FIG. 3 illustrates a partial cross-section view of actuator 38B of a device, according to one example.
  • actuator 38B includes coupling 39B for affixation to grasp portion 32, for example.
  • Coupling 39B can include a leakresistant bonded structure, a threaded structure, or omitted in the case of a unitary assembly.
  • Actuator 38B includes diaphragm 62.
  • Diaphragm 62 has a disc-shaped form and is configured with radiused portions to allow elasticity of the center portion and retention at peripheral portions.
  • Diaphragm 62 can be affixed to actuator 38B by an ultrasonic weld, a threaded joint, or by other means of bonding as shown at bond 66.
  • Diaphragm 62 can be fabricated of an elastic material, such as silicone, or a solid, firm material with elastic borders, either to allow deflection under finger pressure and rebounding when pressure is removed.
  • a finger pressure applied to diaphragm 62 serves to pressurize reservoir 64.
  • Reservoir 64 provides storage for a drug or other fluid along with an air or gas bubble.
  • reservoir 64 has a volume of 1 ml when relaxed in natural state.
  • reservoir 64 is fluidically coupled to the discharge nozzle by internal passageways of actuator 38B. Under pressure, the contents of reservoir 64 are fluidically conveyed to cannula 76 (some portions of which are illustrated here).
  • first tube 41 has a proximal terminus that is open to pneumatic pressure provided by pneumatic port 34A and gas conveyed in first tube 41 can be viewed as a core flow.
  • a lumen of second tube 42 is fluidically coupled to reservoir 64 and fluid conveyed in second tube 42 can be viewed as a sheath flow.
  • First tube 41 is bonded to actuator 38B by bond 68 and second tube 42 is bonded to discharge nozzle of actuator 38B by bond 67.
  • a portion of septum cap 53 is visible in the view of FIG. 3.
  • FIG. 4A includes a view of a cannula, according to one example.
  • the cannula includes a distal portion 76A and a proximate portion 76B.
  • the cannula includes first tube 41 and second tube 42 in coaxial alignment.
  • Arrows 84 indicate the flow of gas within the lumen of first tube 41, received at a proximal end and exiting at end 79.
  • the core gas is met with fluid carried about the periphery of first tube 41 and within the interior of second tube 42.
  • Second tube 42 receive a supply of fluid, such as a drug, by way of proximal closure 86 disposed near a proximal end.
  • Passageways internal to proximal closure 88 convey the fluid from drug port 88, to sheath channel 80.
  • Arrows 90 indicate the flow of fluid in the sheath channel 80.
  • Directional arrow 92 indicates flow of aerosolized or atomized fluid in the region following the length of first tube 41.
  • the mixing of fluid and gas produces either aerosolized droplets or smaller nanoparticles (depending upon gas-flow dynamics) which exit from end 78 of second tube 42.
  • the length of region 75, between end 79 of first tube 41 and end 78 of second tube 42, has a dimension sometimes denoted as distal disparity. Distal disparity can be modified to affect the particle size, aerosol droplet dehydration, and angle of delivery (from end 78).
  • FIG. 4B illustrates a view of cannula 76C, according to one example.
  • first tube 41 is shown to be inside of second tube 42.
  • Crimp 96 depicts a reduced diameter portion of second tube 42.
  • Crimp 96 exerts a compressive force on first tube 41 and maintains relative alignment between the tubes. As such, first tube 41 remains relatively centered on the lumen of second tube 42.
  • Crimp 96 also provides a leak-proof coupling to ensure fluid entering radial aperture or orifice 94, in the wall of second tube 42, is carried to the distal end of second tube 42.
  • FIG. 5 A illustrates a view of actuator 38C, according to one example.
  • actuator 38C is aligned vertically with cannula 76 in upward position as would be the case during filling of the reservoir. Fluid 116, under the force of gravity, settles to the lower portion of the reservoir and air 114 occupies the space above. Air 114 vents through the lumen of second tube 42 via discharge nozzle 18. Diaphragm 62, adjacent the fluid reservoir is guarded from inadvertent manipulation by cover 20 fitted to actuator 38C.
  • Fluid 116 is introduced to actuator 38C by syringe 99 having needle 98 passing through septum cap 53 and penetrating septum 51 and septum 52. Septum 51 and septum 52 are sufficiently elastic to self-close upon withdrawal of needle 98.
  • the reservoir has a volume of approximately 1 ml and is loaded with 0.5 ml of fluid and an equal amount of air.
  • FIG. 5B illustrates a view of actuator 38C, according to one example.
  • actuator 38C is aligned vertically with cannula 76 in a downward position as would be the case when delivering an aerosolized drug.
  • the fluid drug occupies the lower portions of the reservoir, remains in the chamber through capillary forces, and as shown at fluid 116 and air 114 occupies the region above the fluid.
  • the fluid flow force for drug discharge from compressibility of diaphragm 62 exceeds capillary forces and the compressibility of the air remaining in the actuator 38C ensures controlled drug dosing.
  • Diaphragm 62 is accessible by the user and defection of the diaphragm leads to discharge of aerosolized drug via cannula 76.
  • device 100A shown in the system of FIG. 1 depicts the substantially vertical orientation with cannula down during administration.
  • FIG. 6 illustrates flared end 104 on first tube 41. Maintaining concentricity of the tubes in the cannula can promote uniform aerosolization.
  • the figure depicts flared end 104 having longitudinal split portions at slots 106.
  • Flared end 104 has a nominal diameter denoted by dimension D2 which differs from that of the nominal diameter of first tube 41, here donated by dimension DI .
  • D2 is larger than DI .
  • Slots 106 provide pathways by which the fluid can pass into the region of aerosolization.
  • Other structures or configurations are also contemplated. For example, a stand-off, spacer, or perforated bushing can provide passage an provide good concentricity.
  • FIG. 7 illustrates device 100C, according to one example.
  • Device 100C is configured to deliver an aerosolized drug.
  • Device 100C includes pneumatic port 34A configured to receive a supply of gas at one end of handle 30B and deliver aerosolized fluid via cannula 76 at an opposing end of handle 30B.
  • Lever 120 is coupled to handle 30B at joint 122. Joint 122 allows relative movement as to lever 120 and handle 3 OB.
  • Lever 120 when urged in a direction towards handle 30B, exerts a motive force on a plunger of drug chamber 130.
  • Drug chamber 130 includes porting to convey fluid to a sheath channel of cannulas 76.
  • Drug chamber 130 includes septum assembly 54 for receiving a fluid by syringe needle.
  • Device 100C can be filled without regard for orientation relative to gravity.
  • device 100C includes a ratchet or friction element coupled to lever 120 to prevent elastomer spring-back from drawing gas back into the drug chamber.
  • FIG. 8 illustrates device 100D, according to one example.
  • Device 100D is configured to deliver an aerosolized drug.
  • Device 100D includes pneumatic port 34A configured to receive a supply of gas at one end of handle 30C and deliver aerosolized fluid via cannula 76 at an opposing end of handle 30C.
  • syringe coupler 152 is affixed to an end of handle 30C. Syringe coupler 152 provides guides and catch elements to receive and retain syringe body 150 and provide manual access to syringe plunger 140.
  • septum 54 is configured to receive a needle of syringe body 150 and through internal porting of device 100D, convey fluid from syringe body 150 to a sheath channel of cannulas 76.
  • Lever 120 is coupled to handle 30B at joint 122. Joint 122 allows relative movement as to lever 120 and handle 30B. Lever 120, when urged in a direction towards handle 30B, exerts a motive force on a plunger of drug chamber 130. A user can manipulate syringe plunger 140 using a finger movement.
  • FIG. 9 illustrates a flowchart of method 200, according to one example.
  • method 200 includes, at 210, providing a handle.
  • the handle has a pneumatic port coupled to a first channel terminating at a discharge cannula.
  • the pneumatic port can include a fitting at a first end of the handle and the channel couples the port to a cannula disposed at a second end of the handle, opposite the first end.
  • method 200 includes providing a fluid supply coupled to the handle.
  • the fluid supply can include a reservoir coupled to a manually-operable pump.
  • a manually-operable pump can include a syringe, an elastic bladder, a diaphragm, or other type of pump.
  • the fluid supply is configured to couple to a second channel terminating at the discharge cannula.
  • method 200 include positioning the first channel relative to the second channel. In one example, positioning includes aligning the first channel within a lumen of the second channel.
  • positioning can include staggering a terminus of the first channel relative to a terminus of the second channel.
  • positioning includes arranging the first channel coaxially with the second channel.
  • providing the fluid supply includes providing a diaphragm pump.
  • FIGS. 10 and 11 illustrate views of device 100E, according to one example.
  • FIG. 10 illustrates selected internal features and
  • FIG. 11 illustrates a partial section view.
  • Device 100E includes user-replaceable cartridge 126 coupled to handle 30D.
  • Cartridge 126 can include a vial of cylindrical, rigid material, such as glass or plastic.
  • Cartridge 126 has a fluid discharge opening disposed proximate the discharge nozzle and a gas pressure opening disposed proximate the port end of device 100E.
  • Cartridge 126 is fitted between gasket 130A at the discharge end and gasket 130B at the gas pressure opening.
  • Gasket 130A and gasket 130B provide a leak-resistant fluid coupling between the handle 30D and cartridge 126, and in some examples, are fabricated of a rubber material.
  • gasket 130B is illustrated as an O-ring and hydrophobic filter 132 is fitted at the gas pressure opening of cartridge 126.
  • cartridge 126 includes a piston configured to eject the fluid with linear movement of the piston within the cylinder of cartridge 126.
  • Line 12D is a flexible supply line that provides pressurized gas to port 34C of handle 30D. Pressurized gas in line 12D is coupled to both cartridge 126 and coupled to a proximal end of discharge nozzle 18.
  • a y-coupler provides a fluid coupling between port 34C, cartridge 126, and discharge nozzle 18.
  • FIG. 4A illustrates an example of structural details of discharge nozzle 18.
  • FIG. 4A refers to a cannula and the first tube 41 and second tube 42 in coaxial alignment.
  • FIG. 4A can be viewed as discharge nozzle 18 in which a gas is carried by inner tube 41 and a liquid (from, for example cartridge 126) is carried by outer tube 42.
  • Device 100E includes actuator 48.
  • Actuator 48 is depicted here as a user-operable button. Actuator 48 is carried on handle 30D and is urged by spring 49 (or an elastic element) in a generally upward direction in the view shown. Actuator 48 is coupled to valve 72 and is configured for manipulation by a user’s thumb. Valve 72 is fluidly coupled to line 106. One end of line 106 is coupled to the discharge end of cartridge 126 and the other end of line 106 is coupled to discharge nozzle 18.
  • a user can exert a finger pressure to overcome the elastic force of spring 49 and move actuator 48 in a downward direction. Movement of actuator 48 in the downward direction operates on a link coupled to valve 72 in a manner to open valve 72. When valve 72 is opened, fluid in cartridge 126 (under gas pressure received at port 34C) is forced from the cartridge 126 and through line 106 to discharge nozzle 18.
  • Fluid arriving at discharge nozzle 18 from line 106 is atomized by interaction with the pressurized gas carried through handle 30D.
  • finger pressure exerted on actuator 48 opens valve 72 and allows fluid in cartridge 126 to atomize and exit device 100E at discharge nozzle 18.
  • spring 49 raises the actuator and carries the link to manipulate valve 72 into a closed position.
  • valve 72 is closed, fluid flow in line 106 is terminated and discharge nozzle 18 ejects gas only.
  • Valve 72 in the example shown, is configured as a pinch mechanism.
  • Line 106 is an elastic tube and a stud coupled to a linkage manipulated by actuator 48 is moved on a radial with respect to an axis of line 106. Movement of the stud collapses a wall of line 106 and constricts fluid flow in line 106. In the example shown, the stud is moved in a direction to collapse the wall of line 106 under motive force from spring 49. With applied finger pressure, spring 49 is deflected and the stud is carried away from the wall of line 106, thus establishing patency of line 106. In the example shown, line 106 intersects at approximately 45 degree angle with gas carried in handle 30D. Other angles and configurations for blending, or atomizing, the fluid and gas are contemplated.
  • Valve 72 can be configured as an iris valve, a gate valve, a ball valve or other configuration.
  • other linkage arrangements are contemplated to allow user-selection of gas-only or atomized fluid to emerge from discharge nozzle.
  • lock 142 is slidable coupled to handle 30D.
  • Lock 142 includes a bolt that can be selectively positioned fore and aft to limit movement of actuator 48.
  • lock 142 can be manipulated (by user-exerted force on a tab) to insert or retract a bolt to either lock or unlock, respectively, movement of actuator 48.
  • One example includes a handle with a manually-operable drug pump and drug reservoir.
  • One example enables drug atomization by injection a fluid at the periphery of gas flowing in nozzle core.
  • the aerosolization spray pattern from the cannula is dependent on factors, including the distal disparity as to the relative location of the ends of the cannula components.
  • the spray pattern is also a function of the gap in concentricity of the first tube 41 relative to second tube 42.
  • a split flare end, or other configuration providing uniform spacing, is conducive to a uniform flow pattern. Uniformity in flow pattern can promote a favorable medical treatment outcome.
  • one configuration can include a gas sheath and a fluid core.
  • bias cut ends on the first tube 41, or second tube 42 can affect the spray pattern.
  • an example of the present subject matter can be configured for treatment of other regions of a body.
  • the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.”
  • the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated.
  • Geometric terms such as “parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.

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  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Heart & Thoracic Surgery (AREA)
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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.

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 within eye 14. Vent 16 may contain a filter to remove aerosolized drug, but not air from exiting the eye.
FIG. 2 illustrates an exploded view of device 100B, according to one example of the present subject matter. Device 100B includes handle 30A, assembly 29, cannula 76, septum assembly 54. Device 100B includes grasp portion 32 configured as a substantially hollow body having an elongate form aligned on longitudinal axis 15. One end of grasp portion 32 includes pneumatic port 34A. Pneumatic port 34A includes a threaded coupler to engage with corresponding coupler 34B affixed to line 12B. In some examples, the coupling provided by port 34A and coupler 34 is known as a Luer fitting. In some examples, the coupling provided by port 34A and coupler 34 includes a threaded coupling, a hose-and-barb- coupling or other quick connect fitting.
Grasp portion 32 includes actuator coupling 39A disposed at an end opposite that of port 34A. Coupling 39A provides a joint between grasp portion 32 and actuator 38 A. In the example shown, actuator 38A provides a fluid reservoir and a manually-operable fluid pump. The outlet of actuator 38A includes discharge nozzle 18. Discharge nozzle 18 is coupled to cannula 76. In the illustrated example, cannula 76, discharge nozzle 18, grasp portion 32, and pneumatic port 34A are aligned on axis 15.
Actuator 38A receives contact pad 25. Contact pad 25 can include a compliant material such as silicone. Contact pad 25 can be manipulated by a user digit in order to control the discharge of the reservoir contents. Cover 20 can be fitted to engage with portions of the actuator, or other portions of handle 30A, and remain in place. Cover 20 can be fitted or removed without using tools. When in place, cover 20 provides a measure of safety in preventing manipulation of contact pad 25 and inadvertent discharge of reservoir contents. In one example, cover 20 can be translucent and thus, enable viewing of contents in the underlying fluid reservoir.
Actuator 38A can include some or all elements shown in assembly 29. For example, actuator 38 A can include contact pad 25, a diaphragm, a bulb-type reservoir, and other components to provide both a fluid reservoir and a fluid pump. In one example, cover 20 is omitted.
Actuator 38A can be coupled to grasp portion 32 by actuator coupling 39 A. Actuator coupling 39A can include a threaded fitting, a bonded coupling, or an ultrasonically welded coupling.
Cannula 76 includes first tube 41 and second tube 42. In one example, tubes 41 and 42 are coaxially aligned with first tube 41 nested within second tube 42. In this manner, an outer diameter of first tube 41 is less than an inner diameter of second tube 42. As such, first tube 41 provides an inner cannula and second tube 42 provides an outer cannula. First tube 41 and second tube 42 can be retained in alignment and position by ultrasonic welding, by an adhesive bond, through the active flow of fluid between first tube 41 and second tube 42, or by other manner of fastening.
Septum assembly 54 allows for delivering drug to reservoir (bladder) of device 100B. Septum assembly 54 includes first septum 51 and second septum 52 arranged in stacked alignment and retained by cap 53. First septum 51 and second septum 52 can be fabricated of an elastic material such as silicone and allows for needle penetration and self-sealing after needle withdrawal. Septum assembly 54 can include an air gap between first septum 51 and second septum 52. Cap 53 retains the septum assembly relative to the actuator 38 A. Cap 53 can include retention threads or can include a sealing surface to allow bonding to actuator 38 A. In various examples, cap 53 is attached by a crimp, an interference fit, lugs, or a snap fit. In one example, septum assembly 54 includes a single septum component.
FIG. 3 illustrates a partial cross-section view of actuator 38B of a device, according to one example. As shown, actuator 38B includes coupling 39B for affixation to grasp portion 32, for example. Coupling 39B can include a leakresistant bonded structure, a threaded structure, or omitted in the case of a unitary assembly. Actuator 38B includes diaphragm 62. Diaphragm 62 has a disc-shaped form and is configured with radiused portions to allow elasticity of the center portion and retention at peripheral portions. Diaphragm 62 can be affixed to actuator 38B by an ultrasonic weld, a threaded joint, or by other means of bonding as shown at bond 66. Diaphragm 62 can be fabricated of an elastic material, such as silicone, or a solid, firm material with elastic borders, either to allow deflection under finger pressure and rebounding when pressure is removed. A finger pressure applied to diaphragm 62 serves to pressurize reservoir 64. Reservoir 64 provides storage for a drug or other fluid along with an air or gas bubble. In one example, reservoir 64 has a volume of 1 ml when relaxed in natural state. In one example, reservoir 64 is fluidically coupled to the discharge nozzle by internal passageways of actuator 38B. Under pressure, the contents of reservoir 64 are fluidically conveyed to cannula 76 (some portions of which are illustrated here). For example, first tube 41 has a proximal terminus that is open to pneumatic pressure provided by pneumatic port 34A and gas conveyed in first tube 41 can be viewed as a core flow. In addition, a lumen of second tube 42 is fluidically coupled to reservoir 64 and fluid conveyed in second tube 42 can be viewed as a sheath flow. First tube 41 is bonded to actuator 38B by bond 68 and second tube 42 is bonded to discharge nozzle of actuator 38B by bond 67. A portion of septum cap 53 is visible in the view of FIG. 3.
FIG. 4A includes a view of a cannula, according to one example. The cannula includes a distal portion 76A and a proximate portion 76B. As noted, the cannula includes first tube 41 and second tube 42 in coaxial alignment. Arrows 84 indicate the flow of gas within the lumen of first tube 41, received at a proximal end and exiting at end 79. Upon exit from first tube 41, the core gas is met with fluid carried about the periphery of first tube 41 and within the interior of second tube 42. Second tube 42 receive a supply of fluid, such as a drug, by way of proximal closure 86 disposed near a proximal end. Passageways internal to proximal closure 88 convey the fluid from drug port 88, to sheath channel 80. Arrows 90 indicate the flow of fluid in the sheath channel 80. Alternatively, there may be one or more apertures in the shaft of second tube 42, that allows for a drug port access without a sheath (FIG. 4B, orifice 94).
Directional arrow 92 indicates flow of aerosolized or atomized fluid in the region following the length of first tube 41. The mixing of fluid and gas produces either aerosolized droplets or smaller nanoparticles (depending upon gas-flow dynamics) which exit from end 78 of second tube 42. The length of region 75, between end 79 of first tube 41 and end 78 of second tube 42, has a dimension sometimes denoted as distal disparity. Distal disparity can be modified to affect the particle size, aerosol droplet dehydration, and angle of delivery (from end 78).
FIG. 4B illustrates a view of cannula 76C, according to one example. In the figure, first tube 41 is shown to be inside of second tube 42. Crimp 96 depicts a reduced diameter portion of second tube 42. Crimp 96 exerts a compressive force on first tube 41 and maintains relative alignment between the tubes. As such, first tube 41 remains relatively centered on the lumen of second tube 42. Crimp 96 also provides a leak-proof coupling to ensure fluid entering radial aperture or orifice 94, in the wall of second tube 42, is carried to the distal end of second tube 42. FIG. 5 A illustrates a view of actuator 38C, according to one example. In the figure, actuator 38C is aligned vertically with cannula 76 in upward position as would be the case during filling of the reservoir. Fluid 116, under the force of gravity, settles to the lower portion of the reservoir and air 114 occupies the space above. Air 114 vents through the lumen of second tube 42 via discharge nozzle 18. Diaphragm 62, adjacent the fluid reservoir is guarded from inadvertent manipulation by cover 20 fitted to actuator 38C.
Fluid 116 is introduced to actuator 38C by syringe 99 having needle 98 passing through septum cap 53 and penetrating septum 51 and septum 52. Septum 51 and septum 52 are sufficiently elastic to self-close upon withdrawal of needle 98.
In the example shown, the reservoir has a volume of approximately 1 ml and is loaded with 0.5 ml of fluid and an equal amount of air.
FIG. 5B illustrates a view of actuator 38C, according to one example. In the figure, actuator 38C is aligned vertically with cannula 76 in a downward position as would be the case when delivering an aerosolized drug. In this manner, the fluid (drug) occupies the lower portions of the reservoir, remains in the chamber through capillary forces, and as shown at fluid 116 and air 114 occupies the region above the fluid. During dispensing, the fluid flow force for drug discharge from compressibility of diaphragm 62 (FIG. 5A) exceeds capillary forces and the compressibility of the air remaining in the actuator 38C ensures controlled drug dosing. Diaphragm 62 is accessible by the user and defection of the diaphragm leads to discharge of aerosolized drug via cannula 76. Notably, device 100A shown in the system of FIG. 1 depicts the substantially vertical orientation with cannula down during administration.
FIG. 6 illustrates flared end 104 on first tube 41. Maintaining concentricity of the tubes in the cannula can promote uniform aerosolization. The figure depicts flared end 104 having longitudinal split portions at slots 106. Flared end 104 has a nominal diameter denoted by dimension D2 which differs from that of the nominal diameter of first tube 41, here donated by dimension DI . In particular, D2 is larger than DI . Slots 106 provide pathways by which the fluid can pass into the region of aerosolization. Other structures or configurations are also contemplated. For example, a stand-off, spacer, or perforated bushing can provide passage an provide good concentricity.
FIG. 7 illustrates device 100C, according to one example. Device 100C is configured to deliver an aerosolized drug. Device 100C includes pneumatic port 34A configured to receive a supply of gas at one end of handle 30B and deliver aerosolized fluid via cannula 76 at an opposing end of handle 30B. Lever 120 is coupled to handle 30B at joint 122. Joint 122 allows relative movement as to lever 120 and handle 3 OB. Lever 120, when urged in a direction towards handle 30B, exerts a motive force on a plunger of drug chamber 130. Drug chamber 130 includes porting to convey fluid to a sheath channel of cannulas 76. Drug chamber 130 includes septum assembly 54 for receiving a fluid by syringe needle. Surface tension of the fluid inside the narrow tube drug chamber can reduce the incidence of air bubbles trapped behind the drug during filling. Device 100C can be filled without regard for orientation relative to gravity. In one example of the present subject matter, device 100C includes a ratchet or friction element coupled to lever 120 to prevent elastomer spring-back from drawing gas back into the drug chamber.
FIG. 8 illustrates device 100D, according to one example. Device 100D is configured to deliver an aerosolized drug. Device 100D includes pneumatic port 34A configured to receive a supply of gas at one end of handle 30C and deliver aerosolized fluid via cannula 76 at an opposing end of handle 30C. In the example shown, syringe coupler 152 is affixed to an end of handle 30C. Syringe coupler 152 provides guides and catch elements to receive and retain syringe body 150 and provide manual access to syringe plunger 140. In this example, septum 54 is configured to receive a needle of syringe body 150 and through internal porting of device 100D, convey fluid from syringe body 150 to a sheath channel of cannulas 76.
Lever 120 is coupled to handle 30B at joint 122. Joint 122 allows relative movement as to lever 120 and handle 30B. Lever 120, when urged in a direction towards handle 30B, exerts a motive force on a plunger of drug chamber 130. A user can manipulate syringe plunger 140 using a finger movement. FIG. 9 illustrates a flowchart of method 200, according to one example. In the example shown, method 200 includes, at 210, providing a handle. In one example, the handle has a pneumatic port coupled to a first channel terminating at a discharge cannula. The pneumatic port can include a fitting at a first end of the handle and the channel couples the port to a cannula disposed at a second end of the handle, opposite the first end.
At 220, method 200 includes providing a fluid supply coupled to the handle. The fluid supply can include a reservoir coupled to a manually-operable pump. A manually-operable pump can include a syringe, an elastic bladder, a diaphragm, or other type of pump. The fluid supply is configured to couple to a second channel terminating at the discharge cannula.
At 230, method 200 include positioning the first channel relative to the second channel. In one example, positioning includes aligning the first channel within a lumen of the second channel.
In one example, positioning can include staggering a terminus of the first channel relative to a terminus of the second channel.
In one example, positioning includes arranging the first channel coaxially with the second channel.
In one example, providing the fluid supply includes providing a diaphragm pump.
FIGS. 10 and 11 illustrate views of device 100E, according to one example. FIG. 10 illustrates selected internal features and FIG. 11 illustrates a partial section view.
Device 100E includes user-replaceable cartridge 126 coupled to handle 30D. Cartridge 126 can include a vial of cylindrical, rigid material, such as glass or plastic. Cartridge 126 has a fluid discharge opening disposed proximate the discharge nozzle and a gas pressure opening disposed proximate the port end of device 100E. Cartridge 126 is fitted between gasket 130A at the discharge end and gasket 130B at the gas pressure opening. Gasket 130A and gasket 130B provide a leak-resistant fluid coupling between the handle 30D and cartridge 126, and in some examples, are fabricated of a rubber material. In the example shown, gasket 130B is illustrated as an O-ring and hydrophobic filter 132 is fitted at the gas pressure opening of cartridge 126. In one example, cartridge 126 includes a piston configured to eject the fluid with linear movement of the piston within the cylinder of cartridge 126.
Line 12D is a flexible supply line that provides pressurized gas to port 34C of handle 30D. Pressurized gas in line 12D is coupled to both cartridge 126 and coupled to a proximal end of discharge nozzle 18. In the example shown, a y-coupler provides a fluid coupling between port 34C, cartridge 126, and discharge nozzle 18.
Pressurized gas entering at port 34C is carried through handle 30D and exits at the inner tube of discharge nozzle 18. A valve in line 12D controls gas entering at port 34C. In one example, the valve is a foot-operated control manipulated by an operator. FIG. 4A illustrates an example of structural details of discharge nozzle 18. FIG. 4A refers to a cannula and the first tube 41 and second tube 42 in coaxial alignment. In addition, FIG. 4A can be viewed as discharge nozzle 18 in which a gas is carried by inner tube 41 and a liquid (from, for example cartridge 126) is carried by outer tube 42.
Device 100E includes actuator 48. Actuator 48 is depicted here as a user-operable button. Actuator 48 is carried on handle 30D and is urged by spring 49 (or an elastic element) in a generally upward direction in the view shown. Actuator 48 is coupled to valve 72 and is configured for manipulation by a user’s thumb. Valve 72 is fluidly coupled to line 106. One end of line 106 is coupled to the discharge end of cartridge 126 and the other end of line 106 is coupled to discharge nozzle 18.
A user can exert a finger pressure to overcome the elastic force of spring 49 and move actuator 48 in a downward direction. Movement of actuator 48 in the downward direction operates on a link coupled to valve 72 in a manner to open valve 72. When valve 72 is opened, fluid in cartridge 126 (under gas pressure received at port 34C) is forced from the cartridge 126 and through line 106 to discharge nozzle 18.
Fluid arriving at discharge nozzle 18 from line 106 is atomized by interaction with the pressurized gas carried through handle 30D.
In the example shown, finger pressure exerted on actuator 48 opens valve 72 and allows fluid in cartridge 126 to atomize and exit device 100E at discharge nozzle 18. With release of actuator 48 (that is, removing finger pressure atop actuator 48), spring 49 raises the actuator and carries the link to manipulate valve 72 into a closed position. When valve 72 is closed, fluid flow in line 106 is terminated and discharge nozzle 18 ejects gas only.
Valve 72, in the example shown, is configured as a pinch mechanism. Line 106 is an elastic tube and a stud coupled to a linkage manipulated by actuator 48 is moved on a radial with respect to an axis of line 106. Movement of the stud collapses a wall of line 106 and constricts fluid flow in line 106. In the example shown, the stud is moved in a direction to collapse the wall of line 106 under motive force from spring 49. With applied finger pressure, spring 49 is deflected and the stud is carried away from the wall of line 106, thus establishing patency of line 106. In the example shown, line 106 intersects at approximately 45 degree angle with gas carried in handle 30D. Other angles and configurations for blending, or atomizing, the fluid and gas are contemplated.
Valve 72 can be configured as an iris valve, a gate valve, a ball valve or other configuration. In addition , other linkage arrangements are contemplated to allow user-selection of gas-only or atomized fluid to emerge from discharge nozzle.
In the example illustrated, lock 142 is slidable coupled to handle 30D. Lock 142 includes a bolt that can be selectively positioned fore and aft to limit movement of actuator 48. In the example shown, lock 142 can be manipulated (by user-exerted force on a tab) to insert or retract a bolt to either lock or unlock, respectively, movement of actuator 48.
Various Notes
One example includes a handle with a manually-operable drug pump and drug reservoir.
One example enables drug atomization by injection a fluid at the periphery of gas flowing in nozzle core.
In some examples, the aerosolization spray pattern from the cannula is dependent on factors, including the distal disparity as to the relative location of the ends of the cannula components. The spray pattern is also a function of the gap in concentricity of the first tube 41 relative to second tube 42. A split flare end, or other configuration providing uniform spacing, is conducive to a uniform flow pattern. Uniformity in flow pattern can promote a favorable medical treatment outcome.
Other types of nozzles and configurations are also contemplated. For example, rather than a gas core and a fluid sheath, one configuration can include a gas sheath and a fluid core. In addition, bias cut ends on the first tube 41, or second tube 42, can affect the spray pattern.
In addition to the noted procedure for treating the eye, an example of the present subject matter can be configured for treatment of other regions of a body.
The above description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
Geometric terms, such as “parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

THE CLAIMED INVENTION IS:
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. 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. The device of claim 1 wherein an inner diameter of the second tube is greater than an outer diameter of the first tube.
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. The device of claim 1 wherein a proximal end of the second tube is fluidly coupled with the fluid supply.
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. The device of claim 6 wherein the leak-proof coupling includes a crimp.
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. The device of claim 1 wherein the distal end of the first tube includes a slotted flare.
10. The device of claim 1 wherein the reservoir includes an elastic bladder.
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. The device of claim 11 wherein the contact pad and the reservoir are penetrable by a syringe needle.
13. The device of claim 10 wherein the elastic bladder is disposed proximate a first septum.
14. The device of claim 13 wherein the elastic bladder and the first septum is disposed proximate a second septum.
15. The device of claim 1 further including a rigid cover configured for fitment with the actuator.
16. The device of claim 1 wherein the fluid supply includes a syringe.
17. The device of claim 16 wherein the actuator includes a pivot-mounted lever configured to engage a plunger of the syringe.
18. The device of claim 17 wherein a discharge port of the syringe is coupled to a lumen of the second tube.
19. The device of claim 16 further comprising a first septum disposed proximate a plunger of the syringe.
20. The device of claim 19 further comprising a second septum disposed proximate the first septum.
21. 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 a syringe coupler having a syringe port coupled to the discharge nozzle; the pneumatic port, the discharge nozzle, and the grasp portion are aligned along a longitudinal axis; the syringe coupler 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 syringe coupler includes a septum disposed between the syringe port and the second tube.
22. 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.
23. A device comprising: a handle; a fluid supply affixed to the handle, the fluid supply including a reservoir coupled to a manually-operable pump; a pneumatic port affixed to the handle; a nozzle affixed to the handle, the nozzle having a core channel and a peripheral channel; the pneumatic port fluidically coupled to the core channel; and the fluid supply having an output fluidically coupled to the peripheral channel.
24. The device of claim 23 wherein a terminus of a distal end of the first tube differs from a terminus of a distal end of the second tube.
25. The device of claim 23 wherein the manually-operable pump includes an elastic bladder.
26. A device comprising: a fluid supply including a manually-operable pump coupled to a reservoir, the fluid supply affixed to a handle; a pneumatic port and a discharge nozzle affixed to the handle, the discharge nozzle having a core channel and a peripheral channel in coaxial alignment, the pneumatic port coupled to the core channel; and the fluid supply having an output coupled to the peripheral channel.
27. The device of claim 26 wherein a terminus of the core channel and a terminus of the peripheral channel are staggered.
28. The device of claim 26 wherein the manually-operable pump includes an elastic bladder.
29. A method comprising: providing a handle having a pneumatic port coupled to a first channel terminating at a discharge cannula, providing a fluid supply coupled to the handle, the fluid supply including a reservoir coupled to a manually-operable pump, wherein the fluid supply is coupled to a second channel terminating at the discharge cannula; and positioning the first channel within a lumen of the second channel.
30. The method of claim 29 wherein positioning includes staggering a terminus of the first channel relative to a terminus of the second channel.
31. The method of claim 29 wherein positioning includes arranging the first channel coaxially with the second channel.
32. The method of claim 29 wherein providing a fluid supply includes providing a diaphragm pump.
33. 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 coupled to a gas channel coupled to the discharge nozzle and coupled to exert a pressure to a fluid supply; the actuator affixed to the handle and configured for movement relative to the handle; 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 coupled to a valve between the fluid supply and the second tube.
34. The device of claim 33 wherein a terminus of a distal end of the first tube differs from a terminus of a distal end of the second tube.
35. The device of claim 33 wherein an inner diameter of the second tube is greater than an outer diameter of the first tube.
36. The device of claim 33 wherein the fluid supply includes a vial fluidly coupled to the gas channel.
37. The device of claim 36 further including a rubber seal proximate a vial pressure end between the vial and the gas channel.
38. The device of claim 36 further including a rubber seal proximate a vial discharge end between the vial and the discharge nozzle.
39. The device of claim 33 wherein the fluid supply includes a hydrophobic filter.
40. The device of claim 33 wherein the actuator includes an elastic member configured to close the valve.
41. The device of claim 33 wherein the valve includes an elastic wall of a tube.
42. The device of claim 33 wherein the valve includes an iris valve.
43. The device of claim 33 further including an actuator lock coupled to the handle, the actuator lock configured for movement relative to the handle and configured to engage the actuator.
44. The device of claim 33 wherein the actuator lock is configured to limit movement of the actuator.
PCT/US2024/035712 2023-06-29 2024-06-27 Aerosol delivery device Pending WO2025006673A1 (en)

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US3470869A (en) * 1965-07-09 1969-10-07 Cleveland Clinic Foundation Apparatus for gastro-intestinal barium air contrast spraying
US20110112469A1 (en) * 2009-11-08 2011-05-12 Powerscope Incorporated Device and process for dispensing multiple-phase mixtures
US20120174915A1 (en) * 2006-09-15 2012-07-12 Board Of Regents, The University Of Texas System Pulse drug nebulization system, formulations therefore, and methods of use
US9636470B2 (en) * 2005-04-08 2017-05-02 Gerhard Pohlmann Device for dosing and dry nebulization
US20200289768A1 (en) 2013-08-22 2020-09-17 Sipnose Ltd Drug delivery devices and methods for administering substances to a body cavity by heterogenous aerosolization
WO2022125418A1 (en) * 2020-12-07 2022-06-16 Regents Of The University Of Minnesota Aerosolization within respiratory system

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3470869A (en) * 1965-07-09 1969-10-07 Cleveland Clinic Foundation Apparatus for gastro-intestinal barium air contrast spraying
US9636470B2 (en) * 2005-04-08 2017-05-02 Gerhard Pohlmann Device for dosing and dry nebulization
US20120174915A1 (en) * 2006-09-15 2012-07-12 Board Of Regents, The University Of Texas System Pulse drug nebulization system, formulations therefore, and methods of use
US20110112469A1 (en) * 2009-11-08 2011-05-12 Powerscope Incorporated Device and process for dispensing multiple-phase mixtures
US20200289768A1 (en) 2013-08-22 2020-09-17 Sipnose Ltd Drug delivery devices and methods for administering substances to a body cavity by heterogenous aerosolization
WO2022125418A1 (en) * 2020-12-07 2022-06-16 Regents Of The University Of Minnesota Aerosolization within respiratory system

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