Dry powder inhaler with compressed air drug spray

Abstract

This inhaler Fig 1 has a compressed airbox (1) with an air inlet (2) & air outlet (3) valves. Outlet valve has spray nozzle (6) with two jet holes (13), (14), drug spray tube (4) with a drug hopper (11), detachable mouthpiece (5) with a flange (8) and inside pegs (9) sequentially forming spray mechanism. The drug strip (26) is loaded in a drug channel of cross arm (27). Plunging piercing pin (29) in a spring chamber (28) punctures drug strips, drops drug into drug hopper (11) into spray tube floor (15). The air inlet (18) has a bellow (48) to load compressed air. To use, load air box with air, pierce drug strip (26). Keep mouthpiece in mouth, inhale, press outlet valve (3), a soft laminar drug spray (49) with low drug outer channel (50) flows to lungs.

Description

[0001] DRY POWDER INHALER WITH COMPRESSED AIR DRUG SPRAY

[0002] Technical Field:

[0003] The invention relates to new dry powder inhaler with novel compressed air not a gas creating an easy powder spray for asthmatics, COPD patients for delivery of drugs to lungs.

[0004] State of Art:

[0005] Inhalers are used to deliver drugs to asthmatics patients for decades. There are two types of inhalers: MDI- metered dose inhalers with a propellant fluroalkanes for drug spray and DPI dry powder inhalers with our breathing air volume & velocity creating drug spray. Both are 10-15% efficient only with disadvantages for failure too.

[0006] MDI inhalers have disadvantages of:

[0007] 1. Fast & shallow inhalation- so poor delivery into lungs.

[0008] 2. You have to press the drug canister with effort in early inhalation to start spray that can go into lung.

[0009] 3. Coordination of canister pressing and early inhalation are problems for 80% patients causing repeat wasted doses.

[0010] 4. Doses counter needed to warn of end of use of inhaler.

[0011] 5. Spacers are used with inhalers adding to cost, plastic wastes.

[0012] 6. There is need to create no propellant drug spray for big eco reduction of upper atmosphere warming pollution.

[0013] DPI inhalers are not perfect:

[0014] 1. Inhaled air is the force for spray creation in a swirling chamber.

[0015] 2. Often the drug spray particles are in big clamps and coat mouth more than lung deposit.

[0016] 3. Spray is a big wide shape too making more mouth coating.

[0017] 4. Shallow breathers won’t create good drug spray. 5. Many DPI varieties used by patients have not solved poor spray creation. Existing inhalers both DPI, MDI have failures. Why not create a new DPI with better spray?

[0018] Technical Problem

[0019] Inhalers are preferred drug route for lung delivery to lungs for asthma, copd. The mouth 6cms horizontally turns in throat 90* down as larynx 3 centimetres wide, trachea 1.5 to 2 a centimetres and branches as bronchi into both lungs. How to send drug spray in this complex air path? A thin 1.5 centimetres concentrated drug path can deliver more drugs than divergent sprays of existing MDIs or DPIs. The inhaler drugs are micronized soft particles with fillers less than a gram! Creating a soft drug spray of such drug is tricky.

[0020] The defects in the MDI& DPI are:

[0021] 1. There is 10-15% lung deposit only.

[0022] 2. Mouth coating in DPI is more-needing water for gargling out mouth coated spray.

[0023] 3. Spray creation in existing MDI& DPI have wider than trachea sprays that is not appropriate for mouth, larynx, trachea.

[0024] 4. There is no perfect inhaler for both shallow& deep breathers.

[0025] 5. Drug Spray creation: & travel in 6-7t centimetres transverse slit of mouth, turn 90* down in larynx of 3 centimetres wide , travel in narrower 2 centimetres trachea then branch into two lungs of bronchi needs new spray of 1.5cm narrow drug spray channel.

[0026] 6. In Kids the air path is narrower& shorter..

[0027] Solution to Problem

[0028] Our new dry powder inhaler hereafter called DPI has a new, novel different structure and function. New DPI creates a new, novel 1 centimetre wide soft drug spray inside an outer low drug laminar air flow path for delivery to lungs. Our DPI has a new, novel compressed air chamber as energy to blast drug as a soft spray. The novel compressed air path has special spray jet with easy drug loading. The mouth piece is novel too for central drug path and outer lower drug laminar spray with less mouth coating. The compressed air drug spray creation is also novel with regulators or valves to store compressed air and release when device is used for inhalation.

[0029] Accordingly the object of the invention is to identify the solutions for problem associated with the more lung deposits and less wasted drugs in mouth sides. An extensive search has been carried out using the Internet and related patent specifications were studied for dry powder inhalers with compressed air drug spray. Since the present invention is radically different, in using the compressed air source for drug spray with an innovative mouthpiece with laminar central drug path, the inventors are unable to site any patent specification out of the available databases. Search of the USPTO, European patent offices, others, known literature, the inhaler companies literature do not reveal a dry powder inhaler (DPI) like ours with laminar central drug spray path, compressed air not a gas creating the drug spray. There are no DPI with compressed air drug spray, laminar spray. No gas is no container, no reservoir, chemicals or its pollution. This is not a shop floor modification but needed new research on new mouthpiece, drug dropping, spray creation, compressed air box for months in step by step research of parts, and its fit. Search in Classification of patent data bases, others, markets do not reveal a similar structure, functioning dry powder inhaler. We are not able to cite prior art dry powder inhaler of near related structure or function.

[0030] Summary of the invention:

[0031] The new dry powder inhaler has four new improvements.1. Ours has a compressed air box with an air inlet connected to compressed air source with an open / close inlet regulator / valve and an air outlet with an outlet regulator / valve. 2. The outlet valve leads to a novel air jet nozzle with not one but two or more air jet holes to spay drug.3. The air jet nozzle fits a drug spray tube filled from a capsule or drug strip with a spring activated piercing needle .4.The drug spray tube fits a mouth piece that is designed for laminar air- central drug path. The spray width is now smaller to pass through larynx, trachea with more lung deposit for better relief. To use, load air into air box from air inlet bellows, syringes, micro electric motor and close air inlet regulator / valve. Load drug in drug tube from capsule / strip. Keep mouthpiece in mouth. .Inhale slow long. Release the outlet regulator in early inhalation. The compressed air sprays drug as thin central drug rich channel path with an outer sheath air from mouthpiece inhaling. The laminar drug spray with central more drug and little drug outer channel is new. Even kids, elders can benefit more.

[0032] Statement of Drawings:

[0033] These and other objects and features of the invention will become more apparent upon perusal of following description taken in conjunction with accompanying drawings wherein:

[0034] Figure 1 shows the details of new dry powder inhaler.

[0035] Figure 2 shows the parts of our inhaler.

[0036] Figure 3 shows a valve with spring inside air box, a plunger below lid.

[0037] Figure 4. shows a valve modification with spring and plunger above lid.

[0038] Figure 5 shows tap type valve.

[0039] Figure 6 shows inlet valve with syringe for filling air into air box.

[0040] Figure 7 shows inlet valve with bulb for air filling air box.

[0041] Figure 8 shows micro-motor electrical pump for air loading.

[0042] Figure 9 shows drug dropping in transparent drug spray tube& spray formation.

[0043] Figure 10 shows inhaler use in mouth with spray into lungs.

[0044] Figure 11 shows inhaler with round air box.

[0045] DESCRIPTION OF PREFERRED EMBODIMENTS

[0046] The following specification describes salient features of invention, the method of construction, the method of use and the advantages of the novel invention. The novel new dry powder inhaler has handy compressed air box with air inlets, valve, drug loading spray tube, mouthpiece for spray creation and inhalation for years of use and with a different pleasant looks too. It can be carried in shirt pocket.

[0047] The novel dry powder according to invention is better as compressed air spray is a narrower soft spray than chemical propellants of MDI inhalers. The invention is easy to set up, run, and use even by illiterates or kids too. Ours is eco saver too with no chemical pollution & better relief to user!

[0048] The novel device has higher efficiency due to compressed air created narrow drug spray with a new mouthpiece for a central drug path with outer less drug flow. .Laminar drug in air flow is new for asthma inhalers. The existing dry powder inhalers have not been improved for long. The object of the invention is to overcome existing DPI inherent defects. To this end the new invention is addressed. New dry powder inhaler is better than other powder inhalers. Our new DPI is easy to use, maintain, saving health &money too. Inhaler research is tricky& difficult: 1. Spray of less thanl milligram drug and filler chemicals as a spray. Chemical propellants spray fast with evaporation of propellant adding to global warming by MDIs. In existing DPIs your inhalation force for spay often is poor. Our new DPI has a compressed air just for correct good soft spray. Ours is repeatable too. 2, added air volume of compressed air in ours carries more oxygen to lungs along with patient inhaled air.3 Our mouth piece is Icms diameter for adults to make a slow longer deep inhalation- more time for drug spray to reach deep parts of lung.4 Our inhaler can be a deep inhalation physio-therapy device to increase lung elasticity. All existing asthma, COPD drugs can be used in strips or capsules too! For kids smaller mouth piece can be used, parents can trigger drug spray!

[0049] Ours novel inhaler has four modules 1. Compressed air elements 2 drug dropping elements3 air jet spray element for correct soft spray 4. A novel mouth piece for laminar inner drug channel with an outer low drug channel for less mouth coating. In existing MDI, DPIs only two elements the drug delivery, inhaler body drug swirling air channel part creating wide spray with larger mouth coating- no laminar central drug flow!

[0050] We would like to name the new novel parts of our inhaler to reduce confusion. Compressed air tank or chamber we call it as box as it is match box size for carrying in our cloth pockets. Air inlet or air outlet regulator or valves we use word valves for this.

[0051] The device is novel has a handy air boxl .Fig 1. The air box has air an air inlet 2, air outlet 3. The box size may be 4*3*5 centimetres (three match box size!), withstands 0.5 kg of air pressure & fits hand / pockets for easy use and carrying for adults. This air inlet 2 has a valve with a finger button 16 for open or close to feed or lock compressed air in air tank box. This inlet 18 of valve fits nozzle 39 of syringes 40 Fig 6, or bellows 48 Fig.7 or micro electrical air pumps42 Fig 8 for air feed into air box.

[0052] The air box outlet 3 has an outlet valve with a top finger button 16 for finger pressing. The button closes the air outlet with a spring 24. The valve has an air exit air jet nozzle 6 Fig.2, Fig 9 with two pinhole jets 13, 14. The lower jet hole 13 blasts the drug deposited in spray tube floorl5, the upper jet 14 pushes the drug spray into mouth without spray tube inside coating. This spray tube4 has an upper drug hopperl 1 to drop the drug inside the spray tube floor 15, just before nozzle jet holes 13, 14. The drug hopper has a top drug strip 26 Fig 2, Fig9 a piercer pin 29. The front end 7, Fig. 2 of the drug spray tubel3.Fig 2 is smaller than back end 12 to increase spray velocity. Narrow tips can create more drug velocity with less internal deposit as air jet blows. Drug spray tube 4 engages the back side of a detachable mouth piece 5 Fig 1, Fig 2. The mouth piece 5 is a tube narrowing from behind to mouth side 10 adding spray velocity with less deposit inside mouth piece for an optimal size soft spray and has a flared back 8 for collecting more air in inhalation and creating a laminar air flow with inner drug rich 49 air channel (dotted lines), an outer low drug channel path 50,. Fig 11 spray prevents the drug sticking to mouthpiece inside. A short peg 9 inside the back of mouth piece5 or on the outside of drug spray tube 4 creates an air space 47, Fig 10 between mouthpiece and its inner drug spray tube .This air space 47 helps outside air during inhalation to flow as an outer channel 50 with an internal drug spray49 Fig9 as a laminar flow Fig 9, Figi 1 of the whole drug spray into mouth and windpipes.

[0053] The drug dropping elements comprises two support columns 25 Fig 2, with a cross arm 27 that has a drug strip channel for the chosen drug strip 26. The cross arm 27 has a spring chamber 28 with an inner drug strip piercing pin 29. Top of this piercing needle29 has a wide flat top finger press plate for easy pressing the pin to pierce and drop the drug in the below drug hopper 11 of the drug spray tube 4 floor 15Fig.9, for drug spray creation. The sharp pin may have three or four sides to cut hole, keep it spread for easy drop of the powder into drug hopper 11. The drug strip can be a spool, rotated for next use. Drug strip spool is not shown for clarity of figures.

[0054] For capsules piercing in the piercing needle can be thicker .The capsule can be placed in taller drug hopper to hold the capsule. The piercing pin goes up by spring for next drug use. This we have not drawn as strips are cheaper, hold drugs better, longer. Capsules need humidity desiccator granules. Drop capsule into hopper push pin into hopper for drug to fall into spray tube!

[0055] The air box fig2 can be a rectangular box with lid 19, a gasket 23. Screws 22 hold& fix lid with no air leaks with screws22. Press fit / adhesives can be used for lid, box airtight fixing. The lid has air inlet 20, air outlet21 short tubes to fit in air inlet valve 2, air outlet valve 3. Short column 23 fits drug dropping column25.

[0056] The air filling for compressed air box is by syringes40, Fig 6 or bellows or bulb48, Fig 7 as used for B.P measuring cuff. Fig7 with a rubber tube 41with a nozzle39 fitting air inlet valve2 air entry opening 18. Nozzle 39 of a syringe or a bellow or bulb fits air inlet 18 to fill air box. Fig 3 the valve has a body with a plunger30 having a top air leak seal 17 and top finger button 16. The plunger has a plate 31 with a soft rubber coat to prevent air leak in air tank 2. The spring in normal state closes the plunger plate. When plunger is pressed spring is compressed, air flows into air outlet into air jet holes for drug blow as spray. Open valve position with arrows for air flow is shown in fg.3.

[0057] Fig 4 has another type of valve. The plunger30, its spring24 is in valve side. The plunger base plate seals hole52 between valve & air tank. The plunger has an outer column 32 with top fiilcrum34 having finger button 33. When finger button 33 is pressed, the plunger 16 is lifted by fulcrum, opening hole 52 in floor of valve body. Air now escapes into air jet holes for spray. The finger button when freed, the spring24 closes the plunger plate31 on hole 52 for next use.

[0058] In Fig 5, a tap valve with handle 37 rotates a rubber cylinder body 35 with air hole 36 into the outlet for air jet. A seal locks, prevent air leaks. The top chamber 38 hold the rubber cylinder body in place for months of use. The handle 37 can be turned to close for next use.

[0059] In fig 6 micro motor42 pump, with circuit board 43, battery 44, USB 45 for electric power. Motor may be DC type, convenient too. Just fit in air inlet & fill air box. A transparent plastic Air Pressure indicator 51 can be fitted to lid or air box with a coloured float to show pressure be for use. Electronic pressure display can also be used in electric pump models. A tyre valve plug used in vehicle tyres can also be used with longer plunger, a top finger button as valve, this is not shown in figure. To use, the bellows48 or syringes40 are fitted to air inlet 18 of inlet valve2. The inlet valve is kept open. The bellows / syringe are pressed to build air pressure and inlet valve is closed. Compressed air is now trapped in the air boxl. Place the drug in strip26 in cross arm27 drug channel, Fig 2 or capsule is kept in hopperl 1 and pierced by pushing piercer 29. Drug falls into the drug tube4 floor area 15 just before the air jet nozzle holes 14, 13Fig 9. The mouthpiece is kept in mouth and inhaled, Fig 10. The air outlet valve 3 is pressed in early inhalation. The compressed air flows from the air box through outlet valve, the nozzle pin jet holes, sprays the drug as a slender spray in a laminar central path Fg.10, Fig 9 with drug rich inner 49 path(dotted line) and low drug outer 50 path .This laminar flow is new and reduces mouth coating.

[0060] The outside air as we inhales in, flows between the spray tube4 and back of mouth piece5 pegs 9 separating the spray tube 4, mouthpiece 5 for few millimetres for inhaled air to flow, see arrow 47 of air Fig 10, forms an outer sheath 50 trapping drugs in a central drug rich flow49 path and outer lower drug path 50, Fig.9. There is less mouth coating. This is a novel laminar air drug spray flow into the lungs for the first time in any inhalers...

[0061] The extra air from compressed air and natural breathing volume is good for lung drug deposit. After 10 second breath holding, the mouthpiece is removed for next use.

[0062] The air box , its lid, mouthpiece, drug spray tube, columns, drug strip channel, air jet nozzle, valve as described can all be made by injection moulding as separate small parts and assembled. Mouth piece is detachable. Plastic, metal can be used as material for parts making. Spray tube, mouth piece can be non-sticking transparent medical grade plastic.

[0063] The device may be modified. Various sizes for kids, adults can be done. The air box can be of plastic or metal. The air box air inlet and outlets with valves can be on sides or bottom placed. The air inlet valve / regulator can be spring activated for less effort. The air outlet valve can have other types; push down as in fig3, 4 and 5. The Jet nozzle pin hole can be three numbers. The hopper can have strip / capsule piercing spring activated too for easy drug loading. Fig 11 inhaler air box can be round, or stylised shape with an airtight lid. The inlet valve can be in box body. Advantages of the new invention:

[0064] 1. The novel air box creates a compressed air spray source for effective drug spray.

[0065] 2. The inlet valve helps air trapping and closure to form a compressed air source.

[0066] 3. The spring in valves keeps air locked for needed timely use.

[0067] 4. The handle of outlet valve is low effort trigger for drug spray release.

[0068] 5. The air jet nozzle holes create a clump free disaggregated spray of drugs.

[0069] 6. The hopper with easy drug strip piercer pin helps to drop drug in tube

[0070] 7. The mouthpiece is novel to produce a laminar central drug path with lower outer path.

[0071] 8. The device is handy, easy to use

[0072] 9. There is less mouth coating, a deep slow inhalation for more drug deposit in lungs.

[0073] 10. Compressed air adds air& 02 extra volume into lungs- help asthmatics.

[0074] 11. Pressure sensor can help indicate pressure for spray.

Claims

AMENDED CLAIMS received by the International Bureau on 07 January 2025 (07.01.2025)1. The dry powder inhaler with compressed air drug spray comprising:(a) a compressed air element comprising of an air box(l) with an air inlet and its valve(2) and air outlet and its valve, (3),(b) a drug spray element comprising of air outlet valve(3), a spray jet nozzle(6), the drug dropping and spray tube(4), mouthpiece(5) all serially in one axis,(c) drug dropping element comprising of support column (25) with a drug strip channel(26) with drug strip in a cross arm(27), a drug strip piercing pin (29) with a spring (28).

2. The dry powder inhaler with compressed air drug spray as claimed in claim 1, wherein the air box comprising the box (1), its lid (19), air leak preventing element gasket(23) , an air inlet valve (2)with its air inlet(18) , air outlet valve (3)with its air outlet nozzle, the lid on its outside provided with drug dropping columns (25).

3. The dry powder inhaler with compressed air drug spray as claimed in claim 1, wherein the drug spray tube (4) comprises a transparent tube with air jet end(12), a narrower mouthpiece end(7), an upper drug collecting hopper(l 1).

4. The dry powder inhaler with compressed air drug spray as claimed in claim 1, wherein the mouthpiece (5) comprises a tube with drug spray tube end air trapping flange(8), a narrower mouth end(10), the mouthpiece on its inside is provided with pegs(9).

5. The dry powder inhaler with compressed air drug spray as claimed in claim 1, wherein the drug dropping element comprises of two supporting columns (25), a cross arm (27), a drug strip channel (26) in the cross arm (27), a drug strip piercing chamber with an inside spring (28) and a piercing pin (29), the piercing pin is provided with a top finger button.

6. The dry powder inhaler with compressed air drug spray as claimed in claim 1, wherein the spray air jet nozzle (6) is provided with at least two jetholes(13),( 14) one 13 near drug spray tube floor(15) , and another upper jet holes 14 to push drug as spray.

7. The dry powder inhaler with compressed air drug spray as claimed in claim 1, wherein the valve has a plunger (30) with a bottom plate (32), plunger spring (24), leak preventing seal (17) and upper finger button (16), the plunger being configured to move from an occluding position to an open spray release position.

8. The dry powder inhaler with compressed air drug spray as claimed in claim 1, wherein the tap type valve is provided with a handle( 37), a shaft with rubber cylinder (35) with an air channel (36), leak seal in a top lid (38).

9. The dry powder inhaler with compressed air drug spray as claimed in claim 1, wherein an electric micro motor pump (42) with its battery(44), control circuit(43) is compressed air source.

10. The dry powder inhaler with compressed air drug spray as claimed in claim 1, wherein air box is provided with a pressure indicator (51).

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