WO2021234432A1

WO2021234432A1 - Meted dose inhalers (mdi's) efficiency increasing system (shafadam)

Info

Publication number: WO2021234432A1
Application number: PCT/IB2020/054674
Authority: WO
Inventors: Mehdi GHAHRAMANIFAR
Original assignee: Ghahramanifar Mehdi
Priority date: 2020-05-18
Filing date: 2020-05-18
Publication date: 2021-11-25

Abstract

Increasing Efficiency Spacer (Shafadam) inhalant Sprays, is a system designed to increase the amount and the percentage of drug inhaled from a Metered Dose Inhaler (MDI) to bronchus, bronchioles, and alveoli. Shafadam is a cylindrical system with capacity more than 200 cc. In this system three valves with silicon plates was used to lead medicine from the bottom of Shafadam tank toward the patient's mouth and also to separate the inhale flow from exhalation flow. In this system, a curved anti drug adhesion piece of plastic is designed to guide the spray puff path in a rotating manner to vent the previously existing air in the tank around the MDI capsules. Due to differences in the use by the patients, Shafadam Includes a three different system to various age ranges (Under 5 years, 5 to 15 years, 15 to 60 years and patients over 60 years) to use. According to clinical trials, due to the high rate of infant crying when using spacers, a plastic spring doll is designed for children under 2 years old patients. In addition to that, the Shafadam includes a protective case for placing the main tank of the Shafadam, two sprays and masks and a mouthpiece.

Description

FIELD OF THE INVENTION

The present invention relates to a spacer assembly for fitting to a drug delivery inhaler devices, such as a pressurized metered dose inhaler (pMDI) devices. In particular, this invention relates to an end fitting for a disposable spacer assembly for fitting to a drug delivery inhaler device.

BACKGROUND TO THE INVENTION

MDI's(metered dose inhalers) such as alpha agonist and corticosteroid sprays (First-line treatment of asthma and COPD in children and adults) are one of the therapeutic bases in the medical field and are used in both emergency and non emergency situations to improve lung function. The Global Initiative of Asthma (GINA) recommends that patients of all ages using moderate to high doses of inhaled corticosteroids should use a spacer device. Recent discussions in the management of asthma ADMIT (aerosol drug management improvement team) say that the use of spray is essential to get the best response and be able to control the asthma and trying to raise awareness of the proper use of equipment for successful critical treatment.

The following have been carried out from studies and researches since 2002: Among those who received the inappropriate MDI dose, the inappropriate spraying technique had a 14-90% share (with a mean of 50%) among these patients, as well as in asthmatic patients, misuse of the spray has been associated with instability and lack of asthma control.

In another study, only 5% of medical students were able to use the MDI's correctly, with one by one training sessions substantially the proper use of the MDI's increased among them.

Another study also suggested that changing the type of MDI in patients can reduce control and require training of the technique in using them and if not accompanied by training, it can be confusing to use.

Price et al. (2012) also found that the use of MDI's and spacers, the difficulties of using spacers, and the inefficiency of some spacers are the most common errors in using MDI's and inefficiency of controlling patient's illnesse .

According to studies, the effectiveness of MDI's is generally reduced due to problems with the spacers as well as the lack of proper patient education.

Increasing efficiency Spacer of MDI's (Shafadam) by solving all the above problems, increases the effectiveness of the MDI's because with the use of Shafadam, the patient is not in need to be trained on the use of the MDI (in terms of MDI activation and inhale function time) and the problems of the old spacers have also been completely resolved in Shafadam.

SUMMARY OF THE INVENTION

MDI's(metered dose inhalers) such as alpha agonist and corticosteroid sprays (First-line treatment of asthma and COPD in children and adults) are one of the therapeutic bases in the medical field and are used in both emergency and non emergency situations to improve lung function. The presence of spacers which was made in the past, partially increases the effectiveness of MDI's. But according to some valid studies, spacers and patient use have some drawbacks. These are the main reasons for the diminishing of the effectiveness in MDI's: 1) Inability in proper use of the MDI by the patient due to lack of proper training (in terms of MDI activation and inhale function time).

2) Inability to teach MDI use in infants, children and the elderly due to individual conditions.

3) Absence of a compact with an appropriate volume in the available spacers to accommodate a MDI puff (even a single puff).

4) Inability of existing spacers to preserve the drug powder in them due to lack of inlet and outlet air flow regulation.

5) Possibility of contact contamination of MDI's and masks due to the absence of a special storage compartment.

6) Increased chance of oral fungal infections with no spacer use.

7) Babies crying while using the former spacers.

The purpose of the design and manufacture of the Shafadam was to increase the efficiency of the MDI , to eliminate all of the above defects.

BRIEF DESCRIPTION OF THE FIGURES

FIG.l is Increasing efficiency of MDI's spacer (Shafadam) According to the FIG.l

1. Assembled Shape of Shafadam with MDI

2. The main tank

3. MDI connector to the main tank

4. MDI holder

5. 6.7. Air flow importer valve

8. Drug flow path regulator

9. Bouncy doll

10.11.12.13. Inhale and exhale flow Separator valve

14. Breathing chamber Inhale and exhale separator and the mouth piece

15. Mouth piece cap 16.17.18. Exhale flow Ejector valve

19. 2^nd mouth piece

20. Kids mask

21. Adults mask

22. Shafadam, MDI and mask protective bag are provided in a protective bags (22) to the patient. This protective bag is embedded by a place for shafadam (1), one place for masks (20 and 21) and two places for two MDI's. For the use, the patient must remove it from the protective bag and attach the MDI to the main shaft (2) with the connector (3) on the MDI holder arms (4). The cap should then be removed from the mouthpiece (15). In infants or children under 5 years of age, the pediatric mask (20) and in the elderly patients with disabilities, the adult mask (21) is attached to the mouth piece (14). Otherwise, the patient should place the mouth piece between the lips. When the MDI is activated, the drug enters the transparent Shafadam chamber (2) then the patient with a deep inhalation (after a deep exhalation) transfers the air flow outward into the chamber through the terminal valve (5,6,7) which passes through the middle valve (10,11,12) and then the drug enters the body. Then, in the function of exhale, air exits Shafadam through the inhalation and exhalation separator chamber (14) and the side valve (16, 17, and 18). By this system, the drug flows into the patient's lungs, without dependence on the patient's breathing time and the activation time of the MDI's.

Function:

Increasing efficiency of MDI's spacer is a mechanical system which increases the amount and percentage of Metered Dose Inhalers (MDI's) reached to the bronchi, bronchioles, and alveoli which is applicable for all patients using inhaled MDI's.This system was designed and produced by Asia Electro Medical Company (Knowledge Base).

Claims

Claims:

Claim#l: it's claimed that it is a mechanical system designed to increase the amount and percentage of the inhaled drug from MDIs (Metered Dose Inhalers) to bronchi, bronchioles, and alveoli. Shafadam is a cylindrical system with 18 parts. In this system three valves with silicon plates was used to lead drug from the bottom of Shafadam tank toward the patient's mouth and also to separate the inhale flow from exhalation flow. Its main reservoir is made of hygienic crystals with silicon filters in 2 sides and at the far end of that section there is the drug flow leader and on the side there, a MDI slot and a MDI holder is contrived. The crystal tank itself is attached to another piece of hygienic polypropylene so that the enclosed chamber is separated from the crystalline chamber by a silicon valve. This piece contains a mouth piece, a mouth piece cap, a third valve to expel the exhale flow and it is also capable of attaching to the second mouthpiece and Shafadam masks. The protective case is a small plastic case designed to fit the main compartment, a mask and two sprays. The main used materials in the construction are 4: (PS) Polystyrene (thermocole) ‘ polypropylene (PP) ‘Polyvinyl chloride(PVC), Silicone.

Claim #2: In accordance with claim 1: the biggest part of the body is made from a hygienic crystal which when the MDI is activated, the withdrawn drug dose will be placed in it. The container has a volume of over 200 cc, which, with the help of a drug flow conductor, encapsulates the volume of the imported drug completely inside itself. The chamber is cylindrical so that drug enters the side of the chamber and flows toward the patient's mouth.two valves are designed at the beginning and the end of the chamber in a way that the pistol of the first valve placed at the bottom of the chamber and has the task to enter the airstream into the chamber and direct the drug into the second valve. Claim #3: According to Claims 1 and 2: A piece of flexible plastic is attached to the lateral surface of the chamber, which is the joint of the MDI opening.

Claim #4: According to Claims 1 and 2: A plastic piece of crystal is attached to the middle- lateral side of the chamber, which holds the MDI on the chamber.

Claim #5: According to Claims 1 and 2: The pistil part of the filter which is a part of the tank, externally connected to the silicon plate and to the male part of the filter and at the internal part contains two pins that connect to the drug flow control unit.

Claim #6: According to Claims 1 and 2 and 5: it's a circular shape silicone flexible plate with a hole in the center (for the pin to pass) between the pistil & the male part of the 1^st filter. This plate prevents the drug from leaving the compartment when the MDI is activated. At the time of patient's inhale, by directing the air from out of the chamber into it, it passes the drug to the second filter and ultimately to the patient's mouth.

Claim #7: According to Claims 1 and 2 and 5 and 6: It's a porous plastic piece that attached to the end of the chamber via a central pin So that the silicone plate is placed between it and the chamber.

Claim #8: According to Claims 1 and 2 and 5: A curved piece of plastic is used to lead the flow of drug into the compartment and which is attached to the two pins at the bottom of the main tank. The inner surface of this piece is covered with a material that minimize the adhesion of the drug to the plastic.

Claim #9: According to Claims 1 and 2: The spring doll is made of plastic so that when used by infants, connected to the end of the tank in front of the patient. Claim #10: According to Claims 1 and 2: The plastic piece is circular in shape with its center being like the filter on the end of the porous tank and which is considered as the middle plate of the Shafadam. This plate is located between two chambers locked by Shafadam that by binding to its complementary components do its task of passing the drug flow through the patient's mouth and preventing the expiratory flow into the crystalline chamber.

Claim #11: According to Claims 1 and 2 and 6 and 10: It's a circular shape silicone flexible plate with a hole in the center (for the pin to pass) between the pistil & the male part of the 1^st filter. This plate causes the passing of the drug flow through the patient's mouth and preventing the expiratory flow into the crystalline chamber.

Claim #12: According to Claims 1 and 2 and 10 and 11: It's a piece of plastic used as a filter for the second filter.

Claim #13: According to Claims 1 and 2 and 10 and 11: There is a flexible plastic gasket around the center plate which is designed to seal the system and prevent drug from leaving the system.

Claim #14: According to Claims 1 and 2: It is an expiratory chamber, which attached to the crystalline chamber on one side and to the patient's mouth or masks or a second mouth piece on the other side. Between this chamber and the crystal chamber there is the middle plate (second filter). The mouthpiece protector and the location of the third filter components (exhale efflux filter) are located on this part.

Claim #15: According to Claims 1 and 14: it's a flexible plastic piece that is placed on the mouth piece when it is not used by the patient. Claim #16: According to Claims 1 and 6 and 14: It's a circular shape silicone flexible plate with a hole in the center (for the pin to pass) between the pistil & the male part of the 3^st filter. This plate drives out the patient's exhale flow from the Shafadam.

Claim #17: According to Claims 1 and 14: A porous plastic piece that acts as a male component of the third filter and a silicone plate that located on its thorn.

Claim #18: According to Claims 1 and 14 and 17: It's a piece of plastic used as a filterforthe 3^rd filter and stabilizes the silicon plate on the male filter.

Claim #19: According to Claims 1 and 14: A flexible piece of plastic that attached to the mouth piece for the ease of use in patients over 15 years.

Claim #20: According to Claims 1 and 14: Pediatric mask that is attached to the mouth piece and is used for patients under 5 years.

Claim #21: According to Claims 1 and 14: Adult mask that is attached to the mouth piece and used for elderly patients.

Claim #22: According to Claims 1 and 19 and 20 and 21: Shafadam's protective bag is a small plastic bag that is actually a protective bag for the main tank, two MDIs, a mask and a mouth piece. This bag has three separate parts for the Shafadam, MDIs, masks, and a second mouth piece.