WO2002089884A1 - Systeme medical d'administration d'aerosols active par la respiration - Google Patents

Systeme medical d'administration d'aerosols active par la respiration Download PDF

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Publication number
WO2002089884A1
WO2002089884A1 PCT/GB2002/002102 GB0202102W WO02089884A1 WO 2002089884 A1 WO2002089884 A1 WO 2002089884A1 GB 0202102 W GB0202102 W GB 0202102W WO 02089884 A1 WO02089884 A1 WO 02089884A1
Authority
WO
WIPO (PCT)
Prior art keywords
medicament
delivery device
medicament delivery
exhalation
inhalation
Prior art date
Application number
PCT/GB2002/002102
Other languages
English (en)
Inventor
Philip Braithwaite
Original Assignee
Innovata Biomed Limited
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 Innovata Biomed Limited filed Critical Innovata Biomed Limited
Publication of WO2002089884A1 publication Critical patent/WO2002089884A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M15/00—Inhalators
    • A61M15/0091—Inhalators mechanically breath-triggered
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M15/00—Inhalators
    • A61M15/0091—Inhalators mechanically breath-triggered
    • A61M15/0098—Activated by exhalation

Definitions

  • This invention relates to a novel inhalation device and to novel methods related thereto.
  • medicaments administered by inhalation may be administered in the form of a dry powder with the use of a dry powder inhaler (DPI) or in the form of a solution or suspension with the use of a pressurised metered dose inhaler (MDI) or a nebuliser.
  • DPI dry powder inhaler
  • MDI pressurised metered dose inhaler
  • a nebuliser a particular problem encountered with inhaled medicaments delivered by a DPI is that a patient's inspiration may not be sufficient to aerosolise and inhale a medicament into a desired part of the lung. Whilst a particular problem encountered with MDIs is that a patient's inspiration may be too strong, leading to the medicament particles impacting at the back of the throat rather than reaching the upper or lower respiratory tract.
  • inhalation devices a general problem encountered with inhalation devices is the need to coordinate the action of inhalation with the action of inhalation with the actuation of the device. Further, with, for example, a DPI it is necessary to achieve a specific flow rate prior to effective aerosolisation so as to enable the powdered medicament to reach the desired part of the lungs.
  • US Patent No. 5,404,871 describes apparatus for delivering an aerosolised medicine.
  • apparatus which includes a control for detecting changes in a patient's breathing pattern during inspiration to determine the optimum point for release of the medicament to the patient.
  • US Patent No. 5,408,994 describes an inhalation device for administration of an aerosolised medicament to the respiratory system of a patient.
  • the inhalation device is activated by the use of an inhalation trigger.
  • International Patent Application No. WO 01/58514 describes a drug delivery apparatus which includes a monitor which indicates whether a patient's breathing pattern is effective for inhaling drug laden air. The apparatus monitors the duty cycle of a patient on, for example, a nebuliser.
  • US Patent No. 6,129,080 describes an atomiser which is provided with means to prevent or stop atomisation in response to a positive pressure.
  • inhalation activated devices Although a variety of inhalation activated devices are available. Existing inhalation actuated devices have not been entirely successful in overcoming the problem of timing the delivery of a medicament with the inspiration of a patient.
  • Such devices are usually triggered on crossing a fixed threshold inspiratory effort.
  • one object of this invention is to provide an inhalation device constructed to enable the patient to place the mouthpiece in their mouth and first exhale through the mouthpiece to, for example, an exhaust port or an exhalation channel and then, with the mouthpiece still in place, to inhale.
  • the present invention may overcome or mitigate some of the disadvantages of prior art devices.
  • a medicament delivery device for delivery of an aerosolised medicament provided with an exhalation/inhalation trigger.
  • a medicament delivery device for delivery of an aerosolised medicament provided with a breath activated means which means is adapted to be activated at or a short time after the end of exhalation by a patient.
  • the breath activated actuation means is adapted to dispense the medicament either substantially at the point when exhalation by the patient terminates or, preferably a short time, e.g. milliseconds, after the end of exhalation, i.e. the patient has begun to inhale.
  • the activation means may comprise a pair of valves, wherein a first valve is openable upon exhalation by a patient and a second valve is openable upon inhalation by a patient. Most preferably the second valve will be prevented from opening until the first valve has closed or at least partially closed. Therefore in a particularly preferred embodiment the first and second valves, which may be defined as an exhalation valve and an inhalation valve, may be operably linked.
  • the link between the two valves may be a mechanical link, electromechanical link or an electronic link.
  • valves may be used in the device of the invention, one example of such valves is a poppet valve, slidable within an inhalation and an exhalation channel respectively.
  • a medicament delivery device comprising a medicament reservoir, a metering member and a medicament delivery passage wherein the delivery device is provided with an exhalation valve as hereinbefore described.
  • the device of the invention when the device of the invention is a medicament delivery device, the device may have utility in a variety of medicament delivery areas, including, for example, as an oral delivery device, e.g. an inhaler and especially a metered dose inhaler (MDI), or a dry powder inhaler (DPI).
  • an oral delivery device e.g. an inhaler and especially a metered dose inhaler (MDI), or a dry powder inhaler (DPI).
  • MDI metered dose inhaler
  • DPI dry powder inhaler
  • oral administration is referred to, it would be well understood by the skilled man that the delivery device may be suitable for use in relation to other routes of administration, e.g. nasal administration.
  • the inhalation device of the invention may comprise any conventionally known inhalation devices, including, for example, and insufflator, a nebuliser or an inhaler, e.g. an MDI or a DPI.
  • a nebuliser e.g. an MDI or a DPI.
  • the inhaler is a DPI.
  • the inhaler is an MDI.
  • An example of a conventional DPI is a CUCKHALER (available from Innovata Biomed in the UK and described in European Patent application No. 0 539 469) which is provided with an inhalation passage.
  • the delivery device of the invention may optionally he attached, for example, at the outlet end of such an inhaler, to a spacer device.
  • the inhaler may comprise a TECHNOHALER (available from Innovata Biomed in the UK and described in European Patent Application No. 0 626689).
  • a variety of medicaments maybe administered by using the inhaler of the invention.
  • such medicaments may generally include drugs for the treatment of asthma, COPD and/or infections, including antibiotics, bronchodilators or other anti-asthma drugs.
  • medicaments include, but are not limited to ⁇ 2 -agonists, e.g. fenoterol, formoterol, pirbuterol, reproterol, rimiterol, salbutamol, salmeterol and terbutaline; non-selective beta-stimulants such as isoprenaline; xanthine bronchodilators, e.g. theophylline, aminophylline and chorine theophyllinate; anticholinergics, e.g.
  • mast cell stabilisers e.g. sodium cromoglycate and ketotifen
  • bronchial anti-inflammatory agents e.g. nedocromil sodium
  • steroids e.g. beclomethasone dipropionate, fluticasone, budesonide and flunisolide; and combinations thereof.
  • medicaments which may be mentioned include combinations of steroids, such as, beclomethasone dipropionate, fluticasone, budesonide and flunisolide; and combinations of to ⁇ 2 -agonists, such as, formoterol and salmeterol. It is also within the scope of this invention to include combinations of one or more of the aforementioned steroids with one or more of the aforementioned ⁇ 2 -agonists.
  • medicaments which may be mentioned include systemically active materials, such as, proteinaceous compounds and/or macromolecules, for example, hormones and mediators, such as insulin, human growth hormone, leuprolide and alpha interferon; growth factors, anticoagulants, immunomodulators, cytokines and nucleic acids.
  • hormones and mediators such as insulin, human growth hormone, leuprolide and alpha interferon
  • growth factors such as growth factors, anticoagulants, immunomodulators, cytokines and nucleic acids.
  • the particle size of the medicaments maybe varied depending, inter alia, on the type of aerosol being formed.
  • the particle size of the powder, and the carrier, if one is present may be varied.
  • the nature of the carrier may also be varied.
  • the particle size of the powder may be substantially between 1 and 100 ⁇ m. That is, at least 90% w/w of the powder should have a particle size of between 1 and 100 ⁇ m.
  • the preferred particle size may also depend upon the nature of the medicament being delivered. Thus, for example, for the treatment of respiratory disorders a particle size of 4 to 8 ⁇ m may be preferred, e.g. 6 ⁇ m. However, for the delivery of systematically active powders a smaller particle size maybe desirable, for example from 1 to 5 ⁇ m, e.g. 3 ⁇ m.
  • a variety of carriers may be used.
  • Certain carriers may be mentioned, by way of example only, such as sugars, e.g. dextran, mannitol and lactose, for example ⁇ -lactose monohydrate.
  • the particle size of the carrier may be across a wide range, between 0.1 and 500 ⁇ m, preferably between 1 and 200 ⁇ m.
  • the carrier may itself comprise a mixture of fine and coarse particles.
  • the medicament delivery device of the invention is especially suited for use as an inhaler and most especially a dry powder inhaler.
  • a preferred embodiment we provide a method of treatment of a patient with a systemic disorder which comprises the administration of a medicament using an inhaler as hereinbefore described.
  • the medicament delivery device of the invention is especially suited for the efficient delivery of macromolecules, such as insulin.
  • a method of treating insulin dependent diabetes which comprises administration of an effective amount of insulin using a medicament delivery device as hereinbefore described.
  • the device of the invention When the device of the invention is used for the delivery of moisture sensitive molecules, e.g. certain macromolecules, such as insulin, it is important that they be provided in a moisture resistant system.
  • a moisture resistant coating e.g. a paraxylylene coating.
  • a moisture resistant coating may be desirable for use in connection with other molecules, e.g. small molecules.
  • the inhaler of the invention is especially advantageous in that, inter alia, it ensures the lungs are sufficiently empty at the beginning of inhalation and this improves the potential for the drug to reach the lower lung.
  • the device of the invention may have a mechanism for active deaggregation the mechanism can be activated as early as necessary to ensure deaggregation takes place at the most efficient time in the inhalation cycle.
  • Figure 1 is a schematic representation of a patient exhaling into a device
  • Figure 2 is a schematic representation of a patient inhaling from the device
  • Figure 3 is an enlarged cross-sectional representation of the inhalation/exhalation trigger
  • Figure 4 is a cross-sectional representation of the trigger in the rest position
  • Figure 5 is a cross-sectional representation of the trigger during exhalation by a patient
  • Figure 6 is a cross-sectional representation of the trigger at the end of exhalation
  • Figure 7 is a cross-sectional representation of the trigger at the start of inhalation.
  • an inhalation/exhalation trigger (1) comprises an exhalation tube (2) and an inhalation tube (3) connected by a conduit (4).
  • the exhalation tube (2) is provided with an exhalation poppet (5) which is biased by a spring (6) to the closed position.
  • the end (7) of the exhalation tube (2) is provided with a pair of air vents (8 and 9).
  • the poppet (5) is provided with an annular shoulder (10) which, when in the closed position, abuts an annular rim (11) in the exhalation tube (2) to form a closed seal.
  • the poppet (5) is biased in a direction towards the exhalation end (12) of the exhalation tube (2).
  • the inhalation tube (3) is provided with an inhalation poppet (13) which is biased by a spring (14) to the closed position.
  • the inhalation end (15) of the inhalation tube (3) is provided with a pair of air vents (16 and 17).
  • the poppet (13) is provided with an annular shoulder (18) which, when in the closed position, abuts an annular rim (19) in the inhalation tube (3) to form a closed seal.
  • the poppet (13) is biased in a direction away from the inhalation end (12) of the inhalation tube (3).
  • the exhalation poppet (5) is provided with a guide rod (20), the distal end (21) of the rod (20) rests in a slide (22) housed in a slide assembly (23).
  • the slide (22) is shaped such that it comprises a substantially triangular groove.
  • the slide assembly (23) sits in the joining conduit (4) and is moveable (slidable) within the joining conduit.
  • the inhalation poppet (13) is also provided with an inhalation guide rod (26).
  • the distal end (25) of the inhalation guide rod (26) cooperates with a latch (24) in the slide assembly (23).
  • the latch (24) is provided at the end (29) of the slide assembly (23). Beneath the latch (24), the slide assembly (23) is also provided with a guide aperture (30).
  • the inhalation guide rod (26) protrudes through the guide aperture (30) so as to engage with the latch (24).
  • the slide assembly (23) is also provided with a lever (27) to allow manual override if necessary.
  • exhalation poppet (5) and the inhalation poppet (13) are both in the closed position whereby the exhalation poppet (5) abuts the annular rim (11) of the exhalation tube (2) and the inhalation poppet (13) abuts the annular rim (18) of the inhalation tube (3).
  • the exhalation spring (6) is compressed and the exhalation poppet (5) is urged away from the annular rim (11) of the exhalation tube (2). Exhaled air therefore is allowed to flow through the vents (8, 9).
  • the exhalation spring (6) is compressed, the movement of the exhalation poppet (5) causes the end (21) of the guide rod (20) to be urged towards a first corner (28) of the triangular slide (22).
  • the slide assembly (23) is therefore urged to slide within the conduit (4) away from the exhalation poppet (5) and towards the inhalation tube (3) and the inhalation poppet (13). This causes the inhalation guide rod (26) to begin to disengage from the latch (24) of the slide assembly (23).
  • the exhalation poppet (5) is urged by the decompression of the exhalation spring (6) to return to the closed position.
  • the exhalation guide rod (26) is urged to a second corner (31) of the guide triangle (22) thus the slide assembly (23) is therefore urged to slide further within the conduit (4) away from the exhalation poppet (5) and towards the inhalation tube (3) and the inhalation poppet (13).
  • the inhalation guide rod (26) is completely disengaged from the latch (24) and the inhalation guide rod (26) is free to move in the guide aperture (30). Therefore, the inhalation poppet (13) is also free to move within the inhalation tube (3) e.g. to compress the inhalation spring (14).
  • the slide assembly (23) may be biased or may be provided with biasing means (not shown) which urges the slide assembly (23) back to the rest position once a cycle of exhalation and inhalation has been completed

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention porte sur un dispositif de distribution de médicaments sous forme d'aérosol muni d'un déclencheur d'exhalaison/inhalation, et sur un procédé de traitement consistant à administrer un médicament à l'aide du susdit dispositif.
PCT/GB2002/002102 2001-05-10 2002-05-10 Systeme medical d'administration d'aerosols active par la respiration WO2002089884A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0111328.1 2001-05-10
GBGB0111328.1A GB0111328D0 (en) 2001-05-10 2001-05-10 Device

Publications (1)

Publication Number Publication Date
WO2002089884A1 true WO2002089884A1 (fr) 2002-11-14

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PCT/GB2002/002102 WO2002089884A1 (fr) 2001-05-10 2002-05-10 Systeme medical d'administration d'aerosols active par la respiration

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WO (1) WO2002089884A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005037317A2 (fr) * 2003-10-17 2005-04-28 Cornell Research Foundation, Inc. Renine d'origine mastocytaire
US9008761B2 (en) 2010-02-01 2015-04-14 Proteus Digital Health, Inc. Two-wrist data gathering system
US9014779B2 (en) 2010-02-01 2015-04-21 Proteus Digital Health, Inc. Data gathering system
US9084566B2 (en) 2006-07-07 2015-07-21 Proteus Digital Health, Inc. Smart parenteral administration system
US9125979B2 (en) 2007-10-25 2015-09-08 Proteus Digital Health, Inc. Fluid transfer port information system
US10517839B2 (en) 2008-06-09 2019-12-31 Cornell University Mast cell inhibition in diseases of the retina and vitreous

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4677975A (en) * 1984-10-16 1987-07-07 The University Of Auckland Method of dispensing and/or a dispenser
DE4345123C1 (de) * 1993-12-30 1995-04-13 Peter Dr Ing Habil Schaller Ventilanordnung für ein Beatmungsgerät
US5738087A (en) * 1995-09-21 1998-04-14 King; Russell W. Aerosol medication delivery system
US5813401A (en) * 1996-10-15 1998-09-29 Radcliff; Janet H. Nebulizer automatic control valve
WO2000053247A1 (fr) * 1999-03-06 2000-09-14 Glaxo Group Limited Systeme d'apport de medicament

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4677975A (en) * 1984-10-16 1987-07-07 The University Of Auckland Method of dispensing and/or a dispenser
DE4345123C1 (de) * 1993-12-30 1995-04-13 Peter Dr Ing Habil Schaller Ventilanordnung für ein Beatmungsgerät
US5738087A (en) * 1995-09-21 1998-04-14 King; Russell W. Aerosol medication delivery system
US5813401A (en) * 1996-10-15 1998-09-29 Radcliff; Janet H. Nebulizer automatic control valve
WO2000053247A1 (fr) * 1999-03-06 2000-09-14 Glaxo Group Limited Systeme d'apport de medicament

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005037317A2 (fr) * 2003-10-17 2005-04-28 Cornell Research Foundation, Inc. Renine d'origine mastocytaire
WO2005037317A3 (fr) * 2003-10-17 2006-01-19 Cornell Res Foundation Inc Renine d'origine mastocytaire
US9084566B2 (en) 2006-07-07 2015-07-21 Proteus Digital Health, Inc. Smart parenteral administration system
US9125979B2 (en) 2007-10-25 2015-09-08 Proteus Digital Health, Inc. Fluid transfer port information system
US10517839B2 (en) 2008-06-09 2019-12-31 Cornell University Mast cell inhibition in diseases of the retina and vitreous
US9008761B2 (en) 2010-02-01 2015-04-14 Proteus Digital Health, Inc. Two-wrist data gathering system
US9014779B2 (en) 2010-02-01 2015-04-21 Proteus Digital Health, Inc. Data gathering system
US10376218B2 (en) 2010-02-01 2019-08-13 Proteus Digital Health, Inc. Data gathering system

Also Published As

Publication number Publication date
GB0111328D0 (en) 2001-07-04

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