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Respiratory Therapy Medical/Scientific/General Background Marketing Europe Dr. Rainer Jakobs PMM Europe 1 Dr. Rainer Jakobs, PMM Europe RT

Medical/Scientific/General Background 2 Dr. Rainer Jakobs, PMM Europe RT

Medical/Scientific/General Background Anatomy of the Respiratory System Main upper airways/lung diseases and treatment Delivery of medication: drugs, nebulisers Inhalation of medication MDI s, DPI s, General Nebuliser Specifications (EN 13544-1) 3 Dr. Rainer Jakobs, PMM Europe RT

Anatomy of the Respiratory System Throat Larynx Trachea Bronchial Tree J. Rathgeber 4 Dr. Rainer Jakobs, PMM Europe RT

Anatomy of the Respiratory System Nose Mouth Throat Picture only for internal OMRON use 5 Dr. Rainer Jakobs, PMM Europe RT

Anatomy of the Respiratory System The Larynx Vocal Cordes Pictures only for internal OMRON use 6 Dr. Rainer Jakobs, PMM Europe RT

Anatomy of the Respiratory System The Trachea Connecting Larynx and main Bronchi Backside: : Membran Inside: Mucosa,, Cilia and Glands 7 Dr. Rainer Jakobs, PMM Europe RT

Anatomy of the Respiratory System The Bronchial Tree Picture only for internal OMRON use 8 Dr. Rainer Jakobs, PMM Europe RT

Anatomy of the Respiratory System Photo: Astra Zeneca 9 Dr. Rainer Jakobs, PMM Europe RT

Anatomy of the Respiratory System The Alveoli Place of Gas exchange Blood-Air-Barrier Breathing Area ca. 70 m2 Alveoli Capillary Picture only for internal OMRON use 10 Dr. Rainer Jakobs, PMM Europe RT

Anatomy of the Respiratory System Arterial/Venous Bloodflow in the Lung Picture only for internal OMRON use 11 Dr. Rainer Jakobs, PMM Europe RT

Particle Size and Anatomy Size Size 10μm< Depositing Area Nose/Throat Rate Residue Less than 5μm Less than<1μm Airway Alveoli Treatment area 12 Dr. Rainer Jakobs, PMM Europe RT

Main Upper Airway disease Common Cold Characteristics: (Rhino-)Virus infection in the upper airways (nose, throat/pharynx) Treatment: Steam/Aerosol inhalation, with/without etheric oils 13 Dr. Rainer Jakobs, PMM Europe RT

Main Lung diseases Asthma Characteristics: Reduced airflow and difficulties in breathing due to: Muscle contraction, Inflammation mite increased mucous production in the bronchial tubes Triggers: Allergic reaction (pollen, animals, house/dust mites) Environment (cigarette smoke, air pollution) Colds or other virus infections Photo: International Asthma Council 14 Dr. Rainer Jakobs, PMM Europe RT

Main Lung diseases Asthma Prevent contact with trigger factors Treatment: Prevent by using preventer medications: Antiallergica, antihistaminica Anti-inflammatory (steroids and non-steroids) Antibiotics Mucous dissolvers Treat by using reliever medications (bronchodilators, e.g. Salbutamol) 15 Dr. Rainer Jakobs, PMM Europe RT

Main Lung diseases COPD (Chronic obstructive pulmonary disease) Characteristics: Reduced breathing ability and constant coughing with mucous expectoration due to: Chronic inflammation of the bronchial tubes Bronchial tubes are constantly more or less obstructed by mucous Frequent coughing Similar reaction as asthma, but not caused by direct triggers 16 Dr. Rainer Jakobs, PMM Europe RT

Main Lung diseases COPD (Chronic obstructive pulmonary disease) Characteristics, continued: Long-lasting disease with long-standing cause: smoking long-term pollution infections wet and cold air allergens Treatment: Almost similar to asthma With mucus Obstructive; Permanently narrowed 17 Dr. Rainer Jakobs, PMM Europe RT

Main Lung diseases Emphysema Characteristics: Shortness of breath due to damaged air sacs (alveoli). Usually caused by chronic bronchitis. Air sacs become over-inflated and mucous is trapped in the sacs. Less Space To breathe Air Congestion More Space To breathe Constricted bronchy Drugs widen bronchy 18 Dr. Rainer Jakobs, PMM Europe RT

Main Lung diseases Emphysema Treatment: The lung sacs cannot be repaired ; prevent further damage. Medication to treat chronic bronchitis Stop smoking! Photo: Asthma Fonds 19 Dr. Rainer Jakobs, PMM Europe RT

Delivery of Medication 1. Tablets & pills 2. Injections 3. Inhalations: Side specific Smaller dosage needed Less side effects Faster effect Painless Done by aerosol (fine particles) 20 Dr. Rainer Jakobs, PMM Europe RT

Medication (Examples) Prophylactic/Immunmodulators: Antihistaminica, Antiallergica e.g. Dinatriumcromoglicin (DNCG), Nedocromil Bronchodilatatory drugs (ß2-Sympathomimetica, Anticholinergica) e.g. Salbutamol, Fenoterol, Terbutalin, Ipratropium, Tiotropium Mucolytic/Antitussive: Expectorants e.g. Mucosolvan, Acetylcystein Against infections/antibacterial: Antibiotics e.g. Tobramycin Antiinflammatory: Corticosteroide for inhalation or oral, e.g. Budesonid 21 Dr. Rainer Jakobs, PMM Europe RT

Medication with nebulisers (Examples) Beta-Agonists Standard Ultrasonic Low Frequency Vibrating Mesh Albuterol X X Airet X X Proventil X X Ventolin X X Alupent X X Xopenex X X Control Medications Cromolyn - Intal X X Nedocromil X X Corticosteroids Budesonide (Respules) X Anticholinergics Atrovent X X - Compressors x x x x x X x x x x 22 Dr. Rainer Jakobs, PMM Europe RT

Medication: Aerosol characteristics Particle size of aerosol and deposition: 5 ~ 10 µm: Large airways (upper lung) 1 ~ 5 µm: Small airways and air sacs (alveoli) < 0.5 µm: Exhalation Compare: hair diameter approx. 50 µm (0.05 mm) MMAD = Mean Median Aerosol Diameter MMAD = 5 µm, means that 50% of aerosol is smaller than 5 µm. Deposition of particles depends on: Properties of device / particle size Inhalation techniques Airway geometry Degree of obstruction 23 Dr. Rainer Jakobs, PMM Europe RT

Medication: Aerosol characteristics Particle size distribution curve (example) 1 µm 5 µm 9 µm 24 Dr. Rainer Jakobs, PMM Europe RT

Medication: Delivery MDI s (Metered Dose Inhalers), called Puffer Disposable container. When pushing on the container, fixed amount ( metered dose ) is released under high pressure. Propellant gas used to obtain pressure. Example: Ventolin bronchodilator 25 Dr. Rainer Jakobs, PMM Europe RT

Medication: Delivery MDI Pro s & Con s: + Cheap, reimbursed by insurance + Very small and portable + No noise + Very popular, pushed by pharmaceutical companies + No cleaning required Low efficiency, due to high speed release (huge loss in throat and other upper airways) Difficult to coordinate push & inhale (especially children and elderly) Spacer required (big, loss of medication, cleaning) Use of CFC? 26 Dr. Rainer Jakobs, PMM Europe RT

Medication: Delivery DPI s (Dry Powder Inhalers) Medication is dry powder. No propelant gas, release of medication is only result from inhalation. Pro s & Con s: (others than for MDI s): + no CFC required Just dry powder difficult to inhale during asthma attack Spacer not possible 27 Dr. Rainer Jakobs, PMM Europe RT

Nebuliser Specifications Nebulisation rate Output rate Output Particle size (according EN13544-1) (according EN13544-1) (according EN13544-1) 28 Dr. Rainer Jakobs, PMM Europe RT

Nebuliser Specifications Nebulisation Rate Amount of nebulised medication (ml) per minute, measured by weight loss of 0.9% Saline Basic procedure: Nebuliser kit or medication container is filled with 3 or 5 ml of 0.9 % Saline Weight is measureed (W1). Nebulisation for exactly 3 minutes. Nebuliser kit / medication container is reweighted (W2). Nebulisation rate (ml/min) = (W1-W2) / 3 29 Dr. Rainer Jakobs, PMM Europe RT

Nebuliser Specifications Aerosol Output Rate (ml/min) according to EN 13544-1 It is measured how much medication per minute will be administered to the patient (represented by a filter) The nebuliser is connected to a breath simulator pump. A filter is located between the nebulizer and the pump. The nebulizer is filled with 2 ml of a 1% Sodium Fluoride (NaF) solution and operated for 1 minute, during which the aerosol is collected on the filter. The amount of NaF solution on the filter is quantified by chemical analysis and provides the Aerosol Output Rate. Procedure according to EN13544-1 nebuliser standard. 30 Dr. Rainer Jakobs, PMM Europe RT

Nebuliser Specifications Aerosol Output (ml) according to EN 13544-1 It is measured how much medication absolute will be administered to the patient The nebulizer is connected to a breath simulator pump. A filter is located between the nebulizer and the pump. The nebulizer is filled with 2 ml of a 1% Sodium Fluoride (NaF) solution and operated until nebulisation stops, during which the aerosol is collected on the filter. The amount of NaF solution on the filter is quantified by chemical analysis and provides the aerosol output. Procedure according to EN13544-1 nebulizer standard. 31 Dr. Rainer Jakobs, PMM Europe RT

Nebuliser Specifications Particle size Techniques to measure particle size: Aerodynamics (API Aerosizer) Cascade Impactor Centrifuge Electron microscope Impaction Laser Diffraction (Malvern) Spectroscopy Ultracentrifuge All reliable and accepted techniques, however results may be different!! Nebuliser harmonized European standard EN13544-1 describes cascade impaction method. 32 Dr. Rainer Jakobs, PMM Europe RT

Nebuliser Specifications Particle size Techniques to measure particle size: Cascade Impactor 33 Dr. Rainer Jakobs, PMM Europe RT