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Microsoft word - spiralle-2010.doc
Spirale® DDS is the smart way to deliver aerosolised micro-drug particles from an MDI (metered dose inhaler) canister into a respiratory breathing circuit during anaesthesia or intensive care ventilation in the spontaneously breathing or ventilated
• Product Features
Avoids disruption to ventilation settings
• Clinical Efficacy
Clinical efficacy of MDI volumising chambers has been established through independently-published scientific
Such data demonstrates superior alveolar drug deposition when a volumising chamber is used in conjunction with an MDI in
comparison to nebulisation of drug fluid using a gas-driven jet nebuliser. Dosage of medication should be assessed based on
MDI expellant volume, which is normally quantified in micrograms per actuation and be titrated using urine excretion
analysis or other accepted physiological indicators
• Optimal Drug Delivery
Spirale® DDS optimises alveolar drug deposition using a carefully designed jet orifice in combination with volumising
Spirale® DDS can be positioned in the inspiratory limb of the breathing circuit or is equally suitable in a catheter mount or connected directly to the patient connector4.
Spirale® DDS is intended to remain in the breathing circuit, thus negating the risk of environmental contamination of
the breathing circuit and clinical setting, common with the use of gas-driven fluid nebulisers.
It also avoids the need to change ventilation settings when utilised. Closed-circuit suctioning of the patient’s airway can
continue with the Spirale® DDS in place
1 Arnon S
et al. Delivery of Micronized Budesonide Suspension by Metered Dose Inhaler and Jet Nebulizer into a Neonatal Ventilator Circuit.
Paediatric Pulmonary 1992; vol 13; pp. 172-5
2 Rau JL
et al. Evaluation of a Reservoir Device for Metered-Dose Bronchodilator Delivery to Intubated Adults: An In Vitro Study.
Chest 1992; vol 102; pp.924-30
3 Coleman DM
et al. Determinants of Aerosolized Albuterol Delivery to Mechanically Ventilated Infants. Chest 1996; vol 109; pp. 3-10
4 Dhand R
et al. Inhaled Bronchodilator Therapy in Mechanically Ventilated Patients. Am J Respir Crit Care Med 1997; vol.156; pp.156
• Infection Control
Reduce the Risk of Pathogen Transmission in Patients with Respiratory Viral Infection
Swine Influenza A (currently characterized as H1N1) is a fluid-borne contagion in humans. Human-to-human transfer
of H1N1 is aided by the spores being carried in respiratory fluids.
Managing the risks posed by pathogen transmission in confirmed and suspected H1N1 cases in the hospital setting is currently vexing healthcare providers. Of particular concern is aerosol generation during mechanical ventilation in the
intensive care setting caused by bronchoscopy, airway suctioning and drug and saline nebulisation.
Drug or saline nebulisation stimulates the tracheal mucosa often triggering sternutation (sneezing) and/or tussis (coughing) both of which generate expiratory aerosols. These aerosols may be viable for inhalation by persons in the vicinity of the
patient at the time or some time after. The potential risk to other patients and healthcare providers may be significant if the source patient is infected.
Using Spirale® DDS in the Intensive Care Setting Can Help Reduce the Spread of H1N1 The World Health Organisation (WHO) has designated nebulisation as a procedure which may increase the risk of
pathogen transmission1. Spirale® DDS will minimise these risks.
Not only is Spirale® DDS the most efficacious method by which to deliver aerosolised drug particles to mechanically-
ventilated patients, it also offers healthcare providers optimum protection from risk of pathogen transmission. Spirale® DDS is designed to be an integral part of the breathing circuit, thereby avoiding the need to cease ventilation to open the breathing circuit when facilitating aerosolised drug delivery. Opening the circuit risks contamination of both the
breathing circuit and the clinical setting. Unlike conventional jet nebulisers and ultrasonic cups, where the circuit needs to
be opened to administer medication, we believe that Spirale® DDS is safer for users treating confirmed and suspected cases of H1N1. Furthermore, closed circuit suctioning of the airways can continue with Spirale® DDS en-situ.
Spirale® DDS can remain in position for up to 7-days from date of initial use (always refer to the Instructions for Use
supplied with each product).
• How to Use
Spirale® DDS is normally incorporated into the inspiratory limb of a ventilator breathing circuit, proximal to the
patient and positioned as close to the patient connection as setup allows.
The chamber is then used periodically by unlocking and fully expanding the volumising portion and depressing the MDI
canister when engaged in the actuator port provided.
When used in this way it does not add to breathing circuit dead space volume, as the gas pathway does not mix inspiratory
and expiratory gases. However, it should be noted that it adds 16ml compressible volume when in the closed position and
When used on the patient side of the breathing circuit patient connection (for example, as part of a catheter mount) the
dead space volume is 16ml in the collapsed and locked position and 133ml in the open and fully expanded position. After use, the Spirale® DDS must be collapsed and locked.
Spirale® DDS is positioned so that the actuator port is furthest from the patient, thereby allowing aerosolised drug
particles to be suspended in gas volume for subsequent inhalation.
Spirale® DDS may be supplied as an integral part of a catheter mount and mounted proximal to the tracheal tube or laryngeal airway and connected to the Y-piece of the breathing circuit or patient connector if a Universal F breathing circuit is in use.
It should be noted that positioning Spirale® DDS between the patient connection and breathing circuit places the device in
the inspiratory expiratory gas stream and potential does exist for non-inhaled drug particles to be diverted into the
expiratory limb. This potential limitation can be overcome by depressing the MDI canister in the period of expiratory pause,
just prior to the start of the inspiratory phase.
Armstrong Medical has not received reports suggesting that the Spirale® DDS is any less effective in drug delivery when the
device is used between the patient connection and breathing circuit.
Rua Dr. Manuel Arriaga, nº 5 A
Email: firstname.lastname@example.org Web: www.onmedical.pt
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Content and relevant of industrial applicability and/or utility as requirements for patentability. Submitted by: Winnie Tham and Jason Chan, Working Committee for AIPPI Singapore 1. What is the situation in your country? 1.1 Does your country know industrial applicability or utility as an additional requirement for patentability besides novelty and inventive step? 1.2 How does t