LETHO – Automatic Compact Radiopharmaceutical Injector

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Warning! Starting April 2020 “LETHO – Automatic Compact Radiopharmaceutical Injector” is no longer available. See Nuclear Medicine solutions »

Letho is a compact radiopharmaceutical injector system for the automatic intravenous infusion of radio drugs or radio tracers. The system allows for the infusion of gamma and beta-emitting molecules in a radiologically safe manner and with maximum control of all critical parametres such as the flow, the amount and the injection time.

The device was created from a collaboration between Comecer and Codan Argus, a leading Swiss company in hospital infusion pumps for traditional medication and chemotherapy.
The technology and know-how of Comecer are associated with a particular infusion pump system (Argus 717V), among the most common and popular of these applications.

The Letho system works in two ways:

• without the infusion pump, using the force of gravity
• with the infusion pump, for maximum automation of the process

At the heart of the device there is a particular cartridge equipped with a double pierceable septum (one for each end).  This cartridge is filled using traditional dispensing systems and Comecer fractionators (Febo, Clio, Althea or others) like a normal syringe. A patent application (BO2013A000256) has been filed for the cartridge and the entire system, including the holder (the shielded container that houses the cartridge) and the infuser.

Double Septum Cartridge with Tungsten Shielded container

Certified Medical Devices

The Letho system is composed of devices that are individually certified as:

• Letho: Class I medical device
• cartridge: class IIA medical device
• disposable kits: class IIA medical device
• infusion pump: class IIB medical device

Main Innovative Features of the Letho Cartridge:

• allows for the safe transport of a beta/gamma-emitting radio drug or radio tracer, without any loss
• minimises shielding and the weight of the holder thanks to its compact size
• made of plastic material suitable for the containment of injectable radio drugs
• sterilised with ethylene oxide or gamma radiation and supplied in double-seal envelopes
• created to keep the drug uncontaminated and isolated from the external environment
• with two pierceable septa, one upper and the other lower, located at the ends along the axis of the device
• sized to accommodate up to 9 ml of liquid
• with a hydrophobic membrane and micro filter for air ventilation at the time of filling
• head to check the air tightness and the structural strength
• pierceable multiple times without losing air tightness

Advantages and Highlights

• can be connected to a gravity infusion system and, without changing disposables, to an automated system
• can be washed and decontaminated with saline without “aspiration” procedures and thus never violating the essential rule of the one-way-fluid-movement for infusion pumps
• eliminates the residue of the drug not injected
• the extremely compact design reduces the shielding necessary for the reduction of ionising radiation in case of a radioactive fluid
• features pure tungsten shielding in the case of gamma-emitting molecules or plastic and tungsten shielding in the case of beta emitters
• is guaranteed for any type of radio molecule currently in clinical and pre-clinical use.