Conformance to cGMP can be accommodated as part of the company's effort to support the use of Flutec^® Fluids in medical applications.

For physical product data and material safety data sheets please select your product from the list below:

Perfluorodecalin		Perfluorobutane
Perfluorohexane		Perfluorooctane
Octafluoropropane		Perfluoromethyldecalin
Perfluoroperhydrophenanthrene

For many years a huge amount of interest has been shown in perfluorocarbons for medical applications due to their remarkably low toxicity, lack of biological activity, short retention time in the body and their ability to dissolve gases especially oxygen and carbon dioxide.

Blood Extenders (Substitutes)
For many years there has been interest in using perfluorocarbons to minimise the risk of allogeneic blood transfusions. Perfluorocarbons are immisible with blood so they are used in an emulsion form. The first emulsions were developed by the Green Cross Company in Japan in the mid 1970's, new emulsions in development have enhanced oxygen carrying capacity, better emulsion stability, and no associated hemodynamic effects on administration.

Perfluorocarbons emulsions have a relatively small particle size and so have the added advantage that they are able to oxygenate ischaemic tissue and tumours (increasing sensitivity to radiation therapy).

Typical compound used : Perfluorodecalin

Further Reading: ML Nucci, A Abuchowshi, Sci. Amer, Feb 1998, 61-65

Wound Healing
The nearer to the body's surface the less blood flow there is and oxygen supply is correspondingly reduced. The use of oxygen at high pressure to promote wound healing is well known.

Oxygenated perfluorocarbons administered in emulsions will also increase surface oxygen concentration but without the need for an expensive pressure chamber. They are extremely useful for repair of scar tissue, leg ulcers and radiation burns.

Typical Compound : Perfluorodecalin

Further Reading: JD Whitney, Heart and Lung, 1989, 18, 466. General information about high pressure oxygen in wound healing.

Eye Surgery
The density of perfluorocarbon liquids has made them of great interest in ophthalmology. The detachment of the retina from the back of the eye is a serious medical condition potentially leading to blindness. However, reattachment is now possible by passing perfluorocarbon into the eye. The heavy perfluorocarbon excludes the vitreous fluid from behind the retinal tear, gently pressing the retina back into place. The tear is sealed with a laser, and the perfluorocarbon is removed a few weeks later.

Similarly the dislocation of the lens within the eye can be surprisingly well tolerated in many cases but often full removal is required. The use of a high density fluid allows the lens to be floated out without risk to the retina. This can even be done in conjunction with the retinal repair procedure.

Typical Compounds: Perfluorodecalin, Perfluorooctane, Perfluoroperhydrophenanthrene and Octafluoropropane

Further Reading: CL Paris et al, retina, 1991, 11, 301-4, &
Laser ablation of epiretinal membranes in perfluorocarbon fluid-filled eyeballs: Frenz Martin, Ith; Michael, Weber Heinz P, Univ. of Bern; Wesendahl TH,; Janknecht P, Univ of Freiburg; Publication Proc. SPIE Vol 3246, p 199-208, Opthalmic Technologies VIII Pascal O Rol: Karen M Joos, Fabrice Manns; Eds 1998

Sterlisation
The need to sterilise surgical equipment is clear. The most common technique is to use steam under pressure. By selecting a perfluorocarbon with a suitable boiling point the need for a high pressure container is avoided. Perfluorocarbons also have the advantage of being more inert even than water and unlike sterilising with steam they do not corrode cutting edges.

Typical compounds: Perfluoromethyldecalin

Imaging Applications
Perfluorocarbon fluids are being used increasingly in medical diagnostics, specifically ultra-sonic imaging and magnetic resonance imaging (MRI) . For ultra-sound, coronary-scanning applications low boiling perfluorocarbons in microbubbles make excellent contrast imaging agents.

Because the body contains no fluorine the movement of a fluorocarbon through the body is easy to map using magnetic resonance imaging (MRI) attenuating to the 19 fluorine nucleus. 19-fluorine has a sensitivity comparable to 1-hydrogen (proton) and is the only natural isotope. Additionally a perfluorocarbon taken neat and orally can be tracked by the absence of a signal using conventional proton MRI as it contains no hydrogen itself.

Typical compounds Ultra sound - Octafluoropropane, Perfluorobutane. MRI - Perfluorodecalin

Further Reading: H Carmichael, Chem in Britain, Aug 1998, 30-33. B Cotter et al, in "Ultrasound Contrast Agents" ed. B Soldberg 1997 (ISBN 1-85317-283-9( p31 - 42)

Liquid Ventilation
There are two modes of liquid ventilation.
Partial Liquid ventilation, (PLV - also known as perfluorocarbon assisted gas exchange or PAGE). Liquid is added to the lungs up to the Functional residual capacity (FRC - the total volume of the lung minus the normal breathing volume) and breathing is performed normally with gas ventilation.

Tidal Liquid Ventilation, (TLV, also known as total liquid ventilation) in which the lung is filled at each breath with oxygenated perfluorocarbon. This requires very precise volumes of liquid to be administered at each breath.

Liquid ventilation with perfluorocarbons has a number of potential benefits including:

• Increased compliance (more flexibility in the lung material)
• Reduced inflation pressure; as the liquid is not compressible is will evenly spread into the whole lung. This will reduce barotrauma (lung injury due to high pressure).
• Removal of pulmonary debris. TLV washes away any foreign matter from the lungs.
• Promotion of surfactant production
• Anti-inflammatory effect

Liquid ventilation has been used in conjunction with extra-corporeal membrane oxygenation (ECMO), whereby blood is taken from the body, oxygenated by a machine, and returned to the body.

Liquid ventilation has been used in conjunction with ECMO for preterm babies suffering from a condition called cogenital diaphragmatic hernia, where the diaphragm between the upper body cavity and the lower isn't properly formed, allowing the internal organs to 'over flow' into the upper cavity, which is the space that the lungs use for inflation. Perfluorocarbon will gently inflate the lungs, pushing the distended organs into the lower cavity.

Perfluorocarbons can also be used to clean debris out of lungs. Foreign matter tends to float on the dense liquid and is therefore readily removed. This has been demonstrated in the removal of charcoal and aspirated vomit.

Typical Compound: Perfluorodecalin

TH Schaffer at al, Cells, Blood Subs, and Immob. Biotech, 1994, 22, 315-26
CA Cox et al Neonatal Netw. 1996 15 31-43
Liquid ventilation in Adults, Children and full-term neonates, Ronald B Hirschel, Thomas Pranikoff, Paul Guuager, Robert J Schreiner, Ronald Dechert, Robert H Bartlett

Organ Storage / Islet Transplantation
Oxygenated Perfluorodecalin is used in a number of organ preservation methods. The oxygenated fluid extends the life of the preserved organs.

In particular the two layer method (TLM) has been developed to increase storage time after harvesting and increase yield of pancreatic islet cells, which have then been successfully transplanted to alleviate class 1 diabetes.

Typical Compound: Perfluorodecalin

OTHER APPLICATIONS
Drug delivery systems, perfusion of organs, treatment of carbon monoxide poisoning, cryoablation, prevention of post surgical adhesions.