Gas conditioning

Abstract

A compound for the manufacturing of a medicament for reducing or preventing mesothelial cell damage includes a mixture of a carrier gas and between 1 volume percent and 29 volume percent of nitrous oxide gas (N2O) and can be used for prevention of adhesion formation, pain reduction, reducing or preventing acute inflammation, reducing or preventing CO2 resorbtion or reducing tumor cell implantation upon surgery.

Description

FIELD OF THE INVENTION[0001]The present invention relates to products and systems for operation trauma prevention or reduction. More particularly, the present invention relates to compounds, e.g. for use as a pneumoperitoneum and / or gas for flowing over a body part during surgery, to systems controlling the use thereof and to methods of using such compounds or systems.BACKGROUND OF THE INVENTION[0002]In order to perform a laparoscopy the abdomen, which is a virtual cavity, has to be insufflated in order to create a working space. Insufflation pressure is limited to 15 mm of Hg out of fear of gas embolism , although this limit has not been substantiated clinically. CO2 has been traditionally used as a gas for the pneumoperitoneum out of safety concerns. Indeed CO2 has a high solubility in water and an high exchange capacity in the lungs. Therefore the risk of a gas embolism causing a hearth tamponnade should be minimal.[0003]During laparoscopic surgery some flow through the abdominal...

AI Technical Summary

Benefits of technology

[0055]The conditioning means furthermore may comprise any of a ROS scavenger providing means, a calcium channel blockers and phospholipids providing means, a dexamethasone providing means, a barrier gel providing means or a means for providing anti-angeiongic factors or fibroblast manipulation means. The present invention relates to a compound for use in surgery, the compound comprising a mixture of a carrier gas and between 1 volume percent and 29 volume percent nitrous oxide gas (N2O). It is an advantage of embodiments according to the present invention that addition of nitrous oxide gas results in the reduction of operative trauma. It is an advantage of at least some embodiments of the present invention that reduction of adhesion formation can be obtained. The compound may comprise between 5 and 29 volume percentage nitrous oxide gas, e.g. between 5 and 20 volume percentage nitrous oxide gas, e.g. between 5 and 10 volume percentage nitrous oxide gas. It is an advantage of embodiments according to the present invention that only a limited amount of nitrous oxide gas is required, as nitrous oxide gas carries a potential explosion risk when used in concentrations higher than 29%. Considering the risk of gas embolism nitrous oxide moreover is safe considering its high solubility comparable to CO2 in water (solubility of 1.5 and 1.45 g / l for N2O and CO2 respectively). It has been found that N2O concentration advantageously is at least 5 volume percentage as for concentrations lower than 5 volume percentage effects of adhesion prevention are less pronounced, e.g. using 3 volume percentage of N2O in the pneumoperitoneum resulted in about 70% effectiveness and using 1 volume percentage of N2O resulted in about 50% effectiveness. It is an advantage of embodiments according to the present invention that the use of a gas mixture comprising between 1% to 29% N2O results in adhesion prevention, pain reduction and other advantageous effects in the first days after surgery.

[0056]The compound furthermore may comprise between 1 and 10 volume percentage oxygen. It is an advantage of embodiments according to the present invention that also oxygen gas can be added to the gas mixture, as oxygen gas provides an additive effect in prevention or reduction of adhesion formation. Oxygen however has a very low solubility of 0.0391 g / l in water.

[0058]The compound may be a gas reducing or preventing adhesion formation.

[0060]The compound may have a carrier gas having a solubility larger than 0.5 g / l in water.

[0061]The compound may be a medicament or a basis therefore.

[0062]The present invention also relates to a controller for controlling a gas supply system, the controller being programmed for supplying a mixture of a carrier gas and between 1 volume percent and 29 volume percent nitrous oxide gas (N2O). The controller may be programmed for supplying the mixture with between 5 and 20 volume percentage nitrous oxide gas, more preferably between 5 and 10 volume percentage nitrous oxide gas. The controller may be programmed for initially providing a gas or gas mixture comprising the carrier gas but no nitrous oxide gas and for increasing the nitrous oxide gas concentration thereafter to supply the gas mixture. It is an advantage of embodiments according to the present invention that first a good soluble gas may be used for insufflation in order to prevent gas embolism, where after nitrous oxide gas can be introduced, either after a predetermined time or upon activation of the user of the system. The controller furthermore may be programmed for controlling the ratio nitrous oxide gas to carrier gas in the mixture. The controller furthermore may be programmed for controlling the ratio nitrous oxide gas to carrier gas in the mixture according to a predetermined dynamic ratio. The controller furthermore may be programmed for providing between 1 and 10 volume percentage oxygen gas. The controller furthermore may be adapted for controlling the temperature of the gas mixture. It is an advantage of embodiments of the present invention that temperature control can easily be taken into account, as temperature is a further factor that may assist in the prevention or reduction of adhesion formation. The controller furthermore may be adapted for in addition humidification of the gas mixture. It is an advantage of embodiments of the present invention that humidification control can easily be taken into account, as also humidification is a further factor that may assist in the prevention or reduction of adhesion formation.

Problems solved by technology

Especially the high flows used together with a CO2 laser, can induce important uncontrolled desiccation and temperature alterations in the abdominal cavity.

During open surgery, the abdominal content is directly exposed to the air with important desiccation and exposure of the superficial cells to 20% of oxygen, proven to be toxic for the mesothelial cell layer.

It is to be noticed that surgical interventions in the human occasionally may be very long interventions.

Adhesions following surgery are clinically important and cause suffering to the patients and a burden for the cost of health care.

Repeat surgery moreover is more difficult, more tedious and associated with more complications because of adhesions.

From these findings, models have been constructed indicating an enormous cost of adhesions formation for society besides the cost of suffering of the individuals.

Besides good surgical practice, adhesion prevention in the human has been limited to barriers and flotation agents with a reduction of adhesion formation that ranges for all products between 40% to 50%.

This can be explained by the high intra-individual variability, and the variability in surgical interventions which make adequate randomized clinical trials prohibitively large.

Sheet barriers such as Seprafilm (Hyaluronic acid-carboxymethylcellulose), Interceed (Oxidized regenerated cellulose) and Gore-tex(Expanded polytetrafluoroethylene) are proven effective but did not become very popular for various reasons.

A comparison between these 3 gels can unfortunately not be made since comparative trials do not exist.

The strength of the available evidence demonstrating efficacy, is in a Cochrane review not considered very solid.

In this model, dexamethasone further decreased adhesions, whereas anti-inflammatory agents (NSAID's, COX1, COX2 inhibitors) and anti-TNFa monoclonals were close to ineffective.

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