RU2377029C2 - Apparatus for intraperitoneal application of ozone or ozonised oxygen containing liquid in human or animal body and method of application thereof - Google Patents

Abstract

FIELD: medicine. ^ SUBSTANCE: inventions refers to medicine, namely to oncology, and can be used in patients with tumours localised in abdominal cavity. It is ensured by intraperitoneal introduction of the liquid containing ozone or ozonised oxygen. Introduction is enabled with an apparatus comprising a reservoir filled with the liquid containing ozone or ozonised oxygen, and a device for liquid desuflation from abdominal cavity. Said liquid is introduced into abdominal cavity under pressure 20-60 mbar in such volume to ensure pressure in abdominal cavity not exceeding 20 mbar. Specified pressure is maintained during 5-30 minutes followed with monitored desuflation to restore normal pressure in abdominal cavity. ^ EFFECT: inventions allow improving efficiency of oxygen noci-influence on malignant neoplasms regardless of their localisation in abdominal cavity with decreasing such influence on the intact tissues. ^ 18 cl, 1 tbl, 2 dwg

Description

The present invention relates to a device (device) for intraperitoneal application of a fluid containing ozone or ozonized oxygen in accordance with the basic concept of claim 1 and the method of using this device in accordance with the basic concept of claim 7 and the basic concept of claim 10.

From WO 2005/097236 A1, a device for intraperitoneal application of an ozone or ozonized oxygen-containing liquid to a human or animal body is known, which, in particular, contains an accurate pressure gauge for recording insufflation pressure (injection pressure) and a device for dispensing fluid from a fluid reservoir at insufflation pressure 20-60 mbar. With this device, the abdominal cavity can be insufflated by ozone or ozonated oxygen, and the insufflation pressure acting on the precision gauge should preferably be 40 mbar. By means of an accurate pressure gauge, the pressure can be set precisely.

In accordance with WO 2005/097236 A1, the insufflation pressure applied to the precision pressure gauge is maintained at 40 mbar for an extended period of time, and the decrease in the insufflation pressure is indicated by the precision pressure gauge and again compensated by the fluid delivery device.

Using this method, although it is possible to use ozone or ozonated oxygen to suppress tumors in the abdominal cavity without causing side effects that are harmful to health, while ozone or ozonized oxygen is applied in the immediate vicinity of the tumor, the amount of ozone or ozonized to be applied at the same time oxygen is limited, since the insufflation pressure in the abdominal cavity should preferably be 40 mbar, but in no case should it exceed 60 mbar , Since otherwise the intra-abdominal pressure increases to the value of harmful health. Of course, from a medical point of view, it would be desirable to apply even more ozone or ozonated oxygen in order to treat a tumor, metastases, sarcomas or other neoplasms.

Based on this, the present invention is based on the task of creating a device of the type indicated at the beginning, with the help of which as much ozone or ozonized oxygen can be applied.

Moreover, the basis of this invention is the knowledge that after an absorption time of about 20 minutes, based on the rapid reactivity of ozone in the abdomen, it is the same that there is no more ozone or ozonated oxygen.

As a technical solution to this problem, in accordance with the invention, there is provided a device with the distinguishing features of claim 1 of the claims and the use of this device with the distinguishing features of claim 7 and the distinctive features of claim 10. Advantageous further improvements to this device and this application can be taken from the relevant claims.

The use of a device made according to the technical instructions of claim 7 of the claims has the advantage that, by controlling the intra-abdominal pressure, side effects that occur are eliminated. Another advantage arises from this, that the liquid can be applied over a longer period of time, so that ultimately more ozone enters the body.

Another quite significant advantage is that the fluid containing ozone or ozonized oxygen can now be introduced anywhere in the abdominal cavity by controlling the intra-abdominal pressure and it is no longer necessary to inject tumors or the like. Since the wall of the abdominal cavity is very much supplied with blood and since, according to the invention, fluid is present everywhere in the abdominal cavity, ozone or ozonized oxygen reaction products are absorbed by the blood and transported to all parts of the body. This gives a significant advantage that tumors, metastases, sarcomas, or other, in particular, malignant neoplasms that are located anywhere in the body, can be treated with ozone or ozonized oxygen.

In an advantageous further improvement, the intra-abdominal pressure as well as the insufflation pressure are measured with an accurate pressure gauge or recorded by a pressure sensor and compared with the ultimate pressure. If this pressure limit is exceeded, insufflation (injection) is interrupted. At the same time, it turned out to be beneficial to maintain intra-abdominal pressure no more than 20 mbar, and even better than 10 mbar. Only if intra-abdominal pressure drops below the limit value, insufflation continues.

Measurement of insufflation pressure and measurement of intra-abdominal pressure can be performed by a single accurate pressure gauge or by a single pressure gauge. While fluid is transported from the fluid reservoir through the hose to the abdominal cavity, insufflation pressure dominates the hose. If insufflation is interrupted or completed, intra-abdominal pressure dominates the hose. Therefore, only one accurate pressure gauge or one pressure gauge is needed, since it is only necessary to measure the pressure in the hose.

The device and the use of this device with the distinguishing features of claim 10 according to the technical direction of claim 1 of the invention have the advantage that the fluid can be desufflated (diverted) from the abdominal cavity in a targeted, controlled and, first of all, quickly. Since the patient’s pre-treatment condition, in particular intra-abdominal pressure, can quickly recover again, possible side effects are reduced to a minimum.

Another advantage is that due to the rapid restoration of normal intra-abdominal pressure, the body is ready to receive further insufflation. In animal experiments, it turned out that this process of desufflation and subsequent insufflation can be repeated many times. By renewed insufflation, the next portion of ozone or ozonized oxygen is transferred to the patient, so that the dose ultimately received in the body can be increased many times compared to the device known from the state of the art, which then accelerates tumor suppression. It has been found that this treatment is not a medical concern.

In other words, this means that using the present invention in a non-medically dangerous way, a very large amount of ozone or ozonized oxygen can be applied to the body, which then, through its reaction products, enters the blood through the abdominal cavity and suppresses tumors in all parts of the body .

After insufflation of fluid into the abdominal cavity, it turned out to be advantageous to maintain an insufflation pressure of preferably 40 mbar for a period of 5-30 minutes, preferably 15-20 minutes. Due to this, it is achieved that the ozone or ozonized oxygen in the liquid can be perceived by the body, so that the liquid extracted during desufflation contains only a little ozone or even does not contain ozone. Thus, with each insufflation, the maximum possible amount of ozone or ozone-containing oxygen is given, which is necessary to suppress tumors or the like.

In one preferred embodiment, 60-100 ml, preferably 80 ml, of ozonated oxygen per kilogram of body weight are applied for each insufflation. With multiple insufflation, therefore, this amount is introduced into the body many times. This has the advantage that the patient receives the optimum amount of ozone in order to be able to fight off a tumor or the like.

In another advantageous embodiment, the desufflation device includes a controllable valve. This has the advantage that the fluid can be controlledly desufflated from the abdominal cavity.

In yet another advantageous embodiment, the desufflation device includes a preferably metered vacuum pump. By means of this vacuum pump, on the one hand, desufflation can be accelerated and, on the other hand, it is much better to be dosed and controlled.

In one particularly advantageous embodiment, the desufflation apparatus includes a solid separator and / or a liquid separator. With the help of this, the liquid desufflated from the abdominal cavity is cleaned.

In another advantageous embodiment, the desufflation device includes a catalyst for catalyzing the remaining O ₃ in the liquid. Due to this, possibly the ozone remaining in the liquid is removed.

In yet another advantageous embodiment, the desufflation device includes a bacterial filter. With its help, it is possible that bacteria in the liquid are released.

Other advantages of the device in accordance with the invention and the application in accordance with the invention are obtained from the attached drawings and the following embodiments. Also, the above and the following distinctive features in accordance with the invention can be used, respectively, separately or in arbitrary combinations with each other. The mentioned forms of execution should not be understood as a complete enumeration, they are rather approximate. This is shown in the drawings:

figure 1 is a schematic representation of a first embodiment of a device in accordance with the invention;

figure 2 is a schematic representation of a second embodiment of a device in accordance with the invention.

Figure 1 shows a first embodiment of a device in accordance with the invention for intraperitoneal application of a liquid containing ozone or ozonized oxygen into a human or animal body with a liquid reservoir 1, a metering valve 2, a pressure sensor 9, a processing and control unit and a cannula (hollow needle) 3, and the hollow needle 3 is connected by a hose 4 to the metering valve 2 and the liquid reservoir 1. In the liquid reservoir 1, the liquid to be applied is stocked, which contains 2-10% by volume, mainly enno 5% by volume of ozone, and 98-90% by volume, preferably 95% by volume of oxygen. Between the hollow needle 3 and the pressure sensor 9, a T-branch of the hose 5 is provided, to which, in addition to the hose 6, a controllable desufflation valve 7 is connected, and the hose 6 behind the desufflation valve 7 has a hole in the environment 8.

For intraperitoneal insufflation of a fluid containing ozonated oxygen from the fluid reservoir 1, the metering valve is accordingly opened so that fluid through the hose 4 and the cannula 3 can be applied to the abdominal cavity. In this case, the insufflation pressure tends to approximately 40 mbar. The pressure sensor 9 in this case measures the pressure in the hose 4 and transmits the measured value of the effective pressure to the processing and control unit, where the measured pressure value is compared with the reference value.

During the application of fluid in the hose 4, insufflation pressure is applied and after completion or when the insufflation is interrupted, intra-abdominal pressure is applied in the hose 4. Both are constantly recorded by a pressure sensor. If the insufflation pressure exceeds a reference value of 40 mbar, then the metering valve 2 is automatically closed by the control unit.

Insufflation of fluid is performed in 10 intervals. Depending on the patient, only 5 or even up to 30 intervals can also be set. Between the intervals, a pause of 5-55 s, preferably 30 s, is provided. In such a pause, the pressure sensor 9 measures the intra-abdominal pressure in the hose 4. If it is above 10 mbar (in extreme cases also above 20 mbar), then insufflation is interrupted until the intra-abdominal pressure again falls below 10 mbar.

After a period of 15-20 minutes, the desufflation valve 7 opens, so that the liquid in the abdominal cavity through the cannula 3 and the hose 6 can be discharged into the environment. Once the fluid in the abdominal cavity has established approximately normal intra-abdominal pressure, the desufflation valve 7 closes again and a resumed insufflation process can begin. With each pass of insufflation, about 80 ml of ozonized oxygen per kg of patient’s body weight is applied. This process can be repeated many times, up to 30 times in the shortest possible time.

It turned out to be advantageous to lay a pause of about 3 minutes between desufflation and resumed insufflation.

In the second embodiment shown in FIG. 2, the device according to the invention for intraperitoneal application of ozone or ozonized oxygen-containing liquid into the body of a person or animal, except for the liquid reservoir 11, the metering valve 12, the hollow needle 13, the hose 14, the branching hose 15, the hose 16, a desufflation valve 17, a pressure sensor 19, and a processing and control unit, in addition, a solid and / or liquid separator 20 and a bacterial filter 21 are provided between the branching of the hose 15 and the desufflation valve 17. ledom desufflyatsii for the vacuum pump 17 is provided a valve 22 through which fluid may be actively discharged out of the abdominal cavity.

By means of a separator of solid and / or liquid 20, the desuffled liquid is purified, i.e. freed from solids and liquids. In the subsequent bacterial filter 21, possibly existing bacteria are removed, so that the liquid entering the vacuum pump 22 is very well cleaned. Behind the vacuum pump 22, a catalyst 23 is included, in which possible ozone residues are removed and deactivated. The vacuum pump 22 can be electronically controlled and controlled, so that the desufflation process can be selectively performed linearly, gradually or in partial steps.

Intraperitoneal insufflation of fluid is carried out similarly to the embodiment described for FIG. In this case, the metering valve 12 is opened in a controlled manner, so that the liquid in the fluid reservoir 11, on the basis of the excess pressure present there, through the hose 14 and the hollow needle 13 can enter the abdominal cavity. The desired insufflation pressure is set by the metering valve 12 and should be a maximum of 40 mbar. About 20 minutes after the end of insufflation, desufflation begins, since then the ozone or ozonized oxygen present in the liquid is absorbed by the body.

For desufflation, the desufflation valve 17 opens and the vacuum pump 22 is activated. Now the vacuum pump 22 draws in liquid from the abdominal cavity, the liquid through the hose 16 first entering the separator of the solid and / or liquid 20 and then sent to the bacterial filter 21, where the liquid is cleaned solids, liquids and bacteria. Further, the liquid is transported by a vacuum pump 22 to a catalyst 23, in which, possibly, the remaining ozone residues are deactivated.

So much fluid is aspirated from the abdominal cavity until the intra-abdominal pressure drops again to about its normal value before insufflation. In this case, desufflation is interrupted to measure intra-abdominal pressure, if desufflation is not already performed in partial steps. In this case, intra-abdominal pressure is measured between two partial steps.

Desufflation can be linear. In this case, the electronically controlled and electronically controlled vacuum pump 22 pumps out the liquid with a uniform supply power, therefore, linearly.

Alternatively, desufflation may also be carried out gradually. In this case, only part of the liquid is sucked out.

In another embodiment, desufflation may also be carried out in partial steps. In this case, the vacuum pump 22 is driven in up to 50 intervals, and the feed power of the vacuum pump 22 is constant in all interval steps.

In another embodiment, the vacuum pump 22 is also activated in intervals, however, the feed power becomes greater with each partial step.

List of legend in the drawings

one eleven Fluid reservoir 2 12 Metering valve 3 13 Cannula four fourteen Hose 5 fifteen Hose forks 6 16 Hose 7 17 Desufflation valve 8 Environmental hole 9 19 Pressure meter twenty Separator 21 Bacterial filter 22 Vacuum pump 23 Catalyst

Claims (18)

1. Device for intraperitoneal administration of a fluid containing ozone or ozonized oxygen with a fluid reservoir (1, 11) and with means for removing fluid from the fluid reservoir (1, 11) into the abdominal cavity, characterized in that it further comprises a device for desuffling fluid from abdominal cavity. 2. The device according to claim 1, characterized in that the device for desufflation includes a controlled valve desufflation (7, 17). 3. The device according to claim 1, characterized in that the device for desufflation includes an advantageously dosed vacuum pump (22). 4. The device according to claim 1, characterized in that the device for desufflation includes a separator of solids and / or liquids (20). 5. The device according to claim 1, characterized in that the device for desufflation includes a catalyst (23) for the catalytic action of O3 remaining in the liquid. 6. The device according to claim 1, characterized in that the device for desufflation includes a bacterial filter (21). 7. A method for intraperitoneal administration of a liquid containing ozone or ozonized oxygen, wherein the injection pressure is 20-60 mbar, characterized in that so much fluid is introduced that the intraperitoneal pressure does not exceed 20 mbar. 8. The method according to claim 7, characterized in that during the introduction of the specified fluid at predetermined intervals measure the intra-abdominal pressure and that the introduction of the specified fluid is continued only when the intra-abdominal pressure is less than 20 mbar. 9. The method according to any one of claims 7 or 8, characterized in that the introduction of the specified liquid is carried out in intervals, and between two intervals withstand a pause of 5-60 s. 10. A method of intraperitoneal injection of a fluid having ozone or ozonized oxygen, wherein the injection pressure of said liquid is 20-60 mbar, characterized in that the injection pressure of said liquid is maintained for 5-30 minutes, after which controlled desufflation is carried out until normal intraperitoneal pressure is restored and then again introducing the specified liquid. 11. The method according to claim 10, characterized in that the injection pressure of a liquid having ozone or ozonated oxygen is maintained for a period of 15-20 minutes. 12. The method according to one of paragraphs.10 or 11, characterized in that the fluid containing ozone or ozonated oxygen is successively injected into the abdominal cavity 10-15 times, and then desufflated again. 13. The method according to one of paragraphs.10 or 11, characterized in that each introduction of ozone or ozonized oxygen fluids is applied 80 ml of ozonized oxygen per kg of body weight. 14. The method according to one of paragraphs.10 or 11, characterized in that between the desufflation and the renewed introduction having ozone or ozonated oxygen, the liquid withstand a pause of 3 minutes 15. The method according to one of claims 10 or 11, characterized in that the liquid obtained by desufflation from the abdominal cavity is freed from solids and / or liquids. 16. The method according to one of claims 10 or 11, characterized in that the liquid obtained by desufflation from the abdominal cavity is freed from O3 residues, wherein O3 is deactivated. 17. The method according to one of paragraphs.10 or 11, characterized in that the desufflation is performed linearly, gradually or in partial steps. 18. The method according to one of claims 10 or 11, characterized in that a mixture of O2 and O3 is used as the liquid, the liquid having 5 vol.% O3.

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