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Title:
DEVICE FOR INFUSING OXYGENATED CHEMOTHERAPEUTIC SOLUTIONS
Document Type and Number:
WIPO Patent Application WO/2017/196278
Kind Code:
A1
Abstract:
The invention is about a device for measuring and dosing the oxygen concentration of chemotherapy solutions by positioning oxygen probes in the tumor bed where the tumor is intense in the patient's body in intraperitoneal chemotherapy (IP) and hyperthermic intraperitoneal chemotherapy (HIPEC) 0 treatments applied in many types of cancer.

Inventors:
ILHAN TOLGAY TUYAN (TR)
Application Number:
PCT/TR2017/050155
Publication Date:
November 16, 2017
Filing Date:
April 20, 2017
Export Citation:
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Assignee:
ILHAN TOLGAY TUYAN (TR)
International Classes:
A61M5/172; A61K31/00; A61K41/00
Domestic Patent References:
WO1994018954A11994-09-01
Foreign References:
US20120259152A12012-10-11
US5776898A1998-07-07
US20140335018A12014-11-13
Other References:
None
Attorney, Agent or Firm:
AKKAS, Ahmet (TR)
Download PDF:
Claims:
CLAIMS

A device for measuring oxygen concentration in abdominally administered cancer treatments and for varying the dosage of oxygen delivered characterized in that comprising at least one oxygen probe located at diaphragmatic areas, behind the intestine, around the mesenteries that provide blood flow to the intestines, bursa omentalis under the liver, douglas impenetrable regions, an oxygen source fragments, and a software unit.

The software unit of Claim 1 , characterized in that it is a unit capable of varying the amount of oxygen to increase or decrease with respect to the amount of oxygen taken from the oxygen probes, by controlling the openness of the valves at the outlet of the oxygen source.

A device operation method that enables measurement of oxygen concentration in abdominal cancer treatments and makes a change on given oxygen dosage, characterized in that comprising the following steps;

- Installation of probes and circulation hoses,

- Insertion of chemotherapy solution,

- Connecting probes to the device,

- Operation of the device,

- Detection of connected probes by the device and processing of oxygen concentration data from the probes via software,

- Display as numerical data (mm / hg or mmol / It or pmol / It) on the screen of the device,

- The target oxygen concentrations to be determined in clinical trials are entered into the system through the interface and the system primarily determines the oxygen concentration of the chemotherapy solution to be administered

- Oxygen / ozone delivery in the calculated amount from the internal or external oxygen source to the solution, Because the amount of oxygen dissolution will vary according to the temperature of the solution, the amount of oxygen that is initially lost is given to the solution,

The previous procedure is repeated as necessary to balance the target oxygen concentration at a maximum of ± 0.1 mm / hg, When the oxygen concentration in the solution reaches the required value, the pumping process into the patient's abdomen is started,

Since the oxygen concentration in the solution will decrease over time due to diffusion and consumption, increasing the solution flow rate or the oxygen concentration in the solution, if the oxygen concentration is low compared to the data from the probes in one minute intervals,

In the application process, the oxygen values obtained from each probe can be kept in memory and graphically displayed on demand.

Description:
DEVICE FOR INFUSING OXYGENATED CHEMOTHERAPEUTIC SOLUTIONS

TECHNICAL FIELD

The invention is about a device for measuring and dosing the oxygen concentration of chemotherapy solutions by positioning oxygen probes in the tumor bed where the tumor is intense in the patient's body in intraperitoneal chemotherapy (IP) and hyperthermic intraperitoneal chemotherapy (HIPEC) treatments applied in many types of cancer.

PRIOR ART

In current treatment methods, there is a pump system that pumps the chemotherapy solution to the body cavities and retracts it from the body. The chemotherapy solutions are pumped to the body by these pump systems at different temperatures and are retracted after a period of waiting or are kept in a continuously circulate. The solutions can be applied at 0.5L / min - 5L / min. In current applications, the oxygen concentration of the solution is not monitored and there no change is made in the oxygen ratio for therapeutic purposes. The present method is a pumping mechanism and devices for heating the chemotherapy solution. In the known art, there is no structure which allows the adjustment of the oxygen concentration in the chemotherapy application devices. This method can be used in intraperitoneal chemotherapy and HIPEC (Hyperthermic Intraoperative Intraperitoneal Chemotherapy) devices which do not have oxygen level adjustment.

BRIEF DESCRIPTION OF THE INVENTION

The received data from the oxygen concentration can be monitored on the system and adjustments can be made by supplying pressurized oxygen / ozone into the chemotherapy solution via the oxygen / ozone sources either in the device or externally connected to the device. The device is capable of monitoring the oxygen ratio of the solution, monitoring the rate of oxygen in and out of the patient, and adjusting the oxygen ratio of the solution given to the patient.

On the screen of the device, the data coming from the probes connected to the device which tracks the solution oxygen rates at different parts of the body can be monitored and solution flow rates can also be monitored and adjusted on the same screen.

DETAILED DESCRIPTION OF THE INVENTION

Chemotherapy is treatment using anticancer drugs to destroy cancer cells or to control the growth of these cells. Chemotherapy can be administered alone in cancer treatment or in conjunction with surgery and radiotherapy. HIPEC Chemotherapy (intravenous chemotherapy) or intraperitoneal chemotherapy (intra-abdominal chemotherapy (IP)) is a method used in the treatment of tumors originating from intra-abdominal organs, originating from abdominal organs and spreading into the abdomen and abdominal wall or starting from the abdominal wall.

Hot chemotherapy or intra-abdominal chemotherapy method is performed by general surgeons and gynecologists who have been trained or have completed their education, by applying heated or normal temperature chemotherapy drugs in the abdomen post-operatively or during the surgery.

Adding oxygen with our invention improves the sensitivities of existing tumor cells to chemotherapy, particularly in correcting the hypoxic environment in the tumor or tumor bed.

In our invention, at least one oxygen probe is positioned in the body of the patient to measure the concentration of oxygen in the liquid (partial oxygen pressure) in the region / tumor bed where the tumor is concentrated. The areas where these probes are planned to be placed primarily are the areas under the diaphragm, around the mesenteries located behind the intestines that provide blood flow to the intestines the anatomical points such as the bursa omentalis and the douglas dangers under the liver. The fields of application can vary according to the preference of the doctor. These areas are also where the flow rate of the chemotherapy solution is the least due to anatomical reasons. At the same time, oxygen concentration monitoring will ensure that the desired chemotherapy drug concentrations are reached in these regions as a secondary gain.

Another advantage of our invention is that the patient does not need additional incisions for positioning of the probes mentioned above and can be applied together with the catheters. Thus, the desired oxygen concentration in the tumor bed can be monitored instantaneously. The flexibility of the cables that provide the connection of the probes to the device allows the probes to be placed in the desired zones.

The target oxygen concentration for different points can be measured with different probes. If necessary, the number of connected probes can be increased and the oxygen concentration in each target can be monitored. The probes are placed to the areas under the diaphragm, around the mesenteries located behind the intestines that provide blood flow to the intestines the anatomical points such as the bursa omentalis and the douglas dangers under the liver. More probes can be placed to that areas by the doctor if the tumor bed is large and the necessary chemotherapy or oxygen flow cannot be achieved.

In oxygen concentration assessment, the solution is perceived by oxygen probes on the device or by probes positioned at the target site in the abdomen while the solution circulates between the body and the device and the desired changes are done on the oxygen / ozone concentration with the oxygen or ozone on the device or taken from an external oxygen source. Targeted solution - oxygen concentrations for different cancer types will be determined in clinical trials. The target oxygen concentration according to the patient's cancer type can be entered on the device through the interface of the software of the device (in mm / hg or pmol / I). In addition, thanks to the software on the device, the oxygen concentration can be changed automatically on the device side. Valves located at the outlet of the oxygen source can be controlled via software; the software can automatically change the amount of oxygen given to the body by controlling this valve's openness when it wants to increase or decrease the amount of oxygen according to the data received from the oxygen probes. The working method of the device which can measure the oxygen concentration in the intraperitoneal cancer treatments and make the change on the given oxygen dosage comprises the below steps;

- Installation of probes and circulation hoses,

- Insertion of chemotherapy solution,

- Connecting probes to the device,

- Operation of the device,

- Detection of connected probes by the device and processing of oxygen concentration data from the probes via software,

- Display as numerical data (mm / hg or mmol / It or pmol / It) on the screen of the device,

- The target oxygen concentrations to be determined in clinical trials are entered into the system through the interface and the system primarily determines the oxygen concentration of the chemotherapy solution to be administered

- Oxygen / ozone delivery in the calculated amount from the internal or external oxygen source to the solution,

- Because the amount of oxygen dissolution will vary according to the temperature of the solution, the amount of oxygen that is initially lost is given to the solution,

- The previous procedure is repeated as necessary to balance the target oxygen concentration at a maximum of ± 0.1 mm / hg,

- When the oxygen concentration in the solution reaches the required value, the pumping process into the patient's abdomen is started, - Since the oxygen concentration in the solution will decrease over time due to diffusion and consumption, increasing the solution flow rate or the oxygen concentration in the solution, if the oxygen concentration is low compared to the data from the probes in one minute intervals,

- In the application process, the oxygen values obtained from each probe can be kept in memory and graphically displayed on demand.

At this point, the amount of oxygen change in the targeted regions and indirectly the change in the amount of the drug can be followed. The device may also be used with devices capable of chemotherapy at normal temperature and with devices that perform heated chemotherapy. It is adaptable to existing devices. To do this a portable version of the device will be produced that includes the oxygen source, probes, and portions of the oxygen concentrations that can be monitored and exchanged, except for pump characteristics. The main purpose of this device is to provide an adjusted oxygen ratio solution to the existing system. The probes will be placed together with the catheters of the old systems and the oxygen concentrations will be monitored. The data will be processed and oxygen / ozone additions will be made in the necessary amounts in chemotherapy solutions applied with old devices. In addition, due to the oxygen concentration obtained from the placed probes, changes in the patient's position will allow solution flow in the desired regions.