WO2000032270A2

WO2000032270A2 - Hyperthermia installation

Info

Publication number: WO2000032270A2
Application number: PCT/DE1999/003772
Authority: WO
Inventors: Georg KÜNZEL; Reimar Laube; Andreas Niebergall; Klaus-Dieter SCHÜTTERLE; Leo Tetzlaff
Original assignee: Kuenzel Georg; Reimar Laube; Andreas Niebergall; Schuetterle Klaus Dieter; Leo Tetzlaff
Priority date: 1998-11-30
Filing date: 1999-11-29
Publication date: 2000-06-08
Also published as: DE19932580A1; DE19932580C2; WO2000032270A3

Abstract

The invention relates to a hyperthermia installation, preferably a thermo-chemotherapy device for the overheating treatment of tumors using infrared A radiation. The aim of the invention is to make additional synergistic effects for primary and secondary prophylaxis possible while using whole-body overheating and while incorporating additional therapy, treatment, monitoring and diagnostic elements. The inventive device is characterized in that it is configured as a device system (11) with a hyperthermia device (1) constructed as a central primary device, in that a chemotherapy infusiomat (7) and a hyperglycemia infusiomat (8) are directly assigned to said hyperthermia device (1), and in that it is comprised of the following additional devices: of an anesthesia device (6), of a cardiology monitoring device (9) for cardiovascular monitoring, of a cerebral monitoring device (10) for monitoring brain current and, as diagnostic additional devices, of a magnetic resonance tomography device (16) and of a positron emission tomography device (17).

Description

Hyperthermia facility,

5

The invention relates to a hyperthermia device, preferably a thermo-chemo-therapy device for overheating treatment of tumors by infrared A radiation.

10 A large number of facilities with different active principles are known for achieving local overheating in humans. In addition to electromagnetic fields, there are ultrasound waves. Infrared radiation etc. Forms of energy used.

15 For local thermal therapy by means of IR-A radiation sources, a hyperthermia device is known according to patent specification DE 9213404 UI, which allows local heating of surfaces and lower parts of the body of the human body by means of luminescent diodes which are in contact with the body. The luminescent diodes are flexible

20 insulating supports arranged very close together protrude slightly and can be electrically switched in groups. Since the entire facility is still relatively rigid. Their disadvantages are that a constant body temperature of 42.5 ° C cannot be achieved and that local overheating easily leads to symptoms of burns.

"

Other devices are known for whole body hypertermia with a desired body temperature of at least 39.5 ° C, due to which not only the damaging autotherm of the tumor tissue. but those Defense performance of the surrounding tissue and immune-competent cells is to be increased.

The device IRATHEM 2000 from the Ardenne Institute Dresden is known. Although this hyperthermia device is suitable for whole body overheating, the patient is not monitored here. Another disadvantage of this hyperthermia is that the infrared A radiators are arranged at an angle of 90 ° to the patient. This vertical radiation can result in local overheating of the tissue, which can lead to signs of burns. Another disadvantage is that the tensioning of the patient couch network has hitherto only been possible mechanically and with great effort.

The methods for treating tumors listed above are also known individually in connection with chemotherapy or anesthesia. There is already a variant of local hyperthermia treatment in connection with anesthesia. The disadvantage of these forms of treatment is the lack of cardiological and cerebral monitoring and the lack of infussiomats.

Hyperthermia treatments with hypergrykemia and chemotherapy are also known, including the sKMT (systemic cancer multi-step therapy) from v. Ardenne. However, these preclude the anesthesia application and thus the use of an anesthetic machine with the vital oximetric and capnometric control and monitoring.

In general, the known hyperthermic devices and overheating treatment methods of tumors have so far the disadvantage that the there is still no direct evidence of the expected therapeutic success after the end of treatment.

The object of the invention is therefore to develop a Hypertheπnie device in which using the whole body overheating with a body temperature of up to 42.5 ° C eliminates the disadvantageous effects of the known hypothermia devices and which includes further therapy, treatment and Monitoring and diagnostic elements enable additional synergy effects for primary and secondary prophylaxis while treating the patient gently.

According to the invention, the object is achieved in that the hyperthermia device, known to consist of a hyperthermia device for the overheating treatment of tumors, is constructed as a combination of therapy and diagnostic elements to form a device system for whole-body therapy. the hyperthermia device being the central basic device of the device system. The hyperthermia device according to the invention also consists of the central hyperthermia device, which is preferably constructed as a thermo-chemotherapy device. from an assigned chemotherapy infussiomat and a hyperglycemia infussiomat as well as an anesthesia machine for oximetry capnometry (0 ₂ ; C0 ₂ ) and anesthetic gas application. Furthermore, according to the invention, the hyperthermia device includes a cardiology monitoring device for cardiovascular control (ECG) and a cerebral monitoring device for brain current measurement (EEG) as additional therapy devices, as well as a magnetic resonance tomography device and a positron emission tomography device as diagnosis -Accessories assigned. The hyperthermia device according to the invention as a combination treatment and monitoring device system requires a method combination. which leads to a combination effect as a prerequisite for the primary and / or secondary prophylaxis of multi-effective chemotherapy with simultaneous reduction in cytostatics as well as patient and therapist-friendly use. In addition, the hyperthermia device is characterized in that the hyperthermia device is preferably designed as a thermo-chemo device and consists of a movable semicircular upper and lower part of the beam with infrared radiators arranged on all sides with radiation angles of 90 ° to 45 °. The infrared emitters are arranged at an angle of preferably 45 ° to the patient in order to achieve more gentle heating with the same effect.

Furthermore, the hyperthermia device has a retractable and extendable, tiltable and electromotively adjustable patient bed between the top and bottom of the radiator with a horizontally tensionable patient network by means of an electromotor. For this purpose, the hyperthermia device has an electromotive height adjustment for the bed and an electromotive adjustment and tensioning device for the bed network. For the purpose of radiation filtering and cooling, the infrared radiators are preferably flowed through with water and can be regulated individually in the upper and lower part in the leg, abdomen and chest area. The electromotive adjustment and voltage of the patient bed network make the work of the staff easier. during and after treatment, since the patient can be transported to and from the bed with a mobile bed before and after treatment. The anesthesia device is assigned to the hyperthermia device via the patient bed so that, depending on the patient's body temperature, the oximetry is in the range from 41 ° C to 42.5 ° C. Capnometry and thus the physiological gas exchange as well as the duration of anesthesia and the depth of anesthesia can be monitored and controlled in a network, which overall contributes to minimizing the side effects.

Likewise, according to the invention, the infussiomats chemotherapy and hyperglycemia are directly assigned to the hyperthermia device, so that the supply of chemotherapeutic agents and hyperglycemia-triggering infusions can be controlled in a network via the patient couch and depending on the body temperature of the patient.

Furthermore, the cardiology monitoring device arranged according to the invention within the device system and the cerebral monitoring device are likewise assigned to the hyperthermia device via the patient bed. About the measurement data of the cardiology monitoring device, in particular the EKG cardiovascular measurements and the control oximetry. Capnometry. as well as the measurement data of the cerebral monitoring device, in particular the EEG measurements and the control of anesthetic depth, oximetry. Capnometry, the radiation intensity of the hyperthermia device and the body temperature of the patient can be controlled.

The assignment according to the invention of all control and monitoring devices in the entire therapy device system is essential for successful prophylactic treatment in the micrometastasis area. According to the invention, the diagnostic devices assigned to the therapy system also serve this purpose; A magnetic resonance tomography device for treatment indications is preferably connected upstream of the hyperthermia device and a positron emission tomography device is connected downstream for monitoring the course of treatment and the course of the disease.

The connection of the central hyperthermia device with the individual devices of the device system is controlled according to the invention via a central computer, each device of the device system having a control sensor system for its special measurement data. According to the invention, each device is in connection with the hyperthermia device individually and / or in combination with the temperature, monitoring. Anesthesia and infusion sensors can be controlled depending on the type and duration of therapy as well as the patient's current diagnostic and therapeutic parameters.

According to the invention, the central computer is assigned a Thermo-Chemo sensor system, an anesthesia sensor system, an Infussiomat sensor system, a cardiology monitoring sensor system, a cerebral monitoring sensor system, and a signaling module and control module for infrared radiators.

The Thermo-Chemo sensor system, which is assigned to the central hyperthermia device. preferably consists of three infrared sensors for the patient's chest, abdomen and leg area, two temperature sensors for the patient's body temperature and an expansion sensor for possible additional functions. The anesthesia sensor system, which is assigned to the anesthesia device, preferably consists of the 0 ₂ sensor and the C0 ₂ sensor for oximetry capnometry, as well as the anesthetic sensor. preferably a Xenonaas sensor, for anesthesia Patient. According to the invention, the anesthesia sensor system is connected to the cardiology monitoring system and the cerebral monitoring system directly or via the central computer.

The Infussiomat sensor system, which is assigned to the Chemotherapy Infussiomat and the Hyperglycemia Infussiomat, consists of a quantity sensor chemotherapeutic agent and a quantity sensor glucose.

The computer-controlled device system according to the invention has advantageous medical effects due to the combination of therapy and diagnostic elements, since the synergy effects of the device system at the same time enable gentler treatment of the patient with a controllable positive course of the disease. The cardiology monitoring device enables constant heart monitoring so that problems that arise can be recognized immediately. Cerebral monitoring controls the depth of anesthesia, which means that the anesthetic can be dosed even more precisely. This part of the device also reduces the anesthetic burden. All patient and measurement data of the devices of the hyperthermia device system are measured, stored and controlled depending on each other via the central computer.

From a medical point of view, the advantages of the hyperthermia device system according to the invention, consisting of the hyperthermia device combined with hyperglycaemia and zvostatic infusion as well as further additional devices, relate to the following points:

- increasing the heat sensitivity of cancer cells,

- Accelerate the micro-circulation, the reaction speed

microchemical and microphysical cytological and histological processes,

- Increasing the gluco-oxidase level, which among other things leads to a reduction in the p-H value in carcinogenic tissue due to its energy and metabolism-specific properties,

- Increase in the overall physiological metabolism.

- Increasing the flow and passage speed of the cytotoxic noxae, - Proven multiple effectiveness increase of the cytostatics under the conditions of hyperthermic tissue.

The indicative selection of the patients for therapy and the proof of the therapeutic effect through the combination of diagnostic methods using magnetic resonance tomography before treatment and positron emission tomography after treatment enable a more specific influence on the course of the disease.

The invention can be explained in more detail below using an exemplary embodiment.

Show in the accompanying drawings;

Fig. 1: the hyperthermia device in longitudinal section - schematically, Fig. 2: the hyperthermia device in plan view - schematically. 3: the patient couch with hyperthermia device, FIG. 4: the patient couch with tensioning device, FIG. 5: the hyperthermia device system in the block. Fiε. 6: the control system in block circuit.

1 and 2, the hyperthermia device 1 as the central basic device of the entire device system 11 is shown schematically in longitudinal section and schematically in plan view.

The hyperthermia device 1 consists of a movable semicircular upper radiator part 2 and lower radiator part 3 with preferably flat groups of infrared A radiators 5 in the chest, abdomen and leg area of the patient. The radiators 5 are oriented at an inclination of 45 ° to the patient, so that the body is heated more gently and without the risk of local burns. The body heats up much more evenly. The infrared A radiators are also flooded with water for cooling and radiation filtering and individually adjustable in the upper and lower part in the leg, stomach and chest area.

Whole-body heating is carried out up to a body temperature of 42.5 ° C., but in connection with the entire device system 11, chemotherapy and hyperglycaemia in the patient takes place simultaneously via Infussiomats 7 and 8. Since the infusion tomatoes 7 and 8 are directly associated with the hyperthermia device 1, it is preferably designed as a thermo-chemo device. A mobile, tiltable and vertically adjustable patient couch 4 with patient couch net 14 can be extended and retracted between the upper and lower radiator parts 3 and 3 by means of the trolley 15.

The vertical adjustment of the patient bed 4 is carried out by an electromotive height adjustment 12; the patient couch 14 can be tensioned horizontally via an electromotive tensioning device 13. being the Servomotors are preferably arranged on the head and foot of the bed 4 (Fig. 3. Fig. 4). This makes it possible for the patient to be transported more easily from the mobile bed to the patient bed network 14 of the hyperthermia device 1 and back after the treatment without heavy physical strain on the operating personnel.

The anesthesia device 6 is assigned to the thermo-chemotherapy device 1, coupled with the infussiomats 7 and 8, via the patient bed 4. Depending on the achieved body temperature of the patient in the range 41 ° C ... 42.5 ° C, the depth and duration of anesthesia are controlled and monitored via temperature sensors in the patient and the sensor system anesthesia 19. Long-term anesthesia is preferably required for a treatment of approximately 5 to 6 hours. In addition, the gas exchange of the patient when xenon gas is preferably used and the oxymetry capnometry are monitored and controlled via the corresponding sensors, so that the patient has an optimal 0 ₂ -C0 ₂ balance.

The supply of chemotherapeutic and hyperglycemic-triggering infusions can be controlled simultaneously and depending on the body temperature of the patient and the further individual measurable and jointly controllable measurement data via the Sensoiik infussiomat 20.

A cardiological and EKG cardiovascular measurement and monitoring of the patient is carried out via a cardiology monitoring device 9, which is also connected to the hyperthermia device 1 via the patient bed 4 and the patient and to the anesthesia device 6. Likewise, a cerebral monitoring device 10 is assigned to the hyperthermia device 1 with the patient, so that ongoing EEG discharge and monitoring the patient's brainwaves. The radiation intensity of the infrared A radiators 5 can also be controlled in conjunction with the body temperature of the patient via the measurement data of the devices 9 and 10. With the entire hyperthermia device system 11 (FIG. 5) and the device arrangement according to the invention, it is possible to carry out the entire therapy in a secondary prophylactic manner in the micrometastasis range, ie in the early stage of the patient's illness.

A magnetic resonance tomography device MRT 16 for treatment indication and a positron emission tomography device PET 17 for demonstrating the treatment effect and the course of the disease are connected downstream of the hyperthermia device 1 as additional diagnostic devices.

All devices of the hyperthermia device system 11 can be controlled with the patient directly or indirectly via a control sensor system for all measurement data by the devices 6, 7, 8, 9, 10 which are connected to the hyperthermia device 1, each individually or via a special sensor system be controlled in a network.

Depending on the type of therapy and duration of therapy, as well as the patient's current diagnostic and therapeutic parameters, control is carried out by means of temperature, monitoring, anesthesia and infussiomatic sensors.

Fig. 6 shows the control system according to the invention in block circuit. The hyperthermia device system 11 according to the invention is connected to a central computer 23 via the control and real system. The central computer 23, a sensor system Thermo-Chemo 18, a sensor system anesthesia 19, a sensor system Infussiomat 20 as well as a sensor system cardiology monitor 21 and a sensor system cerebral monitor 22 are connected. A correspondingly set optical and / or acoustic signaling is carried out via a signaling module 24, which is also connected to the central computer 23, while monitoring all measurement data within specific limits.

The Thermo-Chemo 18 sensor system, which is preferably arranged on the hyperthermia device 1, consists of an infrared sensor for each of the infrared A radiators in the chest, abdomen and leg areas 18.1, 18.2, 18.3 and two temperature sensors 18.4 and 18.5 for patient temperature measurement. Based on the temperature measurement data, these individual devices can be controlled in a network via the additional sensors on the additional devices. An expansion sensor 18.6 is installed for any additional functions.

The sensory anesthesia 19 consists of a 0 ₂ sensor 19.1, a CCvSensor 19.2 and an anesthetic gas sensor 19.3, which monitor and control the oxygen-carbon dioxide balance of the patient during anesthesia and the application of the anesthetic, preferably xenon gas.

The Chemotherapy Infussiomat 7 and the Hyperglycemia Infussiomat 8 each have a quantity sensor chemotheiapeutics 20.1 and a quantity sensor glucose 20.2 for the precise and metered administration of these agents depending on the body temperature of the patient and the course of therapy. All measurement data of the individual sensor elements are given to a central computer 23, collected, stored and processed as signals for controlling the individual devices of the hyperthermia device system 11 in dependence on one another.

The anesthesia sensor system 19 is also directly connected to the cardiology monitoring sensor 21 and the cerebral monitoring sensor 22. Further design variants of the hyperthermia device system 11 are possible according to the invention in that further diagnostic and therapeutic devices are to be assigned for the continued completion.

The regulation of the infrared A radiator 5 takes place depending on the body temperature, type of therapy and duration of therapy by means of the control module 25, which is also connected to the central computer 23.

Increase in the reference numerals used

1 hyperthermia device (thermo-chemo device)

2 Upper part of the hyperthermia device 1

3 Lower part of the hyperthermia device 1 4 patient bed

5 infrared emitters

6 Anesthesia machine

7 Chemotherapy infussiomat

8 H perglycemia infussiomat 9 cardiology monitoring device

10 Cerebral monitoring device

11 Hyperthermia device system

12 height adjustment

13 tensioning device 14 patient bed net

15 chassis

16 magnetic resonance tomography device (MRT)

17 positron emission tomography (PET) device

18 Thermo-Chemo 1 .1 infrared sensor, chest area

18.2 Abdominal infrared sensor

18.3 Infrared sensor leg area

18.4 Temperature sensor 1 patient 18.5 Temperature sensor 2 patients

18.6 Extension sensor sensor system anesthesia 19.1 0 ₂ sensor 19.2 CO2 sensor

19.3 Anesthetic gas sensor (xenon gas) Infussiomat sensors

20.1 Amounts of sensor chemotherapy drugs

20.2 Quantities of sensor glucose sensors cardiology monitoring sensor technology cerebral monitoring central computer signaling module control module infrared radiator

Claims

claims

1. Hyperthermia device, consisting of a hyperthermia device with infrared lamps for the overheating treatment of tumors, characterized in that

- That it is constructed as a device system (11) for whole body therapy and the hyperthermia device (1) represents the central basic device of the device system (11) and - that it consists of a chemotherapy infussiomat (7) and a hyperglycemia infussiomat which are assigned to the hyperthermia device (1) (8) and an .anesthesia device (6), a cardiology monitoring device (9) for cardiovascular monitoring and a cerebral monitoring device (10) for brain current monitoring as therapy additional devices and from a magnetic Resonance tomography device (16) and a positron

Emission tomography device (17) exists as additional diagnostic devices.

2. Hyperthermia device according to claim 1, characterized in

- That the hyperthermia device (1) of the device system (11)

- is preferably designed as a thermo-chemo device,

- From a movable semicircular upper and lower radiator part (2, 3) with all-round arranged infrared radiators (5) with radiation angles from 90 ° to 45 ^c . preferably 45 °, and - From a between the upper and lower radiator part (2, 3) in and out

Ren, tiltable and electromotically veitikal adjustable patient couch (4) with horizontally electromotively stretchable patient couch (14).

3. Hyperthermia device according to one of claims 1 and 2, characterized.

- That the anesthesia device (6) on the patient bed (4) and the patient the Hjφerthermie device (1) is assigned so that depending on the body temperature of the patient reached in the range of 41 ° C ... 42.5 ° C the duration of the anesthetic, the depth of anesthesia as well as the oximetry-capometric balance and the gas exchange of the patient can be monitored and controlled together.

4. Hyperthenrue device according to one of claims 1 to 3, characterized in

- That the Infussiomat chemotherapy (7) and the Infussiomat hypergry kemia (8) are directly assigned to the hyperthermia device (1) and via the

Patient couch (4) and the patient depending on the reached body temperature of the patient, the supply of chemotherapeutic and hyperglycemic-triggering infusions can be controlled in the network.

5. Hyperthermia device according to one of claims 1 to 4, characterized.

- That the cardiology monitoring device (9) for cardiological and EKG Cardiovascular measurements and the cerebral monitoring device (10) for EEG measurements on the patient bed (4) and the patient are assigned to the hyperthermia device (1) in such a way that the radiation intensity of the Hyperthermia device (1) and thus the body temperature of the patient can be controlled in the network.

6. Hyperthermia device according to one of claims 1 to 5, characterized in that - the hyperthermia device (1) has a magnetic resonance tomography device MRI (16) connected upstream for treatment indication and a positon emission tomography device PET (17) for Treatment and disease course are downstream.

7. Hyperthermia egg seal according to claim 1 to 6, characterized in

- That the devices (6, 7, 8, 9, 10) of the device system (11) have a control sensor system for measurement data with the hyperthermia device (1) individually and / or in conjunction with the temperature, monitoring, anesthesia and Infussiomat sensors (18, 19, 20, 21, 22) can be controlled depending on the type and duration of therapy and the patient's current diagnostic and therapeutic parameters.

8. Hyperthermia device according to one of claims 1 to 7, characterized in

- That the hyperthermia device system (11) is connected via a control system with an central computer (23) and - That the central computer (23) a sensor technology Thermo-Chemo (18), a sensory anesthesia (19). a sensor system Infussiomat (20), a sensor system cardiology monitor (21), a sensor system cerebral monitor (22) and a signaling module (24) and control module infrared emitter (25) are connected.

9. Hyperthermia device according to one of claims 1 to 8, characterized in that - the sensor technology Thermo-Chemo (18) from infrared sensors (18.1, 18.2, 18.3) for the chest, abdomen and leg area, from temperature sensors 1 and 2 (18.4, 18.5) and consists of an expansion sensor (18.6) for additional functions.

10. Hyperthermia device according to one of claims 1 to 8, characterized in

- That the anesthetic sensor system (19) consists of a 0 ₂ sensor (19.1), C0 sensor (19.2) and anesthetic gas sensor (19.3).

11. Hyperthermia device according to one of claims 1 to 8, characterized in

- That the sensor system Infussiomat f20) consists of a λdengen sensor chemotherapeutic (20.1) and a quantity sensor glucose (20.2).

12. Hyperthermia device according to one of claims 1 to 11, characterized,

- That the sensor system anesthesia (19) with the sensory cadiology monitoring (21) and the sensor system cerebral monitoring (22) is connected directly or via the central computer (23).

13. Hyperthermia egg seal according to claim 2, characterized in that

- That the hyperthermia device (1) has an electromotive height adjustment (12) for the patient couch (4) and an electromotive tensioning device (13) for the patient couch (14).