Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F7/02—Compresses or poultices for effecting heating or cooling
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F2007/0059—Heating or cooling appliances for medical or therapeutic treatment of the human body with an open fluid circuit

Definitions

• an object to be heated is a living body such as an animal or a human body, and the entire inside of the living body, such as an animal or a human body, in which the thermal conductivity changes by adjusting the temperature autonomously,
• the present invention relates to a body temperature control device that performs heating or temperature control well.
• hyperthermia has been used to treat cancer by applying high fever to the human body and heating the cancer cells.
• Types include local hyperthermia, which irradiates microwaves directly to cancer cells, and whole-body hyperthermia, which raises the entire body's body temperature. Because local hyperthermia has little effect on advanced metastases, systemic hyperthermia is being studied for advanced cancers. The goal is to increase the rectal temperature to about 42 ° C, which is a measure of overall body temperature.
• Systemic hyperthermia has a therapeutic effect even on advanced metastases with remarkable metastases, and is one of the treatments expected for many cancer patients.
• systemic response caused by increased body temperature expresses various cell growth factors ⁇ ⁇ heat shock proteins, not only in cancer treatment but also in viral diseases such as hepatitis C and AIDS.
• Therapeutic applications are also being studied.
• a heating device that raises the entire body temperature was used to put a human body in a bathtub filled with warm water.
• a warm water warming device that heats the human body by raising the temperature of warm water
• an extracorporeal circulation warming device that circulates blood outside the body to heat it and returns it to the body.
• an infrared heating method apparatus in which the whole body is laid on the bed and the surrounding area is the largest in the chamber, and a heating element that emits infrared rays such as black carbon, ceramic heaters, halogen heaters, etc. is adhered inside and heated.
• a far-infrared whole-body heater which uses a far-infrared heater as a heating element and raises the entire body temperature by radiating far-infrared rays, is used in clinical or research for cancer treatment. Has been used. Disclosure of the invention
• the human body autonomously releases or accumulates heat to the external environmental temperature by maintaining body temperature regulation such as sweating, breathing promotion, and vasodilatory exercise to maintain a constant core temperature.
• body temperature regulation such as sweating, breathing promotion, and vasodilatory exercise to maintain a constant core temperature.
• the temperature of the skin which is the surface, can be easily increased, but it has been extremely difficult to raise the temperature of the entire human body, particularly in the deep part, to 42 ° C.
• the extracorporeal circulation heating device which circulates blood outside the body and warms it, returns it to the body and raises the body temperature, was used more than ten years ago in Japan for the treatment of early whole body hyperthermia at Tokyo Women's Medical University. Was used in science. According to a survey conducted in 1990, out of 1667 cases, Mild improvement was about 40% and exacerbation was 21%. While it certainly raises body temperature and is effective in treating cancer, it involves a very large invasion of perfusing blood outside the body, which poses a significant physical burden on patients and the risk of infectious diseases, making it impossible to continue treatment. is there. There is a limit to its spread as a general therapy device.
• infrared heating devices have been studied.
• the bedding on which the human body lies is covered with a resin or metal housing, and a heating element such as a ceramic heater or a planar far-infrared heater is provided inside to heat the whole body. Since it is performed non-invasively, there is little risk of infection, and heat energy adjustment is easier and relatively safe than heating with hot water or extracorporeal circulation, so it is used in current clinical practice.
• therapeutic effects have been obtained even at temperatures above 40 ° C in combination with anticancer drugs, and treatment with relatively mild heating has been attempted.
• thermoregulatory function is suppressed by anesthesia, and the physician monitors the body temperature, heart rate, blood pressure, and other biological information at each site while responding to physical conditions at that time.
• the calorific value of the heating element is manually adjusted to increase the core body temperature.
• controlling and managing hyperthermia under anesthesia requires skilled medical techniques. Although mild, it applies so much heat energy that it raises the depth to 40 ° C, which can cause burns under the skin if used improperly.
• infrared heating devices are expected to be useful for dissemination of whole-body hyperthermia, they depend largely on the skills of physicians, and safer and easier methods of use have not yet been standardized. Means for solving the problem
• [10] Provide a bed to lie down on the human body or animals, seal the periphery with a resin material such as FRP so that only the head is exposed, and the entire area below the neck is covered.
• a fan to blow air to the head and the head is provided.
• a plurality of heating means such as planar far-infrared heaters and ceramic heaters are provided inside, and temperature sensors such as thermistors detect the skin temperature of the chest, abdomen, and groin and the deep temperature of the human body such as the rectum, esophagus, and eardrum. Then, the surface temperature of the heating means and the air temperature near the body surface are detected. At the same time, it detects biological information such as heart rate, blood pressure, blood oxygen concentration, and respiratory rate.
• the skin temperature and the deep temperature are determined by FFT processing of the analysis means to determine the frequency in the change of the skin temperature and the deep temperature, that is, the time required for one cycle, and the function of maintaining the homeostasis of the human body Define a specific cycle of autonomous thermoregulation.
• the temperature of the heating means is turned ON-OFF with the same cycle and phase as the skin temperature to create periodic fluctuations, and heating is started with the deep temperature as the target temperature.
• Heat generation means In the OFF phase, the internal heat is exhausted by a fan to lower the temperature aggressively to create more cycles.
• the heating cycle of the heating means is arbitrarily changed, and the FFT processing of the analysis means is used to transfer the cycle of skin temperature change and the cycle of deep temperature change.
• Determine the function determine the cycle in which the absolute value of the amplitude or gain in the transfer function is the maximum as the cycle in which the skin temperature and the deep temperature resonate, and generate heat so that it has the same cycle and the same or opposite phase as the resonance cycle Adjust the cycle of
• the amplitude of the period of the heating means that is, the surface temperature or phase is shifted or overlapped, and adjusted to be constant. If you want to reduce the amount of energy so that the body temperature does not rise too much, you can reduce the maximum temperature of the heating element, but on the contrary, the body temperature may drop too much. In that case, the period of the heat generating means is adjusted to a phase opposite to the resonance cycle in the transfer function or the cycle of skin temperature change. Or skin temperature cycle The heating cycle of the heating means is adjusted so that the phase is opposite to the above. If biological information such as heart rate, blood dissolved oxygen concentration, blood pressure, etc.
• the amplitude of the heating cycle of the heating means that is, the maximum temperature in the cycle, may be reduced. Rotates the exhaust fan to the maximum to remove hot air and blows air to the head to lower the permissible value of biological information.
• FIG. 1 is a diagram showing a connection according to the present invention.
• FIG. 2 is a diagram showing data when the present invention is not used.
• FIG. 3 is a diagram showing a flowchart of the present invention.
• FIG. 4 is a diagram showing an effect when the present invention is used.
• FIG. 5 is a diagram showing an effect when the present invention is used.
• Heating means 1 a to lb are provided on the bed that lays down the human body, and heat generating means 1 c to ld are provided on the lower side, and the surrounding area is surrounded by a chamber 7 made of a resin material such as FRP. If the bed is made of a fine mesh such as a lip, it is easy to transmit infrared rays from below.
• the heating means uses four far-infrared heaters with a rating of about 50,000 W made of carbon fiber in the form of a sheet, and the power is supplied through the control board 3 that supplies power and adjusts the amount of power to increase or decrease the heat energy.
• Connect to 8. Provide a guard on the heater surface to prevent direct contact.
• Fans 2a to 2e are provided on the outer wall of chamber 17, and a door through which the human body can enter and exit is provided.
• a fan 2 f that blows wind to the human head is provided, and fans 2 a to f are connected to a power source 8 through a control port 3.
• the number of fans and heating means may be increased or decreased.
• the skin temperature corresponding to the surface layer to be heated is the chest, abdomen, groin, and the deep part of the rectum, esophagus, and eardrum corresponding to the deep part of the human body.
• a temperature sensor 5a to 5e such as a thermistor is provided on the surface, and the temperature is measured by a temperature measuring device 4b which converts an electric signal of the sensor into temperature information.
• the fingertip is equipped with a heart rate sensor 6a for use with a pulse oximeter, etc.
• the arm is equipped with a blood pressure measuring means 6b such as an air pressure sensor to detect heart rate, blood oxygen concentration, blood pressure, etc. Measure these values with measuring means 4a.
• the temperature measurement device 4b and the biological information measurement device 4a are connected to the control port 3 equipped with a function capable of FFT (Fast Fourier Transform) analysis processing, and send the measured values.
• FFT Fast Fourier Transform
• the measured body temperature is taken into the control board 3 and subjected to FFT analysis to specify the cycle. Although it differs greatly depending on the individual and the environment, one standard is a period of several minutes on the surface and about ten minutes on the deep part.
• the FFT is a fast Fourier transform, a method that performs high-speed extraction of which frequency components are contained in a signal and was devised in 1965.
• the reciprocal of the frequency expressed in Hz is the time required for one cycle of a sine wave.
• heat transfer conditions in the body vary greatly depending on various environmental factors.
• the skin surface reacts sensitively to changes in the temperature of the environment, that is, the heat generating means, and radiates or accumulates heat inside the human body by vasomotion or perspiration, thereby keeping the temperature of the probe constant. Since the temperature of the core is slower than the skin temperature and is less likely to be dissipated, the autonomous body temperature control cycle tends to increase.
• the human body is regarded as one system, the cycle of skin temperature change is used as the input waveform, and the cycle of deep temperature change is used as the output waveform, and the transfer function for heat conduction in the body is determined.
• the transfer function is a function that indicates the relationship between the input and output of the signal transmission system, and expresses changes in amplitude and phase between input and output signals of the target transmission system with respect to frequency. .
• the surface temperature of the heating means is changed to heat. If multiple peaks of the absolute value of the amplitude or gain, that is, resonance peaks, appear in the transfer function, select a portion near the skin temperature change period and heat it. If the resonance frequency changes as heating is performed, the heating cycle is also changed following the cycle.
• the temperature cycle is arbitrarily changed, and the response time when the change of the cycle is shown in the cycle change of the skin temperature and when the change in the cycle is shown in the cycle change of the deep temperature are determined. You may choose something close to the time it takes.
• the core temperature reaches a predetermined temperature, adjust the cycle, amplitude and phase of the heating means to keep the temperature constant, taking into account the cycle and amplitude of each body temperature change.
• the heat of the heat generating means may be turned off.However, in some cases, the temperature may drop too much.In such a case, the heat of the heat generating means is maintained, and the period is controlled by the resonance of the transfer function. The phase is opposite to that of the frequency or skin temperature change.
• the amplitude of the heating cycle that is, the temperature of the heating means is increased.
• While heating or maintaining a constant temperature define a safe range where no strain is imposed on the human body, and if it exceeds the range, adjust by lowering the amplitude or blowing air to the head.
• the safe range is heated based on the standard that the heart rate is less than 150 beats per minute, the skin temperature is less than 43 ° C, and the blood pressure and blood oxygen saturation do not change from normal. Make detailed settings according to your physical condition.
• FIG. 2 shows actual data obtained by heating the human body without using the present invention with the target of the deep temperature set at 40 ° C.
• FIG. 3 is a flowchart of the present invention
• FIGS. 4 and 5 show data obtained by heating a human body using the present invention. Note that none of the anesthesia was used during the heating shown in Figs. 2, 4 and 5.
• the eardrum and rectum indicate the core temperature
• the chest indicates the skin temperature
• the set temperature in Fig. 2 indicates the surface temperature of the heating means
• the inside of the compartment indicates the inside temperature, that is, the air temperature near the human body.
• FIG. 2 which was heated without using the present invention, in the early stage of heating, an autonomous function of suppressing an increase in core body temperature by sweating and promotion of respiration works, and at the same time, blood flow increases by vasodilation. As a result, the ability to radiate heat to the outside of the body is increased, and the thermal conductivity inside the human body is reduced, and the rectal temperature corresponding to the core temperature does not increase. At this time, if the heating value or the surface temperature of the heating element is too high, the skin temperature becomes too high, which may cause burns. Therefore, the temperature of the heating element cannot be raised too rapidly.
• Fig. 4 showing the data using the present invention
• the heating means starts heating while arbitrarily and periodically fluctuating in accordance with the appropriate control cycle, and the skin temperature is maintained at 43 ° C or less, which is safe even though it is periodically fluctuated.
• Rectal temperature reached 39 ° C.
• the heart rate was less than 130 beats per minute with little burden on the cardiopulmonary function. After the heating was completed, the subject quickly recovered to a normal state.
• FIG. 5 shows data when the amplitude, that is, the surface temperature of the heating means in the heating cycle is further increased by using the present invention.
• the heating cycle of the heating means ON-OFF is adjusted at about 5 minutes, that is, about 3.3 mHz, and a temporary increase in heart rate is seen 30 minutes later. Therefore, the fan exhausts the hot air in the champ for 30 seconds, and then the heating cycle is about 2 minutes, that is, about 8.3 mHz until about 80 minutes later, and finally the rectal temperature is about The temperature reached 40 ° C.

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• Health & Medical Sciences (AREA)
• Vascular Medicine (AREA)
• Thermal Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Physics & Mathematics (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Thermotherapy And Cooling Therapy Devices (AREA)

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• 2003
  • 2003-12-24 JP JP2003436837A patent/JP2005185797A/ja active Pending
• 2004
  • 2004-12-13 WO PCT/JP2004/018959 patent/WO2005060886A1/ja active Application Filing
  • 2004-12-13 CN CNB2004800383751A patent/CN100355409C/zh not_active Expired - Fee Related

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