EP4061268A1 - Appliance for producing local hyperthermia - Google Patents
Appliance for producing local hyperthermiaInfo
- Publication number
- EP4061268A1 EP4061268A1 EP20810910.8A EP20810910A EP4061268A1 EP 4061268 A1 EP4061268 A1 EP 4061268A1 EP 20810910 A EP20810910 A EP 20810910A EP 4061268 A1 EP4061268 A1 EP 4061268A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- temperature
- cell region
- control unit
- electrode
- local
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00452—Skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
- A61B2018/00803—Temperature with temperature prediction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00994—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1495—Electrodes being detachable from a support structure
Definitions
- the invention relates to a device for changing a cell region on or below the body surface or the hair of a human or animal body by generating a local, in particular pulsed local hyperthermia in this cell region.
- the invention also discloses a method for producing local hyperthermia on a human or animal body with a device.
- Varicose veins nails in the feet, cuts, burns, presbyopia, hair loss, hemorrhoids, muscle pain, osteoarthritis in the fingers, stitches, grains or acute pain in the knees and joints often have a different cause, but have a similar negative impact on people.
- ⁇ Melasma, also known as hormone patches, and pigment disorders are treated and removed using laser light, for example. Reddish veins can hardly be removed permanently from the eyes with any other method.
- adjuvant alternative forms of therapy have been developed in recent years.
- radioactively labeled monoclonal antibodies that are directed against specific epitopes are used for radioimmunotherapy.
- Other immunotherapy methods use bispecific antibodies that induce the formation of an immune complex from tumor cells, T lymphocytes and antigen-presenting cells.
- gene therapy approaches including interleukin 2 (IL 2) or colony-stimulating factors (GM-CSF) are described.
- IL 2 interleukin 2
- GM-CSF colony-stimulating factors
- palliative therapy options such as interstitial laser phototherapy (ILP) or MR-controlled laser-induced thermal therapy (LITT).
- ILP interstitial laser phototherapy
- LITT laser-induced thermal therapy
- the energy of the laser light is directed via a glass fiber and can then be applied repeatedly and directly intratumorally without extensive surgical intervention, minimally invasive.
- a basic idea of the present invention is the idea of working with very specific application of heat in the form of local hyperthermia.
- it is possible to carry out localized destruction of the degenerated tissue by means of heat coagulation, without radiation exposure and without systemic toxicity, or to achieve activation of the cellular tissue in such a way that the goal of cell change occurs.
- it is a regeneration system for activating damaged cells.
- a device in which a regulated and specific local hyperthermia is generated, as a result of which cells or tissue are activated without irreversible cell death.
- the cell is, so to speak, thermally brought into a very specific temperature range or thermally pulsed and preferably activated by mechanical vibration (to generate thermal effects) so that the desired effect occurs depending on the hyperthermia profile set.
- the device must be able to treat the particular types of tissue differently. In this way, fatty tissue is heated, unlike muscle tissue or other tissue, which is implemented by suitable means in the device according to the invention for achieving a specific temperature band and temperature profile.
- the following devices have proven to be particularly effective: Device for generating a specific temperature range:
- a regulating and control device which, depending on a specified depth profile, the tissue type and other factors, at a certain depth ( Target depth) generates a temperature in a certain temperature range.
- a specific control for achieving a febrile temperature hyperthomy is advantageous in which the tissue is kept within the temperature range between 37 ° C and 44 ° C and the coagulation process of protein is prevented or monitored. From approx. 43 ° C - 44 ° C, enzymes stop working. However, if only a local area of tissue is heated, the harmful effects for the entire organism do not occur, as in the case of a fever, but rather repair effects are controlled in a targeted manner. As soon as the temperature is reduced below about 42 °, the enzymes become active again.
- the control is therefore designed so that this temperature band is specifically implemented in a certain tissue depth, the Temperaturgeophl le is always selected in all surrounding cell layers so that the maximum temperature of the temperature band is not or only in a predetermined temperature range of z. B. 3 ° C is exceeded. It is also conceivable to set up a hyperthermia profile in such a way that local cell damage occurs, which is recognized in the surrounding cells, for example by T cells, and leads to local adoption of diseased cells. For this purpose, a temperature range of approx. 55 ° C to 60 ° C is preferably used, which is guided with a defined tolerance range of approx. 3 - 5 ° C and is regulated by the controller. A temperature of an upper tissue region, such as e.g. B. the skin surface
- a sensor and a measuring device are provided that either immediately detects the tissue type when the sensor is brought to this tissue area or, after manual input of the tissue type based on a reference measurement, carries out a plausibility check as to whether the detected tissue with the Correlated data entry.
- a device for changing a cell region on or below the body surface or the hair of a human or animal body by generating a specific local hyperthermia in this cell region comprises at least one device for generating thermal energy that can be arranged or fastened to the body surface, preferably designed with an electrode and a control unit, more preferably with a control unit in order to regulate the hyperterhmia also on the basis of recorded control variables Energy has a contact area for changing a cell structure in the cell region. Furthermore, a sensor is provided which is designed to determine the local temperature or a local temperature change in the cell region of the body to be changed.
- the control Approximation unit for generating a specific temperature profile by means of the electrode or the thermal contact area namely to achieve a temperature and / or the temperature change and / or a temperature profile of the cell region.
- control device is regulated within a hysteresis so that the thermal energy input is reduced or interrupted from a defined temperature range before the target temperature is reached in order to avoid overheating outside the tolerance range of the permissible temperature.
- a sonotrode or a vibrator is also provided in order to generate vibration or vibration excitation of the tissue or of vibratable substances stored in the tissue in that area for generating local hyperthermia. It is also advantageous if at least one or a plurality of the electrodes (7) are formed integrally with a sonotrode or a vibration element for generating a vibration, preferably for generating a vibration with an excitation frequency between 30 and 50 kHz.
- a device for use in a cosmetic treatment on a human or animal body or alternatively for use in a medical or therapeutic treatment on a human or animal body in particular for the treatment of one of the diseases mentioned below, namely a skin disease or a Joint disease, a bone disease, rheumatism, arthritis, osteoarthritis, diabetes or osteoperosis. Investigations into mechanisms of action have shown that the device can also be used successfully in the treatment of the following diseases:
- Pimples veins in the face and eyes, (visually unsightly) skin veins, varicose veins, dark circles, warts, weight loss (e.g. by reducing fat deposits), hair loss, torn muscle fibers (can be seen optically in the calf e.g.), psoriasis, smell of sweat, nausea, dizziness, Quistening, physical and mental fitness and relaxation, glandular function such as dry eyes, pancreatic function (e.g. insulin), liver function (e.g. detoxification of alcohol), lung function (e.g.
- asthma, COPD libido, infertility, kidneys and other glandular functions
- degenerative diseases such as osteoarthritis, osteoporosis and other degenerative diseases
- inflammations such as arthritis, rheumatism, tooth and gum inflammation, inflammation of the limbs and joints, swelling and other inflammations
- infectious diseases such as flu, colds, sore throats, tick bites, other viral and bacterial infections
- trauma such as bruises , Neuralgia, paralysis (e.g. paraplegia), torn muscle fibers, bone fissures and b smells (e.g. B. after operations) and other trauma
- wound healing such as open wounds, healing wounds (e.g.
- the advantage of the device for generating thermal energy that can be arranged or fastened to the body surface is that it can be positioned in the immediate or indirect vicinity of the cell region on the body surface. As a result, the effects of local hyperthermia for changing a cell region on or below the body surface or the hair of a human or animal body are limited to the smallest possible area of the body.
- the contact area for changing a cell structure in the cell region transfers the energy to the body and enables the device to be precisely positioned on the body.
- the local temperature or a local temperature change of the cell region of the body to be changed can be continuously determined.
- the control unit can generate a specific temperature profile by means of the electrode or the thermal contact area, which is specifically adapted to a particular application. In this way, a temperature and / or a temperature change and / or a temperature profile of the cell region are achieved. This stimulates cell renewal processes or a change in cell growth in the corresponding cell region.
- the device can be used in the treatment of benign or malignant skin changes and wounds that are difficult to heal. Various studies have advantageously found that the device is equally suitable for use in the cosmetic treatment of skin spots, warts or osteoarthritis in an arm and a knee. The underlying mechanism of reactivation is the same. Furthermore, the hair color can be changed from light or gray-white to dark or black. In addition, by using the device, the skin or the muscles in the face can be tightened and muscle injuries and muscle diseases can also be treated.
- the thermal contact area is designed to locally change the cell structure of a cell region which is arranged at a certain depth on or below a surface of the body.
- the device generates local hyperthermia below the surface by means of the contact area, although it is only arranged on the surface of the body. This avoids surgical intervention, such as penetration into the body or cutting open of the body.
- the sensor preferably has a sensor reference point for detecting the current local temperature on the body surface immediately above the cell region.
- the control unit is designed to perform a calculation of the temperature or the temperature change and / or the temperature profile of the cell region from the local temperature and from the specific change in the local temperature over time. The advantage of this is that the temperature of the cell region can be determined indirectly using the local temperature determined by the sensor at the sensor reference point, although it cannot be measured directly.
- corresponding correlation functions are stored in the control unit, which determine the relationship between the measured temperature change at the electrode or the sensor reference point and a selected cell type (epidermis, dermis, hair, joint substance, cartilage, etc.) and the temperature is controlled via the correlation functions.
- the control of the device or the electrode for generating the local hyperthermia in the predetermined cell region is adapted to a predetermined application for a predetermined cell type.
- the device or the electrode generates a local temperature on the surface, which indirectly effects the desired temperature or the temperature change and / or the temperature profile of the cell region.
- an embodiment is favorable in which a color tone sensor or a device for color contrast detection is provided in the cell region.
- the corresponding correlation function is selected by the control unit on the basis of the value determined by the color tone sensor or the device for color contrast detection.
- the color tone or the color contrast on the surface of the body can be determined. Due to the stimulation of the cell renewal processes or the Cell growth change in the corresponding cell region results in a change in the color tone or the color contrast on the cell region of the body surface or the hair. For example, dark-colored areas of the cell region of the body surface become lighter or light or white hair becomes darker.
- the correlation function a targeted change in the color tone or the color contrast in the cell region of the surface of the body or of the hair is possible even when the device is used again.
- control unit controls the thermal contact area with a series of predetermined heat pulses.
- the heat pulses are determined using a temperature profile corresponding to the correlation function.
- the interval between two heat impulses, the intensity, the temperature and / or the duration of the heat impulse or the resulting local hyperthermia in the cell region is determined accordingly.
- a combination of a short-term treatment cycle or a micro cycle with a long-term treatment cycle or a macro cycle is also advantageous.
- Acyclic profiles with temperature profiles that include long heat pulses between 36 and 45 ° C with a long pulse duration of one to several seconds, which last over a longer period of time or have a high number of repetitions, preferably 11 to 300 are particularly suitable for a micro cycle Repetitions.
- the temperature profile shows short heat pulses of 80 - 100 ° C for a pulse duration of microseconds to 1 second, which last for a short time or a small number of repetitions. genes than the long heat pulses, preferably 1 to 10 repetitions.
- Favorable macrocycles involve a course of treatment lasting several weeks. During this time, the micro-cycle is applied in accordance with a predetermined interval.
- the following table shows an example of a micro cycle and a macro cycle:
- the device according to the invention is designed in such a way that the device or the electrode can be selected from a set of devices or electrodes adapted to the cell region or hair section to be treated.
- the device can be replaced variably and optimally adapted to the respective application.
- the electrode is piston-shaped, preferably in the shape of a soldering iron, and the control unit controls the thermal contact area with a predetermined heat pulse.
- the shape of the iron or the soldering iron enables one Contact area that can be precisely positioned on the surface of the body. As a result, the generation of local hyperthermia in this cell region is optimally adapted to the respective application.
- the at least one electrode is integrated in a cuff.
- a cuff can be placed around the surface of the body and a correspondingly designed cuff can be fixed to the body with a force fit. This prevents the cuff from slipping on the surface of the body during use.
- a cuff is particularly suitable for use on arms,
- the at least one electrode is integrated in a glove. It is advantageous here that the glove offers two different possible uses. If the device or the electrode or a plurality of electrodes are arranged on an inside or facing inwards, the device is used on a cell region in the area of the wearer's hand. If the device or the electrode or several electrodes are arranged on an outside or facing outwards, the wearer can carry out the application at a desired position by putting on the glove.
- each of the at least one electrode can be controlled individually by the control unit. It is advantageous that the application on the surface of the body is fixed to a predetermined cell region and the control unit only controls electrodes which have an effect on the predetermined cell region. In addition, several electrodes can be controlled simultaneously and with different heat pulses. In this way, parallel applications can be implemented on different cell regions.
- the control unit has an interface for a remote control for regulating the electrodes, whereby the electrodes can be controlled individually, for example from a mobile terminal.
- a method for producing local hyperthermia on a human or animal body with a device comprises the following steps: a. Defining a position of the cell region or hair part to be treated at which the local hyperthermia is to be generated on the human or animal body, b. Selection of an electrode designed accordingly for the cell region, c. Selecting the heat pulse or temperature profile predetermined for the portion of the cell region and the electrode on the basis of the correlation functions of the control unit, d. Generating the local hyperthermia at the position by means of the electrode and regulating the predetermined heat pulse by means of the control unit, e. Repeating step d) corresponding to a predetermined number of repetitions.
- the boundary conditions for the use of the device are established on the basis of the specific position of the cell region or hair section to be treated, at which the local hyperthermia is to be generated on the human or animal body.
- the device can be configured according to the application and a suitable electrode can be selected or all components can be adapted as best as possible to this application.
- the boundary conditions of the application also enable a predetermined heat pulse to be selected based on the correlation functions of the control unit, which stimulates cell renewal processes or a change in cell growth in the corresponding cell region in such a way that a desired result occurs after the application of the method or the device.
- the predetermined heat pulse or the temperature profile of the hyperthermia is adjusted using the correlation functions of the control unit before the repetition of the generation of the local hyperthermia at the position.
- the boundary conditions for the generation of local hyperthermia of the specific cell region change and in this way the heat pulse or the temperature profile are adapted to the changed boundary conditions. This allows the desired result to be achieved or improved.
- Fig. 1 is a schematic view of a device for changing a cell region on or below the body surface or the hair of a human or animal body by generating local hyperthermia in this cell region
- FIG. 3 shows a graphic representation of a heat pulse or several successive heat pulses during the application of the method
- FIG. 1 shows a schematic view of a device 1 for changing a cell region Z below the body surface of a human body K by generating local hyperthermia in this cell region Z.
- the cell region Z is located in FIG. 1 in the area of an arm of the human body K and has a device 2, arranged on the body surface, for generating thermal energy with an electrode 7 and a control unit 3.
- the electrode 7 is specially adapted to the cell region Z to be treated and is designed in the shape of a soldering iron. Furthermore, the device 2 for
- the electrode 7 has a contact area 4, which is arranged at a longitudinal end area of the electrode 7 and contacts the body K.
- the cell region Z intended for the local change in the cell structure is arranged at a certain depth below a surface of the body K.
- FIG. 1 also shows the control unit 3, which controls the electrode 7 or the thermal contact area 4 accordingly in order to generate a specific temperature profile.
- a sensor 5 is provided which is used to determine the local temperature T L or a local temperature change DT Z of the cell region Z of the body K to be changed is trained.
- the sensor 5 has a sensor reference point for detecting the current local temperature T L on the body surface immediately above the cell region Z.
- the device 1 includes a color tone sensor 8 for color contrast detection 8 in the cell region Z.
- FIG Z of the cell region Z shown during the application of the method. The illustration shows the temperature profile over time of the local temperature T L and the temperature T z of the cell region Z.
- the control unit 3 generates a specific local temperature profile TP L by means of the electrode 7 or the thermal contact area 4. This temperature profile TP L is defined in such a way that a predetermined temperature profile TP Z of the cell region Z results therefrom.
- the predetermined temperature profile TP Z in FIG. 2 is a linear increase in the temperature T z of the cell during the time interval from t 1 to t 2.
- the control unit 3 is designed to use the local temperature T L and to calculate the temperature T z or the temperature profile TP Z from the specific change in the local temperature over time.
- correlation functions are stored in the control unit 3, which determine the relationship between the measured local temperature profile TP L at the electrode 7 or the sensor reference point and the selected cell region Z.
- the temperature T z is controlled via the correlation functions.
- FIG. 3 shows a graphic representation of a heat pulse H or several successive heat pulses H during the application of the method.
- the temperature profile TP Z is specified in accordance with a predetermined application and the heat pulses H are determined using one of the Correlation function corresponding temperature profile TPL. Accordingly, the control unit 3 controls the electrode 7 or the thermal contact area 4 with a series of predetermined heat pulses H. Furthermore, FIG. 3 shows the transition from a phase with long heat pulses during a micro cycle to a phase with short heat pulses at time t 1 and the subsequent transition from the phase with short heat pulses to a further phase with long heat pulses at time t 2.
- the short heat pulse phase ending at time ti has a heat pulse of temperature Ti (or 38 ° C).
- the heat impulses of the further phase with long heat impulses have a temperature T 2 (40 ° C.) which is higher than the temperature Ti.
- the short heat pulses last half a second and the long heat pulses one second.
- a very specific increase in the cell temperature T z (from 37.5 ° C. to 38.5 ° C.) can be observed.
- the profiles mentioned are exemplary and, depending on the treatment method or goal, can also be adapted to the corresponding task.
- a PWM control with a predetermined sensing ridge or a modulation level for the heat impulses is particularly suitable in each case. So can.
- the duty cycle (also duty cycle) indicates the ratio of the pulse duration to the period duration for a periodic sequence of heat pulses.
- the equivalent value of the temperature can be changed by suitable variation and design of the duty cycle.
- the underlying pulse width modulation is also a type of modulation for generating continuously adjustable temperature increases from an initial value to a target value and back.
- the signal-pause ratio enables local hyperthermia to be achieved without “burning” the skin or cells, similar to the protective effect of a sun protection cream, in which exposure to the sun of a certain intensity does not trigger sunburn.
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Otolaryngology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Plasma & Fusion (AREA)
- Physics & Mathematics (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
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Abstract
Description
Claims
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102019131115.2A DE102019131115A1 (en) | 2019-11-18 | 2019-11-18 | Device for generating local hyperthermia |
| PCT/EP2020/082544 WO2021099391A1 (en) | 2019-11-18 | 2020-11-18 | Appliance for producing local hyperthermia |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4061268A1 true EP4061268A1 (en) | 2022-09-28 |
Family
ID=73497747
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP20810910.8A Withdrawn EP4061268A1 (en) | 2019-11-18 | 2020-11-18 | Appliance for producing local hyperthermia |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4061268A1 (en) |
| DE (1) | DE102019131115A1 (en) |
| WO (1) | WO2021099391A1 (en) |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2588617A1 (en) * | 2004-12-10 | 2006-06-15 | Therative, Inc. | Devices and methods for treatment of skin conditions |
| WO2008101171A2 (en) * | 2007-02-16 | 2008-08-21 | Thermage, Inc. | Temperature sensing apparatus and methods for treatment devices used to deliver high frequency energy to tissue |
| US20160220834A1 (en) * | 2011-11-16 | 2016-08-04 | Btl Holdings Limited | Method and system for skin treatment |
| EP2802281B1 (en) * | 2012-07-09 | 2015-07-01 | Koninklijke Philips N.V. | Skin treatment method and apparatus |
| EP2967744B1 (en) * | 2013-03-14 | 2017-10-18 | Syneron Medical Ltd. | Skin treatment apparatus |
| TWI772314B (en) * | 2016-07-12 | 2022-08-01 | 德商得瑪法公司 | Device for hyperthermal treatment of pruritus |
-
2019
- 2019-11-18 DE DE102019131115.2A patent/DE102019131115A1/en not_active Withdrawn
-
2020
- 2020-11-18 EP EP20810910.8A patent/EP4061268A1/en not_active Withdrawn
- 2020-11-18 WO PCT/EP2020/082544 patent/WO2021099391A1/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| WO2021099391A1 (en) | 2021-05-27 |
| DE102019131115A1 (en) | 2021-05-20 |
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