EP4096778A1

EP4096778A1 - Therapy device for irradiating a surface of tissue

Info

Publication number: EP4096778A1
Application number: EP20703030.5A
Authority: EP
Inventors: Seppe Vander Beken; Gerald Micko; Karl STORCK; Raphael MADER
Original assignee: Bredent Medical GmbH and Co KG
Current assignee: Bredent Medical GmbH and Co KG
Priority date: 2020-01-31
Filing date: 2020-01-31
Publication date: 2022-12-07
Also published as: WO2021151518A1

Abstract

The invention relates to a therapy device for irradiating a surface (20) of tissue, which therapy device comprises at least two LEDs (22, 26) for outputting electromagnetic radiation of various wavelengths for various types of phototherapy, wherein the LEDs (22, 26) can be controlled separately in terms of power and irradiation duration and have an emission characteristic such that they can emit in simple-polygonal exposure fields (40, 50) in a laterally delimited manner, wherein the exposure fields (40, 50) on the surface (20) of the tissue oriented at a distance from the device form a common irradiation area (52) so that, in a seamless multiple arrangement of simple-polygonal exposure fields (40, 50), the surface (20) of the tissue within the common irradiation area (52) can also be irradiated with location-resolved radiation with a homogeneous power distribution, above a therapy threshold indicated for the first and/or simultaneously for the second type of phototherapy, wherein the electromagnetic radiation, at least outside the device (2) onto the surface (20) of the tissue, is emitted in a substantially parallel beam path.

Description

Therapy device for irradiating a surface of a tissue

The invention relates to a therapy device for irradiating a surface of a tissue, in particular skin tissue or skin wounds.

The use of light sources for therapeutic purposes is known from the general prior art. An example of this is the use of a light source for antimicrobial photodynamic therapy, which is used in many different ways in the dental practice for the treatment of bacterial infections. Antimicrobial photodynamic therapy is used, among other things, to reduce periodontal pathogenic bacteria, so that a complementary treatment option has been created in periodontal therapy. This requires a light source that can perform a light-induced inactivation of cells, microorganisms, molecules or the like in a suitable wavelength range or with a suitable wavelength. The antimicrobial photodynamic therapy is carried out by converting ambient oxygen into reactive oxygen species by means of a photosensitizer, which effects the photochemical transfer of energy.

Outside of the dental field, however, the use for skin treatment in the presence of wound injuries is also known per se.

For example, EP 2440287 B1 discloses a device for photodynamic therapy and / or for killing or reducing microorganisms, containing an irradiation unit with at least one light source by means of which a photosensitizer applied to a wound area to be treated is activated by irradiation, furthermore containing a camera arranged in the irradiation unit for capturing images of the wound and a positioning device by means of which the Irradiation unit can be aligned to the wound area. It is proposed that the light source in the irradiation unit can be moved and positioned sequentially on at least two different irradiation positions of the wound area by means of a guide device and by means of a drive unit Corresponds to irradiation positions of the light source, and that the display is designed in such a way that the irradiation fields to be irradiated by means of the light sources can be marked with marking means in the display.

In addition to the antimicrobial photodynamic therapy, other therapeutic concepts are also known that are carried out under the action of a light source. An example is the regenerative photobiomodulation therapy, which can preferably be carried out in the red to near infrared range and creates an improved healing of wound tissue through an anti-inflammatory effect.

For other therapeutic or cosmetic purposes, irradiation devices with light sources that are aimed at a skin surface have also been used.

From DE102015226377 A1, for example, an irradiation unit for providing radiation pulses for irradiating a skin surface, in particular for epilation, is known, the irradiation unit having a light source unit which is designed to generate the radiation pulses with a predetermined pulse duration, with a predetermined radiation power and at a predetermined pulse interval provide, wherein the light source unit is further designed to provide an area with a predetermined size at a predetermined distance from the light source unit in to illuminate a main emission direction of the light source unit. The light source unit has at least one solid-state light source and the irradiation unit has a sensor unit and a control device in order to control the at least one solid-state light source.

From WO 2004/064923 A1 a device for the cosmetic improvement of a skin area affected by acne is known, in which light radiation is directed onto the skin by a lighting device. The device has a control unit which actuates one or more LEDs of the lighting device. During a time of at least 100ms, the skin receives light energy from the LEDs, which causes a photochemical reaction that stimulates the production of free radicals (singlet oxygen) that react with bacteria and at least partially deactivate or destroy them, which lead to the symptoms of the Contribute to the skin condition, with no photothermal reaction taking place in the skin. The duration of a single dose can last up to 10 hours, e.g. in the case of an overnight treatment.

A device for treating human keratinic materials, in particular the skin or hair, is known from FR 2940915 A1.

The device includes a carrier that carries a photocatalytic material and is configured to come into contact with the keratinic materials. Furthermore, a first light source is provided which is configured to illuminate the photocatalytic material in order to subject impurities present in contact with the material to a photocatalytic reaction, and a second light source is provided which is different from the first and is configured so that it emits light essentially in a range around a dominant wavelength and has a cosmetic or therapeutic effect on the treated keratinic materials. Devices in which a laser beam is guided in a scanning movement over a limited area on a skin surface are known, for example, from EP 1 418984 B1 or WO 2009/088550 A2. A hand-held device for use in phototherapeutic applications on human or animal tissue is known from US 2015/112411 A1, which has two LEDs that can emit the light at different angles in different wavelength ranges in order to be able to carry out different treatments superimposed on the skin surface.

Furthermore, US 2004/0111132 A1 shows a phototherapy device which contains several light sources, the device described in this document allowing both a selection of pixels and two light spectra. The device is placed directly on the surface of the skin.

In order to create the most diverse possible phototherapeutic applications in wound treatment, constant illumination of the surface to be treated with at the same time therapeutically effective or indicated power density is necessary. It should also be possible to combine different types of phototherapy.

It is therefore the object of the invention to create a therapy device for irradiating a surface of a tissue, in particular skin tissue, which enables simple adaptation to different types of therapy.

This object is achieved by the independent patent claim 1. Further advantageous refinements of the invention are each subject matter of the subclaims. These can be combined in a technologically meaningful way be combined. The description, in particular in connection with the drawing, additionally characterizes and specifies the invention.

According to the invention, a therapy device for irradiating a surface of tissue, in particular skin tissue or skin wounds, is specified, which has at least one first LED for emitting electromagnetic radiation with a first central wavelength in at least one first exposure field and at least one second LED for emitting electromagnetic radiation with a having a second central wavelength in at least one second exposure field, the first central wavelength being selected for performing a first type of phototherapy and the second central wavelength being selected for simultaneously performing a second type of phototherapy on the tissue, the at least one first LED and the at least one second LED being selected separately are controllable with regard to their power and irradiation duration as electrical operating variables and have an emission characteristic, so that the at least one first LED laterally delimited into the at least one first simply polygonal belic htungsfeld and the at least one second LED laterally limited radiate into the at least one second single polygonal exposure field, wherein the at least one first exposure field and the at least one second exposure field on the surface of the tissue aligned at a distance from the device form a common irradiation area, so that the The surface of the tissue within the single polygonal first and second exposure fields and within the common irradiation area above a therapy threshold indicated for the first and / or for the second type of phototherapy can be irradiated with a homogeneous power distribution, the emission of the electromagnetic radiation at least outside the device to the surface of the Tissue is carried out with a substantially parallel beam path. Accordingly, a therapy device is created in which the first central wavelength can carry out a first type of phototherapy and the second central wavelength is suitable for carrying out a second phototherapy as a second form of therapy. An exposure field is assigned to each first or second LED, so that surface irradiation on the

Surface of the skin tissue can be switched on individually for each of the exposure fields by means of the two central wavelengths. The first and second exposure fields form a common radiation area on the surface of the tissue, so that for each exposure field it can be selected whether the associated LED should be activated or not. The irradiation durations and power densities are selected in such a way that a threshold corresponding to the selection of the type of phototherapy can be reached for each exposure field in the event that the associated LED is activated. The therapy device according to the invention provides that a different number of first and second exposure fields can be selected, so that a different number of first and second LEDs can be provided for irradiating the common irradiation area. Accordingly, the therapy device according to the invention comprises both versions with only a first and a second LED and versions with several first and second LEDs that differ from one another in number and which, lying next to one another, cover the common irradiation area essentially without gaps. Each of the LEDs has an emission characteristic in the associated exposure field, in which the electromagnetic radiation leaves the device with an essentially parallel beam path. Thus, a central idea of the invention is to irradiate the common irradiation area not with diverging rays, but with an essentially parallel beam path, so that the power output on the surface of the tissue is independent of the distance between the device and the tissue, since a change in the distance at parallel beam path does not lead to any change in the irradiated area and the otherwise distance-dependent creation of gaps between or overlapping of the simple polygonal exposure fields in the common irradiation area can be avoided. This significantly simplifies the control of the therapy with regard to the determination of the delivered dose, since in particular no precise distance control has to be carried out. A plurality of first and / or a plurality of second LEDs can be provided for each exposure field. In general, the term “LED” is understood to mean both a single semiconductor component and a group of semiconductor components. To achieve the energy densities necessary for photodynamic therapy while being as homogeneous as possible

To be able to achieve emission characteristics, it may be necessary to provide several first LEDs for each first exposure field. Typical irradiation powers are in the range of 20 to 200 mW / cm ^2. For an irradiation time of, for example, a maximum of 5 minutes with a required energy density of 20 J / cm ² , the irradiation power is 67 mW / cm ² , which can be safely used, without the skin temperature rising significantly, not even when exposed to highly concentrated methylene blue-colored skin. Too high a power density and the associated increase in skin temperature represent a risk, especially in patients with poor blood circulation, which could possibly impair wound healing. The number and irradiation parameters of the second LEDs should be selected in such a way that, within the same irradiation time, the absorbed dose required for effectiveness can be maintained and cannot be exceeded or fallen below. Typical energy doses in photobiomodulation therapy range from 0.5 to 25 J / cm ² . The areal power of light is homogeneously distributed for the individual exposure fields, a so-called flat-top beam profile, where homogeneity can be defined, for example, as a point-by-point deviation of a maximum of 20% or preferably a maximum of 10% from the mean power density in the inner 80% surface area. The term "simply polygonal" becomes here understood geometrically as a demarcation to "overlap", so that the first or the second exposure field as a polygon without intersecting edge, that is, as an equilateral or equiangular polygon, which, for example, in the form of a triangle, rectangle, square or hexagon as well as generally irregular may be, wherein preferably a gapless stringing together of the exposure fields should be possible in order to be able to completely cover the irradiation area.

According to one embodiment of the invention, the first type of phototherapy is a regenerative photobiomodulation therapy or a photodynamic therapy and the second type of phototherapy is a further regenerative photobiomodulation therapy.

In a further embodiment of the invention, the central wavelength of the at least one second LED for the second type of phototherapy can be selected for the effective simultaneous implementation of both types of phototherapy outside the absorption spectrum of the photo-acceptor molecule or photosensitizer of the first type of phototherapy. Accordingly, both types of phototherapy can also be carried out simultaneously in the irradiation area.

For example, when used in wound treatment, the first central wavelength can be used to irradiate a wound area for disinfection that has previously been wetted on the surface of the tissue to be irradiated with a corresponding photosensitive active ingredient, for example thiazine dyes. The central wavelength of the first LEDs is selected in the activation area of the photosensitive material. The central wavelength of the second LED should be selected so that the light from the second LED can penetrate the photosensitizer. Thus, in those areas where both the first and the second central Wavelength hits the surface of the tissue to be irradiated, a photobiomodulation therapy of the wound bed takes place in addition to the superficial antimicrobial photodynamic therapy. A wavelength in the near-infrared range will be selected for the second LED, since photosensitizers that are frequently used do not absorb in this spectral range and this is suitable for photobiomodulation therapy. Outside of those wound areas that are presumably colonized by pathogenic germs and for which antimicrobial photodynamic therapy is indicated, only the second central wavelength can be activated via the second LEDs for better wound healing or tissue regeneration. In addition, it is even conceivable to also select the first central wavelength via the first LEDs, without using a photosensitizer, at irradiation parameters suitable for photobiomodulation therapy or to switch it on to support the second central wavelength. The two types of photobiomodulation therapy would be different in terms of their depth of penetration into the tissue and their biological / clinical effects on the tissue, so that, due to the different effects, we speak of two types of phototherapy. For example, in the first form of therapy, inflammation and pain can be treated, and with the second form of therapy, blood flow and tissue regeneration or wound healing can be stimulated. Therapeutic indications include non-neoplastic dermatological diseases such as acute and chronic wounds, ulcers, abscesses, blisters and burns, bacterial, viral and dermatophytic skin diseases, localized scleroderma and onychomycosis as well as dermato-oncological ones

Diseases such as actinic keratosis, Bowen's disease, in situ squamous cell carcinoma, and basal cell carcinoma.

According to a further embodiment of the invention, the therapy device has precisely one first exposure field and precisely a second ok

Exposure field formed, which preferably form a rectangular or square irradiation area.

In this embodiment, the outlines of the first exposure field, the second exposure field and the irradiation area fall into a single one

Outline together. The irradiation area can therefore be irradiated both simultaneously via the first LED with electromagnetic radiation of the first central wavelength and via the second LED with electromagnetic radiation of the second central wavelength, and one after the other first via the first LED with electromagnetic radiation of the first central wavelength and then via the second LED can be irradiated with electromagnetic radiation of the second central wavelength or vice versa. A typically rectangular or square irradiation area can be formed on the surface of the tissue, with other geometric shapes not being excluded. Since the electromagnetic radiation from both the first LED and the second LED hits the surface of the tissue essentially in parallel, variations in the energy density at the therapy site due to changing distances or tilting between the therapy device and the surface of the tissue are avoided. Accordingly, the therapy can be controlled in a simple manner, for example by specifying an irradiation duration. A homogeneous power distribution therefore takes place within the therapy device, which is brought into a square or rectangular shape, for example, with an overlay or color mixture of the different emitted wavelengths of electromagnetic radiation from the first LED and the second LED, so that a color mixture is then produced is present, which hits the therapy surface with little divergence in order to minimize the distance dependence of the performance. The color mixing and the shaping can be done divergent, it is only important that the given electromagnetic radiation takes place outside the device by means of minimally divergent radiation.

According to a further embodiment of the invention, the therapy device is designed for manual operation and has a housing with a transparent opening, the opening being formed with an outer dimension which essentially corresponds to the outer dimension of the irradiation area.

The variant with only a first and only a second exposure field is particularly suitable for a hand-held device, since the lower power consumption of a multiple arrangement with many LEDs means that it can be operated independently of the mains, for example with an accumulator. In this case, instead of a display or operating unit, only a representation of a timer can be present, which displays the remaining duration of therapy and, for example, by means of a membrane keyboard

Therapy setting can be operated, additional display units in the form of indicator LEDs are also conceivable. The therapy device has a portable housing and usually does not require any fan cooling. The housing can be designed to match a charging cradle with an optional inductive charging facility and be provided with a suitable interface for a holder to stabilize the device during use.

According to a further embodiment of the invention, a plurality of first exposure fields are designed in the form of a multiple arrangement, which preferably becomes a rectangular or a square one

Complete the irradiation area completely. Furthermore, a plurality of second exposure fields can also be formed in the multiple arrangement, which preferably complement each other seamlessly to form the rectangular or square irradiation area. The first exposure fields and the second exposure fields can be different Show total number. In particular, such a therapy device is designed for stationary operation and has a housing with a window attached to an adjustable holder, the window being formed with an outer dimension which essentially corresponds to the outer dimension of the irradiation area. The associated LEDs for each first

Exposure field and for every second exposure field can be activated individually.

The exposure fields are preferably designed as a two-dimensional arrangement, so that the surface of the tissue can optionally be irradiated with the different central wavelengths in a type of two-dimensional matrix. It is not absolutely necessary here to choose the number of rows or columns for each multiple arrangement of the first exposure fields to be exactly the same as that of that multiple arrangement of the second exposure fields. Thus, there can be areas on the surface of the skin tissue that are irradiated only by the first central wavelength, only by the second central wavelength, by both the first and second central wavelengths, or by none of the central wavelengths. This makes it possible to use different types of therapy in different areas. Thus there is a central idea of this

Further development of the invention consists in dividing a treatment area into a plurality of exposure fields so that the common irradiation area can be freely selected with regard to irradiation with the first or the second central wavelength.

According to a further embodiment of the invention, the therapy device has a preferably flat housing which is attached to an adjustable holder. Due to its compact design, the therapy device requires relatively little space in a direction that corresponds to the emission of light from the LEDs. In addition to the components mentioned, only one cooling body is required on the back of the component carrier, which dissipates the heat from the LEDs, and corresponding cooling devices, for example in the form of fans, can be provided in a plane perpendicular thereto. Overall, the therapy device therefore has a structure whose dimensions are significantly larger in the directions transverse to the direction of emission of the LEDs than perpendicular to it. A therapy device in the form of a flat housing can be brought relatively easily over the area to be treated, an adjustable arm holding the therapy device in the desired position during the treatment.

According to a further embodiment of the invention, the first LEDs and / or the second LEDs can be controlled with regard to their power output. The power output and the switched-on state of the first LEDs and / or the second LEDs can be stored as therapy data in a program memory. Accordingly, it is possible to individually control the power output and, via the switched-on state, the associated exposure field for both the first LEDs and the second LEDs. Information of this kind can typically be stored in a program memory for each patient so that a corresponding therapy can be carried out for a patient. Typically, in addition to the power output and the switch-on status, the duration of the entire treatment per therapy session is also stored. Typical irradiation times are in the range from 20 seconds to 20 minutes.

According to a further embodiment of the invention, the first LEDs and the second LEDs are arranged on a component carrier. The distance between the component carrier in the therapy device and the surface to be irradiated on the tissue is usually around 3 to 30 cm, a typical value is around 10 cm to 15 cm. The two-dimensionally formed treatment area has side lengths which can be approximately in a similar range, ie between 3 and 30 cm.

The component carrier covers the area to be irradiated with regard to its external dimensions. The electromagnetic radiation of each first LED is mapped onto its assigned exposure field with enlargement of the emitter area of a single LED and mixed with electromagnetic radiation from one or more second LEDs, due to the parallel radiation from the device, there is no projection onto an even larger radiation area, so that the dimensions of the exposure fields follow the grid of the LEDs. Due to this procedure, the structure of a therapy device is significantly simplified, since the dose at the treatment site does not depend on the relative position or orientation between the device and tissue and, in addition, the homogeneity over the treatment area is also improved. The first LEDs and the second LEDs can be arranged on selected exposure fields, in particular in the area of the central exposure fields with respect to the surface to be irradiated, so that a free space is formed in the component carrier, which can preferably be used to attach a camera. A display unit can be provided, which is arranged, for example, on an upper side of the therapy device and can be folded out during use so that data from the camera are displayed on the display unit.

According to this procedure, it is possible to make appropriate aids available to a practitioner so that monitoring, for example with regard to the distance of the therapy device from the surface to be irradiated and the selection of the exposure fields with regard to the emitting of light of the first central wavelength or the second central wavelength is possible. The display unit can also be designed as an input unit in a manner customary in the art, as is usually known in the form of touch-sensitive user interfaces. Thus, not only can the image from the camera be displayed and viewed on the display unit, but also a selection of the exposure fields to be irradiated or, in general, a selection of parameter values or program sequences can be made, as well as image recordings for analysis and documentation.

In order to create the free space in the component carrier, the LEDs can be arranged in other positions, for example in the area of the central exposure fields. If, however, several LEDs of the same type are used on these exposure fields, provision is also made for these to be arranged in a different assembly pattern. It can be provided that the LEDs are arranged next to one another in the form of a strip, while the LEDs are arranged in an L-shape or U-shape in the area of the free space, so that they can be attached around the free space. The optical module should be adapted accordingly for LEDs in these areas so that the deviating LED positioning on the component carrier does not destroy the regularity in the multiple arrangement of the radiation fields and the homogeneity of the light output at the therapy level.

In addition, a switchable light source can be provided for optical control by the operator of the surface to be treated. The switchable light source will particularly advantageously emit white light, so that manual alignment of the therapy device relative to the area to be treated can be carried out more easily. The light source designed as a white light LED can be attached to the edge of the housing of the therapy device in order to avoid disturbing reflections from a transparent window covering the underside. According to a further embodiment of the invention, the housing has a fan for removing the heat from the first and / or second LEDs, which fan is typically provided with a filter, preferably with a filter for suspended matter. The suspended matter filter can be used to prevent germs or the like from being carried away within a treatment facility, such as a hospital.

According to a further embodiment of the invention, the therapy device has a distance sensor for measuring a distance to the surface of the tissue to be treated.

Due to the parallel radiation, it is not absolutely necessary to maintain an exact distance, but a distance sensor can enable additional monitoring in order to indicate to the user that a distance is kept within certain limits or to signal that the distance has been left.

In a simple and inexpensive and compactly realizable embodiment, the optical module of the first and / or second LEDs can have an aspherical lens that is manufactured, for example, as a plastic lens. By means of these configurations of the optical modules, homogeneous illumination of the respective exposure fields is possible, whereby lenses of the optical modules for the first and / or second LEDs that are manufactured as plastic lenses can also be combined in a lens matrix. For the optical modules the first LEDs and / or the second LEDs are then each provided with apertures, which are preferably designed as a perforated disk. However, a structure without panels is also possible. The perforated disk can particularly preferably be mounted on the component carrier and, in another embodiment, can also accommodate the optical module. Accordingly, a compact structure is created in which simple and inexpensive assembly of a large-area therapy device is possible. However, this structure of the optics has the disadvantage that the beam path is emitted by the device in a divergent manner and a strong distance dependency arises for the seamless and overlap-free imaging of the exposure fields in the illumination area on the irradiation surface.

A preferred embodiment is therefore that the optical module has a first collimation lens for each LED, which is followed in the beam path to the tissue by at least one micro-lens array and then a collecting lens that carries the electromagnetic radiation mixed in the shaping micro-lens array structure the first LED and the second LED images with a substantially parallel beam path to the surface of the tissue. In another, likewise advantageous embodiment, however, the optical module has its own or a common light guide for each LED, the outer shape of which is adapted to the outer shape of the exposure field and which is followed in the beam path to the tissue by a converging lens, which the light guide mixed electromagnetic radiation of the first LED and images the second LED with a substantially parallel beam path to the surface of the tissue.

Accordingly, the shape of the exposure field can not only be determined by mapping the specific LED light source shape or by superimposing such images of several LEDs, as already described, but also can be achieved by means of an interposed angular light guide (triangle, square or regular hexagon) or alternatively by diffractive optical elements or micro-lens array construction. The minimally divergent radiation, which is caused for example by a converging lens, ensures a homogeneous power distribution over the largest possible therapy distance range and also the complete or almost complete distance independence of the power density with a homogeneous beam profile. The light guide with a corresponding outline catches the light from one or more LEDs (if necessary with an upstream focusing lens) and homogenizes / mixes the light from the LEDs. The shape of the light exit surface with homogeneously mixed light is enlarged by means of an aspherical lens and mapped to infinity by means of the converging lens in order to achieve homogeneous illumination of the therapy surface independent of distance. Alternatively, a structure typically consisting of two microlens arrays (MLA), which are also referred to as fly's eye or (English fly's eye), contain a two-dimensional arrangement of individual optical elements that are assembled or shaped into a single optical element and used to To spatially convert light from an uneven distribution into a uniform distribution of the irradiance in a lighting plane. A collimation lens per exposure field in turn ensures a quasi-collimated image on the therapy surface in order to create only a slight dependence on the distance of the performance. Compared to the light guide, such a structure has a shorter beam path, improved safety of radiation exposure (eg for the eye), improved light output yield and improved color mixing and homogeneity at the therapy level.

Some exemplary embodiments are explained in more detail below with reference to the drawing. Show it: FIG. 1A shows a therapy device according to a first embodiment of FIG

Invention in a perspective side view,

FIG. 1B shows a therapy device according to a second embodiment of the invention in a perspective side view,

FIG. 2 shows a sectional view through a therapy device according to FIG. 1A,

FIG. 3 shows, in a schematic representation, the selection of wavelength ranges for LEDs of one according to the invention

Therapy device,

FIG. 4 shows an assignment of a first and a second exposure field of a therapy device according to the invention to an entire treatment area in a top view,

FIG. 5A / B an assignment of first and second exposure fields of a therapy device according to the invention to an entire treatment area in a top view,

Figure 6 shows a further assignment of the first and second

Exposure fields of a therapy device according to the invention for an entire treatment area in a top view, FIG. 7 a detail of an arrangement of LEDs on a component carrier of a therapy device according to the invention in a top view,

Figure 8-10 a therapy device according to the invention in the treatment of a wound site, FIG. 11 shows a detail of an arrangement of LEDs with an optical module in a side view according to a comparative example of a therapy device, FIG. 12 shows a detail of an arrangement of LEDs with an optical module in a side view according to a first embodiment of a therapy device according to the invention,

FIG. 13 shows a detail of an arrangement of LEDs with an optical module in a side view according to a second embodiment of a therapy device according to the invention, and FIG

FIG. 14 shows the therapy device from FIG. 13 in a perspective side view.

In the figures, identical or functionally identical components are provided with the same reference symbols.

In Figure 1A, a first embodiment of a therapy device 2 according to the invention is shown in a perspective side view. The therapy device 2 is connected to a movable trolley 6 via several adjustable brackets 4. The position of the therapy device 2 can be changed by a multiplicity of adjustment means 8, so that it can be arranged accordingly in relation to a patient. The therapy device 2 has a housing 10, which is provided on its underside 12 with an opening or preferably with a transparent window, so that electromagnetic radiation, hereinafter also referred to as “light”, of different central wavelengths from the therapy device 2 for irradiating a surface a tissue can be used. As tissue, skin tissue or skin wounds are typically subjected to therapeutic treatment. To monitor or control the treatment, a touch-sensitive display unit 14 is provided, which is typically arranged on an upper side 16 of the therapy device 2. The display unit 14 can also be folded out so that it can be swiveled by an operator into a desired position for easier use during treatment. The power supply of the therapy device 2 can be carried out, for example, via the pivotable mounts 4 and the trolley 6 by means of appropriately designed cable ducts.

In Figure 1B, a second embodiment of a therapy device 2 according to the invention is shown in a perspective side view. In contrast to the therapy device 2 from FIG. 1A, the therapy device 2 shown in FIG. 1B is not designed for stationary operation, but for manual operation. The therapy device 2 can be guided by a practitioner by means of a handle 11 which is arranged on the housing 10. One or more operating elements 15, via which a treatment can be started or stopped, can be attached to the handle 11. To control the treatment, the display unit 14 is again provided on the upper side 16, which instead of the operating elements 15 or in addition to them can also be designed to be touch-sensitive. The housing 10 has an opening 17 through which emitted electromagnetic radiation can be emitted. Instead of an opening 17, a transparent window, as already described above in connection with FIG. 1A, can also be provided on the housing 10. The therapy device 2 according to FIG. 1 B can, however, also be provided with a holder which, similar to the holder 4 from FIG. 1A, enables the therapy device 2 to be guided. Stationary and portable embodiments of the invention have been described in FIGS. 1 A and 1 B. It should be noted at this point that numerous modifications are possible for the design of the therapy device 2, in particular with regard to the size and shape of the housing 10 as well as use with or without folding 4 and handle 11, which the skilled person can make without problems depending on the desired use be able. The embodiments shown in FIGS. 1A and 1B are therefore to be understood only as examples. In FIG. 2, a section through the therapy device 2 according to FIG. 1A is shown schematically. It can be seen that the therapy device 2 has a transparent window 18 on its underside 12, so that light for irradiating a surface 20 can emerge from the therapy device 2. In this case, a plurality of first LEDs 22 and at least one second LED 26 are arranged on a component carrier 24 inside the therapy device 2. Towards the subject to be treated

Surface 20, each first LED 22 and second LED 26 are assigned an optical module 28, which is shown only schematically in FIG. Examples of suitable optical modules 28 are explained in more detail below with reference to FIGS. 11 to 14.

In the direction of the upper side 16 of the housing 10, the component carrier 24 is assigned a heat sink 30, which can dissipate heat generated during operation of the first LEDs 22 and the second LEDs 26. For further removal of the heat, active cooling devices 32, for example in the form of fans, can be provided on opposite sides of the housing 10. In addition to fans, the cooling devices 32 can also contain air filters in order to prevent the spread of dust, aerosols, bacteria, virus carrier substances, etc. Furthermore, a control unit 34 is provided in the interior of the housing 10, which control unit can control both the first LEDs 22 and the second LEDs 26 as well as data input or data output via the display unit 14. During operation of the therapy device 2, images from a camera 36 also arranged on the component carrier 24 can advantageously be displayed on the display unit 14, so that the relative position of the therapy device 2 to the surface 20 of the tissue to be irradiated can be checked by a practitioner. By means of a distance sensor (not shown), a distance 38 can be determined, which is communicated to the practitioner via the display unit 14, for example, in which case it may only be necessary to display compliance with the correct intended distance.

As explained with reference to FIG. 2, first LEDs 22 and second LEDs 26 are provided which, for therapeutic applications, emit light on the surface 20 above a therapy-relevant threshold.

It is provided here that the first LEDs 22 have a first central wavelength and the second LEDs 26 use a second central wavelength. The first central wavelength is for

Carrying out a photodynamic therapy is provided, while the second central wavelength is suitable for carrying out a regenerative photobiomodulation therapy on the surface 20 of the tissue. In order to treat an infected wound area appropriately antimicrobially by means of photodynamic therapy and to treat external areas to reduce swelling of inflamed tissue by means of regenerative photobiomodulation therapy, both the first LEDs 22 and the second LEDs 26 are in a multiple arrangement, so that within a common Irradiation area is divided into exposure fields, within which it can be selected whether and which of the first LEDs 22 and the second LEDs 26 should be activated. Two-dimensional irradiation can thus take place in several exposure fields, one or more forms of therapy being selectable for each exposure field.

With reference to FIG. 2, it can be seen that the first LEDs 22 on the surface 20 of the tissue to be treated each emit light into first exposure fields 40. Correspondingly, second exposure fields were provided for the second LEDs 26, which, however, are not shown in FIG. 2 for the sake of simplicity. It should be mentioned at this point that the typically matrix-shaped arrangement of the first LEDs 22 and the second LEDs 26 does not necessarily have to be designed with the same number of rows and columns, so that the multiple arrangements described above with regard to the size of the first exposure fields 40 and the second Distinguish exposure fields. The design of the therapy device 2 with only one first LED 22 and only one second LED 26 is also possible within the scope of the invention. It is important, however, that the first exposure fields 40 and the second exposure fields on the surface 20 of the tissue overlap to form a common irradiation area.

Furthermore, it can be seen from FIG. 2 that the position of the first LEDs 22 is selected to be centered in the first exposure fields 40. However, this only applies to the case where only one first LED 22 is assigned to each first exposure field 40. In some applications, a plurality of first LEDs 22 can also emit light of the first central wavelength in a first exposure field 40. Based on this procedure, it is possible to increase the power output for each first exposure field and, if necessary, to improve the homogeneity of the power distribution. A similar procedure would also be possible with regard to the second LEDs 26. Another point that is essential for the invention is that the optical unit 28 is an image the emitter surface of the first LED 22 on the respective exposure field 40, so that the extent of the component carrier 24 corresponds to the area to be treated on the surface 20. The emitter area of the second LEDs 26 is imaged in the exposure field 50 in a similar manner. In particular, there is no expansion in the form of a projection beyond the associated exposure field. The electromagnetic radiation therefore leaves the therapy device 2 essentially with a parallel beam path, so that the power output at the treatment area does not depend on the distance between the therapy device 2 and the area to be treated on the surface 20, or only very slightly.

A schematic representation of an emitted spectrum of electromagnetic radiation from a first LED 22 and a second LED 26 of the therapy device 2 according to the invention is shown in FIG. 3 in order to achieve a therapeutic effect.

The selection of the central wavelengths for the first LEDs 22 and the second LEDs 26 follows the desired therapeutic effect. The therapy device 2 is suitable for photodynamic therapy with an externally applied photosensitizer and / or for regenerative photobiomodulation therapy, which can be carried out independently of an externally applied photosensitizer.

In photodynamic therapy, a photosensitizer (eg methylene blue) is usually applied to the area to be treated, the absorption spectrum of which is shown as curve 42 in FIG. 3 as a function of the wavelength. For regenerative photobiomodulation therapy, an absorption spectrum is also known based on the components present in the cells, which is shown in FIG. 3 as curve 44. It can be seen that for light of the first central wavelength to carry out an antimicrobial photodynamic therapy, a significant wavelength component in the wavelength range 46 should be selected. To carry out regenerative photobiomodulation therapy, light in the wavelength range 48 should be provided as the second central wavelength. Light of this second central wavelength is not absorbed by the photosensitizer because curve 42 does not have a maximum in wavelength range 48, so that the photobiomodulation therapy can also take place on areas where photosensitizer has been applied. Since the curve 44 also has a clear maximum in the wavelength range 48, the various forms of therapy can therefore be separated over the wavelength.

For photodynamic therapy, the first central wavelength is used in a wavelength which is matched to the absorption maximum of the photosensitizer used, typically but not exclusively in the visual range. The second central wavelength is suitable for an effective photobiomodulation therapy on the basis of the superposition with the absorption spectra of the metal centers of the mitochondrial cytochrome C oxidase within the target cell mitochondria and is located in the red as well as in the near infrared range, typically with a resp. Wavelength between 620 nm and 700 nm and between 780 nm and 850 nm, whereby light with a central wavelength in other visual ranges and between 850 nm and 1020 nm in the near infrared range can also have a biological effect, presumably caused by other photochemical reactions in the Cells. Using the strategy of separating types of therapy based on the absorption spectra shown in FIG. 3, the suitable first LEDs 22 and second LEDs 26 can be selected depending on the application.

FIG. 4 shows a plan view of an assignment of a first exposure field 40 and a second exposure field 50 of the therapy device 2 to one common irradiation area 52 shown. Such an assignment of the first exposure field 40 and the second exposure field 50 is used in particular in the hand-operated therapy device 2 according to FIG. 1B. The first exposure field 40 and the second exposure field 50 of the therapy device 2 have the same dimensions, so that the dimensions of the common irradiation area 52 also coincide with the two exposure fields 40 and 50. The two exposure fields 40 and 50 can each be irradiated by an LED or LED group with electromagnetic radiation of different central wavelengths, with operation using batteries or rechargeable accumulators being possible due to the simpler design compared to a therapy device 2 according to FIG. 1A.

In FIG. 5A, a further assignment of first exposure fields 40 and in FIG. 5B of second exposure fields 50 of the therapy device 2 to the common irradiation area 52 is shown schematically in a top view. This assignment is typically used in therapy device 2 according to FIG. 1A, which is designed as a stand-alone device for stationary operation. In itself, however, it is also conceivable to design the hand-operated therapy device 2 from FIG. 1B with a plurality of first exposure fields and / or a plurality of second exposure fields.

For better illustration, the first exposure fields 40 and second exposure fields 50 have been shown in separate figures. The common irradiation area 52 therefore corresponds to the superposition from FIGS. 5A and 5B and is shown in these figures as an outer frame.

It can be seen from FIG. 5A that an arrangement of 4 × 6 exposure fields was selected for the first exposure fields 40. For the second exposure fields 50, according to FIG. 5B, an arrangement of 2 × 3 was used Exposure fields selected. Both the first exposure fields 40 and the second exposure fields 50 complement each other to form a homogeneous area which is present as a common irradiation area 52 on the surface 20 from FIG. 2 of the tissue to be irradiated. For each of the first exposure fields 40 and second exposure fields 50 shown in FIGS. 5A and 5B, a therapy program can now be used to determine which of the first exposure fields 40 and second exposure fields 50 are to be activated.

FIG. 6 shows a further assignment of the first exposure fields 40 or second exposure fields 50 to a common irradiation area 52. Here an assignment is selected for the first exposure fields 40 as well as for the second exposure fields 50, which is the same with respect to the rows and columns. In the example shown, the common irradiation area 52 is therefore homogeneously illuminated by 4 × 5 first exposure fields 40 or second exposure fields 50. As in the example above, the therapy program can be used to decide which of the exposure fields 40 and 50 should be activated. The example shown in FIG. 6 corresponds to an embodiment with regard to the first exposure fields 40 as in FIG. 2, with an oblique view in the direction of the four adjacent exposure fields 40 being selected in FIG.

In Figure 7, the arrangement of first LEDs 22 and second LEDs 26 on the component carrier 24 is shown in a type of assembly plan to the structure of the component carrier 24 with first LEDs 22 and second LEDs 26 also

To clarify the presence of the optionally provided camera 36 again. This arrangement is superimposed by boundary lines of the first exposure fields 40 and second exposure fields 50 according to the embodiment according to FIG. 6. It can be seen that each first exposure field 40 is equipped with three first LEDs 22. In addition, a single second LED 26 is provided for every second exposure field 50. The first LEDs 22 are arranged in the form of strips, the two central exposure fields being equipped differently so that space is created for the camera 36 at this point. In addition to the first LEDs 22 or second LEDs 26, further white light LEDs (not shown in FIG. 7) can also be used in order to create a higher-contrast image during the optical inspection by means of the camera 36. The white light LEDs can be mounted on the housing 10 on the underside 12. In yet other embodiments, it is also possible to provide a different number of first LEDs 22 or further second LEDs 26.

The use of a therapy device 2 is shown by way of example in FIG. It can be seen that the common irradiation area 52 covers the surface 20, a forearm being shown schematically here as the tissue to be irradiated. On the surface 20, the reference numeral 60 denotes a wound which is surrounded in its outer areas by areas with inflammatory skin areas 62. Before using the therapy device 2, as shown in FIG. 9, the wound 60 is covered with a photosensitizer 64. The lamp is brought over the area of the wound 60 by means of the adjustable holders 4 described in FIG. To control this, the camera 36 or its representation of the recorded images, possibly supplemented with the measurement data of a distance sensor for recording the distance 38, can be used on the

Display unit 14 can be used. In addition, the white light LEDs can be activated as described above.

FIG. 10 now shows the selection of the corresponding forms of therapy. Areas that are not tissue within the common irradiation area 52 cover, are excluded so that no light energy at all is emitted at this point. These are identified with the reference numeral 66 within the common irradiation area 52. First exposure fields 40, which cover the wound area 60 colored with photosensitizer 64, are activated in such a way that an antimicrobial photodynamic therapy can be carried out there. The exposure fields which only cover the skin irritation areas 62 are irradiated by the light from the second LEDs 26, so that a regenerative photobiomodulation therapy is carried out. It should be mentioned at this point that it is also possible to activate the second LEDs 26 in those areas in which the first LEDs 22 are switched on.

Using the shown embodiments of the therapy device 2 according to the invention, a large-area treatment of the wound 60 can thus be carried out, whereby at least two different forms of therapy, spatially resolved in the embodiment with several first or second simply polygonal exposure fields 40, 50 in the irradiation area 52, can be selected. The detail of the arrangement of the therapy device 2 shown in FIG. 7 is illustrated again below with reference to FIG. 11 in a side view using a comparative example. This comparative example, which due to the non-parallel emission behavior does not form part of the invention, first illustrates the structure of an optical module 28.

It can be seen that the optical modules 28 embodied as aspherical lenses image the light from each first LED 22 onto the entire area of the first exposure field 40. The optical modules 28 can be designed as plastic lenses, which in an injection molding process as a common component can be manufactured. A multiple standard lens structure in an opto-mechanical holder is also possible.

At the position of the light passage, a perforated diaphragm 54 can be provided, which accordingly influences the propagation of light. Because of the lower energy when performing regenerative photobiomodulation therapy, typically only one second LED 26 is used per exposure field. The exposure field 40 covers an area of approximately 1 cm ² to 45 cm ² , typically of approximately 9 cm ² , with a distance 38 in the range of 30 mm to 300 between the component carrier 24 in the therapy device and the surface 20 of the tissue to be irradiated mm, typically 150 mm. The variant shown in FIG. 11 can, for example, be coupled to a distance sensor so that the dependency of the power density at the location of the irradiation can be controlled accordingly by measuring the distance, for example by prompting a user to adjust the therapy device 2. An automatic adaptation of the emitted power of the first LED 22 or the second LED 26 would of course also be possible. With reference to FIG. 12, a first embodiment is shown below, in which the optical module 28 generates a parallel beam path between the device at the window 18 and the surface 20 of the tissue to be treated. It can be seen in FIG. 12 that a collimation lens 72 is assigned to each first LED 22, which lens images the light emitted by the first LED 22 onto the cross section of a light guide 74. At the exit of the

A further lens 76 is arranged on the light guide 74 so that, for example, light from the different first LEDs 22 hits a second collimation lens 78 via a diaphragm 54, which generates the parallel beam path in the direction of the surface 20 of the tissue to be treated. In this example, three first LEDs 22 are provided for the first exposure field 40, which are mounted on the component carrier 24. As shown in FIG. 12, the light guide 74 can have a rectangular-colored or square cross-sectional area, although other cross-sections in the form of a triangle or a hexagon are not excluded. The representation of an optical module 28 shown in FIG. 12 can take place in a similar manner for the second LEDs 26. Furthermore, it is also possible to use only a single light guide 74, which is irradiated on the input side by all three first LEDs 22. As already mentioned, the embodiment shown in FIG. 12 has a distance-independent power density during the irradiation on the surface 20 of the tissue.

With reference to FIG. 13, a second embodiment for an optical module 28 with a parallel beam path at the output of the therapy device 2 is described below. The embodiment shown can be used for each first exposure field 40 or each second exposure field 50 in a multiple arrangement or for a single first exposure field 40 and a single second exposure field 50 of the hand-held device 2 according to FIG. 1B and FIG. According to FIG. 13, each of the first LED 22 and each second LED 26 LED has a collimation lens 72 aut. Each collimation lens 72 is followed in the beam path to the surface 20 of the tissue by a structure with typically two micro-lens arrays 80 and a converging lens 78, which show the In the micro-lens array structure 80 mixed and shaped electromagnetic radiation of the first LED 22 and the second LED 26 with a substantially parallel beam path to the surface 20 of the tissue. Advantageously, the electromagnetic radiation of the first LED 22 and the electromagnetic radiation of the second LED 26 are brought together in the micro-lens array structure 80 and shaped in such a way that the light output of the two LEDs 22 and 26 results in a uniform distribution of the irradiance in an illumination plane is spatially transformed. The converging lens 78 per exposure field 40 or 50 in turn ensures a quasi-collimated image on the therapy surface in order to create only a slight dependence on the distance of the performance. It should be mentioned that further optical elements not shown in FIG. 13, such as for example dome lenses, can also be provided at the location of the radiation emission of the two LEDs 22 and 26 on a semiconductor substrate.

The procedure according to the invention is shown again in a perspective view with reference to FIG. It can be seen that the two collimation lenses 72 guide the electromagnetic radiation onto the microlens array structure 80, so that a parallel continuation in the direction of the irradiation area 52 takes place via the converging lens 78. The beam path of the emitted electromagnetic radiation is oriented parallel to an optical axis 82.

The features specified above and in the claims, as well as those which can be derived from the figures, can advantageously be implemented both individually and in various combinations. The invention is not restricted to the exemplary embodiments described, but can be modified in various ways within the scope of the skilled person.

Claims

Expectations:

1. Therapy device for irradiating a surface (20) of a tissue, in particular skin tissue or skin wounds, the at least one first LED (22) for emitting electromagnetic radiation with a first central wavelength into at least one first exposure field (40) and at least one second LED (26 ) for emitting electromagnetic radiation with a second central wavelength into at least one second exposure field (50), the first central wavelength being selected for performing a first type of phototherapy and the second central wavelength being selected for simultaneously performing a second type of phototherapy on the tissue, the at least a first LED (22) and the at least one second LED (26) are separately controllable with regard to their power and irradiation duration as electrical operating variables and have an emission characteristic so that the at least one first LED (22) laterally delimited into the at least one first simply polygonal Exposure processing field (40) and the at least one second LED (26) radiate laterally limited in the at least one second single polygonal exposure field (50), the at least one first exposure field (40) and the at least one second exposure field (50) on the in one Distance to the device-oriented surface (20) of the tissue form a common irradiation area (52), so that the surface of the tissue within the simply polygonal first and second exposure fields (40, 50) and within the common irradiation area (52) above a therapy threshold is indicated for the first and / or for the second type of phototherapy can be irradiated with a homogeneous power distribution, the electromagnetic radiation being emitted at least outside the device towards the surface of the tissue with an essentially parallel beam path.

2. Therapy device according to claim 1, in which the first type of phototherapy is a regenerative photobiomodulation therapy or a photodynamic therapy and in which the second type of phototherapy is a further regenerative photobiomodulation therapy.

3. Therapy device according to claim 2, in which the central wavelength of the at least one second LED for the second type of phototherapy is selected for the effective simultaneous implementation of both types of phototherapy outside the absorption spectrum of the photo-acceptor molecule or photosensitizer of the first type of phototherapy.

4. Therapy device according to one of claims 1 to 3, in which exactly one first exposure field (40) and precisely one second exposure field (50) are formed, which preferably form a rectangular or square irradiation area (52).

5. Therapy device according to claim 4, which is designed for manual operation and has a housing (10) with a transparent opening (17), wherein the opening (17) is formed with an outer dimension which corresponds essentially to that of the irradiation area (52) .

6. Therapy device according to one of claims 1 to 3, in which a plurality of first exposure fields (40) are designed in the form of a multiple arrangement, which preferably complement each other seamlessly to form a rectangular or square irradiation area (52).

7. Therapy device according to claim 6, in which, in addition, a plurality of second exposure fields (50) are formed in the multiple arrangement, which preferably complement each other seamlessly to form a rectangular or square irradiation area (52).

8. Therapy device according to claim 6 or 7, which is designed for stationary operation and has a housing (10) attached to an adjustable holder (4) with a window (18), the window (18) being formed with an external dimension, the in

Essentially corresponds to that of the irradiation area (52).

9. Therapy device according to claim 6 to 8, wherein the first

Exposure fields (40) and the second exposure fields (50) have a different total number.

10. Therapy device according to one of claims 6 to 8, in which the associated LEDs (22, 26) can be activated individually for each first exposure field (40) and for each second exposure field (50).

11. Therapy device according to one of claims 6 to 10, in which the first LEDs (22) and the second LEDs (26) are arranged on a component carrier (24), wherein on selected exposure fields, in particular in the area of the central exposure fields with respect to the to be irradiated Surface (20), a free space is formed in the component carrier (24) in which a camera (36) is attached.

12. Therapy device according to one of claims 6 to 11, in which the housing (10) for removing the heat of the first LEDs (22) and / or second LEDs (26) has a fan as a cooling device (32), which is typically with a filter , is preferably provided with a particulate filter.

13. Therapy device according to one of claims 6 to 12, in which a switchable light source for optical control of the to be treated Surface (20) is provided, wherein the light source is preferably arranged as a further LED adjacent to one of the first LEDs (22) and / or second LEDs (26) or on the housing (10).

14. Therapy device according to one of claims 1 to 13, the one

Has a distance sensor for measuring a distance (38) to the surface (20) of the tissue to be treated.

15. Therapy device according to one of claims 1 to 14, in which the power output, the duration and the switched-on state of the first

LEDs (22) and / or the second LEDs (26) are stored in a program memory as therapy data, so that the first LEDs (22) and / or the second LEDs (26) can be controlled with regard to their output according to a predetermined program.

16. Therapy device according to one of claims 1 to 15, in which the lateral limitation of the radiation of the first LED (22) and the second LED (26) in the simple polygonal area is carried out by means of an optical module (28) arranged adjacent to the LEDs.

17. Therapy device according to claim 16, wherein the optical module (28) for each LED has a first collimation lens, which in the beam path to the tissue is followed by at least one structure with one or more micro-lens arrays and then a collecting lens, which follows in the micro -Lens array construction mixed and shaped electromagnetic

Imaging radiation of the first LED and the second LED with a substantially parallel beam path to the surface of the tissue.

18. Therapy device according to claim 16, wherein the optical module (28) has its own or a common light guide for each LED, the outer shape of which is adapted to the outer shape of the exposure field and followed by a converging lens in the beam path to the tissue, which images the light guides mixed and shaped electromagnetic radiation of the first LED and the second LED with a substantially parallel beam path to the surface of the tissue.