WO2025202671A1 - Device combining soft laser and vacuum for therapeutic and/or cosmetic applications - Google Patents

Abstract

A device for therapeutic and/or cosmetic applications using a combination of soft laser and vacuum, comprising a hollow housing (11) containing at least one laser unit (20), a beam expander (26) placed in its light path and elements for refracting the direction of the light, a hollow bell (13) which is releasably connectable to one end of the housing (11) and has an outer flange (35) which is adapted to be fitted onto the skin surface to be treated, and a vacuum pump (17), wherein the vacuum pump (17) is located in the interior of the housing (11) and comprises a vacuum valve (18) located in the cavity of the housing (11), and two pipe stubs (33, 34) connecting the lower part (21) of the housing (11) to said interior (32), one of the pipe stubs (34) is connected to the suction side of the vacuum pump (17), and the other pipe stub (33) connects the inner space (32) of the bell (13) to one side of the vacuum valve (18), the other side of which is connected to the cavity of the housing (11) and comprises a control unit (40) which controls the vacuum valve (18), the vacuum pump (17) and the laser unit (20), and ensures that, when the bell (13) is placed on the skin surface (30) to be treated, a vacuum is generated in the interior (32) with a given time sequence and that the scattered light of the laser unit (20) is then incident on the skin surface (30) to be treated.

Description

Device combining soft laser and vacuum for therapeutic and/or cosmetic applications

The invention relates to a device for therapeutic and/or cosmetic applications using a combination of soft laser and vacuum, comprising a hollow housing containing at least one laser unit emitting at a wavelength between 400 and 1600 nm and having a power of at least 200 mW, the laser unit comprising at least one laser light source, a beam expander placed in its light path and elements for refracting the direction of the light emitted therefrom, a hollow bell which is detachably connected to one end of the housing in such a way that the laser light emitted is directed outwards through the hollow bell and its outer rim can be fitted onto the skin surface to be treated, and a vacuum pump with its suction side in communication with the interior of the bell.

The laser light source used in the device of the invention is a soft laser, which means that prolonged use of the treated area for up to 3-10 minutes does not cause cell damage, cell death or pain, unlike laser treatments that use short-duration high-energy pulses that, through their thermal or other characteristics, significantly affect or damage the basic vital functions of cells. The average irradiation power of such pulse-like applications is in many cases still in the range of the power of soft lasers, but precisely because of the ablative or other damaging effects caused by the pulses, they cannot be classified as falling within the scope of the invention.

The different therapeutic effects of soft lasers are described in detail in the literature, and only as an example we can mention the publication WO 2019/2011638 Al, which describes these effects and the most important characteristics of soft lasers, in its description of the prior art section. The solution is a specific arrangement in which the light from four laser light sources is directed by means of beam expanders and optical elements that refract the light in all directions so that no damage occurs to the irradiated skin surface, while the light beams, which are directed in different directions, meet each other at depth and can reach much deeper layers in a given area than if the surface were irradiated with a conventional scattered light distribution.

The publication refers to the descriptions at www.safelaser.hu and to the commercially available SL 500 laser treatment device, in which the light from a single 500 mW laser is expanded by a beam expander into a beam about 1-2 cm in diameter and converted into a beam scattered in all directions by a large number of miniature lenses on its outer surface. The diameter of the beam emerging from the device is around 2-3 cm.

The conversion of the laser light exiting the device into a scattered beam is also important from a safety point of view, because if the classic parallel beams accidentally hit the eye, the focusing effect of the lens can cause a high energy density at the surface of the retina that can damage it even within a short period.

In the WO 2017/001876 Al publication, in addition to the use of beam expansion and optical refraction, a homogenizing element, such as a porous polyethylene plate, is placed in the light path to scatter the beams in all directions, which at the same time attenuates the beams. Such a scattered light can be used to irradiate the eye and thus produce various therapeutic effects.

US 7.762.965 B2 also describes in detail the solutions to refract the direction of the laser light consisting of parallel beams and refers to the need for such scattered laser light for treatments, because it prevents the light from accidentally entering the eye from causing damage.

In this document, the use of laser light is combined with the creation of a vacuum in the irradiated area. The aim of the combination is both to absorb the vacuum into the skin surface in each area and to change the blood and lymph supply to the underlying areas and to achieve local cooling of the treated area, which reduces the pain of the pulsed treatment.

In this device, the laser light source is housed in a hand-held and movable housing terminating in a hand-held handle, and a funnel-shaped bell is arranged around the transparent surface of the light source, mainly in a U-shape, the interior of which is connected to a separate vacuum suction unit bypassing the interior of the housing.

It is clear from the description that the laser treatment used in that publication cannot be classified as soft laser treatment as defined above because the duration of the laser irradiation is short (less than 1 minute) and the intensity is high, it disturbs the function of the targeted cells and therefore the treatment cannot belong to soft laser treatments.

A further feature of this device is that it must be held by someone for the duration of the whole treatment, and if movement is required, it must be moved with certain skill around the body surface to be treated. The treatment cannot therefore be carried out under home-circumstances without outside assistance. The problems of home treatment also arise with the well-known soft laser devices referred to, because as long as the treatment has to be carried out on areas of the body that the person being treated has easy access to, the persons can carry out the treatment themselves, but on other areas of the body, such as the back or the back of the thighs, hand-holding the device is uncomfortable or impossible.

The traditional field of non-laser treatment of the body includes massage, particularly therapeutic massage, during which the masseur places a vacuum suction bell on certain areas of the body to induce localized blood flow and to aid the absorption of certain creams and oils. Many versions of such suction bells are known and are an indispensable accompanying tool for therapeutic massage or cosmetic treatments. The most common problem with the use of suction bells is that the skin under the bell is reddened and this redness remains visible for a long time after the bell has been removed, causing serious problems, especially if the treatment has been carried out in a visible area.

The use of simple suction bells is also problematic because the vacuum level is not adjustable and to maintain the vacuum for the time required for treatment, the initial vacuum must be higher than necessary to avoid the inevitable leaks that would cause the bell to fall prematurely. The use of vacuum pumps and precise pressure control has not become widespread because of the costs and inconvenience involved.

The basic objective of the invention is to create an improved soft laser treatment device that takes advantage of the benefits of simultaneous vacuum application, while being more comfortable, easier to use and significantly expanding the possibilities of selftreatment.

The invention also aims to expand the therapeutic possibilities of the combination of vacuum and soft laser treatment.

A further challenge is the creation of a controlled and variable time-course vacuum, where the extent and duration of skin lesions following treatment are significantly reduced.

The solution according to the invention is described in the appended claims.

The design of the soft laser device according to the invention is described in more detail below, with reference to the drawing, by means of examples. The drawing shows:

Figure 1 is a perspective view of an embodiment of the device according to the invention; Figure 2 is a top view of the device as shown in Figure 1 with the lid and circuits removed;

Figure 3 is an enlarged cross-sectional view of the device in the suction position, not including the internal units of the housing;

Figure 4 shows the block diagram of the device according to the invention, and

Figures 5 - 7 show a few typical pressure-time diagrams of the vacuum that can be created with the device.

The device 10 according to the invention has a cylindrical housing 11 with a hollow body closed by a circular cover plate 12. Attached to the housing 11 at the bottom is a cylindrical bell 13, the lower end of which is flush and has a rounded rim, and in use the apparatus 10 is adapted to be fitted by the rim against the surface of the body to be treated. The cover plate 12 in the exemplary embodiment has a display 14 and surrounding operating elements 15, such as push buttons. It is not shown in the drawing, but it is possible to connect the device 10 wirelessly to an external control means, such as a mobile phone with a suitable application management program and receive the necessary control from there via a Bluetooth connection. In this case, neither controls nor a display being inevitably required.

Reference is now made to Figure 2, which shows the top view of the interior of the housing 11 wherein both the cover plate 12 and the printed circuit board containing the electronic components are removed, to show the placement of the three larger units occupying the interior cavity of the housing 11. These units are a centrally located and relatively large battery 16, a vacuum pump 17 and a vacuum valve 18. The top view shows several more spacers 19 with internal threads, some of which are used to hold and secure the cover plate 12 and some of which are used to hold and secure the printed circuit board not shown on the drawing.

Reference is now made to Figure 3, which shows a sectional view of the internal structure of the device 10 in the removed position of the components and supports in the housing 11 with laser unit 20 inserted into the end of the thicker lower part 21 of the housing 11. A short cylindrical stub extends downwardly from the end of the lower portion 21 of the housing 11, the outer surface of the stub having an external thread mating with an internal thread formed in the upper portion of the bell 13, whereby the bell 13 can be coupled to the housing 11 or interchanged with another bell of a different size with a sealing therebetween. The appropriate size is determined by the type of the selected treatment.

The lower part 21 of the housing 11 extends downwardly through said threaded portion and, after a short cylindrical section, continues in a tapered outwardly widening section 22. In this central section there are successive central bores with stepwise varying cross-section, which can be divided into sections of progressively smaller diameter from the bottom upwards. The lower part 21 of the device, with the widening section 22 and the laser unit 20 inserted in said bores, is symmetrical to the axis 23 of the housing 11.

The laser unit 20 can be inserted from below into the longest of the three central bores, which are joined from above by the shoulder of the smaller diameter bore at the top. The elements used to mount the laser unit 20 are not sketched, but they have a cylindrical upper block 24 that contains centrally arranged one or more laser light sources 25, which emit the laser light in axially downward direction. Depending on the nature of the treatment to be applied, the laser light source 25 may emit in any part of the wavelength range 450-1600 nm. For example, it is preferable to use lasers emitting in the 650-670 nm red or 800-830 nm infrared, possibly in the 1500-1600 nm infrared range, but for some therapeutic needs, 460 nm blue light can also be required. The power of the laser light source 25 can vary between about 200 and 2000 mW, the upper limit being essentially limited only by the need to dissipate heat and to ensure that the intensity on the skin surface can be tolerated without causing damage. The power can be increased by increasing the size of the treated surface. The typical power range is between 500 and 1500 mW. However, this range should not be understood in a limiting sense, as the power can be increased if the power density in the irradiated area is still within the permissible limit, i.e. the tissues are not damaged thereby, and the laser light source 25 can be considered as soft lasers as defined above.

In front of the laser light source 25 (following the path of the light, which is the downward direction in Figure 3) is a beam expander 26 of a transparent material, which widens into a downward widening cone shape, and on the lower surface of which a light diffusing grid is arranged of small diameter spherical beads 27 arranged in rows and columns. This arrangement is like that of the beam expander used in the SL 500 laser device referred to in the introduction and distributes the light from the laser light source 25 over a large surface area. In front of (below) the beam expander 26, a transparent closing disc 28 is also fixed in the bottom cylindrical bore of the central section 22 having the largest diameter, the front surface 29 of which can be in direct contact with the body surface 30 to be treated. Inside the central section of the closure disc 28 there is a cavity 31, which is purposefully spherical in shape, and which bulges in the direction of the light, and which is intended to further expand the beam from the beam expander 26 and to distribute the light more evenly along the front surface 29. The presence of the cavity 31 in the given design plays a key role in the uniformity of the light distribution. The thickness of the closure disc 28 is determined by a combination of the value required for the optical sizing of the cavity 31 and the heat capacity required, because the closure disc 28 also cools the skin surface 30 drawn to it by the vacuum created during operation. In Figure 3, a section of the skin 30 under treatment is shown below the device.

Around the downwardly tapering section 22 the interior 32 of the bell 13 is arranged, which bell 13 is releasably connected to the lower part 21 of the housing 11. This interior 32 comprises two pipe stubs 33, 34 leading into the interior of the housing 11. The pipe stub 33 is connected to the vacuum valve 18 and is in a closed or open state depending on its state. In the open position, the pipe stub 33 communicates with the interior of the housing 11, and through it with the outside atmosphere, and therefore rapidly breaks the vacuum previously established in the interior 32. The pipe stub 34 communicates with the suction side of the vacuum pump 17 and, when operated, creates a vacuum in the interior 32 when the mouth opening of the bell 13 is closed by the associated skin 30.

At the end of the bell 13 is a flange 35 of flexible material, which is designed to distribute the compressive force generated by the vacuum over a large surface when the device 10 is placed on the body. The interchangeable design of the bell 30 ensures that the right size is always used for the treated area, for example, a smaller diameter is needed for facial treatment than for abdomen, back or thighs. The elastic surface of the rim 35 seals any gap created by the presence of hairs and prevents vacuum from leaking from the interior 32, although it cannot prevent leaks completely.

An important feature of the device 10 is that the inner space 32 of the bell 13 communicates with the inner space of the housing 11 only through the two tubular pipe stubs 33, 34 in a controlled manner, and the suction effect created is so strong that the device 10 is held stably on the treated body part without any manual intervention. The miniature and lightweight design of the device 10 also contributes to this, eliminating one of the major drawbacks of known solutions, namely the discomfort of the need of holding them on the body and the impossibility of self-use.

The axial distance between the flange 15 and the frontal surface 29 of the laser unit 20 depends on the position of the treatment on the body, because it is desirable to have an axial distance such that the distance between the frontal surface 29 and the skin surface without vacuum in the base position can be overcome by the suction effect of the vacuum and the skin is pressed directly against the frontal surface 29. This distance varies between different parts of the body and different sizes of the bell, and it is typically between 2 and 7 mm.

Before describing the use of the device 10 according to the invention, reference is made to Figure 4, which shows an electrical block diagram of the 10 devices. The device 10 is powered by the rechargeable battery 16. The electronic circuits and units are controlled by an intelligent processor 40 with built-in programming, on the one hand, and by the control elements 15 located next to the display 14 or, in the case of external control, by a mobile device with the appropriate application software and not shown in the drawing, on the other hand.

In Figure 4, if we proceed from top to bottom, the battery 16 is protected by a protective circuit 41 against accidental wrong polarity power supply and their terminals are connected to a charge measuring unit 42. Charging is provided by an external power source via a USB connector 43, which feeds a charge controller 44. and its output is connected partly to the battery 16 and partly to the power supply lines of the device. An alternative is wireless powering, of which different versions are widely known. The regulation is controlled and monitored by the processor 40 at specific times corresponding to specific clock signals, via time gates 45 and 46.

The devices 10 contain speakers 47 (purposefully buzzers), power control 48, flash memory 49, backlighting 50 to illuminate the display 14, bluetooth module 51, and pressure sensor 52. These units are controlled by the processor 40 according to the settings and program. Figure 4 shows the units already sketched in Figures 1 and 2, namely the display 14 and the control elements 15, each marked by a circle (as an activatable pushbutton) and those units, mentioned earlier, are the vacuum pump 17, the vacuum valve 18 and the laser unit 20 itself. The vacuum pump 17 is controlled by the processor 40 in such a way that it can have an operating hysteresis where it switches on at a lower vacuum level and off at a higher one, and the magnitude of the on and off levels can be varied. However, the vacuum can also be set to a predetermined value if a constant vacuum is to be maintained during operation. The vacuum pump 17 or the vacuum valve 18 is connected to the pressure sensor 52. One of the quantities shown on the display 14 is the value of the measured pressure inside the bell 13.

The operation and use of the device 10 according to the invention must be set according to the treatment need and the treatment protocol, which is either provided by the application program or can be selected by one of the operating elements 15 among one of the preset protocols.

Setup begins by connecting both the laser unit 20 and the bell 13 of the appropriate size for the treatment to the housing 11. It can then be set to maintain a constant vacuum during the treatment or to vary the vacuum level cyclically between two extreme values for respective predetermined time periods, thus achieving an effect like a local massage of the area under the bell 13.

Figures 5 - 7 illustrate different pressure setting options, where the pressure in the interior space 32 is plotted against time at different settings.

Figure 5 illustrates the conditions seen when providing a constant vacuum. From an initial atmospheric pressure, the pressure gradually decreases after the vacuum pump 17 is started (the slope is determined by the power of the vacuum pump 17 and the internal volume). When the pressure reaches the set threshold level, the vacuum pump 17 is switched off and the internal pressure rises slowly only because of the system leaks. It is mentioned that the control has an adjustable hysteresis, at the upper value of which the vacuum pump 17 is switched on again and the pressure quickly returns to the set lower level, from which it starts to rise again according to the rate of leakage. This process continues until the treatment is complete, in which case the set vacuum will fluctuate between the two limits for essentially the entire duration of the treatment.

At Figure 6 the objective lies in to create a vacuum that fluctuates between two larger values. When the vacuum reaches the lower value after the vacuum pump 17 is turned on, not only will the vacuum pump 17 be stopped, but the vacuum valve 18 will be opened by the processor 40, and the interior 32 will then get into communication with the interior 11 of the housing, and the pressure will rise rapidly, depending on the crosssection and length of the flow paths, until it reaches the set on level of the vacuum pump 17, at which moment the vacuum pump 17 will be turned on and the vacuum valve 18 will be closed. This will again initiate a pressure drop which will continue until the lower threshold level is reached, after which the cycle will repeat. This fluctuation is perceived by the person being treated as a massage, and the blood supply to the area affected will fluctuate between two values. The amount of fluctuation and the duration of the cycles are determined by the control program.

Figure 7 is a similar diagram to Figure 5, the only difference is that a larger pressure difference (higher hysteresis) has been set between the pressure values for turning off the 17 vacuum pumps and turning them on again.

After the settings are made, the device 10 is placed over the area to be treated and the treatment is started with a light pressure on the housing 11. The vacuum pump 17 is then activated, creating a vacuum in the interior 32. As soon as the vacuum threshold is detected by the processor 40, the laser unit 20 is activated and controlled, which illuminates most of the area covered by the bell 13 with laser light. The resulting vacuum pulls the skin surface under the bell 13 inward until the skin surface is stretched against the frond surface 29, which is sketched very schematically in Figure 3.

The duration of the treatment is determined by the prescribing doctor or protocol, usually 3-6 minutes per session. During this time, the vacuum level fluctuates between the two extreme values, producing the massage effect mentioned above, or the vacuum can be kept constant for the duration of the treatment.

At the end of the treatment period, the power supply to the laser unit 20 and the vacuum pump 17 is cut off and the vacuum valve 18 is opened, causing the pressure in the bell 13 to become equal to the external pressure, and the bell 13 is removed from the skin surface, returning the skin to its original position. The interior of the housing 11 is not hermetically sealed from the outside, and it is preferable to create direct ventilation gaps between the interior and exterior thereof to allow the vacuum to escape quickly.

The device 10 is equipped with a suitable automatic mechanism so that in the event of a power failure or any other problem, the vacuum valve 18 moves to the open position when there is no vacuum inside the bell 13 and the laser is switched off. The use of the device 10 according to the invention has several advantages compared to laser-only treatment of the same area. Laser treatment is most often used to stimulate deeper areas, and one of the biggest obstacles to light penetration is the dampening effect of ubiquitous body fluids. The effect of a vacuum is that body fluids under the treated area effectively flow to adjacent areas and therefore the penetration depth of the laser light will be greater and better absorbed due to less absorption as a resistance. In addition, areas subjected to variable pressure will induce localized blood pooling and a greater volume of blood and lymph flow will be exposed to the laser light and the stimulating effect of the laser light on the cells in the area will be more effective.

As an example, the combined effect of vacuum and laser relaxes the treated tissues, including connective tissue, muscles, joints, and other structures. It also helps to release abnormal adhesions and loosens spasmodic, tight muscles.

Note that a weak vacuum is excellent for treating facial skin, however, occasionally vacuum treatment can cause purplish-blue spots to form, and the appearance of such symptoms are reduced or eliminated by the simultaneous and long-lasting application of laser light. This advantage is significant compared to the previously used combined vacuum and laser treatments, since in such treatments the duration of the laser irradiation was much shorter and more intensive.

Another advantage over conventional laser treatments is that the vacuum fixes the light-weight device to the skin surface, so there is no need to carefully hold the device, which is a major convenience, especially when treatment is required in areas of the body that are difficult to reach by hand. This solution greatly extends the possibilities for home use.

A large number of variations of soft laser treatment of different parts of the body are known, the use of the device 10 according to the invention is enhanced by the additional effects mentioned above, and therefore the invention cannot be limited to any one variation of laser treatment.

Note that periodic vacuum treatment is already known to increase and stimulate circulation locally, and it is precisely because of the increased blood flow that such treatments have a known beneficial therapeutic effect without the use of laser light. However, the combination with soft laser light adds a large and unpredictable advantages, which can provide shorter treatment times and enhanced healing and regeneration. An additional advantage of the device according to the invention is that all the elements necessary for vacuum generation and control are inside the housing 11, eliminating the need for a separate external vacuum pump and a unit to support the device. The battery supplied operation makes the unit independent of the electrical network and therefore eliminates the need for expensive and bulky protective circuits, reducing weight and cost, and significantly increasing reliability and ease of use.

The devices 10 of the invention, whether compared to vacuum massage or laser treatments or their known combinations has significant benefits.

Claims

Claims

1. Device using a combination of soft laser and vacuum for therapeutic and/or cosmetic applications, comprising a hollow housing (11) containing at least one laser unit (20) emitting at wavelengths between 400 and 1600 nm and having a power of at least 200 mW, the laser unit (20) comprising at least one laser light source (25), a beam expander (26) placed in the light path thereof and elements for refracting the direction of the light emerging therefrom, a hollow bell (13) which is detachably connected to one end of the housing (11) in such a way that the laser light scattered is directed outwards through the hollow bell (13) and it has an outer rim (35) adapted to be applied to the skin surface to be treated, and a vacuum pump (17) having its suction side in communication with the interior (32) of the bell (13), characterized in that the vacuum pump (17) is located in the interior (32) of the housing (11), and comprising a vacuum valve (18) with two orifices located in the cavity of the housing (11), and two pipe stubs (33, 34) connecting the lower part (21) of the housing (11) to said interior (32), one of the pipe stubs (34) is connected to the suction side of the vacuum pump (17) and this connection establishes said connection with the interior (32) of the bell (13), and the other pipe stub (33) connects the interior (32) of the bell (13) to one side of the vacuum valve (18), the other side of which is connected to the inner cavity of the housing (11) at atmospheric pressure and includes a control unit (40) which controls and provides for the vacuum valve (18), the vacuum pump (17) and the laser unit (20), that when the bell (13) is placed on the skin surface (30) to be treated, a vacuum is generated in the interior (32) with a given time function, and the scattered light of the laser unit (20) is then incident on the skin surface (30) to be treated.

2. The device according to claim 1, wherein the housing (11) comprises a battery (16) for supplying power to the electrical and electronic units.

3. The device as claimed in claims 1 or 2, wherein the housing (11) has a section (22) with communicating central bores extending into the interior (32) of the bell (13), the laser unit (20) is located in said bores and includes a beam expander (26) and a closure disc (28) below the beam expander (26) closing the lower end of the bores, which has an axial distance of between 2 and 7 mm between its front surface (29) and the rim (35) of the bell (13), allowing the vacuum created in the interior (32) to suck the skin surface (30) to be treated towards the front surface (29) of the closure disc (28).

4. The device according to claim 3, wherein said beam expander (26) has on its outer surface a plurality of small transparent beads (27), which together form said light direction refracting elements.

5. The device according to claim 3 or 4, wherein the closure disc (28) has a centrally arranged light deflecting cavity (31) inside it in the direction of the light path.

6. The devices according to any one of claims 1 to 5, wherein the housing (11) has a cover (12) closing the cavity thereof, the cover (12) having a display (14) and controls (15) for setting the desired mode of operation, the device further comprising a pressure sensor (52) for sensing the pressure of the interior space (32), and a bluetooth module (51) connectable to an external control and transmitting data representative of the status of the apparatus.

7. The device according to claim 6, wherein the control unit (40) comprises a microprocessor which controls the electronic units of the device according to the setting of each of the electronic units and adjusts the difference between the on and off pressure values of the vacuum pump (17).

8. The device according to claim 7, wherein the vacuum valve (18) is controlled to open when the cyclically varying vacuum is to be adjusted and the vacuum has reached the lower pressure threshold, and in the event of a power failure, disturbance, or abnormality in the apparatus.

9. The device according to any one of claims 1 to 8, wherein at least the lower part (21) of the housing (11) and the parts connected thereto are of circular symmetrical design.

10. The device according to any one of claims 1 to 8, wherein the rim (35) of the bell (13) is made of or coated with a flexible, soft material.

11. The device according to any one of claims 1 to 10, wherein the duration of a treatment period is between 3 and 10 minutes.

12. The device according to any one of claims 1 to 11, wherein the power of the laser light source (25) is between 200 and 2500 mW.

13. The device according to any one of claims 1 to 12, wherein the wavelength of the laser light source (25) is between 400 and 1600 nm.

14. The device according to any one of claims 1 to 13, wherein the starting and terminating the operation of the vacuum pump (17) is set at two different negative pressure values, wherein the pressure value associated with the starting is lower.

15. The device according to claim 14, wherein the vacuum valve (18) I set to open state following a predetermined time has elapsed following the starting of the vacuum pump (17).