WO2020043931A1

WO2020043931A1 - Method and system for remote monitoring of an electronic treatment device

Info

Publication number: WO2020043931A1
Application number: PCT/FI2018/050606
Authority: WO
Inventors: Kristo KIVILAAKSO; Juho Lauronen
Original assignee: LymphaTouch Oy
Priority date: 2018-08-28
Filing date: 2018-08-28
Publication date: 2020-03-05

Abstract

A method and a system for remote monitoring of an electronic treatment device (10) for providing treatment on a patient are presented. The method comprises recording (305) device usage data (15) at the electronic treatment device (10), establishing a first communication connection between the electronic treatment device (10) and a patient data server (30), transmitting, via the first communication connection, the device usage data (15) from the electronic treatment device (10) to the patient data server (30), recording (330) patient data (45) at a first electronic device (40), establishing (340) a second communication connection (170) between the first electronic device (40) and the patient data server (30), transmitting (350; 350A, 350B), via the second communication connection (170), the patient data (45) to the patient data server (30), and wherein the device usage data (15) and the patient data (45) at the patient data server (30) are associated with each other.

Description

METHOD AND SYSTEM FOR REMOTE MONITORING OF AN ELECTRONIC TREATMENT DEVICE

FIELD OF THE INVENTION

The present invention relates in general to methods and systems for monitoring of elec- tronic treatment devices. In particular, however not exclusively, the present invention concerns monitoring of a negative pressure treatment device and to a system comprising the negative pressure treatment device.

BACKGROUND

There are known electronic treatment devices, such as ones utilizing negative pressure for treating skin tissue. One of such known solutions is an adjustable massage apparatus. The massage effect of such apparatus is based on a suction effect created in association with a treatment head of the apparatus. The treatment head of the apparatus includes a surface which comes in contact with the skin, a frame, and a low-pressure chamber in connection with this surface and a low-pressure hose in connection with the low-pres- sure chamber for creating low-pressure suction in order to lift the skin tissue.

Known treatment devices are essentially standalone devices which can, however, further include a communication interface for performing maintenance of the device, such as to upload a new firmware into the device. This is typically done by connecting a cable between a computer and the treatment device for establishing a connection there- between.

Treatment of medical condition of a patient is typically supervised and monitored by a medical professional, such as a doctor, a nurse or a physiotherapist. Patients using known treatment devices at home, for instance, must visit the medical professional in certain time intervals for evaluation of their medical condition. During these visits, the medical professional can instruct the patient on using the devices and on which parameters to use, etc. However, the medical professional does not have any information, at least no actual data, of the treatment sessions and on how the patient is following the treatment plan other than what the patient tells the medical professional.

There is thus still a need to develop methods and systems for remote monitoring of treat ment devices, such as its usage in treatment, so that medical professionals as well as the patients themselves can evaluate the following of the treatment plan and the treatment progression, such as the condition of the patient. SUMMARY

An objective of the present invention is to provide a method and a system for remote monitoring of an electronic treatment device suitable for providing treatment on a pa tient. Another objective of the present invention is that the method and the system pro- vide actual data, such as statistics, of the treatment sessions with the electronic treatment device and of the condition of the patient. The patient and/or a medical professional can then access the data remotely to evaluate the effective of the treatment.

The objectives of the invention are reached by a method and a system as defined by the respective independent claims. According to a first aspect, a method for remote monitoring of an electronic treatment device, such as a negative pressure treatment device, suitable for providing treatment on a patient is provided. The method comprises:

- recording device usage data at the electronic treatment device,

- establishing a first communication connection, such as via wireless and/or wired com- munication connection via the internet, between the electronic treatment device and a patient data server,

- transmitting, via the first communication connection, the device usage data from the electronic treatment device to the patient data server,

- recording patient data at a first electronic device, such as a smartphone, - establishing a second communication connection, such as via wireless and/or wired communication connection via the internet, between the first electronic device and the patient data server,

- transmitting, via the second communication connection, the patient data to the patient data server, and wherein the device usage data and the patient data at the patient data server are associ- ated with each other.

The association of the patient data with the device usage data may advantageously be performed on the patient data server. The association in general may be performed based on the patient ID and the device ID, such as a serial number of the device. The patient data server may preferably be secure server configured to store delicate pa tient related data. The access to such server may preferably include authorization such as credentials, username, password, use of smart card to login, etc.

The method may comprise establishing a third communication connection, such as a Wi- Fi™, or BlueTooth™ or some other known short-range wireless connection, between the first electronic device and the electronic treatment device, and receiving from the electronic treatment device, via the third communication connection, the device usage data at the first electronic device.

The first communication connection may include or be arranged via at least the second communication connection and the third communication connection. In these embodi ments, the association of the data may alternatively or in addition be performed at the first electronic device.

The method may comprise providing an interface at the patient data server for connect ing a second electronic device having an authorization to access data on the patient data server. The interface may preferably have been configured to require authorization, such as credentials, from the second electronic device. The method may comprise connecting the second electronic device to the patient data server via the interface, and obtaining, such as via the interface, the associated device usage data and patient data from the pa tient data server.

The method may comprise establishing a fourth communication connection, such as via wireless and/or wired communication connection via the internet, between the electronic treatment device and a device data server, and transmitting the device usage data from the electronic treatment device via the fourth communication connection to the device data server. The device data server may preferably be an independent server with respect to the patient data server. The fourth communication connection may include or be ar ranged via at least the third communication connection and a fifth communication con nection, such as via wireless and/or wired communication connection via the internet. The fifth communication connection may be arranged between the first electronic device and the device data server. Thus there is no need to have a direct communication con nection arranged between the electronic treatment device and the device data server.

The method may comprise receiving at the first electronic device a notification or in structions, such as a reminder or a treatment plan, from the second electronic device on using the electronic treatment device. The first electronic device or the second electronic device may be a personal computer or a laptop, or a smart mobile device, such as a smartphone, a phablet or a tablet, the first electronic device or the second electronic device comprising a display for display ing the patient data and/or the device usage data.

The electronic treatment device may be a negative pressure treatment device configured to introduce negative pressure at a suction opening of the device, wherein the suction opening is configured to be faced towards or pressed against or to be in contact with skin of the patient.

The device usage data may include information about at least one of the following: used values of negative pressure during usage, characteristics of vibration during usage, pul- sation settings or parameters during usage, and used treatment programs, a duration of the use a treatment program, time of use of the treatment program.

The patient data includes information about at least one of the following: pain value, such as visual analogue scale pain value, range of motion, circumference at a treatment target area on the skin, such as circumference of a limb of the patient.

The method may comprise determining the range of motion by utilizing an accelerome- ter and/or a gyroscope comprised in the first electronic device.

According to a second aspect, a system for remote monitoring of an electronic treatment device, such as a negative pressure treatment device, suitable for providing treatment on a patient is provided. The system comprises the electronic treatment device, a patient data server, and a first electronic device, wherein the electronic treatment device is con figured to record device usage data, and the first electronic device is configured to record patient data. The system is configured to

- establish a first communication connection, such as via wireless and/or wired commu nication connection via the internet, between the electronic treatment device and the patient data server,

- establish a second communication connection, such as via wireless and/or wired com munication connection via the internet, between the first electronic device and the pa tient data server,

- transmit, via the first communication connection, the device usage data from the elec tronic treatment device to the patient data server, - transmit, via the second communication connection, the patient data to the patient data server, and wherein the device usage data and the patient data at the patient data server are associ- ated with each other.

The system may be configured to establish a third communication connection, such as a Wi-Fi™, or BlueTooth™ or some other known short-range wireless connection, be- tween the first electronic device and the electronic treatment device, and to transmit from the electronic treatment device, via the third communication connection, the device us- age data to the first electronic device.

The first communication connection may be arranged via at least the second communi cation connection and the third communication connection.

The system may comprise a second electronic device, and the system may be configured to provide an interface at the patient data server for connecting the second electronic device having an authorization to access data on the patient data server.

The system may be configured to connect the second electronic device to the patient data server via the interface, and to obtain, such as via the interface, the associated device usage data and patient data from the patient data server.

The system may comprise a device data server, wherein the system is configured to es tablish a fourth communication connection, such as via wireless and/or wired commu nication connection via the internet, between the electronic treatment device and a de vice data server, and to transmit the device usage data from the electronic treatment device via the fourth communication connection to the device data server.

The fourth communication connection may be arranged via at least the third communi cation connection and a fifth communication connection, wherein the fifth communica tion connection is arranged between the first electronic device and the device data server. Thus there is no need to have a direct communication connection arranged between the electronic treatment device and the device data server.

The system may be configured to receive at the first electronic device a notification or instructions, such as a reminder or a treatment plan, from the second electronic device on using the electronic treatment device. The present invention provides a method and a system for remote monitoring of an elec- tronic treatment device for treating a patient, such as a negative pressure treatment de- vice. The present invention provides advantages over known solutions such that a med- ical professional can remotely monitor essentially in real time or from stored infor mation, such as statistics, self-treatment of the patient or user of the electronic treatment device by having in his or her disposal patient data and corresponding device usage data.

Various other advantages will become clear to a skilled person based on the following detailed description.

The expression "a number of’ may herein refer to any positive integer starting from one (1)·

The expression "a plurality of’ may refer to any positive integer starting from two (2), respectively.

The terms“first”,“second” and“third”, etc., are herein used to distinguish one element from other element, and not to specially prioritize or order them, if not otherwise explic- itly stated.

The exemplary embodiments of the present invention presented herein are not to be in terpreted to pose limitations to the applicability of the appended claims. The verb "to comprise" is used herein as an open limitation that does not exclude the existence of also un-recited features. The features recited in depending claims are mutually freely com- binable unless otherwise explicitly stated.

The novel features which are considered as characteristic of the present invention are set forth in particular in the appended claims. The present invention itself, however, both as to its construction and its method of operation, together with additional objectives and advantages thereof, will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings.

BRIEF DESCRIPTION OF FIGURES

Some embodiments of the invention are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings.

Figure 1 illustrates schematically a system according to an embodiment of the present invention. Figure 2 illustrates schematically an electronic treatment device according to an embod- iment of the present invention.

Figure 3 illustrates schematically some steps of a method according to embodiment of the present invention.

DETAILED DESCRIPTION OF SOME EMBODIMENTS

Figure 1 illustrates schematically a system for remote monitoring of an electronic treat ment device 10, particularly a negative pressure treatment device 10 such as described hereinafter with respect to Fig. 2, according to an embodiment of the present invention. The system may comprise the electronic treatment device 10, a patient data server 30, which may be, for example, cloud-based server comprising memory storage resource 35, and a first electronic device 40. The electronic treatment device 10 may be config ured to record device usage data 15, and the first electronic device 40 may be configured to record patient data 45. The system may be configured to establish a first communica tion connection between the electronic treatment device 10 and the patient data server 30, establishing 340 a second communication connection 170 between the first elec tronic device 40 and the patient data server 30, transmit, via the first communication connection, the device usage data 15 from the electronic treatment device 10 to the pa tient data server 30, transmit 350, via the second communication connection 170, the patient data 45 to the patient data server 30. The device usage data 15 and the patient data 45 at the patient data server 30 may preferably be associated with each other.

The second communication connection 170 may be, for example, wireless connection such as Wi-Fi™ or cellular data connection, for example, by 3G or 4G technology. Pref erably, the second communication connection 170 is a secure connection.

A third communication connection 140 may be configured to be established between the first electronic device 40 and the electronic treatment device 10. The third communica tion connection 140 may preferably be a short-range wireless communication connec tion, such as by Bluetooth™.

According to various embodiment, the first electronic device 40 is a personal computer or a laptop, or, preferably, a smart mobile device, such as a smartphone, a phablet or a tablet, the first electronic device 40 comprising a display for displaying the patient data 45 and/or the device usage data 15. The first electronic device 40 may be, for example, a smartphone running on an operating system, such as android or iOS. The smartphone may include typical features, such as cellular communication means, short-range wireless communication means, camera(s), microphone(s), speaker(s), processing unit(s), display, memory, such as non-transitory memory, element(s), etc. The device 40 may also comprise various inputs and outputs, such as micro-USB (Universal Serial Bus) and/or audio port. The first electronic device 40 may in some embodiments com prise sensors, such as an accelerometer, a gyroscope and/or a GPS (global positioning system).

The electronic treatment device 10 may be configured to record device usage data 15 at the electronic treatment device 10, such as in memory, for example, in a non-transitory memory element or device. The usage data 15 may be recorded and/or stored, for exam ple, as charts or tables in the memory. The device usage data 15 may include information such as how many times the device has been started, average, maximum and minimum pressures used, what treatment programs have been used, vibration, and pulsation set tings used, for instance.

The device usage data may include information about at least one of the following: time of usage, total time of usage, used treatment settings or parameters during usage, used treatment programs during usage.

The first electronic device 40 may be configured to record patient data, such as in memory of the electronic device 40, for example, in a non-transitory memory element or device. The patient data may be recorded and/or stored, for example, as charts or tables in the memory. Furthermore, the electronic device 40 may be configured to re ceive the device usage data via the third communication connection 140.

The patient data 45 may include information about at least one of the following: patient condition, evaluation of effectiveness of treatment.

The patient data server 30 may be configured to receive the device usage data 15 and the patient data 45 via the second communication connection 170. The device usage data 15 and the patient data 45 at the patient data server are preferably associated with each other. According to one alternative embodiment, the association of the device usage data and the patient data with each other is performed at the first electronic device 40, and then transmitted to the patient data server 30. According to another embodiment, the data are transmitted from the first electronic device 40 unassociated and then being as sociated at the patient data server 30.

According to an embodiment, the system may comprise a second electronic device 60 having an authorization to access data on the patient data server 30. The authorization may be implemented by providing credentials or smart cards to medical professionals which are to read the patient data 45 and/or the device usage date 15 from the patient data server 30. The second electronic device 60 may preferably be configured to connect to the patient data server 30, such as over internet. The second electronic device 60 may be connected to the patient data server 30 via a seventh communication connection 160, such as over the internet.

The system may further comprise a device data server 20. The electronic treatment de- vice 10 may be configured to connect to the device data server 20 via a fourth commu nication connection, such as via internet, for transmitting device usage data to the device data server 20. There may be a fifth communication connection 130 may be arranged between the first electronic device and the device data server. Thus there is no need to have a direct communication connection arranged between the electronic treatment de- vice 10 and the device data server 20. However, there may also be a direct communica tion connection 110, such as via the internet, between the electronic treatment device 10 and the device data server 20.

Additionally, the system may comprise a first further electronic device 50 connected to the patient data server 30 or the device data server 20, such as through a first further connection 150, such as via the internet, or through a second further connection 190, such via the internet. This may be, for example, for use in maintenance and/or research and development purposes, such as by analyzing anonymous device usage date 15 on the device data server 20, or initiating updates to one, some or all devices 10 being con nected to the system.

According to an embodiment, there may be a further communication connection 120, such as via the internet, between the device data server 20 and the patient date server 30. Thus information may be exchange between these two servers, for example, so that the patient data server 30 requests information from the device data server 20 in order to see if there are any new device usage date 15 related to the particular device 10, and there fore, to a particular patient. Thus, the treatment plan can be monitored remotely by a medical professional connected to the patient data server.

Figure 2 illustrates schematically a negative pressure treatment device 10 which may be utilized in the system for remote monitoring of the electronic treatment device 10 ac cording to an embodiment of the present invention.

The negative pressure treatment device 10 may comprise a treatment head 2, a central processing unit 1, a treatment cup 3, a low pressure chamber 6, or a negative pressure chamber 6, and means for producing the low pressure, or the negative pressure, in the low pressure chamber 5, and, optionally, a sealing part 4. The central processing unit 1 may be arranged in connection with the treatment head 2 or in connection with a central unit 8 as shown in Fig. 2. The low pressure chamber 6 and the means for producing low pressure in the low pressure chamber 5 are shown schematically by dashed lines in Fig. 2.

The means for producing the low pressure 5 (negative pressure flow/suction effect), e.g. with a vacuum pump or a fan, may be in the treatment head 2 or in the central unit 8 in which case the means for producing the low pressure 5 is arranged in connection with the treatment head 2, e.g., by a hose 9.

There may be a display in the treatment head 2 and/or in the central unit 8. The central unit 8 may further incorporate an interface for an external display. In some embodi- ments, the features of a central unit 8 could even be combined with the treatment head 2 into an integral apparatus. In some embodiments, the pump or fan 5 could be included in the treatment head 2 while there is still provided a central unit 8 or similar element connected to the head 2 by a flexible element such as a cable or wiring for electricity and/or data transfer, for example. These types of embodiments would not obviously ne- cessitate the use of a hose 9 for the suction flow between the elements 2, 8. When the pump or fan 5 is located within a common housing with the chamber 6, these two may still be connected via internal piping, hose(s) and/or duct(s), for example, for conveying the low pressure flow.

One end of the treatment cup 3 may be arranged to be in connection with the low pres- sure chamber 6 and the other end may be arranged to be pressed towards (meaning in this application a degree of contact or a magnitude of force from a gentle touch/contact to more intense pressing) the skin tissue to direct low pressure suction to the target area, typically skin tissue, thus producing a bulge in the skin tissue. The skin preferably refers herein to all skin layers i.e. epidermis, dermis, hypodermis or subcutis.

The end of the treatment cup 3 which is arranged to be pressed towards (typically against) the skin tissue is the lower end of the treatment cup 3 in Fig. 2. The treatment cup 3 is arranged to form a suction opening 7. The suction opening 7 may be of any shape, for example, round, ellipse or oval. There may also be other shapes. The treatment cup 3 with an appropriate size, shape and/or material may be chosen based on the nature or size of the target area of the skin to be treated, for instance. The treatment cup 3 may further comprise a sealing part 4 advantageously made of a flexible material and arranged at the end of the treatment cup 3 that is arranged to be pressed against the skin tissue and to adapt to the shape of the suction opening 7 formed by the treatment cup 3 and to seal the gap between the end of the treatment cup 3 and the skin tissue when the end of the treatment cup 3 is pressed against the skin tissue.

The sealing part 4 may be made of any suitable flexible material, such as polyurethane or elastomeric material. The use of other plastic materials and silicon material is also possible. At the sealing part 4, it is naturally also possible to use a suitable material that reduces or increases the friction between the sealing part 4 and the skin tissue, and/or a material that improves the sealing, depending on whether the objective is to achieve a good mobility for the treatment head or as high a friction force as possible. Mobility may also be increased by using a number rotating elements, such as rollers, which are in connection with the treatment cup 3. The rotating elements, in addition to the sealing part 4, may also provide sealing function between the skin and the treatment cup 3.

As the treatment head 2 of the negative pressure treatment device is moved against the patient's skin, most comfortably using a handle, the effect of the low pressure causes a fold of skin to be pulled up into the low pressure chamber 6.

Regarding the sealing part 4, which is to be pressed against the skin tissue, said part 4 may be arranged to be concave in the direction of at least one of the perpendicular main axes of the suction opening 7 formed by the treatment cup 3.

The sealing part 4 may be a separate part fastened to the end of the treatment cup 3. The sealing part 4 may be a disposable part, which is detached after use and replaced by a new one in the beginning of the treatment of a new patient. Alternatively, the sealing part 4 may be reusable after washing or disinfecting. The fastening to the end of the treatment cup 3 may be achieved by means of various connections. At the end of the treatment cup 3, which is to be pressed against the patient’s skin, there may be a flange in the radial direction, which is used for fastening the sealing part 4 made of a flexible material to its place. Thus, the schematically shown connection of the sealing part 4 in figures is not to be understood as a factor limiting the embodiments of the negative pres- sure treatment device used in connection with the method according to the present in vention. It is also to be noted in this context that the sealing part or portion 4 may be formed as an integral part of the treatment cup 3, for instance. This may be done by molding or casting, such as utilizing a mold, the material of the sealing part 4 on the treatment cup 3, for instance. In various embodiments, an opening 7 for subjecting the target tissue such as skin to the suction may be defined by a treatment cup 3 (part or portion) of the treatment head 2. The treatment cup 3 may be adaptable in size to best fit the shape of the treated body part. The adaptability may be implemented by a plurality of interchangeable cups of different size and/or by an adjustable cup. For example, the applicable size may range from about 10 or 20 mm to 80 or 90 mm in diameter depending on the dimensions and shape of the target area. As a general rule, a largest cup considered suitable for the area may be selected. For instance, 60-80 mm size may be more suitable for the neck than for facial areas that benefit from using a smaller diameter cup and related opening.

The negative pressure treatment device 10 is thus not restricted to the example of the figure in any way, but the apparatuses may be varied entirely freely within the scope of the claims. Thus, it is clear that the invention is by no means restricted to any specific shape or dimension of the treatment cup 3 or other components, for instance, but the shape and/or dimensions of the different elements and parts of the invention may differ from one another freely between embodiments, if desired. The idea of the present inven tion may even be applied in connection with such treatment heads at which rotating elements such as rollers are employed, as mentioned hereinbefore.

The low pressure in the low pressure chamber 6 is advantageously produced by using the aforementioned vacuum pump. Necessary adjusting valves are also advantageously mounted in connection with the vacuum pump.

In addition, in case an embodiment of the negative pressure treatment device with a central unit 8 is utilized, the hose 9 may have a valve which is advantageously positioned near the low pressure chamber 6. The speed of the system may further be improved by using the hose 9 as a low pressure reservoir. Thus, higher or lower pressure may be achieved in the hose 9 compared to the pressure desired in the low pressure chamber 6, especially in case a central unit 8 is utilized lf, for example, change of pressure from 150 to 200 mmHg is desired, the pressure of the low pressure chamber 6 is 150 mmHg and if in the subsequent phase a pressure of 200 mmHg is desired, the pressure of the hose 9 may already be set for example to 500 mmHg, so that upon opening of the valve a pressure of 200 mmHg is achieved quickly in the low pressure chamber 6 and the valve may be closed. The valve may be arranged to be controlled by pulse width modulation for adjusting the low pressure in the low pressure chamber 6. In some embodiments the valve may control higher frequency oscillation (described in more detail hereinafter) produced in addition to lower frequency suction pulses. Alternatively, higher frequency oscillation could be produced by other element(s), such as electric motor or‘vibrator’. In some embodiments, the oscillation could be at least temporarily solely produced (i.e. no simultaneous lower frequency pulsation).

Subsequently, if a pressure of 150 mmHg is again desired, in which case a pressure of for example 50 mmHg may be set in the hose 9 so that a change from 200 mmHg to 150 mmHg is quick. Furthermore, the low pressure chamber 6 when positioned against the target area (skin) may be either substantially sealed or it may have a controlled leakage, for example, through a small opening.

Reverting, in particular, to Figs 1 and 4, the negative pressure treatment device utilizable in the method according to the present invention preferably comprises a number of dif ferent sensors 11 , one of which, for example, measures the composition of the skin tissue and/or underlying tissue, such as the fluid content and/or flow, fat content and/or oil content. For measuring the target characteristics, each sensor 11 may contain a number of exclusive or shared sensor, or‘sensing’, elements such as electrodes or optical sensor elements. Separate sensors 11 may also be used for measuring fluid and fat contents. One sensor 11 may, for example, measure the raised skin (bulge) produced by the suc- tion effect and one other sensor 11 may measure, for example, the suction force applied to the skin. The low pressure suction and specifically e.g. suction force may be adjusted according to the results of the measurements. Therefore, the apparatus may be adaptive and especially dynamically adaptive. Yet, the negative pressure treatment device may comprise a sensor 11 which measures the skin temperature. The sensors 11 may be de- signed for contactless or contact-based (e.g. contact electrodes) measurements.

Still, the apparatus may in some embodiments comprise a sensor 11 for measuring the skin's blood circulation, the measurements of which may be used to adjust of the opera tion of the negative pressure treatment device. Further, the adjustment may be based on measurement of transepidermal water loss and skin pH.

Each sensor 11 may be in connection with the treatment head 2 (e.g. removably or fix edly attached thereto) or communicate with the negative pressure treatment device through a wired or wireless connection, such as, for example, a radio frequency signal, infrared signal or the like. Thus, the sensors 11 may be an integrated or separate part of the negative pressure treatment device.

The apparatus may have at least one sensor that registers a signal given by the patient for increasing/decreasing the suction effect, based on which the adjustment of the suc tion may be done. The patient may thus give a signal to the sensor (for example, based on the pain experienced) and the sensor then relays to the apparatus the wish for the increase/decrease of suction efficiency. The sensor, such as a touch-registering sensor (e.g. a button), may be included in a user interface of the apparatus.

In one embodiment of the negative pressure treatment device, it may further comprise additional energy source(s) for warming the skin tissue and furthermore, means for au- tomatically adjusting the energy source(s) to a set point value based on the measure- ments obtained by one or more sensors 11. Energy source may also be utilized to power up the apparatus for treating a patient.

Measurement techniques utilized in the embodiments of the negative pressure treatment device may include measurement of different sound frequencies, such as ultrasound and infrasound, techniques based on radio frequencies and different wavelengths of light, i.e. optical measurement such as laser and infrared measurement, bioimpedance (bioelectri cal impedance) spectroscopy or other bioimpedance measurement, magnetic resonance spectroscopy, Raman spectroscopy, nuclear magnetic resonance spectroscopy, mi crosensor mapping, heat camera imaging, or spectrofotometric intracutaneous imaging.

Indeed, at least one sensor 11 may be provided, e.g. on either or both sides of the cup 3 or sealing part 4 thereof, to measure water or generally fluid content. The measurement may thus be local and indicate localized or e.g. body segment localized property or quan tity such as the amount of accumulated cell fluid or lymphedema of tissue underlying the target area.

In addition to the mere target area, i.e. area covered by the treatment head 3, 4, or un derlying volume the measurements may be cover further area or volume adjacent thereto, depending on the configuration (positioning/spanned area or volume, type, etc.) of the used sensor(s) 11.

In some embodiments, the negative pressure treatment device may comprise sensors 11 that are wiredly or wirelessly connected thereto and may thus span a considerable larger or different, potentially remote, area/volume than that covered by e.g. the treatment cup 3 or part 4 defining the suction opening 7 of the negative pressure treatment device.

In some embodiments, the at least one sensor 11 may include at least two sensor ele ments such as contact electrodes, optionally e.g. four electrodes. There may be one elec trode per sensor 11, for example, or several electrodes, e.g. an array of electrodes, may be considered to at least functionally belong to the same sensor 11. Nevertheless, the electrodes may be configured to execute e.g. two-terminal or four- terminal sensing of bio impedance or other parameter indicative of tissue fluid content, such as extracellular, intracellular, and/or total fluid content, and thus of potential lymphedema.

For instance, at least two electrodes may be current (driving) electrodes whereas at least other two electrodes serve as voltage (sensing) electrodes. In the case of two electrodes only, for example, both the electrodes may serve current while being used for sensing as well.

In some embodiments, only one electrode may suffice. For example, capacitive sensing may be performed using one or more electrodes.

The central processing unit 1, which may refer to e.g. one or more microcontrollers, microprocessors, signal processors and/or other circuitry, may be configured, in accord- ance with computer program instructions stored thereat (in integral or separate memory), to determine the selected properties or quantities, e.g. one or more indices of bioimped- ance. based on the sensor data typically obtained via a number of electrodes.

The bioimpedance measurement may be executed based on determining resistance to the current flow. From the obtained data, other information may be derived and esti mated regarding e.g. fat level.

In some embodiments, single frequency, multi-frequency or spectroscopy type, i.e. broadband, measurements may be executed for determining the desired property/quan tity such as bioimpedance and/or its constituents such as resistance and reactance. The used frequencies may vary between 0 kHz and 1000 kHz (more specifically e.g. 0-30 kHz), for example, depending on the type of the used sensors and the property to be determined. The desired frequency range of alternating drive current may be covered by a selected number of intermediate frequencies at which measurements are taken.

To diagnose different conditions, such as lymphedema, the obtained measurement re sults such as bioimpedance readings or quantities derived therefrom may be then com pared with selected, typically prestored, threshold values to determine whether the pres ence of condition is likely or not.

Higher frequencies penetrate the cell membranes (which can be modelled as capacitors) better and therefore reach intracellular space and qualify for associated intracellular (fluid) measurements while lower frequencies may be typically used for mere extracel- lular space analysis.

In some embodiments, capacitive sensing may be applied for edema and particularly lymphedema determination. The capacitance measured may be proportionate to the di- electric constant of the skin and the subcutaneous tissue, which in turn indicates the water or fluid content thereof. Frequency or frequencies between e.g. 20 and 500 Hz may be applied in the measurements.

In some embodiments, elastic force of the skin/tissue and e.g. (edema) pressure thereof may be determined. Because of the negative pressure formed in the chamber 6, the in ternal pressure in the inter-tissue/intercellular space, in the blood vessels and the lym phatic vessels expands tissue volume and stretches and/or raises the skin, which is elas tic. At first, the tissue pressure in the expanded point is lower than in the surrounding tissue space. The inter-tissue fluid/interstitial fluid, the blood and the lymph are trans ferred from the higher pressure towards the lower pressure and fill up the expanded vol ume. Thus the skin rises until equilibrium finally is reached because of the elastic force of the tissue. In the state of equilibrium, the forces caused by the elasticity of the tissue and the air pressure in the pressure chamber are of the same magnitude as the force of the tissue pressure. In the above mentioned event, the pressure and the pressure change can, based upon the signal given by a pressure sensor, be measured as a function of time and likewise, based upon the measurements of a range sensor, the rising of the tissue and/or skin is known as a function of time. The results of the measurements are trans ferred to the processing unit 1, where the data is saved and processed. Based upon these measurements, the unit 1 calculates the elastic force of the skin and/or the tissue and further the pressure or edema pressure of the skin and/or the tissue.

Accordingly, mechanical, physical and/or e.g. electrical characteristics of the skin and underlying subcutaneous tissue may be monitored by the embodiments of the present invention through introduction of necessary sensing hardware and logic in the apparatus.

In some embodiments of the negative pressure treatment device, the potentially auto mated adjustment of the low pressure suction and/or suction force is based on mechani cal characteristics and/or electrical characteristics and/or structure and/or composition of the skin. Mechanical characteristics include strength, flexibility, elasticity and resili ence etc. Electrical characteristics include, for example, capacitance, impedance, re sistance, reactance and inductance. In some embodiments, the apparatus may comprise a number of additional elements, which are configured to operate e.g. as energy sources (e.g. laser, ultrasound or infra sound emitter, etc.) for treating the tissue, such as for heating. The elements may be based on sound, light, radio frequency or electricity, for example, The measurements from one or more sensors may be then advantageously used for automatically adjusting the energy sources to the desired value.

In addition, the potentially automated adjustment of the apparatus may in one embodi- ment be based on measurements of the flow of lymphatic fluid. The associated measur ing techniques for the flow of lymphatic fluid may be selected from known techniques, such as, but not limiting to, isotope clearance technique.

In one embodiment of the negative pressure treatment device, the adjustment may also be based on the measurement of the patient's experience of cutaneous pain. Based on the experience, either the patient him/herself, or the operator, or both together adjust the apparatus's running parameters. Skin characteristics, when mentioned in this text, also include the pain felt and experienced on the skin.

In an embodiment of the negative pressure treatment device, a computer program, as alluded to hereinbefore, guides in the application of the suction force by presenting the force level audibly and/or visually in the treatment head 2 and/or in the central unit 8 (e.g. via display 10 in case of visual information). Low pressure suction may be adjusted automatically using the computer program, and thus it is not necessary for the patient or operator to adjust the low pressure suction during the treatment. Advantageously, when the treatment force exceeds the permitted value, the program stops the apparatus or low ers the suction force.

The computer program may be utilized to calculate the target value of one or more on going treatment forces, such as suction force, based on the measurements obtained and/or on the desired value of the suction pressure. Therefore, the apparatus also com prises sensor/sensors as mentioned hereinbefore for measuring one or more ongoing treatment forces, such as the level of the suction force. A computer program may be configured to automatically calculate and adjust the level of low pressure suction to the target value, based on the measurements obtained. The parameters/results of the meas urements, which may be taken into account in determining the target value of the low pressure suction, include e.g. fluid content of the skin tissue, fat content of the skin tis sue, the bulge i.e. the lift of the skin tissue (the size of the fold in the skin) and/or the skin temperature. Furthermore, the computer program may be functionally connected to database, which contains the patient's treatment information. The database may be remote and hosted by a remote computer or computer system, which is accessed via a communications con nection or network, e.g. the Internet. For the purpose the treatment may include a wired or wireless data interface, e.g. USB (Universal Serial Bus), cellular, wireless LAN (Lo- cal Area network) or wired LAN interface, or short-range wireless communication in terface^), such as Bluetooth™ or NFC/RFID (Near-Field Communication/Radio Fre quency Identification).

The computer program or at least part, such as few instructions, thereof may be provided on a non-transitory carrier medium such as a memory card or memory chip, or trans ferred as a wired or wireless signal.

In one embodiment of the negative pressure treatment device, it is desired to combine slow, pulsating low pressure to a faster impulse-like oscillation treatment. For instance, the oscillation treatment may be modulated by a pulsating low pressure treatment. ln one embodiment of the negative pressure treatment device, the negative pressure treat ment device is arranged to provide to the low pressure chamber 6 simultaneously a pul sating low pressure treatment, which preferably has a frequency of below 5 Hz, and an oscillation treatment, which for its part, preferably has a frequency of more than 5 Hz. In other embodiment, the threshold frequency between low pressure pulses and high frequency oscillation may be different.

Moreover, a high frequency oscillation treatment may be particularly added to the suc tion phase of the low frequency pulsating low pressure treatment. The oscillation may extend over the whole duration of the low pressure pulse. In some embodiments, in ad dition to the duration of the pulse, the oscillation could be present also during the neutral portion of the signal period. In some embodiments, the duty cycle of 100% (i.e. contin uous suction/pulse) may be applied, whereupon also the optional oscillation may be on all the time. High frequency in this instance may mean for example an impulse-like pressure change or oscillation with a frequency of more than 5, 10, 15 Hz or higher frequencies such as e.g. 90 Hz or even as high as 200 Hz. The hose 9 may be arranged in this case to be used as a pressure reservoir for accelerating pressure variations in the low pressure chamber 6.

When using the high frequency oscillation, higher frequencies affect the (skin) tissue closer to the surface of the skin while with lower frequencies the effect of the treatment ‘penetrates’ deeper into the tissue. Thus by varying the frequency of the high frequency oscillation, the depth of the effect of the treatment may be varied and problems at dif ferent depths of the (skin) tissue may be more effectively treated.

In an embodiment, the pulsation frequency may range from about 0.1 Hz to about 5 Hz, or occasionally even up to 10 Hz depending on the particular embodiment of the appa ratus (supported frequencies). For instance, it may be about 0.5 Hz that corresponds to a 2 second signal period and 1 second pulse duration with 50/50 duty cycle. The suction on the skin tissue when the treatment cup 3 is facing the skin is naturally introduced during the associated on-time (i.e. 1 second in case of 2 second total signal period with 50/50 duty cycle).

Preferably the configured frequency is user-adjustable via a user interface of the appa ratus. The user interface may include a number of control input elements in the form of a touch display, touch pad, button, mouse, Scrollpoint™, roller, voice input interface, keypad, etc. for the purpose.

Accordingly, the UI (user interface) may include e.g. a display and/or audio response interface (typically buzzer or loudspeaker) for data visualization and feedback provision towards the apparatus operator. The operator may be the patient himself/herself or other person who preferably has adequate medical and technical skills to operate the apparatus in sufficient fashion.

Typical pressure (suction, i.e. negative pressure) of the negative pressure treatment de vice may preferably be of the order of about 80 mmHg, falling e.g. within a range from about 5, 10 or 30 to about 250 mmHg, or even up to about 350 mmHg or higher, e.g. about 500 mmHg. As being clear based on this disclosure, the negative pressure is pref erably user-adjustable or -selectable in at least most embodiments. However, use of fixed (user non-adjustable) pressure and potentially other fixed parameters is possible in some embodiments of the apparatus as well. Such embodiments could be targeted to certain very specific use scenarios or applications, for example.

In some embodiments, the operator of the device is provided, via the UI of the device, a pressure setting and/or pressure readings in predetermined, optionally user-selectable, units such as mmHg or pascal. Alternatively or additionally, e.g. a numeric value in a predetermined scale, e.g. between one and five or one and ten, without any particular units could be used for adjustments and/or indicated to the operator. One end of the scale could represent predetermined minimum suction or zero suction, whereas the other end (e.g. maximum number) could represent predetermined maximum suction. The apparatus manages the conversion between the user-indicated pressure and correspond- ing real pressure established.

Instead or in addition to numeric values, the pressure and/or other parameters could be indicated through other symbols, optionally using dot/circle, star, line, curve or rectan gular shapes.

The order of magnitude of high frequency oscillation may range, for example, from about 2 to about 200 Hz, preferably at least from about 5 or 10 Hz to e.g. about 100 Hz.

In head and neck lymphedema, excessive lymph build-up occurs especially at or above the shoulder level.

When using the apparatus to manipulate skin tissue, optionally, lubricant such as mas sage oil may be initially smeared on a target area of the skin. Care shall be taken that the lubricant does not contain particles that could end up within the apparatus during the treatment to avoid clogging the internals thereof and related cleaning procedures.

The treatment head is located so that the associated contact portion, such as preferably replaceable treatment cup, is in close contact with the skin area to be treated, e.g. on the trapezius muscle (shown), spine, or e.g. sternum.

The diameter of an optimum cup generally varies between patients and from a treating technique to another, but in standard case it may range from about 60 mm to about 80 mm, for example. As an applicable basic rule, one could consider to select the largest suitable treating cup for each target area. Fastening of the treatment cup having regard to the rest of the treatment head may incorporate grooves (in the cup or head) and match ing lips (in the head or cup, respectively), snap fastener(s), threads, magnets, frictional and/or pressure contact (e.g. based on the elasticity (enabling stretching) and/or rough ness of the contacting surface(s) yielding tight, secure fit), or any combination of the above or other feasible attachment technologies providing e.g. sufficiently secure and airtight fit between the connected elements.

The treatment head/cup should be hold onto relatively lightly. The cup may typically be kept on the same location for about three to five pulsations, whereafter it may be moved to adjacent skin area with e.g. 1/3 overlap. The total number of locations, or spots, that are treated depends on the overall coverage of the treated condition, which typically defines the target area of treatment, as well as the size of the cup and related suction opening. The area may encompass from about one or two to ten locations, for instance. Either stationary, sliding or hybrid technique may be applied having regard to the lifting of the treatment head during the movement thereof on the skin between the different treated areas. The general direction of motion may be sideways and/or from the top to the bottom (i.e. from the head towards the torso or shoulder line). Thus the overall du- ration of treating a certain area or spot at a time commonly ranges from about one or few seconds to few tens of seconds depending on the utilized pulse duration and duty cycle and thus the overall signal period.

Pulse length/duration may be about one second, for example, and the used pressure e.g. between 50-80 mmHg. Duty cycle may be about 50/50 (50%) between the pulse period and passive period, i.e. pulse-containing and neutral portions of the treatment signal, respectively, whereupon the overall repeating signal period comprising the pulse portion and neutral/passive portion covers two seconds. The duty cycle with two-second signal period may also be, e.g. 20/80 (20%) or 30/70 (30%) in which cases the pulse-containing portion lasts 0.4 or 0.6 seconds and neutral portion 1.6 or 1.4 seconds, respectively. The signal period may be varied preferably from a half to five seconds thus meaning pulsa tion frequency of 0.2 to 2 Hz. The high frequency oscillation additionally provided at least or exclusively during the pulse-containing period (1 second in case of duty cycle of 50/50 (50%) with a two-second signal period) may preferably be from 20-90 Hz.

One shall acknowledge the fact that also the neutral period (at least no low frequency suction) is usually treatment-wise important e.g. in a sense that during it the skin stretch ing stops and the skin recovers its relaxed position. The effectiveness of the treatment is in many respects due to the back-and- forth movement of the skin, not just due to suction- based stretching thereof.

In some cases, the used pulse duration may be about 1 second, duty cycle 50% (thus rendering the overall signal period to two seconds) and pressure (suction) between about 5-350 mmHg, advantageously about 80-250 mmHg, and most advantageously about 80- 120 mmHg, for example. The optimum treatment cup size is often a bit smaller than with neck treatments, thus typically falling between about 35 mm and 50 mm in diame ter. Stationary technique may be preferred over the sliding or hybrid techniques on the sensitive facial areas, but also the latter may be tried.

Having regard to various embodiments, typically one treatment session lasts for about 10-60 minutes at a time. A treatment period may include multiple sessions, e.g. about 10 sessions. As mentioned hereinbefore, in many cases the obtained results are not necessarily permanent, whereupon the therapy should be regularly practiced even after a more intensive therapy period, e.g. once a week.

In some variations of the negative pressure treatment device described herein, the treat ment head and related elements, e.g. suction cups thereof, could be configured for ena bling substantially contactless operation in addition to or instead of contact-based ther apy. During the contactless therapy, the treatment head could be merely hovered close to the target area without actually contacting the skin, for instance. The apparatus could be provided with audible, tactile and/or visible guidance element such as loudspeaker, buzzer, vibration element, indicative lamps (e.g. LEDs) and/or a display, optionally touchscreen, The guidance element could indicate, in real-time fashion, current and/or proper distance between the target surface (e.g. skin) and the treatment head. In contact- based treatment, the cup/flexible element of the treatment head inherently provides such guidance for maintaining a proper distance (in that case, contact) between the head and target surface.

In addition to or instead of measuring or treating e.g. lymphedema such as head and neck lymphedema or other lymphedema, various embodiments of the present apparatus and method may be applied for measuring, treating or at least ameliorating the symptoms of many other conditions including, but not limited to, cording, myofascial pain, fibrotic tissues, scars, neuropathic pain, diabetic neuropathy, chemotherapy-induced neuropa thy, nerve function disorders, postoperative conditions, fibromyalgia or Lyme disease.

Accordingly, the optimum treatment settings such as pulse duration, signal period, os cillation parameters (e.g. frequency) and/or suction strength, may be selected condition- specifically for obtaining best or generally desired treatment result in each use scenario. The apparatus may contain a plurality of user-selectable presets for treating different conditions.

Figure 3 illustrates schematically some steps of a method according to embodiment of the present invention. The electronic treatment device 10 in Fig. 3 is a negative pressure treatment device 10, such as described in connection with Fig. 2.

As can be seen, the electronic treatment device 10 may be configured to record 305 and store device usage data 15 in a memory of the device 10 during the usage of the device 10. At 310, establishing a third communication connection 140 between a first electronic device 40 and the electronic treatment device 10 is being performed. This may prefera bly be a short-range wireless communication connection, such as by Bluetooth™.

At 320A, device usage data 15 is being received via the established third communication connection 140 at the first electronic device 40 from which it is further, associated or unassociated with the patient data 45, being transmitted to the patient data server 30. As an alternative way, at 320B, device usage data 15 is being received via a sixth commu nication connection 125, such as via the internet, at the patient data server 30. Thus, the first communication connection may be a substantially direct connection or through the first electronic device 40.

At 330, patient data 45 may be recorded 330 at the first electronic device 40.

At 340, a second communication connection 170 is being established between the first electronic device 40 and a patient data server 30.

At 350, the device usage data 15 and/or the patient data 45 are/is being transmitted to the patient data server 30 via the second communication connection 170. The device usage data 15 and the patient data 45 at the patient data server 30 are associated with each other, such as, at least by associating respective patient data 45 and the device usage data 15 of the device 10 which said patient has been using, that is, the corresponding data. In some embodiments, the device usage data 15 and the patient data 45 are associ ated with each other at the first electronic device 40 and then transmitted 350 A to the patient data server 30. In another embodiment, the device usage data 15 and the patient data 45 are associated with each other at the patient data server 30 after receiving them at the patient data server 30.

The method may also comprise providing 360 an interface 65 at the patient data server 30 for connecting a second electronic device 60 having an authorization to access data on the patient data server 30. According to an embodiment, the method comprises con necting 370 the second electronic device 60 to the patient data server 30. The method may further comprise obtaining via the interface 65 the associated device usage data 15 and patient data 45 from the patient data server 30 by the second electronic device 60 having the authorization to access data, such as provided for a medical professional, on the patient data server 30.

Regarding the patient data server 30, the server 30 may be configured as HIPAA (Health Insurance Portability and Accountability Act) compliant server. HIPAA provides guidelines how to protect data and handle it. The server may utilize, for example, Mi crosoft Azure web service.

In an embodiment, the method may comprise establishing a direct communication con nection 110 between the electronic treatment device 10 and a device data server 20, and transmitting the device usage data 15 to the device data server 20. In this way, the device usage data 15 may be sent to the device data server 20 unassociated with the patient data. However, the patient data may also be sent to the device data server 20, preferably, anonymously. Data on the device data server may advantageously be utilized to gather information on the usage of the device 10.

The device data server 20 includes and stores information of the electronic treatment devices 10. The device data server 20 may be configured to provide contact interface for the treatment devices 10 or the app running at least partly (at least the front-end) on the first electronic device 40 to connect and exchange the information therebetween. This way information may be gathered about the treatment device 10, for example, device usage data and/or the current device software version, etc. Device data server may be implemented cloud-based server, for instance. The server may be configured to add de vice specific data columns so that all the device data gathered may easily be synced. Every treatment device 10 may be configured to have a specific device ID. To get the device ID, the treatment device 10 needs to connect first to the device server after which the treatment device 10 may be automatically assigned a specific device ID as a response to connecting for the first time to the device server 20. The device data server 20 may also be used to update the treatment device 10, such as its software, or inform the user that there maybe service issue coming up.

When the device is synced with device data server, information of the device usage is gathered. By comparing the information gathered on how the treatment programs are being used and to the statistics gathered from the patient, such as, visual analogue scale (VAS) values, circumference measurements and range of motion data, correlations therebetween can be determined. The data of the device usage and user measurements may be combined anonymously so the patient can’t be recognized from the data and correlations. The data may be configured to be analyzed with algorithms automatically, and, especially in embodiments including a negative pressure treatment device 10, put ting emphasis on user measurements with respect to used pressures and other device settings. In some embodiments, the first communication connection may be established via the first electronic device 40. The device usage data 15 may then be transmitted to the device data server 20 by the first electronic device 40 via a fifth communication connection 130, therefore, not necessarily requiring to establish any other communication from the treatment device 10 in addition to the connection between the treatment device 10 and the first electronic device 40, such as a smartphone or smart device.

The method may, according to some embodiments, comprise receiving at the first elec- tronic device 40 a notification or instructions, such as a reminder or a treatment plan, from the second electronic device 60 on using the electronic treatment device 10. For example, reminders may be provided to the patient directly via an eighth communication connection 180, such as via cellular network or via the internet.

According to various embodiment, the first electronic device 10 is a personal computer or a laptop, or, preferably, a smart mobile device, such as a smartphone, a phablet or a tablet, the first electronic device 40 comprising a display for displaying the patient data 45 and/or the device usage data 15.

According to various embodiments, the electronic treatment device 10 is a negative pres- sure treatment device 10 configured to introduce negative pressure at a suction opening 7 of the device 10, wherein the suction opening 7 is configured to be faced or pressed against, or to be in contact with skin of the patient. In these embodiments particularly, the device usage data 15 includes information about at least one of the following: used values of negative pressure during usage, characteristics of vibration during usage, pul- sation settings or parameters during usage. The patient data 45, on the other hand, in cludes information about at least one of the following: pain value, such as visual ana logue scale pain value, range of motion, circumference at a treatment target area on the skin, such as circumference of a limb of the patient.

Furthermore, instructions on how and from where to measure the circumferential meas urements may be configured to be displayed on the display of the first electronic device 40. This may entail displaying instructional photos or images or videos, for instance. User or patient may then easily measure the circumferential measurements by them selves in order to get and provide information about swelling of, for example, a limb. The app may provide a form to which the user can input the measurements. Measure ments may be visualized in the treatment history section in the chart form to see how the measurements are changing during the time. The effectiveness of the used pressured to the measurements may then be compared to see if there is correlation. The correlations may be utilized to develop more effective treatment programs having parameters which provide the most efficient treatment to a particular condition.

According to one embodiment, the method comprises determining the range of motion by utilizing an accelerometer comprised in the first electronic device 40. There may be a software product or an application or an“app” being at least partly stored in the memory and being executed by the processing unit on the first electronic device 40 that has instructions how to make this range of movement exercise. The sensor data may then be stored or gathered, and with an algorithm and the display visualized to chart form so it easy to follow the treatment history and improvement of the range of movement.

To connect the first electronic device 40 via the app to the treatment device 10, the app must first be downloaded and installed on the electronic device 40. When the app is executed for the first time, the user needs to log in or create account to be able to use the app after which the content of the app is available for the user. The app may include the instructions on how to connect via the app to the treatment device 10. To connect the device with app, app asks the security code visible on the display of the treatment device. This way unauthorized connection can be avoided.

Furthermore, alternatively or in addition, when the treatment device 10 is being con nected via Bluetooth™ to the electronic device 40, the treatment device 10 syncs its data with the software or the application, and/or, optionally, to the device server 20. The device usage data on the first electronic device may be manipulated in various ways, such as by software algorithms. Said application may include algorithms to generate tables and charts of the data, for instance. The gathered data may be visualized in the app to the user via the display, for example, as“Treatment History”, so that the user or patient can see when and how the treatment device was used.

Device usage data may also be utilized to indicate what parameters, such as used pres- sures in the negative pressure treatment device 10, are most commonly used and how these treatment settings affect to the VAS pain scale value indicated by the patient, for instance. The VAS pain scale value may be asked by the application or software, for example, after every treatment session to get the input or feedback from the user on the effectiveness of the treatment. The range of motion and/or the circumference measure- ments may be configured to be compared to the device usage data by which it may be seen that how the device settings are affecting to the treatment results.

According to an embodiment, the software or application or“app” at least partly on the first electronic device 40 may be configured to utilize and/or to receive push notifications, such as from the second electronic device 60. By this feature, the app may be used by the medical professional to remind the user to treat according to a treatment plan. For example, notification can remind the user that there should be treatment today. Notifications may be used also for marketing purposes by the manufacturer of the elec- tronic treatment device 10. The notifications may be used to remind the patients to do the treatments on time and give mental boost and support this way. By visualizing the whole treatment plan for the next coming weeks or months it is easier for the user or the patient to mentally prepare him/herself to the treatments and plan the daily activities accordingly. The push notification feature may be set from the backend of the app via website. The backend of the app, that is at least portion of it, may reside, for example, on the patient data server 30. The user or the patient may enable and disable this feature.

According to various embodiments, the system may be configured to provide various features for the medical professionals having the authorization to access the patient data server. The medical professional may create push notifications the electronic device 40 of the patient informing the patient to sync the treatment device 10 with the app via BlueTooth™ or via Wi-Fi™ to device server, for example, daily. If this is not performed by the user or patient, the device may be locked remotely or may lock down so that it cannot be used before syncing. Furthermore, the medical professional may generate pa- tient specific treatment plan which may be arranged to available by a push notification or otherwise, such as ready for downloading, in the app. The medical professionals may thus perform patient personalized treatment via app.

Patients may thus be required to sync the app on the first electronic device 40 with the treatment device 10. This way the data from the treatment device 10 is gathered and processed so that the medical professionals may see straight away if the treatment plan has not been followed as there is no new updates in the patient data server. The medical professional may then make a push notification to remind the patient via the app to make the treatment.

Claims

1. A method for remote monitoring of an electronic treatment device (10) suitable for providing treatment on a patient, the method comprising:

- recording (305) device usage data (15) at the electronic treatment device (10), - establishing a first communication connection between the electronic treatment device

(10) and a patient data server (30),

- transmitting, via the first communication connection, the device usage data (15) from the electronic treatment device (10) to the patient data server (30),

- recording (330) patient data (45) at a first electronic device (40), - establishing (340) a second communication connection (170) between the first elec- tronic device (40) and the patient data server (30),

- transmitting (350), via the second communication connection (170), the patient data (45) to the patient data server (30), and wherein the device usage data (15) and the patient data (45) at the patient data server (30) are associated with each other.

2. The method according to claim 1, comprising

- establishing (310) a third communication connection (140) between the first electronic device (40) and the electronic treatment device (10), and

- receiving (320) from the electronic treatment device (10), via the third communication connection (140), the device usage data (15) at the first electronic device (40).

3. The method according to claim 2, wherein the first communication connection includes the second communication connection (170) and the third communication con nection (140).

4. The method according to any one of the preceding claims, comprising providing (360) an interface (65) at the patient data server (30) for connecting a second electronic device (60) having an authorization to access data on the patient data server (30).

5. The method according to claim 4, comprising connecting (370) the second elec- tronic device (60) to the patient data server (30) via the interface (65), and obtaining the associated device usage data (15) and patient data (45) from the patient data server (30).

6. The method according to any one of the preceding claims, comprising establishing a fourth communication connection between the electronic treatment device (10) and a device data server (20), and transmitting the device usage data (15) from the electronic treatment device (10) via the fourth communication connection to the device data server (20).

7. The method according to claim 6, wherein the fourth communication connection includes the third communication connection (140) and a fifth communication connec- tion (130), wherein the fifth communication connection (130) is arranged between the first electronic device (40) and the device data server (20).

8. The method according to any one of the preceding claims, comprising receiving at the first electronic device (40) a notification or instructions, such as a reminder or a treatment plan, from the second electronic device (60) on using the electronic treatment device (10).

9. The method according to any one of the preceding claims, wherein the first elec- tronic device (40) or the second electronic device (60) is a personal computer or a laptop, or a smart mobile device, such as a smartphone, a phablet or a tablet, the first electronic device (40) or the second electronic device (60) comprising a display for displaying the patient data (45) and/or the device usage data (15).

10. The method according to any one of the preceding claims, wherein the electronic treatment device (10) is a negative pressure treatment device (10) configured to intro- duce negative pressure at a suction opening (7) of the device (10), wherein the suction opening (7) is configured to be faced towards or pressed against or to be in contact with skin of the patient.

11. The method according to claim 10, wherein the device usage data (15) includes information about at least one of the following: used values of negative pressure during usage, characteristics of vibration during usage, pulsation settings or parameters during usage, and used treatment programs, a duration of the use a treatment program, time of use of the treatment program.

12. The method according to claim 10 or 11, wherein the patient data (45) includes information about at least one of the following: pain value, such as visual analogue scale pain value, range of motion, circumference at a treatment target area on the skin, such as circumference of a limb of the patient.

13. The method according to claim 12, comprising determining the range of motion by utilizing an accelerometer and/or a gyroscope comprised in the first electronic device (40).

14. A system for remote monitoring of an electronic treatment device (10), such as a negative pressure treatment device (10), suitable for providing treatment on a patient, the system comprising the electronic treatment device (10), a patient data server (30), and a first electronic device (40), wherein

- the electronic treatment device (10) is configured to record device usage data (15), and the first electronic device (40) is configured to record patient data (45), and wherein the system is configured to - establish a first communication connection between the electronic treatment device

(10) and the patient data server (30),

- establish (340) a second communication connection (170) between the first electronic device (40) and the patient data server (30),

- transmit, via the first communication connection, the device usage data (15) from the electronic treatment device (10) to the patient data server (30),

- transmit (350), via the second communication connection (170), the patient data (45) to the patient data server (30), and wherein the device usage data (15) and the patient data (45) at the patient data server (30) are associated with each other.

15. The system according to claim 14, configured to establish (310) a third communi cation connection (140) between the first electronic device (40) and the electronic treat ment device (10), and to transmit (320) from the electronic treatment device (10), via the third communication connection (140), the device usage data (15) to the first elec tronic device (40).

16. The system according to claim 15, wherein the first communication connection is arranged via at least the second communication connection (170) and the third commu nication connection (140).

17. The system according to any one of claims 14-16, comprising a second electronic device (60), and wherein the system is configured to provide (360) an interface (65) at the patient data server (30) for connecting the second electronic device (60) having an authorization to access data on the patient data server (30).

18. The system according to claim 17, configured to connect (370) the second elec- tronic device (60) to the patient data server (30) via the interface (65), and to obtain the associated device usage data (15) and patient data (45) from the patient data server (30).

19. The system according to any one of claims 14-18, comprising a device data server (20), wherein the system is configured to establish a fourth communication connection between the electronic treatment device (10) and a device data server (20), and to trans mit the device usage data (15) from the electronic treatment device (10) via the fourth communication connection to the device data server (20).

20. The system according to claim 19, wherein the fourth communication connection is arranged via at least the third communication connection (140) and a fifth communi cation connection (130), wherein the fifth communication connection (130) is arranged between the first electronic device (40) and the device data server (20).

21. The system according to any one of claims 14-20, configured to receive at the first electronic device (40) a notification or instructions, such as a reminder or a treatment plan, from the second electronic device (60) on using the electronic treatment device (10).

22. The system according to any one of claims 14-21, wherein the first electronic de vice (40) or the second electronic device (60) is a personal computer or a laptop, or a smart mobile device, such as a smartphone, a phablet or a tablet, the first electronic device (40) or the second electronic device (60) comprising a display for displaying the patient data (45) and/or the device usage data (15).

23. The system according to any one of claims 14-22, wherein the electronic treatment device (10) is a negative pressure treatment device (10) configured to introduce negative pressure at a suction opening (7) of the device (10), wherein the suction opening (7) is configured to be faced towards or pressed against or to be in contact with skin of the patient.

24. The system according to claim 23, wherein the device usage data (15) includes information about at least one of the following: used values of negative pressure during usage, characteristics of vibration during usage, pulsation settings or parameters during usage, and used treatment programs, a duration of the use a treatment program, time of use of the treatment program.

25. The system according to claim 23 or 24, wherein the patient data (45) includes information about at least one of the following: pain value, such as visual analogue scale pain value, range of motion, circumference at a treatment target area on the skin, such as circumference of a limb of the patient.

26. The system according to claim 25, configured to determine the range of motion by utilizing an accelerometer and/or a gyroscope comprised in the first electronic device (40).