The present invention relates to a bioelectrical stimulation.

Various bioelectrical stimulation systems are known and these normally comprise at least one pair of electrodes to be placed on a body for receiving electronic pulses from a pulse generator. The pulses are generated by a controller which may provide a constant stream of identical pulses, for example at a common frequency, pulse width and amplitude, or it may provide a series of pulses that vary over a period of time. For example, one or more of frequency, pulse width or amplitude may occasionally be varied in a stepwise manner, or in a progressively ramped manner, with the sequence of pulses possibly varying backwards and forwards between two or more constant states.

The electrical waveforms may be formulated to cause peripheral nerve stimulation for pain management, where the pulses are designed to stimulate endorphin release. Alternatively, the pulses may be formulated to cause neuromuscular stimulation, to increase circulation, to speed recovery, where the pulses stimulate production of proteins and peptides that can maintain healthy body function. Additionally, micro current stimulation may be applied to improve mobility and help speed a body’s healing potential. Micro current stimulation applies a very low continuous current, which encourages the production of adenosine triphosphate. A treatment, or therapy, may include operating a controller to provide sequences of electrical waveforms for both peripheral nerve stimulation and neuromuscular stimulation, for example where there is a requirement for both pain relief and to suppress inflammation.

Present systems often have many “modes” or therapies, where the modes are grouped so that an individual can first indicate the group they require, where the modes within each group may be specifically formulated to provide, for example, pain relief, pain relief where the pain is due to inflammation, increased muscle performance or recovery. The latter may for example result in a therapy that provides a massage sensation for an overly exerted muscle, for repair of cell damage.

Thus, a device may present one or more of these groups for selection by a user. The user may then be offered a choice of modes within a selected group to make a further selection from. Which specific mode within a group should be selected by a user is then normally determined by trial and error, by a user finding out which of the modes tried appears to be most effective for them. However, such systems require a lot of trial and error on the part of a user and direct comparisons will not always be easy, for example the physical condition of a user may vary between subsequent therapies, or the placement of electrodes may vary between subsequent therapies.

It is an object of the present invention to provide an improved bioelectrical stimulation system used for delivering beneficial boielectrical therapies to humans or animals. In the case of humans, in some situations the user may be a medical practitioner or trainer and the recipient is a patient being treated or a person being trained; in other situations the user and recipient may be the same person. In the case of animals, the user may be a veterinary practitioner or trainer or owner and the recipient an animal being treated or trained.

According to the present invention there is provided bioelectrical stimulation system, comprising: a plurality of handheld controllers each for applying electrical stimulation waveforms to an associated user: a plurality of user interfaces each for locally controlling an associated controller, including selecting and commencing a therapy; and at least one central server for communicating either directly or indirectly with each controller, each controller comprising: a battery; a storage medium for storing parameters for generating different electrical waves to be applied to a user; at least one pair of ports; at least one pair of electrodes arranged to be secured to the skin of a user and to the ports, so as to apply electrical signals from the ports to the skin of the user; a signal generator for receiving said parameters and generating, in dependence thereon, said electrical signals at said ports; and a transmitter and receiver for communicating directly or indirectly via the Internet with the at least one central server, wherein: a therapy comprises at least one sequence of waves defining a mode; the at least one central server is arranged to receive characteristics relating to an individual user associated with a controller and to store these characteristics in a database; the at least one central server is further arranged to receive for each controller an indication of a therapy selected and an indication of the effectiveness, or perceived effectiveness, of that therapy and to store this data in a database; the at least one central sever is further arranged to identify groups of users having one or more similar characteristics and to establish, from the apparent effectiveness of therapies, whether a particular therapy is apparently more effective for users having a given characteristic, or group of characteristics, so as to learn what therapies appear to be most effective for users having particular characteristics; the at least one central server is further arranged to communicate with the respective controllers or user interfaces associated with users having said given characteristics, to modify the therapies and or modes applied by the respective controllers to provide a more effective therapy to the associated user.

A bioelectrical stimulation system in accordance with the present invention enables multiple users of the system to be grouped together in accordance with characteristics relating to those individuals, with the apparent effectiveness of a particular therapy being accessed by the at least one central server, to identify which therapies appear to be the most effective for users having a particular common characteristic, or group of characteristics. The ability to learn from a large centrally collated mass of data enable trends to be identified, even though any one single individual may rate a particular mode differently on different days. In addition, the system may learn by the past experiences of individuals and use the knowledge learnt to quickly adapt or modify a therapy offered to a user, in dependence on the particular characteristics of that user. This thus avoids the need for a user to learn over time, by trial and error, which particular mode is most effective. This is a particular advantage because a user will often purchase or rent a controller at a point where they need a therapy that is as effective as it can be from day one, when, for example, an injury, is likely to be at its worst.

A therapy may comprise a number of modes stored within a user interface or a controller, wherein the at least one central server is arranged to communicate with that user interface or that controller to modify the modes which are comprised in a particular therapy. Each mode may be pre-set in the user interface or the controller and a therapy may comprise a single mode, or a sequence of modes employed sequentially, whereby the controller may then provide a therapy comprising modes tailored for a user’s specific characteristics.

In an alternative arrangement to the above, the at least one central server may be arranged to communicate with a controller or user interface to modify the waves comprised in a mode , for example by reducing the frequency and increasing the pulse width to provide a “deeper” therapy, depending on an individual’s characteristics. In addition, the waves comprised in a mode may vary within that mode, in which case the controller may vary the various waves making up that mode, or the duration for which certain waves prevail, before being replaced by a wave of a different pulse width or frequency, for example.

Thus, the at least one central server may be arranged to modify the duration of a wave of a mode, to modify the amplitude of wave of a mode, to modify the frequency of the wave of a mode or to modify the overall duration of the wave of a mode and thus the period for which the mode is implemented. Thus, the at least one central controller may either determine which modes are to be comprised within a therapy, or it may tailor the composition of the waves used in the modes of a therapy, or it may do both.

Preferably, in at least one mode the waves of the mode comprise a plurality of electrical pulses, pulses being particularly effective at stimulating both muscle and nerve activity. Each user interface may be programmed to request a user to select, for each of a plurality of a number of fields, the particular characteristic which best describes the individual and to communicate these characteristics to the at least one central server. In this manner, the at least one central controller may have data from a plurality of users which is all grouped into predefined fields, making it practical to group those individuals by their stated characteristics.

In one embodiment, each controller enables one of a plurality of therapies to be selected by a user, wherein the user interface conveys to the at least one central server how many times a particular therapy is selected, which data is used by the at least one central server as an indication of the effectiveness of a therapy. In this manner the at least one central server may collate data relating to the effectiveness of a therapy without requiring any additional input from a user. However, it is preferable if alternatively each user interface enables one of a plurality of therapies to be selected by a user and requests the user, on completing a therapy, to provide a score relating to the effectiveness of that therapy, wherein the user interface conveys the score with details of the therapy to the at least one central server. This data may then be used by the at least one central server, as an indication of the effectiveness of a therapy. This is a far more effective way of collecting data, for a particularly low score may indicate that a therapy was disappointing, thus enabling the at least one central server to learn more rapidly from the received scores provided by the users.

Preferably, each controller or user interface comprises a monitor which records performance data relating to the performance of a user while receiving a therapy, wherein the controller or user interface conveys to the at least one central server the performance data together with data relating to the therapy being received by the user at the time, which data is used by the at least one central server as an indication of the effectiveness of a therapy. This provides a far less subjective way of monitoring and may provide a better indication of those therapies which are successful, rather than relying on the experience as perceived by the user. In this regard it is preferable that each controller or user interface further comprises one or more sensors from the group comprising of a lactate sensor, a brainwave sensor, a blood oxygen content sensor and a heart rate monitor, wherein the performance data is based on one or more of the following of a user: brainwave activity, lactate content, oxygen content of the blood and heart rate.

Each controller or user interface may have a plurality of therapies grouped into two groups, one group targeted at neuro muscular stimulation and one group targeted at peripheral nerve stimulation, wherein a user identifies whether they want neuro muscular stimulation or peripheral nerve stimulation. The user then chooses one from a number of modes within that group, whereby the central controller or user interface modifies the therapies available in that group in dependence on the characteristics of the user. In this manner, a user may still select one from a number of modes within a group for either neuro muscular stimulation or peripheral nerve stimulation, depending on what the user desires, so that they may still select a therapy from within that group that, by trial and error, they find to be most suited to them. However, the central server modifies the therapies available in that group in dependence of the characteristics of the user, so that each user is provided with a choice of therapies but that choice of therapies is selected by the central server to be a group of therapies that is more likely to be effective for that particular user. In addition to the two groups of therapies mentioned above, a controller or user interface may additionally comprise an additional group for micro current stimulation where a constant low current is applied to a user.

Preferably, each controller or user interface has a plurality of therapies available that may be selected by a user, each therapy comprising a combination of modes, wherein the at least one central server modifies or creates a therapy to include selected modes. In this manner, the controller or user interface may create therapies from modes already existing in the controller or user interface and modes may be permanently set in the controller or user interface. In one embodiment, each controller or user interface has a plurality of modes grouped into two groups, one group targeted at neuro muscular stimulation and one group targeted at peripheral nerve stimulation, wherein the at least one central server modifies or creates a therapy to include selected modes from both groups. In this way, for an individual having particular characteristics, a therapy can be created on the basis of centrally collected data which combines appropriate neuro muscular stimulation with peripheral never stimulation modes.

Each user interface may be separate to an associated controller and comprise a mobile phone, or similar smart user device, arranged to communicate with the internet, the user interface having a program installed on it to permit it to communicate with both an associated controller and the at least one central server, to relay data conveying user inputs to the at least one central server and to receive from the central server signals to cause the therapies and or modes applied by the respective controllers to be modified.

In the above manner the controller may be relatively technically simple, in terms of processing power, relying on the smart device to connect to a suitable communications platform to enable communication with the Internet and with the at least one central server and to provide a user interface which may be a touch screen and which may be reconfigurable by updating the program (app) on the smart device.

In an alternative arrangement, each user interface could be part of a self- contained controller arranged to communicate directly with the Internet.

In one embodiment the user interface or controller may be arranged to cause a waveform to be applied to a user, which waveform comprises at least three modes, each mode comprising a series of six waves having the parameters set out in the following table.

In one embodiment the user interface or controller may be arranged to cause a wave to be applied to a user having a frequency of 396Hz, which frequency has been found to be particularly advantageous for use in the treatment of inflammation and pain management. Each controller or user interface associated with a user may be arranged to communicate a therapy to the controller or user interface associated with another user, enabling sharing of desirable therapies.

Additionally, one controller or user interface may be designated as a master controller or user interface and arranged to communicate therapies to the controllers or user interfaces associated with a predefined group of other users. In this manner a medical practitioner, veterinary practitioner, sports coach or similar, having a master controller or user interface, may “prescribe” a particular therapy to an associated user group.

Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying figures, of which:

Figure 1 is a schematic illustration of a bioelectrical stimulation system in accordance with the present invention;

Figure 2 schematically illustrates a controller and associated components of the bioelectrical stimulation system of Figure 1 ;

Figure 3 shows a screen of a user’s smart phone of the system of Figure 1 , which screen may be presented to a user when requesting personal characteristics;

Figure 4 shows a screen of the user’s smart phone when requesting a user to select an therapy;

Figure 5 shows a screen of the user’s smart phone when requesting a user to select a mode;

Figure 6 schematically illustrates how a particular mode may be made up of a single continuous wave;

Figure 7 shows how a mode may be made up of a sequence of different waves;

Figure 8 shows a screen user’s smart phone when requesting a user to rate a received therapy; Figure 9 is a table illustrating the parameters of three sequences of waves which define three modes and shows how these modes may be selected to be sequentially combined as a waveform which defines a therapy;

Each of Figures 10 to 26 show graphically one of the waves identified in the table of Figure 9, each wave being shown to three different time scales;

Figure 27 represents how one user interface may communicate directly one to one with another user interface of the system;

Figure 28 represents how one user interface may communicate indirectly with multiple other user interfaces of the system;

Figure 29 represents how one user interface may be nominated as a “master” user interface able to communicate with another user interface of the system; and

Figure 30 represents how one user interface may be nominated as a “master” user interface able to communicate with multiple other user interfaces of the system.

Referring now to Figure 1 , here there is shown a bioelectrical stimulation system, indicated generally as 1 , in accordance with the present invention. This comprises a plurality of handheld controllers 2a, 3a and 4a. Although only three controllers 2a, 3a and 4a are illustrated in Figure 1 , there may be tens of thousands of such controllers in various forms comprised in a system, each capable of applying electro stimulation waveforms to a user (not shown)

Each of the three controllers 2a, 3a and 4a has associated with it a respective smart device 2b, 3b and 4b, such as a smart mobile phone, which can communicate with one or more communications networks in a conventional manner and thus with the Internet 5. Each smart device 2b, 3b and 4b has a program or “App” installed, to permit it to communicate through a short-range wireless signal with an associated one of controllers 2a, 3a and 4a. Each smart device 2b, 3b and 4b may also communicate, via the Internet 5 to a central server 6, which has associated with it a data store 7. Although a single central server 6 is shown, this could be one of a plurality of linked servers able to share data. Additionally, the functionality of the smart device could be built directly into the controllers 2a, 3a and 4a, but this would not be a preferred option due to the expense associated with this.

Each of the controllers 2a, 3a and 4a is shown in the form of a handheld device which can wirelessly connect to a smart device, but it could instead be wired to such a device or similar and various ways of achieving the same functionality can be envisaged, which may or may not include the use of a so called “smart device”.

Referring now to Figure 2, this shows the controller 2a and that this comprises a battery 8, a transmitter/receiver 9 for communicating wirelessly via antenna 10 to the smart device 2b and a central processing unit 11 connected to: the transmitter/receiver 9, a memory 12; and to a signal generator 13. The signal generator 13 is connected to ports 14 and 15 to which are connected respective self-adhesive electrode pads 16 and 17, for placement on the skin of a user.

The central processing unit 11 , memory 12, signal generator 13 and transmitter and receiver 9 have been illustrated as separate components. However, this is for illustrative purposes only and is not indicative of any particular circuit layout of the controller 2a.

The memory 12 contains data which represents desired pulse streams, or waves, to be produced by the signal generator 13. These pulse streams may initially be stored in the memory, or downloaded from the central server 6 via the smart device 2b and in this embodiment they may also be updated by the central server 6. The central processing unit 11 controls the updating of data in the memory 12 and uses the data in the memory 12 to control signal generator 13, to provide appropriate signals to the ports 14 and 15, as required, in order to generate electrical waveforms between the electrodes 16 and 17, when placed on a user. Referring now to Figure 3, this illustrates the front screen 18 of the smart device 2b, when the smart device 2b is first being set up. Here the front screen 18 is requesting personal characteristics relating to the user, with the user selecting from an appropriate dropdown menus 19 one of a predetermined number of options. Each personal characteristic, for example age, height, weight, fitness, gender, ethnicity and i llness/d isabil ity represents a data field, with the chosen entry from the appropriate dropdown menu 19 indicating the data entry for that field. These fields and potential selections are the same on each smart device 2b, 3b and 4b shown in Figure 1 and are the same on all such devices using the system 1 . The personal characteristics in these predefined fields are sent by each smart device to the central server 6, where they are stored in a data store 7. From this stored data the central server 6 groups individuals by one or more of their personal characteristics.

Referring now to Figure 4, when a user subsequently wishes to use the controller 2a of Figure 1 for a therapy, the user activates the app on their smart device 2b and is then presented with a screen 18, as illustrated in Figure 4. Here the user may then select an appropriate application. In the examples given, there are five potential applications to choose from. These are for pain, pain and inflammation, cell recovery, performance or recovery.

In the embodiment illustrated, selecting one of the options of Figure 4 may result in a screen 18, as illustrated in Figure 5, being presented to the user. Here the user is asked to select a mode, in this example from modes 1 to 5. These modes provide the user with the option of selecting the same therapy on a subsequent use of the controller 2, if available, or of choosing a variation. As illustrated in Figure 6, selecting a mode, for example mode 1 , may result in a continuous waveform being generated by the signal generator of Figure 2, and this being applied across the electrodes 16 and 17. Alternatively, as illustrated in Figure 7, a mode, in this example mode 2, may comprise a sequence of successive different waveforms, “A” to “E” in the illustrated embodiment. Each waveform could differ in amplitude, pulse duration or frequency for example, or a combination of these.

Returning now to Figure 4, if “pain” is selected as an application and a mode 1 to 5 is selected, then each of those modes, regardless of which one is selected, will create a waveform to provide peripheral nerve stimulation which acts to manage pain by stimulating endorphin release. Alternatively, if a user selected the application “pain + inflammation” in the step illustrated in Figure 4, then the mode subsequently presented for selection would cause waveforms to be generated which function to provide both peripheral nerve stimulation and neuro muscular stimulation, which would help to reduce inflammation. Different waveforms would similarly be produced for the modes associated with performance and those associated with recovery.

Where cell recovery is selected, this would cause a continuous micro current stimulation to be provided where a very low current is provided which acts to cause production of adenosine triphosphate, which helps in the healing of cells. Specialist treatment may also be provided, for example for the treatment of inflammation and pain management.

After a user selects an application and mode and experiences a therapy, they are then requested by the smart device 2b to rate the therapy, between good “1” and poor “5” as indicated in Figure 8. This information is then provided to the central server 6 along with the identity of the user (or the associated user interface 2b) for storage in the data store 7. The central sever 6 may then use this data, together with the personal characteristic data for that user to identify therapies that appear to be effective for a person having a particular characteristic or characteristics. From this, the central server learns what therapies are particularly suited to people with particular characteristics and this is then used to modify the options provided to a user, independence on the characteristics input by the user. Each therapy may comprise a number of modes, wherein in each mode a continuous uniform signal is applied to the ports 14 and 15, as illustrated in Figure 7. Alternatively, each mode may comprise waveforms which vary with time but the modes may be set in the controller and either varied in response to inputs from the central server, or may be set permanently in the controller 2a with the therapies varied by the central server 6 to comprise different modes. Where the modes may be varied by the central server 6, these may be weighted in dependence on individual characteristics of a user, so that selecting a particular therapy may select the same sequence of modes, but with each mode being weighted to suit an individual’s characteristics. Alternatively, the modes may be permanently set within the controller 2a, with the central server 6 modifying the therapies so that a therapy may comprise different combinations of modes.

Referring now to Figure 9, an example a waveform (treatment) applied to the electrode pads 16 and 17 of Figure 1 may be formed from three sequences (modes), with each sequence in turn comprising six different pulse streams or waves. The parameters of each wave are stated in the table of Figure 9 and the form of each wave is also shown in a respective one of Figures 10 to 26.

Referring now to Figure 27 this show schematically how a user may share a treatment or “formulation” F1 they have created directly with another user via respective smart devices 2b and 3b. Similarly, Figure 28 shows how a user may share a treatment or “formulation” F1 they have created with multiple other users via the Internet 5.

Referring now to Figure 29, this shows schematically how a designated “master” smart device, (which could alternatively be another type of computer) may be used to view a user formulation (therapy) F1 stored in a user’s smart device 2b, with the master smart device 20, which may be associated with a clinician, physical fitness coach, physiotherapist, trainer, veterinary practitioner, or user group leader, also able to upload one of a number of new prescriptions P1 to Px to the user smart device 2b and Figure 30 shows how this could be expanded to a user group. The configurations shown in Figures 29 and 30 illustrate how the present invention can be used as a telemedicine platform, supporting the remote treatment, training, and therapy monitoring by a master user of individual users or groups of users via a telecommunications technology.

The above describes an embodiment which illustrated the general principles of a bioelectrical stimulation system in accordance with the present invention. However, it will be appreciated that many variations are possible which fall within the scope of the following claims.