An electrotherapy device and method

ES 2 199 759 T3

DESCRIPTION

Electrotherapy device.

The present invention relates to a device for the fixation of electrodes to a patient, for the stimulation of the abdominal muscles by electrotherapy and the invention also relates to a device for the stimulation of the abdominal muscles by electrotherapy.

Electrotherapy is commonly used to stimulate the abdominal muscles, to improve and tone muscles, and to relieve pain. Known electrotherapy methods and devices require the passage of a pulsating signal, subcutaneously through the patient's body, between a pair of electrodes that are typically aligned with the muscles to be stimulated, in order to define a trajectory of current between the electrode that is collinear with the direction of the muscle. In electrotherapy devices of known type and their methods, it is necessary to arrange a relatively large number of pairs of electrodes to stimulate the most important abdominal muscles, for example the central rectus abdominis muscle and the oblique and transversalis muscles. Typically, one or two pairs of electrodes should be placed on opposite corresponding sides of the umbilicus to stimulate the rectus abdominis muscle, and two pairs of obliquely placed electrodes are needed on the respective sides of the abdominal area to stimulate the transversalis and oblique muscles in the respective sides of the abdomen. Thus, in order to stimulate the rectus abdominis muscle and the transversalis and oblique muscles, three or four pairs of electrodes are required. This leads to a number of disadvantages in that, first of all, except if extreme care is taken in locating the electrodes on the patient's abdomen, some or all of the electrodes can be easily misaligned with the respective muscles or can be displaced, thus leading to significant inefficiencies, and in extreme cases, ineffective treatment. Second, given the large number of pairs of electrodes, a relatively complex signal generator is required to provide pulsing signals properly, so that the pulsing signals are shifted only between the respective pairs between which the pulsing signals are to be shifted. subcutaneously in the patient's body. Third, in many cases there is a danger that transthoracic current paths are defined by the electrodes, which in certain cases can lead to transthoracic currents in the individual's body, which in extreme cases can cause cardiac arrhythmias. The possibility of misalignment of the electrode pairs further increases the risk of transthoracic currents passing through the patient's body.

German patent application DE-A-20 14 944 to Palkay discloses a learning device for exercising the muscles of the neck and back of the patient. The exercise or treatment device comprises a plate for fixing the back of the patient's neck, comprising a flexible support sheet, with a three-corner shape. Fixation bands extend from the support sheet, fixing the plate to the patient's body. Electrode pins are attached to the plate by positive snap fasteners that extend through plate attachment holes. Three fixation holes are provided through the plate for each snap-fit ​​piece, so that the positioning of the electrode pins can be adjusted. It is suggested that a similar treatment device can be fitted to the waist and hip of the patient.

There is, therefore, a need for a device for the fixation of electrodes to the body of a patient to stimulate the abdominal muscles and in particular, to stimulate the rectus abdominis, the transversalis and the oblique muscles, overcoming the indicated problems. There is also a need for an electrotherapeutic device and method for the stimulation of abdominal muscles that overcome the aforementioned problems.

The present invention is directed to achieve this device for the fixation of electrodes to a patient and an electrotherapeutic device of the said type. The invention is also directed to providing the fixation device for use in a device.

According to the invention, a device is provided for the fixation of at least three electrodes to the patient to stimulate the adbominal muscles of the same, the device comprising fixation means intended to extend around the patient's torso, so that it is arranged a primary locating means on the attachment means for locating a center electrode of at least three electrodes adjacent to the patient's umbilicus and two secondary locating means are arranged on the fixation means arranged on corresponding opposite sides of the main fixation means to fix two corresponding lateral electrodes of at least three electrodes spaced apart from each other and with respect to to the central electrode, in a general direction towards a corresponding line of the right and left mid-axillary lines of the torso between the rib cage and the corresponding iliac crests, left and right, so that by applying at least one pulsating signal to the patient's body through the corresponding central and lateral electrodes, the patient's muscles are stimulated, a receptor means is arranged in the fixation device to receive a signal, generating means for generating at least one pulsating signal, arranging an electrically conductive main contact means on the fixing means corresponding to the main locating means for receiving at least one pulsating signal and for sending the signal to the electrode corresponding center, with two secondary electrically conductive contact means being arranged on the fixing means, to receive said pulse signal or signals and to send the signal to the respective corresponding side electrodes, a main electrical connection extending between the receiving means and each of the main contact means for sending said pulse signal or signals from the signal generating means to the corresponding main contact means and a secondary electrical connection means extending between the receiving means and each of the secondary contact means for sending the pulsating signal (s) from the signal generating means to the means of corresponding secondary contacts, the

ES 2 199 759 T3 fixing means with the main and secondary connection means, so that there is no danger that the pulsating signals are applied to the wrong electrodes.

According to one embodiment of the invention, the secondary locating means are arranged on the coupling means to position the respective lateral electrodes towards the midpoint of the corresponding median auxiliary line in the rib cage and the corresponding iliac crest. Preferably, the second locating means is arranged on the fixation means to locate the respective lateral electrodes adjacent to the corresponding mid-axillary line.

Ideally, the second locating means is disposed on the fixation means to position the respective lateral electrodes adjacent to the midpoint of the corresponding median auxiliary line, between the thoracic cage and the corresponding iliac crest.

Preferably, the main locating means is arranged on the fixation means to position the central electrode over the umbilicus muscle and extending around the umbilicus. Advantageously, the main locating means are arranged on the fixation means to position the central electrode on the umbilicus and fully extending around it.

In one embodiment of the invention, the main locating means are arranged on the fixation means to position the central electrode over the umbilicus, but with a greater area of ​​the central electrode located between the umbilicus than above it.

In another embodiment of the invention, the main locating means are arranged on the fixation means to position the central electrode adjacent but not above the umbilicus.

In another embodiment of the invention, the main locating means is arranged on the fixation means to locate the central electrode below the umbilicus.

In yet another embodiment of the invention, the main locating means is arranged on the fixation means to locate the central electrode above the umbilicus.

In yet another embodiment of the invention, the main locating means is arranged on the fixation means to locate the central electrode below and above the umbilicus.

According to one embodiment of the invention, a reference means is disposed on the fixation means to locate the fixation means on the torso, with respect to an anatomical landmark. Preferably the reference means are arranged to position the fixation means circumferentially around the torso. Advantageously, the reference means are arranged to position the fixing means vertically along the torso.

In one embodiment of the invention, the main locating means act as a reference means to position the fixation means with respect to the anatomical landmark provided by the umbilicus.

In another embodiment of the invention, the primary locating means comprises a first primary locating means and a second primary locating means for locating corresponding first and second central electrodes adjacent to the patient's umbilicus.

Advantageously, the first main locating means is arranged to locate the first central electrode above the umbilicus and the second main locating means is arranged to locate the second central electrode below the umbilicus.

In another embodiment of the invention, two sets of at least two secondary-type locating means are arranged on respective opposite sides of the main locating means, to facilitate selective locating of the respective side electrodes to accommodate different structures. torso.

Advantageously, each set of secondary locating means comprises three secondary locating means.

In another embodiment of the invention, parts of the fixing means on respective opposite sides of the main locating means between the main locating means and the corresponding secondary locating means are made of an elastic material to facilitate elastic stretching of the means. fixing between the main locating means and the corresponding secondary locating means. Preferably, the fixing means are made of an elastic material to facilitate the stretching of the fixing means around the torso, the elastic parts of the fixing means being more stretchable than the rest of the fixing means.

Preferably, each of the main contact means is located within the corresponding main locating means.

Advantageously, each of the secondary contact means is located adjacent to the corresponding secondary locating means or to the corresponding set of secondary locating means.

In another embodiment of the invention, each of the secondary contact means is located adjacent to the corresponding set of secondary locating means, so that regardless of which secondary locating means are selected to locate the corresponding side electrode, the electrode The side is in electrically conductive coupling with the secondary contact means.

Advantageously, each of the primary and secondary locating means is provided with visually perceptual locating means. Preferably, each of said primary and secondary locating means is formed by a corresponding locating mark on the fixing means.

Ideally, each of the locating marks defines a profile of a portion of the periphery of the corresponding electrode, corresponding to the locating means.

In one embodiment of the invention, each locating device is adapted to locate a patch-type electrode.

In another embodiment of the invention, the device comprises at least three electrodes. Preferably, each electrode is a patch-type electrode.

In one embodiment of the invention, each electrode

The lateral ES 2 199 759 T3 is dimensioned to cover at least a portion of the corresponding lower thoracic media and the corresponding first and second lumbar nerves.

In another embodiment of the invention, each central electrode is dimensioned to extend substantially to the rectus abdominus muscle.

Advantageously, each electrode defines a contact area over which the electrode makes direct electrical contact with the patient's body, the contact area of ​​each side electrode being such that it does not exceed the contact area of ​​a central electrode or from both. Preferably, the contact area of ​​each side electrode does not exceed one third of the contact area of ​​the center electrode or both.

In one embodiment of the invention, each of the side electrodes has a width in the circumferential direction relative to the patient's torso, in a range of 50mm to 150mm, and has a length in the vertical direction relative to the individual's torso, in a range from 80mm to 120mm.

In one embodiment of the invention, a first electrically conductive coating is provided on one side of each electrode for electrical connection of the electrode to corresponding contact means. Advantageously, the first coating is a gel-like coating containing an electrolyte solution, to increase the electrical contact between the electrode and the corresponding contact means.

In another embodiment of the invention, a second electrically conductive coating is provided on the other side of each electrode for electrical connection of the patch-type electrode to the patient's torso. Preferably, the second coating is a gel-type coating.

According to an embodiment of the invention, the second coating is an adhesive-type coating.

According to another embodiment of the invention, the first coating is an adhesive coating.

Advantageously, the bonding strength of the first coating to the fixing means is higher than the fixing resistance of the second coating to the torso, to facilitate the removal of the fixing means and the electrodes located thereon with respect to the torso of the patient.

Preferably, the electrodes are previously coated with the respective first and second adhesive coatings.

Ideally, each of the electrical connection means is located within the fixing means.

In one embodiment of the invention, the receiving means is releasable receiving means for releasably receiving the signal generating means.

Advantageously, the receiving means receives the signal generating means in a snap-coupling action.

According to an embodiment of the invention, the signal generating means for generating the pulsating signal or signals are arranged in the receiving means.

In one embodiment of the invention, means are provided for selectively selecting at least one pair of electrodes from the three or more electrodes through which at least one pulsating signal is applied to the patient's body.

In another embodiment of the invention, the pulsed signal (s) are applied simultaneously to each of the selected pairs of electrodes. Alternatively, the pulsing signal (s) are applied sequentially to each of the selected pairs of electrodes.

In one embodiment of the invention, one of the selected pairs comprises a side electrode and the center electrode, and another selected pair of electrodes comprises the other side electrode and the center electrode.

In another embodiment of the invention, one of the selected pairs of electrodes comprises the two side electrodes.

In another embodiment of the invention, one of the selected pairs of electrodes comprises one of the lateral electrodes and one of the first and second central electrodes, and another of the selected pairs of electrodes comprises the other of the lateral electrodes and the other of the first. and second central electrodes.

In another embodiment of the invention, one of the selected pairs of electrodes comprises the first and second central electrodes that act as a single electrode and one of the side electrodes, and another of the selected pairs of electrodes comprises the first and second central electrodes that act as a single electrode and the other side electrode.

In yet another embodiment of the invention, one of the selected pairs of electrodes comprises the first and second center electrodes.

In one embodiment of the invention, the pulsating signals generated by the signal generating device to apply to the respective pairs of electrodes may be the same or different.

In one embodiment of the invention, each of the pulsing signals comprises a series of pulses at intervals within a range of 5 milliseconds to 1,000 milliseconds. Preferably, each of the pulsing signals comprises a series of pulses at intervals of 20 milliseconds to 40 milliseconds.

Advantageously, each pulsed signal comprises a series of pulses at intervals of approximately 30 milliseconds ± 20%. Preferably, the pulse interval of each pulsed signal is adjustable.

In another embodiment of the invention, each of the pulsed signals comprises pulses of duration between 10 microseconds and 200,000 microseconds. Advantageously, each of the pulsing signals comprises pulses with a duration comprised between 50 microseconds and 1,000 microseconds.

Preferably, each pulsing signal comprises pulses with a duration between 100 microseconds and 500 microseconds. Ideally, each of the pulsing signals comprises pulses with a duration of approximately 300 milliseconds ± 20%. Preferably, the duration of each pulse signal is adjustable.

In another embodiment of the invention, each of the pulsating signals comprises a series of pulses of magnitude between 0 mA and 100 mA. Preferably, the magnitude of each pulse of each pulsing signal is adjustable.

In one embodiment of the invention, the fixing means comprise a tape or strap.

In another embodiment of the invention, fixing means are provided on the strap to fix the strap.

ES 2 199 759 T3 around the torso of the individual.

In another embodiment of the invention, a main fixing device, corresponding to each of the fixing or locating means, is arranged main for fixing the central electrode corresponding to the fixing means adjacent to the corresponding main locating means.

In yet another embodiment of the invention, two secondary fixing means are arranged on the fixing means to fix the lateral electrodes corresponding to the fixing means adjacent to the corresponding selected secondary locating means.

In one embodiment of the invention, each of the fixation devices comprises a stem fixation device.

In another embodiment of the invention, each of the stem fixing devices comprises a female part and a male part, the female part being fixed to the fixing means.

In another embodiment of the invention, each of the stem attachment devices is electrically conductive, so that the female part of the stem attachment devices form the corresponding contact means.

In one embodiment of the invention, the male and female parts of the stem fixation device fit together with electrically conductive coupling.

Preferably, the exposed surface of the female portion of each stem attachment is made of electrically insulating material.

Advantageously, the exposed surface of each female part of each stem fixing device is provided with an electrically insulating coating.

According to another embodiment of the invention, the exposed outer surface of the female part of the stem fixation device abutting the male part of the stem fixation device is made of an electrically insulating material.

The advantages of the invention are manifold. An important advantage of the invention is that it allows for relatively accurate placement and alignment of the electrodes on the patient. An especially important advantage of the invention results from the fact that the device, according to it, allows a relatively exact positioning of the electrodes on the patient's body, and because of this, it has been observed that with only three electrodes the device , according to the invention, provides adequate stimulation to the abdominal muscles and, in particular, to the rectus abdominis and transversalis, and oblique muscles, particularly with the goal of muscle toning. Surprisingly it has been found that by positioning the central electrode adjacent to the umbilicus and the respective lateral electrodes towards the corresponding mid-axillary lines on the left and right sides respectively of the central electrode, good stimulation of the abdominal muscles is achieved. However, it has been found that the closer to the sides the electrodes are located on the corresponding left and right mid-axillary lines, the better the stimulation. Indeed, it has been observed that optimal stimulation is achieved by locating the respective lateral electrodes on corresponding lines extending from the umbilicus to the midpoint of the left and right mid-axillary lines, between the rib cage and the corresponding iliac crest. In general, it has been found that maximal stimulation of the rectus abdominis, transversalis, and oblique muscles is achieved when the lateral electrodes are positioned on the corresponding mid-axillary line substantially midway between the rib cage and the iliac crest. Another additional advantage of the invention is achieved in the case that the first and second central electrodes are arranged one above and the other below the umbilicus, where it has been found that an even greater stimulation of the abdominal muscles is achieved and, in In particular, the stimulation of the rectus abdominis, transversalis and oblique muscles.

To provide the lateral electrodes adjacent to the mid-axillary line or separate from the central electrode with respect to the mid-axillary line, but in relative proximity to the mid-axillary line, the lateral electrodes apply the pulsating signal (s) to nerve trunks instead of do it to nerve branches that extend from the nerve trunks. The electrical signals applied to the nerve trunks are expanded by the nerve branches from the nerve trunks and are therefore effective in stimulating a significantly larger area of ​​the abdominal muscles than if the electrodes were placed on nerve branches, such as as has been the case so far. Additionally, by placing the central electrode on or adjacent to the umbilicus and the lateral electrodes adjacent or relatively close to the mid-axillary line, the separation between the central and lateral electrodes is such that it causes the pulsating signal (s) to move more deeply. through the subject's body below the fatty tissues. This therefore results in the pulsating signal (s) directed to the nerves that control the deeper muscles providing more effective stimulation of the muscles. Placing the electrodes relatively close to each other, as has been the case up to now, tends to cause the pulsating signal (s) to pass relatively close to the surface of the skin, thus having little effect on the nerves that they control the deepest muscles. Certainly another advantage of separating the electrodes from each other, according to the invention, is that the effect of the subcutaneous currents on the nerves of touch and pain are minimized, thus minimizing the feeling of discomfort for the patient. In addition, by arranging the lateral electrodes of a size that extend over the lower thoracic nerves and the first lumbar nerves adjacent to the mid-axillary line, greater efficiency is achieved by the fact that the pulsating signal (s) is applied to the trunks. of the nerves under consideration. Another advantage of having the electrodes of reasonable dimensions is that the current density of the pulsating signal (s) passing through the electrodes and, in turn, to the patient's body, is minimized, thereby further minimizing discomfort. resulting from the effect of the subcutaneous current on the nerves of touch and pain. Indeed, by arranging the electrodes of considerable dimensions, a higher current can also be applied through the electrodes, if desired, with minimal discomfort to the patient.

Another advantage of the invention is that it is virtually

ES 2 199 759 T3 it is impossible to incorrectly or defectively fix the electrodes to the patient and, furthermore, there is virtually no danger of pulsing signals being applied to the wrong electrodes, since the fixation means have been pre-connected to the connection means. major and minor.

Another advantage of the invention is achieved when the provision is made to selectively select the electrodes in pairs of electrodes, because the individual muscles of the muscle groups can be selectively stimulated and, in addition, if desired, they can be applied different pulsating signals on different pairs of selected electrodes.

The invention will be more clearly understood from the following description of some preferred embodiments given, by way of example only, with reference to the accompanying drawings, in which:

Figure 1 is a front elevation view of the torso of a patient, Figure 2 is a plan view of the device, according to the invention, for the stimulation of the abdominal muscles, Figure 3 is a plan view of the device of the Figure 2, Figure 4 is an exploded perspective view of a detail of the device of Figure 2, Figure 5 is a rear plan view of a part of the device of Figure 2, showing electrode pins arranged on the device, figure 6 is a rear plan and sectional view of another part of the device of figure 2, figures 7 and 8 are perspective views of respective electrodes of the device of figure 2, Figure 9 is a cross-sectional view of the electrode of Figure 7 according to the line IX-IX of Figure 7, Figure 10 is a front elevation view of the torso of a patient showing the device of Figure 2 in use, Figure 11 is a front elevation view of the torso of the patient of Figure 10 showing the correct positioning of the electrodes of the device of figure 2, figure 12 is a side elevation view of the torso of the patient of figure 10 also showing the correct positioning of the electrodes of the device of figure 2, Figure 13 is a block circuit diagram of the device of Figure 2, Figure 14 is a graphical representation of pulsed signals generated by the device of Figure 2, Figure 15 is a block representation of an alternative circuit device of the device of figure 2, figure 16 is a graphical representation of pulsed signals generated by the device of figure 2, in the configuration of figure 15, Figure 17 is a block representation of an alternative circuit device of the device of Figure 2, Figure 18 is a graphical representation of pulsed signals generated by the device of Figure 2 in the configuration of Figure 17, Figure 19 is a rear plan view of a device according to another embodiment of the invention for stimulating abdominal muscles, Figure 20 is a front elevation view of the torso of a patient showing the device of Figure 19 in use, Figure 21 is a front elevation view of the torso of the patient of Figure 20 showing the correct positioning of the electrodes of Figure 19, Figures 22 to 24 are block representations of alternative circuit configurations of the device of Figure 19, Figure 25 is a schematic representation of subcutaneous current paths that can develop in the patient using the device of Figure 19, Figure 26 is a block representation of a circuit configuration of the device of Figure 19, Figure 27 is a block representation of an alternate circuit configuration of the device of Figure 19, Figure 28 is a rear plan view of the device according to another embodiment of the invention for stimulating the abdominal muscles, Figure 29 is an exploded cross-section in detail of the device of Figure 28, and Figure 30 is a view in perspective of a part of a detail of the device of figure 28.

With reference to the drawings and initially to Figures 1 to 18, an electrotherapeutic device according to the invention has been shown, indicated generally by the reference numeral (1) for the stimulation of abdominal muscles of a patient and, in particular, to stimulate the rectus abdominis, transversalis and oblique muscles of the patient's abdomen for muscle toning. Before describing the device (1), the position of the muscles in the abdominal septum of the patient will be described first, with reference to Figure 1.

Referring in particular to Figure 1, the torso (3) of a patient has been shown. The abdomen (5) of the patient is located between the rib cage (6) and the pelvis (7) and between the left and right iliac crests (8) and (9) respectively on the left and right side (10) and (11 ) from the patient's body. The umbilicus muscle (12) is located centrally in the abdomen (5). The left and right mid-axillary lines (13) and (14) extend between the left and right iliac crests and the rib cage (6) on the left and right sides (10) and (11) of the torso (3). The rectus abdominis muscles that are indicated by reference numeral (15) extend substantially longitudinally from a position below the rib cage (6) to a position above the pelvis, while the transverse muscles, which are indicated by reference numeral (16), extend transversely through the abdomen between the left and right sides (10) and (11) thereof, while the oblique muscles indicated with reference (17) extend obliquely between respective positions below the rib cage (6) on one side thereof and a central position adjacent to the pelvis (7).

In known electrotherapeutic methods and devices, in order to stimulate these three muscles, i.e. the rectus abdominis muscles (15), the transversalis muscles (16) and the oblique muscles (17), pulsating signals are applied to the abdomen of the patient through of four pairs of electrodes (20a) and (20b), (21a) and (21b), (22a) and (22b), (23a) and (23b), arranged

ES 2 199 759 T3 cough as shown in figure 1. The pairs of electrodes (20a) and (20b), and (21a) and (21b) stimulate the rectus abdominis muscles (15), while the pairs of electrodes (22) and (23a) and (b) stimulate the transverse muscles and oblique muscles for toning.

With reference now, in particular to Figures 2 to 12, the device (1) comprises fixation devices, that is, a belt (25) to extend around the torso (3) of the patient to position and retain three electrodes, which in this embodiment of the invention they are patch electrodes, i.e. a central electrode (26) and a pair of lateral electrodes (27) adjacent to the abdomen (5) for the application of one or more pulsating signals generated by a signal generating device, that is, a signal generator (28) that is detachably mounted on the belt (25), as will be described later. A main locating device and two sets of secondary locating means arranged respectively by primary and secondary locating marks (29) and (30), respectively, are arranged on the inner side (34) of the belt (25) to locate the central electrode (26) and side electrodes (27), respectively on the belt (25).

The primary location marks (29) define two opposite peripheral sides of the center electrode (26) to define a primary location area (31) for receiving and locating the center electrode (26) to precisely locate the center electrode (26) on the belt (25), so that in use it is arranged centrally over the navel (12). In this embodiment of the invention, each set of secondary location marks (30a), (30b), and (30c) define three corresponding secondary location areas (32a), (32b), and (32c) into which they can be selectively coupled. the lateral electrodes (27) to the belt (25), so that in use the lateral electrodes are preferably arranged centrally on the corresponding left and right mid-axillary line (13) and (14) of the patient, and at a midpoint that is substantially midway between the rib cage (6) and the corresponding iliac crest of said left and right iliac crests (8) and (9). Although in practice, it is desirable that the lateral electrodes (27) are aligned on the corresponding mid-axillary lines, it has been found that, in general, adequate stimulation of the muscles is achieved if the lateral electrodes (27) are positioned over the belt (25) resting on respective lines extending from the navel to the midpoint of the corresponding mid-axillary lines and towards the mid-axillary lines. In this embodiment of the invention, the second location marks (30a), (30b) and (30c) define a periphery (33) of one end of the electrode of the corresponding (27) to indicate the three secondary location areas (32a ), (32b) and (32c) in which the lateral electrodes (27) can be placed on the belt (25) to adapt to torsos of different shape around the waist.

The main location area (31) and the secondary location areas (32a), (32b) and (32c) are arranged on the belt (25) so that, when the central electrode (26) is located in the main area location (31), and the side electrodes (27) are located in the appropriate area of ​​the secondary location areas (32a), (32b) or (32c), and when the belt (25) is fixed around the torso (3) with the central electrode (26) located centrally on the navel (12), the respective lateral electrodes (27) are located on the middle axillary lines of the left and of the right (13) and (14), respectively, between the rib cage (6) and the left and right iliac crests (8) and (9), or with relative proximity to the mid-axillary lines.

A fixing means, in this embodiment of the invention made up of hooks and loops of the type marketed under the VELCRO brand, is arranged at the respective ends (35) and (36) of the belt (25), leaving a band of hooks ( 38) of said set of hooks and loops on the inner face (34) at the end (35), while the bands of loops (39) of the set of hooks and loops are arranged on the outer face (40) at the end (36) from the belt (25). In this embodiment of the invention, four bands of loops (39) are arranged with spacing intervals to facilitate the attachment of the belt (25) to torsos (3) of different structure around the waist.

A main electrically conductive contact device, that is, a main electrically conductive contact (45), is located on the belt (25) centrally in the main location area (31) to apply one or more pulsating signals generated by the signal generator (28) towards the central electrode (26). A pair of secondary contact means constituted by secondary electrical connection contacts (46) are located in the respective sets of secondary location areas (32) to apply signals generated by the signal generator (28) to the respective lateral electrodes (27 ). Each of the secondary contacts (46) is located in the sets of secondary locating areas (32) such that, regardless of which of the secondary locating areas (32) is selected to receive the side electrode (27) , said lateral electrode (27) is always in contact with the corresponding secondary contact (46).

A reference device to position the belt (25) with respect to an anatomical reference, that is, the navel in this embodiment of the invention, is constituted by the main location area (31) and, in turn, the central electrode (26) to place the belt (25) on the torso (3). The central electrode (26) when centrally located in the main location area (31) is arranged in a position where, when the belt (25) is attached to the torso (3) with the central electrode (26) located centrally On the navel (12), the belt (25) is located centrally circumferentially and vertically on the torso (3). In this way, when the belt (25) is well fixed around the torso (3), the lateral electrodes (27) are located, relatively exactly on or relatively close to the mid axillary lines (13) and (14) centrally. between the rib cage (6) and the respective left and right iliac crests (8) and (9).

In order that the belt (25) and, in turn, the central and lateral electrodes (26) and (27) remain intimately fixed to the patient's body and, also, to additionally adapt to different structures of the torso (3), The belt (25) is made of an elastic material to facilitate the stretching of the belt (25) between the respective ends (35) and (36). However, for

ES 2 199 759 T3 further facilitate the adaptation to torsos (3) of different structures, parts (47) between the interrupted lines (48), see figure 3, of the belt (25), on respective opposite sides of the main location area ( 29) and between the closest secondary location areas (32a), are more elastic than the rest of the belt (25) to facilitate additional stretch characteristics of the belt (25) in the elastic portions (47). This further facilitates the alignment of the lateral electrodes (27) with the respective left and right mid-axillary lines (13) and (14).

The belt (25) comprises a pair of outer layers (49) of stretchable textile material and an inner layer (50) of stretchable sponge material that are attached to each other by an edge element (51) extending to respective opposite sides of the belt. belt (25) and which is sewn to the outer layers (49) and to the inner layer (50). The element (51) is also made of stretchable material and the stitching of said element (51) to the outer and inner layers (49) and (50) is respectively arranged to provide a greater stretch character in the elastic parts (47) with respect to to the rest of the belt (25).

A receiving means of this embodiment of the invention constituted by a receiving support (54) of the plastic material is fixed to the external face (40) of the belt (25) to fix, in a removable manner, the signal generator (28) to the belt. (25). Guides (55) on the receiver bracket (54) engage corresponding guide grooves (56) of the signal generator (28) with a snap-fit ​​action for detachable and secure retention of the signal generator ( 28) on the receiver support (54). A three-contact male plug (57) located on the receiver bracket (54) is coupled to a corresponding three-contact socket (58) of the signal generator (28) to connect said signal generator (28) to the electrodes. central and lateral (26) and (27).

The main and secondary connection means, that is, the main and secondary cables (59) and (60) respectively, coming from the male plug (57) are connected respectively to the main contact (45) and the secondary contacts (46). The main and secondary cables (59) and (60) are located between the outer layers (49) of the belt (25), and the secondary cables (60) are arranged in the form of a bellows to facilitate the expansion of the elastic parts (47 ) from the belt (25). The control buttons (62) are arranged on the signal generator (28) for the operation of corresponding control switches within the signal generator (28) to control the signals generated by the signal generator (28), such as will be described later.

Referring to the center and side electrodes (26) and (27) and, referring in particular to Figures 7 to 9, the electrodes (26) and (27) are formed from an electrically conductive foil (65). A first electrically conductive element comprising a first electrically conductive adhesive gel coating (67) is arranged on one side (66) of the laminar element (65) to fix the respective central and lateral electrodes (26) and (27) to the belt ( 25) and to provide electrical continuity between the laminar element (65) of the electrodes (26) and (27) and the corresponding main or secondary contacts (45) and (46) respectively. A second electrically conductive element, that is, a second electrically conductive adhesive gel coating (68), is arranged on the external face (69) of the laminar element (65) for adhesion of the electrodes (26) and (27) to the skin of the patient, and to provide satisfactory electrical continuity between the corresponding electrodes (26) and (27) and the skin of the individual. In this embodiment of the invention, in order to further increase the electrical continuity between the laminar element (65) of the electrodes (26) and (27) and the corresponding main and secondary contacts (45) and (46), the first layer (67) of adhesive comprises an electrolyte. Additionally, the adherence resistance of the first adhesive coating (67) to the belt (25) is greater than the adherence of the second adhesive coating (66) to the patient's skin to facilitate the removal of the belt (25) and the electrodes (26). and (27) from the patient's body without causing detachment of said electrodes (26) and (27) with respect to the belt (25).

In this embodiment of the invention, the central electrode (26) has dimensions of 100mm ± 20% width in the circumferential direction around the torso (3) and 100mm ± 50% height in the vertical direction. The side electrodes (27) have a height respectively of 75mm ± 20% by 100mm of width ± 20%. The central and lateral electrodes (26) and (27) of these dimensions have been found to have sufficient dimensions, such that the central electrode (26), when applied centrally on the navel, extends to an important part of the rectus abdominis muscle. and the lateral electrodes (27), when they are located centrally on the mid axillary lines (13) and (14), or relatively close to them, They cover a sufficient area of ​​the thoracic nerves of the lower and first and second lumbar nerves to provide stimulation of the rectus abdominis and transversalis muscles, as well as the oblique muscles.

The central and lateral electrodes (26) and (27) receive release sheets (not shown) on the corresponding opposite faces thereof for protection of the corresponding first and second adhesive coatings indicated above (67) and (68).

Referring to Figures 13 to 18, a number of pulsed signals that can be generated by the signal generator (28) and various connections from the main and center electrodes (26) and (27) to the pulse generator (28) will be described. Referring initially to Figures 13 and 14, in this connection configuration the respective left and right side electrodes (27a) and (27b) which are also designated by the reference letters L and R, respectively, are independently connected to the pulse generator (28), and independently apply the corresponding pulsating signals I1 and I2 to the patient, which are generated by the pulse generator (28). The central electrodes (26) that are designated with the reference letter U, act as a common return electrode to return the sum I3 of the pulsating signals I1 + I2 to the signal generator (28), in which I3 = I1 + I2 . Accordingly, in this configuration the electrodes (26) and (27) are selected in pairs, so that one pair is formed by the central electrode (26) and one of the side electrodes (27), and the other pair It is formed by the central electrode (26) and the other of the lateral electrodes (27). In other words, the pairs of electrodes are the pairs R - U and L - U.

ES 2 199 759 T3

In this embodiment of the invention the duration of the pulses of each pulsed signal that is applied to the respective pairs of electrodes can be independently varied between 50 microseconds and 1000 microseconds. The pulse interval of the pulsing signals can also be independently varied between 5 milliseconds and 1000 milliseconds. The magnitude M of the pulses of each pulsating signal I1 and I2 is independently variable by the signal generator (28) and can be between 0 mA and 100 mA. The pulses of the respective pulsing signals I1 and I2 are in phase, and therefore, the pulses returned to the signal generator (28) through the central electrodes (26) is the sum of the output pulses I1 and I2 .

Two of the control buttons (62) of the signal generator (28) provide the independent manual variation of the magnitudes M of the pulses of the respective pulsing signals I1 and I2, and another of the buttons (62) of the signal generator ( 28) provides the balancing of the magnitude of the pulses of the respective pulsing signals. Two other of the buttons (62) of the signal generator (28) provide the variation of the interval between pulses of the pulsed signals. The duration of the pulses of each pulsed signal is varied by two other of the buttons (62) on the signal generator (28). The control of the magnitude, the interval between the pulses and the duration of the pulses by the signal generator (28) will not be described further, since the generation and control of said pulsed signals are well known to those skilled in the art.

Figures 15 and 16 show an alternative connection configuration of the central and lateral electrodes (26) and (27) to the signal generator (28). In this configuration the electrodes (26) and (27) are selected in pairs similar to those described with reference to Figures 13 and 14, that is, the pairs R-U and L-U. However, only a pulsed signal I3 is generated by the signal generator (28) and is applied to the two side electrodes (27a) and (27b) and returned through the central electrode (26) which acts as a common return. In this embodiment of the invention, the respective proportion I1 and I1 of the pulsating signals passing through the lateral electrodes (27a) and (27b) may be similar or different, depending on the impedance between the respective lateral electrodes (27) and electrode center (26) across the patient, and the impedance between the respective side electrodes (27) and the patient's skin. The magnitude of the pulses are varied by one of the buttons (62) on the signal generator (28).

Referring now to Figures 17 and 18, another alternative connection configuration of the central and lateral electrodes (26) and (27) with the signal generator (28) and the alternative pulsating signals generated by the signal generator has been shown. (28). In this configuration the electrodes (26) and (27) are selected in pairs in a similar way to those described with reference to Figures 13 and 14, that is, the pairs R-U and L-U. The signal generator (28) generates two pulsating signals I1 and I2 which are applied respectively to the lateral electrodes (27a) and (27b) and are returned through the central electrode (26) which acts as a common return. The pulses of the pulsing signals I1 and I2 are in this case 180 ° out of phase with each other, however, the interval between the pulses of the respective pulsing signals is similar. The magnitude and duration of the pulses of the respective pulsing signals are independently variable, as can be seen in figure 18 in which the pulses of the pulsing signal I1 are of greater magnitude but of shorter duration than the pulses of the signal. pulsating I2.

In use, with the belt (25) laid flat and its internal face (34) directed upwards, the central electrode (26) is centrally fixed in the main location or location area (31). The appropriate secondary location area (32a), (32b) or (32c) is selected, depending on the structure of the torso (3) of the patient, and the respective lateral electrodes (27) are fixed to the internal face (34) of the belt (25) with the peripheral edge (33) of the side electrodes (27) aligned with the appropriate secondary location marks (30a), (30b) or (30c). The remaining release or release sheets are then removed from the lateral and central electrodes (26) and (27) and the belt (25) is presented to the torso (3) of the patient with the central electrode (26) aligned centrally with the navel. (12). The belt (25) is then stretched around the torso (3) of the patient until the lateral electrodes (27) are centrally aligned with the corresponding left and right mid-axillary lines centrally between the rib cage (6) and the respective iliac crests. left and right or relatively close to them. The belt (25) is then attached to the patient by the band of hooks (38) which engage the appropriate object band (39). Figures 11 and 12 show the preferred locations of the central electrode (26) and of the lateral electrodes (27) on the torso (3) when the belt (25) is tightly fixed on the torso (3).

The signal generator (28) is then activated, and the desired pulse signal (s) are selected. The signal generator (28) is driven to achieve two independent pulse signals, the magnitude and / or duration of the signal pulses respective pulses, as the case may be, are adjusted to the desired level and the interval between pulses in certain cases can be adjusted. Pulsing signals can also be balanced as desired.

Surprisingly, it has been discovered that by centrally arranging the central electrode (26) on the navel, such that the central electrode (26) extends around the navel (12), and by arranging the lateral electrodes (27) centrally aligned with the mid-axillary lines, centrally between the rib cage (6) and the corresponding left and right iliac crests, or between the umbilicus and the mid-axillary line towards said mid-axillary line, Only three electrodes are required to achieve adequate stimulation of the rectus abdominis and transverse and oblique muscles for muscle toning.

Referring now to Figures 19 to 27, devices are shown, according to another embodiment of the invention, generally indicated by reference numeral 75, for stimulating the abdominal muscles for toning. Device (75) substantially similar to device (1) and similar components have been identified by the same reference numerals. The main difference between the device (75) and the device (1) is that instead of having a single main location area, a couple of areas are arranged

ES 2 199 759 T3 main locating area, that is, a first main locating area (76) and a second main locating area (77) for locating corresponding first and second central electrodes (78) and (79), respectively on the belt (25) for location respectively above and below the navel (12). Otherwise, the device, with the exception of the signal generator (28), is similar to the device (1). The first and second main location areas (76) and (77) and in turn the first and second central electrodes (78) and (79), act as reference means to place the belt (25) on the torso (3) . The belt (25) is located on the torso (3) with the navel (12) located centrally between the respective first and second main location areas (76) and (77), see figures 20 and 21.

Referring now to Figures 22 to 27, alternate connection configurations are shown for connecting electrodes 78, 79, and 27 to signal generator 28, to apply pulsating signals to the patient through the electrodes (78), (79) and (27). The left side and right side electrodes (27a) and (27b) are designated by reference letters L and R, respectively, and the first and second center electrodes (78) and (79) are designated by reference letters U1 and U2, respectively. In Figure 22 the first and second electrodes (78) and (79) and the side electrodes (27) are connected such that the side electrodes (27) and the first center electrode (78) effectively form a single electrode. , while the second electrode (79) forms the other electrode, that is, the return electrode. In the connection configuration of Figure 23 the electrodes (78), (79) and (27) are connected in such a way that the side electrodes (27) are connected to each other and the first and second center electrodes (78) and ( 79) are independently connected to the signal generator (28). In this way the electrodes are selected in pairs such that a selected pair of electrodes is formed by the side electrodes (27) that effectively act as an electrode, and the second central electrodes (79) that act as a return electrode, and The other pair of selected electrodes comprises the first center electrode (78) and the second electrode (79), which also acts as a return electrode for the selected pair of electrodes. In other words, the electrode pairs are the pairs (RL) - U2 and U1 - U2. A first pulsating signal is applied to the selected electrode pair comprising the side electrodes (27) and the second center electrode (79), and a second pulsating signal is applied to the selected electrode pair comprising the first and second center electrodes (78) and (79). The first and second pulsating signals can be identical or different and can be independently varied as shown with reference to Figures 13, 14, 17 and 18.

Referring now to Figure 24, another alternative connection configuration of the first and second center electrodes (78) and (79), and the side electrodes (27) to the signal generator (28) is shown. In this configuration, the electrodes are selected according to the following pairs. A selected pair comprises the side electrodes (27a) and (27b), so that one of the side electrodes, that is, the left side electrode (27a) acts as a return electrode, and the other pair of electrodes is selected to starting from the first and second central electrodes (78) and (79), so that the second central electrode (79) acts as a return electrode. In other words, the electrode pairs are the pairs R - L and U1 - U2. In this connection configuration, the signal generator generates two pulsing signals independently of each other, one of which is applied to the patient through the lateral electrodes, while the other is applied to the patient, through the first and second central electrodes ( 78) and (79). The two pulsing signals may be the same or different, however, in order to prevent a signal applied to the side electrode (27b) from being returned through the second electrode (79), and similarly, in order to prevent a signal applied to the first central electrodes (78) is returned through the lateral electrode (27a), the signals are multiplexed to the electrodes, and preferably, they are 180 ° out of phase.

Referring again to Figure 25, there is shown a schematic representation of several pairs of electrodes that can be selectively selected from said first and second center electrodes (78) and (79) and side electrodes (27) to the signal generator ( 28). In this embodiment of the invention the electrodes can be selectively selected from the following pairs of electrodes:

<td>R-U1</td><td>L-U2</td>

<td>R-U2</td><td>RL</td>

<td>L-U1</td><td>U1-U2</td>

The subcutaneous currents passing through the patient between the corresponding first and second central electrodes (78) and (79) and the lateral electrodes (27) are shown in Figure 25 and are designated RU1, LU1, RU2, LU2, RL and U1U2, and are also designated by the Roman numerals I to VI. The signals generated by the signal generator (28) can be applied to the first and second center electrodes (78) and (79) and the side electrodes (27) on any or all of the six pairs of electrodes, and can be applied sequentially, simultaneously, or partially simultaneously and sequentially to the electrode pairs in any order to selectively stimulate the abdominal muscles. The signals can be multiplexed to the second pair of electrodes, and the signals applied to the respective pairs of electrodes can be different to provide different stimulation to the different abdominal muscles.

Referring now to FIG. 26, there is shown a circuit arrangement for applying signals to the patient through some or all of the electrode pairs selected from electrodes 78, 79, and 27 described with reference to the figure

25. In this embodiment of the invention the signal generator (28) is provided with a pair of pulse generators, that is, a first pulse generator (90) and a second pulse generator (91) that apply corresponding pulse signals to the first and second central electrodes (78) and (79) and side electrodes (27) through selection means, that is, an array of switches (S1) to (S16). The pulsed signal from the first pulse generator (90) is applied to the electrodes (78), (79) and (27) through the switches (S1) to (S8), while the signal 10

ES 2 199 759 T3 pulsed signal of the second pulse generator (91) is applied to the electrodes (78), (79) and (27) through the switches (S9) to (S16). A microprocessor (not shown) of the signal generator (28) selectively actuates the switches (S1) to (S16) to select the pairs of electrodes and to apply the respective pulsing signals of the first and second pulse generators (90) and (91 ) to the first and second center electrodes (78) and (79) and to the side electrodes (27) in some or all of the selected pairs described with reference to Figure 25. Switches (S1) to (S16) can be relays or semiconductor switches and in certain cases they can be manually operated switches. The microprocessor (not shown) also controls the first and second pulse generators (90) and (91) to determine the signals to be generated by the respective pulse generators, so that the signals emitted by the pulse generators (90) and (91) can be varied to apply different pulsating signals to different selected pairs of electrodes to provide different levels of stimulation for different muscles of the abdomen. Thus, the subcutaneous current paths through the patient are selectable by selecting the appropriate electrode pairs, and the signal to pass through each of the current paths is also selectable. In this way, the current distribution and effective pulse frequency at each electrode can be used for the tissues to be stimulated.

Figure 27 shows an alternative circuit arrangement for applying signals generated by the signal generator (28) to the first and second center electrodes (78) and (79) and to the side electrodes (27). This circuit comprises selection means provided by the switches (S1), (S2) and (S3) to apply the signals generated by the signal generator (28) to the electrodes (78), (79) and (27). Switches (S1), (S2) and (S3) provide selective selection of electrodes on the following electrode pairs:

<td>R-U1 L-U1 L-U2</td><td>R-U2 U1-U2</td>

A microprocessor (not shown) of the signal generator (28) controls the switches (S1), (S2) and (S3) and the pulsed signals are multiplexed from a pulse generator (74) within the signal generator (28) to via switches (S1), (S2) and (S3) under the control of the microprocessor (not shown). Switches (S1), (S2) and (S3) can be relays or semiconductor switches. When switches S1 and S2 are closed and switch S3 is closed on contact a, current paths I, II, III and IV are activated. When the switch (S3) is closed on the contact (b), the current path V is activated. In this circuit arrangement, there is no provision to select the electrode pair RL to provide the current path VI.

It has been discovered that by arranging a first and a second central electrode, so that the first central electrode is located just above the umbilicus and the second central electrode is located just below the umbilicus, in certain circumstances stimulation of the rectus abdominis muscles.

Referring now to Figures 28-30, there is shown a device according to yet another embodiment of the invention which is indicated generally at reference numeral 80 for stimulation of the abdominal muscles of a patient. Device 80 is substantially similar to device 1 and similar components are identified by the same reference numerals. The main difference between device (80) and device (1) is that in this embodiment of the invention, primary and secondary attachment means comprising primary and secondary stem attachment devices (81) and (82) are arranged to fixing the corresponding electrodes (26) and (27) to the primary and secondary location areas (31) and (32). In this embodiment of the invention, each of the stem attachment devices (81) and (82) comprises a female portion (83) and a male portion (84). The male parts (84) are fixed and are electrically coupled with the electrodes (26) and (27), while the female parts (83) are fixed to the belt (25) and provide electrical continuity between the electrodes (26) and (27) and the signal generator (28) through the corresponding primary and secondary cables (59) and (60).

In this embodiment of the invention, one of the female portions (83) of the stem attachment devices (82) is disposed in each of the three secondary location areas (32a), (32b), and (32c) to receive the corresponding male part (84) with the corresponding side electrodes (27) in the desired secondary location area (32). The female and male parts (83) and (84) of the stem clamping devices (81) and (82) are made of an electrically conductive material, in this case, chrome-plated steel. An electrically insulating coating (85) is applied on the surface (86) of each of the female parts (83) that is exposed and that could come into contact with the patient's skin, if it were not covered by one of the electrodes. sides (27). This, therefore, avoids any damage caused by a signal applied to the female part (83) of a secondary stem fixation device (82) as the signal generator (28) is transferred directly to the patient, from the surface ( 86) of the female part (83). However, the inside of the female plug (87) of each female part (83) provides good electrical continuity with a corresponding male protrusion (88) from the corresponding male part (84) to ensure electrical continuity between the female and male parts (83 ) and (84) of the stem clamping devices (81) and (82).

The use of the device (80) is similar to that of figure 1, once the central and lateral electrodes (26) and (27) have been fixed to the belt (25) by the rod fixing devices (81) and (82).

Although the central and lateral electrodes have been described as comprising an electrically conductive adhesive coating on the side of the electrodes for adhesion of the electrodes to the skin of the patient, certain cases are envisaged that the electrically conductive coating may be non-adhesive and certainly that It may be of the type that provides a low friction surface. In certain cases, this coating is expected to be electrically

ES 2 199 759 T3 conductive can provide adequate electrical contact between the electrodes and the patient.

Of course, it will be appreciated that in addition to having the ability to vary the current, pulse width, pulse interval, and / or other parameters of the pulsed signal, the direction of current through the subcutaneous pathways of the patient can also be reversed. Of course, it will be appreciated that any of the subcutaneous current paths that can be selected by properly selecting the electrodes in appropriate selected pairs, can be selected in any order, and the order and selection can vary during a treatment regimen by programming in such a way. the same processor as the signal generator.