ES2264905B1 - DEVICE FOR ELECTRICAL HOLDERS FOR THE APPLICATION OF A PLURALITY OF ELECTRODES TO THE TORSO OF A PERSON, AND A SET THAT INCLUDES A PLURALITY OF SUCH DEVICES. - Google Patents

Abstract

Electrode holder device for the application of a plurality of electrodes to the torso of a person, and assembly comprising a plurality of such devices. The electrode holder device, which can be in the form of a vest and which is configured to allow the application of a plurality of electrodes to the torso of a person, comprises: an element (1) of elastic material configured to be able to engage on the torso of a person; a plurality of perforations (2) that pass through the elastic material and that are configured to accommodate electrodes; and on an external surface of the element (1) of elastic material, a plurality of ribbons (3) of elastic material covering said perforations (2).

Description

Electrode holder device for application from a plurality of electrodes to a person's torso, and set comprising a plurality of such devices.

Technical Field of the Invention

The invention is included in the field of electrical cardiac surface mapping.

Background of the invention

Electrical surface mapping is a technique derived from clinical electrocardiography that deals with know the full distribution of the generated electric potential by the heart on the surface of the torso. It differs from the electrocardiography for clinical use in the number of electrodes a use and in the format of data representation, which can be done in the traditional way or through potential maps electrical showing the distribution of voltage over the torso in a certain moment This technique is currently in research phase since, although several studies have demonstrated its diagnostic superiority against the electrocardiogram Traditional twelve leads, the number needs to grow of cases studied to have the trust of the community medical

The simultaneous registration of a large number of electrocardiographic signals for use in mapping Cardiac electrical surface presents a number of problems. First of all it is necessary to fix the electrodes to the body of the patient so that the electrical contact is good, with a constant impedance and no oscillations. If the contact of the electrodes with the skin is good, signals will be recorded electrocardiographic of sufficient quality. Otherwise the Registered signals may have deterioration such that they are subtracted  diagnostic capacity Second, for a study electrical map of the torso surface, it is necessary that the electrodes are in established positions, forming a certain mesh that allows to reconstruct the electric potential distribution of the entire surface of the torso from the knowledge of the location of the electrodes Finally, it is necessary that these measures be reproducible, and can be carried out in a reasonable time, since that otherwise the difficulty in taking the measures will that is not useful in clinical diagnosis.

Previously they have been described differently systems to facilitate reproducibility in systems electrocardiographic with a more limited number of leads, specifically for the twelve referrals for clinical use or for three derivations of use in vectocardiography.

US-A-3409007 describes a vest adjustable to the patient for the placement of the twelve electrocardiographic leads without the need for intervention by a specialist.
list.

Another system is described in the patent US-A-4608987, which proposes a fabric vest adjustable to the patient by means of Velcro strips or similar material on the sides.

U.S. patent US-A-3534727 shows another solution for use in vectocardiography. In this case the use of elastic materials for the manufacture of vest, together with the coupling of the sensor electrodes in the same vest, so that it is secured to the skin. Without However, this approach incorporates the electrodes itself vest and does not allow the use of electrodes reusable

All electrode placement systems described above serve to facilitate placement of a limited number of electrodes. However, the placement of a large number of them present additional difficulties if You want the application time to be low. The team trades Prime ECG from Meridian Technologies presents a solution  different for solving the fixation and placement problem of the electrodes. It is a system of electrode strips disposable and one size This system, which has the advantage to ensure good contact of the electrodes with the skin, requires a moderate application time and the intervention of staff with a previous training, since it is necessary to fix correctly each of the strips in a specific place so that The measurements are correct. In addition, this electrode system is disposable, which increases the cost of each acquisition of measurements.

Description of the invention

Therefore, it has been considered that it would be convenient to develop a system that allows to attach a large number of electrodes to the torso of an individual, so that the electrode distribution over the torso fits a preset scheme, and that allows the use of electrodes reusable (so that the same electrodes can be used in successive acquisitions or corresponding measurements to different people or patients).

A first aspect of the invention relates to an electrode holder device for the application of a plurality of electrodes to the torso of a person, whose device comprises an elastic material element configured to be able to fit tightly over a person's torso so which covers at least a substantial part of the front and rear of said torso.

According to the invention, the device It also includes:

- a plurality of through holes or perforations that cross said elastic material, each being perforation configured to accommodate an electrode so that the electrode can rest on the skin of the torso of a person when the elastic material element is attached or applied on the torso of the person with an internal surface of the element of elastic material in contact with said torso; Y

- on an external surface of the element of elastic material, a plurality of ribbons of elastic material which cover said perforations.

In this way, multi-use electrodes can be placed in the perforations. With an adequate size of the electrodes with respect to the dimensions of the perforations, the electrodes can be retained and with well-defined positions with respect to the user's torso. The elasticity of the material of the element and the tapes makes the device adapts to the body of the person, so that the relative distribution of the electrodes on the torso will always be adequate. The electrodes can be inserted into the perforations through the defined space between each tape and the outer surface of the elastic material element. In this way, it is easy to place the electrodes, and once placed, they can be used for a large number of tests or measurements acquisitions, or be removed and cleaned between one acquisition and the next. In this way, high quality reusable electrodes can be used, without implying a cost
excessive.

Therefore, with the device of the invention It facilitates the placement and fixation of multiple electrodes reusable for use in record acquisition electrocardiographic The device facilitates the correct hold of the electrodes and the reproducibility of the measurements, since the device makes it easy for electrodes to always be ready with an adequate distribution on the torso of the person to whom The device is applied. Therefore, the device is very useful for the acquisition of electrocardiographic records for electrical surface cartographic studies.

Perforations may be present both in a front part as in a dorsal part of said element of elastic material, so that signals can be captured both in the front as in the dorsal part of a person's torso (and also in the lateral parts of the torso, if desired), of simultaneously.

The elastic material element may have vest shape, something that can be practical since it is of a device that must be attached to the user's torso, by example, as a garment.

The elastic material element may present at least one zipper that runs the element in the direction longitudinal (corresponding to the direction from the feet to the head of the person to whom the device must be attached), of so that the zipper serves to close the vest once coupled to the torso of a person. In addition, the device can comprise a plurality of velcro closures or the like located in correspondence with the zipper, to facilitate the closure of the zipper during a coupling phase of the device to Torso of a person. In this way, first the device closing the velcro closures (which each can comprise a velcro strap on one side of the opening longitudinal, and a tape with a ring on the other side) first, and the zipper afterwards, to avoid excessive tension in the Zipper during closing operation.

Elastic material tapes can be extend in a transverse direction in the material element elastic, that is, in a substantially perpendicular direction to the direction from the feet to the head of the wearer (when the device is applied to a carrier).

The tapes can be attached to the element of elastic material by means of seams that run through said element of elastic material in a direction perpendicular to the direction in which extend the tapes. Seams can go through tapes at a distance greater than or equal to 0.5 cm from the closer drilling, something that allows the tape to "lift" easily with respect to the outer surface of the element and in correspondence with the drilling, in order that an electrode can be introduced into the perforation, below tape.

Tapes can, for example, have a width between 1 and 3 cm, something that allows a secure retention of  the electrodes (since the tapes can completely cover the perforations) while the tapes allow access to the perforation during placement or removal of electrodes.

The plurality of perforations may comprise 64 or more perforations, so the device can be useful to perform electrical cardiac surface mapping.

The tapes can include, in correspondence with perforations, alphanumeric symbols indicative of shunts corresponding to the perforations (for example, the Alphanumeric symbols may form indications such as "A1", "A11", "B9", etc., usually used in electrocardiac records of this type).

The elastic material element may have a thickness of, for example, between 3 mm and 6 mm. This thickness has proved adequate to obtain a good fixation of the electrodes

The device may additionally comprise a plurality of electrodes housed in the perforations of such that a contact part of each electrode is located in correspondence with the internal surface of the material element flexible.

Another aspect of the invention relates to a set of devices according to what has been described more above. This set includes devices that present different "sizes" or different extensions in at least the longitudinal direction, so that you can choose a device to use depending on the height of the person whose Torso should be applied device. In this way, for one part, the elasticity of the device or vest makes the electrode distribution in the "transverse" direction is the adequate, while a choice of "size" in the sense longitudinal of the device allows to obtain a distribution also suitable longitudinally, depending on the height of  the person to whom you want to apply the device.

Description of the figures

To complement the description and in order to  help a better understanding of the characteristics of the invention, according to a preferred embodiment practice thereof, is accompanied as an integral part of said description, a set of figures in which with illustrative character and not limiting, the following has been represented:

Figure 1.- Shows a plan view of a device according to a preferred embodiment of the invention, seen from the front.

Figure 2.- Shows a plan view of the device of figure 1, seen from behind.

Figure 3.- Shows a detail of the device.

Figure 4.- Shows another detail of the device.

Figure 5.- Shows the device applied to the Torso of a person.

Figure 6.- Shows a cross section of the vest.

Figure 7.- Schematically shows a "kit" of three vests, seen from the front, with different "length".

Preferred Embodiment of the Invention

Figure 1 shows an agreement device with a preferred embodiment of the invention, in the form of a vest.  This vest is made of an elastic material, for example, neoprene or lycra-neoprene, with a thickness of approximately 3 mm. The elasticity allows the vest to adapt to the contour of the torso of the person to whom it is applied, it is that is, it adapts to the dimensions of the torso, especially the dimensions in cross direction. In figure 1 you can observe as in element 1 of elastic material that forms the vest itself, a plurality of elastic bands 3 covering a plurality of through holes (not illustrated in Figure 1) configured to house electrodes, which can be introduced in the holes below the tapes 3. The tapes 3 are located on the outer surface of the element 1, so that the electrodes are hidden under the tapes and peek through the inner surface of the vest, to being in contact with the user's skin when he wears the vest put on. The tapes have a width of approximately 14 mm and are attached to the elastic material element 1 by seams 6 extending in the longitudinal direction (i.e. perpendicular to the tapes). As you can see, the tapes are equipped with alphanumeric symbols 31 indicative of corresponding leads, so that it is easy for the user place each electrode in the corresponding hole. Also the electrodes that are used can carry this type of referral indications.

As can be seen in figure 1, the vest it is equipped with a zipper 4. The zipper is located on the dorsal part of the vest, which can be best seen in the figure 2. In this figure, the vest already incorporates the electrodes, that are housed in the corresponding perforations, so which can be seen as the conductive wires 10 that join the electrodes with measuring instruments enter through Under the tapes. In addition, in Figure 2 you can see the electrodes known as CMS 15 (which is the reference electrical of all torso signals) and DRL 16 (electrode with which measures the current to act in case they are exceeded recommended values). In figure 2 you can also see as the vest, in addition to the zipper, wears closures of Velcro 5 that can be best seen in Figure 4: these closures, each comprising a velcro type 51 and a eye 52 located on both sides of the longitudinal opening of the vest, allow to close the vest so that it is adjusted to the user, before performing the final closure using the zipper. This facilitates the zipper closure operation, and prevents zipper breaks due to excessive force applied to it during the closing operation. This is important, since it is a vest made of elastic material certain thickness that must be adjusted to torsos more or less thick, for which sometimes produces very large tensions in the material, especially in the transverse direction.

In figure 3 you can see how to lift a part of an elastic band 3 you can access the 2 perforation hidden under the belt, for example to place an electrode in said perforation 2. It also looks like tape 3 is attached to the elastic material element 1 by means of a seam 6 extending longitudinally and joining the tape 3 to the element 1 at a certain distance from the perforation. This distance must be large enough to allow the tape to Easily lift to allow access to drilling from the outer surface of element 1 (but not so large as to that the tape can "loosen" in the area of the drilling).

On the other hand, in figure 5 you can see a vest according to the invention applied to the torso of a person, with the electrodes mounted on the perforations corresponding. As you can see, tapes 3 of elastic material extend transversely with respect to the body of the person, that is, when the person is standing, the Ribbons extend horizontally. Each tape can serve to cover a "row" of perforations.

Figure 6 schematically illustrates a section  transverse of the vest, and can be seen as in the perforation 2 of the elastic material element 1 is housed a electrode 11 that occupies all the perforation and that is retained in the perforation by the tape 3 fixed to the elastic element by the seam 6, and by the skin 50 of the person wearing vest. The electrode has a metallic contact 12 to which has applied a conductive gel 13.

Figure 7 reflects a set or "kit" of three vests, with different sizes, which allows to obtain comparable measurements of people of different
height.

The described system allows the electrodes They can be easily inserted into the perforations. A once placed in the vest they do not move in any of the phases of the registration process (neither during patient placement nor during electrocardiographic examination). On the other hand, each cavity or perforation can be numbered (with symbols alphanumeric on the tape) to facilitate the placement of each electrode (electrodes can also be identified with the same alphanumeric symbols) according to the "derivation" it represents.

Although the vest is elastic and can be adapted to a large number of people and ensure a lateral / transverse adaptation of the distribution of the electrodes with respect to the torso, it may be advisable to have several sizes, especially to choose a suitable size depending on the height of the person, and thus ensure that the distribution of the electrodes is adequate (or, at least, within tolerance limits) also in a vertical or longitudinal direction of the
person.

The use procedure can be the next:

First the electrodes are placed Reusable in each of their positions. With the vest open if applicable, conductive gel is applied to each electrode (by inner part of the vest, where the electrodes hover over the perforations). Next the vest is placed on the person, closing velcro closures 5 (folding velcro straps 51 on themselves, once passed through the rings 52 corresponding). With the velcro closures closed then it turns out simple to zip, so that the vest is fully fixed to the person, and the electrodes have a good Contact. This procedure can take about 10 minutes. to place 64 electrodes in the vest and only a few seconds to its fixation to the person.

In this text, the word "understand" and its variants (such as "understanding", etc.) should not be interpreted excluding, that is, they do not exclude the possibility that the described include other elements, steps etc.

On the other hand, the invention is not limited to the specific embodiments that have been described but encompasses also, for example, the variants that can be made by the average expert in the field (for example, in terms of choice of materials, dimensions, components, configuration, etc.), within what follows from the claims.

Claims (14)

1. Electrode holder device for application of a plurality of electrodes to a person's torso,  the device comprising an element (1) of elastic material configured to fit tightly over the torso of a person so that it covers at least a substantial part of the front and back of said torso; characterized in that it also includes: a plurality of perforations (2) that they cross said elastic material, each perforation being configured to house an electrode so that the electrode can rest on the skin of a person's torso when the element (1) of elastic material is coupled on the torso of the person with an internal surface of the material element (1) elastic in contact with said torso; Y on an external surface of the element (1) of elastic material, a plurality of ribbons (3) of material elastic covering said perforations (2). Device according to claim 1, characterized in that said perforations (2) are present both in a front part and in a dorsal part of said element (1) of elastic material. 3. Device according to any of the preceding claims, characterized in that the elastic material element (1) is in the form of a vest. Device according to claim 3, characterized in that the element (1) of elastic material has at least one zipper (4) that travels the element in the longitudinal direction, so that the zipper serves to close the vest once coupled to the torso of a person. Device according to claim 4, characterized in that it comprises a plurality of velcro fasteners (5) located in correspondence with the zipper, to facilitate the closing of the zipper during a phase of coupling the device to the torso of a person. Device according to any one of the preceding claims, characterized in that the tapes (3) extend in a transverse direction in the element (1) of elastic material. Device according to any of the preceding claims, characterized in that the tapes (3) are attached to the element (1) of elastic material by means of seams (6) that run said element (1) of elastic material in a direction perpendicular to the direction in the one that extends the tapes (3). Device according to claim 7, characterized in that the seams (6) cross the belts (3) at a distance greater than or equal to 0.5 cm from the nearest perforation. 9. Device according to any of the preceding claims, characterized in that the tapes are between 1 and 3 cm wide. Device according to any one of the preceding claims, characterized in that said plurality of perforations comprises at least 64 perforations. Device according to any of the preceding claims, characterized in that the tapes (3) include, in correspondence with the perforations, alphanumeric symbols (31) indicative of derivations corresponding to the perforations. 12. Device according to any of the preceding claims, characterized in that the elastic material element has a thickness of between 3 mm and
6 mm 13. Device according to any of the preceding claims, characterized in that it further comprises a plurality of electrodes housed in the perforations so that a contact part of each electrode is located in correspondence with the internal surface of the flexible material element (1). 14. A set of devices according to any of the preceding claims, characterized in that it comprises devices that have different extensions in at least the longitudinal direction, so that a device to be used can be chosen depending on the height of the person whose Torso should be applied device.