WO2019095085A1 - Wraparound chest pad for e.c.g. monitoring - Google Patents

Abstract

The invention relates to a wraparound chest pad for E.C.G. monitoring made up of a first sheet (1) and a second sheet (2) adjacent to the first sheet, both of which are flexible and inelastic. A single planar magnetic laminar part (30, 31) capable of copying the changes of direction by adapting to the contour of the patient's torso (42) is placed between the two sheets; a plurality of capsules (10), presenting against the second sheet (2) and at the opposite end of said capsule an electrical contact that rests on the patient's epidermis are provided on the second sheet and in correspondence with said planar magnetic laminar part; each capsule has means for transmitting the cardiac signal received by said contact to an E.C.G. device. Reciprocal connection means (40, 41) are provided adjacent to the free ends of said chest pad.

Description

 WRAPPER WRAPPER FOR MONITORING E.C.G.

Field of application of the invention:

 The subject of the present invention is an enveloping bib that is capable of selectively positioning a plurality of terminals on the epidermis of the patient for each patient in particular, establishing a series of electrical contacts in a secure manner for the monitoring of precordial electrical signals.

 Particularly, the present invention covers the construction of wrap-around breastplates with selectively positionable electrodes that are imprisoned in their selected position against the torso of the patient, preventing movements of the patient from moving the selected position for each electrode, resulting in this pechare particularly suitable for patients with uncontrolled movements, or involuntary, such as occurs with neonates with 24 to 40 weeks of age and with people of all ages in a state of shock or in a serious state of alteration.

Antecedents v Art Previous to the invention:

It is known that to perform an ECG, a series of electrodes, usually six of them, are arranged on the chest and back of the patient's torso, depending on the case, with which the precordial signals that determine the parameters and state in time are captured. real of the patient's heart. For its realization, traditional electrodes composed of a plate carrying a small electrical contact and with an adhesive or alternative means of temporary bonding with the epidermis of the patient or rubber or rubber soothers that adhere to the skin by the action can be used. negative pressure over the region where the electrode is fixed.

 To achieve the best signal capture, it is necessary to add the filters available in the devices, in case they do not have them or are effective, to decrease the movements in a voluntary way or mechanical containment in case of infants and children.

 Obviously, if the patient during this examination practices sudden movements, apart from altering the result of the signals, it releases the electrodes or pacifiers.

 Particularly in the case of babies with a birth time of 24 to 40 weeks, it becomes difficult to decrease the movements during the examination, so the heartbeat signal can not always be captured, adding the difficulties in terms of the size of the circumference of the hemithorax, where the driving devices must be placed, in addition to the possibilities of generating injuries or traumatisms that we will mention next.

 It is necessary for all these cases detailed above to establish the existence of electrical conduction using means that secure the electrodes against the epidermis without the possibility of accidental displacements or detachments.

 Additionally, if we use the adhesive plates with adhesive on the torso of the patient in neonates, especially premature neonates, we have recognized the following problems;

i) The adhesives used in the art need to firmly fix these plates with the terminal to the torso of the small patient, whereupon said adhesives adhere strongly and turn out to be very aggressive for the very sensitive epidermis of the newborn, being able to produce injuries or traumas when removing and / or repeatedly apply the plates with adhesive on the patient's skin, generating possible entry doors to microorganisms with high possibilities of producing an infection locally or systemically;

ii) If we use plates with more friendly adhesives, the risk of electric contacts leaking or slipping, distorting ECG monitoring, especially if continuous monitoring is indicated for short-term procedures (such as administering an antiarrhythmic agent) intravenous);

iii) The placement of elements that generate negative pressure on the epidermis in extreme premature infants, will surely generate lesions in the same, generating high levels of pain and may cause cerebral hemorrhages of different degrees; iv) In most of the times when an attempt is made to perform an ECG on premature patients, the diameter of the aforementioned devices is greater than the space of the thorax where they should be placed, having to cut them to the appropriate size without losing areas of contact or adherence, increasing the time in the procedure and not complying with the minimum care protocols used in these patients.

It is convenient to remember that in some cases the monitoring of the newborn patient can last 24 or 48 hours continuously and being able to perform an ECG for diagnosis and treatment must be carried out in the quickest and simplest way possible, it must meet stability conditions so as not to produce traumatic effects on its very delicate epidermis and its neurological development ...

Problems to solve in the Previous Art: It is then evident that it is necessary, and often essential, to have a means capable of wrapping the torso of the patient and retaining against it a plurality of electrical contacts capable of perceiving and transmitting the cardiac pulses.

 It is also necessary, especially for neonatal patients, that such contacts settle against the patient's body without the need to use adhesives or other devices that use negative pressure on the skin for adherence.

 Considering the different diameters of torso that may exist between patients of the same age range, it is also necessary that this enveloping medium has the ability to firmly adjust to them without producing any type of injury.

Objects of the present invention:

 The object of the invention is a wraparound bib for monitoring E.C.G. able to adapt to the different torso diameters of patients holding between the same and the patient's epidermis a series of electrical contacts with absolute absence of an adhesive.

 It is also an object of the invention that said electrical contacts are selectively positionable.

 It is still an object of the invention to offer a tool for the operators of this study and diagnosis system that facilitates the technique and reduces the time of the procedure, especially when these studies are performed on young children, term newborns and especially newborns premature

Summary of the invention: WRAPPER WRAP FOR ECG MONITORING characterized by being constituted by at least one flexible and substantially inelastic wrapping sheet and fixable on the torso of the patient; On the surface of said sheet that is attached to the user's body, a plurality of capsules is selectively displaceable, each capsule being removably retained against said surface by

retention means; each of said capsules is formed by a body with side walls, on the end of which it rests on the sheet surface that adjoins the body of the user has a first retention means cooperating with a second retention means linked to said sheet, and in the opposite end of said capsule has an electrical contact resting on the epidermis of the patient, each capsule result pressed between the torso of the user and said sheet; each capsule having means of transmitting the cardiac signal received by said contact to a device of E.C.G.

 In one of the possible constructions of the invention, said at least one sheet at least partially overlaps a second sheet of the same characteristics, the second sheet with its perimeter being connected to the first sheet defining between them a space in the which said two sheets are not linked; within at least part of said space there is arranged at least one flat piece made of a magnetic material capable of copying the changes of direction of the two aforementioned flexible sheets by adapting to the contour of the torso of the patient; on the external surface of the second sheet and in correspondence with said at least one flat magnetic part.

Examples of preferred construction of the present invention: In order to exemplify the preferred embodiments of the present invention, the following drawings illustrating them are attached, with the support of the description thereof given below, these examples of embodiment having to be interpreted as one of the many possible constructions of the invention. invention, so it is not appropriate to assign any limiting value to it, including

within the scope of protection of the invention the possible means equivalent to those illustrated; the amplitude of the present invention being determined by the first claim enclosed in the corresponding chapter of Claims.

 Likewise, in these Figures, the same references identify equal and / or equivalent means.

Figure 1 shows a development in a plane of one of the constructions of this chest seen from the side that supports against the body of the user;

Figure 2 illustrates the same object in the same position, with the second sheet partially removed, leaving the space between the two sheets uncovered, with in the foreground one of the constructions of the magnetic means;

or Figure 3 shows the closed chest pressing on a torso (not shown); o Figure 4 shows in perspective one of the possible constructions of the capsule with the magnet and the electric contactor;

or Figure 5 illustrates the diametral section of the capsule of Figure 4;

o Figure 6 shows the same cut, with a variant of the electric contactor;

or Figure 7 illustrates another embodiment of the present invention;

o Figures 8, 9 and 10 respectively show the cuts AA, BB and CC;

or Figure 11 illustrates a flexible magnetic sheet piece useful to the present invention as alternative to the magnetic pieces illustrated in Figure 2.

In the exemplified figures, it has been chosen to illustrate a construction in which there are two superimposed sheets, defining between them a gap inside which one or several magnetic metal plates are interposed.

 However, this is one of the possible constructions of the invention so that it does not assist the same limiting intention. In fact, in a constructive version (not illustrated) of the invention, the sheet is unique and the magnetic means can be a flexible flat sheet of a polymeric cake with iron powder adhered on the surface of said sheet facing the torso of the user. In another construction (not illustrated) the retaining means may be a flexible plaque of caltrops (Velero type) and on the base of each capsule there is a complementary portion of said caltrous retention system, and in another embodiment, pacifiers are used. for fixing the capsules on the surface of the sheet.

In the construction illustrated in Figure 1, the bib of the invention is shown in one of its possible embodiments, seen with the surface of the second sheet 2 in the foreground, which is the exposed surface in contact with the torso of the patient. In this particular embodiment, the second sheet (2) is completely superimposed on the first sheet (1) (not observable in this figure), in which case the union of (1) with (2) occurs throughout all the perimeter (4). This second sheet can be partial, as shown by dashed line (3) of Figure 1, in which case the linkage occurs along the portion superimposed on (1) and linked to it in (3) . Whatever the chosen architecture for these sheets or superimposed portions of them, the space (6) between them (see Figure 8), enclosed by the perimeter of reciprocal linking is free, that is, a space (6) is generated between both sheets.

 In Figure 2 the breastplate of Figure 1 is shown, with the second sheet (2) partially detached, showing how the inner face (2a) of the second sheet 2 is bonded against the inner face (1 a) of the first sheet (one ).

 Regarding the shape of the perimeter of the sheets, it preferably has a sufficient extension to surround the torso of the patient, with a configuration with at least one notch in (5) to allow the chest to surround the torso of the patient can be accommodate under the armpit, but nothing prevents the

Chest is made up of laminar pieces (1, 2) rectangular without said recesses. Regarding the chosen material, the use of sheets of an inextensible and flexible polymeric material, or with a low stretch ratio, such as PCV sheets, is preferred, so that the perimeter connection (4) between both sheets can be effected by electro - fusion or welding.

On the external surface of the second sheet (2) a plurality of capsules generically indicated with the reference (10) are arranged. In the construction example illustrated in Figures 1 and 2, which is indicated by way of example only illustrative and not limiting the means of connectivity of the bib with the ECG equipment is observed that the means of transmission of each capsule of the cardiac signal consist of a cable (20) connected to each contactor (14, 15) (See Fig. 4 and 6) of each capsule which is inserted in a plate (22) and enters the interior of the gap or separation ( 6) between both sheets (1, 2) and from there the cables (20) are grouped in a bunch or sheath (23) projecting from the gap or space (6) interlaminates by terminating each cable (20) in a terminal or connection means (24) those that connect with the ECG device (not illustrated).

 This mode of connectivity can be supplanted by means of wireless transmission between the capsule and the E.C.G. whereby the cables (20), the plate (22) and the bundle of cables (23) together with the terminals are eliminated in whole or in part.

(24) Particularly applicable is the technology that involves linking a transmitter to each capsule and that it transmits its signals to a receiving medium that decodes them, orders them and sends them to the E.C.G.

 The capsules (10) must be positionable in a functional way to the anatomy and particularities of each patient, so that each capsule must be able to be moved along an area of the chest that corresponds to the areas where these contactors are usually placed. the measurements with ECG and once

that the intervening professional determines the zones or locations the capsules must remain fixed, with the capacity so that their location can be electively modifiable throughout the entire work area. For this purpose, a magnetic laminar means is arranged in the space (6) between the faces (1a, 2a) of the mutually facing sheets (1, 2). Figure 2 shows one of the possible constructions of said magnetic laminar means, consisting of a plurality of segments of thin flat sheets (30), of a magnetic metal and arranged parallel and contiguous with each other along the longitudinal axis of the torso of the patient with a minimum separation (21) between sheets and adhesively bonded preferably to the inner face (1a) of the first flexible sheet (1). These magnetic means can be replaced by a continuous and flexible sheet, such as that indicated by (31) in Figure 11. This sheet (31) can conveniently consist of a thin flexible metal mesh made with magnetic metal filaments or in a sheet of a magnetic plastic paste that is flexible by its nature, such as is used in labels that adhere to a metal surface. Whatever the chosen magnetic means (30) or (31), it must be capable of accompanying and copying the curvature imposed on the sheets (1, 2) by sticking on the wearer's torso.

 Figures 4, 5 and 6 illustrate one of the possible constructions of the capsule (10).

In the figures it is observed that the capsule (10) has a lateral wall (11) ideally cylindrical made in a dielectric material such as a plastic, which has in its upper portion internally a partition (12), which defines a housing (13) for the contactor which may consist of an electrically conductive metal washer (14) or a domed body (15) (see Figure 6), also metallic and electrically conductive. The interior of the body (10) is hollow and inferiorly, separated from (14, 15), a magnet (16) integral with (10) is arranged. The conductor cable (20) of the electrical signal perceived by (14, 5) is connected to the contactor means (14, 15) inside the capsule and passing through the septum (12), and they exit the capsule through a recess (17) therein. The lateral walls (11) of the capsule have been shown cylindrical, but nothing prevents the capsules from being prismatic, or frustoconical.

 In FIG. 1, the sheets of magnetic material (30) are shown in dashed lines to emphasize the relationship between the positioning of the same and the position of the capsules (10) selectively positionable on said sheets (30). , 31), while in Figure 2, conversely, with broken lines, the position that the capsules can have on said parts (30, 31) has been represented.

In Figure 3 we see how the flexible laminar pieces (1, 2) perimeter joined are bent by copying the contour of the torso (not illustrated) and are fitted on it, with the capsules 10 already pre-positioned, the ends joining which are secured by any conventional means already known, such as the one known as "sailboat" (40, 41).

Figure 8 shows the section AA of Figure 1 in which the interior space (6) is illustrated. Of course, in the area where the magnetic pieces are not found (30, 31) the sheets (1, 2) can have further intermediate welds sectioning this space (6) without thereby altering the desired result.

 Figure 9 shows section BB of Figure 1, in which a portion of the torso (42) of a generic user has been schematically added. It is noted that the reason for having the capsules (10) a side wall height (11) of at least

5mm is that when the chest is pressed adjusting against the contour of the torso of the user the external face of the second sheet (2) forces the capsules to press

against the assured epidermis an excellent contact interface without having to resort to the use of adhesives that could damage the epidermis, especially in the case of neonates. In turn, the sheets (1, 2) have sufficient flexibility to yield to the pressure of the capsule acting as an elastic medium that exerts a gentle pressure.

 An alternative of the present invention is to condition the whole of the bib in a sterile pouch or envelope (43) welded by its perimeter seams (44) and made, for example, in a friseline fabric. This assembly can be sterilized by any of the methods known in the art, and before its use, the bib is removed from the sterilized pouch (43). Figure 10 shows the section CC of Figure 7, in which it is observed that the sterile bag in turn can be conditioned within a second envelope (45) or container, if necessary.

Claims

Claims:  1. WRAPPER WRAPPER FOR MONITORING E.C.G. characterized by being constituted by at least one first flexible and substantially inelastic wrapping sheet and fixable on the torso of the patient; on the surface of said sheet that is attached to the user's body a plurality of capsules is selectively displaceable, each capsule being removably retained against said surface by retaining means; each of said capsules is formed by a body with side walls, on the end of which it rests on the sheet surface that adjoins the body of the user has a first retention means cooperating with a second retention means linked to said sheet, and in the opposite end of said capsule has an electrical contact resting on the epidermis of the patient, each capsule result pressed between the torso of the user and said sheet; each capsule having means of transmitting the cardiac signal received by said contact to a device of E.C.G; in adjacency of the free ends of said chest, there are reciprocal linking means of said ends fitting on the torso of the patient.  2. WRAPPING WATCH, according to claim 1, characterized in that the retention means of each capsule on said surface of the sheet are chosen from a system of caltrops, a flexible sheet of a polymeric material with iron filings adhered on said face of the first sheet, each capsule having a magnet at its base, and a vacuum suction device capable of adhering on the flexible sheet. 3. PECHERA ENVOLVENTE, according to what is claimed in 1, characterized because on the first flexible and substantially inelastic sheet at least partially overlaps a second sheet of the same characteristics, the second sheet being linked to the first sheet at least along its perimeter defining between the two sheets a space in which said two plates are not linked; within at least part of said space there is arranged at least one flat magnetic sheet piece capable of copying the changes of direction of the two said flexible sheets by adapting to the contour of the patient's torso; each of said capsules has a magnet at the end that supports against said external face of the second sheet facing the torso of the user.  4. WRAPPING BITCH, according to claim 3 characterized in that the at least one flat magnetic sheet is chosen from: a plurality of metal sheets arranged vertically and mutually attached establishing an angular displacement between each sheet that copies the development of the torso of the user against whom the breastplate rests and a flexible integral piece made of a magnetic material chosen between a metal mesh or a laminated paste with magnetic material.  5. WRAPPER WRAPPER, according to that claimed in 1 to 3, characterized in that said capsules are chosen between capsules with cylindrical, prismatic or frustoconical side walls, with a height greater than 5mm; said capsule having an interior partition defining a recess into which the contactor that rests against the epidermis of the user is housed and said partition separating said contactor from the magnetic medium located at the opposite end. 6. PECHERA ENVOLVENTE, according to what is claimed in 1 to 3, characterized because said first and second sheets are in a laminar and inextensible plastic material.  7. WRAPPING BREAKER, according to that claimed in 1, characterized in that the means of transmitting the cardiac signal received by said contact to a device of E.C.G. it is chosen from: an electrical cable that connects each contactor with the device E.C.G; or a device transmitting the electrical signal by wireless means and linked to each capsule communicating with a receiver decoding means of the signals that are then communicated to the E.C.G.  8. WRAPPING WATCH, according to claim 1, characterized in that the reciprocal linking means of said ends adjusting said chest on the torso of the patient are chosen between a system of caltrops and ribbons in adjacency of the free ends of said chest.