WO2018152652A1

WO2018152652A1 - Bracelet for measuring electrical conduction for monitoring frontal cardiological leads without trauma to delicate skin

Info

Publication number: WO2018152652A1
Application number: PCT/CL2018/050013
Authority: WO
Inventors: Gastón Gabriel Alegre
Original assignee: ANGUITA ARRIAGADA, Amalia Rebeca
Priority date: 2017-02-24
Filing date: 2018-02-22
Publication date: 2018-08-30
Also published as: AR107745A1

Abstract

The invention relates to a bracelet for measuring electrical conduction for monitoring frontal cardiological leads, without trauma to delicate skin, formed by a flat strap or band (1) that defines an upper surface (2) and a lower surface (6). On the upper surface (2) is located a terminal (3) and in axial correspondence against the lower surface is situated a contact (9) that establishes, passing through the material of the strap or band (1), electrical contact and mechanical retention between the terminal (3) and the contact (9). The flat strap or band (1) is fitted on the ankle or wrist of the patient, the positions of same being secured with retention means chosen from hook-and-loop fasteners (7, 8) or sections with adhesive.

Description

BRACELET FOR M EDITION OF ELECTRIC DUCTION FOR DERIVATION MONITORING IS CARDIOLOGICAL FRONT, WITHOUT

TRAUMATISMS TO DELICATE EPIDERMIS

Field of application of the invention:

The present invention aims at a bracelet capable of establishing an electrical contact in a secure and eventually prolonged manner of a terminal on the patient's epidermis for continuous monitoring of its electrical signals, without causing trauma on the patient's epidermis.

Background v Art Prior to the invention:

When a newborn is born, the medical team attending the birth should immediately establish the health conditions of the newborn, which are basically breathing without assistance, reflexes to establish the neurological response, and heart rate.

Particularly in the case of the birth of premature babies, with a gestation time ranging from 28 to 36 weeks, the need for the use of resuscitation protocols to assist the newborn in its first moments of life is frequent or at least possible. Eventually, avoid his death. If, depending on the suspicion or determination of problems, resuscitation of the newborn, particularly in the case of premature babies, the doctor determines the need to implement resuscitation protocols for the newborn, it is of fundamental importance to establish the existence of a heartbeat, that is, heart rate.

The beat cannot always be perceived, as there are cases in which it is so weak that it is not audible or detectable by conventional means.

This results in the need to establish the existence of electrical conduction to verify the existence of a heartbeat, and for this there is a window of approximately 15 minutes, after which, if there is no electrical conduction (i.e. heart rate), sequelae originate that can be irreversible for the health, and in many cases, the life of the premature infant. Multi-parametric monitors do not establish electrocardiogram (ECG) measurements, so cardiac monitoring must be established as a matter of urgency. For this, it is essential to establish appropriate interfaces with the patient and the terminal blocks to the ECG. Here, and always thinking about premature infants, a series of problems arise that to date do not have a satisfactory solution: a) As is known, for effective ECG monitoring it is necessary to establish at least three electrical conduction connections with the body of the patient who carry their corresponding signals to the ECG and these can be three or more connections fixed on the patient's torso or connections established on three limbs of the newborn, such as in the two wrists and an ankle, or their variants of connections; b) The terminals known in the art are of two types: b1) those that adhere to the patient's torso constituted by a flat flexible piece, generally in the form of a disc, with a strong adhesive on one side, which may include a gel interface. The connection terminal has a projection projecting from the opposite side to the adhesive, defining a terminal or terminal to connect with the ECG and on the opposite side, in contact with the interface, usually surrounded by a crown of said adhesive, it has an electrical contact terminal that rests against the user's skin. There are several constructions on this same variant; b2) the other type of connector contemplates a clamp that is affirmed on the wrists and / or ankles of the patient, with the terminals of connection with the ECG, and an interface on the inner surface of the clamp that supports and presses on the extremities of the patient establishing electrical contact. c) If we use in neonates the connector plates with adhesive on the patient's torso, especially premature neonates, we have recognized the following problems; c1) on the one hand, the surface of the torso of a premature infant is very small, which makes difficult the correct location of these plates with terminals, not forgetting that they usually have relevant area dimensions compared to the patient's torso area; c2) on the other hand, the adhesives turn out to be very aggressive for the very sensitive epidermis of the neonate, being able to produce injuries or trauma when removing and / or repeatedly applying the plates with adhesive on the patient's skin; d) The use of the forceps is particularly excluded given the undeniable fragility of the bone structure of the premature infant, since the known forceps are rigid and press with a relatively significant force intensity against the wrist and / or ankles. e) If we use plates with more friendly adhesives, or tweezers that exert a lower tightening request, there is a risk that the electrical contacts will detach or slide, distorting ECG monitoring, especially if continuous monitoring is indicated. It is convenient to remember that in many cases the monitoring of the patient can last 24 or 48 hours continuously, so that the connection to the patient must meet stability conditions and not produce traumatic effects on the bone structure of the premature infant, or its very delicate epidermis

It is appropriate to make a brief mention of some paragraphs of the NEONATAL CARDIOPULMONARY RESUSCITATION MANUAL, edited by the Argentine Society of Pediatrics, (Bs. As, 2016). From this manual, we read: i- Premature babies born are at risk of several initial health complications. Some of these factors are a consequence of the same situations that have determined his premature birth. The quality of medical care that prematurity receives in its first minutes of life has a direct consequence on its future quality of life. Of special care is the control of temperature and oxygen level. Medical personnel must have high knowledge in advanced resuscitation techniques. ii- Among the various conditions this work makes specific mention of the use of three lead ECG. iii- In Table 1 of this work, entitled "Characteristics of Premature Babies", on page 42, it is observed:

iv- In the same work, in the chapter entitled "After Resuscitation", among other considerations, the need to control the presence of apneas, brachycardia or hypoxia is read, recommending immediate intervention by placing a respiratory cardio monitor.

Problems to solve in the Prior Art:

It is then evident that it is necessary, and often essential, to have ECG monitoring. For this, the small patient could not tolerate the application of thepaspastes on his torso, because they cause bleeding. Nor is it advisable to use the traditional adhesive plates because the adhesives are very irritating to the delicate epidermis of prematurity and any stimulation can lead to an increase in pressure, with the risk of cerebral hemorrhage. It is then as a resource, practically unique, to establish the electrical contacts to the terminals of connection with the ECG in three points of the patient, such as the ankles and wrists. But for this, only the use of tweezers is known in the art, the use of which is excluded for premature babies for the reasons indicated above.

The conditions that must be met by a device capable of seating an electrical contact on the skin of a premature baby, which is effective and immovable are the following: a) That it embraces the ankle or wrist, that is, surrounding and holding it on said limb; b) It does not contain any adhesive in contact with the skin; c) That it is inextensible and at the same time softly flexible; d) That it can accompany the baby's movements without detaching and / or moving; e) That it is waterproof, since it is not necessary to forget that some emergencies of the premature baby arise immediately just after the birth and in this case, it is the so-called "unbaby babies", even covered by placental fluids, previous a traditional cleaning bath that is provided to a healthy baby. In these cases the same fat that still maintains the baby's skin acts as an effective interface between the electrical contact and the epidermis; f) That in the face of certain emergencies, it can be removed without trauma for the baby, washed and replaced without altering the quality of support and / or electrical conduction.

Objects of the present invention:

The object of the present invention is an adjustable bracelet or bracelet in waterproof and inelastic material under usual tensile stresses, that is, that it is not stretched during handling and installation, that is supple and flexible, without sharp edges and with a sufficient width to distribute the adjustment pressure on the patient's limb. It is also an object that this bracelet is simple to adjust and detach from the patient's limb (ankle and / or wrist) without causing any trauma or the limbs to which it is applied, or the epidermis.

It is also the object of the invention that the bracelet of the invention be kept in the chosen site without moving for the entire time of the ECG monitoring, even for days without any trauma to the patient.

It is an object of the invention that the surface of the bracelet in contact with the epidermis of the patient has an electrical connection element capable of driving the patient's electrical pulses to an ECG connector terminal arranged on the opposite surface of the bracelet.

It is further object that the area of influence of this electrical connection may have a gel or similar material capable of inducing a correct interface with the patient

SUMMARY OF THE INVENTION: BRACELET FOR ELECTRICAL DRIVING MEASUREMENT FOR

CONTINUOUS MONITORING OF CARDIOLOGICAL FRONT DERIVATIONS, WITHOUT TRAUMATISMS TO DELICATE EPIDERMIS, which includes a band or band that surrounds adjusting on a patient's ankle or wrist, characterized in that said band or tape is made of a flat, waterproof, flexible, supple and dielectric material resistant to elongation, with a thickness of range 0.4 mm to 1.5 mm, which forms a loop that closes on the patient's limb, said band or tape being provided with joining means defining the selective reduction of the diameter; on the outer surface to the patient said bracelet has a terminal that defines the means of connection with the ECG, in electrical connection with an electrically conductive substantially coplanar means disposed on the inner face of said band or tape, and in contact with the patient's epidermis .

Description of the preferred embodiments of the present invention:

In order to exemplify the preferred embodiments of the present invention, the following drawings illustrating it are attached, with the support of the description thereof given below, these examples of embodiment should be interpreted as one of the many possible constructions of the invention, so it is not appropriate to assign any limiting value thereto, including within the scope of protection of the invention possible means equivalent to illustrated; the breadth of the present invention being determined by the first claim attached in the corresponding Claims chapter.

Also, in these Figures, the same references identify equal and / or equivalent means. or Figure 1 illustrates in an upper perspective an embodiment of the invention, in its open condition, that is, without adjusting on it a patient's limb; o Figure 2 shows in a side view the construction of Figure 1, at the moment of being closed forming the loop; or Figure 3 shows a side view of another construction of the invention, at the moment the loop on the patient's limb is closed; o Figure 4 shows an enlarged detail seen in lateral elevation of the section according to the plane AA of Figure 1 passing through the diameter of the connecting element and terminal; o Figure 5 shows a detail of another construction of the invention detailing an alternative closure means, and o Figure 6 shows the BB section of Figure 5.

For the purpose of a better understanding of the following description of the preferred constructions of the invention, it should be understood that the following terms have the following meaning in broad terms:

• Band or Tape; It is understood as such a flat piece of very little thickness and relative width, with a length of preponderant magnitude compared to the other two.

• Flexible and Supple: indicates the ability to adapt to the contour of the wrist and / or ankle in a smooth and total way, without the need to introduce deformation solicitations, that is, without any effort. Elongation Resistant: it is the power not to deform by elongation for normal use solicitations, even under gentle traction.

Means of joining: are the means capable of joining or adhering the two ends of the band or tape, in the constructions of the invention from initially flat tapes, that is to say open and with two free ends, or capable of adhering a section on the other reducing the diameter of the loop.

Dielectric: that does not conduct electricity, that is, it acts as an insulator.

In the construction of the invention shown in Figure 1 we observe the existence of a flat tape or band (1) in its open condition, that is, prior to its placement on the patient's limb. This tape has a back or upper surface (2) and the opposite or lower surface (6), with open ends (4, 5). On an intermediate portion at both ends (4, 5), ideally in the median between ends, a connector terminal (3) is placed that projects from the upper surface (2). This tape or flat band is preferably made of a piece of vinyl or other polymer material and can have a width between 1 cm to 4 cm, preferably between 1.5 to 3.5 cm and is very thin, with a thickness between 0, 4 mm to 1.5 mm, ensuring its ability to copy and settle intimately on the contour of the wrist or ankle.

The adjustment on the patient's limb is achieved by setting, for example, the end (4) on the (5), and for this purpose the bracelet of the invention has reciprocal bonding means chosen between a layer of adhesive and the so-called closure. Figure 1 and 2 schematically illustrates a closure by abrojos, consisting of a section (7) with a plurality of hooks, for example, linked on the end (4) of the lower surface (6), facing a section (8) that has a tangle of tangled fibers, linked to the outer surface (2) of the other end (5). As it is known, the hooks establish a soft and firm repeatable bond with the fiber mantle, and it is enough to support (7) on (8) adjusting the tape or flat band (1) surrounding and pressing on the perimeter of the patient's limb (not illustrated), as illustrated in Figure 2. In Figure 2 it is observed in lateral elevation to the construction of Figure 1 in the act of being closed on a patient's limb (not illustrated), and in this figure the contact means (9) emerging from the bottom surface (6) in electrical connection with the terminal (3) is observed. This contact (9) preferably has an annular shape with a semi-toric section, presenting a rounded back to the patient's epidermis, without aggressive edges. Figure 3 illustrates in side elevation to another construction of the invention, consisting of a band 1 forming a closed loop, with a diameter much larger than the perimeter of the patient's wrist or ankle (not shown); inserted this closed loop by passing the referred wrist or ankle inside, the portion (10) is held against the patient's limb and bent in (1 1) and (13) the excess of the loop, forming the fold (12 ). In this construction, a suitable contact adhesive layer (14) with a protective sheet (15) has been chosen which, when removed (see arrow R), allows the firm bonding of (12) on (14).

Figure 4 shows in a very enlarged form and in section AA of Figure 1 a preferred construction of the terminal (3) and of the contact (9). It is observed that the terminal (9) has a small post or pillar (17) that emerges from a bottom that ends in a semi-toric formation (17) open downwards. The contact (9) has a complementary semi-toric shape, that is to say open upwards, with a plurality of sharp extensions (19) in the form of a crown, which pierce the material of the tape or band (1) and deform against the walls curved interiors of (17) establishing on the one hand the electrical contact of (9) with (3), and on the other hand, the mechanical connection of the terminal (3) with the contact (9). It is observed that the termination of the contact (9) has a rounded back (18), and practically coplanar with the face or lower surface (6) of the tape (1). The annular end edge (21) of (9) presses against the lower surface (6) of the tape or band. The same figure illustrates how a thin sheet of a spongy or open-cell material (20) can be optionally arranged against the lower surface (6) and within the area enclosed by (18) said spongy material can be a carrier of a gel to establish the interface with the patient's epidermis, or polymer for the same purpose, already known in the art. The use of these gelled interface polymers is not essential, especially in the case of use with the so-called "high pre-maturos".

Figure 5 and Figure 6 of the BB cut show a possible variant of the adhesive protector. In this construction it is possible to select only a part or portion of the adhesive area (14), selectively separating one or two portions of protective sheet (15a), properly segmented, and provided with a protruding flange (22) to facilitate its separation and expose the desired adhesive portion (14). In Figure 5, the trance portion of being separated is indicated by (22a). As is known, at least three of these bracelets are necessary for ECG monitoring. Also, these bracelets can also be used in children and adults.

Claims

Cuff for measuring electrical conduction for continuous monitoring of cardiac frontal shunts, without trauma to delicate epidermis, which includes a surrounding band or tape adjusting on the patient's ankle or wrist, CHARACTERIZED because said band or tape is made of a flat dielectric material , waterproof, flexible, supple and elongation resistant, with a thickness of range 0,

4 mm to 1,

5 mm, which forms a loop that closes on the patient's limb, said band or tape being provided with joining means that define the selective reduction of the diameter until the aforementioned adjustment ratio on the ankle or wrist is achieved; in said band or tape projecting from the outer surface to the patient said bracelet has a terminal that defines the means of connection with the ECG, in electrical connection with an electrically conductive means arranged substantially coplanar on the inner face of said band or tape, and in contact with the patient's epidermis.

Bracelet, as claimed in 1, CHARACTERIZED because in its unlinked position of the patient, it has a flat ribbon shape with its free ends.

Bracelet, as claimed in 1, CHARACTERIZED because in its unlinked position of the patient, it has a closed loop shape with a diameter greater than the perimeter of the wrist or ankle of the patient defining a section in excess of the profile of the perimeter of the wrist or ankle to which it is applicable, foldable on itself by adjusting on said perimeter of the wrist or ankle.

Bracelet, as claimed in 1 to 3, CHARACTERIZED because the said joining means that define the adjustment of the bracelet on the patient's ankle or wrist are chosen from a system of buckles or a layer of adhesive arranged on one of the surfaces of the bracelet to be faced during the positioning operation with adjustment thereof on said perimeter of the wrist or ankle.

Bracelet, as claimed in 4, CHARACTERIZED because the adhesive layer has a selectively removable protective sheet.

6. Bracelet, as claimed in 4 and 5, CHARACTERIZED because the adhesive layer has a protective sheet partitioned in parallel, perpendicular or oblique segments with respect to the longitudinal axis of the bracelet, individually removable by releasing a selective portion of the adhesive.

7. Bracelet, as claimed in 4 to 6, CHARACTERIZED because the adhesive layer has a protective sheet with a part of the same projection, which defines a removable fastening end thereof.

8. Bracelet, as claimed in any of the preceding claims, CHARACTERIZED in that the terminal has a post or pillar emerging from a bottom that ends in a semi-toric formation open downwards that rests on the upper surface of the tape or band of the bracelet, while the contact disposed against the lower surface of the bracelet and in axial correspondence with said post or pillar, presents a complementary semi-toric shape open upwards, with a plurality of sharp extensions in the form of a through crown through the material of the tape or band establishing electrical contact with said terminal and determining the mechanical bonding thereof with respect to the bracelet.

9. Bracelet, as claimed in any of the preceding claims, CHARACTERIZED because said contact disposed on the lower surface of the tape or band has a rounded back and substantially coplanar with said lower surface.

10. Bracelet, as claimed in any of the preceding claims, CHARACTERIZED because the interior space of the semi-toric surface of the contact defines a space where it houses a component in the form of an adjuvant gel of the interface with the patient's epidermis.

eleven . Bracelet, as claimed in any of the preceding claims, CHARACTERIZED because the semi-toric contact has between it and the lower surface of the tape or band a layer of spongy material capable of retaining said gel, said spongy material also being pierced by the sharp crown formations.