Fastening system for orotracheal tubes and / or gastric probes

Abstract

The present invention describes a fastening system for orotracheal tubes and / or gastric probes in a patient. The proposed system comprises a set of components, namely, a tube anchoring mask (3), a lower fastening strip (8), an upper fastening strip (7), elastic fastening strips (4, 5), lateral facial fastening accessory strips (6) and a sagittal fastening accessory strip (2), which when combined together, allow mitigating risks related to accidental release and / or displacement of orotracheal tubes and / or gastric probes in a patient.

Description

FASTENING SYSTEM FOR OROTRACHEAL TUBES AND / OR GASTRIC PROBES

[0001] The present invention describes a fastening system for orotracheal tubes and / or gastric probes.

[0002] Intensive Care Units (ICUs) are the "end of the line", where patients with potentially treatable serious illnesses are treated, and are the only suitable place to treat patients with multiple organ failure.

[0003] To perform their functions effectively, ICUs need intensive care physicians and nurses, but also highly differentiated technical / technological equipment.

[0004] Adequate care / treatment of patients in ICUs, and particularly patients with multiple organ failure, involves an invasive approach to the airway in order to allow invasive ventilatory support / invasive mechanical ventilation.

[0005] One of the difficulties inherent to invasive mechanical ventilation, and after placement of the endotracheal tube (ETT), is its correct maintenance in place, ideally ensuring that accidental extubation does not occur, as well as minimizing excessive mobilization of this ETT.

[0006] It is important to emphasize: 1) Accidental extubation may result in the death of the patient; 2) Excessive endotracheal mobilization could result in an increased risk of ventilator-associated pneumonia (VAP), a result of repeated microaspiration, significantly increasing mortality in ICUs.

[0007] Considering the above, and the current state of the art, unable to meet the identified needs, the present invention describes a solution focused on the development of a fastening system for orotracheal tubes, capable of reducing accidental extubation, as well as optimizing the maintenance of the ETT in the desired positioning.

[0008] The present application describes a system for securing orotracheal tubes and / or gastric probes in a patient, characterized by comprising: a tube anchoring mask; a lower fastening strip, contouring the patient's occipital curvature, connecting, by means of a system of fasteners existing there, to the tube anchoring mask; a first elastic fastening strip and a second elastic fastening strip, the first elastic fastening strip promoting the fastening of an orotracheal tube inserted in the patient to the tube anchoring mask, and the second elastic fastening strip promoting the fastening of a probe gastric probe inserted in the patient to the anchoring mask.

[0009] In a proposed embodiment, the system for fastening orotracheal tubes and / or gastric probes in a patient comprises an upper fastening strip, installed perimetrically at the upper frontal-occipital level of the patient's head and connected by means of a closure system to the lower fastening strip; two accessory side facial fastening strips, connected independently by means of a fastening system between the upper fastening strip and the lower fastening strip; and an accessory sagittal fastening strip connected in the patient's anteroposterior sagittal position by means of a closure system between two points of the upper fastening strip.

[0010] In yet another embodiment, the tube anchor mask comprises a first anchoring pin and / or a second anchor pin.

[0011] In yet another embodiment, the first elastic fastening strip promotes the correct fixation of the orotracheal tube to the first anchoring pin and the second elastic fastening strip promotes the correct fixation of the gastric probe to the second anchoring pin; or the first elastic fastening strip promotes the correct fixation of the orotracheal tube to the first anchoring pin and the second elastic fastening strip promotes the correct fixation of the gastric probe to the first anchoring pin; or the first elastic fastening strip promotes the correct fixation of the orotracheal tube to the second anchoring pin and the second elastic fastening strip promotes the correct fixation of the gastric probe to the second anchoring pin.

[0012] In yet another embodiment, the first elastic fastening strip has yellow markings or coloring and the second elastic fastening strip has pink markings or coloring.

[0013] In yet another embodiment, the tube anchor mask comprises an interposition pad.

[0014] In yet another embodiment, the system comprises suitable fastening elements for adapting to the sagittal attachment accessory strip and the lateral facial attachment accessory strip.

[0015] In yet another embodiment, the tube anchor mask comprises a shape identical to that of a horseshoe, in which, at each of its outer ends there is a groove.

[0016] In yet another embodiment, each of the two lateral facial fastening accessory strips are installed in opposite positions relative to the patient's face.

[0017] In yet another embodiment, the upper fastening strip comprises two fixed occipital strips descending towards the lower fastening strip and attaching thereto by contact.

[0018] This application also describes the method of assembling and applying the fastening system for orotracheal tubes and / or gastric probes in a patient described above, characterized by comprising the steps of: - placement of the orotracheal tube and / or gastric probe in the patient; - positioning of the tube anchoring mask on the patient's face, in a position between the patient's nose and mouth; - application of the lower fastening strip below the patient's occipital curvature, supported by the patient's neck; - applying the fastening / closing of the ends of the lower fastening strip on both sides of the anchoring mask, passing this strip at each of its ends through the grooves of the mask in order to promote its fastening; - fastening the orotracheal tube to the mask using the first elastic fastening strip, attaching it to the first anchoring pin or the second anchoring pin of the tube anchoring mask, ensuring that the orotracheal tube does not slip and / or rotate, leaving the first elastic fastening strip under tension; and - fastening the gastric probe to the mask using the second elastic fastening strip, attaching it to the first anchoring pin or the second anchoring pin of the tube anchoring mask, ensuring that the gastric probe does not slip and / or rotate, leaving the second elastic fastening strip under tension.

[0019] In a proposed embodiment, the method of assembling and applying the fastening system for orotracheal tubes and / or gastric probes to a patient also comprises the steps of: - optimization of the positioning of the fastening system, through: - placement of the upper fastening strip perimetrically at the upper frontal-occipital level of the patient's head; - positioning of the upper fastening strip on the patient's head by connecting by contact / closing the two fixed occipital strips descending from the strip towards the lower fastening strip and which are fixed to it by contact / closing; - application of two accessory lateral facial fastening strips, between the upper fastening strip and the lower fastening strip, which are intended for fastening and anterolateral positioning of the mask on the patient, between the anterior temporal region above and laterally to the fixation point of the lower strip to the anchoring mask; - application of an accessory sagittal fixation strip, designed to connect sagittal anteroposterior between two points of the upper fastening strip.Brief description

[0020] The present invention describes a positioning / fastening system for orotracheal tubes to a patient.

[0021] The present invention is important for optimizing the intervention of the intensive care physician in one of the most critical moments in the approach to a patient with respiratory failure.

[0022] In this context, the fastening system for orotracheal tubes was developed to meet a need felt in Intensive Care Units, related to the fixation of the orotracheal tube (OTT) and gastric, nasogastric (NGT) or orogastric (OGT) tubes, traditionally held with tape or adhesive to the patient's skin.

[0023] In this context, the developed fastening system for orotracheal tubes seeks to solve, or at least mitigate, the following technical problems: i. Displacement and accidental exit from OTT (extubation); ii. Accidental exit from NGT or OGT; iii. Traumatic injuries to the labial commissure; iv. Involuntary slippage of the OTT, which is believed to increase the risk of ventilator-associated pneumonia.

[0024] In addition to this main use, the developed orotracheal tube fastening system can also be used for the fixation of orotracheal tubes, laryngeal masks or Combitube: - in Operating Rooms; - in the Extra-Hospital setting.

[0025] The fastening system for orotracheal tubes will be used in Intensive Care Units, Operating Rooms, Emergency Rooms and Pre-Hospital Emergency Rooms and Ambulances. Therefore, it was designed exclusively for hospital and / or pre-hospital medical use, being a single-use product with no sterilization purpose.

[0026] The endotracheal tube holder is designed to secure single or double lumen airway tubes, such as endotracheal tubes (ETTs), laryngeal mask airways (LMAs), and other supraglottic airway devices (SGs), after insertion into the trachea or in the esophagus, to reduce the risk of accidental extubation. It is therefore a non-sterile device, which represents a set of accessories that can be used with medical activity support equipment. All accessories related to this group fall here (V08: medical activity support devices).

[0027] The orotracheal tube fastening system is designed for fixation of single or double lumen airway devices, such as orotracheal tubes (OTT) and laryngeal mask airways (LM) or other devices (e.g. Combitube), after endotracheal or esophageal placement, with the aim of reducing the risk of accidental extubation.

[0028] For an easier understanding of this application, figures are attached, which represent embodiments that are not intended to limit the technique disclosed herein.

[0029] illustrates a representation of the fastening / closing elements (1).

[0030] illustrates a sagittal fastening accessory strip (2).

[0031] illustrates the tube anchoring mask (3).

[0032] illustrates the shape of the first elastic fastening strip (4).

[0033] illustrates the shape of the second elastic fastening strip (5).

[0034] illustrates a side facial fastening strip (6).

[0035] illustrates an upper fastening strip (7).

[0036] illustrates a lower fastening strip (8).

[0037] illustrates an interposition pad (9).

[0038] illustrates a way of applying the fastening system for orotracheal tubes (10) and gastric probes (11) to a patient (20), in a front view.

[0039] illustrates a way of applying the fastening system for orotracheal tubes (10) to a patient (20), in a rear view of the patient.

[0040] With reference to the figures, some embodiments are now described in more detail, which are not intended, however, to limit the scope of the present application.

[0041] In a preferred embodiment, a fastening system for orotracheal tubes (10) and / or gastric probes (11) in a patient (20) comprises the following set of components: • fastening elements (1) for the sagittal (2) and lateral facial (6) fastening accessory strips, preferably six units; • sagittal fastening accessory strip (2), preferably one unit; • tube anchor mask (3), preferably one unit; • first elastic fastening strips (4), preferably four units; • second elastic fastening strips (5), preferably four units; • side facial fastening accessory strips (6), preferably two units; • upper fastening strip (7), preferably one unit; • lower fastening strip (8), preferably one unit; • interposition pad (9), preferably one unit.

[0042] In one of the preferred embodiments of the present invention, the method of assembling and applying the fastening system for orotracheal tubes (10) and / or gastric probes (11) in a patient (20) comprises: - placement of the orotracheal tube (10) and / or gastric probe (11) in the patient (20), - positioning the tube anchoring mask (3) on the patient's face (20) in a position between the patient's nose and mouth, then performing: - application of the lower fastening strip (8) below the patient's occipital curvature (20), supported by the patient's neck (20); - applying the fastening / closing of the ends of the lower fastening strip (8) on both sides of the anchoring mask (3), passing this strip (8) at each of its ends through the grooves (3.1) of the mask (3) in order to promote its fixation, but without putting too much pressure on the patient's face (20); - fastening the orotracheal tube (10) to the mask (3) using the first elastic fastening strip (4), attaching it to the first anchoring pin (3.2) or the second anchoring pin (3.3) of the tube anchoring mask (3), ensuring that the orotracheal tube (10) does not slip and / or rotate, leaving the first elastic fastening strip (4) under tension; and - fastening the gastric probe (11) to the mask (3) using the second elastic fastening strip (5), fastening this to the first anchoring pin (3.2) or to the second anchoring pin (3.3) of the tube anchoring mask (3), ensuring that the gastric probe (11) does not slip and / or rotate, leaving the second elastic fastening strip (5) under tension.

[0043] The method may also include optimizing the positioning of the fastening system, through: - placement of the upper fastening strip (7) perimetrically at the upper frontal-occipital level of the patient's head (20); - positioning of the upper fastening strip (7) on the patient's head (20) by connecting by contact / closing the two descending occipital strips (fixed) of the strip (7) towards the lower fastening strip (8) and which are connected to it fixed by contact / closure; - application of two accessory lateral facial fastening strips (6), between the upper fastening strip (7) and the lower fastening strip (8), which are intended for fastening and anterolateral positioning of the mask (3) on the patient (20), i.e., between the anterior temporal region above and laterally to the point of attachment of the lower strip (8) to the anchoring mask (3), thus limiting the tendency for the orotracheal tube (10) to move downwards; - application of an accessory sagittal fastening strip (2), designed to connect sagittal anteroposterior between two points of the upper fastening strip (7), ensuring that it does not slide downwards.

[0044] In one of the complementary embodiments, the gastric probe (11) can be attached directly to the orotracheal tube (10), by means of the second elastic fastening strip (5), thus ensuring a more appropriate positioning of these elements in relation to the patient.

[0045] To reduce the risk of accidental extubation, during the assembly and application of the orotracheal tubes fastening system in a patient (20), it is strongly recommended that the sequence described above be followed, thus, and by convention, the first elastic fastening strip (4) associated and fixed to the orotracheal tube (10) and second the elastic fastening strip (5) associated and fixed to the gastric probe (11).

[0046] In one of the preferred embodiments of the present invention, the lateral facial fastening accessory strips (6) comprise at their ends fastening elements (1) that promote their connection / fixation both with the upper fastening strip (7) and with the lower fastening strip (8). The fastening elements (1) may comprise various geometric and / or anatomical shapes in order to ensure adequate and resistant fastening between the parts in contact. In either solution, the fastening elements (1) may be attachable and / or removable, comprising Velcro on each of their faces to allow attachment to at least two elements of suitable fabric, or they may be already incorporated on the respective strips in order to optimize and accelerate the application process on the patient (20). The sagittal fastening accessory strip (2) has fastening elements (1) at its ends that promote its connection / fixation with the upper fastening strip (7). The fastening / closing elements (1) may include the use of two fabric strips, one with small hooks and the other with tiny rings that ensure the fit between both parts, like a Velcro fastener.

[0047] In one of the preferred non-limiting embodiments, the sagittal fastening accessory strip (2) is 25 cm long. It may also have a rectilinear linear format or another format technically suitable for this purpose.

[0048] In one embodiment, the mask (3) has a shape similar to that of a horseshoe, with a lower contour capable of comfortably accommodating the mouth of a patient (20), being positioned, in the vicinity of this contour, and in each of the its inner ends, a first anchoring (3.2) and a second anchoring (3.3). In one embodiment, the second anchoring pin (3.3) may be further away from the base plane of the mask (3) in relation to the first anchoring pin (3.2), facilitating its proximity to the patient (20), and therefore, improving the fixation of the gastric probe (11) and its proximity to the nose. The mask (3) comprises the application of the interposition pad (9), on the inner face of said mask (3), by means of a glue, adhesive or other technically suitable fastening system. When applying the mask (3) to the patient (20), the pad (9) is in direct contact with the patient's skin (20). The mask (3) comprises an anatomical shape adaptable to the shape of the patient's face (20). The mask (3) comprises, at each of its ends of its horseshoe-like shape, grooves (3.1) capable of accommodating the passage and fastening of the lower fastening strip (8). The mask (3) also has contours and / or curvatures suitable for adapting to the generic shape of the common patient's face (20).

[0049] In one embodiment, the first elastic fastening strips (4) and the second elastic fastening strips (5) have the same construction format but have distinct colors that ensure their correct application on the first anchoring pin (3.2) and on the second anchoring pin (3.3) of the mask (3). The first elastic fastening strips (4) and / or the second elastic fastening strips (5) may aesthetically have a smooth or flat shape or even a circular shape identical to that of a screw, with a flat head with a small square protrusion on top. The said existing projection allows the elastic fastening strips (4;5) to be pointed at the pins (3.2;3.3) of the mask (3) and to fix the said strips in the opening above the pins (3.2;3.3) of the mask (3). The aforementioned projections, together with the serrated teeth on the opposite ends of the strips (4;5), allow the tightening pressure of the tubes (10;11) on the mask (3) to be adjusted in order to ensure sufficient tension, but without interrupting air circulation between the patient (20) and the assistive equipment. The body of the strips may be cylindrical with a threaded or toothed end. The threads are angled and may be sharpened to facilitate tying around the fixation pins (3.2, 3.3) and the orotracheal tubes (10) or gastric probes (11). In a preferred embodiment, the first elastic fastening strips (4) and / or the second elastic fastening strips (5) may comprise in their construction the use of materials from the TPE (Thermoplastic Elastomers) family that allow for sufficient elasticity, maintaining a minimum pressure that allows the tubes / probes to be fixed, loosening and allowing retightening, maintaining the same efficiency, without breakage.

[0050] In one of the preferred non-limiting embodiments, the lateral facial fastening strip (6) is 14 cm in length. It may also have a rectilinear linear shape, although it is identical to the sagittal fastening accessory strip (2).

[0051] In one embodiment, the upper fastening strip (7) is identical to the sagittal fastening accessory strip (2) but with different dimensions, and comprises, in an intermediate position, two fixed strips, suggesting a T shape, which promote fastening by contact / closing with the lower fastening strip (8).

[0052] In one embodiment, the lower fastening strip (8) is identical to the sagittal fastening accessory strip (2) but with different dimensions, and comprises, in an intermediate position, an upper projection in its shape to promote a contact fixation zone / closing with the two fixed strips of the upper fastening strip (7). The lower fastening strip (8) could also, in one embodiment, comprise the use of foam-like and / or padded components to promote a more pleasant / less traumatic contact to the patient (20), particularly relevant, for example, in pediatric applications. The lower fastening strip (8) may also, in one embodiment, comprise in its construction materials such as polyurethane, silicone or other materials technically suitable for the proposed purpose.

[0053] In one embodiment, the interposition pad (9) comprises the same shape and anatomical contour as the mask (3).

[0054] In one embodiment, the tube anchor mask (3) may comprise the use of materials from the PE (Polyethylene) family which ensures sufficient malleability to the mask so as to have a certain robustness, but at the same time allow adaptation / adjustment depending on the patients face configuration.

[0055] In one embodiment, the interposition pad (9) may comprise in its construction polyurethane foam that is UV resistant, pleasant to the touch and has high color stability. In a non-limiting preferred embodiment, said pad (9) has an approximate thickness of up to 5.5 mm.

[0056] In one embodiment, the fastening / closing elements could comprise a textile closing strip consisting of two fabric ribbons with small hooks and loops that join by pressure and release by traction, for example a Cierre strip, or Velcro closure.

[0057] Additionally, a carded mesh laminated on both sides with foam (100% polyurethane, non-limiting) may be used in the elements sagittal fastening accessory strip (2), a lateral facial fastening accessory strip (6), an upper fastening strip (7), and a lower fastening strip (8) to ensure minimum comfort.

[0058] The present description is, of course, in no way restricted to the embodiments presented in this document and a person with average knowledge of the area will be able to foresee many possibilities for modifying it without departing from the general idea, as defined in the claims. The preferred embodiments described above are obviously combinable with each other. The following claims further define preferred embodiments.

Claims

System for fastening orotracheal tubes (10) and / or gastric probes (11) in a patient (20) characterized in that it comprises: a tube anchor mask (3); a lower fastening strip (8), contouring the patient's occipital curvature (20), connecting via a closure system to the tube anchoring mask (3); a first elastic fastening strip (4) and a second elastic fastening strip (5), the first elastic fastening strip (4) promoting the fastening of an orotracheal tube (10) inserted in the patient (20) to the anchoring mask tubes (3), and the second elastic fastening strip (5) promoting the fastening of a gastric probe (11) inserted in the patient (20) to the tube anchoring mask (3).System for fastening orotracheal tubes (10) and / or gastric probes (11) in a patient (20) according to claim 1, characterized in that it comprises an upper fastening strip (7), installed perimetrically at the upper frontal-occipital level of the patient's head (20) and connected by means of a fastening system to the lower fastening strip (8); two accessory side facial fastening strips (6), connected independently by means of a fastening system between the upper fastening strip (7) and the lower fastening strip (8); and an accessory sagittal fastening strip (2) connected in the patient's anteroposterior sagittal position (20) by means of a closure system between two points of the upper fastening strip (7).System for fastening orotracheal tubes (10) and / or gastric probes (11) in a patient (20) according to any one of the preceding claims, characterized in that the tube anchoring mask (3) comprises a first anchoring pin (3.2) and / or a second anchoring pin (3.3).System for fastening orotracheal tubes (10) and / or gastric probes (11) in a patient (20) according to any one of the preceding claims, characterized in that the first elastic fastening strip (4) promotes the correct fastening of the orotracheal tube (10) to the first anchoring pin (3.2) and the second elastic fastening strip (5) promotes the correct fastening of the gastric probe (11) to the second pin anchoring (3.3); or the first elastic fastening strip (4) promotes the correct fastening of the orotracheal tube (10) to the first anchoring pin (3.2) and the second elastic fastening strip (5) promotes the correct fastening of the gastric probe (11) to the first pin anchoring (3.2); or the first elastic fastening strip (4) promotes the correct fixation of the orotracheal tube (10) to the second anchoring pin (3.3) and the second elastic fastening strip (5) promotes the correct fixation of the gastric probe (11) second anchoring pin anchoring (3.3).System for fastening orotracheal tubes (10) and / or gastric probes (11) in a patient (20) according to any one of the preceding claims, characterized in that the first elastic fastening strip (4) presents markings or coloring of yellow hue and the second elastic fastening strip (5) has markings or a pink hue.System for fastening orotracheal tubes (10) and / or gastric probes (11) in a patient (20) according to any one of the preceding claims, characterized in that the tube anchoring mask (3) comprises an interposition pad (9).System for fastening orotracheal tubes (10) and / or gastric probes (11) in a patient (20) according to any one of the preceding claims, characterized in that it comprises fastening elements (1) suitable for adapting to the accessory strip of sagittal fixation (2) and the lateral facial fastening accessory strip (6).System for fastening orotracheal tubes (10) and / or gastric probes (11) in a patient (20) according to any one of the preceding claims, characterized in that the tube anchoring mask (3) comprises a shape identical to the of a horseshoe, in which, at each of its outer ends there is a groove (3.1).System for fastening orotracheal tubes (10) and / or gastric probes (11) in a patient (20) according to any one of the preceding claims, characterized in that each of the two lateral facial fastening accessory strips (6) is installed in opposite positions in relation to the patient's face (20).System for fastening orotracheal tubes (10) and / or gastric probes (11) in a patient (20) according to any one of the preceding claims, characterized in that the upper fastening strip (7) comprises two fixed descending occipital strips towards the lower fastening strip (8) and which are fixed to it by contact.Method of assembling and applying the fastening system for orotracheal tubes (10) and / or gastric probes (11) in a patient (20) according to any one of the previous claims 1 to 9, characterized in that it comprises the steps of: - placement of the orotracheal tube (10) and / or gastric probe (11) in the patient (20); - positioning of the tube anchoring mask (3) on the patient's face (20), in a position between the patient's nose and mouth; - application of the lower fastening strip (8) below the patient's occipital curvature (20), supported by the patient's neck (20); - applying the fastening / closing of the ends of the lower fastening strip (8) on both sides of the anchoring mask (3), passing this strip (8) at each of its ends through the grooves (3.1) of the mask (3) in order to promote its fixation; - fastening the orotracheal tube (10) to the mask (3) using the first elastic fastening strip (4), attaching it to the first anchoring pin (3.2) or the second anchoring pin (3.3) of the tube anchoring mask (3), ensuring that the orotracheal tube (10) does not slip and / or rotate, leaving the first elastic fastening strip (4) under tension; and - fastening the gastric probe (11) to the mask (3) using the second elastic fastening strip (5), fastening this to the first anchoring pin (3.2) or to the second anchoring pin (3.3) of the tube anchoring mask (3), ensuring that the gastric probe (11) does not slip and / or rotate, leaving the second elastic fastening strip (5) under tension.Method of assembling and applying the fastening system for orotracheal tubes (10) and / or gastric probes (11) in a patient (20) according to any one of the previous claims, characterized in that it comprises the steps of: - optimization of the positioning of the fastening system, through: - placement of the upper fastening strip (7) perimetrically at the upper frontal-occipital level of the patient's head (20); - positioning of the upper fastening strip (7) on the patient's head (20) by connecting by contact / closing the two descending occipital strips (fixed) of the strip (7) towards the lower fastening strip (8) and which are connected to it fixed by contact / closure; - application of two accessory lateral facial fastening strips (6), between the upper fastening strip (7) and the lower fastening strip (8), which are intended for fastening and anterolateral positioning of the mask (3) on the patient (20), between the anterior temporal region above and laterally to the point of attachment of the lower strip (8) to the anchoring mask (3); - application of an accessory sagittal fastening strip (2), designed to connect sagittal anteroposterior between two points of the upper fastening strip (7).

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