WO2017145101A1

WO2017145101A1 - Device for fixing tubes for the oral intubation of patients

Info

Publication number: WO2017145101A1
Application number: PCT/IB2017/051060
Authority: WO
Inventors: Claudio Reverberi
Original assignee: Safe - S.R.L.
Priority date: 2016-02-25
Filing date: 2017-02-24
Publication date: 2017-08-31
Also published as: ITUB20161066A1

Abstract

A device (1) for fixing tubes for the oral intubation of patients, comprising a flexible body (2) adapted to be arranged proximate to the mouth of a patient and a seat (3) associated with the body (2) for accommodating a respiration tube (T), provided with reversible means (4) for retaining the tube; the seat (3) comprises a longitudinal opening (5) for the insertion of the tube (T) inside it after insertion in the body of the patient by means of a movement of the tube transversely to its longitudinal extension.

Description

DEVICE FOR FIXING TUBES FOR THE ORAL INTUBATION OF PATIENTS

The present invention relates to a device for fixing tubes for the oral intubation of patients to be subjected to a surgical procedure or intensive care treatment.

Devices for oral intubation of patients are known in the medical field for the management of the air passages during anesthesia, resuscitation and intensive care, such as laryngeal masks and endotracheal tubes.

These devices comprise a tube which must be arranged so that its distal end is inserted in the body of the patient orally until it is arranged along the trachea or larynx in order to allow adequate ventilation of the lungs and so that the proximal end protrudes from the mouth of said patient for connection to devices for assisted or manual respiration.

Once it has been positioned, the tube must be fixed so as to maintain its position, avoiding accidental movements in a longitudinal direction that risk compromising the correct ventilation of the patient.

For this purpose it is known to secure the tube by using portions of an ordinary adhesive bandage in roll form, which are applied around the tube and to the face of the patient.

However, this method of fixing the tube is not sufficiently stable, is awkward to perform for operators, who must handle the adhesive bandage with sterile latex gloves, with the risk of tearing them, requires time to be performed correctly, and requires the intervention of an operator with both hands free.

In order to obviate these drawbacks, fixation devices, known as tube fixation devices, have been developed which consist of a sort of mask with a hole for the passage of the tube which is provided with reversible means for the retention of said tube, which must be arranged on the mouth of the patient and is secured by means of a strap that must be worn around the head of said patient. Even these tube fixation devices, despite ensuring stable positioning of the tubes, are bulky and often do not allow access to the mouth of the patient once they have been positioned.

As an alternative, in order to obviate these drawbacks, Italian patent no. 1 ,259,978 discloses a preformed element for the positioning and retention of orotracheal tubes which essentially consists of a flattened horseshoe-shaped body adapted to adhere to the face of the patient proximate to the mouth. In the vertex region of said body, which is adapted to be arranged at a corner of the mouth, there is a hole through which a sleeve is accommodated in which the tube must be inserted. Furthermore, there is a clamp element which is adapted to be fastened onto the end of the sleeve that is designed to be directed outward, in order to deform it and fasten it onto the tube inserted through it, and it is possible to use a fixation element inside the mouth of the patient, which can be coupled to the end of the sleeve that is designed to protrude inside said mouth.

Although this solution solves the drawbacks cited above, it leaves the cavity of the mouth only partially accessible, it is rather invasive for the patient and complicates intubation operations, since the tube must be inserted in its seat by passing through the sleeve of the preformed element already applied to the patient.

Furthermore, all devices of the known type are not free from drawbacks, which include the fact that once they have been positioned they must be removed in order to allow tube replacement.

The aim of the present invention is to eliminate the drawbacks cited above of the background art, by providing a device for fixing tubes for the oral intubation of patients that allows maximum freedom of movement of the tube, up to its complete replacement, without having to be removed.

Within this aim, an object of the present invention is to provide a device that is such as to keep the access to the cavity of the mouth substantially clear, in order to be able to inspect it even when the patient is intubated during the execution of surgical procedures or in intensive care treatment.

A further object of the present invention is to provide a device that allows a longitudinal locking of the tube that is reliable and at the same time easily reversible, does not require the execution of particular maneuvers by the operators and does not complicate the execution of intubation.

Another object of the present invention is to provide a device that is compact and minimally invasive for the patient.

A further object of the present invention is to provide a device that can be fully sterilized and can be marketed individually or directly paired with the intubation kit in sterile packages, so that it can be used even on injured skin.

Another object of the present invention is to provide a device that has a simple structure, is relatively easy to provide in practice, is safe in use and effective in operation, and is relatively modest in cost.

This aim and these and other objects that will become better apparent hereinafter are all achieved by the present device for fixing tubes for the oral intubation of patients, comprising a flexible body adapted to be arranged proximate to the mouth of a patient and a seat associated with said body for accommodating a respiration tube, provided with reversible means for retaining said tube, characterized in that said seat comprises a longitudinal opening for the insertion of the tube inside it after insertion in the body of the patient by means of a movement of said tube transversely to its longitudinal extension.

Further characteristics and advantages of the present invention will become better apparent from the detailed description of a preferred but not exclusive embodiment of a device for fixing tubes for the oral intubation of patients, illustrated by way of nonlimiting example in the accompanying drawings, wherein:

Figures 1 and 2 are perspective views of a device for fixing tubes for the oral intubation of patients according to the invention, applied to a patient before and after performing intubation;

Figures 3-6 are schematic perspective views of the steps of insertion and securing of a tube for intubation with the device according to the invention;

Figure 7 is a schematic sectional view of the device according to the invention in the tube securing configuration.

With particular reference to the figures, the reference numeral 1 generally designates a device for fixing tubes for the oral intubation of patients.

The device 1 can be used as an aid to intubation devices of a known type, such as endotracheal tubes or laryngeal masks, which comprise a tube T which is adapted to be inserted in the body of the patient orally, until the distal end thereof is arranged along the trachea or larynx and the proximal end protrudes from the mouth of the patient for connection to devices for assisted or manual respiration.

The device 1 comprises a flexible body 2 which is adapted to be arranged proximate to the mouth of a patient and a seat 3 which is associated with the body 2 to accommodate a respiration tube T, the seat being provided with reversible means 4 for the retention of the tube.

The seat 3 comprises a longitudinal opening 5 for the insertion of the tube T inside it after insertion in the body of the patient by means of a movement of the tube transversely to its longitudinal extension.

In this manner, when needed, the tube T can be moved out of the seat 3 and maneuvered independently of the device 1. In case of extraction or replacement of the tube T, the device 1 therefore does not need to be removed or replaced.

In use, the seat 3 is adapted to be arranged at a lateral corner of the mouth of the patient (Figures 1 and 2), so as to not obstruct the cavity of the mouth and keep it accessible for any inspections and maneuvers. In greater detail, the body 2 has a substantially flattened shape, with a first face 7 that is adapted to be arranged in contact with the face of the patient and a second face 6 that is arranged opposite thereto. The body 2 can be provided, for example, with a contoured lamina made of plastic material such as polyethylene or silicone.

The seat 3 is formed within a collar 8 arranged along the peripheral region of the body 2 and protrudes from its second face 6. The collar 8 is constituted by a sector of a cylindrical wall that is extended along a circular arc and the opening 5 is formed between the mutually opposite sides 9 of the sector.

The collar 8 is welded to the body 2 so that it does not protrude with respect to the first face 7, so that it is smooth and without discontinuities.

In an alternative embodiment, not shown, the collar 8 can be associated detachably with the body 2, for example to allow the ventilation of the patient with the body 2 applied to the face by using a face mask, prior to positioning of the collar 8 and of the tube T in the seat 3.

In this case, a first C-shaped flange made of rigid plastic material, such as PVC, is welded to the body 2 and the collar 8 is provided externally with a second flange that corresponds to the first one. Elements for quick engagement/release are interposed between the first flange and the second flange and allow, when needed, to fit the collar 8 with the corresponding seat 3 for positioning the tube T, or to remove the collar 8 in order to allow manual ventilation of the patient.

Preferably, the body 2 is provided with at least one protruding flap 10, which is adapted to be arranged above or below the mouth of the patient. In the embodiment shown, in order to improve the stability of the device 1 there are two flaps 10, of which one is adapted to be arranged above the mouth and the other one below, and the collar 8 is arranged in the central region of the body 2 between the flaps.

The diameter of the collar 8 can vary as a function of the diameter of the tube T with which it is to be paired.

Furthermore, the device 1 generally is provided with adhesive means which are associated with at least one portion of the first face 7 for the adhesion of the body 2 to the skin of the patient. In this case the device 1 can be provided with a removable film for covering the adhesive means, which is adapted to be removed before use and is not shown in the figures.

The body 2 comprises a plurality of holes 11, which are distributed along its extension and pass through its thickness, in order to allow skin transpiration, avoiding separations of the device 1 caused by skin perspiration. Moreover, the body 2 is provided with a plurality of slots 12, which are distributed along its peripheral region and pass through its thickness, if it is necessary to fix the device 1 to the skin of the patient by means of suture stitches for prolonged intubations or for patients with a thick beard and/or mustache.

The reversible retention means 4 comprise an internally threaded ring 13, which is constituted by an annular sector coupled to an external thread provided on the collar 8, and elastically deformable means 14 interposed between the ring 13 and the collar 8. By virtue of the screwing of the ring

13 along the collar 8, deformation by compression of the deformable means

14 is achieved and the means tend to protrude inside the collar, securing the tube T longitudinally. By unscrewing the ring 13, the deformable means 14 are returned to inactive conditions so that the tube T is disengaged longitudinally in order to perform any repositioning.

The deformable means 14 are constituted by a compressible rubber element, which is retained between two profiles 15 and 16 which protrude radially inward, respectively, from the ring 13 and from the collar 8. By screwing the ring 13 onto the collar 8, the profiles 15 and 16 move mutually closer and compress the rubber element 14, whereas by unscrewing the ring 13 the profiles 15 and 16 move further apart and the rubber element 14 returns to inactive conditions. The collar 8 and the ring 13 are extended along a circular arc of approximately 300°. There can also be different angular dimensions of the collar 8 and of the ring 13, which are in any case greater than 180° so that the ring 13 can be rotated with respect to the collar 8 while remaining engaged on the corresponding external thread.

The rubber element 14 has a C-like shape that matches the shape of the internal wall of the ring 13.

In this case, the opening 5 has an extension that is equal to the circular arc that is complementary to the extension along which the collar 8 is extended, i.e., on the order of 60°.

For the insertion of the tube T along the seat 3, the ring 13 is rotated so as to leave the opening 5 free (Figures 3-5), whereas to secure the tube T the ring is screwed onto the collar 8 until the rubber element 14 is deformed adequately and such ring is locked in such an angular position as to close the tube T within the seat 3 (Figure 6).

Advantageously, the device 1 can be provided monolithically using materials that can be sterilized by means of conventional methods, such as plastic materials, and can be supplied in single-use sterile packages individually or in a complete kit for oral intubation which comprises a conventional endotracheal tube or a conventional laryngeal mask.

In this manner, the device 1 can be supplied ready for use in a sterile package and can be used even on patients who have wounded or burned face skin, without entailing the risk of infections or suppuration of the skin, which might cause the forming of permanent scars.

In use, the device 1 is arranged on the face of the patient by making the body 2 adhere to the skin, the body being arranged so that the corresponding flaps 10 are above and below the mouth and the collar 8 is at the lateral corner of the mouth.

The insertion of the endotracheal tube or the positioning of the laryngeal mask can occur according to conventional methods of operation which are known to health workers, and once the tube T has been arranged correctly along the air passages it is moved transversely to insert it in the seat 3, making it pass through the opening 5. The elastic deformability of the tube T allows to compress it slightly in order to be able to insert the inlet through the opening 5.

Once the tube T has been arranged along the seat 3, the ring 13 is rotated until the tube is secured by friction against the rubber element 14.

In order to disengage the tube T in an axial direction it is sufficient to unscrew the ring 13 slightly until it reduces the deformation of the rubber element 14 so that it does not interfere with the tube.

In order to release the tube T completely from the device 1, if one needs greater freedom to move it in a longitudinal direction or to replace it, it is sufficient to align the ring 13 with the collar 8 so as to clear the opening 5 in order to make the tube T exit from the seat 3 through the opening.

In practice it has been found that the described invention achieves the intended aim and objects and in particular the fact is stressed that the device according to the invention allows to maximize the possibility to move the tube without having to remove the device and keep the cavity of the mouth completely accessible.

Moreover, the device according to the invention allows an axial securing of the tube that is reliable and easily reversible by the operator without requiring particular maneuvers and without removing the device.

Moreover, the device according to the invention has modest space occupations and is minimally invasive for the patient.

Not least, the device according to the invention can be provided in a sterile package and can be optionally incorporated in the intubation kit without affecting the corresponding costs excessively.

The invention thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims. All the details may further be replaced with other technically equivalent elements.

In practice, the materials used, as well as the contingent shapes and dimensions, may be any according to the requirements without thereby abandoning the protective scope of the claims that follow.

The disclosures in Italian Patent Application no. 102016000019362 (UB2016A001066), from which this application claims priority, are incorporated herein by reference.

Where technical features mentioned in any claim are followed by reference signs, those reference signs have been included for the sole purpose of increasing the intelligibility of the claims and accordingly such reference signs do not have any limiting effect on the interpretation of each element identified by way of example by such reference signs.

Claims

1. A device (1) for fixing tubes for the oral intubation of patients, comprising a flexible body (2) adapted to be arranged proximate to the mouth of a patient and a seat (3) associated with said body (2) for accommodating a respiration tube (T), provided with reversible means (4) for retaining said tube, characterized in that said seat (3) comprises a longitudinal opening (5) for the insertion of the tube (T) inside it after insertion in the body (2) of the patient by means of a movement of said tube transversely to its longitudinal extension.

2. The device (1) according to claim 1, characterized in that said body (2) has a substantially flat shape, with a first face (7) adapted to be arranged in contact with the face of the patient and a second face (6) arranged opposite said first face, the seat (3) being formed inside a collar (8) arranged along the peripheral region of said body (2) and protruding from its second face (6), said collar being constituted by a sector of a cylindrical wall, the longitudinal opening (5) being defined between the mutually opposite sides (9) of said sector.

3. The device (1) according to claim 2, characterized in that said reversible retention means (4) comprise an internally threaded ring (13), which is constituted by an annular sector coupled to an external thread associated with said collar (8), and elastically deformable means (14) interposed between said ring (13) and said collar (8) inside the collar itself, the screwing of the ring (13) on the collar (8) being adapted to cause the protrusion of said deformable means (14) toward the inside of said collar in order to retain the tube (T).

4. The device (1) according to claims 2 and 3, characterized in that said collar (8) and said ring (13) are extended along a circular arc on the order of 300°, the opening (5) having an angular extension on the order of an arc of 60°.

5. The device (1) according to claim 2, characterized in that said collar (8) is associated detachably with said body (2).

6. The device (1) according to one or more of the preceding claims, characterized in that it comprises adhesive means associated with at least one portion of said first face (7) for the adhesion of said body (2) to the face of the patient.

7. The device (1) according to one or more of the preceding claims, characterized in that said body (2) comprises at least one protruding flap (10) adapted to be arranged above or below the mouth of the patient.

8. The device (1) according to one or more of the preceding claims, characterized in that said body (2) comprises a plurality of holes (11) distributed over its extension for the transpiration of the patient.

9. The device (1) according to one or more of the preceding claims, characterized in that said body (2) comprises a plurality of slots (12) arranged on its peripheral region for connection to the face of the patient by means of suture stitches.

10. The device (1) according to one or more of the preceding claims, characterized in that is made of sterilizable material.

11. A kit for orotracheal intubation of a patient, characterized in that it comprises an endotracheal tube and a device (1) according to one or more of claims 1 to 10.

12. A kit for orolaryngeal intubation of a patient, characterized in that it comprises a laryngeal mask and a device (1) according to one or more of claims 1 to 10.