WO2019030368A1

WO2019030368A1 - Medical tube fixation arrangement

Info

Publication number: WO2019030368A1
Application number: PCT/EP2018/071723
Authority: WO
Inventors: Nils Petter OVELAND
Original assignee: Helse Stavanger Hf; The University Of Stavanger
Priority date: 2017-08-10
Filing date: 2018-08-10
Publication date: 2019-02-14
Also published as: EP3664879A1; SE1750981A1; SE542712C2

Abstract

A medical tube fixation arrangement (2) structured to position and secure a medical tube (4) in a predetermined position through the mouth (6) of a patient, comprising an elongated member (8) configured to assist positioning and to secure the arrangement to the back of the head. The elongated member comprises an attachment member (12) with at least one attachment element (14) for attaching the tube. The arrangement comprises at least one tightening member (16) configured to apply tightening forces in the longitudinal direction of the elongated member in order to position and secure the tube in a predetermined position. The attachment element comprises a tube holding part (18) structured to circumferentially apply radially directed holding forces to the medical tube.

Description

Medical tube fixation arrangement

Technical field

The present disclosure relates to a medical tube fixation arrangement and in particular an endotracheal tube fixation arrangement with improved safety and that is easy to apply and adjust.

Background

One of the most important and common procedures in emergency medicine is to secure the airway of critical ill and injured patients by performing endotracheal intubation (ETI). Unplanned extubation is a life-threatening event that quickly can lead to oxygen deficit in the blood followed by irreversible brain damage, and in recent years has been a focus of continuous quality improvement programs. While these programs and research have improved the care of the intubated patient, relatively little attention has been given to experimental comparisons between methods for endotracheal tube (ETT) securement. This problem affects multiple disciplines, notably anaesthesia, critical care, military field use, emergency medicine and prehospital critical care.

The time period before the patient arrives at the hospital is especially vulnerable due to the moving and transportation of the patient, but also in the hospital, ETT securement methods are an important topic. These methods/devices can be broadly classified into three groups:

• Adhesive tape, applied to the face and head in a variety of ways.

• Twill or umbilical tape or ribbon, tied around the tube and around the neck and the posterior occiput (back) portion of the head.

Specialized devices, both purpose-built commercial devices, and devices or arrangements fashioned by clinicians using a variety of hospital products. Commercial devices are only used in a small percentage of intubated patients; one study shows that in less than 5% of intubations in the USA, commercial devices are used.

After the intubation the ETT must be secured at the correct length (i.e. the correct distance from the teeth to the trachea). The cuff (distal end) of the endotracheal tube 4 should be placed just beneath the vocal cords and then inflated, see figure 1. The inflated cuff will secure the airway from any foreign material, such as stomach content, blood or mucus, entering the trachea. The tube should then be fixated in the corner of the mouth, i.e. on the left or right side. It is important that the tube is secured in this position for two main reasons:

1. To avoid that the tip of the tube is pushed down from the trachea into one of the main bronchi. The result is then one-lung ventilation with impaired oxygenation of the blood.

2. Even more dangerous is the dislodgement of the tube out of the trachea and into the oesophagus or pharyngeal/oral cavity. This can happen if the tube is jerked or if the patient^'s head is rotated or otherwise moved.

It is often difficult both to insert the ETT into the trachea and to thereafter secure it in position. For instance, bodily fluids, face/head injuries, facial anatomy and hair, skin conditions or allergies, dental prostheses and clothes may all impair attachment using known devices and maintenance of the position of the ETT. The risk of unplanned extubation is increased for patients in the prehospital setting and the emergency room; they may not always be adequately sedated, they may be moved frequently, and physical monitoring may not always be consistent. Also, as mentioned, it is important to keep the tube at a specific depth into the trachea. Furthermore, the need for a simple and easy-to- use fixation arrangement is especially useful in emergency airway management, where there is a high risk of pulmonary aspiration (i.e. from stomach content or blood/mucus in the oral/pharyngeal cavity). The present disclosure relates to a specialized device and some such prior art devices will now be briefly discussed.

US-2009/0229616 discloses an endotracheal tube holder for retaining a tube into a proper registration for application of medical treatment to a patient, and more particularly to a flexible holder for positioning of an endotracheal tube. US-2011/0240034 discloses a securement system for an endotracheal tube in position upon a patient and arrests movement of the endotracheal tube. The system includes a support member and a retainer that defines a channel configured to receive the

endotracheal tube. A head securement member attaches the support member to the head of the patient. The securement system includes a track for securing the tube at a plurality of locations relative to the support member. The system can maintain the tube in position upon a patient and allow access to the patient's oral cavity.

US-5205832 relates to an endotracheal tube support comprising a strap means to be positioned about the face and the back head of the patient. A portion is threaded through the length of the tubing for securing the tubing in the vicinity of the patient's nose or mouth, and a portion of the strap means protrudes through the aperture to form a loop for capturing the endotracheal tube. An object of the present invention is to achieve an improved arrangement for fixating and securing a medical tube, e.g. an endotracheal tube, to a patient in an intended position.

Summary

The above-mentioned object is achieved by the medical tube fixation arrangement according to the independent claim.

Preferred embodiments are set forth in the dependent claims.

The present disclosure relates to a specialized easy-to-use device with high fixation strength suitable for, but not limited to, emergency and field use. The improvement lies in that the arrangement is easy to use as it comprises few parts, it has a structure that enables mounting without unnecessary moving the patient's head, and it has a limited physical extension that provides an essentially free access to the patient's oral cavity. Furthermore, it has a limited physical extension such that it may be provided in a kit package together with the medical tube.

Thus, the arrangement comprises an elongated member configured to assist positioning and to secure the arrangement to the back of the head. The elongated member has two opposite attachment end portions and is configured to be arranged around the patient's head. The elongated member is connected to an attachment member comprising at least one attachment element for attaching the tube. The elongated member comprises at least one tightening member configured to be operated to alter the length of the elongated member and to fixate the length such that tightening forces in the longitudinal direction of the elongated member are applied in order to position and secure the tube in a

predetermined position. The attachment element is directly connected to the attachment end portion and comprises a tube holding part structured to apply radially directed holding forces to the medical tube essentially around the entire circumference of said tube.

The fixation arrangement may further be provided with a fastening element adapted to connect the two ends of the fixation arrangement to each other by connecting the attachment element to the opposite end of the elongated member, thus providing easy attachment around the patient's head. Further, a rigid elongated member may be provided as part of the device, to facilitate passing the device around the head during positioning.

The attachment element may be configured to be in two states, a positioning state where the tube may be moved to a desired position, and a fixated state where the tube is fixated by the holding forces.

In some aspects, the medical tube fixation arrangement may be provided with an essentially rigid portion having a flat elongated shape, which can be slipped under the back of the head or neck e.g. when a patient is lying flat on his/her back on the ground or other surface. A rigid portion to assist placement of the device may be provided in different manners, as will be described further below.

A tube attachment element is provided with a tube holding part which is structured to enclose the entire circumference of the medical tube and double back on itself to a locking mechanism, and is also preferably provided with a friction-increasing inner surface, e.g. "teeth" or knobs, that grip the outside surface of the medical tube when the tube holding part is tightened around the medical tube. The locking mechanism is releasable, such that the tube may be adjusted or repositioned, and thereafter relocked into a fixated state. The feature that the attachment element is directly connected to the elongated member is important in order to easily adjust the position of the attachment element and thus the medical tube, which enables accurate positioning of the medical tube through the mouth of the patient. This is controlled by adjusting the length of the elongated member by operating the tightening member, which will be described further below. Thus, no position adjustments need to be performed in the vicinity of the attachment element which is advantageous as it simplifies the positioning procedure and is less cumbersome for the patient.

The medical tube fixation arrangement disclosed herein has the following advantages. It is easy to arrange on the patient without significantly moving the head. The arrangement also provides for secure attachment of a medical tube at the mouth of the patient, by providing balanced forces applied to the tube from both sides.

The adjustable, circumferential tube holding part around the medical tube provides for radially directed forces around essentially the entire circumference of the tube. The circumferential forces and configuration of the attachment element(s) provide for secure maintenance or adjustment of the depth position of the medical tube into the trachea.

Further, the arrangement does not significantly impair reading of a length scale, e.g. in cm, along the length of the medical tube.

The attachment element has a limited physical extension that does not significantly hinder access to the face or head, and enables easy access to the oral and pharyngeal cavity, which e.g. allows inspection and possible insertion of another device, such as a gastric tube or a sucking device into the mouth.

It is small, easily transported and easily included in a kit package that also includes the medical tube, e.g. an endotracheal tube. Brief description of the drawings

Figure 1 is an anatomical illustration of a patient having an endotracheal tube inserted via the mouth.

Figure 2 is a simplified illustration of the medical tube fixation arrangement.

Figures 3-4 disclose various views of a medical tube fixation arrangement.

Figures 5 a and 5b disclose various views of a medical tube fixation arrangement.

Figures 6 and 7 disclose various views of a medical tube fixation arrangement.

Figures 8-10 show various perspective views of an attachment element.

Figure 11 shows a perspective view of a tube fixation arrangement.

Figure 12 shows a perspective view of a tube fixation arrangement.

Figure 13 is a schematic illustration showing a cross-sectional view of a medical kit. Figures 14-17 show various perspective views of an attachment element with different fastening elements.

Figure 18 shows a further view of a tube fixation arrangement.

Detailed description

The fixation arrangement will now be described in detail with references to the appended figures. Throughout the figures the same, or similar, items have the same reference signs. Moreover, the items and the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.

First, the fixation arrangement will be described with references to the schematic and simplified illustration shown in figure 2. A medical tube fixation arrangement 2 is provided being structured to position and to secure a medical tube 4 in a predetermined position through the mouth 6 of a patient (see e.g. figure 4 or figure 5b), preferably close to the corner of the mouth of the patient.

The fixation arrangement 2 comprises an elongated member 8 having two opposite attachment end portions 10, 10' and being configured to be arranged around the patient's head. The elongated member 8 is connected to an attachment member 12 arranged at one attachment end portion 10 of the elongated member 8. The attachment member 12 comprises at least one attachment element 14 for attaching the tube. In figure 2 an arrangement comprising one attachment element 14 is illustrated. Two attachment elements 14 may also be provided, as will be described later.

The elongated member 8 may at least partly be elastic in a longitudinal direction. As an alternative, the elongated member 8 may be non-elastic in a longitudinal direction. The elongated member 8 may comprise at least one tightening member 16 configured to be operated to alter the length of the elongated member 8 and to fixate the length such that tightening forces in the longitudinal direction of the elongated member 8 are applied in order to position and secure the tube 4 in the predetermined position. This is indicated by a double-arrow in figure 2. A tightening member 16 may be arranged essentially midways along the elongated member 8, i.e. such that when the arrangement is arranged around the patient's head, the tightening member will be at the back of the patient's head. In a preferred aspect, a tightening member 16 is arranged such that it is closer to one end of the device than the other, and thus be positioned on one side of the patient's head when in use. In a further aspect, two tightening members 16 may be provided, and preferably be arranged such that they will be positioned on each side of the patient's head when in use. If the one or two tightening members 16 are arranged on one or two sides, respectively, of the patient's head, it may be easier to access and adjust the tightening member if needed when in use. Further, when using such a device, the patient's head does not have to be repositioned and moved as much, which is an advantage e.g. if there is a risk or occurrence of neck or head trauma.

It should be noted that throughout this disclosure, it is understood that the terms "to position" or "positioning" in relation to the medical tube, is used both for sideways adjustment across or within essentially the plane of the mouth, and for longitudinal adjustment, i.e. length of the tube inserted into the mouth and trachea. The at least one attachment element 14 is directly connected to one attachment end portion 10, 10' and comprises a tube holding part 18 structured to apply radially directed holding forces to the medical tube 4 essentially around the entire circumference of said tube. The at least one attachment element 14 may be configured to be in two states, a positioning state where the tube 4 may be moved to a desired position, and a fixated state where the tube is fixated by the holding forces. In figure 2 the attachment element 14 is in a positioning state as the tube holding part does not apply the holding forces to the medical tube. The fixation arrangement may further preferably be provided with a fastening element adapted to connect the attachment element 14 to the opposite end of the elongated member, thus providing easy attachment around the patient's head. This will be described in detail further along. Further, a rigid elongated member (not shown in Figure 2) may be provided at one end of the device, to facilitate passing the device around the head during positioning.

An advantage of the fixation arrangement as disclosed herein is that essentially equal forces are applied from each side of the patient's head, i.e. the endotracheal tube is held in a balanced and secured sideways position in the mouth. Further, due to the radially directed circumferential holding forces when the tube holding part 18 is attached to a medical tube 4, the tube is secured from slipping in a longitudinal direction. As will be further described below, a friction increasing surface may be provided to increase the holding forces. As an alternative, the fixation arrangement may comprise two attachment elements 14, respectively arranged at a respective attachment end portion 10, 10' of the elongated member 8. Different variations of these arrangements are illustrated in figures 3-4, 6-7, and 11. The arrangement in Figure 5 comprises one attachment element. It is to be understood that various features of the different medical tube fixation arrangements described herein may be combined when possible. As seen in Figures 2 and 3, the elongated member 8 may comprise two elongated member parts 20, each provided with two end portions, the attachment end portion 10, 10' and a tightening end portion 22, and that the tightening member 16 is arranged between the two tightening end portions and connects these to each other. In another aspect, the tightening member 16 may arranged such that it is closer to one end of the device than the other, and thus be positioned on one side of the patient's head when in use. Further, two such tightening members 16 may be arranged on either side of a patient's head.

As seen in e.g. Figures 3, 5a, 6, 7, 11 and 12 the tightening member 16 may comprise an adjustment element 24 structured to alter the length of the elongated member 8 and to fixate the length of the elongated member. The adjustment element 24 may be

implemented in many different ways.

As shown in Figures 5a and 5b, as well as in Figure 12, an adjustment element 24 may comprise a strap buckle or similar structure, applicable for allowing length adjustment of the elongated member 8 and for locking it at a desired length. This allows for easy adjustment of the device without having to loosen the device more than minimally around the patient's head, and also minimizes movement of the head when making an adjustment. Other types of adjustment elements are also conceived. In the arrangement illustrated in figure 11 the adjustment element 24 is embodied by a Velcro band. In the arrangement illustrated in figures 6 and 7 a mechanical locking wheel 24 is provided that cooperates with a saw-tooth structure provided and connected to the elongated member, and in the arrangement illustrated in figures 3-4 a wind-up member is provided to wind-up and unwind the elongated member having a thread-like structure in the illustrated example.

As illustrated in figures 3-4, the elongated member 8 may at least partly have a thread-like extension, i.e. an extension with a circular or oval cross-section. In the arrangements illustrated in figures 5-12 the elongated member 8 has an at least partly flat extension, e.g. having a shape of a band or a ribbon. As will be described further below, the elongated member 8 may be made of any suitable material, preferably a durable and skin- friendly material and parts of or the entire elongated member 8 may optionally be provided with a soft and skin- friendly lining or cover to minimize abrasions against the skin.

When using the arrangement it is important that the fixation arrangement easily may be mounted on the patient without unnecessary moving the head of the patient. With a patient lying in the supine position, with the back of the head towards the ground or e.g. a stretcher, it can be difficult to get one end of a fixation device underneath the neck and out on the other side without extensively moving the head and neck (as the access may be blocked by hair and clothes etc.) One way to facilitate this is to provide a rigid elongated member 37 having an elongated flat physical shape with a structural integrity in its longitudinal direction at one end of the elongated member 8. One such rigid elongated member 37, in the form of an elongated tab, is shown in Figure 5a. This tab 37 is adapted to facilitate passing one end of the device, i.e. one of the two attachment end portions (10, 10') around a patient's head. This makes it possible to easily arrange the fixation arrangement without moving the patient's head more than necessary. As an example, a person who has suffered physical damage is often found lying down on e.g. the ground, and in such a situation it is important gently and minimally move the patient's head to avoid worsening any head, neck or back injuries. As another example, a similar situation is when a patient is lying on a stretcher or hospital bed. The tab 37 makes it easier for a user to slide one end of the fixation arrangement under the head or neck or the patient especially when the patient is lying flat on his/her back on the ground or other surface, and therefore helps the user in reaching the rigid portion or tab. This makes the device easy to apply to a supine patient where e.g. hair and clothes can block space behind the head and neck.

As shown in Figures 5a and 18, such a rigid elongated member 37 may be provided with preformed perforations or indentions 38 at one or several points along the extended part of the rigid elongated member 37, said perforations or indentations 38 adapted to facilitate breaking off any excess length of said rigid elongated member 37. Thus, after arranging the device around a patient's head, the tab 37 may be broken off and discarded, which frees up space near the face and mouth of the patient. Turning to Figure 11, another way of facilitating mounting the device is to provide an elongated member 8 with an essentially rigid neck portion 26 structured to be positioned at the back of the patient's head and having an elongated flat physical shape with a structural integrity in its longitudinal direction that facilitates easy mounting of the elongated member. Further, the rigid portion 26 is preferably shaped in a slightly curved shape, to fit the back of the head, and/or in a material that is rigid but at least partly shapeable to fit the back of the head. One such rigid neck portion 26 is illustrated in figures 11 and 12. Also the wheel and saw-tooth arrangement 16 shown in figures 6 and 7 may be provided as an essentially rigid neck portion, and thus falls under the definition of an essentially rigid portion structured to be positioned at the back of the patient's head and having an elongated flat physical shape with a structural integrity in its longitudinal direction that facilitates easy mounting of the elongated member.

Providing the rigid portion 26 makes it easier for a user to slide the device under the head or neck of a patient, e.g. when a patient is lying flat on his/her back on the ground or other surface, and therefore helps the user in reaching the ribbon or band attach to one end of the rigid portion. This makes the device easy to apply to a supine patient where e.g. hair and clothes can block space behind the head and neck. Naturally, a medical tube fixation arrangement may comprise both a rigid tab 37, as shown in e.g. Figure 5a and 18, and a rigid neck portion 16,26 as shown in Figures, 6, 7 and 11.

The attachment element 14 comprises a locking part 28 structured to lock the tube holding part 18 to the tube when the attachment element 14 is in the fixated state. One example of a locking part is shown in figure 3 and 4, and further described below. Another example is shown in figures 8-10, and further described below. Yet another example is shown in figures 14-18, which will also be described further below. Preferably the locking part is releasable, such that the medical tube may be released and adjusted, and thereafter the tube holding part 18 locked again. This allows adjustment of the position of the medical tube.

The locking part 28 has a limited physical shape preferably having a largest outer extension that is essentially the same as the outer diameter of said medical tube 4, and at the most three times the outer diameter of the tube. Preferably, the locking part 28 has a largest outer extension that is at the most twice the outer diameter of the tube 4. The small size facilitated easy transport and less occupied space when in use. In the illustrated arrangements the medical tube is exemplified as an endotracheal tube. However, any medical tube, or tube-like medical device, intended for insertion into the patient via the mouth may be secured and positioned by the fixation arrangement disclosed herein. Thus, the medical tube may e.g. be, but is not limited to, an oesophageal tube, an orogastric tube, an esophageal device, a feeding tube, an ultrasound probe, a gastroscope etc. Furthermore, it should be understood that the patient indicated herein may be a human or animal.

The arrangements illustrated in figures 3-12 will now be disclosed in detail. Figures 3-4 disclose various views of one aspect of a medical tube fixation arrangement. In this arrangement the elongated member part 20 has a thread-like structure. The tightening member 16 may comprise an adjustment element (not shown in Figure 3-4) structured to alter the length of the elongated member parts 20 and to fixate the length to a desired length. The attachment elements 14 comprise tube holding parts 18 that are wrapped around the tube 4 and then locked to the tube by the locking part 28. The illustrated locking part 28 includes a spring-loaded button that may be pressed down to release a locking force applied to the elongated member part in order to tighten or release the tightening member wrapped around the tube. In figure 4 the fixation arrangement is illustrated in use where an endotracheal is positioned and secured in the corner of the mouth 6 of a patient.

Figures 5 a and 5b show another aspect of the of a medical tube fixation arrangement. Here the elongated member part 8 has a ribbon or band-structure. The tightening member may comprise an adjustment element in the form of a strap buckle 24 or similar structure, structured to alter the length of the elongated member 8 and to fixate the length to a desired length. The attachment element 14 comprises a tube holding part 18 that is configured to wrap around the tube 4 and then lock onto the tube by the locking part 28. The illustrated locking part 28 includes a button 29 that may be pressed down to release a locking force applied to the medical tube 4 in order to tighten or release the tube holding parti 8 wrapped around the tube. In figure 5b the fixation arrangement is illustrated in use where an endotracheal tube 4 is positioned and secured in the corner of the mouth 6 of a patient. The fastening element 40 will be described in further detail later on.

Figures 6 and 7 disclose various views of a further aspect of a medical tube fixation arrangement. In this arrangement the elongated member parts 20 have generally flat extensions, e.g. like a ribbon, and being flexible in order to be bent around the patient's head. The elongated member parts 20 are connected to each other via the tightening member 16. In the illustrated fixation arrangement the tightening member 16 comprises an adjustment element 24 which is embodied by a mechanical locking wheel that cooperates with a saw-tooth structure being connected to the elongated member parts. By turning the locking wheel the lengths of the elongated member parts easily will be altered. The illustrated attachment element 14 has a function similar to that of a cable tie and will be further discussed in relation to figures 8-10. In addition, the illustrated attachment element 14 further comprises an optional tube holder 34 providing for a snap-on grip for any other tube or suitable medical device. This will be further described below.

The attachment element 14 will now be described with references to the perspective views shown in figures 8-10. The below is also applicable to the attachment element 14 seen in Figures 14-18, if not stated otherwise. In figure 8 the tube holding part 18 of the attachment element 14 is seen doubling back on itself in order to enclose a medical tube (not shown) and inserted into the locking part 28 where it is held in position; similar to the function of a cable tie. This manner of attaching a medical tube is applicable to all attachment elements described herein. As may be understood, the arrangement may be used with essentially any sized medical tube, or as an alternative, with any type of medical device having a tubular or similar shape. Thus the arrangement has a high adaptability to different uses. Preferably a release member 29 is provided, which is in figure 8 and 10 is shown as a button on one side of the locking element 28. In Figures 14-18 a button 29 is provided on a top surface of the locking element 28. However, other mechanisms may be used. A release member 29 allows the locking device to be unlocked, such that the medical tube may be adjusted or repositioned, and thereafter the attachment element 14 may be reattached to or locked onto the medical tube. Further, due to the configuration of the attachment element 14, it is easily attached to a medical tube which is e.g. already inserted through a patient's mouth. There is no need to thread any part over a tube, instead the attachment element may be attached from the side of a tube. This feature, especially in combination with a rigid portion of the device, allows for ease of use of the fixation arrangement. The attachment end portion 10 of the elongated member 8 may be attached to the attachment element 14 by wrapping around a connecting part of the attachment element 14, as shown in e.g. Figures 5a, 8, 11 and 18. As an alternative, not shown in the figures, the end of the elongated member 8 may be attached to the attachment element 14 via a pivotable link or hook arrangement to lessen or avoid having the elongate member 8 end up twisted after mounting the fixation device. This allows the elongated strap member 8 to rest flat against the cheek and face of the patient, thus minimising abrasions and unnecessary pressure points.

Further, as seen in Figure 8 and also in Figure 10, as well as figures 14-18, a finger grip surface 36 may be provided on one side of the locking device 28, which is intended for holding or gripping the device with a finger or thumb grip and to facilitate manipulation of the attachment member 14. This grip surface 36 is preferably provided with a friction- increasing structure, such as ribs, embossments or other structures, to minimise the risk of slippage in a user's hand.

Figure 9 A and 9B show the attachment element 14 alone without any attached elongated member. Figure 9B shows a magnified view of the locking part 28, as shown in Figure 9 A, in order to illustrate specific details. These details are applicable to an attachment element 14 and locking part 28 as shown in Figures 14-18 as well. The surface of the tube holding part 18 intended to face the medical tube is preferably provided with a friction- increasing surface in order to increase the grip around the tube. The friction-increasing surface may be embodied by numerous embossments 35 and/or similar teeth-like structures. In addition, the part of the surface intended to face the medical tube adjacent the locking part 28 may preferably be provided on one or several micro-arches 33, i.e. the shape of the surface is adapted to match an outer rounded surface of the medical tube when attached. In other words, when the tube holding part 18 is inserted into the locking part 28, as shown in e.g. Figure 8 or Figure 10, and the tube holding part 18 is tightened around the tube, the arched structure 33 of the inner gripping surface of the tube holding part 18 will provide an increased total surface area contacting the tube, thus increasing the holding forces on the tube. In figure 10 two variations of the attachment element are shown where the tube holding part 18 is inserted through the locking part 28; the attachment element to the left is provided with an optional additional tube holder 34. Notably, an arrangement may comprise two attachment elements with such an additional tube holder 34 on one or both ends, such that one or two further tube or devices may be secured in the patient's mouth when the fixation device is applied. The tube holder 34 may be adapted to be used with any sized medical tube, or as an alternative, with any type of medical device having a tubular or similar shape. Further, the tube holder 34 may be adapted for use with any tube or device, such as, but not limited to, an oesophageal tube, an orogastric tube, an esophageal device, a feeding tube, an ultrasound probe, a gastroscope etc.

The attachment element 14 is preferably made in one piece and from any suitable material for disposable medical devices. Non-limiting examples of materials are thermoplastics and thermoset plastics, e.g. polyethylene, polypropylene, polyvinyl-chloride, polystyrene, unsaturated polyester plastic, urea plastics, phenol plastics, melamine plastics, urethane plastics and epoxy resin plastics.

As shown in e.g. Figure 18, and applicable to all fixation arrangements described herein, the attachment element 14 may be provided with preformed perforations or indentions 39 along the extended part of the tube holding part 18. Such perforations allow a user to break off any protruding parts at a desired length when the attachment element 14 is secured and it is determined that no more adjustment of the tube is needed. Breaking off any excess length of the tube holding part 18 allows more space around the arrangement, and thus e.g. easier access to the mouth of the patient. It also prevents the excess length of the tube holding part to rub against the patients face and thereby avoids any bruises or cuts. Figure 11 shows a perspective view of another aspect of the tube fixation arrangement. In this aspect the arrangement comprises the same attachment element 14 as described in figures 8-10, but could as an alternative be provided with any attachment element 14 described herein. The tightening member 16 is herein embodied by allowing the elongated member part 20 to double back on itself, and by attaching it e.g. by Velcro, adhesive or any similar attachment means. In the illustrated arrangement two tightening members 16 are provided, however it is possible to only provide one tightening member 16, preferably adapted to be positioned on one side of the patient's head. In this arrangement the elongated member comprises an essentially rigid neck portion 26 structured to be positioned at the back of the patient's head and having an elongated flat physical shape with a structural integrity in its longitudinal direction that facilitates easy mounting of the elongated member. The rigid neck portion 26 of the elongated member is preferably arranged at the part of the elongated member that, during use, is positioned at the back of the head of the patient. It should be noted that providing a rigid neck portion 26 is applicable to all arrangements disclosed herein.

Figure 12 shows a perspective view of a further aspect of the tube fixation arrangement. Also in this aspect the arrangement comprises the same attachment element 14 as described in figures 8-10, but could be provided with any attachment element 14 described herein. A rigid neck portion 26 is provided having the same function as described in relation to the arrangement in figure 11. Note that only one elongated member part 20 is illustrated in figure 12; even though two are provided when used. The tightening member 16 is embodied by the elongated member doubling back on itself, and by a suitable connecting member, such as a strap buckle or similar structure, applicable for allowing length adjustment of the elongated member and for locking it in a desired position. As seen in e.g. Figure 5b, a tube fixation arrangement preferably comprises a fastening element 40 adapted to connect and attach the two attachment end portions 10, 10' to each other near or adjacent the mouth of the patient. A fastening element 40 comprises a first part 40a attached to one of the two attachment end portions 10, 10', and a second part attached to the other of the two attachment end portions 10, 10'. A fastening element 40 may comprise a variety of different configurations and manners of attachment, such as, but not limited to, Velcro, snaps, hooks, bikini-clasps, clips, buttons etc. The fastening element 40 is preferably adapted such that it is quick and easy to attach, and likewise easy to detach, while still providing optimal secure attachment. This is especially important when using the fixation arrangement in emergency and trauma settings. Several preferred examples of fastening elements are described in detail below.

In figures 14-18 several further variations of an attachment element 14 are shown. These attachment elements 14 may be provided in a medical tube fixation arrangement according to Figures 5a and 5b, but could also be used in any other medical tube fixation

arrangements disclosed herein. In Figures 14-17 four different attachment elements 14 are shown in a respective perspective view (top and middle) and side view (bottom). The attachment element 14 is provided with a first part 40a of a fastening element 40. In a fixation arrangement a corresponding second part 40b of a fastening element 40 is provided at the opposite end of the device, i.e. at the opposite attachment end portion 10, 10' of the elongated member 8. The top image in each of figure 14-17 is an illustration of the fastening element 40 on the attachment element 14 before fastening to the opposite end of the fixation device. The middle and bottom images show the fastening element 40 in a connected or attached state.

In figure 14 the fastening element is shown as an interlocking clip, which is releasable by pressing on the sides of the clip 40 when it is fastened. The first part 40a is provided on the locking part 28 of the attachment element 14, and the second part 40b is provided at the opposite end of the elongated member, e.g. directly attached to the strap 20 (as may be seen in e.g. figure 18). Another type of fastening element 40 is shown in Figure 15, wherein a flattened hook 40b is adapted to attach to a corresponding opening 40a. Such a fastening element 40 may be detached by angling the hook 40b slightly in relation to the opening 40a and thereafter pushing the hook free of the opening.

Yet another example is shown in Figure 16. Here the locking part 28 is provided with a peg 40a and the opposite end of the strap 20 is provided with an essentially flat part 40b with a matching keyhole-shaped opening. The peg 40a may be shaped with a narrow stem and essentially circular wider top part with a larger diameter than the stem. Further, the finger grip surface 36 may be provided on top of peg 40a, to increase the grip of a user manipulating the device. The keyhole-shaped opening of the flat part 40b is adapted such that the larger diameter hole is larger than the top of peg 40a, and the narrower part is smaller than the top of the peg, but larger than the bottom or stem of the peg 40a. Thus, as may be understood from the figure, when attaching, the larger opening is threaded over the peg 40a and the flat part 40b is then pulled back to hold smaller part of the opening adjacent to the stem, such that the two part are held together securely. Note that this fastening element allows the two parts to be attached in many different orientations in relation to each other. In the top image of Figure 16, the two parts may be seen in a perpendicular orientation when threading the hole over the peg. Naturally, the hole and peg may be adapted to other shapes and sizes, as long as they correspond to each other and allow attachment.

Another example of a fastening element 40 is shown in Figure 17. First and second parts 40a, 40b form a so called "bikini clip", i.e. two interlocking parts that may be attached by hooking into each other, and snapped into a locking position. Notably, in this figure the fastening element 40 is provided on the opposite side of a locking part 28 of an attachment element 14, compared to the previous three figures. This attachment element 14 may thus be provided at the opposite end of the fixation arrangement, i.e. at opposite attachment end portions 10, 10', than those shown in Figures 14, 15 and 16. It should be noted that any fastening element, including those shown in Figures 14-17, may be provided at any side of the locking part 28, and thus a medical tube fixation arrangement may be provided with an attachment element 14 on either end of the device. Any of the above described medical tube fixation arrangements may further be provided with an inner lining along at least part of the elongated member 8, such inner lining adapted to a more comfortable fit against a patient's face and cheeks. The elongated member 8 may also be made of any suitable material, preferably a durable and skin- friendly material to reduce the risk of abrasions on the patient's neck and face. Examples of materials are soft cotton, soft fabric, soft plastic, silicone, latex free plastic etc.

A fixation arrangement comprising an attachment element 14 as described above was subjected to a simple pull test on secured tubes placed for intubation, and compared to known methods and devices. Previous experimental studies using mannequins have demonstrated that the force required to pull out a secured tube by hand is between 20 N and 242 N. The pull test performed by the inventor therefore represents a clinically relevant force interval, as forces from 7 N - 100 N were tested. In short, a medical mannequin placed in a lateral resting position was intubated, and the intubation tube fixated at a specific depth into the mouth of the mannequin. Any lengthwise movement of the intubation tube was measured by laser. A rope was attached to the tube, and threaded through a suspended ring above the mannequin, and weights applied to the rope to exert force on the tube. The pull force (in Newton) was measured with a digital force gauge attached to the rope. The fixation arrangement as described above was tested and compared to known methods and devices, specifically adhesive tape, twill/umbilical tape and a Thomas Tube Holder™ device, respectively. The latter three all resulted in extubation at around ~ 25-69 N. However, the fixation device in the present disclosure kept the tube in place in the full range tested, 7 N - 100 N, thus greatly outperformed the other arrangements.

With reference to figure 13, the present invention also relates to a medical kit 30 comprising a kit package 32, e.g. made from a suitable plastic material. The kit package is configured to enclose a medical tube 4, e.g. an endotracheal tube, and a medical tube fixation arrangement 2 according to any of the arrangements disclosed herein. The present invention is not limited to the above-described preferred embodiments. Various alternatives, modifications and equivalents may be used. Therefore, the above embodiments should not be taken as limiting the scope of the invention, which is defined by the appending claims.

Claims

1. A medical tube fixation arrangement (2) structured to position and secure a medical tube (4) in a predetermined position through the mouth (6) of a patient, the fixation arrangement (2) comprises an elongated member (8) having a first attachment end portion (10) and a second attachment end portion (10'), said two attachment end portions (10, 10') being at opposite ends of said elongated member (8), said elongated member (8) being configured to be arranged around a patient's head, the elongated member (8) further comprises at least one attachment member (12) arranged at at least one attachment end portion (10, 10') of said elongated member (8), and comprising at least one attachment element (14) for attaching said tube, c h a r a c t e r i z e d i n t h a t the elongated member (8) further comprises at least one tightening member (16) configured to be operated to alter the length of the elongated member (8) and to fixate the length such that tightening forces in the longitudinal direction of the elongated member (8) are applied in order to position and secure the tube (4) in the predetermined position, and

that said at least one attachment element (14) is directly connected to one of said

attachment end portions (10, 10') and

wherein said at least one attachment element (14) comprises a tube holding part (18) structured to apply radially directed holding forces to the medical tube (4) essentially around the entire circumference of said tube,

wherein said at least one attachment element (14) further comprises first part of a

fastening element (40), and

the other of the two attachment end portions (10, 10') comprises a second part of said fastening element (40), said first and second parts of said fastening element (40) being configured to attach to each other such that, in use, said first attachment end portion (10) and said second attachment end portion (10') are connected via said attachment member (12).

2. The fixation arrangement (2) according to claim 1 , wherein at least one of said two attachment end portions (10, 10') comprises a rigid elongated member (37) having an elongated flat physical shape with a structural integrity in its longitudinal direction and being adapted to facilitate passing said elongated member (8) around a patient's head.

3. The fixation arrangement (2) according to claim 2, wherein the rigid elongated member 37) is provided with preformed perforations or indentions (38) at one or several points along the extended part of the rigid elongated member (37), said perforations or indentations adapted to facilitate breaking off any excess length of said rigid elongated member (37).

4. The fixation arrangement (2) according to any preceding claim, wherein said

tightening member (16) comprises an adjustment element (24) structured to alter the length of said elongated member (8) and to fixate said length.

5. The fixation arrangement (2) according to any preceding claim, wherein said

elongated member (8) has at least partly an extension with a circular or oval cross- section.

6. The fixation arrangement (2) according to any of claims 1-4, wherein said elongated member (8) has at least partly a flat extension, e.g. having a shape of a band or a ribbon.

7. The fixation arrangement (2) according to any preceding claim, wherein said

elongated member (8) comprises an essentially rigid neck portion (26) structured to be positioned at the back of the patient's head and having an elongated flat physical shape with a structural integrity in its longitudinal direction that facilitates easy mounting of the elongated member.

8. The fixation arrangement (2) according to any preceding claim, wherein the

attachment element (14) comprises a locking part (28) structured to lock the tube holding part (18) to the tube when said attachment element (14) is in said fixated state.

9. The fixation arrangement (2) according to claim 8, wherein the locking part (28) has a limited physical shape having a largest outer extension that is essentially the same as the outer diameter of said medical tube (4), and at the most three times the outer diameter of the medical tube (4), preferably twice the outer diameter of the tube (4), wherein said outer extension is a width of said locking part (28) in a plane perpendicular to an intended insertion direction of said medical tube (4).

10. The fixation arrangement (2) according to any preceding claim, wherein the attachment element (14) is provided with an additional tube holder (34).

11. The fixation arrangement (2) according to any preceding claim, wherein said medical tube (4) is an endotracheal tube.

12. A medical kit (30) comprising a kit package (32) configured to enclose a medical tube (4) and a fixation arrangement (2) according to any of claims 1-11.