Patent Description:
Endotracheal intubation is an important procedure in both anaesthetized and critically ill patients. Endotracheal tube displacement is one of the leading causes for airway relates complications. Securing the endotracheal tube, therefore, is critically important in preventing accidental extubation, which can be life threatening.

Rates of unintentional extubation are found to range from <NUM>% to <NUM>% between anaesthesia and intensive care. In a study of <NUM> adult intensive care unit (ICU) patients, <NUM>% experienced at least one episode of unplanned extubation, and it was found that a lack of a strong tube fixation was one of the major predisposing factors to unplanned extubation in ventilated adult patients.

There is a variety of commercially available products that seek to provide secure endotracheal tube fixation. These include the Thomas™ Endotracheal Tube holder which consists of a rigid plastic holder connected to an elasticated strap, and the Portex® RSP Tracheal Tube holder which consists of a slide-on locking device connected to an adhesive backed base. Products such as these are configured to connect to a tube of a particular size. Additionally, products with elasticated straps may lead to pressure sores on the patient. Fundamentally, however, complex products, such as those comprising multiple materials and/or plastics moulded parts have a high (relative) cost associated with them such that widespread adoption of the product across a medical facility (such as a hospital) can be prohibitively expensive.

An alternative to these products is to simply use medical tape to affix an endotracheal tube to a patient and this is often the most commonly practiced method. Whilst less costly than a dedicated fixation device, the use of medical tape is not without its disadvantages. In particular, once the packaging of a roll of medical tape is opened, the roll of tape is never cleaned or sterilized. While a single strip of tape may be single use, the roll itself is often the only piece of surgical equipment that is re-used and not sterilized. As such, the re-use of rolls of tape between patients presents a potential risk of introducing infection to the airway (or skin) of intubated patients.

Furthermore, given that medical tape is intended for a broad range of applications, it is not necessarily suited for application on the delicate skin of the face. Indeed, removal of medical tape from a patient's face can remove superficial layers of skin which can cause tears. In addition to causing patient discomfort, skin abrasions can also be a common entry point for bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

<CIT>) describes a tracheal tube support apparatus that includes a pair of oppositely disposed adhesively mountable flanges for releasably mounting to the face of the patient. A pair of adhesive-backed wings is provided for releasable mounting to a portion of the tracheal tube once intubated. <CIT> describes an example of a clamp for adapted for use with so called Hepburn type locks for catheter needles. The clamp includes a one piece substrate having a medical grade double sided adhesive base.

An endotracheal tube is not the only device for which secure tube fixation is important. Secure fixation is also required for protruding oral or nasal devices such as supraglottic airways, oral monitoring devices such and naso-gastric tubes. It is an object of certain embodiments of the present invention to provide a securement device for a protruding oral or nasal device that overcomes at least some advantages associated with the prior art. It is an object of certain embodiments of the present invention to provide an alternative securement device for a protruding oral or nasal device relative to the prior art.

In accordance with an aspect of the present invention there is provided a securement device for a protruding oral or nasal device, comprising a continuous strip extending along a longitudinal axis between a first end and a second end, the continuous strip having:.

In certain embodiments, the first anchor portion and the second anchor portion are offset from one another relative to the longitudinal axis.

The first bridge portion may be substantially aligned with the longitudinal axis.

The securement device may comprise a third bridge portion disposed between the second bridge portion and the second anchor portion, wherein the third bridge portion may be substantially aligned with the longitudinal axis.

Either or both of the first anchor portion and second anchor portion may include a plurality of limbs. The plurality of limbs may comprise a pair of limbs extending from one another, where the pair of limbs may form a V-shape. The pair of limbs may form an intersection angle of between <NUM>° and <NUM>°.

The strip may have a length along the longitudinal axis between <NUM> and <NUM>, and optionally about <NUM>.

The first bridge portion may extend along a length between <NUM> and <NUM>, and optionally about <NUM>.

The second bridge portion may extend along a length between <NUM> and <NUM>, and optionally about <NUM>.

The second bridge portion may extend at an angle of between <NUM>° and <NUM>°, and optionally about <NUM>° relative to the longitudinal axis.

The adhesive is provided on a back side of the strip. The adhesive may be provided in selected regions of the back side of the strip. Alternatively, the adhesive may be provided substantially over the entire back side of the strip. The adhesive may comprise multiple adhesives or an adhesive having varying strengths across the strip.

In accordance with another aspect of the present invention, there is provided a kit comprising a packaging containing a securement device as defined above. The securement device may be in a sterile state in the packaging prior to opening of the packaging.

In accordance with another aspect of the present invention, there is provided an assembly comprising an oral or nasal device and a securement device as defined above, wherein the securement device is wound around the oral or nasal device such that the first anchor portion and the second anchor portion extend from opposite sides of the oral or nasal device.

In certain embodiments, the second bridge portion of the securement device may be wound around the oral or nasal device.

In accordance with another aspect of the present invention, there is provided a method of attaching a securement device to a protruding oral or nasal device and a patient comprising:.

In certain embodiments, winding the securement device around the tube may comprise winding the second bridge portion around the oral or nasal device.

In certain embodiments, the securement device may be wound around the oral or nasal device and the first anchor portion may be adhered to the patient so that the first bridge portion leads away from the first anchor portion towards the lips of the patient.

In certain embodiments, when either or both of the first anchor portion and second anchor portion include a plurality of limbs, a first limb of the plurality of limbs may be adhered in the region of the cheek bone of the patient and a second limb of the plurality of limbs may be adhered in the region of the jaw bone of the patient.

A securement device <NUM> according to an embodiment of the present invention is shown in <FIG>. The securement device <NUM> is suitable for the securement of a protruding oral or nasal device (not shown in <FIG>). The securement device <NUM> comprises a strip <NUM> that extends along a longitudinal axis <NUM> between a first end 12a and a second end 12b. An adhesive (not visible in the Figures) is provided on a back side of the strip <NUM> for affixing the strip <NUM> to a patient. The strip <NUM> includes a first anchor portion <NUM> at the first end 12a and a second anchor portion <NUM> at the second end 12b.

Between the first end 12a and second end 12b, the strip <NUM> includes a first bridge portion <NUM>, a second bridge portion <NUM> and a third bridge portion <NUM>. More specifically, the first bridge portion <NUM> is disposed between the first anchor portion <NUM> and the second bridge portion <NUM>, the second bridge portion <NUM> is disposed between the first bridge portion <NUM> and the third bridge portion <NUM>, and the third bridge portion <NUM> is disposed between the second bridge portion <NUM> and the second anchor portion <NUM>. In the embodiment shown in <FIG>, each of the first bridge portion <NUM> and the third bridge portion <NUM> is substantially parallel to the longitudinal axis <NUM> (and one another). The second bridge portion <NUM> extends at an inclined angle θ relative to the longitudinal axis <NUM> and each of the first bridge portion <NUM> and the third bridge portion <NUM>. The first anchor portion <NUM> and the second anchor portion <NUM> are offset from one another relative to the longitudinal axis <NUM>. That is, the first anchor portion <NUM> extends from the longitudinal axis <NUM> by an amount that differs from the amount that the second anchor portion <NUM> extends from the longitudinal axis <NUM> in the same direction.

The strip <NUM> has a length L1 (taken along its longitudinal axis <NUM> between the first end 12a and second end 12b). The first bridge portion <NUM> has a length L2, the second bridge portion <NUM> extends along a length L3, while the third bridge portion <NUM> extends along a length L4. In certain non-limiting embodiments, L1 is between <NUM> and <NUM> and is optionally around <NUM>, and/or L2 is between <NUM> and <NUM> and is optionally around <NUM>, and/or L3 is between <NUM> and <NUM> and is optionally around <NUM>, and/or L4 is between <NUM> and <NUM> and is optionally around <NUM>. In certain non-limiting embodiments, the inclination angle θ of the second bridge portion <NUM> relative to the longitudinal axis <NUM> is between <NUM>° and <NUM>° and is optionally around <NUM>°. Notwithstanding the above mentioned example lengths and angles, embodiments of the present invention may encompass other lengths and angles.

In the illustrated embodiment, the first anchor portion <NUM> comprises a first limb <NUM> and a second limb <NUM> that extend from one another in a V-shape and form an intersection angle α. In certain embodiments, the intersection angle α may be between <NUM>° and <NUM>° and may optionally be around <NUM>°. The first limb <NUM> is configured to attach to the face of a patient in the region of the patient's cheek bone whilst the second limb <NUM> is configured to attach to the face of the patient face in the region of the jaw bone. The relative lengths of the first limb <NUM> and second limb <NUM> and the magnitude of the intersection angle α may therefore be configured so that the first anchor portion <NUM> may affix to the cheek and jaw bone of a certain patient or group of patients. That is, in certain embodiments the first limb <NUM>, second limb <NUM> and intersection angle α may be configured so that the first anchor portion <NUM> may affix to the cheek and jaw bone of an adult patient, whereas in other embodiments, the first limb <NUM>, second limb <NUM> and intersection angle α may be configured so that the first anchor portion <NUM> may affix to the cheek and jaw bone of an infant patient.

In the illustrated embodiment, the second anchor portion <NUM> comprises a single limb that extends substantially parallel to the longitudinal axis <NUM> away from the third bridge portion <NUM>.

In other embodiments, either or both of the first anchor portion <NUM> and the second anchor portion <NUM> may include any number of limbs that extend from one another. The limbs may form a V-shape or other configuration, and the limbs may form any suitable intersection angle.

A non-limiting example of the relative lengths of the bridge portions and anchor portions of the securement device <NUM> is shown in <FIG>. In the example, the width W1 of the third bridge portion <NUM> is shown as equal to <NUM> and all other dimensions in the example are provided relative to W1. In this non-limiting example, the first bridge portion <NUM> has a length L2 equal to <NUM>, the second bridge portion has a length L3 equal to <NUM> and the third bridge portion has a length L4 equal to <NUM>. The inclination angle θ of the second bridge portion <NUM> relative to the longitudinal axis <NUM> is <NUM>°. In this example, the first anchor portion <NUM> comprises a first limb <NUM> and a second limb <NUM>. The first limb <NUM> and the second limb <NUM> have a width W2 equal to <NUM> and a length L5 equal to <NUM>. The first and second limbs are each inclined at an angle of <NUM>° relative to the longitudinal axis <NUM>, as such, the intersection angle α is <NUM>°. The first limb and second limb each have a tapered portion at the first end 12a of the strip <NUM>, the tapered portions have a length L6 equal to <NUM>. In this example, the second anchor portion comprises: a first portion with a length L7 equal to <NUM> which inclined at an angle of <NUM>° relative to the longitudinal axis <NUM>; a second portion substantially parallel to the longitudinal axis <NUM> with a length L8 equal to <NUM> and a width W3 equal to <NUM>; and a third tapered portion at the second end 12b of the strip <NUM> that has a length L9 equal to <NUM> in the direction parallel to the longitudinal axis <NUM>.

In use, the strip <NUM> is wound around a protruding oral or nasal device and is affixed to the patient's face by the adhesive on the back side of the strip <NUM>. The protruding oral or nasal devices may include but are not limited to: endotracheal tubes such as standard endotracheal tubes, south facing endotracheal tubes, north facing endotracheal tubes, armoured or flexible endotracheal tubes, microlaryngoscopy tubes, double lumen endotracheal tubes, nasal endotracheal tubes and low pressure endotracheal tubes; supraglottic airways including standard laryngeal mask and flexible or armoured laryngeal masks; oral monitoring devices such as temperature probes and oesophogeal dopplers; and naso-gastric tubes. Indeed, the protruding oral or nasal device may include any device that protrudes form a patient's oral or nasal cavity. <FIG> and <FIG> show examples of an endotracheal tube <NUM> secured to a patient <NUM> using a securement device <NUM> in accordance with an embodiment of the present invention.

As shown in <FIG> and <FIG>, the strip <NUM> is wound around the endotracheal tube <NUM> and is adhered to the face of the patient <NUM>. In particular, the first limb <NUM> is adhered to the face of the patient <NUM> in the region of the cheek bone and the second limb <NUM> is adhered to the patient <NUM> in the region of the jaw bone. The first bridge portion <NUM> leads away from the first anchor portion <NUM> towards the lips <NUM> of the patient <NUM>. The second bridge portion <NUM> is wound around the endotracheal tube <NUM>. Advantageously, due to the inclination angle θ of the second bridge portion <NUM> relative to the longitudinal axis <NUM> of the strip <NUM> (and/or the first bridge portion <NUM>), the second bridge portion <NUM> may wind around the endotracheal tube <NUM> such that the adhesive back side of the strip <NUM> is substantially affixed to the endotracheal tube <NUM> rather than the strip <NUM> itself. That is, the configuration of the second bridge portion <NUM> relative to the first bridge portion <NUM> may facilitate a secure winding of the strip <NUM> around the endotracheal tube <NUM> whilst avoiding winding of the strip <NUM> on itself. In particular, this configuration may also maximise the contact of the adhesive back side of the strip <NUM> to the endotracheal tube <NUM> whilst avoiding kinks being formed in the strip <NUM> as it is wound around the endotracheal tube <NUM>.

Additionally, the configuration of the second bridge portion <NUM> relative to the first bridge portion <NUM> permits the strip <NUM> to be wound below the endotracheal tube <NUM> such that the strip <NUM> may be affixed to the face of the patient <NUM> below the lips <NUM> of the patient. This is advantageous as it may permit the lips <NUM> of the patient <NUM> to remain visible during surgical procedures thereby allowing any colour change of the lips <NUM>, which may be an indication of blood oxygen levels, to be monitored. A further advantage of a winding around the endotracheal tube <NUM> that is below the lips <NUM> of the patient <NUM> is that the potential infection risk to the patient <NUM> is reduced since the securement device <NUM> is not in close proximity to the nose of the patient <NUM> (which is a major entry point for infection).

The third bridge portion <NUM> extends substantially parallel to the longitudinal axis <NUM> beneath the lips <NUM>. By extending substantially parallel to the longitudinal axis <NUM>, the third bridge portion <NUM> may extend so that (at least) the entire top lip <NUM> remains visible. In other embodiments, the third bridge portion <NUM> may not be substantially parallel to the longitudinal axis <NUM> such that at least some of the lips <NUM> may be obscured by the third bridge portion <NUM>.

In certain embodiments, the third bridge portion <NUM> may be omitted entirely. That is, two bridge portions may be present between the first anchor portion <NUM> and the second anchor portion <NUM>, where one of the bridge portions may be inclined relative to the longitudinal axis <NUM> of the strip <NUM>. In such embodiments, one of the two bridge portions may extend between the endotracheal tube <NUM> (when attached thereto) and the second anchor portion <NUM>. In other embodiments, additional bridge portions may be provided between the first anchor portion <NUM> and the second anchor portion <NUM>. The additional bridge portions may be parallel to or inclined relative to the longitudinal axis <NUM>.

Due to the asymmetry of the securement device <NUM>, the endotracheal tube <NUM> may be secured at one side of the patient's mouth. In other embodiments, the relative lengths of the bridge portions <NUM>, <NUM>, <NUM> may be such that the endotracheal tube <NUM> is secured around the centre of the patient's mouth. Although the use of the securement device <NUM> is described in relation to use with endotracheal tubes, the securement device may be similarly used with other oral and nasal devices and provide similar advantages.

In certain embodiments, the securement device <NUM> may be perforated along the longitudinal axis <NUM>. The perforation of the securement device <NUM> may extend along the longitudinal axis from the second end 12b. The perforation may extend along the length of the second anchor portion <NUM>. The perforation may also extend at least partially into the third bridge portion <NUM>. In the non-limiting embodiment shown in <FIG>, the perforation of the securement device <NUM> extends along the second anchor portion <NUM> and the third bridge portion <NUM>, and is illustrated by a dashed line <NUM> which lies on the longitudinal axis (not shown). The perforation of the securement device <NUM> enables the second anchor portion <NUM> to be separated into two strips. The separation of the second anchor portion <NUM> may advantageously improve the fixation of the securement device <NUM> to a patient for certain positions of the oral or nasal device.

The adhesive may be provided on the back side of the strip <NUM> and may be initially covered with a removable cover material. When the securement device <NUM> is to be used, the cover material may be removed to expose the adhesive and the adhesive may subsequently be used to affix the strip <NUM> to the oral or nasal device, and the strip <NUM> to the face of the patient <NUM>. The adhesive may be provided over the entire surface of the back side of the strip <NUM> or the adhesive may be provided on one or more selected regions of the back side of the strip <NUM>. The adhesive is preferably one that provides an adequate securement of the strip <NUM> to the patient and/or the oral or nasal device but is not so strong that the skin of the patient is significantly damaged when the strip <NUM> is removed therefrom. Ideally, the adhesive strikes a balance between providing security of fitting whilst minimizing skin damage. In certain embodiments, multiple adhesives or an adhesive having varying strengths may be provided on the strip <NUM>. For example, a different adhesive may be provided for securing the strip <NUM> to the oral or nasal device relative to the adhesive provided for affixing the strip <NUM> to the face of the patient <NUM>.

The securement device <NUM> may comprise any suitable material. In selecting a suitable material for the securement device <NUM> consideration may be given to: the integrity of the material (i.e. signs of peeling, wrinkling or moisture absorption of the material during use); the ease of removal from a patient; and the kindness of the material to the patient's skin (i.e. whether the tape causes redness, soreness, irritation, abrasions or tearing of the skin). An example of a suitable material for the securement device <NUM> is a medical tape. A preferred example of a suitable medical tape for the securement device <NUM> is <NUM>™ Microfoam Surgical Tape <NUM>. It has been found that <NUM>™ Microfoam Surgical Tape <NUM> performs better than other examples of medical tapes with regard to material integrity, ease of removal and kindness to skin. The tape comprises a poly(vinyl chloride) foam layer with an acrylate adhesive. An alternative example of a suitable medical tape is the <NUM>™ Medical White Rayon Nonwoven Tape <NUM> which comprises a non-woven rayon tape with a pressure sensitive, hypoallergenic acrylate adhesive. Another example of a suitable medical tape is the <NUM>™ Single Coated Polyilefin Medical Tape <NUM> which comprises a perforated polyolefin tape coated with a pressure sensitive, hypoallergenic acrylate adhesive.

The securement device <NUM> may be sterile and be provided in a sterile package that may be opened when required to provide the sterile securement device <NUM>. In preferable embodiments, the securement device <NUM> may be intended for a single use and may be disposed after a single use.

Embodiments of the present invention may improve patient safety by reducing rates of infection and/or accidental extubation. Additionally or alternatively, patient experience may be improved by reducing the likelihood and severity of skin tears on the face (e.g. the lips). As such, the length of stay in hospital may be reduced for patients and costs associated with hospital acquired infections (HAls) may be reduced.

Embodiments of the present invention may be less costly in comparison to prior art securement devices which include multiple materials and/or moulded parts. Additionally, embodiments of the present invention may provide improved versatility relative to prior art devices, since the present invention is not necessarily limited to use with oral or nasal devices of any particular diameter. Securement devices <NUM> according to embodiments of the present invention may be more secure and less damaging to the skin relative to standard medical tape. Furthermore, securement devices <NUM> according to embodiments of the present invention may reduce infection risk relative to a roll of tape which may be used on multiple patients. Indeed, the use of a securement device <NUM> in accordance with embodiments of the present invention may help to introduce new best practice in hospitals given its suitability to single usage.

The invention is not restricted to the details of any foregoing embodiments. The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claim 1:
A securement device (<NUM>) for a protruding oral or nasal device (<NUM>), comprising a continuous strip (<NUM>) extending along a longitudinal axis (<NUM>) between a first end (12a) and a second end (12b), the continuous strip having:
a first anchor portion (<NUM>) at the first end;
a second anchor portion (<NUM>) at the second end;
a first bridge portion (<NUM>);
a second bridge portion (<NUM>); and
an adhesive for affixing the strip to a patient (<NUM>);
wherein the first bridge portion (<NUM>) is disposed between the first anchor portion (<NUM>) and the second bridge portion (<NUM>), the second bridge portion (<NUM>) is disposed between the first bridge portion (<NUM>) and the second anchor portion (<NUM>), the second bridge portion (<NUM>) extends at an angle relative to the longitudinal axis (<NUM>), and the first anchor portion (<NUM>) and the second anchor portion (<NUM>) are offset from one another relative to the longitudinal axis (<NUM>).