Nasoenteric tube securement device

Abstract

The present invention relates to a nasoenteric tube securement device for securely holding and nasoenteric tube in place on a user's face to prevent the nasoenteric tube from coming out. The nasoenteric tube securement device includes a securing formation configured for clamping on to a user's nose or ear, cooking onto a user's nose or ear, or looping around the users here in use. The nasoenteric tube securement device further includes an attachment formation connected to the securing formation. The attachment formation is configured for securely holding and nasoenteric feeding tube. The nasoenteric tube securement device can include a clamping arrangement, hooking arrangement, and / or a looping arrangement.

Description

NASOENTERIC TUBE SECUREMENT DEVICEField of the Invention

[0001] The present invention relates to securing systems for nasoenteric feeding tubes, including nasogastric, nasoduodenal, and nasojejunal applications .

[0002] The invention has been developed primarily for use in / with holding a nasoenteric feeding tube in place on a patient and will be described hereinafter with reference to this application. However, it will be appreciated that the invention is not limited to this particular field of use.Background of the Invention

[0003] A nasoenteric feeding tube is of flexible medical tube inserted via the nasal passage through the oesophagus and terminating in the stomach, duodenum or jejunum. This category includes nasogastric (NG), nasoduodenal (ND), and nasojejunal (NJ) tubes. A nasoenteric feeding tube is typically temporarily placed in patients to deliver substances to the stomach or small intestine such as administering nutrients or medication, adding contrast to the stomach for x-rays or to remove substances such as liquids or air from the stomach or small intestine.

[0004] Presently to hold the nasoenteric feeding tube in place, part of the tube near the nose adhered to the face with an adhesive tape or with the assistance of a nasal bridle.

[0005] When adhesive tape is used, it is usually applied to the cheek and / or near the nose of the patient. The tape is strongly adhesive to ensure that the skin sticks to the nasoenteric feeding tube.

[0006] However, there are a number of disadvantages of using tape to adhere the nasoenteric feeding tube to the face. In order to adequately adhere the tape, the adhesive must be sufficiently strong and applying and peeling off the tape can damage skin. The tape can also slide or come undone changing the position of the tube within the person. For example, the tube can slide from the stomach into the small intestine due to peristalsis. The adhesive tape can also cause skin irritation, breakdown and even allergic reactions in some people.

[0007] Another option for securing a nasoenteric feeding tube is a nasal bridle. This is often used to prevent a patient from pulling on and dislodging their nasoenteric feeding tube. A nasal bridle consists of bridle tubing which passes through both nostrils and around the vomer bone. The bridle is attached to the tube. If a user pulls on the tube, they will feel pressure on the nasal bone which will be uncomfortable. This will deter the user from pulling on the bridle. The bridle tubing has a clip located near an end of the tubing for holding thenasoenteric feeding tube. Once the bridle tubing is positioned around the vomer bone and the clip is secured to the nasoenteric feeding tube, both ends of the bridle tubing can be tied together.

[0008] There are a number of disadvantages of using a nasal bridle. Firstly, the process of securing a nasal bridle is uncomfortable for a patient. Secondly, incorrect placement or pulling on the nasal bridle can cause accidental damage to the vomer bone or surrounding sensitive nasal cavity areas.

[0009] The present invention seeks to provide a solution, which will overcome or substantially ameliorate at least some of the deficiencies of the prior art, orto at least provide an alternative.

[0010] It is to be understood that, if any prior art information is referred to herein, such reference does not constitute an admission that the information forms part of the common general knowledge in the art, in Australia or any other country.Summary of the Invention

[0011] According to a further aspect of the present invention, there is provided a nasoenteric tube securement device for holding a nasoenteric feeding tube in place on a user’s face, comprising:a. a securing formation configured for one or more selected from:i clamping onto one or more selected from the user’s nose and the user’s ear in use;ii hooking onto one or more selected from the user’s nose and the user’s ear in use; andHi looping around the users ear in use; andb. an attachment formation connected to the securing formation, the attachment formation adapted, in use, for securely holding a nasoenteric feeding tube.

[0012] In one embodiment, the securing formation includes a clamping arrangement.

[0013] In one embodiment, the clamping arrangement includes a base and plurality of arms extending from the base.

[0014] In one embodiment, the clamping arrangement defines a pair of opposed jaws for clamping onto one or more selected from the users ear and the user’s nose in use.

[0015] In one embodiment, the arms are one or more selected froma. at least partly resiliently flexible; andb. at least partly plastically flexible.

[0016] In one embodiment, the clamping arrangement includes a biasing arrangement.

[0017] In one embodiment, the securing formation includes a hooking arrangement configured for hooking onto a user’s ear in use.

[0018] In one embodiment, the hooking arrangement is configured for extending around the rear of a user’s ear in use.

[0019] In one embodiment, the securing formation includes a looping arrangement configured for looping around a user’s ear in use.

[0020] In one embodiment, the securing formation includes one or more selected from an aperture and a recess adapted to receive at least part of the nasoenteric feeding tube.

[0021] In one embodiment, the attachment formation is configured for removable attachment to the nasoenteric feeding tube.

[0022] In one embodiment, the securing formation is at least partly resiliently flexible.

[0023] In one embodiment, the securing formation is at least partly plastically deformable.

[0024] In one embodiment, the nasoenteric tube securement device includes a webbed basket at least partially receivable within the nose of a user.

[0025] In one embodiment, the nasoenteric tube securement device includes a sensor arrangement.

[0026] In one embodiment, the nasoenteric tube securement device includes an indicator formation configured for indicating a distance that the nasoenteric feeding tube has been moved from its location on initially being inserted.

[0027] According to a first aspect of the present invention, there is provided a nasoenteric tube securement device for holding a nasoenteric feeding tube in place on a user’s face, comprising:a. a clamping formation configured for clamping to one or more selected from the user’s nose and the user’s ear;b. an attachment formation connected to the securing formation, the attachment formation adapted, in use, for securely holding a nasoenteric feeding tube.

[0028] According to a first aspect of the present invention, there is provided a nasoenteric tube securement device for holding a nasoenteric feeding tube in place on a user’s face, comprising:a. a hooking formation configured for hooking onto one or more selected from the user’s nose and the user’s ear;b. an attachment formation connected to the securing formation, the attachment formation adapted, in use, for securely holding a nasoenteric feeding tube.

[0029] According to a further aspect of the present invention, there is provided a nasoenteric tube securement device for holding a nasoenteric feeding tube in place on a user’s face, comprising:a. a looping formation configured for looping around the user’s ear;b. an attachment formation connected to the securing formation, the attachment formation adapted, in use, for securely holding a nasoenteric feeding tube.

[0030] According to a first aspect of the present invention, there is provided a nasoenteric tube securement device for holding a nasoenteric feeding tube in place on a user’s face, comprising:a. a securing formation configured for securing to one or more selected from the user’s nose and the user’s ear;b. an attachment formation connected to the securing formation, the attachment formation adapted, in use, for securely holding a nasoenteric feeding tube.

[0031] In one embodiment, the attachment formation is removably securable to the nasoenteric feeding tube.

[0032] In one embodiment, the attachment formation is removably securable to the nasoenteric feeding tube while the nasoenteric feeding tube remains in position on a user in use.

[0033] In one embodiment, the attachment formation is removably securable to the nasoenteric feeding tube well the nasoenteric tube securement device remains in position on a user in use.

[0034] In one embodiment, the securing formation is adapted to clamp onto one or more selected from the user’s nose and the user’s ear.

[0035] In one embodiment, the securing formation includes an ear engaging arrangement.

[0036] In one embodiment, the securing formation includes a nose engaging arrangement.

[0037] In one embodiment, the securing formation includes a clamping arrangement.

[0038] In one embodiment, the securing formation is adapted to hook onto one or more selected from the user’s nose and the user’s ear.

[0039] In one embodiment, the securing formation includes a hooking arrangement.

[0040] In one embodiment, the securing formation is adapted to live around at least one of the user’s ears.

[0041] In one embodiment, the securing formation includes a looping arrangement.

[0042] In one embodiment, the securing formation is hollow.

[0043] In one embodiment, the attachment formation is configured for removable attachment to the nasoenteric feeding tube.

[0044] In one embodiment, the securing formation is at least partly flexible.

[0045] In one embodiment, the securing formation is at least partly resiliently flexible.

[0046] In one embodiment, the securing formation is at least partly plastically deformable.

[0047] According to a further aspect of the present invention, there is provided a nasoenteric tube securement device comprising:a. a clamping arrangement including two opposed jaw members adapted to clamp, in use, onto a part of the nose or ear of a user; andb. an attachment formation provided on the body, the attachment formation adapted, in use, for securely holding a nasoenteric feeding tube.

[0048] In one embodiment, the attachment formation is removably securable to the nasoenteric feeding tube.

[0049] In one embodiment, the attachment formation is removably securable to the nasoenteric feeding tube while the nasoenteric feeding tube remains in position on a user in use.

[0050] In one embodiment, the attachment formation is removably securable to the nasoenteric feeding tube well the nasoenteric tube securement device remains in position on a user in use.

[0051] In one embodiment the clamping arrangement includes a clamping formation.

[0052] In one embodiment, the clamping formation includes a base and plurality of arms extending from the base.

[0053] In one embodiment, the arms are resiliently flexible.

[0054] In one embodiment, the arms are plastically flexible.

[0055] In one embodiment, the body is a substantially U-shaped body.

[0056] In one embodiment, the body includes a base and a pair of arms.

[0057] In one embodiment, the arms define the ends.

[0058] According to a further aspect of the present invention, there is provided a nasoenteric tube securement device comprising:a. a body including two opposed ends which are biased relative to each other towards each other and together provide a clamping formation adapted secure the body, in use, around a part of the nose or ear of a user; and b. an attachment formation provided on the body, the attachment formation adapted, in use, for securely holding a nasoenteric feeding tube.

[0059] In one embodiment, the body is a substantially U-shaped body.

[0060] In one embodiment, the body includes a base and a pair of arms.

[0061] In one embodiment, the arms define the ends.

[0062] In one embodiment, the arms are resiliently flexible.

[0063] In one embodiment, the arms are plastically flexible.

[0064] In one embodiment, the part of the nose or ear may be selected from the group consisting of:a. a nasal septum ,b. columella,c. ala,d. helix,e. lobule,f. anti-helix,g. concha, andh. tragus.

[0065] In one embodiment, the body may be adjustable.

[0066] In one embodiment, the body may be flexible.

[0067] In one embodiment, the body may be resiliently flexible.

[0068] In one embodiment, the body may comprise a substantially U-shaped portion comprising the two opposed ends.

[0069] In one embodiment, the body may comprise a first arm and a second arm which are of the same length.

[0070] In one embodiment, the body may be made of a resiliently flexible material.

[0071] In one embodiment, each of the two opposing ends may include a magnet at least partially providing the bias of the two ends into a clamping formation adapted to secure the body around the part of the nose or ear.

[0072] In one embodiment, the attachment formation may comprise a clip.

[0073] In one embodiment, the clip of the attachment formation may be a circlip.

[0074] In one embodiment, the attachment formation may be fixed to the body.

[0075] In one embodiment, the attachment formation may be removably attachable to the body.

[0076] In one embodiment, the attachment formation may be removably attachable to the body via a tongue and groove arrangement. A tongue may be provided on the attachment formation and a corresponding groove is provided on the body.

[0077] In one embodiment, the attachment formation may be removably attachable to the body via a tongue and groove arrangement. A tongue may be provided on the body and a corresponding groove is provided on the attachment formation.

[0078] In one embodiment, the body may comprise a first arm with a first end and a second arm with a second end, the first arm being longer than the second end and adapted to extend up to and engage with the alar crease on the outside of the nose, in use.

[0079] In one embodiment, the body may be adapted to grippingly engage with and be secured around the helix of a user.

[0080] In one embodiment, a hook-shaped formation may be provided at each of the two opposing ends.

[0081] In one embodiment, a skin-engaging portion may be provided at each of the two opposing ends.

[0082] In one embodiment, each end may comprise a cushioning material.

[0083] In one embodiment, the cushioning material may be a medical grade polymeric material.

[0084] In one embodiment, the cushioning material may be breathable.

[0085] In one embodiment, the cushioning material may be silicone.

[0086] In one embodiment, the body may comprise an inner portion or outer that is harderthan the cushioning material.

[0087] In one embodiment, the body may be of unitary construction.

[0088] In one embodiment, the cushioning material may be overmoulded over the harder material.

[0089] In one embodiment, the harder material may be made of a resiliently flexible material.

[0090] In one embodiment, the nasoenteric tube securement device may further comprise webbed baskets attached to each of the first arm and second arm.

[0091] The webbed baskets may be in contact with and cover the attachment formation.

[0092] In another aspect of the present invention, there is provided a method for securing a nasoenteric feeding tube to a user comprising:a. providing a nasoenteric tube securement device as described above, b. positioning the two arms of the body around the part of a nose or ear of the user such that the body grippingly engages with the part of the nose or ear, andc. engaging the nasoenteric feeding tube with the attachment formation.

[0093] In one embodiment, upon engaging the nasoenteric feeding tube with the attachment formation, the nasoenteric feeding tube may be retained within the attachment formation.

[0094] In one embodiment, the part of the nose or ear may be selected from the group consisting of: a nasal septum, columella, ala, helix, lobule, anti-helix, concha and tragus.

[0095] In yet another aspect of the present invention, there is provided a nasoenteric tube securement device for holding a nasoenteric feeding tube to a user’s ear comprising:a. a body adapted to, in use, engage securely with the user’s ear;b. at least one attachment formation attached to the flexible body , the attachment formation being adapted for holding the nasoenteric feeding tube to the ear of the user, in use.

[0096] In one embodiment, the body is flexible.

[0097] In one embodiment, the body is resiliently flexible.

[0098] In one embodiment, the body is plastically deformable.

[0099] In one embodiment, the flexible body is adapted to extend around the back of the user’s ear.

[0100] In one embodiment, the flexible body includes a hook formation adapted to engage with a part of the user’s ear.

[0101] In one embodiment, the flexible body includes a loop formation adapted to loop around the user’s ear.

[0102] In one embodiment, the nasoenteric tube securement device includes an engagement formation configured for closing the loop.

[0103] In one embodiment, one or more selected from the hook formation and the loop formation is configured for securely engaging with a part of the user’s ear selected from the group consisting ofa. an intertragic notch;b. helix,c. anti-helix, andd. tragus.

[0104] In one embodiment, the flexible body extends from a first end located adjacent the lobe of the ear, and use, to a second end located behind the superior part of the helix of the user’s ear, in use.

[0105] In one embodiment, the flexible body may comprise a first bend located behind the superior part of the helix, in use.

[0106] In one embodiment, the flexible body may comprise a first bend located adjacent the lobe of the ear, in use.

[0107] In one embodiment, the at least one attachment formation may be located at the second end of the body.

[0108] In one embodiment, the at least one other attachment formation may be located at the first bend of the body.

[0109] In one embodiment, the at least one attachment formation may comprise a circlip.

[0110] In one embodiment, a coating or cover of a medical grade polymer may be provided on the body.

[0111] In one embodiment, a silicone cover or coating may be provided on the body.

[0112] In one embodiment, the flexible body may define a slot for receiving the nasoenteric feeding tube.

[0113] In yet another aspect of the present invention, there is provided a nasoenteric tube securement device for connecting a nasoenteric feeding tube to an ear of theuser,a. a body extending from a first end to a second end and adapted, in use, to form a loop around the ear;b. at least one attachment formation provided on the body, the attachment formation adapted to, in use, engage with the nasoenteric feeding tube.

[0114] In one embodiment, the nasoenteric tube securement device includes an engagement formation located at one end of the flexible body for engaging with a portion of the flexible body to close the loop, in use.

[0115] In one embodiment, the body is flexible.

[0116] In one embodiment, the body is resiliently flexible.

[0117] In one embodiment, the body is plastically deformable.

[0118] In one embodiment, the engagement formation may be adapted to engage a portion of the flexible body adjacent an inferior portion of the ear, in use.

[0119] In one embodiment, at least one attachment formation may be located adjacent the lobe of the ear and adapted to engage the nasoenteric feeding tube adjacent a cheek of the user.

[0120] In one embodiment, the at least one attachment formation may be provided adjacent the top of the ear, in use.

[0121] In one embodiment, the at least one attachment formation may be a circlip.

[0122] In one embodiment, the engagement formation may be formed of the wire.

[0123] In one embodiment, the engagement formation may comprise a loop.

[0124] In one embodiment, a fit of the body on the ear can be varied by changing the position at which the engagement formation engages with the flexible body.

[0125] In one embodiment, the body may be made of a flexible wire coated with a medical grade polymer.

[0126] In one embodiment, the body may be made of a flexible wire coated with silicone.

[0127] In one embodiment, the nasoenteric tube securement device may be of unitary construction.

[0128] To those skilled in the art to which the invention relates, many changes in construction and widely differing embodiments and applications of the invention will suggest themselves without departing from the scope of the invention as defined in the appended claims. The disclosures and the descriptions herein are purely illustrative and are notintended to be in any sense limiting.

[0129] Other aspects of the invention are also disclosed.Brief Description of the Drawings

[0130] Notwithstanding any other forms which may fall within the scope of the present invention, a preferred embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0131] Figure 1 shows a side view of a user wearing an embodiment of a nasoenteric tube securement device for attachment to the nose;

[0132] Figure 2 shows a side view of the embodiment of Figure 1 ;

[0133] Figure 3 shows a front view of another embodiment of a nasoenteric tube securement device ;

[0134] Figures 4A and 4B show a front and side view of another embodiment of a nasoenteric tube securement device for attachment to the user’s nose, including a body in 4A and a bottom view of an attachment formation in 4B for attachment to the body of 4A;

[0135] Figure 5 shows a front view yet another embodiment of a nasoenteric tube securement device for attachment around the nasal septum of a user;

[0136] Figure 6 shows a front view of another embodiment of a nasoenteric tube securement device for attachment around the nasal septum of a user;

[0137] Figure 7 shows a perspective view of another embodiment of a nasoenteric tube securement device for attachment around the nasal septum of a user;

[0138] Figure 8 shows a front view of yet another embodiment of a nasoenteric tube securement device for attachment around the nasal septum of a user ;

[0139] Figure 9A shows a side view of another embodiment of the nasoenteric tube securement device for attachment to the ear on a user;

[0140] Figure 9B shows a side view of the embodiment of a nasoenteric tube securement device depicted in Figure 9A;

[0141] Figure 10A shows a side view of another embodiment of the nasoenteric tube securement device for attachment to the ear on a user;

[0142] Figure 10B shows a side view of the embodiment depicted in Figure 10A;

[0143] Figure 11 shows a side view of another embodiment of a nasoenteric tube securement device for attachment to the ear;

[0144] Figures 12Ato 12Cshow views from different sides of another embodiment of a nasoenteric tube securement device for attachment to the ear on a user when worn by a user;

[0145] Figure 12D shows a side view of the nasoenteric tube securement device of figures 12A-C;

[0146] Figures 13A shows a side view of another embodiment of a nasoenteric tube securement device for attachment to the ear on a user when worn by a user;

[0147] Figure 13B shows a side view of the nasoenteric tube securement device of figure 13A;

[0148] Figure 14A shows a front view of a further embodiment of a nasoenteric tube securement device attached to a user’s ear;

[0149] Figure 14B shows a front view of a nasoenteric tube securement device similar to the nasoenteric tube securement device of 14A, but mirrored for the other side of the user’s head;

[0150] Figure 14C shows a side view of another embodiment of a nasoenteric tube securement device attached to a user’s nose;

[0151] Figure 14D shows a front view of the embodiments shown in figure 14C;

[0152] Figure 15A shows a side view of another embodiment of a nasoenteric tube securement device attached to a user’s ear;

[0153] Figures 15B and 15C show opposed side views of the nasoenteric tube securement device of figure 15A ;

[0154] Figure 16A shows a right rear perspective view of another embodiment of a nasoenteric tube securement device attached to a user’s ear with a nasoenteric feeding tube attached;

[0155] Figure 16B shows a right rear perspective view of the nasoenteric tube securement device of figure 16A without the nasoenteric feeding tube attached;

[0156] Figure 16C shows a front view of the nasoenteric tube securement device of figure 16 A without a nasoenteric feeding tube attached;

[0157] Figure 16D shows front view of the nasoenteric tube securement device of figure 16A;

[0158] Figure 16E shows a left side view of the nasoenteric tube securement device of figure 16A;

[0159] Figure 16F shows a top left perspective view of the nasoenteric tube securement device of figure 16A;

[0160] Figure 17Ashows a rear view of a further embodiment of a nasoenteric tube securement device attached to a user’s ear with a nasoenteric feeding tube attached;

[0161] Figure 17B shows a side view of a mirrored copy of the nasoenteric tube securement device of figure 17 A attached to a user’s ear with a nasoenteric feeding tube attached;

[0162] Figures 18A shows a right side view of a further embodiment of a nasoenteric tube securement device attached to a user’s ear with a nasoenteric feeding tube attached;

[0163] Figure 18B shows a rear view of the embodiment of a nasoenteric tube securement device shown in figure 18 A;

[0164] Figures 19A and 19B show a rear right view of a further embodiment of a nasoenteric tube securement device attached to it uses ear, with and without the nasoenteric feeding tube attached;

[0165] Figures 19C shows a left side view of the nasoenteric tube securement device of figure 19A with a nasoenteric feeding tube attached;

[0166] Figure 19D shows a top right perspective view of the nasoenteric tube securement device of figure 19C with a nasoenteric feeding tube attached;

[0167] Figure 20A shows a rear view of the nasoenteric tube securement device of figure 19C on a user’s ear with a nasoenteric feeding tube attached;

[0168] Figure 20B shows a top right perspective view of the nasoenteric tube securement device of figure 19C with a nasoenteric feeding tube attached;

[0169] Figure 20 C shows a top left perspective view of the nasoenteric tube securement device of figure 19C with a nasoenteric feeding tube attached;

[0170] Figures 21A and 21 B shows a left side view and a front left perspective view of the nasoenteric tube securement device of figure 19C with a nasoenteric feeding tube attached;

[0171] Figures 22Ashows a side view of another embodiment of a nasoenteric tube securement device attached to a user with a nasoenteric feeding tube attached;

[0172] Figure 22B shows a top left perspective view of the nasoenteric tube securement device of figure 22Awith a nasoenteric feeding tube attached;

[0173] Figure 22C shows a close-up view of the nasoenteric tube securement device of figure 22A showing a nasoenteric feeding tube received within a slot;

[0174] Figure 23A shows a top left perspective view of a further embodiment of anasoenteric tube securement device;

[0175] Figure 23B shows a close-up rear view of a nasoenteric feeding tube being received within a slot on the body;

[0176] Figures 24A to 24B show a front view and a left side view of a further embodiment of a nasoenteric tube securement device attached to both of the users ears, illustrating how it can be used with alternative nose clipping arrangement ;

[0177] Figure 25 shows a close-up front view of a further embodiment of a nasoenteric tube securement device including an nose clipping arrangement with webbed baskets as attachment formations;;

[0178] Figure 26A - 26B shows a rear left perspective view and a front left perspective view of the nasoenteric tube securement device of figure 20A;

[0179] Figure 26C shows a top view of the nasoenteric tube securement device of figure 20A without the nose clipping arrangement and attachment formation;

[0180] Figure 27 shows a top right front perspective view of the nasoenteric tube securement device of figure 20A with a nasoenteric feeding tube attached;

[0181] Figure 28 shows a top left front perspective view of a the nasoenteric tube securement device of figure 20 A without the nose clipping arrangement and attachment formation;

[0182] Figures 29A shows a front perspective view of a nasoenteric tube securement device including an nose clipping arrangement and an attachment formation that can be attached using a dovetailed connecting formation;

[0183] Figure 29B shows the same front perspective view of the nasoenteric tube securement device of figure 29A with 1 of the arms cut away

[0184] Figure 29C show a bottom front perspective views of the nasoenteric tube securement device of figure 20 9A including a nose clamping arrangement and an attachment formation that can be attached using a dovetailed connecting formation ;

[0185] Figures 30A to 30B show front views and cutaway front views, respectively, of a further embodiment of a nasoenteric tube securement device with a barbed connecting arrangement for connecting the attachment formation ;.

[0186] Figure 31 A shows a top front right perspective view of a further embodiment of a nasoenteric tube securement device;

[0187] Figures 31 B and 31 C show front right perspective views of the nasoenteric tube securement device of figure 30 1A located on a user;

[0188] Figure 32A shows a left side view of a further embodiment of a nasoenteric tube securement device located on a user with a nasoenteric feeding tube attached;

[0189] Figure 32B-D shows a front, bottom front exploded, front right perspective, and front view, respectively, of the nasoenteric tube securement device of figure 32A with a nasoenteric feeding tube attached;

[0190] Figure 33A and 33B shows a left front perspective view and bottom rear perspective view of a further embodiment of a nasoenteric tube securement device, with a nasoenteric feeding tube attached;

[0191] Figure 34A shows a hidden detail front view of a further embodiment of a nasoenteric tube securement device using an inverse mushroom / dome connecting arrangement between the body and the attachment formation;

[0192] Figure 34B shows a bottom front perspective view of the nasoenteric tube securement device of figure 34A with a nasoenteric feeding tube attached;

[0193] Figure 34C shows a bottom left front cutaway perspective view of a further embodiment of a nasoenteric tube securement device using a dovetail connecting arrangement between the

[0194] Figure 34D shows a hidden detail front view of the nasoenteric tube securement device of figure 34C;

[0195] Figure 35A shows a front right perspective view of a further embodiment of a nasoenteric tube securement device on a user’s face, with the nasoenteric feeding tube attached;

[0196] Figure 35B shows a front right bottom perspective view of another embodiment of a nasoenteric tube securement device with a nasoenteric feeding tube attached;

[0197] Figure 35C shows a bottom left front perspective view of another embodiment of a nasoenteric tube securement device with a clamping arrangement including curved arms;

[0198] Figure 36A-C shows a front left view, front right hidden detail view, and top front left view, respectively of a further embodiment of a nasoenteric tube securement device in place on a user’s face, with figure 36A including a nasoenteric feeding tube;

[0199] Figures 37A - 37B shows a bottom front right perspective view and a top front right perspective view showing hidden detail of a further embodiment of a nasoenteric tube securement device attached to a user’s nose, including nasoenteric feeding tubes;

[0200] Figure 37C shows a front view of a nasoenteric tube securement device of figure 37A, with nasoenteric feeding tube attached;

[0201] Figure 37D shows a front view of a further embodiment of a nasoenteric tube securement device attached to a pair of nasoenteric feeding tubes;

[0202] Figure 38A and 38B shows a front view and a front right perspective view of the nasoenteric tube securement device of figure 37D, attached to a pair of nasoenteric feeding tubes;

[0203] Figure 39A shows a front right perspective view of another embodiment of a nasoenteric tube securement device attached to a user’s nose, further attached to a nasoenteric feeding tube;

[0204] Figure 39B shows a front right perspective view of the nasoenteric tube securement device of figure 39A, attached to a nasoenteric feeding tube;

[0205] Figure 40A and 40B shows bottom front wireframe views of the nasoenteric tube securement device of figure 39A;

[0206] Figure 41 A and 41 B shows a front view of another embodiment of a nasoenteric tube securement device with a pair of webbed baskets attached as attachment formations, attached to a user’s nose with nasoenteric feeding tubes attached;

[0207] Figures 41 C - 41 E show front views of the nasoenteric tube securement device of figure 41 A that includes a basket mount;

[0208] Figure 42A - 42C shows a top left perspective view, a left front perspective view, and a right front perspective view of another embodiment of a nasoenteric tube securement device using a basket mount, respectively, attached to a nasoenteric feeding tube;

[0209] Figure 42D shows a top front perspective view of the nasoenteric tube securement device of figure 42A-C, without a nasoenteric feeding tube;

[0210] Figure 43A - 43C shows various perspective views of another embodiment of a nasoenteric tube securement device using basket mounts, with and without a nasoenteric feeding tube;

[0211] Figure 44 shows a top front left perspective view of another embodiment of a nasoenteric tube securement device including a sensor arrangement; and

[0212] Figure 45 shows a bottom front right view of another embodiment of a nasoenteric tube securement device including an indicator formation.Description of Embodiments

[0213] A nasal tube holder or nasoenteric tube securement device according to a first aspect of the invention is generally indicated by the numeral 100 or a multiple thereof and isshown in Figures 1 and 2.

[0214] One embodiment of a nasoenteric tube securement device 100 is shown in Figure 2. The nasoenteric tube securement device comprises a securing formation in the form of a body 110. The body 110 includes a base 105 and two arms 111, 113 extending from the base 105. The arms 111, 113 define two opposed ends 112, 114. The ends 111, 113 act as jaws of a clamping arrangement. The arms 111 , 113 are preferably composed of a resiliency flexible material, such as plastic, rubber, or the like. When the arms 111, 130 and are pushed apart, then the resilience of the material will cause the ends 111, 113 to move back into their original position under bias of the resilient material, thereby clamping an item as a part of a user’s nose between the ends. In this way the ends 112, 114 are biased relative to each other and together provide a clamping formation adapted to secure the body, in use, around a part of the nose or ear of a user. An attachment formation 120 is provided on the body, the attachment formation 120 adapted, in use, for securely, and preferably removably, holding a nasoenteric feeding tube 10.

[0215] In figure 1, the body is adapted to be secured around a part of the nose of the user. In Figure 1, the part of the nose being an ala. In other embodiments the part of the nose can be a nasal septum or a columella. In other embodiments, it is envisaged that the body may be secured around a part or parts of the ear of the user. The parts can include a helix, lobule, anti-helix, concha or tragus.

[0216] In Figure 2, the body 110 is substantially u-shaped and comprises a pair of arms 111, 113 that define two opposed ends 111, 113. The embodiment in Figure 1 is also substantially J shaped as the body comprises a first arm 111 with a first end 112 and a second arm 113 with a second end 114, the first arm 111 being longer than the second arm 113 and adapted to extend up to and engage with the alar crease on the outside of the nose, in use as shown in Figure 1.

[0217] In embodiment shown in figures 1, 2 and 3 a disk-shaped skin-engaging portion 115 is provided at the first end of the first arm 112. In other embodiments, a disk-shaped skinengaging portion is provided at each of the two opposing ends.

[0218] The disk-shaped skin-engaging portion 115 comprises a cushioning material for comfort. The cushioning material is preferably a medical grade polymeric material. The cushioning material may be breathable. The cushioning material can be silicone.

[0219] The attachment formation 120 can be permanently attached to the body or can be removably attachable to the body.

[0220] In the illustrated embodiment in Figure 2, the attachment formation 120 is a sleeve which is adapted to encircle and grip the tube to prevent it from moving relative to the holder.The sleeve preferably has a slit opening (not shown) extending along the length of the sleeve and is preferably made of a resiliently flexible material to allow a nasoenteric feeding tube to be introduced through the slit opening. The nasoenteric feeding tube 10 is pressed into the slit opening and is gripped and retained within the sleeve due to the resiliently flexible material.

[0221] In Figure 3 the attachment formation 220 is a curved resilient formation or circlip that is permanently attached to the body. In this embodiment, the tube can be pushed into an opening of the circlip to be secured within the circlip.

[0222] In the embodiment shown in figures 4A and 4B, the attachment formation 320 is removably attachable to the body 310 of the nasoenteric tube securement device by a. The attachment formation 320 is removably attachable to the body via a tongue and groove arrangement, wherein a tongue 330 is provided on the body and a corresponding groove (not shown) is provided on the attachment formation 320.

[0223] In another embodiment (not shown) where the attachment formation is removably attachable to the body via a tongue and groove arrangement, a tongue can be provided on the attachment formation and a corresponding groove can be provided on the body.

[0224] It will be apparent to persons skilled in the art that securing formation may be connected to the attachment formation by a wide variety of connecting arrangement, including tongue and groove connecting arrangement, dovetails style connecting arrangements, screw in type connecting arrangements, clipping connecting arrangement, and the like.

[0225] In other embodiments the attachment formation can comprise any type of suitable fastener for fastening the attachment formation around a nasoenteric feeding tube 10. In figure 4B, the fastener is a twist type fastener. The attachment formation 320 is shown in an open configuration on the left hand side and in a closed configuration on the right hand side. In other embodiments, the fastener can be a snap fit or click type fastener in which two ends engage with each other when pushed towards each other to form a closure.

[0226] It is envisaged that the attachment formation may be positioned by the securing formation within a nostril of the user, or outside the nostril of the user.

[0227] It is further envisaged that the securing formation need not necessarily be resiliently flexible, and can be plastically flexible (for example constructed from a bendable metal, and covered with a suitably hygienic layer), and wherein the securing formation is deformable to clamp against a part of the user’s nose and / or ear.

[0228] Figure 5 shows another embodiment of the nasoenteric tube securement device 400. In this embodiment, the body is substantially U-shaped to fit around a columella and grip anasal septum of the user. Each end 412, 414, of arms 411, 413 preferably includes a diskshaped skin-engaging portion with has cushioning material.

[0229] In this illustrated embodiment of figure 5, the attachment formation 420 is a curved resilient formation or circlip which is adapted and dimensioned so that a nasoenteric feeding tube can be clipped into it.

[0230] Figure 6 shows another example of the nasoenteric tube securement device. In this embodiment, there are prongs 518, 519 extending from each end of the U-shaped body 510 of the nasoenteric tube securement device 500. The prongs press outwardly to abut the inner walls of the nostrils and so, provide comfort and stability, to thereby retain the securing formation within the users nostril in use. In this embodiment, a pair of attachment formations 520 provided for two nasoenteric feeding tubes. These may be permanently attached to the prongs. In alternative embodiment, the attachment formations to be attached to the body 510.

[0231] Figure 7 shows an embodiment of the nasoenteric tube securement device 600 including magnets located in each end 611,613 and in which the attachment formation 620 is removably attachable to the body 610.

[0232] Each end 611, 613 includes a magnet 616, 617 which attract each other to bias the two ends 611, 613 into a clamping formation adapted to secure the body 610 around a part of the user’s nose. The attraction between magnets 616, 617 may at least partially serve to bias the two ends towards each other, causing it to clamp around a part of the user’s nose as a clamping formation. . It is envisaged that magnets can similarly be included in the ends or any part of the body of any other embodiment such as to secure the body around the ear. In other embodiments not including magnets, the ends are biased towards each other due to the resilient flexibility of the material they are made of.

[0233] It is further envisaged that in alternative embodiments (not shown) the body can comprise a pair of jaws that are biased to other by a spring biasing mechanism

[0234] In Figure 7, the body 610 comprises a tongue 630 and the attachment formation in the form of sleeve 620 comprises a groove 640 which corresponds to the tongue 630. The tongue 630 can therefore, be inserted into and retained within the groove 640. The tongue 630 may be retained within the groove 640 by friction.

[0235] A nasoenteric feeding tube 10 can be inserted onto the sleeve 620 in a number of ways. There can be an opening through the side of the sleeve or the tube can be inserted through an opening at and end of the sleeve.

[0236] Figure 8 shows another embodiment of a nasoenteric tube securement device 700 which can be secured around the nasal septum / columella. In this embodiment, thenasoenteric tube securement device further includes webbed baskets 750 which are in a cone shape attached to each arm of the body 710 of the nasoenteric tube securement device. The webbed baskets 750 are adapted to be in contact with and fit around the attachment formation 720 which is a cuff or short tube in this embodiment. Hence, in use, the nasoenteric feeding tube 10 extends through the attachment formation 720 and basket 750. The baskets 750 provide extra grip / friction for retaining the attachment formation 720 in position on the body 710 of the nasoenteric tube securement device 700. The webbed baskets 750 may be removably attachable to the attachment formation 720. The webbed baskets 750 may be integrated with the attachment formation 720. In this embodiment, the attachment formation is removably attachable to the body 710 of the nasoenteric tube securement device 700.

[0237] It is preferable if the attachment formation of any of the embodiments is removably attachable to the nasoenteric feeding tube while the securing formation is in place connected to the user.

[0238] In another embodiment shown in Figures 9A and 9B there is provided a nasoenteric tube securement device 800 comprising a flexible body 810 adapted to, in use, to bend and extend around a back of the users ear 2, the flexible body 810 extending from a first end 811 to a second end 813. The second end 813 comprises a hook formation 814 adapted to engage with a part of the ear, in use. The nasoenteric tube securement device 800 further comprises at least one attachment formation 820 attached to the wire, the attachment formation 820 adapted for holding the nasoenteric feeding tube 10 at the ear 2 of the user, in use. In the embodiments shown, the attachment formation is a curved clipping formation into which the nasoenteric feeding tube 10 can be clipped.

[0239] The flexible body 810 can be made of a malleable, plastically deformable, formable or bendable material which can be formed closely around the ear 2 of the user as shown in figure 9. For example, the flexible body 810 can be made of a wire bent into shape to suit the particular user’s anatomy. For example the wire can be coated or surrounded with a plastic material or silicone for comfort. In other embodiments it can be made of a suitable polymer or metal.

[0240] In the embodiment of figures 9A and 9B, the body 810 is a wireform and extends from adjacent the cheek to around the ear 2 of the user. In particular, the wireform extends upwardly towards and around the apex of the ear 2 near the helix, then downwardly around the back of ear 2 and under the ear 2. The flexible body 810 extends from a first end 811 adjacent the cheek, around the top of the ear 813 through the space between the helix and the user scalp, and around the rear of the ear to a second end 813, in use.

[0241] A hook formation 814 is provided at the second end of the ear 813. In thisembodiment, the hook formation 814 extends into and engages with the intertragic notch of the ear 2 to hold the body 810 in place.

[0242] Two attachment formations 820 are provided along the flexible body. The first attachment formation 820A is located near the first end 811 adjacent the cheek of the user. The second attachment formation 820B is located near the superior part of the helix. In this embodiment the flexible body comprises a first bend 812 located adjacent and behind the superior part of the helix.

[0243] In any embodiments there can be one or more than two attachment formations provided along the body or securing formation.

[0244] The attachment formation 820A, 820B can be a circlip or a sleeve made of resiliency flexible material. The circlip or sleeve can have a slit opening which can be pried open to allow the nasoenteric feeding tube in and which resiliently flexes back into its original size once released. For example, the nasoenteric feeding tube coming out of a nostril of the user can be pushed through the opening in the circlip or sleeve to secure the nasoenteric feeding tube within the attachment formation.

[0245] In other embodiments the attachment formation can be any type of suitable fastener which engages with and attaches the nasoenteric feeding tube to the holder. Any of the attachment formation shown in the embodiments can be used with any other of the securing formations shown.

[0246] Figures 10A and 10B show another embodiment of the nasoenteric tube securement device 900 which engages with the ear 2 of the user. In this embodiment, the flexible body 910 extends from adjacent the cheek of the user to under the ear, then under that unit in the gap between the lobule and scalp, and upwardly behind the ear to extend through the gap between the helix and the users scalp and over and around the top of the ear. The flexible body 910 extends from a first end 911 adjacent the cheek to a second end 913 near the top of the ear, in use. There is a hook formation 914 provided at the top of the ear at the second end 913 of the body 910. Preferably the flexible body 910 is composed of a wire that may be bent into a hook formation 914 at the second end. The hook formation 914 engages with the antihelix of the ear near the top of the ear to secure the body 910 in place.

[0247] The flexible body 910 comprises a first bend 917 located adjacent the lobe of the ear, in use.

[0248] In the embodiment shown in figures 10A and 10B, two attachment formations 920A, 920B are provided on the body 910. A first attachment formation 920A is provided near the first end of the flexible body 911 at the cheek of the user and the second attachment formation 920B is provided at the lobe of the ear.

[0249] In this embodiment the nasoenteric feeding tube 10 extends past the bottom of the ear towards behind the head.

[0250] In the embodiment shown in figure 11, the nasoenteric tube securement device comprises two attachment formations. Each attachment formation is curved clipping formation or circlip. In this embodiment, a first circlip 1020A is located at the first end of the body. A second circlip 1020B is located at the top of the ear adjacent the hook formation.

[0251] Figures 12A, 12B, 12C and 12D illustrate another embodiment of the nasoenteric tube securement device 1100 comprising a securing formation in the form of a body 1110 which extends around the ear 2. In this embodiment the body 1110 extends across the cheek and above the top of the ear, continues behind the ear and then ends below the ear.

[0252] In this embodiment the nasoenteric tube securement device 1100 comprises a silicone cover. Advantageously the silicone cover makes it comfortable for the user to wear the nasoenteric tube securement device 1100 for extended periods of time.

[0253] In this embodiment the body 1110 is substantially hollow. The body 1110 is hollow at the first end and is continuously hollow until the hook formation at the second end of the body. The hollow tubular body 1110 is adapted to define an internal channel (not shown) which is sized to receive or fit the nasoenteric feeding tube 10. Hence, in use, the nasoenteric feeding tube 10 extends into the body at the first end approximately users cheek and continues within the body until an exit point 1116 of the tube located behind the ear at a lower portion of the ear. In this embodiment, the rest of the nasoenteric feeding tube 10 which exits the body 1110 extends to behind a neck of the user.

[0254] In another embodiment, for example as shown in figure 27, the body may include a groove running along the side of the body which is adapted to fit the nasoenteric feeding tube. The nasoenteric feeding tube can then be pressed into the side of the body and retained within the groove.

[0255] In the embodiment illustrated in figures 12C and 12D, the body 1110 comprises two hook formations 1114, 1115. The first hook formation 1114 is located at the top of the ear and extends into the fossa of the antihelix. The second hook formation 1115 is located at the bottom of the ear and extends into and engages with the intertragic notch of the ear.

[0256] Advantageously in this embodiment the body fits well around the ear and is retained better on the ear.

[0257] In other embodiments (not shown), there may be more than two hook formations. The one or more extra hook formations can engage with the side of the ear or with other parts of the ear such as the helix, anti-helix and tragus.

[0258] Figures 13A and 13B illustrate an embodiment of the nasoenteric tube securement device in which the fit of the holder around the ear is adjustable. The advantage of this is that the same holder can be used on a variety of ear shapes and sizes and the fit can be varied according to patient comfort.

[0259] The nasoenteric tube securement device 1200 comprises a flexible body 1210 extending from a first end 1211 to a second end 1213 and adapted, in use, to form a loop around the ear. The nasoenteric tube securement device comprises an engagement formation 1230 located at one end of the flexible body 1210 for engaging with another portion of the flexible body 1210 to close the loop, in use. The nasoenteric tube securement device also comprises an attachment formation 1220 provided on the body 1210, the attachment formation 1220 adapted to, in use, engage with the nasoenteric feeding tube 10.

[0260] The nasoenteric tube securement device body 1210 comprises a tube insert portion 1240 adjacent the cheek of the user which provides a guide to the nasoenteric feeding tube 10. There is an exit aperture 1218 provided in the body 1210 of the nasoenteric tube securement device located behind the ear for the tube to exit the tube insert portion 1240. The tube insert portion 1240 comprises a silicone sleeve for comfort of the user.

[0261] In this embodiment the body 1210 extends from a first end 1211 adjacent the cheek of the user, under the ear then extends upwardly behind the ear, loops around the top of the ear and then extends in front of the ear to the second end 1213. The engagement formation 1230 is provided at the second end of the body and engages with the body 1210 to form a looping arrangement around the ear. The loop can be made of the same material as the body. In this embodiment, the body includes a malleable wire and so the looping arrangement is formed from a the wire. The looping arrangement is engaged with and encircles a portion of the tube insert portion.

[0262] In this embodiment, one or more attachment formations 1220 A &B may be provided on the wire to help hold and guide the nasoenteric feeding tube.

[0263] In the illustrated embodiment, the nasoenteric tube securement device 1200 comprises two attachment formations which are resilient curved clips or circlips to hold the nasoenteric feeding tube in place. The first circlip 1220A is provided behind the ear and the second circlip 1220B is provided at the top of the ear when the nasoenteric tube securement device body is worn.

[0264] To tighten the nasoenteric tube securement device 1200, the user can slide the loop 1240 backwards towards the ear. To loosen the nasoenteric tube securement device 1200, the user can slide the loop 1240 forwards away from the ear. Once loosened, the looping arrangement can be removed from around the ear.

[0265] In other embodiments (not shown), the tube insert portion is not provided but a simple coated, covered or insulated wire is provided instead.

[0266] In some embodiments the device can be manufactured in one piece i.e. the nasoenteric tube securement device is of unitary construction. In some embodiments, the nasoenteric tube securement device may be moulded, for example using injection moulding, blow moulding, rotary moulding, or the like. However, where there are silicone or plastic coatings or coverings or portions, there may be a secondary manufacturing process to add these components to a base body component. The secondary manufacturing process may include overmoulding. In an example the body of the nasoenteric tube securement device comprises an inner or outer portion that is harder than cushioning material. For example, this harder portion of the body can be moulded or drawn (if it is composed of a malleable wire). Cushioning material can then be overmoulded over the harder material.

[0267] Referring to figures 14 to 40, the nasoenteric tube securement device is fabricated from medical grade hypoallergenic silicone to securely fasten the enteral feeding tube to a patient’s face.

[0268] The nasoenteric tube securement device 1300 as shown in figures 14A-D can comprise a combination of a first body 1310a providing a clamping formation adapted to remain securely within the nasal cavity and a second body 1310b distal to the first body adapted to secure the second body 1310b, in use, around a part of a patient’s ear. As shown, each of the first body 1310a and second body 1310b adaptations include attachment formations 1320 a and b to receive and secure the nasal feeding tube.

[0269] The first body1310a is adapted for use in the nasal cavity and ensures the nasoenteric feeding tube is securely supported within or adjacent to the nasal cavity, reducing the risk of secondary infection and dislodgement. In addition, the second body adapted for securing to the patient’s ear, improves comfort and provides a secure fit with a textured, flat bottom surface that includes a coating layer 1340b that is preferably composed of a tacky silicone which creates an adhesive-like effect without causing patient discomfort or harm to the skin barrier. Preferably the layer is hypoallergenic, and sits flat against the face of the user.

[0270] Another embodiment of a nasoenteric tube securement device 1400 is shown in figures 15A and 15B. In this embodiment, the nasoenteric tube securement device 1400 includes an ear mounting part and a face attachment part. The face attachment part at least has a textured flat surface which in use sits against the patient’s face between the ear and nose. The flat surface includes a sticky hypoallergenic coating layer 1440 which rests and remains against the patient’s face. The ear mounting part of the second body is shown in position in Figure 15A and at least a part of the ear mounting part supports the faceattachment part. The body 1410 is shown having a plurality of spaced attachment formations 1420 for securing the nasal feeding tube between the ear and the nasal cavity. Various different embodiments of a nasoenteric tube securement device are shown in figures 16 to 24. Some of these include multiple anchor points configured to improve comfort of a wearer and evenly distribute weight and ensuring secure mounting during feeding. Preferably these anchor points have been strategically placed to enhance comfort, evenly distribute weight, and ensure a high grade of security of attachment.

[0037] Figures 16A - 16D show an embodiment that includes a rigid support portion 1650 of the body 1610 that is adapted for holding the tube weight, while still being malleable, while an ear engaging portion 1660 of the body 1610 that extends around the ear that may be composed of a soft foam or silicon to avoid pressure points and sores on the ear.

[0271] The inclusion of a second body adapted to secure the ear of a patient has shown to alleviate tension and pulling pressure associated with intestinal spasms reducing pressure and friction within the nasal and sinus cavities.

[0272] In another embodiment of a nasoenteric tube securement device 2000 shown in figure 22A, 22B, 22C and 23A-23B, a nasal feeding tube is enclosed within a receiving slot or slit 2070 the ear mounting part of the second body to further improve feeding tube stabilisation.

[0273] It is envisaged that any of the features shown in any of the embodiments shown can be used together with features in any of the other embodiments, and that any of the embodiments of a nasoenteric tube securement device can be used together with other embodiments.

[0274] For example, in figure 24A and Band 26 A- C another embodiment of a nasoenteric tube securement device 2100 is shown. In this embodiment, the nasoenteric tube securement device includes the engaging portions that extend around the rear of the user’s head to engage with both of the users ears. In this way, a very stable support for the nasoenteric feeding tube is provided.

[0275] Further, envisaged that the nasoenteric tube securement device 2100 will be combined with a nasoenteric tube securement device for engagement with a user’s nose as described with reference to figure 8, or with a nasoenteric feeding tube for engagement with a user’s nose as described with reference to figure 3, or both. Such an embodiment may be suited for patients with a high risk of tube displacement.

[0276] If two nasoenteric tube securement devices provided for engagement with a user’s nose is shown in figure 25, this will also provide dual nasal anchoring support for patients disposed to high risk of tube displacement. The dual nasal anchoring support is provided by nasoenteric tube securement device 700 as described with reference to figure 8, withadjustable baskets 750 disposed on either side of body 710. Each basket is adapted to receive a feeding tube therethrough. Another nasoenteric tube securement device 200 similar to that described with reference to figure 3 is provided for clamping to the user’s ala . The external clip can include a quick release nasoenteric feeding tube attachment mechanism such as a curved clip for circlip, so that the nasoenteric feeding tube can be readily detached.

[0277] The nasoenteric feeding tube 2200 holder shown in Figure 25 incorporates a 4-point securement mechanism encircling the head, along with 3 ear anchor points, and a single continuous band encircling the back of the head. The feeding or nasoenteric feeding tube is firmly held within the attachment utilising the method of figures 22A and 22B. The attachment arm extends to the outer edge of the nose, where it gradually tapers off and is anchored / secured to the nose by a nasoenteric tube securement device 700 similar to that shown in figure 8. For added security against tube displacement, improved patient comfort, enhanced airflow, and reduced risk of secondary infection, the additional use of the 4-point securement method of figure 25 can be integrated to further stabilise the device.

[0278] The embodiment of a nasoenteric tube securement device 2300 shown in Figure 27 and 28 shows a similar dual ear engaging body 2310 combined with a nasoenteric tube securement device 200 shown in figure 3.

[0279] Figure 29A - C show an embodiment of a nasoenteric tube securement device 2400 that includes a flat base 2405 for increased comfort by the user. The attachment formation 2420 is connected to the securing formation or body 2410 by a dovetail style connecting arrangement 2480.

[0280] Figures 30A and 30 B show another embodiment of a nasoenteric tube securement device 2500, wherein the attachment formation 2520 is connected to the body 2510 by a barbed connecting arrangement 2580 that prevents the removal of the attachment formation 2520 from the body 2510.

[0281] Figures 31A - 31C shows another embodiment of a nasoenteric tube securement device 2600 with a J shaped body and a detachable tube clip or attachment formation.

[0282] Figures 32A - 32E show another embodiment of a nasoenteric tube securement device 2700, wherein the attachment formation 2720 is removably attachable from the securing formation or body 2710 by a snap fit type connecting arrangement 2780, whereby a projection is received within a recess in a snap fit fashion. Conveniently, the attachment formation 2720 is removed by pulling downwardly on the attachment formation 2720 while holding the body 2710, in the same direction for pulling the nasoenteric feeding tube 10 out of the patient.

[0283] Figures 33 A - 33 B show another embodiment of a nasoenteric tube securement device 2800, with a silicon padding lining 2840 with a textured surface to enhance grip. Figures 34A - 34B show a further embodiment of a nasoenteric tube securement device 2900, including an inverse dome connecting arrangement 2980.

[0284] Figures 34C - 34D show another embodiment of a nasoenteric tube securement device 3000 including a tongue and groove type connecting arrangement 3080.

[0285] Figures 35A - 35B shows another embodiment of a nasoenteric tube securement device 3100 with a rounded base.

[0286] Figure 35C shows another embodiment of a nasoenteric tube securement device 3200 with curved arms 3211, 3213 for conforming to the natural curvature of the nasal passage, and a flat base 3205.

[0287] Figure 36A - 36C shows another embodiment of a nasoenteric tube securement device 2400 in use, the nasoenteric tube securement device 2400 being similar to that shown in figure 29.

[0288] The nasoenteric tube securement devices 3300, 3400 shown in figures 37A to 37D and 38A-38B includes a pair of wings 3385, 3485 integrated with the first body forming a substantially symmetric configuration about an axis extending between the ends of the body. This embodiment is adapted for simultaneous retention of multiple nasoenteric feeding tubes (for example nasojejunal and nasogastric). The wings are angled in an opposed direction to the direction of extension of the arms 3311, 3411 and 3313, 3413, and include attachments for receiving and attaching to a nasal feeding tube for each nostril. This arrangement is generally intended for situations where patients need a nasojejunal tube for nutrition or medication and a nasogastric tube for suctioning.

[0289] Figures 39A - 39B and 40A - 40B show the nasoenteric tube securement device 2700 similar to that shown in figures 32A - 32E. As shown in figures 40A, 40B and 41, the nasal body can include recesses or ports therewithin for removably receiving attachment formations or baskets.

[0290] Figures 41 A - 41 E show another embodiment of a nasoenteric tube securement device 3500 including a U-shaped body 3510 with a rounded base 3505 , and with webbed baskets 3550 attached to either side of the body. The webbed baskets 3550 are removably attachable to the nasoenteric feeding tube 10 while the nasoenteric feeding tube is in place in a user. The webbed baskets 3550 include a hinge (not shown) and a clipping formation (shown better with reference to figures 42A - 42D later) whereby the webbed baskets can be changed open along a longitudinal hinge to allow the webbed baskets 3552 be clipped onto a nasoenteric feeding tube 10.

[0291] Figures 42A - 42D show another embodiment of a nasoenteric tube securement device 3600.

[0292] It includes a U-shaped body 3610 that is attached to webbed baskets 3650 to 2 one side (both sides also envisaged) the webbed baskets are divided longitudinally into two portions3650 a & b, each portion being capable of pivoting relative to the other portion about a substantially longitudinal hinge axis A. A batch formation 3690 is provided for each basket 3650 to allow the baskets to be firmly secured around a nasoenteric feeding tube 10. In the embodiments shown, the catch formation is a ratchet-type formation, however a wide variety of alternative catch formations are envisaged and will be apparent to a person skilled in the art.

[0293] It is further envisaged that the attachment formation 3620 internal to the webbed basket 3650 will similarly open in two portions when the basket opens up.

[0294] Another embodiment of a nasoenteric tube securement device 3700 is shown in figure 44. In this embodiment, a sensor arrangement 3792 is provided that may be able to sense a variety of conditions, including one or more selected froma. fluid flow through the nasoenteric feeding tube;b. pressure, including pressure increase or decrease in the nasoenteric feeding tube;c. blockages in the nasoenteric feeding tube;d. acceleration;e. movement of the nasoenteric feeding tube; andf. any other useful condition.

[0295] It is envisaged that the accelerometer could also be placed in close proximity to the users ear or nose, and may be able to sense the conditions anywhere in the nasoenteric feeding tube.

[0296] The sensor arrangement 3792 may be provided with its own power source in the form of a battery. Alternatively, the sensor arrangement may be powered by a charging cable (not shown). It is further envisaged that the sensor arrangement may be able to communicate the sensor conditions by wired or wireless communication and / or display the conditions on a display screen (not shown). It is further envisaged that the sensor arrangement 3792 may be able to save the sensor conditions on digital storage media. The sensor arrangement 3792 may include digital storage media.

[0297] Another embodiment of a nasoenteric tube securement device 3800 is shown infigure 45. In this embodiment, an indicator formation 3895 is provided. The indicator formation 3895 is configured for facilitating the indication of a distance that the nasoenteric feeding tube has been moved from its location on initially being inserted. In this embodiment, the indicator formation 3895 includes an aperture through the attachment formation 3820. The aperture can be used by carers to mark the location of the nasoenteric feeding tube 10 in relation to the nasoenteric tube securement device 3800 when the nasoenteric tube securement device 3800 is initially attached to the nasoenteric feeding tube 10. This can be done by using a pen or blade to mark the nasoenteric feeding tube through the aperture. If the nasoenteric feeding tube is inadvertently withdrawn from user’s airways and / or stomach, the carers may be able to insert the nasoenteric feeding tube back to the original position without having to use x-rays, ultrasound, similar imaging to place the nasoenteric feeding tube 10. It will be appreciated by a person skilled in the art that a wide variety of indicator formations may be used. The indicator formation may include a blade or similar shop formation for notching or marking the nasoenteric feeding tube.Embodiments:

[0298] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

[0299] Similarly it should be appreciated that in the above description of example embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description of Specific Embodiments are hereby expressly incorporated into this Detailed Description of Specific Embodiments, with each claim standing on its own as a separate embodiment of this invention.

[0300] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as wouldbe understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.Comprising and Including:

[0301] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” are used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

[0302] Any one of the terms: including or which includes or that includes as used herein is also an open term that also means including at least the elements / features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising. Industrial Applicability

[0303] It is apparent from the above, that the arrangements described are applicable to the medical device manufacturing and / or healthcare industries.

Claims

ClaimsThe claims defining the invention are as follows:

1. A nasoenteric tube securement device for holding a nasoenteric feeding tube in place on a user’s face, comprising:a. a securing formation configured for one or more selected from:• clamping onto one or more selected from the user’s nose and the user’s ear in use;• hooking onto one or more selected from the user’s nose and the user’s ear in use; and• looping around the users ear in use; andb. an attachment formation connected to the securing formation, the attachment formation adapted, in use, for securely holding a nasoenteric feeding tube.

2. The nasoenteric tube securement device as claimed in claim 1, wherein the securing formation includes a clamping arrangement.

3. The nasoenteric tube securement device as claimed in claim 2, wherein the clamping arrangement includes a base and plurality of arms extending from the base.

4. The nasoenteric tube securement device as claimed in either of claims 2 or 3, wherein the clamping arrangement defines a pair of opposed jaws for clamping onto one or more selected from the users ear and the user’s nose in use.

5. The nasoenteric tube securement device as claimed in either of claims 3 or 4, wherein the arms are one or more selected froma. at least partly resiliently flexible; andb. at least partly plastically flexible.

6. The nasoenteric tube securement device as claimed in any one of claims 2 to 5, wherein the clamping arrangement includes a biasing arrangement.

7. The nasoenteric tube securement device as claimed in any one of claims 1 to 6, wherein the securing formation includes a hooking arrangement configured for hookingonto a user’s ear in use.

8. The nasoenteric tube securement device as claimed in claim 7, wherein the hooking arrangement is configured for extending around the rear of a user’s ear in use.

9. The nasoenteric tube securement device as claimed in any one of claims 1 to 8, wherein the securing formation includes a looping arrangement configured for looping around a user’s ear in use.

10. The nasoenteric tube securement device as claimed in any one of claims 1 to 9, wherein the securing formation includes one or more selected from an aperture and a recess adapted to receive at least part of the nasoenteric feeding tube.

11. The nasoenteric tube securement device as claimed in any one of claims 1 to 10, wherein the attachment formation is configured for removable attachment to the nasoenteric feeding tube.

12. The nasoenteric tube securement device as claimed in claim 1, wherein the securing formation is at least partly resiliently flexible.

13. The nasoenteric tube securement device as claimed in any one of claims 1 to 12, wherein the securing formation is at least partly plastically deformable.

14. The nasoenteric tube securement device as claimed in any one of claims 1 to 13, wherein the nasoenteric tube securement device includes a webbed basket at least partially receivable within the nose of a user.

15. The nasoenteric tube securement device as claimed in any one of claims 1 to 14, wherein the nasoenteric tube securement device includes a sensor arrangement.

16. The nasoenteric tube securement device as claimed in any one of claims 1 to 15, wherein the nasoenteric tube securement device includes an indicator formation configured for indicating a distance that the nasoenteric feeding tube has been moved from its location on initially being inserted.

17. A nasoenteric tube securement device for holding a nasoenteric feeding tube in place on a user’s face, comprising:a. a clamping formation configured for clamping to one or more selected from the user’s nose and the user’s ear;b. an attachment formation connected to the securing formation, the attachmentformation adapted, in use, for securely holding a nasoenteric feeding tube.

18. A nasoenteric tube securement device for holding a nasoenteric feeding tube in place on a user’s face, comprising:a. a hooking formation configured for hooking onto one or more selected from the user’s nose and the user’s ear;b. an attachment formation connected to the securing formation, the attachment formation adapted, in use, for securely holding a nasoenteric feeding tube.

19. A nasoenteric tube securement device for holding a nasoenteric feeding tube in place on a user’s face, comprising:a. a looping formation configured for looping around the user’s ear;b. an attachment formation connected to the securing formation, the attachment formation adapted, in use, for securely holding a nasoenteric feeding tube.

20. A nasoenteric tube securement device for holding a nasoenteric feeding tube in place on a user’s face, the nasoenteric tube securement device comprising:a. a clamping arrangement including a plurality of opposed jaw members adapted to clamp, in use, onto a part of the nose or ear of a user; and b. an attachment formation provided on the body, the attachment formation adapted, in use, for securely holding a nasoenteric feeding tube.

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