Patent Application
20160193117
This application claims priority from Australian provisional patent application no. 2013903386 filed on 4 Sep. 2013, the contents of which are incorporated by reference.
The invention relates to an apparatus for holding a tube and, in particular, an apparatus in the form of a tube holder for securing a nasal gastric tube on a face of a user. The invention also relates to a method of fitting or securing a tube such as a nasal gastric tube to the face of a user with a tube holder.
There are a number of medical conditions that require patients or users to require a tube fitted into the user's nose or mouth. These tubes may be, for example, oxygen tubes, oral gastric tubes or nasal gastric tubes. Such tubes are required to be secured in place and are often attached directly to the face of the user with an adhesive strip or tape.
One specific example of a tube, which is required to be fixed in use to the face of a user, is a nasal gastric tube that is fitted to the nose of the user and proceeds into the stomach of the user for feeding. The nasal gastric tube is typically fitted to the user for extended periods of time. The nasal gastric tube may then need to be adjusted in length or removed.
Currently the method to adhere and secure a nasal gastric tube to the face of a user include: Applying a layer of Duoderm™ to the user's cheek to protect the sensitive skin; Inserting the nasal gastric tube into the user's nasal passage to the correct insertion measurement; Placing a piece of tape onto the nasal gastric tube to secure the correct insertion measurement to the user's face, and checking the tube is in correct position by drawing back with a syringe on the tube to ensure that the tube is correctly placed into the user's stomach; and cutting two more pieces of tape and secure the nasal gastric tube in place on the user's face.
During the above method the user, which may be an infant or child, becomes uncomfortable and agitated. This is further exacerbated as, typically, the tape on, the user's face must be changed at least two times each week as it soils and becomes ineffective and lifts up from the user's face. Also there has to be two pieces of tape on different angles to shape to the face of the user and ensure that the user does not easily dislodge the tape.
A problem with the current tape based methods is that the user, which may be an infant or child, may attempt to dislodge the tape and the tube. Another problem with the above method and use of tape is the need to regularly change the tape. Another problem is that the tube is required to be held in place whist the tape is applied, this typically requires two people to fit the tube with the first person holding the tube whilst the second person fits the tape. Other problems include the need to apply and remove multiple pieces of tape which each need to be cut to a particular length.
The invention disclosed herein seeks to overcome one or more of the above identified problems or at least provide a useful or more favourable alternative.
In accordance with a first main aspect there is provided, an apparatus for securing a nasal gastric tube to a face of a user between an ear of the user and a nose of the user in a fitted condition, the apparatus including an elongate body having a securing side adapted to affix to the face of the user and a tube locating, side including a locator arranged receive and locate a received portion of the tube substantially inline with the elongate body between the ear and nose of the user. The apparatus may also further include a cover couped to the elongate body so as to be moveable between an open condition in which the received portion of the tube is receivable by the locator and a closed condition in which the received portion of the tube is concealed by the cover.
In another aspect, the locator is arranged to temporarily movably hold the received portion of the tube in the open condition so as to allow for moveable adjustment of the tube prior to the cover being moved to the closed condition.
In yet another aspect, the locating side of the elongate body is substantially free of adhesive.
In yet another aspect, the elongate body includes a first end oriented toward the nose in the fitted condition and an opposing second end oriented toward the ear in the fitted condition, and wherein the elongate body tapers toward the first end so as to provide a nose fitting portion which allows positioning of the elongate body at least partially below and adjacent to a nostril of the nose of the user.
In yet another aspect, wherein the elongate body tapers toward the second end so as to provide a second nose fitting portion so as to allow the tube holder to be fitted to the face in a right-hand or a left-hand orientation.
In yet another aspect, the locator is provided in the form of a channel shaped to receive and locate the received portion of the tube, the channel extending lengthwise at least partially between the first end and the second end of the elongate body.
In yet another aspect, the channel terminates short of the first end and is arranged so as to allow the nasal gastric tube to pass across the nose-fitting portion to the nostril whilst the first end of the elongate body continues to extend at least partially below the nostril.
In yet another aspect, the cover is shaped to substantially match the shape of the elongate body and has a corresponding nose fitting portion arranged to align with the nose fitting portion of the elongate body in the closed condition.
In yet another aspect, the elongate body includes first and second opposing sides extending between the first and second ends, and wherein the cover includes an attached side coupled to the first side of the elongate body and an opposing free end side which substantially meets with the second side of the elongate body in the closed condition.
In yet another aspect, the second side of the elongate body includes a securing tab which is arranged to fold at least partially over the cover in the closed condition thereby seeming the cover in the closed condition.
In yet another aspect, the channel is defined by two elongate members coupled to the locating face of the elongate body, the two elongate members being arranged parallel and spaced apart from one another.
In yet another aspect, the base of the channel is provided by the locating side of the elongate body such that in the fitted condition the tube is lies substantially along the locating side.
In yet another aspect, the elongate members are formed from a flexible foam material.
In yet another aspect, the cover is at least one of cleat or translucent so as to allow visual inspection of the tube beneath the cover.
In yet another aspect, the cover includes an inner securing surface and an outer surface, the inner securing surface being adapted affix to the locating face of the elongate body in the closed condition and the outer surface being substantially smooth.
In yet another aspect, the cover at least one of a urethane or polyurethane.
In yet another aspect, the cover and elongate body are formed from a unitary material being at least one of a urethane or polyurethane.
In, yet another aspect, the securing side of the elongate body includes a hydrocolloid substance adapted to adhere to the skin.
In yet another aspect, the locating side of the body includes at least one of silicone, urethane or polyurethane material.
In accordance with a second main aspect there is provided, a method of retaining a tube using a tube holder on a face of a user between a nose of the user and an ear of the user, the method including the steps of: affixing a securing side of an elongate body of the tube holder such that the elongate body is substantially aligned between the nose and the ear and locating a received portion of the tube using a locator coupled to the elongate body and adapted to receive received portion such that the received portion of the tube substantially inline with the elongate body. The method may further include the step of moving a cover coupled to the elongate body from an open condition to a closed condition to cover the tube when the tube is received by the locator.
In one aspect, the elongate body tapers toward a first end to provide a nose fitting portion, and wherein the method includes the steps of, positioning of the tube holder with the nose fitting portion at least partially below and adjacent to a nostril of the nose of the user; and fitting the tube to the locator so as to extend from the locator across the nose fitting portion and into the nostril of the nose of the user.
The invention is described, by way of non-limiting example only, by reference to the accompanying figures, in which;
Referring to
In this example, the tube 11 may be a nasal gastric tube 11. However, other tubes or tube like structures may be utilized with the tube holder 11 such as oxygen tubes or even wires which need to be directed from an external source toward the user. It is also noted that whilst tube holder 21 is primarily described as directing the tube 11 toward or into the nostrils 7, the tube holder 21 may also be utilized to direct the tube 11 into a mouth 4 of the user 3.
Considering now the specific application of a nasal gastric tube 11 in more detail, the nasal gastric tube 11 is a continuous tube used for feeding and includes the feed section 11A from the food source feeding to an entry portion 11B at the nostrils 7 of the user, into the section 11C extending through the nasopharynx and section 11D extending through the esophagus 8 into the stomach 9.
In this particular application, there are a number of considerations. Firstly, the face of the user 3 has soft tissue over the cheek 5 and therefore attachment at that point is uncomfortable and particularly affected when tube holder 11 is attached and reattached. Secondly, the nasal gastric tube 11 needs to be directionally fed to the nostrils 7 and preferably from above the mouth 4 so as to not further inconvenience the user. Thirdly, the tube section 11C extending internally of the nostrils 7 and to the nasopharynx needs to be retained fairly stationary as constant movement will cause severe irritation and further could cause expelling of internal fluids out of the nose 7 or into the back of the mouth 4 and thereby further irritating the user. Fourthly, the tube section 11D needs to extend into the stomach 9 of the user and be retained at the right position so that food is directed to the right location and level in the stomach and not cause choking or blockage or incorrect processing or other complications if at the wrong position. Also it is important to not damage the inner lining of the stomach 9. Accordingly, it is important that the tube holder 21 secures the tube 11 so as to be substantially immobile and is attached or affixed to the face 13 is a manner so as to not irritate or damage the skin of the face 13.
With the above considerations in mind, the first example of the tube holder 21 is now described in more detail with reference to
The body 22 of the nasal gastric tube holder 21 includes a directing means or locator 33 in the form of a channel 25 extending longitudinally along a central section of an upper surface 24 of the body 22 between a channel opening 26 at a one end 32 of the body and a channel outlet 27 at the other end 30 of the body 22.
Accordingly, the channel 25 assists to hold the nasal gastric tube 11 at a particular relative position to the body 22 to ensure correct length of the nasal gastric tube 11 extending from the body 22 to the nasal cavity 7 of the user 3 when in position and into the stomach 9.
The upper surface 24 of the body 22 may be a clear silicone material to provide a cleanable outer surface with the under surface preferably being waterproof and not skin irritant so as to be comfortably rested on the face of the user. An underside or backing surface 29 of the body 23 may include the attachment means 23 in the form of a layer of adhesive gel such as a hydrocolloid gel, which may be for example, Duoderm™.
The body 22 may be fitted with a cover 28 so as to form a sheath over the tube 11 when received by the channel 25. The cover 28 includes an adhesive underside to adhere to the upper surface 24 of the body 22 and the smooth water resistant or waterproof outer surface to protect the underlying body 22 and tube 11. In use, the cover 28 thereby serving to hold and shield the nasal gastric tube 11 in the nasal gastric tube holder 21. In this way, in position the channel 25 receives the nasal gastric tube 11 close to the ear 6 and directs the tube 11 to the nostril 7 of the user 3.
In other example forms, the channel 25 may remain uncovered but have means to retain the nasal gastric tube 11 in the channel 25 at least at the channel opening 26 at one end of the body 22 and at the channel outlet 27 at the other end of the body 22. An example of such a means is further described below with reference to
Referring more specifically to
With the nasal gastric tube holder 11 attached to a particular relative position to the body a part of the extent of the nasal gastric tube 11A is fixed along the body 22 so that the portion 11B, 11C and 11D entering the nostrils 7 of the user 3 and through the nasopharynx to the esophagus 8 to the stomach 9 is fixed in length relative to the user to ensure correct positioning.
The body 22 is preferably flexible and moudable to contour to the particular shape of user's face. The body 22 may be hand manipulated so as to readily allow shaping to a shape at which it remains that follows the contours of the face. In some example, the body 22 may include a thermosettable material to be moulded to a fixed form which is shaped to contour to the shape of user's face.
In use or operation the nasal gastric tube holder 21 is applied to face 13 similar to a Bandaid™ and holds the nasal gastric tube 11 substantially inside the gastric tube holder 21. The holder 21 preferably generally waterproof, with a clear water proof cover 28 and may moudable or shaped to fit around nose 7, contour along the cheek 5 and up to top of ear 6 adhering to face 13. The overall nasal gastric tube holder 21 is preferably lightweight.
The above described first example of the nasal gastric tube holder 21 may be utilised in a method of holding a nasal gastric tube 21 for a user 3 to be fed including the steps of providing a body 22 to hold and direct the nasal gastric tube 11, and attaching the body 22 to the user's face between the ear 6 and the nostrils 7 of the user 3. The method may also include the steps of shaping the body to fit with or contour in accordance with the contour or shape of the user's face 3
Also the steps allow directing the nasal gastric tube at a particular relative position to the body to ensure directing the nasal gastric tube in a controlled manner by extending between a nasal gastric receiving position near the ear and exiting near the nostril of the user when in position and holding the nasal gastric tube relative to the body of the nasal gastric tube holder to a particular relative position to the body to ensure correct length of the nasal gastric tube extending from the body to the nasal cavity of the user when in position and locating the nasal gastric tube relative to then body.
Referring now to
Referring more specifically to
The tube holder 121 includes an elongate body 122 having a first end or nose end 130, a second end or opposing ear end 132, an underside or backing 129 adapted to be securable to the face of the user 3 and a locator 133 provided in the form of a channel 125 extending lengthwise at least partially between the nose end 130 and the ear end 312. The channel 125 is adapted to receive an elongate correspondingly received portion 11F of the nasal gastric tube 11 so as to maintain the orientation of the corresponding portion 11F substantially inline with the elongate body 122 and thereby between the ear 6 and nose 7 of the user 3 as is best shown in
The elongate body 122 includes a tapered or curved fitting portion 134 that tapers or concaves toward the nose end 130 so as to allow positioning of the tube holder 121 at least partially below and adjacent to the nostril 7 of the user 3, as is best shown in
In more detail, in this example, the channel 125 is provided by a channel arrangement 148 including two elongate and parallel foam parts 136 which define the channel 125 therebetween. The foam parts 136 have a flat underside 138 so as to fit with an upper side 124 of the body 212 and a curved upper side 140 which taper from an inner side 142 adjacent the channel 125 to the outer side 144 adjacent the body 122. The foam parts 136 are formed from a flexible foam material such as polyurethane foam so as to bend or contour to the shape of the face 13 of the user 3. The height of the channel arrangement 148, more specifically the foam parts 136, which defines the depth or height of the channel 125, is about the same or slightly greater than the diameter of the tube 11 which depending on the application may be about 3 mm to 6 mm. The width of the channel 125, defined by the distance between the foam parts 136, may be about the same or slightly less than the diameter of the tube 11 so as to locate and snuggly received the tube 11 in the fitted condition.
Accordingly, the channel 125 serves to locate and retain the tube 11 between the first and second ends 130, 132 and hold the tube 11 in position whilst the position of the tube 11 is assessed. For example, the method of fitting a nasal gastric tube 11 includes the step of drawing back on the tube 11 when initially fitted to check that the tube 11 is within the stomach 9. Then once the tube 11 is determined to be in the correct location, a cover 128, as is further described below, is fitted over the tube 11 within the channel 125 and the elongate body 122 to secure the tube 11 in place.
In this example, the tube holder 221 further includes a folding cover or flap 128 pivotally attached or coupled to the elongate body 122. The cover 128 is moveable between an open condition, as shown in
The elongate body 122 includes a first side 154 and second opposing side 156 extending between the nose end 130 and the ear end 132. The cover 128 includes an attached side 162 pivotally coupled via the fold line 160 to the first side 154 of the elongate body 122 and an opposing free end side 164 which substantially meets with the second side 156 of the elongate body 122 in the closed condition. The cover 128 includes a first tab 166 coupled to free end side 164 and the elongate body 122 includes second tab 168 coupled to the second side 156 of the elongate body 122. The second tab 168 includes an aperture 170 arranged to receive the first tab 166 to secure the cover 128 in the closed condition.
Turning now to the materials of construction, and referring additionally to
In some forms, the adhesive layer 181 may include a substance such as an adhesive gel such as a hydrocolloid substance or gel, which may be similar to, for example, Duoderm™. The hydrocolloid gel may be carried by the upper layer 124 which may be thin flexible polyurethane or urethane material. The foam parts 136 may then be adhered to the opposing side of upper layer 124 relative to the hydrocolloid gel.
The cover 128 is also preferably made from a flexible polyurethane or urethane material and may be formed from the same piece of material as the body 122 or at least the same material is the upper surface or layer 124 of the body 122. In some forms, the cover is a urethane breathable non-woven sheet having an acrylic adhesive such as the ST-284 urethane sheet available form Nitto™. The cover 128 is waterproof.
In some applications, the cover 128 is clear, opaque or may include a clear window to allow for visual inspection of any liquids passing through or within the tube 11. The cover 128 includes an outer side 184 and an opposing inner side 183 which carries an adhesive substance or layer 189 to adhere or fix to the body 122 in the closed condition. The first tab 166 may also include an adhesive layer 185. As is best shown in
In this example, the overall length of the tube holder 121 is about 8 cm to 10 cm so as to span between the nose 7 and ear 6 of an infant or child. However, other sizes may be utilised. For example, an adult version may be shorter relative to the face of the adult and only extend part of the way from the nose toward the ear of the adult use. The materials of the tube holder 121 including the flexible elongate body 121 and flexible cover 128 allow the tube holder 121 to fit with and contour with a variety of face shapes and sizes. It is noted that in this example the tube holder 121 is shaped for use on the left-hand side of the face 13. However, tube holder 121 may also be formed in a right-hand version for fitting with the right-hand side of the face 13.
Referring to
Referring now to
In this third example, the tube holder 221 has been simplified by removal of the first and second tabs 166, 168. Accordingly, the body 222 and the cover 228 substantially mirror one another in a butterfly type arrangement being symmetrical about the fold joint 260. In this example, the fold joint is provided on the lower side of the tube holder 221 in the closed and fitted condition. However, the fold joint 260 could also be provided on the upper side of the tube holder 221 in the closed and fitted condition, similar to that shown in
Referring now to
In this example, the tube holder 321 is symmetrical so as to be fitted with the nose or nostril 7 of the user 3 along either the right hand side or left hand side of the face 13. In more detail, in this fourth example, the elongate body 322 tapers toward both of the first end 330 and second end 332 so as to include symmetrical nose receiving or fitting portions 334 toward each of the first and second ends 330, 332. In this example, the elongate body 322 having a wider central section 331 that carries a securing tab 333 that is folder over the cover 328 when the cover 328 is in the closed condition. Similar to the previous example, the cover 328 has a similar shape to the elongate body 322 so as to fit with and match the shape of the elongate body 322 when the cover 328 is in the closed condition.
Similar to the second and third examples of the tube holder 11, in this example, the locator 333 is provided in the form of the channel 325 which is extends between the first end 330 and second end 332 of the elongate body 322. The channel 325 is centred between the first end 330 and second end 332 and terminates short of the first end 330 and second end 332 such that the tube 11 is free to extend from the channel 325 and across the respective nose-fitting portions 334 in use. This allows the received portion of the tube 11 to be held and aligned by the channel 325 whilst the tube 11 is being positioned within the nostril 7 of the user 3. The cover 328 which includes the inner adhesive securing surface 383 is then closed over the fitted tube 11 and the ends of the tube 11 extending from the receive portion 11F are directly captured and fixed in the desired orientation relative to the nostril 7 of the user 3. The securing tab 333 secures and seals the cover 328 in the closed condition.
In each of the second, third and forth examples, tube holder 121, 221, 321 the tube holder 11 broadly functions in a similar way. The example below is described with reference to the second example of the tube holder 121 but is equally applicable to the other examples.
Accordingly, a method of retaining a tube 11 using the tube holder 121 on the face 13 of the user 3 between the nose 7 of the user 3 and the ear 6 of the user 3 may include the methods steps of affixing the securing side 129 of an elongate body 122 of the tube holder 121 such that the elongate body 1 substantially aligned between the nose 7 and the ear 6. The method then includes locating a received portion 11F of the tube 11 using the locator 133 of the elongate body 122 such that the received portion 11F of the tube 11 is substantially inline with the elongate body 122. The received portion 11F may include a marking to ensure the tube 11 is of the correct length.
The method may also include the steps of positioning of the tube holder 121 with a nose fitting portion 134 at least partially below and adjacent to the nostril 7 the user 3 and fitting the tube 11 to the locator 133 so as to extend from the locator 133 across the nose fitting portion 134 and into the nostril 7 of the user 3.
Advantageously, having the locator 133 in the form of the channel 125 functions to maintain overall lengthwise alignment of the tube 11 and provides a structure to hold tube and allow for moveable adjustment of the tube 11 before the cover 128 is moved to the closed condition. The ends of the tube 11 which extend from the channel 125 and across the nose-fitting portion 134 are typically moved and adjusted for each user 3 to achieve a customised fit with the nostril 7.
Accordingly, once the location of the tube 11 has been determined to be correct, the method further includes the step of moving the cover 128 coupled to the elongate body 122 from an open condition to a closed condition to cover the tube 11 when the tube 11 is received by the locator 133. The cover 128 being arranged to fit with and have a substantially similar shape to the body 122. The cover 128 is affixed to or secures against the elongate body 122 to retain and secure the tube 11 in the desired location. In particular, because the channel 125 terminates short of the first end 30 of the body 122, the portion of the tube 11 between the nostril 7 and the channel 25 may be bent and shaped for a customised fit. The cover 128 is then directly secured around the tube 11 to fix the tube 11 in the customised position and within the channel 25. Furthermore, the concave or tapered end of the body 122 which provides the nose fitting, portions 134, 152 allows the body 12 and adhesive cover 128 to be placed very near and beneath the nostril 7 which further assist to secure the position and location of the tube 11 relative to the nostril 7. The remainder of the elongate body 122 and, in particular the channel 125, then serving to securely support and direct the tube 11 along the cheek 5 and preferably to a position over the ear 6. The cover 128 being arranged to substantially cover the tube 11 between the nostril 7 and the ear 6 which advantageously assist to inhibit a user, such as child or toddler, from clasping the tube 11 and attempting to dislodge the tube 11.
The above described apparatus and method provide a number of advantageous features and functionality. In particular, the tube holder allows for a single caregiver to fit the tube to the user as the locator provides for temporary support of the tube whilst the overall length and positioning of the tube is checked. The pre-shaped attached cover can then be simply folded over the body and tube to secure the tube. The shaping of the elongate body and cover is also highly advantageous to allow very close positioning to the nostrils and the channel terminating short of the ends of the body allow the portion of tube between the channel and nostril to custom fitted and secured in the custom position directly by the cover. The cover, when fitted, serving to protect the tube holder and when securing tabs are used, the securing tabs provide a secondary measure to ensure that the cover remains closed. The tube holder has a unitary and substantially waterproof structure which assists it to remain attached to the face for longer periods of time.
Other advantageous aspects of the above described apparatus and method include: quicker and easier to apply and fit an oral or a nasal gastric tube. Easier to insert by fitting the tube to the locator at the correct stomach measurement; Longer lasting in position so as to minimize times for replacement or reattachment of nasal gastric tube; nasal gastric tube holder will last longer—contouring shaped design to mould to the face, waterproof adhesive similar to Duoderm™ with clear silicone or skin tone top; Less traumatic for the patient (no need to change frayed tape 2 to 3 times per week); User friendly—less stressful for the person such as parents or patient carer inserting the nasal gastric tube; Less traumatic for nasal gastric tube fed children and the parents, nurses and doctors inserting the tube; Correct measurement pre-marked of tube relative to tube holder by inserting the nasal gastric tube at the predefined location in the nasal gastric tube holder; More hygienic; Looks better than messy tape and cleaner design with smooth surface, which is less noticeable on the skin. Nasal gastric tube holder is one shaped design corresponding with patient's face; nasal gastric tube holder feeds the nasal gastric tube close to the nostril and therefore directs well and minimizes irritation and likely removal by patient; Children may not become as aversive to the nasal gastric tube with the nasal gastric tube holder due to it being quicker and lasting longer.
The nasal gastric tube holder can be provided in a pack of six (3× left face nasal gastric tube holders and 3× right face nasal gastric tube holders). The tube holders may be hygienically wrapped until use to maintain sterility.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising”, will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.
The reference in this specification to any known matter or any prior publication is not, and should not be taken to be, an acknowledgment or admission or suggestion that the known matter or prior art publication forms part of the common general knowledge in the field to which this specification relates.
While specific examples of the invention have been described, it will be understood that the invention extends to alternative combinations of the features disclosed or evident from the disclosure provided herein.
Many and various modifications will be apparent to those skilled in the art without departing from the scope of the invention disclosed or evident from the disclosure provided herein.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2013903386 | Sep 2013 | AU | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/AU2014/050205 | 9/2/2014 | WO | 00 |
