Line fixation device

Abstract

The present invention relates to a device for supporting a separately placed line, the device comprising: (i) a base (106) having an opening (116) therein for receiving a separately placed first line extending from a patient; wherein the base comprises: a connector mounted to the base and having a first end for connection to an end of the said first line and a second end for connection to a second line; and a wall (120) extending from the base, wherein the wall defines an interior of the base and an exterior of the base, and wherein the wall is arranged to releasably connect with a lid (122), wherein the connector extends through the wall, the first end of the connector being within the interior of the base and the second end of the connector being within the exterior of the base; (ii) a lid arranged to form an enclosure over the interior of the base and enclose the opening in the base, wherein at least a portion of the wall and / or at least a portion of the lid are manually deformable and elastic, and wherein when the lid is releasably connected with the base, the device has intrinsic strength against compressive forces.

Description

[0001] LINE FIXATION DEVICE

[0002] TECHNICAL FIELD

[0003] The present invention relates to a means of providing fixation of a line to a patient. More specifically, this invention relates to devices and methods for supporting a line extending from an entry site in a patient and for providing fixation of the line to the patient.

[0004] BACKGROUND

[0005] Many medical procedures conducted on a patient require the patient to be provided with a line, such as a surgical line or a drainage catheter, which extends into the patient through an entry site formed in the skin of the patient. Such lines are usually used for the introduction of fluids and medications directly into the patient or the removal of fluids from the patient. It is often desirable to maintain these lines over an extended period of time during the treatment or recovery of the patient.

[0006] One example of such a line is placed into the body of the patient to remove fluids therefrom, for example at the site of a wound or after surgery. Such lines are inserted into the body of the patient through an entry site, with the open end of the line within the body being positioned to receive fluid from the target site. The fluid may be allowed to drain from the patient under the action of gravity using a passive system. Alternatively, the fluid may be drawn from the patient using an active system, for example by connecting the distal end of the line to a suitable vacuum pump.

[0007] Given that these lines need to remain in situ for a period of time, the lines are secured to the patient after insertion and placement. In certain cases, the line is inserted through an incision and is secured to the skin of the patient using sutures, adhesive tape or a commercially available fixation device. Such securement is important for keeping the line properly positioned for the duration of the treatment. However, a particular problem with lines is that they may become dislodged, for example as a result of movement of the patient. This can result in the line losing its correct placement within the patient and, in extreme cases, the line being pulled out of the patient. A further cause of the line being dislodged or pulled out from the patient is where it is connected to a drainage bag or some other receptacle or component. In many applications, such bags will hold significant volumes of fluid (e.g. around a litre) and thus can have significant mass when partially or totally filled. If such bags are inadvertently dropped, then this will impart a sharp pulling force on the line.

[0008] Devices for supporting lines are known in the art. For example, US 2007 / 043326 discloses a device for fixing a line to the body of a patient. The device includes a housing, which can be closed by a lid, and a base coupled to the housing, surrounding the housing and enabling the housing to be fixed to the skin of the patient. The housing includes a first chamber through which the outer part of the line, which is placed in the vein, passes without being connected thereto and a second chamber for accommodating and maintaining the line. One drawback of this configuration is that the end of the line extending from the fixation device is susceptible to pulling forces which could result in disconnection of it from the device and / or dislodgment of the needle entering the patient.

[0009] US 4659329 discloses a system having a retaining assembly comprising, a base plate for placement adjacent the patient, and an upright wall extending substantially peripherally around the base plate and having an opening, with the base plate having an aperture to receive the line and an upright retaining member having a groove extending from the aperture to receive the line in the groove. The line is wound in at least one coil inside the wall and extends toward the wall opening. In the device, the line is connected directly to a drainage tube which is again susceptible to pulling forces which could result in disconnection of the drainage tube from the device and / or dislodgment of the line from within the patient.

[0010] US 2006 / 0025723 discloses a line securing device. The device comprises a main body portion or base of a generally oval shape. A plurality of holes is formed in the periphery of the base to allow the device to be secured to the skin of a patient by means of sutures. The device comprises a tubular element extending from the surface of the base The tubular element and the base define a generally tubular bore extending therethrough for accepting a line. The tubular element may extend perpendicular from the base or at an angle to the perpendicular. The device comprises a means for securing a line within the tubular element. US 2006 / 0025723 discloses several different embodiments of the securing means. In a first design, a pair of locking screws are provided, which extend through threaded bores in the tubular element and can be tightened to grip the outer surface of the line within the tubular element. In an alternative arrangement, the tubular element is provided with an inflatable inner collar, which may be inflated using liquid or gas, to grip the line and hold it in position within the bore of the tubular element.

[0011] The known devices for securing lines, such as those discussed above, suffer from several disadvantages. In some of these devices, a line is connected directly to the line exiting the patient and thus are susceptible to pulling forces which can result in the line entering the patient being dislodged or the lines being disconnected. Further, some known devices rely upon some form of clamp or other means to grasp either line. As the lines are generally flexible tubes, this can cause the bore of the tube to be partially occluded, reducing the effectiveness of the line in transporting fluids, and, in extreme cases, fully closing and blocking the line. The twisting forces exerted on the line can result in kinking of the line leading to catheter occlusion and impaired drainage

[0012] EP2768566 discloses a device for providing fixation of a line to a subject and addresses the issues discussed above. The device comprises a connector mounted to the base which is connectable to a first line exiting the patient and a second line connected to the exterior of the device. Through use of such a configuration, pull forces applied to the second line are not transmitted to the first line and thus do not result in dislodgment of the first line. However, the disclosure regarding the construction and configuration of the device in EP2768566 is limited; no guidance is provided in that document regarding the dimensions or properties of the device and it is merely stated that the product may be produced from 'medical grade polymers'.

[0013] The inventors have identified that the device disclosed in EP2768566 is not configured for straightforward manual manipulation, including opening of the device to gain access to the interior of the housing. Accordingly, use of that device can be challenging particularly when it is being applied or configured by a medical practitioner during application or replacement of a line which is typically a task requiring dexterity, or when it is being accessed or manipulated by a patient who is elderly or infirm. Additionally, the inventors have also found that large scale production of the devices disclosed in EP2768566 is challenging, primarily owing to the domed shape of the housing which is difficult to mold. Accordingly, there is a need for an improved device for supporting a line when in place in a patient which simultaneously achieves the objectives of preventing dislodgement, kinking and / or twisting of a line while ensuring ease of usability of the device, particularly gaining access to the interior of the device. There is also a need for a device which achieves these objectives and is straightforward to manufacture.

[0014] SUMMARY

[0015] A first aspect of the present invention relates to a device for supporting a separately placed line, the device comprising:

[0016] (i) a base having an opening therein for receiving a separately placed first line extending from a patient; wherein the base comprises: a connector mounted to the base and having a first end for connection to an end of the said first line and a second end for connection to a second line; and a wall extending from the base, wherein the wall defines an interior of the base and an exterior of the base, and wherein the wall is arranged to releasably connect with a lid, wherein the connector extends through the wall, the first end of the connector being within the interior of the base and the second end of the connector being within the exterior of the base;

[0017] (ii) a lid arranged to form an enclosure over the interior of the base and enclose the opening in the base, wherein at least a portion of the wall and / or at least a portion of the lid are manually deformable and elastic, and wherein when the lid is releasably connected with the base, the device has intrinsic strength against compressive forces.

[0018] Through the use of a base and a lid, at least portions of which are manually deformable and elastic, those two parts of the device can be conveniently connected and disconnected manually, e.g. without the use of tools. In embodiments, at least a portion of the wall of the base is manually deformable and elastic. In certain embodiments the entirety of the wall of the base is manually deformable and elastic.

[0019] The lid may be configured to be releasably connected to the base using any means known to the skilled person. In certain embodiments, the lid may be mechanically connectable to the base. In some embodiments, the lid and / or the base may be provided with connection means to permit their connection. Such connection means may comprise interlocking components or surfaces, engaging components or surfaces, or the like.

[0020] In some embodiments, the lid comprises a wall. The wall of the lid may be shaped to engage or abut the wall of the base to provide a releasable connection between the lid and the base. In embodiments, at least a portion of the wall of the lid is manually deformable and elastic. In certain embodiments the entirety of the wall of the lid is manually deformable and elastic. In certain embodiments, at least a portion of the wall of the base and the wall of the lid are manually deformable and elastic.

[0021] The lid may comprise an upper panel comprising an outer surface and an inner surface. The inner surface and / or the outer surface of the upper panel of the lid may be generally planar. In use, the inner surface of the panel, when the lid is connected to the base may be disposed towards the skin of a patient and may further define the interior of the device. In some embodiments, the wall of the lid may extend generally perpendicular from the inner surface of the panel.

[0022] In embodiments of the invention, the upper panel and the wall of the lid may be integrally formed. Additionally or alternatively, the floor and the wall of the base may be integrally formed. The integral formation of the lid and / or the base is advantageous as this simplifies manufacture of those components of the device, which then do not require assembly and / or can be manufactured in a single molding operation.

[0023] The base may comprise a floor comprising a first surface which may be generally planar. In use, the first surface may be disposed towards a patient, exterior of the base. The floor of the base may further comprise a second surface disposed away from the skin in use and which, in addition to the wall, further defines the interior of the base. In embodiments, the wall may extend generally perpendicularly to the second surface. As used to define the relationship between walls and surfaces of the lid and / or base from which they extend, the term 'generally perpendicular' is intended to mean an angle of about 45°or less from perpendicular, about 40°or less from perpendicular, about 35°or less from perpendicular, about 30°or less from perpendicular, about 25°or less from perpendicular, about 20°or less from perpendicular, about 15°or less from perpendicular or about 10°or less from perpendicular. Perpendicular is used to mean 90°from the plane of the respective surface of the lid or base.

[0024] The floor of the base may comprise the opening.

[0025] The device may further comprise a means for attaching the base to the skin of a patient. Such means may comprise adhesive on the generally flat first surface of the floor of the base.

[0026] In some embodiments, the connector is mounted directly to the floor of the base, e.g. to the second surface. In other embodiments, the connector may be indirectly mounted to the base. For example, the connector may be mounted in the wall of the base.

[0027] In some embodiments, the connector further comprises a conduit extending between the first and second ends, through which fluids may flow between the said first line and the second line without clamping or crushing the line. At least one of the first and the second ends of the connector may comprise a Luer connector. In some embodiments, both of the first and second ends of the connector are provided with a Luer connector, one of the first and second ends being provided with a male Luer connector and the other of the first and second ends being provided with a female Luer connector.

[0028] In embodiments of the invention, the connector is rotatably mounted in the base. In alternative embodiments, the connector is fixedly mounted in the base. In preferred embodiments the mounting of the connector in the base is water-tight.

[0029] At least a portion of the lid may be transparent. The entire lid may be transparent.

[0030] The lid and / or the base may additionally comprise one or more openings therein to provide ventilation to the interior of the device. In such embodiments, the device may also comprise a moveable plug, which is configured to close the openings of the lid and / or base, preferably to provide a water-tight closure. Advantageously, the inclusion of such a moveable plug permits the device to provide ventilation to the interior of the device during normal operation via the one or more openings but can then be used to close the one or more openings if needed, for example if the user is using a shower. Often, fixation devices would require changing before or after showering.

[0031] In some embodiments, the base and lid are arranged to provide clearance spacing between a first line extending from a patient and a first end of the connector, wherein the clearance spacing is configured such that the said first line may be connected to the connector and coiled within the interior of the device.

[0032] In a separate embodiment, the base and the lid are arranged to provide clearance spacing extending around a first line extending from a patient and a first end of the connector, wherein the clearance spacing is configured such that the said first line may be connected to the connector and coiled within the interior of the device.

[0033] The means could also comprise one or more openings in the base or one or more loops extending from the base.

[0034] The device of the invention may comprise a plurality of connectors, which each extend through the base and optionally the lid. In some embodiments, part of the connector comprises flexible tubing.

[0035] The wall of the base may be fixed to the base and optionally be integral to said base.

[0036] BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 is a perspective view of a device according to EP2768566, wherein the device is on the skin of a patient.

[0038] Figure 2 is a side cross-section view of the base of the device of one embodiment of the present invention.

[0039] Figure 3 is a perspective view from above of the base in an embodiment of the present invention.

[0040] Figure 4 is a perspective view from above of the lid in an embodiment of the present invention.

[0041] Figure 5 is a perspective view of the underside of the lid in the embodiment of the present invention shown in Figure 4. Figure 6 is a perspective view of the assembled device of one embodiment of the present invention.

[0042] Figures 7A to 7D are images depicting the manual deformability of the base (Figures 7A and 7B) and the lid (7C and 7D) of the present invention.

[0043] Figures 8A to 8C are images depicting the intrinsic strength of the assembled device of the present invention to compression forces.

[0044] DETAILED DESCRIPTION

[0045] As explained above, in a first aspect, the present invention provides a device for supporting a separately placed line, the device comprising: (i) a base having an opening therein for receiving a separately placed first line extending from a patient; wherein the base comprises: a connector mounted to the base and having a first end for connection to an end of the said first line and a second end for connection to a second line; and a wall extending from the base, wherein the wall defines an interior of the base and an exterior of the base, and wherein the wall is arranged to releasably connect with a lid, wherein the connector extends through the wall, the first end of the connector being within the interior of the base and the second end of the connector being exterior of the base; (ii) a lid arranged to form an enclosure over the interior of the base and enclose the opening in the base, wherein at least a portion of the wall and / or at least a portion of the lid are manually deformable and elastic, and wherein when the lid is releasably connected with the base, the device has intrinsic strength against compressive forces.

[0046] The device of the invention comprises multiple components which will now be discussed.

[0047] Base

[0048] The device of the present invention comprises a base. The base may be any suitable shape. A particularly suitable shape is generally rounded, for example, circular, oval or ovoid. Alternatively, the base may have angled corners, e.g. it may be a triangle, square, oblong, trapezoid, pentagon, hexagon or other polygon and one, some or all of its corners may optionally be rounded.

[0049] In embodiments, the base may comprise a floor comprising a first surface which may be generally planar. The shape of the floor of the base may be any of those detailed in the preceding paragraph. In use, the first surface may be disposed towards a patient. The floor of the base may further comprise a second surface disposed away from the skin in use and which, in addition to the wall of the base, further defines the interior of the base. In embodiments, the wall may extend generally perpendicularly to the second surface.

[0050] In some embodiments, the floor of the base may be any suitable shape. A particularly suitable shape is generally rounded, for example, circular, oval or ovoid. Alternatively, the base may have angled corners, e.g. it may be a triangle, square, oblong, trapezoid, pentagon, hexagon or other polygon and one, some or all of its corners may optionally be rounded. The floor is preferably flexible and conformable against the body of the patient.

[0051] The base is provided with an opening therein, optionally in the floor of the base. In use, the opening receives a first line, such as a drain tube, extending from the patient. Further, in use, the device is preferably located on the patient so as to have the opening in the base of the device extend over the site of entry of the first line into the patient (i.e. the entry site) , such as an incision. The opening in the base may be any suitable shape and size to receive the first line. In one preferred embodiment, the opening is generally circular. However, the opening may be other shapes, as appropriate.

[0052] The base may be provided with a slit or slot therein, extending from an edge of the base to the opening therein, to allow the base to be slid onto the line from the side, for example close to the patient.

[0053] The base comprises a connector mounted to the base having a first end for connection to an end of a first line and a second end for connection to a second line.

[0054] The base (and particularly the floor of the base) may be flexible, for example to permit it to conform to curved anatomy, thus, allowing the device to be attached to the patient with ease and stay fixed in place, even if the patient is motile following application of the base.

[0055] Suitable materials for forming the base include flexible copolymers, for example thermoplastic elastomers (TPEs), which have both thermoplastic and elastomeric properties. Such thermoplastic elastomers include styrenic block copolymers, TPS (TPE-s), thermoplastic polyolefin elastomers, TPO (TPE-o), thermoplastic vulcanizates, TPV (TPE-v or TPV), thermoplastic polyurethanes, TPU (TPU), thermoplastic copolyester, TPC (TPE-E), thermoplastic polyamides, TPA (TPE-A), unclassified thermoplastic elastomers, TPZ. Examples of materials that may be used to produce the base comprised in the device of the invention include those commercialised under the Mediprene® trade mark by Hexpol. The 500M grade of Mediprene® is particularly preferred. In embodiments, the material from which the base is formed is free of silicone, PVC and / or latex.

[0056] The material from which the base is formed preferably has a Shore A Hardness value of about 0 A to about 100 A, about 50 A to about 90 A, or about 60 A to about 80 A when tested in accordance with ASTM D2240.

[0057] The device may be secured to the skin of a patient by means of the base. In an embodiment, the base is provided with attachment means for securing the device to the skin of the patient. Such means include, for example, an adhesive layer which may optionally be applied on a portion or all of the first surface of the floor of the base. In such embodiments, the adhesive may be covered with a release liner.

[0058] In an embodiment the adhesive layer on the base may be removable. In some embodiments, the adhesive layer may be replaceable. For example, the adhesive layer may be removably sealed, coupled or otherwise attached to the first surface of the floor of the base. As and when the adhesive layer requires replacement, the adhesive layer can be separated from the base and replaced with a fresh adhesive layer. In use, this allows the device to be used for longer, with only the adhesive layer needing to be replaced.

[0059] In such an embodiment, the base of the device may comprise a fastening means, which is connectable to a first side of an adhesive pad, for example, a hook and loop fastener (e.g. Velcro). The adhesive pad may comprise a first surface suitable for use with the hook and loop fastener and an adhesive second surface which is in contact with the patient in use. In this embodiment, the adhesive pad can be replaced when needed, and / or the adhesive on the adhesive pad can be replaced as required. In use, this allows an easy method of renewing the adhesive, allowing the device to be used for longer. In addition, this would reduce the cost and environmental impact of the device, as only the adhesive pad, or adhesive would need to be replaced.

[0060] Alternatively, or in addition, the attachment means may comprise one or more attachment openings therein or loops extending therefrom, to allow the base to be secured to the skin of the patient by sutures. The attachment openings in the base may extend therefrom in an embodiment and may be adjacent to the opening in the base to allow the base to be secured to the skin of the patient by sutures.

[0061] As a further alternative or in addition, the attachment means may comprise one or more straps for securing the device to the patient. The straps may be secured to the device in any suitable manner. For example, the base may be provided with one or more openings therein or loops extending therefrom to which one or more straps may be attached. In an embodiment, the device is secured to the patient via medical grade adhesive, in a non-invasive manner.

[0062] The base may comprise a floor optionally having a first surface which may be generally flat. In use, the first surface may be disposed towards or against the skin of the patient, and the second surface disposed away from the skin in use, and may further define the interior of the base. In an embodiment, for example when the device is to be placed and arranged on a curved portion of the patient, a flexible adhesive layer may be provided on some or all of the first surface of the floor of the base which is preferably flexible.

[0063] In use, the device may be additionally secured to the patient by means of one or more portions of adhesive tape applied to the second surface of the base and the adjacent skin of the patient.

[0064] The base of the device comprises a wall. The wall may extend from the base, for example from the floor of the base. In such embodiments, the wall may extend from the second surface of the floor of the base.

[0065] In some embodiments, the wall is integral with the base, for example with the floor of the base. The integral formation of the base is advantageous as this simplifies manufacture of that component which does not require assembly of component parts and / or can be manufactured in a single molding operation

[0066] In embodiments in which the wall extends from the base (or components such as the floor, optionally its second surface), the wall may extend therefrom generally perpendicularly.

[0067] The wall may partially or totally extend from the base (or components thereof such as the floor, optionally its second surface) around the edge of the base, the floor (e.g. the second surface thereof) or other such components of the base. Alternatively, the location at which the wall extends from the base may be inset by a distance from the edge of the base (or a component thereof, e.g. from the edge of the floor (optionally the second surface thereof) or some other component of the base. The location at which the wall may partially or totally extend from the base (or such components thereof such as the second surface of the floor of the base) may be at a distance (e.g. about 1mm to about 50mm, about 2 to about 30mm or about 5 to about 20mm) from the edge of the base or such components.

[0068] In such embodiments, the portion of the base, the floor or the other component of the base which lies between the edge thereof and the wall which extends therefrom defines a flange region. In embodiments, the flange region is conformable. Through the inclusion of such a flange region, the surface area of the base which is positioned against the skin of the user is maximized and can be conformably positioned around curved sections of the user's body, while the components of the device housing the first line and connector can be relatively compact. Further, inclusion of a flange region additionally facilitates the connection of the base of the device to the patient as the person fiting the device to the patient can manually press down on the flange region to facilitate adhesion of the base to the patient without having to apply pressure in the interior of the base, i.e. close to the entry site to do so.

[0069] In embodiments of the invention, the wall comprises an interior surface which defines the interior of the base and an exterior surface which defines the exterior of the base. The interior surface of the wall of the base may be partially or totally generally flat. Additionally or alternatively, the interior surface of the wall of the base may be partially or totally convex. In some embodiments, the interior surface of the wall of the base may be partially or totally concave.

[0070] In some embodiments, the exterior surface of the wall of the base may be partially or totally generally flat. Additionally or alternatively, the exterior surface of the wall of the base may be partially or totally convex. In some embodiments, the exterior surface of the wall of the base may be partially or totally concave

[0071] In some embodiments, one surface of the wall of the base may be flat while another surface of the wall may be convex or concave. For example, in one embodiment, the interior surface of the wall of the base may be generally flat, while the exterior surface of the wall may be concave or convex. Alternatively, the interior surface of the wall of the base may be concave or convex, while the exterior surface of the wall may be generally flat.

[0072] In certain embodiments, both surfaces (i.e. the interior surface and the exterior surface) of the wall of the base may be concave and / or convex. For example, in some embodiments, both surfaces of the wall of the base may be concave or convex. Alternatively, in some embodiments, one of the surfaces of the wall of the base may be concave and the other may be convex.

[0073] In embodiments of the invention, the average thickness of the wall of the base may be about 1mm to about 10mm or about 2mm to about 5mm. In certain embodiments, the average thickness of the wall of the base may be about 1mm to about 4mm. For the avoidance of doubt, where the wall of the base or the lid is provided with reinforcing means in the form of thickened sections, the thickness of those sections should not be considered when determining the average thickness of the wall.

[0074] The wall may extend continuously around the base, i.e. it may connect to itself thus, completely enclosing the interior of the base. As will be explained in more detail herein, such embodiments are advantageous as, along with the remainder of the base and the lid, the interior of the device which, in use, surrounds the first line and the site of entry of the first line into the patient (i.e. the entry site) is completely enclosed. In alternative embodiments, the wall may not continuously extend around the base.

[0075] In certain embodiments, the wall of the base is arranged to allow contact and optionally releasable coupling with the lid. For example, the wall of the base may be configured be connectable with the lid, e.g. the wall of the lid if present. In such embodiments, the connection between the wall of the base and the lid may be water-tight.

[0076] In such embodiments, the interior surface of the wall of the base may be concave while the surface of the wall of the lid facing the exterior of the device may be convex. Alternatively, the interior surface of the wall of the base may be convex while the surface of the wall of the lid facing the exterior of the device may be concave. Still alternatively, the surface of the wall of the base facing the exterior of the device may be convex while the interior surface of the wall of the lid facing the interior of the lid defined by the wall may be concave. In a yet further embodiment, the surface of the wall of the base facing the exterior of the device may be concave while the surface of the wall of the lid facing the interior of the lid defined by the wall may be convex.

[0077] In some embodiments, the wall of the base may be partially or totally manually deformable and elastic thus conveniently facilitating the wall to be manually manipulated with ease in order to releasably connect the base to the lid.

[0078] In certain embodiments, e.g. those in which the base and lid are disconnectable upon the application of manual pressure at specific locations, the base (e.g. the wall of the base) may not be totally manually deformable and elastic, but only selected regions may be manually deformable and elastic, e.g. in specific locations in which manual pressure is to be applied to disconnect the base and the lid.

[0079] This may be achieved through providing weakened or thinner regions of the base and / or lid and / or forming those regions from a more manually deformable material.

[0080] In certain embodiments, the base and / or the lid (e.g. the wall of the base and / or the wall of the lid) may comprise means to facilitate deformation (e.g. at specific locations of the base and / or the lid), such as formations in the wall of the base and / or the lid, such as angled sections, shoulders, hinged regions, and / or curved sections, or the like.

[0081] In embodiments of the invention, the base and / or the lid (e.g. the wall of the base and / or the wall of the lid) may comprise reinforcing means to assist with the base and / or the lid retaining their shape, for example following repeated deformation. Advantageously, the reinforcing means may assist with rendering regions of the base and / or lid less manually deformable which may be preferable in embodiments in which the disconnection of the lid and the base is facilitated by the application of pressure at specific locations. In embodiments, the reinforcing means may take the form of a thickened region (e.g. having a thickness which is at least about 2x, or at least about 3x greater than the average thickness of the wall) or reinforced region of the lid and / or base, a lip extending round the lid and / or base, for example around part or all of the wall of the lid (e.g. at its edge) and / or part or all of the wall of the base (e.g. at its edge), or the like. In embodiments in which the device is provided with reinforcing means, these are preferably shaped to facilitate connection between the base and the lid. In an embodiment, the interior of the base is hollow, and the interior of the base is arranged to provide clearance spacing between a first line extending from a patient and a first end of the connector, wherein the clearance spacing is configured such that the said first line may be connected to the connector and coiled within the interior of the base.

[0082] The interior of the base may be arranged to provide clearance spacing extending around a first line extending from a patient and a first end of the connector, wherein the clearance spacing is configured such that the said first line may be connected to the connector and coiled within the interior of the base. The interior of the base provides a space suitable for accommodating a length of line exiting the patient and for connecting to a first end of the connector.

[0083] Further, the interior of the base may be of a size to accommodate therein any excess or surplus length of the line that is not required in use. For example, the surplus length of line may be coiled or folded inside the interior of the base. In this way, the excess line is kept housed and is not exposed, preventing the line from being caught or snagged in use by the patient or another person. In an embodiment the interior of the base is arranged to provide sufficient space and clearance to permit any excess or surplus length of a separately placed first line to be coiled within the interior of the base prior to attachment to the connector.

[0084] The facility to coil and house the line is advantageous as many lines have standard lengths prior to insertion. Therefore, if the intended target point for the line is relatively superficial within the patient, then there will accordingly be a greater length of the line extending out of the patient than if the target had been deeper. To avoid excess line protruding in an untidy or potentially hazardous way the excess length is neatly coiled within the interior of the base prior to attachment to the connector.

[0085] The space and clearance are such that the line can be accommodated in this coiled arrangement within the interior of the base and then held securely at the connector so that there are no transfer of forces from the second line to the first and vice versa. This means that there is no pulling force exerted on or transferred to the line exiting the patient.

[0086] The base may be of any configuration to provide an interior having a suitable size and shape. As noted above, the interior of the base should be of sufficient size to hold the portion of the first line extending from the patient therein. In one preferred embodiment, the interior of the base is of a size to extend over only a portion of the base, leaving one or more flange regions of the base extending laterally from the wall, for example to provide a means for securing the base to the skin of the patient, as described above. The interior of the base may have any suitable shape.

[0087] The interior of the base comprises an opening (i.e., an aperture) through which the first line may extend. For example, the first line may extend from an opening in the body of the patient into the interior, and then extend from the interior to the connector.

[0088] The base may be entirely opaque. In embodiments, the base comprises at least a portion that is transparent, allowing the interior of the base to be viewed.

[0089] In some embodiments, the connector is mounted directly to the floor of the base, e.g. to the second surface. In other embodiments, the connector may be mounted in the wall of the base.

[0090] The device of the invention comprises a connector which is mounted to the base, e.g. to the wall of the base such that the free end of the first line extending from the patient is connected to the first end of the connector within the interior of the base. A further connection piece may be used to connect the free end of the first line extending from the patient to the first end of the connector within the interior of the base. The connector in an embodiment is fixed and connected to the base, e.g. the wall. A second line may then be connected to the second end of the connector exterior of the base, as described above.

[0091] The connector has a first end, to which the distal end of the first line extending from the patient is connected in use. The connector has a second end, to which is connected an end of a second line. In an embodiment, the connector further comprises a conduit extending between the first and second ends, through which fluids may flow between the first and second lines.

[0092] In this way, a line, such as a drainage catheter may have some or all of the portion external of the patient held within the interior of the base. The line may be connected to a second line via the connector extending from the exterior of the device, through which fluid may be provided to or removed and carried away from the patient in the normal manner. The first and / or second line, in an embodiment, may be connected and optionally physically attached to the base. Thus, in some embodiments of the invention, the first line is used to carry fluid away from a patient, e.g. blood or urine.

[0093] Similarly, a line, such as an intravenous catheter, may have some or all of the portion external to the patient held within the interior of the base. The line may be connected to a second line via the connector extending from the exterior of the device, through which fluid may be provided to the patient in the normal manner. The first and / or second line, in an embodiment, may be connected and optionally physically attached to the base.

[0094] Thus, in some embodiments of the invention, the first line is used to deliver fluid to a patient, for example medicine (e.g. where the first line is an intravenous catheter) or blood (e.g. in a transfusion).

[0095] The connector may comprise any suitable form for its first and second ends for connection to the respective lines. Part of the connector may comprise flexible tubing. It is known that some lines if tightly coiled can kink if the bends are too acute. By providing part of the connector between the first and second ends with flexible tubing this overcomes the problem as it allows the first line to form a less tight coil with a less acute bend, thus minimizing the chances of kinking. The device design prevents any external twisting or kinking forces acting on the drain (e.g., catheter) itself, which reduces / prevents draining occlusion.

[0096] In embodiments, the form of connection at the first and second ends of the connector is such that the lines being connected are not required to be clamped or crushed. This is achieved, for example, by providing the end of the connector and the end of the respective line with suitable interlocking connector portions. Such connector portions are known in the art. Preferably, the first end of the connector comprises a standard Luer connector, more preferably a male Luer connector, for connection to a corresponding Luer connector provided on the first line. Preferably, the second end of the connector comprises a standard Luer connector, more preferably a female Luer connector, for connection to a corresponding Luer connector provided on the second line. Luer connectors and their form, in particular a body having a Luer taper provided therein, are widely used and are well known to the skilled person.

[0097] This means that the first line is physically attached to the base via the connector and the result seen is that no clamping or crushing of the line is required in order to attach the line. The reduction in the occurrence of clamping or crushing prolongs the lifetime of the equipment and improves the safety of the procedure for the patient. The separately placed first line with connector secured at the base and not with a clamp improves equipment lifetime and allows the connector portion to be inside the interior of the base and any excess length of line to be coiled within the interior of the base.

[0098] The connector may be formed from any suitable material. Suitable medical grade polymers are well known in the art. In embodiments of the invention, the body of the connector is formed of nylon. The connector may be formed from a polymer having a greater hardness than the lines or tubes connected thereto. With the connector being connected to the base, in particular in a manner that avoids the connector being clamped or crushed, the need to clamp any part of the series of lines and the connector is avoided. In this way, the risk of occluding or blocking a line through use of the device is avoided.

[0099] Those skilled in the art will be familiar with the different types of lines that may be used with the device of the invention. As used herein, the term "line" should be interpreted broadly and encompasses surgical lines, drainage lines and / or catheter lines or the like. The lines may be formed of any material and be of any size or configuration. In embodiments of the invention, the first line connects an entry site in a patient to the connector mounted in the device of the invention. In some embodiments, the second line connects the connector mounted in the device of the invention to a receptacle, for example a bag.

[0100] In one preferred embodiment, the connector is provided with a means to release the connection of the first line to the second line at a predetermined force. The predetermined force is less than that required to break another connection in the lines and is less than the force required to disturb or dislodge the device from the skin of the patient. In this way, an inadvertent pull on a line, for example as a result of a sharp movement of the patient, does not disturb the placement of the line in the patient, avoiding possible injury to the patient.

[0101] In a particularly preferred embodiment, the connector is provided in the body of the base, e.g. in the wall, with its first end in the interior of the base and its second end exterior of the base and the conduit of the connector extending through the base, e.g. through the wall of the base. In this way, the portion of the first line extending from within the patient is retained wholly within the interior of the base and is connected at its end to the first end of the connector. The second line is connected to the second end of the connector exterior of the base.

[0102] The device may be provided with a single connector. Alternatively, a plurality of connectors, for example two, three or four connectors, may be provided, for example spaced around the device. In this way, the device may provide alternative positions for the lines, so as to best suit the situation of the device and the entry site in the patient. Alternatively, the plurality of connectors may allow the device to be used with more than one line, in particular where a plurality of lines extend from openings in close proximity or when a single line possesses more than one channel.

[0103] The fact that the first line is physically attached to the base via the connector means no clamping or crushing of the line occurs. This configuration allows the device to accommodate various lengths of line, allowing them to be coiled within the interior.

[0104] Lid

[0105] The lid may be arranged to form an enclosure over the base and enclose the opening and / or the interior of the base. In such arrangements, the lid advantageously provides protection for the entry site of the line into the patient, for example protection against infection and / or the entry of foreign materials. In addition, the lid, by extending over and covering the entry site of the line in the patient, prevents the line and its entry site being tampered with, for example by the patient. The lid being releasably connected to the base, allows access to the interior of the device. Access to the interior of the device is required when the separately placed first line is connected and also to permit visual inspection and / or cleaning of the first line, the connector and / or the entry site of the line in the patient.

[0106] Suitable materials for forming the lid include flexible copolymers, for example thermoplastic elastomers (TPEs), which have both thermoplastic and elastomeric properties. Such thermoplastic elastomers include styrenic block copolymers, TPS (TPE-s), thermoplastic polyolefin elastomers, TPO (TPE-o), thermoplastic vulcanizates, TPV (TPE-v or TPV), thermoplastic polyurethanes, TPU (TPU), thermoplastic copolyester, TPC (TPE-E), thermoplastic polyamides, TPA (TPE-A), unclassified thermoplastic elastomers, TPZ. Examples of materials that may be used to produce the lid comprised in the device of the invention include those commercialised under the Mediprene® trade mark by Hexpol. The 500M grade of Mediprene® is particularly preferred. In embodiments, the material from which the base is formed is free of silicone, PVC and / or latex.

[0107] The material from which the base is formed preferably has a Shore A Hardness value of about 0 A to about 100 A, about 10 A to about 80 A, about 15 A to about 70 A or about 20 A to about 60 A when tested in accordance with ASTM D2240.

[0108] The lid may be configured to be releasably connected to the base using any means known to the skilled person. In certain embodiments, the lid may be mechanically connectable to the base. In some embodiments, the lid and / or the base (e.g. the wall of the lid and / or the wall of the base) may be provided with connection means to permit their connection. Such connection means may comprise complementary surfaces which interlock, abut and / or fit contiguously; components which interlock or engage; and / or adhesive coating; or the like.

[0109] In embodiments in which the lid and / or the base are provided with connection means (e.g. on the wall of the lid and / or on the wall of the base), the connection means may be provided with means to enhance connection, for example protrusions (e.g. ribs, stippling, or other formations), treatment (e.g. a coating) with an additive that enhances friction, and / or an adhesive, or the like.

[0110] An issue with certain prior art catheter fixation devices is that they are threadedly connected, requiring a twisting motion to gain access to the interior of the device. The present inventors have recognized that the application of a twisting force to line fixation devices is not preferred as this can result in the transmission of the twisting force to the patient's skin or the entry site which can result in the device being moved, the tube contained within becoming twisted or kinked and / or discomfort or pain being caused to the patient. Therefore, in embodiments of the invention, the base and / or lid of the invention comprise connection means which do not require the application of twisting force to connect or disconnect the base and lid. For example, in embodiments, the connection means may not be threaded.

[0111] In some embodiments, the lid comprises a wall. The wall may define an interior of the lid (e.g. via an interior surface) and an exterior of the lid (e.g. via an exterior surface). The wall of the lid may be shaped to engage or abut the wall of the base to facilitate a releasable connection (which is preferably water-tight) between the lid and the base. In embodiments, at least a portion of the wall is manually deformable and elastic. In certain embodiments the entirety of the wall is manually deformable and elastic. In certain embodiments, at least a portion of the wall of the base and the wall of the lid are manually deformable and elastic.

[0112] The lid may comprise an upper panel comprising an outer surface and an inner surface. The inner surface and / or the outer surface of the upper panel of the lid may be generally planar which advantageously renders the lid less challenging to manufacture on a commercial scale, as compared to the dome shaped device of EP2768566. In use, the inner surface of the panel, when the lid is connected to the base may be disposed towards the skin of a patient and may further define the interior of the lid. The outer surface, in use, faces away from the skin of the patient, and defines the exterior of the lid.

[0113] In embodiments of the invention, the upper panel and the wall of the lid may be integrally formed. The integral formation of the lid is advantageous as this simplifies manufacture of that component which does not require assembly and / or can be manufactured in a single molding operation.

[0114] In embodiments in which the wall extends from the lid (or components such as the upper panel, optionally its inner surface), the wall may extend therefrom generally perpendicularly.

[0115] Additionally or alternatively, the wall may partially or totally extend from the lid (or components thereof such as the upper panel, optionally from the inner surface of the upper panel) around the edge of the lid or such components.

[0116] In embodiments of the invention, the interior surface of the wall of the lid (i.e. that enclosing the interior of the lid) may be partially or totally generally flat. Additionally or alternatively, the interior surface of the wall of the lid may be partially or totally convex. In some embodiments, the interior surface of the wall of the lid may be partially or totally concave.

[0117] In some embodiments, the exterior surface of the wall of the lid (i.e. that facing away from the interior of the base, defining the exterior of the lid) may be partially or totally generally flat. Additionally or alternatively, the exterior surface of the wall of the lid may be partially or totally convex. In some embodiments, the exterior surface of the wall of the lid may be partially or totally concave

[0118] In some embodiments, one surface of the wall of the lid may be generally flat while another surface of the wall may be convex or concave. For example, in one embodiment, the interior surface of the wall of the lid may be generally flat, while the exterior surface wall of the lid may be concave or convex. Alternatively, the interior surface of the wall of the lid may be concave or convex, while the exterior surface of the wall of the lid may be generally flat.

[0119] The wall may extend continuously around the lid, i.e. it may connect to itself thus, completely enclosing the interior of the lid defined by the wall. As will be explained in more detail herein, such embodiments are advantageous as, along with the remainder of the lid and the base, such configurations result in the complete enclosure of the interior of the device (save for any openings in the lid) when assembled. In alternative embodiments, the wall may not continuously extend around the lid.

[0120] In certain embodiments, the wall of the lid is arranged to allow contact and optionally releasable coupling with the base. For example, the wall of the lid may be connectable with the base, e.g. the wall of the base. In such embodiments, the connection between the wall of the lid and the base may be water-tight.

[0121] In some embodiments, the wall of the lid may be partially or totally manually deformable and elastic thus conveniently facilitating the wall to be manually manipulated with ease in order to releasably connect the lid to the base.

[0122] In some embodiments, one surface of the wall of the lid may be flat while its other surface may be convex or concave. For example, in one embodiment, the interior surface of the wall of the lid may be flat, while the exterior surface of the wall of the lid may be concave or convex. Alternatively, the interior surface of the wall of the lid may be concave or convex, while the exterior surface of the wall of the lid may be generally flat.

[0123] In certain embodiments, both surfaces (i.e. the interior surface and the exterior surface) of the wall of the lid may be concave and / or convex. For example, in some embodiments, both surfaces of the wall of the lid may be concave or convex. Alternatively, in some embodiments, one of the surfaces of the wall of the lid may be concave and the other may be convex.

[0124] In embodiments of the invention, the average thickness of the wall of the lid may be about 1mm to about 10mm or about 2mm to about 5mm. In certain embodiments, the average thickness of the wall of the lid may be about 1mm to about 4mm. The lid may be entirely opaque. In a preferred embodiment, at least a portion of the lid is transparent, allowing the interior of the device to be viewed. For example, the lid may comprise a viewing port. The viewing port may comprise an opening in the lid, e.g. in the upper panel of the lid into which is mounted a body of transparent material. The inclusion of a viewing port is particularly advantageous as it allows the condition of the entry site of the line into the patient, the first line and / or the connector to be readily inspected. The lid may also be entirely transparent.

[0125] In a preferred embodiment, the lid and / or base is provided with one or more openings therein to provide ventilation to the interior of the device.

[0126] In embodiments, the openings may comprise a filter, for example an air filter. The air filter may be replaceable. The air filter may be sterile, antibacterial and / or a High Efficiency Particulate Air (HEPA) filter. In preferred embodiments, the filter may be a medical grade filter. The use of an air filter allows ventilation to occur whilst preventing particulates from entering the interior of the device, therefore, preventing infection.

[0127] In another preferred embodiment, the lid and / or base comprises a moveable plug configured to fit over the one or more openings in the lid and / or base. When in use, the plug can be moved to fit over the openings, such that the openings are closed, preferably water-tightly. This integral system provides the benefit of making the device water resistant. Beneficially, patients can shower with confidence and ease, and further waterproofing of the device is unnecessary (i.e., the user or healthcare provider does not need to cover up the device). The plug can be moved back to its original position, thus restoring ventilation to the interior.

[0128] In embodiments, the plug may be formed from the same or a different material than the remainder of the lid and / or base. In embodiments in which the plug is formed of a different material to the remainder of the lid and / or base, it may be formed from a material having a higher Shore A Hardness rating than the material from which the lid and / or base is formed.

[0129] The lid may be configured to accommodate the passage therethrough of the connector. For example, the lid, e.g. in a component thereof such as the wall, may comprise a connector port to accommodate the connector mounted in the base. In use, the first line may be curled within the interior of the base before being connected to a first end of the connector within the interior of the device. The lid may then be reversibly connected to the base. A drainage bag can then be connected to the second end of the connector via a second line.

[0130] Assembled Device

[0131] When the base and the lid are connected, they define an interior of the device. The interior of the device is defined by one or more of the interior surface of the wall of the base, the interior surface of the wall of the lid, the second surface of the floor of the base, and the inner surface of the upper panel of the lid. The exterior of the device is defined by one or more of the exterior surface of the wall of the base, the exterior surface of the wall of the lid, the first surface of the floor of the base and the outer surface of the upper panel of the lid.

[0132] The device may have a length along its longest dimension of about 200mm or less, about 150mm or less, 100mm or less, about 90mm or less, or about 80mm or less. Preferably, the device has a length along its longest dimension of about 75 to 85mm, more preferably the device has a length of about 80mm.

[0133] The device may have a width, e.g. a dimension generally perpendicular to the length of the device, of about 150mm or less about 100mm or less, about 85 mm or less, about 75mm or less, or about 65mm or less. Preferably, the device has a width of about 60 to 70mm, more preferably the device has a width of about 65mm.

[0134] The device may have a height, e.g. a dimension from the lower surface of the base to the upper surface of the lid of about 50mm or less about 30mm or less, about 20mm or less, about 18mm or less, or preferably about 15mm or less. Preferably, the device may have a height of about 10 to 14mm, more preferably the device may have a height of about 12mm.

[0135] The interior of the device, when assembled, may comprise the interior of the base and the interior of the lid. The first end of the connector is preferably located within the interior of the device, when assembled.

[0136] As noted above, portions of the base and / or the lid are manually deformable and elastic. This permits the convenient and reversible manual connection between these components. However, advantageously, the device is configured such that when the base and the lid are connected, the device has intrinsic strength, forming a relatively rigid shell enclosing the interior of the device and protecting it from compressive forces that would otherwise damage, compress or kink the line comprised therein, or cause pain or injury to the patient. Thus, the device of the invention provides protection for the line (e.g., catheter) and the patient.

[0137] In embodiments of the invention, as demonstrated in the accompanying examples, the base and / or the lid may be configured to be disconnected from each other when pressure is applied at one or more specific locations of the connected device. In some embodiments, the base and / or the lid may be configured to be disconnected from each other when pressure is applied at two or more specific locations of the connected device.

[0138] For example, the base and / or lid may be shaped to determine or facilitate disengagement when pressure is applied at a specific location. For example, in embodiments in which the device is ovoid (e.g. as shown Figure 6), when lateral compressive forces are exerted (e.g. as shown in Figure 8C), the apex of the device will be the first site of disengagement of the lid. Thus, in embodiments of the invention, the device may be ovoid, oval, tear-shaped, pear- shaped or similar. In some embodiments, the device, as viewed from above, comprises lateral walls (e.g. to which manual pressure is applied to open the device) connected by an apex (e.g. which is the first site of disengagement of the lid from the base).

[0139] Alternatively, in some embodiments, e.g. in applications in which the straightforward removal of the lid (e.g. by the patient) may not be desirable (for example, when used on a child) the device may a substantially circular shape. This configuration requires additional forces, for example, forces applied between the lid and the base to prise the lid off the base. In some embodiments, the lid and the base may require a tool to be disengaged.

[0140] Advantageously, configuring the device in this way ensures that the base and the lid will not be disconnected during normal use of the device, but only when pressure is applied at specific locations. Those skilled in the art, with the benefit of the disclosure herein of various features that may improve resilience or enhance manually deformability at different regions of the components of the device, as well as their common general knowledge, will identify embodiments (in addition to those exemplified in the present disclosure) in which the base and lid may be disconnected upon the application of pressure at one or more specific locations without undue burden.

[0141] In such embodiments, the specific location / s may be marked with indicia (e.g. target circles or finger print images) to demonstrate the location of these region / s to the user.

[0142] Those skilled in the art will recognize that the use of different materials to produce the base and lid will mean that the thickness of those components needed to resist compressive force will vary. However, in embodiments of the invention in which the wall of the base and the lid are contiguous with each other when the base and the lid are connected, the combined thickness of the wall of the base and lid is from about 2mm to about 20mm, from about 3mm to about 15mm or from about 4mm to about 10mm. In certain embodiments, the combined thickness of the wall of the base and the lid is from about 2mm to about 6mm.

[0143] Additionally or alternatively, the thickness of the lid, e.g. the upper panel, may be about 2mm to about 20mm, from about 4mm to about 15mm or from about 5mm to about 10mm. In certain embodiments, the thickness of the upper panel of the lid may be about 1mm to about 6mm. Additionally or alternatively, in embodiments, the thickness of the upper panel of the lid is greater than the average thickness of the wall of the lid.

[0144] The intrinsic strength of the assembled device means that when, in use on a patient's skin, and force is applied to the device, there is only minimal deformation of the device.

[0145] In addition to its ease of connection, a further advantage of the use of manually deformable and elastic components in the device of the invention is that this provides the device with a degree of flexibility permiting forces to dissipate through the device. For example, in cases where the second line is connected to a drainage bag that is accidentally dropped, force dissipates through the device and then through to the patient's surrounding skin. Thus, no singular force acts directly on the first line or the entry site. This allows the device to remain in place, preventing inadvertent dislodgment.

[0146] In embodiments of the invention in which the wall of the base and / or lid are partially or totally manually deformable and elastic, this conveniently permits disconnection of those components through the application of lateral squeezing pressure by the fingers of a medical practitioner or the patient themselves, resulting in the lid being easily removable. Notably, this very specific squeezing action would not be a force that would be encountered whilst wearing the device, when only shear and compressive forces will be encountered. Beneficially, the device only allows access to the interior of the device when a deliberate movement is applied.

[0147] In certain embodiments, when not connected, the base and the lid may be separate components. Alternatively, they may be hingedly joined or connected by a cord or some other means.

[0148] The device of the invention advantageously permits repeated access to the interior thereof, e.g. to enable a user or medical professional to view or clean the entry site, without damage being caused to the device, the first line and / or the patient. Accordingly, the device of the invention may be used for prolonged periods of time, e.g. about 1 or more days, about 2 or more days, about 3 or more days, about 1 or more weeks, about 2 or more weeks. In embodiments of the invention, the device may be formed of material which is sterilisable (e.g. using steam, ethylene oxide (ETO) sterilisation or gamma irradiation) permiting its re-use.

[0149] Method of Application

[0150] According to a further aspect of the present invention, there is provided a method of fiting a line fixation device to a patient having a line extending from an entry site in the body of the patient comprising: i) feeding the line through the opening in the base of the device as described herein, ii) affixing the base to the body of the patient, iii) connecting the line to a first end of the connector mounted in the base, and iv) connecting the base to the lid of the device as described herein.

[0151] For the avoidance of doubt the steps of the method may be performed in any order.

[0152] In certain embodiments, the method may additionally comprise the step of connecting a second line to the second end of the connector.

[0153] In some embodiments, the method may further comprise the step of manually disconnecting the base and the lid to provide access to the interior of the device, and optionally performing a cleaning operation on the device, the first line and / or the patient. Such steps may be followed by the base and the lid being reconnected. Examples

[0154] Example 1 (Prior Art)

[0155] The device generally indicated as (2) is secured to the skin (4) of a patient. The device (2) comprises a base (6) having a first surface (8) disposed against the skin (4) and a second, exposed surface (10). The base (6) is provided with a layer (12) of medical grade adhesive on its first surface (8) to secure the device to the skin of the patient. Additionally, the device may be secured by means of adhesive tape applied to the edge portion of the second surface (10) and the adjacent skin (4) and / or by means of sutures extending through suitable openings (14) in the base. The base (6) is provided with an opening (16) at its centre.

[0156] The base (6) of the device comprises a curved wall (20) extending upwardly therefrom. A connector (34) is retained in a recess (32), with a first end (36) disposed within the interior of the device and a second end (36) located exterior of the recess (32). The first end (36) of the connector (34) is connected to a first line (44) which passes into the body of a patient (40), while the second end (38) of the connector (34) is connected to a second line (46) which carries fluid drained from the patient to a drainage bag (not shown).

[0157] The illustrated device further comprises a lid (22) which is releasably connected to the base (6) via a threaded flange (24). The lid (22) is provided with transparent sections (26) separated by ribs (28). To remove the lid (22) from the base (6), the lid (22) must be gripped by the user and rotated which may be undesirable as this is a dextrous action which can be challenging, and also imparts a twisting force to the patient's body and entry site which can potentially dislodge the first line (40, 44). While the material from which the lid (22) and wall (20) of the base (6) are formed are not specified in EP2768566, those skilled in the art will recognise that these components must be rigidly formed in order to permit i) the lid to be gripped with sufficient strength to permit connection / disconnection with the base, and ii) for the threading to function effectively and provide a tight closure.

[0158] Example 2

[0159] A cross-section view of a base (106) of an embodiment of the present invention is shown in Figure 2. The base (106) is provided with a floor having a lower, first surface (108) which, in use, will be applied to the skin of the patient, and an upper surface (110) from which the wall (120) upwardly extends generally perpendicularly. The position at which the wall (120) extends is inset from the outer edge of the floor, providing a flange region between the outer edge of the floor and the wall (120) which maximises the surface area of the base which will be applied to the patient, thus facilitating a stronger connection. The wall (120) is continuous and, along with the floor of the base (108, 110) defines an interior of the base (106). The base (106) is provided with an opening (116).

[0160] The base (106) is formed from a thermoplastic elastomer (TPE) commercialised under the Mediprene® trade mark commercialised by Hexpol. which is manually deformable and elastic. The wall (120) is provided with features to facilitate deformation, namely a shoulder (150). The exterior surface of the wall (120) has a convex shape with respect to the interior of the base (106) and is also provided with means to enhance connection with the lid, namely three ribs (152). The wall is also provided with a collar (154) into which the connector (not shown) can be mounted.

[0161] The wall (120) is formed integrally with the floor of the base (106) which advantageously permits the simple manufacture of the base (106) using a single moulding operation.

[0162] Example 3

[0163] A perspective image of an alternative base (106) is shown in Figure 3. This base (106) is similar to that shown in Figure 2, except that the wall (120) is provided without ribs and a connector (134) is mounted into the collar (154).

[0164] A lid (122) for use with the base (106) shown in Figure 3 is shown from above in Figure 4. The lid comprises an upper panel (160) comprising an upper surface visible in the figure and a lower surface (not shown) which encloses an interior (also not shown). The lid (122) comprises a continuous wall (162) which extends around the edge of the upper panel (160) and also encloses the interior. The inner surface of the wall (162) is concave with respect to the interior defined by the wall (162) and is shaped to be contiguous with the outer surface of the wall (120) of the base (106) which is convex with respect to the interior defined by the base (106).

[0165] The upper panel (160) of the lid (122) is provided with a plurality of openings (164) which provide ventilation to the interior of the device. Conveniently, the upper panel (160) is also provided with a moveable plug (166) which permits the openings to be temporarily closed. This permits the device, when in use on the skin of the patient, to be closed so that the user can wash the skin around the entry site without the line fixation device having to be separately enclosed or changed.

[0166] To permit the user or a medical professional to inspect the site of entry of the line or the condition of the line (e.g. to ensure that it is not occluded or kinked), the lid (122) is also provided with a viewing port (168).

[0167] The lid (122) is also provided with a connector port (170) to permit the connector (134) mounted in the wall of the base to pass through the wall (162) of the lid (122).

[0168] In Figure 5, the lid (122) is shown from below. Many of the features shown in Figure 4 are visible. Additionally, this figure shows that the interior surface of the wall (162) has a concave shape, and the wall is configured to fit contiguously with the convex outer surface of the wall of the base to form a releasable coupling. Additionally, a reinforcing member in the form of a lip (172) extending around the edge of the wall is provided which not only assists with the lid (122) retaining its shape but is also configured to fit contiguously against the wall of the base, thus strengthening the connection with the base when the base and the lid are connected.

[0169] The wall (162) is formed integrally with the upper panel (160) of the lid (122) which advantageously permits the simple manufacture of the lid (122) using a single moulding operation.

[0170] Figure 6 shows the assembled device, with the lid and base being releasably connected.

[0171] Figures 7A to 7D demonstrate that when not connected, the base (Figures 7A and 7B) and the lid (Figures 7C and 7D) are easily manually deformable which advantageously permits the positioning and manipulation of those components by the user. However, as shown in Figures 8A and 8B, when the base and lid are connected, the device exhibits intrinsic strength against compressive forces which would otherwise compress or kink the line, or potentially cause pain or tissue damage to the user.

[0172] Advantageously, as shown in Figure 8C, the device is configured to permit disconnection of the base and the lid through the application of manual pressure at two specific locations. This application of manual pressure in these specific locations provide force to which the device would not be exposed whilst the user is wearing the device, when only shear force and compressive force from above the device would be encountered. By configuring the device in this way, disconnection of the base and lid to provide access to the interior of the device is permitted when a particular deliberate pressure is applied that will not occur in normal use. In conventional use of line fixation devices, significant pulling forces may be applied to the second line. For example, where the second line is connected to a catheter drainage bag, that bag may hold around 1 litre of fluid, and thus have a mass of around 1 kilogram. To test the ability of the device of the invention to resist such pulling forces and prevent the removal or dislodgement of the first line connecting the device of the invention to the patient, the device of this example was connected to a 0.5 metre length of tube which was connected at one end to the device of the invention which was adhered to the abdomen of a subject and at the other end to a catheter bag containing 1 litre of water. The subject then stood and the bag was allowed to drop. Despite the pulling force applied to the tube and the connector, the device remained adhered to the patient without being moved.

Claims

CLAIMS1. A first aspect of the present invention relates to a device for supporting a separately placed line, the device comprising:(i) a base having an opening therein for receiving a separately placed first line extending from a patient; wherein the base comprises: a connector mounted to the base and having a first end for connection to an end of the said first line and a second end for connection to a second line; and a wall extending from the base, wherein the wall defines an interior of the base and an exterior of the base, and wherein the wall is arranged to releasably connect with a lid, wherein the connector extends through the wall, the first end of the connector being within the interior of the base and the second end of the connector being within the exterior of the base;(ii) a lid arranged to form an enclosure over the interior of the base and enclose the opening in the base, wherein at least a portion of the wall and / or at least a portion of the lid are manually deformable and elastic, and wherein when the lid is releasably connected with the base, the device has intrinsic strength against compressive forces.

2. The device of Claim 1, wherein the base comprises a floor having a first surface which further defines the exterior of the base and a second surface which further defines the interior of the base.

3. The device of Claim 2, wherein the wall of the base extends generally perpendicularly from the second surface of the floor.

4. The device of Claim 2 or Claim 3, wherein the floor comprises a flange region between the edge of the floor and the location at which the wall extends from the floor.

5. The device of any one of Claims 1 to 4, wherein the wall comprises an interior surface and an exterior surface.

6. The device of Claim 5, wherein one of the interior or exterior surfaces of the wall is convex.

7. The device of Claim 5 or 6, wherein one of the interior or exterior surfaces of the wall is concave.

8. The device of any one of Claims 5 to 7, wherein both of the interior and exterior surfaces of the wall are independently convex or concave.

9. The device of any one of Claims 1 to 8, wherein the lid comprises a wall.

10. The device of Claim 9, wherein the wall comprises an interior surface defining an interior of the lid and an exterior wall defining an exterior of the lid.

11. The device of any one of Claims 1 to 10, wherein the lid comprises an upper panel comprising an outer surface defining an exterior of the lid, and an inner surface defining an interior of the lid.

12. The device of Claim 11, wherein the wall of the lid extends generally perpendicularly from the inner surface of the upper panel of the lid.

13. The device of Claim 10, wherein one of the interior or exterior surfaces of the wall of the lid is convex.

14. The device of Claim 10 or 13, wherein one of the interior or exterior surfaces of the wall of the lid is concave.

15. The device of any one of Claims 10, 13 or 14, wherein both of the interior and exterior surfaces of the wall of the lid are independently convex or concave.

16. The device of any one of Claims 9 to 15, wherein the wall of the base and the wall of the lid are shaped to engage or abut each other to provide a releasable connection.

17. The device of any one of Claims 1 to 16, wherein the base and / or the lid are configured to be disconnected from each other when pressure is applied at one or more specific locations on the base and / or the lid.

18. The device of Claim 17, wherein the device comprises two lateral walls at which pressure is to be applied, wherein the lateral walls are joined by an apex.

19. The device of any one of Claims 1 to 18, wherein the base is provided with a layer of adhesive, optionally covered by a release liner.

20. The device of any one of Claims 1 to 19, wherein the base and / or lid are provided with means to facilitate deformation.

21. The device of any one of Claims 1 to 20, wherein the base and / or the lid are provided with reinforcing means.

22. The device of any one of Claims 1 to 21, wherein the lid and / or the base comprises one or more openings to provide ventilation into the interior of the device.

23. The device of Claim 22, wherein the device further comprises a movable plug capable of reversibly closing the one or more openings.

24. The device of any one of Claims 1 to 23, wherein the base and / or the lid are formed of an elastomeric material having a Shore A Hardness value of about 50 A to about 80 A when tested in accordance with ASTM D2240.

25. A method of fiting a line fixation device to a patient having a line extending from an entry site in the body of the patient comprising: i) feeding the line through the opening in the base, ii) affixing the base to the body of the patient, iii) connecting the line to a first end of the connector mounted in the base, and iv) connecting the base to the lid of the device.

26. The method of Claim 25, further comprising the step of connecting a second line to the second end of the connector.

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