SE1550518A1 - Tube fixation device - Google Patents

Abstract

The present invention relates to a tube fixation device, such as a chest tube fixation device. The tube fixation device according to the invention provides an improved way of securing a drainage tube to a patient's body thereby avoiding kinking of the tube. The structure of the device also provides an improved way of absorbing any excreted body fluids from the area around the drainage entry. The structure also prevents air leakage around the chest tube and compresses and stops bleeding from the skin incision. The introduction of the tube fixation device according to the invention will simplify the procedure of fixating tubes, such as chest tubes and reduce the time from skin incision to chest tube fixation and avoid some of the complications. That makes it. very suited for trauma patients in immediate need of chest drainage, especially in challenging environments such as prehospital, battle-field, remote areas and emergency departments.

Description

TUBE FIXATION DEVICE TECHNICAL FIELD The present invention relates to the field of medical devices foruse in surgical procedures, in particular medical devices for aidingin procedures involving draining of gases and fluids from body cavities in a trauma setting.BACKGROUND OF THE INVENTION Trauma is one of the leading causes of death worldwide (5.l million deaths in 2010) and can be characterized as a global epidemicbecause it accounts for one in every l0 deaths. Patients withmultiple blunt injuries are far more common in civilian practice,but both penetrating and blunt trauma present significant challengesto national health care systems and necessitate a policy action toprevent them. Chest injury is the direct cause of death in 25% ofblunt trauma victims and a contributing factor in up to another 50%of trauma deaths, which can be explained by the large number ofmotor vehicle crashes and falls. Serious consequences of chesttrauma are pneumothorax and/or haemothorax, potential life-threatening conditions that sometimes requires immediate treatmentwith chest drainage (i.e. thoracostomy) to prevent patient death.Between l8% and 40% of patients sustaining thoracic trauma can betreated with chest tubes alone. A thoracotomy (i.e. a largerincision commonly used to gain access to organs within the chest)will only be required for between 3% and 9% of patients. Even amongthose with penetrating trauma, only l4% of stab wounds and betweenl5% and 20% of gunshot to the chest require thoracotomy. Inconclusion, most chest trauma patients can be managed with chest tubes.

Chest tube thoracostomy is a common and very useful therapeutic procedure. It is indicated in pneumothorax with or without tension, traumatic haemothorax, haemopneumothorax, etc. However, it is not without risk, especially when aggressively used in trauma patients.After placement, the chest tube position may be altered if the drainis not secured tightly to the chest. Different techniques have been described for anchoring chest tubes, but have various disadvantages.

Previous art has shown that a surgical tape can be used to cover theincision and anchor the tube close to the chest wall and an omentaltag of tape can hold the tube close to the chest wall, allowing somemotion of the tube without kinking. Additionally, the accessorytubing can be pinned to the hospital bed for more security. However,the problem with using surgical tape in trauma patients is thatblood and sweat on the skin often prevent a decent grip. A morecommon technique is to anchor the drain to the chest with sutures.Still, There are numerous ways of doing this. the technique requires a suture-kit, clinical experience in stitching and is time- consuming.

In general chest tube complications are categorized as insertional, positional or infective. More specifically, pain, vascular injury, improper positioning of the tube, inadvertent tube removal, postremoval complications, longer hospital stays, empyema and pneumonia have been reported in up to 30% of cases.

Today there are several solutions on the market. One “homemade”solution is to use a defibrillation pad and tape it around the chesttube. Commercial solutions of surgical tape are similar and use somekind of adhesive dressing that surrounds the chest drain. Ininterventional radiology smaller chest catheters are often insertedinto the pleural cavity and fixated with some kind of lockingmechanism. Still, the most common fixation method is to suture thedrain to the chest.described in US 2014/0031753, 2006/02572, and GB 2l60776.

Examples of tube fixation devices are also WO 9325264, CN 202892621, US If the patient is stable and the chest drain is inserted at thehospital under optimal conditions different “surgical tapes” will beStill, sufficient to secure the drain. if the patients moves and/or pulls the drain it may very well be dislodged. In trauma patientsthe surgical tape will often not fasten due to blood and sweat onthe skin. This allows for inadvertent tube removal and considerableleakage of air around the chest tube. An addition problem is kinkingof the drain underneath tape/dressings. This may remain unrecognizedby health care providers until the patients get unstable. Suturing techniques requires experience, a suture-kit and is above all time- consuming. The latter is a problem in unstable trauma patients in rapid need of transportation to hospital. Therefore, tubethoracostomy is not performed or delayed in some critical situations.

In conclusion, sutures are an adequate method to secure chest tubes in injured patients, but it is time-consuming, requires a suture-kit and clinical experience/skills.

Hence, there is still a need in the art to provide improved medicaldevices for providing an easier and more straightforward manner toperform drainage of fluids and gases from mammalian bodies, especially in time-critical situations and in non-hospital settings.SUMMARY OF THE INVENTION The present invention solves or at least mitigates the above citedproblems by providing a tube fixation device for maintaining a tubeinserted into a mammalian body in a releasably fixated position,wherein said tube fixation device comprises a tube receiving elementadapted to receive said tube; a fastening element arranged inconnection to said tube receiving element and wherein said fasteningelement is adapted to releasably fixate said tube when said tube isarranged in said tube receiving element; and a supportive elementattached to said tube receiving element and adapted to be positionedon a surface area of said mammalian body. The supportive elementcomprises a layered structure, wherein the layered structurecomprises at least a ductile layer comprising a ductile material.The ductile layer is configured to be shapeable to conform to athree-dimensional shape of the surface area on the mammalian body.Further, the ductile layer is configured to essentially maintain the obtained three-dimensional shape.

In addition, the invention relates to a kit comprising a tube fixation device, and further comprising at least a device forapplying surgical staples or stitches, a tube and instructions for USG .

The invention also concerns a method for maintaining a tube inserted into a mammalian body in a releasably fixated position comprising arranging said tube into a device and thereafter fastening said tube through said fastening element.

Notably, the device as presented herein is particularly suitable forfixation of a chest tube which has been inserted into a mammalian body.

BRIEF DESCRIPTION OF THE DRAWINGS Figures la and lb show a schematic perspective of a side view of a device according to the present invention.

Figures 2a and 2b show a schematic perspective of a top view of a device according to the present invention.

Figure 3 shows a bottom view of a supportive element (adhesive layer) according to one embodiment of the present invention.

Figure 4 shows a side view of a device according to one embodiment of the present invention.

Figure 5 shows a cross-section of a tube receiving element, afastening element and a supportive element according to one embodiment of the invention.

Figures 6a-b show perspective views of from a top side and bottom side, respectively, of a device according to one embodiment of the invention.

Figures 7a-b show a schematic side view and a top view,respectively, of a device according to according to one embodiment of the invention.

Figures 8a-d shows different views of another embodiment of the device according to the invention.

Figure 9 shows an illustration of insertion of a tube for subsequent fixation with a tube fixation device according to the invention.

Figures lOa and lOb show two different examples of a kit comprising a tube fixation device.

Figure ll shows a tube fixation device according to one embodiment of the invention when attached in position.

Fig 12 shows a tube fixation device according to another embodiment of the invention.

Figure l3a and l3b show a ductile layer of a supportive element in a tube fixation device according to one embodiment of the invention.

Figure 14 shows a tube fixation device according to yet another embodiment of the invention.

DETAILED DISCLOSURE OF THE INVENTION The present invention concerns a tube fixation device (1) formaintaining a tube (2) inserted into a mammalian body during adrainage procedure. The tube fixation device comprises a tubereceiving element adapted to receive said tube; a fastening elementarranged in connection to said tube receiving element and whereinsaid fastening element is adapted to releasably fixate said tubewhen said tube is arranged in said tube receiving element; and asupportive element attached to said tube receiving element andadapted to be positioned on a specified surface area of saidmammalian body. The supportive element comprises a layeredstructure, wherein the layered structure comprises at least aductile layer comprising a ductile material. The supportive elementcan comprise one or several further layers, such as an absorbent layer, a flexible layer, and/or an adhesive layer. In someembodiments the supportive element can also comprise further layers,such as a sealing layer and/or an anti-infective layer. These will be described in detail below.

The device allows anchoring of tubes, such as chest tubes to thepatient's chest without the need of time-consuming and technicalchallenging suture techniques. Its ease to use will save time incritical situations and the device is designed to be applied in aquick and easy manner. The fixation of the tube avoids kinking thereof, and use of staples or stitches and/or an adhesive further provides a more time efficient manner of attaching the device.

Blood and sweat from the skin will be removed by components of thedual core system of a preferred embodiment of the device (l).

Herein, a dual core system refers to a layered structure including an absorbent layer and ductile layer forming part of the supportive element (5) for the tube fixation device (l). The dual core is capable of absorbing blood, sweat and other bodily fluids.

The ductile layer may comprise a plate, such as a metal or plastic plate, for better fitting of the device to a part of the body, such as the chest, of a subject. Herein, the word ductile refers to any material which contributes the characteristics of the ductile layer,and thereby the supportive element, being able to conform to athree-dimensional shape under certain pressure and essentiallymaintain the resulting shape after pressure is removed. Or, phraseddifferently, the ductile layer is adapted to be shapeable under certain applied pressure to conform to, i.e. follow the contours of, the three-dimensional shape of the surface area on the mammalianbody. Further, the ductile layer will also essentially maintain theobtained three-dimensional shape after the pressure is removed. In other words, a ductile layer in a tube fixation device will allow a user to apply the tube fixation device by pressing down, e.g. by pressing with his/her hands, on the supportive element, such that the ductile layer, and thus the supportive element, will adapt to the three-dimensional shape of the underlying body part, e.g. achest area. When the applied pressure is removed, the ductile layer,and thus the supportive element, will essentially maintain thethree-dimensional shape of the underlying body part. Thiscontributes to providing pressure on the underlying mammalian body.Further, if needed, by applying pressure to the supportive elementagain, the ductile layer can be re-shaped to a new three-dimensional shape.

Thus, the ductile layer ensures a tight interaction between the supportive element and the surface application area on the mammalianbody, both during application of the device, and throughout the timeperiod during which the chest tube fixation device is maintained onthe mammalian body. The ductile layer also provides for a durable supportive element, which is an advantage under harsh conditions, such as applying a chest tube fixation device at an accident site, under emergency transport or in a military field setting.

Preferably, the ductile layer is a layer with a surface areacorresponding essentially a majority of the surface area of thesupportive element, such that the major part of the supportiveelement can be shaped to follow the curvature of the underlying body.

In a preferred embodiment, a tube fixation device according to theinvention is also provided with an absorbent layer as one of the layers in the supportive element. The absorbent layer is preferablyadapted to be arranged below or under said ductile layer in relationi.e. closer to the skin of the patient than (24) to said mammalian body, the ductile layer. The absorbent layer provides for theabsorption of any body fluids excreted from or present around theentry area of the tube drainage. In addition, a supportive elementcomprising both a ductile layer and an absorbent layer provides foreffectively lessening or even preventing bleeding from the skinincision, based on the absorbing layer absorbing fluids and thecompressive force due to the ductile layer. In such an embodiment,the ductile layer and the absorbent layer preferably form layers ofessentially the same surface area within the supportive element, andpreferably the size and shape of the respective surface areas correspond to each other.

In a preferred embodiment, the ductile layer is essentially or completely impermeable to any fluids and other contaminants. Thisarrangement will prevent any fluids from soaking through all thelayers of the supportive element. Thus, any body fluids stemmingfrom the wound site will be contained under the ductile layer.such as rain, dirt, Likewise, any fluid or other contaminants, bacteria etc., will be kept away from the wound site. Hence, animpermeable ductile layer has the advantage of being an importanthygienic precaution to protect the users of the device to get incontact with foreign body fluids, and to preserve sterility of the wound site.

In some embodiments, a flexible layer is arranged in the supportive element. This flexible layer is then arranged above or over theother layers, such that the flexible layer provides both overallflexibility of the supportive device, and also protects the other layers and the wound site. In one embodiment, the flexible layer is made of a waterproof and/or wear-proof material, such that the woundsite and the underlying ductile and absorbent layers are sealed offhence and protected from rain, wind, dirt, bacteria etc.; contamination of the wound site is reduced or avoided, similarly to the ductile layer being impermeable, as described above. Preferably,the flexible layer covers at least the same surface area as thealso at least the same surface area ductile layer and, if present, as the absorbent layer.

The flexible layer can further be provided with a rim extendingbeyond the other layers, which thus allows for fastening of thedevice to the body by stitches or staples through the rim (22) of the flexible layer (see Figure lb and below). This provides for quick and secure attachment of the device to the patient. In such anembodiment, the flexible layer thus covers a surface area extending beyond the surface area of any underlying layers.

In a preferred embodiment of the invention, the tube receiving element (3) and the supportive element (5) are tightly attached to each other, which provides for sealing of any leakage of air or fluid outside the tube receiving element (3). In one embodiment, thetube receiving element is continuously connected with the ductilelayer, either by being molded as one piece, or welded or glued together such that they form a continuous part. This is furtherdescribed below.(3), will be further addressed below.

Further, sealing within the tube receiving element i.e. around the tube (2) inside the tube receiving element (3), Furthermore, usage of staples to secure the tube fixation device (l) to the skin of the patient may further prevent the tube (2) from dislodging when the patient moves or is being transported. This is especially true when also using an adhesive layer, as described below. Therefore, the tube fixation device (l) according to the invention is particularly useful to use in emergency clinical or pre-hospital situations as it is faster than conventionalprocedures. The time required is considerable less than thetechniques available today. Preliminary animal trials indicate thatthe time required in one third of the normal stitching technique (Oveland et al, SEARCH 20l3).

In the below the device will be further described with reference tothe figures. Throughout the figures the same or similar functions/items have been given the same reference signs.

Figure la illustrates a side view of a tube fixation device (l) formaintaining a tube (2) inserted into a mammalian body in areleasably fixated position, said tube fixation device (l)comprising a tube receiving element (3) adapted to receive said tube (2) (not shown), a fastening element (4) arranged in connection to said tube receiving element (3) and wherein said fastening element(4) is adapted to releasably fixate said tube (2) when said tube (2)is arranged in said tube receiving element (3) and a supportiveelement (5) attached to said tube receiving element and adapted to be positioned on said mammalian body. In the present context, thetube is fixated when it is secured in position in the tube receiving(3), long as it fulfils its purpose as presented herein, element however it may be slightly movable when in position as i.e. does notmove in a longitudinal direction. (22) Fig lb illustrates the embodiment where a rim of the top flexible layer (l8) (20, 24, 26), extends beyond the edges of the below layers as indicated above.

In this embodiment, the fastening element (4) is configured to apply a radially directed fastening pressure in relation to said tube (2).Such a force may be applied e.g. by carefully pushing or squeezingthe tube receiving element (3) against the tube (2) thereby securing the tube (2) against the walls of the tube receiving element (3).The tube receiving element (3) may have any suitable structure still allowing the tube (2) to be securely releasably fixated against the(3), preferably an elongated shape. tube receiving element such as a cylindrical (pipe-shaped) or rectangular shape, The tube receivingelement (3) may be made from any material suitable for the purpose such as plastic, metal material or made of a fabric. Examples of suitable materials for the respective parts of the device are further exemplified herein. As an example, if made of fabric, the tube receiving element (3) may contain threads or strips allowingfor tightening of the tube receiving element (3) around the tube (2) upon receiving the tube, i.e. the fastening pressure is a squeezingor gripping pressure equally spread around the circumference of theIn another embodiment, tube receiving element. the fastening element may be a clamp that applies a similar circumferential squeezing or gripping pressure.

In a further embodiment, the tube receiving element (3) may be transparent for easy visibility of the tube when present in the tube receiving element (3). This is further described below.

Figure 2a illustrates a cross-section of a device (schematic) according to the invention wherein the tube receiving element (3) is illustrated as having a cylindrical hollow (30) shape, even if it is not limited to having such a shape, to therein receive the tube (2).The tube receiving element (3) may also have an opening for a(4), to securely releasably fixate the tube by protruding through the fastening element wherein the fastening element may be adapted opening into the tube receiving element (3) and thereby compressing the tube against a wall of the tube receiving element (3). The tubeis secured with a suitable pressure but without damaging the tube(2). The tube (2) may then be released from the tube fixation device(l) by withdrawing the fastening element (4) through the opening inthe tube receiving element (3). The fastening element may be adaptedto be slidably fixated by friction in an opening of the tube barbs or the like to receiving element, or be provided with threads, attach the fastening element to the tube receiving element (3). The fastening element (4) may be a plug or a wedge. Figure 2b illustrates the device (l) including the supportive element (5).

Further advantages of the device of the present invention include(2),This will be achieved by the drain or (4), The technique according to the reduction of spontaneous movement of the tube e.g. the chesttube due to patient movement.the tube being tightly fastened through the fastening elementsuch as a screw-handle (see figure).present invention is also a quick and a more easy technique in trauma patients in acute need of chest drainage, especially in ll challenging settings such as pre-hospital, battle-field, remote areas and emergency departments.

In one embodiment of the invention, (20), the supportive element comprisesa ductile layer (24) (18) an absorbent layer and a flexible layerIn addition, (26) as described above (see e.g. Figure la and lb). the supportive element (5) further comprises an adhesive layer comprising an adhesive material, such as a tape. The adhesive layeris arranged below or under the absorbent layer in relation to saidmammalian body, i.e. closest to the skin of the patient. The adhesive layer provides for improved attachment of the fixation device to the mammalian body.

Figure 3 shows a bottom view of a supportive element (5) of a further embodiment of the device according to the invention, wherein(30) for the tube (2) an aperture has been made through the supportive element (5) to pass through, (26) (32) and wherein an adhesive layeris shown having pores allowing for bodily fluids to pass through the adhesive layer (26).

In one embodiment said fastening element (4) comprises an elongated threaded element (6) and said tube receiving element contains athreaded opening (8) adapted to receive and rotatably attach said threaded element (6) to said tube receiving element (3). Said threaded element (6) may be a screw, said screw optionally being arranged with a handle, or a similar structure, wherein the screw isadapted to fixate the tube in the tube receiving element (3) byrotating the screw via the threaded opening (8) and thereby compressing the tube against the wall of the tube receiving element(3). An end of said threaded element (6) (10) may also comprise an engagement member for engaging and fixating said tube (2).

Example of such an embodiment of the device according to the invention is illustrated in figures 4 and 5.

Said engagement member (lO) may have a flattened surface (l2) for engaging and fixating said tube (2). This is illustrated in an embodiment of Figure 8, but the feature is not limited thereto. As shown in figure 4 and 5, said tube receiving element may have the shape of an elongated hollow pipe (3). The pipe (3) may be made of 12any suitable material as mentioned herein. Said elongated hollow pipe (3) may be arranged with an aperture (l4) for receiving said fastening element (3).

In one embodiment, said tube receiving element (3) has a clamp-likestructure and said threaded element is in the form of a screw with ahandle.Further, in other embodiments, the pipe (3) is a round cylinder witha side aperture where a screw with a handle is attached. Bytightening the screw, the tubes that goes through the pipe and plateof the device is therewith fastened. The tip of the screw presses the chest tube against the wall inside the pipe (3).

In other embodiments, a pipe or a similar structure could also beused but the mechanism is that the screw is tightened to compressthe chest tube against another “wall” of the tube receiving element.The tip, i.e. the engagement member, of the screw may also be in a shape that fits the round shape of the tubes. The advantages of areleasable fastening element are that it is possible to unscrew, reposition and replace the tubes if necessary.

The materials of the pipe may be metal of hard plastic, or transparent so the number readings on the tubes are visible.

As an alternative to using a fastening element with a radiallydirected fastening pressure, it is also conceivable that a circumferential gripping pressure be used. Such solutions, as will be described below, are understood to be able to replace or be usedin combination with the radially directed fastening pressuresolutions described herein. Thus, in the figures, any fastening element (4) could also be arranged around the entire circumference or parts of the circumference of the tube receiving element.

One such alternative fixation mechanism for the tube (2) is to have(3), in the form of a screw on the side. a tube receiving element such as a pipe, without a fastening element (4) This embodimentcorresponds to e.g. Figure la wherein the fastening element (4)(3), Turning the tube instead is arranged around the circumference of the pipe and not just at one position as shown in the figure. 13receiving element (3) or the pipe in a clockwise direction willdecrease the diameter of the aperture and finally compress the tube(chest tube) i.e. around the whole circumference, exerting a circumferential squeezing or gripping pressure. The process will bereversed when the pipe (3) is turned in the anticlockwise directioni.e. the diameter will increase and the chest tube unfixed to do any adjustments.

As an alternative to, or used in combination with a rotational lock as described above, a pull-lock can be arranged. In such an embodiment, the tube receiving element is arranged with a lockingmechanism where the diameter is decreased when the tube receivingelement is pulled up or away from the supportive element, such thatthe tube is fastened. When the tube receiving element is pushedIt is downward, the diameter is increased, and the tube released. also conceivable that the mechanism is reserved, i.e. that when thetube receiving element is pushed down or towards the supportiveelement the diameter is decreased and the tube is fastened in the tube receiving element.

Another alternative is wherein said tube receiving element (3) is a “soft” pipe not made of metal or plastic, but of fabric.Incorporated in the fabric may be a thread or strips. The tubefixation device slides over the chest tube, through the central holein the plate and the soft fabric pipe/protrusion. Then the thread orstrips are tightened around the circumference of the chest tube toexert a circumferential or gripping pressure.

As mentioned above and illustrated in figures l, 4, and 7, a tubefixation device (l) (l6). comprises a supportive element (5) comprising a layered structure The supportive element (5) is adapted to provide a supportive structure for the tube receiving element (3)(4),allow for the absorbing of bodily fluids, and the fastening element and in preferred embodiments, to such as blood and sweat.

Further, in some embodiments, a flexible layer allows for fastening of the device to the body by stitches or staples through the rim (22) of the flexible layer. Said layered structure (l6) may comprise at least two layers, such as three, four, five or more layers. 14 Said layered structure (16) comprises a ductile layer (20) comprising a ductile material, such as a plastic or metal material.

Non-limiting examples of materials that can be used are shape- retaining plastic materials (e.g. PA2200 or a similar flexible plastic polymer) or a bendable and strong metal material such as Alumide® or an equally bendable metal alloy (reference www.shapeways.com). A preferred material is a thin sheet of a metal alloy such as an aluminum alloy, preferably with a thickness in the range of about 0,5-5 mm, more preferably in the range of about 1,0- 3,0 mm. However, any choice of material is within the scope of the invention, as long as the ductile layer (20) provides a bendable layer which can be shaped to the curvatures of the body, such as thechest wall, on application of a pressure as described above.Further, any material providing the same function can be used. Theductile material has the characteristics in that it is bendable inall directions so that it can be fitted to the shape of a body. Inaddition, the ductile material is preferably a light-weight, strong material and capable of maintaining its own shape after being shaped by hand by applying pressure.

In addition, the material in the ductile layer should preferably essentially not be affected by extreme temperatures, especiallyrelating to the bendability and shapeability characteristics, as well as being capable of maintaining its shape when in position.

In a preferred embodiment, the ductile layer is essentially radiolucent, i.e. does not cause any major disturbances or affect the picture quality to any discernable degree when imaging techniques are used, e.g. X-ray or CT (Computed Tomography). Thus, an advantage of the ductile layer being radiolucent is that insituations when an imaging technique, such as CT or X-ray imaging,needs to be used on the subject having the fixation device attachedIn certain thereto, picture quality is essentially unaffected. imaging procedures, metal materials will disrupt or distort the image and/or cause other problems, however the inventor has shown that by using the preferred material described above, a thin e.g. sheet of aluminum alloy or the like, the ductile layer will not affect either an X-ray image or a CT image to any to any discernable degree.

A flexible layer (18) herein may comprise a flexible or elastic material, such as a rubber material, plastic material, or the like, or a material comprising rubber or plastic providing a similarstructure. Non-limiting examples of such materials are polyamide (PA), polyoximetylen (POM), and high molecular polyethylene (HMPE).

Said flexible layer may comprise a non-permeable flexible material,a water repellant or water resistant material. The material couldalso be a fabric with the required characteristics. The flexible layer may also be referred to as the top layer.

As illustrated in figure 4, said flexible layer (18) may extend beyond at least one of the edges of the ductile layer thereby(22) of a flexible material around said (22) forming an outer rim supportive element (5). Such a rim may be used to attach stitches to the body to which the tube fixation device (l) isattached to, providing a thin material which is easy to attachstitches through. The (22) This is also illustrated in figure 9 and ll. rim may have a width of about 0.5 cm, i.e. the rim extends beyond the edges of the adhesive layer, the adsorbent layer and/or the ductile, bendable layer with about 0.5 cm (see figure 4), but is not limited thereto. Other examples of rim widths are in the range of about 0,2-4 cm, preferably in the range of about 0,4-l,O cm.

Accordingly, the medical staples pass through the rim (22) and attach the device to the skin (see e.g. figure ll and 9).

Said layered structure (16) (24), herein may also comprise an absorbent layer said layer comprising an absorbent material. Examples of suitable materials for the absorbent material are also providedherein, but may be any available absorbent material suitable for thepurpose. The absorbent material allows for absorbing bodily fluids around the drainage area during the use of the tube fixation device(l). As mentioned above, the ductile layer and the absorbent layer may also be referred herein as forming a dual core. The combinationof arranging a ductile layer and an absorbent layer, especially when arranging the ductile layer on top of, or above, the absorbent layer, creates a synergy to contain body fluids within the device, 16 and to prevent as much bleeding as possible from the wound site. Asmentioned above, the compressive force of the ductile layer workstogether with the absorbent material in the absorbent layer to effectively prevent bleeding from the wound site.

Said layered structure (16) herein may also comprise an adhesivelayer (26), said layer (26) comprising an adhesive material, ordressing. The adhesive layer can also contain a tape or another suitable adhesive. The adhesive layer is the layer of the supportiveelement that is arranged closest to the body to which the tubefixation device (1) is attached. This layer provides for attachmentof the device to the body. As mentioned above, the adhesive layershould preferably be provided with a number of small pores or holesto increase the diffusion of liquids, fluids, such as blood and other bodyfrom the wound area to be absorbed into an absorbent layer.

This layer may also be referred to as the bottom layer.

Hence, the attachment of the device (1) to the body may be through using both an adhesive layer a tape or other suitable (22). (e.g. adhesive) and stitches through the rim This technique provides an improved and faster technique than conventional methods.

Accordingly, said layered structure (16) may comprise at least four layers in the following consecutive order: (26):(24): a) an adhesive layerb) an absorbent layerc) a ductile, (20), bendable layer such as a metal layer; and d) a flexible layer (18),and wherein layer a) is adapted to be arranged in directcontact with a mammalian body as an inner or bottom layer,and wherein layer d) forms the outer or top layer of the layered structure and being arranged with a rim (22) for attaching stitches through the rim (22) of said flexiblelayer.Examples of shapes of the layered structure (16) or the supportive element are apparent from the figures. The different layers are preferably of the same shape as each other and cover essentially the 17 same surface area. However, it is also conceivable that some layer cover a smaller area than others. The overall shape of the supportive element is an essentially flat structure, and can be any suitable shape, such as square, rectangular, circular, elliptical etc. As mentioned, when the flexible layer forms a rim, this layer extends beyond the other layers.

The absorbent layer (24) and the ductile bendable layer (20) are also referred to herein as the dual core of the layered structure, e.g. the dual core bendable plate and the dual core absorbent dressing.

One embodiment of the invention is illustrated in figure 6a, wherein the device (l) may have the following features. The tube receiving element (3) is in the form of a pipe-like structure with a screw or a threaded element and a handle. The tube is to be threaded through the pipe and opening. The screw may be tightened to fasten the drain after insertion. The tube receiving element (3) may prevent kinking of the tube. The device further comprises a layered structure (16)comprising a dual core that comprises two materials - a ductilemetal plate that makes the device bendable to better fit to thecurvatures of the patient\s chest and a (super) absorbing dressing to remove any blood and sweat from the skin. In addition, a paste adhesive dressing underneath the supporting element may further fixthe plate to the skin and reduce any leakage of air around the chesttube. This forms the adhesive layer.

Additionally, a surgical stapler may stitch the supportive element, e.g. the plate to thepatient's chest through the rubber rim that surrounds the tube(l), the rubber rim is a part of the flexible layer as fixation device (e.g. by the use of a Proximate® Skin Stapler).Accordingly,further described herein (see figure 4). Accordingly, an adhesivelayer combined with a threaded element such as a screw handle andthe stitches through the rubber rim is useful for securing the drainand holding it in place even in challenging situations withincreased chance of pulling out the drain (transportation, emergency room examination, ICU-settings etc.) l8 Figure 6b illustrates a supportive element (5) of an embodiment of the device (l) showing the layered structure (16), as described above.

Figure 8 illustrates another embodiment of the invention, wherein the tube receiving element (3) and the fastening element (4) together forms a clamp-like structure allowing the tube (2) to be fixated by the fastening element (4) being in the form of a screw- like structure optionally with a handle that when rotated tightens or compresses the tube (2) against the wall of the tube receiving element (see Figure 8b). As seen in figure 8d, the tube fixation device may be provided in an adult size (left) and a pediatric size (right). The tube receiving element (3) and the fastening element (4) may be made of plastic or metal.

In one embodiment, the tube receiving element (3) has a cylindrical, shape, like a pipe, and comprises a metal material, the fastening element (4) comprises a screw of a metal material, the flexible layer (18) comprises a rubber material, such as a rubber band, theabsorbent layer (24) comprises a super absorbent dressing, theadhesive layer (26) comprises an adhesive tape, and the ductile layer (20) comprises a metal material. The flexible layer (18) is provided with a rim (22) surrounding the supportive element (5). The rim may have a width in the range of about 0,2-4 cm, preferably about 0.5 cm.

In some embodiments, the tube receiving element (3) is welded, glued or similarly fastened to at least one of the layers of the supportive element, the ductile layer. In such an embodiment, e.g. when suitable materials are used in the respective elements, such as a plastic or metal in the tube receiving element (3) and a shapeable but firm metal, plastic or polymer in the ductile layer, the tube receiving element (3) can be angled or bent in relationship to the supportive element (5). Preferably, materials are chosen such that achosen angle is maintained after bending the tube receiving element(3) in a desired angle. Thus, the chest tube is protected againstkinking and it is possible to arrange and rearrange the tube receiving element (3) in a suitable working position on the outside of the patient's body. 19 In further embodiments, and as shown in figure 7a, the supportive element (5) of the tube fixation device (l) (28). comprises a sealinglayer The sealing layer can preferably be arranged under the ductile layer (20), i.e.(20). (24), closer to a patient's skin than the ductilelayer If the supportive layer also comprises an absorbent layer the sealing layer (28)(24), (24). is preferably arranged above the absorbent layer i.e. between the ductile layer (20) and the absorbent layer as an alternative, (28) However, the sealing layercan be arranged under the absorbent layer (18) (not shown in Figure7a). A flexible layer can be arranged on top of all layers, asshown in Figure 7a and as described above, (22) and can preferablycomprise a rim extending beyond the underlying layers (as described for Figure 4).

Preferably, the sealing layer (28) extends over essentially the samesurface area as the ductile and/or any absorbent layer, i.e. amajority of the surface area of the supportive element (5), with the addition of also extending inward into the opening for the tubereceiving element (3). This is illustrated in figure 7b for oneembodiment. Thus, (30) the sealing layer in this embodiment comprises a(2), (30)tube is arranged centrally in the opening for the tube receiving (30) small opening for a tube wherein the opening for a element (3) in the supportive element (5). This small openingfor a tube is considerably smaller than the size of the opening forthe tube receiving element (3) in the supportive element, and isadapted to be have a diameter that is smaller than a tube to be inserted into the tube receiving element (3).

As an alternative to a small opening in a sealing layer (28) to(3), a sealing layer could also be arranged with two or more overlapping receive the tip of a tube (2) within the tube receiving element flaps of essentially flat material (not shown in the figures)extending into the circumference defined by the tube receivingelement, or with a single or cross-shaped slit in a flat material(not shown in the figures), such that a tube can be pushed throughthe plurality of flaps or through a slit to effectively seal around the tube in a similar way as described above.

It is also conceivable that the sealing layer according to any ofthe above embodiments does not extend over the entire surface of thesupportive element, but instead extends only a certain distanceoutside the circumference of the tube receiving element, as long asthe coverage is enough to provide the sealing features described herein.

The sealing layer (28) comprises a pliable and durable material, and provides the supportive device (5) and thereby the tube fixationdevice with an additional sealing function over the entire surfaceof the supportive element against fluids and air leakage from thewound site on the body. Non-limiting examples of materials of thesealing layer are thin rubber or plastic such as latex, poly- urethane, and polyisoprene.

Further, as the sealing layer (28) is provided with an opening (30) of a smaller diameter than the diameter of a tube to be inserted,and being pliable and/or elastic, the sealing layer will seal tightagainst the outside of a tube inserted therethrough. Thus, thesealing layer preferably provides leakage protection both around theperiphery of the wound site, but also around the tube which isinserted into the tube receiving element. The sealing layer also further adds to the maintenance of sterility in the wound area, asbacteria and other contaminants from the outside are also sealed off.

In the embodiments with a sealing layer, a further advantage is also obtained. The sealing layer arranging in the opening for the tubeenables an optional pre-loading feature of the device which saves time when applying the tube fixation device. Briefly, a tube can be inserted through the multi-layered structure of the supportive element (5) and the sealing layer (28) will fasten the tube (2) to the fixation device before the tube is to be inserted into the body.This is illustrated in Figure l2, which shows the supportive element from the bottom side, i.e. the side to be applied towards the mammalian body. Thus, a user can preload a device on a chest tube, and when the time comes to apply the device to a patient, thepreloading will save time and effort in the application procedure.

The preloaded chest tube can be quickly inserted into the patient, 2l and thereafter the fixation device slid down along the tube and placed in position.

As an alternative to, or in addition to, a sealing layer as described above, the tube receiving element can be arranged with afoam material of a suitable kind (not shown in the figures),preferably with a small opening or passage therethrough, such thatwhen a tube is inserted through the tube receiving element, the foamwill hold and fill the volume around the tube within the tubewhile receiving element, and effectively hold the tube in place, providing a sealing function similar to a sealing layer. A pre-loading procedure as described above can be used with such a foam material.

In a further preferred embodiment, the layered structure (l6) may comprise at least five layers in the following consecutive order: a) an adhesive layer (26);b) an absorbent layer (24);c) a sealing layer (28); d) a ductile layer (20); ande) a flexible layer (l8), and wherein layer a) is adapted to be arranged in directcontact with a mammalian body as an inner or bottomlayer, and wherein layer e) forms the outer or top layerof the layered structure and being arranged with a rim(22) (22) for attaching stitches through the rim of said flexible layer.

In any embodiment herein, a ductile layer can comprise two different zones with different material characteristics. This is illustratedin Figure l3, where Figure l3a shows a schematic side view of a(28) (3), For illustrative purposes ductile layer and a tube receiving element and Figure l3b shows a schematic top view of the same.other parts of the tube fixation device and the supportive layer arenot shown in Figure l3. A first area (zone A) of the ductile layeris arranged around the tube receiving element, preferably with a diameter within the range of about 2-6 cm, more preferably about 3-5 22 cm. The shape of zone A can be circular, as illustrated in Figure l3b, but can also be any other suitable shape, such as square, rectangular, elliptical, star-shaped etc. Outside zone A, a second area (zone B) is arranged, extending to the periphery of the ductile layer. In some embodiments, zone A comprises a thinner, more compressible or shapeable material, and zone B a more firm andstable material. The two materials can be any suitable material, metal or plastic. Further, the two zones A and B can comprise e.g. the same material, a metal alloy, but with different e.g. thicknesses. The two zones can also be two different materials, e.g.two different metal alloys, or a metal alloy in one zone and a plastic or other material in the others zone.

In an embodiment with two different zones in the ductile layer, theinner zone A allows better adaptability to underlying curvature andalso allows for better bending of the tube receiving element. Aductile layer with zone A comprising a more compressible orshapeable material also improves the maintenance of pressure applieddirectly over the wound site, to effectively lessen bleeding orseeping of fluid. A user can effectively press down harder on thei.e. central area of the device, zone A and the tube receiving element, which can bend in towards the body. The surrounding area of a firmer material, defined by zone B, keeps the supportive element adapted to the chest curvature. The combination of using twodifferent materials as described is an improved adaptability to thepatient's body while providing optimal sealing of the wound site combined with optimal wound compression.

Using two different zones in the ductile material can also furtherenhance the feature of being able to bend the tube receiving elementin different directions, as described above. Using a more shapeablematerial in the inner zone A will enable easier bending andmaintenance of a desired angle of the tube receiving element in relation to the mammalian body.

In other embodiments, zone A comprises a transparent material, and zone B a non-transparent material. In such an embodiment, the shapes of the other layers in the supportive element are adapted to the shape of zone B, such that a user can see through the supportive 23 element to the underlying wound site. This enables a user to view the wound site and can monitor e.g. bleeding from the wound, fluid seepage, fluid buildup, infection and other changes. Especially if a transparent tube receiving element is combined with a transparentarea of the supportive element surrounding the chest tube receiving element, optimal viewing of the wound site and chest tube is achieved.

In yet another embodiment, a tube receiving element (3) for a tube fixation device (l) can be arranged to be bendable. This is illustrated in Figure l4, wherein a tube fixation device (l) is shown comprising a supportive element (5) as described in any embodiment herein, and comprising a bendable tube receiving element (3). The tube receiving element (3) can comprise any suitable material as described previously, and is provided with a bendable section. Thus, the tube receiving element can be bent in any desired direction. This embodiment can also be combined with using two different materials in the ductile layer, to provide enhanced possibilities for the user to direct the tube receiving element in a desired direction.

In further embodiments, the ductile layer, or at least a part of the ductile layer, such as a metal part, is arranged in the supportive element such that it can be removed and optionally reinserted or reattached (not shown in the figures). This is useful in situations when an imaging technique, such as CT (Computed Tomography) or X-ray imaging, needs to be used on the patient. In certain imaging procedures, metal materials will disrupt or distort the image and/orcause other problems. In such situations it is an advantage to be able to temporarily or permanently remove the ductile layer, withoutremoving the rest of the chest tube fixation device. In somesituations, it may not be necessary to reinsert or reattach the ductile layer after imaging, if bleeding has lessened or e.g.stopped.

Another example of when a removable and optionally re-attachable ductile layer is useful is in very hot or cold climates. For instance, in extreme temperatures, a metal layer can cause burns or freezing injuries to a patient, and can thus not be applied or at 24 least should be removed after a short time period, e.g. when thebleeding has lessened.In embodiments comprising a removable ductile layer, it may be necessary to arrange the layers of the supportive device in a different order than described above. In one example, a removable ductile layer is arranged as a top layer, i.e. farthest from the skin, to enable easy removal, and attached to underlying layer using an adhesive or glue allowing removal, a Velcro-fastening or e.g. removable tape. In such an embodiment, the ductile layer will still impart compressive forces to the underlying absorbent layer. As anexample, the supportive element could comprise in the following consecutive order: a) an adhesive layer (26); b) an absorbent layer (24); c) optionally a sealing layer (28);d) a flexible layer (l8); and e) a removable ductile layer (20), and wherein layer a) is adapted to be arranged in directcontact with a mammalian body as an inner or bottom layer,and wherein layer e) forms the outer or top layer of the layered structure.

In any embodiment above, an anti-infective agent can be comprised within the supportive element. The anti-infective agent can be impregnated into the absorbent material, can be applied as a coatingon e.g. the entire of part of the absorbent layer and/or theor can be comprised in a separate layer, adhesive layer, or any combination of the above. Such ananti-infective layer may be arranged between the absorbing layer and adhesive layer. The anti-infective agent will protect against bacterial growth around and inthe wound site. Non-limiting examples of anti-infective agents are disinfectants, alcohols, or antibiotics.

In a further preferred embodiment, the layered structure (l6) may comprise at least six layers in the following consecutive order: a) an adhesive layer (26); b) an anti-infective layer; c) an absorbent layer (24);d) a sealing layer (28); e) a ductile layer (20); andf) a flexible layer (l8), and wherein layer a) is adapted to be arranged in direct contact with a mammalian body as an inner or bottom layer, and wherein layer f) forms the outer or top layer of the layered structure and being arranged with a rim (22) for attaching stitches through the rim (22) of said flexible layer.

A tube fixation device (l) as defined herein may be a tube fixation device (l) for a chest tube. Accordingly, encompassed by the present invention is a chest tube fixation device (l) containing any structural features as defined herein.

As illustrated in figure lO, the invention also relates to a kit (29) comprising a tube fixation device (l) (29) as defined in any of thesaid kit at least further (30), a aspects or embodiments herein,comprising a device for applying surgical staples tube (2) (3l). (stapler) and instructions for use The tube (2) provided in the kit may be a chest tube. such a kit (29) A further illustrated in figure l0a, may be comprised in a box, such as a sterile box.

In another embodiment, shown in figure l0b, a kit (29) comprising a tube fixation device (l) as defined in any of the aspects orembodiments herein further comprises an outer packaging (32) (29), adaptedto contain and enclose components of said kit (32) said packagingbeing adapted to receive and contain fluids and air in aninterior space and wherein said packaging preferably comprises a(33)to said tube (2). connection means (32) for connecting said interior space of said packaging The connection means (33) is preferably provided with a means to connect a suction device, suchthat suction can be applied to the interior of the bag and thus alsoto the chest tube when connected to the bag. This will improve drainage through the tube and also make it possible to quickly empty the bag during or after use. 26 Such an outer packaging can be e.g. a medical collection bag (32), for connection to a tube (2) and collection of drainage fluidsand/or air from a wound site or body cavity. Such a bag could be asoft or pliable medical collection bag for fluids. (29) In a preferred embodiment, the components of such a kit are packaged within such a collection bag, which doubles as a container bag for the kit materials.

In such a kit packaged in a medical collection bag (32), it is also conceivable that the bag comprises at least two separatecompartments, and that one such compartment is adapted to containthe above described kit components, and the other compartment isadapted for collection of fluids or air, preferably with a connection means for said tube, as described above.

The kit can also further comprise one or several of the following: a scalpel, tweezers, sterile gloves and medical wipes. Preferably the size of a kit comprising the tube fixation device is adapted to asize which can be inserted into a standard clothes pocket of e.g.medical or military personnel, such as ambulance or emergency room personnel, soldiers or field medics.

Preferably a kit (32), contained in a bag as described, can be provided with a Ziploc or similar easy-to-open opening means. Thisenables ease of use, especially in field or ambulance settings,where the bag can easily be opened and closed to access the components, and more preferably to be able to empty the collected fluids and air during a drainage procedure. Thus, such a bag can then be reused several times.

In another aspect, the invention relates to a method for maintaining a tube (2) inserted into a mammalian body, such as a human body, also referred to as the patient, in a releasably fixated position,comprising arranging said tube (2) into a mammalian body in need ofa drainage, (3) of said device (l) and fastening said tube (2) in said tube receiving means through said fastening element (4) of saiddevice (l). The method further may further comprise a step of attaching the supportive element (5) of the device (l) to the mammalian body by using a stapler adding stitches through the rim 27(22) of the supportive element thereby attaching the device (l)through the supportive element (5) to the skin of the mammalian body. The tube (2) introduced may be a chest tube.

Figure 9 illustrates an example of the insertion of a drainage tube(2) into the body of a patient and attachment with a tube fixationas defined herein. device (l) One such procedure possible is described in the below: Inserting: First the skin is disinfected using a disinfectionsolution. Then a chest wall skin incision is made of 2-3 cm inlength. Normally the incision is made in the 5-7th intercostal spacejust laterally to the large pectoral muscle. To penetrate the chestwall scissor and large surgical forceps used to divide deeper musclelayers and finally penetrate the inner pleural layers to enter the chest cavity. A finger is put through the hole to expand the channelwhere the chest tube will be put.

Finally, the chest tube is guided by finger into the chest cavity.

Fixating with the tube fixation device (1): The four-step use of the tube fixation device (l). A) The chest tube is inserted through askin incision into the chest cavity as described above. B) The tubefixation device (l) is slid over the tube and taped to the skin. Theductile layer, e.g. the metal plate within the core makes itflexible so it can be shaped to better fit the chest wall. The core dressing, i.e. the absorbent layer, will absorb blood and sweat from the skin. The plate closes off the hole through the chest wall so noair will leak around the plastic tube and the compression from thedevice stop bleeding from the skin incision. C) Staples goingthrough the rubber rim into the skin attaches the dual core plateeven more, preventing inadvertent tube removal. D) The chest tube istightly fastened with the screw mechanism inside the central pipe.The transparency makes it possible to read the length of the chesttube inside the cavity. The protruding pipe also prevents anykinking of the chest tube on the outside of the chest. If unscrewed,the chest tube position may be adjusted. It is also possible to pre- load the device onto the chest tube as described above.

Examples of materials and dimensions applicable herein 28 The below are only examples, the invention is not intended to be limited thereto. Any combinations of the below materials may be used.

Flexible layer (l8)The upper layer may be a rubber sheet; a thin layer of rubber that covers the dual core plate (absorbent layer and ductile, bendable layer) with the rim exceeding the four edges of the plate. Thedevice may be pegged to the skin by medical staples going throughthe rubber rim into the skin. The suggested material is rubber bandage (see table). Another possibility is to use a thin wear proof fabric. The main criteria are that the rubber/fabric should be thin so the medical stables goes through and into the skin.

The medical stapler used in our testing of the prototype isProximate® Skin Stapler, 35 mm wide(http://www.ethicon.com/healthcare-professionals/products/wound- closure/skin-staplers/proximate-fixed-head).

Dual core material l (absorbent layer): Absorbing dressing. An absorbing material inside the core should be used. The preferredsolution is a thin super absorber. A lot of different dressings areavailable (see table l).Anti-infective chemicals could be imbedded in the absorbing layer.

Dual core material 2 (ductile, bendable layer): Bendable plate to be shaped to the curvatures of the chest wall. In our prototype we useda thin metal plate used in SAM Medical products, www.sammedical.com.This material is a thin sheet of aluminum alloy. The material could also be something else than metal, such as plastic. Examples ofdifferent materials than can be uses is shape-retaining plasticmaterial (e.g. PA22OO or a similar flexible plastic polymer)or abendable and strong metal such as Alumide® or equal bendable metalalloy (reference www.shapeways.com). The key element is that it isbendable in all directions so that it can be fitted to the shape of the chest and retains its shape as described above.

The adhesive cover underneath layer of adhesive tape/dressing. on the market. 29 (adhesive layer).

Underneath is a There are many different producers Non-limiting examples of material in the sealing layer is any suitable thin wearable rubber, Table l. plastic or latex.

Non-limiting examples of possible materials for the tube fixation device (4 layers)Part of the Material Other Producers of suchDual Core in our possible materialsChest Tube first materialsFix prototypePipe (tube Metal(e.g. Hard Metal in prototype boughtreceiving aluminium) plastic, at Clas Ohlson store.element wear-(3)) prooffabricScrew Metal(e.g. Hard Metal in prototype bought(fastening aluminium) plastic at Clas Ohlson store.element (4) (seepictures)Thread/stri Not used Thread andps in our plasticprototype stripsRubber/plas Rubber Thin wear l) VBM Meizintechnik GmbH,tic proof Germany www.vbm-medical.de(flexible fabric Examples as describedlayer (l8)) aboveDual core - 1) Other l)Curea Medical GmbH,dressing Superabsor absorbent Germany. www.curea-(absorbent bent wound dressings medical.de/ueber-uns/layer (24)) dressing such as 2) OneMed. Finland.2) Game Swabs 3)OneMed. Finland.3) www.onemed.noAbsorbent 4) Molnlycke Healthdressing Care, Sweden.Evercare www.molnlycke.no4) Mesoft. 5)Bastos Viegas,5) Non- Portugal.adherent www.onemed.nodressing 6)Shaoxing Zhengde6) Surgical DressingCompresses Co., Ltd. China.from http://www.zhende.com Zhende Dual core l) Metal, Other l) Same metal used insideflexible/be aluminium bendable/f the SAM splint fromndable alloy lexible www.sammedical.com.plate materials; Norwegian supplier is(ductile, Plastic Ferno Norden,bendable www.fernonorden.comlayer (20)) Examples as describedaboveSealing Not Thin l. Same rubber as inlayer applicable strong condomsrubber 2. Same membrane as inmembrane Prometheus Medical\s chestseal product.3. Examples of materialsof the sealing layer arethin rubber or plasticsuch as latex,polyurethane,polyisoprene.Adhesive Different Any E.g:tape tape adhesive(adhesive solutions tape Allevyn Adhesive dressinglayer (26)) from Smith and Nephew.

England. www.sm**ñ*nephew.com/professional/products/advanced~wound~management/allevyn/allevyn~ag~gentle~border/ Tape from underneathdefibrillation pads toLifePack l5: The following are examples of dimensions applicable to the tube fixation device (l) not limited to these dimensions. according to the invention however the device is Suggested dimensions of the tube fixation device (1): 1) Adult square version Dimensions dual core plate: (8 i Pipe height: Pipe diameter: 2 i 1.0 cm 1.5 - 3 cm 4 cm) X (8 i 4 cm) 31 Thickness supportive element less than 1.0 cm,cm Weight less than 100 gram 2) Pediatric square version: Dimensions dual core plate: (4 i 2 cm) x (4Pipe height: 1 i 1.0 cm1 cm Pipe diameter: 0.5 - Thickness supportive element less than 1.0 cm, cmWeight less than 50 gramWe could also consider a round version.3) Adult round version (8 i Diameter dual core plate: 4 cm) Pipe height: 2 i 1.0 cmPipe diameter: 1.5 - 3 cm Thickness supportive element less than 1.0 cm,cm Weight less than 100 gram 4) Pediatric round version: Diameter dual core plate: (4 i 2 cm)Pipe height: 1 i 1.0 cm2 cm Pipe diameter: 0.5 - Thickness supportive element less than 1.0 cm, Cm Weight less than 50 gram ductile layer 0.1-0.4 i 2 cm) ductile layer 0.1-0.4 ductile layer 0.1-0.4 ductile layer 0.1-0.4 32 EXPERIMENTAL SECT ION The prototype of the device according to the invention has beentested on anesthetized pigs in an experimental animal laboratory called Sandnes Education And Research Centre Høyland (SEARCH).

The highlights of the protocol that we used: ° Two pigs where anesthetized.

° One chest tube was inserted on the left side using a standard surgical set and fixated with sutures.

° One chest tube was inserted on the opposite right side with a surgical set and fixated with our Dual Core Chest Tube Fix.

° The time trial measurement A) We measured the time from skinincision to the completion of tube fixation on the left side(Dual Core Chest (sutures) and compared the time with the right side Tube Fix). The results are in the table.

° We then performed a “pull” test by pulling the Dual Core ChestTube Fix as shown in the picture B). That was just to see how much force that was needed before the device detached from the skin. Thistest may be more objective in later prototype testing, by attachingincreasing number of weights to the chest tube Different anchoring methods should be compared in the future.

Time from skin incision to chest tube fixation: Results of the trials at SEARCH Normal suture technique 4 min 5 sec Dual Core Chest Tube Fix l min 25 sec Above, the invention has been described with reference to specific embodiments. It is however obvious to a person skilled in the artthat other embodiments may be used to achieve the same results within the scope of the invention as defined by the claims. 33 REFERENCES Rashid MA, Wikstrom T, Ortenwall P. A simple technique for anchoring chest tubes. Eur respire J 1998; 12: 958-959.

Ball CG, Lord J, Laupland KB, Gmora S, Mulloy RH, Ng AK, Schieman C, Kirkpatrick A. Chest tube complications:450-458.

How well are we training our residents. Can J Surg; 50: Waydhas C, Sauerland S. Pre-hospital pleural decompression and chesttube placement after blunt trauma: 11-25.

A systematic review.

Resuscitation 2007; 72: NHS trust. Guidelines for the insertion and management of chest drains. Web-page: http://www.ruh.nhs_uk/about/policies/documents/clinical policies/blu e clinical/Blue 784 Chest Drain Policy and Procedure.pdf Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY et al: Global and regional mortalityfrom 235 causes of death for 20 age groups in 1990 and 2010: asystematic analysis for the Global Burden of Disease Study 2010.

Lancet 2013, 380(9859):2095-2l28.

Claims (9)

1. 34 Claims ld A tube fixation device (l) for maintaining a tube (2) inserted into a mammalian body in a releasably fixatedposition, said tube fixation device (l) comprising: a tube receiving element (3) configured to receive saidtube (2); a fastening element (4) arranged in connection to saidtube receiving element (3) and wherein said fasteningelement (4) is configured to releasably fixate said tube(2) when said tube (2) is arranged in said tube receivingelement (3); and a supportive element (5) attached to said tube receivingelement (3) and configured to be positioned on a surfacearea of said mammalian body, characterized in that thesupportive element (5) comprises a layered structure(16), wherein said layered structure comprises at least aductile layer (20) comprising a ductile material, whereinthe ductile layer is configured to be shapeable toconform to a three-dimensional shape of said surface areaon said mammalian body and said ductile layer is furtherconfigured to essentially maintain said obtained three- dimensional shape. .

2. A tube fixation device (l) according to claim l, wherein the ductile material comprises ashape-retaining plastic material, a plastic polymer, a metal and/or an alloy. .

3. A tube fixation device (l) according to any preceding claim, wherein said ductile layer, or at least a part ofsaid ductile layer, is adapted to be removed andoptionally reinserted or reattached in said supportive element.

4. A tube fixation device (1) according to any preceding claim, wherein said ductile layer comprises at least twozones comprising different materials, wherein one of saidmaterials defines a first area or zone (A) arrangedcentrally around said tube receiving element, and thesecond of said materials defines a second area or zone (B) arranged more peripherally in said ductile layer. A tube fixation device (1) according to any precedingclaim, wherein said layered structure further comprisesan absorbent layer (24) comprising an absorbent material,wherein said absorbent layer (24) is arranged below orunder said ductile layer (20) in relation to said surface area of said mammalian body. A tube fixation device (1) according to any precedingclaim, wherein said layered structure (16) comprises aflexible layer (18) comprising a flexible material,wherein said flexible layer (18) is arranged above or ontop of said ductile layer (20) in relation to said surface area of said mammalian body. A tube fixation device (1) according to claim 6, whereinsaid flexible layer (18) extends beyond at least one ofthe edges of the ductile layer (20) thereby forming a rim(22) of a flexible material around at least a part of said supportive element (5). A tube fixation device (1) according to any precedingclaim, wherein said layered structure comprises anadhesive layer (26) comprising an adhesive material,wherein said adhesive layer (26) is arranged closest to said surface area of said mammalian body, to provide lO. ll. 12. 13. l4. 36 adhesion of said supportive element (5) to said mammalian body. A tube fixation device (1) according to any one of claims 5-8, wherein said tube fixation device (1) comprises a sealing material adapted to essentially seal a spacewhen said tube (2) surrounding said tube (2) is arranged in said tube receiving element (3) from any leakage offluid or air.according to claim 9, wherein (28) A tube fixation device (1) said sealing material is a sealing layer within said layered structure (16). A tube fixation device (1) according to claim 10, wherein (28) is arranged between said ductile (24). said sealing layer layer (20) and said absorbent layer A tube fixation device (1) according to any preceding claim, wherein said fastening element (4) is configuredto apply a radially directed fastening pressure inrelation to said tube (2). A tube fixation device (1) according to any preceding claim, wherein said fastening element (4) comprises an elongated threaded element (6) and wherein said tubereceiving element contains a threaded opening (8) adaptedto receive and rotatably attach said threaded element (6)to said tube receiving element (3). A tube fixation device (1) according to any one of claims 1-ll, wherein said fastening element (4) is configured to apply a circumferential fastening pressure in relation to 1

5. 1

6. 1

7. 1

8. 37 said tube (2).A tube fixation device (1) according to any preceding claim, wherein said tube receiving element (3) is an elongated hollow pipe (3).A tube fixation device (1) according to any precedingclaim, wherein said layered structure comprises at least four layers in the following consecutive order: a)an adhesive layer (26); b) an absorbent layer (24); c)said ductile layer (20); and d)a flexible layer (18), and wherein layer a) is adapted to be arranged in direct contact with amammalian body as an inner or bottom layer, andwherein layer d) forms the outer or top layer of thelayered structure and being arranged with a rim (22)for attaching stitches or staples through the rim (22) of said flexible layer. A tube fixation device (1) according to any one of the preceding claims, wherein said tube (2) is a chest tube. A kit (29) comprising a tube fixation device (1) for maintaining a tube (2) inserted into a mammalian body ina releasably fixated position, said tube fixation device(l) comprising: a tube receiving element (3)(2): a fastening element (4) tube (2) adapted to receive said tube arranged in connection to saidreceiving element and wherein said fastening element (4) is adapted to releasably fixate said tube (2)when said tube (2) (3); and is arranged in said tube receivingelement a supportive element (5) attached to said tube receiving 1

9. 20. 38 element and adapted to be positioned on a surface area of said mammalian body, said kit further comprising a device for applying surgical staples (30), a chest tube (2) and instructions for use (31). A kit (29) comprising a tube fixation device (1) according to any of claims 1-17, said kit further comprising a device for applying surgical staples (30), a chest tube (2) and instructions for use (31). A kit (29) according to claim 18 or 19, said kit furthercomprising an outer packaging (32) adapted to contain andenclose components of said kit (29), said packaging (32) being adapted to receive and contain fluids and air in aninterior space and wherein said packaging comprises a (33)(32) connection means for connecting said interior space of said packaging to said tube (2).