SE543141C2

SE543141C2 - Fixation device for an intravascular tube

Info

Publication number: SE543141C2
Application number: SE1950298A
Authority: SE
Inventors: Nils Petter Oveland
Original assignee: Dr No Invest As
Priority date: 2019-03-08
Filing date: 2019-03-08
Publication date: 2020-10-13
Also published as: WO2020182686A1; SE1950298A1; WO2020182686A9

Abstract

There is provided a fixation device (100) for fixating and securing an intravascular, IV, tube, and a medical kit (300) including such a fixation device (100). The fixation device (100) comprises a flexible elongated member (110) comprising a first portion (112) and a second portion (114) configured to be attachable to each other, wherein the elongated member (110) is configured to be attached around a limb (500) of a human or animal patient at a first location, via said first and second portions (112, 114). The fixation device (100) further comprises a fixation dressing (120), comprising at least one adhesive layer (122) configured to be attachable to the skin of the patient, wherein the fixation dressing (120) is further detachably attached to the elongated member (110) at a third portion (116) of the elongated member (110). The elongated member (110) is further configured to be tightened around the limb (500) to provide vascular stasis, thereby enabling easier introduction of an IV tube.

Description

FIXATION DEVICE FOR AN INTRAVASCULAR TUBE TECHNICAL FIELD The present disclosure relates to a fixation device structured to fixate and secure an intravascular (IV) tube, and a medical kit comprising such a fixation device.BACKGROUND ln medicine, terms such as peripheral venous catheter, peripheral venous line, peripheralintravenous line, peripheral venous access catheter, peripheral arteria| catheter, peripheralarteria| line, peripheral intra-arterial line, peripheral arteria| access catheter, cannula andmore are used for describing a small, flexible tube, which is configured to be introducedintravascularly into a peripheral vein or artery of a human or animal patient in order toadminister medication or fluids, measure intravascular blood pressure or draw blood fortesting. Hereinafter, such catheters or other small flexible tubes are referred to asintravascular (IV) tubes. Hereinafter, veins and arteries may be collectively referred to as blood vessels.

Upon insertion, the IV tube can also be used to draw blood. An IV tube is typically placed in avein or artery on the hand, arm, or other suitable limb of the human or animal patient. The IVtube is introduced into the vein or artery by a needle (similar to blood drawing), which issubsequently removed while the small flexible tube of the IV tube remains in place. The IVtube is then fixed by taping it to the patient's skin (unless there is allergy to adhesives).Newer IV tubes have been equipped with additional safety features to avoid needle-stickinjuries.

The IV tube is the most commonly used vascular access in medicine. lt is given to mostcritical ill and surgical patients, and before some radiological imaging techniques using radio contrast, for example.

However, this procedure is not without complications. lnsertion of an IV tube is a painfulprocedure that can lead to anxiety and stress. Infection, phlebitis, extravasation, infiltration, air embolism, haemorrhage (bleeding) and formation of a hematoma (bruise) may also occur.

Another problem is when IV tubes are dislodged, i.e. pulled out of the vein or artery, due toinadequate securement. This often leads to bleeding from the blood vessel or toand fluid infusions. extravasation of medical Due to the common complication of dislodgement of the IV tube extra securement with tape is often needed.

There is thus a need for an improved IV tube procedure that that reduces the risk ofdislodgement with additional bleeding from the puncture site and the risk of insertion-relatedinfections and at the same time shortens the time and effort needed to place the IV tube andfixating and securing it to the skin of the patient, thereby reducing the discomfort of the patient, saving valuable time for the medical staff, and consequently also reducing costs.SUMMARY Embodiments of the present disclosure aim at solving or at least ameliorating the identified problems.

According to a first aspect, there is provided a fixation device for fixating and securing anintravascular, IV, tube, the fixation device comprising: a flexible elongated member,comprising a first portion and a second portion configured to be attachable to each other,wherein the elongated member is configured to be attached, and possibly also tightened,around a Iimb of a human or animal patient at a first location, via said first and secondportions; a fixation dressing, comprising at least one adhesive layer configured to beattachable to the skin of the patient, wherein the fixation dressing is detachably attached to the elongated member at a third portion of the elongated member. The elongated member is further configured to be tlqittened around the iimb to provide vascuiar stasis in the limo, titereby enablino easier introduction of an IV tube.

In some embodiments, the fixation dressing further comprises an absorbent layer.ln some embodiments, the fixation dressing further comprises a top protective layer.ln some embodiments, the fixation dressing further comprises a bottom protective layer.

In some embodiments, the detachable attachment between the elongated member andfixation dressing may be achieved by means of at least one of: perforation, indentions, punching, stitching, welding, Velcro® and adhesive.

In some embodiments, the detachable attachment between the elongated member andfixation dressing comprises the fixation dressing being detachably attached to the elongated member along a longitudinal side of the third portion.

In some embodiments, the elongated member has a first, non-cutaneous, surface facingaway from the skin of the patient when the elongated member is attached to the limb; and anopposing second, cutaneous, surface, facing towards the skin of the patient when theelongated member is attached to the limb; wherein the fixation dressing has a first, non-cutaneous, surface facing away from the skin of the patient when the elongated member is attached to the limb; and an opposing second, cutaneous, surface facing towards the skin of2 the patient when the elongated member is attached to the limb. In these embodiments, thedetachable attachment may comprise the first, non-cutaneous, surface of the fixationdressing being detachably attached to the second, cutaneous, surface of the third portion ofthe elongated member. Alternatively, the detachable attachment may comprise the second,cutaneous, surface of the fixation dressing being detachably attached to the first, non- cutaneous, surface of the third portion of the elongated member. ln some embodiments, the fixation dressing is foldable in relation to the elongated member along an axis parallel to, or substantially parallel to, the |ongitudina| side of the third portion. ln some embodiments, the elongated member is further configured to, after detachment fromthe fixation dressing, be attached around the limb of the human or animal patient at a secondlocation, to provide further fixation and securement of the IV tube. The elongated membermay in these embodiments be configured to be attached around the limb (500), at thesecond location, via said first and second portions. Alternatively, or in combination with theprevious option, the elongated member may in these embodiments have a first, non-cutaneous, surface and a second, cutaneous, surface, and further comprise an adhesivelayer on at least one of said first, non-cutaneous, surface and said second, cutaneous,surface. The adhesive layer may be configured to be attachable to the skin of the human oranimal patient and/or to the first, non-cutaneous, surface of the fixation dressing, for examplecrossing the fixation dressing underneath or over the IV tube, wherein the elongated membermay be configured to be attached around the limb, at the second location, via the adhesive layen ln some embodiments, the elongated member is made from at least one of, but not limited to,the following materials: Tyvek® paper, other non-rip paper, non-rip polymer material, fabric, Velcro® and a suitable plastic material.

According to second aspect, there is provided a medical kit comprising a kit packageconfigured to enclose a fixation device according to any of the embodiments presentedherein, and at least one of: one or more disinfection wipes for washing the skin of a patient; an IV tube to insert into a vein or artery; and a syringe prefilled with a saline solution.BRIEF DESCRIPTION OF THE DRAWINGS The invention is now to be explained more closely by means of one or more embodiments, which are disclosed as examples, and with reference to the attached drawings.Figure 1A shows a fixation device according to one or more embodiments; Figure 1B shows a fixation device according to one or more embodiments;3 Figure 2A to 2D, respectively, show a schematic overview of detachable attachment alternatives according to different embodiments; Figure 3A to 3H show the layered structure of fixation dressing alternatives according to different embodiments; Figure 4 illustrates as example of a standard IV tube; Figures 5A and 5B i||ustrate a previous solution for an IV tube procedure; Figures 6A to 6D i||ustrate an IV tube procedure according to one or more embodiments; Figure 7 shows a schematic overview of a medical kit according to one or more embodiments; Figures 8A and 8B show exemplary embodiments of connection of a first and second portion of the elongated member;DETAILED DESCRIPTION The fixation device will now be described in detail with reference to the appended figures.However, the invention is further not restricted to the described embodiments in the figures, but may be varied freely within the scope of the claims.

Throughout the figures the same, or similar, items have the same reference signs. Moreover,the items and the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.

An IV tube in the context of this disclosure may include any known type of IV catheter, IVline, peripheral venous catheter, peripheral venous line, peripheral intravenous line,peripheral venous access catheter, peripheral arterial catheter, peripheral arterial line,peripheral intra-arterial line, peripheral arterial access catheter, cannula, needle, IV tube,guidewire, introducer, or other small, flexible tube that is configured to be introduced into a vein or artery of a human or animal patient.

Figure 4 illustrates an example of a standard IV tube, 400, wherein the IV tube itself iscomposed of a tip 401 for insertion into a blood vessel, i.e. a vein or an artery, wings 402 formanual handling and securing the IV tube with adhesives, a valve 403 to allow injection ofdrugs with a syringe, and an end 404 which allows connection to an IV infusion line, andcapping in between uses. ln Figure 4 there is further shown a needle 410 (partially retractedin the figure) which serves to puncture the skin and further and thereafter as a guide-wire forinserting the IV tube into the blood vessel, and a protection cap 420, which normally coversthe needle's tip when the needle is not in use.4 The steps of attaching a fixation device to a limb of a human or animal patient, optionallyproviding stasis in the limb to make identification of a blood vessel and thereby introductionof an IV tube easier for the health care personnel, and further fixation of the IV tube after ithas been inserted, may hereinafter be referred to as an IV tube procedure. lf the IV tube is tobe introduced into a vein, it is evident that stasis facilitates this introduction, as stasiscompresses the veins of the limb so that they fill up with blood whereby the diameter of the vessel lumen is increase and the veins are easier to identify, manually or using visualization. lf the IV tube is to be introduced into an artery, it is not as evident that stasis need to beobtained. However, stasis may be advantageous also in this case, since ultrasoundidentification of arteries can be made easier if there is a light stasis of the limb, since a lightpressure against an artery makes it pulsate more and therefore makes it easier to identify, using manual palpation or ultrasound visualization.

A typical previous solution for the IV tube procedure is now described in connection withfigures 5A and 5B.

Figure 5A illustrates how an elongated member 501, for example in the form of an elasticbelt, is attached around a patient's limb 500, in this case an arm. The elastic belt may betightened around the limb 500 to obtain vascular stasis, which may be light or strongdepending on which type of blood vessel the IV tube is intended to be introduced into. Theelastic belt 501 is typically used on multiple consecutive patients, not uncommonly withoutbeing washed or disinfected in-between patients. This may cause hygienic problems such asspreading of infections etc. between patients and possibly also to the health care personnel.Once stasis is obtained, the insertion site is washed with a disinfective solution; where afteran IV tube 400 is inserted, possibly using a needle 410 to puncture the skin and thereafter asa guide-wire to slide or introduce the IV tube 400 into the blood vessel. ln figure 5B, the IVtube 400 has been inserted into a blood vessel of the patient, by a health care personnel, theneedle 410, if used, is retracted, and the IV tube 400 is taped to the patients skin using anadhesive bandage 502. The adhesive bandage 502 is typically placed such that it covers thewings 402 of the IV tube 400. Once in position, an IV infusion line 504, also referred to as anIV line 504, may be connected to the end 404 of the IV tube 400.

There exist multiple commercial available types of adhesive bandages, which may also bereferred to as fixation dressings, used to fixate and secure IV tubes, but very few havesufficient fixation strength to withstand a direct pull of the IV tube or a pull of the IV infusionline. A pull of the IV infusion line could easily pull the IV tube out of the blood vessel. This is an unnecessary, but far too common, complication, especially in emergency situations. lf the IV tube is pulled out of the blood vessel, the health care personnel will lose the opportunity toadminister drugs and fluid, and will often have to repeat the IV tube procedure, which takesadditional time in a sometimes already time critical situation, keeps the health care personnelfrom performing other tasks, and increases the discomfort of the currently treated patient,including pain from multiple punctures to the skin. Other complications that may arise due toan IV tube being pulled out from the blood vessel are bleeding from the puncture site,increased risk of infection and increased costs for the hospital/health institution due toexcessive equipment use. Therefore, extra securement with additional strong tape is typicallyused to avoid dislodgement of the IV tube. ln the case of cold and/or moist patient limbs, orblood and/or sweat on the limbs, sufficient fixation to the patient's skin is even harder. lnFigure 5B, extra securement with a tape 503 over the back of the hand of the patient (hereexemplified as a human patient), as well as around the forearm is shown, to secure the IV tube 400 and IV infusion line, is shown.

A problem with the rolls of tape is that they often “dry-out” before all the tape is used, i.e.making it difficult to use the last part of the roll. The additional use of new rolls of tape makesthis an expensive product. Furthermore, the strong tape needed cannot be by torn or pulledapart by hand force, especially when wearing protective gloves, whereby additional tools such as scissors are required.Embodiments of the present device presented herein solve these and other problems. ln Figures 1A and 1B, embodiments of a fixation device 100 for fixating and securing an intravascular, IV, tube are shown.

As shown in Figures 1A and 1B, the fixation device 100 comprises a flexible elongatedmember 110 and a fixation dressing 120, wherein the fixation dressing 120 is detachablyattached to the elongated member 110, at a third portion 116 of the elongated member 110.The elongated member comprises a first portion 112 and a second portion 114 configured to be attachable to each other. ln the embodiments presented herein, detachably attached is to be understood as theattached elongated member 110 and fixation dressing 120 being detachable from each otherby hand force. ln other words, the fixation device 100 is configured such that a healthcareprovider that inserts IV tubes as part of their work, for instance a physician, a nurse, amedical student, an emergency medical service worker, a veterinarian etc., can pull apart, orin other ways separate from each other, the flexible elongated member 110 and the fixationdressing by hand force. ln other words, there is no need for any additional tool. For example,scissors are not required. Furthermore, as both the procedure of achieving stasis before6 insertion of an IV tube into a blood vessel, and the procedure of fixating and securing the IVtube after it has been inserted into the blood vessel, is obtained using a single device, i.e. thefixation device 100, without the need for any additional tools or devices, the desired result isachieved faster and requiring less effort from the health care personnel compared to previous solutions.

The first and second portions 112, 114 may further be configured to, after attachment, furtherbe detachable from and re-attachable to each other. Thereby, attachment of the elongated member 110, as described in connection with Figure 6D, may further be enabled.

The elongated member 110 may be configured to be attached, and possibly also tightened,around a limb 500 of a human or animal patient, at a first location, via said first and secondportions 112, 114. ln some embodiments, the attachment and possibly also tightening of theelongated member 110 provides vascular, i.e. venous or arterial, stasis in the limb 500. Byproviding venous or arterial stasis, the health care personnel are enabled to easier identify ablood vessel for penetration with the IV tube, using manual palpation or ultrasound/ultrasonicvisualization for arteries, or eye sight, visualization or ultrasound/ultrasonic visualization for veins.

Further advantages of being able to attach the fixation device 100 to the limb 500 of thehuman or animal patient is that it may assist the health care personnel in aligning the IV tube400 against the limb 500, and that the fixation dressing 120 is close at hand after the IV tube has been introduced into the blood vessel, as further described herein.

The fixation dressing 120 comprises a Iayered structure, wherein the fixation dressing 120comprises at least an adhesive layer 122 configured to be attachable to the skin of thepatient. The fixation dressing 120 may comprise one or several further Iayers, such as anabsorbent layer, a top protective layer, and/or a bottom protective layer. These alternative embodiments are further described in connection with figures 3A to 3H. ln some embodiments, the fixation dressing may be partly or fully transparent to visualize theunderlying insertion point of the IV tube and/or skin of the human or animal patient. This canmake it easier for the health care personnel to identify bleeding and infection around the puncture site or even identify kinking of the IV tube, dislodgement or extravasation.

The elongated member 110 may in the context of this disclosure include any known type ofband etc. that is configured to be attached around a limb 500 of a human or animal patient,to provide vascular stasis in said limb. The elongated member 110 may be made of any material, or selection of materials, that have the properties of being flexible enough to be Wrapped around a limb 500, strong enough not to rip or tear when a longitudinal force isapplied on it upon tightening around a limb 500 to obtain vascular stasis, and preferably alsocheap to produce. Non-limiting examples of materials that can be used are strong types ofpaper, as a specific non-limiting example the paper can be Tyvek® paper, a non-rip polymermaterial or a suitable plastic material. The elongated member 110 may at least partly beelastic in a longitudinal direction. As an alternative, the elongated member 110 may be non- elastic in a longitudinal direction.

The fixation device 100 may advantageously be sterile and/or for single use. Single use inthis context means that the fixation device 100 is used on a single patient during one IV tubeprocedure, wherein the IV tube procedure is defined as attaching the elongated member 110to the limb 500, and optionally providing stasis, before introduction of an IV tube, and fixatingand securing the IV tube to the patient after it has been introduced. After use on one patient,during one IV tube procedure, both the elongated member 110 and the fixation dressing 120may be disposed of, once they have fulfilled their respective purpose. ln the case of thefixation dressing 120, this may be disposed of after the IV tube has been removed from thelimb of the human or animal patient. As the elongated member 110 is sterile and/or singleuse and can be disposed after having been attached around a limb of the human or animalpatient at a first location, and optionally also at a second location, as described in connectionwith Figure 6D, this is clearly more hygienic than an elastic belt or other alternatives that areused on multiple patients before being washed, if ever. lf the health care center has a systemfor Washing these elastic belts or other alternatives, the Washing procedure further takes timeand costs money. The fixation device 100 according to the embodiments presented herein is therefore more hygienic and time-efficient than previous solutions. ln the example embodiments shown in figures 5A to 5B and 6A to 6D, the limb 500 isillustrated as an arm of a human. However, this is for illustrational purposes only. Theembodiments presented herein are not limited for use on humans, but may alsoadvantageously be used on animal patients. The embodiments presented herein are furthernot limited for use on a specific limb, but may be used on any suitable limb or body partwhere introduction of an IV tube is desired. Some non-limiting examples of such limbs are a wrist, an underarm, an upper arm, a thigh, a foot and a leg.

The elongated member 110 is made to a sufficient length to wrap around a type of limb towhich the IV fixation device 100 is intended to be attached. ln one or more embodiments, theelongated member 110 is made to a sufficient length to wrap around a type of limb to which the IV fixation device 100 is intended to be attached and to permit an area of overlap at the ends thereof. For example, if the first and second portions 112, 114 are located at arespective end of the elongated member 110, there may be permitted an overlap of at least part of the first and second portions 112, 114. ln some embodiments, one of the first and second portions 112, 114 may comprise afastening element (not shown in the figures) adapted to connect or attach to the other of thefirst and second portions 112, 114, thus providing easy attachment around the patient's limb500. The fastening element may further be adapted to disconnect or detach after attachment,and optionally also be adapted to reconnect or reattach to the other of the first and secondportions 112, 114. As an alternative, each of the first and second portions 112, 114 maycomprise or form a respective part of a fastening element (not shown in the figures) adaptedto connect or attach to each other, thus providing easy attachment around the patient's limb500 in an alternative manner. The parts of the fastening element may also in this case furtherbe adapted to disconnect or detach from each other after attachment, and optionally also be adapted to reconnect or reattach to each other.

Two exemplary embodiments of connection of the first and second portions 112, 114,wherein the first and second portion 112, 114 overlap in different manners, are shown inFigures 8A and 8B.

A fastening element, in one or two parts, may comprise a variety of different configurationsand manners of attachment, including, but not limited to, Velcro®, snaps, hooks, bikini-clasps, clips, buttons, adhesive applied to one or both of the first and second portions 112,114, etc. Such embodiments are schematically illustrated in Figure 8A. A fastening element,in one or two parts, may in other embodiments comprise a variety of different configurationsand manners of connecting the first and second portions 112, 114, including, but not limitedto a strap buckle, clasp or similar structure. Such embodiments are schematically illustrated in Figure 8B.

The fastening element is preferably adapted such that it is quick and easy to attach, andlikewise easy to detach, while still providing optimal secure attachment. This is especiallyimportant when using the fixation arrangement in medical emergency and trauma settings, orwhen the patient shows signs of anxiety. The secure attachment may be enabled by thefastening member locking the elongated member 110 in the desired tightened position. lfthere is no locking mechanism, the same result may be achieved by the first portion 112further being configured to be fixedly attached or connected to a fourth portion 812, bymeans of an adhesive or any of the other manners of attachment described in connection with Figure 8A. ln one example, a strap buckle, clasp or similar structure may be used for 9 locking the elongated member 110 at a desired length around the limb 500 by means of alocking mechanism, or the further attachment of the first portion 112 to the fourth portion 812.Just like the connection or attachment of the first portion 112 to the second portion 114 canbe reversed, i.e. the first and second portions 112, 114 can be detached again from eachother, the connection or attachment of the first portion 112 to the fourth portion 812 can alsobe reversed, i.e. the first and fourth portions 112, 812 can be detached again from eachother. An advantage with the embodiments of the fastening member of Figure 8B is that agreat variation of the resulting length of the elongated member after attachment to the limb500 is enabled. Therefore, the fixation device 100 according to embodiments presentedherein work well for limbs of different diameter, as the elongated member 110 can have the necessary length to fit around any sized limb 500. lt is to be understood that various features of the different connection or fastening embodiments described herein may be combined when possible.

The size of the elongated member 110, i.e. the length/longitudinal extension and/or the widthof the elongated member 110, may further be adapted to fit/wrap around a type of limb to which the IV fixation device 100 is intended to be attached. ln the embodiments of Figure 1A, a border 118, also referred to as a longitudinal side 118,along the third portion 116, marks the location where the fixation dressing 120 is detachablyattached to the elongated member 110. ln other words, in one or more embodimentsillustrated by Figure 1A, the detachable attachment comprises the fixation dressing 120being detachably attached to the elongated member 110 along a longitudinal side 118 of thethird portion 116. This is further illustrated in Figure 2A, which shows a side view of the thirdportion 116 of the elongated member 110, the fixation dressing 120, and the border 118 atwhich the third portion 116 and the fixation dressing 120 are detachably attached, andthereby being configured to allow a user to apply hand force to break, rip, pull or tear the fixation dressing 120 from the elongated member 110 via the border or longitudinal side 118.

Figure 2C is very similar to Figure 2A, but further includes an element 130, between the thirdportion 116 and the fixation dressing 120, which may in some embodiments represent anadhesive, stitching, punching, Velcro®, welding, i.e. textile welding, ultrasonic welding orelectro welding or similar, or other attachment means detachably attaching the third portion116 of the elongated element 110 to the fixation dressing 120, and being configured to allowa user to apply hand force to break, rip, pull or tear the fixation dressing 120 from the elongated member 110 via the border or longitudinal side 118.

Referring now to Figure 1B, there is illustrated an alternative embodiment for the fixationdressing 120 being detachably attached to the elongated member 110. ln one or moreembodiment of Figure 1B, the third portion 116 of the elongated member 110 overlaps with the fixation dressing 120, and the detachable attachment is provided in the overlapping area.

Figure 2B shows a side view of the third portion 116 of the elongated member 110 and thefixation dressing 120 overlapping. As indicated in Figure 2B, the third portion 116 of theelongated member 110 has a first, non-cutaneous, surface 113 and a second, cutaneous,surface 115. As further indicated in Figure 2B, the fixation dressing 120 has a first, non-cutaneous, surface 117 and a second, cutaneous, surface 119. ln some embodiments thedetachable attachment may comprises the second, cutaneous, surface 115 of the thirdportion 116 of the elongated member 110 being detachably attached to the entire, or part ofthe, first, non-cutaneous, surface 117 of the fixation dressing 120. This is illustrated in Figure2B.

Alternatively, the elongated member 110 and the fixation dressing 120 may instead becombined in the opposite order, with the fixation dressing 120 above or over the elongatedmember 110, or in other words farther away from the |imb 500 than the elongated member110. ln these embodiments, the detachable attachment may comprise the second,cutaneous, surface 119 of the fixation dressing 120 being detachably attached to the entire,or part of the, first, non-cutaneous, surface 113 of the third portion 118 of the elongatedmember 110, thereby being configured to allow a user to apply hand force to break rip, pull or tear the fixation dressing 120 from the elongated member 110 via the third portion 116.

Figure 2D is very similar to Figure 2B, but further includes an element 130, between the thirdportion 116 of the elongated element 110 and the fixation dressing 120 (which may becombined in any order, as described herein). The element 130 may in some embodimentsrepresent an adhesive, stitching, perforation, indentions, punching, Velcro®, welding, i.e.textile welding, ultrasonic welding or electro welding or similar, or other attachment meansconfigured to detachably attaching the third portion 116 of the elongated element 110 to thefixation dressing 120, and further being configured to allow a user to apply hand force tobreak rip, pull or tear the fixation dressing 120 from the elongated member 110 via the third portion 116. The attachment means may be applied over all or part of the overlapping area. ln some embodiments, the fixation dressing 120 extends on both sides of the elongatedmember 110, as indicated by the dotted part of the fixation dressing 120, extending on theother side of the elongated member 110 as seen from the main part of the fixation dressing, by a distance D. The fixation dressing 120 may be substantially rectangular in shape, as 11 illustrated in the figures. The fixation dressing 120 is not, however, limited to this shape, butmay have any other shape that is suitable for fixating and securing an IV tube when thefixation dressing is applied or attached onto the skin of the human or animal patient. ln oneor more embodiments, the fixation dressing 120 may have a cutout portion 121 configured toreceive an IV tube when the fixation dressing 120 is applied or attached onto the skin of thehuman or animal patient. The cutout portion 121 will then improve the fixation of the IV tube 400 by enabling the fixation dressing 120 to cover the wings 402 of the IV tube 400.

Figure 3A to 3H show the layered structure of a fixation dressing according to differentembodiments. Said layered structure may comprise at least one layer, including the options of comprising one, two, three, four, five or more layers.

Figure 3A shows an embodiment wherein the fixation dressing 120 comprises a singleadhesive layer 122, comprising any adhesive material structured to attach to the skin of ahuman or animal, to make the fixation dressing 120 easy to attach and keep attached. Theadhesive layer can also contain a tape or another suitable adhesive. The adhesive layer 122is the layer of the fixation dressing 120 that is arranged closest to the limb 500 to which thefixation dressing 120 is attached. This layer provides for attachment of the device to the skin of the human or animal patient. ln one or more embodiments, the adhesive layer 122 may comprise a hydrogel. ln this embodiment, the hydrogel may advantageously be an adhesive hydrogel. ln one or more embodiments, the fixation dressing 120 is also provided with an absorbentlayer 126. The absorbent layer may in one or more embodiments be combined with theadhesive layer 122, as shown in Figure 3B. The absorbent layer is preferably adapted to bearranged above or over said adhesive layer 122 in relation to the body of said human or animal patient, i.e. further from the skin of the patient than the adhesive layer 122.

The absorbent layer 126, which may in these embodiments be described as the core of thefixation dressing 120, advantageously functions to absorb excess fluids, such as blood,sweat and other bodily fluids, making the fixation dressing 120 easier to secure and keepattached. This advantageous effect enables good fixation even if the patient's skin is cold ormoist. The absorbent layer 126 further provides for the absorption of any body fluidsexcreted from or present around the entry area of the IV tube 400. Preferably, the absorbentlayer 126 covers at least the same surface area as the adhesive layer 122. The adhesivelayer 122 may comprise pores or be othenNise structured to allow for bodily fluids to pass through the adhesive layer 122. 12 The absorbent layer 126 may comprise a disinfection substance that is excreted by saidlayer or pores of the absorbent layer 126, to be absorbed by the skin and/or surroundingtissue around the puncture site of the human or animal patient. This is to prevent infectionaround the puncture site and phlebitis. ln some embodiments, the disinfection substancemay constitute a separate disinfection layer (not shown in the figures). The disinfection layermay be adapted to be arranged in direct connection to, i.e. over or under, the absorbent layer126, and/or be adapted to be arranged above or over said adhesive layer 122 in relation tothe body of said human or animal patient, i.e. further from the skin of the patient than the adhesive layer 122. ln a non-limiting example, the absorbent layer 126 comprises a hydrogel. The absorbentlayer 126 may however comprise any available absorbent material suitable for the purpose,for example one or more Gauze swabs, absorbent dressing Evercare, Mesoft, non-adherent dressing, one or more compresses or superabsorbent wound dressing. ln some embodiments, the fixation dressing 120 comprises a top protective layer 124. Thistop protective layer 124 is then arranged above or over the other layers, i.e. further from theskin of the patient than the other layers, such that the top protective layer 124 protects theother layers, the skin of the patient and the entry area of the IV tube 400, when this iscovered by the fixation dressing 120. The top protective layer 124 may comprise a non-permeable flexible or elastic material, and/or a water repellant or water-resistant material.The material may in some embodiments be a fabric, a woven fabric, a plastic material or bemade from fiber. Preferably, the top protective layer 124 covers at least the same surfacearea as the adhesive layer 122 and, if present, also at least the same surface area as theabsorbent layer 126. The top protective layer 124 may be combined with any combination ofthe other layer described herein, for example as illustrated in the example embodiments ofFigures 3C, 3D, 3E or 3G, further described below. ln some embodiments, the fixationdressing 120 further comprises a bottom protective layer 128 which is configured to protectthe adhesive layer. The bottom protective layer 128 is further configured to be removed,partly or fully, before the fixation dressing 120 is attached to the skin of the human or animalpatient. This bottom protective layer 128 is then arranged below or under the adhesive layer122, such that the bottom protective layer 128 protects the adhesive layer 122 beforeattachment of the fixation dressing 120. The bottom protective layer 128 may be structured tobe removed in one piece. Alternatively, the bottom protective layer 128 may be divided intotwo or more parts, of which at least two may partly overlap. The two or more parts of the bottom protective layer 128 may be structured to be removed separately. 13 The bottom protective layer 128 may be combined with any combination of the other layer described herein, for example as illustrated in Figures 3D, 3F, 3G or 3H.

According to the exemplary embodiments of Figures 3C to 3H, the layered structure may be structured in any of the following manners: A layered structure comprising, in consecutive order from the bottom up: an adhesive layer 122; an absorbent layer 126; and a top protective layer 124, as shown in Figure 3C.

A layered structure comprising, in consecutive order from the bottom up: a bottom protectivelayer 128; an adhesive layer 122; an absorbent layer 126; and a top protective layer 124, as shown in Figure 3D.

A layered structure comprising, in consecutive order from the bottom up: an adhesive layer 122 and a top protective layer 124, as shown in Figure 3E.

A layered structure comprising, in consecutive order from the bottom up: a bottom protective layer 128 and an adhesive layer 122, as shown in Figure 3F.

A layered structure comprising, in consecutive order from the bottom up: a bottom protective layer 128; an adhesive layer 122 and a top protective layer 124, as shown in Figure 3G.

A layered structure comprising, in consecutive order from the bottom up: a bottom protective layer 128; an adhesive layer 122 and an absorbent layer 126, as shown in Figure 3H.

The different layers of the fixation dressing 120 are preferably of the same shape as eachother and cover essentially the same surface area. However, it is also conceivable that somelayer covers a smaller area than others. The overall shape of the supportive element is an essentially flat structure, and can be any suitable shape.

We will now describe an IV tube procedure wherein the fixation device according to one ormore embodiments described herein is used, in connection with Figures 6A to 6D. Forillustrational purposes, we describe in connection with Figured 6A to 6D the insertion of theIV tube into a vein, but the procedure is not limited to this, as is apparent from the alternative embodiments described in the present disclosure.

Figure 6A illustrates attachment of the fixation device 100 to the limb 500 of the patient, inthis example illustrated as an arm of a human. ln some embodiments, the fixation dressing120 may be foldable in relation to the elongated member 110 along the longitudinal side 118of the third portion 116, into a second position. This is indicated in Figure 6A by the dottedline showing the original position of the fixation dressing 120 before it was folded along the longitudinal side 118 of the third portion 116, the dotted arrow indicating the folding motion, 14 and the fixation dressing 120 in its second position, i.e. after folding. The arrow 110 indicatesthat when the fixation dressing has been folded into its second position, the elongatedmember 110 is located under the fixation dressing 120, i.e. closer to the skin of the human oranimal patient than the fixation dressing 120. The folding option is especially useful when thefixation device 100 is placed close to the planned insertion site for the IV tube 400, such thatthe fixation dressing could block the entry of the vein, or artery, with the IV tube 400 if foldingwas not enabled. In other words, the folding possibility advantageously enables health carepersonnel to place the fixation device 100 closer to the intended entry point for the IV tube, orclose to any other medical equipment or item attached to the limb 500 that may otherwise be obstructed by the fixation device 120 during entry of the IV tube into the vein or artery.

During attachment of the fixation device 100, the elongated member 110 may be tightenedaround the limb 500 to enable easier visualization of a vein or blood vessel to penetrate witha needle 410. Thereafter, the needle tip 401 of an IV tube 400 is introduced into the selectedvein or blood vessel, where after the needle 410 is slightly retracted and used as guide to introduce the IV tube into the vessel, according to methods known in the art.

Once the IV tube 400 is inserted, the needle 410 is removed and the end of the IV tube iscapped (not shown in the picture), or an infusion line is attached to the end 404 of the IV tube400. Thereafter, the fixation dressing 120 is folded back, if it was previously folded, and anybottom protective layer 128 that may be present on the fixation dressing 120 is removed.Thereafter, the fixation dressing 120 is attached to the skin of the human or animal patient.The attachment location of the fixation dressing 120 is preferably selected such that thefixation dressing 120, once attached, covers the wings 402 of the IV tube 400, to provide asecure attachment of the IV tube 400. The result is illustrated in Figure 6B. Figure 6B also shows an IV infusion line 504 which has been introduced into the end 404 of the IV tube 400.

Thereafter, the elongated member 110 is Ioosened, or completely opened, by untighteningthe pulling force that is applied around the limb 500, or opening the fastening element. Theelongated member 110 can then be separated from the fixation dressing 120 by hand force.

The separated parts are illustrated in figure 6C.

In some embodiments, the separation of the elongated member 110 from the fixationdressing 120 may be performed before the fixation dressing 120 is attached to the skin of thepatient. This is useful if the planned insertion site of the IV tube 400 and the area where theelongated member 110 is fastened around the limb 500 are far from each other. Forexample, in one or more embodiments it may be advantageous to attach or fasten, and tighten, the elongated member 110 at a proximal part of the limb 500 to obtain strong stasis. ln the non-limiting illustrative examples of the figures this may for example correspond tofastening the elongated member 110 to an upper arm. ln the same one or moreembodiments, it may further be advantageous to select the entry point for the IV tube 400 tobe at a more distal part of the limb 500, for example the back of the hand of the patient limb500 illustrated in the example of the figures. Thereby, the elongated member 110 and theentry point will be located at a distance from each other that is too large to enable fixation ofthe IV tube 400 by the fixation dressing 120, if the fixation dressing 120 is attached to theskin of the human or animal patient at its present location. Since the fixation dressing 120and the elongated member 110 can be separated by pulling them apart before the fixationdressing 120 is attached to the skin of the patient, the health care personnel is enabled tofasten the elongated member 110 at a distance from the intended entry point of the IV tube400, but still have the fixation dressing 120 within reach for the fixation step, since it isdetachably attached to the elongated member 110. The health care personnel do not have tohold the fixation dressing 120 while fastening the elongated member 110. Neither do theyhave to reach far to obtain it, or risk forgetting the elongated member 110 and having to getup to find it in a cabin or drawer after having attached the elongated member 110. This isclearly advantageous over having to keep track of two separate items in the form of a stasisband and an adhesive bandage, as is required according to previous solutions. Theseadvantages are of course equally true for all embodiments presented herein, for example allembodiment wherein the elongated member 110 is detached from the fixation dressing 120after the fixation dressing 120 has been attached to the skin of the human or animal patient.ln other words, embodiments presented herein facilitate the Work of a health care person during the IV tube procedure, by reducing both the time and the effort required. ln one or more embodiments, the detachment of the elongated member 110 from the fixationdressing 120, along the border or side 118, or along the second, cutaneous surface 115 ofthe third portion 116, in the different manners described herein, is irreversible. ln someembodiments, the detached elongated member 110 can be reattached to the fixationdressing 120 along the same border 118; the same first, non-cutaneous surface 113; or the same second, cutaneous surface 115, of the third portion 116.

Turning now to Figure 6D, one or more embodiments for providing further improved fixation and securing of the fixation dressing 120 to the limb 500 of the patient will be described. ln one or more embodiments, the elongated member 110 is further configured to, afterdetachment from the fixation dressing 120, be attached around the limb 500 of the human or animal patient at a second location, to provide further fixation and securement of the IV tube 16 400 and/or IV infusion line. The second location may be different from the first location. lnFigure 6D, three non-limiting alternatives for the second location are illustrated, by the dottedoutlines of the elongated member 110 in three versions. ln the specific exemplaryembodiments of Figures 6A and 6D, the limb 500 is an arm of a human patient, the firstlocation is at the wrist of the human patient, and the second location is exemplified as being located at the hand, the wrist and/or across the underarm of the human patient.

As shown in the examples of Figure 6D, the second location may be selected such that theelongated member 110 is attached across at least a part of the fixation dressing 120, toprovide further fixation and securement of the IV tube 400, by reducing the risk of dislodgement due to pulling of the IV tube 400. ln some embodiments, wherein the fixation dressing 120 comprises a cutout portion 121, thesecond location is further selected such that elongated member 110, when attached to thelimb 500 in the second location, covers at least part of the cutout portion 121. This is usefulbecause the area of the cut out 121 of the fixation dressing 120 represents a weak point of the dressing where the IV tube might be pulled out if a dragging or pulling force is applied. ln some embodiments, the second location is selected such that the elongated member 110is attached across at least a part of the IV tube 400. ln alternative embodiments, the secondlocation is selected such that the elongated member 110 is attached under the IV tube 400 and at the same time covers at least part of the cutout portion 121.

As further shown in Figure 6D, the second location may be selected such that the elongatedmember 110 is attached across at least a part of the IV line 504, thereby providing furtherfixation and securement of the IV tube 401 by reducing the risk of dislodgement due topulling of the IV line 504. ln one or more embodiments, the elongated member 110 may be configured to be dividedinto two or more sections, for example into two, three, or four sections. ln theseembodiments, each of the resulting sections may be configured to be attached around thelimb 500 of the human or animal patient, according to any of the attachment optionspresented herein, to provide further fixation and securement of the IV tube 401 by reducingthe risk of dislodgement due to pulling of the IV tube 400 or the IV line 504. For example, theelongated member may be long enough to be divided into two, three or four sections,wherein each section is long enough to wrap around the limb 500 of the human or animalpatient, and wherein each section comprises attachment means for attaching the section tothe skin of the patient, and/or to attach the ends of the section to each other once the sectionhas been wrapped around the limb 500 of the patient. As a non-limiting example, the17 attachment means may be provided by means of adhesive. The division of the elongatedmember 110 into two or more sections may be done before removal of a possible protectionlayer covering an adhesive layer, according to any of the relevant embodiments describedherein. The elongated member 110 may be configured to be divided into two or moresections via a respective one or more “tear off edge” or section border between the sectionsof the elongated member 110. Each section is in these embodiments configured to bedetachable from its neighboring section or sections by hand force, via the respective sectionborders. The detachment may be enabled by means the border being defined by of at leastone of perforations, indentions, punching, stitching, welding and adhesive. The possibility ofdividing the elongated member 110 into several sections, each applicable for attachmentaround the limb 500, provides the advantage of enabling even further improved fixation andsecuring possibilities, still using only one fixation device 100. Thereby, additional fixationmeans, in addition to those the ones already described herein, are also available at the samelocation. This reduces the time and effort required by the health care personnel even further.Also, since the section are configured to be detachable from its neighboring section orsections by hand force, the advantage of not having need for any other tools, such as forexample scissors, applies also to these embodiments. Each section may be attached aroundthe limb 500 at the same or at a different (second, third, fourth etc.) location compared to any of the other sections. ln some embodiments, the elongated member 110, or one or more sections of the elongatedmember 110, is configured to be attached around the limb 500, at the second location, viasaid first and second portions 112, 114, in any known manner, for example according to any of the manners described in connection with Figures 1A and 1B. ln other embodiments, wherein the elongated member 110 has a first, non-cutaneoussurface 113 and a second, cutaneous surface 115, the elongated member 110 furthercomprises an adhesive layer on at least one of the first, non-cutaneous surface 113 and thesecond, cutaneous surface 115. The adhesive layer is configured to be attachable to the skinof the patient and to the first, non-cutaneous surface 117 of the fixation dressing 120, whenthe fixation dressing 120 is attached to the limb 500. The elongated member 110 is in theseembodiments configured to be attached around the limb 500, at the second location, via theadhesive layer. The adhesive layer may be distributed over all or a part of the at least onefirst and second surface 113, 115 of the elongated member 110. To make the elongatedmember 110 easier to handle before fixation of the IV tube, the elongated member 110 mayfurther comprise a protective layer covering the adhesive layer, the protective layer being configured to be removed, partly or fully, before attachment of the elongated member 110 in18 the second location. The protective layer may be structured to be removed in one piece.Alternatively, the protective layer may be divided into two or more parts, of which at least twoparts may optionally partly overlap. The two or more parts of the protective layer may in this case be structured to be removed separately.

Of course, a combination of the options of attaching via said first and second portions 112,114, and via an adhesive layer of the elongated member 110, may be provided for possibly even further improved fixation and securement of the IV tube. lt is further feasible that, if found necessary, additional tape or other conventional fixationmeans may be used in combination with the fixation device 100 according to any of the embodiments presented herein.

Figure 7 shows a schematic overview of a medical kit 300 according to one or moreembodiments, comprising a kit package 310 configured to enclose a fixation device 100according to any of the embodiments presented herein and at least one of: one or moredisinfection wipes 320 for washing the skin of a patient; an IV tube to insert into a bloodvessel; and a syringe prefilled with a saline solution. The health care personnel thus get allthe essential equipment, i.e. fixation dressing 120 and the elongated member 110 in onepack/solution. Advantageously, everything needed for the IV tube procedure is therebyaccessible to the health care personnel in the same medical kit. Preferably, the kit package310 is flat, which is enabled by the components enclosed therein all being substantially flat.

Preferably, the kit 300 is single use and/or sterile.

The invention is further not restricted to the described embodiments in the figures, but may be varied freely within the scope of the claims. 19

Claims

1. CLA||\/IS _ A fixation device (100) for fixating and securing an intravascular, IV, tube, the fixation device (100) comprising: a flexible elongated member (110), comprising a first portion (112) and a secondportion (114) configured to be attachable to each other, wherein the elongatedmember (110) is configured to be attached around a limb (500) of a human or animal patient at a first location, via said first and second portions (112, 114); a fixation dressing (120), comprising at least one adhesive layer (122) configured to be attachable to the skin of the patient, wherein the fixation dressing (120) is detachably attached to the elongated member(110) at a third portion (116) ofthe elongated member (110), characterized in that the elongated member (110) is further configured to betightened around said limb (500) to provide vascular stasis in the limb, thereby enabling easier introduction of an IV tube. _ The fixation device (100) of c|aim 1, wherein the fixation dressing (120) further comprises an absorbent layer (126). _ The fixation device (100) of any of the claims 1 or 2, wherein the fixation dressing (120) further comprises a top protective layer (124). _ The fixation device (100) of any of the preceding claims, wherein the fixation dressing (120) further comprises a bottom protective layer (128). _ The fixation device (100) of any of the preceding claims, wherein the detachable attachment is configured to enable a user to break, rip, pull or tear the fixation dressing(120) from the elongated member (110) by applying hand force, wherein the detachableattachment is achieved by means of at least one of: perforation, indentions, punching, stitching, welding and adhesive. _ The fixation device (100) of c|aim 5, wherein the detachable attachment comprises the fixation dressing (120) being detachably attached to the elongated member along alongitudinal side (118) ofthe third portion (116). _ The fixation device (100) of any of the claims 1 to 4, wherein the detachable attachment is configured to enable a user to break, rip, pull or tear the fixation dressing (120) from the elongated member (110) by applying hand force, wherein the detachable attachment 10. 11. 12. is achieved by means of at least one of: perforation, indentions, punching, welding, Ve|cro®, adhesive and stitching. The fixation device (100) of claim 7, wherein the third portion (116) of the elongatedmember (110) has a first, non-cutaneous, surface (113) facing away from the skin of thepatient when the elongated member (110) is attached to the limb (500); and an opposingsecond, cutaneous, surface (115), facing towards the skin of the patient when theelongated member (110) is attached to the limb (500); wherein the fixation dressing (120)has a first, non-cutaneous, surface (117) facing away from the skin of the patient whenthe elongated member (110) is attached to the limb (500); and an opposing second,cutaneous, surface (119) facing towards the skin of the patient when the elongatedmember (110) is attached to the limb (500); wherein the detachable attachmentcomprises the first, non-cutaneous, surface (117) of the fixation dressing (120) beingdetachably attached to the second, cutaneous, surface (115) of the third portion (116) of the elongated member (110). The fixation device (100) of claim 5 or 6, wherein the fixation dressing (120) is foldable inrelation to the elongated member (110) along an axis parallel or substantially parallel tothe longitudinal side (118) ofthe third portion (116). The fixation device (100) of any of the preceding claims, wherein the elongated member(110) is further configured to, after detachment from the fixation dressing (120), beattached around the limb (500) of the human or animal patient at a second location,across the fixation dressing (120), to provide further fixation and securement of the IVtube. The fixation device (100) of claim 10, wherein the elongated member (110) is configuredto be attached around the limb (500), at the second location, via said first and secondportions (112, 114). The fixation device (100) of claim 10, wherein the elongated member (110) has a first,non-cutaneous, surface (113) and a second, cutaneous, surface (115), wherein theelongated member (1 10) further comprises an adhesive layer distributed over all or a partof said second, cutaneous surface (113), wherein the adhesive layer is configured to beattachable to the skin of the patient or to the first, non-cutaneous, surface (117) of thefixation dressing (120), and wherein the elongated member (110) is configured to be attached around the limb (500), at the second location, via said adhesive layer. 21 13. The fixation device (100) of any of the preceding claims, wherein the elongated member(110) is made from at least one of the following materials: non-rip paper, non-rip polymer material, fabric, Ve|cro® and a suitable plastic material. 14. A medical kit (300) comprising a kit package (310) configured to enclose a fixationdevice (100) according to any of claims 1-13 and at least one of: one or more disinfectionWipes (320) for washing the skin of a patient; an IV tube to insert into a vein or artery; and a syringe prefilled with a saline solution. 22