GB2464662A

GB2464662A - Fixation device

Info

Publication number: GB2464662A
Application number: GB0816350A
Authority: GB
Inventors: Gregory F Devenish
Original assignee: Polarseal Tapes & Conversions
Current assignee: Polarseal Tapes & Conversions
Priority date: 2008-09-08
Filing date: 2008-09-08
Publication date: 2010-04-28
Also published as: GB0816350D0

Abstract

An all-in-one dressing and fixation device 4, 6 for securing an I.V. device 42, 44, 46 to a patient's skin 40 comprising means 30 to seal about the needle 44 insertion point to provide a sterile dressing and means 8 to secure a portion of the tube 46 remote from the needle 44 to the patient 40. The tube 46 securing means 8 may secure the tube 46 in a looped back configuration when the device is folded. The device may further comprise a landing strip with an adhesive surface 26 for supporting and securing the inserted needle 44 above the skin 40. One part of the device 4 may be a cushion section and the other part 6 a cover section having securing means.

Description

FIXATION DEVICE

The present invention relates to a fixation device and in particular a device in the form of a dressing for securing a cannula or the like to a patient's skin.

A cannula or catheter is a device which can be inserted into a patient to enable the delivery or removal of fluid. The cannula usually comprises a soft flexible tube with a body at one end which carries a needle, the opposite end of the tube is adapted to be connected to, for example, a source of medication or food. In use the needle or device is inserted into, for example, a vein of a patient in order to deliver the medication to the patient. The cannula can remain in place for days. It is therefore necessary to fix the cannula in place to prevent the accidental removal of the needle S *S from the patient. The fixing of the cannula often comprises the use of several pieces S... * . S...

of adhesive tape to hold the end of the tube and its body to the patient's skin. Also, the puncture wound is best if it is covered with a separate urethane dressing to cover *..

the puncture! insertion site to keep it sterile. The problem with applying the fixing S...

means in this maimer is that it can require more than one person to apply, because more than two hands are required to both hold the various components of the cannula in place whilst applying the dressing and fixing the tapes. This is a time consuming use of resources. Also because of the separate nature of the components used the quality of the fixing and dressing is not always consistent. It is usually necessary to change the dressing in order to maintain sterility, further leading to reduction of efficiency. The separate nature of the components also means there is a potential reduction in sterility, leading to the greater possibility of infection.

In accordance with the present invention there is provided an all-in-one dressing and fixation device for securing an I.V. device to a patient's skin, the LV.

device being of the type comprising a needle which in use is inserted into the patient's skin and a tube connecting the needle to a delivery or extraction system, wherein the all-in-one device comprises means to seal about the needle insertion point to provide a sterile dressing and to secure the needle, and further comprising means to secure a portion of the tube remote from the needle to the patient.

The tube securing means may be provided to secure the tube in a looped back configuration.

The all-in-one device may further comprise means to support the inserted needle above the skin, which may comprise a landing strip with an adhesive surface *. . for securing the needle thereon, it may also comprise a hydrocolloid material which * may have at least one of the properties breathable and absorbent. The material may * S* comprise an anti-microbial agent which is adapted to be effective in both dry and moist conditions and may increase its efficiency over time. The support means may S...

have an adhesive surface for releasably securing the support means to the patient's skin. The adhesive may be combined with the hydrocolloid material.

The support means may be profiled to fit around the needle insertion point, the profile may be a V-shaped notch in the support means.

The support means may be hinged to the sealing means whereby the sealing means is adapted to fold over the support means to substantially cover the support means.

The line securing means may be provided between the folded support and sealing means.

The sealing means may have a transparent portion to enable visual inspection of the needle insertion point. At least the transparent portion may be waterproof. The sealing means may be provided with a frame support about the transparent portion.

The surface of the sealing means adapted to fold over the support means may carry an adhesive surface to provide said seal.

All adhesive surfaces may be covered with a respective removable liner, which may have a respective tab to facilitate removal.

The securing means may be impregnated with an anti-microbial agent.

In accordance with a second aspect of the present invention there is provide an all-in-one dressing and fixation device for securing an I.V. device to a patient's skin, the J.V. device being of the type comprising a needle which in use is inserted into the patients skin and a tube connecting the needle to a delivery or extraction system, wherein the fixation device comprises a cushion section which is adapted to fit between the patient's skin and the inserted needle to support the needle body above the skin and a cover section hinged to the cushion section which is adapted to * selectively fold over the cushion section, the cover section having securing means to S..

seal about the needle insertion point and to secure the needle and cushion section to the patient, wherein the device further has an I.V. line securing means, which may secure the line remote from the needle and may secure it as a looped back configuration.

By way of example only a specific embodiment of the invention will now be described with reference to the accompanying drawings, in which:-Fig. 1 is an exploded view of a fixation device constructed in accordance with the present invention, liners omitted; Fig. 2 is a schematic view of the fixation device with liners in place; Fig. 3 is a view of the opposite side of the fixation device to that shown in Fig. 2, liners omitted; Fig. 4 is a view showing the fixation device in a folded configuration, caimula omitted and showing surface of fixing device which is applied to the skin in use; and Fig. 5 is a view of the folded fixation device attached to the skin holding a cannula and its line in place.

In the exploded view of Fig. I the various sections of the fixation device 4,6 are shown separated to provide an indication of how they fit together to complete the all-in-one fixation means and dressing for a cannula. The device 4, 6 comprises two * * main sections which are fixed and hinged together to provide a cushion section 4 and S... * . S...

a cover section 6. They are fixed and hinged together by a double sided adhesive tape S...

8 which is used to join adjacent edges 10, 12 of the cover and cushion sections 6,4 S..

with a slight overlap (as shown in Fig. 2). a...

The cushioned section 4 comprises a plastic film 14 coated on one side with a hydrocolloid material 16. The hydrocolloid material 16 contains an adhesive which provides a self adhesive surface to that side of the cushioned material 4 and which enables it to be adhered to the skin of a patient. The adhesive surface 16 is covered and protected by a pealable liner E (see Fig. 2) which has a tab 1 which enables the liner E to be grasped and peeled from the cushioned section 4, when applying the fixation device 4, described further herein under.

The cushioned section 4 has v-shaped cut-out 18 at one edge which provides two wings 20, 22 in the cushioned section 4 linked by a main body portion 24. The opposite side of the film 14 is provided with a landing strip 26 which takes the form of a double-sided adhesive strip, one side of which fixes the strip 26 to the film 14, the opposite side of the strip 26 is also covered by a removable liner D with a tab 2 to protect the adhesive surface until required. The landing strip 26 extends from the edge of the cut-out section 18 across the main body portion 24 of the cushioned section 4 to the opposite edge of the cushioned section 4.

The cover 6 comprises a non-woven tape material layer 28 laminated on a further plastics film 30, the cover 6 is completed by an adhesive coating which covers the material layer 28 and the surface of the further film layer 30 below to provide a self-adhesive side to the cover 6. As before a removable liner C with tab 3 protects and covers the adhesive. The adhesive side of the cover is in-line with the landing *:*::* strip 26 carrying side of the cushioned layer 4, such that the hydrocolloid adhesive * * layer 16 is on the opposite side of the fixation device 4, 6 to that of the cover 6 **** : adhesive layer. Liner 6 covering the adhesive side of the cover 6 is provided with a *** marker 32 (as best illustrated in Fig. 2). The marker 32 is a line with the instruction S...

* written thereon "place line here". This marker line 32 is provided parallel to the S..

landing strip 26 and over the adhesive surface of the cover 6.

The further plastic layer 30 is clear and a window 34 is provided in the cover layer 6 in that the non-woven tape material layer 28 comprises a cut-out 34 in a central region thereof The fixation device is applied as follows: Firstly a cannula is inserted in the patient 40 in the normal manner. The cannula comprises a cannula head 42, which a needle 44 extending from one end and a cannula tube 4 6 extending from the other end. Initially liner E covering the self-adhesive hydrocolloid layer 16 of the cushioned section 4 is removed. The cushioned section 4 is then positioned under the cannula 42, 44, 46, adhesive side facing the skin 40, such that the main body portion 24 is beneath the head of the cannula 42 and the wings 20, 22 extend either side of the needle 44 insertion point. The cushioned section 4 is then gently pressed to the skin 40 to adhere the cushioned section 40 to the patient's skin 40.

Liner D covering the landing strip 26 is then removed to reveal the adhesive surface thereof and the cannula head 42 is gently pressed on the adhesive surface to fix the cannula head in place. Next the cannula line 46 is looped back and placed along the marker line 32. Liner C is then removed to reveal the adhesive coating on the cover section 6. The cover section 6 is then folded over the cushion section 4 * :* :* which secures the cannula line 46 between the hinge 8 connecting the cover section 6 *. * S S...

to the cushion section 4. This also secures the cannula body since the cover section 6 S...

* : seals over the cushion section 4. The cover section 6 is then gently pressed down *** around the puncture! insertion site of the caimula needle 44 to remove any air pockets *.

between the cover 6 and the skin 40.

In this position the window 34 is positioned over the needle 44 insertion site which enables visible and continuous inspection of the puncture site, whilst providing an effective bacteria barrier.

The V-shaped cut-out 18 in the cushion section 4 enables the cushion section to fit around a plurality of different sized cannula heads either ported or non-ported and to also fit around cannula heads with or without wings. Whilst a V-shape has been described, other shapes of cut-out could be employed.

The fixation device is removed by grasping the device 4,6 and lifting it away from the patients skin, because the cushioned section 4 is situated below the cannula and the cover section 6 is adhered over the cushion section this automatically removes the cannula with the fixation device 4, 6. Thus enabling removal of the fixation means, dressing and cannula with one easy movement compared to prior device, which required separate removal of all fixation strips and the dressings, before the cannula can be removed.

The hydrocolloid material 16 of the cushion section is selected to provide properties which enables the dressing to be left on the skin for up to 7 days, reducing the need! cost of changing the dressing. It is selected to be breathable, absorbent and retain any moisture around the puncture site caused by leaking, or moisture from * ** washing. It further provides a cushion on which the cannula sits reducing discomfort pressure, bruising or skin damage. ****

The hydrocolloid material 16 further includes the adhesive and an antimicrobial agent formulated to be effective against bacteria and viruses and strains **** which become resistant to these. The agent is adapted to be stable and effective in S..

both dry and moist conditions and to increase its efficiency over time.

The hydrocolloid material as mentioned above is laminated to a plastics film 14. A variety of materials may be employed to provide the film which acts as a carrier for the hydrocolloid material 16 but it is preferred that the material is breathable, acts as a bacterial barrier and is water resistant. Polyurethane is particularly suitable.

The landing strip 26 constructed from double sided tape has an extraordinary high tack to the majority of materials. This allows an extensive range of cannula to be secured. The adhesive used is selected to remain effective even when subjected to moisture from body fluids or washing and thereby enables fixation even when the patient is perspiring. The adhesive is adapted to secure a variety of materials to its surface including at least plastics, metals and silicones. The same adhesive is used for the hinge 8 between the cushion and cover sections 4, 6.

The landing strip further adds to the cushioning effect of the hydrocolloid material, which a variety of depths of cushions may be suitable it has been found that the combined hydrocolloid base pad and strip with a height of 0.75 mm is particularly efficient and cost effective to suspend the cannula off the patient's skin The plastics film 30 and material 28 of the cover section 28 coated with the adhesive is also impregnated with an anti-microbial agent for example silver. The * ** * film is transparent to provide inspection of the puncture site through the window 34. * S * *

It is also waterproof, allowing the patient to wash without risk of wetting the insertion site and forms a seal around the insertion site. It is also semi-permeable, impervious to bacteria and promotes water vapour transmission (MVTR), thus preventing * �.e * accumulation of moisture under the film. This coupled with the anti-microbial agent ** S in the adhesive, significantly reduces the risk of bacterial and virus infections. The adhesive is skin-safe and has high tack properties reducing the risk of patient's circumstances dislodging the cannula, whilst also being relatively low trauma for easy removal. Polyurethane has been found to have the required properties.

The non-woven tape material 28 creates a frame to provide support and stability to the film 30 and its window 34 preventing edge rolling. It further assists in securing the cannula. All materials used are hypoallergic and tested to an approved standard for cytoxicity, sensitivity and biocompatibility.

The fixation device is shape designed to reduce the possibility of catching on clothes! bedding allowing relatively free movement due to the cannula line being safely secured simultaneously and within the same device. To this end the device has no sharp corners and rounded edges.

Whilst a specific cannula has been described, the fixation device is also suitable for use with central line catheters, I.V. cannula liner -ported and non-ported, umbilical catheters, epidural catheters, feeding tubes or any invasive device entering the skin.

The dressing may be provided with a patient identification strip which has a writable surface enabling information to be recorded.

It will be appreciated that the above embodiment has been described by way * a.

of example only and many variations are possible without departing from the scope of * . the invention. **** * . a

S S..

S a... * . . I. *

S S..

Claims

CLAIMS1. An all-in-one dressing and fixation device for securing an I.'V. device to a patient's skin, the I.V. device being of the type comprising a needle or the like which in use is inserted into the patient's skin and a tube connecting the needle to a delivery or extraction system, wherein the all-in-one device comprises means to seal about the needle insertion point to provide a sterile dressing and to secure the needle, and further comprising means to secure a portion of the tube remote from the needle to the patient.
2. A device according to claim 1, wherein the tube securing means is adapted to enable the tube to be secured in a looped back configuration.
3. A device according to claims 2 or 3, comprising means to support the * ** inserted needle above the skin. * S*. * *
4. A device accordingly to claim 3, wherein the support means comprises a landing strip with an adhesive surface for securing the needle thereon. 0**
5. A device according to claim 4, wherein at least the landing strip * 0..: comprises a hydrocolloid material. *.S
6. A device according the claim 5, wherein the hydrocolloid material has at least one of the properties breathable and absorbent.
7. A device according to claim S or 6, wherein the hydrocolloid material comprises an anti-microbial agent which is adapted to be effective in both dry and moist conditions.
8. A device according to claim 7, wherein the anti-microbial agent increases its efficiency over time.
9. A device according to anyone of claims 3 to 8, wherein the support means has an adhesive surface for releasably securing the support means to the patient's skin.
10. A device according to anyone of claims 5 to 9, wherein the adhesive is combined with the or a hydrocolloid material.
11. A device according to anyone of claims 3 to 10, wherein the support means is profiled to fit around the needle insertion point.
12. A device according to claim 11, wherein the profile is a V-shaped notch in the support means.
13. A device according to anyone of claims 3 to 12, wherein the support means is hinged to the sealing means whereby the sealing means is adapted to * ** fold over the support means to substantially cover the support means.
14. A device according to claim 13, wherein the line securing means is ** ** : provided between the folded support and sealing means.
15. A device according to any one of the preceding claims, wherein the ** sealing means has a transparent portion to enable visual inspection of the **.needle insertion point.
16. A device according to claim 15, wherein at least the transparent portion is waterproof.
17. A device according to claims 15 or 16, wherein the sealing means is provided with a frame support about the transparent portion.
18. A device according to anyone of claims 13 to 17, wherein the surface of the sealing means adapted to fold over the support means carries an adhesive surface to provide said seal.
19. A device according to anyone of the preceding claims, wherein the or all adhesive surfaces are covered with a respective removable liner.
20. A device according to claim 19, wherein each adhesive surface has a respective tab to facilitate removal.
21. A device according to anyone of the preceding claims, wherein the securing means is impregnated with an anti-microbial agent.
22. An all-in-one dressing and fixation device for securing an I.V. device to a patient's skin, the I.V. device being of the type comprising a needle or the like which in use is inserted into the patients skin and a tube connecting the needle or the like to a delivery or extraction system, wherein the fixation device comprises a cushion section which is adapted to fit between the * ** patient's skin and the inserted needle to support the needle body above the *.*. * I I...skin and a cover section hinged to the cushion section which is adapted to selectively fold over the cushion section, the cover section having securing means to seal about the needle insertion point and to secure the needle and *.*.cushion section to the patient, wherein the device further has an I.V. lineSsecuring means.
23. A device according to claim 22, wherein the I.V. line securing means secures the line remote from the needle.
24. A device according to claim 22 or 23, wherein the I.V. line securing means secures the line in a looped back configuration.
25. An all-in-one dressing and fixation device for securing an LV. device to a patient's skin constructed and adapted to operate substantially as described herein with reference to the accompanying drawings.