GB2507318A

GB2507318A - Securement device for medical tubing

Info

Publication number: GB2507318A
Application number: GB201219271A
Authority: GB
Inventors: Peter Brenikov
Original assignee: EUROPLAZ TECHNOLOGIES Ltd
Current assignee: EUROPLAZ TECHNOLOGIES Ltd
Priority date: 2012-10-25
Filing date: 2012-10-25
Publication date: 2014-04-30
Also published as: GB201219271D0

Abstract

A securement device for holding medical tubing e.g. near the site of an intravenous cannula in a TIVA apparatus comprises a tube holder 1 and an adhesive patch (7, fig 6), the patch being adherable to the body of a patient. The tube holder has a flat base 2 which in use is adhered to a surface of the adhesive patch and lies flat against the skin of the patient. The tube holder 1 is in the form of a moulding which includes an integral tube-receiving portion 3 for the tubing which in use is held above the adhesive patch. A connecting portion 5 which joins the base and tube-receiving portion extends through a central rectangular opening in the patch. The tube receiving portion may be configured to receive multiple tubes (fig 7) and may be tapered to securely hold the tubes.

Description

MEDICAL SECUREMENT DEVICE

The invention relates to an attachment system for securing medical apparatus such as tubing (or line) to a patient eg during anaesthesia or a similar process.

In many areas of medical treatment, particularly surgery, patients require an anaesthetic. This can commonly involve an anaesthesia process know as Total IntraVenous Anaesthesia (TIVA) whereby the drug fluids are directly injected into the bloodstream, rather than using gas and air system supplied via the lungs of the patient.

It is common in a TIVA system for the anaesthetic drug such as say remifentanol to be fed into the patient via an infusion pump under pressure.

The tubing (lines) containing the anaesthetic drug are micro bore ie typically 1mm internal diameter and 3mm external diameter. In a typical anaesthesia procedure one two or three micro bore lines can be attached to pumps and the drugs passed into the patient.

It is essential that the tubing remains firmly in place. If the tube became displaced or detached or removed the flow of anaesthesia drug could stop and the patient could become awake or aware in a short period of time with potentially very serious consequences.

The surgical team, theatre nurse or anaesthetist commonly employs adhesive bandages or surgical tape to attach the lines to a patient, typically at the back of the hand or other convenient location dependent on the operation being undertaken. This tape maintains the lines in place on the skin of the patient.

If it becomes necessary to adjust the position of the device the adhesive bandage or tape has to be removed and replaced. This often leads to poor positioning of the lines because any adjustment causes discomfort to the patient, adds time to the surgery and also wastes surgical tape or bandages.

The surgical team may therefore frequently reposition the tubing and re-tape the line securement. As a result of this the surgical team may also need to frequently clean the insertion site and change the site dressings.

The surgeon, theatre nurse or anaesthetist can take considerable time applying, removing and reapplying tape. The frequent application and removal of the tape also commonly excoriates the patient's skin about the insertion site. Patients may also be concerned about line displacement during a dressing change, especially by inexperienced staff.

Several additional drawbacks result from the use of tape to secure a TIVA line, the first being contamination. A surgical staff member when preparing a patient for anaesthesia frequently tears off small strips of tape prior to use.

Clostridium and other bacteria, however, can exist on theatre surfaces and can be transferred to the patient's skin including in the proximity of the insertion site. Additionally, medical tape securement requires the nurse to handle the tape while wearing protective latex gloves. Tearing adhesive tape tends to produce microscopic and/or visible holes in the gloves and thus destroys glove barrier protection. The current tape line securement methods have not served the patient well.

It would also be desirable to secure other lightweight medical apparatus to a patient's skin.

Accordingly an object of the present invention is to provide an improved securement device for medical applications.

The invention provides a securement device for mounting medical apparatus on a patient, the device comprising an apparatus holder and a retaining strip, the retaining strip being securable to the body of a patient, the apparatus holder having a base which in use is held beneath the retaining strip and an apparatus-receiving portion which in use is held above the retaining strip, wherein a connecting portion which joins the base and apparatus-receiving portion extends through an opening in the retaining strip.

This construction prevents the apparatus holder from being dislodged from beneath the retaining strip (which is preferably in the form of an adhesive patch).

In a preferred embodiment the apparatus holder is a tube holder for eg TIVA line. However in other embodiments other small lightweight apparatus eg an intravenous catheter or catheter adaptor can be secured to a patient.

Other preferred features are defined in the dependent claims.

The securement device of the invention is easy and quick to apply yet remains totally secure during surgery and afterwards in post recovery and can be easily adjusted both prior to and during surgery if required.

In a preferred embodiment particularly but not exclusively for for TIVA applications the device is generally heart-shaped or has a swept back delta shape and has sufficient surface area of adhesive dressing to enable a holder for up to triple (three lumen) TIVA line to be secured if required.

In a preferred embodiment, the securement device strongly retains the TIVA line in a fixed position relative to an intravenous entry point but is capable of simple adjustment of the line position if required.

In one embodiment the invention provides a line securement device comprising a base which is a sterile flexible adhesive medical dressing material with a self adhesive backing protected prior to use by coated backing paper with a butterfly opening method; a securement moulding, mounted through the underneath of the dressing for maximum strength and contact area to the dressing and simplicity of construction.

In a preferred embodiment the apparatus-receiving portion is a tube-receiving portion shaped and dimensioned to frictionally engage one or more lengths of medical tubing, eg TIVA line In this embodiment the inner surface of the tube-receiving portion (eg a clip) through which the micro bore tubing passes is shaped and dimensioned (eg tapered) to permit insertion of the line with firm pressure yet hold the line firmly at all other times yet without crushing the wall of the tube and restricting in any way the flow of the anaesthetic from the pumps. In different versions of the device the tube-receiving portion has a bore dimensioned to receive one line, two lines or three lines respectively.

The device of the invention is suitably provided in sterile form, eg in a sterile package.

Same preferred embodiments of the invention will now be described, by way of example, with reference to Figures 1 to 8 the accompanying drawings, wherein: Figure 1 is a perspective view of a tube holder for use in a line securement device in accordance with a first embodiment of the invention; Figure 2 is an end elevation of the tube holder of Figure 1; Figure 2A is an end elevation of a variant of the tube holder of Figures 1 and 2; Figure 2B is an end elevation of a further variant of the tube holder of Figures land 2; Figures 3is a side elevation of the tube holder of Figure 1; Figure 4 is atop plan view of an adhesive patch which is attached to the tube holder to make a securement device in accordance with the invention; Figure 5 is a top plan view of a securement device in accordance with the invention comprising the adhesive patch of Figure 4 and tube holder of Figure 2k Figure 6 is a transverse cross-section taken on VI-VI of Figure 5; Figure 7 is a similar cross-section of the device of Figure 6 attached to a patient's arm after removing the liner, and Figure 8 is a schematic plan view of a TIVA apparatus utilising the device of Figure 7.

S

Referring to Figures 1, 2 and 3 the tube holder 1 is a polypropylene moulding comprising a generally rectangular laminar base I having a convex forward edge, a tube-receiving portion 3 being supported above the base by an integral connecting portion or pillar 5 of rectangular cross-section. A bore 4 of diameter 3.2 mm is formed in tube-receiving portion 3 and is dimensioned to frictionally engage standard medical tubing, eg as used in TWA (Totally IntraVenous Anaesthesia). The bore is preferably tapered (at least in the plane parallel to the base 2) towards the forward end in order to facilitate insertion and impede retraction of medical tubing.

In Figure 2A a variant 1A is shown in which the bore 4A of tube holder 3A is expanded transversely to accommodate two sections of tubing side by side.

In Figure 2B a further variant 2B is shown in which the bore 4B of tube holder 3B is expanded further to accommodate three sections of tubing side by side.

In both these variants the bore is preferably tapered in the plane parallel to the base 2 towards the forward end.

Figure 4 shows a flexible adhesive patch 7 having a layer of medical grade adhesive (not shown) on its lower (hidden) surface and a rectangular aperture 6 formed in its mid-region.

The aperture 6 is smaller than the base 2 of the apparatus holder (tube holder 1A).

Preferably the dimensions of aperture 6 match those of the cross-section of the connecting portion 5.

The patch in this embodiment is generally swept back delta-shaped with a concave rear edge and convex side edges which form a radiused forward tip (shown lowermost in the drawing) and have radiused rear corners. These radiused portions reduce the risk of corners catching clothing or surgical instruments which might start to unpeel the patch from the patient.

Adhesive patch 7 is formed from material which is transparent, conformable to the human body, free of natural rubber latex, and having a layer of hypoallergenic adhesive on one side. One suitable material is 3M 1525L single coated medical tape.

To make a preferred securement device 9 in accordance with the invention for holding two lengths of TIVA tubing side by side, a tube holder 1A is disposed beneath the patch 7 with the convex front edge of the tube holder facing forward (downward in Figure 4), and tube-receiving portion 3 is aligned with the aperture 6 and inserted upwardly until the tube-receiving portion protrudes through the aperture and the upper surface of the base 2 presses against, and adheres to, the adhesive layer on the lower surface of patch 7. A standard siliconised liner of kraft paper is then applied to the layer of adhesive in two parts 8A and 88 which are provided with peeling flaps in a standard butterfly configuration as shown in Figure 5.

The resulting device is shown in cross-section in Figure 6. A layer of adhesive (not referenced) is sandwiched between liner 8A/8B and the peripheral portion of the patch 7. The base of the tube holder IA is permanently secured to the mid-region of the patch by the adhesive layer. The adhesive layer is however formulated to be attachable to, removable from and repositionable on the skin of a patient whilst having sufficient tack and adhesion to retain eg TIVA lines in position near the site of a venous cannula.

For example a transfer adhesive available from Minnesota Mining and Manufacturing Company (3M), could be employed. The adhesive preferably is a medical-grade acrylic adhesive and can be diaphoric. The patch member 7 is suitably formed from a polyethylene tape (1 -2mm thick) with a coating of up to 120g/square metre of a suitable acrylic adhesive. The adhesive can be applied to the patch 7 of the securement device in any of a variety of conventional ways, such as by transfer technology (e.g., thin film transfer tape).

The removable paper or plastic backing or liner 8A, 8B preferably resists tearing and is divided into two pieces to ease attachment of the dressing to a patient's skin.

In the illustrated embodiment, the liner is a polycoated, siliconized paper. It is conveniently split along a centre line of the patch 7 in order to expose only half of the adhesive bottom surface at one time with a butterfly configuration.

This enables it to be removed without touching the adhesive layer.

The device can then be applied to a patient's arm 10 as shown in Figure 7.

Lengths of TIVA tubing 11 can then be inserted rearwardly through the tube holder IA.

A typical TIVA assembly is shown in Figure 8, which shows a venous cannula 13 injecting anaesthetic and fed from a junction 14 which receives a gravity line and the flow from a combiner 12 connected to the two TIVA lines 11. The flow rates are electronically controlled. The securement device 9 is positioned close to the injection site of the venous cannula 13 and prevents it from being dislodged in use.

Claims

CLAIMS: 1. A securement device for mounting medical apparatus on a patient, the device comprising an apparatus holder and a retaining strip, the retaining strip being securable to the body of a patient, the apparatus holder having a base which in use is held beneath the retaining strip and an apparatus-receiving portion which in use is held above the retaining strip, wherein a connecting portion which joins the base and apparatus-receiving portion extends through an opening in the retaining strip.
2. A securement device according to claim 1 wherein the retaining strip is a pliable adhesive patch which in use can be adhered to the skin of a patient.
3. A securement device according to claim 1 or claim 2 wherein the base is generally laminar and in use is held flat beneath the retaining strip, and the connecting portion projects through an aperture formed in the retaining strip.
4. A securement device according to claim 1 or claim 2 wherein an upper surface of the base is secured by a layer of adhesive to a facing surface of the retaining strip.
5. A securement device according to any preceding claim wherein the connection portion projects from a mid-portion of the base.
6. A securement device according to any preceding claim wherein the retaining strip has a layer of adhesive protected by a removable liner.
7. A securement device according to claim 7 wherein said removable liner is divided into two portions which are peelable in opposite directions to enable the device to be applied to a patient's skin without the user touching the layer of adhesive.
8. A securement device according to any preceding claim wherein said base, connecting portion and apparatus-receiving portion are integrally formed in a one-piece moulding.
9. A securement device according to any preceding claim wherein the apparatus-receiving portion is a tube-receiving portion shaped and dimensioned to frictionally engage one or more lengths of medical tubing.
10. A securement device according to claim 9 wherein said tube-receiving portion has a bore which is dimensioned to frictionally engage one or mare TIVA lines.
11. A securement device according to claim 10 wherein said bore is non-cylindrical and is arranged in use to receive two or more TIVA lines lying side by side.
12. A securement device according to claim 10 or claim 11 wherein said bore is tapered to facilitate insertion and/or to prevent withdrawal of medical tubing.
13. A securement device according to claim 12 wherein said securement strip has a shape is tapered in the direction of taper of said bore.
14. A securement device for medical tubing, the securement device being substantially as described hereinabove with reference to Figures 1 to 3 and 4 and 5 of the accompanying drawings, optionally as modified in accordance with Figure 2A or Figure 2B of the accompanying drawings.
15. Apparatus for intravenous anaesthesia comprising at least one intravenous line terminating in an intravenous cannula, the intravenous line being arranged in use to be secured adjacent the site of the intravenous cannula by a securement device as claimed in any of claims 9 to 14.
16. Apparatus for intravenous anaesthesia substantially as described hereinabove with reference to Figures 1, 2A, 3, 4 and 6 to 8 of the accompanying drawings, optionally as modified in accordance with Figures 1 and 2 or Figure 2B of the accompanying drawings.