WO2002085427A2

WO2002085427A2 - Intravenous catheter immobilizer

Info

Publication number: WO2002085427A2
Application number: PCT/IL2002/000321
Authority: WO
Inventors: Haim Halevy
Original assignee: H.H. Biotech Ltd.
Priority date: 2001-04-23
Filing date: 2002-04-23
Publication date: 2002-10-31
Also published as: AU2002307783A1; WO2002085427A3

Abstract

IV immobilizer wrap comprising self-adherent film (110) selected for high self-adherence and adherent to IV tubing (113) usually made from plastic materials. The self-adherence permits the film to be wounded around a limb (114) and IV (112) and onto itself and maintained with little or no aid from glue-type adhesive. Furthermore, the adherence caused by the affinity of the self-adherent film (110) with the kinds of plastic tubing used for IV’s, prevents the IV from slipping out from under the film and therefore helps to maintain the IV needle in place.

Description

INTRAVENOUS CATHETER MMOBILIZER

Field of the Invention

The present invention relates to an irnmobilizer for immobilizing an intravenous catheter (hereinafter "IN"). More particularly, the present invention relates to the immobilization of the IN by enwrapping the IN and the limb in which it is inserted with an irnmobilizer wrap comprising a self-adherent, and optionally, IV-tubing adherent film.

Background Of The Invention

Many medical patients experience disturbances that may cause involuntary IN mobilization, for example, the movement of a patient onto a stretcher, to ambulance, back onto a stretcher, onto a hospital bed, onto an operating room table, onto an X-ray table, etc., all are activities that may cause undesirable displacement or even premature removal or withdrawal of the IN needle. The most commonly used method of IN immobilization, taping the IN to the patient's limb with adhesive tape, is relatively ineffective. It too frequently fails to achieve the objective of preventing involuntary IN removal.

Dislodgment of the IV, besides requiring reinsertion of the IV, which is already an unpleasant experience, can often cause serious difficulties, especially when we consider reinsertion of an IN in patients with collapsed veins and pediatric patients. Other problems related to using adhesive tape for trying to secure an IN in place, besides the frequent failure rate, are that taping heavily hampers detection of problems at the IV insertion site, such as vein infiltration and infection, and that applying the tape not too tightly and yet neatly can be difficult and removal of tape from hirsute skin can be very painful. Therefore, a more effective form of IN immobilization is required. Summary and Objects of the Invention

The present invention provides a means for IN immobilization, without sacrificing the ability to visually detect medical problems that may arise in the vicinity of the point of IN insertion. Furthermore, the proposed means of IN immobilization, a self-adherent film, such as polymer film, eliminating the problem detailed above, painful removal of adhesives from hair-covered skin. Additionally, the proposed means of IN immobilization is adherent to IV, saving the patient unnecessary pain caused by a tight wrapping, which would be warranted by the use of a material that is not as adherent to IN. Finally, immobilization of IN will lead to a reduction in the frequency IN reinsertion is required, saving the patient additional pain and reducing the possibility for infections.

These and other objectives not mentioned hereinabove are achieved by the present invention which provides a means for IN immobilization, comprising constructing in situ a wrap of a self-adherent film. In an exemplary embodiment, the film contemplated by the present invention is a polymer film of the type which is also adherent to the IN tubing. Due to its self-adherent properties, further securement of the film using tape may be unnecessary once it has been wrapped around the limb and IN several times.

In various embodiments, the film may be imparted with several optional properties. One such property is transparency. This property assists medical staff in the early detection of complications that may arise in the vicinity of the insertion point of the IN needle. Another such property is ultra-violet light permeability. This property would allow sterilization of ultra-violet susceptible bacteria. An additional such property is air and humidity permeability. The presence of air at the point of insertion of the IN needle may help expedite healing of any medical complications and the permeability to humidity can reduce risk of anaerobic conditions from prevailing at the IN insertion point.

The self-adherent film may also be tinted a number of colors. Certain colors may highlight bruising in the area of the insertion of the IN needle, making them more easily detectable visually.

The method of applying the self-adherent film is by wrapping a length of self-adherent film around the mammal's limb and the tubing of the IN that has been inserted into said limb. The present invention allows for variations on this method of applying. For example, in order to attain a stronger fastening, a layer of self-adherent film may be applied under the tubing, before insertion of the IN catheter needle into the limb, and then additional layers of film may be wrapped around and over the catheter, tubing and limb. For that matter, it may be desirable to first apply a layer of film around the limb (after disinfecting the insertion site), then inserting the catheter needle through the film into the patient's vein, and then continuing to wrap the film numerous times

The self-adherent film may be supplied in roll form. The film may then be dispensed from a roll-dispenser. The dispenser may be equipped with a blade, to facilitate tearing of the film. Alternatively, the film can be dispensed in packages pre-cut to a predetermined length.

Brief Description of the Drawings

Figure 1 is a view of a limb with an IN catheter inserted into it and immobilized by self- adherent film wrapped around the catheter and the limb into which it is inserted. Figure 2 is a cross section of a limb wherein an IV needle is inserted into a limb, and an IN catheter is secured by a layer of self-adherent film under it, as well as on top of it.

Figure 3 is a perspective view of an IV immobilizing self-adherent film roll dispenser with a blade.

Figure 4 is a perspective view of an adhering self-adherent film with adhesive-layer coated extremities.

Figure 5 is a perspective view of chest wound bandaged by an adhering film.

Detailed Description of Exemplary Embodiments

The present invention is a method and apparatus for IN immobilization. It is more dependable than previously known methods of IN immobilization. This added dependability stems from the use of a self-adherent film such as polymer packaging film that is very similar to sandwich wrap. In an exemplary embodiment, the film is a polymer sheet that has been treated to increase its static electricity levels. The polymer structure does not allow much air to remain in the film. When the film is applied to non-porous materials, the contact between the film and the covered material is more intimate, possibly or partly due to the lack of air between the two materials. The material used to make IN tubing is non-porous and the resultant vacuum causes a high level of adherence between the film and the IN, resulting in the immobilization of the IN. The IN tubing is also plastic, and therefore also possesses electro-static properties, which enhance the adherence of the tubing to the film. The tubing is also smooth, which increases the contact area, thereby augmenting the level of adherence between the tubing and the film. In contrast, skin is porous, and therefore the film is not adhesive to skin. This is advantageous, as it eliminates complications related to undesired sticking of film to skin that may have otherwise arisen during the application and removal of the film.

Referring now to FIG. 1, an IV immobilizing wrap constructed in accordance with the present invention is made by wrapping a length of film 110 a few times around the insertion point 111 of the IN 112 and the limb 114 into which the IN has been inserted. IN 112 comprises a tube 113 in sealed contact with needle 115 insertable to the patient's body. Due to the high level of adherence between the IV tubing 113, needle 115 and the self-adherent film 110, the wrapping of film 110 around IV 112 and limb 114 maintains the integrity of IV 112. Since IV 112 integrity is maintained to a greater degree by use of the self-adherent film, the use of some forms of patient restraint are made unnecessary. Additionally, the non-adherence of the self-adherent film to skin saves the patient further agony, resulting from the removal of tapes from hair-covered skin.

Self-adherent film 110 may be provided in a transparent form. This feature allows the medical staff to monitor the IV 112 needle 115 insertion location 111, and check whether it has moved out of place. It also provides for observation of the area around the place of infusion, allowing prompt reactions to any visually detectable complications that may arise, which may have otherwise remained undetected for a longer time period. In alternate embodiments, the film may also be tinted in a variety of colors. Tints of certain colors may highlight bruising and swelling, thereby assisting in the visual detection of medical complications arising in the vicinity of the IV 112 infusion. A non-transparent version of the film may also be used.

The application of the self-adherent film IV 110 irnmobilizer is carried out as follows. Immediately upon insertion of the IN needle 115 into the patient's limb and after sterilizing the area with alcohol or another disinfectant, film 110 is wrapped around the patient's limb 114 and the IN tubing 113 at least two or three times, preferably four or five or more times, as necessary. The applier may opt to use adhesive tape 116 to tape down the free end of film 110, for additional assurance that the film will remain in place. In one exemplary embodiment, adhesive tape 116 which can be transparent, may be wrapped around the entire outer layer of film 110, so as to retain all the advantages of using self-adherent film 110 for IV 112 immobilization, with the added insurance which tape 116 provides that the film will not come unwrapped.

Fig. 2 shows a method of use wherein it may be desirable to wrap a first layer 209 of film 210 around limb 214 before insertion of the TV 212 needle 215, insert IN 212 and then wrap additional layers of film 210 around the limb and the IN, as shown in FIG. 2. Such a wrapping would provide an even more secure immobilization of IN 212, as tube 213 would be surrounded by adherent film on all sides.

It is recommended that the film be packaged in (or at least dispensed from) a custom roll dispenser 302 equipped with a cutting blade, as shown in FIG. 3. Dispenser 302 comprises a box 312. Box 312 includes two wheel shaped areas 310 located in registration on two opposite faces of box 312. Dispenser 302 is also equipped with film cutting means such as blade 314 attached to one of box 312 sides perpendicular to said opposite faces, blade 314 cutting edge 315 extends away from said side. Wheel-shaped area 310 comprises two circular recesses 318, with a rod or axis 319 whose two extremities 316 supported by recesses 318 and rolling within them. Self-adherent film 310 is wrapped around rod 319 and can be pulled out of dispenser 302 through groove 320 which is preferably parallel to cutting edge 315. Rod 319 is preferably removable to allow for reloading of new self-adherent film rolls into dispenser 302.

In an alternative embodiment, film may be selected which either allows or prevents the penetration of ultra-violet light. It may be desirable to use an ultra-violet transmitting film, so as to allow sterilization of ultra-violet susceptible bacteria. The decision whether to use ultraviolet transmissive film or not could be made, based on each individual patient's needs. In another alternative, the film is gas-permeable, so as to allow the permeation of air. Air permeation may expedite the patient's healing process. The semi-permeable film must, of course, retain the self-adherent qualities of the non-permeable film.

The use of self-adherent film, such as the polymer film, is an inexpensive method of IN immobilization or for preventing of wound opening. It can also be used before suturing in the field, which can be done through the applied and supporting film.

The film may be provided in pre-cut sterile strips and supplied in sterile packaging, in much the same manner as bandages for small cuts and abrasions. The film may come in the form of precut lengths of from 1 foot in length to as much as 20 or 30 feet, as opposed to the suggested roll style. The consumer could choose between various lengths and widths, so as to allow for variations in limb circumference between different sized people and different sized limbs. After the initial length of sterilized film is in place, the application of the film may be continued with non-sterile roll-film, until the desired amount of layers have been applied.

An additional embodiment of the film, in which the film is also supplied in precut lengths, is proposed. In this embodiment, the film is precut into strips of between two and three feet, and supplied in a roll. At each end of the length of film is double sided tape. One side of the tape is attached to the length of film, while the other is protected. Upon application of the film to the patient's limb, the protection is removed from the tape, and the end of the film is taped to the patient's limb. The film is then applied as described above. When the end of the length of film is reached, the protection is removed from the tape at that end as well, and the film is taped to the layer of film below it, providing additional security.

In still another embodiment shown in FIG. 4, film 410 has either one layer 412 or two layers 412, 414 of adhesive strips covered with peel-off bands 416 on at least one of its extremities. This way the adhesive could be applied either to the patient's limb 418 skin, to film 410 next turn or to film 410 one-before the last turn.

In yet another embodiment the adhesive film is used to hold together the sides of a cut, thus facilitating its healing by preventing its re-opening, as depicted in FIG. 5. Cut 512 in patient's chest is held together by wrapping film 510 around the chest. Film 510 may have adhesive edges, as shown hereinabove.

The film may be stretched during application in order to attain a tighter grip on the IN tubing. It may be necessary to stretch the film in order to activate its adherence qualities. In such a case, the film may be sold in a roll dispenser that, upon dispensation, provides the resistance needed to activate the adherence qualities of the film.

The width of the film may be from one inch to a foot. This allows for variations in size of the area where the IV has been inserted. The desired is chosen according to the location of the IN. For example, an IN inserted in the hand may require a narrower film. In alternative embodiments of the invention, the film is selected to allow several different levels of water permeability. The decision of which film to use for each patient will be partially based on that factor, amongst the other above-mentioned alternatives. In order to minimize the amount of moisture around the point of insertion of the IN needle, the present invention allows for the insertion of a moisture-absorbing packet under the film, without interfering with the level of the film's adherence.

Claims

Claims:What is claimed is:

1. A wrap of film for immobilizing an intravenous catheter, said wrap comprising a strip of film which is self-adherent and which is adherent to IV tubing.

2. A wrap according to claim 1, wherein said film is transparent to visible light.

3. 3. A wrap according to claim 1, wherein said film is transparent to ultra-violet light.

4. A wrap according to claim 1, wherein said film is air permeable.

5. A wrap according to claim 1, wherein said film is tinted.

6. A wrap according to claim 1, wherein said film has applied near at least one end thereof adhesive which is inactivated until required for application.

7. A method of immobilizing an IN which has been inserted into the body of a mammal, comprising winding a self-adherent film around the IN and that portion of the mammal's body into which said IV has been inserted.

8. A method of dressing a wound comprising:

Applying a gauze to said wound and wrapping said wound and said gauze with self-adherent film.

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