WO2010031105A1

WO2010031105A1 - Article and method for applying a pressure garment

Info

Publication number: WO2010031105A1
Application number: PCT/AU2009/001049
Authority: WO
Inventors: Bessie Paea; Alexa Kinnane
Original assignee: Bessie Paea; Alexa Kinnane
Priority date: 2008-09-16
Filing date: 2009-08-14
Publication date: 2010-03-25
Also published as: AU2009202462A1

Abstract

An article for aiding application of a pressure garment to limb of a wearer has flexible tubular shape, a proximal opening for receiving the limb, a skin-facing interior surface and a low coefficient of friction exterior surface. In use, the garment is applied to the limb over the article, and the article is thereafter removed from beneath the garment. A method of applying a pressure stocking to a leg of a wearer involves use of the article. A container may dispense the articles in singular fashion and in hygienic condition.

Description

ARTICLE AND METHOD FOR APPLYING A PRESSURE GARMENT

Field of the Invention

The present invention relates to application of garments such as medical compression stockings to a wearer. It relates particularly but not exclusively to an article and a method for assisting users in the application of e.g. anti- embolism (AE) and Thrombo Embolic Deterrent (T. E. D.@) stockings to the limb of a wearer, particularly in the hospital setting. An aspect of the invention also relates to a dispenser for dispensing the articles.

Background to the Invention

Medical compression stockings such as Anti-Embolism (AE) stockings and Thrombo Embolic Deterrent (T.E.D.®) stockings are frequently prescribed as part of e.g. post-operative medical treatment where a patient is at risk of deep vein thrombosis (DVT), pulmonary embolism (PE) or other circulatory complications. Pressure stockings may also reduce the risk of developing varicose veins and are frequently used in non-medical settings.

AE and T.E.D.® stockings contain concentric rings of elastic material designed to apply pressure of e.g. 10-20 mmHg to the limb. By applying pressure, the stockings create increased blood flow in the superficial and deep veins and aid in venous valve function. Compression stockings are typically applied to the legs and are available in various lengths, the most common being knee and thigh high. Some stockings are designed with toe openings to facilitate inspection of circulation at the toe without the need to remove the stocking.

Typically, compression at the ankle is greatest and, depending on the manufacturer, may be in the range 13-20 mmHg. The compression gradually decreases as the distance from the ankle increases. Due to the tightness required to achieve this pressure, the stockings can be very difficult to apply. Although healthcare professionals are trained in application of these articles, their use is a source of frustration among nurses and patients alike. The application process post-surgery can exacerbate patient discomfort and as a result, there is the potential to delay treatment with AE and T.E.D.® stockings until both patient and nurse are feeling confident and willing to deal with the challenge of applying the stocking. This undermines the prescribed treatment plan and can result in serious but preventable complications.

The present invention provides an article to assist in the application of compression garments to a wearer.

The discussion of the background to the invention included herein including reference to documents, acts, materials, devices, articles and the like is intended to explain the context of the present invention. This is not to be taken as an admission or a suggestion that any of the material referred to was published, known or part of the common general knowledge in Australia as at the priority date of any of the claims.

Summary of the Invention

Viewed from one aspect, the present invention provides an article for aiding application of a pressure garment to limb of a wearer. The article has a flexible tubular shape with a proximal opening for receiving the limb, a skin- facing interior surface and a low coefficient of friction exterior surface. Preferably, the article has boot-like shape. In use, the garment is applied to the limb over the article, and the article is thereafter removed from beneath the garment.

Preferably, the article is tapered having increasing cross sectional area toward the proximal opening. The article may also include one or more frangible lines, i.e. perforations for detaching portions of the article facilitating removal of the article from beneath the garment. The perforations may be provided in a line around at least part of or the entire circumference of the article in the ankle region, proximal of the heel and/or along at least part of the anteromedial aspect of the article. The article may also include a pocket for receiving an information tag bearing e.g. patient identification information. Alternatively or additionally, the article may include a zone for receiving information (such as patient identification information) applied to the article directly e.g. using a permanent marker or the like.

The article may be manufactured at least in part from a non-woven material part or all of which may be transparent to facilitate inspection of the skin during application of the article and stocking. Various colours, colour combinations and patterns are contemplated. Alternatively/additionally, the article or at least part of it may be manufactured from a woven material such as e.g. nylon. The material from which the article is constructed may be generally slippery in nature, at least on the exterior surface of the article. In an embodiment, the external surface of the article includes a low coefficient of friction coating which may be either wet (e.g. a liquid lubricant) or dry (e.g. Teflon, silicon or other dry but lubricious substance).

In one embodiment, the distal end of the article is closed. In an alternate embodiment, the distal end of the article has an opening and one or more webs for positioning between digits (e.g. toes) of the wearer to preclude travel of the article along the limb during application of a pressure stocking. Although the distal end of the article may be closed, in one embodiment it further includes one or more air vents in the form of holes, slots or slits for releasing air from the article, e.g. during use of the article to assist in removing a pressure garment from a limb of a wearer.

Viewed from another aspect, the present invention provides a method of applying a pressure stocking to a leg of a wearer using an article having features as disclosed above. The method involves inserting the wearer's foot through the opening into the article and drawing the opening proximally to cover at least from the forefoot (preferably including the toes) to above the heel with the article. The pressure stocking is then applied over the article from the toe by sliding the stocking over the ankle and adjusting into position on the leg. Once the stocking has been applied to the leg, the article is removed by drawing a distal opening of the stocking proximally over the foot to just above the heel and withdrawing at least a portion of the article from beneath the stocking by pulling distally off the foot. The article may be removed in one piece or in separate pieces. Once the article is removed, the stocking is re-positioned over the ankle and foot.

Viewed from yet another aspect the present invention provides a container for dispensing articles as described above. The container is configured to dispense the articles in singular fashion and in hygienic condition. For convenience, the container may be attached to a wall or other structure in a patient room or ward so as to provide quick and easy access to the articles by nurses and other medical staff.

Brief Description of the Drawings

The invention will now be described with reference to the embodiments illustrated in the accompanying drawings. It is to be understood that the embodiments illustrated are examples only and their specificity does not supersede the generality of the preceding parts of the description.

Figure 1 is a schematic illustration of an embodiment of the present invention.

Figure 2 is a schematic illustration of another embodiment of the present invention. Figure 3a is a side view of a variation of the embodiment illustrated in

Figure 2. Figure 3b is a front view of the embodiment illustrated in Figure 3a.

Figure 4 is a schematic illustration of another embodiment of the present invention.

Figure 5 is a schematic illustration of a container dispensing articles according to an embodiment of the present invention.

Figure 6 is a schematic illustration of an alternative container for dispensing articles according to an embodiment of the present invention.

Figure 7 is a schematic illustration of another alternative container for dispensing articles according to an embodiment of the present invention. Figure 8 is a schematic illustration of another embodiment of the invention showing air vents in the form of holes. Detailed Description

Referring firstly to Figure 1 , there is shown an article according to an embodiment of the present invention for aiding in application of a pressure garment such as an AE/T.E.D.® stocking to the leg of a wearer. Although the present invention is described in the context of applying a pressure stocking to the leg of a wearer, it is to be understood that corresponding features may be incorporated in an article for application of a pressure garment to a wearer's arm.

Similarly, while the embodiments described herein have been provided in the context of an AE/T.E.D.® stocking being applied to a patient's leg by a nurse, it is to be understood that any person applying a pressure garment may benefit from use of the article. Such persons include patients and wearers themselves as well as non-nurse carers in the medical setting.

For ease of description, the term "proximal" has been used throughout the description and the claims with reference to both the inventive article and the pressure garment. This term is to be construed relevant to the wearer. Thus, drawing the article proximally along the leg is to draw the article from the wearer's toes toward the knee.

A basic article according to an embodiment of the invention is shown in Figure 1 , having flexible tube-like appearance and a boot shape which is large enough to accommodate the foot, ankle and lower calf of the wearer. Any excess volume in the article can be eliminated by gathering the article around the leg to form flutes, pleats or folds beneath the pressure stocking during application. The article is sufficiently thin that such flutes, pleats or folds do not adversely affect the operation and utility of the article. Alternatively, the article may be of substantially straight tube-like appearance (i.e. not shaped like a "boot").

A preferred form of the article is shown in Figure 2. The article shown generally at 100 is shaped like a sock or boot in a similar fashion to the shape of the wearer's lower leg and the embodiment in Figure 1 , but with a tapered shape where the cross sectional area of the article increases toward the proximal opening 101. This shape accommodates patients who have a larger calf bulk.

During application, the wearer's foot is inserted into the article through proximal opening 101. The opening is then drawn proximally, up the patient's leg to cover a lower portion of the leg from at least the fore-foot to above the heel and ankle. Preferably, as illustrated in Figure 1 , the article encloses the whole foot including the toes, the lower leg and lower calf and may extend to mid-way up the calf.

The article may be manufactured from a range of suitable materials including woven and non-woven materials or combinations of these. Woven articles have textile based construction and are preferably antimicrobial in nature or treated to imbibe antimicrobial characteristics to minimise risk to the wearer of infection (e.g. where there are wounds or sores on the wearer's skin) and cross contamination between a nurse and the patient during application of a pressure stocking. For woven materials, nylons or other generally slippery textiles are suitable. Such articles may be laundered and re-used where necessary.

The article has smooth interior and exterior surfaces. Interior surface 102 provides a smooth, continuous wall which faces the patient's skin enabling the patient's foot to be inserted into the article without compromising skin integrity. Low coefficient of friction exterior surface 103 contacts the pressure stocking during application. The low coefficient of friction exterior surface aids in application of the garment by ensuring it glides over the heel protuberance and up the ankle. This is an area which, without use of the inventive article, is a source of considerable resistance and difficulty when applying pressure stockings.

In a preferred embodiment, the article is manufactured from a disposable non- woven material such as a plastic or polymer-based material. Preferably the material is hygienically treated or treated with an anti-microbial agent or has inherently antimicrobial characteristics. The polymer is very thin, preferably less than 60 micrometres in thickness, more preferably less than 45 micrometres in thickness and more preferably still between 35 to 45 micrometres in thickness although thinner walled constructions (e.g. 15 to 30 micrometres) may also be suitable. The article may be manufactured using a moulding, extruding or blowing process to produce the article in the desired shape in a seamless piece. Alternatively, the article may be manufactured by e.g. heat sealing around two flat sheets of plastic/polymer die cut into the required shape. In one embodiment, the article or at least part of it is manufactured from a transparent material to permit inspection of skin integrity during use.

Polymers having a low coefficient of friction surface, particularly on the external surface of the article are preferable. Such polymers may include but are not limited to e.g. silicon polymers and fluoro-polymers and polypropylenes containing additives to increase the lubricious properties of the external surface of the article. Alternatively/additionally, the requisite low- friction characteristic may be achieved by use of a coating on the external surface, such as e.g. a Teflon coating. Such coating may be wet or dry and may also be antimicrobial in nature. Antimicrobial agents may include e.g. silver, or chemical compounds doped into the material.

Now referring to Figures 3a and 3b there is shown a variation on the embodiment illustrated in Figure 2 which includes a pocket 104 and perforations 105a, 105b. The pocket may be transparent or opaque and is configured to receive a label bearing information such as patient identification information. When the pocket is transparent, it acts as a window to view the patient information on the label. This enables the article to be re-used on a particular patient while minimising the incidence of cross-contamination between patients. Preferably, the pocket is provided on the lateral or medial dorsal aspect of the article although other areas may be similarly useful. As an alternative to the pocket and label arrangement, the article may simply identify a zone where patient identification information may be appended to the article directly, e.g. using a permanent marker. Thus, after a compression stocking is applied to a patient the article is removed from beneath the stocking and stowed away in the patient's drawer or cupboard with other personal belongings. During re-dressing e.g. after bathing, the nurse re-uses the article from the drawer, checking the patient identification information on the label in pocket 104 matches the patient, and re-applies the pressure stocking in continuation of the doctor's prescribed treatment. Upon discharge the patient may take the article home for continued use, or it may be disposed of. If made from woven material, the article may be laundered and preferably re-treated with an antimicrobial agent and then used for a new patient.

In one embodiment, frangible lines in the form of perforations are provided for easy separation of the article into pieces. Perforations 105a are provided around at least part of or the entire circumference of the article, in the ankle region. This enables a nurse to separate the foot portion of the article from the leg portion whereafter the foot portion may be removed by drawing distally from the patient, through an inspection opening at the toe of the stocking. The leg portion of the article can be removed through the same inspection opening, or by drawing the leg portion toward the patient, through the proximal opening of the stocking. Additional perforations 105b may be provided along at least part of the anteromedial aspect of the article. This facilitates separation of the article into two, three or more pieces for removal of the article from beneath the stocking after application.

Articles which are configured for removal from beneath the stocking in pieces (e.g. the embodiments illustrated in Figures 3a and 3b) are intended for once- only usage and are thus disposable. Preferably, such disposable articles are biodegradable to minimise the effect on landfill. Preferably, the biodegradable characteristics inherent in the material can be controlled so that degradation does not occur until after the article has been used. For example, the composition of the material from which the article is manufactured may be such that material break-down does not occur until the article has been e.g. exposed to moisture and/or oxygen and/or light and and/or oils in the skin for a certain period of time. This minimises the risk of product deterioration during shelf life.

Although not illustrated herein, it is to be understood that the article may be manufactured in a range of different colours, sizes and shapes while still falling within the ambit of the invention as described previously and as defined in the claims appended hereto. Accordingly, the article may be produced in e.g. sizes small, medium, large and extra large. Such sizes may ensure that a range of patients including children, adolescents, adults, and particularly large patients are catered for. The different sizes may be colour coded for ease of identification.

Alternatively, the articles may be brightly coloured and/or patterned to encourage use by nurses and patients alike. Colour schemes may be used for promotional or advertising purposes. For example, pink articles could be used to promote breast cancer awareness while yellow articles could be used to promote cancer awareness generally. Alternatively/additionally advertising or patterns may be printed on the article's exterior surface.

The embodiments illustrated in Figures 1 to 2 have a closed toe. However, in an alternate embodiment such as illustrated in Figure 4, the article may be provided with a substantially open toe and with one or more web members 200 for positioning between the toes. Web members ensure that during application of a stocking over the article, the article does not travel along the leg as the compression stocking is being drawn over the foot, heel and ankle and up the leg.

The inventors have found that the inventive article can also be used to assist in the removal of a compression stocking from a patient's limb. To remove the stocking, the article is applied over the top of the stocking. The stocking is then turned down over the article and drawn distally, toward the foot for removal. The lubricious surface on the external wall of the article enables the stocking to slide over the ankle and heel protuberance with ease, obviating the usual problems encountered due to the high friction between contacting layers of stocking.

It has been found however that during use of the article to remove a compression stocking, air can become captured in the toe region. If sufficient air is captured, the toe region of the article can become prone to rupture. In one embodiment, one or more air vents in the form of slots, slits or holes are provided to permit air to escape from the article during removal of a compression stocking. Figure 8 illustrates one such embodiment, with air vents in the form of holes 806. The air vents also assist with breathability of the article, in the event that the article is left on the patient's leg, under the stocking, for a length of time.

Importantly, even when a proximal region of the article has been removed, e.g. by separation along a perforation around the ankle region of the article, the remaining portion of the article is still useable for the purpose of removing a compression stocking, since the remaining portion still covers the problematic regions of the limb (i.e. the ankle and heel region).

A method of using the article for the application of a compression stocking to a patient will now be described. Prior to inserting the foot, a nurse or other carer may hold the article in the hands, with the article gathered between the thumb and forefinger. The patient's foot is inserted into the proximal opening and the proximal opening is drawn up the leg to cover the forefoot to above the heel. Using the embodiments illustrated in the accompanying drawings, once the article is applied to the patient it will cover most (Figure 4) or all (Figures 1 to 3b) of the foot and part of the leg to lower and /or mid way up the calf. Articles with a longer leg portion are also contemplated for use with full leg compression stockings, to aid in application of the stocking over both the heel protuberance and the knee.

Once the article has been applied to the leg, the stocking is then gathered between the thumb and forefinger of each hand, gathering to just above the heel. The pressure stocking is then applied over the article drawing the large opening proximally from the toe. Once the stocking is over the toes it is drawn smoothly, in one continuous easy movement to cover the foot, heel protuberance and ankle. The remainder of the stocking can then be arranged easily over the leg. The low friction exterior surface of the article enables the stocking to glide over the heel protuberance with very little resistance providing a vast improvement over application methods attempted without the inventive article.

Once the stocking has been applied to the patient, the article is removed. This can be achieved by drawing the inspection opening of the stocking proximally along the foot to just above the heel and withdrawing the article. The article may be removed from beneath the stocking in a single piece in which case the article may be re-used, or in two or more pieces. Removing the article in pieces may be suitable where the compression stocking is particularly tight- fitting and is achieved by separating the article along one or more frangible lines such as perforation lines 105a and 105b illustrated in Figures 3a and 3b. Once the article has been removed from the foot, the compression stocking can be re-positioned over the foot.

In addition, part of the article may be removed through the proximal opening of the stocking. Thus, the nurse may roll the proximal end of the stocking distally toward the foot revealing the article which may then be removed proximally along the patient's leg. To facilitate dissection and removal of the annular leg portion of the article an additional perforation line may be provided which extends from the ankle to the proximal opening.

A further aspect of the present invention relates to a container for dispensing articles according to embodiments of the present invention. Examples of such containers are provided in Figures 5, 6 and 7. Figure 5 shows a box dispensing articles 100 which are removed by drawing the article through opening 501. Figure 6 shows a wall or bed mountable container 600 dispensing articles 100 which are removed by drawing an article down through opening 601. Figure 7 shows the articles manufactured on a roll which is dispensed e.g. as in a roll of hand paper. In either of the embodiments, it is preferred that the articles are folded and packed into the container e.g. by machine so that they are easily removed in piecewise singular fashion to maintain hygiene and so that removal of one article presents the next article for use.

An advantage of the present invention is that it facilitates smooth and continuous gliding of a compression stocking over the foot, heel protuberance and over the ankle enabling quick and safe application of the pressure stocking without compromising the patient's skin integrity and without compromising the nurse's own health and safety. This encourages timely application of AE/T.E.D.® stockings in the hospital setting, and facilitates accurate positioning, enhancing ease of use. The articles are also hygienic and lightweight and in most constructions may be wiped clean.

Use of the inventive article to apply a pressure stocking decreases the likelihood of nurses sustaining musculoskeletal injuries or strain injuries often associated with pulling and pushing for forced application of a pressure stocking to arrange the garment over the foot, ankle and heel protuberance and into position covering the patient's lower leg. Similarly, use of the inventive article minimises patient discomfort and the risk of sustaining a skin tear during application of a pressure stocking. This is an important consideration as many patients who are candidates for treatment with AE/T.E.D.® stockings may also be prescribed blood-thinning agents as part of their anti-embolic treatment plan which can exacerbate the tendency to develop skin tears and bruising.

Importantly, use of the present invention is likely to increase the likelihood of immediate compliance with doctor's orders prescribing use of pressure stockings.

It is to be understood that various modifications, additions and/or alterations may be made to the parts previously described without departing from the ambit of the present invention as defined in the claims appended hereto.

Claims

The claims defining the invention are as follows.

1. An article for aiding application of a pressure garment to limb of a wearer, the article having: - flexible tubular shape;

- a proximal opening for receiving the limb;

- a skin-facing interior surface; and

- a low coefficient of friction exterior surface; wherein in use, the garment is applied to the limb over the article, and the article is thereafter removed from beneath the garment.

2. An article according to claim 1 wherein the article is tapered having increasing cross sectional area toward the proximal opening.

3. An article according to claim 1 or claim 2 wherein the article is generally boot shaped.

4. An article according to any one of the preceding claims wherein the article includes one or more frangible lines for detaching portions of the article facilitating removal of the article, in portions, from beneath the garment.

5. An article according to claim 4 wherein the article is configured for use with a leg garment and includes a frangible line around at least part of the circumference of the article in the ankle region, proximal of the heel.

6. An article according to claim 4 or claim 5 wherein the article includes a frangible line along at least part of the anteromedial aspect of the article.

7. An article according to any one of the preceding claims further including a pocket for receiving an information tag bearing e.g. patient identification information.

8. An article according to any one of the preceding claims further including a zone for receiving information applied directly to the surface of the article.

9. An article according to any one of the preceding claims manufactured, at least in part from a non-woven material.

10. An article according to claim 9 wherein at least part or all of the non- woven material is transparent.

11. An article according to any one of the preceding claims manufactured at least in part from a woven material.

12. An article according to any one of the preceding claims further including a low coefficient of friction coating on the exterior surface.

13. An article according to any one of the preceding claims wherein the distal end of the article has an opening and one or more webs for positioning between digits of the wearer to preclude travel of the article along the limb.

14. An article according to any one of claims 1 to 12 wherein the distal end of the article is closed.

15. An article according to any one of the preceding claims further including one or more air vents.

16. An article according to any one of the preceding claims having antimicrobial properties.

17. An article according to any one of the preceding claims coloured or patterned according to a sizing scheme.

18. An article according to any one of the preceding claims printed with promotional or advertising content.

19. A method of applying a pressure stocking to a leg of a wearer using the article according to any one of claims 1 to 18 including the steps of:

(a) inserting the wearer's foot through the opening into the article and drawing the opening proximally to cover at least from the forefoot to above the heel;

(b) applying the pressure stocking from the toe over the article including drawing over the ankle and adjusting into position on the leg;

(c) removing the article by:

(i) drawing a distal opening of the stocking over the foot to just above the heel; and

(ii) withdrawing at least a portion of the article from beneath the stocking by pulling distally off the foot; and

(d) re-positioning the stocking over the ankle and foot.

20. A method according to claim 19 wherein the removing step includes separating the article along frangible lines into two or more pieces prior to being withdrawn from beneath the stocking.

21. A container for dispensing articles according to any one of claims 1 to 18, the container configured to dispense the articles in singular fashion and in hygienic condition.

22. An article substantially as hereinbefore described with reference to any one of the embodiments illustrated in the accompanying drawings.

23. A method for applying a pressure garment substantially as hereinbefore described with reference to any one of the embodiments illustrated in the accompanying drawings.

24. A container for dispensing an article for use in applying a pressure garment, the container substantially as hereinbefore described with reference to any one of the embodiments illustrated in Figures 5 to 7.