Leg ulceration is a common complaint with an estimated prevalence of 1 to 1. 3% of the population. Management of leg ulcers is predominant in the workload of community nurses in the United Kingdom. Currently more than i600 million per annum are spent on their care.

An estimated 80% of leg ulcers are due to chronic venous stasis disease and are frequently associated with surrounding venous eczema. The ability to soak the affected area in water containing an emollient or other therapeutic substance, such as potassium permanganate (KMnO4), is an important aspect of care. The use of KMnO4 solution in the management of ulcers colonised with methicillin resistant Staphylococcus Aureus (MRSA) is widely used and allows treatment without the need for antibiotics. Frequently it is necessary to soak the patient's limb in order to remove an adherent dressing.

A typical treatment involves soaking the affected limb in a solution of potassium permanganate for up to 20 minutes once or twice a day. This process is time consuming and difficult, particularly if a purpose-built plumbed-in waterbath or trough is not available, as typically occurs in the home setting. Manhandling large vessels to a convenient position, and then emptying them, is not an easy task. In the United Kingdom nurses are instructed by their employers to avoid all lifting, this being a Health and Safety issue to protect the nurses from back injury.

There is accordingly a need for an effective system, which is convenient both for the patient and for the clinician and which enables a limb to be soaked using less

water, and hence less weight to be carried and poured away.

There is a further need to provide a device for treatment of leg ulcers or venous eczema with a therapeutic solution, such as potassium permanganate solution.

According to one aspect of the present invention there is provided a device for treatment of a leg of a human patient with a therapeutic liquid medium comprising a portable waterproof receptacle for receipt of a portion of a human leg having a foot, a heel and a calf, the portion including the heel and at least a substantial portion of the calf, and for receipt of a therapeutic liquid medium.

The invention further provides therapeutic means for treatment of a leg of a human patient requiring treatment with a therapeutic liquid medium comprising a portable waterproof receptacle for receipt of a portion of a human leg having a foot, a heel and a calf, the portion including the heel and at least a substantial portion of the calf, and a quantity of a therapeutic liquid medium contained in the receptacle.

In another of its aspects the invention provides a method of treatment of a leg of a human patient with a therapeutic liquid medium comprising inserting a portion of the patient's leg including the heel and at least a substantial portion of the calf thereof in a portable waterproof receptacle for receipt of a portion of a human leg having a foot, a heel and a calf, the portion including the heel and at least a substantial portion of the calf, and bathing the inserted portion of the patient's leg with a quantity of a therapeutic liquid medium.

The therapeutic liquid medium may be any therapeutic solution, emulsion or foam suitable for treating a dermatological condition of a human leg, such as a leg ulcer or venous eczema. Suitable therapeutic liquid media include

a potassium permanganate solution.

The receptacle may comprise a self-sustaining boot- shaped receptacle or a flexible liner for a self-sustaining boot-shaped receptacle. The inner surface of the receptacle preferably comprises a water-impermeable plastics film or sheet material. When the receptacle is a flexible liner it may comprise a sealed package which contains a predetermined quantity of a dry therapeutic agent, such as potassium permanganate crystals, the predetermined quantity of the therapeutic agent being selected so that upon dissolution in a suitable liquid medium, e. g. water, a solution of the therapeutic agent at a therapeutic concentration is formed.

The quantity of the liquid used for dissolution should be no more than the free volume within the liner after insertion of the patient's leg. Such a liner can be provided with handles to facilitate emptying of the liner after use. It may include a tear strip enabling formation of an exit spout for facilitating emptying of the contents of the liner after use.

In another embodiment the portable waterproof container comprises a generally boot-shaped container provided with a pair of wheels and a handle, preferably an extensible handle, to facilitate transport of the boot and liquid medium to a disposal site after use. Conveniently the wheels are mounted on or adjacent a heel portion of the boot-shaped container. Such a boot-shaped container may include an exit orifice to facilitate emptying the container after use. Conveniently such an exit orifice is provided in a toe portion of the boot-shaped container. The orifice may be provided with an outlet pipe fitted with an outlet valve for drainage of spent treatment medium from the receptacle.

The outlet pipe can also be used for filling of the receptacle prior to treatment.

In another preferred embodiment the receptacle comprises a collapsible boot-shaped bag. Such a collapsible boot-shaped bag can be provided at its upper end with a pair of handles to assist in carrying the receptacle and spent liquid medium to a disposal station for disposal of the spent liquid medium. Moreover such a receptacle may include a pipe, optionally having an exit valve, for filling and discharging of treatment solution. The upper end of such a collapsible receptacle may be provided with an inflated or inflatable cuff.

In a further embodiment of the invention the receptacle comprises an open-fronted boot-shaped bath having a heel- receiving portion. Such a bath can further comprise a foot- receiving portion and a calf-receiving portion and can be supported with its calf-receiving portion inclined at an angle to the vertical so that the liquid medium collects in the heel-receiving portion of the open-topped bath. In this embodiment a recirculating pump may be provided for pumping liquid from the heel-receiving portion of the open-topped bath through a conduit to spray means for spraying treatment medium on the front of a patient's leg positioned in the bath.

In order that the invention may be clearly understood and readily carried into effect some preferred embodiments thereof will now be described, by way of example only, with reference to the accompanying diagrammatic drawings wherein: Figure 1 is a perspective view of a device for treatment of a leg of a human patient with a therapeutic liquid medium; Figure 2 is a similar perspective view of the device of Figure 1, with its handle extended, being transported to a disposal station after use ; Figure 3 illustrates an attachment for filling the

device of Figure 1; Figure 4 illustrates an alternative attachment for filling the device of Figure 1; Figure 5 illustrates a second form of the device for treatment of a leg of a human patient with a therapeutic liquid medium in its collapsed condition; Figure 6 illustrates the device of Figure 5 in condition for use; Figure 7 illustrates a third form of device for treatment of a leg of a human patient with a therapeutic liquid medium; Figure 8 is a cross-section through the device of Figure 7; Figure 9 is a cross-section through a modified form of the device of Figure 7; Figures 10 to 14 illustrate further forms of device for treatment of a leg of a human patient with a therapeutic liquid medium; Figures 15 and 16 are sections on an enlarged scale of part of the device of Figure 14; Figure 17 is a schematic side view of a further form of limb bath; Figures 18 and 19 are respectively views of left and right panels used in the construction of the limb bath of Figure 17; Figure 20 is a plan view of a foot panel used in construction of the limb bath of Figures 17 to 19; Figure 21 is a perspective view of part of the panel of Figure 18 showing the construction of a pleat; Figure 22 is a cross section of the pleat of Figure 21; and Figure 23 is a plan view of a strap forming part of the limb bath of Figures 17 to 22.

Referring to the drawings, and to Figures 1 to 4 in particular, a device 1 for treatment of a leg of a human

patient with a therapeutic liquid medium, such as a potassium permanganate solution, comprises a portable waterproof boot-shaped receptacle for receipt of a portion of a human leg (not shown) having a foot, a heel, and a calf. Device 1 is conveniently moulded from a thermoplastic material and has a water-impermeable smooth finish to its inner surface so as to facilitate'cleaning of the interior of the device 1 and subsequent drying thereof. The height of device 1 is sufficient to accommodate the heel and at least a substantial portion of the calf of a patient's leg.

There is sufficient room, after insertion of a patient's leg, for receipt within the device 1 of a suitable treatment quantity of a therapeutic liquid medium, such as a potassium permanganate solution. Such a therapeutic quantity comprises a quantity sufficient to immerse the area of the patient's lower leg requiring treatment but insufficient to cause overflowing of device 1 after insertion of the patient's foot into the device 1.

Device 1 is provided near its heel-receiving portion with a pair of wheels 2. It is further provided with an extensible handle 3 which is telescopically mounted in the rear of device 1.

At the toe end of the device 1 there is provided a drainage conduit 4 fitted with a tap 5 or other valve device. The hollow interior 6 of the device 1 is large enough to accommodate the foot and a substantial portion of the calf of a leg of a patient requiring treatment and ankle portion 7 is sufficiently large to facilitate entry of the foot, even of an arthritic elderly patient, into device 1.

Figure 2 illustrates the device being wheeled away to a disposal station for disposal of the spent treatment medium after use. The handle 3 and wheels 2 enable the device to be moved readily to the disposal station without any

necessity for a nurse or other carer to lift a heavy weight.

Figure 3 illustrates how the device 1 can be filled with the liquid treatment medium either before or after insertion of the patient's leg within device 1. As illustrated in Figure 3 a funnel 8 can be inserted in the open end of the outlet conduit 4 to facilitate loading of an appropriate quantity of liquid treatment medium into the device 1.

Figure 4 shows an alternative arrangement for preparing the device 1 for treatment of a patient. In this case the outlet pipe 4 is connected to a T-shaped connector 9 to which a pair of branching pipes 10,11 are also connected.

The free ends of the pipes 10,11 carry conventional connectors, e. g. rubber cups, for connection to hot and cold running water supplies. In this case the therapeutic agent in concentrated form, e. g. potassium permanganate crystals or a concentrated solution thereof, is first placed in device 1 whereafter water is admitted via pipes 10,11 and conduits 4 to boot-shaped receptacle 1. The amounts of hot and cold water are desirably selected such as to impart to the therapeutic liquid medium a temperature at or a little above body temperature.

In use the patient's leg is inserted into interior 6 of the device 1, either before or after filling with potassium permanganate solution or other therapeutic liquid medium, for a period of, for example, from about 5 to about 60 minutes, preferably from about 10 to about 45 minutes, and typically about 15 to about 30 minutes, whereafter the patient's leg is withdrawn from device 1 and rinsed. The device 1 can then be wheeled to a disposal station and the spent treatment medium passed for disposal (for example to a drain in the floor) through exit conduit 4 with the aid of tap or valve 5.

Figure 5 illustrates a second embodiment of the invention in the form of a collapsible boot-shaped device 21 with an inflated cuff 22 at its upper end.

Figure 6 illustrates the device of Figure 5 in its operative condition. Device 21 has a pair of handles 23 by means of which the patient can, after inserting his or her foot in device 21, pull the remainder of the device 21 upwardly around his or her calf until it reaches the position shown in Figure 6. The inflated cuff 22 can then be further inflated, if necessary, through a suitable valve (not shown) in order to retain the upper end of device 21 in place above the thickest part of the patient's calf.

Thereafter the device can be filled with liquid treatment medium through conduit 24. This form of device has the advantage of enabling the patient to walk around during treatment.

Figures 7 and 8 illustrate a third form of device in the form of an open-topped boot-shaped bath 31 which is supported under its heel-receiving portion 32. Desirably the device 31 is pivotally mounted by its heel portion so that the angle of the calf-receiving portion 33 to the horizontal can be varied. Reference numeral 34 indicates a strut pivotally attached to an upper end of device 31, the free end of which can be received in one of a number of notches 35 in a base portion 36 of the device 31 whereby the calf portion 33 of the device 31 can be set at an angle to suit the patient and the position of the leg ulcer or venous eczema being treated.

A pump (not shown) is mounted in a portion 37 of the device adjacent the heel portion 32 by means of which solution collecting in the heel portion 32 can be circulated through conduit 38 to a spray device 39 for spraying therapeutic liquid medium over the affected portion of the

patient's leg. A timing device (not shown) can also be incorporated in portion 37 by means of which the pump can be automatically switched off at the end of the desired treatment period.

After treatment has been completed, the spray device 39 can be held over a convenient sink or washbasin whereafter the device 31 can be emptied by means of the pump.

A modification of the device 31 of Figures 7 and 8 is shown in Figure 9. This is generally similar to the device 31 except that the single spray device 39 is replaced by a pair of spray devices 40.

Figure 10 shows a further form of device 41 for treatment of a leg of a human patient with a therapeutic liquid medium. This is made of a flexible plastics material and has a drawstring 42 at its upper end for securing the top end of the device 41 around the patient's leg above the biggest part of the patient's calf. Reference numeral 43 indicates a self-indicating temperature strip to indicate to the nurse or carer the temperature of the therapeutic liquid medium within the device 41.

Figure 11 shows a fifth form of device 51 for treatment of a leg of a human patient with a therapeutic liquid medium. This comprises a self-supporting boot 51 for receipt of the patient's leg and the therapeutic liquid medium. It can be provided with a pouring spout 52 to facilitate disposal of the spent liquid medium after use.

Alternatively it can be provided with a peelable seal 53 to facilitate pouring away of at least the bulk of the therapeutic liquid medium after use.

Reference numeral 54 indicates a timing device whereby the patient and the nurse or carer can monitor the length of time which the treatment has lasted.

Figure 12 shows the sixth form of the device 61 which

comprises a double-walled boot-shaped container made of a flexible plastics material, such as polyethylene or nylon.

Between the inner wall 62 and the outer wall 63 of the device 61 there is an insulating space 64. This can be filled with a flexible foam material so as to provide heat insulation properties. Device 61 can be sold in an aseptically sealed package (not shown) with a suitable quantity of a therapeutic agent, such as potassium permanganate crystals 65 already contained in device 61. At the time of use the device 61 can be inserted over the foot of a patient whose leg requires treatment, whereafter warm water can be added between the patient's leg and the inside wall 62 to dissolve the crystals 65. Alternatively the crystals 65 can be dissolved in water within device 61 prior to insertion of the patient's foot.

Figure 13 illustrates a similar form of device 71 which is also boot-shaped. This has a concealed rear-closing zip or similar device to facilitate insertion of the patient's foot into the device. It is also provided with carrying handles 73 to facilitate emptying of the boot after treatment has been completed.

Figure 14 illustrates a further device 81 in accordance with the invention. This takes the form of a disposable liner for insertion within a self-sustaining boot, such as a conventional Wellington boot. Alternatively it may be inserted within a purpose made boot with a zipper device running down the calf portion and, optionally, also running down over an instep portion of the boot to facilitate insertion of the patient's foot and liner 81 within the boot.

Device 81 is formed from two layers 82,83 of plastics sheet material, preferably a heat sealable plastics sheet material, such as polyethylene. These sheets comprise a

calf portion 84 and a foot portion 85 and they are sealed one to another by means of a peripheral seal 86 which extends from a top edge 87 thereof down the back of calf portion 84, around foot portion 85 and up the front edge of calf portion 84 again to the top edge 87. A pair of notches 88, which extend partly only through seal 86 are provided adjacent a toe portion 89 of device 81 for a purpose which will be explained hereafter.

Adjacent top edge 87 of sheet 82 there is adhered a female portion 90 of a peelable zipper-like resealable seal of a type used in food packaging while sheet 83 has adhered thereto a corresponding male portion 91 of the resealable seal.

A predetermined quantity of potassium permanganate crystals 92 are contained within the device 81.

A pair of handles 93 are adhered to an upper portion of device 81, one being adhered to sheet 82 and the other to sheet 83. The sheets 82 and 83 may be reinforced in the region of the attachment of handles 93.

A further sheet of plastics material 94 is adhered to an upper portion of sheet 82 while a corresponding further sheet of plastics material 95 is adhered to a corresponding upper portion of sheet 83. Sheets 94 and 95 are sealed one to another along their upper edge 96 so as to form a sealed package. A pair of notches 99 joined by a line of perforations 100 are formed in the respective seals 97 and 98.

Prior to use, the nurse or other carer or the patient will tear off the upper end of the seal along the lines of perforation 100, thereby allowing access to the upper edges 87. These can then be pulled apart to separate portions 90 and 91 of the resealable seal. The device 81 can then be inserted in the boot and filled with water of an appropriate

temperature to dissolve the potassium permanganate crystals 92. The patient can then insert his or her foot.

At the end of treatment, the boot can be unzipped, if a zipper is provided, or the patient can remove his or her foot from inside the device 81.

The device 81 with the spent therapeutic liquid medium can then be carried to a suitable disposal point by means of the handles 93. At the disposal point the toe of the boot can be torn off, the notches 88 facilitating removal of the toe portion of the device 81, to enable spent therapeutic liquid medium to be emptied into a sink or floor drain.

If desired, any of the embodiments described above and/or illustrated herein, which are not already provided with a handle or handles, can be provided with a handle or handles in order to facilitate carrying thereof either prior to or following treatment of a patient's leg, for example during the filling operation, during carrying of the filled device to or from the patient, or during emptying of the spent therapeutic liquid medium. It may further be convenient to provide a frame having an appropriately positioned hook or hooks from which the device may be suspended at a convenient height with the aid of the handle or handles so as to facilitate filling of the device, treatment of the patient, or emptying of the device.

The limb bath 191 of Figure 17 is formed from a pleated left panel 192 (see Figure 18), a pleated right panel 193 (see Figure 19), and a foot panel 194 (see Figure 20), each of which is preferably made from a flexible sheet of a heat sealable plastics material. In addition limb bath 191 includes a strap 195 (see Figure 23). Panels 192,193, 194 are sized so that the limb bath can accommodate loosely a lower leg and foot of a patient requiring treatment. As can be seen from Figures 21 and 22, in particular, panel 192 is

folded to form a pleat 196 on that surface which is to form the outside of the panel 192. Lines 197,198 indicate in Figures 17 and 18 the outer edges of pleat 196. In a similar manner panel 193 is folded to form a pleat 196 on that surface of panel 193 which is to form the outside of the limb bath 191. Cutouts 201 and 202 are formed in corresponding positions in panels 192,193 respectively so that, after the panels 192,193 are assembled, cutouts 201, 202 coincide one with another to form a handle. Panel 192 is also provided with a pair of tabs 203,204, while panel 193 has a corresponding pair of tabs 205,206. Each of tabs 203,204, 205,206 has a slot 207 cut through it to receive strap 195. A sticky tab 208 is provided at one end of strap 195. Prior to use sticky tab 208 is covered with a piece of release paper (not shown) to prevent the adhesive coating on tab 208 from sticking prematurely and unintentionally to objects into contact with which it may come.

To assemble limb bath 191 of Figure 17 areas indicated by reference letters a to h in Figures 18 to 20 are each sealed along their edge portions by any suitable manner, e. g. by heat sealing, to a corresponding edge portion of an area on another of the panels 192,193, 194 which bears the same reference letter. In this way. form edge seals are formed which run from the vicinity of one pair of tabs 203, 206 to the other pair of tabs 204,205 around the periphery of the foot and calf portions of the limb bath 191. Tabs 203,206 are likewise sealed one to another and so are tabs 204,205. However, areas above the cutouts 201,202 are not sealed together so as to provide an open top for access of the patient's foot. Limb bath 191 is, it will readily be appreciated, suitable for treatment of either a left leg and foot or a right leg and foot. Strap 195 is also sealed to tabs 204,205 and inserted through the slots 207 in tabs

203,206.

After insertion of a patient's foot, during which operation the pleats 196 permit wider opening of the top of the limb bath 191, an appropriate quantity of treatment liquid can be poured in, the release paper can be removed from sticky tab 208, and strap 195 tightened as required, whereafter the sticky tab 208 can be stuck to another part of the strap 195 or panel 192 or 193 so as to hold the strap 195 secure while treatment occurs.

At the conclusion of treatment tab 208 can be released and the patient's foot withdrawn from bath 191. The limb bath 191 and its contents can then be carried to a convenient sink or other receptacle, such as a bucket, or to a floor drain, for disposal. The toe portion of limb bath 191 can be cut off to facilitate emptying of its liquid contents.

Instead of sealing strap 195 to tabs 204,205, it is alternatively possible to provide a strap 195 which is long enough to pass through the slots 207 of both of the pairs of tabs 203,206 and 204,205 and extend right around the patient's leg.

It is also envisaged that a fastener of the hook and loop type, such as that sold under the trade mark VELCRO, can be used in place of an adhesive fastener such as the sticky tab 208.