TITLE
Compression Bandage
DESCRIPTION
Field of the Invention
The invention relates to an elasticated compression support, for use as a compression bandage around an absorbent dressing for the management of venous insufficiency in a patient's limb, particularly the lower leg, and for the control of extra vascular fluid in the treatment of venous ulcers and lymphoedemia .
Background Art
An elasticated compression support, described as a compression bandage, for holding an absorbent dressing in compression around a limb is disclosed in our published Patent Application No. O99/36019. The absorbent dressing may be as disclosed in our Patent Application No. PCT/GBOO/00149. The combination, of absorbent dressing and compression support or bandage, is superior to the traditional "four- layer bandage" system which is conventionally used in the treatment of venous ulcers. The traditional four-layer bandage system for the lower leg as pioneered by the Charing Cross Hospital, London comprises the following layers: layer 1 : A loose spiral of orthopaedic wool bandage applied without tension. This layer is designed to absorb exudate and redistribute pressure around the ankle, protecting the bony prominences such as the malleoli, tibial crest and dorsum of the foot from excessive pressure. 10 cm wide orthopaedic wool bandages sold under the trade Marks VELBAND or SOFFBAN are suitable.
layer 2: A spiral of crepe bandage, preferably of width 10 cm. This layer increases the absorbency of, and smooths, the orthopaedic wool layer (layer 1) . It also preserves the elastic energy of the main compression layer (layer 3 ) .
layer 3: A 20 cm elastic conformable compression bandage, such as that sold under the Trade Mark ELSET, would at mid-stretch in a figure-of-eight configuration around the limb, with a 50% overlap. The compression bandage should be applied to provide a mean pressure of 17 mmHg on ankles measuring 18 to 25 cm.
layer 4: A 10 cm lightweight, elastic adhesive bandage, such as that sold under the Trade Mark COBAN, wound at mid-stretch around the limb with a 50% overlap. This outer bandage layer should increase the mean pressure to 123 mmHg for ankles measuring 18 to 25 cm. It maintains the underlying three layers in place until removal, and adds durability to the system.
The intention of the four-layer bandage system is to create a graduated pressure gradient increasing from the ankle to the knee. There is considerable clinical guidance for the use of this system (see for example Journal of Wound Care, Vol 2 No. 2, March 1992, pages 91 to 94) but ultimately the conventional four-layer bandage system requires the services of a skilled nurse for correct application, and even when applied with skill and care relies on a purely subjective assessment by the nurse of the pressure being applied as the compression bandage layer is wound around the limb. Too little pressure makes the treatment less effective or ineffective. Too much pressure is hazardous to the patient as it can cause pressure necrosis. Even a skilled nurse cannot be completely certain that the applied pressure is correct, and the only guidance that is given is that the third and fourth layer bandages should be applied at 50% of their maximum possible stretch.
The combination of a compression support or bandage according to O99/36019 over an absorbent dressing according to PCT/GB00/00149 has the advantage that the
compression support or bandage at least can be washed and re-used; the intention of those prior proposals was that the limb should be capable of being be dressed by the patient or by an untrained helper; and the pressure can be regulated with- much greater certainty than with the conventional four-layer system. However there are still areas in which the compression support or bandage of O99/36019 requires improvement. The article has side fastenings which are difficult to apply by the patient working alone. The pressure is uneven around and along the limb. For example, the pressure on the limb tends to be greater in the zone immediately adjacent to the fastenings themselves as opposed to zones diametrically remote from those fastenings. And there is a tendency for rings of higher pressure to alternate with rings of lower pressure along the length of the limb, rather than the support creating a uniform pressure throughout. In the case of a lower leg dressing, the desideratum is for a lower pressure at the ankle, and a gradually increasing pressure as one progressed up the calf. That is difficult to achieve with the compression support or bandage of WO99/36019.
It is an object of the invention to overcome the above deficiencies and disadvantages.
The Invention
The invention provides an elastic compression support for an absorbent wound dressing, comprising a panel of air-permeable elasticated material shaped to conform to the shape of a limb to be dressed when placed around the limb, and a line of fastenings for drawing together two long edges of the panel as it is tightened around the limb to provide compression support for an absorbent wound dressing around the limb, characterised in that a tongue is provided, arranged to lie between the two long edges of the panel and the limb
as the panel is tightened around the limb; and the fastenings comprise mutually aligned pairs of tapes secured to or tabs integral with the panel along its long edges, arranged so that drawing the tapes or tabs apart in mutually opposite directions causes the panel to be tightened in compression around the limb; and scale markings on the tapes or tabs give a visual indication of the compression applied by each mutually aligned pair of tapes or tabs .
The panel of air-permeable elasticated material used in the support of ' the invention may be a panel of air-permeable neoprene microperforated rubber, covered on both faces by knitted, woven or non-woven stretchable material . The faced neoprene rubber used in the construction of divers' wet-suits is suitable. The material can be chosen to have a desirable modulus of elasticity. Preferably, however, the panel is made up from three or more pieces of material butt-jointed and edge-sewn together. The shaping of the individual pieces enables the made-up panel to have a three-dimensional shape which is better able to' conform to the shape of a human limb than would be a single-piece panel. Also it is highly desirable for the panel pieces forming and lying directly alongside the two long edges of the panel to have a higher modulus of elasticity than the remainder of the panel. It has been found that in the above preferred embodiment of the invention, as each pair of mutually aligned tapes or tabs is tightened, the above construction provides a far more even pressure distribution circumferentially around the limb than if that circumference were made up exclusively of material with the same stretch characteristic. In the compression support or bandage of O99/36019 the use of a single material, and therefore a single stretch characteristic, around the limb was found to create increased pressure in the vicinity of the line of fastenings than elsewhere around the circumference of the limb. The use, in the
above described preferred embodiment of the invention, of short-stretch material adjacent the fastenings and long-stretch material around the back of the panel creates a significantly more uniform pressure distribution.
In the compression support or bandage of WO99/36019 the fastenings of Figures 6 to 10 incorporate tabs down one long edge of the bandage panel, so in order to tighten the bandage the other long edge had to be held against the patient's leg while the tabs are pulled to tension the support or bandage. Inevitably this means pulling the tabs over the fingers of the _perspn applying the support or bandage and then removing those fingers. This application process is not convenient for a patient attempting to apply the support or bandage unaided. In the compression supports or bandages of Figures 1 to 5 of WO99/36019 the tabs on opposite long edges are mutually staggered so that adjacent tabs can be pulled in opposite directions to tension the panel of bandage, without one tab of each pair overlying the other. One unforeseen consequence of this geometry of tabs has been found to be the creation of bands of alternating higher and lower pressure along the length of the limb on opposite sides of the line of fastenings. This is extremely undesirable in the treatment of lymphoedemia and venous ulcers.
According to the present invention the tapes or tabs are arranged in mutually aligned pairs along the long edges of the panel . That is to say, each tape or tab on one long edge is aligned with its counterpart tape or tab on the other long edge. The tape or tab configuration to enable the tapes or tabs to be drawn apart in mutually opposite directions as the panel is tightened in compression around the limb may comprise a slit in one tape or tab of each pair, though which the other tape or tab may pass; or it may comprise a buckle through which the two tapes or tabs of the pair are drawn and turned back on themselves so
that by pulling their outer or distal ends apart the inner ends of the tapes or tabs are drawn together.
Once tightened, the tapes or tabs are preferably held in their tightened condition by hook-and-pile fastenings. Open hooks formed on the distal end of each tape or tab may be embedded in a pile fabric of the panel. That pile fabric may be a patch of suitable fabric sewn onto the fabric of the panel, or it may be a characteristic of the panel material itself. A suitable hook-and-pile fastening system is that sold under the Trade Mark VELCRO.
An alternative means for holding the tapes or tabs in their tightened condition, when the tapes or tabs of each pair pass through a buckle and are turned back on themselves, is a frictional anchorage in the buckle itself .
The markings on the tapes or tabs creating the visual indication of a scale of compression may, when the tapes or tabs are passed through buckles and folded back on themselves, be a series of equally spaced markings on each tape or tab or on one tape or tab only of each pair. The user draws the tapes or tabs through the buckles until the panel is drawn closely around the limb, and then observes the markings as increasing pressure is applied by drawing the tapes or tabs further apart. The particular treatment regime for that patient may call for an increase in pressure of one, or two, or three more markings on each tape or tab to be drawn through the buckle before the panel exerts the optimum compression. If the markings on all tapes or tabs spread along the long edges of the panel are at the same spacing, then the treatment regime may call for a different number of markings to be drawn through the different buckles after initial close positioning, as the fastenings are progressively tightened from the ankle to the knee. In that way a desired pressure gradient can be established from the ankle to the
knee. If the mutual spacing between the markings on tapes or tabs near the ankle is different from that on tabs near the knee, then it may be possible to draw the same number of markings through the buckles at all fastenings distributed along the limb, while still achieving the same desired pressure gradient.
The compression support of the invention may be washed and reused, in conjunction with a dressing which as disclosed in PCT/GB00/00149 itself may be washed and reused. This is a significant advantage over the once-only use of bandages in the four-layer .bandaging system discussed above .
The internal tongue, between the two long edges of the panel and the limb and immediately behind the line of fastenings, acts in part to cushion the user's limb against being rubbed or bruised by the fastenings and in particular by buckles incorporated into the fastenings. More significantly, it provides a surface over which the two long edges of the panel can slide during tightening of the fastenings, without causing ruckling of the absorbent dressing. Preferably the tongue itself is stiff, or is reinforced by astiffening panel, to prevent it from becoming ruckled or bunched together between the two long edges of the panel as the fastenings are tightened. The tongue is also preferably provided with a smooth or shiny outer surface to facilitate such sliding. If three bar buckles are used, then the tapes or tabs may be passed around the outer bars of the buckles and folded back on themselves, and the middle bar may be anchored to the tongue .
Drawings
Figure 1 is a perspective view of an elasticated compression support according to the invention, for a lower leg dressing; Figure 2A is a detail of a buckle fastening of Figure 1;
Figure 2B is a detail of an alternative buckle fastening using a three-bar buckle;
Figure 2C is a detail of a non-buckle fastening as used at the foot portion of Figure 1; and
Figure 3 is a plan view of the tongue of Figure 1.
Figure 1 illustrates an elasticated compression support according to the invention for supporting a wound dressing around the lower leg and foot of a patient. A panel 1 is shaped and contoured to conform to the shape of the lower leg of the patient by forming it from three panel pieces, 2, 3 and 4 which are edge-butted and oversewn together to avoid the creation of bulky seams. Each panel piece is made from fabric-faced microperforated neoprene and is therefore both elastic and air-permeable. The panel pieces 2 and 3, which lie along the shin and front leg of the patient, are made from a short-stretch microperforated neoprene the front face of which is covered with a pile fabric providing a continuous anchorage for a hook-and-pile fastener. The panel piece 4, which lies at the back of the calf and continues under the foot, is made of a long-stretch microperforated neoprene with a lower modulus of elasticity. The panel 1 is tailored to a typical patient's leg size and shape. It is envisaged that the invention would be available in a range of standardized sizes, to fit closely around the limbs of a range of patients. Alternatively it would be possible to have the panel 1 custom-made for a more accurate fit .
Down the front long edges of the panel 1 are five fastenings 5 extending down the shin, and three fastenings 6 lying over the top of the foot of the patient. Each fastening comprises a buckle 7 which in use lies between the two facing long edges of the panel 1 and is protected from chafing contact with the patient's shin by a tingue 8. Each fastening 5 further comprises two mutually aligned tapes 9 each secured to one long edge of the panel 1. The buckle is not anchored to the tongue 8 but is
simply held between the two tapes 9. It is illustrated in Figure 2A as being threaded through one tape on the left hand of the Figure but not through the identical tape on the right hand side. In use however both tapes are threaded through the buckle 7 and folded back on themselves as illustrated in Figure 1.
Distal portions 10 of the tapes 9 are provided, on their inner surfaces as viewed in Figure 2A, with the hook components of a hook-and-pile fastening, so that after pulling the tapes in mutually opposite directions to tension the panel 1 around the lower limb, they can be anchored under tension by simply pressing the hook fastenings against the pile of the panel pieces 2 and 3.
Marked on the outwardly facing side of the tapes 9 is a series of scale markings 11. It will be readily appreciated from Figure 1 how, after the tapes 9 have been pulled apart just sufficient to draw the panel 1 around the patient's calf and to close it around the calf without applying pressure, the tapes can be pulled further while counting the number of scale markings 11 passing through the buckle 7. If the person applying the compression support counts a predetermined number of markings passing through the buckle, then it will known that a predetermined and repeatable degree of tension will have been established in the panel 1 at the level of that particular fastening 5, so that the individual fastenings 5 can be reliably and reproducibly fastened to a predetermined regime of compression around the patient's lower limb.
Figure 2B shows an alternative fastening 5, utilising a three-bar buckle 7'. In Figure 2B, the three-bar buckle 7 ' is secured to the front of a tongue 8 so as to lie in use between the two long edges of the panel 1. Each fastening 5 comprises a tape 9 secured to one long edge of the panel 1. The tapes 9 are shown in Figure 2B as being
withdrawn from the buckle 7 ' , but in use pass around the outer bars of the buckle 7' so that the distal ends 10 of the tapes 9 can be pulled in mutually opposite directions. The tapes 9 are arranged in pairs down the long edges of the panel 1, each pair of tapes 9 being mutually aligned so that in use they are passed through the opposite outer bars of the same buckle 7'. In all other respects the fastening of Figure 2B is the same as that of Figure 2A.
The fastenings 6 over the foot portion of the panel 1 are designed slightly differently so as to lie flat against the foot and permit the user, to wear a shoe or slipper. One such fastening 6 is illustrated in Figure 2C. As with the fastenings 5, each fastening 6 comprises two tapes 12 and 13, arranged in mutual alignment and fastened one to panel piece 2 and one to the panel piece 3 of the panel 1. The tapes 12 and 13 are however elastic tapes, for reasons which will be described below. The tape 12 is broader than the tape 13, and is anchored to the panel piece 2 at extremities only of its width so as to create a slit 14 through which the tape 13 can pass. In use the tape 13 is threaded through the slit 14, and the tapes 12 and 13 are then pulled in mutually opposite directions until the panel 1 is drawn closely around the foot of the patient without exerting tension. Thereafter the tension on the tapes 12 and 13 can be increased until a predetermined number of markings 11 on the tape 13 have been pulled through the slit 14, at which stage a predetermined tension has been applied to the tapes, generating a predetermined compression on the foot of the patient. The tapes 12 and 13 are elastic tapes because they must expand to allow the patient's foot to spread as the patient stands and walks. They have at their distal end portions 15 pads of open hook fastening material (on the undersides as viewed in Figure 2C) which can be anchored to the pile covering of the panels 2 and 3 to maintain the desired tension around the patient's foot.
As the respective pairs of aligned tapes 5 are tightened so as to create compressive support on the lower limb of the patient, the panel pieces 2 and 3 stretch but to an extent less than the panel piece 4. This differential stretching causes a more uniform distribution of the pressure around the circumference of the patient ' s lower limb than would be the case if the same microperforated neoprene had been used for the whole of the panel 1. The introduction of a greater number of panel pieces, with graduated moduli of elasticity, can create even more uniform pressure distribution about the lower limb.
Figure 3 illustrates the tongue 8 which is placed on the inside of the panel 1 beneath the buckles 7. The tongue 8 is anchored at the toe end by a double web 16 of tape the underside of which carries open hook components of a hook-and-pile fastening. The pile component of the fastening is provided by the outer covering of the panel pieces 2 and 3. The material of the tongue 8 is preferably microperforated neoprene, with a panel 17 of non-stretch foam cushion material along the front leg portion to lie under the buckles 7. If three-bar buckles are used, then these may be secured to the tongue 8 as illustrated in Figure 2B. Alternatively if the two-bar buckles of Figure 2B are used the simple tongue 8 of Figure 3 is appropriate, and the buckles are held solely by the tapes 9.
Advantages of the compression support of the invention are that it can be applied easily and to a consistent predefined applied pressure by a patient, with the pulling apart of the pairs of tapes of the individual fasteners being a particularly simple, comfortable and reliable method of creating the desired degree of compression which is clearly discernible from the graduated markings on the fastening tapes.