TECHNICAL FIELD

The present invention relates to a compression garment assembly for providing compression to a limb and a method of applying compression to a limb. The present invention is particularly but not exclusively suitable for treating venous insufficiency of the lower leg. Aspects of the invention relate to a compression garment assembly and method of use.

BACKGROUND

Venous disorders of the lower leg include varicose veins and resulting conditions, such as lipodermatosclerosis, venous ulceration, venous haemorrhage and thrombophlebitis. These conditions are typically treated with compression therapy, in which controlled pressure is exerted on the affected limb. Compression therapy is described in Hague A, Pherwani A, Rajagopalan S. Role of compression therapy in pathophysiology of the venous system in lower limbs. The Surgeon 15 (2017) 40-46.

Compression is conventionally applied to the lower limb using compression bandages. Compression bandages have the disadvantage that they require weekly renewal by a healthcare provider; this renewal can become more frequent as the oedema and thus limb circumference reduces.

Another product used to apply compression to legs is graduated compression stockings. These require the patient's legs to be measured by a specialist, before the correct sized stocking can be issued. Compression stockings have the disadvantage that as they are designed to fit tightly around the leg, they can be difficult for the patient to put on; this is particularly the case for patients suffering from arthritis, tremors, or who are frail.

Applying compression to the lower leg can have the disadvantage of impeding the flow of lymph in the lower leg and thus negatively impacting on the lymphatic system. Furthermore, applying too much compression has the risk that pressure exceeding arterial pressure will prevent blood from reaching the foot.

It is the object of the invention to address disadvantages associated with the prior art.

SUMMARY OF THE INVENTION

A first aspect of the invention provides a compression garment assembly for providing compression to a limb, comprising:

a wrap-around garment for wrapping around the limb of a patient, said wrap around garment comprising a releasable fastening for securing the wrap- around garment in position, and one or more inflatable chambers for applying compression to the limb;

wherein an external surface of said at least one inflatable chamber is configured to form recessed passages when inflated which, in use, extend substantially parallel with the longitudinal directions of the limb.

In use, the recessed passages are spaced from the patient's limb and enable movement of air between the wrap-around garment and the patient's limb. This enhances the comfort of the wrap-around garment, which improves patient compliance in wearing it. By arranging the recessed passages parallel with the longitudinal direction of the limb, pressure is not applied continuously around the full circumference of the limb, improving flow of lymph in the limb and the comfort of the user. The recessed passages may extend substantially parallel with the longitudinal direction of the limb in a linear or non-linear path. The inflatable chamber may comprise first and second opposite sides defining an internal space between them, wherein the first and second sides are joined together along join lines, defining channels in the internal space and recess passages on the external surface.

The wrap-around garment may comprise a leg covering portion and a foot covering portion. This allows compression to be applied to both the leg and the foot. The leg covering portion and the foot covering portion may comprise a single garment. The one or more inflatable chamber may be provided on the leg covering portion. The foot covering portion may have no inflatable chambers. This enables the patient to wear a normal shoe whilst wearing the wrap-around garment. The foot covering portion may be provided with a recess to

accommodate the heel of a patient. This assists with positioning the wrap- around garment correctly on the lower limb. The one or more releasable fastening may comprise a first releasable fastening on the leg covering portion and a second releasable fastening on the foot covering portion.

The compression garment assembly may comprise at least one connector for releasable connection to a pump assembly, such as a Luer connection. The compression garment assembly may comprise at least one conduit connecting the at least one connector with the at least one inflatable chamber. The compression garment assembly may comprise a valve to control flow of air into and out of the inflatable chamber. The valve may comprise a check valve which prevents the inflatable chamber from deflating when the pump is removed from the connector. The compression garment assembly may comprise a pressure relief valve. The pressure relief valve may control the maximum pressure in the inflatable chamber. The compression garment assembly may comprise a pressure gauge. The pressure gauge may comprise a display which provides a visual indication of the desired pressure range, for example by using colour.

The compression garment assembly enables more accurate pressures to be achieved, reducing the risk of impeding the flow of lymph or arterial flow. This results in the patient being able to wear the compression garment assembly for longer, more comfort for the patient and thus increased likelihood that the compression garment assembly will be worn as directed.

The compression garment assembly may comprise a pump assembly to provide pressurized air to each inflatable chamber. The pump assembly may comprise a hand pump. The pump may be removable from the warp-around garment, to enable the patient to be ambulatory.

The wrap-around garment may comprise an elastic material. The wrap-around garment may comprise a breathable material. Examples of suitable material include polyester, polyester/Lycra™ blend and polyester/Lycra™/Emana™ blend. The wrap-around garment may comprise at least one pocket to house the at least one inflatable chambers. The at least one inflatable chamber may be removable from the at least one pocket. This enables the inflatable chamber to be removed for washing and enables replacement of damaged inflatable chambers.

The at least one inflatable chamber may be integral with the at least one pocket. For example, the wrap-around garment may comprise two adjacent layers of material, with the integral inflatable chamber located between said two adjacent layers of material.

The compression garment assembly may comprise a pressure sensor to monitor pressure in said at least one inflatable chamber and a transmitter for

transmitting pressure data measured by the sensor. Suitable means of

transmission include wireless communication technologies, such as Bluetooth™ and Zigbee™.

The compression garment assembly may comprise a pressure monitoring device, the pressure monitoring device comprising means for:

receiving a pressure data signal indicative of the pressure within the inflatable chamber; and

determining automatically from the pressure data signal whether the pressure within the inflatable chamber is within the predetermined pressure range.

The pressure monitoring device may comprise means for alerting the patient that the pressure within the inflatable chamber is outside the predetermined pressure range.

The compression garment assembly may comprise a pressure monitoring device, the pressure monitoring device comprising:

an electronic processor having an electrical input for receiving a pressure signal for the inflatable chamber, the pressure data signal being automatically generated and output by the pressure sensor; an electronic memory device electrically coupled to the electronic processor and having instructions stored therein,

wherein the electronic processor is configured to access the memory device and execute the instructions stored therein such that it is operable to determine whether the air pressure data is within a predefined range.

The electronic processor may be configured to access the memory device and execute the instructions stored therein such that it is operable to alert the patient that the pressure within the inflatable chamber is outside the predefined range.

The pressure recording device may be part of an existing device, such as a smart phone, PC, laptop, tablet, phablet, smart watch, smart glasses, or may be a bespoke device. For example the pressure recording device may comprise an app on a smart phone or other personal electronic device.

The alert may be selected from an email, a text, a notification banner, an audible signal, and a vibration.

The wrap-around garment may comprise an upper edge, wherein the one or more inflatable chambers is parallel with but offset from the upper edge. The one or more inflatable chambers may comprise two or more inflatable chambers, which are parallel to and offset from each other. In one embodiment, the at least one inflatable chamber may comprise three inflatable chambers, parallel to and offset from each other. The compression garment assembly may comprise three conduits, each delivering pressurized air to a separate one of the inflatable chambers.

The leg covering portion may comprise a first side edge and a second side edge opposite said first side edge, wherein the second side edge is provided with one or more strap, and wherein the releasable fastener is located on the one or more strap. The one or more strap assists the patient to stretch the material of the warp-around garment as it is being wrapped around the limb and fastened. The one or more strap may be in-line with the one or more inflatable chamber. This assists in adjustment of the tightness of the wrap-around garment at the location of each inflatable chamber. The one or more strap may be elongate, which makes them easy to handle, even for frail patients, for example those with arthritis and tremors.

The releasable fastening may comprise a hook and fastening, such as Velcro™ for attaching to the loops of the material of the wrap-around garment.

The patient may comprise a human patient.

The compression garment assembly is suitable for applying compression therapy to the lower leg. For example, the compression garment assembly may be used to treat venous insufficiency of the lower leg. Venous insufficiency of the lower leg may include varicose veins and resulting conditions, such as

lipodermatosclerosis, venous ulceration, venous haemorrhage and

thrombophlebitis.

The compression garment assembly provides a consistent compression to hydrostatic forces leading to tissue oedema including, but not limited to, the effects of venous valvular incompetence causing tissue oedema and breakdown.

A second aspect of the invention provides a method of applying compression to a limb of a patient, comprising:

wrapping a wrap-around garment around the limb of a patient, said wrap around garment comprising a releasable fastening for securing the wrap-around garment in position, and one or more inflatable chambers for applying

compression to the limb;

fastening the warp-around garment in place around the limb using the releasable fastening;

inflating the inflatable chambers.

A third aspect of the invention provides a compression garment assembly for providing compression to a limb, comprising:

a wrap-around garment for wrapping around the limb of a patient, said wrap around garment comprising a releasable fastening for securing the wrap- around garment in position, and one or more inflatable chambers for applying compression to the limb. A fourth aspect of the invention provides a compression garment assembly for providing compression to a limb, comprising:

a wrap-around garment for wrapping around the limb of a patient, said wrap around garment comprising a releasable fastening for securing the wrap- around garment in position, one or more inflatable chambers for applying compression to the limb, a pressure sensor to monitor pressure in said at least one inflatable chamber and a transmitter for transmitting pressure data measured by the sensor; and

a pressure monitoring device, the pressure monitoring device comprising means for:

receiving a pressure data signal indicative of the pressure within the inflatable chamber; and

determining automatically from the pressure data signal whether the pressure within the inflatable chamber is within the predetermined pressure range.

A fifth aspect of the invention provides a compression garment assembly for providing compression to a limb, comprising:

a wrap-around garment for wrapping around the limb of a patient, said wrap around garment comprising a releasable fastening for securing the wrap- around garment in position, one or more inflatable chambers for applying compression to the limb;

wherein the wrap-around garment comprises a leg covering portion and a foot covering portion.

The foot covering portion may be provided with a recess to accommodate the heel of a patient.

A sixth aspect of the invention provides use of a compression garment comprising a wrap-around garment for wrapping around the limb of a patient, said wrap around garment comprising a releasable fastening for securing the wrap-around garment in position, and one or more inflatable chambers for applying compression to the limb; wherein an external surface of said at least one inflatable chamber is configured to form recessed passages when inflated which, in use, extend substantially parallel with the longitudinal directions of the limb, for treatment of venous insufficiency of the lower limb.

A seventh aspect of the present invention provides the use of a compression garment assembly comprising a wrap-around garment for wrapping around the limb of a patient, said wrap around garment comprising a releasable fastening for securing the wrap-around garment in position, and one or more inflatable chambers for applying compression to the limb, for treatment of venous insufficiency of the lower limb.

An eighth aspect of the present invention provides the use of a compression garment assembly comprising: a wrap-around garment for wrapping around the limb of a patient, said wrap around garment comprising a releasable fastening for securing the wrap-around garment in position, one or more inflatable chambers for applying compression to the limb, a pressure sensor to monitor pressure in said at least one inflatable chamber and a transmitter for

transmitting pressure data measured by the sensor; and a pressure monitoring device, the pressure monitoring device comprising means for: receiving a pressure data signal indicative of the pressure within the inflatable chamber; and determining automatically from the pressure data signal whether the pressure within the inflatable chamber is within the predetermined pressure range for the treatment of venous insufficiency of the lower limb.

A ninth aspect of the present invention provides the use of a compression garment assembly comprising a wrap-around garment for wrapping around the limb of a patient, said wrap around garment comprising a releasable fastening for securing the wrap-around garment in position, one or more inflatable chambers for applying compression to the limb; wherein the wrap-around garment comprises a leg covering portion and a foot covering portion, for the treatment of venous insufficiency of the lower limb.

Throughout the description and claims of this specification, the words "comprise" and "contain" and variations of the words, for example "comprising" and "comprises", mean "including but not limited to", and do not exclude other components, integers or steps. Moreover the singular encompasses the plural unless the context otherwise requires: in particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

Preferred features of each aspect of the invention may be as described in connection with any of the other aspects. Within the scope of this application it is expressly intended that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, in the claims and/or in the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination, unless such features are incompatible.

BRIEF DESCRIPTION OF THE DRAWINGS

One or more embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which :

Fig 1 shows a first side of an embodiment of the wrap-around garment;

Fig 2 shows a second side of the wrap-around garment of Fig 1;

Fig 3 is a perspective view of the wrap-around garment of Figs 1 and 2 worn by a patient;

Figs 4A-D are front, top, back and perspective views of a first embodiment of an inflatable chamber;

Figs 5A-D are front, top, back and perspective views of a second embodiment of an inflatable chamber;

Fig 6 is a cross section of an embodiment of a valve assembly; and

Fig 7 is a schematic diagram showing a third embodiment of the inflatable chamber and pressure monitoring device.

DETAILED DESCRIPTION

The wrap-around compression garment 10 is illustrated in Figs 1,2 and 3. Fig 1 illustrates a first side, which in use will be the inner side, lying against the patient's lower leg and foot. Fig 2 illustrates a second side, which in use will be the outer side. As shown in Fig 1, the wrap-around compression garment 10 is made up of a leg covering portion 12, which in use covers a patients leg and a foot covering portion 14, which in use covers a patient's foot.

The leg covering portion 12 comprises an upper edge 16 and a lower edge 18.

As shown in Fig 3, in use the upper edge lies just below the patient's knee and the lower edge lies just above the patient's ankle.

The leg covering portion 12 comprises three pockets (not shown), in which are housed three inflatable chambers 20,22,24. The three inflatable chambers 20,22,24 are positioned substantially parallel to each other and to the upper edge 16. The three inflatable chambers 20,22,24 are dimensioned so that they will substantially encircle a patient's lower leg, when the wrap-around

compression garment 10 is in place. Conduits 26,28,30, in the form of tubing, are provided for delivering pressurized air to each inflatable chamber.

One side of the leg covering portion 12 is provided with three straps 32,34,36. Each strap is provided with a releasable fastening 38,40,42 in the form of a hook fastening (for example Velcro™), which will fasten to the loops in the fabric of the wrap-around compression garment 10. The three straps 32,34,36 are positioned substantially in-line with the three inflatable chambers 20,22,24. The three straps 32,34, 36 are elongate, making them easy to grip and allowing them to wrap around the patient's limb.

The foot covering portion 14 is made of first and second foot sections 44,46, which extend from the lower edge 18 of the leg covering portion 12. The first and second foot sections 44,46 are separated by a gap 48, which in use acts to locate the patient's heel. The second foot section 46 is provided with a releasable fastening 50 in the form of a hook fastening (for example Velcro™), which will fasten to the loops in the fabric of the foot portion 14, which in use is used to secure the foot portion 14 over the patient's foot.

The outer side of the wrap-around garment 10 (illustrated in Fig 2) is provided with a manifold 52 just below the upper edge 16 of the leg covering portion 12. Conduits 26,28,30, shown in Fig 1, pass through holes in the fabric of the wrap- around garment 10 and connect to the manifold 52.

As illustrated in Fig 2, the side of the leg covering portion 12 opposite the straps 32,34,36 is provided with a releasable fastening 54 in the form of a hook fastening (for example Velcro™), which will fasten to the loops in the fabric of the wrap-around compression garment 10.

Fig 3 shows the wrap-around compression garment 10 in place on a patient's leg. In a first step, the patient locates the gap 48 in the foot covering portion 14 around the patient's heel, with the inner surface (shown in Fig 1) against the patient's leg, to correctly position the wrap-around compression garment. Then the leg covering portion 12 is wrapped around the patient's leg, with the edge 56 opposite straps 32,34,36 laid on the leg first and the edge 58 adjacent straps 32,34,36 laid on top of edge 56. The leg covering portion is adjusted until comfortably in position and reasonably tight; once in position, releasable fastening 54 is used to hold it in place. The three straps 32,34,36 are then wrapped around the leg and releasable fastenings 38,40,42 are used to hold them firmly in position. The releasable fastenings 54,38,40 and 42 can be adjusted, until the wrap-around garment has the desired tightness.

The foot covering portion 14 is positioned around the patient's foot by

overlapping lower edges 60,62 of first and second foot sections 44,46

underneath the patient's foot. The upper edge 64 of first foot portion 44 is wrapped over the top of the patient's foot, with the upper edge 66 of the second foot portion 46 wrapped over the top and secured in place by releasable fastening 50. The pressure exerted on the foot by the foot portion can be varied by adjusting the amount of overlap of first and second foot portions 44 and 46.

Fig 3 also shows a pump 68, in the form of a hand pump in fluid connection with the manifold 52 by a length of tubing 70. Once the wrap-around compression garment 10 is wrapped around the patient's lower leg and foot, the inflatable chambers 20,22,24 are inflated using pump 68. A pressure sensor 72 is provided to monitor the pressure inside the inflatable chambers. Once the inflatable chambers 20,22,24 have been inflated, the pump 68 and tubing 70 can be removed, allowing the patient to be ambulatory and carry out their normal daily activities. Figs 4A-4D show a first embodiment of the inflatable chamber 20 in more detail.

The inflatable chamber 20 is a bladder having flexible sides defining an internal space. In this embodiment, the inflatable chamber is made from two sheets of polyurethane welded together. A conduit 26, manufactured from polyurethane flexible tubing is welded to the bladder so that it is in fluid communication with the internal space. The internal space is divided into channels 74 by weld lines 76. In this embodiment, the weld lines 76 are transverse to the longitudinal direction of the elongate bladder, making the channels vertical when the wrap- around garment is in place. The weld lines 76 do not extend all the way to the edges of the internal space, thereby allowing air in the internal space to circulate between channels. The inflatable chamber is between about 20cm and 25cm in length and between about 5cm and about 10cm in width. Each channel is between about 1.5cm and 2.0cm wide, with between 10 and 15 channels provided in the inflatable chamber. When inflated, the weld lines 76 cause the external surfaces of the inflatable chamber to have a corrugated profile, with ridges above the channels 74 and recessed passages above the weld lines 76.

Figs 5A-5D show a second embodiment of the inflatable chamber 20 in more detail. As with the previous embodiment, the inflatable chamber 20 is a bladder having flexible sides defining an internal space. The inflatable chamber is made from two sheets of polyurethane welded together. An elbow connector 79 is welded to one corner of the inflatable chamber 20 and in fluid connection with the internal space of the inflatable chamber. A conduit 26, in the form of manufactured from polyurethane flexible tubing is UV bonded to the elbow connector, so that it is in fluid communication with the internal space.

The internal space is divided into channels 78 by weld lines 80. In this embodiment, the weld lines 80 are parallel to the longitudinal direction of the elongate bladder, making them horizontal when the wrap-around garment is in place. (The vertical lines shown in Fig 5C merely illustrate the position of the weld lines 76 in the embodiment of Figs 4A to 4D for comparison). The weld lines 80 do not extend all the way to the edges of the internal space, thereby allowing air in the internal space to circulate between channels. The inflatable chamber is between about 20cm and 25cm in length and between about 5cm and about 10cm in width. Each channel is between about 1.5cm and 2.0cm wide, with between 10 and 15 channels provided in the inflatable chamber.

When inflated, the weld lines 80 cause the external surfaces of the inflatable chamber to have a corrugated profile, with ridges above the channels 78 and recessed passages above the weld lines 80. These recessed passages allow movement of air between the patient's leg and the leg covering portion, resulting in breathability.

Alternatively, the weld lines could be provided in a different configuration, for example in an "X" formation comprising a first set of parallel diagonal weld lines and a second set of parallel diagonal weld lines, said second set being transverse to the first set. This configuration would produce a larger number of smaller chambers across the inflatable chamber.

In the embodiments of 4A to 4D and Figures 5A to 5D, the weld lines create chambers which promote increased flexibility of the inflatable chamber by restricting the expansion of the inflatable chamber, whilst still enabling the pressure to build up. In addition, the chambers promote breathability by virtue of the recessed passages formed between the inflatable chamber and the patient's leg.

The three conduits 26,28,30 are each provided with a valve assembly 82. The valve assembly 82 has a first end 84 for connection to the air pump 68 via tubing 70 and a second end 86 for connection to conduit 26,28 or 30. A combined connector and valve 88, in the form of a Luer lock valve, is provided at the first end 85 for releasable connection to the pump assembly, with the valve providing control of air flow into/out of the valve assembly 82. The valve assembly 82 is provided with a pressure relief valve 90, which will vent to atmosphere when the maximum pressure is exceeded. Two reducer sections 92,94 are also provided. A pressure gauge (not shown) is provided in each valve assembly, with a visual display to indicate whether the inflatable chamber is inflated to the correct pressure. The visual display (not shown) has coloured lines or a coloured section showing the correct pressure for ease of use. The three inflatable chambers may be inflated to different pressures, in which case the visual displays will indicate the correct pressure ranges for the inflatable chamber for which it is in fluid communication. The three valve assemblies 82 (one for each of the conduits 26,28,30) are housed together in a manifold 52, illustrated in Figs 2 and 3.

In a further embodiment illustrated in Fig 7, a pressure sensor 92 is provided in each inflatable chamber 20. A transmitter 94 is also provided in the inflatable chamber to transmit pressure data from the pressure sensor to a receiver 96 in a separate device 102, in this case a smart phone. In this embodiment, the transmitter 94 and receiver 96 communicate by Bluetooth. The pressure data is stored into memory 98 and an electronic processor 100 processes the data to determine whether the pressure data is within a predefined range. If the pressure is outside the predefined range, for example the pressure has dropped, an alert may be sent to the patient, for example by sending a text, displaying a notification screen, vibrating and/or making an audible signal. This alerts the patient that he/she needs to make adjustments to the wrap-around garment assembly, for example by using the hand pump to top up the pressure. This data can additionally be used by the patient and healthcare provider to monitor the use of the wrap-around garment assembly. For example, the patient's compliance in wearing the wrap-around garment assembly can be an important part of the assessment of the effectiveness of the treatment. Although the pressure sensor and transmitter are shown in the inflatable chamber, they could alternatively be located in the valve assembly or conduit.

The compression garment assembly of the present invention has the advantage that it allows the patient to perambulate with the wrap-around garment inflated, allowing the patient to continue with everyday activities. The pressure exerted by the compression garment assembly is finely controlled, providing effective treatment. The patient is alerted if the pressure drops below the predetermined range and needs to be topped up.

The external surface of the inflatable chamber provides air passages between the inflatable chamber and the patient's limb, improving comfort to the user.

The wrap around design and use of releasable fastenings provides ease of putting on the wrap-around garment.