COMPRESSION DEVICE

Abstract

A medical device comprising a bladder (or plurality of bladders), an attachment mechanism, a fluid inlet, a fluid outlet, a compressor, a pressure regulator system, and a perfusion sensor, which is compressed against intact tissue (unbroken skin or surface tissue in a cavity) for the purpose of minimising blood perfusion to prevent drug delivery to a non-target site.

Claims

1. A pneumatic compression device (1,100) for use in preventing or treating chemotherapy-induced alopecia or chemotherapy-induced peripheral neuropathy (CIPN) in a subject receiving chemotherapy treatment, the device (1,100) comprising: an attachment member (2), a first layer (3) connected to the attachment member (2), at least one primary bladder (5); and a fluid inlet (12), wherein the at least one primary bladder (5) is configured to inflate with a fluid at ambient temperature, and which exerts a compressive pressure to the non-treated area of the subject when the bladder (5) is inflated minimising blood perfusion to prevent chemotherapy delivery to the non-treated area.

2. The pneumatic compression device (1) of claim 1, further comprising a second layer (4) and an outer mesh layer (6) surrounding the second layer (4).

3. The pneumatic compression device (1) of claim 1 or claim 2, further comprising an inner membrane (7), the inner membrane (7) forms an inner lining of the device (1), nestling between the second layer (4) and the tissue of the subject.

4. The pneumatic compression device of any one of the preceding claims, further comprising a secondary bladder (11), wherein the secondary bladder (11) is configured to attach to the attachment member (2) such that the secondary bladder (11) comes in contact with the tissue of the subject.

5. The pneumatic compression device (1) of any one of the preceding claims, further comprising a first fastening system (16) configured to prevent the outward movement of the outer mesh layer (6).

6. The pneumatic compression device (1) of claim 5, further comprising a second fastening system (17) adapted to tighten the attachment member (2) to the subject.

7. The pneumatic compression device (1) of any one of claims 2 to 6, wherein the at least one primary bladder (5) is attached along its inner edge (5a) to the second layer (4), and along its perimeter surface (5b) to the first layer (3) and along its lower edge surface (5c) to the attachment member (2).

8. The pneumatic compression device (1) of any one of the preceding claims, further comprising at least one adjustable strap (10) to secure the device (1) under, around or over the chin of the subject.

9. The pneumatic compression device (100) of claim 1, wherein the at least one primary bladder (5) is configured to have a plurality of sockets (108) to accommodate the fingers of the hand or the toes of the foot of the subject.

10. The pneumatic compression device (100) of claim 1 or claim 9, wherein the at least one primary bladder (5) is configured to be a single socket that accommodates the whole hand or the foot of the subject.

11. The pneumatic compression device (100) of any one of claim 1, 9 or 10, further comprising a first securing member (102) to secure the device (100) in place.

12. The pneumatic compression device (100) of any one of claim 1, 9, 10 or 11, further comprising a second securing member (103) to secure the device (100) in place.

13. The pneumatic compression device (1,100) of any one of the preceding claims, wherein the attachment member (2), the first fastening system (16), second fastening system (17), the first securing member (102), or the second securing member (103) can be used with greater force to tighten the device (1,100) against the surface of the scalp, foot, or hand through a drawstring mechanism.

14. A pneumatic compression device (200) for use in preventing or treating chemotherapy-induced infertility in a subject receiving chemotherapy treatment, the device (200) comprising: at least one primary bladder (205), an applicator (202) adapted to accommodate the at least one primary bladder (205), and a cap (204) configured to contain the at least one primary bladder (205) within the applicator (202) when deflated, wherein the at least one primary bladder (205) located within the applicator (202) is configured to inflate with air or a gas at ambient temperature, and which exerts a compressive pressure when the bladder (205) is inflated.

15. The pneumatic compression device (200) of claim 14, further comprising an outer shell (210) and an inner shell (212), which combine to form an enclosure (214) that accommodates the at least one primary bladder (205).

16. The pneumatic compression device (200) of claim 14 or claim 15, further comprising a support means (208) housed internally in the applicator (202) and in communication with the cap (204).

17. The pneumatic compression device (200) of claim 16, wherein the support means (208) is surrounded by the at least one primary bladder (205).

18. The pneumatic compression device (200) of any one of claims 14 to 17, wherein the cap (204) is reversibly connected to the applicator (202) and is released from the applicator (202) when the at least one primary bladder (205) is inflated.

19. The pneumatic compression device (200) of any one of claims 14 to 17, wherein the cap (204) is fixed to the applicator (202) and further comprises an aperture (206) through which the at least one primary bladder (205) is pushed through prior to inflation.

20. The pneumatic compression device (1,100,200) of the preceding claims, further comprising a control element (9).

21. The pneumatic compression device (1,100,200) of claim 20, wherein the control element (9) comprises a pump, a pressure sensor, and a tissue perfusion sensor.

22. The pneumatic compression device (1,100,200) of claim 21, wherein the pressure sensor is in communication with the at least one primary bladder (5,205).

23. The pneumatic compression (1,100,200) device of any one of the preceding claims, wherein the at least one primary bladder (5,205) further comprises a plurality of bladder compartments, each bladder compartment operating independently of each other.

24. The pneumatic compression device (1,100,200) of any one of claims 1 to 22, wherein the at least one primary bladder (5,205) further comprises a plurality of bladder compartments, each of the plurality of bladder compartments are in fluid communication with a bladder compartment juxtaposed it.

25. The pneumatic compression device (1,100,200) of claim 23 or claim 24, wherein the at least one primary bladder (5,205) or the plurality of bladder compartments are connected to the pump, the pump having a two-way valve system to control the inflow and outflow of the fluid.

26. The pneumatic compression device (1,100,200) of any one of the preceding claims, wherein when activated, the device (1,100,200) applies a compressive pressure of between about 20 mmHg to about 100 mmHg to the subject.

27. The pneumatic compression device (1,100,200) of claim 26, wherein the compressive pressure being applied is between about 25 mmHg and about 75 mmHg.

28. The pneumatic compression device (1,100,200) of claim 26 or claim 27, wherein the compressive pressure being applied is between about 40 mmHg and about 60 mmHg.

29. The pneumatic compression device (1,100,200) of any one of the preceding claims, wherein the compressive pressure is applied incrementally.

30. The pneumatic compression device (1,100,200) of claim 29, wherein the compressive pressure is applied uniformly and/or non-uniformly.

31. The pneumatic compression device (1,100,200) of any one of the preceding claims, further comprising a foam layer inserted within the at least one primary bladder (5,205) or one or more of the plurality of bladders; wherein the foam layer exerts a reaction force through the bladder onto the scalp, foot, hand, or within a cavity when air is withdrawn incrementally creating a vacuum inside the at least one primary bladder (5,205) or one or more of the plurality of bladders.

32. The pneumatic compression device (1,100) according to any one of the preceding claims, wherein a fluid or a solid which is viscous at ambient pressure and a solid form at pressures lower than atmospheric pressure, is inserted into the at least one primary bladder (5) or one or more of the plurality of bladders, wherein when pressure within the at least one primary bladder (5) decreases, the fluid or the sold hardens, creating a modifiable compressive force against the tissue.

33. The pneumatic compression device (1,100,200) of any one of the preceding claims, wherein the at least one primary bladder (5,205) or the plurality of bladders, are inflated are to a pre-determined pressure level below the target therapeutic pressure level prior to the user using the device (1,100,200).

34. The pneumatic compression device (1,100,200) of any one of the preceding claims, wherein the at least one primary bladder (5,205) or the plurality of bladders are provided at a pre-determined pressure level and are not further inflated.

35. The pneumatic compression device (1,100,200) of any one of the preceding claims, wherein the attachment member (2) further comprises at least one status indicator light (13).

36. A method of controlling drug delivery via the blood vessels to a target site on the body, the method comprising: mechanically compressing the skin/surface tissue at a target tissue site at a predetermined compressive force to occlude the upstream blood vessels; maintaining the compressive force for a predetermined period; and releasing the compressive force applied to the tissue at the target site at a pre-determined rate and in a pre-determined geometric pattern.

37. The method of claim 36, wherein the compressive force is applied to the tissue site upstream of the intended effect site.

38. The method of claim 36 or claim 37, wherein the compressive force is applied to the skin/surface tissue at the target site at about 20 mmHg to about 100 mmHg.

39. The method of any one of claims 36 to 38, wherein the compressive force applied is configured to mechanically occlude the microvasculature close to the surface of the tissue and local arterial supply vessels.

40. The method of any one of claims 36 to 39, wherein the compressive pressure is applied uniformly across the tissue site to be treated.

41. The method of any one of claims 36 to 40, wherein the compressive force is maintained for a period of between 30 minutes and 7 hours.

42. The method of any one of claims 36 to 41, wherein the compressive force is applied at different areas of the tissue.

43. The method of any one of claims 36 to 42, wherein the compressive force is applied in a pulsatile fashion.

44. A method of controlling drug delivery to a target site on the body, followed by a period of reactivating blood flow to ensure long-term tissue viability, the method, comprising: mechanically compressing the skin/surface tissue at the target site with a predetermined compressive force to cause occlusion of the local microvasculature; maintaining microvasculature occlusion for a predetermined period of time such that drugs circulating through the vascular system do not reach the target site or site downstream of the target site; releasing the occlusion in a controlled manner at a pre-determined rate and in a pre-determined geometric pattern; sensing a physiological parameter; adjusting the mechanical compression applied to the tissue site based on the sensed physiological parameter; and applying compressive forces in a pulsatile fashion against the skin tissue to promote blood flow allowing waste agents to be removed from the local vasculature.

45. The method of claim 44, wherein the sensed physiological parameter is the blood perfusion in the tissue site being treated.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0112] The invention will be more clearly understood from the following description of an embodiment thereof, given by way of example only, with reference to the accompanying drawings, in which:—

[0113] FIG. 1 illustrates a perspective view of a pneumatic compression device of the claimed invention.

[0114] FIG. 2 illustrates the pneumatic compression device of FIG. 1 with a cut-away portion showing the layers of the device.

[0115] FIG. 3A illustrates a control element of the claimed invention for use with the pneumatic compression device of FIG. 1, while FIG. 3B illustrates the control element affixed to the rear of the device of the claimed invention. The scalp compression device of FIG. 1 in use, where (a) the device is placed on the head of the patient, (b) a dial at the back of the device is turned to tighten and align the device on the head of the patient, and (c) pressure sensors activate a motorised dial at the front of the device to gradually apply and control the pressure in the device to create the desired compression.

[0116] FIG. 4 illustrates a rear perspective view of the device illustrated above with a secondary bladder indicated by the dotted line.

[0117] FIG. 5 illustrates a device of the claimed invention for use on the hand of a subject receiving chemotherapy treatment.

[0118] FIG. 6 illustrates the device of FIG. 5 with the outer layer in cross section, revealing the primary bladder beneath.

[0119] FIG. 7 illustrates the device of FIG. 5 and FIG. 6 in cross section.

[0120] FIG. 8 illustrates the device of the claimed invention for use on the foot of a subject receiving chemotherapy treatment.

[0121] FIG. 9 illustrates the device of FIG. 8 with the outer layer in cross section, revealing the primary bladder beneath.

[0122] FIG. 10 illustrates a device of the claimed invention for use in a cavity of a subject receiving chemotherapy treatment, where (A) shows the device in situ but not deployed; (B) shows the device during deployment; and (C) shows the device fully deployed, while (D) shows the fully deployed device in (C) in cross-section, revealing the inner elements of the device.

[0123] FIG. 11 illustrates a device of the claimed invention for use in a cavity of a subject receiving chemotherapy treatment, where (A) shows the device in situ but not deployed; (B) shows the device during deployment; (C) shows the device in (B) in cross-section, revealing the inner elements of the device; and (D) shows the device fully deployed.

[0124] FIG. 12 illustrates a graph showing the reduction in tissue perfusion compared to perfusion at baseline at a target site (in the case the scalp) in eight human volunteers when varying levels of compressive pressure are applied using a device of the claimed invention. Tissue perfusion is measured in relative perfusion units as provided by a Moor Instruments Laser Doppler monitor.

DETAILED DESCRIPTION OF THE DRAWINGS

[0125] Localised microvascular compression therapy has applications in the prevention of CIA, CIN, CII, and other drug side effects such as dry skin, and mucositis. The pneumatic compression device of the claimed invention modulates localised drug delivery to protect off-target tissue. The pneumatic compression device applies tissue and/or vessel compression, in a range of 20 mmHg to 200 mmHg (preferably from about 20 mmHg to about 100 mmHg), from a pneumatic compression against unbroken (not punctured) skin or internal structures (such as within the vaginal cavity), to occlude local blood vessels, leading partially or completely to reduced blood perfusion at the protected site, and consequently reduced drug delivery at an effect site (or protected tissue site). This modulation of localised drug delivery reduces or eliminates unwanted side effects at the protected tissue site caused by drugs in the circulatory system.

[0126] Firstly, the pneumatic compression device will apply pressure over a large area to reduce blood prefusion to the protected tissue. This large area approach allows for lower pressure levels (20-100 mmHg) compared to traditional tourniquet devices (these apply high pressure over a small region). This large pressure footprint allows for greater patient comfort during treatment. Secondly, the applied pressure is modulated during treatment to reduce or avoid perfusion related damage to the tissue at the occlusion site or the protected site. The reduction of pressure post therapy will also be controlled to avoid reperfusion injury.

[0127] The above pneumatic compression device can significantly reduce off-target drug-related damage to skin, peripheral nerve endings, ovaries or bladder, amongst other tissues and organs.

[0128] The present invention provides a pneumatic compression device designed to apply either uniform or non-uniform incremental pressure to an area of the subject for the therapeutic purpose of preventing damage done by chemotherapeutic drugs. Before chemotherapy infusion, the device can be fitted to the head, foot, hand or within a cavity of the subject, fastened in place (if appropriate), and then activated. The device may be used with any size or shape of head, foot, hand, or cavity, which allows it to be used for all ages (from an infant to an adult), providing a flexibility and ease of use. An inner bladder mechanism inflates incrementally using a fluid at room temperature to apply (uniform/non-uniform) pressure to the area of interest, for example, the scalp. With this level of therapeutic pressure applied before, during and after chemotherapy treatment, the device causes local vasoconstriction of the blood vessels, reducing the tissue perfusion in the area of interest, and thus preventing drug delivery to, for example, the hair follicle or other non-target areas.

[0129] Referring now to the figures, where FIG. 1 illustrates a general embodiment of a pneumatic compression device of the present invention for use with a scalp of a subject. Specifically, FIG. 1 illustrates a perspective view of the pneumatic compression device of the present invention fitted to the head of a subject and is generally referred to by reference numeral 1. The device 1 of the illustrated embodiment comprises an attachment member 2 adapted for fitting the device 1 to the head of the subject. The attachment member 2 is connected to a first layer 3, a second layer 4 (see FIG. 2), and at least one primary bladder 5 sandwiched therebetween (see FIG. 2). The attachment member 2 acts as an anchor for the other elements of the device 1. The at least one primary bladder 5 is attached along its inner edge 5a to the second layer 4, and along its perimeter surface 5b to the first layer 3 and along its lower edge surface 5c the attachment member 2. The at least one primary bladder 5 is inflated using a fluid, preferably air or a gas, which is preferably at room temperature. The first layer 3 is typically encased with an outer mesh layer 6, which is also attached to the attachment member 2. The attachment member 2 is typically rigid.

[0130] When inflated, the at least one primary bladder 5 expands and applies pressure to the scalp, as the bladder 5 can only expand towards the scalp. The outer mesh layer 6 stops any outward expansion of the device 1 away from the scalp. One of the functions of the outer mesh layer 6 is to constrain the primary bladder 5 so that air pressure inside the primary bladder 5 is applied to the scalp. If a series of interconnected primary bladders 5 or a series of bladder compartments are used, varying amounts of pressure can be applied to the same or to different areas of the scalp.

[0131] The device 1 further comprises an inner membrane 7. The inner membrane 7 ensures that the device 1 is a comfortable fit on the subject. In one aspect, the inner membrane 7 runs in conjunction with the attachment member 2, that is, circumferentially around the head of the subject. The inner membrane 7 forms a seal around the scalp of the subject. In one aspect, the inner membrane 7 forms the innermost lining of the device 1 and nestles between the second layer 4 and the head of the subject, substantially enveloping the entire area of the scalp when the device 1 is fitted to the subject. The inner membrane 7 is typically a soft or malleable (compliant) material that is comfortable for the wearer.

[0132] The inflatable at least one primary bladder 5 is configured to connect to a pump which inflates the at least one primary bladder 5 with air or a gas when the device 1 is switched on. The pump, and any related electronic controlling architecture, is contained within a removable control element 9 attached within a slot 20 located in the attachment member 2 at the rear of the device 1. The at least one primary bladder 5, which is constrained in place by both the attachment member 2 and the outer mesh layer 6, is thus enabled to apply an incremental compressive force on the head of the subject wearing the device 1.

[0133] In use, the device 1 is positioned on the scalp of the subject and can be fastened in place by a plurality of adjustable straps 10 affixed to the attachment member 2, which are either anchored on, around or under the chin of the subject (see FIG. 2). In one aspect, adjustable straps can be replaced with a drawstring system attached to the sides of the device 1. In one aspect, the device 1 is secured on the scalp by a secondary bladder 11 which is located on the inner surface of the attachment member 2 such that it is in contact with the forehead, temples and nape of the subject wearing the device 1 (see FIG. 1, FIG. 4). When fluid, preferably air or a gas, is provided to the secondary bladder 11, it inflates to create a seal against the forehead, temples and base or nape of the head of the subject, securing the device 1 in place and creating a seal while the at least one primary bladder 5 is filled with air or a gas and applies the therapeutic compression to the scalp.

[0134] Turning now to FIG. 3a and FIG. 3B, the control element 9 is shown isolated (FIG. 3A) and in situ within the slot 20 (FIG. 3B). The control element 9 typically contains the pump, at least one air or a gas vent 12 for accessing air or gas inflow and for allowing air or gas to flow back out, at least one pressure sensor and a tactile on/off switch 14. The at least one pressure sensor can also be located within the at least one primary bladder 5 or on the scalp-facing side of the at least one primary bladder 5 and remain connected to the control element 9. This control element 9 further comprises a controlling electronic architecture for reading inputs from the pump and the at least one air pressure sensor. The pump is powered by a battery which is contained within the control element 9 of the device 1. The battery can be a rechargeable battery or a single use battery.

[0135] The headband member 2 also incorporates at least one status indicator light 13 (see FIG. 1), that is in communication with the control element 9. The status indicator light 13 communicates to the control element 9 via a wired connection through the attachment member 2 and into the control element 9. The at least one indicator light 13 is used to indicate whether the device 1 is on and functioning, turned off, or malfunctioning.

[0136] Any incremental changes in pressure is measured by the at least one air pressure sensor, which is connected to the at least one primary bladder 5. The compressive pressure that is applied to the scalp by the device 1 is in the range of about 20 mmHg to about 350 mmHg, or to about 200 mmHg; but preferably between about 20 mmHg to about 150 mmHg, more preferably between about 20 mmHg and about 100 mmHg; ideally between about 25 mmHg and about 75 mmHg. Typically, the compressive pressure applied is between about 40 mmHg and 60 mmHg. When activated, the pump contained within the device 1 inflates the at least one primary bladder 5 to a specified compressive pressure, thus acting like a pneumatic device. This compressive pressure causes local vasoconstriction and a reduced level of skin tissue perfusion, which prevents drug delivery to the hair follicle. When chemotherapy treatment is completed, the device 1 is deflated using a valve system or using the pump in reverse polarity.

[0137] In one aspect, the device 1 comprises several air pressure sensors located at several points within the device 1. When the pressure reaches a certain threshold, either low (for example, 30 mmHg or 40 mmHg pressure) or high (for example, between about 60 mmHg to about 200 mmHg pressure), at one or more of the points measured by the pressure sensors, the pump is activated to either pump more air (fluid) into the at least one primary bladder 5 causing more scalp compression, or removing air from the at least one primary bladder 5 causing less scalp compression, as required. In one aspect, the at least one primary bladder 5 comprises several individual bladder compartments, each bladder compartment corresponding to a different section of the device 1 and a different part of the scalp of the subject. Each individual bladder compartment is connected to its own pump in the control element 9 and pressure sensor.

[0138] In one aspect, a tissue perfusion sensor, such as a laser Doppler blood flow sensor, is incorporated within or on the scalp-facing surface of the second layer 4 or the attachment member 2. The tissue perfusion sensor analyses the level of blood flow in the scalp tissue being compressed. Using an embedded software system and controlled by the architecture of the control element 9, this information is used to activate the pump to either increase or decrease the pressure in the at least one primary bladder 5 or the bladder compartments.

[0139] The tissue perfusion sensor can be incorporated in several ways. In one aspect, the tissue perfusion sensor is incorporated in a hollow in the material making up the second layer 4 so that the sensor is in contact with the scalp of the subject. In one aspect there are at least two tissue perfusion sensors incorporated within the attachment member 2 so that the positioning of the tissue perfusion sensors corresponds to the temple area of the user on each side of the head. In another aspect, there are a plurality of tissue perfusion sensors configured to be patterned around the scalp by being adhered to or within the at least one primary bladder 5 in a particular pattern, or within or on each of the polarity of bladder compartments, ensuring that the perfusion sensors are scattered around and cover the scalp area. In a further aspect, a plurality of tissue perfusion sensors are integrated into the inner shell 4 such that they are in direct contact with the scalp of the subject. The use of a single, two or a plurality of tissue perfusion sensor, permits the user to determine blood flow at different points of the scalp of the subject and to determine how much pressure is needed to constrict the blood vessels to prevent blood flow at that point in the scalp.

[0140] In one aspect, the sensors (air pressure, tissue perfusion) and pump(s) further comprise a power source, circuitry to measure its resistance and a means to control the sensors and pump(s) and record readings. In other aspects of any embodiment described here, the air pressure sensor, the tissue perfusion sensor and the pump(s) can further comprise a wireless technology for exchanging data between the sensors and pump(s) and the control element 9 of the device 1 over short distances using, for example, short-wavelength UHF radio waves (for example, Bluetooth®), other wireless data transmission methods such as wireless mesh networks targeted at battery-powered devices in wireless control and monitoring applications (such as ZigBee®), local area networking of devices and Internet access (such as WIFI®), and other wireless communications protocol using a mesh network using low-energy radio waves to communicate from appliance to appliance (such as Z-Wave®). Typically, a remote app can be used on or with the device 1 to record the readings from the air pressure sensor, tissue perfusion sensor, and/or the pump(s). This way, the user can control the inflation of the at least one primary bladder 5, the second bladder 11 and the bladder compartments remotely. Alternatively, the device 1 itself controls the inflation pressure based on feedback from the sensors to the control element 9. The sensors (air pressure and tissue perfusion) and the pump can also be connected to the control element 9 physically by wiring.

[0141] At the rear of the device 1 there is a first fastening system 16 which is configured to tighten the outer mesh layer 6 in order to fasten the device 1 to the head of the wearer (see FIG. 3B). In use, and to provide an initial fastening of the device 1 to the head of the subject, the subject twists the first fastening system 16 in one direction (for example, in a clockwise direction) to tighten the outer mesh layer 6, and twists the first fastening system 16 in the opposite direction (for example, in an anticlockwise direction) to loosen the outer mesh layer 6.

[0142] In a similar fashion, a second fastening system 17 is used to tighten the attachment member 2 to the temples, forehead, and nape of the subject. This means that the subject may place the device 1 in a comfortable position, tighten the headband member 2 in a mechanical fashion initially by twisting the first fastening system 16 and/or the second fastening system 17 to ensure the device 1 is positioned correctly for the subject, and then activate the on/off switch 14 to fill the secondary bladder 11 and create a seal around the forehead, temples and lower regions of the head of the subject to keep the device 1 in place.

[0143] The first and second fastening systems 16,17 can be adjusted manually by the user or adjusted electronically by the architecture of the control element 9. The first and second fastening systems 16,17 typically have a motor within their structure which twists the fastening elements of the systems 16,17. It should be noted that the device 1 can be used without the first and second fastening systems 16,17; or used with only one of the first and second fastening systems 16,17 engaged.

[0144] Referring now to the figures, where FIGS. 5 to 9 illustrate a general embodiment of a pneumatic compression device of the present invention for use with a hand or a foot of a subject. Where elements of each embodiment are shared, the same reference numerals are used. Specifically, FIG. 5 illustrates a perspective view of the pneumatic compression device of the present invention fitted to the hand of a subject and is generally referred to by reference numeral 100. The device 100 comprises a first layer 3 in the shape of a glove or mitten which can be fitted over the hand of the user. The first layer 3 is secured to the wearer using an attachment member 2, which tightens the device 100 against the wearer. In addition, a first and a second securing member 102,103, respectively, can also be used to secure the first layer 3 in place around the fingers of the user. At least one primary bladder 5, connected by a single fluid inlet 12, is attached to an inner surface of the first layer 3 (see FIG. 6 and FIG. 7). The at least one primary bladder 5 is arranged such that each point on the skin of the fingers, wrist and forearm of the wearer is in contact with the primary bladder 5. The fluid inlet 12 is then connected to a pump (not shown), electronically coupled with a pressure regulating system/sensor. The pump drives the fluid (such as air, oxygen, water) into the fluid inlet 12 and then into the at least one primary bladder 5. The primary bladder can be arranged to have a plurality of sockets 108, which accommodate the fingers and thumb of the hand of the user (see FIG. 6 and FIG. 7). Alternatively, a network of primary bladders 5 are provided that can form contacts with individual fingers and the thumb of the user. The at least one primary bladder 5 inflates and incrementally applies compressive pressure against the skin of the wearer. The device 100 is programmable to remain inflated until the pressure reduces the skin perfusion of the user and drug delivery is prevented. When a treatment is completed, the device 100 is deflated using the pump and a fluid outlet (or the fluid inlet (12) in reverse).

[0145] In one aspect, one or more perfusion sensors are placed on the surface of the plurality of sockets 108 forming the at least one primary bladder 5, which are in contact with the skin of the wearer. The inputs from the perfusion sensors can be used to modulate the level of compressive pressure applied by the at least one bladder 5 to the wearer.

[0146] Referring now to FIG. 8, there is illustrated a general embodiment of a pneumatic compression device of the present invention for use with a foot of a subject. Where elements of each embodiment are shared, the same reference numerals are used. Specifically, FIG. 8 illustrates a perspective view of the pneumatic compression device of the present invention fitted to the foot of a subject and is generally referred to by reference numeral 100. The first layer 3 is formed in the shape of a sock which can be fitted over the foot of the user. In this embodiment, the at least one primary bladder 5 is arranged such that each skin surface on the toes, foot, and ankle of the user is in contact with the at least one primary bladder 5. In one aspect, a network of primary bladders 5 are provided that can form contacts with individual toes, as well as the foot and ankle of the user. At least one primary bladder 5, connected by a single fluid inlet 12, is attached to an inner surface of the first layer 3 (see FIG. 9).

[0147] A sterile contact layer is placed between the at least one primary bladder 5 and the skin surface of the wearer. This sterile contact layer is typically made from a biocompatible, sterilisable plastic such as polyethylene. The first layer 3 is secured to the wearer using an attachment member 2, which tightens the device 100 against the wearer. Further, a first and second securing member 102,103, respectively, can also be used to secure the first layer 3 in place around the foot of the user. The fluid inlet 12 is then connected to a pump (not shown), electronically coupled with a pressure regulating system/sensor, that is, a control system (as described for the device 1). The pump drives the fluid (such as air, oxygen, water) into the fluid inlet 12 and then into the at least one primary bladder 5. A network of primary bladders 5 are provided that can form contacts with individual toes, the heel, ball of the foot, and ankle of the user. The at least one primary bladder 5 inflates and incrementally applies compressive pressure against the skin of the wearer. The device 100 is programmable to remain inflated until the pressure reduces the skin perfusion of the user and drug delivery is prevented. When a treatment is completed, the device 100 is deflated using the pump and a fluid outlet (or the fluid inlet (12) in reverse).

[0148] In one aspect, one or more perfusion sensors are placed on the surface of the plurality of sockets 108 forming the at least one primary bladder 5, which are in contact with the skin of the wearer. The inputs from the perfusion sensors can be used to modulate the level of compressive pressure applied by the at least one bladder 5 to the wearer.

[0149] Referring now to FIG. 10 and FIG. 11, there is illustrated a general embodiment of a pneumatic compression device of the present invention for use within a cavity of a subject. Where elements of each embodiment are shared, the same reference numerals are used. Specifically, FIG. 10A illustrates a perspective view of the pneumatic compression device of the present invention in situ within the vaginal cavity of a subject and is generally referred to by reference numeral 200. The device 200 comprises at least one primary bladder 205 and an applicator 202 comprising an outer shell 210 and an inner shell 212 which forms an enclosure 214 that houses the at least one primary bladder 205, and a cap 204 that sits atop the applicator 202. The applicator 202 delivers the at least one primary bladder 205 to the tissue target when in an internal cavity, such as in the vaginal cavity as per FIG. 10 and FIG. 11. When placed correctly in the cavity by the user, the at least one primary bladder 205 is pushed from the enclosure 214 by a support axis 208 (see FIG. 10D) to within the confines of the cavity. The cap 204 is in communication with the support axis 208 and disengages from the end of the applicator 202 when activated (see FIG. 10B and FIG. 10D). When the at least one primary bladder 205 is outside of the enclosure 214 of the applicator 202, the at least one primary bladder 205, or a plurality of primary bladders 205, is inflated using a pump through the inlet 12, via a control system, as described above for devices 1 and 100, such that the at least one primary bladder 205, or a plurality of primary bladders 205, expand to apply compression against the walls of the cavity (see FIG. 100 and FIG. 10D).

[0150] The at least one primary bladder 205 inflates and incrementally applies compressive pressure against the skin of the wearer. The device 200 is programmable to remain inflated until the pressure reduces the tissue perfusion of the user and drug delivery is prevented. When a treatment is completed, the device 200 is deflated using the pump and a fluid outlet (or the fluid inlet (12) in reverse).

[0151] In one aspect, one or more perfusion sensors are placed on the surface of the at least one primary bladder 205, or the plurality of primary bladders 205, which are in contact with the tissue of the cavity. The inputs from the perfusion sensors can be used to modulate the level of compressive pressure applied by the at least one primary bladder 205, or a plurality of primary bladders 205, to the user.

[0152] Referring now in more detail to FIG. 11, the cap 204 that sits atop the applicator 202 further comprises an aperture 206. The aperture 206 is configured to guide the at least one primary bladder 205 from the enclosure 214 to the cavity. When a user acts on the support axis 208, the at least one primary bladder 205 exits the aperture 206 and into the confines of the cavity (see FIG. 11B). The cap 204 is disengaged from the support axis 208 and remains in communication with the top of the applicator 202. The support axis 208 remains engaged with the at least one primary bladder 205 (see FIG. 11C). When the at least one primary bladder 205 is outside of the enclosure 214 of the applicator 202, the at least one primary bladder 205, or a plurality of primary bladders 205, is inflated using a pump through the inlet 12, via the control system, as described above for devices 1 and 100, such that the at least one primary bladder 205, or a plurality of primary bladders 205, expand to apply compression against the walls of the cavity (see FIG. 11D).

[0153] The at least one primary bladder 205 inflates and incrementally applies compressive pressure against the skin of the wearer. The device 200 is programmable to remain inflated until the pressure reduces the tissue perfusion of the user and drug delivery is prevented. When a treatment is completed, the device 200 is deflated using the pump and a fluid outlet (or the fluid inlet (12) in reverse).

[0154] In one aspect, one or more perfusion sensors are placed on the surface of the at least one primary bladder 205, or the plurality of primary bladders 205, which are in contact with the tissue of the cavity. The inputs from the perfusion sensors can be used to modulate the level of compressive pressure applied by the at least one primary bladder 205, or a plurality of primary bladders 205, to the user.

[0155] Materials and Methods

[0156] The device 1,100,200 is operated by the wearer in the clinical setting as set out below. [0157] 1. The device 1,100,200 is provided in a loose, unfastened fashion. [0158] 2. For the scalp, the clinician or user places the device 1 loosely over the head of the subject and straps the device 1 in place using the securing mechanism 10 and the secondary bladder 11, the first fastening system 16 or the second fastening system 17, or a combination thereof. [0159] 3. The device 1 is switched on by pressing the on button 14 at the rear of the device 1. The device 1 then begins to inflate, and the status light 13 indicates that the device 1 is switched on and the at least one primary bladder 5 is beginning to inflate. [0160] 4. When the device 1 reaches the target pressure application, the status light 13 indicates that the device 1 is now in “active” mode. The device 1 will stay active for a pre-programmed period of time. [0161] 5. For the hand or foot, the clinician or user places the device 100 loosely over the hand or foot of the subject and straps the device 100 in place using the first securing member 2, the second securing member 102 or the third fastening member 103, or a combination thereof. [0162] 6. The device 100 is switched on by pressing a button on a control system that incorporates a pump electronically coupled with a pressure regulating system/sensor. The pump then begins to inflate the at least one primary bladder and a status light on the control system indicates that the device 100 is switched on and the at least one primary bladder 5 is beginning to inflate. [0163] 7. When the device 100 reaches the target pressure application, the status light indicates that the device 100 is now in “active” mode. The device 100 will stay active for a pre-programmed period of time. [0164] 8. For the cavity, the clinician or user places the device 200 within the cavity. [0165] 9. The device 200 is switched on by pressing a button on a control system that incorporates a pump electronically coupled with a pressure regulating system/sensor. The pump then begins to inflate the at least one primary bladder 205, and a status light on the control system indicates that the device 200 is switched on and the at least one primary bladder 205 is beginning to inflate. [0166] 10. When the device 200 reaches the target pressure application, the status light indicates that the device 200 is now in “active” mode. The device 200 will stay active for a pre-programmed period of time. [0167] 11. The clinician can then begin to operate the chemotherapy infusion process. [0168] 12. Once the chemotherapy infusion is complete, the patient is free to leave the clinical setting while wearing the device 1,100,200. [0169] 13. Once the active chemotherapeutic period is over, the status indicator light will show that the treatment is complete. The control element 9 or control system further comprises a timing system that can be set to a particular amount of time that the device 1,100,200 is inflated to apply pressure to the scalp/hand/foot/cavity of the user. The timing system can be set to the amount of time the chemotherapeutic treatment is being administered, or the control element 9 or control system can connect to the chemotherapeutic treatment delivery device (either physically connected via a plug-in-and-play wiring set up or wirelessly) and mirror the time the treatment will take. When the time period is complete, user can either then press the off button (14) or the off button (14) will automatically be disengaged by the control element 9 or control system, which triggers the pump to draw the fluid out of at least one primary bladder (or from the plurality of bladder compartments 5,205) and expel the fluid through the vent to release the pressure slowly from the device 1,100,200. [0170] 14. Once the pressure is released, the device 1,100,200 completes a shutdown procedure, and the user is then free to unfasten or remove the device 1,100,200 and store it. [0171] 15. The user brings the device 1,100,200 to clinic at their next appointment.

CONCLUSION

[0172] The device 1,100,200 can be worn before, during and after chemotherapy treatment for a defined period. The projected wearing time is up to about 30 minutes before chemotherapy infusion, constant wearing during chemotherapy infusion and for a further 60-120 minutes, preferably 90 minutes, after infusion is completed. The key benefit of this solution is that the subject can leave the infusion ward while wearing the device 1,100,200, instead of having to spend the additional time after infusion treatment has finished in the infusion centre wearing the device 1,100,200.

[0173] The device 1,100,200 of the claimed invention is an elegant, comfortable, and portable solution to preventing hair loss during chemotherapy. The device 1,100,200, which is designed to fit into the existing clinical workflow, avoids the capital cost, infection control and patient discomfort issues associated with existing products.

[0174] The use of pneumatic bladders in the device 1,100,200 inherently expand to fill the empty space around them. This is a highly advantageous property in the device 1,100,200 because it means given enough room to expand, the bladder system will expand to fit any shape of head, hand, foot, or cavity, and will apply the same pressure equally to every surface it contacts.

[0175] The device 1,100,200 modulate drug delivery at the microvascular level with low levels of pressure to avoid any issues with lack of blood flow to a large portion of the body. This is illustrated in FIG. 12, where the reduction in tissue perfusion at the target site from a “baseline” resting state to a significantly lower level is demonstrated when compression is applied using the device 1. This graph shows the average reduction in tissue perfusion at a depth of 1.5 mm (as measured using a Laser Doppler Flowmeter) at the target site while using the device 1 across eight healthy human volunteers. The existing devices of the prior art use vasoconstriction induced by cryogenics, and existing compression devices mainly focus on increasing blood flow.

[0176] In the specification the terms “comprise, comprises, comprised and comprising” or any variation thereof and the terms “include, includes, included and including” or any variation thereof are considered to be totally interchangeable and they should all be afforded the widest possible interpretation and vice versa.

[0177] The invention is not limited to the embodiments hereinbefore described but may be varied in both construction and detail.