GB2519175A

GB2519175A - Topical isolation module

Info

Publication number: GB2519175A
Application number: GB1318183.9A
Authority: GB
Inventors: Ali Moasser
Original assignee: CROSS MEDICAL SOLUTIONS Ltd
Current assignee: CROSS MEDICAL SOLUTIONS Ltd
Priority date: 2013-10-14
Filing date: 2013-10-14
Publication date: 2015-04-15
Also published as: GB201318183D0

Abstract

A topical isolation module includes a gas impermeable shell 1 having a wall 1a and defining a substantially closed internal chamber. The wall has an opening that communicates with the internal chamber, and the chamber being arranged to cover an external portion of a user's body to be treated. Sealing means 5 provided along the perimeter of the opening, which are arranged to seal the shell to the user's body about the portion to be treated. Gas introduction means, which are arranged to introduce one or more therapeutic gases, such as oxygen or carbon dioxide, into the substantially closed internal chamber. There is also a light source arranged to irradiate the portion to be treated. The light source may be LEDs emitting light of wavelength 390 nm, 630 nm, or 980 nm. The pressure in the chamber may be controlled by a control unit, and there may be a pressure relief valve.

Description

Topical Isolation Module The present disclosure relates to a topical isolation module, to a wound management apparatus comprising the topical isolation module, and to a method of treatment.

There is extensive clinical evidence that encapsulating an area of skin comprising a wound and exposing the encapsulated skin to a high dosage of medical gas (or to a mixture of medical gasses) at a predetermined pressure above atmospheric pressure has a highly positive impact on the healing of the wound. For example, chronic wounds may heal when exposed to high-pressure oxygen and psoriasis lesions respond positively to high-pressure carbon dioxide.

Hyperbaric chambers have long been used, which create sealed environments for the application of such high pressure gases. Hyperbaric chambers originally encompassed large portions of the user's body. In recent years topical hyperbaric chambers have been developed to encompass only a small region of the user's body.

It remains difficult, however, to topically encapsulate large and/or protruding anatomical sections to permit suitable treatment. Prior art topical hyperbaric chambers have either not been suitable for encapsulating any region of a user's anatomy that is not substantially planar or have achieved the necessary seal with the body of the user through a cuff, which is problematic since the cuff has a tendency to inhibit circulation to the area of interest.

Furthermore, whilst supplemental treatments have been used with hyperbaric treatments, for example by the introduction of a medicament into the hyperbaric chamber, there remains scope for alternative supplemental treatments that have a synergistic effect with the high-pressure gaseous environments therein.

The present invention arose in a bid to provide an improved topical isolation module and an apparatus using the module.

According to the present invention in a first aspect, there is provided a topical isolation module comprising a gas impermeable shell having a wall and defining a substantially closed internal chamber, the wall having an opening therethrough that communicates with the internal chamber, and the chamber being arranged to cover an external portion of a user's body to be treated; sealing means provided along the perimeter of the opening, which are arranged to seal the shell to the user's body about the portion to be treated; gas introduction means, which are arranged to introduce one or more therapeutic gases into the substantially closed internal chamber; and a light source arranged to irradiate the portion to be treated.

According to the present invention in a further aspect, there is provided a wound management apparatus, which comprises a topical isolation module as defined above, one or more gas sources and a control unit, wherein the control unit is arranged to control the light source, and/or to control the gas pressure within the internal chamber.

According to the present invention in a yet further aspect, there is provided a method for treating a wound by isolating a portion of a user's body comprising the wound in a substantially closed chamber, introducing one or more therapeutic gases into the substantially closed chamber and irradiating the isolated portion of the body with light of a predetermined wavelength.

Further preferred features are presented in the dependent claims.

Non-limiting embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 shows, schematically, a wound management apparatus according to the present invention; Figure 2 shows top and side views of a topical isolation module, suitable for use in the wound management apparatus of Figure 1; Figure 3 shows an exploded perspective view of an alternative topical isolation module suitable for use in the wound management apparatus of Figure 1; and Figure 4 shows a further alternative topical isolation module suitable for use in the wound management apparatus of Figure 1.

With reference to Figure 1, there is shown a wound management apparatus 100, which comprises, generally, a topical isolation module 10, a source of therapeutic gas 20 and a control unit 30.

The topical isolation module of the apparatus 100 may take various forms.

Exemplary topical isolation modules, in accordance with the present invention, are shown in Figures 2 to 4, each of which comprises, generally, a gas impermeable shell 1 having a wall la defining a substantially closed internal chamber (as seen most clearly in Figure 2), the wall having an opening therethrough that communicates with the internal chamber, and the chamber being arranged to cover an external portion of a user's body to be treated; sealing means 5 provided along the perimeter of the opening, which are arranged to seal the shell to the user's body about the portion to be treated; and gas introduction means 2, which are arranged to introduce one or more therapeutic gases into the substantially closed internal chamber.

The topical isolation module may be of a standard form, such as those shown in Figures 2 and 3, or may be custom moulded (as discussed in detail below) to fit a particular portion of the anatomy of a user, as shown in Figure 4. Whether the module is of a standard form/size or custom moulded, the seal section is arranged to mirror the anatomy of the body portion to be treated so that a gas-tight seal can be formed without excess pressure on the skin and the compromising of the circulation to the wound/lesion. The seal section preferably comprises a surgical grade adhesive. The chamber is bigger than the anatomical part to be covered so that an internal volume is defined and a target portion of the user's body bathes in the required gas.

A light source 6 (as discussed in detail below), arranged to irradiate the portion of the body to be treated, is provided in all topical isolation modules for use in the apparatus 100, including those depicted in Figures 2 and 4.

The control unit of the wound management apparatus is arranged to control the gas pressure within the internal chamber; and to control the intensity, duration and/or pattern of light emitted from the light source.

The control unit is preferably configured as a small mobile module that is battery powered/re-chargeable and allows for patient mobility, particularly when used in combination with a mobile gas source.

The medical application of the apparatus 100 can be any clinical indication where an envelope of a certain type of gas is deemed useful or remedial. The topical isolation module insulates and isolates a target section of the user's body, which allows the target section to be enveloped' by a medical gas in a controlled manner. The pressure of the internal chamber at the target section can be controlled and manipulated using the control unit.

The gas may be oxygen, carbon dioxide or any other gas useful in hyperbaric treatments.

The gas pressure of the internal chamber is maintained at a pressure above atmospheric pressure and may be maintained at a constant (static) pressure of 2 atmospheres, since this has been determined by the patentee to be a particularly beneficial gas pressure for wound treatment. Alternatively, a changing gas pressure profile may be applied to the internal chamber. The changing gas pressure profile may be a simple pulsation or may be modulated by a physiological signal such as, but not limited to, blood oxygen saturation (SPO2). Suitable sensor(s) for monitoring a desired physiological signal or multiple desired physiological signals may be provided that are linked to the control unit.

The pressure may be alternated and modulated, as required.

The gas pressure of the internal chamber is preferably monitored using a pressure feedback sensor 3, which is operatively linked to the control unit.

The source of pressurized therapeutic gas 20 may be a systemic source from a hospital outlet (or similar), or it can be from an individual compressor or an individual gas canister, as shown in Figure 1. The use of a gas canister is beneficial, since, dependant on the location and nature of the wound to be treated, the user (patient) may retain mobility during treatment.

The control unit may allow extra gas to enter the internal chamber by controlling a solenoid valve 7, or similar. Gas enters the internal chamber through a port, which comprises the gas introduction means 2, and may take any conventional form.

An injection nozzle 8 may be provided at a point in the gas path downstream of the valve to allow for a vapour (or similar) of desired substances/medicaments to be mixed with the therapeutic gas. This option can be used to infuse the internal chamber with medication such as anti-biotic vapour. The injection nozzle may also be used to introduce photosensitisors for PDT into the internal chamber in the gas flow. The injection nozzle is controlled by the control unit.

An outlet 4 for gas may be provided, which may comprise a pressure release valve that is also under control of the control unit and allows for pressure release during balancing of the pressure in the closed internal chamber.

The clinical efficacy of photo therapy is often questioned. The present inventor has, however, determined that there is a unique synergy between photo therapy and hyperbaric treatments. The introduction of a light source into the topical isolation modules of the present invention allows for phototherapy treatment, particularly a photo dynamic therapy (PDT) treatment, to supplement the hyperbaric treatment provided thereby.

The light source may comprise any light source that is capable of irradiating the body portion within the internal chamber with light of a desired wavelength. The light source may comprise a plurality of light emitting diodes (LED5) (as shown in the arrangement of Figure 3) that are positioned and placed on the module. In Figure 3 a ring of LED5 is provided. Numerous alternative LED arrangements will, however, be appreciated by those skilled in the art. Moreover, in alternative arrangements one or more sources of laser light may be provided in addition to or an alternative to LED5. For example, one or more laser diodes may be used.

The light source is switched on and off under the control of the control unit. The intensity, frequency, duration and pattern of the light from the light source may be controlled by the control unit. An array of multiple different frequency LEDs (or other light sources) may be provided, wherein the frequency of light may be altered by only turning on a plurality of the LED5 (or other light sources) of a particular wavelength. The intensity may be increased by increasing the number of LEDs (or other light sources) of the same wavelength that are switched on simultaneously.

Particularly preferred wavelengths for PDT are 390 nm, 630 nm and 980 nm and these wavelengths may be used in the apparatus of the present invention. As will be readily appreciated by those skilled in the art, however, different wavelengths may also be used.

The module may comprise one or more insertion slots/grooves/openings in the wall for receiving individual LED5, rows of LED5 or moulded housings for special light sources.

As discussed, the topical isolation module may be of a standard form or may be uniquely customized for a particular individual.

The modules will be attached to the skin using a surgical grade adhesive, as mentioned. Whilst the seal will not be perfect, the desired pressure in the chamber will be maintained by the control unit. There will be small leaks, and skin (epidermis) sheds itself causing even additional leakage. The module may require periodical re-sealing. Once every 24 hours of treatment, for example. The base line gas pressure is preferably 2 atmospheres, as mentioned.

Standard modules will look very similar, differing from one another principally in their size. These are intended for more flat sections of anatomy.

Custom moulded topical isolation modules will be available in any number of different shapes and sizes, tailored to the needs of individual users. An exemplary custom moulded module is shown in Figure 4 covering a portion of a user's foot.

For formation of a custom module, a mould of the relevant anatomical part will be made. A cast will be made from the mould, which is larger than the cast to allow for an internal volume in the finished module. During this formation step, the cast is manipulated without impacting the seal section, so that it remains a perfect copy. The module may be made using injection moulding, 3D printing or CAD casting and may be formed from a rigid, flexible or semi-flexible material, as will be readily appreciated by those skilled in the art.

Allowance is made in the design to attach the required airways, light sources and sensors in the module.

The custom shape of the modules beneficially allows the modules to mirror and match anatomical sections; and to provide an airtight seal that matches the respective anatomical section.

The apparatus of the present invention, using either a standard or a custom moulded module allows the maintenance of the gas pressure inside the internal chamber with the feedback system; the manipulation of the pressure inside the module based on protocols or physiological signals; the combination of hyperbaric treatment with PDT at very close range; the combination of drugs and photosensitizorsto work together on a contained area of interest on the anatomy; and to allow for various frequencies (wavelengths) of PDT to be applied to the same patient, at the same treatment session, on the same platform.

Numerous alternatives and modifications within the scope of the appended claims will be readily appreciated by those skilled in the art.

Claims

Claims 1. A topical isolation module comprising: a gas impermeable shell having a wall and defining a substantially closed internal chamber, the wall having an opening therethrough that communicates with the internal chamber, and the chamber being arranged to cover an external portion of a user's body to be treated; sealing means provided along the perimeter of the opening, which are arranged to seal the shell to the user's body about the portion to be treated; gas introduction means, which are arranged to introduce one or more therapeutic gases into the substantially closed internal chamber; and a light source arranged to irradiate the portion to be treated.
2. A module as claimed in Claim 1, wherein the light source comprises one or more light emitting diodes (LEDs) and/or one or more sources of laser light.
3. A module as claimed in any preceding claim, wherein the light source emits light having a wavelength of 390 nm, 630 nm or 980 nm.
4. A module as claimed in any preceding claim, wherein an injection means is provided, which is arranged to introduce a photosensitiser and/or a medicament into the closed internal chamber.
5. A module as claimed in any preceding claim, wherein the shell is custom moulded to the user's body.
6. A wound management apparatus comprising a topical isolation module as defined in any preceding claim, at least one gas source, and a control unit, wherein the control unit is arranged to control the light source, and/or to control the gas pressure within the internal chamber.
7. An apparatus as claimed in Claim 6, wherein the control unit is arranged to maintain the gas pressure within the internal chamber at a pressure above atmospheric pressure.
8. An apparatus as claimed in Claim 6 or 7, wherein the control unit is arranged to maintain the gas pressure within the internal chamber at a pressure of substantially 2 atmospheres.
9. An apparatus as claimed in any of Claims 6 to 8, wherein the topical isolation module comprises a pressure sensor that is linked to the control unit, wherein the control unit is arranged to increase the gas pressure in the closed internal chamber if it is sensed that the gas pressure has dropped below a predetermined pressure.
10. An apparatus as claimed in Claim 9, wherein the topical isolation module comprises a pressure relief valve that is linked to the control unit, wherein the control unit is arranged to reduce the gas pressure in the closed internal chamber if it is sensed that the gas pressure has reached a predetermined level.
11. An apparatus as claimed in any of Claims 6 to 10, when dependent on Claim 4, wherein the injection means is linked to the control unit.
12. An apparatus as claimed in any of Claims 6 to 11, wherein the light source comprises an array of individual light sources that are identical to one another or of different wavelengths, wherein the individual light sources of the array are arranged to be switched on/off by the control unit, such that the intensity, frequency, duration and pattern of the light from the light source is controllable by the control unit.
13. An apparatus as hereinbefore described with reference to the accompanying figures.
14. A wound management apparatus as hereinbefore described with reference to the accompanying figures.