WO2011050372A1

WO2011050372A1 - Wound management system

Info

Publication number: WO2011050372A1
Application number: PCT/ZA2010/000055
Authority: WO
Inventors: Gilbert John Bell
Original assignee: Wondermed (Pty) Ltd
Priority date: 2009-09-18
Filing date: 2010-09-20
Publication date: 2011-04-28

Abstract

A wound management system adapted to deliver, concurrently, to a patient undergoing treatment, an irrigation fluid and a pressure fluid constituted by a pressurised gas, the system comprising a housing including a support structure and an irrigation fluid reservoir supported within the housing and a pressure fluid source; a hand-holdable fluid dispensing device adapted for connection to the housing by means of at least one conduit; one or more conduits adapted to connect the pressure fluid source and the irrigation fluid reservoir to the fluid dispensing device; a master flow control mechanism adapted to control the supply pressure and volume of the pressure fluid and the supply pressure and volume of the irrigation fluid from the pressure fluid source and the irrigation fluid reservoir respectively; and the fluid dispensing device being constituted by one of a plurality of nozzle assemblies, each of which comprises a dispensing nozzle adapted to convey and apply the pressure fluid and the irrigation fluid to the patient, concurrently, in a jet in which the fluids are combined.

Description

WOUND MANAGEMENT SYSTEM

Field of the invention

[001] This invention relates to medical apparatus.

[002] In particular the invention relates to medical apparatus in the form of a wound management system adapted for use in the treatment of wounds by means of wound irrigation, lavage and debridement techniques and near-wound skin massage techniques.

Background to the invention

[003] The wound management system of the invention provides a means for delivering fluids to a wound site by means of a variety of fluid applicator nozzles.

[004] In addition to using isotonic saline, which is the most commonly used wound irrigation fluid, the wound management system of the invention is adapted to use ozonated water and the invention includes an ozone generator for use in the wound management system.

[005] The wound management system is intended for use in the management of open wounds, including burns, road and tar abrasions, but it can also be used with an air massage jet that is adapted to use the pulsed, intermittent positive pressure provided by the wound management system to implement massage treatment procedures intended to treat the symptoms of peripheral vascular disease, prevent bedsores, reduce neuropathy and accelerate healing of diabetic ulcers and similar wounds.

[006] It is now universally accepted that proper wound management requires, in and around the wound, a clean, sterile and optimized environment for healing, including good oxygenation, nutrition and vascular flow. Many wounds are compromised as a result of traumatic injury or from infection superimposed by or on underlying disease processes that renders the body incapable of dealing with wound tissue compromise and microbial load.

[007] Wound management by cleansing with the use of lavage techniques is well-known.

[008] The terms "irrigation", "lavage" and "debridement" are used in wound management to describe the actions taken to remove debris, surface pathogens and wound tissue (preferably only non-viable tissue) from the wound. The terms are frequently used interchangeably since the techniques and processes involved tend to blend from one form of treatment into the next.

[009] For the sake of clarity, however, the terms will be given specific meanings in this specification as follows.

[0010] In wound management or wound cleansing, the term "irrigation" is generally (but not exclusively) used to refer to all forms of wound treatment using spray technology (including lavage and debridement) in which liquids, typically saline water solutions, but which might include topically applied liquids, ointments, gels or a combination thereof, are applied to the wound as cleansing fluids or irrigants. The term "irrigation" will be used in such a general, inclusive sense in this specification.

[0011] Irrigation processes normally involve the steps of selecting an irrigating solution (or irrigant) and a mechanical means for delivering that solution to the wound. Isotonic saline is the most commonly used irrigant, followed by antibiotic preparations and surfactants (in liquid, ointment or gel form) on their own or in combination with a saline solution or sometimes simply with water.

[0012] Simple irrigation-type wound treatment devices include pour- or squeeze bottles, bulb- and piston syringes and hose pipes with various jets, but normally using rose jets. More complex irrigation devices and apparatus are available that make use of pressurised irrigant fluids, either as a continuous stream (constant stream irrigation) or intermittent or pulsed stream irrigation.

[0013] Lavage is a specific form of irrigation and the term is sometimes used to refer exclusively to wound cleansing processes that involve the application of liquids under relatively low pressure.

[0014] Often however, the term "lavage" is used to refer to wound cleansing processes that involve the application of a pressure fluid stream, under pressures that extend from normal to high. The pressure fluid stream is applied to the wound to remove debris, surface pathogens and wound tissue (preferably only non-viable tissue) from the wound. The term "lavage" will be used in such a general, non-exclusive sense in this specification, unless the context clearly indicates otherwise.

[0015] As regards "normal pressure", the USA Agency for Health Care Policy and Research (AHCPR), following Bergstrom et al - Treatment of Pressure . Ulcers: AHCPR Clinical Practice Guideline No. 15, recommends irrigation pressures ranging from 28 kPa to 103 kPa (4 to 15 psi) and this pressure range will be referred to in this specification as "normal pressure".

[0016] The term "debridement" is generally used to describe more aggressive, potentially intrusive wound treatment techniques. Debridement techniques and devices are used to remove dead tissue and foreign matter from a wound, often by excision of contaminates and non-viable tissue, making debridement a potentially invasive or even surgical technique. The term "debridement" will be used in such a sense in this specification. Debridement processes commonly include the use of mechanical devices (cutting, scraping and scrubbing instruments) to remove more persistently adherent material from a wound.

[0017] Debridement can also be achieved without mechanical devices, with the use of aggressive lavage, which typically involves the application of higher fluid pressures.

[0018] At a certain fluid application or fluid/tissue impact pressure (substantially greater than normal pressure), it becomes necessary to refer to the techniques involved as surgical techniques. Whether the fluid stream is pulsed (for instance the Interpulse™ system supplied by Stryker Corporation, Inc.) or steady-stream (for instance the VERSAJET™ system supplied by Smith & Nephew), these devices (and devices like them) are adapted to achieve surgical or near-surgical wound debridement. In most cases the devices are used to remove dead tissue and foreign matter from a wound by excision of contaminates and non-viable tissue. The VERSAJET™ system, for instance, is described, in the suppliers' marketing material and technical specifications as a hydrosurgery system that uses pressurized, steady stream jets of sterile fluid to cut, ablate and remove tissue and foreign matter from wounds, allowing a surgeon to excise and evacuate non-viable tissue and contaminates.

[0019] Where the pressurised fluid is supplied as an intermittent (pulsed) stream, the technique is referred to as pulsed lavage, pulsatile lavage or, depending on the fluid operating pressure, high pressure pulsatile lavage (HPPL).

[0020] Since the wound management system of this invention is adapted to implement lavage techniques to achieve non-invasive debridement at relatively low pressures (within or not exceedingly greater than the normal pressure range of 28 to 103 kPa recommended by the AHCPR), it is necessary, in this specification, to differentiate between such low pressure lavage, which will be referred to as "low intensity lavage" and high intensity lavage, which will be referred to as "high pressure lavage", "high intensity lavage" or "invasive lavage", since these techniques are intended to achieve more conventional, invasive debridement.

[0021] There is a body of research evidence pointing to the fact that high- pressure lavage might disseminate contaminants to surrounding tissue and it is generally accepted that low intensity lavage is the safest, most efficacious wound treatment, provided the operating pressures fall within or do not greatly exceed the AHCPR guideline pressures (between 4 and 15 psi) - Pulsed Lavage in Wound Cleansing - Kathleen A Luedtke-Hoffmann (PT, MBA - School of Physical Therapy, Texas Woman's University); D S Schafer (PT, PhD, Associate Dean for the School of Physical Therapy, Texas Woman's University, Dallas - Physical Therapy Journal - PHYS THER; Vol. 80, No. 3, March 2000.

[0022] It is an object of this invention to provide a wound management system that may be used to implement one or more of the lavage techniques described and defined above. [0023] It is a further object of this invention to provide a wound management system that may be used to implement one or more of the lavage techniques described and defined above to perform low intensity lavage and also to perform debridement at relatively low operating pressures (pressures that do not greatly exceed the AHCPR recommend irrigation pressures).

[0024] It is yet a further object of this invention to provide an ozone generator adapted for inclusion in the wound management system by means of which ozonated water may be generated and supplied in-line for use as an irrigant fluid.

[0025] It is yet a further object of this invention to provide an air massage jet that is adapted for inclusion in the wound management system and by means of which the wound management system may be used to implement on-wound and near-wound massage treatment.

Summary of the invention

[0026] This invention provides a wound management system adapted to deliver, concurrently, to a patient undergoing treatment, an irrigation fluid and a pressure fluid constituted by a pressurised gas, the system comprising: a housing including a support structure and an irrigation fluid reservoir supported within the housing and a pressure fluid source; a hand-holdable fluid dispensing device adapted for connection to the housing by means of at least one conduit; one or more conduits adapted to connect the pressure fluid source and the irrigation fluid reservoir to the fluid dispensing device; a master flow control mechanism adapted to control the supply pressure and volume of the pressure fluid and the supply pressure and volume of the irrigation fluid from the pressure fluid source and the irrigation fluid reservoir respectively; and the fluid dispensing device being constituted by one of a plurality of nozzle assemblies, each of which comprises a dispensing nozzle adapted to convey and apply the pressure fluid and the irrigation fluid to the patient, concurrently, in a jet in which the fluids are combined.

[0027] The housing is preferably a mobile cabinet adapted for connection to a pressure fluid source by means of pressure hoses or the like.

[0028] The pressure fluid is preferably a gas, filtered compressed air being preferred.

[0029] The hand-holdable fluid dispensing device may conveniently be one of a plurality of nozzle assemblies, each comprising a dispensing nozzle and a body that is preferably ergonomically designed to serve as a manually manipulate grip.

[0030] The or at least some of the nozzle assemblies may be provided with one or more control valves by means of which the flow of fluids through the nozzle assembly may be controlled separately of the master flow control.

[0031] The or at least some of the nozzle assemblies may be adapted to operate with a plurality of interchangeable dispensing nozzles.

[0032] The irrigation fluids are preferably liquids and may comprise conventional solutions such as saline solution or a purified water based cleansing solution. [0033] In the preferred form of the invention however, the irrigation fluid is ozonated water, the system including a water ozonator comprising: a sealed container including inlets for un-ozonated water and ozonated oxygen; at least one outlet for ozonated water that is adapted for connection to a point of use constituted by a fluid dispensing device; a gas vent by means of which off-gas, including excess ozonated oxygen, may be vented from the container; and the ozonator including a porous sparger connected to the ozonated oxygen inlet and located at an operationally low point of the container; the sparger being adapted to diffuse ozonated oxygen supplied into the container into the water in the container, in use, as a finely dispersed mass of gas bubbles.

[0034] The sparger is preferably a porous element constituted by a frit (or fritted glass) element disposed across the bottom of the container, the sparger forming part of a sparger assembly comprising: a hollow glass stem connected to the ozonated gas inlet at its one end and at its other into the frit sparger; the sparger being secured within and closing off the upper end of a circular glass cup; the plan outline shape of the cup and sparger being complemental to the internal cross-sectional shape of the container; and the frit glass sparger disc being spaced apart from the base of the cup and the space between the underside of the sparger and the bottom of the cup to define a plenum in the cup within which, in use, ozonated oxygen may be supplied to substantially the entire sparger undersurface, thereby to ensure release of the gas through the sparger over substantially the entire cross-sectional area of the glass cup and container.

[0035] In the preferred form of the invention, the container is right circular cylindrical in shape and the sparger assembly is round and complemental to the interior dimensions of the cylindrical container.

[0036] The oxygen supplied to the ozone generator may be drawn from an oxygen supply, such as medical grade oxygen drawn from a hospital or clinic supply, or the ozone generator may be adapted to generate ozone from compressed air. The generation of ozone from ambient air gives rise to the production of nitrogen oxides as a by-product and it is therefore preferred to use a pure oxygen supply if it is available.

[0037] To this end the ozonator of the invention is preferably provided with means to connect the off-gas vent to an off-gas scavenging and destruction system that draws the off-gas (including unused ozone) through an activated charcoal filter before discharging to atmosphere.

[0038] The container may be un-pressurised, in which event the gas vent may be essentially unobstructed but for conduits attached thereto by means of which off-gas vented from the gas vent may be discharged remotely of the ozonator.

[0039] Alternatively, the container may be pressurised, in which event the ozonated oxygen supply and the off-gas outlet vent are valve-controlled and control means is provided to co-ordinate the opening and closing of the gas inlet and outlet valves.

[0040] In addition, the water inlet and the excess water outlet may be valve- controlled, with control means being provided to co-ordinate the opening and closing of the water inlet and outlet valves.

[0041] In each case the control means is adapted to operate the valves to prevent the internal container pressure forcing water back up through the ozonated gas inlet and conduit into the corona discharge tube of the ozone generator, where water ingress could cause electrical faults.

[0042] The ozonator may be adapted for operation as a batch producer of ozonated water, to which end the ozonator may conveniently be provided with control valves and a switch mechanism adapted for operation to feed a quantity of water into the container and then to switch on the ozonated oxygen supply to ozonate the water in the container.

[0043] As described above, the irrigation fluid may be a saline solution or ozonated water, but the system may also adapted to apply, as irrigants, supplemental irrigants or as additives to the irrigants, a wide range of topical creams or liquids with different viscosities, including topical antibiotics, anti- bacterials, antiseptics, alginates and gels that are used for the treatment of wounds generally, the system housing or cabinet being fitted with sterile, hermetically sealed reservoirs appropriate to the substance to be applied and the reservoirs being connected to the fluid dispensing device by means of appropriate conduits.

[0044] The master controller preferably means to control an adjustable fluid pressure oscillator or oscillators that are adapted to act on either or both the pressure fluid supply and the irrigation fluid supply, the oscillator being adjustable, by means of the master control, to obtain a variety of pulse settings.

[0045] In one form of this embodiment of the invention, the oscillator may be adapted to pulse a pneumatic valve connected in-line in the pressure fluid supply between the open (or partly open) and closed (or partly closed) positions of the valve, thereby to pulse the pressure fluid supplied to the fluid dispensing device.

[0046] Alternatively, the oscillator may be simply pulse a pump adapted to pump irrigation fluid to the fluid dispensing device.

[0047] In a further alterative embodiment, the oscillator may be adapted to pulse a fluid valve connected in-line in the irrigation fluid supply between the open (or partly open) and closed (or partly closed) positions of the valve, thereby to pulse the irrigation fluid supplied to the fluid dispensing device.

[0048] The same oscillator may be used to pulse both the pressure fluid and the irrigation fluid.

[0049] In the preferred form of this embodiment of the invention, the wound management system of the invention includes a fluid dispensing device constituted by a hand-holdable fluid massage jet comprising: a substantially ball-shaped body, the exterior of which is dimensioned for manual manipulation; and a domed diaphragm that is adapted to define a part of the body surface and to constitute, in co-operation with the body, a variable volume chamber that is adapted to receive and discharge the pressure fluid through one or more nozzle outlets formed in the diaphragm; the diaphragm being flexible and adapted to vibrate upon the passage therethrough of the pressure fluid in use.

[0050] The diaphragm is essentially a vibrating massage head.

[0051] The massage jet body is preferably substantially hollow and formed with a cavity within which the domed diaphragm is mounted to close the cavity, the diaphragm being constituted by an enclosed, externally domed insert that is adapted for mounting on the massage jet body to close the body cavity, the diaphragm insert and the body together defining an enclosed chamber, the internally facing surface of which is formed with one or more inlets for the pressure fluid and the externally facing surface of which is formed with one or more pressure fluid nozzle outlets by means of which pressure fluid supplied to the interior of the diaphragm chamber may be discharged.

[0052] The fluid massage jet is preferably provided with a number of different, interchangeable diaphragms. The diaphragms may have differing degrees of hardness and differing pressure fluid outlets to provided differing massage effects.

[0053] The pressure fluid is preferably compressed air and the fluid massage jet may conveniently be adapted to operate with one or more massage oils entrained in the air stream in the wound management system upstream of the fluid massage jet.

[0054] The fluid massage jet of the invention may be used to provide massage treatments similar to tapotement, a massage technique conventionally executed with cupped hands, fingers or the edge of the hand with short, alternating taps to the patient.

[0055] The invention includes a method for the treatment of wounds in an animal or human body using a wound management system such as that described above.

[0056] The method may include the steps of applying a conventional irrigant solution such as saline solution or a purified water based cleansing solution to the wound, but in the preferred form of the invention, using a system including a water ozonating device and an ozonated water reservoir within the system housing or cabinet, the method may conveniently comprise the specific step of applying ozonated water as an irrigating fluid to the wound.

[0057] The method may further comprise the steps of applying to the wound, a wide range of topical creams or liquids with different viscosities, including topical antibiotics, anti-bacterials, antiseptics, alginates and gels that are used for the treatment of wounds generally, the system housing or cabinet being fitted with reservoirs appropriate to the substance to be applied.

[0058] The method of the invention may be specifically adapted for the treatment of wounds by means of lavage or debridement, using any one of a number of irrigant and pressure fluid supply hoses, each terminated in one or more interchangeable nozzles.

[0059] For instance, at predetermined fluid pressure settings of the wound management system (none of which exceed normal pressure), the method of the invention can be used to implement debridement techniques to agitate, ablate and evacuate non-viable tissue, necrotic tissue, contaminates and foreign matter from the wound. [0060] In the form of the invention in which the system master controller includes an adjustable fluid pressure oscillator on an irrigation fluid supply, the method of the invention may conveniently include the steps of adjusting the oscillator to obtain one of a number of fluid pressure pulse settings and applying the irrigation fluid with pulsed, intermittent positive pressure to debride the wound.

[0061] In the form of the invention in which the system master controller includes an adjustable fluid pressure oscillator on an pressure fluid supply, the method of the invention may conveniently include the steps of adjusting the oscillator to obtain one of a number of pressure pulse settings and applying the pressure fluid, with or without intermittent positive pressure to provide one of a number of massage treatments.

Brief Description of the drawings

[0062] The invention will be further described with reference to the accompanying drawings in which:

Figure 1 is an isometric view of a wound management system according to the invention;

Figure 2 is a front elevation of the wound management system of Figure 1 with the door of the cabinet open to reveal the system of reservoirs and hoses (fluid supply conduits) forming a part of the wound management system; and

Figure 3 is a side elevation of a vertical channel plate located within the system cabinet; and Figure 4 is a sectional side elevation through the channel plate of Figure 3 showing the hose management system of the system of the invention;

Figure 5 is a diagrammatic sectional side elevation of an ozone reservoir according to this invention

Figure 6 is a diagrammatic side elevation of an air massage jet according to this invention; and

Figure 7 is a diagrammatic sectional side elevation of the air massage jet of Figure 6.

Description of embodiments of the invention

[0063] The wound management system of the invention rely largely on filtered, pressurised gas (preferably compressed air), alone or in combination with one or more irrigation fluids or irrigants.

[0064] The gas pressure (and therefore the application pressure of the irrigants) is deliberately kept to relatively low operating pressures (not greatly in excess of the normal, AHCPR recommend irrigation pressures - 28 kPa to 103 kPa (4 to 15 psi) to achieve low intensity lavage and debridement.

[0065] The added advantage of such a low intensity system is that it can be used to perform a variety of massage techniques as well.

[0066] The wound management system 10 by means of which these treatments is implemented consists of a housing in the form of a cabinet 12 mounted on casters 14. The cabinet 12 houses a fluid reservoir support structure in the form of a vertical channel plate 16 (visible in Figure 2 and illustrated in more detail in Figures 3 and 4). The channel plate 16 is provided with cross bars 18 with hooked ends that hook and bolt onto corresponding brackets (not shown) disposed internally of the cabinet 12.

[0067] The system 10 is driven by externally supplied filtered, compressed air, whether from the hospital or clinic compressed air supply or from a compressor supplied with the system 10. To enhance sterility, the wound management system 10 is provided with its own supplied air filtration system, using a sub-micron filter (a filter with a pore size less than 1 μιτι and preferably around 0.003 μηι). The cabinet 12 is provided with a suitable compressed air supply coupling for this purpose into which the terminal coupling of a compressed air supply hose from an external compressed air supply (not shown), is plugged to connect the cabinet to the compressed air supply.

[0068] The system is managed from a control console 20 that includes a number of switches and dials by means of which the various functions of the system 10 may be controlled. The control console 20 constitutes the front-end of a control system (not shown) that includes a a plurality of microcontrollers that provide the control system with the on-board intelligence necessary to implement and control the various functions of the wound management system 10.

[0069] Within the cabinet 12 (as can be seen from Figure 2) the wound management system 10 includes a number of refillable supply reservoirs 22 for irrigation fluids or irrigants.

[0070] The basic irrigants used in the system 10 are ozonated water and isotonic saline, which is the most commonly used irrigant in wound management systems such as this. Saline is supplied by way of a conventional saline solution bottle. For this purpose, the wound management system 10 includes an initially sterile saline bottle cap (not shown) that is adapted to fit a standard saline bottle, the cap including a breather tube that allows one-time installation of the saline bottle and that dispenses with the need to decant the saline solution for purposes of treatment, thereby contributing to the sterility of the treatment.

[0071] The wound management system 10 includes heater means (not shown) to heat the saline solution. Since it is counterproductive to heat ozonated water, heated saline will be used to alternate with (relatively colder) ozonated water treatments, thereby to avoid possible patient hypothermia.

[0072] The reservoirs 22 could also be used to contain and supply antibiotic preparations, topical creams and surfactants with varying viscosities, whether in liquid, ointment or gel form, on their own or in combination with a saline solution or simply with water. In doing so, the system 10 can deliver a range of topical creams, applied according to the required coverage or thickness in a fraction of the time required for manual applications. This includes topical antibiotics, anti- bacterials, antiseptics, alginates and gels that are used for the treatment of wounds generally.

[0073] The system 10 includes one or more heating elements (not shown) by means of which the irrigants other than ozonated water and preferably also the compressed air may be heated before application thereof to a patient.

[0074] The system 10 can work with conventional saline solutions, but ozonated water has a superior cleansing ability and ozonated water is therefore the preferred disinfectant irrigant for use with the wound management system 10. [0075] Ozone cannot be stored and transported like other industrial gases because it quickly decays into diatomic oxygen and must therefore be produced on site. To this end, the system 10 is fitted with an on-board water ozonating system.

[0076] The ozone generator used in the system 10 can be any conventional medical grade ozone generator.

[0077] From the ozone generator, the ozone-rich air is fed to a reservoir 24 containing a predetermined quantity of filtered water. The ozone-rich air is bubbled through the filtered water in the reservoir 24 to produce a predetermined quantity of ozonated water that is then stored in the reservoir 24 for immediate use. It has been shown that ozone in water kills viruses more than 3,000 times faster than an equivalent quantity of chlorine, with a disinfection efficiency of 99.9%, given a retention time of less than a minute (57 seconds).

[0078] The ozone production system is described in more detail below.

[0079] Besides the compressed air supply hose, the system 10 uses a number of irrigant and gas output hoses 26, each connected or connectable to a reservoir 22, 24. The hoses 26 are fed through hose apertures 27 formed in the top of the cabinet 12. Each hose 26 is terminated in a connector for a fluid dispensing device in the form of a nozzle or jet assembly (not shown).

[0080] The nozzle assemblies are each constituted by a hand-holdable fluid dispensing device comprising a body adapted for manual manipulation and a dispensing nozzle.

[0081] The system 10 includes a hose management system, as illustrated in Figures 3 and 4 that allows full extension and retractability of the output hoses 26 in use.

[0082] The hoses 26 are each connected or connectable to the reservoirs 22 by means of one or more manifolds 28 and non-return valves, one of which (29) is illustrated in Figure 3. The non-return valve 29 is typical, being connected in-line in a cream or lotion supply line where it serves to prevent blow-back of cream into the system, the cream reservoir 22.1 and supply line being pressurised to obviate the need for priming of the cream supply line.

[0083] Each hose is then fed over an upper pulley 30 and a lower pulley 32 arranged on common upper (34) and lower (36) pulley axles. The upper pulley axle 34 is fixedly mounted at the top of the channel plate 16. The lower pulley axle 36 is free-floating, but restrained by a series of tension springs 38 connected, at their one end, to the lower pulley axle 36 and, at their other end, to a bar 40 transversely mounted at the lower end of the channel 16. The springs tend to draw the lower pulleys 34 downwardly into the channel plate 16, thereby acting to reel in and retract the hoses 26 once they have been extended in use.

[0084] Some of the nozzle assemblies are provided with one or more control valves by means of which the flow of fluids through the nozzle assembly may be controlled and

[0085] In addition, some of the nozzle assemblies are adapted to operate with a plurality of interchangeable dispensing nozzles.

[0086] The control console 20 serves as a master flow control mechanism by means of which a large number of treatment regimes may be implemented using the system 10. In a wound management system 10 with appropriate programmable logic, one or more of these treatment regimes may be stored as programs in memory in the control console microcontrollers.

[0087] Using the control console, the clinician may treat a patient, with full manual control of every aspect of the treatment - from compressed air supply pressure; to irrigant type; to irrigant pressure and more.

[0088] In the event that the wound management system 10 has treatment regimes stored as programs in memory in the control console microcontrollers, the clinician will nevertheless be given the option of manually overriding every program of the control console. Alternatively, the clinician may choose to invoke one of the complete treatment regimes stored in memory in the control console. It will also be possible to invoke a treatment regime and to part- override the programmed regime.

[0089] The control console 20 or master controller includes means to control an adjustable pressure oscillator (not shown) in the irrigation fluid supply line by means of which the irrigation fluid supply pressure may be oscillated or pulsed.

[0090] The same or a separate oscillator is also connected in-line in the compressed air supply. The or each oscillator is infinitely adjustable to obtain a variety of pressure and pulse settings.

[0091] The wound management system 10 is intended for use in the management of open wounds, including burns, road and tar abrasions and diabetic or other ulcers. The system 10 produces a high volume, low impact pressure irrigant mist. The irrigant mist can be produced using a conventional saline solution, but as indicated above, ozonated water with its superior cleansing ability, is the preferred irrigant. [0092] Using the adjustable oscillator on the irrigant supply line and with the system 10 in this debrider mode, the application pressure of the irrigant mist to the wound can be adjusted to obtain a variety of pressure pulse or "jack- hammer" settings to provide a means of non-invasive wound agitation.

[0093] The wound management system 10 permits of a number of pressure pulse setting mechanisms. For instance, pump settings for the pressure fluid (gas or compressed air) and the irrigant fluids may be adjustable, in the latter case by varying either or both the pump stroke rate and length. In addition, the oscillator mechanism described above can be adjusted. The clinician can also use one of a number of different nozzle assemblies as well as nozzles with adjustable outlet settings to adjust the volume of irrigant and pressure fluid applied to the wound.

[0094] The intermittent positive pressure of the irrigant supply pulses can be used with different degrees of aggression, depending upon the requirements for specific wounds. In many cases this will avoid the need for hard (mechanical) debridement, anaesthesia and theatre admission. This will be of advantage to treatment centres, such as rural clinics in Africa, where access to these facilities is non-existent or difficult at best.

[0095] The use of concurrently supplied compressed air permits the installation of this agitation mechanism and this constitutes the key differential between the wound management system 10 and known fluid-only wound debridement systems.

[0096] Where these known systems do make use of gas- or air nozzles at the wound site, they make use of a variety of aspiration techniques in which venturi- or other vacuum nozzle systems draw spent irrigant and ablated tissue remains away from the wound site. A number of these devices use irrigant fluids that are supplied at surgically high pressures to cut, ablate or remove tissue surgically from the wound. All of these systems and techniques are essentially invasive.

[0097] It is critical, in wound management, to ensure that any treatment lifts and removes contaminates with no or very limited damage to viable tissue. The wound management system 10 complies with this requirement by limiting the operating pressures of the system 10 to pressures within or not exceedingly greater than the normal pressure range of 28 to 103 kPa recommended by the AHCPR.

[0098] In this regard, most studies use the Bernoulli equation to convert output pressure from the device or nozzle in use, to impact pressure on the wound surface. The applicant has conducted studies measuring the actual wound impact pressures, where pressures are sufficient to be recordable, using sensor needles placed under the skin, anemometers and differential pressure manometers. All the pressures recorded, including peak pulse pressures during agitation treatment as described below, were well within the normal pressure range.

[0099] The use of lower pressures has the added advantage of minimising the aerosolisation of hazardous substances and pathogens, such as may arise from atomisation and overspray when dealing with infected wound tissue.

[00100] In addition, the use of lower pressures reduces the risk of dissemination of particulate matter or bacteria through or from the wound to surrounding healthy tissue.

[00101] At all fluid pressure settings of the wound management system 10 (none of which exceed normal pressure), the system can be used to implement debridement techniques to agitate, ablate and evacuate contaminates such as non-viable tissue, necrotic tissue and foreign matter from the wound, as well as to remove debris, surface pathogens, non-viable wound tissue, dressings and dressing remnants, including dressings adhering to strike-through bleeding and scabs.

[00102] Since no high pressure fluid application is involved, even the debridement techniques offered by the wound management system 10 are essentially soft debridement

[00103] In combination, the use of ozone and soft debridement, as practised with the use of the wound management system 10 of the invention, lead to a substantial reduction of damage to healthy tissue, the use of ozone causing substantially less tissue damage, particularly compared to disinfectants like hydrogen peroxide and chlorine.

[00104] Studies conducted by the applicant have demonstrated that the use of the wound management system of the invention leads to a demonstrated reduction in pain for the patient.

[00105] Using the adjustable oscillator on the compressed air supply line to provide pulsed pressurised air, the wound management system can be used to provide a variety of massage treatments.

[00106] To do this, the system includes a number of nozzle assemblies (not shown) that are adapted to use the pulsed, intermittent positive pressure to implement massage treatment procedures intended to treat the symptoms of peripheral vascular disease, prevent bedsores, reduce neuropathy and accelerate healing of diabetic ulcers and similar wounds. [00107] The wound management system 10 can be set, using the appropriate nozzle, to apply a high volume, low impact pressure mist spray onto the wound to create an evaporative local anaesthetizing effect, which is particularly important in the treatment of child burn victims. The irrigant is not cooled in this treatment and both the pressurised gas (normally compressed air) and the liquid (typically saline solution) are preferably heated to the desired temperature to minimise contact cooling of the wound surface whilst nevertheless enhancing evaporative cooling of the air immediately adjacent the wound to ensure proper cleansing with little or no discomfort.

[00108] When this treatment is applied using heated, compressed air only, the wound can be dried. This facility is useful where large wounds have been cooled during the irrigation process after which a broad, flat nozzle may be used to apply a high volume of air, warmed to the desired temperature and applied with imperceptible impact pressure to provide increased patient comfort and prevent hypothermia.

[00109] The system 10 includes a slide mounted disinfectant box 42 that may be mounted and removed slidably to the top of the cabinet 12 on a slide bar 44. The disinfectant box is simply an autoclavable box that, in use, will contain a quantity of disinfectant and in which re-usable components of the system used during treatment, such as detachable nozzles and nozzle assemblies, may be stored pending autoclaving thereof.

[00110] Figure 5 illustrates a water ozonator 110 for use in the wound management system 10.

[00111] Ozone (O₃) is an allotrope of oxygen that is much less stable than the normal diatomic form of oxygen (O₂), which makes ozone a powerful oxidizing agent and disinfectant. [00112] Unlike saline, which rinses away rather than destroys viruses, bacteria and other pathogens, ozonated water destroys such pathogens completely and efficiently - many times more efficiently and with less collateral damage than conventional oxidising agents, such as chlorine or hydrogen peroxide. As regards the latter, even though peroxide is a by-product of many human metabolic processes, it is nevertheless harmful and to prevent tissue damage it must be rapidly converted into less dangerous substances. To this end, catalase, a common enzyme found in nearly all living creatures functions to catalyze the decomposition of the hydrogen peroxide to water and oxygen, but in the presence of the high volume of hydrogen peroxide typically used in wound irrigation, catalase levels can become depleted and damage can occur to otherwise healthy cells.

[00113] Ozone does not suffer from such a disadvantage. In addition, it can be manufactured within the system 10 at a fraction of the cost of saline. Ozone cannot be stored and transported like other industrial gases because it quickly decays into diatomic oxygen and must therefore be produced on site. To this end, the system 10 is fitted with an on-board water ozonating system in the form of the water ozonator 110 illustrated in Figure 5.

[00114] The ozone generator that is used to supply the ozonator 110 with ozone, is a conventional medical grade ozone generator and for this reason is not illustrated.

[00115] The ozone generator generates ozone from pure oxygen obtained from a hospital or clinic oxygen supply or, if pure oxygen is not available, oxygen can be obtained from the compressed air drawn from the system compressed air supply. Since ambient air-derived ozone also yields off-gas byproducts, such as nitrogen oxides, it is preferred to use a pure oxygen supply if it is available. The system 110 is nevertheless fitted with an off-gas scavenging and destruction system which is described in more detail below.

[00116] Gas flow (whether oxygen or air) through the ozone generator is governed by means of a flow regulator (not shown).

[00117] The water ozonator 110 comprises a sealed container 112 of stainless steel which is shown in Figure 5 in its operationally correct, upright position.

[00118] The ozonator 110 includes a water system and a gas system.

[00119] The water system includes an inlet 114 by means of which filtered, un-ozonated water is fed into the container 112 and a pair of outlets 118, 1120 by means of which ozonated water is delivered from the container. The outlets 118, 1120 are fitted with connector fittings by means of which the outlets 118, 1120 are connected to ozone-using appliances, such as treatment nozzles at a point of use or treatment.

[00120] The first outlet fitting 118 is positioned at the base of the container 112 and feeds a treatment appliance or nozzle by means of a suitable conduit (not shown in Figure 5, but which would typically be a conduit 26 supplying the fluid dispensing device by way of the connectors included in the housing 12).

[00121] The second outlet fitting 1120 is positioned on the end of a vertical tube 122 that extends deep into the container 112 and opens well below the level of ozonated water in the container in use. The second outlet 1120 feeds a treatment appliance or nozzle by means of a suitable conduit (not shown).

[00122] The gas system includes an ozonated gas inlet 116 and an off-gas outlet 124. Ozonated oxygen is fed into the container 112 from the ozone generator by way of a conduit (not shown) that connects to the ozonated gas inlet 116. The outlet 124 is a gas vent by means of which off-gas, including excess ozonated oxygen, may be vented from the container.

[00123] As stated above, the generation of ozone, particularly when it is generated from ambient air, gives rise to the production of nitrogen oxides as a by-product. To this end the vent 124 is provided with a connector by means of which a conduit can be used to connect the off-gas vent 124 to an off-gas scavenging and destruction system that uses a partial vacuum to draw the off- gas (including unused ozone) through a replaceable, activated charcoal filter before discharging to atmosphere.

[00124] The discharged off-gas stream contains no ozone, since any ozone remaining in the off gas stream will revert to the more stable diatomic form of oxygen. If desired (although this is not necessary), the discharge hose could be connected to and discharge, via a suitable hose, into the waste or atmospheric exhaust of the hospital or clinic ventilation system.

[00125] The container 112 may be un-pressurised, in which event the gas vent 124 may be essentially unobstructed.

[00126] Alternatively, the container may be pressurised, in which event the gas system will be controlled to prevent the ingress of water into the gas system.

[00127] In this case, the ozonated oxygen supply inlet 116 and the off-gas outlet vent 124 as well as the water inlet 114 and the ozonated water outlets 118, 1120 are valve-controlled by means of stainless steel valves. The wound management system 10 includes programmable logic means programmed to co-ordinate the opening and closing of the water inlet and outlet valves. In each case the control means is programmed to operate the valves to prevent the internal container pressure forcing water back up through the ozonated gas inlet 116 and conduit into the corona discharge tube of the ozone generator, where water ingress could cause electrical faults.

[00128] In addition to this valving arrangement, the gas and water conduits of the wound management system 110 are preferably configured to form Hartford recirculating loops to prevent water from the container flawing into the gas system.

[00129] Within the container 12, the ozonated oxygen or air is bubbled through the filtered water in the container 112 to produce a predetermined quantity of ozonated water that is then stored in the container for immediate use. It has been shown that ozone in water kills viruses more than 3,000 times faster than an equivalent quantity of chlorine, with a disinfection efficiency of 99.9%, given a retention time of less than a minute (57 seconds).

[00130] To introduce the ozonated air or oxygen into the water, the ozonator 110 includes a sparger assembly 126.

[00131] In chemistry and process chemistry, sparging is a technique which involves bubbling a gas through a liquid. It is normally used to remove dissolved gases from the liquid, but it can also be used to introduce gases into the liquid, as is the case in this invention.

[00132] In this instance, the sparger 126 is located at an operationally low point in the container 112 and is adapted to diffuse ozonated oxygen into the water in the container (in use) as a finely dispersed mass of gas bubbles - the finer the gas bubbles, the greater the gas take-up efficiency. [00133] The container 112 is of right circular cylindrical shape and the sparger comprises a hollow glass stem or feed tube 128 connected to the ozonated gas inlet 116 at its one end by means of a feed tube cap 130. At its other end, the feed tube 128 is secured into a frit glass sparger disc 132 that is secured horizontally within the open upper end of a circular glass cup 134.

[00134] Frit glass or fritted glass is manufactured from particles of glass which are fused, or sintered into a solid, but porous glass body, which can be sealed into glass tubing as a filter or sparger made entirely of glass.

[00135] The cup 134 is a close fit within the container, the outer diameter of the cup 34 being just smaller than the internal diameter of the container 112.

[00136] The frit glass sparger disc 132 is spaced apart from the base of the cup 134 and the space 136 between the underside of the sparger and the bottom of the cup 134 defines a plenum 136 within which, in use, ozonated oxygen may be supplied to substantially the entire sparger disc undersurface, thereby to ensure release of the gas through the sparger over substantially the entire glass cup diameter and therefore and container diameter..

[00137] The sparger 126 is fitted with neoprene foot pads to raise the outside base of the cup 134 off the floor of the container 112, so as not to impede drainage of water from the container 112 by way of the outlet 1120.

[00138] The container 112 is tall and narrow to maximise the take-up and absorption of ozone by the water in the container 112.

[00139] The ozonator is made to produce ozonated water in batches and the ozonator 110 is provided with a magneto/electric switch mechanism constituted by a float switch assembly including a tube-mounted float 136. When the float reaches a limit ring at the bottom of the tube 138, the switch mechanism opens the water inlet valve to allow filtered water to enter the container 112 via the water inlet 114. As water floods into the container 112, the float rises up the tube 138 until it reaches a limit ring 140 at which point the switch mechanism closes the water inlet valve. Only when the correct quantity of water has been fed into the container, that is when the switch mechanism closes the water inlet valve, will the gas system be activated. Upon activation of the gas system, the ozone generator switches on and ozonated gas is fed into the container by way of the ozonated gas inlet 116, the switching mechanism opening the ozonated gas inlet valve.

[00140] To determine the degree of ozonation of the water in the container, a simple timer may be used. Alternatively a probe may be used to measure the oxygen reduction potential of the water as is it being ozonated.

[00141] As a safety precaution, the wound management system programmable logic means is preferably programmed to ensure that the ozone generator will not operate if there is no water in the container 112. Other safety features may also be programmed in, for instance to ensure that the ozonator 10 will not operate when other operations are taking place that might be jeopardised by the presence of ozone.

[00142] Figures 6 and 7 illustrate a fluid massage jet that is configured as a ball massager 210.

[00143] The ball massager 210 is hand-holdable, comprising a body 212 dimensioned for manual manipulation and a massage head constituted by a flexible diaphragm 214.

[00144] The ball massager body 212 is economically designed to fit into the hand of the operator, the spherical shape being adapted to allow an operator easily to swivel the ball massager 210 within the palm of her hand. At its base, the ball massager 210 is formed with an enlarged rim 216 within which the massage head 214 is adapted to be mounted. The rim 216 is also designed to prevent the operator's hand from slipping down onto the patient while massaging.

[00145] Compressed air is supplied to the ball massager 210 by way of an air hose (not shown in Figures 6 and 7 but which, typically, will be a hose 26 routed to the ball massager 210 by way of the system housing or cabinet 12). The air hose is connected to the external port 218.1 of a two-way connector 218. The ball massager body 212 is hollow and within the hollow body, the massage head 214 is connected to an internal port 218.2 of the connector 218. The massage head includes a connecting tube 220 leading from the internal connector port 218.2 into a three-way manifold 222.

[00146] As shown in Figure 3, the massage head 214 is constituted by a biconvex externally domed insert that defines an enclosed hollow diaphragm chamber 224. The internally facing surface 226 of the massage head insert 214 is formed with a plurality of inlets 228 for compressed air, each inlet having a manifold tube 222 bonded thereto by means of a suitable adhesive. The three- way manifold 222 allows a more even pressure distribution across the back of the externally facing wall 230 of the massage head 214.

[00147] The externally facing wall 230 of the massage head 214 is formed with a plurality of outlets 232 by means of which compressed air supplied to the interior of the massage head chamber 224 may be discharged.

[00148] The massage head 214 is formed with a groove 234 about its periphery by means of which the massage head 214 may be mounted on the cavity defined by the rim 216, thereby substantially to close the massage head body cavity 222.

[00149] The ball massager 210 is preferably provided with a number of different, interchangeable massage heads 214 with differing degrees of hardness and differing compressed air outlets 232 to provided differing massage effects. To replace the massage head 214, the head is un-clipped from the rim 216 and the connection tube 220 is disconnected from the internal compressed air port 218.1. The replacement head 214 is then installed in the reverse of this procedure. The different massage heads 214 are adapted to provide different massage effects.

[00150] The massage head 214 is essentially a diaphragm that is adapted to vibrate when compressed air is fed through the diaphragm chamber 224. The vibration effect is enhanced when the the massage head 214 is subject to intermittent air pressure, provided by the wound management system.

[00151] The wound management system master controller is used to adjust the pressure oscillator in the compressed air supply line by means of which the compressed air supply pressure is oscillated or pulsed. The oscillator is infinitely adjustable to obtain a variety of pressure and pulse settings.

[00152] Using the oscillator facility of the wound management system 10, the ball massager 210 can be used to provide massage treatments very similar to tapoutment or tapotement, a Swedish massage technique recognised by the American Massage Therapy Association. Conventional tapotement is executed with cupped hands, fingers or the edge of the hand with short, alternating (almost drumming) taps to the patient.

[00153] This treatment can be mimicked using the ball massager and a pulsed, oscillating pressurised air supply. The treatment improves subcutaneous circulation and blood flow and reduces oedema, which is especially useful for post mastectomy and other conditions of lymph damage, neuropathy in diabetic limbs and to prevent pressure ulcers.

Claims

1. A wound management system adapted to deliver, concurrently, to a patient undergoing treatment, an irrigation fluid and a pressure fluid constituted by a pressurised gas, the system comprising: a housing including a support structure and an irrigation fluid reservoir supported within the housing and a pressure fluid source; a hand-holdable fluid dispensing device adapted for connection to the housing by means of at least one conduit; one or more conduits adapted to connect the pressure fluid source and the irrigation fluid reservoir to the fluid dispensing device; a master flow control mechanism adapted to control the supply pressure and volume of the pressure fluid and the supply pressure and volume of the irrigation fluid from the pressure fluid source and the irrigation fluid reservoir respectively; and the fluid dispensing device being constituted by one of a plurality of nozzle assemblies, each of which comprises a dispensing nozzle adapted to convey and apply the pressure fluid and the irrigation fluid to the patient, concurrently, in a jet in which the fluids are combined.

2. A wound management system according to claim 1 in which the nozzle assembly includes at least one control that is adapted, separately of the system master flow control, to control the supply pressure and volume of the pressure fluid and the supply pressure and volume of the irrigation fluid from the pressure fluid source and the irrigation fluid reservoir respectively.

3. A wound management system according to either of claims 1 or 2 in which the irrigation fluid is ozonated water, the system including a water ozonator comprising: a sealed container including inlets for un-ozonated water and ozonated oxygen; at least one outlet for ozonated water that is adapted for connection to a point of use constituted by a fluid dispensing device; a gas vent by means of which off-gas, including excess ozonated oxygen, may be vented from the container; and the ozonator including a porous sparger connected to the ozonated oxygen inlet and located at an operationally low point of the container; the sparger being adapted to diffuse ozonated oxygen supplied into the container into the water in the container, in use, as a finely dispersed mass of gas bubbles.

A wound management system according to claim 3 in which the sparger is a porous element constituted by a frit (or fritted glass) element disposed across the bottom of the container, the sparger forming part of a sparger assembly comprising: a hollow glass stem connected to the ozonated gas inlet at its one end and at its other into the frit sparger; the sparger being secured within and closing off the upper end of a circular glass cup; the plan outline shape of the cup and sparger being complemental to the internal cross-sectional shape of the container; and the frit glass sparger disc being spaced apart from the base of the cup and the space between the underside of the sparger and the bottom of the cup to define a plenum in the cup within which, in use, ozonated oxygen may be supplied to substantially the entire sparger undersurface, thereby to ensure release of the gas through the sparger over substantially the entire cross-sectional area of the glass cup and container.

A wound management system according to any one of the preceding claims including an oscillator that is adjustable by means of the master controller and that is adapted to pulse a pneumatic valve connected in-line in the pressure fluid supply between the open (or partly open) and closed (or partly closed) positions of the valve, thereby to pulse the pressure fluid supplied to the fluid dispensing device.

A wound management system according to any one of the preceding claims including an oscillator that is adjustable by means of the master controller and that is adapted to pulse a pump adapted to pump irrigation fluid to the fluid dispensing device.

A wound management system according to either of claims 5 or 6 including an oscillator that is adjustable by means of the master controller and that is adapted to pulse a fluid valve connected in-line in the irrigation fluid supply between the open (or partly open) and closed (or partly closed) positions of the valve, thereby to pulse the irrigation fluid supplied to the fluid dispensing device.

A wound management system according to any one of claims 5 to 7 including a fluid dispensing device constituted by a hand-holdable fluid massage jet comprising a substantially ball-shaped body, the exterior of which is dimensioned for manual manipulation, and a domed diaphragm that is adapted to define a part of the body surface and to constitute, in co-operation with the body, a variable volume chamber that is adapted to receive and discharge the pressure fluid through one or more nozzle outlets formed in the diaphragm, which is flexible and adapted to vibrate upon the passage therethrough of the pressure fluid in use.

A wound management system according to claim 8 in which the massage jet body is substantially hollow and formed with a cavity within which the domed diaphragm is mounted to close the cavity, the diaphragm being constituted by an enclosed, externally domed insert that is adapted for mounting on the massage jet body to close the body cavity, the diaphragm insert and the body together defining an enclosed chamber, the internally facing surface of which is formed with one or more inlets for the pressure fluid and the externally facing surface of which is formed with one or more pressure fluid nozzle outlets by means of which pressure fluid supplied to the interior of the diaphragm chamber may be discharged.

10. The invention includes a method for the treatment of wounds in an animal or human body using a wound management system according to any one of the preceding claims.

11. A method of treatment according to claim 10 by means of a wound management system according to any one of claims 5 to 7, the method comprising the specific step of applying ozonated water as an irrigating fluid to the wound.

12. A method of treatment according to claim 11 by means of a wound management system according to any one of claims 8 or 9, the method comprising the specific step of adjusting the wound management system oscillator to obtain one of a number of pressure pulse settings and applying the pressure fluid to the massage jet to provide a massage treatment.