RELATED APPLICATIONS

[001] This application claims the priority of Australian Provisional Patent Application No. 2022900523 in the name of Towers Group Pty Ltd, which was filed on 4 March 2022, entitled “Apparatus, System and Method for Resuscitation in Hazardous Environments” and the specification thereof is incorporated herein by reference in its entirety and for all purposes.

FIELD OF INVENTION

[002] The present invention relates to the field of resuscitation and breathing apparatus utilised by first responders, which is primarily directed at military and/or policing application in associated threat environments. It will be convenient to hereinafter describe the invention in relation to an apparatus and system for coupling medical grade oxygen and/or filtered air for inhalation of a patient wearing a respiration mask device in a Chemical Biological Radiological and Nuclear (CBRN) environment, however it should be appreciated that the present invention is not limited to that use, only.

BACKGROUND ART

[003] Throughout this specification the use of the word “inventor” in singular form may be taken as reference to one (singular) inventor or more than one (plural) inventor of the present invention.

[004] It is to be appreciated that any discussion of documents, devices, acts or knowledge in this specification is included to explain the context of the present invention. Further, the discussion throughout this specification comes about due to the realisation of the inventor and/or the identification of certain related art problems by the inventor. Moreover, any discussion of material such as documents, devices, acts or knowledge in this specification is included to explain the context of the invention in terms of the inventor’s knowledge and experience and, accordingly, any such discussion should not be taken as an admission that any of the material forms part of the prior art base or the common general knowledge in the relevant art in Australia, or elsewhere, on or before the priority date of the disclosure and claims herein. [005] In the context of the present application and disclosure herein, the term “first responder” is to be taken as reference to personnel with specialized training that are among the first to arrive and provide assistance and/or pre-hospital care at the scene of an emergency, such as an accident, natural disaster, battle scene or terrorism event. First responders typically include law enforcement officers, paramedics, emergency medical technicians (EMT's) and firefighters. In some areas, hospital emergency department personnel and other medical personnel are also required to respond to disasters and critical situations, designating them also as first responders. Typically, the first responders envisaged to make use of embodiments of the present invention include Defence Force personnel, Police and Fire Services, Paramedical and Medical personnel, Fire Services personnel. It is also envisaged that personnel in toxic industrial environments will have use of embodiments of the present invention.

[006] More particularly, with environments and circumstances involving Chemical, Biological, Radiological and Nuclear (CBRN) threats, typical situations may involve military operations where high grade Chemical Warfare Agents (CWA) are used. The most common of those agents are as follows:

Choking agents such as, for example, chlorine and/or phosgene;

Vesicant or Blister agents such as, for example, sulphur mustard and/or mustard gas, Lewisite, and phosgene oxime;

Blood agents such as, for example, cyanide, or hydrogen cyanide; and

Nerve agents such as, for example, tabun, sarin, soman, and VX.

[007] Further material that may be considered a CWA, and which is primarily used during domestic operations, is riot control agent, namely, tear gas.

[008] Threats related to Chemical, Biological, Radiological and Nuclear (CBRN) weapons, which are commonly encompassed in the term Weapons of Mass Destruction (WMD), are evolving rapidly alongside changes in the political environment and developments in technology. The continuing threat of the use of WMD in armed conflict has, in particular, underlined the fragile nature of existing arms control agreements. The use of WMD is well recognised as a serious problem and the risk of the use of these weapons, including by terrorist groups, is recognised to be increasing by such organisations as the World Health Organisation. The ability of defence force personnel at sea, on land, and in the air to maintain operational capability before, during, and after an attack utilising CBRN weapons remains fundamental to defending sovereign interests.

[009] In life-threatening emergency, disaster, and/or attack circumstances, it is imperative that first responders are able to provide adequate life support. Resuscitation and, in particular, safe and effective ventilation of a patient is paramount in providing life support.

[0010] The capability available for providing first responders with the ability to resuscitate an outfitted patient (i.e., wearing and using an appropriate ventilation mask connected to a ventilation system) within an adverse CBRN environment without exposing the patient to noxious or toxic gases and substances by removing their protective mask is poor to non-existent.

[0011 ] In the prior art, there have been a number of attempts at providing adaptors and adaptations for interfacing a supply of air or medical gas to a patient interface or mask, as such.

[0012] An example of prior art improvements to resuscitation provided by first responders is disclosed in WO 2012/162048 (Zoll Medical Corporation) entitled “Medical Ventilation System with Ventilation Quality Feedback Unit”. Zoll discloses a manual patient ventilation unit defining an airflow path. The unit is arranged so that when it is applied to a patient, the airflow path is in fluid communication with the patient's airway. The patient ventilation unit comprises a ventilation bag (i.e., resus bag) configured to enable manual ventilation of the patient by a rescuer; an airflow sensor in the airflow path positioned to sense the presence of ventilation airflow and measure a gas flow rate in the airflow path, a pressure sensor in the airflow path positioned to sense gas pressure in the airflow path, and a processor arranged to receive data generated by the air flow sensor and the pressure sensor and determine one or more ventilation quality parameters based at least in part on a gas flow volume calculated based on the sensed gas flow rate and gas pressures. A feedback unit provides feedback to a rescuer based on the one or more ventilation quality parameters. However, such a medical ventilation system has its limitations in certain emergency and hazardous environments. In the presence of noxious or toxic gases and substances it is desirable that a medical ventilation system should include the ability for the medical ventilation system to connect to a respiration mask suitable for a CBRN environment. The system disclosed in WO 2012/162048 provides for a ventilation unit defining an airflow path which can include a handheld breathing tube or a mouthguard configured to fit between a patient’s lips and teeth or a mask that seals to and fits over the lower portion of a patient’s face. Such devices are not suitable in a CBRN environment since the seal provided between the ventilation unit and the patient does not sufficiently isolate the patient’s respiration from the noxious or toxic gases and substances likely to be present in the CBRN environment. The system disclosed in WO 2012/162048 provides no ability for any medical ventilation systems to interface with a CBRN Mask. Additionally, there is no ability to interface and provide filtered air or medical oxygen via CBRN cannister ports located on the CBRN mask.

[0013] Another example of prior art is found in US patent No. 8,707,950 (Rubin) entitled “Universal Medical Gas Delivery System”. Ruben discloses a medical gas delivery system which can be used for coupling any of a plurality of different medical gas sources to a medical gas tube leading to any of a plurality of different medical gas utilizing devices, such as facial masks. The apparatus and system disclosed are directed to medical gas delivery in hospitals, clinics, doctors’ offices, nursing homes and in home care. Specifically, Rubin discloses a first source of medical gas, for example an oxygen supply, having a generally cylindrical male outlet with a cylindrical bore and a threaded outer cylindrical surface. A flexible cylindrical elastomeric medical gas tubing has an input end with a bushing making a flush abutment with the male outlet at the output orifice of the first source of medical gas. An output end attaches to any of a plurality of medical gas utilizing devices, e.g., a facial mask, but preferably with a dampening disperser held in position in the space in the vicinity of a patient's nose and mouth. An annular flange of the input end bushing resides within a central cylindrical bored out region extending through the first end of the input and nearly to the second end of the input of a rotatable connector forming an interior surface of a connector with threads coupling with the threads of the male outlet of the first source of medical gas. The input’s second end is an annular abutment against the annular flange holding the input end tubing bushing against the outlet of the source and providing an airtight coupling. The output end of the disclosed gas delivery system utilises the same generally female connections as the input end for connection to a face mask. The system of Rubin provides no ability to deliver ventilation whilst operating in a CBRN environment as it is only designed to provide air to the patient who is not wearing a CBRN mask utilising an “over-the-nose” system. Additionally, it lacks the ability to interface with any CBRN Mask or provide filtered air/medical oxygen via CBRN cannister ports located on the CBRN mask.

[0014] Another example is found in US patent No. 9,186,474 (Rollins III), which discloses a multi-function oxygen mask comprising a mask body and a gas delivery adapter. The mask body forms an internal cavity configured to cover a nose and mouth of a patient. A nasal chamber is formed in the upper portion of the mask body, the nasal chamber includes an upper portion, a lower portion and a gas delivery adapter aperture adjacent the lower portion of the nasal chamber. An access aperture is formed through and adjacent to the lower portion of the mask body. The access aperture is configured to permit access to the mouth of a patient. The gas delivery adapter has a general tubular structure and includes a first end an opposing second end, the first end of the gas delivery adapter is coupled to the gas delivery adapter aperture. An oxygen supply port radially extends outward from the gas delivery adapter and adjacent to the first end of the gas delivery adapter. The oxygen supply port further includes an external inlet portion, an outlet portion positioned within a volumetric space of the gas delivery adapter and a diverter member adjacent to the outlet portion. The diverter member is configured to direct a flow towards the first end of the gas delivery adapter. A meter-dose inhaler port radially extends outward from the gas delivery adapter. Finally, the gas delivery adapter includes a meter-dose inhaler port and a nebulizer port. The disclosure of Rollins is directed at interchanging a multiple of treatment inputs to a patient in a multi-ported mask and adaptor. The multi-function mask of Rollins III is very similar to other oxygen masks that currently exist on the market; in that, it is only designed to cover the nose and/or, nose and mouth of the patient in a non-contaminated environment. The disclosed multi-function mask also lacks the ability to connect directly into a CBRN mask to allow for resuscitation or preservation of life.

[0015] WO 2017/049357 (Resmed Limited) entitled “Elbow Assembly” discloses medical apparatus and its use, primarily for one or more of the detection, diagnosis, treatment, prevention and amelioration of respiratory-related disorders, most particularly for treating sleep apnoea. Resmed Limited does disclose an elbow assembly for a patient interface, the elbow assembly comprising: a swivel component adapted to connect to a patient interface; and an elbow component adapted to connect to an air circuit, wherein the swivel component is coupled to the elbow component by a ball and socket joint and a hinge joint which allows the elbow component to pivot relative to the swivel component about a single axis. In described embodiments, there is an elbow assembly including a swivel component (6610) connected to a patient interface (6000) by a pair of spring arms (6650) and coupled to an elbow component (6620) by ball and socket joint and a hinge joint (6645) which allows pivoting about a single axis. Hinge joint prevents the elbow component from contacting the spring arms. Swivel component includes inner radial wall (6630) and outer radial wall (6632) defining radial channel (7633) leading to vent holes (6640) for gas washout, tracks or guide walls (7637) within the channel providing discrete flow paths to the vent holes, an inwardly extending lip or chevron (8631 ) redirects flow to reduce noise and/or minimize flow directly onto sensitive parts the face. Ball portion (6662) includes opposed recesses (6664) engaged with pivot pins (6645) on swivel component to form the hinge. The Resmed “Elbow Assembly” system was primarily designed for sleeping disorders such as Sleep Apnea and Cheyne-Stokes Respiration. Both of which are treated through the use of medical oxygen in a controlled environment or at home; not in a CBRN operational environment. The system also lacks the ability to connect directly into a CBRN mask to allow for resuscitation or preservation of life.

[0016] WO 2007/088330 (Smiths Group PLC) is directed to resuscitator arrangements and filter assemblies, per se. In general, this disclosure is directed to a resuscitator that has an NBC (Nuclear, Biological & Chemical) filter assembly connected between an outlet of the resuscitator and a patient valve coupled to a face mask or breathing tube. The filter assembly comprises a filter canister with a threaded outlet coupling and a resilient inlet fitment with a collar that seals around a projecting bead on the canister. An exhaust collector with a one-way valve is fitted over the outlet of the patient valve to prevent contamination entering the patient valve. The filter assembly disclosed is for connection to a standard (medical type) face mask, which in general terms only covers the mouth and nose. There is no solution offered for coupling a respirator to a military style mask in this disclosure. Accordingly, it should be kept in mind that when operating in a high-threat CBRN environment a full-face respirator along with a CBRN uniform is required, due to the fact that CWA agents can enter the body through inhalation, ingestion and absorption through the skin. Furthermore, the filter assembly disclosed in WO 2007/088330 requires the intermediate connection with a cannister and tubes in a respirator device. It is also noted that the filter assembly of WO 2007/088330 requires a bracket which clamps over or locks onto a cannister. If being used in an actual CBRN environment with CWA’s, this would involve a need for the bracket to be fitted to the cannister prior to deploying into a Chemical Warfare environment, which means the cannister is required to be removed from its vacuum seal packaging, the bracket fitted and then put back into a carry bag, which leaves the device now unprotected from CWA agents and creating a higher risk of contamination or exposure for the intended user. Alternatively, if the intent was to have the cannister attached to the tubes already, there are three steps to removing or replacing the cannister. This is a significant detriment as some of the CWAs listed above can degrade a cannister within 20mins, so more time is required to swap it out. [** Pini Comment:

[0017] US patent No. 11 ,253,670 (Parazynski et al.) discloses respiratory isolation and/or treatment devices and methods in which a device includes a body defining a respiration passage in fluidic communication with a filter fitting disposed on a first end of the body and a mask fitting disposed on a second end of the body, and a treatment passage in fluidic communication with the mask fitting. A treatment fitting is disposed on the body and is coupleable to a treatment source such that a seal in the treatment fitting transitions from a closed state to an open state to allow fluidic communication between the treatment source and the treatment passage. The device is configured to permit (i) inhalation air and/or exhaled breath to be drawn and/or expelled through the filter fitting, the respiration passage, and the mask fitting and (ii) a respiratory therapeutic to be drawn from the treatment source coupled to the treatment fitting, through the treatment passage, and through the mask fitting. Again, the device of Parazynski et al. is an assembly for connection to a standard (medical type) face mask, which in general terms only covers the mouth and nose. Whilst Parazynski et al. states at column 9, lines 43-46, that “In some implementations, the filter F can be a filter suitable for use in chemical, biological, radiological, and/or nuclear defense response situations (e.g., military, governmental, and/or civilian use)”, as such, this disclosure offers no solution for coupling a respirator to a military style mask.

[0018] However, the prior art examples disclosed herein and above are not suitable for use in a CBRN environment. In the presence of noxious or toxic gases and substances, it is desirable that a medical ventilation system should include the ability for the medical ventilation system to include a respiration mask suitable for a CBRN environment. The prior art devices are not suitable in a CBRN environment since the ventilation unit does not connect to a mask sufficient to isolate the patient’s respiration from the noxious or toxic gases and substances likely to be present in the CBRN environment which the invention disclosed does. [0019] Generally speaking, the prior art of note would require a complete redesign to be adapted to use in the CBRN environment due to the fact that it is not capable of using a resus bag (for example, only a nebuliser) and may still require direct O2 (carriage and use of O2 Cylinders). The masks themselves which are disclosed in the prior art will need to be removed as well as any associated ‘generic off the shelf’ plastic tubing to be replaced with useable couplers from scratch for use in the CBRN environment. Another detriment of the prior art is that it is not designed for the person that is either having respiratory issues or not breathing at all, such that it is convenient for first responder medical personnel to give either Expired Air Resuscitation (EAR) Cardiopulmonary Resuscitation within a CBRN Environment without the need for removal of a CBRN Mask and provide the patient with a supply of air every 5-6 seconds, corresponding to the average adult breathing rate, via a resus bag. By way of example, the systems disclosed in Rollins III and Rubin, above, only use O2 regulated from a cylinder with a constant flow of oxygen. In a CBRN environment, where the patient cannot remove their mask and the Saturation of Peripheral Oxygen (SP02) cannot be measured, oxygen toxicity may be of concern, and put the patient in greater harm.

[0020] Considering numerous off the shelf devices available in the prior art, none of them meet the following criteria:

• Can be utilised within a CBRN Environment

• Ability to provide pure O2 or ‘filter’ air via a hand resus bag

• Ability to provide Ear and CPR to a patient in a CBRN environment

• Lightweight and transportable (carry in a backpack)

• Can be adapted on either the left or right side of the mask.

• Does not need the use of O2 Cylinders

• Capable of being used in conjunction with military grade CBRN masks

• Capable of being used with various resuscitation bags

[0021 ] The preceding discussion of background art is intended to facilitate an understanding of the present invention only. The discussion is not an acknowledgement or admission that any of the material referred to is or was part of the common general knowledge as at the priority date of the application. SUMMARY OF INVENTION

[0022] Generally, the present invention provides a fluid coupling providing a substantially hermetically sealed fluid path for an in-situ CBRN respirator comprising: a first connector for operatively engaging an inhalation port of the in-situ CBRN respirator, a second connector adapted for engaging any one of a plurality of sources of resuscitation gas connectable to a supply of resuscitation gas, wherein a substantially hermetically sealed fluid path is formed between the supply of resuscitation gas and an internal cavity of the in-situ CBRN respirator.

[0023] In preferred embodiments, the first connector comprises a base and a collar with an intermediately disposed cover seal adapted to provide a hermetic seal when operatively connected with the in-situ CBRN respirator.

[0024] Preferably, the hermetic seal is a radially disposed seal between the inhalation port of the CBRN respirator and the second connector.

[0025] The source of resuscitation gas may comprise a resuscitation bag. Preferably, the resuscitation bag is a manual resuscitation bag. Furthermore, the source of resuscitation gas may comprise or include a filter assembly.

[0026] According to preferred embodiments, the supply of resuscitation gas comprises one or a combination of: medical grade oxygen; filtered air; fresh air; medical gas.

[0027] The in-situ respirator of preferred embodiments comprises one of: a military grade gas mask; a CBRN mask. [0028] In general, the present invention provides an interface that integrates directly with in-service CBRN masks and medical ventilating systems and provides a substantially fluid impermeable seal thereby creating a system suitable for use in CBRN environments where the capability of personnel operating in those environments to effectively deal with patient rescue and resuscitation is otherwise significantly limited. The innovative design of the CBRN Resus Coupler described herein allows all military personnel to continue to save and preserve the lives of their colleagues whilst operating within a CBRN or Toxic Industrial Chemical (TICs) environment.

[0029] According to embodiments disclosed herein there is provided a fluid coupling providing a substantially hermetically sealed fluid path for an in-situ respirator comprising: a first connector for engaging an inhalation port of the in-situ respirator, a second connector for engaging a source of resuscitation gas connectable to a supply of resuscitation gas, wherein a substantially hermetically sealed fluid path is formed between the supply of resuscitation gas and an internal cavity of the in-situ respirator.

[0030] The CBRN Resus Coupler of embodiments described herein allows soldiers and/or medical personnel to continue to supply air to a patient undergoing Cardiopulmonary Resuscitation (CPR) without having to remove their CBRN Respirator, including whilst the patient is being evacuated through a decontamination station, thus increasing the chance of survival.

[0031 ] Embodiments described herein provide interfaces that will improve the rescue and resuscitation of patients in the presence of noxious gases or toxic substances and thereby enhance the survivability of such persons including the survivability of combatants in hostile environments.

[0032] It is an objective of the present invention is to alleviate at least one disadvantage associated with the related art.

[0033] In another aspect of embodiments described herein there is provided a gripping means for the swivel connector which is chosen from physical gripping means including, but not limited to, grooves, fingertip indentations, radially protruding flanges, angled surfaces and edges, curved surfaces and edges, surface bumps and friction inducing roughened surfaces. [0034] In yet a further aspect of embodiments described herein there is provided a connection and mask interface adaption which is comprised of material chosen from a class of materials including, but not limited to, rigid materials, semi rigid materials, semi flexible materials, flexible materials and combinations thereof.

[0035] In yet a further aspect of embodiments described herein there is provided a fluidic mechanical seal selected from a class of mechanical seals including, but not limited to, washers, O-rings, X-rings, Q-rings, square rings and gaskets and further selected from mechanical seals that are removably replaced within the coupling and mechanical seals that are an integral component of the coupling and any combinations thereof.

[0036] Embodiments of the present invention will find use with first responders.

[0037] Accordingly, embodiments of the present invention provide a system and or device that will allow first responders, such as, soldiers and/or medical personnel, to continue to supply air to a patient undergoing first aid and/or life support, e.g., Cardiopulmonary Resuscitation (CPR), without having to remove their CBRN Respirator, including whilst the patient is being evacuated through a decontamination station, thus increasing the survival rate.

[0038] Other aspects and preferred forms are disclosed in the specification and/or defined in the appended claims, forming a part of the description of the invention.

[0039] In essence, embodiments of the present invention stem from the realization that prior art ventilation systems do not allow for coupling to respiration masks suitable for use in a CBRN environment resulting in a capability gap for providing medical and resuscitation support to combatants and breathing support to rescue personnel and thereby provide first-line medical support in a CBRN environment including to combatants operating in such environments.

[0040] Advantages provided by the present invention comprise the following:

• Embodiments of the invention allows first responders / soldiers to provide first aid to fallen comrades or equivalently emergency responders and medical personnel to provide life support to a soldier who may be contaminated or have other medical issues whilst in a contaminated environment whilst limiting the exposure of both the combatant and emergency responder to CBRN environmental conditions. • Allows for medical grade oxygen and/or filtered air to be inhaled by a patient whilst wearing a respirator (or mask) in a Chemical Biological Radiological and Nuclear (CBRN) Environment or in a Toxic Industrial Environment (TIC) without need for removing the respirator.

• Provides a higher rate of survivability for patients whilst being treated, operated on, or evacuated/transported out of a CBRN or TIC environment.

• Reduces exposure of patients and first responders to extreme environmental conditions.

• Provides for in situ supply to patients of filtered air, medical oxygen or other medical gases.

• Embodiments allow for filter air and/or medical oxygen to be delivered to the patient via the adaption system, which connects directly into the CBRN mask. The adaptors have also been constructed to fit in accordance with ISO 10651 - 4:2002(en) Lung Ventilators - Part 4: Particular requirements for operator- power resuscitators to ensure fit to all ISO approved resuscitation bags.

[0041 ] Further scope of applicability of embodiments of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the disclosure herein will become apparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Further disclosure, objects, advantages and aspects of preferred and other embodiments of the present invention may be better understood by those skilled in the relevant art by reference to the following description of embodiments taken in conjunction with the accompanying drawings, which are given by way of illustration only, and thus are not limitative of the disclosure herein, and in which:

FIG. 1 is a schematic illustrating an array of resuscitation equipment incorporating three embodiments of a coupling according the present invention;

FIG. 2 shows a prototype embodiment of the present invention; FIG. 3 shows a perspective view of a male connection seal in accordance with one embodiment of the invention;

FIG. 4 shows a perspective view of a connection seal in accordance with another embodiment of the invention;

FIG. 5 shows a sealed connector engaged with an auxiliary port of a CBRN mask in accordance with a preferred embodiment of the invention;

FIG. 6 is a schematic showing a perspective view of variations to the connectors in use with a seal of preferred embodiments of the invention;

FIG.’s 7 and 7a are cross sectional and perspective views respectively showing a first embodiment of a straight male form connector and seal in accordance with the invention;

FIG. 8 is a cross sectional view showing a first embodiment of a straight female form connector and seal in accordance with the invention;

FIG. 9 is a cross sectional view showing a first embodiment of an elbow male form connector and seal in accordance with the invention;

FIG. 10 is a cross sectional view showing a first embodiment of an elbow female form connector and seal in accordance with the invention;

FIG. 11 is a perspective view showing a first embodiment of a single piece moulding connector and seal in accordance with the invention;

FIG. 12 is a cross sectional view showing a second embodiment of a straight male form connector and seal in accordance with the invention;

FIG. 13 is a perspective cross sectional view of the connector of FIG. 12 showing a seal arrangement; FIG. 14 shows perspective views of alternate swivel connectors in accordance with an embodiment of the present invention;

FIG. 15 is a schematic showing perspective views of further alternate connectors in use with a seal of preferred embodiments of the invention;

FIG. 16 is a cross sectional perspective view showing a third embodiment of a straight male form connector and seal in accordance with the invention;

FIG. 17 is a schematic showing perspective views of alternate connectors in use with a seal of the third embodiment of the invention;

FIG. 18 is a cross sectional perspective view showing a fourth embodiment of a straight male form connector and seal in accordance with the invention;

FIG. 19 is a schematic showing perspective views of alternate connectors in use with a seal of the fourth embodiment of the invention;

FIG. 20 is a perspective view of a male form connector in accordance with another embodiment of the invention;

FIG. 21 is a perspective view of a male form connector in accordance with another embodiment of the invention;

FIG. 22 shows a mask and resus bag in operative connection using the connector of FIG.’s 3 and 4;

FIG. 23 is a perspective view of a female form connector in accordance with another embodiment of the invention allowing for direct connection to a standard resus bag connection port which is compliant with the International Organisation for Standardisation (ISO) standard for such a connection port; The connector allows for direct connection to a ISO 22 degree resus bag connection port. FIG. 24 is a perspective view of a coupler designed to fit military and emergency responder designed CBRN / Toxic Environment masks.

FIG. 25 shows a mask and resus bag in operative connection using the connector of FIG. 23 and 24;

FIG. 26 is perspective view showing a further embodiment of a straight male form 360- degree swivel connector and seal in accordance with the invention;

FIG. 27 is a perspective view of a coupler designed to fit military and emergency responder designed CBRN / Toxic environment masks.

FIG. 28 is a cross sectional perspective view of the connector of FIG. 26;

FIG. 29 is an exploded view showing component parts of the connector of FIG. 26.

FIG. 30 shows insertion of the connector of FIG. 26 into a face mask;

FIG. 31 shows the connector of FIG. 26 inserted and assembled providing connection between a face mask and resuscitation bag;

FIG. 32 shows an alternate orientation of the inserted and assembled connector of FIG. 26;

FIG. 33 is perspective view showing a further embodiment of a straight female form 360- degree swivel connector and seal in accordance with the invention;

FIG. 34 is a perspective view of a coupler designed to fit military and emergency responder designed CBRN / Toxic environment masks.

FIG. 35 is a cross sectional perspective view of the connector of FIG. 33;

FIG. 36 shows a mask and resus bag in operative connection using the connector of FIG. 33 and 34; FIG.’s 37a, 37b and 37c are alternate perspective views and a cross sectional perspective view, respectively, of a further embodiment of an elbow male form swivel connector and seal in accordance with the invention;

FIG.’s 38a, 38b and 38c are alternate perspective views and a cross sectional perspective view, respectively, of a further embodiment of an elbow female form swivel connector and seal in accordance with the invention;

FIG. 39 is a perspective view showing a further embodiment of a straight male single piece moulding connector and seal in accordance with the invention;

DETAILED DESCRIPTION

[0043] In a preferred set of embodiments, connectors have been designed to interface between a range of regulatory authority approved resuscitation bags including, but not limited to, Therapeutic Goods Administration (TGA) approved and ISO 10651 -4:2002(en) Lung Ventilators resuscitation bags. As such, preferred embodiments have been developed for:

1 . Straight Connector of filter to bag having female thread to male taper connecting filter cartridge to resus bag.

2. Connector elbow having female taper to male thread connector to connect a resus bag to CBRN Mask as per FIG 10.

3. Connector elbow with 360° swivel and press-fit with female connector to connect resus bag to CBRN mask.

4. Connector straight or elbow with hose having male taper connector to male taper to connect Resus Bag to CBRN mask with hose.

5. Press fit connector onto O2 airline hose to threaded connector with connection to O2 regulator. These Couplers will allow for the rapid connection of an O2 line into a CBRN mask to provide a patient with O2.

[0044] Figure 2 shows a prototype embodiment where the proof of concept has been demonstrated by way of sourcing an ‘off-the-shelf’ airline in-port cap wherein the coupler removably engages with the CBRN mask and the airline in port cap allows rapid connection to an oxygen line. The coupler interfaces with the CBRN mask, the airline inport cap is part of the coupler which allows rapid connection to an O2 line.

Swivel Connector with Over moulded Radial Seal

[0045] The components as shown in FIG.’s 3 and 4 provide a refined aesthetic connection to the port of an in-situ CBRN respirator and reduce or minimise dust and dirt ingress to the resuscitation equipment. FIGs 3 and 4 shows a perspective view of a connection seal. FIG. 5 illustrates the components of FIG. 3 in place with an auxiliary port of a military grade full facial gas mask. The construction is ultrasonically welded to the base of the coupler. This provides a robust join that is tamper-proof, preferably hermetically sealed and ensures the connection and seal are substantially fluid impermeable.

[0046] As illustrated in FIG .6, the radial seal design of preferred embodiments can be applied to each of the various connectors, 1 to 5, noted above. The base 1 (green) and collar 2 (blue) components may be universal and common across all swivel variations. Variants are possible with minimised tooling overhead since the points where the components connectively interface are of common design parameters.

[0047] With reference to FIG.’s 7 and 7a, a first embodiment of a straight male swivel connector and seal is shown. There are three components to this piece. With there being no O-ring this ensures that the couple will maintain a seal through its lifespan with reduced maintenance requirements. The three elements include the interface to the CBRN Mask via a screw thread; the interface to the resus bag (male connection); and the cover/seal 3. The male swivel connector, as shown, provides for reduced dust and dirt ingress and good tolerance control in its manufacture for the cylindrical sealing surfaces providing repeatable seal compression. Accordingly, every time the system is used, a suitable seal will be achieved. [0048] With reference to FIG. 8, a first embodiment of a straight female swivel connector is shown. There are three components to this piece. With there being no O- ring this ensures that the couple will maintain a seal through its lifespan with reduced maintenance requirements. The three elements include the interface to the CBRN mask via a screw thread, the interface to the resus bag, and the cover/seal 3.

[0049] With reference to FIG. 9, a first embodiment of an elbow male form swivel connector and seal is shown. There are three components to this piece. The fact that there is no O-ring ensures that the couple will maintain a seal through its lifespan with reduce maintenance requirements. The three elements include the interface to the CBRN Mask via a screw thread; the interface to the resus bag (male connection) with an elbow which provides a different angle for the operator (Medic/Combatant) to attach the resus bag; and the cover/seal 3.

[0050] With reference to FIG. 10, a first embodiment of an elbow female form connector and seal is shown. There are three components to this piece. The fact that there is no O- ring ensures that the couple will maintain a seal through its lifespan with reduce maintenance requirements. The three elements include the interface to the CBRN Mask via a screw thread; the interface to the resus bag (female connection) with an elbow which provides a different angle for the operator (Medic/Combatant) to attach the resus bag; and the cover/seal.

[0051 ] With reference to FIG. 1 1 , a first embodiment of a single piece moulding connector and seal is shown where the single piece moulding is adapted for use as a connector to oxygen supply specifically for O2 flow using standard oxygen tubing from an oxygen cylinder. This coupler provides an interface to the CBRN Mask via a screw thread and a direct connection of an O2 line from an O2 Cylinder.

[0052] With reference to FIG. 12, a second embodiment of a straight male form swivel connector and seal in accordance with the invention is shown. The swivel connector as shown includes an over moulded radial seal in which the component parts of the seal are moulded over each other in an at least two step process to form a single seal to ensure that the ingress of any contaminants is countered. This ensures that the system is protected and improves the seal by preventing ingress of any contaminants. There are three components to this piece. The fact that there is no O-ring ensures that the couple will maintain a seal through its lifespan with reduced maintenance requirements. The three elements include the interface to the CBRN Mask via a screw thread; the interface to the resus bag (male connection); and the cover/seal. FIG. 13 shows a perspective cross sectional view of the connector of FIG. 12 showing a seal arrangement allowing the operator to engage the coupler to the CBRN mask coupler interface without disrupting the patient. The Male Iso taper is in accordance with the manufacturing standards for Resus bags and will connect to any resus bag constructed in accordance with accepted standards. The radial seal provides a suitable seal and allows the operator (Medic/Combatant) to screw the coupler interface to the CBRN Mask quickly, without disrupting the patient.

[0053] FIG. 14 shows embodiments of alternate swivel connectors with specialised connectors for engaging with a standard oxygen line. There are two components to this piece. The two elements include the interface to the CBRN Mask via a screw thread; and a “push connector” which interfaces to an O2 line.

[0054] FIG. 15 shows perspective views of further alternate connectors in use with a seal of preferred embodiments of the invention. FIG 15 shows the range of couplers available to a Combat Medic to provide resuscitation in a CBRN environment under varying conditions.

[0055] FIG. 16 is a cross sectional perspective view showing a third embodiment of a straight male form connector and seal in accordance with the invention. There are three components to this piece. The fact that there is no O-ring ensures that the couple will maintain a seal through its lifespan with reduced maintenance requirements. The three elements include the interface to the CBRN Mask via a screw thread; the interface to the resus bag (male connection); and the cover/seal.

[0056] FIG. 17 shows perspective views of alternate connectors in use with a seal of the third embodiment of the invention. FIG. 17 shows the cross-sections of the various configurations of the coupler identified in this document.

[0057] FIG. 18 is a cross sectional perspective view showing a fourth embodiment of a straight male form connector and seal in accordance with the invention. In this embodiment, a cushion seal is employed. This provides a different sealing system which testing will determine which sealing methodology is most appropriate for the final system. [0058] FIG. 19 shows perspective views of alternate connectors in use with a seal of the fourth embodiment of the invention where cross-sections of the various configurations of the coupler are identified.

[0059] FIG. 20 shows a perspective view of a male form connector in accordance with another embodiment of the invention in which the coupler is a single moulded piece that engages with a CBRN mask via a screw thread and engages directly to a resus bag via the male form connector.

[0060] With reference to FIG. 21 shows an alternate perspective view of the male form connector of FIG. 20 in which the invention is a single moulded piece that engages with a CBRN mask via a screw thread and engages directly to a resus bag via the male form connector.

[0061 ] FIG. 22 shows a mask and resus bag in operative connection using the connector of FIG.’s 3 and 4.

[0062] FIG. 23 shows a perspective view of a female form connector in accordance with another embodiment of the invention in which the coupler is a single moulded piece that engages with a CBRN mask via a screw thread and engages directly to a resus bag via the female form connector.

[0063] With reference to FIG. 24 shows an alternative perspective view of the female form connector of Fig. 23 in which the invention is a single moulded piece that engages with a CBRN mask via a screw thread and engages directly to a resus bag via the female form connector.

[0064] FIG. 25 shows a mask and resus bag in operative connection using the connector of FIG. 23 and 24.

[0065] FIG. 26 shows a perspective view of a straight male form swivel connector and seal in accordance with a further embodiment of the invention and FIG. 27 shows an alternate perspective view of the straight male form swivel connector of FIG. 26. Fig 27 is a different view of the coupler in FIG 26. With reference to FIG. 28, a cross-sectional view of the connector of FIG. 26 is shown with the inclusion of an in-situ O ring. FIG 28 shows the O-Ring concept which has been superseded. The three elements include the interface to the CBRN Mask via a screw thread; the interface to the resus bag (male connection); and the cover/seal.

[0066] FIG. 29 is an exploded view showing component parts of the connector of FIG. 26. With reference to FIG. 29, the straight male swivel connector and seal comprises a retaining ring 291 , a male form tube 292, a seal in the form of an O-ring 293 and a treaded collar 294.

[0067] FIG. 30 shows insertion of the connector of FIG. 26 into a face mask in which the operation of the swivel connector allows the rotatable engagement of the coupler to the CBRN mask without rotation of the CBRN mask or the resuscitation bag. The 360 swivel on the coupler allows the resus bag and the CBRN Mask to remain stationary.

[0068] FIG. 33 shows a perspective view of a straight female form swivel connector and seal in accordance with another embodiment of the invention. There are three components to this piece. The three elements include the interface to the CBRN Mask via a screw thread; the interface to the resus bag (female connection) with an elbow which provides a different angle for the operator (Medic/Combatant) to attach the resus bag; and the cover/seal.

[0069] With reference to FIG. 35, a cross sectional view of the connector of FIG. 33 is shown. It is envisaged that this design may be altered to remove the O-ring which ensures that the coupler will maintain a seal through its lifespan with reduce maintenance requirements.

[0070] FIG. 36 shows a mask and resus bag in operative connection using the connector of FIG. 33 and 34. The working parts are designed to fit the 22mm ISO Taper for any Medical Resus Bag and interface with any O2 supply systems. Male and Female connections are for operators to have multiple options to utilise in different emergency situations (Training and Operational). A 360 degree swivel is provided for the bag to remain steady whilst connection to the CBRN mask is made.

[0071 ] FIG.’s 37a, 37b, and 37c are alternate perspective views and a cross-sectional perspective view, respectively, of a further embodiment of an elbow male form swivel connector and seal in accordance with the invention. The working parts are designed to fit the 22mm ISO Taper for any Medical Resus Bag and interface with any O2 supply systems. Male and Female connections are for operators to have multiple options to utilise in different emergency situations (Training and Operational). Note, the O-ring design has been superseded.

[0072] FIG.’s 38a, 38b and 38c are alternate perspective views and a cross sectional perspective view, respectively, of a further embodiment of an elbow female form swivel connector and seal in accordance with the invention. The working parts are designed to fit the 22mm ISO Taper for any Medical Resus Bag and interface with any O2 supply systems. Male and Female connections are for operators to have multiple options to utilise in different emergency situations (Training and Operational). Note, the O-ring design has been superseded.

[0073] FIG. 39 is a perspective view showing a further embodiment of a straight male single piece moulding connector and seal in accordance with the invention. The working parts are designed to fit the 22mm ISO Taper for any Medical Resus Bag and interface with any O2 supply systems. Male and Female connections are for operators to have multiple options to utilise in different emergency situations (Training and Operational).

[0074] The adaption system of embodiments of the present invention allows oxygen or filtered air to flow into a respirator (mask), where the person is injured or not breathing without having to remove the respirator (mask) and exposing them to further environmental complications. The adaption system enables direct connection between the respirator (mask) and various resuscitation bags as well as medical O2 cylinders. Whilst connected to the medical O2 cylinder, it will provide a closed circuit and continuous medical grade O2 that can be regulated. When the adaption system of preferred embodiments is connected to a resuscitation bag, the system will enable the provision of filtered air which is being drawn into the bag through a CBRN or TIC approved canister.

[0075] As noted above in further detailed description variations have been provided, such as follows:

1 . Straight-line female to female single solid piece adapter.

2. Straight-line male I female two-piece adapter with 360-degree swivel.

3. 45-degree male I female two-piece adapter with 180-degree swivel.

4. Single piece, non-kink with wire core, medical grade Oxygen tube with embedded adaptor to suit resuscitation, suction and oxygen therapy delivery systems such as Oxy Viva™ oxygen regulators that supply O2 to patients as used in hospitals, by medical support personnel and military personnel. [0076] It is noted that embodiments of the invention are adapted to interface with Defence in-service respirators (i.e., Hand pump) and Defence in-service O2 supply system. Furthermore, embodiments of the invention are directed to an interface or coupling between a patient’s respirator/mask and a manual resuscitation bag, which in turn is operatively connected to a supply of clean air and/or oxygen, preferably in cannister form. As such, embodiments provide a clean and sealed source of air to be manually supplied to the patient/soldier whilst they are being treated in situ and/or evacuated from the CBRN environment and passed, for example, through a decontamination station. As such, a resuscitation capability has been developed to function on patients exposed to Chemical, Biological, Radiological, and Nuclear (CBRN) environments. This includes an interface which integrates existing in-service CBRN masks and a medical ventilation device which will allow medical staff to manually administer an air supply to a patient undergoing CPR without having to remove their CBRN respirator. Embodiments of the preferred resus coupler will allow soldiers and/or medical personnel to continue to supply air to a patient undergoing Cardiopulmonary Resuscitation (CPR) without having to remove their CBRN Respirator, including whilst the patient is being evacuated through a decontamination station, thus increasing the chance of survival.

[0077] Embodiments have been developed through the conduct of a series of tests utilising various subject matter experts (e.g., Respiratory Physician) to ensure thresholds are met and exceeded. Noting accepted concerns such as those in connection with exhalation valves, development of embodiments of the present invention are contributing to ensuring gas exchange occurs allowing the flow of expelled carbon dioxide to be filtered out of a respirator under CBRN and TIC conditions. This will prevent the build-up of carbon dioxide and allow oxygen to not only reach the patients lungs but also reduce the risk of respiratory failure.

[0078] The intent of certain embodiments of the invention is to design and make the prototype IAW ISO 13485:2016 - Medical Devices, to ensure the correct materials are used. ISO 10651 -4:2002 Lung Ventilators Part 4 have also been drawn upon. In particular, requirements for operator-powered resuscitators, as elements from the standard can be used to support testing requirements i.e., Inspiratory resistance, Ventilation performance, Bag inlet valve connectors and Minimum delivered volumes; etc. to develop a CBRN Resuscitation Capability, that integrates with in-service CBRN masks and medical ventilating systems to support the ADF and in particular the VCDF’s Directive. The design of the CBRN Resuscitation Capability of preferred embodiments allows all military personnel to continue to save and preserve the lives of their colleagues whilst operating within a CBRN or Toxic Industrial Chemical (TICs) environment. The CBRN Resuscitation Capability allows soldiers and/or medical personnel to continue to supply air to a patient undergoing Cardiopulmonary Resuscitation (CPR) without having to remove their CBRN Respirator, including whilst the patient is being evacuated through a decontamination station, thus increasing the chance of survival.

[0079] Embodiments of the present invention have been subjected to a proving system involving tests in a simulated and controlled known environment to determine the success of the integration process and potential/feasibility for system development towards operational capability for the ADF. As such, the design, manufacture and introduction into service of embodiments of the coupler combine two discrete pieces of in-service equipment into a combined lifesaving capability.

[0080] Embodiments of the present invention are envisaged to operate robustly, efficaciously and safely under a range of environmental conditions. This capability is specifically developed to help sustain human life, therefore, safety is the highest priority. An exemplary testing environment for embodiments of the invention may be drawn from a compliance with an acceptable hazard management scheme that is in accordance with United States Military Standard 882E and considers safety hazards that exist across all activities that embodiments of the invention may be subjected to. This will typically include design related hazards, functional hazards and operational hazards to personnel across the lifecycle of equipment embodying the present invention. The hazard (severity) categories, probability (level) indicators and corresponding risk assessment matrix as set out in the above noted US military standard is detailed in the following Tables (1 and 2).

Table 1

Table 2

[0081 ] While this invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modification(s). This application is intended to cover any variations uses or adaptations of the invention following in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains and as may be applied to the essential features hereinbefore set forth.

[0082] As the present invention may be embodied in several forms without departing from the spirit of the essential characteristics of the invention, it should be understood that the above described embodiments are not to limit the present invention unless otherwise specified, but rather should be construed broadly within the spirit and scope of the invention as defined in the appended claims. The described embodiments are to be considered in all respects as illustrative only and not restrictive.

[0083] Various modifications and equivalent arrangements are intended to be included within the spirit and scope of the invention and appended claims. Therefore, the specific embodiments are to be understood to be illustrative of the many ways in which the principles of the present invention may be practiced. In the following claims, any means- plus-function clauses are intended to cover structures as performing the defined function

SUBSTITUTE SHEET (RULE 26) and not only structural equivalents, but also equivalent structures. For example, although a nail and a screw may not be structural equivalents in that a nail employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical surface to secure wooden parts together, in the environment of fastening wooden parts, a nail and a screw are equivalent structures.

The following sections I - VII provide a guide to interpreting the present specification.

I. Terms

[0084] The term “fluid” means a substance that has no fixed shape and yields easily to external pressure; in particular a gas or a liquid.

[0085] The term “product” means any machine, manufacture and/or composition of matter, unless expressly specified otherwise.

[0086] The term “process” means any process, algorithm, method or the like, unless expressly specified otherwise.

[0087] Each process (whether called a method, algorithm or otherwise) inherently includes one or more steps, and therefore all references to a “step” or “steps” of a process have an inherent antecedent basis in the mere recitation of the term ‘process’ or a like term. Accordingly, any reference in a claim to a ‘step’ or ‘steps’ of a process has sufficient antecedent basis.

[0088] The term “invention” and the like mean “the one or more inventions disclosed in this specification”, unless expressly specified otherwise.

[0089] The terms “an embodiment”, “embodiment”, “embodiments”, “the embodiment”, “the embodiments”, “one or more embodiments”, “some embodiments”, “certain embodiments”, “one embodiment”, “another embodiment” and the like mean “one or more (but not all) embodiments of the disclosed invention(s)”, unless expressly specified otherwise.

[0090] The term “variation” of an invention means an embodiment of the invention, unless expressly specified otherwise. [0091 ] A reference to “another embodiment” in describing an embodiment does not imply that the referenced embodiment is mutually exclusive with another embodiment (e.g., an embodiment described before the referenced embodiment), unless expressly specified otherwise.

[0092] The terms “including”, “comprising” and variations thereof mean “including but not limited to”, unless expressly specified otherwise.

[0093] The terms “a”, “an” and “the” mean “one or more”, unless expressly specified otherwise.

[0094] The term “plurality” means “two or more”, unless expressly specified otherwise.

[0095] The term “herein” means “in the present specification, including anything which may be incorporated by reference”, unless expressly specified otherwise.

[0096] The phrase “at least one of’, when such phrase modifies a plurality of things (such as an enumerated list of things), means any combination of one or more of those things, unless expressly specified otherwise. For example, the phrase “at least one of a widget, a car and a wheel” means either (i) a widget, (ii) a car, (iii) a wheel, (iv) a widget and a car, (v) a widget and a wheel, (vi) a car and a wheel, or (vii) a widget, a car and a wheel. The phrase “at least one of”, when such phrase modifies a plurality of things, does not mean “one of each of” the plurality of things.

[0097] Numerical terms such as “one”, “two”, etc. when used as cardinal numbers to indicate quantity of something (e.g., one widget, two widgets), mean the quantity indicated by that numerical term, but do not mean at least the quantity indicated by that numerical term. For example, the phrase “one widget” does not mean “at least one widget”, and therefore the phrase “one widget” does not cover, e.g., two widgets.

[0098] The phrase “based on” does not mean “based only on”, unless expressly specified otherwise. In other words, the phrase “based on” describes both “based only on” and “based at least on”. The phrase “based at least on” is equivalent to the phrase “based at least in part on”.

[0099] The term “represent” and like terms are not exclusive, unless expressly specified otherwise. For example, the term “represents” do not mean “represents only”, unless expressly specified otherwise. In other words, the phrase “the data represents a credit card number” describes both “the data represents only a credit card number” and “the data represents a credit card number and the data also represents something else”.

[00100] The term “whereby” is used herein only to precede a clause or other set of words that express only the intended result, objective or consequence of something that is previously and explicitly recited. Thus, when the term “whereby” is used in a claim, the clause or other words that the term “whereby” modifies do not establish specific further limitations of the claim or otherwise restricts the meaning or scope of the claim.

[00101 ] The term “e.g.” and like terms mean “for example”, and thus does not limit the term or phrase it explains. For example, in the sentence “the computer sends data (e.g., instructions, a data structure) over the Internet”, the term “e.g.” explains that “instructions” are an example of “data” that the computer may send over the Internet, and also explains that “a data structure” is an example of “data” that the computer may send over the Internet. However, both “instructions” and “a data structure” are merely examples of “data”, and other things besides “instructions” and “a data structure” can be “data”.

[00102] The term “i.e.” and like terms mean “that is”, and thus limits the term or phrase it explains. For example, in the sentence “the computer sends data (i.e., instructions) over the Internet”, the term “i.e.” explains that “instructions” are the “data” that the computer sends over the Internet.

[00103] Any given numerical range shall include whole and fractions of numbers within the range. For example, the range “1 to 10” shall be interpreted to specifically include whole numbers between 1 and 10 (e.g., 2, 3, 4, . . . 9) and non-whole numbers (e.g., 1.1 ,

I .2, . . . 1.9).

II. Determining

[00104] The term “determining” and grammatical variants thereof (e.g., to determine a price, determining a value, determine an object which meets a certain criterion) is used in an extremely broad sense. The term “determining” encompasses a wide variety of actions and therefore “determining” can include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Also, “determining” can include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like. Also, “determining” can include resolving, selecting, choosing, establishing, and the like.

[00105] The term “determining” does not imply certainty or absolute precision, and therefore “determining” can include estimating, extrapolating, predicting, guessing and the like.

[00106] The term “determining” does not imply that mathematical processing must be performed, and does not imply that numerical methods must be used, and does not imply that an algorithm or process is used.

[00107] The term “determining” does not imply that any particular device must be used. For example, a computer need not necessarily perform the determining.

III. Indication

[00108] The term “indication” is used in an extremely broad sense. The term “indication” may, among other things, encompass a sign, symptom, or token of something else.

[00109] The term “indication” may be used to refer to any indicia and/or other information indicative of or associated with a subject, item, entity, and/or other object and/or idea.

[00110] As used herein, the phrases “information indicative of” and “indicia” may be used to refer to any information that represents, describes, and/or is otherwise associated with a related entity, subject, or object.

[0011 1 ] Indicia of information may include, for example, a symbol, a code, a reference, a link, a signal, an identifier, and/or any combination thereof and/or any other informative representation associated with the information.

[00112] In some embodiments, indicia of information (or indicative of the information) may be or include the information itself and/or any portion or component of the information. In some embodiments, an indication may include a request, a solicitation, a broadcast, and/or any other form of information gathering and/or dissemination.

IV. Forms of Sentences

[00113] Where a limitation of a first claim would cover one of a feature as well as more than one of a feature (e.g., a limitation such as “at least one widget” covers one widget as well as more than one widget), and where in a second claim that depends on the first claim, the second claim uses a definite article “the” to refer to the limitation (e.g., “the widget”), this does not imply that the first claim covers only one of the feature, and this does not imply that the second claim covers only one of the feature (e.g., “the widget” can cover both one widget and more than one widget).

[00114] When an ordinal number (such as “first”, “second”, “third” and so on) is used as an adjective before a term, that ordinal number is used (unless expressly specified otherwise) merely to indicate a particular feature, such as to distinguish that particular feature from another feature that is described by the same term or by a similar term. For example, a “first widget” may be so named merely to distinguish it from, e.g., a “second widget”. Thus, the mere usage of the ordinal numbers “first” and “second” before the term “widget” does not indicate any other relationship between the two widgets, and likewise does not indicate any other characteristics of either or both widgets. For example, the mere usage of the ordinal numbers “first” and “second” before the term “widget” (1 ) does not indicate that either widget comes before or after any other in order or location; (2) does not indicate that either widget occurs or acts before or after any other in time; and (3) does not indicate that either widget ranks above or below any other, as in importance or quality. In addition, the mere usage of ordinal numbers does not define a numerical limit to the features identified with the ordinal numbers. For example, the mere usage of the ordinal numbers “first” and “second” before the term “widget” does not indicate that there must be no more than two widgets.

[00115] When a single device or article is described herein, more than one device/article (whether or not they cooperate) may alternatively be used in place of the single device/article that is described. Accordingly, the functionality that is described as being possessed by a device may alternatively be possessed by more than one device/article (whether or not they cooperate).

[00116] Similarly, where more than one device or article is described herein (whether or not they cooperate), a single device/article may alternatively be used in place of the more than one device or article that is described. For example, a plurality of computer-based devices may be substituted with a single computer-based device. Accordingly, the various functionality that is described as being possessed by more than one device or article may alternatively be possessed by a single device/article. [00117] The functionality and/or the features of a single device that is described may be alternatively embodied by one or more other devices which are described but are not explicitly described as having such functionality/features. Thus, other embodiments need not include the described device itself, but rather can include the one or more other devices which would, in those other embodiments, have such functionality/features.

V. Disclosed Examples and Terminology Are Not Limiting

[00118] Neither the Title nor the Abstract in this specification is intended to be taken as limiting in any way as the scope of the disclosed invention(s). The title and headings of sections provided in the specification are for convenience only, and are not to be taken as limiting the disclosure in any way.

[00119] Numerous embodiments are described in the present application, and are presented for illustrative purposes only. The described embodiments are not, and are not intended to be, limiting in any sense. The presently disclosed invention(s) are widely applicable to numerous embodiments, as is readily apparent from the disclosure. One of ordinary skill in the art will recognise that the disclosed invention(s) may be practised with various modifications and alterations, such as structural, logical, software, and electrical modifications. Although particular features of the disclosed invention(s) may be described with reference to one or more particular embodiments and/or drawings, it should be understood that such features are not limited to usage in the one or more particular embodiments or drawings with reference to which they are described, unless expressly specified otherwise.

[00120] The present disclosure is not a literal description of all embodiments of the invention(s). Also, the present disclosure is not a listing of features of the invention(s) which must be present in all embodiments.

[00121 ] Devices that are described as in communication with each other need not be in continuous communication with each other, unless expressly specified otherwise. On the contrary, such devices need only transmit to each other as necessary or desirable, and may actually refrain from exchanging data most of the time. For example, a machine in communication with another machine via the Internet may not transmit data to the other machine for long period of time (e.g. weeks at a time). In addition, devices that are in communication with each other may communicate directly or indirectly through one or more intermediaries.

[00122] A description of an embodiment with several components or features does not imply that all or even any of such components/features are required. On the contrary, a variety of optional components are described to illustrate the wide variety of possible embodiments of the present invention(s). Unless otherwise specified explicitly, no component/feature is essential or required.

[00123] Although process steps, operations, algorithms or the like may be described in a particular sequential order, such processes may be configured to work in different orders. In other words, any sequence or order of steps that may be explicitly described does not necessarily indicate a requirement that the steps be performed in that order. The steps of processes described herein may be performed in any order practical. Further, some steps may be performed simultaneously despite being described or implied as occurring non- simultaneously (e.g., because one step is described after the other step). Moreover, the illustration of a process by its depiction in a drawing does not imply that the illustrated process is exclusive of other variations and modifications thereto, does not imply that the illustrated process or any of its steps are necessary to the invention(s), and does not imply that the illustrated process is preferred.

[00124] Although a process may be described as including a plurality of steps, that does not imply that all or any of the steps are preferred, essential or required. Various other embodiments within the scope of the described invention(s) include other processes that omit some or all of the described steps. Unless otherwise specified explicitly, no step is essential or required.

[00125] Although a process may be described singly or without reference to other products or methods, in an embodiment the process may interact with other products or methods. For example, such interaction may include linking one business model to another business model. Such interaction may be provided to enhance the flexibility or desirability of the process.

[00126] Although a product may be described as including a plurality of components, aspects, qualities, characteristics and/or features, that does not indicate that any or all of the plurality are preferred, essential or required. Various other embodiments within the scope of the described invention(s) include other products that omit some or all of the described plurality.

[00127] An enumerated list of items (which may or may not be numbered) does not imply that any or all of the items are mutually exclusive, unless expressly specified otherwise. Likewise, an enumerated list of items (which may or may not be numbered) does not imply that any or all of the items are comprehensive of any category, unless expressly specified otherwise. For example, the enumerated list “a computer, a laptop, a PDA” does not imply that any or all of the three items of that list are mutually exclusive and does not imply that any or all of the three items of that list are comprehensive of any category.

[00128] An enumerated list of items (which may or may not be numbered) does not imply that any or all of the items are equivalent to each other or readily substituted for each other.

[00129] All embodiments are illustrative, and do not imply that the invention or any embodiments were made or performed, as the case may be.

[00130] “Comprises/comprising” and “includes/including” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof. Thus, unless the context clearly requires otherwise, throughout the description and the claims, the words ‘comprise’, ‘comprising’, ‘includes’, ‘including’ and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to”.