WO2013111111A1

WO2013111111A1 - Medical simulation methods, systems and mannequins

Info

Publication number: WO2013111111A1
Application number: PCT/IB2013/050667
Authority: WO
Inventors: Ravid SEGAL; Amitai ZIV; Kim MACMILLAN; Zvi MARCUS; Lior ASHER; Avi MOR; Zami ZEMER; Gregory CHU
Original assignee: Petrus Aviation 1979 Ltd; Tel HaShomer Medical Research Infrastructure and Services Ltd; Rix Industries
Current assignee: Petrus Aviation 1979 Ltd; Tel HaShomer Medical Research Infrastructure and Services Ltd; Rix Industries
Priority date: 2012-01-25
Filing date: 2013-01-25
Publication date: 2013-08-01
Anticipated expiration: 2014-07-25

Description

MEDICAL SIMULATION METHODS, SYSTEMS AND MANNEQUINS

RELATED APPLICATION/S

The present application gains priority from U.S. Provisional Patent Application No. 61/590,632 filed 25 January 2012 which is included by reference as if fully set forth herein.

FIELD AND BACKGROUND OF THE INVENTION

The invention, in at least some embodiments, relates to the field of medical simulations and medical simulation mannequins.

Medical simulation mannequins are life-sized, three-dimensional representations of a whole or part of the human body, used for training of health-care and rescue professionals under realistic scenarios. The medical simulation mannequin may be programmed to simulate various lifelike symptoms and physiological responses to treatment. It is preferred that such mannequins simulate a human as accurately as possible, in terms of appearance and feel (bones, muscle, skin, flexibility at joints, etc).

Some medical simulation mannequins include hydraulic or pneumatic internal assemblies that simulate physiological aspects such as respiration, blood circulation and bleeding. Such medical simulation assemblies are typically driven by a pressurized operating gas. A disadvantage of such mannequins is that these are "tethered" requiring a gas pipe connected to an external source of pressurized operating gas. Such tethering damages the realism of a mannequin in terms of appearance and manipulability (moving, carrying or turning the mannequin over). Such tethering also limits the utility and realism of mannequins for training of mass-casualty events, inter alia, due to the need of many (criss-crossing) gas pipes and limits on where mannequins can be placed (in vehicles, trapped in wreckage and rubble).

SUMMARY OF THE INVENTION

The invention, in at least some embodiments, relates to tetherless medical simulation mannequins, to methods of medical simulation using such mannequins and systems suitable for implementing the methods.

According to an aspect of some embodiments of the invention, there is provided a tetherless pneumatic medical simulation mannequin comprising:

a gas-pressure driven medical simulation assembly having an operating gas inlet configured for accepting an operating gas; a first rechargeable on-board gas storage tank for storing the operating gas, having: a capacity to hold an amount of the operating gas sufficient for not less than 30 minutes of continuous operation of the medical simulation assembly, and a recharging port allowing filling of the first on-board gas-storage tank with the operating gas;

a gas conduit providing fluid communication between the gas storage tank and the gas-driven medical simulation assembly, the gas conduit having a pressure regulator for regulating the pressure of operating gas expanding from the storage tank to a pressure suitable for input to the operating gas inlet.

In some embodiments, the on-board gas storage tank is preferably produced in accordance with aeronautic and transportation system standards, such that the mannequin is safe for transport and use. Suitable such gas storage tanks are commercially available from RIX Industries (Benicia, California, USA).

In some embodiments, no electrical supply is required for use and/or filling of the onboard gas storage tank.

In some embodiments, no electrical power is required by the on-board gas storage tank, so that the life of a battery required for other simulation activities (e.g., operation of the medical simulation assembly) is prolonged.

Unlike energy stored in batteries, energy stored (as gas-pressure) in the on-board gas storage tank, in some embodiments, does not dissipate when the mannequin is not in use.

In some embodiments, the on-board gas storage tank and associated components do not require routine maintenance and therefore provide longer usage time and lower mannequin maintenance costs than otherwise.

An advantage of a rechargeable on-board gas-storage tank as a source of operating gas for a gas-pressure driven simulation assembly of a tetherless mannequin compared to other alternatives such as an on-board compressor is substantially no generation of noise. An onboard compressor typically makes noise (e.g., humming, whirring) and generate heat that damage the quality of the simulation, for example, of simulated physiological functions such as heart beat or breathing or of search and rescue simulations that begin with a need to find a mannequin substantially hidden from view, e.g., under rubble.

In some embodiments, the recharging port is configured for in situ filling of the first on-board gas storage tank, that is to say the recharging port is typically accessible and operable for charging of the first on-board gas storage tank without need for substantial movement or dissassembly of the mannequin, in some embodiments thereby improving simulation quality.

In some embodiments the mannequin (especially components such as the recharging port and/or the first rechargeable on-board gas storage tank and/or the regulator) is configured for substantially uninterrupted operation of the medical simulation assembly while the first rechargeable on-board gas storage tank is being filled with operating gas through the recharging port, in some embodiments thereby improving simulation quality.

In some embodiments the mannequin is configured (especially components such as the recharging port and/or the first rechargeable on-board gas storage tank) so that during filling of the first on-board gas-storage tank with the operating gas through the recharging port from a higher-pressure gas source, substantially no noise is produced that interferes with simulation of physiological functions and allows filling to be completed in a relatively short time, in some such embodiments not more than about 5 seconds, not more than about 4 seconds, not more than about 3 seconds, not more than about 2 seconds and even not more than about 1 second, in some embodiments thereby improving simulation quality.. In some embodiments, such configuration includes relatively large internal-diameter recharging port shaped to prevent whistling.

As typically known gas-pressure driven medical simulation assemblies require an operating gas supply at a pressure (at the operating gas inlet) of around 1.5 bar, in some embodiments, the pressure regulator is configured for regulating the pressure of operating gas from the storage tank to a pressure of not more than about 2 bar.

In some embodiments, the first on-board gas storage tank is configured to store the operating gas at a maximum pressure of not less than about 100 bar, not less than about 200 bar and even not less than about 300 bar. In some embodiments, the gas storage tank is configured to store the operating gas at a maximum pressure of about 345 bar.

In some embodiments, the first on-board gas storage tank is held inside the mannequin. In some embodiments, the first on-board gas storage tank is held inside a leg of the mannequin. In some embodiments, the first on-board gas storage tank is held inside a lower leg of the mannequin. In some embodiments, the first gas storage tank simulates a shin bone of the mannequin.

In some embodiments, the mannequin further comprises a second on-board gas storage tank.

In some embodiments, the second on-board gas storage tank is in fluid communication with the first on-board gas storage tank. In some embodiments, the second on-board gas storage tank is in fluid communication with the first on-board gas storage tank such that operating gas from the first on-board gas storage tank flowing to the operating gas inlet (freely) passes through the second on-board gas storage tank.

In some embodiments, the second on-board gas storage tank is in fluid communication with the first on-board gas storage tank such that operating gas filling the first on-board gas storage tank through the recharging port also flows to and fills the second onboard gas storage tank.

In some embodiments, the second on-board gas storage tank is held within a leg of the mannequin.

In some embodiments, the first on-board gas storage tank is held within a lower leg of the mannequin and the second on-board gas storage tank is held within a corresponding thigh of the leg of the mannequin.

In some embodiments, the fluid communication between the first on-board gas storage tank and the second on-board gas storage tank is provided by a connecting element passing through a corresponding knee of the leg of the mannequin. In some embodiments, the mannequin has a knee joint, moveable in a manner simulating the movement of a knee. In some such embodiments, the connecting element is flexible, so as not to interfere with knee movement. For example, in some embodiments the connecting element constitutes the knee joint, and in some embodiments there exists a separate knee-joint component.

As noted above, it is advantageous that the recharging port be configured to allow access thereto without need for substantial movement of the mannequin. Accordingly, in some embodiments the recharging port is accessible at the heel of the foot of the leg of the mannequin. In some such embodiments, the recharging port is connected to the on-board gas storage tank through a connecting element located at the ankle of the leg of the mannequin. In some embodiments, the recharging-port / storage tank connecting element is configured to rotate in an ankle-like fashion.

In some embodiments the capacity of the on-board gas storage (in the first, and if present, the second tanks) is sufficient to store an amount of the operating gas sufficient for not less than about 1, not less than about 2, not less than about 3 and in some embodiments even not less than about 4 hours of the continuous operation of the medical simulation assembly, in at least some embodiments thereby improving simulation quality. Continuous operation is understood as "normal" operation by a person having ordinary skill in the art or the manufacturer of a medical simulation mannequin. In some embodiments, the mannequin further comprises an operating-gas gauge configured to determine and wirelessly report a measure of the amount of operating gas actually stored in the on-board gas storage tank. For example, in some embodiments, such a gauge includes a gas-pressure gauge associated with a Bluetooth® or RFID transceiver for continuous, non-continuous or post-interrogation reporting of the measure of the amount of operating gas.

According to an aspect of some embodiments of the invention, there is also provided a medical simulation system, comprising:

at least one (in some embodiments at least 2 or even at least 3) tetherless mannequins according to the teachings herein;

at least one portable refill pack including at least one refill tank for holding operating gas for refilling a first on-board gas storage tank of a mannequin; and

a refill-pack filling station for refilling a refill tank of a portable refill pack with operating gas.

By "portable" is meant that an individual refill pack is configured to be practically transportable, also over rough terrain by not more than three humans, and even not more than two humans. In preferred embodiments, a single refill pack is man-portable and is transportable by a single human. Such configuration typically includes a weight of not more than about 40 kg, not more than about 30 kg, not more than about 25kg, not more than about 20 kg, and even not more than about 15 kg.

As noted above, in some embodiments, the first on-board gas storage tank of a mannequin is configured to store the operating gas at a maximum pressure of not less than about 100 bar, not less than about 200 bar and even not less than about 300 bar. In some embodiments, the gas storage tank is configured to store the operating gas at a maximum pressure of about 345 bar.

In some embodiments, a refill pack is configured to allow refilling of the first onboard gas storage tank of a mannequin by establishment of a fluid communication between the refill tank and the first on-board gas storage tank through the recharging port, allowing (preferably unassisted) operating gas expansion from the refill tank to the first on-board gas storage tank. As known to a person having ordinary skill in the art, such configuration requires, inter alia, that the refill tank store operating gas at a higher internal pressure than the first on-board gas storage tank. As refilling of the on-board gas storage tank is by expansion from a refill tank, the operating gas cools so quick refilling is not associated with dangerous heating that can be a safety hazard or compromise the integrity of the mannequin and components thereof.

In some embodiments, the refill tank of a refill pack is configured to hold the operating gas at a maximum pressure of not less than about 200 bar, not less than about 300 bar, not less than about 400 bar, not less than about 500 bar and even not less than about 600 bar. In some embodiments, the gas storage tank is configured to store the operating gas at a maximum pressure of about 611 bar.

A greater capacity allows a refill pack to be used to refill more mannequin on-board gas storage tanks before requiring a recharging. In some embodiments, a refill pack has a capacity (in terms of the amount of operating gas that can be held in the refill tanks thereof) at least about twice, and in some embodiments, at least about three times that of a mannequin (held in the first, and if present also second, on-board gas storage tank. For example, in a typical embodiment, the total capacity of a mannequin is up to about 5 liter, more typically not more than about 4 liters and usually not more than about 3 liters. In a typical embodiment, a refill pack has a capacity of about 12.5 liters, about the size of a diving cylinder.

The filling station of a system according to the teachings herein is typically relatively large and its purpose is to refill spent refill pack refill tanks. Although a filling station is typically mobile, for example, is vehicle or trolley mounted, in some embodiments a filling station is fixed. In some embodiments, a filling station is configured for filling a single refill tank or a single refill pack at a time. In some embodiments, a filling station is configured for filling at least two, at least three and even more refill tanks or refill packs simultaneously.

In some embodiments, the filling station comprises a gas reservoir tank for holding operating gas with which to refill a refill tank. In some embodiments, the filling station is configured to allow the refilling of a refill tank of a refill pack by establishment of fluid communication between the reservoir tank and the refill tank, allowing (preferably unassisted) operating gas expansion from the reservoir tank to the refill tank. Analogously to the discussed above, as refilling of the refill packs is by expansion from a gas reservoir tank, the operating gas cools so quick refilling is not associated with dangerous heating that can be a safety hazard.

In some embodiments, the reservoir tank is configured to hold the operating gas at a maximum pressure of not less than about 250 bar, not less than about 350 bar, not less than about 450 bar, not less than about 550 bar and even not less than about 650 bar. In some embodiments, the gas storage tank is configured to store operating gas at a maximum pressure of about 689 bar.

A greater capacity allows a reservoir tank to be used to refill more refill tanks before requiring refilling. More importantly, a greater capacity ensures that the pressure drop in the reservoir tank caused by filling a single refill tank is less substantial, helping ensure that filling is quick. Thus, in some embodiments, a reservoir tank has a capacity (in terms of the amount of operating gas that can be held therein) at least about twice, and in some embodiments, at least about five and even at least about ten times that of a refill pack. As noted above, in a typical embodiment, a refill pack has a capacity of about 12.5 liters. In a typical embodiment, a reservoir tank has a capacity of 162 liter.

In some embodiments, the filling station further comprising a compressor (or like component) for filling the reservoir tank, for example, when needed or continuously. In some such embodiments, the filling station requires an external power source although in preferred embodiments, the filling station includes batteries and/or a generator for providing power to operate the compressor.

In some embodiments, the filling station includes a compressor (or like component) that is configured for directly refilling a refill tank with operating gas. In some such embodiments, the filling station requires an external power source although in preferred embodiments, the filling station includes batteries and/or a generator for providing power to operate the compressor. Such embodiments are typically less preferred as these fill the refill tank more slowly, are less reliable, and allowance must be made for cooling the refill tank being filled.

According to an aspect of some embodiments of the invention, there is also provided a method for medical training, the method comprising:

a. providing:

at least one mannequin according to the teachings herein;

at least one portable refill pack (as described herein) including at least one refill tank for holding operating gas for refilling the first on-board gas storage tank of a mannequin; and

at least one refill-pack filling station (as described above) for refilling a refilling tank of a portable refill pack with operating gas,

b. for at least one mannequin, placing the mannequin at a simulation-location and activating the medical simulation assembly of the mannequin, thereby operating the mannequin to simulate a medical event allowing a trainee to undergo training using the mannequin;

c. during the operating and as needed, recharging a the first on-board gas storage tank of the mannequin at the simulation-location by establishing fluid communication between the on-board gas storage tank of the mannequin and a refill tank of a portable refill pack through the recharging port to effect transfer of operating gas from the refill tank to the first on-board gas storage tank; and

d. during the operating and as needed, at the filling station refilling a refill tank of a portable refill pack with operating gas.

In some embodiments, the medical event being simulated is a mass-casualty event. In some embodiments, at least two, at least 3, at least 4, at least 5 and even at least 10 mannequins are placed at a simulation location and the respective medical simulation assemblies activated.

In some embodiments, in 'c', the need for recharging a first on-board gas storage tank of a mannequin is according to a decision of a supervisor of the simulation. In some embodiments, the in 'c', the need for recharging a first on-board gas storage tank of a mannequin is according to a schedule. In some embodiments, in 'c', the need for recharging a first on-board gas storage tank of a mannequin is based on wirelessly receiving an indication that an amount of operating gas in the on-board gas storage tank of a mannequin is lower than a threshold.

In some embodiments, the recharging 'c' of a first on-board gas storage tank includes (a human) carrying a portable refill pack to proximity of a mannequin to allow the transfer of operating gas to the first on-board gas storage tank of the mannequin.

In some embodiments, the recharging 'c' of a first on-board gas storage tank of a mannequin is performed in situ, without substantial movement of the mannequin during the simulation.

In some embodiments, the recharging 'c' of a first on-board gas storage tank of a mannequin is without substantial interruption of operation of the medical simulation assembly of the mannequin.

In some embodiments, the recharging 'c' of a first on-board gas storage tank of a mannequin is without generation of substantial noise, that is to say, noise sufficient to substantially interfere with a simulated physiological function. In some embodiments, the recharging 'c' of a first on-board gas storage tank of a mannequin is completed in not more than about 5, not more than about 4, not more than about 3, not more than about 2 and even not more than about 1 second.

In some embodiments, the method further comprises: maintaining the pressure and amount of operating gas in the refill tank of the refill pack relative to that of a first on-board gas storage tank such that the refilling 'c' of a first on-board gas storage tank of a mannequin includes, subsequent to establishing fluid communication between the refill tank and the first on-board gas storage tank, the pressure and amount of operating gas in the refill tank being sufficient for (preferably unassisted) operating gas expansion from the refill tank to the first on-board gas storage tank, as discussed above.

Eventually a refill pack requires refilling. In some embodiments, refilling 'd' a refill tank includes (preferably a human) carrying a portable refill pack to proximity of a filling station to allow refilling of the refill tank. In some instances, the human leaves the refill pack to be filled (eventually) by someone else, and takes an already full refill pack to continue the task 'c' of refilling the on-board gas storage tanks.

In some embodiments, the filling station comprises a gas reservoir tank for holding operating gas, as described above.

In some embodiments, the method further comprises: maintaining the pressure and amount of operating gas in the gas reservoir tank relative to that of a refill tank of a refill pack such that the refilling of the refill tank 'd' includes, subsequent to establishing fluid communication between the refill tank and the reservoir tank, the pressure and amount of operating gas in the reservoir tank being sufficient for (preferably unassisted) operating gas expansion from the gas reservoir tank to the refill tank, as discussed above. In some embodiments, maintaining the pressure and amount of operating gas in the gas reservoir tank is effected by operating a compressor.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. In case of conflict, the specification, including definitions, takes precedence.

As used herein, the terms "comprising", "including", "having" and grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise.

As used herein, when a numerical value is preceded by the term "about", the term "about" is intended to indicate +/-10%.

For convenience and clarity in addressing a person from the relevant technical field, pressures are expressed herein in units of bar. As is known to a person having ordinary skill in the art, 1 bar is equal to 100 kPa.

BRIEF DESCRIPTION OF THE FIGURES

Some embodiments of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments of the invention may be practiced. The figures are for the purpose of illustrative discussion and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.

In the Figures:

FIG. 1 is a perspective view of an embodiment of a medical simulation mannequin according to the teachings herein;

FIG. 2 is a side perspective view of a leg of an embodiment of a medical simulation mannequin according to the teachings herein comprising a first on-board gas storage tank located within a lower leg and simulating a shin bone and a second on-board storage tank located within a thigh of the mannequin;

FIG. 3 is a back perspective view of a leg of an embodiment of a medical simulation mannequin according to the teachings herein comprising a first on-board gas storage tank located within a lower leg and simulating a shin bone and a second on-board gas storage tank located within a thigh of the mannequin;

FIG. 4 is a schematic view of a medical simulation system comprising the medical simulation mannequin of Figure 1, a portable refill pack and a filling station.

FIG. 5 is a perspective view of an embodiment of a portable refill pack according to the teachings herein; and

FIG. 6 is a perspective view of an embodiment of a filling station according to the teachings herein. DESCRIPTION OF SOME EMBODIMENTS OF THE INVENTION

Tetherless medical simulation mannequins provide greater mobility and flexibility of use than tethered mannequins, thereby allowing a more realistic, therefore effective, simulation experience.

To function tetherlessly, a supply of operating gas must be provided within the mannequin to drive the medical simulation assembly of the mannequin. Tetherless medical simulation mannequins with a compressor installed within a leg are known, but such compressors create an unrealistic noise that, inter alia, interferes with important simulated physiological sounds (e.g., breathing or heart beats). Also, because compressors are power- hungry, , training session durations are limited by the storage capacity of batteries in the mannequin, and must be interrupted for battery replacement and re-charging time. Additionally, small compressors suitable for such uses are fine mechanical devices that must undergo at least annual removal and dissassembly as preventive maintenance.

As noted above, the teachings herein, in at least some embodiments, relate to tetherless medical simulation mannequins, to methods of medical simulation using such mannequins and systems suitable for implementing the methods that in some embodiments overcome at least some of the problems known in the art.

a gas-pressure driven medical simulation assembly having an operating gas inlet configured for accepting an operating gas;

a first rechargeable on-board gas storage tank for storing the operating gas, having: a capacity to hold an amount of the operating gas sufficient for not less than 30 minutes of continuous operation of the medical simulation assembly, and a recharging port allowing filling of the first on-board gas-storage tank with the operating gas;

a gas conduit providing fluid communication between the gas storage tank and the gas-driven medical simulation assembly, the gas conduit having a pressure regulator for regulating the pressure of operating gas expanding from the storage tank to a pressure suitable for input to the operating gas inlet. According to an aspect of some embodiments of the invention, there is also provided a medical simulation system, comprising:

at least one tetherless mannequins according to the teachings herein;

a. providing: at least one mannequin according to the teachings herein; at least one portable refill pack (as described herein) including at least one refill tank for holding operating gas for refilling the first on-board gas storage tank of a mannequin; and at least one refill-pack filling station (as described above) for refilling a refilling tank of a portable refill pack with operating gas,

The principles, uses and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art is able to implement the invention without undue effort or experimentation. In the figures, like reference numerals refer to like parts throughout.

Before explaining at least one embodiment in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth herein. The invention is capable of other embodiments or of being practiced or carried out in various ways. The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting.

Referring now to Figure 1 , there is shown a tetherless pneumatic medical simulation mannequin 10 comprising a gas-pressure driven medical simulation assembly 12. Examples of suitable medical simulation mannequins which may be adapted for use in embodiments described herein include the Harvey® or SimMan® mannequin (both from Laerdal Corporation, Stavanger, Norway).

As depicted in Figure 1 , in some embodiments the mannequin comprises a full-body mannequin, providing a life-like representation of a full human body. In some embodiments, such a full-body mannequin is devoid of one or more limbs, for simulating amputation. Alternatively, in some embodiments the mannequin comprises a partial-body mannequin, providing a life-like representation of a part of the human body, such as the head and torso for simulation of medical situations involving only specific parts of the human body. The human body represented is male, female or indeterminate. In some embodiments the mannequin simulates an adult. In some embodiments the mannequin simulates a pregnant female, with or without simulated fetus. In some embodiments the mannequin simulates a child. In some embodiments the mannequin simulates an infant.

Medical simulation assembly 12 may be configured to control simulation of a specific physiological function or group of functions, such as, for example, cardiovascular functions. Medical simulation assembly 12 comprises an operating gas inlet 14 configured for accepting an operating gas at a pressure of not more than about 2 bar. For example, known suitable such medical simulation assemblies typically accept an operating gas at a pressure of 1.5 bar.

Medical simulation mannequin 10 further comprise a first on-board gas storage tank 16, suitable for holding an operating gas (such as air, nitrogen, argon or neon, or a combination thereof) used for driving medical simulation assembly 12. First on-board gas storage tank 16 preferably has a capacity sufficient for not less than 30 minutes continuous operation of medical simulation assembly 12, preferably far more, e.g., not less than about 1 hour, not less than about 2 hours, not less than about 3 hours and even not less than about 4 hours. In order for a sufficiently small first on-board gas storage tank 16 to have a sufficient capacity for not less than 30 minutes continuous operation of medical simulation assembly 12, the internal pressure in first on-board gas storage tank 16 is typically at least about 100 bar, at least about 200 bar, at least about 300 bar, and even at least about 400 bar. For weight savings and safety, in some embodiments, first on-board gas storage tank 16 comprises non- metallic walls, such as carbon fiber walls. First on-board gas storage tank 16 is provided with an outlet 18 and a separate recharging port 44 allowing filling of first on-board gas storage tank 16 with operating gas. Mannequin 10 is configured for substantially uninterrupted operation of medical simulation assembly 12 while first rechargeable on-board gas storage tank 16 is being filled with operating gas through recharging port 44.

Providing fluid communication between outlet 18 of first on-board gas storage tank 16 and inlet 14 of medical simulation assembly 12 is gas conduit 20. To regulate (especially reduce) operating gas pressure from that provided by first on-board gas storage tank 16 to a pressure suitable for being accepted by operating gas inlet 14, gas conduit 20 comprises a pressure regulator 22 for regulating gas pressure to operating gas inlet 14. Gas conduit 20 comprises a gas conduit inlet 24 configured for coupling to outlet 18 of on-board gas storage tank 16, and a gas conduit outlet 28 for coupling to operating gas inlet 14 of medical simulation assembly 12. Gas conduit 20 provides fluid communication between gas conduit inlet 24 and gas conduit outlet 28 while pressure regulator 22 regulates the pressure of operating gas expanding from on-board gas storage tank 16 to a pressure suitable for input to inlet 14. In some embodiments, pressure regulator 22 regulates pressure at gas conduit outlet 28 to a pressure of not more than about 2 bar, such as, for example, not more than about 1.8 bar, not more than about 1.5 bar, or not more than about 1 bar.

In some embodiments, the capacity of on-board gas storage tank 16 is such that operating gas at a pressure of not more than about 2 bar is provided to inlet 14 for a period of about 2 hours when medical simulation assembly 12 is in constant use, or for a period of up to about 3 hours when used for about 60% of the time.

In Figure 1, first on-board gas storage tank 16 is held inside medical simulation mannequin 10,inside a leg 34, specifically a lower leg 32 of medical simulation mannequin 10, simulating a shin bone of mannequin 10. In some embodiments, the first on-board gas storage tank 16 is held in a cavity elsewhere within the mannequin, such as within the upper leg or torso. In some, less preferred, embodiments, a first on-board gas storage tank 16 is located outside the body of the mannequin. In order to maintain a life-like simulation and ensure portability, first on-board gas storage tank 16, when provided outside the body of a medical simulation mannequin, is preferably concealed within or fashioned as an accessory, such as a backpack, attached to the mannequin. In Figure 1, pressure gauge 39 is configured to determine the pressure in gas conduit 20, and therefore in first on-board gas storage tank 16, and to report the determined pressure by wireless transmission (over a Bluetooth® piconet using a battery-powered integrated Bluetooth® transceiver). The reported pressure can be used by an operator to determine the actual amount of operating gas stored in first onboard gas storage tank 16.

In Figure 2 is depicted a leg 34 of a different embodiment of a medical simulation mannequin according to the teachings herein, having a first on-board storage gas tank 16 held within a lower leg 32 and a second on-board gas storage tank 36, held within thigh 38, in fluid communication with first on-board gas storage tank 16 such that operating gas from first on-board gas storage tank 36 flowing to operating gas inlet 14 passes through second onboard gas storage tank 36 and operating gas filling first on-board gas storage tank 16 through said recharging port 44 also flows to and fills second on-board gas storage tank 36. In leg 34 depicted in Figure 2, the fluid communication between first on-board storage gas tank 16 and second on-board gas storage tank 36 is through a connecting conduit 35 passing through a knee 42 of leg 34. In Figure 2, connecting conduit 35 is a flexible steel-reinforced tube that does not interfere with the movement of knee 42 around knee joint 37.. Second on-board gas storage tank 36 is provided with an outlet 25. In some embodiments, second on-board gas storage tank 36 comprises non-metallic walls, such as carbon fiber walls.

Both the mannequin depicted in Figure 1 and in Figure 2 comprise a recharging port 44 of first rechargeable on board gas storage tank 16, accessible at the heel 46 of foot 48 of leg 34. Filling port 44 is connected to on-board gas storage tank 16 by a second connecting element 50 located at the ankle 52 of foot 48 of leg 34. Second connecting element 50 is preferably configured to function as a simulated ankle-joint to rotate in an ankle-like fashion so that ankle movement is not impeded. In some embodiments, there is a separate ankle-joint simulating component, and recharging port 44 and/or the respective second connecting element 50 are configured (e.g., being flexible) so as not to interfere with the ankle motion.

The fact that recharging port 44 is accessible at heel 46 configures recharging port 44 for in situ filling of first on-board gas storage tank 16: while the mannequin is located in almost any relevant location (e.g., under rubble, on the ground, on a stretcher) and almost any posture (e.g., laying face-down, face-up on the side, sprawled) recharging port 44 is accessible for filling operating without need for moving or interfering with the use of the mannequin for simulation and/or training.

In Figure 3 is shown a back view of a leg 34 of an additional embodiment of a medical simulation mannequin according to the teachings herein, comprising first on-board gas storage tank 16 within lower leg 32 simulating a shin bone, and second on-board gas storage tank 36 within upper leg 38 simulating a thigh bone of the mannequin. Fluid communication between on-board gas storage tank 16 and second on-board gas storage tank 36 is provided by first connecting element 40 located at knee 42 of leg 34. First connecting element 40 is configured to simulate the knee joint by bending in a knee-like fashion. First on-board storage gas tank 16 further comprises a recharging port 44, accessible at the heel 46 of foot 48 of leg 34. Filling port 44 is connected to first on-board gas storage tank 16 by a second connecting element 50 located at the ankle 52 of foot 48 of leg 34. Second connecting element 50 is preferably configured to simulate an ankle joint by moving in an ankle-like fashion.

As discussed above, medical simulation mannequins according to the teachings herein, such as depicted in Figure 1, 2 and 3, are exceptionally useful as components of embodiments of a medical simulation system according to the teachings herein and/or for implementing embodiments of a method for medical training according to the teachings herein.

An embodiment of a medical simulation system according to the teachings herein, system 54, is schematically depicted in Figure 4., comprising at least one medical simulation mannequin 10 according to the teachings herein (for example, at least one, at least two, at least three, at least four, or more mannequins), at least one portable refill pack 56 including at least one refill tank 68 for holding operating gas for refilling the first on-board gas storage tank of the mannequins, and at least one refill-pack filling station 58 for refilling refill tanks 68 of the portable refill packs 56 with operating gas. In Figure 4, filling station 58 comprises a reservoir tank 60 a compressor 62 having a gas inlet 64 and connected to a power supply 66, such as a generator, a battery or electrical outlet.

Figure 5 depicts an embodiment of a portable refill pack 56 in the form of a backpack comprising two refill tanks 68a and 68b secured to a carrying rack 70 with carrying straps 72 Refill pack 56 includes a single inlet port 57, allowing simultaneous filling of both refill tanks 68a and 68b with operating gas, and a single outlet port 59 functionally associated with switch 61, refill hose 63 and coupling element 65. For use, coupling element 65 is forcefully coupled with a recharging port 44 of a mannequin and switch 61 is activated to open outlet port 59. When outlet port 59 opens, operating gas from tanks 68a and 68b passes through outlet port 59, through hose 63, coupling element 65, into the recharging port 44 and into the first rechargeable on-board gas storage tank 16. Typically, a refill pack 56 includes a safety feature that prevents over filling of a first on-board gas-storage tank, for example an outlet port 59 is configured to prevent exist of operating gas at a pressure higher than is safe for a first on-board gas-storage tank. Portable refill pack 56 depicted in Figure 5 is of dimensions and weight to be easily carried and operated, even over rough terrain by a a single human. Such configuration enables an operator to quickly, easily and unobtrusively refill an on-board gas storage tank 16 of a mannequin 10 while mannequin 10 is in use in situ with insubstantial effect on the simulation and the trainees. In some embodiments, a portable refill pack according to the teachings herein comprises one, two or more refill tanks. Preferably the gas passages from air tanks 68 through the first on-board gas storage tank 16 are configured so that during refilling the gas passes not only quickly, but also substantially silently so as to not substantially effect the simulation.

In some embodiments, a portable refill pack contains a sufficient amount of gas at a sufficient pressure compared to the pressure and needed recharge volume of on-board gas storage tank 16, so that transfer is by unassisted expansion of operating gas from a refill tank 68 to an on-board storage tank 16.

In some embodiments, a portable refill pack 56 holds a sufficient amount of operating gas to provide multiple recharging of at least one on-board gas storage tank 16 of a mannequin 10. Use of a portable refill pack in accordance with the teachings herein allows the on-board gas tanks of a mannequin to be refilled in remote locations, and extends the period over which a medical simulation mannequin can be continuously used in challenging environments (e.g., field, rough terrain, wreckage and rubble) for many hours. In some embodiments, the total weight of a portable refill pack 56 such as depicted in Figure 5 comprising two refill tanks 68a and 68b is about 38 kg. In some embodiments, portable refill tanks such as 68a and 68b are constructed using a lightweight carbon fiber.

In Figure 6 a filling station 58 suitable for implementing the teachings herein is depicted, comprising reservoir tank 60, compressor 62 having gas inlet 64 and preferably a power supply 66. Filling station 58 is preferably mobile, for example provided on a vehicle, trolley or cart. Examples of suitable compressors include compressor SA-3E from RIX Industries, Benicia CA, USA. The pressure of gas entering compressor 62 through gas inlet 64 is optionally brought to a pressure of about 230 bars, for example at a rate of about 60 standard liters per minute. Compressor 62 further comprises an intensifier (not shown), which increases the pressure of the gas to about 700 bar before passing to reservoir tank 60.

Compressor 62 comprises an electric motor and requires connection to a power supply 66, such as an AC power supply, for example 220-230V, 1 phase, 50 Hz. In some embodiments, the intensifier is driven by air pressure and requires a low pressure source, such as 6 bar. In a hospital environment, the low pressure source may be provided by the central air system. Alternatively, the intensifier may be driven by an electrical motor. Reservoir tank 60 preferably has a large capacity relative to portable refill pack 56. In some embodiments, reservoir tank 60 of filling station 58 contains a sufficient amount of gas at a sufficient pressure compared to the pressure and needed recharge volume of portable refill pack 56, so that said transfer is by (preferably unassisted) expansion of gas from reservoir tank 60 to portable refill pack 56.

Preferably, the capacity of reservoir tank 60 is sufficiently greater than that of portable refill tanks 68 that multiple charging packs 56 can be filled without requiring interruption of a medical simulation for refilling of reservoir tank 60 by compressor 62. In some embodiments, reservoir tank 60 is configured to contain about 160 liters of gas at pressure of about 700 bar , wherein the gas pressure is maintained by the compressor for about 32 hours after filling of reservoir tank 60.

In some embodiments, use of reservoir tank 60 containing high pressure gas enables portable refill pack 56 to be rapidly refilled, such as within a time period of no greater than 2 minutes and even less. It is preferred that recharging of portable refill pack 56 at filling station 58 be quick and fail-safe, even under challenging conditions of weather and lighting (such as at night). In some embodiments, filling station 58 further comprises a regulator (not shown) that releases gas into portable refill pack 56 at the required safe pressure. In some embodiments, a single filling station 56 has at least two, at least three filling conduits each having an own regulator to allow concurrent filling of multiple portable refill packs 56.

In some embodiments, when a portable refill pack 56 is connected to reservoir tank 60 of filling station 58, pressure is rapidly equalized to about 611 bar. Portable refill pack 56 is then disconnected from reservoir tank 60, and can be used immediately with no need for cooling. If needed, compressor 62 is activated and restores pressure in reservoir tank 60 to about 690 bars within less than about 4 hours. In some embodiments, additional reservoir tanks and/or compressors and/or smaller portable refill packs may be used to decrease the restoration time.

The pressure at which gas is discharged into on-board gas storage tank 16 affects the operating time of medical simulation mannequin 10. The system described herein may comprise multiple medical simulation mannequins 10. For example, in some embodiments the system described herein may provide 3 hours of operation for 27 individual mannequins.

According to an aspect of some embodiments, there is provided a retrofit kit for use with a known medical simulation mannequin comprising a gas-pressure driven medical simulation assembly comprising an operating gas inlet, the kit comprising an on-board gas storage tank 16 holding a gas at a pressure of at least 100 bar, and a gas conduit 20 comprising a pressure regulator 22 for regulating gas pressure to an operating gas inlet of a gas-pressure driven medical simulation assembly. On-bard gas storage tank 16 provided with an outlet 18. Gas conduit 20 comprises a gas conduit inlet 24, configured for coupling to outlet 18 of on-board gas storage tank 16, and a gas conduit outlet 28 configured for coupling to an operating gas inlet of a medical simulation mannequin.

In some embodiments, the retrofit kit is installed in a known medical simulation mannequin by removing a limb, such as a leg of the standard mannequin and replacing with a limb fitted with the retrofit kit. In some embodiments, the retrofit kit is installed in an existing limb of a known medical simulation mannequin.

As noted above, according to an aspect of some embodiments of the invention, there is also provided a method for medical training, the method comprising:

a. providing:

at least one mannequin (for example, at least one, at least two, at least three, at least four, at least 10 or more mannequins )according to the teachings herein; at least one portable refill pack (as described herein) including at least one refill tank for holding operating gas for refilling the first on-board gas storage tank of a mannequin; and

In some embodiments of the method of medical training, the mannequins are placed in a relevant simulation location and position, such as on a bed, gurney or ground, in the field, in a wreck of a building or vehicle (e.g., car, bus, aircraft, train), or under rubble, depending on the medical event to be simulated. In some embodiments, the medical training is of a mass casualty event, such as, for example, a terrorist attack (including bioterrorism), chemical emergency, radiation emergency, natural disaster (such as earthquake, hurricane, flood and the like), or a multiple- vehicle accident.

The method of medical training may be used for training of medical personnel, including doctors, nurses, paramedics, ambulance crew, and medical technicians, as well as first responders such as firefighters, police or military personnel.

In some embodiments, the method of medical training further comprises monitoring an amount of gas in at least a first on-board gas storage tank of a medical simulation mannequin as an aid to deciding when to recharge the operating gas of the mannequins.

In some embodiments, the method of medical training further comprises intermittently recharging first on-board gas storage tanks, for example according to a predetermined schedule, or as convenient for the operator. Preferably, first on-board gas storage tank is recharged without substantial interruption or effect of the simulation of a medical event.

In some embodiments, the method of medical training further comprises monitoring an amount of gas in a portable refill pack . In some such embodiments, a portable refill pack further comprises a pressure gauge, which indicates the amount of operating gas held in the respective refill tank or tanks 68, allowing the operator to monitors when there is a need to refill the operating gas in the portable refill pack.

In some embodiments, the method of medical training further comprises intermittently recharging portable refill pack, for example according to a predetermined schedule, or as convenient for the operator.

In some embodiments, the method of medical training further comprises maintaining reservoir tank of filling station filled with sufficient gas, such as by operating compressor to compress gas into reservoir tank.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements. Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the scope of the appended claims.

Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the invention.

Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

Claims

WHAT IS CLAIMED IS:

1. A tetherless pneumatic medical simulation mannequin comprising:

a first rechargeable on-board gas storage tank for storing said operating gas, having: a capacity to hold an amount of said operating gas sufficient for not less than 30 minutes of continuous operation of said medical simulation assembly, and a recharging port allowing filling of said first on-board gas-storage tank with said operating gas;

a gas conduit providing fluid communication between said gas storage tank and said medical simulation assembly, the gas conduit having a pressure regulator for regulating the pressure of operating gas expanding from said storage tank to a pressure suitable for input to said operating gas inlet.

3. The mannequin according to claim 2, configured for substantially uninterrupted operation of said medical simulation assembly while said first rechargeable on-board gas storage tank is filled with said operating gas through said recharging port.

4. The mannequin according to any one of claims 1 to 3, wherein said on-board gas storage tank is configured to store said operating gas at a maximum pressure of not less than about 100 bar.

5. The mannequin according to any one of claims 1 to 4, wherein said first on-board gas storage tank is held inside the mannequin.

6. The mannequin according to any one of claims 1 or 5, wherein said first on-board gas storage tank is held inside a leg of the mannequin.

7. The mannequin according to claim 6, wherein said first on-board gas storage tank is held inside a lower leg of the mannequin.

8. The mannequin according to claim 7, wherein said first gas storage tank simulates a shin bone of the mannequin.

9. The mannequin according to any one of claims 1 to 8, further comprising a second onboard gas storage tank.

10. The mannequin according to claim 9, wherein said second on-board gas storage tank is in fluid communication with said first on-board gas storage tank.

11. The mannequin according to claim 10, wherein said second on-board gas storage tank is in fluid communication with said first on-board gas storage tank such that operating gas from said first on-board gas storage tank flowing to said operating gas inlet passes through said second on-board gas storage tank.

12. The mannequin according to any one of claims 10 to 11, wherein said second onboard gas storage tank is in fluid communication with said first on-board gas storage tank such that operating gas filling said first on-board gas storage tank through said recharging port also flows to and fills said second on-board gas storage tank.

13. The mannequin according to claim 10 to 12, wherein said second on-board gas storage tank is held within a leg of the mannequin.

14. The mannequin according to claim 13 , wherein:

said first on-board gas storage tank is held within a lower leg of the mannequin and said second on-board gas storage tank is held within a corresponding thigh of said leg of the mannequin.

15. The mannequin according to claim 14, wherein said fluid communication between said first on-board gas storage tank and said second on-board gas storage tank is provided by a connecting element passing through a corresponding knee of said leg of the mannequin.

16. The mannequin according to claim 9, wherein said connecting element is flexible, so as not to interfere with knee movement.

17. The mannequin according to any one of claims 14 to 16, said recharging port accessible at the heel of the foot of said leg of the mannequin.

18. The mannequin according to claim 11, wherein said recharging port is connected to said on-board gas storage tank through a connecting element located at the ankle of said leg of the mannequin.

19. The mannequin according to claim 18, wherein said recharging-port / storage tank connecting element is configured to rotate in an ankle-like fashion.

20. The mannequin according to any one of claims 1 to 19, further comprising an operating gas gauge configured to determine and wirelessly report a measure of the amount of operating gas actually stored in said on-board gas storage tank.

21. A medical simulation system, comprising:

at least one mannequin according to any one of claims 1 to 20;

at least one portable refill pack including at least one refill tank for holding operating gas for refilling a said first on-board gas storage tank of said mannequin; and a refill-pack filling station for refilling a said refill tank of a said portable refill pack with said operating gas.

22. The system according to claim 21, wherein said first on-board gas storage tank of a said mannequin is configured to store said operating gas at a maximum pressure of not less than about 100 bar.

23. The system according to claim 22, wherein a said portable refill pack is configured to allow refilling of a said first on-board gas storage tank of a said mannequin by establishment of a fluid communication between said refill tank and said first on-board gas storage tank through said recharging port, allowing operating gas expansion from said refill tank to said first on-board gas storage tank.

24. The system according to claim 23, wherein said refill tank is configured to hold said operating gas at a maximum pressure of not less than about 200 bar.

25. The system according to any one of claims 23 to 24, wherein a said refill pack has a capacity to hold said operating gas at least twice that of a said mannequin.

26. The system according to any one of claims 21 to 25, wherein said filling station comprises a gas reservoir tank for holding operating gas with which to refill a said refill tank.

27. The system according to claim 26, wherein said filling station is configured to allow said refilling of a said refill tank of a refill pack by establishment of fluid communication between said reservoir tank and a said refill tank, allowing operating gas expansion from said reservoir tank to said refill tank.

28. The system according to any one of claims 26 to 27, wherein said reservoir tank is configured to hold said operating gas at a maximum pressure of not less than about 250 bar.

29. The system according to any one of claims 26 to 28, wherein said reservoir tank has a capacity to hold said operating gas at least twice that of a said refill tank

30. The system according to any one of claims 26 to 29, said filling station further comprising a compressor for filling said reservoir tank.

31. The system according to any one of claims 26, wherein said filling station comprises a compressor configured for directly refilling a said refill tank.

32. A method for medical training, the method comprising:

a. providing:

at least one mannequin according to any one of claims 1 to 20; at least one portable refill pack including at least one refill tank for holding operating gas for refilling a said first on-board gas storage tank of a said mannequin; and

at least one refill-pack filling station for refilling a said refilling tank of a said portable refill pack with operating gas,

b. for at least one said mannequin, placing said mannequin at a simulation- location and activating said medical simulation assembly of said mannequin, thereby operating said mannequin to simulate a medical event allowing a trainee to undergo training using said mannequin;

c. during said operating and as needed, recharging a said first on-board gas storage tank of a said mannequin at the simulation-location by establishing fluid communication between said on-board gas storage tank of said mannequin and a refill tank of a said portable refill pack through said recharging port to effect transfer of operating gas from said refill tank to said first on-board gas storage tank; and d. during said operating and as needed, at a said filling station refilling a refill tank of a said portable refill pack with operating gas.

33. The method according to claim 32, wherein said medical event is a mass-casualty event.

34. The method according to any one of claims 32 to 33, wherein at least two said mannequins are placed and activated,

35. The method according to any one of claims 32 to 35, wherein in said 'c' , said need for recharging a said first on-board gas storage tank of a said mannequin is according to a supervisor decision.

36. The method according to any one of claims 32 to 35, wherein in said 'c' , said need for recharging a said first on-board gas storage tank of a said mannequin is according to a schedule.

37. The method according to any one of claims 32 to 36, wherein in said 'c' , said need for recharging a said first on-board gas storage tank of a said mannequin is based on wirelessly receiving an indication that an amount of operating gas in a said on-board gas storage tank of a mannequin is lower than a threshold.

38. The method according to any one of claims 32 to 37, wherein said recharging 'c' a said first on-board gas storage tank includes carrying a said portable refill pack to proximity of a said mannequin to allow said transfer of operating gas to a said first on-board gas storage tank of said mannequin.

39. The method according to any one of claims 32 to 38, wherein said recharging 'c' of a first on-board gas storage tank of a said mannequin is performed in situ.

40. The method according to any one of claims 32 to 39, wherein said recharging 'c' of a first on-board gas storage tank of a said mannequin is without substantial interruption of operation of said medical simulation assembly of said mannequin.

41. The method according to any one of claims 32 to 40, wherein said recharging 'c' of a first on-board gas storage tank of a said mannequin is without generation of substantial noise.

42. The method according to any one of claims 32 to 41, wherein said recharging 'c' of a first on-board gas storage tank of a said mannequin is completed in not more than about 5 seconds.

43. The method according to any one of claims 32 to 42, further comprising: maintaining the pressure and amount of operating gas in a said refill tank relative to that of a said first onboard gas storage tank such that said refilling 'c' of a first on-board gas storage tank of a said mannequin includes, subsequent to said establishing fluid communication between said refill tank and said first on-board gas storage tank, the pressure and amount of operating gas in said refill tank being sufficient for operating gas expansion from said refill tank to said first onboard gas storage tank.

44. The method according to any one of claims 32 to 43, wherein said refilling 'd' a said refill tank includes carrying a said portable refill pack to proximity of a said filling station to allow said refilling of said refill tank.

45. The method according to any one of claims 32 to 44, wherein said filling station comprises a gas reservoir tank for holding operating gas.

46. The method according to claim 45, further comprising: maintaining the pressure and amount of operating gas in said gas reservoir tank relative to that of said refill tank of a said refill pack such that said refilling said refill tank 'd' includes, subsequent to establishing fluid communication between said refill tank and said reservoir tank, the pressure and amount of operating gas in said reservoir tank being sufficient for operating gas expansion from said gas reservoir tank to said refill tank.

47. The method according to claim 46, said maintaining the pressure and amount of operating gas in said gas reservoir tank effected by operating a compressor.