Abstract:
A portable, interactive electronic training device for prompting a trainee on the proper sequence of steps for performing CPR, using a defibrillator and performing CPR in conjunction with the use of a defibrillator. The device simulates the obtaining of direct information about a patient&#39;s condition, such as ECG data collected directly from the patient. The device receives information pertinent to the treatment of the patient indirectly through an operator of the device. The device prompts a trainee on the medically appropriate action such as a defibrillation shock in response to the indirect and direct information. Indirect information is obtained through information processing means that includes means for prompting the operator of the device and means for receiving the operator&#39;s responses thereto. Prompts may include both questions and instructions, and in one embodiment the information processing means obtains the assent of the operator before causing the defibrillation shock. Indirect information may include information as to whether the patient is conscious, whether the patient is an adult, baby or child, and as to whether or not cardiopulmonary resuscitation has been performed. The device also prompts the user on proper placement of training electrode pads upon a simulated victim&#39;s chest by prompting feedback to the trainee if the pads are not placed on the conductive targets located upon the simulated victim&#39;s chest.

Description:
This application claims the benefit of Provisional Application No. 60/117,727, filed Jan. 29, 1999. 
    
    
     FIELD OF THE INVENTION 
     The present invention pertains generally to a training device used to assist a student operator in rescue procedures, and more particularly a hand-on training device used to assist a student in learning cardiopulmonary resuscitation (CPR), training instructions in the use of a defibrillator and rescue procedures such as rescue breathing and choking procedures. 
     BACKGROUND OF THE INVENTION 
     It has been estimated that over 350,000 deaths occur each year in the United States due to cardiac arrhythmia. Many of these deaths could be prevented by rescue procedures such as CPR and defibrillation by properly trained persons in rescue procedures. Thus, there is a continuing need to provide training to the public and to medical personnel in the proper treatment of a patient undergoing cardiac arrest or in need of rescue procedures. In order to train a student properly in rescue techniques, hands-on training aids such as manikins are often utilized. The disadvantage to prior art training aids is that separate devices are often needed to provide the full range of training. For example, CPR manikins and CPR prompting devices are used in training students CPR, while real defibrillator devices are used as defibrillator training aids. These devices can be quite costly. Further, the use of real defibrillator devices in a training environment creates a possible danger of discharging an unintended potent electric shock. Further, these type of devices in general only assist in the instruction of the use of the defibrillator, and do not provide instruction in the use of CPR or other rescue techniques such as rescue breathing. Still further yet, these training devices generally assume that the patient is of a sufficient age to receive shock treatment. In addition, prior art defibrillator and CPR training devices generally do not instruct the trainee to check for a pulse after a victim has received a shock treatment nor after a series of CPR compressions have been given. Finally, these type of training devices do not teach the proper placement of the paddles upon the patient. These and other features and advantages of the invention will become apparent in the detailed description and claims to follow, taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of a CPR-AED training device shown in use with a manikin according to the present invention; 
         FIG. 2  is a front view of the CPR-AED training device of  FIG. 1  with the cover plate removed and the electrodes withdrawn. 
         FIG. 3  is a rear view of the CPR-AED training device of  FIG. 1  with the programmable display panel in view. 
         FIG. 4  is a perspective view of a training electrode pad and cable shown with a removable attachment clip for insertion onto the training electrode pads. 
         FIG. 5  is an enlarged perspective view of the removable attachment clip shown in  FIG. 4  which is shown installed on the training electrode pad. 
         FIG. 6  is a side view of the removable attachment clip shown in the direction  6 — 6  of FIG.  5 . 
         FIG. 7  is an enlarged view of the removable attachment clip shown in the direction  7 — 7  of FIG.  6 . 
         FIG. 8  is a bottom view of a training electrode pad with the target means shown in phantom in several locations. 
         FIG. 9  is a block diagram of the CPR-AED training device of FIG.  1 . 
         FIGS. 10-12  are logic diagrams of the CPR-AED training device in the CPR ONLY Mode, the AED MODE, and the CPR-AED Mode. 
         FIGS. 13-15  are program control logic diagrams of the prompting sequences of the CPR-AED training device in CPR Mode, AED Mode, and CPR-AED Mode, respectively. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Mechanical System 
     Referring initially to  FIGS. 1-3 , a CPR-AED training device  10  of the present invention is shown. The device  10  prompts trainees with instructions on the proper sequence of steps of CPR and defibrillation in a non-emergency setting, with input information from the trainee to the device  10 . With respect to the defibrillation prompting, the device  10  allows a trainee to evaluate simulated patient electrocardiogram (ECG) signals and perform simulated defibrillation with or without CPR prompting. As shown in  FIG. 1 , the device  10  may be used alone or in conjunction with a manikin  100  or other means for simulating a victim. The CPR-AED training device  10  comprises a body  12  having a front panel  14  and a rear panel  16 , a cover plate  18 , and carrying handle  20 . The training device  10  further comprises an audio speaker  30  with volume control (not shown) for audibly prompting a trainee in rescue operations. The cover plate  18  is slidably mounted within grooves (not shown) of the body  12  of the training device and may be used to cover and protect the device CPR keypad  40 . The CPR keypad  40  comprises a plurality of interactive key switches which are operative in the CPR mode  74  and are used by the trainee to provide feedback to the device  10  of the simulated victim&#39;s condition. The CPR keypad  40  includes an adult key  41 , a baby key  42  and a child key  43  used by trainee to provide feedback to the device  10  of the victim&#39;s age. Additionally, the keypad  40  comprises a Heimlich maneuver labeled key “1”  44  used when victim is conscious and choking, and an abdominal thrust key “2”  45  utilized when the victim is unconscious with a blocked airway. Key “3” labeled Rescue breathing  46  is used when victim has a pulse but is unconscious, while key 4  47  labeled “CPR” is used when victim has been assessed by the trainee to be unconscious with no pulse or breathing. The CPR keypad  40  further comprises an off switch  48  which will switch off the device, and the pause key  49  which will pause the algorithm. The off switch is operative in all three modes, while the pause key is only active in both mode  76  and CPR mode  74 . Finally, each of the keys (except the off key) on keypad has its own LED indicator light to indicate when the key has been activated by the trainee. 
     The front panel  14  further comprises an AED keypad  50  comprising an AED POWER switch  52 , an ANALYZE switch  54 , and a SHOCK switch  56 . Each AED switch  52 - 56  has its own LED indicating light  58 - 62  to indicated that the switch has been activated when lit. In addition, the front panel of the device  10  further comprises a Select Prompting Mode switch  70  for allowing the trainee to select only defibrillation mode denoted as “AED” as mode  72  the CPR mode  74 , or both CPR and AED prompts denoted as “Both”  76 . 
     As shown in  FIG. 3 , the rear panel  16  of the device  10  comprises a power source  80  such as a battery pack and a Shock Sequence keypad  90 . The Shock Sequence keypad  90  is used by the trainee or instructor to program the sequences of shockable and non-shockable simulated heart rhythms when in the AED mode  72  or CPR-AED mode  76 , as explained in more detail below. 
     As shown in  FIGS. 1 and 2 , the front panel of the device  10  also comprises a plug receptacle  110  for receiving the plug end  112  of electrode cables  114 . The plug end  112  of the electrode cables has a built in jumper (not shown) in order to indicate continuity of the plug connection when it is properly installed within receptacle  110 . If not, trainee will be prompted to install the cable until the trainee has successfully plugged the electrode cable  114  into its receptacle  110 - 114 . 
     The opposite ends of the electrode cables  114  all connected to disposable electrode pads  120  via an electrode clip  140 . The disposable electrode pads  120  are simulated defibrillator pads and are to be inserted into the electrode clip  140  and then mounted by the trainee upon a simulated victim&#39;s chest as explained in more detail, below. The electrode clip  140  as best shown in  FIGS. 4-6 , comprises two main components made of any suitable non-conductive material such as plastic. The first main component of the electrode clip  140  is the housing  142  which has a first and second mating member  144 , 146 , which together form a slot  148  for receiving an electrode training pad  120  therein. The first and second mating members  144 , 146  are connected together by a screw  150  or other connecting means. The second main component of the clip  140  is the securing means  160  which secures the electrode training pads  120  to the clip  140 . The securing means  160  comprises a first and second arm  162  rotatably mounted to the clip housing  142 , and a planar surface  164  with a tabular extension  166  for easy opening and closing of the clip securing means  160  to the housing  142 . The inner surface of the tabular extension  166  has two spaced prongs  168  aligned for insertion into holes  169  of the first and second mating members  144 , 146  and holes  122  of the electrode pads  120 . 
     Each electrode-training pad  120  is disposable and comprises an upper surface layer  123 , a lower adhesive layer  124 , and a conductive layer  126 . The upper surface layer  123  of the training pad comprises a flexible plastic or foam material. The upper surface layer  123  of each training pad  120  is color coded with a graphic design  128  on the front surface layer  123  of the pads which illustrates the proper placement upon a victim&#39;s chest. The design further includes the number 1 or 2 that indicates the proper sequence of placement of the pads  120  upon the simulated victim&#39;s chest. The lower adhesive layer  124  of the electrode pads  120  has a removable protective liner  130  which is peeled away by the trainee prior to installation upon the simulated victim. The outer conductive layer  126  is adhered to the lower adhesive layer  124 , and is formed of a thin plastic having a metallic or conductive substrate bonded thereto. The outer conductive layer  126  of each electrode training pad  120  acts as a built in sensor means which generates an output signal to the device  10  when the training pad is properly connected to the electrode clip  140  and placed in contact with a conductive target means  170 . The conductive target means  170  is preferably an adhesive disc having an outer conductive layer such as metal. The conductive target means  170  are mounted upon a simulated victim&#39;s chest in the upper right chest and lower left rib position for defibrillation. 
     The sensor means  126  of the electrode training pad  120  as shown in  FIG. 4  in phantom, has a first and second conductive path  132 , 134  respectively, with said second conductive path  134  preferably being located within the interior of said first conductive path  132 , without touching said first conductive path  132 . Preferably, each of said paths have an elongated rectangular shape, although other shapes would work for the invention. When the electrode pad  120  is received within the slot of the clip  160 , the first and second conductive paths  132 , 134  of the sensor means  126  contact a first and second conducting strip  136 , 138  mounted upon the interior surface of the first mounting member  144  of the clip housing  142 . The first and second conducting strip  136 , 138  is soldered to a first and second wire of the electrode cable  114  which has been inserted into the rear end of the clip housing  142 . 
     Thus in order for the trainee to secure the removable electrode pads  120  to the clips  140 , the holes  122  of the electrode training pad  120  are inserted through the slot  148  of the clip  140  such that the holes  122  and  169  are aligned. Then the clip securing means  160  is rotated into position such that the prongs  168  are inserted into the aligned holes  122  and  169 , such that the first and second conducting strip  136 , 138  of the first mating member of the clip  140  contact with the conductive layer  126  of the electrode pads  120 . After notched receiving end of the electrode pad  120  is inserted into the slot  148 , the securing means  160  of the clip  140  is snapped into place such that the prongs  168  are inserted through holes  169  and  122  of the members and the electrode pad, respectively. When the trainee properly mounts each of the electrode pads within its clip  160  and properly places each electrode training pad  120  over its respective target means  170  on the simulated victim&#39;s chest, the target means  170  shorts or completes the circuit formed by the first and second conductive paths  132 , 134 . When the circuit is closed, a small current is generated by the device  10  through the first conducting strip  136  and the first conductive path  132 , through the target means  170  and then back to the device through the second conductive path  134  and the strip  138 , thus indicating that the electrode training pad  120  has been properly placed upon the target  170 . Each electrode training pad  120  must be properly placed over its conductive target  170 , else the trainee will be continually prompted to “PLACE PADS ON VICTIMS BARE CHEST” until the operation is performed correctly for each pad  120 . The trainee will continually be voice prompted until the sequence of operations has been correctly performed. 
     In an alternative embodiment of the invention, a reed switch is utilized as the sensing means in each disposable electrode pads. A reed switch may be attached to the outer surface layer of each electrode pad or mounted within the pad. The reed switch is used to sense when the pads are in close proximity to a target means having a magnet or magnetized surface. The target means are mounted in the proper area of a victim&#39;s chest for defibrillation. Alternatively, a magnet may be mounted upon the electrode pads and the reed switched mounted on the simulated victim&#39;s chest. When the reed switch is in close proximity to the target means, the reed switch generates an electric signal which is communicated to the device  10 , and the trainee will no longer be prompted to “PLACE PADS ON VICTIM&#39;S BARE CHEST”. 
     Electrical System 
     There is shown in  FIG. 9 , a block diagram illustrating the logical arrangement of a system  200  according to the invention. The invention includes a first and second electronic input device, which is preferably keypads  18  and  50  or other keying means. The invention also includes multiple button switches and LED indicator lights. An energy source  210  such as battery pack provides power to the system. The training device further comprises a central processing unit  220 , memory  230  (ROM), and a speech synthesizer unit or chip  240 . The speech synthesizer unit  240  is in electrical communication with an amplifier  250  and a speaker  260 . The speech chip  280  may comprise any chip which furnishes understandable speech suitable for use in the invention. The speech synthesizer unit or chip  240  converts digital data stored in ROM and converts it to analog data. 
     Operation of the Device 
     In order to begin operation of the AED-CPR training device  10 , the trainee first selects the desired training mode using the Prompting Mode switch  70 . The AED-CPR training device  10  has three different training modes denoted as: “AED”, “BOTH”, and “CPR”. If the AED mode is selected, the training device  10  will only provide training prompts that simulate the operation of an actual defibrillator device. The device  10  will first simulate the collection of patient ECG data, then simulate the analyzing of the ECG data by the training device and then the delivery of a simulated electrical pulse to a simulated patient in response to actuation by the trainee. No actual electrical pulse is delivered. If the CPR mode is selected by the trainee, the training device  10  will provide detailed training prompts for the proper sequence of CPR rescue steps. If the “BOTH” mode is selected, the device  10  will provide the trainee with CPR and AED prompts. The operation of these three modes is described in more detail, below. 
     AED Mode 
     If the trainee selects the AED mode by setting the Prompting Mode switch  70  to the “AED” position, the CPR panel  40  is deactivated and the AED panel  50  is activated. The AED mode has three programmable modes for the ANALYZE key. The ANALYZE key may be programmed using the Shock Sequence keypad  90  to toggle key  111  to simulate a manual defibrillator, a semi-automatic defibrillator or an automatic defibrillator. The programming steps are described in more detail, below. 
     As illustrated in  FIGS. 12 &amp; 13 , the simulation of a manual defibrillator in AED mode  72  is described as follows. The trainee must press the “AED” switch  52  in order to begin. The trainee is then prompted by the device to place the training electrode pads  120  on the simulated victim&#39;s bare chest, with pad “1” to be placed on victim&#39;s upper right chest and pad “2” to be positioned on victim&#39;s lower left ribs. If the training electrode pads are not placed on the simulated victim in the proper sequence, i.e., first training pad labeled “1” and then training pad labeled “2”, the trainee will be continually prompted until the trainee performs the operation in the required sequence. Further, each training electrode pad  120  must be placed such that each of its respective sensors  132 ,  134  contacts the respective conductive target  170  located on the simulated victim  100  or manikin. The trainee will continue to be prompted until the trainee successfully performs the sequence of operations. The trainee will then be prompted to connect the electrode plug  112  into the plug receptacle  110  of the device  10 . If the trainee performs this operation successfully, a jumper  113  located within the plug will complete the internal circuit. The device  10  senses that the plug  112  is installed when the jumper  113  completes the intended current. 
     After the training electrode pads  120  and the plug  112  of the electrode cable have been properly installed by the trainee, the trainee is prompted to press the “ANALYZE” switch  54  and to “STAND CLEAR” of the victim. The analyze LED  60  will flash on and off while the device simulates the Analyze function of a real defibrillator. The device  10  will have been previously programmed by an instructor or the trainee as described in more detail, below. The device will indicate to the user via voice prompting whether a shock is advised. If a shock is advised, the Analyze LED  60  will turn off and the shock LED light  62  will flash on and off, while the trainee is voice prompted “SHOCK ADVISED”. If a shock sequence is advised, the trainee will be prompted to “STAND CLEAR” of the victim while a simulated charging tone is emitted from the speaker. The trainee is prompted to “SHOUT ALL CLEAR” and to check if all clear and then press the “SHOCK” key  56 . When the “SHOCK” key  56  is pressed, the trainee will hear a simulated shock ready tone of approximately 15 seconds in duration and then a simulated shock delivered tone. Then the Shock LED light  62  will be deactivated. The trainee will be prompted to press the ANALYZE key  54  to repeat the process. If no shock is advised, the Analyze LED  60  is turned off and the trainee is prompted to check the simulated victim&#39;s breathing and pulse. If no pulse is detected, the trainee is prompted to do CPR for a 1 minute interval. If no pulse is detected by the simulated defibrillator after the trainee has performed CPR for a set interval of time, the trainee is prompted to check the victim&#39;s pulse, and if no pulse is found, to press the Analyze key  54 . 
     The shock sequence as described above is programmable by the trainee or instructor using the shock sequence keypad  90  located on the rear panel. Thus the user may program the sequence of shock/no shock heart rhythms. Up to seven shock/no-shock sequences may be programmed. In order to program the device, the set key  92  is toggled on. Adjacent the set key  92  is seven toggle keys  93 - 99  labeled “1” through “7+”, with each numbered key representing the numerical cycle of analyzed heart rhythms. Thus key “1”  93  represents the first cycle of simulated analyzed heart rhythms, key “2”  94  represents the second cycle of simulated analyzed heart rhythms, etc. Thus up to seven cycles may be programmed. In addition, each numerical key has its own LED indicator light  101  located immediately thereabove. The indicator light indicates (i.e., when lit) whether a shockable rhythm has been programmed. When the set key  92  is toggled on, the LED indicator lights  101  will light up if a shockable rhythm is desired for its respective numerical cycle. If the LED indicator light  101  is not lit, then the device will not recommend a shockable rhythm for that particular cycle. For example, if the American Heart Association recommended teaching shock sequence is: shock:shock:shock:no shock:shock:shock, then keys 1-3 and keys 5-7 will be toggled on such the their respective LED indicator lights  101  are lit. When finished programming, the set key  92  is toggled off. 
     The Shock Sequence Panel  90  also provides for turning on a “REFIBRILLATE” key  102 . To program the device for the REFIBRILLATE function, the set key  92  is toggled on and then the REFIBRILLATE key  102  is toggled on such that the LED indicator light  103  labeled “ON” lights up. The set key  92  is then toggled off. In order to use this feature, a non shockable rhythm must have been programmed. After the trainee receives the first “NO SHOCK ADVISED” prompt, the trainee will be instructed to “CHECK BREATHING AND PULSE”, and “IF NO PULSE PERFORM CPR”. The CPR interval will be interrupted to instruct the trainee that the victim has went into a shockable rhythm. The trainee will be prompted to press the ANALYZE key. Thus when the REFIBRILLATE key is activated, a simulation of a non-shockable rhythm which converts into a shockable rhythm is demonstrated. 
     The Shock Sequence panel  90  also provides for the simulation of a manual, semi-automatic or automatic defibrillator by programming the Analyze key  105 . The simulation of a semi-automatic defibrillator is the same as the manual defibrillator as described above, except the trainee is not prompted to press the Analyze key after it has been pressed once by the trainee. The simulation of an automatic defibrillator is the same as the above description, except the trainee is not prompted to press the ANALYZE key at anytime, as the device automatically goes into the simulated Analyze mode. 
     The Shock Sequence panel  90  also provides for the altering of the CPR prompting based upon the number of rescuers present for the CPR mode. After the set key  92  is toggled on, the “ADULT/CPR/TIME” key  106  may be set to either “1 Rescuer”  107  or “2 Rescuer”  108  mode. The timing of the CPR interval and the breathing rate will be affected. For 1 Rescuer attending a victim, the trainee will be prompted to do cycles of 5 chest compressions and 1 breath for 1 minute, while 2 Rescuers will be prompted to do cycles of 15 compressions and 2 breaths for 1 minute intervals. In addition, the Shock Sequence panel  90  also allows the trainee to program short or long prompting scripts for the rescue instructions for the AED, CPR or AED/CPR modes of operation by selecting the “PROMPTING FORMAT” key  109  and setting it to “short” or “long” formats. The “short” prompting format contains only the essential prompting queues, while “long” format gives trainee more detailed instructions. In addition, the Shock Sequence Panel  90  provides for programming the CPR interval, i.e., the time CPR is prompted, to 30, 60 or 90 second intervals. 
     CPR Mode 
     When the trainee manually sets the SELECT PROMPTING MODE switch  70  to CPR mode  74 , the trainee will receive instructive prompts for performing CPR in conjunction with other rescue operations such as the HEIMLICH maneuver, abdominal thrusts and rescue breathing. In order to activate the device in this mode, the trainee must assess the victim&#39;s age and select the appropriate ADULT, BABY or CHILD key. As shown in  FIGS. 10 and 13 , the trainee will be prompted to “REMAIN CALM; SHAKE VICTIM GENTLY AND SHOUT ARE YOU OKAY; IF NO RESPONSE CALL 911 NOW.” Next the trainee is prompted to “POSITION THE VICTIM ON HIS OR HER BACK ON A FIRM SURFACE.” and to “TILT HEAD; LIFT CHIN; CHECK BREATHING.” The trainee is then prompted to assess whether the victim is breathing. If the victim is not breathing, the trainee is instructed to “TILT HEAD LIFT CHIN; PINCH NOSE; BLOW; BLOW.” The trainee is then prompted to press pause key and repeat the above steps if no chest rise. The trainee will then be prompted to CHECK THE VICTIM&#39;S PULSE. If a pulse is found but the victim is not breathing, the trainee is prompted to press Key 3 (Rescue Breathing). If no pulse is found, the trainee is instructed to press KEY 4 CPR. IF the victim&#39;s airway is blocked, the trainee is prompted to press KEY 2 for abdominal thrust prompting. 
     CPR Plus AED (Both) Mode 
     When the trainee manually sets the SELECT PROMPTING MODE switch to BOTH, the trainee will receive instructive prompts for performing CPR in conjunction with use of a defibrillator. The user may initiate this mode by pressing the ADULT key after assessing the victim&#39;s age. If the BABY or CHILD key is pressed, the trainee will be prompted that he or she has pressed a wrong key, because infants or children are not recommended to receive defibrillation. After the ADULT key is selected, the trainee will be prompted as described above under the CPR mode. However, if no pulse is found, the trainee is instructed to press the AED power key  52  instead of the CPR key 4. The AED sequence of prompting is as described above under the AED ONLY section. 
     While the preferred embodiments of the invention have been illustrated and described, it should be understood that variations will become apparent to those skilled in the art. Accordingly, the invention is not to be limited to the specific embodiments illustrated and described herein, but rather the true scope and spirit of the invention are to be determined by reference to the appended claims.