Abstract:
The present invention is directed to a system and method which allows a device user who is within a sterile environment to interact remotely with a device physically located outside of the sterile zone. In one embodiment, the remote link is wireless and allows the operator to adjust critical controls without breaking the sterile environment. The remote device is designed to be sheathed in sterile sheaths and further designed, in one embodiment, to keep the remote control element from physically interacting with the patient and in some cases with the device operator. In one embodiment, the remote device operator interacts with the remote device verbally.

Description:
BACKGROUND OF THE INVENTION 
     There are many situations were medical equipment, such as sonogram devices, must be used in a sterile environment. When such equipment is used in a sterile environment the person using the equipment (a sonographer in the case of sonographic devices) must from time to time interact with the device controls for a variety of reasons. However, because of the sterile conditions the sonographer must have a method of interaction with the equipment that will not compromise the sterile environment. 
     Some areas of particular concern occurs when sonography is used for assisting with nerve blocks and peripherally inserted central catheter (PICC) lines both of which procedures must be performed in sterile environments. Thus, the patient is sterile, the doctor and nurses are sterile, but the sonograph machine is sitting a way from the sterile zone and is not sterile. If the operator were to touch the machine, as would occur in order to manually adjust a dial or operate a switch, the operator would no longer be sterile. Since various machine operations, such as depth and gain adjustments, must occur during the procedure the operator must interact with the sonogram machine several times during the course of a procedure. 
     One method for dealing with this issue is to use a second person who physically interacts with the machine outside of the sterile zone based upon instructions given by a person within the sterile zone. Using two people is costly and inefficient. 
     One method of eliminating the second person is for the person in the sterile environment to use a fresh sterile gauze pad (usually a 4×4 pad) every time the sonogram machine is to be touched. This presupposes that a stack of such sterile pads are available (which requires planning and prior execution) and also presupposes that the operator can reach the machine, which sometimes is positioned across the patient and sometimes several yards from the patient. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention is directed to a system and method which allows a device user who is within a sterile environment to interact remotely with a device physically located outside of the sterile zone. In one embodiment, the remote link is wireless and allows the operator to adjust critical controls without breaking the sterile environment. The remote device is designed to be sheathed in sterile sheaths and further designed, in one embodiment, to keep the remote control element from physically interacting with the patient and in some cases with the device operator. In one embodiment, the remote device operator interacts with the remote device verbally. 
     The foregoing has outlined rather broadly the features and technical advantages of the present invention in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the invention will be described hereinafter which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the invention as set forth in the appended claims. The novel features which are believed to be characteristic of the invention, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a more complete understanding of the present invention, reference is now made to the following descriptions taken in conjunction with the accompanying drawing, in which: 
         FIG. 1  illustrates one embodiment of a remote control device in accordance with an aspect of the invention; 
         FIG. 2  is a block diagram of one embodiment of the control circuitry for the device shown in  FIG. 1 ; 
         FIG. 3  is a flow chart illustrating one embodiment of a method of operation of the remote system; 
         FIG. 4  illustrates one method for training a remote unit to be user specific; and 
         FIG. 5  shows an operating theater having both sterile and non-sterile environments. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  illustrates one embodiment of a remote control device, such as device  10 , in accordance with an aspect of the invention. Device  10  contains shell  101  and key pad  23 . The key pad wraps around the internal circuit board (not shown) and seals against the shell. The key pad acts as a seal to the unit and also encloses the battery case. This provides a very clean back and side surface without screw holes to trap grunge and germs. The battery, in this embodiment, is charged inductively. 
     In one embodiment, key pad  23  is a single piece of silicon ballistae having an anti-microbial surface that is easily cleanable. Key pad  23  stretches over the entire top surface of the remote device making it easier to clean. In one embodiment, the silicon is stretched over two-part shell  101  and tucked in between the two parts of the shell prior to the top half of the shell being bonded to the bottom half. 
     Dimensions of device are, in one embodiment, about 2½ inches by 4 inches by 0.75 inches deep. The example shown in  FIG. 1  has six buttons plus power button  12 . Power button  12  can, if desired, be touched located on shell portion  101  and an on-off light be made visible through pad  23 . Four buttons, are arranged around circular bezel  14 . These buttons are depth up  14 - 1 , depth down  14 - 3 , gain plus  14 - 4  and gain minus  14 - 2 . Two additional buttons  15  and  16  control freeze and save, respectively. If desired, any button could be reprogrammed to do other things. There are LED indicators (not visible) to indicate when the device is charging, when it is in training mode, when it is in use, and when it is connected to the main sonographic equipment, etc. 
     The buttons are positioned and/or sized so that they can be used by feel even without reading the button labels and even without seeing the buttons. In one embodiment, the buttons are not of uniform size or positioned with uniform spacing allowing a user to navigate based on size and relative position of the buttons. The control buttons are thus arranged in an asymmetrical manner, so the user can feel when he/she is at the top of the device versus the bottom of the device. There&#39;s also a physical marker on the back to indicate device orientation. In some embodiments, small bumps are positioned on the keys to indicate when a finger is over the top of a particular button. 
     Note that the keys do not come through openings in the surface but rather are part of the surface structure. The elimination of openings in the keypad surface eliminates potential for liquid and other unwanted material from entering the device and also eliminates areas where germs and bacteria can accumulate. In this manner, the remote input device can receive an input stimulus from a user without physically penetrating a surface of the input device. The remote input device can then process the received stimuli and send one or more command messages to at least one medical device physically located away from the remote input device. Thus, the input device can control at least a portion of a medical procedure being performed on a patient in close proximity to the remote input device. The medical device can then send adjusted parameters, such as power levels, beam forming, etc. with respect to a medical procedure being performed on the patient. 
     The keys can be programmable so that from time to time the function of a key could change, or the function of the key can be made to change in context to a stage of a program that is currently being controlled. In addition, the device can be set up, for example, with microphone  24  so that the user can issue verbal commands thereby avoiding, or at least minimizing, the need to physically contact the remote device. Voice activation can be specific to a particular user such that commands in the room from other than a “taught” user have no effect. 
     In some embodiments, the remote device can be set up to handle different main devices. Thus, it becomes a personal assistant to a particular user (or group of user&#39;s) controlling different pieces of sonographic equipment located in the vicinity of the user at any point in time. If desired, a personalized label, such as label  17 , can be added so the user whose voice is trained on a specific device can recognize the device. 
     If desired, the entire remote device can be clipped onto the user and can be fully, or primarily, responsive to voice commands. All of the commands, whether by voice or by touching a control key, would be relayed wirelessly (or by wire, if desired) to main sonographic device, such as to device  200 - 1 ,  FIG. 2 . Note that the commands from remote device  10  could, if desired, be delivered to more than one piece of equipment which need not all be sonographic devices. 
     In one embodiment, the microphone can be built in (as illustrated) and in other embodiments the microphone can be external (not shown) and can communicate with device  10  wirelessly (for example, using Bluetooth) or by a cord and plugged into device  10 . 
       FIG. 2  is a block diagram of one embodiment of the control circuitry for device  10  shown in  FIG. 1 . As illustrated, the remote device includes microprocessor  21 , voice control unit  22 , and RF transceiver  25 . The microprocessor controls the remote device and can be set to follow one or more programs stored, for example on code, therein (or in separate memory, not shown). The programs could be changed or updated from time time, for example, via data received though port  26  from an external source such as one of the equipment  200 -N. 
     Processor  21  receives its input command via keypad  23  or via voice control  22  or through USB port  26 . Commands can be sent, as will be discussed in more detail with respect to  FIGS. 3 and 4 , to the microprocessor to program the voice control unit in a training mode. The microprocessor determines whether communication to main sonographic device  200 - 1  is between RF transceiver  25  and RF transceiver  201  or between port  26  and a port on main sonographic device  200 - 1  As will be seen, the remote device can control other equipment, such as equipment  200 -N. A computer, having a database can be one of the other equipment and can store information from one or more patients or could supply settings or other data to the remote control device. The communication from the other equipment can be routed through a sonographic device, such as through device  200 - 1  or directly to device  10 . 
     Voice control  22  has an interface through microphone  24  and has both a learning mode and an operational mode. During learning mode it learns, as is well-known, a user&#39;s voice signature. If voice control is not used, the input is through one of the six buttons on the keypad as discussed above. Remote device  10  has at least one battery  27  which can be changed from time to time or preferably charged through a speed connector not shown, or, if desired, via inductive charging. 
     Voice control  22 , for example, could be obtained from Sentry and would actually perform the digital signal processing internally by matching the voice signature that is stored on the voice control unit, or external to the unit, for example, in database  28 , with the voice that is coming in from the user. In one embodiment, the remote device could have a handshake routine with the main sonographic device so as to allow for sharing of remote devices among several medical or other devices. Database  28  could also be used to store program code for controlling processor  21 , voice control  22  keypad  23  and/or RF transceiver  25 . In a preferred embodiment, database  28  is part of processor  21 . 
     When the remote device is being used as a personal assistant, it could, for example, record notes and various other inputs before, during and after the procedure. During the procedure, in addition to storing notes from the user, it would, if desired, be used to control the sonographic device, such as beam forming angles, depth, axis orientation, etc. The notes and other information could be immediately communicated (in real time) to a computer separate from the sonographic device, or the data can be stored local and sent in delayed time after the procedure is completed. 
     In some situations, the information already on file, for example in some other equipment, such as equipment  200 -N, could be uploaded to the remote device in order to set the various fields. One example, would be that the user would say, “patient Jane Doe, 57 year old female, here for a nerve block. She has diabetes and high blood pressure.” Based on this input, setting information can be uploaded to the remote device and then sent onto the main device or delivered directly via a wireless or wireline (neither shown) from device  200 -N to device  200 - 1 . 
     In addition, while not shown, the keys could be replaced or supplemented by a screen display that could be used both for input and for presenting to a user, or a physician, selected images as required. Also, the screen could be used for handwritten input. 
     Since the remote device is an input device to the main sonographic device any number of different input methods can be used. One could envision embedding a bar code reader, or a camera, or a scanner all used to input data into the system to provide records and retention for the procedure being performed. 
       FIG. 3  is a flow chart illustrating one embodiment  30  of a method of operation of the remote system. Sound is received by process  301  and process  302  determines if the remote device is in the training mode. If it is, the incoming sound is processed as will be discussed with respect to  FIG. 4 . If the system is not in the training mode then process  303  determines if the sound is coming from a known user (speaker). If it is, then process  304  determines if the sound is a known command. If not, then process  305  communicates to the user that the command was not understood. This communication can be, audible, visual or even motion, as by vibrating the remote. 
     If the command is understood the proper instruction is sent to the proper equipment for execution by that equipment. Note that the same command word from different speakers could, if desired, result in commands to different external equipment, or in some cases the same command from different speakers could result in different commands going to the same equipment. For example, a sonographer could issue the command, “brighter” and the command sent to the main equipment from the remote (as translated, for example, by processor  21  operating in conjunction with database  28 ) could be to change the angle of the beam former. However, if the physician (assuming he/she were a trained speaker on the system) were to say, “brighter” the command to the main sonographic equipment might be to brighten the readout display. Alternatively, the remote device could be set up such that when the physician said, “brighter” the intensity of the lighting over the visual operating field of the patient could be increased. 
       FIG. 4  illustrates one method  40  for training a remote unit to be user specific. If the remote device is in the training mode (either under manual control or by a voice command) when a verbal command is received, process  401  saves the sound to a database and process  402  then instructs the user as to the next steps in the training process. This could be to have the user repeat the command a few times, or to say specific commands, or a combination of instructions. 
     Process  403  determines if the sound is from a known user and if it is the sound is stored by process  404  in a database in association with a known user. The process then would receive instructions as to what device the instruction pertains and what command should be associated with the instruction. Thus, in the example above, the command “brighter” from user A (sonographer) would be saved in association with a command to change beam forming angles on machine  200 - 1  while the command, “brighter” from user B (physician) would be in association with a command to the lighting system to increase intensity. 
     If the incoming sound were not recognized as belonging to a known user then process  405  would assign a new user id to the sound and process  406  would store the sound in the database in association with the new user. Then subsequent sounds arriving would be processed by processes  403  and  404  as above-described for known users. 
       FIG. 5  shows operating theater  50  having both sterile and non-sterile environments. Main sonographic equipment  200 - 1  is located outside of sterile environment  502  and could be in the same room or even in a different room from patient  56 . As illustrated, sonographer  51  controls probe  53  which is in communication, either wirelessly or via wireline, with device  200 - 1 , and, if desired, with device  10 . Probe  53 , in this embodiment, is used to send sound signals into the patent and to receive reflected signals back from the patient for processing by device  200 - 1 . Images  54  are formed from the processed signals are displayed on display  55 , which in this example would show catheter  54  being inserted into and artery by physician  52 . If desired, the image could also be displayed on device  10 . 
     The sonographer has remote device  10  which is used to control device  200 - 1 . As discussed, when the remote device responds to verbal commands it can be pinned to the sonographer, or hang around his/her neck. In some situations, the remote device can be in a pocket with the microphone separate therefrom. Communication from the microphone, which could be held under a sterile mask covering the sonographer&#39;s mouth to the remote device can be, for example, by Bluetooth transmission. 
     Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.