Method And Apparatus For Multi-System Remote Surgical Navigation From A Single Control Center

[0001] This application is a continuation-in-part of U.S. patent application Ser. No. 11/484,883, filed Jul. 11, 2006, which application claims the benefit of U.S. Provisional Patent Application Serial No. 60/702,486, filed Jul. 26, 2005, the entire disclosure of which is incorporated herein by reference.

[0002] The present invention relates to the medical procedures which utilize navigation of medical devices within a subject body, and more specifically to remotely performing medical procedures utilizing navigation of medical devices in a subject body.

[0003] Navigation systems have been commercially developed recently for actuation of medical devices to be steered within a patient's anatomy, from a remote location nearby the patient. An example is the Niobe magnetic navigation system developed and sold by Stereotaxis, Inc. Such a system typically allows for control of the navigation of a minimally interventional device with the help of a Graphical User Interface and user input devices such as a mouse, keyboard, joystick or other form of interface input device.

[0004] While the use of such a remote navigation system can bring higher efficiencies to the Catheter Lab where it is installed, at centers where a larger volume of cases are typically performed, it is advantageous to install and use more than one remote navigation system. However, controls for each navigation system are costly, and a physician with significant expertise in such systems may not be available for every navigation system and patient.

[0005] The present invention describes methods and apparatus details for the functioning of a Control Center from which multiple remote navigation systems could be controlled simultaneously or nearly simultaneously. The ability to perform multiple procedures simultaneously from a single integrated Control Center is advantageous. There are significant potential benefits in terms of cost and time savings with such a single Control Center. Likewise, an expert physician could control and perform a procedure at a distant site, possibly thousands of kilometers away, or even at multiple distant sites, from such an integrated Control Center. Such a scenario will result in cost and time savings, as well as expert care for a patient who might otherwise not have access to suitable expert physicians.

[0006] In accordance with one aspect of the invention, various embodiments are provided of a system for performing remote surgical navigation in multiple systems from a single control center, where there are at least two remote navigation systems in separate procedure rooms. The at least two remote navigation systems each include respective control computers. The system further includes a Control Center that is physically separated by at least 5 meters from each procedure room, the Control Center having a set of displays and interface input devices. A switch may also be included for connecting the set of displays and interface input devices to the Control Center, and also for connecting to each of aforesaid remote navigation systems by means of communication links. The switch may include user-selectable settings for selecting and routing interaction between the set of displays and interface input devices and any one of the remote navigation systems.

[0007] In another aspect of the present invention, one embodiment of a method is provided for performing multiple simultaneous remote medical interventional procedures on any of a set of remote navigation systems from a single, physically distant Control Center. The method includes the step of displaying information that is transmitted over a link from any of the remote navigation systems to the Control Center. The method also includes receiving or accepting user input into the Control Center computer, and establishing an encryption key between the Control Center computer and the remote navigation system computer. The Control Center converts the user input data to a pre-determined data stream format, and then encrypts this data on the Control Center computer. The Control Center further transmits the encrypted data over a link from the Control Center computer to a computer at the remote navigation system site. The transmitted data received by the remote systems is then decrypted and converted to a set of pre-determined script commands corresponding to medical device control and user interaction elements. The decrypted pre-determined script commands may then be transmitted to the remote navigation system control computer via a local, standard Ethernet link. Alternatively, the script commands may be transmitted to the remote navigation system control computer via a local, standard USB cable link.

[0008] Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.

[0009] The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:

[0010] FIG. 1 shows a schematic of a Multi-System Control Center capable of linking to remote location sites.

[0011] FIG. 2 shows a schematic of one embodiment of a method of command data transmission from a Multi-System Control Center for execution at an on-site remote navigation system.

[0012] The following description of the various embodiments is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.

[0013] In some embodiments, each remote navigation system is installed in its own procedure room. At sites where there are multiple such systems at the same clinical facility, other embodiments comprise remote navigation systems that are installed in adjacent rooms so that economies of scale could result in net installation costs that are lower. In one embodiment, a system is provided for performing multiple simultaneous remote medical interventional procedures from a single Control Center where at least two remote navigation systems are included. The at least two remote navigation systems are in separate procedure rooms, and have respective control computers for each remote navigation system. The system includes a Control Center that is physically separated by at least 5 meters from each procedure room. The Control Center has a set of at least one display and at least one interface input device corresponding to each of aforesaid remote navigation systems that are respectively connected to the respective control computers of the remote navigation systems by means of corresponding communication links. The system may further include a switch connected to the set of displays and interface input devices in the Control Center. The switch is also connected to each of aforesaid remote navigation systems by means of communication links, and has user-selectable settings for selecting and routing interaction between the set of displays and interface input devices and any one of the remote navigation systems. The communication link in the system may be a physical connection that comprises optical fibers, or alternatively copper conductors. The communication link may also be a wireless connection, and may employ a portion of the electromagnetic spectrum of the individual navigation systems for establishing wireless communication.

[0014] In some embodiments, the switch of the system may also accept inputs from audio channels for each remote navigation system, to provide for two-way audio communication between the Control Center and each procedure room. System selection on the switch unit automatically routes the two-way audio signals from the appropriate procedure room to the Control Center. The system may further include a means to indicate that communication is awaited by a procedure room different from the one currently selected is passed along to the user.

[0015] The switch connecting the set of interface input devices to the Control Center also enables the Control Center to provide master/slave arrangement for control of various remote navigation systems. For example, where a procedure is being performed on a patient at a remote navigation system by a physician at the remote navigation system, a physician at the Control Center may monitor the procedure being performed at the remote navigation system, and even participate. From the Control Center, a physician possessing expertise with such navigation systems can monitor several procedures being performed remotely at several remote navigation systems. The Control Center may be configured to receive user input data from each remote navigation system through the switch, and to convert the data stream to a set of pre-determined script commands corresponding to medical device control for the each remote navigation system. The Control Center may also comprise a local user interface means for controlling a remote navigation system, where the Control Center's interface means overrides the user input data received from the remote navigation system and provides medical device control commands to the remote navigation system. If the expert physician at the Control Center determines that a certain procedure needs his assistance, the expert physician may use interface means at the Control Center to control the remote navigation system, and override the physician at the remote navigation system. Thus, each patient at each remote navigation system can receive the benefit of an expert physician supervising the medical procedure being performed.

[0016] In one embodiment, the Control Center has one set of displays for each remote navigation system that is to be controlled from there. The different displays are set up as part of an operating console within which the physician performing the procedures sits. In addition to at least one display corresponding to each remote navigation system, there is at least one set of interface input devices (such as a computer mouse, keyboard, joystick, etc.) associated with each remote navigation system. Each interface input device is connected to its corresponding remote navigation system computer through a standard USB cable possibly by routing through at least one USB Switch unit and cable extensions if extended lengths are required due to larger physical separations. These input devices can be used to steer the medical device. FIG. 1 shows a Multi-system application 20 having a Control Center 22 from which remote navigation systems 24, 26, 28, 30, 32, 34 and 36 are controlled for performing multiple simultaneous interventional medical procedures. Each navigation system comprises a patient support 42, one or more magnetic field sources 44, and other user input and navigational display consoles for use by a physician. One or more of these remote systems could be distant from the Control Center. Systems 22-34 are connected to displays and interface input devices 24-36 in the Control Center by means of links 40.

[0017] In the case of a magnetic navigation system, a magnetic field can be directed suitably and applied to steer the device. In the case of a mechanical remote navigation system, the tension in various pull wires can be controlled or various servo motors can be controlled to suitably actuate and steer the device. Other schemes of remote actuation are familiar to those skilled in the art and the teachings here apply to any such remote actuation scheme.

[0018] In an alternate, second embodiment, the Control Center employs a single set of displays and interface input devices. In this case, a switch unit for system selection, possibly specially customized, is used by the user to select the remote navigation system that the user currently desires to control. The switch unit for system selection has a knob or sliding bar control and a set of markings labeling the different remote navigation systems connected to it. The interface input devices are connected to the switch unit for system selection. Given a particular system selection set by the user, the switch unit routes the inputs from the set of interface input devices to that particular remote navigation system computer through a suitable USB cable connection. Likewise, the various system displays feed into the switch unit for system selection. Depending on the system selected, the corresponding data for the set of displays of the selected remote navigation system are fed on to the actual set of displays in the Control Center. Thus in this embodiment, the user works from a single set of displays and directly controls the remote navigation system that he/she has currently selected. Clutter in the Control Center is thereby reduced in this embodiment since there is only a single set of displays and interface input devices.

[0019] In a third embodiment that augments the first embodiment, audio data from the procedure rooms also feed into as many speakers and microphones in the Control Center for two-way audio communication. The microphone in the Control Center that is associated with each remote navigation system is endowed with a button so that the user can choose to speak into the microphone for a given remote navigation system for purposes of verbally addressing the corresponding procedure room.

[0020] In a fourth embodiment that augments the second embodiment with a single set of displays, the switch unit for system selection also accepts inputs from the audio channels for each remote navigation system. System selection on the switch unit automatically routes the two-way audio signals from the appropriate procedure room to the Control Center. In this manner, two-way audio communication between the procedure room of the currently selected remote navigation system and the Control Center is established. If a different procedure room other than the one selected desires to establish audio communication (by depressing a button to indicate the corresponding microphone is enabled), the associated button press signal is detected by the switch unit for system selection and a corresponding signal is passed along as a periodic audible tone to a speaker installed in the Control Center for this purpose. Thus an indication that communication is awaited by a procedure room different from the one currently selected is passed along to the user in the Control Center.

[0021] In a fifth embodiment, in addition to some of the features in the previous embodiments described, the remote navigation system being controlled from the Control Center could be located at a distant and distinct clinical site. In this case, a dedicated cable channel, satellite channel or a direct Copper or optical link is used to provide system command transmissions from the Control Center to the remote/distant site and data, confirmation messages and display details in the reverse direction. It is desirable for safety reasons that this be a dedicated, secure link. If for technical reasons security is not guaranteed, then any data or commands that are exchanged are encrypted before being sent. In this case there is additionally a computer in the Control Center. The key for the encryption is established upon initiation of the connection between the Control Center computer and the remote navigation system computer at the distant site according to standard public key encryption protocols. Whereas previously data and commands were exchanged from the Control Center and the remote navigation system by means of USB connections, in the case of the present embodiment, USB signals are not directly exchanged. Rather, the Control Center computer converts the USB data to a pre-determined data stream format before encryption and transmission as system commands. The data is received by a reception computer at the remote navigation system site that could be one of the existing remote navigation system computers, or an additional one that exists to accept the incoming encrypted data, decrypts the data, converts the data from the pre-determined data stream format to USB data (thereby functioning as an USB emulator), and then passes it on to the remote navigation system control computer at the distant site via a local, standard USB cable link. In this manner the commands are again provided as standard system interface inputs such as joystick movements, mouse click events at a particular location on the GUI, etc. at the distant site.

[0022] In a sixth embodiment, the data from the reception computer could, instead of being converted to USB data, be sent to the remote navigation system control computer in the form of script commands that execute certain processes on the latter that serve to implement the desired user actions in order to control the remote navigation system and the medical device used in the procedure. Such actions could include, for instance in the case of a magnetic navigation system, clicking on a GUI to change external magnetic fields, advance or retract the device, mark anatomical reference locations. In the case of a mechanically actuated remote navigation system, these actions could include requesting actuations that increase or decrease deflection of the medical device, advance or retract a medical device, and other typical catheter manipulations.

[0023] FIG. 2 shows a schematic of a method of command data transmission from a Multi-System Control Center for execution at an on-site remote navigation system shown at 134. The process described in the latter two embodiments is schematically represented in this Figure. In at least one embodiment, a method is provided for performing multiple simultaneous remote medical interventional procedures on any of a set of remote navigation systems from a single, physically distant Control Center. The method includes the step of displaying information that is transmitted over a link from any of the remote navigation systems to the Control Center. The method also includes receiving or accepting user input at step 102, into the Control Center computer at step 106, and establishing an encryption key at step 110 between the Control Center computer and the remote navigation system computer 130. At step 106, the Control Center converts the user input data to a pre-determined data stream format, and then encrypts this data on the Control Center computer at step 110. At step 114, the Control Center further transmits the encrypted data over a link from the Control Center computer to a computer at the remote navigation system site. The transmitted data received by the remote systems at step 118 is then decrypted at step 122, and then converted at step 126 to a set of pre-determined script commands corresponding to medical device control and user interaction elements. The decrypted pre-determined script commands may then be transmitted at step 130 to the remote navigation system control computer via a local, standard Ethernet link. Alternatively, the script commands may be transmitted to the remote navigation system control computer via a local, standard USB cable link.

[0024] In some of the latter embodiments, the reception computer also sends data such as display data to the Control Center computer. For efficiency reasons, it would only send updates or changes to currently existing displays to the Control Center computer. Since only system commands and incremental changes to existing displays are transmitted over the dedicated/secure link, this is an efficient methodology for system communication between the Control Center and the remote navigation site and provides a good platform for real-time control of a distant remote navigation system from the Control Center, regardless of where these are located physically.

[0025] In the various embodiments, a local over-ride option at each remote navigation site is implemented as an additional safety feature in case transmission from the Control Center fails for any reason, or is intermittent, or if the clinical situation in the procedure room warrants this. The local over-ride could be implemented for instance as a fail-safe button that when pressed remains visibly depressed/pushed down, possibly including the display of messages on the User Interface indicating that local over-ride is in effect. Such messages would also be attempted to be transmitted back to the Control Center. The local over-ride would take precedence over any commands issued from the Control Center.

[0026] The above teachings clearly could be applied to a variety of remotely actuated navigation systems in interventional medicine, whether the actuation scheme is magnetic, mechanical, electrostrictive, hydraulic, or any other form familiar to those skilled in the art. Likewise, while specific embodiments are detailed above, variations and alternative embodiments dictated by convenience and ease of implementation are within the scope of the teachings contained herein, and limited only by the appended claims.

[0027] The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.