Medical device systems, methods for operating medical device systems, and computer-readable mediums for operation

Abstract

To provide a robotic medical device system that includes a robotic medical device and a controller.SOLUTION: A robotic medical device system includes a robotic medical device and a controller. The controller is configured to control, in response to one or more control signals, movement of the robotic medical device to maintain a substantially constant overshoot for different step responses of the robotic medical device system independently of variations in a delay associated with control of the robotic medical device, where the one or more control signals are received via a network.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] One or more example implementations relate to robotically controlled medical device systems, remote communication means and remote control systems for devices used in robotically controlled interventional procedures, methods of operation thereof and / or non-transitory computer readable media for operation thereof. [Background technology]

[0002] Catheters (and other elongated medical devices) may be used in minimally invasive medical procedures for the diagnosis and treatment of various vascular diseases, including neurovascular intervention (NVI) (also known as neurointerventional surgery), percutaneous coronary intervention (PCI), and peripheral vascular intervention (PVI). Robotic catheterization systems are used to assist physicians in performing such catheterization procedures. Summary of the Invention

[0003] According to at least one example embodiment, a robotically controlled medical device system is provided that includes a robotically controlled medical device and a controller configured to control operation of the robotically controlled medical device in response to one or more control signals received over a network and to maintain a substantially constant overshoot in each of the step responses of the robotically controlled medical device system regardless of variations in delay associated with control of the robotically controlled medical device.

[0004] In accordance with at least one example embodiment, a robotically controlled medical device system is provided that includes a robotically controlled medical device and a control means that controls operation of the robotically controlled medical device in response to one or more control signals received over a network to maintain a substantially constant overshoot in each step response of the robotically controlled medical device system regardless of variations in delays associated with control of the robotically controlled medical device.

[0005] According to one or more example aspects, the delay may include at least one of a command delay and an image feedback delay.

[0006] The controller can be configured to control operation of the robotically controlled medical device and maintain a substantially constant maximum overtravel distance of the robotically controlled medical device.

[0007] The delay may be due, at least in part, to transmission delays in the network.

[0008] The motion of the robotically controlled medical device includes at least one of linear and rotational motion.

[0009] The controller can be configured to control the velocity of the robotically controlled medical device to maintain a substantially constant overshoot.

[0010] The controller can be configured to control the velocity of the robotically controlled medical device and to limit a maximum over-travel distance of the robotically controlled medical device.

[0011] The speed may be the speed of a linear or rotational movement.

[0012] The control means may include means for controlling operation of the robotically controlled medical device and for maintaining a substantially constant maximum over-travel distance of the robotically controlled medical device.

[0013] The control means may include means for controlling the velocity of the robotically controlled medical device and maintaining a substantially constant overshoot.

[0014] The control means may include means for controlling the speed of the robotically controlled medical device and for limiting the maximum over-travel distance of the robotically controlled medical device.

[0015] According to at least one example aspect, a method of operating a robotically controlled medical device system including a robotically controlled medical device and a controller is provided, the method including controlling operation of the robotically controlled medical device in response to one or more control signals received over a network, and maintaining a substantially constant overshoot in each step response of the robotically controlled medical device system regardless of variations in delay associated with control of the robotically controlled medical device.

[0016] In accordance with at least one example aspect, a non-transitory computer-readable storage medium is provided having computer-readable instructions stored thereon that, when executed by a controller and / or one or more processors of a robotically controlled medical device system, cause the robotically controlled medical device system to perform a method including controlling operation of a robotically controlled medical device in response to one or more control signals received over a network, and maintaining a substantially constant overshoot in each step response of the robotically controlled medical device system regardless of variations in delay associated with control of the robotically controlled medical device.

[0017] According to one or more example aspects, the delay may include at least one of a command delay and an image feedback delay.

[0018] Controlling the movement of the robotically controlled medical device can be controlling the movement of the robotically controlled medical device to maintain a substantially constant maximum over-travel distance of the robotically controlled medical device.

[0019] The delay may be due, at least in part, to transmission delays in the network.

[0020] The motion of the robotically controlled medical device includes at least one of linear and rotational motion.

[0021] Controlling the operation of the robotically controlled medical device can include controlling the velocity of the robotically controlled medical device and maintaining a substantially constant overshoot.

[0022] Controlling the velocity of the robotically controlled medical device may include controlling the velocity of the robotically controlled medical device and limiting a maximum over-travel distance of the robotically controlled medical device.

[0023] The speed may be the speed of a linear or rotational movement.

[0024] According to at least one other example aspect, a robotically controlled medical device system is provided that includes a robotically controlled medical device and a controller configured to control operation of the robotically controlled medical device in response to one or more control signals received over a network, and to maintain a substantially constant maximum overtravel distance of the robotically controlled medical device regardless of variations in a delay associated with control of the robotically controlled medical device, the delay being between a maximum allowable delay threshold and an override threshold.

[0025] According to at least one other example embodiment, a robotically controlled medical device system is provided that includes a robotically controlled medical device and a control means that, in response to one or more control signals received over a network, controls operation of the robotically controlled medical device to maintain a substantially constant maximum overtravel distance of the robotically controlled medical device regardless of variations in a delay associated with control of the robotically controlled medical device, the delay being between a maximum allowable delay threshold and an override threshold.

[0026] According to one or more example aspects, the controller can be configured to disable operation of the robotically controlled medical device if the delay is greater than a disable threshold.

[0027] The control means may include means for disabling operation of the robotically controlled medical device if the delay is greater than a disabling threshold.

[0028] The controller can be configured to limit the velocity of the robotically controlled medical device to maintain a substantially constant maximum over-travel distance when the delay is between a maximum allowable delay threshold and an override threshold.

[0029] The control means may include means for limiting the velocity of the robotically controlled medical device to maintain a substantially constant maximum over-travel distance when the delay is between a maximum allowable delay threshold and an override threshold.

[0030] The speed of the robotically controlled medical device may not be limited if the delay is less than a maximum allowable delay threshold.

[0031] According to at least one other example aspect, a method of operation of a robotically controlled medical device system including a robotically controlled medical device and a controller is provided, the method including controlling operation of the robotically controlled medical device in response to one or more control signals received over a network, and maintaining a substantially constant maximum overtravel distance of the robotically controlled medical device regardless of variations in a delay associated with control of the robotically controlled medical device, the delay being between a maximum allowable delay threshold and an override threshold.

[0032] In accordance with at least one example embodiment, a non-transitory computer-readable storage medium is provided having computer-readable instructions stored thereon that, when executed by a controller and / or one or more processors of a robotically controlled medical device system, cause the robotically controlled medical device system to perform a method including controlling operation of a robotically controlled medical device in response to one or more control signals received over a network, and maintaining a substantially constant maximum over-travel distance of the robotically controlled medical device regardless of variations in a delay associated with control of the robotically controlled medical device, the delay being between a maximum allowable delay threshold and an override threshold.

[0033] According to one or more example aspects, the method may further include disabling operation of the robotically controlled medical device if the delay is greater than a disable threshold.

[0034] The method may further include limiting a velocity of the robotically controlled medical device to maintain a substantially constant maximum overtravel distance if the delay is between a maximum allowable delay threshold and an override threshold.

[0035] The speed of the robotically controlled medical device may not be limited if the delay is less than a maximum allowable delay threshold. [Brief description of the drawings]

[0036] The illustrated embodiments can be better understood from the following detailed description and the drawings, in which like elements are represented by like reference numerals, and in which: The drawings are provided for illustrative purposes only and are therefore not intended to limit the scope of the disclosure.

[0037] [Figure 1] 1 is a perspective view of a catheter treatment system according to an embodiment. [Diagram 2] 1 is a schematic block diagram of a catheter treatment system according to an embodiment. [Diagram 3] FIG. 1 is a block diagram of a communication means and control system of a robotically controlled medical device system according to an embodiment. [Figure 4] FIG. 1 is a block diagram of a communication means and control system of a robotically controlled medical device system according to an embodiment. [Diagram 5] 1 is an illustration of a method for controlling the operation of a robotically controlled medical device system, according to an embodiment. [Figure 6] 13 illustrates an example of a graphical user interface at a control center according to an embodiment. [Figure 7] 1 illustrates an example of a graphical user interface for a robotically controlled medical device system, according to an embodiment. [Figure 8] 13A-13C are example displays of data and images at a local site robotic controlled medical device system according to an embodiment. [Figure 9] 13 illustrates an example display at a remote site control center with hemodynamic data, according to an embodiment. [Figure 10] 13 is a display example at a control center at a remote site in the embodiment. [Figure 11] 13A illustrates an example of a user interface when neither the control center nor the robotically controlled medical device system is controlling the robotically controlled medical device, according to an embodiment. [Figure 12] 13 illustrates an example of a user interface when a robotically controlled medical device system is controlling a robotically controlled medical device, according to an embodiment. [Figure 13] 13 illustrates an example of a user interface when a control center is controlling a robotically controlled medical device, according to an embodiment. [Figure 14] 13 is a display example at a control center at a remote site in the embodiment. [Figure 15] 13 is a display example at a control center at a remote site in the embodiment. [Figure 16] FIG. 1 is a block diagram of a many-to-many configuration of multiple control centers and multiple robotically controlled medical device systems, according to an embodiment. [Figure 17] 4 is a flowchart illustrating a method according to an embodiment. [Figure 18] 11 is a flowchart illustrating another method according to an embodiment. [Figure 19] 13 is a graph illustrating a step response of a robotically controlled medical device system, according to an embodiment. [Figure 20] 13A to 13C are examples of displays of a graphical user interface in a robot-controlled medical device system according to an embodiment. [Figure 21] 13 is another example display of a graphical user interface in a robotically controlled medical device system according to an embodiment. [Figure 22] 13 is a graph illustrating attenuation gain versus total delay time for a robotically controlled medical device system, according to an embodiment. [Diagram 23]23A-23C are example two-dimensional step response graphs for a robotically controlled medical device system according to an embodiment. [Figure 24] 13 is another example of a graph illustrating step response versus total delay for a robotically controlled medical device system, according to an embodiment. [Diagram 25] 13 is another example of a graph illustrating percent overshoot versus total delay for a robotically controlled medical device system, in accordance with an embodiment.

[0038] It should be noted that the above drawings are intended to illustrate schematic features of methods, structures and / or materials utilized in certain embodiments and to supplement the description set forth below. However, these drawings are not to scale, may not precisely reflect the precise structural or functional characteristics of any embodiment, and should not be construed as defining or limiting the range of values ​​or characteristics encompassed by the examples. The use of similar or identical reference symbols in the various drawings is intended to indicate the presence of similar or identical elements or features. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] Various embodiments are described in more detail below with reference to the drawings, which show some of the embodiments.

[0040] Exemplary embodiments are disclosed herein in detail. However, specific structural and functional details disclosed herein are presented merely for the purpose of describing the examples. That is, the examples may be implemented in many alternative forms and should not be construed as being limited to only the forms described herein.

[0041] Thus, while the embodiments are susceptible to various modifications and alternative forms, a form has been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that there is no intention to limit the embodiments to the specific forms disclosed. Rather, the embodiments are intended to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure. Like reference numerals refer to like elements throughout the description of the drawings.

[0042] Catheters (and other elongated medical devices) may be used in minimally invasive medical procedures for the diagnosis and treatment of various vascular diseases, including neurovascular intervention (NVI) (also known as neurointerventional surgery), percutaneous coronary intervention (PCI), and / or peripheral vascular intervention (PVI). These procedures typically involve navigating a guidewire through the vascular system and using the guidewire to advance a working catheter to perform the treatment. A catheter procedure begins with gaining access into an appropriate vessel, such as an artery or vein, using standard percutaneous techniques with a sheath or guide catheter. The sheath or guide catheter is advanced using a diagnostic guidewire to a primary location, such as the internal carotid artery for NVI, the coronary ostium for PCI, or the superficial femoral artery for PVI. A guidewire appropriate for the vasculature is then navigated through the sheath or guide catheter to a target location within the vasculature. In certain situations, such as tortuous anatomy, a support catheter or microcatheter is inserted through the guidewire to aid in the navigation of the guidewire. The physician or operator can use an imaging system (e.g., a fluoroscopy device) to acquire cines with contrast injection and select a fixed frame to use as a roadmap to navigate a guidewire or catheter to a target location, e.g., a lesion.

[0043] Contrast images can also be obtained while the physician is delivering the guidewire or catheter device, allowing the physician to verify that the device is moving along the correct path to the target location. Using fluoroscopy to view the anatomy, the physician can manipulate the proximal end of the guidewire or catheter to place the distal end in the appropriate vessel to the lesion and avoid traveling into a side branch.

[0044] Robotic catheterization systems can be used to assist physicians in performing catheterization procedures such as NVI, PCI, and PVI. Examples of NVI catheterization procedures include coil embolization of aneurysms, liquid embolization of arteriovenous malformations, and mechanical thrombectomy of large vessel occlusions in the setting of acute ischemic stroke.

[0045] In NVI, physicians use a robotic control system to manipulate neurovascular guidewires and microcatheters to gain lesion access and perform procedures to restore normal blood flow. Access can be achieved through a sheath or guide catheter, but may require intermediate catheters for more distal areas or to provide adequate support for the microcatheters and guidewires. The distal end of the guidewire is navigated into or beyond the lesion, depending on the lesion and type of treatment.

[0046] In the treatment of aneurysms, a microcatheter is advanced into the lesion, the guidewire is removed, and several coils are deployed through the microcatheter into the aneurysm and used to embolize the aneurysm.

[0047] In the treatment of arteriovenous malformations, a liquid embolus is injected into the malformation via a microcatheter.

[0048] Mechanical thrombectomy to treat vascular occlusion can be accomplished by either aspiration or the use of a stent retriever. Aspiration can be achieved either directly through a microcatheter or with a larger bore aspiration catheter. An aspiration catheter is placed at the lesion and negative pressure is applied through the catheter to remove the clot. Alternatively, the clot can be removed by placing a stent retriever through the microcatheter. The stent retriever entangles the clot and then the stent retriever and microcatheter are retracted into the guide catheter to retrieve the clot.

[0049] In PCI, the physician uses a robotic control system to manipulate a coronary guidewire to gain lesion access to administer therapy and restore normal blood flow. Access is achieved by seating a guide catheter at the coronary ostium. The distal tip of the guidewire is navigated past the lesion and, in complex anatomy, a microcatheter may be used to provide adequate support for the guidewire. Blood flow is restored by delivering and placing a stent or balloon at the lesion. Prior to stent placement, the lesion may require preparation, either by delivering a balloon for pre-dilatation of the lesion or by performing atherectomy, for example, using a laser or rotational atherectomy catheter and a balloon over the guidewire. Diagnostic imaging and physiologic measurements may be performed to determine appropriate therapy, using an imaging catheter or FFR measurements.

[0050] In PVI, the physician uses a robotic control system to perform the procedure and restore blood flow using techniques similar to NVI. The distal tip of a guidewire is navigated past the lesion, and a microcatheter can be used to provide adequate support for the guidewire in complex anatomy. Blood flow is restored by delivering and deploying a stent or balloon at the lesion. As with PCI, lesion preparation and diagnostic imaging may also be performed.

[0051] In one example, an operator of a robotic control system used for a medical procedure is located in the same room as the patient and the robotic control system or in an adjacent room. In another example, the operator is located in a remote location (e.g., another building, another city, etc.) to operate the robotic control system and perform the medical procedure. A system that allows a remote operator to control and operate a robotic control medical procedure system provides patients, for example, in small communities, with access to medical expertise that may not be available locally. Furthermore, patients who require emergency medical care can receive care from a remote specialist at a local hospital, reducing the time to perform an interventional procedure. For example, interventional procedures can be performed more quickly to treat patients with acute ischemic stroke due to large vessel occlusion (LVO) or to treat patients with ST-segment elevation myocardial infarction (STEMI).

[0052] FIG. 1 is a perspective view of a catheter treatment system according to an embodiment.

[0053] Referring to FIG. 1, the catheter procedure system 100 may be used to perform catheter-based medical procedures, including percutaneous interventional procedures such as percutaneous coronary intervention (PCI), neurovascular intervention procedures (e.g., to treat large vessel occlusion (LVO)), PCI for ST-segment elevation myocardial infarction, peripheral vascular intervention procedures, and the like.

[0054] Catheter-based medical procedures can also include diagnostic catheterization procedures in which one or more catheters (or other elongated medical devices) are used to aid in diagnosing a patient's disease. For example, in at least one embodiment of a catheter-based diagnostic procedure, a contrast agent is injected through a catheter into one or more coronary arteries to obtain images of the patient's heart.

[0055] Catheter-based medical procedures can also include catheter-based therapeutic procedures in which a catheter (or other elongated medical device) is used to treat a condition (eg, angioplasty, stent placement, treatment of peripheral vascular disease, etc.).

[0056] Of course, one of ordinary skill in the art will recognize that certain specific percutaneous intervention devices or components (e.g., type of guidewire, type of catheter, etc.) may be selected based on the type of procedure being performed. The catheterization system 100 can perform any number of catheter-based medical procedures with minor adjustments to accommodate the specific percutaneous intervention devices used in the procedure. In particular, although the embodiments of the catheterization system 100 disclosed herein are primarily described with respect to diagnosing and / or treating coronary artery disease, the catheterization system 100 may be used to diagnose and / or treat any type of disease or condition suitable for diagnosis and / or treatment using a catheter-based procedure.

[0057] The catheterization system 100 includes a laboratory unit 106 and a workstation 116. A robotically controlled catheterization system, shown as a bedside system 110, is located in the laboratory unit 106 adjacent to a patient 102. The patient 102 is reclined on a table 108. Generally, the bedside system 110 may be equipped with suitable percutaneous interventional devices or other components (e.g., guidewires, guide catheters, working catheters such as balloon catheters or stent delivery systems, contrast agents, medications, diagnostic catheters, etc.) to enable a user to perform a catheter-based medical procedure via the robotically controlled system by manipulating various controls, such as those at the workstation 116. The bedside system 110 may include any number and / or combination of components to provide the bedside system 110 with the functionality described herein.

[0058] Bedside system 110 includes, among other elements, a drive assembly 111 supported by a robotically controlled arm 112. Drive assembly 111 includes a cassette 114 mounted to a robotically controlled drive 113 and is used to drive an elongated medical device 115, such as a catheter or guidewire. For example, drive assembly 111 can be used to automatically thread a guidewire into a guide catheter seated in an artery of patient 102.

[0059] The bedside system 110 communicates with the workstation 116, allowing signals generated by user inputs at the workstation 116 to be transmitted to the bedside system 110 to control various functions of the bedside system 110. The bedside system 110 can also provide feedback signals to the workstation 116 (e.g., operating conditions, warning signals, error codes, etc.). The bedside system 110 can be connected to the workstation 116 via a communication link 140 (shown in FIG. 2). The communication link 140 can be a wireless connection, a cable connection, or any other means that allows communication between the workstation 116 and the bedside system 110.

[0060] The workstation 116 includes a user interface 126 configured to receive user inputs to operate various components or systems of the catheterization system 100. The user interface 126 includes a control device 118 that allows a user to control the bedside system 110 to perform a catheter-based medical procedure. For example, the control device 118 is configured to cause the bedside system 110 to perform various tasks using various percutaneous intervention devices (e.g., elongated medical devices) that may be equipped with the bedside system 110 (e.g., advance, retract, or rotate a guidewire, advance, retract, or rotate a working catheter, advance, retract, or rotate a guide catheter, inflate or deflate a balloon disposed in a catheter, place and / or deploy a stent, inject contrast into the catheter, inject medication into the catheter, or perform any other function that may be performed as part of a catheter-based medical procedure). The drive assembly 111 includes various drive mechanisms for causing movement (e.g., axial and rotational movement) of each component of the bedside system 110, including the percutaneous intervention devices.

[0061] In one embodiment, the controls 118 include a touch screen 124, one or more joysticks 128, and buttons 130, 132. The joystick 128 can be configured to advance, retract, or rotate various components or percutaneous interventional devices, such as a guidewire, a guide catheter, or a working catheter. The buttons 130, 132 can include, for example, an emergency stop button and a magnification button. When the emergency stop button is pressed, a relay is triggered to cut off power to the bedside system 110.

[0062] The magnification buttons act to increase or decrease the speed at which an associated component operates in response to manipulation of the control device 118. In one embodiment, the control device 118 includes one or more controllers or icons (not shown) displayed on the touch screen 124 that can be used to operate components of the catheter procedure system 100.

[0063] The control device 118 may also include a balloon or stent controller configured to inflate or deflate the balloon and / or stent. Each of the controllers may include one or more buttons, joysticks, touch screens, etc. configurable to control the particular component to which the control is assigned. Additionally, the touch screen 124 may display one or more icons (not shown) relating to various portions of the control device 118 or related to various components of the catheter procedure system 100.

[0064] The user interface 126 includes a first monitor (or display) 120 and a second monitor (or display) 122. In other embodiments, the user interface 126 can include one display or more than two displays. The first monitor 120 and the second monitor 122 are configured to display information and patient-specific data to a user at the workstation 116. For example, the first monitor 120 and the second monitor 122 are configured to display image data (e.g., x-ray images, MRI images, CT images, ultrasound images, etc.), hemodynamic data (e.g., blood pressure, heart rate, etc.), and patient chart information (e.g., medical history, age, weight, etc.). Additionally, the first monitor 120 and the second monitor 122 are also configured to display procedure-specific information (e.g., time of procedure, catheter or guidewire position, volume of drug or contrast agent to be administered, etc.). The first monitor 120 and the second monitor 122 are also configured to display information regarding the position of the guide catheter. Additionally, first monitor 120 and second monitor 122 are also configured to display information providing functionality associated with controller 134 (shown in FIG. 2). In another embodiment, user interface 126 includes a single screen large enough to display one or more of the display and / or touch screen components described herein.

[0065] The catheter procedure system 100 also includes an imaging system 104 located within the laboratory unit 106. The imaging system 104 can be a variety of medical imaging systems (e.g., non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.) that can be used in conjunction with catheter-based medical procedures. In one embodiment, the imaging system 104 is a digital x-ray imaging device in communication with a workstation 116. In one embodiment, the imaging system 104 can include a C-arm (not shown) that allows the imaging system 104 to rotate partially or fully around the patient 102 to obtain images at various angular positions relative to the patient 102 (e.g., sagittal, caudal, anterior-posterior, etc.).

[0066] The imaging system 104 may be configured to take x-ray images of appropriate areas of the patient 102 during a particular procedure. For example, the imaging system 104 may be configured to take one or more x-ray images of the heart to diagnose a cardiac condition.

[0067] The imaging system 104 may also be configured to take one or more x-ray images (e.g., real-time images) during a catheter-based medical procedure to assist a user of the workstation 116 in properly positioning a guidewire, guide catheter, stent, or the like during the procedure. The one or more images may be displayed on the first monitor 120 and / or the second monitor 122. In particular, the images may be displayed on the first monitor 120 and / or the second monitor 122 to, for example, enable a user to accurately move a guide catheter to the appropriate position.

[0068] Referring to FIG. 2, a block diagram of an embodiment of a catheterization system 100 is shown. The catheterization system 100 includes a controller 134. The controller 134 may be part of the workstation 116 (shown in FIG. 1). The controller 134 may generally be an electronic control unit suitable for providing the catheterization system 100 with the various functions described herein. For example, the controller 134 may be an embedded system, a dedicated circuit, a general-purpose system programmed with the functions described herein, etc. The controller 134 is in communication with one or more of the bedside system 110, the control device 118, the monitors 120 and 122, the imaging system 104, and the patient sensors 136 (e.g., an electrocardiogram ("ECG") device, an electroencephalogram ("EEG") device, a blood pressure monitor, a temperature monitor, a heart rate monitor, a respiratory monitor, etc.). In one embodiment, the controller 134 is also in communication with a contrast injection system 152 and an intravascular ultrasound (IVUS) system 154. The controller 134 may also communicate with other medical systems 156, such as, for example, an OCT system, an FFR system, or an aspiration pump. In one embodiment, the controller 134 is configured to generate control signals based on a user's interaction with the control device 118 and / or based on information accessible to the control device 134 so that a medical procedure can be performed using the catheter procedure system 100. Additionally, the controller 134 may communicate with a hospital network (hospital data management system) 142 and one or more other output devices 138 (e.g., printers, disk drives, CD / DVD writers, etc.).

[0069] Communication between the various components of the catheter procedure system 100 is accomplished via communication links 140. The communication links 140 may be dedicated wired or wireless connections. The communication links 140 may also represent communication over a network. The catheter procedure system 100 may be connected or configured to include various other systems and / or devices not expressly illustrated. For example, the catheter procedure system 100 may include an image processing engine, a data storage and archiving system, an automated balloon and / or stent expansion system, a medication injection system, a medication tracking and / or recording system, a user log, an encryption system, a system for limiting access or use of the catheter procedure system 100, and the like.

[0070] As described above, controller 134 communicates with bedside system 110 and provides control signals to bedside system 110 to control operation of motors and drive mechanisms used to drive percutaneous interventional devices (e.g., guidewires, catheters, etc.). Bedside system 110 may include, for example, a guidewire axial drive mechanism that provides for advancement and / or retraction of a guidewire, a working catheter axial drive mechanism that provides for advancement and / or retraction of a working catheter, and a guidewire rotational drive mechanism configured to rotate a guidewire about its longitudinal axis. In one embodiment, drive assembly 114 (shown in FIG. 1 ) houses these various drive mechanisms.

[0071] Robotically controlled medical device systems, such as the example catheter procedure system described above with respect to Figures 1 and 2, can be remotely controlled.

[0072] FIG. 3 is a schematic diagram of a communication means and control system of a robotic-controlled medical device system according to an embodiment. The communication means and control system 10 includes a control center 12 at a remote site (or distant location) and a robotic-controlled medical device system 14 at a local site (or on-site). The local site is the location of the robotic-controlled medical device system and the patient (or subject), and the remote site is the location of an operator (e.g., a physician) and the control center used to remotely control the robotic-controlled medical device system. The control center 12 and the robotic-controlled medical device system 14 communicate over a network 16, such as the Internet. In one embodiment, the remote site and the local site are separate from each other, such as different rooms in the same building, different buildings in the same city, different cities, or other different locations where the remote site does not have physical access to the robotic-controlled medical device system or the patient at the local site. The control center 12 and the robotic-controlled medical device system 14 communicate (e.g., data, images, instructions, and control signals) over the network 16.

[0073] An operator at a remote site uses a control center 12 to control and operate a robotic-controlled medical device system 14 at a local site to perform a medical procedure. In one embodiment, multiple control centers 12 communicate with one robotic-controlled medical device system 14 over a network 16, with each control center 12 being used to control the robotic-controlled medical device system 14 from a separate location. In another embodiment, multiple control centers 12 communicate with multiple robotic-controlled medical device systems 14 over a network 16, with each of the control centers 12 being used to control each of the robotic-controlled medical device systems 14.

[0074] The robotic-controlled medical device system 14 is, for example, a catheterization system or other medical device system that is robotically controlled to perform a procedure. In one embodiment, the network 16 is a secure network, such as, for example, a virtual private network (VPN). The control center 12 can include, for example, a workstation with a user interface. In one embodiment, the control center 12 includes a user interface similar to the user interface provided to the robotic-controlled medical device system 14. For example, if the robotic-controlled medical device system 14 is a catheterization system, such as the system described above in connection with FIGS. 1 and 2, the control center 12 can include a workstation having a user interface and controls similar to the workstation 116, the user interface 126, and the control device 118 of the catheterization system 100. In another embodiment, the control center 12 includes a workstation or user interface that is part of a robotic-controlled medical device system at a remote site. The control center 12 is configured to allow an operator to operate each component of the robotic-controlled medical device system 14 from a remote site. Information such as data, images, command and control signals are transmitted from the control center 12 over the network 16 to the robotic-controlled medical device systems 14, and information such as data, images, and the like is transmitted from the robotic-controlled medical device systems 14 over the network 16 to the control center 12.

[0075] FIG. 4 is a block diagram of a communication and control system of a robotic-controlled medical device system according to an embodiment. The communication and control system 200 includes a control center 202 at a remote site and a robotic-controlled medical device system 204 at a local site. The control center 202 and the robotic-controlled medical device system 204 communicate through a network 206. The network may include or communicate with a Network Time Protocol (NTP) pool. In one embodiment, the network 206 is a secure network established using a remote firewall 208 at the control center 202 and a local firewall 210 at the robotic-controlled medical device system 204. For example, the network 206 may be a VPN. The network 206 is configured to transmit and receive data, images, commands, and control signals. In the system 200 shown in FIG. 4, one control center 202 and one robotic-controlled medical device system 204 are shown. In one embodiment, multiple control centers 202 communicate with one robotically controlled medical device system 204 over network 206, where each control center 202 may be used to control one or more medical devices 246 using a robotic control system 245 of the robotically controlled medical device system 204 from a separate location. The robotic control system 245 may be, for example, a robotically controlled arm, a robotically controlled drive, and / or other robotic control device that may be used to drive a medical device. In an embodiment where the robotically controlled medical device system is a catheter system, the robotic control system 245 may be the robotically controlled arm 112 and drive assembly 111 described above with respect to FIG. 1. In another embodiment, multiple control centers 202 communicate with multiple robotically controlled medical device systems 204 over network 206, where each of the control centers 202 may be used to control one or more medical devices 246 using a robotic control system 245 in each of the robotically controlled medical device systems 204.

[0076] Additionally, the control center 202 includes a remote command and control module 212 and a remote controller 216 that are connected to and communicate with the firewall 208. In one embodiment, the remote firewall 208, the remote command and control module 212, and the remote controller 216 are implemented in separate hardware (e.g., computer systems). In another embodiment, the remote firewall 208, the remote command and control module 212, and the remote controller 216 are implemented as separate software components or logical subsystem components in one computer system. In one embodiment, the remote command and control module 212 and the remote controller 216 can be implemented in a single component (software and / or hardware) or logical subsystem component of one or distributed computer systems. The remote command and control module 212 and the remote controller 216 may be collectively referred to as a controller or remote controller. The software components or logical subsystem components may be accomplished using, for example, a microkernel, a virtual machine, or well-known operating systems with real-time extensions. In another embodiment, the remote controller 216 and the remote firewall 208 may be implemented as a software program that executes on the remote command and control module 212. The remote command and control module 212 receives command and control signals from a control console 236 at the control center. The control console 236 is configured to receive user input from an operator at the remote site to operate the robotically-controlled medical device system 204 and other systems and devices at the remote site. For example, the control console 236 may include displays and controls such as a touch screen, one or more joysticks, and buttons. A first display 240 at the control center 202 is connected to the remote command and control module 212 and is used to display data and images received from the robotically-controlled medical device system 204.The remote command and control module 212 may be configured to decompress images received from the robotically controlled medical device system 204 .

[0077] The remote command and control module 212 is also connected to a time-synchronized reference clock, such as a remote reference clock 220, and receives time information from the remote reference clock 220. The remote reference clock 220 may be, for example, a grand master clock. As will be described in more detail below, the time information may be used to calculate delays in the transmission of signals and data (e.g., command and control signals, and images) between the remote site and the local site. The remote reference clock 220 is connected to an antenna 232 and receives time information from an external time source, such as a satellite-based time source or an external network, and provides time stamp information to the remote command and control module 212. In one embodiment, the time information is provided from a Global Positioning System (GPS). In another embodiment, the time information is provided from a Satellite Time & Location (STL) system. A remote switch 224 is connected to the remote reference clock 220. In one embodiment, the remote reference clock 220, the remote switch 224, and the remote command and control module 212 use a Precision Time Protocol (PTP) network. The remote command and control module 212 uses the time stamp information from the remote reference clock 220 to time stamp command and control signals received from the control console 236. The time stamped command and control signals are transmitted over the network 206 to a local command and control module 214 in the robotically controlled medical device system 204. The local command and control module 214 is configured, for example, to provide command and control signals over the network 206 to a robotic control system 245 of the robotically controlled medical device system 204 to control the operation of the medical device 246. The time stamps applied to the command and control signals by the remote command and control module 212 based on information from the remote reference clock 220 are used to monitor and control delays in the transmission of command and control signals over the network 206 during medical procedures performed using the medical device 246.The local command and control module 214 is configured to measure the delay in receiving command and control signals from the control center 202 based on the timestamps, as described in more detail below with respect to FIG. 5, and to take appropriate action based on the amount of delay.

[0078] The local command and control module 214 and the local controller 218 are connected to and communicate with the local firewall 210. In one embodiment, the local firewall 210, the local command and control module 214, and the local controller 218 are implemented in separate hardware (e.g., computer systems). In another embodiment, the local firewall 210, the local command and control module 214, and the local controller 218 are implemented as separate software components or logical subsystem components in one computer system. In one embodiment, the local command and control module 214 and the local controller 218 can be implemented in a single component (software and / or hardware) or logical subsystem component of one or a distributed computer system. The local command and control module 214 and the local controller 218 may be collectively referred to as a controller or local controller. The software components or logical subsystem components may be accomplished using, for example, a microkernel, a virtual machine, or well-known operating systems with real-time extensions. In another embodiment, the local controller 218 and the local firewall 210 can be implemented as a software program executed on the local command and control module 214. The local command and control module 214 also receives command and control signals from a robotic controlled medical device system control console 238. The control console 238 is configured to receive user input from a local site operator for operation of the local site robotic controlled medical device system 204. For example, the control console 238 may include a display and controls such as a touch screen, one or more joysticks, and buttons. A display 241 is connected to the local command and control module 214 and is used to display data and images. The local command and control module 214 also receives images from an imaging system 248 and hemodynamic data from patient sensors 250.In an embodiment where the robotic controlled medical device system 204 is a catheterization system as described above with respect to Figures 2 and 3, the local controller 218 may be connected to the display 120, 122 or the touch screen 124. Images from the imaging system 248 may be captured and scaled using a first video capture and scaling device 242, and hemodynamic data may be captured and scaled using a second video capture and scaling device 244. The local command and control module 214 may be configured to compress the image data before transmitting to the control center 202, and the local controller 218 may be configured to compress the hemodynamic data before transmitting to the control center 202. In another embodiment, the local command and control module 214 is connected to and receives data from an intravascular ultrasound (IVUS) system 254. Data from the IVUS system 254 is transmitted to the control center 202.

[0079] The local command and control module 214 is also connected to a time synchronization reference clock, such as a local reference clock 226, and receives time information from the local reference clock 226. The local reference clock is, for example, a grand master clock. The time information is used to calculate delays in the transmission of signals and data (e.g., command and control signals, and images) between the remote site and the local site. The local reference clock 226 is connected to an antenna 234 and receives time information from an external time source, such as a satellite-based time source, and provides time stamp information to the local command and control module 214. In one embodiment, the time information is provided from a Global Positioning System (GPS). In another embodiment, the time information is provided from a Satellite Time & Location (STL) system. A local switch 230 is connected to the local reference clock 226. In one embodiment, the local reference clock 226, the local switch 230, and the local command and control module 214 use a Precision Time Protocol (PTP) network. The local command and control module 214 uses the time stamp information from the local reference clock 226 to time stamp the image data received from the first video capture and scaling device 242. In another embodiment, the local controller 218 uses the time stamp information from the local reference clock 226 to time stamp the hemodynamic data received from the second video capture and scaling device 244. The time stamped image and hemodynamic data are transmitted over the network 206 to the remote command and control module 212 in the control center 202.

[0080] Although illustrated in FIG. 4, in other embodiments, the second video capture and scaling device 244 and the patient sensor 250 may be omitted.

[0081] The remote command and control module 212 is configured to provide images to the display 240 of the control center 202 and hemodynamic data to the display 240 of the control center 202 or to another display. The timestamps provided to the images and hemodynamic data by the local command and control module 214 based on information from the local reference clock 226 are used to monitor and control delays in the transmission of images and hemodynamic data over the network 206 during a medical procedure performed using the control center 202 to control the robotic control system 245 and one or more medical devices 246. Components of the system 200, or control of the system between the control center 202 and the robotic controlled medical device system 204, may be paused or halted based on delays in the transmission of images and / or hemodynamic data.

[0082] As described above, the control center 202 includes a precision time protocol enabled remote reference clock 220 and the robotic-controlled medical device system 204 includes a precision time protocol enabled local reference clock 226. The remote reference clock 220 and the local reference clock 226 communicate with a common external time source, such as a satellite-based time source like GPS or STL, to receive time information. At least this embodiment allows the control center 202 and the robotic-controlled medical device system 204 to communicate through a secure tunnel over the network 206 (e.g., the Internet) to calculate command delays and round trip delays to ensure safe and reliable operation. Each site uses a dedicated reference clock (e.g., respective reference clocks 220, 226) and an isolated Ethernet network for time synchronization. Either NTP or PTP is used for synchronization in this embodiment. The use of a dedicated reference clock at each site through an isolated network reduces and / or eliminates the attack surface of network attacks targeting time references made accessible from the Internet. Such vulnerabilities include, but are not limited to, denial of service (DoS) that would render the GMC unavailable, and stack overflows that would place the command and control module under the control of an attacker. As described further below with respect to Figure 16, in one embodiment, the firewall can be used to establish a dedicated hardware IPSec encrypted tunnel between two nodes with secret keys for a relatively high level of security and low (e.g., minimal) latency impact on communications.

[0083] In another embodiment, the control center 202 and the robotic-controlled medical device system 204 may not include their own reference clocks. That is, the control center 202 and the robotic-controlled medical device system 204 are configured to utilize NTP and NTP pools that communicate with a single network grandmaster clock to receive time information. As described above, the time information can be used to generate timestamps for the command and control signals and other data (e.g., images and hemodynamic data). In at least one embodiment, the timestamps are provided by a common time source (e.g., GPS or STL) to measure the total command and control signal transmission delay. In another embodiment, the timestamps are provided by a single time source (e.g., a network grandmaster clock or an internal clock) to measure the total command and control signal transmission delay. In this embodiment, the timestamps from the "remote" site are used, so that when the timestamps are returned with the image transmission from the "local" site, the round-trip command and control signal and image delays are calculated.

[0084] As described above, the control center 202 is used by an operator at a remote site to operate and control the robotic medical device system 204 and other systems and devices at the local site. In one embodiment, the control center 202 provides command and control signals to the imaging system 248 or the contrast injection system 252 over the network 206. For example, the control center 202 is used to control image capture by the imaging system 248. In another embodiment, the control center 202 is used to control contrast injection by the contrast injection system 252. In one embodiment, the control center 202 is used to control the activation of an aspiration pump or the deployment of a stent retriever.

[0085] The control center 202 includes a telepresence module 260, and the robotic-controlled medical device system 204 includes a telepresence module 262. Each telepresence module 260, 262 is configured to provide audio and video communications (e.g., telepresence, videoconferencing) between an operator at a remote site and a user at a local site or local staff. In at least one embodiment, the telepresence modules 260, 262 are stand-alone modules and are connected to the remote firewall 208 and the local firewall 210, respectively, as shown in FIG. 4. In at least one other embodiment, the elements of the telepresence modules 260, 262 are software programs that execute on the remote controller 216 or the local controller 218, respectively. The telepresence modules 260, 262 may include, for example, a video camera, a monitor, a speaker, and a microphone. In one embodiment, a video conference can be established between the remote site telepresence module 260 and the local site telepresence module 262, so that an operator at the remote site using the control center 202 can view the procedure room and equipment where the procedure is performed, and can communicate using audio and video with personnel supporting the procedure at the local site (e.g., technicians, doctors, etc.), so that the operator can operate the medical device 246 using the local site robotic control system 245. In one embodiment, audio and video communication is established between the remote site telepresence module 260 and the local site telepresence module 262 using a dedicated audio and video communication system that establishes secure communication over a computer network (e.g., a cloud network). For example, the remote site telepresence module 260 is configured to transmit audio (e.g., speech) and video from the remote site in an encrypted format (e.g., SRTP / AES-128) and receive and decrypt audio (e.g., speech) and video from the local site telepresence module 262.The telepresence module 262 at the local site is configured to transmit audio (e.g., speech) and video from the local site in an encrypted format (e.g., SRTP / AES-128) and to receive and decrypt audio (e.g., speech) and video from the telepresence module 260 at the remote site. Signaling and routing between the telepresence module 260 and the telepresence module 262 may be established using a cloud network. In at least one embodiment, the encrypted audio and video data is transmitted between the remote firewall 208 and the local firewall 210 without further encryption (e.g., the audio and video data is whitelisted).

[0086] FIG. 5 illustrates a method of controlling the operation of a robotically controlled medical device system, according to an embodiment.

[0087] 4 and 5, at block 302, command and control signals are received by the local command and control module 214 at the local site from, for example, the control center 202 at the remote site.

[0088] At block 304, the delay in receiving the command and control signals is measured, for example by the local command and control module 214, based on the timestamp information.

[0089] At block 306, the delay is compared to a threshold. In one embodiment, the threshold is a predetermined (or alternatively preferred or predetermined) value based, for example, on whether it is perceptible to a user. In one example, the threshold is 250 ms. In another embodiment, described in more detail below, the threshold can be determined at block 316 based on at least one parameter of the robotic medical device system, for example, the procedure being performed by the robotic medical device system, the patient's anatomy, the type of medical device, and the location of the medical device.

[0090] If the delay is greater than a threshold in block 308, corrective action can be taken in block 314. In at least one embodiment, the medical device 246 and other components of the robotically controlled medical device system 204 can be paused or stopped. In one example of pausing, if the delay exceeds a threshold and then progresses below the threshold, the device or component can be paused when the delay progresses beyond the threshold and then restarted. In another example, if the delay is too large, the operation of the device or component can be paused until the delay is low enough to resume operation. In another embodiment, the speed or velocity (e.g., of forward, backward, or rotation) of the components of the robotically controlled medical device system can be slowed down. If the network connection is lost or the speed of the network 206 slows below a predetermined (or preferred or predetermined) rate, the control center 202 can return control of the robotically controlled system 245 and medical device 246 to the robotically controlled medical device system 204. An emergency stop can also be provided to allow a user at the local site to stop a procedure in the event of an emergency. In one embodiment, the threshold has a threshold range. When the control center 202 has control of the robotic control system 245 and the medical devices 246 and the delay in command and control signals is greater than a first threshold and less than a second threshold, the control console 236 (e.g., a joystick) of the control center 202 is disabled, but the control console 236 maintains control of the robotic control system 245 and the medical devices 246. When the control center 202 has control of the robotic control system 245 and the medical devices 246 and the delay in command and control signals is greater than a second threshold, the control center 202 can be disabled.

[0091] In block 308, when the control center 202 has control of the robotic control system 245 and the medical device 246, if the delay in the command and control signals does not reach a threshold, in block 310, the control console 236 of the control center 202 can be used to control and operate the robotic control medical device system 204, including the robotic control system 245 and the medical device 246.

[0092] In block 312, the speed of the medical device 246 is adjusted based on the delay of the command and control signals if it is being controlled by the control center 202. If the control center 202 has control of the robotic control system 245 and the medical device 246, the delay of the command and control signals (t delay ) is the specified threshold amount (t predetermined ) and greater than zero, the commanded velocity (v command ) is the rate at which the device 246 speeds up as the delay increases towards the threshold amount (v device ) is scaled so that the speed of the device decreases. In this embodiment, the speed of the device is given by equation (1) below. (1) JPEG2025023973000002.jpg26167

[0093] For example, delay t delay is the threshold t predetermined If the device speed is equal to half of device is the command speed v command The delay t delay Slowing down the device 246 as the delay t increases helps ensure system stability and reduces risks with device control, for example, from moving the device too far forward or backward. delay is the threshold amount t predetermined If it is greater than (block 308), then the device speed v device is set to zero and operation of the device 246 stops (block 314).device can be adjusted based on the total network delay, which is the delay of the command and control signals t delay and the delay t of the image received from the robotic medical device system 204 imagedelay In this example, the device speed v device is given by the following equation (2). (2) JPEG2025023973000003.jpg12140

[0094] Total network delay t total =(t delay +t imagedelay ) based on the device's command speed v command Scaling the command rate can ensure stable operation and robust performance for the position control of the device. One or more of the above embodiments for scaling the command rate can be adjusted to ensure stability for any total delay. If the delay is unknown, too large a delay can cause instability.

[0095] The frequency response of the open loop system under constant total delay is given by equation (3) below. (3) JPEG2025023973000004.jpg2594

[0096] Based on the Nyquist stability criterion, for the stability to be guaranteed for the direct proportional feedback, the total network delay must satisfy the following constraint: total ≦(π / 2) seconds. Threshold t predetermined Scaling equation (2) above with =π / 2 results in a frequency response given by equation (4) below. (4) JPEG2025023973000005.jpg31115

[0097] In another embodiment, the threshold t predeterminedOther optimal values ​​for can be calculated and used in scaling equation (2). From equation (4), stability is guaranteed for proportional-direct feedback if the gain margin is now infinite for direct proportional feedback. Other methods can be used in a similar manner with knowledge of the feedback delay to ensure stability. An example of an approach using wave variables to ensure stability without knowledge of the feedback delay, as in controlling the position of a device using a velocity command, is described in "Design of Networked Control Systems Using Passivity", N. Kottenstette, JF Hall, X. Koutsoukos, J. Sztipanovits and P. Antsaklis, IEEE Transactions on Control Systems Technology, vol. 21, no. 3, pp. 649-665, May 2013, which is incorporated herein by reference in its entirety.

[0098] As described above, in block 316, the delay threshold is determined based on at least one parameter of the robotically controlled medical device system 204, including, for example, the procedure being performed by the robotically controlled medical device system. For example, the robotically controlled medical device system 204 is a catheterization procedure system that controls the movement, manipulation of an elongated medical device (e.g., catheter, guidewire, balloon catheter, microcatheter, etc.). The amount of acceptable delay may vary depending on various parameters of the catheterization procedure system. The value of the delay threshold is based, for example, on the type of procedure being performed, the patient's anatomy, the type of elongated medical device (e.g., catheter, balloon catheter, guide catheter, guidewire, microcatheter, etc.), the position of the elongated medical device, the distance between the elongated medical device (e.g., the tip or distal end of the instrument) and the target location, or the type of movement (e.g., advance, rotate, retract, etc.) performed by the elongated medical device. For example, a larger delay may be acceptable if the elongate medical device (e.g., the tip of the elongate medical device) is significantly far from the target location, if the elongate medical device is being retracted, or if the elongate medical device is a device that moves along a wire (e.g., a microcatheter or balloon catheter) or guidewire.

[0099] In at least one embodiment, the remote controller 216 (shown in FIG. 4) and the local controller 218 (shown in FIG. 4) each generate and display a similar graphical user interface.

[0100] 6 is an example of a graphical user interface of a control center according to an embodiment. FIG 7 is another example of a graphical user interface of a robotically controlled medical device system according to an embodiment.

[0101] 6 and 7, graphical user interfaces 460, 462 are for controlling an example catheter procedure system. The graphical user interface 460 for the control center and the graphical user interface 462 for the robotic controlled medical device system are configured to show, for example, the same measurements, speeds, saved settings, and which controls of the control console are being operated at the active site (e.g., either the control center at a remote site or the robotic controlled medical device system at the local site). Each graphical user interface 460, 462 displays the image delay 464, 466 of the transmitted image from the robotic controlled medical device system to the control console and the command delay 468, 470 of the command and control signals from the control center to the robotic controlled medical device system.

[0102] As discussed above with respect to FIG. 4, the display 240 of the control center 202 can be used to display data and images received from the robotically controlled medical device system 204 over the network 206.

[0103] FIG. 8 shows an example of displaying data and images of the robot-controlled medical device system according to the embodiment.

[0104] 8, the display 500 includes a display of data and images acquired by the robotically controlled medical device system 204, such as, for example, hemodynamic data 502, reference images 506, and live images 508 related to the operation of the robotically controlled medical device to perform a procedure. Specifically, in the embodiment shown in FIG. 8, the data and images relate to a catheterization procedure. The robotically controlled medical device system 204 may be configured to select a section or region of interest on the display 500 for transmission to the control center 202 at the remote site.

[0105] Thus, for example, the display 500 can be cropped to allow separate transmission of the hemodynamic data 502, the reference image 506, and the live image 508. The selected section or region of interest can be of any shape that captures the desired information to be transmitted. Cropping the display 500 can potentially reduce the bandwidth required to transmit the images and data.

[0106] FIG. 9 illustrates an example display of a control center at a remote site with a selected area of ​​interest including hemodynamic data, according to an embodiment.

[0107] In FIG. 9, a display 600 includes hemodynamic data received from the robotic medical device system 204.

[0108] In another embodiment, the remote controller 216 and display 240 may be configured to allow an operator to selectively circularly buffer up to a predetermined (or preferred or predefined) time (e.g., 10 seconds) of live image data (e.g., fluoroscopic image data for a catheter procedure), as shown in FIG. 10. For example, a user may activate a control that starts a capture and creates a circular buffer for playback for a predetermined time. In the embodiment shown in FIG. 10, a playback image 702 displayed on the display 700 is scaled to be the same scale as a live image 704. The playback image 702 is real-time at a predetermined (or preferred or predefined) number of frames per second. In at least one embodiment, controls are provided that allow an operator to pause, step forward, and step back the playback image 702.

[0109] Replay images can be used, for example, to facilitate the generation of roadmaps and capture the progression of events.

[0110] In another embodiment, the display of images at the remote site (eg, on display 240 shown in FIG. 4) may be configured to display image delay times and command and control signal delay times, as shown in FIG.

[0111] In Figure 14, display 1100 includes a playback image 1102 and a live image 1104. The display of the live image includes a display of the image delay 1106 of the transmitted image from the robotic controlled medical device system to the control console, and the command and control signal delay 1108 from the control center to the robotic controlled medical device system. In another embodiment, the display of the image at the remote site (e.g., on display 240 shown in Figure 4) may be configured to display the total delay, as shown in Figure 15. The total delay is the sum of the image delay time and the command and control signal delay time. In another example, the total delay may be displayed as a drop-down overlay on display 240.

[0112] In FIG. 15 , the display 1200 includes a playback image 1202 and a live image 1204, which may include additional live information about the procedure, such as total delay and frame rate for images acquired by an imaging system associated with the local site robotic controlled medical device system 204. In at least one embodiment, the playback image 1202 may be scrolled to the area of ​​interest after the image is acquired. The display of the live image 1204 includes a display of a total delay 1206 and a frame rate 1208. The frame rate 1208 may be calculated in units of received frames per second. The total delay 1206 and frame rate 1208 may be updated in real time and / or filtered to an appropriate bandwidth to improve the viewer's perception of these values.

[0113] As described above with respect to FIG. 4, the communication means and control system 200 is configured to allow an operator (e.g., a physician) at a remote site to control and operate the robotic-controlled medical device system 204 at a local site. The system 200 is also configured to allow an operator at a local site to control and operate the robotic-controlled medical device system 204. A control management process is provided to manage whether the control center 202 or the robotic-controlled medical device system 204 has control of the robotic control system 245 and the medical device 246. The control management process is configured, for example, to prevent deadlocks between the remote and local sites. In at least one embodiment, a control token is used to determine whether the control center 202 or the robotic-controlled medical device system 204 has operational control to perform a procedure. The control token is a virtual token implemented in software. The system holding the control token (e.g., either the control center 202 or the robotic controlled medical device system 204) is given control of the robotic control system 245 and medical devices 246 of the robotic controlled medical device system 204, and the other system is disabled and removed from control of the robotic control system 245 and medical devices 246. In the first state, the control token is "free" and can be used by either the control center 202 or the robotic controlled medical device system 204.

[0114] FIG. 11, according to an embodiment, illustrates an example of a user interface when neither the control center nor the robotic-controlled medical device system is controlling the robotic-controlled medical device. The graphical user interfaces 802, 804 are illustrated for controlling an example catheterization system (e.g., the catheterization system 100 shown in FIGS. 2 and 3). When the control token is "FREE," the robotic-controlled medical device system does not have a control token (Without Token) and can obtain control by, for example, operating an "Enable All" button on the robotic-controlled medical device system's graphical user interface 802. The control center also does not have a control token (Without Token) and can take control by, for example, operating an "RCL Disabled" button for the robotic-controlled medical device system on the control center's graphical user interface 804. In at least one embodiment, the "Enable All" button on the graphical user interface 804 is shown with a background or color that indicates that the control center does not have control, e.g., the button text and background are grayed out.

[0115] In the second state, the control token is held by the robotic controlled medical device system 204.

[0116] 12, according to an embodiment, shows an example of a user interface when a robotically controlled medical device system is controlling a robotically controlled medical device. Graphical user interfaces 902, 904 are shown for controlling an example catheterization system (e.g., the catheterization system 100 shown in FIGS. 2 and 3). When a control token is obtained by the robotically controlled medical device system, control is given to the robotically controlled medical device system and can be used to operate the robotically controlled medical device.

[0117] 12, when the robot-controlled medical device system has the control token and has acquired the control right, the "Enable All" button is disabled and changed to "Disable All" in the graphical user interface 902 of the robot-controlled medical device system (With Token). The operator can return the control token to "Free" by operating the "Disable All" button. In the graphical user interface 904 of the control center (Without Token), the "Disabled" button of the robot-controlled medical device system is disabled. In one embodiment, the "Enable All" button and the "RCL Enabled" button in the graphical user interface 904 are displayed with a background or color that indicates that the control center does not have the control right, for example, the button text and background are displayed in gray.

[0118] In a third state, the control token has been acquired by the control center 202. FIG. 13, according to an embodiment, shows an example of a user interface when the control center is controlling a robotically-controlled medical device. Graphical user interfaces 1002, 1004 are shown for controlling an example catheterization system (e.g., the catheterization system 100 shown in FIGS. 2 and 3). When the control center holds the control token, control is given to the control center and can be used to operate the robotically-controlled medical device.

[0119] In FIG. 13 , when the control center has the control token and has acquired the control authority, the “Enable All” button is enabled in the graphical user interface 1004 of the control center (With Token). Furthermore, “RCL Disabled” is enabled in the graphical user interface 1004 of the control center. In one embodiment, the “RCL Disabled” button in the graphical user interface 1004 is displayed with a highlight, background, or color indicating that the control center has the control authority. For example, the graphical user interface 1004 is displayed with “RCL Disabled” underlined. In another embodiment, the “RCL Disabled” button is displayed in a color, such as green. In the graphical user interface 1002 of the robot-controlled medical device system (Without Token), the “Enable All” button is disabled, and the robot-controlled medical device system cannot obtain the control authority. In one embodiment, the “Enable All” button in the graphical user interface 1002 is displayed with a background or color indicating that the robot-controlled medical device system does not have the control authority, such as, for example, the text and background of the button are grayed out.

[0120] In one embodiment, in the second and third states where either the control center or the robotic-controlled medical device system holds the control token, a site that does not have the control token can hold a request token or a forced request token. The request token or the forced request token are virtual tokens implemented in software. The request token and the forced request token can be used to request control rights or to force a change in control rights. For example, if the control center holds the control token, the robotic-controlled medical device system can send a request token to the control center to request that the control token be made "free" so that the robotic-controlled medical device system can obtain the control token. In response to receiving the request token, the control center can, for example, make the control token "free", choose to keep the control token, or suspend and keep the control token. In another example, if the control center holds the control token, the robotic-controlled medical device system can send a forced request token to the control center to request that the control token be made "free" so that the robotic-controlled medical device system can obtain the control token. A control center responding to a forced request token can, for example, "free" the control token, choose to keep the control token, or suspend and relinquish the control token.

[0121] As discussed above with respect to Figures 3 and 4, it is also possible for multiple control centers 202 to communicate with multiple robotically controlled medical device systems 204 over the network 206 (eg, a many-to-many configuration).

[0122] FIG. 16 is a block diagram of a many-to-many configuration of multiple control centers and multiple robotically controlled medical device systems according to an embodiment.

[0123] In Figure 16, a first control center 1302, a second control center 1304, a first robotic controlled medical device system 1306, and a second robotic controlled medical device system 1308 communicate via a network 1350. In one embodiment, each site (i.e., the first control center 1302, the second control center 1304, the first robotic controlled medical device system 1306, and the second robotic controlled medical device system 1308) is at a separate location or is located remotely from each other. The first control center 1302 is at a first remote site, the second control center 1304 is at a second remote site, the first robotic controlled medical device system 1306 is at a first local site, and the second robotic controlled medical device system 1308 is at a second local site. The first control center 1302 can be used to control either the first robotic controlled medical device system 1306 or the second robotic controlled medical device system 1308. The second control center 1304 can be used to control either the first robotic controlled medical device system 1306 or the second robotic controlled medical device system 1308.

[0124] The first control center 1302 includes a first remote firewall 1310, the second control center 1304 includes a second remote firewall 1312, the first robotically controlled medical device system 1306 includes a first local firewall 1314, and the second robotically controlled medical device system 1308 includes a second local firewall 1316. The first remote firewall 1310 is connected to a first remote controller 1318, the second remote firewall 1312 is connected to a second remote controller 1320, the first local firewall 1314 is connected to a first local controller 1322, and the second local firewall 1316 is connected to a second local controller 1324. The first remote firewall 1310 includes a LAN port 1334 and a WAN port 1336. The second remote firewall 1312 includes a LAN port 1332 and a WAN port 1330. The first local firewall 1314 includes a LAN port 1340 and a WAN port 1338. The second local firewall 1316 includes a LAN port 1326 and a WAN port 1328.

[0125] Each firewall 1310, 1312, 1314, 1316 is configured to establish secure connections with other sites and to terminate secure connections with other sites. Preferably, the control and management of establishing and torn down secure connections is handled automatically by each firewall and is kept separate from other hardware and software functions of each site. In at least one embodiment, a command line interface (CLI) and secure shell (SSH) protocol are used to establish a secure connection between the two sites. In this embodiment, each firewall 1310, 1312, 1314, 1316 has a unique static IP address. Although the following description describes establishing a secure connection between the second control center 1304 and the second robotic-controlled medical device system 1308, the method described herein may be used to establish and terminate connections between any combination of sites in a many-to-many configuration. In at least one embodiment, a centralized approach is used. In the centralized approach, the WAN port 1330 of the second control center 1304 and the WAN port 1328 of the second robotic-controlled medical device system 1308 are opened for SSH login. In this configuration, both sites (e.g., the second control center 1304 and the second robotic-controlled medical device system 1308) can create a tunnel through the LAN port of its local firewall and the WAN port of the other site. For example, the second local controller 1324 of the second robotic-controlled medical device system 1308 can enable SSH on the local LAN port 1326 of the second local firewall 1316, and the second local controller 1324 can enable SSH on the WAN port 1330 of the second remote firewall 1312 of the second control center 1304 to establish a tunnel.In another example of a centralized approach, a second remote controller 1320 of the second control center 1304 can enable SSH on a WAN port 1328 of a second local firewall 1316 of the second robotic controlled medical device system 1308, and the second remote controller 1320 of the second control center 1304 can enable SSH on a local LAN port 1332 of the second remote firewall 1312.

[0126] In another embodiment, a distributed approach is used. In the distributed approach, the WAN port 1330 of the second control center 1304 and the WAN port 1328 of the second robotic-controlled medical device system 1308 do not allow SSH login. In this embodiment, each site launches a corresponding tunnel connection using the LAN port of their respective local firewalls so that the WAN port can keep SSH login closed for enhanced security. For example, the second local controller 1324 allows SSH on the LAN port 1326 and the second remote controller 1320 allows SSH on the LAN port 1332.

[0127] In another embodiment, secure connections are established using patch panel direct routing, where direct physical wiring is used between all of the sites (or nodes) at the patch panel, and the connected ports may be switched when a specific site needs to be connected.

[0128] In one embodiment, secure connections are established by using two static IP addresses for every site (or node). The same two static IP addresses are reserved on every router at the site. Sites are simply plugged (by the user) into the system when in use and unplugged (by the user) from the Ethernet port when not in use.

[0129] In another embodiment, the secure connection is established using the same static IP address for all sites (or nodes). The static IP address and Ethernet port mapping can be manually reconfigured on the router.

[0130] In another embodiment, the secure tunnel established between the two firewalls is a secure virtual private network, such as an IPSec tunnel. To establish an IPSec tunnel, in one example, the first control center 1302 and the first robotic-controlled medical device system 1306 have a shared key. The first local firewall 1314 of the first robotic-controlled medical device system 1306 sets up a tunnel pointing to the first remote firewall 1310 of the first control center 1302. The first remote firewall 1310 then sets up a tunnel pointing to the first local firewall 1314. In this example, neither site opens its WAN port to allow SSH login. In another example, to establish an IPSec tunnel, the first local firewall 1314 allows SSH logon. The first remote firewall 1310 logs on to the first local firewall 1314 using SSH. The first remote firewall 1310 then sets up a tunnel end of the first local firewall 1314 to point to the first remote firewall 1310. The first remote firewall 1310 directs the tunnel to the first local firewall 1314. The first remote firewall 1310 can then determine keys for both sites. In one embodiment, there is a pre-existing network topology map such that all local and remote sites are aware of their network locations.

[0131] In another embodiment, management of multiple systems and connections in a many-to-many configuration is performed using cloud computing. For example, a cloud-based infrastructure management solution can be used to manage the firewalls at each site (or node). Each firewall (e.g., first remote firewall 1310, second remote firewall 1312, first local firewall 1314, and second local firewall 1316 shown in FIG. 16) is connected to the Internet and to a cloud used for management. Cloud-based management allows an operator at any site, or an operator remote from each site, to monitor and manage the firewalls.

[0132] One or more embodiments also provide a remote medical device system, method, and / or non-transitory computer-readable storage medium configured to maintain system stability and limit and / or maintain a constant maximum overtravel of a robotically-controlled medical device caused, for example, by delays and / or jitter in the transmission of control signals (including operation instructions) and images. Overtravel (also referred to herein as overtravel distance) refers to the distance (difference) between the actual (or intended) position of the robotically-controlled medical device at the patient and the user-perceived (or displayed) position of the robotically-controlled medical device at the remote control center.

[0133] Overtravel can be the result of a user closing a loop at the intended position of a robotically controlled medical device in a situation where image feedback and / or velocity (motion) commands (e.g., linear and / or rotational) to the robotically controlled medical device are delayed.

[0134] One or more embodiments also provide a robotically controlled medical device system, method, and / or non-transitory computer-readable storage medium configured to maintain a constant or substantially constant percent overshoot of the step response regardless of total delay, e.g., due to delay and / or jitter in the transmission of control signals and images between a control center and the robotically controlled medical device system.

[0135] According to the embodiments described below, the robotically controlled medical device system may be a catheterization system that controls the movement and actuation of an elongated medical device (e.g., a catheter, a guidewire, a balloon catheter, a microcatheter, etc.). That is, the robotically controlled medical device may be one or more elongated medical devices, each of which may have linear and / or rotational motion. The linear and rotational motions may be performed separately, in parallel, or simultaneously. For clarity, the embodiments are described with respect to a robotically controlled medical device.

[0136] Although described separately, aspects of the embodiments described herein may be combined.

[0137] Returning to the communication means and control system 200 shown in FIG. 4, according to an embodiment, the local command and control module 214 may calculate a desired speed (speed command or commanded speed), for example axial (linear) or rotational, based on a speed control function G(T delay ) can be applied to dampen and control the operation of the medical device 246. In one embodiment, a rate control function G(T delay ) is between 0 and 1 (0 <G(T delay )≦1) delay In another example, the speed control function G(T delay ) is between 0 and 2 (0 <G(T delay However, the embodiment should not be limited to these examples.

[0138] Speed ​​control function G(T delay) may be determined based on limiting maximum overtravel from a risk mitigation perspective.

[0139] Total delay T delay is the instruction delay T given by the following equation (5): command and image feedback delay T image is the sum of. (5) T delay =T command +T image

[0140] At least in this embodiment, the instruction delay T command refers to the delay or latency in the transmission of command and control signals from the control center 202 to the robotic-controlled medical device system 204. As mentioned above, in one embodiment, the local command and control module 214 determines the command delay T based on the timestamps provided in the command and control signals from the remote command and control module 212. command For example, the instruction delay T command can be calculated as the difference between the time when the user issues a command at the control center 202 and the time when the command is received at the robotic controlled medical device system 204.

[0141] Image feedback delay T image refers to the delay or latency associated with the transmission of images and / or hemodynamic data sent from the robotic medical device system 204 to the control center 202 for display to a remote user (e.g., on the display 240 and / or for storage in memory). Image Feedback Delay T image may include image and / or hemodynamic data, but for simplicity, the examples are described with respect to image data.

[0142] In one example, the image feedback delay T image is calculated by the remote command and control module 212, and the total delay T delayA signal is sent to the local command and control module 214 to calculate the image feedback delay T. In another embodiment, the local command and control module 214 can measure the round trip delay of the image data as described above or in any suitable manner (e.g., based on the transmission time information and acknowledgement information at the local command and control module 214). In another more specific example, the image feedback delay T image is the time when the image frame was captured (T patientside ) (e.g., as indicated via a timestamp) and the time at which the captured image frame was received at the control center 202 (T controlside ) is calculated as the difference between

[0143] In at least one other embodiment, the total delay T delay is calculated as follows:

[0144] The local command and control module 214 determines the image frame capture time T f This indicates the time that the image frame was captured at the patient site (e.g., via a timestamp). The local command and control module 214 then records the image frame capture time T along with the captured image frame. f to the control center 202, which then transmits the image frame capture time T f Next, the local command and control module 214 includes the command package frame (image frame capture time T f The command reception time T c and time T f The total delay T delay (i.e., T delay =T c -T f ).

[0145] Command Delay Tcommand or image feedback delay T image One or more of the above may be the result of network delay and / or jitter between the control center 202 and the robotically controlled medical device system 204.

[0146] In at least one embodiment, the local command and control module 214 determines the command rate v contained in the command and control signal received from the control center 202. command The speed control function G(T delay ) to operate the robotically controlled medical device 246 at a device speed v device Thus, the local command and control module 214 obtains the commanded speed v command and the speed control function G(T delay ), the device velocity v at which the robot-controlled medical device 246 operates at time t device In at least one embodiment, the speed control function G(T delay ) may be applied when necessary to limit and / or maintain a constant or substantially constant maximum overtravel of the robotically controlled medical device 246. command Attenuate and / or reduce.

[0147] For example, to send a velocity command using a joystick, the user would enter [-v max ,v max ] range. Under uncompensated delay control, the speed control function G(T delay )=1. In one embodiment, the maximum commanded velocity v for linear motion (advance or retract) of the guidewire is max is approximately 12 mm / s in "normal" mode and approximately 60 mm / s in "turbo" mode. For rotational motion, in one example, the maximum commanded speed v max is approximately 360 degrees per second.

[0148] In another example, the maximum commanded velocity v for linear motion (forward or backward) of the guide catheter is maxis about 24 mm / sec. For rotational motion, in one example, the maximum commanded speed v max is a unit of revolutions per second (e.g., approximately 0.5 revolutions per second).

[0149] The speed control function G(T delay ) may also be called a speed adjustment function, a speed constraint function, or a speed decay function.

[0150] Speed ​​control function G(T delay ) will be described in detail below with reference to examples.

[0151] The Nyquist stability criterion is command and image feedback delay T image In this discrimination method, a user in the loop (e.g., a user providing instructions at the control center 202) determines at time t the command velocity v for operating the robotically controlled medical device 246. command Assume that the command speed v command (t) is the planned device position r desired (t) and the delayed feedback position x of the robotic medical device 246 to the user of the control center 202 device (tT image ) is proportional to the difference between the delayed feedback position x device (tT image ) is the time (tT image ) is the position of the robotically controlled medical device 246 in the

[0152] The local command and control module 214 determines the velocity control function G(T delay )∈[0,∞], the delayed command rate v command (tT delay ) is attenuated, where T delay =(T image +T command ) whereby the velocity v of the robot-controlled medical device 246 at time t isdevice (i.e., v device (t) is given by the following equation (6). (6) v device (t) = G(T delay )(r desired (tT command )-x device (t-(T image +T command ))) =G(T delay )v command (tT delay )

[0153] In formula (6), r desired (tT command ) is the time (tT command ) is the planned position in x device (t-(T image +T command )) is the time (t-(T image +T command ))=(tT delay ) is the position of the robotically-controlled medical device 246 at time t. Thus, the velocity v device (t) is the speed control function G(T delay ), the planned (or assumed) device location r desired (tT command ), and time point (t-(T image +T command )) Actual device position x device (t-(T image +T command )) The device velocity v of the robotically controlled medical device 246 at time t is measured based on the device (t) is the speed control function G(T delay ) and the delayed command rate v received by the local command and control module 214. command (tT delay ) As will be described later, in one embodiment, the tolerable delay threshold t acceptable Total delay over T delay, the device velocity v of the robotically controlled medical device 246 at time t device (t) is the speed control function G(T delay ) based on the delayed command speed v command On the other hand, the total delay T delay is the tolerable delay threshold t acceptable If less than , the speed control function G(T delay ) takes the value of 1, and the delayed command speed v command (tT delay ) is not attenuated.

[0154] In a robotically controlled medical device system according to one or more embodiments, a total delay T delay Regarding , the forward loop transfer function H(s) can be used to determine the Nyquist stability of the system, as shown below in equation (7). (7) JPEG2025023973000006.jpg28136

[0155] Since the robotically controlled medical device system does not contain any unstable poles, equation (8) below is a necessary and sufficient condition for stability. (8) JPEG2025023973000007.jpg22139

[0156] As a result, the following function satisfies the Nyquist stability of the system: JPEG2025023973000008.jpg21138

[0157] Although the above functions are described herein, other functions may also satisfy the constraints. For example, if a fixed phase margin φ is desired (e.g., to ensure a relatively or substantially constant step response with a fixed feedback delay), then the speed control function G(T delay ) is given by the following equation (9). (9) JPEG2025023973000009.jpg30116

[0158] In this case, φ=π / 4 and G(T delay )=π / (4T delay ), one may choose a constant phase margin of 45 degrees.

[0159] According to one embodiment, the speed control function G(T delay ) can take values ​​greater than 1. In such cases, the rate control function G(T delay ) can also have other constraints. These additional constraints can be added and / or selected by the user. In one embodiment, the additional constraints are delay ) is the total delay at a given time T delay The total delay T delay Based on the speed control function G(T delay ) with additional constraints is shown in equation (10). (10) JPEG2025023973000010.jpg53145

[0160] In this example, the speed control function G(T delay ) to a lower delay constant (e.g., 0≦T delay <(π / 8)S) can be reduced to 2 or 1, for example, G(T delay ) is useful in practice, as system performance is perceived as satisfactory when it is equal to 1.

[0161] Equation (10) is a relatively simple example that illustrates how the phase margin is specified and corresponds to the delay selection, resulting in a piecewise continuous function. In one example, the gain is 2 when the delay is π / 8. Equation (10) is based on the global stability and is bounded by equation (9) above.

[0162] The constraints in equation (10) are T delay ={0,0.5,1.0,1.5} with the speed control function G(T delay)={2,π / 2,π / 4,π / 6}, which provides the step response shown in FIG. 19. FIG. 19 also shows the nominal gain (e.g., the speed control function G(T delay )) is 1.5 seconds of total delay (T delay = 1.5s), the step response when it remains at 1.0 is also shown.

[0163] As shown in FIG. 19, without damping, the robotically controlled medical device system delay )=1, it is nearly unstable as the maximum total delay is reached. However, as also shown in Figure 19, the rate control function G(T delay ) maintains a constant phase margin, so that the overshoot remains constant with increasing step response settling time (independent of changes in the step response settling time).

[0164] According to one or more embodiments, the speed control function G(T delay ) is further constrained to satisfy both the performance constraints regarding the desired stability and the desired phase margin of the system while limiting the energy injected into the system, as shown in equation (11). (11) JPEG2025023973000011.jpg37149

[0165] In the example shown in equation (11), the speed control function G(T delay ) is the tolerable delay threshold t acceptable but not less than the maximum delay threshold t disable Total delay less than T delay (t acceptable ≦T delay <t disable ) according to the command speed v command The tolerable delay threshold t acceptable This condition described here may be referred to as the "medium latency condition."

[0166] Maximum delay threshold t disable(also called the disable or maximum latency threshold) may be the maximum time that a command from a user (e.g., an action command) may be enabled. For example, the maximum latency threshold t disable is approximately 1.0 seconds (1000 milliseconds), although the embodiment should not be limited to this example. delay is the maximum delay threshold t disable A condition equal to or greater than this may be referred to as a "high latency condition."

[0167] In another example, the device velocity v device (t) is the overtravel (x) greater than 0 when the user attempts to return the robotically controlled medical device 246 to zero motion (no motion). overtravel >0). (12) JPEG2025023973000012.jpg28132

[0168] In this case, the speed control function G(T delay ) is further calculated as the total delay T delay and maximum command speed v max Maximum overtravel distance x for the product of max_overtravel It is based on the ratio of t acceptable and disable The total delay between delay In the case of delay ) is the smallest value of 1,(π-2φ) / 2T delay and x max_overtravel / T delay v max , so that only the maximum overtravel distance occurs when the user stops (returns to zero motion) the robotically controlled medical device 246. device The maximum overtravel distance is user selectable.

[0169] Maximum overtravel distance x max_overtravel is the tolerable delay threshold t acceptable and maximum command speed v max If based on (xmax_overtravel =t acceptable v max ), speed control function G(T delay ) but t acceptable ≦T delay <t disable s, the minimum value is 1,(π-2φ) / 2T delay ,t acceptable / T delay Equation (12) can be rewritten as equation (13) below, so that (13) JPEG2025023973000013.jpg32162

[0170] In one example, the robotically controlled medical device is a guidewire, and for linear or axial motion, t acceptable = 400ms and v max = 12mm / s (normal mode), and the maximum overtravel distance x max_overtravel =t acceptable v max = 4.8 mm. acceptable = 400ms and v max = 60mm / s (turbo mode), max overtravel distance x max_overtravel =t acceptable v max =24mm.

[0171] Regarding the rotational motion when the robotically controlled medical device is a guidewire, t acceptable = 400ms, v max = 360 degrees / s, maximum overtravel distance x max_overtravel =t acceptable v max =144 degrees.

[0172] In one embodiment, the robotically controlled medical device is a guide catheter, and for linear or axial motion, t acceptable = 400ms and v max = 24mm / s, maximum overtravel distance x max_overtravel =t acceptable v max =9.6mm.

[0173] Regarding the rotational motion when the robotically controlled medical device is a guide catheter, t acceptable = 400ms and v max = 0.5 revolutions / s, maximum overtravel distance x max_overtravel =t acceptable v max =0.2 rotations.

[0174] In accordance with one or more embodiments, a stability criterion is used to provide necessary and sufficient conditions to ensure stability. These conditions are delay ) may be greater than 1.0.

[0175] By utilizing the embodiment, additional energy can be introduced while still maintaining the stability of the system.

[0176] Additionally, robust distance constraints based on perceptible delays can be utilized to satisfy system stability without introducing additional energy into the system and without allowing a maximum possible overtravel that would cause the user to interrupt (stop) the operation of the robotically controlled medical device.

[0177] A method for controlling the operation of a robot-controlled medical device system according to an embodiment based on the above-described speed control function will now be described with reference to the flowcharts shown in FIGS.

[0178] For illustrative purposes, the embodiments shown in Figures 17 and 18 are described with respect to the systems and components shown in Figures 1-4. Moreover, in some cases, the embodiments are described with respect to a robotically controlled medical device system that is a catheterization system (e.g., a catheterization system that controls the movement, actuation, etc. of an elongated medical device, such as a catheter, guidewire, balloon catheter, microcatheter, etc.). However, the embodiments should not be limited to this example. Furthermore, in at least some examples, the embodiments are described with respect to the linear (or axial) velocity (forward or backward) of the robotically controlled medical device. However, it should be understood that the embodiments are equally applicable to angular or rotational speeds and / or angular or rotational velocities.

[0179] Additionally, although the embodiments illustrated in FIG. 17 and / or FIG. 18 are primarily described with respect to operations performed in the local command and control module 214 of the robotically controlled medical device system 204, the embodiments should not be limited to this example. Instead, the embodiments may be implemented in other components, such as the remote command and control module 212, or distributed across elements / components of the control center 202 and / or the robotically controlled medical device system 204. For example, it should be understood that the embodiments illustrated in FIG. 17 and / or FIG. 18 may similarly be described with respect to the robotically controlled medical device system 204 performing one or more of the functions / operations illustrated in FIG. 17 and / or FIG. 18. In another example, the embodiments illustrated in FIG. 17 and / or FIG. 18 may be described with respect to a processor or controller configured to perform one or more of the functions / operations illustrated in FIG. 17 and / or FIG. 18. In this case, the processor is configured to execute computer-readable instructions to cause the robotically controlled medical device system to perform one or more of the functions / operations illustrated in FIG. 17 and / or FIG. 18.

[0180] For illustrative purposes, Figures 17 and 18 each show an iteration of a method according to an embodiment (e.g., in response to command and control signals received up until a stop command), although the embodiment should not be limited to this example. It should be understood that the method shown in Figures 17 and / or 18 may be performed repeatedly and / or periodically as set in response to operation of the robot-controlled medical device system.

[0181] FIG. 17 is a flow chart illustrating an embodiment of a method for controlling the operation of a robotically controlled medical device system.

[0182] 17, at S1702, the local command and control module 214 receives command and control signals from the control center 202. In at least one embodiment, the command and control signals include motion commands (forward, backward, turn, etc.) and desired speeds for the motion (commanded speed v command The command and control signals may be similar, the same, or substantially the same as those signals described above.

[0183] At S1704, the local command and control module 214, in response to receiving the command and control signals, determines a total delay T delay As described above, the local command and control module 214 calculates the command delay T command and image feedback delay T image The total delay T delay Calculate.

[0184] In S1706, the local command and control module 214 calculates the total delay T delay is the maximum delay threshold t disable In one example, the local command and control module 214 determines whether the total delay T delay The maximum delay threshold t disable By comparing with the total delay T delay is the maximum delay threshold t disable Determine if greater than.

[0185] The local command and control module 214 determines the total delay T delay is the maximum delay threshold t disable If it is determined that the commanded velocity v is less than or equal to v (N), then in S1714, the local command and control module 214 operates the robotic medical device system 204 with a velocity decay according to one or more embodiments. command is the total delay T delay is (selectively) attenuated based on

[0186] According to at least some embodiments, the local command and control module 214 may be configured to receive a command rate v , which may be included in the command and control signals received from the control center 202. command one or more of the speed control functions G(T delay ) to operate the robotically controlled medical device 246 in response to the commands and control signals. device In one embodiment, the local command and control module 214 operates the robotic medical device system 204 with velocity damping (if necessary) by obtaining the velocity control function G(T delay ) can be applied.

[0187] 17, if during operation of the robotically-controlled medical device 246, at S1718, a stop command is received by the local command and control module 214 (Y), at S1720, the local command and control module 214 stops operation of the robotically-controlled medical device 246. The process iteration then ends.

[0188] In one embodiment, similar to that described above, the stop command may be an indication from the remote command and control module 212 that the user no longer desires operation of the robotically controlled medical device 246 (joystick in rest position). In another example, the stop command is an emergency stop.

[0189] Returning to S1718, if the local command and control module 214 did not receive a stop command (N), the process returns to S1704, where the total delay T delay is recalculated and the process described herein continues.

[0190] In S1706 of FIG. 17, the total delay T delay is the maximum delay threshold t disable If (Y), then in S1710, the local command and control module 214 disables remote actuation of the robotically controlled medical device system 204. The process then proceeds to step S1718 and continues as described herein.

[0191] In one embodiment, in S1710, the local command and control module 214 pauses or stops (eg, temporarily) the remote control (and possibly the operation) of the medical device 246 and other components of the robotically controlled medical device system 204.

[0192] The disabling of remote actuation of the robotically-controlled medical device 204 is temporary, and the remote actuation is continued for a total delay T delay is the maximum delay threshold t disable It can be re-enabled (or resumed) by dropping below

[0193] According to one embodiment, when remote operation of the robotically-controlled medical device system 204 is disabled, control of the robotically-controlled medical device system 204 may be transferred to the local control console 238 or bedside system (e.g., via token passing as described above). In this case, the local command and control module 214 can re-enable remote operation of the robotically-controlled medical device system 204 by transferring control to the control center 202.

[0194] In the embodiment shown in FIG. 17, the speed control function G(T delay ) at command speed v command, without specifying an acceptable latency threshold, above which users will perceive latency as affecting performance, device However, according to another embodiment, the speed control function G(T delay ) is determined by determining the allowable delay threshold t so as to satisfy both the desired system stability and the performance constraints for a given phase margin while also limiting the energy injected into the system. acceptable This can be further constrained by considering: Such an embodiment will now be described in detail with reference to FIG.

[0195] FIG. 18 is a flow chart illustrating an embodiment of a method for controlling the operation of a robotically controlled medical device system.

[0196] The embodiment shown in FIG. 18 is similar to the embodiment shown in FIG. 17, except that the method uses a speed control function G(T delay ) to satisfy both the desired system stability and the performance constraints for a given phase margin while also limiting the energy injected into the system. acceptable For brevity, only those portions of Figure 18 which differ from Figure 17 will be described in detail.

[0197] Referring to FIG. 18, at S1702, the local command and control module 214 receives command and control signals from the control center 202 at the local site.

[0198] At S1704, the local command and control module 214 responds to receiving the command and control signals by calculating a total delay T delay Calculate.

[0199] In S1706, in the same or substantially the same manner as the embodiment shown in FIG. 17, the local command and control module 214 calculates the total delay T delayis the maximum delay threshold t disable Determine whether it is greater than (or equal to or greater than).

[0200] In this embodiment, the local command and control module 214 determines the total delay T delay is the maximum delay threshold t disable If it is determined that the total delay T delay is the tolerable delay threshold t acceptable It is determined whether or not the number is equal to or greater than this.

[0201] Total delay T delay is the tolerable delay threshold t acceptable If N is less than G(T), then in S1716, the local command and control module 214 operates the robotic medical device system without velocity damping (e.g., as given by Equation (11), Equation (12), or Equation (13)). delay )=1,0≦T delay <T acceptable In this case, the local command and control module 214 determines the command speed (v device =v command ) to operate the robotically controlled medical device 246.

[0202] If, in step S1718, the local command and control module 214 receives a stop command (Y), then, in step S1720, the local command and control module 214 stops operation of the robotically-controlled medical device 246. The process iteration then ends.

[0203] Returning to S1718, if the local command and control module 214 did not receive a stop command (N), the process returns to S1704 and the total delay T delay Recalculate and proceed as described herein.

[0204] In S1708, the total delay T delay is the tolerable delay threshold t acceptable It is equal to or greater than (tacceptable ≦T delay <t disable If (Y), then in S1714, the local command and control module 214 operates the robotically controlled medical device system 204 with velocity damping according to one or more embodiments. The process then proceeds to S1718 and continues as described herein.

[0205] In one example, in S1714, the local command and control module 214 calculates G(T delay )=min{1,(π-2φ) / (2T delay )} is the command speed v included in the command and control signal received from the control center 202 in S1702. command to operate the robotically controlled medical device 246 in response to the commands and control signals. device By obtaining:

[0206] In another example, the local command and control module 214 may use G(T delay )=min{1,(π-2φ) / (2T delay ),x max_overtravel / (T delay v max )}, or G(T delay )=min{1,(π-2φ) / (2T delay ),t acceptable / T delay} to obtain the total delay T delay , the device velocity v of the robotically-controlled medical device 246 in S1714 is maintained at a substantially constant maximum overtravel and / or percent overshoot of the step response for the robotically-controlled medical device system 204, regardless of variations in device Determine or control.

[0207] Returning to S1706 in FIG. 18, the total delay T delay is the maximum delay threshold t disableIf so (Y), then in S1710, the local command and control module 214 disables remote actuation of the robotically controlled medical device system 204 in the same or substantially the same manner described above with respect to Figure 17. The process then proceeds to step S1718 and continues as described herein.

[0208] 20 and 21 show example user interface displays of a robotically controlled medical device system according to an embodiment.

[0209] In Figures 20 and 21, a graphical user interface display is for control of an example catheter treatment system.

[0210] As shown, the control center (and similarly the robotic-controlled medical device system) graphical user interface display 2000 shows, for example, the same measurements, speeds, stored settings, and which controls of the control console are being operated at the active site (i.e., the control center at one of the remote sites). Although not shown in Figures 20 and 21, in the same or substantially the same manner as described above, each graphical user interface display may also display the images and total delay T transmitted from the robotic-controlled medical device system 204 to the control center 202. delay can also be displayed.

[0211] Referring to FIG. 20, when there is no latency condition (e.g., T delay <t acceptable ), a graphical user interface display 2000 is displayed at the control center 202 (e.g., on the display 240 or on the control console 236). In this case, all drive controls (devices, guidewires, guide catheters, etc.) are available to the user at the control center 202. The graphical user interface display 2000 includes, among other things, the "Disable All" button described above.

[0212] The drive control device of the robot-controlled medical device 246 includes a drive control device that controls the forward or backward speed (v command ) in the robotic medical device 246. In one example, the linear speed controller 20202 is a discrete controller that causes the robotic medical device 246 to move 1 mm per button press. However, the embodiment should not be limited to this example.

[0213] The guidewire drive control includes a linear speed controller 20203 for controlling the advancement or retraction of the guidewire, and a rotational speed controller 20204 for controlling the rotational speed and direction of the guidewire. In one example, the linear speed controller 20203 is a discrete controller that causes the guidewire to move 1 mm per button press. Similarly, the rotational speed controller 20204 is a discrete controller that causes the guidewire to rotate 225 degrees per button press. However, embodiments should not be limited to this example.

[0214] The guide catheter drive controls include a linear speed controller 20206 (eg, a discrete controller for 1 mm forward and backward movement) and a position meter display 20208.

[0215] Referring to FIG. 20, the graphical user interface display 2000 also includes the current relative measurement position compared to the previous reset value (in this example, 125.8) and the most recent stored measurement (in this example, 34.7).

[0216] The occurrence of a high latency condition (e.g., T in S1706 of FIG. 17 and / or FIG. 18) delay ≧t disable ), the control center 202 displays a High Latency popup 2002 to the user. The High Latency popup 2002 is an overlay on the user interface display 2000 and indicates that the current network latency is greater than or equal to the maximum delay threshold t disable(in this example, 1 second) and the remote console control device has been disabled. According to at least one embodiment, the high latency popup 2002 involves deactivating the robotically controlled medical device 246 and disabling the remote console control device in S1710 of FIG. 17 and / or FIG. 18.

[0217] Once the user acknowledges the high latency condition (eg, by clicking or pressing the "OK" button in the high latency popup 2002), the high latency popup 2002 is cleared.

[0218] After clearing the high latency popup 2002, continue to wait until the high latency condition is completely resolved (for example, total latency T delay is the maximum delay threshold t disable ), a graphical user interface display 2004 is displayed to the user. As shown, the graphical user interface display 2004 indicates that the console controls are disabled and may also include a high latency condition indicator 20040. Once cleared, the robotic-controlled medical device system 204 can enable the remote controls (e.g., by manually pressing an "ENABLE ALL" button) and the user at the control center 202 can continue to operate the robotic-controlled medical device system 204.

[0219] According to one or more embodiments, the high latency popup 2002 appears in response to the first (e.g., first) occurrence of a high latency condition, but not thereafter. In response to a subsequent high latency condition, the graphical user interface display 2000 changes directly to the graphical user interface display 2004, which notifies the user of the high latency condition and disables the remote control device.

[0220] At the local control console 238, in response to the occurrence of a high latency condition, a graphical user interface display 2006 is displayed to the local patient side user. As shown, the graphical user interface display 2006 informs the local user that the remote console controls have been disabled.

[0221] Referring to FIG. 21, in the medium latency condition (e.g., t acceptable ≦T delay <t disable ), an intermediate latency pop-up 2100 is displayed to the user at the control console 236. In this case, the intermediate latency pop-up 2100 indicates that an intermediate latency condition is occurring and that the sensitivity of a controller (e.g., joystick) is being adjusted and / or scaled (e.g., through damping the command rate with application of a rate control function). Once the user acknowledges the intermediate latency condition by clicking an "OK" button, the intermediate latency pop-up 2100 is cleared and the user at the control center 202 can continue to control the robotically-controlled medical device system 204 from the remote control console 236.

[0222] After clearing the intermediate latency popup 2100, the system continues to wait until the intermediate latency condition is completely resolved (e.g., total latency T delay is the tolerable delay threshold t acceptable 20 ) (until the latency drops below 10 ms), a graphical user interface display 2102 is displayed to the user. The graphical user interface display 2102 is similar to the graphical user interface display 2000 shown in Figure 20, except that the graphical user interface display 2102 further includes an intermediate latency indicator 21020 to indicate that an intermediate latency condition exists. After resolution, the intermediate latency indicator 21020 is cleared.

[0223] 20, the medium latency popup 2100 is raised in response to a first (e.g., first) occurrence of a medium latency condition, but not thereafter. In response to a subsequent medium latency condition, a graphical user interface display 2102 including a medium latency indicator 21020 is displayed to the user.

[0224] 21, in response to an intermediate latency condition, a graphical user interface display 2104 is displayed to the local user at the local control console 238 (patient side). The user interface 2104 informs the local user that the remote console controls are enabled, but that joystick sensitivity has been adjusted and / or scaled.

[0225] 22 to 25 are graphs illustrating various aspects of the embodiment.

[0226] FIG. 22, according to an embodiment, is a graph showing an example gain profile for a robotically controlled medical device system. In this example, G 2 Equation (11) marked as G 4 The speed control function G(T delay ) gain profile.

[0227] As shown in FIG. 22, the speed control function G(T delay ) Regarding G 2 and the total delay T delay is about 433ms (t acceptable = 433 ms), the commanded velocity starts to decay or scale. The velocity control function G(T delay ) Regarding G 4 and the total delay T delay is about 400ms (t acceptable = 400 ms), the commanded velocity begins to decay or scale. As shown, in both cases the velocity scaling or decay is non-linear.

[0228] 23A to 23C are diagrams showing the T delay 13 is a graph showing an example of a step response of a robotically controlled medical device system at different values ​​of

[0229] More specifically, FIG. 23A shows 2 The speed control function G(T delay ) when applying T delay 4 shows examples of step responses of a robotically controlled medical device system for various values ​​of

[0230] FIG. 23B shows 4 The speed control function G(T delay ) when applying T delay 4 shows examples of step responses of a robotically controlled medical device system for various values ​​of

[0231] FIG. 23C for an embodiment (without compensation or damping) shows the speed control function G(T delay ) is not applied, T delay 4 shows examples of step responses of a robotically controlled medical device system for various values ​​of

[0232] As can be seen by comparing Figures 23A and 23B with Figures 23C, application of the rate control function according to the embodiment maintains system stability with increasing total delay.

[0233] FIG. 24 illustrates an example of a step response versus total delay T of a robotically controlled medical device system. delay 1 is a graph showing an example of the response time of G 2 Equation (11) and G 4 The speed control function G(T delay ) is shown along with a graph showing the step response without compensation or damping (G=1). As shown, the step response time (t response) is a T of about 400 ms or more when the speed control function according to the embodiment is applied. delay It shows a stable and linear increase with

[0234] Figure 25 shows the total delay T delay 1 is a graph showing an example of step response overshoot versus total delay T delay is about 400ms (t acceptable = 400ms), the total delay T delay As G continues to increase, so does Percent Overshoot. In this example, the increase is nonlinear. In contrast, G 2 Formula (11) and G 4 The speed control function G(T delay ), the percent overshoot is essentially constant (G 4 ) or slightly increased (G 2 ), so the total delay T delay is about 400ms (t acceptable = 400 ms), remains essentially constant.

[0235] One or more embodiments may be utilized without defining an allowable delay (eg, approximately 400 ms) before a rate control algorithm (also referred to as a rate decay algorithm) is applied.

[0236] The embodiment provides a mechanism to achieve a constant or substantially constant phase margin (leading to constant or substantially constant overshoot for different step responses) and further constrain the gain due to maximum overtravel for safety.

[0237] According to one or more embodiments, the gain G is calculated based on limiting maximum overtravel (e.g., from a risk mitigation perspective) rather than on a control system stability perspective. One or more embodiments also define when the speed control algorithm can be applied (e.g., between about 400 ms and about 1 s).

[0238] Terms such as first, second, etc. are used herein to describe various elements, but these elements should not be limited by such terms. Such terms are used only to distinguish one element from another. For example, a first element could be termed a second element, and similarly, a second element could be termed a first element, without departing from the scope of the disclosure. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0239] When an element is referred to as being "connected" or "coupled" to another element, this may mean that it is directly connected or coupled to the other element, or there may be intervening elements. In contrast, when an element is referred to as being "directly coupled" or "directly coupled" to another element, there are no intervening elements. Other words used to describe the relationship between elements should be construed in a similar manner (e.g., "directly between" as opposed to "between," "directly adjacent" as opposed to "adjacent," etc.).

[0240] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. Furthermore, "comprises," "comprising," and / or "includes," "including," when used herein, are understood to specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, and / or components.

[0241] It should also be understood that in some alternative embodiments, the functions / acts noted may occur out of the order noted in the figures. For example, two figures shown in succession may in fact be executed substantially concurrently or may sometimes be executed in the reverse order, depending on the functions / acts involved.

[0242] Specific details are provided in the following description to provide a thorough understanding of the embodiments. However, it will be apparent to one skilled in the art that the embodiments may be practiced without the specific details. For example, systems are shown in block diagrams in order to avoid obscuring the embodiments in unnecessary detail. In other instances, well-known processes, structures and techniques are shown without unnecessary detail in order to avoid obscuring the embodiments.

[0243] The embodiments described herein are described with reference to symbolic representations of acts and operations (e.g., in the form of flowcharts, flow diagrams, data flow diagrams, structure diagrams, block diagrams, etc.) that are implemented as program modules or functional processes including routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types, and that are implemented using existing hardware in existing robotically controlled medical device systems, such as those disclosed in U.S. Patent Application Publication No. 2021 / 0220064 and / or International Publication No. WO2019 / 222641, the entire contents of which are incorporated herein by reference. This existing hardware may be processing or control circuitry such as, but not limited to, one or more processors, one or more central processing units (CPUs), one or more controllers, one or more arithmetic logic units (ALUs), one or more digital signal processors (DSPs), one or more microcomputers, one or more field programmable gate arrays (FPGAs), one or more systems on a chip (SoCs), one or more programmable logic units (PLUs), one or more microprocessors, one or more application specific integrated circuits (ASICs), or one or more other devices capable of responding to and executing instructions in a defined manner.

[0244] Although the flowcharts describe operations as a sequential process, many of the operations may occur in parallel, simultaneously, or simultaneously. Also, the order of operations may be rearranged. A process may terminate when the operations are completed, or may have additional steps not included in the figures. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. When a process corresponds to a function, its termination may correspond to a return of the function to the calling function or to the main function.

[0245] The terms "storage medium," "computer-readable storage medium," or "non-transitory computer-readable storage medium" disclosed herein refer to one or more devices that store data, including read-only memory (ROM), random access memory (RAM), magnetic RAM, core memory, magnetic disk storage media, optical storage media, flash memory devices, and / or other tangible machine-readable media for storing information. The term "computer-readable medium" includes, but is not limited to, portable or non-removable storage devices, optical storage devices, and various other media capable of storing, carrying, or transporting instructions and / or data.

[0246] Furthermore, the embodiments may be implemented by hardware, software, firmware, middleware, microcode, hardware description languages, or any combination thereof. When implemented in software, firmware, middleware, or microcode, the program code or code segments to perform the necessary tasks are stored in a machine or computer readable medium, such as a computer readable storage medium. When implemented in software, one or more processors perform the necessary tasks. For example, according to one or more embodiments described above, at least one memory includes or stores computer program code, which at least one memory and computer program code are configured to cause at least one processor to perform the necessary tasks in the robotic controlled medical device system. Additionally, the processor, memory, and example algorithms encoded as computer program code function as means for providing or causing the performance of the operations described herein.

[0247] A code segment of computer program code represents a procedure, a function, a subprogram, a program, a routine, a subroutine, a module, a software package, a class, or any combination of instructions, data structures, or program statements. A code segment communicates with another code segment or a hardware circuit by passing and / or receiving information, data, arguments, parameters, or memory contents. The information, arguments, parameters, data, etc. may be passed, forwarded, or transmitted via any suitable technique including memory sharing, message passing, token passing, network transmission, etc.

[0248] The terms "including" and / or "having" as used herein are defined as "comprising" (i.e., open language). The term "coupled" as used herein is defined as connected, not necessarily directly, and not necessarily mechanically. Terms derived from the word "indicating" (e.g., "indicates" and "indication") are intended to encompass all of the various technologies available for communicating or referencing the indicated object / information. Some, but not all, examples of technologies available for communicating or referencing the indicated object / information include conveying the indicated object / information, conveying an identifier for the indicated object / information, conveying information used to generate the indicated object / information, conveying a portion or percentage of the indicated object / information, conveying some origin of the indicated object / information, and conveying a symbol representing the indicated object / information.

[0249] According to an embodiment, one or more elements of a robotically controlled medical device system (e.g., local and / or remote command and control modules), etc., are (or include) hardware, firmware, hardware executing software, or a combination thereof. Such hardware includes, but is not limited to, processing or control circuitry, such as one or more processors, one or more CPUs, one or more controllers, one or more ALUs, one or more DSPs, one or more microcomputers, one or more FPGAs, one or more SoCs, one or more PLUs, one or more microprocessors, one or more ASICs, or one or more other devices capable of responding to and executing instructions in a specified manner.

[0250] Benefits, other advantages, and solutions to problems have been described with respect to specific embodiments of the present invention. However, the advantages, advantages, solutions to problems, and any elements which derive or lead to such advantages, advantages, or solutions, or which make such advantages, advantages, or solutions more noticeable, should not be construed as critical, necessary, or essential features or elements of any claim.

[0251] Details of the embodiments are illustrated in the accompanying drawings, examples of which are shown with like reference numerals throughout to refer to like elements. In this regard, the embodiments may have different forms and should not be construed as being limited to the description set forth herein. That is, the embodiments are merely described in order to clarify the embodiments according to the present description by reference to the drawings. Various embodiment aspects are specified in the claims.

Claims

1. 1. A robotic controlled medical device system, comprising: a robotic medical device; and a controller; A robotically controlled medical device system, wherein the controller is configured to control operation of the robotically controlled medical device in response to one or more control signals received over a network, and to maintain a substantially constant overshoot in various step responses of the robotically controlled medical device system regardless of variations in delay associated with control of the robotically controlled medical device.

2. The robotically controlled medical device system of claim 1 , wherein the delay comprises at least one of a command delay or an image feedback delay.

3. The robotically controlled medical device system of claim 1 , wherein the controller is configured to control operation of the robotically controlled medical device to maintain a substantially constant maximum overtravel distance of the robotically controlled medical device.

4. The robotically controlled medical device system of claim 1 , wherein the delay is based at least in part on a transmission delay in the network.

5. The robotically controlled medical device system of claim 1 , wherein the motion of the robotically controlled medical device includes at least one of linear motion and rotational motion.

6. The robotically controlled medical device system of claim 1 , wherein the controller is configured to control a velocity of the robotically controlled medical device and maintain a substantially constant overshoot.

7. The robotically controlled medical device system of claim 6 , wherein the controller is configured to control a velocity of the robotically controlled medical device and to limit a maximum overtravel distance of the robotically controlled medical device.

8. The robotically controlled medical device system of claim 6 , wherein the velocity is a velocity of linear or rotational motion.

9. 1. A method of operating a robotically controlled medical device system including a robotically controlled medical device and a controller, comprising: A method of operation comprising: controlling operation of the robotically-controlled medical device in response to one or more control signals received over a network; and maintaining a substantially constant overshoot in various step responses of the robotically-controlled medical device system regardless of variations in delay associated with control of the robotically-controlled medical device.

10. The method of claim 9 , wherein the delay comprises at least one of a command delay or an image feedback delay.

11. The method of claim 9 , wherein the control controls operation of the robotically controlled medical device to maintain a substantially constant maximum overtravel distance of the robotically controlled medical device.

12. The method of claim 9 , wherein the delay is based at least in part on a transmission delay in the network.

13. The method of claim 9 , wherein the movement of the robotically controlled medical device includes at least one of a linear movement and a rotational movement.

14. The method of claim 9 , wherein the controlling comprises controlling a velocity of the robotically controlled medical device to maintain a substantially constant overshoot.

15. The method of claim 14 , wherein controlling the velocity includes controlling a velocity of the robotically controlled medical device and limiting a maximum overtravel distance of the robotically controlled medical device.

16. The method of claim 14, wherein the speed is a speed of linear or rotational motion.

17. 1. A robotic controlled medical device system, comprising: a robotic medical device; and a controller; the controller is configured to control operation of the robotically-controlled medical device in response to one or more control signals received over a network to maintain a substantially constant maximum over-travel distance of the robotically-controlled medical device regardless of variations in delay associated with control of the robotically-controlled medical device; A robotically controlled medical device system, wherein the delay is between a maximum allowable delay threshold and an override threshold.

18. The robotically controlled medical device system of claim 17 , wherein the controller is configured to disable operation of the robotically controlled medical device if the delay is greater than the disable threshold.

19. 20. The robotically controlled medical device system of claim 17, wherein the controller is configured to limit a velocity of the robotically controlled medical device to maintain a substantially constant maximum overtravel distance when the delay is between the maximum allowable delay threshold and the override threshold.

20. The robotically controlled medical device system of claim 19 , wherein the speed of the robotically controlled medical device is not limited if the delay is less than the maximum allowable delay threshold.

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