Patent Description:
<CIT> discloses a robotic catheter procedure system for performing a procedure on a patient. <CIT> discloses an imaging apparatus having an X-ray detector and an image display unit comprising first and second display magnification calculation units and a selection unit. <CIT> discloses an x-ray guided automated guide wire. <CIT> discloses a method for detecting an R-wave from an electrocardiogram (ECG) signal derived from a living body. Catheters may be used for many medical procedures, including inserting a guide wire, delivering a stent and delivering and inflating a balloon. Catheterization procedures are commonly performed for diagnosis and treatment of diseases of the heart and vascular systems. The catheterization procedure is generally initiated by inserting a guide wire into a blood vessel in the patient's body. The guide wire is then advanced to the desired location, most commonly in one of the heart vessels or elsewhere in the vascular system. At this point, a catheter is slid over the guide wire into the blood vessel and/or heart. In some procedures, the catheter is a balloon catheter or stent delivery system that when deployed at the site of the lesion allows for increased blood flow through the portion of the coronary artery that is affected by the lesion.

Robotic catheter procedure systems have been developed that may be used to aid a physician in performing a catheterization procedure such as a percutaneous coronary intervention (PCI). The physician uses a robotic system to precisely steer a coronary guide wire, balloon catheter or stent delivery system in order to, for example, widen an obstructed artery. In order to perform PCI, the distal tip of a guide wire must be navigated through coronary anatomy past a target lesion. While observing the coronary anatomy using fluoroscopy, the physician manipulates the proximal end of the guide wire in order to direct the distal tip into the appropriate vessels toward the lesion and avoid advancing into side branches. A fluoroscopy imaging system uses x-rays to obtain real-time images of the human vasculature and percutaneous devices within the vasculature. The frequency of images taken, or the frame rate (e.g., frames per second) effects the amount of radiation exposure or radiation dose for the patient and the medical professionals performing the catheter procedure. The frame rate can also affect the quality of the image acquired by the fluoroscopy system.

It would be desirable to provide a system and method for controlling x-ray frame rate of an imaging system for a catheter procedure system to reduce the number of x-ray images taken to reduce the x-ray exposure and also to provide appropriate quality of images to perform the catheter procedure.

In accordance with an embodiment, a method for controlling x-ray frame rate of an imaging system for a catheter procedure system, includes generating a first control signal that indicates a first frame rate, providing the first control signal to an imaging system, obtaining a first set of images at the first frame rate, determining at least one parameter of a catheter procedure performed by the catheter procedure system, generating a second control signal based on the at least one parameter of the catheter procedure, the second control signal indicating second frame rate, providing the second control signal to the imaging system to adjust the first frame rate to the second frame rate, obtaining a second set of images at the second frame rate and displaying the second set of images on a display.

In accordance with another embodiment, a catheter procedure system includes a bedside system having at least one percutaneous device and at least one drive mechanism coupled to the at least one percutaneous device, an imaging system; and a workstation coupled to the bed side system and the imaging system, the workstation having a user interface, at least one display, a controller coupled to the bedside system, the user interface, the at least one display and the imaging system, the controller programmed to generate a first control signal that indicates a first frame rate, provide the first control signal to the imaging system, determine at least one parameter of a catheter procedure performed by the catheter procedure system, generate a second control signal based on the at least one parameter of the catheter procedure, the second control signal indicating second frame rate and provide the second control signal to the imaging system to adjust the first frame rate to the second frame rate, wherein the imaging system is configured to obtain a first set of images at the first fame rate and to obtain a second set of images at the second frame rate.

This application will become more fully understood from the following detailed description, taken in conjunction with the accompanying figures, wherein like reference numerals refer to like elements in which:.

<FIG> is a perspective view of an exemplary catheter procedure system in accordance with an embodiment. In <FIG>, a catheter procedure system <NUM> may be used to perform catheter based medical procedures (e.g., a percutaneous intervention procedure). Catheter based medical procedures may include diagnostic catheterization procedures during which one or more catheters are used to aid in the diagnosis of a patient's disease. For example, during one embodiment of a catheter based diagnostic procedure, a contrast media is injected onto one or more coronary arteries through a catheter and an image of the patient's heart is taken. Catheter based medical procedures may also include catheter based therapeutic procedures (e.g., angioplasty, stent placement, treatment of peripheral vascular disease, etc.) during which a catheter is used to treat a disease. It should be noted, however, that one skilled in the art would recognize that certain specific percutaneous intervention devices or components (e.g., type of guide wire, type of catheter, etc.) will be selected based on the type of procedure that is to be performed. Catheter procedure system <NUM> is capable of performing any number of catheter based medical procedures with minor adjustments to accommodate the specific percutaneous intervention devices to be used in the procedure. In particular, while the embodiments of catheter procedure system <NUM> describe herein are explained primarily in relation to the treatment of coronary disease, catheter procedure system <NUM> may be used to diagnose and/or treat any type of disease or condition amenable to diagnosis and/or treatment via a catheter based procedure.

Catheter procedure system <NUM> includes lab unit <NUM> and workstation <NUM>. Catheter procedure system <NUM> includes a robotic catheter system, shown as bedside system <NUM>, located within lab unit <NUM> adjacent a patient <NUM>. Patient <NUM> is supported on a table <NUM>. Generally, bedside system <NUM> may be equipped with the appropriate percutaneous intervention devices or other components (e.g., guide wires, guide catheters, working catheters such as balloon catheters and stent delivery systems, contrast media, medicine, diagnostic catheters, etc.) to allow the user to perform a catheter based medical procedure via a robotic system by operating various controls such as the controls located at workstation <NUM>. Bedside system <NUM> may include any number and/or combination of components to provide bedside system <NUM> with the functionality described herein. Bedside system <NUM> includes, among other elements, a drive assembly <NUM> (e.g., that may contain a sterile, disposable portion) supported by a robotic arm <NUM> which may be used to automatically advance a guide wire into a guide catheter seated in an artery of the patient <NUM>.

Bedside system <NUM> is in communication with workstation <NUM>, allowing signals generated by the user inputs of workstation <NUM> to be transmitted to bedside system <NUM> to control the various functions of bedside system <NUM>. Bedside system <NUM> may also provide feedback signals (e.g., operating conditions, warning signals, error codes, etc.) to workstation <NUM>. Bedside system <NUM> may be connected to workstation <NUM> via a communication link <NUM> (shown in <FIG>) that may be a wireless connection, cable connections, or any other means capable of allowing communication to occur between workstation <NUM> and bedside system <NUM>.

Workstation <NUM> includes a user interface <NUM> configured to receive user inputs to operate various components or systems of catheter procedure system <NUM>. User interface <NUM> includes controls <NUM> that allow the user to control bedside system <NUM> to perform a catheter based medical procedure. For example, controls <NUM> may be configured to cause bedside system <NUM> to perform various tasks using the various percutaneous intervention devices with which bedside system <NUM> may be equipped (e.g., to advance, retract, or rotate a guide wire, advance, retract or rotate a working catheter, advance, retract, or rotate a guide catheter, inflate or deflate a balloon located on a catheter, position and/or deploy a stent, inject contrast media into a catheter, inject medicine into a catheter, or to perform any other function that may be performed as part of a catheter based medical procedure). Drive assembly <NUM> includes various drive mechanisms to cause movement (e.g., axial and rotational movement) of the components of the bedside system <NUM> including the percutaneous devices.

In one embodiment, controls <NUM> include a touch screen <NUM>, one or more joysticks <NUM> and buttons <NUM>, <NUM>. The joystick <NUM> may be configured to advance, retract, or rotate various components and percutaneous devices such as, for example, a guide wire, a guide catheter or a working catheter. Buttons <NUM>, <NUM> may include, for example, an emergency stop button and a multiplier button. When an emergency stop button is pushed a relay is triggered to cut the power supply to bedside system <NUM>. Multiplier button acts to increase or decrease the speed at which the associated component is moved in response to a manipulation of controls <NUM>. In one embodiment, controls <NUM> may include one or more controls or icons (not shown) displayed on touch screen <NUM>, that, when activated, causes operation of a component of the catheter procedure system <NUM>. Controls <NUM> may also include a balloon or stent control that is configured to inflate or deflate a balloon and/or a stent. Each of the controls may include one or more buttons, joysticks, touch screen, etc. that may be desirable to control the particular component to which the control is dedicated. In addition, touch screen <NUM> may display one or more icons (not shown) related to various portions of controls <NUM> or to various components of catheter procedure system <NUM>.

User interface <NUM> may include a first monitor or display <NUM> and a second monitor or display <NUM>. First monitor <NUM> and second monitor <NUM> may be configured to display information or patient specific data to the user located at workstation <NUM>. For example, first monitor <NUM> and second monitor <NUM> may be 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.), patient record information (e.g., medical history, age, weight, etc.). In addition, first monitor <NUM> and second monitor <NUM> may be configured to display procedure specific information (e.g., duration of procedure, catheter or guide wire position, volume of medicine or contrast agent delivered, etc.). Monitor <NUM> and monitor <NUM> may be configured to display information regarding the position the guide catheter. Further, monitor <NUM> and monitor <NUM> may be configured to display information to provide the functionalities associated with controller <NUM> (shown in <FIG>) discussed below. In another embodiment, user interface <NUM> includes a single screen of sufficient size to display one or more of the display components and/or touch screen components discussed herein.

Catheter procedure system <NUM> also includes an imaging system <NUM> located within lab unit <NUM>. Imaging system <NUM> may be any medical imaging system that may be used in conjunction with a catheter based medical procedure (e.g., non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment, imaging system <NUM> is a digital x-ray imaging device that is in communication with workstation <NUM>. In one embodiment, imaging system <NUM> may include a C-arm (not shown) that allows imaging system <NUM> to partially or completely rotate around patient <NUM> in order to obtain images at different angular positions relative to patient <NUM> (e.g., sagittal views, caudal views, anterior-posterior views, etc.).

Imaging system <NUM> may be configured to take x-ray images of the appropriate area of patient <NUM> during a particular procedure. For example, imaging system <NUM> may be configured to take one or more x-ray images of the heart to diagnose a heart condition. Imaging system <NUM> may also be configured to take one or more x-ray images during a catheter based medical procedure (e.g., real time images) to assist the user of workstation <NUM> to properly position a guide wire, guide catheter, stent, etc. during the procedure. The image or images may be displayed on first monitor <NUM> and/or second monitor <NUM>. In particular, images may be displayed on first monitor <NUM> and/or second monitor <NUM> to allow the user to, for example, accurately move a guide catheter into the proper position.

In addition, a user of workstation <NUM> may be able to control the angular position of imaging system <NUM> relative to the patient to obtain and display various views of the patient's heart on first monitor <NUM> and/or second monitor <NUM>. Displaying different views at different portions of the procedure may aid the user of workstation <NUM> to properly move and position the percutaneous interventional devices within the 3D geometry of the patient's heart. In an embodiment, imaging system <NUM> may be a 2D imaging system. In another embodiment, imaging system <NUM> may be any 3D imaging modality such as an x-ray based computed tomography (CT) imaging device, a magnetic resonance imaging device, a 3D ultrasound imaging device, etc. In this embodiment, the image of the patient's heart that is displayed during the procedure may be a 3D image. In addition, controls <NUM> may also be configured to allow the user positioned at workstation <NUM> to control various functions of imaging system <NUM> (e.g., image capture, magnification, collimation, c-arm positioning, etc.).

Referring to <FIG>, a block diagram of catheter procedure system <NUM> is shown according to an exemplary embodiment. Catheter procedure system <NUM> may include a control system, shown as controller <NUM>. Controller <NUM> may be part of workstation <NUM>. Controller <NUM> may generally be an electronic control unit suitable to provide catheter procedure system <NUM> with the various functionalities described herein. For example, controller <NUM> may be an embedded system, a dedicated circuit, a general purpose system programed with the functionality described herein, etc. Controller <NUM> is in communication with one or more bedside systems <NUM>, controls <NUM>, monitors <NUM> and <NUM>, imaging system <NUM> and patient sensors <NUM> (e.g., electrocardiogram ("ECG") devices, electroencephalogram ("EEG") devices, blood pressure monitors, temperature monitors, heart rate monitors, respiratory monitors, etc.). In various embodiments, controller <NUM> is configured to generate control signals based on the user's interaction with controls <NUM> and/or based upon information accessible to controller <NUM> such that a medical procedure may be performed using catheter procedure system <NUM>. In addition, controller <NUM> may be in communication with a hospital data management system or hospital network <NUM> and one or more additional output devices <NUM> (e.g., printer, disk drive, cd/dvd writer, etc.).

Communication between the various components of catheter procedure system <NUM> may be accomplished via communication links <NUM>. Communication links <NUM> may be dedicated wires or wireless connections. Communication links <NUM> may also represent communication over a network. Catheter procedure system <NUM> may be connected or configured to include any other systems and/or devices not explicitly shown. For example, catheter procedure system <NUM> may include IVUS systems, image processing engines, data storage and archive systems, automatic balloon and/or stent inflation systems, medicine injection systems, medicine tracking and/or logging systems, user logs, encryption systems, systems to restrict access or use of catheter procedure system <NUM>, etc..

As mentioned above, the controller <NUM> is in communication with the imaging system <NUM> and controller <NUM> may be used to control the imaging system <NUM>. In one embodiment, controller <NUM> is configured to adjust the frame rate (e.g., x-ray frame rate) utilized by imaging system <NUM> based on various parameters or states of the catheter procedure being performed using the catheter procedure system <NUM>. <FIG> illustrates a method for controlling x-ray frame rate of an imaging system for a catheter procedure system in accordance with an embodiment. At block <NUM>, controller <NUM> (shown in <FIG>) generates a first control signal for the imaging system <NUM> (shown in <FIG> and <FIG>). The first control signal indicates a first frame rate (e.g., frames per second) for image acquisition by the imaging system <NUM>. In one embodiment, the first frame rate is a predetermined frame rate, for example, a standard frame rate for use unless, as described further below, the characteristics of the catheter procedure indicate a state where an alternative frame rate (e.g., lower or higher) may be used for image acquisition. In another embodiment, as discussed further below, the first frame rate is selected based on one or more parameters of the catheter procedure. At block <NUM>, controller <NUM> provides the first control signal to the imaging system <NUM> and, at block <NUM>, the imaging system obtains a first set of images at the first frame rate. At block <NUM>, the first set of images may be displayed, according to an embodiment, using, for example, a display <NUM> or <NUM> of the catheter procedure system.

At block <NUM>, at least one parameter of the catheter procedure is determined and, at block <NUM>, a second control signal is generated by controller <NUM> based on the at least one parameter to indicate a second frame rate for image acquisition by the imaging system <NUM>. Accordingly, the frame rate utilized by the imaging system may be adjusted automatically based on the different states of the catheter procedure. In one embodiment, the parameter of the catheter procedure is the speed of a percutaneous device being advanced through the vasculature of the patient by the catheter procedure system. For example, the percutaneous device may be a guide wire and the parameter is the speed of the distal end or tip of the guide wire as it is moved within the patient. In one embodiment, if the speed of the percutaneous device is slower than a predetermined threshold, the second frame rate is selected to be a higher frame rate than the first frame rate or the same frame rate as the first frame rate. If the speed of the percutaneous device is faster than the predetermined threshold, the second frame is selected to be a lower frame rate than the first frame rate or the same frame rate as the first frame rate.

In another embodiment, the parameter of the catheter procedure is the magnification level selected by a user (e.g., using user interface <NUM>) for viewing a region of interest of the images generated by the imaging system. If the magnification level is increased to "zoom-in" on a region of interest, e.g., the magnification level is selected to be greater than a predetermined magnification threshold, the second frame rate may be selected to be a higher frame rate than the first frame rate. If the magnification level is reduced to the predetermined magnification threshold or below the predetermined magnification threshold to "zoom-out", the second frame rate may be selected to be a lower or reduced frame rate than the first frame rate.

In another embodiment, the parameter is the location of a percutaneous device (or a selected portion of the percutaneous device) positioned within or being advanced through the vasculature by the catheter procedure system. The location of the percutaneous device may be determined using, for example, the images obtained by the imaging system either by a user or automatically using the controller of the catheter procedure system. In one embodiment, the parameter is the location of the percutaneous device (or a selected portion of the percutaneous device) in relation to a region of interest (i.e., the proximity to or a distance between the percutaneous device and the region of interest) such as a lesion. For example, a region <NUM> having a predetermined distance before and after a lesion <NUM> may be identified as shown in <FIG>. When the distal end <NUM> of, for example, a guide wire <NUM> is within the region <NUM>, the second frame rate may be selected to be higher than the first frame rate. In another embodiment, the parameter is the location of the percutaneous device (or a selected portion of the percutaneous device) in relation to the geometry of the vasculature such as, for example, the width of the lumen proximate to a distal end of the percutaneous device or the proximity of a distal end of the percutaneous device to a juncture in the vasculature. If the width of the vasculature proximate a distal end of, for example, a guide wire is greater than a predetermined width, then the second frame rate may be selected to be lower than the first frame rate. If the width of the vasculature proximate a distal end of the guide wire is led than a predetermined width, then the second frame rate may be selected to be the same as or higher than the first frame rate. In another example, a path to a lesion <NUM> may pass through one or more junction points or junctures <NUM> in the coronary anatomy as shown in <FIG>. At juncture <NUM>, the distal end <NUM> of a percutaneous device, for example, a guide wire <NUM>, may be advanced down either a first lumen <NUM> or a second lumen <NUM>. The distal end <NUM> of the guide wire <NUM> should be advanced through the proper lumen to reach the desired location, for example, lesion <NUM>. The location of the distal end <NUM> of the guide wire <NUM> and the juncture <NUM> may be determined using, for example, the images obtained by the imaging system either by a user or automatically using the controller of the catheter procedure system. If the distal end <NUM> is located proximate to (e.g., at a predetermined distance from) the juncture <NUM>, the second frame rate may be selected to be higher than the first frame rate. If the distal end <NUM> is not located within a predetermined distance from the juncture <NUM>, the second frame rate may be selected to be the same as or lower than the first frame rate.

In another embodiment, the parameter of the catheter procedure is the location of a first percutaneous device in relation to a second percutaneous device. For example, the location of a guide wire within a guide catheter as the guide wire is navigated towards a lesion or other region of interest. <FIG> is a schematic of the placement of a guide catheter and a guide wire in the vasculature of a patient in accordance with an embodiment. In <FIG>, a guide catheter <NUM> has been fed into the torso <NUM> of a patient to reach the cardiac region <NUM>. Within the guide catheter <NUM> is a guide wire <NUM> which distal end or tip <NUM> has not yet passed out of the distal end <NUM> of the guide catheter <NUM>. The images obtained by the imaging system may be used to identify the location of the guide wire <NUM> within the guide catheter <NUM> and monitor the progress of the guide wire <NUM> as it passes through the guide catheter <NUM>. If the guide wire <NUM> is located within the guide catheter and the distal end of <NUM> of the guide wire <NUM> has not yet passed out of the guide catheter <NUM>, the second frame rate may be selected to be lower than the first frame rate.

In another embodiment, the parameter of the catheter procedure is a comparison of successive images obtained by the imaging system to identify, for example, movement of the vasculature (e.g., a beating heart) or if the percutaneous device is not moving or idle. If a selected portion of the percutaneous device (e.g., the distal end of a guide wire) is located within a region of moving vasculature, the second frame rate may be selected to be higher than the first frame rate. If the selected portion of the percutaneous device is not located within a region of moving vasculature, the second frame rate may be selected to be the same as or lower than the first frame rate. If the percutaneous device is idle, the second frame rate may be selected to be lower than the first frame rate.

Once the second frame rate is selected and the second control signal has been generated, the controller <NUM> provides the second control signal to the imaging system at block <NUM> to adjust the first frame rate to the second frame rate. At block <NUM>, the imaging system obtains a second set of images at the second frame rate. At block <NUM>, the second set of images may be displayed, according to an embodiment, using, for example, a display <NUM> or <NUM> of the catheter procedure system. One or more of the parameters discussed above may be used to adjust the frame rate as the catheter procedure is performed and progresses through different states of the procedure (e.g., the advancement and location of the percutaneous device within the vasculature). By identifying when the frame rate may be reduced, the x-ray exposure or dose during the procedure may be reduced.

Computer-executable instructions for controlling x-ray frame rate of an imaging system for a catheter procedure system according to the above-described method may be stored on a form of computer readable media. Computer readable media includes volatile and nonvolatile, removable, and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data. Computer readable media includes, but is not limited to, random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory or other memory technology, compact disk ROM (CD-ROM), digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired instructions and which may be accessed by system <NUM> (shown in <FIG>), including by internet or other computer network form of access.

This written description used examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to make and use the invention. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art.

Claim 1:
A catheter procedure system (<NUM>) comprising:
a bedside system (<NUM>) comprising at least one percutaneous device and at least one drive mechanism coupled to the at least one percutaneous device;
an imaging system (<NUM>); and
a workstation (<NUM>) coupled to the bed side system and the imaging system (<NUM>), the workstation (<NUM>) comprising:
a user interface (<NUM>);
at least one display (<NUM>, <NUM>);
a controller (<NUM>) coupled to the bedside system (<NUM>), the user interface (<NUM>), the at least one display (<NUM>, <NUM>) and the imaging system (<NUM>), the controller (<NUM>) programmed to:
generate a first control signal that indicates a first x-ray frame rate;
provide the first control signal to the imaging system (<NUM>);
determine at least one parameter of a catheter procedure performed by the catheter procedure system (<NUM>);
generate a second control signal based on the at least one parameter of the catheter procedure, the second control signal indicating second x-ray frame rate; and
provide the second control signal to the imaging system (<NUM>) to adjust the first x-ray frame rate to the second x-ray frame rate, wherein the second x-ray frame rate is lower than the first x-ray frame rate or wherein the second x-ray frame rate is higher than the first x-ray frame rate;
wherein the imaging system (<NUM>) is configured to obtain a first set of images at the first x-ray frame rate and to obtain a second set of images at the second x-ray frame rate;
wherein the at least one parameter of the catheter procedure is a magnification level of at least one image in the first set of images,
wherein when the x-ray frame rate is reduced the x-ray exposure or dose is reduced.