System for detecting a position of a guide catheter support

0001The present invention generally relates to the field of robotic catheter systems for performing diagnostic and / or therapeutic procedures, and more particularly to devices and methods for detecting the position of a guide catheter support.

0002Cross-reference of related applications This application claims the interests of US Provisional Application No. 62 / 186,832 filed June 30, 2015. The whole is incorporated here as a reference.

0003Catheter is used for many medical procedures including insertion of guide wires, delivery of stents, and delivery and inflating of balloons. Catheterization is widely used for the purpose of diagnosing and treating diseases of the heart and vascular system. Catheterization generally begins by inserting a guide wire into a blood vessel in the patient's body. The guide wire is then most commonly guided to the desired location within one of the blood vessels of the heart or other locations in the vasculature. At this point, the catheter is slid along the guide wire into the blood vessels and / or the heart. In some procedures, the catheter is equipped with a balloon or stent that, when deployed to the site of the lesion, can increase blood flow through the portion of the coronary artery affected by the lesion.

0004For the purpose of manual insertion of the catheter, the physician exerts torque and axial pressing on the proximal end of the guidewire, resulting in apical and axial advance at the distal end. Robotic catheter systems have been developed that can be used to assist physicians in performing catheter procedures such as percutaneous coronary intervention (PCI). Physicians use, for example, coronary guide wires, balloon catheters, or robotic catheter systems that accurately steer stent delivery systems to dilate occluded arteries. To perform PCI, various elongated medical devices (eg, guidewires, guide catheters, working catheters) need to be navigated to the target lesion through the anatomical structures of the coronary arteries. While observing coronary anatomical structures using fluorescence fluoroscopy, doctors manipulate elongated medical devices to insert them into the appropriate blood vessels leading to the lesion and not to advance into the lateral branches. To. The robotic catheterization system includes a drive mechanism that drives various elongated medical devices used in catheterization (eg, guide wires, guide catheters, working catheters) to provide linear and rotational movements of the elongated medical device.

0005During one type of intervention procedure, a guide catheter is inserted through the introducer into either the patient's femoral or radial artery, and the guide catheter is positioned near the coronary valve ostium of the patient's heart. .. During the procedure, the guide catheter is used to guide other elongated medical devices such as guide wires and balloon catheters into the patient. If the guide catheter comes out of the valve opening during the PCI procedure, the operator may wish the robot to reposition the end of the guide catheter. A guide catheter support structure, such as a flexible track, can be used to provide support to the guide catheter while in motion. It is desired to provide a system and method for detecting the position of the guide catheter support.

<p num="0006"><patcit num="1"><text>International Publication No. 2015/057821</text></patcit><patcit num="2"><text>U.S. Patent Application Publication No. 2008/0146942</text></patcit><patcit num="3"><text>U.S. Patent Application Publication No. 2009/0318799</text></patcit><patcit num="4"><text>U.S. Pat. No. 5,427,107</text></patcit></p>

0007According to one embodiment, the catheter treatment system includes a base and a robotic mechanism that has a longitudinal axis and is movable along the longitudinal axis with respect to the base, the robotic mechanism being at least one. A robot drive base including a drive mechanism, a cassette operably fixed to the robot drive base, a rigid guide coupled to the cassette and fixed to the robot mechanism, and a distal end, a proximal end, And a flexible track having multiple reflective sections and a position detector attached to the robot drive base and positioned below the flexible track, at least a portion of the flexible track. Placed in a rigid guide, the position detector is configured to detect light reflected from the reflective section of the flexible track and is flexible based on the detected reflected light. It is configured to position the distal end of the sex track.

0008The present invention will be more fully understood from the following detailed description in conjunction with the accompanying drawings. Here, the reference number indicates a similar part.

0009<figref num="1">It is a perspective view of the typical catheter treatment system which concerns on one Embodiment.</figref><figref num="2">It is a schematic block diagram of the catheter treatment system which concerns on one Embodiment.</figref><figref num="3">It is an isometric view of the bedside system of the catheter treatment system which concerns on one Embodiment.</figref><figref num="4">FIG. 5 is an isometric view of the anterior portion of the catheter treatment system of FIG. 3 according to one embodiment, in which the Y-connector support cover is in the raised position.</figref><figref num="5">FIG. 5 is a plan view of the anterior portion of the catheter treatment system of FIG. 3 according to an embodiment, in which the guide catheter is in an extended position.</figref><figref num="6">FIG. 3 is an isometric view of the anterior portion of the catheterization system of FIG. 3 in one embodiment, in which the flexible track is extended.</figref><figref num="7">FIG. 5 is a plan view of a catheterization system in a position where the flexible track is fully retracted, according to an embodiment.</figref><figref num="8">It is a top view of the catheter treatment system in the extended position of the flexible track according to one embodiment.</figref><figref num="9">It is a top view of the catheter treatment system in which the robot mechanism is in the 1st position which concerns on one Embodiment.</figref><figref num="10">FIG. 5 is a plan view of a catheter treatment system in which the robotic mechanism is in a second extended position, according to one embodiment.</figref><figref num="11">FIG. 6 is a rear isometric view of a catheter treatment system with linear drive according to an embodiment.</figref><figref num="12">It is a perspective view of the catheter treatment system at the position before assembling the cassette with respect to the robot drive base which concerns on one Embodiment.</figref><figref num="13">It is a perspective view of the cassette attached to the robot drive base which concerns on one Embodiment.</figref><figref num="14">FIG. 5 is a front sectional view of a robot drive base and a cassette showing a position detector according to an embodiment.</figref><figref num="15">It is a perspective view of the position detector which concerns on one Embodiment.</figref><figref num="16">It is sectional drawing of the position detector which concerns on one Embodiment.</figref><figref num="17">FIG. 5 is an enlarged front sectional view of a robot drive base, a cassette, and a position detector according to an embodiment.</figref><figref num="18">It is a schematic block diagram of the position detector which concerns on one Embodiment.</figref><figref num="19">It is sectional drawing of the proximal end of the flexible track and the rigid body guide which concerns on one Embodiment.</figref><figref num="20">It is an enlarged top view of the proximal end of the rigid body guide which concerns on one Embodiment.</figref>

0010FIG. 1 is a perspective view of a typical catheter treatment system according to an embodiment. In FIG. 1, the catheter treatment system 100 can be used to perform catheter-based medical procedures (eg, percutaneous interventional procedures). Catheter-based medical procedures may include diagnostic catheter procedures in which one or more catheters are used to assist in the diagnosis of a patient's disease. For example, during a catheter-based diagnostic procedure of one embodiment, a contrast agent is injected through a catheter into one or more coronary arteries and an image of the patient's heart is taken. Catheter-based medical procedures may also include catheter-based therapeutic procedures in which catheters are used to treat the disease (eg, angioplasty, stent placement, treatment of peripheral vascular disease, etc.). However, it should be noted that those skilled in the art will recognize that certain unique percutaneous intervention devices or components (eg, certain types of guidewires, certain types of catheters, etc.) will be selected based on the type of treatment performed. Should be. The catheterization system 100 can perform any number of catheter-based medical procedures with slight adjustments to adapt the intrinsic percutaneous intervention device to its use in the procedure. More specifically, a plurality of embodiments of the catheter treatment system 100 described herein will be described primarily in connection with the diagnosis and / or treatment of coronary artery disease, although the catheter treatment system 100 is via catheter-based treatment. It can also be used to diagnose and / or treat any type of disease or condition suitable for diagnosis and / or treatment.

0011Catheter treatment system 100 includes lab unit 106 and workstation 116. The catheter treatment system 100 includes a robot catheter system. This is shown as a bedside system 110 placed within lab unit 106 adjacent to patient 102. Patient 102 is supported on table 108. In general, bedside systems 110 include suitable percutaneous intervention devices or other components (eg, working catheters such as guide wires, guide catheters, balloon catheters and stent delivery systems, contrasting agents, drugs, diagnostic catheters, etc.). Equipped with, the user can perform catheter-based medical procedures via a robot system by operating various controls, such as controls located at workstation 116. The bedside system 110 may include any number and / or any combination of components that provide the functions described herein to the bedside system 110. The bedside system 110 includes, among other things, a cassette 114 supported by a robot arm 112 used to automatically supply a guide wire into a guide catheter placed in the artery of patient 102.

0012By communicating with the workstation 116, the bedside system 110 sends signals generated by the user input of the workstation 116 to the bedside system 110 to control various functions of the bedside system 110. The bedside system 110 can also provide feedback signals (eg, operating conditions, error codes, etc.) to workstation 116. The bedside system 110 can be a wireless connection, a cable connection, or any other means capable of allowing communication between the workstation 116 and the bedside system 110 (shown in FIG. 4). ) Can be connected to workstation 116.

0013The workstation 116 includes a user interface 126 configured to receive user input to operate various components or systems of the catheterization system 100. The user interface 126 includes a control unit 118 that allows the user to control the bedside system 110 to perform catheter-based medical procedures. For example, the control unit 118 uses various percutaneous intervention devices that can be equipped in the bedside system 110 to perform various tasks (for example, forward, backward or rotation of the guide wire, forward, backward movement of the working catheter). Or rotation, forward, backward or rotation of a guide catheter, expansion or contraction of a balloon placed on the catheter, positioning and / or deployment of a stent, injection of a contrast agent into a catheter, injection of a drug into a catheter, or catheter-based medical care. It can be configured to cause the bedside system 110 to perform any other function that can be performed as part of the procedure. The cassette 114 includes various drive mechanisms that provide movement (eg, axial movement, rotational movement) of the components of the bedside system 110, including a percutaneous intervention device.

0014In one embodiment, the control unit 118 includes 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 such as guidewires, guide catheters or working catheters and percutaneous intervention devices. Buttons 130, 132 may include, for example, an emergency stop button and a multiplier button. When the emergency stop button is pressed, the relay is triggered and the power supply to the bedside system 110 is cut off. The multiplier button acts to increase or decrease the speed at which the associated component moves in response to the operation of control 118. In one embodiment, the control unit 118 may include one or more control units or icons (not shown) displayed on the touch screen 124. When activated, they cause the operation of the components of the catheterization system 100. The control unit 118 may also include a balloon or stent control unit configured to inflate or deflate the balloon and / or stent. Each control unit may include one or more buttons, joysticks, touch screens, etc. for which it is desirable to control unique components. The unique component is dedicated to the control. In addition, the touch screen 124 may display one or more icons (not shown) associated with various parts of the control unit 118 or with various components of the catheterization system 100.

0015The user interface 126 may include a first monitor or display 120 and a second monitor or display 122. The first monitor 120 and the second monitor 122 are configured to display information or patient-specific data to a user located at workstation 116. For example, the first monitor 120 and the second monitor 122 may use image data (for example, X-ray image, MRI image, CT image, ultrasonic image, etc.), hemodynamic data (for example, blood pressure, heart rate, etc.), and patient record information (for example, blood pressure, heart rate, etc.). For example, it can be configured to display treatment history, age, weight, etc.). In addition, the first monitor 120 and the second monitor 122 are configured to display treatment-specific information (eg, duration of treatment, position of catheter or guidewire, volume of drug or contrast agent delivered, etc.). can do. Monitors 120 and 122 can be configured to display information about the position of the guide catheter. Further, the monitor 120 and the monitor 122 can be configured to display information for providing the function associated with the control 134 (shown in FIG. 4) described below. In other embodiments, the user interface 126 includes a single screen sized enough to display one or more of the display and / or touch screen components described herein.

0016Catheter treatment system 100 also includes imaging system 104 located within lab unit 106. The imaging system 104 may be any medical imaging system that can be used in conjunction with catheter-based medical procedures (eg, non-digital X-rays, digital X-rays, CT, MRI, ultrasound, etc.). In a typical embodiment, the imaging system 104 is a digital X-ray imaging device that communicates with workstation 116. In one embodiment, the imaging system 104 uses the imaging system 104 partially or completely around the patient 102 to capture images at different angular positions with respect to the patient 102 (eg, sagittal, caudal, anterior-posterior, etc.). Includes a C-arm (not shown) that allows rotation to.

0017The imaging system 104 can be configured to take an X-ray image of the appropriate area of patient 102 during a particular procedure. For example, the imaging system 104 can be configured to take one or more X-ray images of the heart to diagnose the condition of the heart. The imaging system 104 also includes one or more X-ray images during catheter-based medical procedures to assist the user of workstation 116 in properly positioning guide wires, guide catheters, stents, etc. during the procedure. For example, it can be configured to take a real-time image). One or more images may be displayed on the first monitor 120 and / or the second monitor 122. Specifically, for example, a plurality of images may be displayed on the first monitor 120 and / or the second monitor 122 to allow the user to move the guide catheter accurately to the proper position.

0018With reference to FIG. 2, a block diagram of the catheter treatment system 100 according to a typical embodiment is shown. The catheter treatment system 100 may include a control system designated as a controller 134. The controller 134 may be part of workstation 116. The controller 134 may generally be an electronic control unit suitable for providing the various functions described herein to the catheter treatment system 100. For example, the controller 134 may be an embedded system, a dedicated circuit, a general-purpose system programmed to include the functions described herein, or the like. The controller 134 includes one or more bedside systems 110, controls 118, monitors 120 and 122, imaging systems 104, and patient sensor 136 (eg, electrocardiogram ("ECG") devices, electroencephalogram ("EEG") devices, etc. Communicate with blood pressure monitor, body temperature monitor, heart rate monitor, respiratory monitor, etc.). In various embodiments, the controller 134 is configured to generate control signals based on its interaction with the user's control unit 118 and / or on the information accessible to the controller 134. As a result, the catheter treatment system 100 can be used to perform medical procedures. In addition, the controller 134 can communicate with a hospital data management system or hospital network 142, and one or more additional output devices 138 (eg, printers, disk drives, cd / dvd writers, etc.).

0019Communication between the various components of the catheterization system 100 can be achieved via the communication link 140. The communication link 140 may be a dedicated wired or wireless connection. Communication link 140 may also represent communication over a network. The catheterization system 100 can be connected or configured to include other systems and / or devices not explicitly indicated. For example, the catheter treatment system 100 includes an IVUS system, an image processing engine, a data storage and archiving system, an automatic balloon and / or stent expansion system, a drug infusion system, a drug tracking and / or logging system, a user log, an encryption system, a catheter. It may include systems that restrict access or use of the treatment system 100.

0020As described above, the controller 134 communicates with the bedside system 110 to control the operation of motors and drive mechanisms used to drive percutaneous intervention devices (eg, guidewires, catheters, etc.). A signal can be given to the bedside system 110. The bedside system 110 includes, for example, a guide wire axial drive mechanism that provides forward and / or backward movement of the guide wire, a working catheter axial drive mechanism that provides forward and / or backward movement of the working catheter, and a longitudinal axis of the guide wire. It may include a guide wire rotation drive mechanism configured to rotate around. In one embodiment, the various drive mechanisms are housed in cassette 114 (shown in FIG. 1).

0021FIG. 3 is an isometric view of the bedside system of the catheter treatment system according to the embodiment. In FIG. 3, the bedside system 210 includes a robotic mechanism 212 that can be used by a robot to move an elongated medical device. The robot mechanism 212 is movable with respect to the base 214. The robot mechanism 212 includes a robot drive base 220 that is movable with respect to the base 214, and a cassette 222 that is operably fixed to the robot drive base 220. In one embodiment, the base 214 is secured to a joint arm 224 that allows the user to position the robot mechanism 212 near the patient. In one embodiment, the base 214 is the distal portion of the joint arm 224. The joint arm 224 is fixed to the patient bed by a rail clamp or a bed clamp 226. In this embodiment, the base 214 is secured to the patient bed. By manipulating the joint arm 224, the base 214 is placed at a fixed location for the patient lying on the patient bed. The arm of the joint arm can be fixed once the desired arrangement of the robot mechanism 212 has been set for the patient.

0022As used herein, the distal direction is the direction towards the patient and the proximal direction is the direction away from the patient. The terms "upper" and "upper" refer to the general direction away from the direction of gravity, and the terms "bottom", "lower" and "lower" refer to the general direction of gravity. The term "front" refers to the side of the robotic mechanism facing the user and away from the joint arm. The term "rear" refers to the side of the robotic mechanism closest to the joint arm. The term "inside" refers to the inside portion of a feature. The term "outside" refers to the outer portion of a feature.

0023The bedside system 210 also includes a flexible track 216 that is movable along a rigid guide track 218 with a non-linear portion. Flexible track 216 includes proximal end 228 and distal end 230. The flexible track 216 supports an elongated medical device such as a guide catheter so that the guide catheter can be advanced into the patient without buckling. In one embodiment, the cassette 222 comprises a structure defining a rigid body guide 218. In other embodiments, the base 214 comprises a structure defining the rigid guide 218 alone or in combination with the cassette 222.

0024With reference to FIGS. 4 and 5, an elongated medical device, such as the guide catheter 238, is operably secured to the robotic mechanism 212 via the cassette 222. The guide catheter 238 includes a proximal end 240 and an opposite distal end 242. In one embodiment, the proximal end 240 of the guide catheter 238 can be operably secured to the Y-connector 244 and the Y-connector engagement mechanism 246. The Y-connector 244 may be, for example, a hemostatic valve fixed to the cassette 222 via the Y-connector engagement mechanism 246. The Y-connector engaging mechanism 246 includes a Y-connector base 248 that is part of the cassette 222 and an enclosure member 252 that includes a lid 250 and a support member 254. The Y-connector base 248 may include a guide catheter drive mechanism (not shown) located on the cassette 222. It is operably connected to the robot base 220. The guide catheter drive mechanism engages and rotates the guide catheter 238 operably along its longitudinal axis based on commands given by a controller (such as controller 134 shown in FIG. 2). Includes a drive mechanism to drive.

0025Referring to FIG. 5, the guide catheter 238 maintains its linear position along its longitudinal axis 256 within the cassette 222 with respect to at least a predetermined distance of the distal cassette 222. In one embodiment, the longitudinal axis 256 corresponds to the longitudinal axis of the cassette 222. During medical procedures such as percutaneous coronary intervention (PCI), the guide catheter 238 guides other elongated medical devices such as guide wires and balloon stent catheters into the patient, eg, exploratory diagnosis. It is used to perform or treat stenosis in the patient's vasculature. In one such procedure, the distal end 242 of the guide catheter 238 is placed within the valve opening of the patient's heart. The robotic mechanism 212 drives a guide wire and / or a working catheter such as a balloon stent catheter into and out of the patient. The guide wire and working catheter are driven within the guide catheter 238 between the distal end of the robotic mechanism 212 and the patient. In one embodiment, the longitudinal axis 256 is axis 3, around which the cassette 222 provides rotation of the guide wire, which drives the guide wire along its longitudinal axis and along its longitudinal axis. To drive a working catheter such as a balloon stent catheter.

0026With reference to FIGS. 5 and 6, a collar 258 is formed at the distal end 260 of the rigid guide 218. The end 230 of the flexible track 216 is secured to a sheath clip 232 releasably connected to the cassette 222. The rigid body guide 218 includes an inner channel. The flexible track 216 moves relative to the rigid guide 218 through the inner channel. The flexible track 216 includes an opening 264 located near the distal distal end 230 of the flexible track 216. When the distal end 230 of the flexible track 216 is positioned near the collar 258, the opening 264 is directed from the collar 258 to the region where the rigid guide 218 initiates an arched path away from the longitudinal axis 248. Extend. In one embodiment, the arched path forms an S-curve with at least one inflection point along the arched path. The opening 264 provides a path for the guide catheter 238 to be placed into the hollow cavity of the flexible track 216. The opening 264 tapers towards the slit 266 which extends to the substantially overall length of the flexible track 216. In one embodiment, the slit 266 is from the opening 264 only sufficient distance for the guide catheter 238 to enter and exit the inner portion of the flexible track 216 throughout the intended operation of the robotic catheter system. Extend.

0027Referring to FIG. 3, the flexible track 216 has the distal end 230 of the flexible track 216 to the proximal opening 234 of the rigid guide 218 and the distal end 230 of the flexible track 216 to the rigid guide 218. It is first positioned in the rigid guide 218 by feeding it until it extends beyond the collar 258. The distal end 230 of the flexible track 216 is operably connected to the sheath clip 232. The rigid body guide includes a linear portion starting from the proximal opening 234 and a non-linear portion. In one embodiment, the non-linear portion is an arched portion with at least one inflection point. FIG. 6 shows a portion of the flexible track 216 extending beyond the collar 258. Since the flexible track 216 is formed from a flexible material having a modulus of elasticity less than that of the rigid body guide material, the flexible track 216 is a curved non-linear portion of the channel defined by the rigid body guide 218. Move along.

0028Referring to FIGS. 7 and 8, the sheath clip 232 is pulled away from the cassette 222 along the longitudinal axis 256 until the distal end 262 of the sheath clip 232 is close to the patient to perform the procedure. .. In one embodiment, an introducer (not shown) is secured to the distal end 262 of the sheath clip 232. The introducer is a device that is fixed to the patient to ensure that the introducer is positioned on the patient. This allows elongated medical devices such as guide catheters, guide wires and / or working catheters to be inserted and removed into the patient with minimal tissue damage to the patient. Once the operator pulls the sheath clip 232 and the accompanying flexible track 216 towards the patient so that the introducer is closer to the patient, the flexible track 216 is locked in place by the locking clamp 236. .. The locking clamp 236 secures the flexible track 216 to the base 214. A portion of the flexible track 216 is present in the patient bed and in a fixed position with respect to the patient to the extent that the patient still lays on the patient bed.

0029Referring to FIG. 11, the robot mechanism 212 includes a linear drive mechanism 276. The linear drive mechanism 276 shown in FIG. 11 includes a linear slide controlled by the user by a robot via a remote workstation (eg, workstation 116 shown in FIG. 1). The linear drive mechanism 276 drives the robot mechanism 212 along the longitudinal axis 256. Since the rigid body guide 218 is fixed to the robot mechanism 212, the rigid body guide 218 and the robot mechanism 212 move with respect to the flexible track 216 as the robot mechanism 212 moves along the longitudinal axis 256.

0030With reference to FIGS. 7 and 8, the operation of the flexible track 215 and its movement with respect to the rigid guide 218 will be described. Referring to FIG. 7, the flexible track 216 is shown to be in the first installation position where the guide catheter 238 is positioned within the sheath clip 232 and the flexible track opening 264 as described above. Referring to FIG. 8, once the sheath clip 232 is released from the cassette 222, the sheath clip 232 and the distal end 230 of the flexible track 216 are pulled by the user away from the cassette 222. As a result, the distal end 262 of the sheath clip 232 is located near the point of entry of the patient undergoing percutaneous intervention. The locking clamp 236 operably tightens a portion of the flexible track 216 to secure the flexible track 216 to the base 214.

0031With reference to FIGS. 7 and 8, the portion of the flexible track 216 positioned within the arcuate portion of the rigid guide 218 generally extends out along the longitudinal axis 256 from the distal end 262 of the rigid guide 218. Be pulled. Similarly, a portion 268 of the flexible track 216 that is outside the arcuate portion of the rigid body guide 218 and is not located therein is pulled into the arched portion of the rigid body guide 218. Depending on how far the distal distal end 230 of the flexible track 216 is pulled towards the patient, portion 268 of the flexible track 216 enters and from the arcuate portion of the rigid body guide. Extend. In other words, the flexible track 216 has three general areas that vary with the operation of the guide catheter system. First, there is a proximal region that includes a flexible track portion from the proximal end 228 of the flexible track 216 to the proximal end 270 of the arched portion of the rigid guide 218. The flexible track 216 includes a second portion located between the proximal end 270 of the bow of the rigid guide 218 and the distal end 272 of the bow of the rigid guide 218 close to the collar 258. .. The flexible track 216 includes a third region extending from the collar 258 of the rigid guide 218 in a direction generally defined by a vector along the longitudinal axis 256. Here, the vector starts at the Y-connector and extends in the direction towards collar 258. The first and second regions of the flexible track 216 are offset from the longitudinal axis 256 and are not aligned with the longitudinal axis 256, as described above. The third portion of the flexible track 216 is generally coaxial with the longitudinal axis 256 as the flexible track 216 exits the collar 258 of the rigid guide 218.

0032During one type of intervention procedure, the guide catheter 238 is inserted into the patient's femoral artery through the introducer and positioned near the coronary valve ostium of the patient's heart. The operator may wish to robotically reposition the distal end of the guide catheter. With reference to FIGS. 9 and 10, the control of the distal end of the guide catheter 238 and the movement of the robot mechanism 212 and the rigid guide 218 with respect to the flexible track 216 are described. Referring to FIG. 9, the guide catheter 238 is a distal portion extending beyond the distal end 262 of the sheath clip 232 such that the end of the guide catheter 238 extends away from the distal distal end 262 of the sheath clip 232. Has. As mentioned above, the distal end of the guide catheter 238 can be placed near the patient's valve mouth. Robotic control of the distal end of the guide catheter 238 is achieved by the movement of the robotic drive mechanism 212 with respect to the base 214 and the flexible track 216 by a linear drive 276. The guide catheter 238 is placed in the channel of the flexible track 216 from the cassette 222 to the sheath clip 232.

0033When the guide catheter comes out of the valve opening during the PCI procedure, the distal end of the guide catheter 238 is extended back to the patient's valve opening by robotically moving the robot mechanism 212 toward the patient. Can be done. When doing this, the distal end of the guide catheter 238 is moved towards the patient, in one example the distal end of the guide catheter is reinserted or grounded into the patient's valve mouth. When the robot drive mechanism 212 is moved along the longitudinal axis 256, the rigid guide 218 is moved relative to the flexible track 216. The portion of the flexible track 216 located within the arched section of the rigid guide 216 changes as the robotic mechanism 212 and the rigid guide 218 move. The portion of the flexible track 218 disposed within the rigid body guide moves toward and away from the longitudinal axis 256, depending on the direction in which the robot drive mechanism 212 is moving. The guide catheter 238 moves into or out of a section of the flexible track 216 that is moving into and out of the arched portion of the rigid guide 218. In this embodiment, the portion of the guide catheter 238 between the cassette 222 and the sheath clip 232 is always located within the channel of the flexible track 216. In this embodiment, the guide catheter 238 can be operated within the flexible track 216 during a percutaneous intervention procedure without buckling or causing other undesired movements.

0034With reference to FIGS. 9 and 10, the position of the flexible track 216 with respect to the rigid guide 218 is described as being associated with one section A on the flexible track 216. In one example, section A on the flexible track 216 is located distal to collar 258 of the rigid guide 218. A remote work that drives the robot drive 212 distally along the longitudinal axis 256 when the operator decides to further insert the guide catheter 238 into or towards the patient in a direction away from the collar 258. At the station, the user operates the input device by activating the linear drive unit 276. Since the proximal end of the guide catheter 238 is longitudinally fixed in the cassette 222, the robot drive 212, including the cassette 222, is displaced by the linear drive 276 with respect to the base 214 and the flexible track 216. When moved towards the patient, the guide catheter 238 moves distally along the longitudinal axis 256. As a result, the distal end of the guide catheter 238 moves towards and / or into the patient.

0035When the robot mechanism 212 is moved along the longitudinal axis 256, section A of the flexible track 216 passes through the collar 258 and along the arch of the rigid body guide, section A of the flexible track 216 is rigid. Move into the arcuate portion of the rigid guide 218 until adjacent to the proximal end of the guide 218. In this embodiment, the distal end 230 of the flexible track 216 remains in an invariant position, but section A of the flexible track 216 is moved out or offset from the longitudinal axis 256. .. As section A moves into the arched channel defined by the rigid guide 218, the guide catheter 238 of the flexible track 216 passes through a slit adjacent to the engagement zone proximal to the collar 258. Enter the channel or hollow lumen. In this embodiment, the flexible track 216 is continuous for the collar 258 and the guide catheter 238 between the patients as the distal end of the guide catheter 238 is moved towards and away from the patient. Give support and guidance.

0036Similarly, if the operator wishes to retract the distal end of the guide catheter 238 from within the patient, the user linearly drives the robot drive mechanism 212 away from the patient via a remote workstation. Give a command to part 276. Thus, section A of the flexible track 216 enters the proximal end of the arcuate portion of the rigid body guide and is guided within the channel of the rigid body guide 218 until section A exits the distal end of the rigid body guide 218. .. Guide catheter 238 enters the slit in section A. In other words, a portion of the guide catheter 238 enters the flexible track 216 through that portion of the concentric slits in section A of the flexible track 216. It should be noted that when the robotic mechanism is moved towards and away from the patient, multiple sections of the flexible track are positioned proximal to the flexible track, even though they are positioned in different regions of the rigid body guide. The ends and distal ends remain fixed when the robotic mechanism is moved along the longitudinal axis.

0037The robot mechanism 212 also provides a position sensor to determine the distance (eg, distance from collar 258) that the distal end 230 of the flexible track 216 is pulled away from the cassette 222 along the longitudinal axis 256. May include. Positional information about the distal end 230 of the flexible track 216 can be used to control or limit the distance that the robotic mechanism 212 moves toward the patient along the longitudinal axis 256. FIG. 12 is an exploded view of the bedside system in which the cassette is in the position before assembly with respect to the robot drive base according to the embodiment. 396 is generally specified on the front surface of the robot mechanism 312, but 398 is generally specified on the rear surface of the robot mechanism 312. The position detector 380 is coupled to the robot drive base 320 of the robot mechanism 312. The position detector 380 is located at the proximal end 394 of the robot drive base 320. The position detector 380 is positioned on the robot drive base 320 so that when the cassette 322 is attached to the robot drive base 320, it rests below the proximal portion of the flexible track 316. FIG. 13 shows a cassette 322 mounted on the robot drive base 320 and placed on the position detector 380. FIG. 14 is a front sectional view of a robot drive base and a cassette showing a position detector according to an embodiment. FIG. 14 shows a front sectional view of the position detector 380. The position detector 380 is attached to the robot drive base 320 and is located below the flexible track 316. As mentioned above, the flexible track 316 penetrates the rigid guide 318. When the flexible track is moved towards or away from the patient, the position detector 380 displaces the distal end 230 (shown in FIG. 8) of the flexible track 316 from cassette 322. Configured to determine.

0038The position detector 380 may be, for example, a photodetector. Therefore, the flexible track may include a pattern of reflective and non-reflective sections. With reference to FIG. 13, the flexible track 316 includes reflective lines or stripes 395 at least in the proximal portion of the flexible track 316. The reflective line 395 is separated by a non-reflective line or section 397. Reflective lines can be made on flexible tracks, for example by printing white lines on tracks made of translucent material. In another example, the flexible track has a highly reflective opaque surface (eg, a surface of titanium dioxide) and non-reflective lines are added by laser etching. In other embodiments, the flexible track 316 is formed from a translucent reflective material and non-reflective lines or sections can be etched into the flexible track 316 using a laser. In other embodiments, the flexible track 316 is formed from a non-reflective material and reflective lines can also be added, for example by a printing or etching process. In one embodiment, the reflective lines 395 are evenly spaced from each other along the proximal portion of the flexible track 316 so that the reflective line width (t)._r) Is the non-reflective line width (t)_s). In this embodiment, the resulting resolution of the position detector 380 is such that the reflective and non-reflective line widths are equal to 2B (ie, t)._r= t_s= 2B) B unit. Referring to FIG. 14, the position detector 380 is configured as an optical sensor that detects the light reflected from the reflective stripe or line 395 as the flexible track 316 passes over the position detector 380. In one embodiment, the reflected light can be enhanced by providing a reflective target within the proximal end of the rigid body guide. FIG. 19 is a cross-sectional view of the proximal end of the flexible track and the rigid body guide according to the embodiment. In FIG. 19, the reflective target 381 is shown to be placed in the rigid guide 318 and the flexible track 316, and on the position detector 380. The reflective target 381 is formed from a reflective material. The flexible track 316 is, for example, a laser-etched translucent track that passes through a reflective target as the track 316 passes over the position detector 380. FIG. 20 is an enlarged top view of the proximal end of the rigid body guide according to the embodiment. In FIG. 20, the reflective target 381 can be attached to the rigid guide 318 using tab 399. As mentioned above, the flexible track 316 includes a longitudinal slit 266 (shown in FIG. 6). The slit slides over tab 399 as the flexible track moves towards and away from the patient.

003915 and 16 illustrate a typical position detector assembly according to an embodiment. The position detector 380 includes a housing 384, a window and / or a slit 382, and a reed switch 386. In one embodiment, the window and / or slit has a width of B unit or less. Window 382 includes, for example, a transparent material such as glass with or without anti-reflective coating. In various embodiments, the position detector may include one or more windows 382. The position detector 380 includes at least one photodetector located within the housing 384. FIG. 16 is a cross-sectional view of the position detector according to the embodiment. The photodetector includes a light emitting diode (LED) 388 and a light emitting diode 390 located in the housing 384 below the window 382. The LED 388 is positioned so that the light from the LED passes through the window 382 towards the flexible track 316. The photodiode 390 is positioned so that it can detect the light reflected from the reflective line of the flexible track 316. The LED 388 and the light diode 390 are coupled to a circuit board (eg, a printed circuit board) 392. Although one photodetector (ie, a pair of LED 388 and photodiode 392) is shown in FIG. 16, in various embodiments, the position detector 380 may include more than one photodetector. FIG. 17 is an enlarged cross-sectional view of the robot mechanism provided with the position detector according to the embodiment. In FIG. 17, the position detector 370 includes four photodetectors. A cross-sectional view of the position detector 380 shows that of four photodetectors, namely the first photodetector 383, the second photodetector 385, the third photodetector 387, and the fourth photodetector 389. Indicates each LED. As described above, as the distal end of the flexible track 316 moves away from or towards the cassette, the proximal end of the flexible track passes over the position sensor 380.

0040Returning to FIG. 16, the circuit board 392 may include a circuit configured to generate a signal indicating the distance traveled by the distal end of the flexible track based on the reflected light detected by the photodiode 390. .. In one embodiment, the position detector is configured to recognize a 2-bit Gray Code. In one embodiment, the position sensor 380 includes two photodetectors. This is shown in FIG. 18, which is a block diagram of the position detector according to the embodiment. In FIG. 18, the position detector 480 includes a first photodetector 491 and a second photodetector 493 located within the housing 484. The first photodetector 491 includes LEDs and photodiodes, and the second photodetector 493 includes LEDs and photodiodes. To recognize the 2-bit Gray Code, a first photodetector 491 can be positioned at the distal end of the housing 484 and designated as the most significant bit (MSB). The second photodetector 493 can be positioned at a distance l (eg l = {B, 5B, 9B, ...}) from the first photodetector 487 and designated as the least significant bit (LSB). Flexible track 416 includes reflective line 495 and non-reflective line 497. Each reflective line 495 has the same width t_rHave a distance t from each other_s(For example, t_s= 2B unit width) evenly separated. In one embodiment, the reflective and non-reflective line widths are equal (ie, t)._r= t_s). Each of the first photodetector 491 and the second photodetector 493 increases the output voltage as the photodiode detects light from the LED reflected from the reflective line 495 of the flexible track 416. To generate. Reflected light is used to detect the presence or absence of reflective line 495.

0041If the output voltage of the first photodetector 491 or the second photodetector 493 is greater than a predetermined value (ie, when the presence of reflective lines is detected), each photodetector is assigned a logical value of 1. be able to. When the output voltage of the first photodetector 491 or the second photodetector 493 falls below a predetermined value (ie, no reflective line is detected), the photodetector can be assigned a logical value of 0. When the distal end of the flexible track 416 is moved away from or towards the cassette and the proximal portion of the flexible track 416 passes over the position detector 480, the first photodetector The 491 and the second photodetector 493 make transitions between logic 1 and logic 0. The distance that the distal end of the flexible track 416 is moved away from or towards the cassette is the transition of the first photodetector 491 and the second photodetector 493, as well as the detected reflectivity. It can be determined based on line 495. In one embodiment, the first photodetector 491 and the second photodetector 493 are (0,0) (0) after each displacement of the distal end of the flexible track away from the cassette, i.e. the B unit. , 1) (1,1) (1,0) (0,0). The first photodetector 491 and the second photodetector 493 displace each displacement of the distal end of the flexible track towards the cassette-after the B unit, (1,0) (1,1) The transition is as follows: (0,1) (0,0) (1,0).

0042In other embodiments, the four photodetectors can be used to recognize the 2-bit Gray Code. Referring to FIG. 17, the second photodetector 385 and the third photodetector 387 represent the LSB photodetector and the MSB photodetector, respectively. In this embodiment, the first photodetector 383 (designated as ~ LSB) and the fourth photodetector 389 (designated as ~ MSB) have the ~ LSB photodetector 383 located at the proximal end of the position detector 380. The closest and ~ MSB photodetector 389 is placed in the position detector 380 so that it is closest to the distal end of the position detector 380. In other words, pointing from the proximal end to the distal end of the position detector 380, the first photodetector 383 is designated as ~ LSB, the second photodetector 385 is designated as the LSB, and the second The third photodetector 387 is designated as the MSB and the fourth photodetector 389 is designated as the ~ MSB. The third photodetector 387 is positioned at a distance of l (eg l = {B, 5B, 9B ...}) from the second photodetector 385. If the LSB photodetector 385 is centered on the reflective line, then the ~ LSB photodetector 383 is centered on the non-reflective line so that the corresponding ~ LSB photodetector 383 is centered on the non-reflective line. {2B, 6B, 8B, ...} Can be placed at a unit distance. If the MSB photodetector 387 is centered on a reflective line, the ~ MSB photodetector 389 is centered on the non-reflective line, so that the corresponding ~ MSB photodetector 389 is centered on the non-reflective line. = {2B, 6B, 8B, ...} Can be placed at a unit distance. In one embodiment, the distances l and l bars are minimized. As mentioned above with reference to FIG. 16, each reflective line 495 has the same width t._rHave a distance t from each other_s(For example, t_s= 2B unit width) evenly separated. In one embodiment, the reflective line width and the non-reflective line width are equal (ie, t)._r= t_s). If the difference in output voltage between MSB photodetector 387 and ~ MSB photodetector 389, or the difference in output voltage between LSB photodetector 385 and ~ LSB photodetector 383 is greater than the specified value, each photodetector A logical value of 1 is assigned to the vessel. The difference in output voltage between MSB photodetector 387 and ~ MSB photodetector 389, or the difference in output voltage between LSB photodetector 385 and ~ LSB photodetector 383 is smaller than the specified value (that is, the reflective line is If not detected), the photodetector is assigned a logical value of 0. As mentioned above, the distance at which the distal end of the flexible track 416 is moved away from or towards the cassette should be determined based on the photodetector transition between logic 1 and logic 0. Can be done.

0043The signal-to-noise ratio shall be the difference between the output voltage of the MSB photodetector 387 and the output voltage of the ~ MSB photodetector 389, and the difference between the output voltage of the LSB photodetector 385 and the ~ LSB photodetector 383. Can be increased by. In addition, the system is centered on the difference between the reflective and non-reflective lines of the flexible track 316, so it can balance itself. This embodiment allows for offset compensation due to the optical assembly and the gentle irregularities on the surface of the flexible track 316.

0044A computer-executable instruction for locating a flexible track can be stored in a form of computer-readable medium by the method described above. Computer-readable media are volatile and non-volatile, removable and non-removable, implemented by any method or technique for storing information such as computer-readable instructions, data structures, program modules or other data. Includes medium. Computer-readable media include random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory or other memory technologies, compact disk ROM (CD-ROM), and digital multi-use. Applications Disks (DVDs) or other optical storage, magnetic cassettes, magnetic tapes, magnetic disk storage or other magnetic storage devices, or forms of access via the Internet or other computer networks that can be used to store desired instructions. Including, but not limited to, any other medium accessible by the including system 10 (shown in FIG. 1).

0045In the present specification, a plurality of examples including the best mode have been used in order to disclose the present invention and to enable any person skilled in the art to make and use the present invention. The patentable scope of the present invention is defined by the claims and may include other examples reminiscent of those skilled in the art. Such other examples may be within the claims if they have structural elements that do not differ from the wording of the claim, or if they contain equivalent structural elements that have non-substantial differences from the wording of the claim. Intended. The sequence and sequence of any process or method step may be modified or rearranged according to alternative embodiments.

0046Many other modifications and modifications can be made to the invention without departing from the spirit of the invention. The scope of these and other changes will be apparent from the appended claims.