HK1121703B

HK1121703B - Remotely controlled catheter insertion system

Info

Publication number: HK1121703B
Application number: HK09101677.9A
Authority: HK
Inventors: 托蒂‧J.‧克罕尔; 迈克尔‧艾兰博格
Original assignee: 导管机器人技术公司
Priority date: 2005-07-11
Filing date: 2006-07-11
Publication date: 2013-10-11

Description

Remote catheter insertion system

Cross Reference to Related Applications

This patent application is based on an unlicensed, assigned U.S. provisional patent application entitled "System and method for telerobotic electrophysiology" (7/11/2005 application, application number US60/698,271), the entire contents of which are incorporated herein by reference.

Technical Field

The present invention relates to the positioning of medical devices within a patient. The invention is particularly concerned with the use of a remote control system for positioning medical devices, such as catheters, within a patient. Alternatively, the present invention may be used to position and place cardiac pacemakers (pacemakers) and/or cardioverter defibrillator leads (defibrillator leads).

Background

Interventional procedures, such as interventional electrophysiology procedures, are very complex and currently require the use of radiation, such as fluoroscopy (fluorocopy), to view the position of a device, such as a catheter, and to help determine the position of the device in situ within the patient's body, such as the heart or circulatory system. To facilitate catheter placement, multi-polar, shaped steerable catheters have been developed in some fields, including the electrophysiology field. In addition, three-dimensional non-fluoroscopic localization systems have been developed to help identify the spatial location of the catheter and record its position as well as the electrical activity of the heart.

Even with the advent of the above-described catheter and positioning systems, these medical procedures still expose patients, surgeons, and other personnel to a high cumulative amount of radiation, which can have long term adverse effects on the irradiated personnel. For a patient, such direct irradiation treatment may be performed only once or twice; however, for a large number of operators or staff, such direct and indirect exposure to radiation may continue over a long period of multiple surgeries. In order to protect the operation and the staff from radiation, people adopt shielding measures, including wearing waistcoats, gowns, glasses, skirts and the like with lead. However, these lead garments, particularly lead vests, are quite heavy and uncomfortable to wear and can cause neck and lumbar spine injuries when worn.

An alternative to this lead shielding is to use "mock" lead materials, i.e. lead-like substances are used as the barrier. However, even such relatively lightweight shielding garments can continue to stress the spine, cause discomfort, and can cause injury to the cervical, dorsal, and/or sacral spine over time.

In view of the concern over radiation exposure and the deficiencies of lead shielding, techniques and systems have been developed to allow a physician or technician to remotely control the insertion and movement of a catheter. Catheters currently available on the market, such as balloon angioplasty catheters (balloon dilation angioplasty catheters), typically have at least six ranges of motion. Known catheter remote control systems require the use of specialized catheters that are compatible with a particular system, which are more expensive than commercially available off-the-shelf catheters. In addition, the control functions of known remote catheterization systems are not intuitive, unlike the medical approaches typically taught by medical schools. To this end, the operator is required to learn to insert the catheter using a new instrument and a new motion control function.

Thus, there is a need for a remotely controllable catheter insertion system that can utilize commercially available catheters and that can take advantage of the known characteristics of such catheters. This allows the user to use the device via a control input means which is comfortable and familiar to the user as to how to operate.

Disclosure of Invention

It is an object of the present invention to provide an apparatus and method for deploying a medical device in a patient.

It is another object of the present invention to provide an apparatus and method for positioning a medical device, such as a catheter, within a patient using a telerobotic system.

It is a further object of the present invention to provide a system with a control handle for remotely positioning a medical device within a patient, the system comprising:

a robotic device for positioning a medical device within a patient;

a remote control mechanism for controlling the robot device;

wherein the robotic device further comprises a modular handle controller for receiving the control handle.

It is a further object of the present invention to provide a method of using the system to insert a thin, elongated medical device into a patient and perform any of a variety of diagnostic and/or therapeutic procedures.

All of the above and other objects of the present invention will be revealed by the following description.

In accordance with the present invention, a system and method are provided for telerobotic devices for inserting and positioning medical devices, such as catheters, within a human or animal patient. The device may be visualized using standard fluoroscopy (with X-ray)/cine imaging (cine imaging)/and/or three-dimensional mapping non-fluoroscopic imaging equipment with direct and/or remote monitoring capabilities. Certain embodiments of the present invention allow an operator, such as a physician or other medical personnel, to control the insertion, placement and positioning of a robotic device, such as a catheter, within a patient's body using remote control mechanisms, including remote control stations and controllers, at a location remote from the patient's true location. The catheter may be delivered to a non-vascular portion of the body in order to find a target and record, diagnose, and/or deliver a treatment or therapy. The catheter introducer may be driven by a telescoping rod without a rotor. The system may integrate an imaging device with a remote monitor and may locate the medical device in vivo by remote visualization of the medical device. The device can then be positioned using the system described above.

In one embodiment of the invention, access to a venous or arterial vessel, or to a non-vessel, is accomplished directly by the operator, and a medical device, such as a catheter, is inserted into the catheter sheath and then delivered, advanced and guided into position. In another embodiment of the invention, vascular access may also be achieved. In these embodiments, an operator performing a medical treatment can advance, remove, program, guide, and deflect a standard electrophysiology catheter, such as an ablation catheter, within a patient at a location remote from the patient, such as in a shielded control room, avoiding exposure to potentially harmful radiation typically associated with such treatments. In this manner, the present invention may eliminate the need for a doctor or other medical personnel to wear protective clothing during the performance of medical treatments, as such protective clothing may be uncomfortable, inefficient, and may cause injury to the wearer.

In another embodiment of the invention, a system and method for controlling a robotic device to position a medical device within a patient. The medical device is an elongated medical device having a control handle, examples of which include a catheter, a guide wire, an introducer sheath or catheter, and an introducer sheath or catheter. Specific catheters include, but are not limited to, ablation catheters, mapping catheters, balloon dilation catheters, irrigation catheters, pacemaker and/or defibrillator leads, and the like. This embodiment includes a robotic device capable of positioning a medical device within a patient's body, and a remote control mechanism or system capable of controlling the robotic device to position the medical device. The remote control mechanism preferably comprises: (1) a remote control station and (2) a controller connected to the remote control station. The robotic device preferably has a handle controller for receiving a control handle of the medical device. The remote control mechanism may include a remote control station and a robotic device controller, wherein an operator, such as a doctor or other medical personnel, may use the remote control station to control the robotic device. The remote control station includes appropriate control knobs, levers, switches, buttons, sliders or other controls, such as joysticks.

When operated manually, modern catheter devices are capable of moving through six ranges of movement. For example, the catheter can certainly be moved forward and backward so that a longer portion of the catheter can be inserted into or removed from the object. The catheter may also be rotated clockwise and counter-clockwise. In addition, the tip or tip of many catheters can deflect in multiple directions, referred to as "steerable.

The remote control mechanism may also include one or more transmitters, receivers, or transceivers to communicate between the remote control station and the robotic device controller, and may employ any wired and/or wireless transmission mechanism, including dial-up, cable, or broadband modem internet transmission. The operator may control the robotic device from a location remote from the patient location, including, but not limited to, a shielded control room. The robotic device may include one or more sensors to deliver information to the remote control station regarding catheter motion and the environment in which the catheter is located within the patient.

In another embodiment of the present invention, the robotic device may be configured to allow an operator to insert a medical device within a patient and to position the medical device within the patient. The medical device may be a catheter and the robotic apparatus may be a catheter control apparatus configured to allow an operator to use the teleoperator to perform one or more of the following operations within the patient: inserting a catheter, advancing and delivering a catheter, guiding a catheter, rotating a catheter, placing a catheter, shaping a catheter, or deflecting a catheter. Catheters or other medical devices may be inserted and positioned in various portions and systems within a patient's body, such as in the patient's heart or circulatory system.

In another embodiment of the invention, the elongate medical device may be a catheter, such as an electrophysiology catheter and/or an interventional catheter. The catheter or other medical device may be used for cardiac, vascular, radiation, gastrointestinal, or renal treatments, or a combination of two or more of the foregoing, and it may also be used for such treatments, including delivery of biologics such as stem cells, growth factors, and the like. Catheters may also be used for mapping (mapping), catheter ablation (catheter ablation), stenting (stenting), angioplasty (angioplasty), atrial fibrillation ablation (atrial fibrillation ablation), ventricular tachycardia ablation (ventricular tachycardia ablation) and/or other complex catheter ablations (e.g., multiple atrial tachycardia (multiple atrial tachycardia), etc.), or drug delivery, or a combination of two or more of these therapies.

In another embodiment of the invention, a robotic device includes a catheter introducer and a handle control assembly. In further embodiments of the present invention, the control device may comprise a catheter introducer, a clip model, a handle control assembly and/or a catheter control assembly. The feeder system may comprise an outer housing assembly, wherein the outer housing assembly may comprise an outer ring and one or more gears, and a clip assembly, wherein the clip assembly may comprise one or more clip holders, clips, or bands. The device may be designed to avoid hard wiring on the outer ring. For example, contacts may be used to energize a motor and deflect the tip. The handle assembly may include a handle outer housing assembly including an outer ring and one or more gears. The control means may further comprise means for securely supporting said medical device, means for rotating said medical device, and means for one or more of: forming, deflecting, guiding, placing, or positioning a medical device within a patient.

In another embodiment of the invention, the remote control station may include a joystick. In a further embodiment of the invention, a computer navigation system may be used with the same or equivalent catheter introducer system with sensor feedback to transmit electrical resistance, tip pressure and catheter motion to the remote catheter introducer system/model that occurs during actual movement in the body. The human model with the conventional sheath and catheter, plus the sensors, can be used as a controller to transmit information to the handle control and delivery system. This equipment can allow an operator to insert and manipulate a catheter, deliver and manipulate an interventional catheter remotely within the body, in a standard manner.

The remote control mechanism may optionally include a device or model into which the catheter is introduced or in which the catheter is manipulated, as is the case with catheters that are inserted into the human body. The catheter and model controller can send information back and forth to the catheter handle control and catheter introducer system for delivery operations to perform remote operations on the actual interventional system. Sensors and recorders (remote control mechanisms) in the model deliver the actual tactile sensation of the interventional catheter to the catheter in the catheter model remote control. In one embodiment, the device or model simulates human anatomy for insertion of a catheter. The mold comprises a catheter sheath; catheter and handle and gear; and sensors, resistors and transistors. In another embodiment of the invention, when an imaging device (e.g., 3D mapping) is integrated, the remote control is a computer in which translation (translation), motion (movement)/manipulation (manipulations) of the catheter can be safely performed remotely (possibly automatically with the ability of manual intervention and/or input) by safe iterative steps to safely reach the target site for catheter deployment (deployment).

In another embodiment of the invention, the handle, knobs and/or switches on the handle of the operating catheter are manipulated as a remote control that is translated into precise movements and sensations similar to a catheter that is inserted into the body and operated by a robot.

In another embodiment of the present invention, a robotic device comprises:

a handle controller operatively housing a control handle of a medical device having at least three ranges of motion and a distal end;

a first motor connected to the handle controller and capable of axially moving the medical device;

a second motor connected to the handle controller and capable of rotating the distal end of the medical device;

a third motor connected to the handle controller and capable of deflecting the distal end of the medical device; and

and a control unit connected to the first, second and third motors.

In a further embodiment of the invention, the first motor is coupled to an externally threaded drive screw, the handle controller is coupled to an internally threaded drive bracket, and the drive screw is engaged with the drive bracket. The handle controller is connected to the telescoping rod such that when the catheter is inserted into the handle controller, the sheath of the catheter is inserted into the telescoping rod, and the telescoping rod is connected to the catheter feeder. The catheter feeder, which includes a clamp or connector at its distal end, is secured to the outer housing at the proximal end of a standard catheter sheath to deliver the catheter into the patient without wrinkling.

In another embodiment of the invention, there may be more or less than three motors. In addition, there may be a back-office unit to control a second medical device, such as a catheter, stylet (skilette), or guidewire. For example, a first assembly system may control the steerable sheath and a second backend system or controller may control the steerable catheter. Thus, there may be multiple controllers to achieve additional mobility.

In a further embodiment of the invention, a sensor is disposed proximate the first motor, the sensor being effective to detect motion of the first motor.

In another embodiment of the invention, the handle controller further comprises a stabilizing rod that is effective to receive the flexible portion of the catheter.

In a further embodiment of the invention, the stabilizing rod is effective to engage the flexible portion of the conduit in a snap-fit manner. A force sensor is built into the stabilizer bar to record the pressure to which the forward moving catheter is subjected. This is useful if the inner box is swaying, so that all the conversion force is transferred to the stabilizer bar.

In a further embodiment of the invention, the handle controller is removably mounted to the rotating assembly.

In a further embodiment of the invention, the handle controller comprises a cylinder, the second motor is coupled to a drive wheel, and the drive wheel is coupled to the cylinder.

In a further embodiment of the invention, the rotating assembly comprises a drive wheel and a driven wheel.

In a further embodiment of the invention, the rotating assembly further comprises a support wheel.

In a further embodiment of the invention, the support wheels are slotted.

In a further embodiment of the invention, the handle controller further comprises a slip ring.

In a further embodiment of the invention, a sensor is disposed proximate to the second motor, the sensor being effective to detect motion of the second motor.

In a further embodiment of the invention, the catheter comprises a knob effective to control deflection of the tip; and a third motor is connected to the knob.

In a further embodiment of the invention, the third motor is connected to the knob by at least one gear.

In a further embodiment of the present invention, a third motor is coupled to the knob via first, second and third gears, the third gear including a gear extension that defines an opening for placement of the knob.

In a further embodiment of the invention, a sensor is provided adjacent the third motor, the sensor being effective to detect movement of the third motor.

In another embodiment of the present invention, the third motor is coupled to the knob via first, second and third gears, the third gear including a gear extension that defines an opening for the knob.

In a further embodiment of the invention, the control unit is connected to the first, second and third motors by wires.

In a further embodiment of the invention, the control unit is wirelessly connected to the first, second and third motors.

In a further embodiment of the invention, the control unit comprises a separate control unit for each of the first, second and third motors.

In a further embodiment of the present invention, is a method of moving a device using a remotely controlled catheter, the method comprising:

inserting a first catheter into the first handle;

inserting a first handle into the device;

operating the device;

removing the first catheter and the first handle;

inserting a second catheter into the second handle, the second catheter having a distinct structure from the first catheter;

inserting a second handle into the device;

the device is operated.

In a further embodiment of the method of the present invention, the handle is inserted into the rotating assembly.

In a further embodiment of the invention, the rotating assembly comprises a drive wheel, a driven wheel and a support wheel.

In a further embodiment of the present invention, inserting the first conduit into the first handle comprises inserting the first conduit into the stabilization rod.

In a further embodiment of the present invention, inserting the first catheter into the first handle includes coupling the first catheter to a motor that is effective to impart deflection to the tip of the first catheter.

In a further embodiment of the present invention, inserting the first catheter into the first handle comprises clamping the first catheter to the first handle.

In a further embodiment of the invention, in a system for remotely positioning a medical device within a patient, the system comprises a robotic device capable of positioning the medical device within the patient. The robotic device includes a handle controller that is effective to manipulate any controls on the medical device; an actuator effective to move the medical device forward and backward; and a catheter introducer effective to deliver a medical device in vivo. The apparatus further includes a remote control mechanism that is effective to control the robotic device.

The medical device may be a catheter, a guidewire, an introducer sheath, or a guide catheter, or a pacemaker or defibrillator lead. The handle controller may be modular in that each module is adaptable to a particular type of catheter or other medical device. The handle controller may be configured in the shape of a particular catheter. The handle controller may be configured to control features of the catheter to change its shape, profile, and deflect the catheter. The catheter feeder may comprise a telescoping unit. The telescopic unit may be sterile or disposable. The catheter may be a lead for sensing, pacing and/or defibrillation. Locations where the catheter may be placed include the right atrium, right ventricle, left atrium, left ventricle, endocardium of the heart, epicardium of the heart, and the like.

In a further embodiment of the invention, the remote control mechanism comprises a remote control station robotic device controller, the operator using the remote control station to control the robotic device.

In a further embodiment of the invention, the remote control mechanism comprises one or more transmitters, receivers and/or transceivers to communicate between the remote control station and the robotic device controller.

In a further embodiment of the invention, the robotic device is controlled by a remote control station located remotely from the patient location, such as a shielded control room.

In a further embodiment of the invention, the handle controller is a standard component.

In a further embodiment of the invention, a standard handle controller is specifically designed to control a particular type or standard medical device.

In a further embodiment of the invention, a standard handle controller is specifically designed to control a particular catheter handle and its controls.

In a further embodiment of the present invention, a standard handle controller is specifically designed to control the delivery, positioning, and placement of the pacemaker and/or defibrillator leads.

In further embodiments of the present invention, the handle controller can be adapted for use with a variety of different medical devices.

In a further embodiment of the invention, the handle controller of the robotic device engages a control handle of the catheter.

In a further embodiment of the invention, the handle controller uses standard features of a catheter control handle to insert a catheter, guide a catheter, rotate a catheter, place a catheter, shape a catheter, or deflect a catheter, or a combination of two or more of the foregoing, within a patient.

In further embodiments of the present invention, the catheter is used for mapping and catheter ablation.

In further embodiments of the invention, the catheter is used for stenting, angioplasty, or drug delivery or a combination of two or more of the foregoing.

In a further embodiment of the present invention, the handle controller further comprises a catheter delivery system.

In a further embodiment of the present invention, the handle controller further comprises: a clamp (clamp); a handle assembly; and a catheter control assembly.

In a further embodiment of the present invention, the handle controller further comprises:

an outer housing assembly, wherein the outer housing assembly comprises an outer ring and one or more gears; and

a clip assembly effective to clamp a control handle of a medical device to a handle controller, wherein the clip assembly comprises one or more clip carriers, clips, or bands.

In a further embodiment of the present invention, the handle assembly comprises a handle outer housing assembly comprising an outer ring and one or more gears.

means for securely supporting the catheter;

means for rotating the catheter; and

a device for shaping, deflecting, guiding, placing, or positioning a catheter, or a combination of two or more thereof, within a patient.

In a further embodiment of the invention, the handle controller further comprises one or more sensors for communicating with the remote control device regarding catheter motion and the environment of the catheter within the patient.

In a further embodiment of the invention, the information is transmitted to a remote station.

In a further embodiment of the invention, the remote control mechanism contains information about manual introduction or manipulation of the catheter in the patient's body, and the control mechanism is capable of sending information forward and backward to the catheter handle control and the catheter advancement system, thereby transferring the remotely performed operation to the actual interventional system.

In a further embodiment of the invention, the remote control comprises a computer that enables catheter actions and manipulations to be performed remotely by safe iterative steps (safe iterative steps) to safely reach the target site for catheter deployment.

In a further embodiment of the invention, the repeating step is performed under manual supervision.

In a further embodiment of the invention, a handle, knob, switch, or control on the catheter control handle is manipulated by the handle controller to simulate the precise motion and tactile feel of the same catheter inserted and manually operated within the patient.

In a further embodiment of the invention, the system is securely affixed to a base or support to deliver a medical device to a patient in a stable, predictable, and safe manner.

In a further embodiment of the invention, the system is mounted on a ceiling, table, wall, floor, tripod, or cart by means of a locking wheel.

In a further embodiment of the invention, the medical device is a pacemaker and/or defibrillator lead.

In further embodiments of the invention, the robotic device is capable of advancing and removing the guidewire and/or rotating the guidewire clockwise and counterclockwise.

In a further embodiment of the invention, the system also comprises means for fixating and/or deploying a lead for pacing or shocking in the coronary sinus (coronary sinus) or a branch thereof, e.g. a cardioverting or a defibrillator (defibrillation).

In a further embodiment of the invention, a lead is deployed that is capable of applying low and/or high pressure therapy to the left atrium or ventricle.

In a further embodiment of the invention, the medical device is a guide wire or a stylet.

In further embodiments of the invention, the robotic device is capable of advancing and removing the guide wire or stylet and/or rotating the guide wire or stylet clockwise and counterclockwise.

In a further embodiment of the invention, the electrophysiology catheter is a mapping and/or ablation catheter.

In a further embodiment of the invention, the system can be used for atrial fibrillation ablation.

In a further embodiment of the invention, the system can be used for performing ventricular tachycardia (ventriculrtachycardia) ablation.

In a further embodiment of the invention, the system can be used to perform atrial flutter (atrial flutter) ablation.

In a further embodiment of the invention, the system can be used for performing atrial tachycardia (atrialchocardia) ablation.

In a further embodiment of the invention, the system can be used for large vein electrical isolation (pulmony veinisation).

In a further embodiment of the invention, the system can be used to perform simple or complex ablations.

In a further embodiment of the invention, the system can be used for complex ablation for bypass-mediated tachycardia (assisted tachycardia).

In a further embodiment of the invention, the system has a restrictor to limit advancement or retraction of the medical device.

In a further embodiment of the invention, a robotic device comprises:

a handle controller effective to receive a control handle of a catheter having at least three ranges of movement and a distal end;

a first motor coupled to the handle controller and effective to move the catheter at least forwardly and/or rearwardly;

a second motor connected to the handle controller and effective to at least rotate the catheter;

a third motor coupled to the handle controller and effective to deflect the tip in at least the first direction; and

and a control unit connected to the first, second and third motors.

In a further embodiment of the present invention, the first motor is connected to an externally threaded drive screw; the handle controller is connected to the internally threaded drive screw; the drive screw is engaged with the drive bracket.

In a further embodiment of the invention, the handle controller is coupled to the telescoping rod such that when the catheter control handle is inserted into the handle controller, the distal end of the catheter is inserted into and through the telescoping rod.

In a further embodiment of the invention, a telescoping rod extends from the handle controller to the catheter introducer.

In a further embodiment of the invention, the telescoping rod is a collapsible tube having an inner diameter that allows for easy delivery of medical devices, such as catheters or guidewires, without buckling.

In a further embodiment of the invention, the telescoping rod is constructed of interlocking cylinders such that the cylinder closest to the handle controller is larger than the cylinder furthest from the handle controller.

In a further embodiment of the invention, the telescopic rod is sterile.

In a further embodiment of the invention, the telescopic rod is disposable.

In a further embodiment of the invention, the telescopic rod is sterilizable.

In a further embodiment of the invention, the telescoping rod is connected to a catheter feeder, which includes a clamp effective to prevent the sheath from buckling.

In a further embodiment of the invention, a specially designed clamp securely holds the control tip to the catheter sheath to maintain a short fixed distance and prevent the catheter from buckling during remote catheter manipulation.

In a further embodiment of the invention, the clip is sterile.

In a further embodiment of the invention, the clip is disposable.

In a further embodiment of the invention, the clip is sterilizable.

In a further embodiment of the invention, the system further comprises a sensor disposed proximate the first motor, the sensor being effective to detect motion of the first motor.

In a further embodiment of the invention, the handle controller further comprises a stabilizing rod that is effective to receive the flexible portion of the catheter.

In a further embodiment of the invention, the stabilizer bar is operatively engaged with the flexible portion in a snap-fit manner.

In a further embodiment of the invention, the system further comprises a sensor disposed proximate the stabilizing bar, the sensor being effective to detect motion of the catheter.

In a further embodiment of the invention, the system further comprises a limiter coupled to the sensor and effective to limit the first motor.

In a further embodiment of the invention, the handle controller comprises a cylinder and the second motor is connected to a drive wheel, which is connected to the cylinder.

In a further embodiment of the invention, the support wheels are slotted.

In a further embodiment of the invention, the system further comprises a sensor disposed proximate the second motor, the sensor being effective to detect motion of the second motor.

In a further embodiment of the invention, the catheter comprises at least one control member effective to control deflection of the tip, and the third motor is coupled to the at least one control member.

In a further embodiment of the invention, each control member is a switch, knob, lever, slider, gear, or button.

In a further embodiment of the invention, the third motor is connected to the at least one control member via at least one gear.

In a further embodiment of the present invention, the third motor is coupled to the at least one control member by first, second and third gears, the third gear including a gear extension defining an opening in which the at least one control member is disposed.

In a further embodiment of the invention, a sensor is provided adjacent the third motor, the sensor being effective to detect the action of the third motor.

In a further embodiment of the present invention, the third motor is coupled to the at least one control member by first, second and third gears, the third gear including a gear extension that defines an opening for the knob.

In a further embodiment of the invention, the control unit comprises separate controllers for the first, second and third motors.

In another embodiment of the invention, the robotic device is configured such that the tubing extending to the medical device does not tangle when the medical device is rotated.

In another embodiment of the present invention, a rotating connector in the system is coupled to the proximal end of the medical device.

In another embodiment of the invention, the medical device is a commercially available steerable catheter, introducer sheath, pacemaker or defibrillator lead, guidewire, or stylet.

In another embodiment of the invention is a method of using a telerobotic catheter device, the method comprising:

inserting a control handle of a first catheter into a first handle controller;

inserting a first handle controller into a robotic device;

operating the device;

removing the first catheter and the first handle controller;

inserting a control handle of a second catheter into a second handle controller, the second catheter having a distinct structure from the first catheter;

inserting a second handle controller into the robotic device; and is

The device is operated.

In a further embodiment of the invention, the handle controller is inserted into the rotating assembly.

In a further embodiment of the present invention, inserting the control handle of the first catheter into the first handle controller comprises inserting the first control handle into the stabilization rod.

In a further embodiment of the invention, inserting the first catheter control handle into the first handle controller comprises coupling the first catheter to a motor effective to transmit the deflection to the distal end of the first catheter.

In a further embodiment of the present invention, inserting the first catheter control handle into the first handle controller comprises clamping the first catheter control handle to the first handle controller.

In further embodiments of the invention, the medical device is a commercially available steerable catheter, introducer sheath, pacemaker or defibrillator lead, guidewire, or probe.

In a further embodiment of the present invention, in an improved method for mapping, tracking, or delivering therapy with a medical device incorporating imaging technology, wherein the improvement comprises using the remote positioning control system of the present invention to position the medical device.

In a further embodiment of the present invention, in an improved method of mapping and catheter ablation by inserting a mapping and ablation catheter into a patient, the improvement comprising positioning the catheter using the remote positioning control system of the present invention.

In further embodiments of the present invention, pacemaker and/or defibrillator leads are placed, deployed and/or screwed in.

In further embodiments of the present invention, pacemaker and/or defibrillator leads are delivered remotely to the right atrium, left atrium, right ventricle, left ventricle.

In further embodiments of the invention, the lead is delivered epicardially, endocardially, or through the coronary sinus.

In a further embodiment of the present invention, is a system for remotely positioning a medical device within a patient, the system comprising:

a robotic device for positioning a medical device within a patient;

the robot device includes:

a handle controller that can effectively operate any controls on the medical device;

an actuator effective to move the medical device forward and backward; and

a catheter introducer effective to deliver a medical device in vivo;

and

a remote control mechanism capable of effectively controlling the robot apparatus.

In a further embodiment of the invention, the handle controller is modular, each adapted for use with a particular type of medical equipment.

In further embodiments of the present invention, the handle controller is adaptable to a variety of medical devices.

In a further embodiment of the present invention, a system for remotely positioning within a patient an elongated medical device having a proximal end, the system comprising:

a robotic device for positioning a medical device within a patient; and

a remote control mechanism for controlling the robot device,

wherein the robotic device includes a handle controller for receiving the proximal end of the medical device.

a robotic device for positioning a medical device within a patient; the robot device includes:

at least two controllers; a remote controller to control the large medical device; a proximal controller for controlling a small medical device that passes through a large medical device, wherein the controller is capable of effectively manipulating any controller on the medical device and/or the medical device itself;

at least two actuators effective to move the proximal medical device forward or backward in the distal medical device and also to advance the distal medical device forward independently of the proximal medical device;

a catheter introducer effective to deliver a medical device in vivo;

In another embodiment of the invention, the telescoping rods are constructed of interlocking cylinders so that they become progressively smaller as the cylinders approach the handle controller.

In another embodiment of the invention, the telescoping rods are constructed of interlocking cylinders so that they become progressively larger as the cylinders approach the handle controller.

Drawings

The following drawings, which are incorporated in and constitute a part of this application, are provided for illustrative purposes only and the scope of the present invention is not limited thereto.

FIG. 1 is a top view of a catheter used in accordance with an embodiment of the present invention;

FIG. 2 is a front view of a remotely controlled catheterization system according to an embodiment of the present invention;

FIG. 3 is a front view of a remotely controlled catheterization system according to an embodiment of the present invention;

FIG. 4 is a side cross-sectional view of a drive bracket according to an embodiment of the invention;

FIG. 5 is a perspective view of a handle controller according to an embodiment of the present invention;

FIG. 6 is a top perspective view of a handle controller according to an embodiment of the present invention;

FIG. 7 is a top view of a handle controller according to an embodiment of the present invention;

FIG. 8 is a side perspective view of a handle controller according to an embodiment of the present invention;

FIG. 9 is a side perspective view of a handle controller according to an embodiment of the present invention;

FIG. 10 is a side perspective view of a remotely controlled catheterization system in accordance with an embodiment of the present invention;

fig. 11 is a side view of a stabilizer bar according to an embodiment of the present invention;

FIG. 12 is a top perspective view of a telescoping pole according to an embodiment of the invention;

FIG. 13 is a side perspective view of a remotely controlled catheterization system in accordance with an embodiment of the present invention;

FIG. 14 is a top view of a controller according to an embodiment of the present invention;

FIG. 15 is a front view of a system setup according to an embodiment of the invention;

Detailed Description

The invention may be better understood by reference to the following drawings. In FIG. 1, conduit 142 is a schematic illustration of a conduit that may be used with embodiments of the present invention. The catheter 142 includes a handle portion 172 that a user can grasp. Handle portion 172, in turn, includes a proximal end 174 and a gripping portion 176. Inserted into proximal end 174 may be a wire 190 or a tube that may provide power, coolant, heat, etc. to catheter 142. The grip portion 176 includes an adjustment dial 178 for adjusting the tightness of a knob 180. At the end of the handle 172 is a flexible tip 186 which in turn is connected to a distally extending catheter sheath or tubular member 182.

As is known in the art, catheter sheath 182 may be inserted into a patient by a variety of known methods and devices. The end of catheter sheath 182 is at tip 188. Tip 188 may include, for example, electrodes to provide electrical stimulation, cooling fluid, heat, and the like.

Catheter sheath 182 is physically coupled to handle 172 such that forward or rearward movement of the handle in the direction of arrows 192 or 194 causes catheter sheath 182 and tip 188 to likewise move. Rotating handle 172 clockwise or counterclockwise, as indicated by arrows 196 and 198, may cause corresponding rotation of catheter sheath 182. Turning the knob 180 in the direction of arrows 200 or 202 may cause the tip 188 to deflect in one of the directions indicated as 188a and 188 b. In this way, when used manually, commercially available catheters can work within six ranges of movement: back and forth movement in the direction of arrows 192 and 194, rotation in the direction of arrows 196 and 198, and deflection in the position shown at 188a and 188 b. Known remote catheter insertion devices cannot be used in all these ranges of movement as the device of the present invention.

The embodiments shown in the drawings relate primarily to the application of the invention to steerable catheters. However, the robotic control system of the present invention is equally applicable to other flexible medical devices, such as guidewires, introducer sheaths, guide catheters, or any similar medical device.

Referring to fig. 2 and 3, a remotely controlled catheterization system 100 is shown that may be used in accordance with an embodiment of the present invention. The insertion system 100 includes a base 102 supporting a motor housing 104, a handle controller 120, and a catheter transporter 124. The motor housing 104 houses a motor 105 which receives power and control signals through wires 126 via the junction box 106 and the terminal connectors 108. Wires 126 may also be fed into handle controller 120 via terminal connectors 108. How the wires 126 provide power and control signals to the motor 105 and the handle controller 120 will be described in detail below.

The handle controller 120 is movably supported on the base 102 by a metal drive screw 112. The handle controller 120 is connected to the drive screw 112 through the drive bracket 118. The drive bracket 118 is internally threaded, and the internal threads of the drive bracket 118 engage the external threads of the drive screw 112. Thus, as the drive screw 112 rotates, the drive bracket 118 moves laterally (left to right, right to left, or in the directions 192 and 194, as shown) due to the engagement of the internal threads of the drive bracket 118 with the external threads of the drive screw 112. The stops 110 and 114 limit the range of motion of the drive bracket 118 and, in turn, the handle controller 120.

As best shown in fig. 4, the drive bracket 118 includes a support base 130 that is connected to a cantilevered top bracket 128 and an internally threaded member 132. The top bracket 128 is connected to the support base 114 of the handle controller 120. As shown in phantom, the drive screw 112 passes through the aperture of the support base 130 and engages the threads of the internally threaded member 132. Returning again to fig. 2-4, rotation of the drive screw 112 causes the internally threaded member 132 to move back or forward (i.e., to move left or right in the direction of 192 or 194). This action is also communicated to the support base 130, the top bracket 128 and, in turn, the handle controller 120. Sensors may be provided near the motor 105, drive screw 112, drive bracket 118, or handle controller 120 to monitor movement of the handle controller 120.

The structure of the handle controller 120 is described in more detail in fig. 5, 6 and 7. The handle controller 120 includes a housing 134 (the open position shown in fig. 5) and a support base 114. The rotating assembly 152, the motor 148 and the terminal connector 146 are mounted on the support base 114. Like the terminal connector 108, the terminal connector 146 may facilitate connection of the wires 126 to the motor 148. The detachable handle 136 is shown attached to the rotating assembly 152. A conduit 142 (fig. 1) is disposed within the handle 136.

A very important feature of the present invention is that commercially available catheters can be used. Since handle 136 is removable from rotating assembly 152, different handles may be used for different types of catheters 142. In the example shown in FIG. 1, the trademark BLAZER II XP is used^TMA cardiac ablation catheter (available from Boston Scientific Corporation, Natick, MA) located in tokyo, MA, with a corresponding handle 136. It will be apparent that other handles and catheters may be used. For example, SAFIRE may also be used with a corresponding handle 136^TMBi-directional ablation catheter (available from St.Jude Medical, St.Paul, MN) located in St.Jordan Medical, St.Paul, Minn.). Likewise, RF MARINER may also be used，RFCONTRACTOR，RF CONDUCTRAn ablation catheter (available from Medtronic, inc., Minneapolis, MN) located in Minneapolis, MN). A fastening mechanism 140 may be used to connect the conduit 142 to the handle 136.

Rotation assembly 152 includes drive wheel 164, driven wheel 150, support wheel 162, and slotted support wheel 139. The motor 148 drives the drive wheel 164, which rotates the handle 136. Driven wheel 150 supports and facilitates rotation of handle 136. The handle 136 includes a hollow cylinder 160 having a circumferential portion engaged with the drive wheel 164, the driven wheel 150 and the support wheel 162. The radial edges of the cylinder 160 engage with grooved support wheels 139. In use, the conduit 142 is inserted into the hollow portion of the cylinder 160 and mounted to the handle 136 using the fastening mechanism 140, the fastening mechanism 140 including the clip mount 154 and the clip 156. The clip 156 is secured to the clip base 154 with screws 158.

As shown in FIG. 7, when the motor 148 is activated, the shaft 166 begins to rotate, which rotates the drive wheel 164. The rotation of the driving wheel 164 rotates the cylinder 160 supported by the supporting wheel 162 and the driven wheel 150. The conduit 142 is disposed within the cylinder 160 and is retained within the cylinder by the fastening mechanism 140. Thus, the handle 136 may be rotated clockwise and counterclockwise by activating the motor 148. A slip ring connector (not shown) may be used at the end of the handle 136 so that the wire 190 of the catheter 142 is free to rotate. Sensors (not shown) may be positioned adjacent to the motor 148 and any components of the rotating assembly 152 to monitor the rotation of the handle 136.

Figures 8 and 9 illustrate one configuration for controlling deflection of the catheter tip. A portion of the handle controller 120 enables deflection of the distal end of the catheter 142 (fig. 1). The motor 209 is disposed under the supporting base 144, and drives the transmission gear 210 to rotate. The driving gear 210 is engaged with the first driven gear 208. The first driven gear has an elongated end which in turn meshes with the second driven gear 206. The second driven gear 206 has a gear extension 204 extending upward. The gear extension 204 defines an opening for receiving the knob 180 of the handle 176 of the catheter 142. Due to the opening formed by the gear extension 204, rotation of the gear 206 causes the gear extension 204 to rotate, which in turn causes the knob 180 to rotate. Therefore, when the motor 209 rotates, the driving gear 210, the first driven gear 208, the second driven gear 206, the gear extension 204 and the knob 180 are driven to rotate. This action deflects the tip 188 of the catheter 142 (as shown in FIG. 1). A sensor (not shown) may be positioned adjacent to the motor 209 or any of the gears 206, 208 or 210 to measure the rotation of the gear and thereby measure or predict deflection at the tip 188.

The catheter 142 is inserted into the handle 136 at three locations. The knob 180 is inserted into the space defined by the gear extension 204 as described above. As discussed with reference to fig. 6, the proximal end 174 of the catheter 172 is mounted to the handle 136 by the fastening mechanism 140 using the clip 156. In addition, the proximal end 186 of the catheter 172 snaps into place within the stabilization rod, as shown in fig. 5, 8, 10, and 11. If there is additional range of motion for catheter 142, such as a deflection point in the mayonney ablation catheter, another motor may be installed to drive a corresponding control mechanism on the handle.

Referring to fig. 10 and 11, the stabilization rod 212 includes a bottom portion 214 and a top portion 216 that forms an opening 218. Opening 218 is designed to be large enough to fit just over flexible catheter sheath 182 of catheter 142 in a snap-fit manner. As illustrated in FIG. 10, the stabilizing bar 212 is mounted to the inside of the handle 136, effectively stabilizing the catheter 142 mounted therein. In addition, the stabilizer bar 212 may also be used to absorb the amount of excess forward or backward movement transmitted to the conduit 142. For example, if the conduit 142 is pushed forward too hard or too quickly, the openings 218 of the stabilizer bar 212 will slide along the circumference of the flexible portion 186. Also, a sensor (not clearly visible in the figures) may be mounted within the stabilizing rod 212 to measure the movement of forward or backward forces transmitted to the conduit 172. A limiter may be connected to the motor for limiting the amount of forward or backward movement based on the measurement record of the sensor.

Catheter sheath 182 is very flexible. This flexibility means that if catheter sheath 182 is over-stressed, catheter sheath 182 will buckle and not advance into the patient. The remote catheter insertion system 100 has various mechanisms to avoid the occurrence of such wrinkles. Referring to fig. 12, after flexible catheter sheath 182 is inserted into stabilization rod 212, catheter sheath 182 is inserted into guide plate 138. The catheter sheath 182 is further inserted into a telescopic rod (telescoping rod) 220. As the handle controller 120 (fig. 2) moves forward and backward in directions 192 and 194, the catheter sheath 182 moves inward into the telescoping rod 220. In addition, since the extension rod 220 is fixed to the end of the support base 144 of the handle controller 120 by the fastening mechanism 222, the movement of the handle controller 120 causes the extension rod 220 to perform an extension and contraction action. That is, the telescopic link 220 is retracted or extended according to the forward/backward movement of the handle controller 120. After each use of the catheter 172, the telescoping rod 220 can be disengaged from the fastening mechanism 222 and the telescoping rod disposed of or sterilized. The telescoping shaft 220 may be a collapsible tube, using interlocking cylinders (or cones) of relatively small size, with an internal diameter well suited for the passage of catheters, guidewires or medical devices, without significant resistance, much like a collapsible cup or antenna. According to embodiments of the present invention, the controller may deliver substantially the entire catheter, guidewire and/or medical device into the patient.

To further assist in feeding catheter sheath 182, while avoiding wrinkling, catheter transport 124 is used. Referring to fig. 10, 12 and 13, the end of the telescoping rod 220 is connected to the catheter feeder 124 and includes a box 226 and a caliper portion 224. As previously described, the catheter sheath 182 is inserted into the telescoping rod 220 from within. Catheter sheath 182 extends from catheter sheath 124 via a clamp 224. Clamp 224 is an external device that attaches the exterior of catheter delivery device 124 directly to an introducer sheath (not shown) to maintain a fixed precise distance (i.e., in close proximity) from catheter sheath 182 and further prevent catheter sheath 182 from buckling. If desired, the introducer sheath 124 can be secured to the end of the clamp 224 so that the catheter sheath 182 is withdrawn from the catheter transporter 124 and immediately advanced into the introducer. The conduit carrier 124 is mounted to the base 102 of the system 100 by brackets 228.

Referring again to fig. 1, as mentioned above, catheter 142 may be manipulated over six ranges of movement: move forward and backward in directions 192 and 194, rotate clockwise and counterclockwise in directions 196 and 198, and deflect end-to-end to positions 188a and 188 b. In system 100, forward and rearward movement in directions 192 and 194 is controlled by activating motor 105 and by engagement between drive screw 112 and drive bracket 118, as best seen in fig. 2 and 3. Clockwise and counterclockwise rotation 196 and 198 is effected by activation of the motor 148 to move the drive wheel 164 and cylinder 160 as shown in figure 7. Deflection of the tip 188 to positions 188a and 188b may be accomplished by activating the motor 209 and by engagement between the gears 210, 208, and 206, as shown in fig. 8. Thus, three motors, each operating in two directions, can provide control over six ranges of motion. It is also possible to add a motor to provide other moving actions of the catheter, but this is also within the scope of the invention.

FIG. 14 illustrates a remote control station 240 that may be used in accordance with embodiments of the present invention. The remote control station 240 has a master switch 242 that can provide power to each motor connected to the remote control station 240. The forward/reverse dial 244 is coupled to the motor 105 (fig. 2) such that operation of the dial 244 provides power and control signals to the motor and causes the conduit 142 to move forward and backward. A forward/reverse power switch 250 may selectively provide power to the turntable 244. The dial 246 is connected to the motor 148 (see fig. 7) and operation of the dial 246 provides power and control signals to the motor to rotate the conduit 142. A rotary power switch 248 may selectively provide power to the turntable 246. The yaw turntable 254 is connected to the motor 209 (see fig. 8). Operation of the dial 244 provides power and control signals to the motor 209 and deflects the distal end 188 of the catheter 142. The deflection power switch 252 may selectively provide power to the deflection turntable 254. In this way, the full range of motion of catheter 142 can be controlled by use of remote control station 240. If the conduit is provided with wires for power, heating or cooling, such wires may also be connected to the control station 240. These dials may be used to generate switching signals or analog signals corresponding to various speeds of the motor.

Referring now to fig. 15, the location settings of the remote control station 240 may be separated from the rest of the system 100. For example, a technician or physician operating system 100 may remotely control catheter 142 by using remote control station 240. The remote control station 240 may even be located in another room separate from the other devices of the system. The technician may be able to view a screen 256 providing information about the treatment procedure, such as fluoroscopy, while at the same time operating the control station 240. The control station 240 may be connected to the system 100 in a variety of ways, including by wire and/or wirelessly. The systems described herein may be used simultaneously or with other mapping and/or visualization systems, but are within the scope of the present invention. Other similar systems include CARTO(available from Biosense Webster, Inc., of Diamond Bar, Calif.) or EnSite^TMA mapping system (available from Endocardial Solutions Inc. of St. Paul, Minn.) or a conventional infrared or ultrasonic viewing system, etc.

To this end, a more suitable, less expensive, remotely controlled catheterization system may be implemented by utilizing conventional commercially available catheters. Since a standard catheter is used and the catheter is the only instrument inserted into the object, no additional government approval may be required. Due to the use of the modular handle, catheters of various sizes, shapes and manufacturers can be incorporated into the system. The use of a telescopic rod means that the system is easier to sterilise, since the telescopic rod can easily be designed to be disposable. In addition, the use of a motor for delivering the catheter into the patient may be eliminated, thereby improving the stability, synchronization and control of the catheter. The technician can easily adapt to the use of the controller because the control device and the screen are familiar and visible to the technician.

The system described above is relatively secure in that it provides a number of features. For example, the motor that moves the catheter forward and backward ultimately applies less force than a human hand does, and thus there is less concern about perforation. Such forces may be sensed by various sensors to ensure that excessive forces are not applied through, for example, a stabilizer bar. Also, sensors may be used to detect the amount of clockwise and counterclockwise movement and the amount of movement of the gears, facilitating deflection of the catheter tip. Using the data of all these sensors helps to ensure a safe system. Furthermore, certain limits, cutoff values, etc. may provide a degree of safety, even beyond that of manually administered treatments.

It is clear that any other type of catheter may be used, such as a diagnostic catheter or an angiographic catheter, or a catheter comprising various types of pumps, stylet guidewires, guidewires or balloons. The position of the catheter can be maintained even in the event of a power failure. For example, all six ranges of motion do not rely on a continuous power source. The amount of forward or backward movement, rotation and yaw are independent of the continuous power supply. For example, a specific yaw may be set, and then the yaw motor may be turned off while the rotary motor is applied. Similarly, a continuous radio frequency ablation treatment (radio frequency ablation treatment) can be performed at a particular deflection angle, while the catheter can be remotely pulled back to form a linear ablation. Certain types of treatment include microwave, ultrasound, radio frequency, cryoablation, chemical ablation, biologic administration, and the like. Conventional non-fluoroscopic three-dimensional mapping may be used for applications that track catheter movement and ablation.

While prior art controllers require the user to learn a new control scheme, the present invention requires only control schemes that are already known to the user and are generally control techniques learned in school.

The position of the catheter may be measured and recorded using fluoroscopy and/or a three-dimensional mapping system. Through computer programs and feedback systems, the robotic device can automatically or semi-automatically manipulate catheter mapping and placement as desired by the operator. Software programs of feedback information from the catheter system can steer and perform catheter ablation at precise target locations without the need for an operator to move the catheter remotely. The catheter system has a corresponding fail-safe function. The operator can monitor the automatic and targeted procedure and shut down the system if there is a deviation from the originally planned targeted mapping/ablation procedure. For example, the software program may analyze the motion of each motor and/or gear via the sensors to place the catheter at a particular location within the object. For example, the technician may first perform a treatment procedure while the software analyzes the motion of each motor. The software can thereafter be supplemented with a control station to robotically control the catheter to a particular location and/or perform a particular treatment procedure. This functionality is particularly useful in certain treatment procedures that require multiple repetitions. In addition, the computer software may operate the catheter to repeatedly move multiple times toward a three-dimensional object, ultimately focusing on the object. The software program can learn about the situation from the actions and return to certain locations, perform a series of maneuvers (actions that can be enacted or determined on a computer), such as by applying ablation to encircle the pulmonary veins, achieving pulmonary vein isolation. Additionally, a tricuspid annulus isthmus (cavo-tricuspid isthmus) line may be established to ablate atrial flutter (atrial flute). Finally, scar map points are established and ablation lines are automatically or semi-automatically formed to prevent reentry ventricular tachycardia (reentrant ventricular tachycardias).

The system may be placed anywhere, including on a beam, e.g. -ceiling, on a table, or on a side or entrance of an object, etc. These systems can be mounted and firmly secured to the insertion site so that insertion forces can be translated without the need for rearward movement.

In addition, a backend module may also be added to remotely manipulate, such as forward/backward, rotation, deflection, drug/contrast delivery, balloon inflation, energy/therapy delivery, or stent/device placement.

While the preferred embodiment has been described, the invention is not to be limited except as by the scope of the appended claims.

Those skilled in the art will appreciate that the method and system of the present invention has a variety of uses and may be embodied in a variety of ways and, thus, is not limited to the exemplary embodiments described above and illustrated below. Furthermore, the functions of the various parts of the embodiments described above and in the following may be implemented in different ways. In addition, it is understood that the steps in the embodiments may be performed in any suitable order, combined into a few steps, or divided into more steps. Thus, as will be appreciated by those skilled in the art, the scope of the present invention covers various different schemes and adaptations of the various parts of the systems described herein that are conventionally known and developed in the future.

Claims

1. A system for remotely mapping a catheter with a catheter handle portion within a patient, the system comprising:

robotic means for positioning and controlling the catheter within the patient, wherein the system is fixedly secured to a base or support; and

a remote control mechanism for controlling the robot device,

wherein the robot device includes:

a modular handle controller adapted to engage the catheter handle portion, the modular handle controller comprising:

clamping a hoop;

a handle assembly, and

a catheter control assembly configured to engage a control mechanism located on a catheter handle portion when the catheter handle portion is inserted into the modular handle controller;

a first motor connected to the modular handle controller and configured to move the catheter at least forward and backward;

a second motor coupled to the modular handle controller and configured to rotate the catheter about a long axis in at least a clockwise and counterclockwise direction;

a third motor connected to the modular handle controller and configured to engage the catheter control assembly such that when the third motor is activated, a control mechanism on the catheter handle portion deflects the tip of the catheter in at least a first direction; and

a control unit connected to the first, second and third motors,

wherein a handle, knob or switch on the catheter handle portion is operated by the modular handle controller to control movement of the catheter in a manner similar to manual control of the catheter handle portion.

2. The system of claim 1, wherein the remote control mechanism comprises a remote control station and a robotic device controller, the remote control station being used by an operator to control the robotic device.

3. The system of claim 2, wherein the remote control mechanism comprises one or more transmitters, receivers, and/or transceivers for communicating between the remote control station and the robotic device controller.

4. The system of claim 2, wherein the remote control station is located in a shielded control room.

5. The system of claim 1, wherein the modular handle controller uses standard features of a catheter control handle to insert a catheter, guide a catheter, rotate a catheter, place a catheter, shape a catheter, or deflect a catheter within a patient.

6. The system of claim 1, wherein the modular handle controller further comprises a catheter introducer.

7. The system of claim 1, wherein the modular handle controller further comprises one or more sensors for communicating with the remote control device regarding movement of the catheter and the environment of the catheter within the patient.

8. The system of claim 7, wherein information from the sensor is delivered to a remote control station.

9. The system of claim 1, further comprising a restrictor for restricting advancement or retraction of the catheter.

10. The system of claim 1, wherein,

the first motor is connected to the external thread transmission screw;

the modular handle controller is connected to an internal thread transmission bracket; and

the drive screw is engaged with the drive bracket.

11. The system of claim 6, wherein a clamp is provided to securely hold the catheter introducer tip to the introducer sheath to prevent buckling of the catheter during remote manipulation of the catheter.

12. The system of claim 11, wherein the clamp is disposable.

13. The system of claim 11, wherein the clamp is sterilizable.

14. The system of claim 1, further comprising a sensor disposed proximate the first motor, the sensor being effective to detect motion of the first motor.

15. The system of claim 1, wherein the modular handle controller further comprises a stabilizing rod effective to receive a flexible portion of a catheter.

16. The system of claim 15, wherein the stabilizing rod is effective to engage the flexible portion in a snap-fit manner.

17. The system of claim 15, further comprising a sensor disposed proximate the stabilizing bar, the sensor being effective to detect a force applied by the distal end of the catheter.

18. The system of claim 17, further comprising a restraint coupled to the sensor and effective to restrain the first motor.

19. The system of claim 1, wherein the modular handle controller is removably mounted on the rotating assembly.

20. The system of claim 19, wherein the modular handle controller comprises a drum and the second motor is coupled to a drive wheel coupled to the drum.

21. The system of claim 20, wherein the rotating assembly comprises the drive wheel and a driven wheel.

22. The system of claim 21, wherein the rotating assembly further comprises a support wheel.

23. The system of claim 22, wherein the support wheels are slotted.

24. The system of claim 19, wherein the modular handle controller further comprises a slip ring.

25. The system of claim 1, further comprising a sensor disposed proximate the second motor, the sensor being effective to detect motion, force, or both of the second motor.

26. The system of claim 1, wherein the third motor is coupled to at least one control member.

27. The system of claim 26, wherein the third motor is coupled to the at least one control member through first, second, and third gears, the third gear including a gear extension defining an opening for placement of the at least one control member.

28. The system of claim 1, further comprising a sensor disposed proximate to the third motor, the sensor being effective to detect motion, force, or both of the third motor.

29. The system of claim 26, wherein the at least one control member is a switch, knob, lever, slider, gear, or button.

30. The system of claim 26, wherein the third motor is coupled to the at least one control member via at least one gear.

31. The system of claim 30, wherein the third motor is coupled to the at least one control member via first, second, and third gears, the third gear including a gear extension that defines an opening for the knob.

32. The system of claim 1, wherein the control unit is wirelessly coupled to the first, second, and third motors.

33. The system of claim 1, wherein the control unit comprises independent controllers for the first, second, and third motors.