a. Field of the Invention
The present invention relates to robotic catheter systems, and more particularly, to improved input devices for controlling movement of catheters and sheaths within a treatment area, such as a cardiac chamber. Input devices according to the present teachings may also be used with other computer-based medical systems, such as simulation systems for training.
b. Background Art
Electrophysiology catheters are used for an ever-increasing number of procedures. For example, catheters have been used for diagnostic, therapeutic, mapping and ablative procedures, to name just a few examples. Typically, a catheter is manipulated through the patient's vasculature to an intended site, for example, a site within the patient's heart, and carries one or more electrodes, which may be used for mapping, ablation, diagnosis, or other treatments.
Traditional techniques of manipulating catheters to, and within, a treatment area typically include a physician manipulating a handle connected to a catheter. The handle generally includes a mechanism directly connected to guide wires for controlling the deflection of a catheter. A second handle is generally provided for controlling deflection of a sheath. Rotating and advancing a catheter or sheath generally requires an electrophysiologist (EP) to physically rotate and advance the associated handle.
Recently, catheter systems have been developed that work in concert with visualization/mapping systems, such as the NavX™ or EnSite™ systems commercialized by St. Jude Medical, Inc. However, conventional systems still generally involve an EP manually controlling a catheter and sheath system, and associated visualization systems typically reactively monitor catheter movement.
Systems are provided for receiving user inputs and providing signals representative of the user inputs to a catheter system, which may be a robotic catheter system. An embodiment of a robotic catheter system (also referred to as “the system”) may be used, for example, to manipulate the location and orientation of sheaths and catheters in a heart chamber or in another body portion. The system may incorporate a human input device, e.g., a joystick, configured for interaction with a user; an electronic control system that translates motion of the user at the input device into a resulting movement of a catheter tip; and a visualization device that provides a user with real-time or near-real-time positioning information concerning the catheter tip. The system may provide the user with a similar type of control provided by a conventional manual system, and allow for repeatable, precise, and dynamic movements. The input system may thus provide a user, such as an electrophysiologist, with an input device that mimics a device the user already understands and is familiar with.
In an embodiment, the input device includes a first handle and a second handle. The first handle and the second handle may be aligned coaxially along a shaft. The handles may include selector switches, dials or buttons such as, for example, slider switches or thumb wheels, which may be configured to control movement of the catheter and the sheath. Handles may be longitudinally displaceable along a shaft, and may be configured such that longitudinal displacement of a shaft results in a longitudinal displacement of the associated catheter/sheath. In an embodiment, the input device may include a single handle configured to control the sheath and catheter, either together or independently. In embodiments, the input device may include a selector mechanism, such as a three position switch, through which a user may selectively control the catheter, the sheath, or both the catheter and sheath.
In an embodiment, an input device may include one or more indicators configured to provide an indication to a user concerning whether a catheter, a sheath, or both a catheter and a sheath, are selected for control. For example, input devices may include an LED indicator (e.g., a white LED) to indicate a catheter is selected for control, and another LED (e.g., a blue LED) to indicate a sheath is selected for control.
In an embodiment, an input device may include a device control switch that must be activated before the user input will transmit signals indicative of user inputs. For example, a system in communication with an input device may be configured to accept inputs from user input device only when a device control switch is activated.
A system according to the present teachings may be configured to receive the inputs from the user input control, and to transmit the user inputs to a robotic catheter system configured to cause corresponding motion of a catheter system.
Referring now to the drawings wherein like reference numerals are used to identify like components in the various views, an embodiment of a robotic catheter system 10 (described in detail in co-pending application titled “Robotic Catheter System” filed Sep. 24, 2008, hereby incorporated herein by reference in its entirety), also referred to as “the system,” is illustrated. The system 10 may be used, for example, to manipulate the location and orientation of catheters and sheaths in a treatment area, such as within a heart chamber or another body cavity. As generally illustrated in
Input control system 100 may permit a user to control the movement and advancement of both a catheter and sheath. Generally, several types of input devices may be employed. The subject input devices of this teaching include, without limitation, instrumented catheter handle controls which may comprise one or more joysticks generally resembling traditional catheter controls. In embodiments, for example and without limitation, the input device may be self-centering, so that a movement from the center position causes an incremental movement of the actual catheter tip. Alternatively, the input device may work in absolute terms. Haptic feedback may also be employed in connection with the input device or input control system 100 to provide a user with a physical indication associated with contact (e.g., an indication when contact has been made). By way of example, and without limitation, haptic feedback may include heating or cooling a handle of the input device (e.g., to provide a user with an indication as to electrode temperature); vibrating a handle (e.g., to indicate contact with tissue); and/or providing resistance to movement of the input device. In addition to being indicative of contact, haptic feedback may also be employed to represent physical limitations of a device. For example, haptic feedback may be provided to indicate that a catheter or sheath has reached the end of available translation, achieved a maximum deflection, and/or to indicate another physical property of an associated medical device. In an embodiment, vibrating a handle, or providing resistance to movement, may be implemented using one or more motors coupled or in operative communication with a handle.
Many additional features may be included with the system 10, which may be used to help improve the accuracy and/or effectiveness of the system. Such features may include providing feedback using a visualization system 12, employing a magnetic positioning system, (e.g., for creating cardiac chamber geometries or models), displaying activation timing and voltage data, etc. Such features may be useful to, e.g., identify arrhythmias, guide precise movement of catheters or optical force transducers, etc. Additional features may include active tensioning of “passive” steering wires to reduce the system response time; cumulative ablation while an electrode tip is following a front-to-back ironing motion; and/or reactive/resistive impedance monitoring.
System 10 may include visualization system 12 which may provide a user with real-time or near-real-time positioning information concerning the catheter tip. In an exemplary embodiment, system 12 may include a monitor 16 for displaying cardiac chamber geometries or models, displaying activation timing and voltage data to identify arrhythmias, and for facilitating guidance of catheter movement. A fluoroscopy monitor 18 may be provided for displaying a real-time x-ray image for assisting a physician with catheter movement. Additional exemplary displays may include an Intracardiac Echo (“ICE”) and EP Pruka displays, 20, 22, respectively.
Referring further to
As generally shown in
Robotic catheter manipulator assembly 300 may be usable with a robotic catheter rotatable device cartridge. Manipulator base may be replaced with a robotic catheter rotatable drive head and a robotic catheter rotatable drive mechanism.
As briefly discussed above, robotic catheter system 10 may include one or more cartridges 400, with manipulator 300 including at least two cartridges, each of which may be configured to control the distal movement of either the catheter or the sheath. With respect to a catheter cartridge, a catheter may be substantially connected or affixed to the cartridge, so that advancement of the cartridge correspondingly advances the catheter, and retraction of the cartridge retracts the catheter. Each cartridge may, for example, include slider blocks rigidly and independently coupled to one of a plurality of catheter steering wires in a manner to permit independent tensioning of each steering wire. The cartridge may be provided as a disposable item that is capable of being easily positioned (e.g., snapped) into place in an overall assembly. In an embodiment, the cartridge may include an electrical “handshake” device or component to allow the system 10 to properly identify the cartridge (e.g., by type and/or proper placement/positioning). A sheath cartridge may be designed in a similar manner as the catheter cartridge, but may be configured to provide for the passage of a catheter. The assembly may include a plurality (e.g., as many as ten or more) of independent driving mechanisms (e.g. motor driven ball screws).
Robotic catheter system 10 may be useful for a variety of procedures and in connection with a variety of tools and/or catheters. Such tools and/or catheters may include, without limitation, spiral catheters, ablation catheters, mapping catheters, balloon catheters, transseptal catheters, needle/dilator tools, cutting tools, cauterizing tools, and/or gripping tools. The system 10 may additionally include a means of identifying the nature and/or type of catheter/tool cartridge that is installed for use, and/or position or connection related information. It may also be desirable for the system 10 to automatically access/obtain additional information about the cartridge, such as, without limitation, its creation date, serial number, sterilization date, prior uses, etc.
Handle 102 may also include a switch 112, which may, for example, comprise a three-position switch. Switch 112 may be configured to provide an input representative of a desired control scheme. For example, switch 112 may have a first position wherein manipulation of handle 102 results in corresponding manipulation of a catheter. Switch 112 may have a second position wherein manipulation of handle 102 results in a corresponding manipulation of a sheath. Switch 112 may also have a third position wherein manipulation of handle 102 results in a corresponding manipulation of both a catheter and a sheath. Selective control, or individual control, of each of a catheter and a sheath may be beneficial in that it may allow for compound movement and bending of the distal tip of the catheter and sheath. Combined control may be beneficial when it is desired that the catheter and the sheath move, for example, in a common direction, or along a common plane.
In the illustrated embodiment, upper portion 118A defines a plurality (in this case a pair) of apertures through which lights 116 may be visible. Lights 116 may be, for example, light emitting diodes (LEDs). A first light 116A may be configured to illuminate when switch 112 is positioned such that handle 102 controls a sheath. A second light 116B may be configured to illuminate when switch 112 is positioned such that handle 102 controls a catheter. In an embodiment, lights 116A, 116B may be configured to illuminate when switch 112 is positioned such that handle 102 controls both a sheath and a catheter. Lights 116A, 116B may be the same color, or may be different colors (e.g., colors associated with the components being controlled). As such, the use of different color lights may be useful in providing a user with contrasting indications of devices selected for control.
Handle 102 may include another switch, such as button 114, which may be embedded in slider switch 110. Button 114 may be configured to provide one or more inputs to control box 104 during operation. In an embodiment, button 114 may be configured to act as a device control switch, such as a dead-man switch. For example, in such an embodiment, if button 114 is not depressed, manipulation of handle 102 will not result in manipulation of an associated catheter or sheath. In another embodiment, button 114 may be configured to perform another function, such as providing an “on” signal for an associated ablation electrode. It is understood that handle 102 may also include one or more other switches (not pictured). A device control switch, or dead man switch, may also be implemented in another manner, such as by an optical relay or a capacitive switch which, when covered, indicates a user intends to manipulate an associated catheter or sheath.
Control box 104 generally includes a number of mechanisms configured to receive inputs from handle 102 and to output those inputs as electrical signals, or outputs. Accordingly, control box 104 generally includes a rotation mechanism 122, a deflection mechanism 124, and a translation mechanism 126. Rotation mechanism 122 is configured to detect and/or measure rotational movement of handle 102. Deflection mechanism 124 is configured to detect and/or measure movement of slider switch 110. Translation mechanism 126 is configured to detect and/or measure translational movement of the handle 102. Control box 104 may also include an interface mechanism 128, which may be configured to transmit and/or receive one or more electrical signals, and/or to provide power to one or more of rotation mechanism 122, deflection mechanism 124, and translation mechanism 126. In another embodiment (not illustrated), slider switch 110 could be replaced with a deflection dial configured to rotate with respect to handle 102. A rotary potentiometer, or other rotary sensor, could detect rotation of the dial and transmit a signal representative of the rotation.
Referring now to
Rotational mechanism 122, as shown in
Motor 132 may be configured to rotate in response to a rotation of spline 106. Rotation of motor 132 may be driven in a direct-drive manner, without any intermediate gearing or reduction of power or speed. That is, rotation of motor 132 may be directly resultant from a rotation of spline 106. Alternatively, rotation of motor 132 may be indirect, such as through belt 134, rotational potentiometer 136, and/or hub 137. When rotated, rotational potentiometer 136 may be configured to transmit a signal to, for example, a controller (not pictured) or an electronic interface, such as interface mechanism 128. The controller, or interface mechanism 128, may receive the signal from rotational potentiometer 136 and may determine one or more properties of the rotation. For example, the angle of rotation may be determined based on the number of counts received by a controller, or a voltage change of a potentiometer, and the speed of rotation could be determined by computing the time derivative of the calculated position.
In an embodiment, motor 132 may be configured to cause rotational movement of spline 106. For example, the system may include a self-centering feature, wherein spline 106, and handle 102, may return to a home position, as if connected to a torsional spring. Motor 132 may be configured to receive a signal from a controller, such as interface mechanism 128, which may cause motor 132 to return spline 106 to the home position.
Deflection mechanism 124, as generally illustrated in
Translation mechanism 126, as generally illustrated in
Deflection mechanism 124 and translation mechanism 126 may be mounted to respective bases, 140, 142. In an embodiment, deflection base 140 may be configured to interact with translation base 142, for example, as further described below. As illustrated in
In an embodiment, as illustrated in
As illustrated, for example, in
Each of the belts 150A, 150B may be configured to couple deflection mechanism 124 and translation mechanism 126 to respective motors 162A, 162B. In an embodiment, motors 162A, 162B may be coupled with an associated controller, and/or may be connected to interface mechanism 128. Motors 162A, 162B may transmit signals representative of motion induced on the motor, such as by induction mechanism 124 or translation mechanism 126. Additionally, or alternatively, motors 162A and 162B may be configured to induce motion of respective mechanisms 124, 126. For example, the system may be equipped with a self centering feature. Motor 162A may be configured to receive signals from an interface, such as interface mechanism 128, and to induce motion in deflection mechanism 124 to return deflection mechanism 124 to an initial or a centered state. “Centered state” may refer to the geometric center of the available motion of the deflection slider switch 110. “Centered state” may, additionally or alternatively, refer to a preset position or state programmable prior to, or during, a procedure. Similarly, motor 162B may be configured to receive position signals, and to return translation mechanism 126, and the associated spline 106, to a centered state.
In an embodiment, handle 102A may be configured to control a catheter, and handle 102B may be configured to control a sheath. In such an embodiment, handles 102A, 102B may be configured to move independently. Slider switch 110A may be configured to control deflection of an associated catheter, and slider switch 110B may be configured to control deflection of an associated sheath.
In an embodiment, handles, such as handle 102, 102A, 102B, may be configured to be removable and replaceable. For example, a first user may prefer a handle 102 having a slider switch 110 to control deflection. A second user may prefer a handle 102 having a dial switch (not pictured) to control deflection. A handle 102 may be configured to be easily removed and replaced with a handle including varying methods of providing input.
Control box 104 may be coupled to a base 121 via one or more rotary couplers 123. Rotary couplers 123 may be selectively adjustable to allow changing of the angle of control box 104. Base 121 may include an emergency stop button 125, which may be configured to, e.g., retract an associated medical device, such as a catheter and/or sheath, or to remove ablation energy from an ablation catheter. Base 121 may further include one or more switches 127, which may be selectively assignable by a user.
Input device 101 may be configured such that control arms 133, and associated elements, may be configured to provide force feedback to a user. For example, motors, sensors, and/or controllers may be coupled to one or more of sections 135 of arms 133 to induce, assist or resist motion in a particular direction. Multiple motors, sensors, controllers, etc., may work in concert to induce, assist, or resist motion in a spherical manner. Moreover, input device 101 may be configured such that one or more of control arms 133, and/or one or more of sections 135, may be selectively lockable. For example, motor 141 may selectively power, or lock one or more of motors 141 to restrict handle motion 102. In an embodiment, input device 101 may restrict handle 102 motion to a particular plane, such as an x-y plane, or may, for example, prevent motion within the x-y plane while allowing handle 102 to translate and rotate on an axis, such as the Z-axis. In another embodiment, input device 101 may be configured to lock rotation along an axis, such as the Z-axis, while allowing handle 102 otherwise unrestricted movement.
Although embodiments of this invention have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this invention. For example, while embodiments have been described using potentiometers, it is to be understood that additional embodiment could include other types of sensors and encoders including, without limitation, absolute position encoders, relative position encoders, optical encoders, linear encoders, linear actuators, and linear variable differential transformers. All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present invention, and do not create limitations, particularly as to the position, orientation, or use of the invention. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims.
This application is a continuation of U.S. application Ser. No. 12/933,063, filed 16 Sep. 2010, which is a national stage filing and claims priority to international application no. PCT/US2009/038618, filed 27 Mar. 2009, which claims the benefit of U.S. provisional application Nos. 61/040,141, filed 27 Mar. 2008; 61/040,142, filed 27 Mar. 2008; 61/040,143, filed 27 Mar. 2008; 61/099,904, filed 24 Sep. 2008; and 61/141,971, filed 31 Dec. 2008, the entire disclosures of which are hereby incorporated by reference as though fully set forth herein.
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| 2008103212 | Aug 2008 | WO |
| 2008101228 | Aug 2008 | WO |
| 2009120940 | Oct 2009 | WO |
| 2009120982 | Oct 2009 | WO |
| 2009120992 | Oct 2009 | WO |
| 2010025338 | Mar 2010 | WO |
| 2010059179 | May 2010 | WO |
| 2010068783 | Jun 2010 | WO |
| 2010107916 | Sep 2010 | WO |
| Entry |
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| Number | Date | Country | |
|---|---|---|---|
| 20140194897 A1 | Jul 2014 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12933063 | US | |
| Child | 14151258 | US |