Patent Description:
Generally, a normal heartbeat involves a generation of an electrical impulse by a sinoatrial node in the right atrium that propagates through the atrium chambers causing the atrium chambers to contract and pump blood into the ventricular chambers. The electrical pulse further propagates from the atrium chambers to an atrioventricular node of the heart located between the atrium and ventricular chambers causing the ventricular chamber to fill with blood, and the further propagates from the atrioventricular node to the ventricular chambers causing the ventricular chambers to contract and pump blood through the blood vessels.

Atrial fibrillation is an abnormal heart rhythm whereby the regular electrical impulses generated by the sinoatrial node are overwhelmed by abnormal electrical impulses propagating from the upper chambers to the lower chambers resulting in an uncoordinated rhythm between the atrium and ventricular chambers. The Cox-Maze procedure as known in the art is a surgical procedure to treat atrial fibrillation by an ablation of the atrium chambers in a maze like pattern to block the irregular electrical impulses.

In a traditional Cox-Maze procedure, a sternotomy and rib spreading is required to access the atrium of the heart. Due to invasiveness of this procedure, traditional Cox-Maze procedure is rarely performed as a stand-alone treatment, and is usually done adjacent to other heart procedures, such as bypass or valve surgery. Minimally invasive procedures are designed to allow stand-alone Cox-Maze. However, due to the maze-like path of traditional rigid instruments, current implementation of a minimally invasive Cox-Maze procedure usually requires six (<NUM>) ports between the ribs due to complexity of ablation instrument path on the heart. Moreover, any robotic based minimally invasive Cox-Maze procedure involves human operation of the robot. <CIT>, <CIT>, <CIT>, <CIT> and <CIT> disclose relevant prior art.

The present disclosure provides systems utilizing an image guided dexterous robot for autonomously performing single-port minimally invasive procedures within an anatomical region (e.g., a thoracic region, a cranial region, an abdominal region, a dorsal region or a lumbar region), particularly an X-ray guided robot for autonomously performing a single-port minimally invasive Cox-Maze procedure within the thoracic region.

One form of the present disclosure is a robotic surgical system for executing a procedural treatment of an anatomical structure within an anatomical region (e.g., a minimally invasive Cox-Maze ablation procedure of a heart within the thoracic region).

The robotic surgical system employs a treatment catheter (e.g., a thermoablation catheter or a cyroablation catheter), and an articulated robot including a plurality of linkages and one or more joints interconnecting the linkages. The articulated robot is for navigating the treatment catheter within the anatomical region.

The robotic surgical system further employs a robot controller for controlling a navigation by the articulated robot of the treatment catheter along a navigation by the articulated robot of the treatment catheter along an intraoperative treatment path within the anatomical region relative to the anatomical structure derived from a planned treatment path within the anatomical region relative to the anatomical structure based on a registration between the articulated robot and a preoperative image illustrative of the planned treatment path within the anatomical region relative to the anatomical structure.

Further, the articulated robot may be structurally designed to alternatively or concurrently navigate the treatment catheter and a camera catheter within the anatomical region.

An unclaimed form of the present disclosure is a robotic surgical method for executing the procedural treatment of the anatomical structure within the anatomical region (e.g., a minimally invasive Cox-Maze ablation procedure of a heart within the thoracic region).

The robotic surgical method involves an imaging controller controlling an image registration between the preoperative image (e.g., a CT, MRI or US image of the thoracic region) and the articulated robot, wherein the preoperative image is illustrative a planned treatment path within an anatomical region relative to the anatomical structure.

Based on the registration by the imaging controller between the preoperative image and the articulated robot, the robotic surgical method further involves a robot controller controlling a navigation by the articulated robot of the treatment catheter along a intraoperative treatment path within the anatomical region relative to the anatomical structure derived from a planned treatment path within the anatomical region relative to the anatomical structure.

For purposes of the systems of the present disclosure, terms of the art including, but not limited to, "treatment catheter", "camera catheter", "autonomous control", "image registration", "imaging modality", "preoperative image" and "intraoperative image" are to be interpreted as understood in the art of the present disclosure and as exemplary described herein.

For purposes of the systems of the term "planned treatment path" broadly encompasses a delineation of a path for the treatment catheter within a preoperative image of an anatomical region for executing a planned treatment of an anatomical structure (e.g., a path planning for a minimally invasive Cox-Maze ablation procedure of a heart within the thoracic region as illustrated within the preoperative CT, MRI or US image), and the term "intraoperative treatment path" broadly encompasses a delineation of a path for the treatment catheter within the anatomical region for implementing the planned treatment path as controlled by the articulated robot.

For purposes of the systems of the present disclosure, the term "articulated robot" broadly encompasses any robotic device structurally configured, entirely or partially, with motorized control of one or more joints (e.g., a pivot joint) serially connected with rigid linkages including a proximal linkage, a distal linkage and optionally one or more intermediate linkages.

For purposes of the systems of the present disclosure, the term "controller" broadly encompasses all structural configurations of an application specific main board or an application specific integrated circuit housed within or linked to a workstation for controlling an application of various inventive principles of the present disclosure as subsequently described herein. The structural configuration of the controller may include, but is not limited to, processor(s), computer-usable/computer readable storage medium(s), an operating system, application module(s), peripheral device controller(s), slot(s) and port(s).

Examples of the workstation include, but are not limited to, an assembly of one or more computing devices (e.g., a client computer, a desktop and a tablet), a display/monitor, and one or more input devices (e.g., a keyboard, joysticks and mouse).

For purposes of the systems of the present disclosure, the term "application module" broadly encompasses a component of the controller consisting of an electronic circuit and/or an executable program (e.g., executable software and/firmware) for executing a specific application.

For purposes of the systems of the present disclosure, any descriptive labeling of the a controller herein (e.g., a "robot" controller and an "imaging" controller) serves to identify a particular controller as described and claimed herein without specifying or implying any additional limitation to the term "controller".

Similarly, for purposes of the systems of the present disclosure, any descriptive labeling of an application module herein (e.g., a "path planning control" module, a "registration control" module, a "transformation control" module, and an "image feedback control" module) serves to identify a particular application module as described and claimed herein without specifying or implying any additional limitation to the term "application module".

The foregoing forms and other forms of the present disclosure as well as various features and advantages of the present disclosure will become further apparent from the following detailed description of various embodiments of the present disclosure read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the present disclosure rather than limiting, the scope of the present disclosure being defined by the appended claims and equivalents thereof.

To facilitate an understanding of the present disclosure, the following description of <FIG>, teaches basic inventive principles of an image guidance based autonomous control of an articulated robot <NUM> for performing a single-port minimally invasive Cox-Maze procedure on a patient <NUM> involving a treatment catheter in the form of an ablation catheter. From this description, those having ordinary skill in the art will appreciate how to apply the inventive principles of the present disclosure to various single-port minimally invasive treatment procedures incorporating image guidance based autonomous control of an articulated robot involving any type of treatment catheter.

Referring to <FIG>, a preoperative phase of the minimally invasive Cox-Maze procedure involves a preoperative imaging controller 22a controlling a generation by a preoperative imaging modality 20a (e.g., a CT, MRI or US imaging modality) as known in the art of a preoperative image 21a illustrative of a heart <NUM> within a thoracic region of patient <NUM>. During the preoperative phase, preoperative imaging controller 22a further controls a display as known in the art of preoperative image 21a of heart <NUM> on a monitor 23a for diagnostic purposes, particularly for delineating a planned ablation path traversing heart <NUM> within preoperative image 21a.

Still referring to <FIG>, an intraoperative phase of the minimally invasive Cox-Maze procedure involves a single-port incision <NUM> into the thoracic region of patient <NUM> (e.g., between the ribs or subxypoid) whereby a robot controller <NUM> may autonomously control a navigation by an articulated robot <NUM> of an ablation catheter <NUM> within the thoracic region of patient <NUM> in accordance with the preoperative planned ablation path traversing heart <NUM>. In practice, articulated robot <NUM> may support a navigation of a camera catheter <NUM> alternatively or concurrently with ablation catheter <NUM>.

To execute the procedural ablation of heart <NUM> as planned, articulated robot <NUM> must be registered to preoperative image 21a. To this end, articulated robot <NUM> supporting ablation catheter <NUM> (and optionally camera catheter <NUM>) is manually or robotically inserted via a robot controller <NUM> within the thoracic region of patient <NUM> adjacent heart <NUM> whereby an intraoperative imaging controller 22b controls a generation by an intraoperative imaging modality 20b (e.g., an X-ray or endoscopic imaging modality) as known in the art of an intraoperative image 21b illustrative of articulated robot <NUM> relative to heart <NUM> within the thoracic region of patient <NUM>. If camera catheter <NUM> is deployed via articulated robot <NUM>, then a camera catheter controller <NUM> controls a display an endoscopic video view of heart <NUM> via camera catheter <NUM> on monitor 23b or an additional monitor 23c as known in the art for positioning purposes of articulated robot <NUM> relative to heart <NUM> of patient <NUM> and/or for registration purposes of preoperative image 21a and intraoperative image 21b.

The registration of articulated robot <NUM> to preoperative image 21a is accomplished by one of the controllers 22a, 22b or <NUM> in accordance with the following equation [<NUM>]: <MAT>.

A more detailed exemplary description of a registration of articulated robot <NUM> to preoperative image 21a will be provided herein with the description of <FIG>.

Still referring to <FIG>, upon the registration, robot controller <NUM> is capable of autonomously controlling a navigation by articulated robot <NUM> of ablation catheter <NUM> within the thoracic region of patient <NUM> in accordance with the ablation path traversing heart <NUM> as planned during the preoperative phase. In practice, ablation catheter <NUM> may be a cyroablation catheter or a thermoablation catheter whereby an appropriate energy source (not shown) is controlled by an ablation catheter controller <NUM> to provide ablation catheter <NUM> with a specified degree of energy to perform the desired ablation of heart <NUM> as ablation catheter <NUM> is traversed across <NUM>. During the ablation, preoperative imaging controller 22a or intraoperative imaging controller 22b controls a display of a virtual navigation of ablation catheter <NUM> within preoperative image 21a of heart <NUM> as known in the art for surgical feedback purposes.

Upon completion, the execution of the Cox-Maze procedure as shown in <FIG> results in an ablation of heart <NUM> that impedes any future occurrences of an atrial fibrillation of heart <NUM>.

In practice, preoperative imaging modality 20a and intraoperative imaging modality 20b may or may not be the same type of imaging modality.

Also in practice, the controllers of <FIG> may be installed within a single workstation or distributed across multiple workstations.

For example, <FIG> illustrates a preoperative imaging workstation <NUM> having preoperative imaging controller 22a installed therein for CT, MRI or US imaging, and an intraoperative imaging workstation <NUM> having intraoperative imaging controller 22b installed therein for X-ray or endoscopic imaging. <FIG> further illustrates a surgical robot workstation <NUM> having ablation catheter controller <NUM>, robot controller <NUM> and camera catheter controller <NUM> installed therein for autonomously executing the Cox-Maze procedure under image guidance.

Also by example, <FIG> illustrates an imaging workstation <NUM> having both preoperative imaging controller 22a and intraoperative imaging controller 22b installed therein for the same type of imaging or different types of imaging. <FIG> further illustrates surgical robot workstation <NUM> for autonomously executing the Cox-Maze procedure under image guidance.

By further example, <FIG> illustrates a surgical workstation <NUM> having all controllers of <FIG> installed therein for the same type of imaging or different types of imaging and for autonomously executing the Cox-Maze procedure under image guidance.

To facilitate a further understanding of the present disclosure, the following description of <FIG>, teaches basic inventive principles of an articulated robot. From this description, those having ordinary skill in the art will appreciate how to apply the inventive principles of the present disclosure to any type of articulated robot suitable for a single-port minimally invasive procedure.

Generally, an articulated robot of the present disclosure employs a proximal linkage, a distal linkage and optionally one or more intermediate linkages. The articulated robot further includes joints interconnecting the linkages in a complete or partial serial arrangement, and controllable by the robot controller.

In practice, joint may be any type of pivot joint including, but not limited to, a ball and socket j oint, a hinge j oint, a condyloid joint, a saddle j oint and a rotary joint.

Also in practice, each joint may be equipped with a motor for controlling a pose of each linkage, and/or a position sensor of any type (e.g., an encoder) for generating pose data informative of a pose (i.e., orientation and/or location) of the distal linkage relative to the proximal linkage.

For example, referring to <FIG>, an articulated robot 40a employs a proximal linkage 41p and a distal linkage 41d interconnected by a motorized pivot joint 42a equipped with a rotary encoder (not shown) to generate an encoded signal ESP informative of an angular orientation between proximal linkage 41p and distal linkage 41d. <FIG> illustrates a <NUM>o angular orientation between proximal linkage 41p and distal linkage 41d, and <FIG> illustrates an approximate <NUM>o angular orientation between proximal linkage 41p and distal linkage 41d. Given the single pivot joint 42a, the angular orientation between proximal linkage 41p and distal linkage 41d is informative of a pose (i.e., orientation and/or location) of distal linkage 41d relative to proximal linkage 41p.

By further example, referring to <FIG>, an articulated robot 40b further employs a pair of intermediate linkages 43a and 43b between proximal linkage 41p and distal linkage 41d with all linkages <NUM> and <NUM> being interconnected by motorized pivot joint 42b-42d equipped with rotary encoders (not shown) to generate encoded signals ESP1-ESP3 collectively informative of a pose (i.e., orientation and/or location) of distal linkage 41d relative to proximal linkage 41p.

Also in practice, an articulated art of the present disclosure may have a static connection to a robot platform for maintaining a stationary positon of the proximal linkage, or alternatively employs a pivot base, for connection to the robot platform that enables a manual or robotic control of a pivotal motion of the proximal linkage relative to the robot platform.

For example, referring to <FIG>, an articulated robot 40c is a version of articulated robot 40a (<FIG>) further employing a motorized pivot base <NUM> connectable to a robot platform (not shown), and connected to proximal linkage 41p by a motorized pivot joint <NUM> equipped with a rotary encoder (not shown) to generate an encoded signal ESB informative of an angular orientation between proximal linkage 41p and the robot platform.

By further example, referring to <FIG>, an articulated robot 40d is a version of articulated robot 40b (<FIG>) further employing motorized pivot base <NUM> connectable to a robot platform (not shown), and connected to proximal linkage 41p by motorized pivot joint <NUM> equipped with a rotary encoder (not shown) to generate an encoded signal ESB informative of an angular orientation between proximal linkage 41p and the robot platform.

Also in practice, the linkages of an articulated robot of the present disclosure may be structurally designed with one or more internal and/or external channels for an ablation catheter and/or a camera catheter.

For example, <FIG> illustrates a single internal channel <NUM> extending through linkages <NUM> of articulated robot 40a shown in <FIG>. For this channel embodiment, during the procedure, a camera catheter is first extended through channel <NUM> of linkages <NUM> and aligned with a distal tip of articulated robot 40a for imaging purposes when initially inserting articulated robot 40a within the anatomical region. Thereafter, for the ablation procedure, an ablation catheter is extended through channel <NUM> of linkages <NUM> and aligned with the distal tip of articulated robot 40a for ablation purposes as articulated robot 40a is traversed across the anatomical structure.

By further example, <FIG> illustrates a pair of internal channels <NUM> and <NUM> extending through linkages <NUM> of articulated robot 40a shown in <FIG>. For this channel embodiment, during the procedure, a camera catheter and an ablation catheter are simultaneously extended respectively through channels <NUM> and <NUM> for the aforementioned imaging and ablation purposes.

To facilitate a further understanding of the present disclosure, the following description of <FIG> and <FIG>, teaches basic inventive principles of a robotic surgical method of the present disclosure. From this description, those having ordinary skill in the art will appreciate how to apply the inventive principles of the present disclosure to for any type of single-port minimally invasive procedure.

Referring to <FIG>, a flowchart <NUM> representative of a robotic surgical method of the present disclosure involves a stage S72 for preoperative planning, a stage S74 for intraoperative preparation and a stage S76 for intraoperative ablation.

Specifically, stage S72 of flowchart <NUM> encompasses a preoperative diagnostic scan of the patient, an outlining of an anatomical structure within the anatomical region, and a defining of a planned ablation path traversing the outlined anatomical structure.

For example, <FIG> illustrates a preoperative image 21a of a heart <NUM> of a patient <NUM> generated by a preoperative imaging modality 20a as controlled by preoperative imaging controller 22a. For stage S72, the raw data of preoperative image 21a is loaded into a path planning control module <NUM> as shown in <FIG> whereby the raw data of preoperative image 21a is converted into a 3D working model <NUM> of heart <NUM> having a rear perspective view of a superior vena cava ("SVC"), an inferior vena cava ("IVC"), mitral valve ("MV") and left atrial appendage ("LAA"), and further whereby a surgeon may interact with path planning control module <NUM> to define a planned ablation path symbolically shown as dashed lines traversing model <NUM> of heart <NUM>.

In practice, path planning control module <NUM> may implement any virtual planning technique known in the art that is suitable for the particular type of minimally invasive procedure being performed.

Also in practice, path planning control module <NUM> may be an application module of preoperative imaging controller 22a, intraoperative imaging controller 22b or robot controller <NUM>.

Referring back to <FIG>, a stage S74 of flowchart <NUM> encompasses a registration of the articulated robot to the intraoperative image, an intraoperative imaging of the articulated robot as inserted into the patient, a registration of the intraoperative-preoperative images, and a transformation of the planned ablation path into an intraoperative ablation path.

For example, a registration control module <NUM> is utilized to calculate a transformation ITR of articulated robot <NUM> as held by a robot platform <NUM> to intraoperative image 21b. In practice, registration control module <NUM> may implement any known registration technique suitable for articulated robot <NUM>.

Subsequently, articulated robot <NUM> is inserted within patient <NUM> and positioned relative to heart <NUM> as previously described herein to facilitate a generation of intraoperative image 21b of articulated robot <NUM> relative to heart <NUM>. In particular, for X-ray imaging, multiple X-ray images are loaded into registration control module <NUM> for a 3D reconstruction of intraoperative image 21b to enable an identification by registration control module <NUM> of articulated robot <NUM> relative to heart <NUM>. In practice, a distal linkage and the most distal pivot joint of articulated robot <NUM> should be illustrated in intraoperative image 21b to facilitate the identification of articulated robot <NUM> relative to heart <NUM>.

From a heart identification within preoperative image 21a and intraoperative image 21b, registration control module <NUM> calculates a transformation PTI of intraoperative image 21b to preoperative image 21a. In practice, registration control module <NUM> may implement any known identification/registration techniques suitable for such a registration.

Also in practice, registration control module <NUM> may be an application module of preoperative imaging controller 22a, intraoperative imaging controller 22b and robot controller <NUM>, or distributed between preoperative imaging controller 22a, intraoperative imaging controller 22b and robot controller <NUM>.

From the calculated of intraoperative image 21b to preoperative image 21a, registration control module <NUM> calculates a transformation PTR of articulated robot to preoperative image 21a in accordance with the equation [<NUM>]: <MAT>.

From the calculated transformation PTR of articulated robot to preoperative image 21a, a transformation control module <NUM> as shown in <FIG> transforms the virtual planned path into an intraoperative ablation path <NUM> within the robotic coordinate system.

In practice, transformation control module <NUM> may implement any known transformation technique as known in the art suitable for articulated robot <NUM>. Also in practice, transformation control module <NUM> may be an application module of preoperative imaging controller 22a, intraoperative imaging controller 22b or robot controller <NUM>.

Referring back to <FIG>, a stage S76 of flowchart <NUM> encompasses an autonomous control by the robot controller of the ablation catheter within the anatomical region based on the intraoperative ablation path of stage S74, and a display of a virtual navigation feedback of the ablation catheter traversing the anatomical structure via the intraoperative ablation path.

For example, robot controller <NUM> of <FIG> executes a servo control of the motorized pivot joints of articulated robot <NUM> in accordance with the intraoperative ablation path shown in <FIG>, and an image feedback control module <NUM> controls a display of a virtual articulated robot <NUM> traversing a working model <NUM> of preoperative image volume 21a.

Referring back to <FIG>, flowchart <NUM> is terminated upon a completion of the path or any of the stages S72-<NUM> may be repeated to any degree as necessary.

Referring to <FIG>, those having ordinary skill in the art will appreciate numerous benefits of the present disclosure including, but not limited to the robotic approach to a single port minimally invasive procedure, particularly a minimally invasive Cox-Maze procedure.

Furthermore, as one having ordinary skill in the art will appreciate in view of the teachings provided herein, features, elements, components, etc. described in the present disclosure/specification and/or depicted in the <FIG> may be implemented in various combinations of electronic components/circuitry, hardware, executable software and executable firmware and provide functions which may be combined in a single element or multiple elements. For example, the functions of the various features, elements, components, etc. shown/illustrated/depicted in the <FIG> can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared and/or multiplexed. Moreover, explicit use of the term "processor" should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor ("DSP") hardware, memory (e.g., read only memory ("ROM") for storing software, random access memory ("RAM"), non-volatile storage, etc.) and virtually any means and/or machine (including hardware, software, firmware, circuitry, combinations thereof, etc.) which is capable of (and/or configurable) to perform and/or control a process.

Furthermore, exemplary embodiments of the present disclosure can take the form of a computer program product or application module accessible from a computer-usable and/or computer-readable storage medium providing program code and/or instructions for use by or in connection with, e.g., a computer or any instruction execution system. In accordance with the present disclosure, a computer-usable or computer readable storage medium can be any apparatus that can, e.g., include, store, communicate, propagate or transport the program for use by or in connection with the instruction execution system, apparatus or device. Such exemplary medium can be, e.g., an electronic, magnetic, optical, electromagnetic, infrared or semiconductor system (or apparatus or device) or a propagation medium. Examples of a computer-readable medium include, e.g., a semiconductor or solid state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), flash (drive), a rigid magnetic disk and an optical disk. Current examples of optical disks include compact disk - read only memory (CD-ROM), compact disk - read/write (CD-R/W) and DVD. Further, it should be understood that any new computer-readable medium which may hereafter be developed should also be considered as computer-readable medium as may be used or referred to in accordance with exemplary embodiments of the present disclosure and disclosure.

Having described preferred and exemplary embodiments of single-port image guided minimally invasive procedures, particularly for minimally invasive Cox-Maze procedures (which embodiments are intended to be illustrative and not limiting), it is noted that modifications and variations can be made by persons having ordinary skill in the art in light of the teachings provided herein, including the <FIG>. It is therefore to be understood that changes can be made in/to the preferred and exemplary embodiments of the present disclosure which are within the scope of the embodiments disclosed herein.

Claim 1:
A robotic surgical system for executing a procedural treatment of an anatomical structure within an anatomical region, the robotic surgical system comprising:
a treatment catheter (<NUM>);
an articulated robot (<NUM>) insertable within the anatomical region and operable to navigate the treatment catheter (<NUM>) within the anatomical region,
wherein the articulated robot (<NUM>) includes a plurality of linkages and at least one joint interconnecting the plurality of linkages;
a registration control module operable, responsive to a reception of the preoperative image (21a) and a reception of an intraoperative image (21b) registered to the articulated robot (<NUM>), to control an image registration between the preoperative image (21a) and the intraoperative image (21b) based on a delineation of the anatomical structure as illustrated within the preoperative image (21a) and the intraoperative image (21b);
a transformation control module operable, responsive to the image registration between the preoperative image (21a) and the intraoperative image (21b), to control a transformation of a planned treatment path relative to the anatomical structure as illustrated within the preoperative image (21a) into an intraoperative treatment path within the anatomical region relative to the anatomical structure; and
a robot controller (<NUM>) operable in communication with the at least one joint to control a navigation by the articulated robot (<NUM>) of the treatment catheter (<NUM>) along the intraoperative treatment path within the anatomical region relative to the anatomical structure derived from the planned treatment path within the anatomical region relative to the anatomical structure based on the registration between the intraoperative image (21b) illustrative of the articulated robot (<NUM>) within the anatomical region relative to the anatomical structure and the preoperative image (21a) illustrative of the planned treatment path within the anatomical region relative to the anatomical structure.